DATA SHEETS
Clinical Trials Data
CT Canada - MDMA
CT Canada - MDMA.xlsx
| Title | Status | Study Results | Conditions | Outcome Measures | Sponsor/Collaborators |
|---|---|---|---|---|---|
| A MULTI-SITE OPEN-LABEL SAFETY TRIAL | Completed | Published | MDMA-ASSISTED THERAPY FOR THE TREATMENT OF PARTICIPANTS WITH POSTTRAUMATIC STRESS DISORDER | A MULTI-SITE OPEN-LABEL SAFETY EXTENSION STUDY OF MANUALIZED MDMA-ASSISTED THERAPY FOR THE TREATMENT OF PARTICIPANTS WITH POSTTRAUMATIC STRESS DISORDER | MULTIDISIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES |
| A PHASE 2 OPEN LABEL STUDY OF THE SAFETY AND EFFECTIVENESS OF MDMA-ASSISTED THERAPY FOR PARTICIPANTS WITH POSTTRAUMATIC STRESS DISORDER | Pending | No Results Available | POST-TRAUMATIC STRESS DISORDER | SAFETY AND EFFECTIVENESS OF MDMA-ASSISTED THERAPY FOR PARTICIPANTS WITH POSTTRAUMATIC STRESS DISORDER | MULTIDISIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES |
| A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-SITE PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF MANUALIZED MDMA-ASSISTED PSYCHOTHERAPY FOR THE TREATMENT OF SEVERE POSTTRAUMATIC STRESS DISORDER | Completed | Published | POST-TRAUMATIC STRESS DISORDER | EFFICACY AND SAFETY OF MANUALIZED MDMA-ASSISTED PSYCHOTHERAPY FOR THE TREATMENT OF SEVERE POSTTRAUMATIC STRESS DISORDER | MULTIDISIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES |
| PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF MANUALIZED MDMA-ASSISTED THERAPY | Completed | Published | POST-TRAUMATIC STRESS DISORDER | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-SITE PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF MANUALIZED MDMA-ASSISTED THERAPY FOR THE TREATMENT OF POSTTRAUMATIC STRESS DISORDER OF MODERATE OR GREATER SEVERITY | MULTIDISIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES |
| AN OPEN-LABEL, MULTI-SITE PHASE 2 STUDY OF THE SAFETY AND EFFECT OF MANUALIZED MDMA-ASSISTED PSYCHOTHERAPY | Completed | Published | POST-TRAUMATIC STRESS DISORDER | AN OPEN-LABEL, MULTI-SITE PHASE 2 STUDY OF THE SAFETY AND EFFECT OF MANUALIZED MDMA-ASSISTED PSYCHOTHERAPY FOR THE TREATMENT OF SEVERE POSTTRAUMATIC STRESS DISORDER | MULTIDISIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES |
| PHASE 2 STUDY OF THE SAFETY AND FEASIBILITY OF MDMA-ASSISTED PSYCHOTHERAPY FOR EATING DISORDERS | Pending | No Results Available | MDMA-ASSISTED PSYCHOTHERAPY FOR EATING DISORDERS | AN OPEN-LABEL, MULTI-SITE PHASE 2 STUDY OF THE SAFETY AND FEASIBILITY OF MDMA-ASSISTED PSYCHOTHERAPY FOR EATING DISORDERS | MULTIDISIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES |
| PHASE 2 TREATMENT DEVELOPMENT STUDY OF MDMA-ASSISTED PSYCHOTHERAPY IN CONJUNCTION WITH COGNITIVE PROCESSING THERAPY (CPT) FOR POSTTRAUMATIC STRESS DISORDER (PTSD) | Ongoing | No Results Available | POST-TRAUMATIC STRESS DISORDER | MDMA-ASSISTED PSYCHOTHERAPY IN CONJUNCTION WITH COGNITIVE PROCESSING THERAPY (CPT) FOR POSTTRAUMATIC STRESS DISORDER (PTSD) | MULTIDISIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES |
| MDMA-ASSISTED COGNITIVE-BEHAVIOURAL CONJOINT THERAPY (CBCT) VERSUS CBCT IN DYADS IN WHICH ONE MEMBER HAS POSTTRAUMATIC STRESS DISORDER (PTSD) | Pending | No Results Available | POST-TRAUMATIC STRESS DISORDER | A RANDOMIZED TRIAL OF MDMA-ASSISTED COGNITIVE-BEHAVIOURAL CONJOINT THERAPY (CBCT) VERSUS CBCT IN DYADS IN WHICH ONE MEMBER HAS POSTTRAUMATIC STRESS DISORDER (PTSD) | REMEDY INSTITUTE |
CT Canada - Psilocybin
CT Canada - Psilocybin.xlsx
| Title | Status | Study Results | Conditions | Outcome Measures | Sponsor/Collaborators |
|---|---|---|---|---|---|
| Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder | Active, not recruiting | No Results Available | Treatment Resistant Disorders|Post Traumatic Stress Disorder | Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess|PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)|Subjective distress caused by traumatic events as measured by the Impact of Events Scale Revised (IES-R).|Symptoms of Psychopathology as measured by the Symptom Checklist 90-R (SC90-R).|Symptom severity, treatment response, and the efficacy of treatment studies of patients with mental disorders as measured by the Clinical Global Impression - Improvement (CGI-I)/ Clinical Global Impression - Severity (CGI-S).|Anxiety as measured by the Beck Anxiety Inventory (BAI).|Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).|Depression as measured by the Beck Depression Inventory (BDI).|Depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).|Impairments in daily living as measured by the Sheehan Disability Scale (SDS).|Addiction severity as measured by the Addiction Severity Index (ASI).|Body Mass Index (BMI) | Halucenex Life Sciences Inc.|Everest Clinical Research|KGK Science Inc. |
| Psilocybin for Treatment-Resistant Depression | Active, not recruiting | No Results Available | Treatment Resistant Depression | Feasibility of the study based on participant retention|Feasibility of the study based on suicidal ideation and behaviour scores|Feasibility of the study based on adverse events|Montgomery-Ã…sberg Depression Rating Scale (MADRS) total score|Montgomery-Ã…sberg Depression Rating Scale (MADRS) response rate|Montgomery-Ã…sberg Depression Rating Scale (MADRS) remission rate|McIntyre and Rosenblat Rapid Response Scale (MARRRS)|Patient Health Questionnaire 9-item (PHQ-9)|Clinical Global Impressions Scale (CGI)|Quick Inventory for Depressive Symptomatology, Self-Report, 16-item (QIDS-SR-16)|Columbia Suicide Severity Rating Scale (CSSRS)|Clinician-Administered Dissociative States Scale (CADSS), 23-item|Clinician-Administered Dissociative States Scale (CADSS), 6-item|Brief Psychiatric Rating Scale (BPRS)|Young Mania Rating Scale (YMRS)|Mystical Experiences Questionnaire (MEQ)|Sheehan Disability Scale (SDS)|EuroQol-5D 5-Level (EQ-5D-5L)|World Health Organization-5 Well-Being Index (WHO-5)|World Productivity and Impairment Questionnaire (WPAI)|Perceived Deficits Questionnaire - Depression - 5-Item (PDQ-5-D)|Digit Symbol Substitution Test (DSST)|Trail Making Test A (TMT-A)|Trail Making Test B (TMT-B)|Generalized Anxiety Disorder-7 (GAD-7)|Snaith-Hamilton Pleasure Scale (SHAPS)|Peripheral inflammatory and metabolic biomarkers | Brain and Cognition Discovery Foundation|Braxia Scientific Corp.|Usona Institute |
| Microdosing Psychedelics to Improve Mood | Not yet recruiting | No Results Available | Persistent Depressive Disorder, Dysthymia | Change in Cornell Dysthymia Rating Scale (CDRS)|Change in Patient Health Questionnaire Somatic-Anxiety-Depression | Rotem Petranker|Nikean Foundation|University of Toronto |
| PHASE 2 CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF PSILOCYBIN-ASSISTED PSYCHOTHERAPY IN ADULTS WITH ALCOHOL USE DISORDER (AUD) | Active | No Results Available | ALCOHOL USE DISORDER | A 24-WEEK, MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, PHASE 2 CLINICAL TRIAL TO EVALUATE EFFICACY AND SAFETY OF PSILOCYBIN-ASSISTED PSYCHOTHERAPY IN ADULTS WITH ALCOHOL USE DISORDER (AUD) | CLAIRVOYANT THERAPEUTICS INC. |
| SAFETY, TOLERABILITY AND EFFICACY OF PSILOCYBIN IN ADULTS WITH POST-TRAUMATIC STRESS DISORDER (PTSD) | Active, not recruiting | No Results Available | POST-TRAUMATIC STRESS DISORDER | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFICACY OF PSILOCYBIN IN ADULTS WITH POST-TRAUMATIC STRESS DISORDER (PTSD) | APEX LABS INC. |
| SEROTONIN REUPTAKE INHIBITORS (SSRIS) ON THE RESPONSE TO PSILOCYBIN-ASSISTED THERAPY IN MILD-MODERATE MAJOR DEPRESSIVE DISORDER (MDD) | Active, not recruiting | No Results Available | SSRI and Psilocybin | EVALUATING THE EFFECT OF LENGTH OF TIME ON SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIS) ON THE RESPONSE TO PSILOCYBIN-ASSISTED THERAPY IN INDIVIDUALS WITH MILD-MODERATE MAJOR DEPRESSIVE DISORDER (MDD) | Cybin Inc. |
| NEUROBIOLOGICAL EFFECTS OF PSILOCYBIN IN TREATMENT RESISTANT BIPOLAR DEPRESSION: AN EMOTIONAL-PROCESSING FMRI PILOT STUDY | Active, not recruiting | No Results Available | Bipolar Depression | NEUROBIOLOGICAL EFFECTS OF PSILOCYBIN IN TREATMENT RESISTANT BIPOLAR DEPRESSION: AN EMOTIONAL-PROCESSING FMRI PILOT STUDY | UNIVERSITY HEALTH NETWORK |
| PSILOCYBIN-ASSISTED PSYCHOTHERAPY FOR TAPERING OF OPIOID MEDICATION | Active, not recruiting | No Results Available | Tapering Opioids | STANDARDIZED NATURAL PSILOCYBIN-ASSISTED PSYCHOTHERAPY FOR TAPERING OF OPIOID MEDICATION IN PATIENTS WITH CHRONIC PAIN: AN OPEN-LABEL FEASIBILITY STUDY | PSILO SCIENTIFIC LTD. (Filament) |
| THE SAFETY AND EFFICACY OF PSILOCYBIN IN PARTICIPANTS WITH TREATMENT-RESISTANT DEPRESSION (P-TRD) | Completed | Published | Treatment Resistant Depression | THE SAFETY AND EFFICACY OF PSILOCYBIN IN PARTICIPANTS WITH TREATMENT-RESISTANT DEPRESSION (P-TRD) | Compass |
| N500 Phase II Efficacy of Psilocybin on Burned Out Frontline Healthcare Workers | Active, not recruiting | No Results Available | Anxiety, Deppression and Burned Out Frontline Healthcare Workers From Covid-19 | The primary objective of the trial is to assess the capacity of psilocybin to improve the overall mental health of healthcare providers.As a secondary exploratory objective, participants will complete an assessment of their psilocybin experience to inform the potential utility of psilocybin in a clinical setting from the perspective of a healthcare provider. | ATMA Journey Centers Inc. |
CT World - DMT-5-MEO
CT World - DMT-5-MEO.csv
| Title | Conditions | Interventions | Outcome Measures | Sponsor/Collaborators | Locations |
|---|---|---|---|---|---|
| Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans | Major Depressive Disorder|Depression | Drug: 0.1 mg/kg Dimethyltryptamine (DMT)|Drug: 0.3 mg/kg Dimethyltryptamine (DMT) | Change in Blood Pressure|Change in Heart Rate|Change in Psychedelic Effects|Change in Anxiety|Drug Reinforcing Effects|Overall Tolerability assessed by the VAS | Yale University | Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine, West Haven, Connecticut, United States |
| Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study | Healthy | Drug: N,N-Dimethyltryptamine (54 mg)|Drug: N,N-Dimethyltryptamine (108 mg)|Drug: N,N-Dimethyltryptamine (162 mg)|Drug: N,N-Dimethyltryptamine (216 mg)|Drug: Placebo|Drug: N,N-Dimethyltryptamine (108 mg) + dose titration | Altered states of consciousness profile (5D-ASC)|Subjective effect ratings over time|AMRS|MEQ43|Spiritual Realms Questionnaire|Blood pressure|heart rate|body temperature|Plasma level DMT|Plasma level of oxytocin|Plasma level of cortisol|Plasma level of BDNF|Plasma level of Prolactin|Urine recovery of DMT|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Personality Inventory (FPI-R)|Saarbrücker Personality Questionnaire (SPF)|Elliot Humility Scale (EHS)|Defense Style Questionnaire (DSQ-40)|Jankowski Humility Scale (JHS)|Psychological insight (PIQ) | University Hospital, Basel, Switzerland | |
| Effects of Dimethyltryptamine in Healthy Subjects | Healthy | Drug: Dimethyltryptamine (DMT)|Drug: Saline | Altered states of consciousness profile|Subjective effect ratings over time|Subjective mood ratings|Mystical-type experiences|Autonomic effects I|Autonomic effects II|Plasma levels of DMT|Plasma levels of blood-derived neurotrophic factor (BDNF)|Plasma levels of oxytocin|Renal clearance of DMT|Effect moderation through personality traits I|Effect moderation through personality traits II|Effect moderation through personality traits III|Effect moderation through personality trait IV|Effect moderation through personality trait V|Effect moderation through personality trait VI|Effect moderation through personality trait VII|Adverse effects | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Basel-Stadt BS, Switzerland |
| Evaluation of the Dexmedetomidine Transdermal Systems for Postoperative Analgesia Following Abdominoplasty | Pain, Postoperative | Drug: DMTS Patch|Drug: Placebo Patch | Time-interval weighted summed pain intensity (SPI) at designated time points|Time-interval weighted summed pain intensity (SPI) over various time intervals|Rescue Medication|Rescue Medication units|Integrated Pain score and Rescue Medication | Teikoku Pharma USA, Inc. | Anaheim Clinical Trials, LLC, Anaheim, California, United States|JBR Clinical Research, Salt Lake City, Utah, United States |
| Single and Repeat Doses of DMT in Healthy Subjects | Stroke | Drug: N,N-Dimethyltryptamine|Drug: Placebo | Safety and Tolerability: Proportion of subjects with abnormal vital signs|Safety and Tolerability: Proportion of subjects with abnormal ECG readings|Safety and Tolerability: Proportion of subjects with abnormal physical examination findings|Safety and Tolerability: percentage of subjects with abnormal haematology, clinical chemistry, coagulation, and urinalysis values|Safety and Tolerability: percentage of subjects with local reactions at the injection site|Safety and Tolerability: proportion of subjects with abnormal findings on the Columbia-Suicide Severity Ratings Scale (C-SSRS)|Safety and Tolerability: proportion of subjects with occurrence of psychotic symptoms (BPRS)|Safety and Tolerability: proportion of subjects with occurrence of central 5-HT toxicity|Safety and Tolerability: proportion of subjects with at least one adverse event (AE)|DMT - Maximum Plasma Concentration (Cmax)|DMT - Time to peak drug concentration (tmax)|DMT - Area Under Curve last (AUClast)|DMT - Area Under Curve 0-t (AUC0-t)|DMT - Area Under Curve infinity (AUCinf)|DMT - %AUCextrap|DMT - Half Life (t1/2)|DMT - Clearance (CL) | Algernon Pharmaceuticals|Centre for Human Drug Research, Netherlands | Centre for Human Drug Research, Leiden, Netherlands |
| DMT210 Topical Gel in the Treatment of Atopic Dermatitis | Atopic Dermatitis | Drug: DMT210 Topical Gel|Drug: Vehicle Control | ADSI (Atopic Dermatitis Severity Index) score of each Target lesion|Individual Signs and Symptoms of Atopic Dermatitis of each Target Lesion|Investigator Global Assessment (IGA) of the Treatment Area | Dermata Therapeutics | Dermata Investigational Site, Houston, Texas, United States|Dermata Investigational Site, Norfolk, Virginia, United States |
| DMT310-003 Topical in the Treatment of Acne Vulgaris | Acne Vulgaris | Drug: DMT310|Drug: Placebo | Efficacy as measured by lesion counts|Efficacy as measured by Investigator Global Assessment (IGA)|Incidence of adverse events as a measure of safety and tolerability | Dermata Therapeutics | Dermata Investigational Site, Austin, Texas, United States |
| Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects | Pharmacokinetics in Healthy Adults | Drug: 5-MeO-DMT|Other: Placebo | Percentage of subjects with treatment emergent AEs (TEAES)|Peak plasma concentration (Cmax)|Time to reach Cmax (tmax)|Area under the plasma concentration- time curve | Beckley Psytech Limited | King's College London, London, United Kingdom |
| DMT210 Topical Gel in the Treatment of Acne Rosacea | Acne Rosacea | Drug: DMT210 Topical Gel 5%|Other: Vehicle Control | Efficacy as measured by Inflammatory lesion counts|Efficacy as measured by Investigator Global Assessment (IGA)|Efficacy as measured by 5-point Clinical Erythema Assessment (CEA)|Efficacy as measured by 5-point Patient Severity Assessment of Erythema (PSA)|Incidence of adverse events as a measure of safety and tolerability | Dermata Therapeutics | Dermata Investigational Site, San Diego, California, United States|Dermata Investigational Site, Miami, Florida, United States|Dermata Investigational Site, Fridley, Minnesota, United States|Dermata Investigational Site, Omaha, Nebraska, United States|Dermata Investigational Site, High Point, North Carolina, United States|Dermata Investigational Site, Broomall, Pennsylvania, United States|Dermata Investigational Site, Nashville, Tennessee, United States|Dermata Investigational Site, Austin, Texas, United States|Dermata Investigational Site, Norfolk, Virginia, United States |
| Open Label Randomized Multicenter to Assess Efficacy & Tolerability of Ofatumumab 20mg vs. First Line DMT in RMS | Multiple Sclerosis | Drug: Ofatumumab|Drug: First line DMT | Number of participants with no evidence of disease activity (NEDA-3)|Number of relapses|Annual relapse rate|Percentage of relapse-free patients and proportion of relapse free patients with MRI activity free|Time to 3 month Confirmed Disability Worsening (CDW) and time to 6-month Confirmed Disability Worsening (CDW)|Change in expanded disability status scale (EDSS)|Percentage of disability-progression free patients|Number of Gd+ T1 lesions of brain|The number and percentage of patients with Treatment emergent adverse events (TEAE) or adverse events reports|Volume of Gd+ T1 lesions of brain|Number of new/enlarging T2 lesions of brain|Volume of new enlarging T2 lesions of brain|Mean time to first relapse|Percentage of SAEs, and SAEs with hospitalizations|Percentage of treatment compliance of participants|Percentage of patient with AEs|Percentage of withdrawn patients|Percentage of treatment discontinuation or interruptions | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Bayonne, Bayonne Cedex, France|Novartis Investigative Site, Nantes, Cedex 1, France|Novartis Investigative Site, Amiens, France|Novartis Investigative Site, Bordeaux Cedex, France|Novartis Investigative Site, Clermont-Ferrand Cedex 1, France|Novartis Investigative Site, Creteil, France|Novartis Investigative Site, Gonesse, France|Novartis Investigative Site, Grenoble, France|Novartis Investigative Site, Lille Cedex, France|Novartis Investigative Site, Montpellier, France|Novartis Investigative Site, Nice Cedex, France|Novartis Investigative Site, Nimes, France|Novartis Investigative Site, Poissy, France|Novartis Investigative Site, Rennes Cedex, France|Novartis Investigative Site, Strasbourg, France|Novartis Investigative Site, Suresnes, France|Novartis Investigative Site, Bayreuth, Germany|Novartis Investigative Site, Berlin, Germany|Novartis Investigative Site, Bielefeld, Germany|Novartis Investigative Site, Dortmund, Germany|Novartis Investigative Site, Heidelberg, Germany|Novartis Investigative Site, Kassel, Germany|Novartis Investigative Site, Siegen, Germany|Novartis Investigative Site, Ulm, Germany|Novartis Investigative Site, Ulm, Germany|Novartis Investigative Site, Westerstede/Oldenburg, Germany|Novartis Investigative Site, Montichiari, BS, Italy|Novartis Investigative Site, Milano, MI, Italy|Novartis Investigative Site, Roma, RM, Italy|Novartis Investigative Site, Roma, RM, Italy|Novartis Investigative Site, Malaga, Andalucia, Spain|Novartis Investigative Site, Sevilla, Andalucia, Spain|Novartis Investigative Site, Salt, Cataluna, Spain|Novartis Investigative Site, Santiago de Compostela, Galicia, Spain|Novartis Investigative Site, El Palmar, Murcia, Spain|Novartis Investigative Site, Baracaldo, Vizcaya, Spain|Novartis Investigative Site, Barcelona, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Valencia, Spain|Novartis Investigative Site, Zaragoza, Spain|Novartis Investigative Site, Exeter, United Kingdom|Novartis Investigative Site, Glasgow, United Kingdom |
| Dexmedetomidine Transdermal System (DMTS) for Post-Operative Analgesia Following Bunionectomy | Pain, Postoperative | Drug: DMTS|Drug: Placebo | Time-interval weighted summed pain intensity (SPI), measured using the 11 point (0 to 10) numeric rating scale (NRS) at designated time points from 4 to 24 hours following surgery (NRSSPI).|Time-interval weighted summed pain intensity over various time intervals|The proportion of subjects using opioid rescue pain medication|The time to first use of rescue pain medication | Teikoku Pharma USA, Inc.|Premier Research Group plc | Nucleus Network LTD, Melbourne, Victoria, Australia|Linear Clinical Research, Nedlands, Western Australia, Australia |
| DMT310-001 Topical in the Treatment of Acne Vulgaris | Acne Vulgaris | Drug: DMT310|Drug: Hydrogen Peroxide|Drug: Placebo | Efficacy as measured by lesion counts|Efficacy as measured by Investigator Global Assessment (IGA)|Incidence of adverse events as a measure of safety and tolerability | Dermata Therapeutics | Dermata Investigational Site, San Diego, California, United States|Dermata Investigational Site, Saint Joseph, Missouri, United States|Dermata Investigational Site, Henderson, Nevada, United States|Dermata Investigational Site, Albuquerque, New Mexico, United States|Dermata Investigational Site, High Point, North Carolina, United States|Dermata Investigational Site, Tennessee, Tennessee, United States|Dermata Investigational Site, Austin, Texas, United States|Dermata Investigational Site, College Station, Texas, United States|Dermata Investigational Site, Katy, Texas, United States |
| Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study | Premature Birth of Newborn | Other: Developmental Massage Therapy|Other: no intervention | Growth|Salivary cortisol levels|Neurobehavioral Assessment | University of Utah|National Institutes of Health (NIH) | Intermountain Medical Center, Murray, Utah, United States|St. Mark's Hospital, Salt Lake City, Utah, United States|University of Utah, Salt Lake City, Utah, United States |
| DMT310-005 Topical in the Treatment of Acne Rosacea | Acne Rosacea | Drug: Topical Powder|Drug: Placebo Topical Powder | Efficacy as measured by lesion counts|Efficacy as measured by Investigator Global Assessment (IGA)|Incidence of adverse events as a measure of safety and tolerability | Dermata Therapeutics | Dermata Investigational Site, Austin, Texas, United States |
| Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3) | Breast Cancer Detection|Dense Breast Parenchyma|Benign Breast Findings|Normal Breast Screening|Abnormal Breast Screening | Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography | MRMC Analysis: ROC AUC|Sensitivity and Specificity | Delphinus Medical Technologies, Inc.|University of Chicago|Boston Biomedical Associates | Delphinus Medical Technologies, Inc., Novi, Michigan, United States |
| SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients | Major Depressive Disorder | Drug: SPL026|Drug: Placebo | Safety and tolerability in healthy volunteers|Efficacy of SPL026 in MDD patients with moderate to severe depression | Small Pharma Ltd | MAC Clinical Research, Liverpool, United Kingdom|Hammersmith Medicines Research, London, United Kingdom |
| Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects | Emotions|Mood|Cognitive Function 1, Social|Empathy | Drug: DMT|Drug: Harmine|Drug: Placebo (Harmine)|Drug: Placebo (DMT) | Change in Behavioral Outcome Measures (Social Value Orientation - SVO, Charity Donation Frank Task)|Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task)|Change in Pharmacological-EEG (Lagged Phase Synchronicity)|Change in Pharmacological-EEG (Resting State)|Change in Pharmacological-EEG|Change in biomarkers|Psychometry | Psychiatric University Hospital, Zurich|University of Basel | Psychiatric University Hospital, Zürich, Switzerland |
| Impact of Disease Modifying Therapies (DMTs) and Associated Support Services in Relapsing Multiple Sclerosis (RMS) Patients | Relapsing Multiple Sclerosis | Drug: Rebif|Other: Other: Disease modifying therapies (DMT) | Treatment Satisfaction|Work Productivity|Health Related Quality of Life|Health Related Quality of Life EuroQoL (EQ-5D)-5L Questionnaire|Device satisfaction|Evaluation of support services | Merck KGaA, Darmstadt, Germany|Merck Serono Limited, UK | Please contact the, Merck KGaA Communication Center for locations, United Kingdom |
| SPL026 With or Without SSRIs in Participants With MDD | Major Depressive Disorder | Drug: SPL026 | Safety & tolerability: Adverse Events|Safety & tolerability: Lab biochemistry|Safety & tolerability: Vital signs|Safety & tolerability: Electrocardiogram|Safety & tolerability: Suicidal Ideation|Evaluation of plasma levels of DMT|Mystical Experience Questionnaire (MEQ)|Challenging Experience Questionnaire (CEQ)|Ruminative Responses Scale (RRS)|Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) | Small Pharma Ltd | Mac Clinical Research, Manchester, Greater Manchester, United Kingdom|MAC Clinical Research, Liverpool, Prescot, United Kingdom |
| Impact of the Arrival on the French Market of New First Line Oral Treatments on the Delay Between MS Onset and First Disease Modifying Treatment (DMTs) Administration | C10.114.375.500 | Other: Delay between MS onset and introduction of first line DMT|Other: EDI | Date of MS onset|Date of introduction of first line DMT|Residence location | University Hospital, Caen|Genzyme, a Sanofi Company|Ligue contre le cancer, France | Groupement des Hôpitaux de l'Institut Catholique de Lille (HICL), Lille, Hauts-de-France, France|University Hospital of Lille, Lille, Hauts-de-France, France|University Hospital Center of Caen, Caen, Normandie, France|University Hospital of Rouen, Rouen, Normandie, France |
| Pharmacokinetics of GH001 in Healthy Volunteers | Healthy Volunteers | Drug: 5 Methoxy N,N Dimethyltryptamine|Drug: Placebo | The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine|Safety: Adverse Event (AE) reporting|Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording|Safety: Frequency of clinically significant changes from baseline in vital signs measurement|Safety: Frequency of clinically significant changes from baseline in safety laboratory tests of blood and urine|Safety: Frequency of clinically significant changes from baseline in Peak Flow Respirometry|Safety: Frequency of clinically significant changes from baseline in level of sedation|Safety: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)|Safety: Assessment of Subject-Discharge readiness|Mental Health: Change from baseline in Brief Psychiatric Rating Scale (BPRS)|Mental Health: Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)|Pharmacodynamic assessment: The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale|Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)|Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)|Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)|Cognitive Function: Change from baseline in Psychomotor Vigilance Task (PVT)|Cognitive Function: Change from baseline in Auditory Verbal Learning Test (AVLT)|Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task|Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST) | GH Research Ireland Limited | GH Research Clinical Trial Site, Groningen, Netherlands |
| MSC Administration for the Management of Type 1 Diabetic Patients | Type 1 Diabetes Mellitus | Biological: MSCs | Changes in insulin pancreatic reserve|Changes in insulin requirement | Universidad del Desarrollo|Clinica Alemana de Santiago | Clinica Alemana de Santiago, Santiago, Region Metropolitana, Chile |
| Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial) | Hypoxic-Ischemic Encephalopathy|Pain | Drug: Dexmedetomidine Hydrochloride|Drug: Morphine Sulfate | Examine Safety Measures in infants receiving DMT to those receiving morphine|DMT plasma levels | University of Utah | Intermountain Medical Center, Murray, Utah, United States|Primary Children's Hospital, Salt Lake City, Utah, United States|University of Utah Health, Salt Lake City, Utah, United States |
| Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS): Extension of the DISCOMS Study | Multiple Sclerosis | Number of participants off drug that have new inflammatory disease compared to those on drug.|Compare the change in disability using the EDSS over the duration of the trial in those who were able to maintain their treatment assignment without inflammatory activity. | University of Colorado, Denver|EMD Serono|National Multiple Sclerosis Society | University of Colorado Denver, Aurora, Colorado, United States|New York University, New York, New York, United States|Mount Sinai, New York, New York, United States|University of Rochester, Rochester, New York, United States|Cleveland Clinic, Cleveland, Ohio, United States|University of Pennsylvania, Philadelphia, Pennsylvania, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, United States|Vanderbilt University, Nashville, Tennessee, United States|University of Virginia, Charlottesville, Virginia, United States|Swedish, Seattle, Washington, United States | |
| Evaluating Efficacy of the Dexmedetomidine Transdermal System for Postoperative Analgesia Following Abdominoplasty | Pain, Postoperative | Drug: DMTS|Drug: Placebo | Time-interval weighted summed pain intensity (SPI) with activity|Time-interval weighted summed pain intensity (SPI) (rest and activity)|Rescue Medication|Rescue Medication time|Rescue Medication units|Integrated Pain score and Rescue Medication | Teikoku Pharma USA, Inc. | Arizona Research Center, Phoenix, Arizona, United States|HD Research, Bellaire, Texas, United States|Endeavor Clinical Trials, San Antonio, Texas, United States|JBR Clinical Research, Salt Lake City, Utah, United States |
| Delphinus SoftVue™ ROC Reader Study | Breast Cancer Detection|Dense Breast Parenchyma|Benign Breast Findings|Normal Breast Screening|Abnormal Breast Screening | Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography | MRMC Analysis: ROC AUC|Sensitivity and Specificity | Delphinus Medical Technologies, Inc.|University of Chicago|Boston Biomedical Associates|Reed Technical Associates, LLC | Cobo Center, Detroit, Michigan, United States |
| Disease Modifying Therapies Withdrawal in Inactive Secondary Progressive Multiple Sclerosis Patients Older Than 50 Years (STOP-I-SEP) | Multiple Sclerosis | Other: DMT withdrawal|Drug: DMT continuation | Disability progression measured by EDSS|Time of Disability progression|Disability progression measured by composite score|Disability progression measured by SDMT|Percentage of patients with Relapse|Annualized relapse rate|Time of Relapses|Percentage of patients with brain lesion|Percentage of patients with gadolinium enhancing lesion|Change in brain volume|Percentage of patients with no evidence of disease activity|Percentage of patients who resume DMT in the treatment withdrawal group|Quality of life measured by SEP-59 score|Quality of life measured by EQ-5D score|Medico economic impact | Rennes University Hospital | CHU Angers, Angers, France|CHU Brest, Brest, France|CHU Clermont-Ferrand, Clermont-Ferrand, France|Hôpital Henri Mondor, Créteil, France|CHU Dijon, Dijon, France|CHU Grenoble, Grenoble, France|CHU Lille, Lille, France|Hôpital Saint Vincent de Paul, Lille, France|Hospices Civils Lyon, Lyon, France|AP-HM, Marseille, France|CHU Montpellier, Montpellier, France|CHU Nancy, Nancy, France|CHU Nantes, Nantes, France|CHU Nice, Nice, France|CHU de Nîmes, Nîmes, France|AP-HP (La Pitié Salpêtrière), Paris, France|Fondation de Rothschild, Paris, France|CH Poissy, Poissy, France|CHU Poitiers, Poitiers, France|CH Quimper, Quimper, France|CHU Rennes, Rennes, France|CHU Strasbourg, Strasbourg, France|CHU Tours, Tours, France |
| Delphinus SoftVue™ ROC Reader Study | Breast Cancer|Breast Neoplasms | Device: Reading of Automated Breast Ultrasound in conjunction with Screening Mammography | MRMC Analysis: ROC AUC|Sensitivity and Specificity | Delphinus Medical Technologies, Inc.|University of Chicago|Biostatistics Consulting, LLC|Reed Technical Associates, LLC | University of Chicago, Chicago, Illinois, United States |
| A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMT | Multiple Sclerosis | Drug: Alemtuzumab GZ402673|Drug: Glatiramer acetate|Drug: Beta-Interferon|Drug: Methylprednisolone|Drug: Ranitidine|Drug: Ceterizine|Drug: Dexchlorpheniramine|Drug: Paracetamol|Drug: Acyclovir|Drug: Prednisolone|Drug: Diphenydramine|Drug: Other H1 antagonist | Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan|Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Participants With New or Enlarged T2 Lesions Per MRI Scan|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Months 4 and 8|Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAE)|Annualized Relapse Rate (ARR)|Change From Baseline in Cognition Test Scores of Brief Visuospatial Memory Test - Revised (BVMT-R)|Change From Baseline in Cognition Test Scores of Symbol Digit Modality Test (SDMT)|Change From Baseline in Quality of Life (QoL) Measures of Pediatric Quality of Life (PedsQL) Questionnaire Score|Change From Baseline in Pediatric Quality of Life in Neurological Disorders (NeuroQoL) Questionnaire Score|Serum Concentrations of Alemtuzumab Over Time|Maximum Serum Concentration Observed (Cmax) of Alemtuzumab|Time to Reach Maximum Observed Plasma Concentration (Tmax) of Alemtuzumab|Area Under the Plasma Concentration-Time Curve (AUC) of Alemtuzumab|Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Alemtuzumab|Terminal Half-life (T1/2z) of Alemtuzumab|Assessment of Lymphocyte Phenotyping|Percentage of Participants With Incidence of Antidrug Antibodies (ADA) | Genzyme, a Sanofi Company|Sanofi | Investigational Site Number :0400001, Wien, Austria|Investigational Site Number :0560001, Gent, Belgium|Investigational Site Number :2500001, Le Kremlin Bicetre, France|Investigational Site Number :2500002, Strasbourg, France|Investigational Site Number :3800005, Cagliari, Italy|Investigational Site Number :3800001, Milano, Italy|Investigational Site Number :3800004, Napoli, Italy|Investigational Site Number :5280001, Rotterdam, Netherlands|Investigational Site Number :6160003, Lodz, Lódzkie, Poland|Investigational Site Number :6160002, Poznan, Wielkopolskie, Poland|Investigational Site Number :6160001, Warszawa, Poland|Investigational Site Number :6200001, Coimbra, Portugal|Investigational Site Number :6430001, Moscow, Russian Federation|Investigational Site Number :6430004, Moscow, Russian Federation|Investigational Site Number :6430005, Saint-Petersburg, Russian Federation|Investigational Site Number :6430002, St-Petersburg, Russian Federation|Investigational Site Number :7920002, Ankara, Turkey|Investigational Site Number :7920001, Ankara, Turkey|Investigational Site Number :7920003, Istanbul, Turkey|Investigational Site Number :7920004, Istanbul, Turkey|Investigational Site Number :8260002, London, London, City Of, United Kingdom |
| Safety of GH001 in Healthy Volunteers | Healthy Volunteers | Drug: 5 Methoxy N,N Dimethyltryptamine | The safety and tolerability of GH001|The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale | GH Research Ireland Limited | Clinical Trial Site, Maastricht, Netherlands |
| Clinical Study of GH001 in Depression | Treatment Resistant Depression|Major Depressive Disorder|Depression | Drug: 5 Methoxy N,N Dimethyltryptamine | Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13.|Phase 2: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)|Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)|Phase 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13 | GH Research Ireland Limited | Clinical Trial Site, Maastricht, Netherlands |
| Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS). | Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting|Multiple Sclerosis, Secondary Progressive | Drug: DMT | Clinical relapses|New lesions on MRI-brain|EDSS (Expanded Disability Status Scale)|9-hole peg test|Timed 25-Foot Walk|Symbol Digits Modalities Test|MRI-parameter: T1 post-contrast lesion number|MRI-parameter: T2 post-contrast lesion number|Multiple Sclerosis Impact Scale (MSIS-29)|Short Form health survey (SF-36)|Checklist Individual Strength (CIS20r)|Treatment Satisfaction Questionnaire for Medication (TSQM)|EuroQol 5 dimensions questionnaire (EQ-5D-5L)|Medical consumption questionnaire (iMCQ)|Productivity costs questionnaire (iPCQ)|Neurofilament light level in serum | Amsterdam UMC, location VUmc | Amsterdam UMC, Amsterdam, Netherlands |
| Relationship Between Oral DMT Burden and Adherence in MS | Multiple Sclerosis|Adherence, Medication | Drug: Cladribine|Drug: Dimethyl fumarate|Drug: Fingolimod|Drug: Teriflunomide|Drug: Ozanimod|Drug: Diroximel fumarate | Medication Burden|Medication Adherence (MPR)|Medication Adherence (PDC)|Multiple Sclerosis Quality of Life-54 (MSQOL-54) | Monash University | Monash University, Melbourne, Victoria, Australia |
| Validation of a Shared Decision-Making Tool for Multiple Sclerosis | Multiple Sclerosis | Other: MS-SUPPORT | Start/Switch DMT|Patient-provider communication|Adherence to DMT|Decision Quality|Quality of Life--Healthy Days Core Module|CAHPS Quality of Care|Decision Conflict | Shared Decision Making Resources|EMD Serono|Multiple Sclerosis Association of America | Shared Decision Making Resources, Georgetown, Maine, United States |
| Type 1 Diabetes and Eating Disorder Diurnal Glucose Patterns | Type I Diabetes Mellitus Without Complication|Eating Disorder | Variation in Glycemic Profiles of ED-DMT1 and ED/only|Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only | HealthPartners Institute|Park Nicollet Foundation|Melrose Institute|International Diabetes Center at Park Nicollet | Melrose Institute, Minneapolis, Minnesota, United States | |
| Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain | Chronic Low-back Pain | Behavioral: Mindfulness-based dance/movement therapy (M-DMT)|Behavioral: Chronic pain social support group | Feasibility of Recruitment: Number of participants eligible|Recruitment Rate|Recruitment time|Feasibility of recruiting male participants: Proportion of male participant enrolled|Treatment Completion Rate|Retention Rate|Reason for withdrawal|M-DMT intervention credibility and expectancy|Treatment Fidelity|Treatment satisfaction and acceptability: Likert-scale survey|M-DMT intervention acceptability|Adverse Event|Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a|Pain interference: PROMIS® Pain Interference -8a|Chronic pain acceptance: Chronic Pain Acceptance Questionnaire|Mindfulness|Physical activity (Accelerometry data)|Physical activity (Self-report data) | Drexel University|National Center for Complementary and Integrative Health (NCCIH)|Stony Brook University | Drexel Universitsy, Philadelphia, Pennsylvania, United States |
| COVID-19 and Multiple Sclerosis Disease Modifying Therapies | Covid19|Multiple Sclerosis | Prevalence of testing positive for SARS-CoV-2 in people with MS taking DMTs|Clinical outcomes of COVID-19 among people with MS taking DMTs|Risk of contracting COVID-19 associated with individual DMTs/other clinical and paraclinical factors|Association between clinical outcomes of COVID-19 and individual DMTs/other clinical and paraclinical factors | Nottingham University Hospitals NHS Trust | Nottingham University Hospitals NHS Trust, Nottingham, Nottinghamshire, United Kingdom | |
| Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: Discontinuation of disease modifying therapy|Drug: Standard of Care | Safety as measured by the proportion of participants developing a new MS relapse and/or MRI Brain Lesion over the course of the study duration.|Proportion with Significant, Confirmed Change in Physical Disability using the Expanded Disability Status Scale (EDSS)|Change in Neuro-QoL (quality of life) short form scores.|Change in SymptoMScreen composite score (SymptoMScreen - overall symptom severity).|Change in Patient-Determined Disease Steps (PDDS - disability).|Change in Symbol Digit Modalities Test (SDMT - cognition).|Evaluation of the patient's Quality of Life using the MSIS-29 Scale | University of Colorado, Denver|Patient-Centered Outcomes Research Institute|National Multiple Sclerosis Society|University of Alabama at Birmingham | University of California, Los Angeles, California, United States|University of Colorado Denver - Anschutz Medical Campus, Aurora, Colorado, United States|Georgetown University, Washington, District of Columbia, United States|University of Miami, Miami, Florida, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|Massachusetts General Hospital, Boston, Massachusetts, United States|Washington University St. Louis, Saint Louis, Missouri, United States|NYU Langone Medical Center, New York, New York, United States|Mt. Sinai University, New York, New York, United States|University of Rochester, Rochester, New York, United States|Cleveland Clinic, Cleveland, Ohio, United States|The Ohio State University, Columbus, Ohio, United States|Oregon Health and Science University, Portland, Oregon, United States|University of Pennsylvania, Philadelphia, Pennsylvania, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, United States|Vanderbilt University, Nashville, Tennessee, United States|University of Virginia, Charlottesville, Virginia, United States|Swedish Health Services, Seattle, Washington, United States |
| Pediatric SMA China Registry | Muscular Atrophy, Spinal | Natural History and Utilization of Disease Modifying Therapy (DMT) Treatments Among Pediatric Chinese Participants With Spinal Muscular Atrophy Linked to Chromosome 5q (5q-SMA) | Biogen | ||
| Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod|Drug: Standard MS DMT | Change From Baseline in Patient-reported Treatment Satisfaction|Change From Baseline in Patient-reported Activities of Daily Living (ADL)|Change From Baseline in Patient-reported Fatigue|Change From Baseline in Patient-Reported Effectiveness and Convenience|Change From Baseline in Patient-reported Depression|Change From Baseline in Patient-reported Health Related Quality of Life (QOL)|Physician-reported Clinical Global Impression of Improvement (CGI-I) | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Ancona, AN, Italy|Novartis Investigative Site, Ponderano, BI, Italy|Novartis Investigative Site, Caltanissetta, CL, Italy|Novartis Investigative Site, Cuneo, CN, Italy|Novartis Investigative Site, Como, CO, Italy|Novartis Investigative Site, Catania, CT, Italy|Novartis Investigative Site, Foggia, FG, Italy|Novartis Investigative Site, Castelfiorentino, FI, Italy|Novartis Investigative Site, Milano, MI, Italy|Novartis Investigative Site, Milano, MI, Italy|Novartis Investigative Site, San Donato Milanese, MI, Italy|Novartis Investigative Site, Modena, MO, Italy|Novartis Investigative Site, Palermo, PA, Italy|Novartis Investigative Site, Palermo, PA, Italy|Novartis Investigative Site, Pisa, PI, Italy|Novartis Investigative Site, Legnago, VR, Italy|Novartis Investigative Site, Novara, Italy |
| Programme Evaluation on Effectiveness of The Use of Movement-based x 'Elderspirituality - Fu Le Mun Sum' Intervention to Support Elderly People With Depressive Symptoms | Depression in Old Age | Behavioral: Dance Movement Therapy (DMT) | Spirituality Scale for Chinese Elders (SSCE)|The 15-item Geriatric Depression Scale (GDS-15)|The 5-level EQ-5D version (EQ-5D-5L) | The University of Hong Kong|Tung Wah Group of Hospitals | Sau Po Centre on Ageing, Hong Kong, Hong Kong |
| A Multicenter Study of Continued Current Therapy vs Transition to Ofatumumab After Neurofilament (NfL) Elevation | Relapsing-Remitting Multiple Sclerosis | Drug: Ofatumumab|Drug: Disease modifying treatment (DMT) | Percentage of participants achieving NEDA-3 (No Evidence of Disease Activity-3)|Percentage of participants with a single baseline NfL≥10pg/ml and NfL<10pg/ml achieving NEDA-3 (No Evidence of Disease Activity-3)|Annualized relapse rate in Months 3 to 15|Percentage of participants without a worsening of their disability|Percentage of participants with NEDA (No Evidence of Disease Activity) - Clinical|Percentage of participants with NEDA (No Evidence of Disease Activity) - Radiological|Mean change in The Symbol-Digit Modality Test|Mean change in the Time 25 Foot Walk|Mean change in the 9 Hole Peg Test|Mean change in Gd+ lesion count|Mean change in Gd+ lesion volume|Mean change in T2 lesion count|Mean change in T2 lesion volume|Mean change from Baseline in T1|Mean change in MSQOL-54|Mean whole brain and regional volume loss from Baseline|Percentage of participants reporting treatment emergent adverse events (TEAEs) and serious adverse events | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Knoxville, Tennessee, United States|Novartis Investigative Site, Levis, Quebec, Canada |
| Comparison Safety and Efficacy of Basal Insulin Lantus® (Insulin Glargine) vs NPH Insulin in Combination With Oral Antidiabetic Drugs (OADs) in Patients With Diabetes Mellitus, Type 2 (DMT2) | Diabetes Mellitus, Type 2 | Drug: insulin glargine | The change in blood glucose variability|Occurrence of adverse events|Development of diabetes compensation - fastig blood glucose and HbA1|Development of weight of patients|Comparison of dose of insulins NPH vs Lantus | Sanofi | Sanofi-Aventis Administrative Office, Praha, Czech Republic |
| A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis | Drug: Fingolimod|Drug: Standard MS DMTs | Change From Baseline in the Global Satisfaction Subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM) at Month 6|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Change From Baseline in Patient-reported Activities of Daily Living (ADL) Using the Multiple Sclerosis Activities Scale (PRIMUS-Activities) at Month 6|Change From Baseline in Patient-reported Fatigue Using the Fatigue Severity Scale (FSS)|Change From Baseline in the Patient-reported Effectiveness Subscale Using the TSQM v1.4|Change From Baseline in the Patient-reported Side Effects Subscale Using the TSQM v1.4|Change From Baseline in the Patient-reported Convenience Subscale Using the TSQM v1.4|Change From Baseline in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Standard (SF-36 v2)|Change From Baseline in Patient-reported Depression Using the Beck Depression Inventory (BDI-II)|Physician-reported Clinical Global Impression of Improvement (CGI-I) | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Birmingham, Alabama, United States|Novartis Investigative Site, Cullman, Alabama, United States|Novartis Investigative Site, Phoenix, Arizona, United States|Novartis Investigative Site, Phoenix, Arizona, United States|Novartis Investigative Site, Phoenix, Arizona, United States|Novartis Investigative Site, Phoenix, Arizona, United States|Novartis Investigative Site, Tucson, Arizona, United States|Novartis Investigative Site, Anaheim, California, United States|Novartis Investigative Site, Berkeley, California, United States|Novartis Investigative Site, Fresno, California, United States|Novartis Investigative Site, Fullerton, California, United States|Novartis Investigative Site, La Habra, California, United States|Novartis Investigative Site, Loma Linda, California, United States|Novartis Investigative Site, Newport Beach, California, United States|Novartis Investigative Site, Oceanside, California, United States|Novartis Investigative Site, Sacramento, California, United States|Novartis Investigative Site, Walnut Creek, California, United States|Novartis Investigative Site, Boulder, Colorado, United States|Novartis Investigative Site, Colorado Springs, Colorado, United States|Novartis Investigative Site, Fort Collins, Colorado, United States|Novartis Investigative Site, Fairfield, Connecticut, United States|Novartis Investigative Site, New London, Connecticut, United States|Novartis Investigative Site, Stratford, Connecticut, United States|Novartis Investigative Site, Dover, Delaware, United States|Novartis Investigative Site, Newark, Delaware, United States|Novartis Investigative Site, Atlantis, Florida, United States|Novartis Investigative Site, Bradenton, Florida, United States|Novartis Investigative Site, Doral, Florida, United States|Novartis Investigative Site, Fort Lauderdale, Florida, United States|Novartis Investigative Site, Hollywood, Florida, United States|Novartis Investigative Site, Jacksonville, Florida, United States|Novartis Investigative Site, Jacksonville, Florida, United States|Novartis Investigative Site, Lighthouse Point, Florida, United States|Novartis Investigative Site, Maitland, Florida, United States|Novartis Investigative Site, Miami, Florida, United States|Novartis Investigative Site, Miami, Florida, United States|Novartis Investigative Site, Pompano Beach, Florida, United States|Novartis Investigative Site, Ponte Vedra Beach, Florida, United States|Novartis Investigative Site, Port Orange, Florida, United States|Novartis Investigative Site, Sarasota, Florida, United States|Novartis Investigative Site, St. Petersburg, Florida, United States|Novartis Investigative Site, Sunrise, Florida, United States|Novartis Investigative Site, Tallahassee, Florida, United States|Novartis Investigative Site, Tampa, Florida, United States|Novartis Investigative Site, Tampa, Florida, United States|Novartis Investigative Site, Vero Beach, Florida, United States|Novartis Investigative Site, West Palm Beach, Florida, United States|Novartis Investigative Site, Atlanta, Georgia, United States|Novartis Investigative Site, Atlanta, Georgia, United States|Novartis Investigative Site, Columbus, Georgia, United States|Novartis Investigative Site, Decatur, Georgia, United States|Novartis Investigative Site, Idaho Falls, Idaho, United States|Novartis Investigative Site, Elk Grove Village, Illinois, United States|Novartis Investigative Site, Evanston, Illinois, United States|Novartis Investigative Site, Flossmoor, Illinois, United States|Novartis Investigative Site, Northbrook, Illinois, United States|Novartis Investigative Site, Anderson, Indiana, United States|Novartis Investigative Site, Indianapolis, Indiana, United States|Novartis Investigative Site, Indianapolis, Indiana, United States|Novartis Investigative Site, Merrillville, Indiana, United States|Novartis Investigative Site, Valparaiso, Indiana, United States|Novartis Investigative Site, Des Moines, Iowa, United States|Novartis Investigative Site, Lenexa, Kansas, United States|Novartis Investigative Site, Baton Rouge, Louisiana, United States|Novartis Investigative Site, Destrehan, Louisiana, United States|Novartis Investigative Site, Hammond, Louisiana, United States|Novartis Investigative Site, Metairie, Louisiana, United States|Novartis Investigative Site, Shreveport, Louisiana, United States|Novartis Investigative Site, Shreveport, Louisiana, United States|Novartis Investigative Site, Baltimore, Maryland, United States|Novartis Investigative Site, Bethesda, Maryland, United States|Novartis Investigative Site, Boston, Massachusetts, United States|Novartis Investigative Site, Springfield, Massachusetts, United States|Novartis Investigative Site, Worcester, Massachusetts, United States|Novartis Investigative Site, Worcester, Massachusetts, United States|Novartis Investigative Site, Detroit, Michigan, United States|Novartis Investigative Site, Grand Rapids, Michigan, United States|Novartis Investigative Site, Kalamazoo, Michigan, United States|Novartis Investigative Site, Southfield, Michigan, United States|Novartis Investigative Site, Bolivar, Missouri, United States|Novartis Investigative Site, Kansas City, Missouri, United States|Novartis Investigative Site, Kansas City, Missouri, United States|Novartis Investigative Site, Nixa, Missouri, United States|Novartis Investigative Site, North Kansas City, Missouri, United States|Novartis Investigative Site, St. Louis, Missouri, United States|Novartis Investigative Site, Billings, Montana, United States|Novartis Investigative Site, Freehold, New Jersey, United States|Novartis Investigative Site, Somerset, New Jersey, United States|Novartis Investigative Site, Teaneck, New Jersey, United States|Novartis Investigative Site, Toms River, New Jersey, United States|Novartis Investigative Site, Amherst, New York, United States|Novartis Investigative Site, Latham, New York, United States|Novartis Investigative Site, New York, New York, United States|Novartis Investigative Site, Patchogue, New York, United States|Novartis Investigative Site, Plainview, New York, United States|Novartis Investigative Site, Asheville, North Carolina, United States|Novartis Investigative Site, Burlington, North Carolina, United States|Novartis Investigative Site, Charlotte, North Carolina, United States|Novartis Investigative Site, Charlotte, North Carolina, United States|Novartis Investigative Site, Greensboro, North Carolina, United States|Novartis Investigative Site, Greenville, North Carolina, United States|Novartis Investigative Site, Raleigh, North Carolina, United States|Novartis Investigative Site, Salisbury, North Carolina, United States|Novartis Investigative Site, Wilmington, North Carolina, United States|Novartis Investigative Site, Winston-Salem, North Carolina, United States|Novartis Investigative Site, Akron, Ohio, United States|Novartis Investigative Site, Bellevue, Ohio, United States|Novartis Investigative Site, Canton, Ohio, United States|Novartis Investigative Site, Cincinnati, Ohio, United States|Novartis Investigative Site, Columbus, Ohio, United States|Novartis Investigative Site, Uniontown, Ohio, United States|Novartis Investigative Site, Oklahoma City, Oklahoma, United States|Novartis Investigative Site, Corvallis, Oregon, United States|Novartis Investigative Site, Eugene, Oregon, United States|Novartis Investigative Site, Medford, Oregon, United States|Novartis Investigative Site, Portland, Oregon, United States|Novartis Investigative Site, Monroeville, Pennsylvania, United States|Novartis Investigative Site, Rumford, Rhode Island, United States|Novartis Investigative Site, Beufort, South Carolina, United States|Novartis Investigative Site, Columbia, Tennessee, United States|Novartis Investigative Site, Cordova, Tennessee, United States|Novartis Investigative Site, Knoxville, Tennessee, United States|Novartis Investigative Site, Nashville, Tennessee, United States|Novartis Investigative Site, Austin, Texas, United States|Novartis Investigative Site, Colleyville, Texas, United States|Novartis Investigative Site, Dallas, Texas, United States|Novartis Investigative Site, Houston, Texas, United States|Novartis Investigative Site, Lubbock, Texas, United States|Novartis Investigative Site, Plano, Texas, United States|Novartis Investigative Site, Round Rock, Texas, United States|Novartis Investigative Site, San Antonio, Texas, United States|Novartis Investigative Site, San Antonio, Texas, United States|Novartis Investigative Site, Sherman, Texas, United States|Novartis Investigative Site, Salt Lake City, Utah, United States|Novartis Investigative Site, Newport News, Virginia, United States|Novartis Investigative Site, Richmond, Virginia, United States|Novartis Investigative Site, Roanoke, Virginia, United States|Novartis Investigative Site, Vienna, Virginia, United States|Novartis Investigative Site, Kirkland, Washington, United States|Novartis Investigative Site, Seattle, Washington, United States|Novartis Investigative Site, Seattle, Washington, United States|Novartis Investigative Site, Morgantown, West Virginia, United States|Novartis Investigative Site, Calgary, Alberta, Canada|Novartis Investigative Site, Nepean, Ontario, Canada|Novartis Investigative Site, Ottawa, Ontario, Canada|Novartis Investigative Site, Greenfield Park, Quebec, Canada|Novartis Investigative Site, Montreal, Quebec, Canada|Novartis Investigative Site, Montreal, Quebec, Canada|Novartis Investigative Site, Guaynabo, Puerto Rico |
| Unified Cognitive-Behavioral Therapy (CBT) vs. Combined CBT and Dance/Movement Therapy (DMT) for Anxiety Disorders | Anxiety Disorders | Behavioral: Unified Cognitive-Behavioral Therapy|Behavioral: Combined Cognitive-Behavioral and Dance/Movement Therapy | Change in Hamilton Anxiety Rating Scale|Change in Depression, Anxiety, Stress Scales-21|Change in Valued Living Questionnaire|Change in Mini International Neuropsychiatric Interview | Shalvata Mental Health Center | Shalvata Mental Health Center, Hod Hasharon, Israel |
| A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period|Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy|Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period|Time to Protocol-Defined Event|Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period|Time to Onset of First Protocol-Defined Relapse|Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI|Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI|Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score|Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI|Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI|Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI|Percentage of Participants With Adverse Events | Genentech, Inc. | North Central Neurology Associates, Cullman, Alabama, United States|Phoenix Neurological Associates Ltd, Phoenix, Arizona, United States|Barrow Neurological Institute, Phoenix, Arizona, United States|Territory Neurology and Research Institute, Tucson, Arizona, United States|The Research Center of Southern California, LLC, Carlsbad, California, United States|Mercy Medical Group; MS Centre Nurse, Carmichael, California, United States|Fullerton Neurology and Headache Center, Fullerton, California, United States|Scripps Health, La Jolla, California, United States|UCSF- Multiple Sclerosis Centre; Department of Neurology, San Francisco, California, United States|Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, United States|Mountain Neurological Research Center; Roaring Fork Neurologt, P.C., Basalt, Colorado, United States|IMMUNOe Research Centers, Centennial, Colorado, United States|Colorado Neurological Institute, Englewood, Colorado, United States|Advanced Neurology of Colorado, LLC, Fort Collins, Colorado, United States|Associated Neurologists of Southern CT PC, Fairfield, Connecticut, United States|KI Health Partners, LLC; New England Institute for Clinical Research, Stamford, Connecticut, United States|Neurology Associates PA, Maitland, Florida, United States|University of Miami Miller School of Medicine; Clinical Reseach Building, Miami, Florida, United States|Neurostudies Inc, Port Charlotte, Florida, United States|Infinity Clinical Research, LLC, Sunrise, Florida, United States|Axiom Clinical Research of Florida, Tampa, Florida, United States|University of South Florida - Bradenton, Tampa, Florida, United States|Ms Center Of Atlanta, Atlanta, Georgia, United States|University of Chicago Hospital, Chicago, Illinois, United States|Consultants in Neurology Ltd, Northbrook, Illinois, United States|American Health Network Institute, LLC, Avon, Indiana, United States|Josephson Wallack Munshower Neurology PC, Indianapolis, Indiana, United States|University of Kansas Medical Center; Division of Nuclear Medicine, Kansas City, Kansas, United States|Lahey Clinic Med Ctr, Lexington, Kentucky, United States|Associates in Neurology PSC, Lexington, Kentucky, United States|Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services, Louisville, Kentucky, United States|Ochsner Clinic Foundation, New Orleans, Louisiana, United States|University of Maryland Medical Center; Department of Neurology, Baltimore, Maryland, United States|John Hopkins University School of Medicine, Baltimore, Maryland, United States|Massachusetts General Hospital, Boston, Massachusetts, United States|Beth Israel Deaconess Med Ctr; Neurology/MS Center, Boston, Massachusetts, United States|Dragonfly Research, LLC, Wellesley, Massachusetts, United States|UMASS Memorial Medical Center, Worcester, Massachusetts, United States|Wayne State University; Department of Neurology, Detroit, Michigan, United States|Minneapolis Clinic of Neurology, Golden Valley, Minnesota, United States|Washington University School of Medicine; Department of Neurology, Saint Louis, Missouri, United States|Cleveland Clinic Lou Ruvo; Center for Brain Research, Las Vegas, Nevada, United States|Rutgers New Jersey Medical School, Newark, New Jersey, United States|Holy Name Hospital; Institute For Clinical Research, Teaneck, New Jersey, United States|Jacobs Neurological Institute, Buffalo, New York, United States|The MS Center of Northeastern New York, Latham, New York, United States|Columbia University Medical Center, New York, New York, United States|South Shore Neurologic Associates P.C., Patchogue, New York, United States|Island Neurological Associates, P.C., Plainview, New York, United States|Raleigh Neurology Associates, Raleigh, North Carolina, United States|UC Health Clinical Trials Office, Cincinnati, Ohio, United States|Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40, Cleveland, Ohio, United States|The Ohio State University Wexner Medical Center; Department of Neurology, Columbus, Ohio, United States|Neurology Specialists, Inc, Dayton, Ohio, United States|Neurology and Neuroscience Assoc., Inc., Westerville, Ohio, United States|Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States|Providence Multiple Sclerosis Center, Portland, Oregon, United States|Allegheny Neurological Associates, Pittsburgh, Pennsylvania, United States|Neurology Clinic PC, Cordova, Tennessee, United States|Hope Neurology, Knoxville, Tennessee, United States|Uni of Texas Health Science Center At Houston, Houston, Texas, United States|Bhupesh Dihenia M.D. P.A., Lubbock, Texas, United States|Central Texas Neurology Consultants, Round Rock, Texas, United States|Neurology Center of San Antonio, San Antonio, Texas, United States|Rocky Mountain MS Clinic, Salt Lake City, Utah, United States|Swedish Neuroscience Institute, Seattle, Washington, United States|MultiCare Health System Institute for Research and Innovation, Tacoma, Washington, United States|Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience, Calgary, Alberta, Canada|University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine,, Edmonton, Alberta, Canada|Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy, Burnaby, British Columbia, Canada|Horizon Health Network - Multiple Sclerosis Clinic, Saint John, New Brunswick, Canada|Dalhousie Multiple Sclerosis Research Unit, Halifax, Nova Scotia, Canada|Hamilton General Hospital, Hamilton, Ontario, Canada|The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis, Ottawa, Ontario, Canada|St. Michael's Hospital MS Clinic, MS Research Centre, Toronto, Ontario, Canada|Clinique NeuroOutaouais, Gatineau, Quebec, Canada|Recherche Sepmus, Inc., Greenfield Park, Quebec, Canada|Hopital Hotel Dieu de Levis, Levis, Quebec, Canada|Chum Campus Notre Dame, Montreal, Quebec, Canada|McGill University; Montreal Neurological Institute; Neurological and Psychiatric, Montreal, Quebec, Canada|MS Clinic Mauricie Bois Francs, Trois Rivieres, Quebec, Canada|CHU De Quebec Universite Laval, Quebec, Canada |
| A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) | Multiple Sclerosis, Relapsing-Remitting | Biological: Ocrelizumab | Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period|Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period|Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period|Time to First Protocol-Defined Event of Disease Activity|Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)|Absolute Change From Baseline in EDSS Category at Week 96|Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96|Annualized Protocol-defined Relapse Rate at Week 96|Time to Onset of 24-week Confirmed Disability Progression|Time to Onset of First Protocol-Defined Relapse|Time to Onset of First New and/or Enlarging T2 Lesion|Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96|Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From|Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI|Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96|Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan|Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume|Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume|Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume|Adjusted Mean Percentage Change From Baseline in Brain Volume|Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume|Adjusted Mean Percentage Change From Baseline in White Matter Volume|Mean Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score|Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score|Percentage Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score|Percentage Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score|Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Hoffmann-La Roche | St George Hospital, Kogarah, New South Wales, New South Wales, Australia|Hospital Erasme, Bruxelles, Belgium|Cliniques Universitaires St-Luc, Bruxelles, Belgium|UZ Antwerpen, Edegem, Belgium|UZ Gent, Gent, Belgium|CHU Tivoli, La Louvière, Belgium|UZ Leuven Gasthuisberg, Leuven, Belgium|Nationaal MS Centrum, Melsbroek, Belgium|Revalidatie en MS Centrum, Overpelt, Belgium|Fakultni nemocnice u sv. Anny; Neurologicka klinika, Brno, Czechia|Nemocnice Jihlava; NEU-Neurologicke oddeleni, Jihlava, Czechia|VFN Praha Poliklinika Rs Centrum - Budova A, Prague, Czechia|Fakultni nemocnice Motol; Neurologicka klinika, Praha, Czechia|Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken, Aarhus N, Denmark|Rigshospitalet Glostrup; Neurologisk Klinik, Glostrup, Denmark|Odense Universitetshospital, Neurologisk Afdeling N, Odense C, Denmark|Sydjysk Skleroseklinik - Sønderborg, Sønderborg, Denmark|East Tallinn Central Hospital; Neurology Department, Tallinn, Estonia|West Tallinn Central Hospital, Tallinn, Estonia|Tartu University Hospital, Tartu, Estonia|Terveystalo Tampere, Tampere, Finland|Mehiläinen Neo Turku, Turku, Finland|CHU de Besancon Hopital Jean Minjoz; Service de Neurologie, Besançon, France|Groupe Hospitalier Pellegrin; Service de neurochirurgie B, Bordeaux, France|Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A, Bron, France|Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B, Clermont-Ferrand, France|Hopital Roger Salengro; Service de Neurologie, Lille, France|CHU de la Timone - Hopital d Adultes; Service de Neurologie, Marseille, France|Hopital Gui de Chauliac; Neurologie, Montpellier, France|Hôpital Guillaume et René Laënnec; Service Neurologie, Nantes, France|Hôpital Pasteur; Service de Neurologie, Nice, France|Fondation Rothschild; Service de Neurologie, Paris, France|Groupe Hospitalier Pitié- Salpétrière; Service Neurologie, Paris, France|Hôpital Maison Blanche; Service de Neurologie, Reims, France|Hôpitaux Universitaires de strasbourg - hôpital civil, Strasbourg, France|CHU toulouse - Hôpital Purpan; Departement de Neurologie, Toulouse, France|CHRU - Hôpital Bretonneau; Neurologie, Tours, France|Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie, Augsburg, Germany|Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH, Berg, Germany|Charite - Universitatsmedizin Berlin; Klinik fur Neurologie, Berlin, Germany|Praxis Dr. Said Masri, Berlin, Germany|Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz, Berlin, Germany|Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie, Berlin, Germany|St. Josef-Hospital, Klinik für Neurologie, Bochum, Germany|Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc, Bonn, Germany|PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge, Buchholz, Germany|Studienzentrum für Neurologie und Psychiatrie, Böblingen, Germany|Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften, Dresden, Germany|Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito, Düsseldorf, Germany|NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich, Erbach/Odenwald, Germany|Universitaetsklinikum Frankfurt; Klinik für Neurologie, Frankfurt, Germany|Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie, Freiburg, Germany|Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik, Hamburg, Germany|Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt, Hamburg, Germany|MultipEL Studies - Institut für klinische Studien, Hamburg, Germany|Henriettenstiftung Hannover; Klinik fuer Neurologie und Klinische Neurophysiologie, Hannover, Germany|Neurologische Klinik, Universitätsklinikum Heidelberg, Heidelberg, Germany|Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie, Hennigsdorf, Germany|Neurozentrum am Klosterforst in Itzehoe, Itzehoe, Germany|Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische, Kassel, Germany|PANAKEIA - Arzneimittelforschung Leipzig GmbH, Leipzig, Germany|Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie, Magdeburg, Germany|Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie, Mainz, Germany|Universitaetsklinikum Marburg; Klinik fuer Neurologie, Marburg, Germany|Max-Planck-Institut für Psychiatrie, München, Germany|Klinikum Grosshadern der LMU; Neuroimmunologie II, München, Germany|Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum, München, Germany|Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie, Münster, Germany|Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie, Neuruppin, Germany|AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie, Oldenburg in Holstein, Germany|St. Josefs-Krankenhaus, Klinik für Neurologie, Potsdam, Germany|NeuroConcept AG C/O mind mvz GmbH, Stuttgart, Germany|Universitätsklinikum Tübingen, Zentrum für Neurologie, Tübingen, Germany|NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH, Ulm, Germany|Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz, Westerstede, Germany|Cork University Hospital; Clinical Research Facility, Cork, Ireland|St Vincents University Hospital, Dublin 4, Ireland|Beaumont Hospital, Dublin, Ireland|Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla, Chieti, Abruzzo, Italy|Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla, L'Aquila, Abruzzo, Italy|A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche, Napoli, Campania, Italy|Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur, Napoli, Campania, Italy|Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA, Bologna, Emilia-Romagna, Italy|Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla, Roma, Lazio, Italy|Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico, Roma, Lazio, Italy|Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla, Roma, Lazio, Italy|Azienda Ospedaliera Sant'Andrea; UOC Neurologia, Roma, Lazio, Italy|Irccs A.O.U.San Martino Ist; Dinogmi, Genova, Liguria, Italy|ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla, Bergamo, Lombardia, Italy|Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico, Gallarate, Lombardia, Italy|Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative, Milano, Lombardia, Italy|IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla, Milano, Lombardia, Italy|Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari, Milano, Lombardia, Italy|Ospedale Civile di Montichiari; Centro Sclerosi Multipla, Montichiari, Lombardia, Italy|IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla, Pavia, Lombardia, Italy|AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla, Ancona, Marche, Italy|IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla, Pozzilli, Molise, Italy|Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia, Barletta, Puglia, Italy|IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia, San Giovanni Rotondo, Puglia, Italy|Ospedale Binaghi; Centro Sclerosi Multipla, Cagliari, Sardegna, Italy|AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla, Catania, Sicilia, Italy|Fondazione Istituto S. Raffaele - Giglio; UO Neurologia, Cefalù, Sicilia, Italy|AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla, Palermo, Sicilia, Italy|AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia, Palermo, Sicilia, Italy|AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA), Firenze, Toscana, Italy|AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2, Firenze, Toscana, Italy|AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale, Siena, Toscana, Italy|AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica, Perugia, Umbria, Italy|Azienda Ospedaliera di Padova; Clinica Neurologica, Padova, Veneto, Italy|Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla, Verona, Veneto, Italy|Amphia Ziekenhuis, Breda, Netherlands|St. Antonius Ziekenhuis Nieuwegein, Nieuwegein, Netherlands|Maasstadziekenhuis, Rotterdam, Netherlands|Zuyderland Medisch Centrum - Sittard Geleen, Sittard-Geleen, Netherlands|Sint Elizabeth Ziekenhuis, Tilburg, Netherlands|Haukeland Universitetssykehus, Bergen, Norway|Sykehuset Buskerud HF; Nevrologisk avdeling, Drammen, Norway|Hospital Universitario Central de Asturias; Servicio de Neurología, Oviedo, Asturias, Spain|Hospital Universitari de Bellvitge; Servicio de Neurologia, L'Hospitalet de Llobregat, Barcelona, Spain|Hospital General de Castellon; Servicio de Neurología, Castelló de la Plana, Castellon, Spain|Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia, Salt, Girona, Spain|Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia, Coruña, LA Coruña, Spain|Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología, Lleida, Lerida, Spain|Hospital Quiron de Madrid; Servicio de Neurologia, Pozuelo de Alarcon, Madrid, Spain|Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia, Vigo, Pontevedra, Spain|Hospital del Mar; Servicio de Neurologia, Barcelona, Spain|Hospital Vall d'Hebron; Servicio de Neurología, Barcelona, Spain|Hospital Puerta del Mar; Sevicio de Neurologia, Cadiz, Spain|Universitario de La Princesa; Servicio de Neurología, Madrid, Spain|Hospital Universitario Clínico San Carlos; Servicio de Neurología, Madrid, Spain|Hospital Universitario 12 de Octubre; Servicio de Neurologia, Madrid, Spain|Hospital Universitario La Paz; Servicio de Neurologia, Madrid, Spain|Hospital Universitario Virgen de Arrixaca; Servicio de Neurología, Murcia, Spain|Hospital Universitario Virgen Macarena; Servicio de Neurologia, Sevilla, Spain|Hospital Clinico Universitario de Valencia; Servicio de Neurologia, Valencia, Spain|Hospital Universitario la Fe; Servicio de Neurologia, Valencia, Spain|Sahlgrenska Sjukhuset; Neurology, Göteborg, Sweden|Länssjukhuset Ryhov; Medicinkliniken / Neurologmottagningen, Jönköping, Sweden|Centrum för Neurologi, Stockholm, Sweden|Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik, Basel, Switzerland|CHUV Lausanne Méd.Neurologie, Lausanne, Switzerland|Hacettepe University Medical Faculty; Neurology, Ankara, Turkey|Istanbul Uni Istanbul Medical Faculty, Istanbul, Turkey|Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali, Istanbul, Turkey|Ege University Medical Faculty, Izmir, Turkey|Kocaeli University Hospital; Department of Neurology, Kocaeli, Turkey|Mersin University Medical Faculty; Neurology, Mersin, Turkey|Ondokuz Mayis Univ. Med. Fac.; Neurology, Samsun, Turkey|Karadeniz Tecnical Uni. Med. Fac.; Neurology, Trabzon, Turkey|New Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom|Western General Hospital, Edinburgh, United Kingdom|Royal Devon and Exeter Hospital (Wonford), Exeter, United Kingdom|Queen Elizabeth University Hospital, Glasgow, United Kingdom|Raigmore Hospital, Inverness, United Kingdom|Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom|The Royal London Hospital, London, United Kingdom|Kings College Hospital, London, United Kingdom|Charing Cross Hospital, London, United Kingdom|Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom|Salford Royal NHS Foundation Trust, Salford, United Kingdom|Royal Hallamshire Hospita, Sheffield, United Kingdom|Morriston Hospital, Swansea, United Kingdom|Royal Cornwall Hospital, Truro, United Kingdom |
| Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC) | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod|Drug: Interferon beta - 1a (IFN)|Drug: Glatiramer acetate (GA) | Change in Patient-reported Treatment Satisfaction|Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death|Changes in Patient-reported Effectiveness, Side Effects and Convenience|Change in Patient-reported Depression|Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute) | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Arkhangelsk, Russia, Russian Federation|Novartis Investigative Site, Barnaul, Russian Federation|Novartis Investigative Site, Belgorod, Russian Federation|Novartis Investigative Site, Kazan, Russian Federation|Novartis Investigative Site, Kemerovo, Russian Federation|Novartis Investigative Site, Khanty-Mansiysk, Russian Federation|Novartis Investigative Site, Kirov, Russian Federation|Novartis Investigative Site, Krasnodar, Russian Federation|Novartis Investigative Site, Kursk, Russian Federation|Novartis Investigative Site, Moscow, Russian Federation|Novartis Investigative Site, Moscow, Russian Federation|Novartis Investigative Site, N.Novgorod, Russian Federation|Novartis Investigative Site, Nizhniy Novgorod, Russian Federation|Novartis Investigative Site, Nizhny Novgorod, Russian Federation|Novartis Investigative Site, Novosibirsk, Russian Federation|Novartis Investigative Site, Perm, Russian Federation|Novartis Investigative Site, Saransk, Russian Federation|Novartis Investigative Site, Saratov, Russian Federation|Novartis Investigative Site, Smolensk, Russian Federation|Novartis Investigative Site, St. Petersburg, Russian Federation|Novartis Investigative Site, Tomsk, Russian Federation|Novartis Investigative Site, Tumen, Russian Federation|Novartis Investigative Site, Tver, Russian Federation|Novartis Investigative Site, Ufa, Russian Federation|Novartis Investigative Site, Ulyanovsk, Russian Federation|Novartis Investigative Site, Yaroslavl, Russian Federation |
| Participants Preferences to Disease Modifying Agents in Relapsing Remitting Multiple Sclerosis Condition | Multiple Sclerosis, Relapsing-Remitting | Percentage of Participants with Serious Adverse Events (Severe Life-Threatening or Less Severe)|Percentage of Participants With DMT Administration Schedule Preferences|Percentage of Participants With DMT Route of Administration Preferences|DMT Efficacy Based on Annualized Relapse Rate|Participants Education Level|Participants Employment Status|Participants RRMS Disease Duration|Number of Relapses of RRMS in Last 2 Years|Duration since Last Relapse of RRMS|Participants Current DMT for RRMS|Number of Previous DMTs Taken Prior to Switch to Current DMT|Expanded Disability Status Scale (EDSS) Score|Health-Related Quality of Life Assessment Using Euro-Quality of Life 5 Dimension Questionnaire (EQ-5D) Scale Score|Participant's Role in Decision Making measured by the Shared Decision Making Questionnaire 9-item version (SDM-Q-9) Score|Cognitive performance as measured by the Medical Outcomes Study Cognitive Functioning Scale (MOS Cog-R) Score | Hoffmann-La Roche | Hospital Sant Joan Despi Moises Broggi; Servicio de Neurología, Sant Joan Despí, Barcelona, Spain|Hospital Universitario Marques de Valdecilla; Servicio de Neurología, Santander, Cantabria, Spain|Hospital General de Castellon; Servicio de Neurología, Castelló de la Plana, Castellon, Spain|Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología, Lleida, Lerida, Spain|Hospital Universitario del Sureste; Servicio de Neurologia, Arganda del Rey, Madrid, Spain|Hospital Universitario Rey Juan Carlos de Móstoles; Servicio de Neurología, Móstoles, Madrid, Spain|Hospital Quiron de Madrid; Servicio de Neurologia, Pozuelo de Alarcon, Madrid, Spain|Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia, Vigo, Pontevedra, Spain|Hospital Universitario de Canarias; Servicio de Neurologia, San Cristóbal de La Laguna, Tenerife, Spain|Hospital del Mar; Servicio de Neurologia, Barcelona, Spain|Hospital Universitario Reina Sofia; Servicio de Neurologia, Cordoba, Spain|Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia, Girona, Spain|Hospital General Universitario Gregorio Marañon; Servicio de Neurologia, Madrid, Spain|Fundacion Jimenez Diaz; Servicio de Neurología, Madrid, Spain|Hospital Universitario 12 de Octubre; Servicio de Neurologia, Madrid, Spain|Hospital Clinico Universitario de Valencia; Servicio de Neurologia, Valencia, Spain|Hospital Universitario Dr. Peset; Servicio de Neurologia, Valencia, Spain|Hospital Universitario La Fe; Unidad de Esclerosis Multiple, Valencia, Spain | |
| PDT and Periodontal Treatment in DMT2 Patients | Periodontitis|Diabetes Mellitus Type 2 | Procedure: Periodontal treatment|Procedure: Periodontal treatment and PDT | Change in the clinical attachment level at 180 days.|Changes in the fasting blood and glycated hemoglobin (HBA1C)|Cytokines in the crevicular fluid | University of Nove de Julho | Universidade Nove de Julho, São Paulo, SP, Brazil |
| Tecfidera and the Gut Microbiota | Multiple Sclerosis, Relapsing-Remitting | Drug: dimethyl fumarate|Drug: injectable MS DMT | Comparison of the change in gut microbiota composition in participants pre vs. post initiation of DMF treatment.|Change in gut microbiota composition between DMF treated participants that do or do not develop GI AEs as measured by an increase in the Gastrointestinal Symptom Rating Scale (GSRS) score.|Changes in gut microbiota composition in participants treated with DMF compared to participants treated with an alternative injectable multiple sclerosis (MS) disease modifying therapies (DMT)|Baseline differences in the gut microbiota composition between DMF treated participants that do or do not develop GI AEs.|Changes in the gut microbiota composition of DMF treated participants after resolution of GI AEs vs. during GI AE occurrences. | Biogen | Research site, Drammen, Norway|Research site, Haukeland, Norway|Research Site, Lillehammer, Norway|Research site, Lørenskog, Norway|Research site, Molde, Norway|Research site, Oslo, Norway|Research site, Stavanger, Norway |
| Dance Movement Therapy in the Treatment of Depressed Patients: A Randomised Controlled Trial | Depression | Behavioral: Dance Movement Therapy group | Change from baseline depressive symptoms (Beck Depression Inventory; BDI) at 10-week post-treatment measurement|Change from post-treatment depressive symptoms (Beck Depression Inventory; BDI) at three-month follow-up measurement|Change from baseline psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at 10-week post-treatment measurement|Change from post-treatment psychological distress (Clinical Outcomes in Routine Evaluation - Outcome Measure; CORE-OM) at three-month follow-up measurement|Change from baseline physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at 10-week post-treatment measurement|Change from post-treatment physiological and psychological symptoms (the Symptoms Check List-90; SCL-90) at three-month follow-up measurement | University of Jyvaskyla|The Social Insurance Institution of Finland|Finnish Dance Therapy Association | |
| Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: BIIB033 (opicinumab)|Drug: Placebo | Part 1: Overall Response Score|Part 2: Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)|Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND|Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or 3-Second Paced Auditory Serial Addition Test (PASAT-3)|Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and Without Confirmed Worsening in Any of the 4 Assessments During the 72 Weeks of the Study|Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and Symbol Digit Modalities Test (SDMT)|Part 1: Percentage of Participants With 12-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% Thresholds for T25FW and 9HPT)|Part 2: Overall Response Score|Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND|Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, or PASAT-3|Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND, and Without Confirmed Worsening in Any of the 4 Assessments During the 96 Weeks of the Study|Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, 9HPT-ND, and SDMT|Part 2: Percentage of Participants With 24-week Confirmed Improvement in at Least 1 of the Following Assessments: EDSS, T25FW, 9HPT-D, or 9HPT-ND (20% Thresholds for T25FW and 9HPT)|Part 2: Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values|Part 2: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Values|Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Vital Signs Values|Part 2: Percentage of Participants With Potentially Clinically Significant Abnormal Weight Values|Part 2: Number of Participants With Columbia Suicide Severity Rating Scale (C-SSRS) Score at Any Post-Baseline Visit | Biogen | Research Site, Cullman, Alabama, United States|Research Site, Gilbert, Arizona, United States|Research Site, Berkeley, California, United States|Research Site, Long Beach, California, United States|Research Site, Newport Beach, California, United States|Research Site, Orange, California, United States|Research Site, Centennial, Colorado, United States|Research Site, Fort Collins, Colorado, United States|Research Site, Stamford, Connecticut, United States|Research Site, Washington, District of Columbia, United States|Research Site, Sunrise, Florida, United States|Research Site, Tampa, Florida, United States|Research Site, Atlanta, Georgia, United States|Research Site, Chicago, Illinois, United States|Research Site, Chicago, Illinois, United States|Research Site, Overland Park, Kansas, United States|Research Site, Lexington, Kentucky, United States|Research Site, Baltimore, Maryland, United States|Research Site, Boston, Massachusetts, United States|Research Site, Boston, Massachusetts, United States|Research Site, Lexington, Massachusetts, United States|Research Site, Wellesley, Massachusetts, United States|Research Site, Farmington Hills, Michigan, United States|Research Site, Minneapolis, Minnesota, United States|Research Site, Saint Louis, Missouri, United States|Research Site, Saint Louis, Missouri, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Freehold, New Jersey, United States|Research Site, Teaneck, New Jersey, United States|Research Site, Latham, New York, United States|Research Site, New York, New York, United States|Research Site, Patchogue, New York, United States|Research Site, Rochester, New York, United States|Research Site, Stony Brook, New York, United States|Research Site, Durham, North Carolina, United States|Research Site, Raleigh, North Carolina, United States|Research Site, Columbus, Ohio, United States|Research Site, Dayton, Ohio, United States|Research Site, Oklahoma City, Oklahoma, United States|Research Site, Portland, Oregon, United States|Research Site, Pittsburgh, Pennsylvania, United States|Research Site, Willow Grove, Pennsylvania, United States|Research Site, Knoxville, Tennessee, United States|Research Site, Memphis, Tennessee, United States|Research Site, Dallas, Texas, United States|Research Site, Houston, Texas, United States|Research Site, Round Rock, Texas, United States|Research Site, Orem, Utah, United States|Research Site, Salt Lake City, Utah, United States|Research Site, Seattle, Washington, United States|Research Site, Seattle, Washington, United States|Research Site, Box Hill, Victoria, Australia|Research Site, Clayton, Victoria, Australia|Research Site, Heidelberg, Victoria, Australia|Research Site, Melbourne, Victoria, Australia|Research Site, Parkville, Victoria, Australia|Research Site, New Lambton Heights, Australia|Research Site, Westmead, Australia|Research Site, Brugge, Belgium|Research Site, Bruxelles, Belgium|Research Site, Bruxelles, Belgium|Research Site, Gent, Belgium|Research Site, La Louvière, Belgium|Research Site, Leuven, Belgium|Research Site, Roeselare, Belgium|Research Site, Edmonton, Alberta, Canada|Research Site, Vancouver, British Columbia, Canada|Research Site, Victoria, British Columbia, Canada|Research Site, Ottawa, Ontario, Canada|Research Site, Toronto, Ontario, Canada|Research Site, Gatineau, Quebec, Canada|Research Site, Longueuil, Quebec, Canada|Research Site, Montreal, Quebec, Canada|Research Site, Brno, Czechia|Research Site, Brno, Czechia|Research Site, Hradec Kralove, Czechia|Research Site, Jihlava, Czechia|Research Site, Pardubice, Czechia|Research Site, Praha 2, Czechia|Research Site, Strasbourg Cedex, Bas Rhin, France|Research Site, Nimes, Gard, France|Research Site, Bordeaux, Gironde, France|Research Site, Toulouse, Haute Garonne, France|Research Site, Montpellier, Herault, France|Research Site, Nantes Cedex 1, Loire Atlantique, France|Research Site, Lille, Nord, France|Research Site, Clermont-Ferrand, Puy De Dome, France|Research Site, Bron Cedex, Rhone, France|Research Site, Amiens Cedex 1, Somme, France|Research Site, Paris, France|Research Site, Freiburg, Baden Wuerttemberg, Germany|Research Site, Tuebingen, Baden Wuerttemberg, Germany|Research Site, Ulm, Baden Wuerttemberg, Germany|Research Site, Muenchen, Bavaria, Germany|Research Site, Bochum, North Rhine-Westphalia, Germany|Research Site, Duesseldorf, North Rhine-Westphalia, Germany|Research Site, Trier, Rhineland-Palatinate, Germany|Research Site, Dresden, Saxony, Germany|Research Site, Berlin, Germany|Research Site, Muenster, Germany|Research Site, Budapest, Hungary|Research Site, Budapest, Hungary|Research Site, Budapest, Hungary|Research Site, Esztergom, Hungary|Research Site, Kistarcsa, Hungary|Research Site, Pecs, Hungary|Research Site, Ramat Gan, Israel|Research Site, Montichiari, Brescia, Italy|Research Site, Pozzilli, Isernia, Italy|Research Site, Cefalù, Palermo, Italy|Research Site, Genova, Italy|Research Site, Messina, Italy|Research Site, Milano, Italy|Research Site, Milano, Italy|Research Site, Napoli, Italy|Research Site, Napoli, Italy|Research Site, Napoli, Italy|Research Site, Pisa, Italy|Research Site, Roma, Italy|Research Site, Verona, Italy|Research Site, Geleen, Netherlands|Research Site, Bydgoszcz, Poland|Research Site, Gdansk, Poland|Research Site, Katowice, Poland|Research Site, Katowice, Poland|Research Site, Krakow, Poland|Research Site, Lodz, Poland|Research Site, Lublin, Poland|Research Site, Szczecin, Poland|Research Site, Warszawa, Poland|Research Site, Zabrze, Poland|Research Site, Salt, Girona, Spain|Research Site, Majadahonda, Madrid, Spain|Research Site, Barakaldo, Vizcaya, Spain|Research Site, Barcelona, Spain|Research Site, Barcelona, Spain|Research Site, Barcelona, Spain|Research Site, Cordoba, Spain|Research Site, Madrid, Spain|Research Site, Sevilla, Spain|Research Site, Aarau, Switzerland|Research Site, Basel, Switzerland|Research Site, Bern, Switzerland|Research Site, Lugano, Switzerland|Research Site, Zurich, Switzerland|Research Site, Exeter, Devon, United Kingdom|Research Site, Plymouth, Devon, United Kingdom|Research Site, London, Greater London, United Kingdom|Research Site, London, Greater London, United Kingdom|Research Site, Salford, Greater Manchester, United Kingdom|Research Site, Liverpool, Merseyside, United Kingdom|Research Site, Nottingham, Nottinghamshire, United Kingdom|Research Site, Oxford, Oxfordshire, United Kingdom|Research Site, Glasgow, Strathclyde, United Kingdom|Research Site, Newcastle Upon Tyne, Tyne & Wear, United Kingdom|Research Site, Leeds, West Yorkshire, United Kingdom|Research Site, Brighton, United Kingdom|Research Site, Sheffield, United Kingdom|Research Site, Swansea, United Kingdom |
| Dancing for Better Aging: Evaluating the Impact of a Dance/Movement Therapy (D/MT) Program for Older Adults | Aging | Other: Dance/Movement Therapy (DMT)|Other: Aerobics Exercise (AE) | Z-score change on Cognitive Functioning|Z-score change on Psychological Condition|Z-score change on Dietary Screener Questionnaire|Z-score change on Pittsburgh Sleep Quality Index (PSQI)|Z-score change on Brief Pain Inventory|Z-score change on International Consultation on Incontinence Questionnaire-Urinary Incontinence ( ICIQ-UI)|Z-score change on Physical Functioning|Z-score change on Physical Condition | Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal | IUGM, Montreal, Quebec, Canada |
| Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod|Drug: Dimethyl Fumarate | effectiveness of fingolimod 0.5 mg once daily versus dimethyl-fumarate 240 mg twice daily|Annual relapse rate|Number of Gd+ MRI lesions|Brain volume loss|Prevention of sustained disability progression (EDSS worsening)|Prevention of Objective sustained disability progression|Patient-NEDA|Prevention of Cognitive decline|Evaluation of social cognition|Evaluation of quality of decision making|Preservation of Quality of life|Convenience perception|Psychiatric symptoms|Fatigue | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta|Patient-Centered Outcomes Research Institute|Universita degli Studi di Genova | Fondazione IRCCS Istituto Neurologico C. Besta, Neuroimmunology Unit, Milan, Italy |
| The Influence of Vibration on Bone Mineral Density in Women Who Have Weak Bones After Menopause | Bone Density|Osteopenia|Osteoporosis|Post-Menopause | Device: Juvent 1000 Dynamic Motion Therapy (DMT) Platform | Trabecul volumetric bone mineral density (BMD) of the lower tibia (using peripheral quantitative computed tomography; pQCT))|Total BMD of the lower tibia (using pQCT)|Cortical BMD and cortical thickness of the lower tibia (using pQCT)|Trabecular thickness, separation, and number of the lower tibia (using pQCT)|Total BMD of the distal radius (using pQCT)|Cortical BMD and cortical thickness of the distal radius (using pQCT)|Trabecular BMD and thickness, separation, and number of the distal radius (using pQCT)|BMD at the total hip (using dual x-ray absorptiometry; DXA)|BMD at the femoral neck (using DXA)|BMD lumbar spine (using DXA)|BMD at the calcaneus (using quantitative ultrasound; QUS)|Speed of sound and broadband ultrasound attenuation at the calcaneus (QUS) | University Health Network, Toronto|The Physicians' Services Incorporated Foundation | University Health Network, Toronto, Ontario, Canada |
| Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2)-Related Multiple Sclerosis (MS) Vaccination Study | Multiple Sclerosis (MS) | Number of Participants who Developed an Immune Response to Their Last SARS-CoV-2-Vaccination|Number of Participants who Retained an Immune Response to Their Last SARS-CoV-2-Vaccination|Change From Baseline in SARS-CoV-2 Spike Immunoglobulin A (IgA) Levels|Change From Baseline in SARS-CoV-2 Spike Immunoglobulin G (IgG) Levels|Change From Baseline in SARS-CoV-2-Nucleocapsid Protein (NCP) IgG Levels|Number of Participants who Developed an Immune Response to Their SARS-CoV-2-Vaccination|Number of Participants by Applied SARS-CoV-2 Vaccine and Vaccination Cycle|Number of Participants per Vaccination Cycle|Number of Participants with the Tolerability to the Applied Vaccine According to the Predefined Categories | Biogen | Multiple Sklerose Zentrum, Bamberg, Germany|St. Josef Hospital, Klinikum der Ruhr-Universität Bochum, Bochum, Germany|Universitätsklinikum Erlangen, Neurologische Klinik, Erlangen, Germany|Universitätsklinik Freiburg, Neurologie, Freiburg, Germany|Klinik für Neurologie, Haar, Germany|UKE Hamburg, Klinik und Poliklinik für Neurologie, Hamburg, Germany|Univ.-Klinikum Heidelberg, Neurologische Klinik, Heidelberg, Germany|Klinik und Poliklinik für Neurologie, Leipzig, Germany|Klinik und Poliklinik für Neurologie, Munich, Germany|Universitätsklinikum Tübingen, Neurologie, Tübingen, Germany|Neuropraxis München Süd, Unterhaching, Germany|DKD Helios Klinik, Neurologie, Wiesbaden, Germany | |
| Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult | Developmental Stuttering | Behavioral: Digital Manipulation of Thyroid cartilage|Behavioral: Fluency Shaping Therapy|Behavioral: combination Group | Scale for Rating the severity of stuttering|Modified Erickson scale of communication attitude(24)|Assessment of Physiological Factors Associated with Stuttering | Isra University | National Institute of Rehabilitation Medicine (NIRM), Islamabad, Federal, Pakistan |
| Screening Epidemiological Program on Compensation Evaluation of Diabetes Mellitus Type 2 (DMT2) Patients on Oral Anti-diabetic (OAD) Monotherapy and Physicians Satisfaction of Their Usage | Type 2 Diabetes | To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy|To assess frequency of target levels of HbA1c ≤ 7% in patients with T2D during OAD monotherapy|To assess fasting glycemia in patients with T2D on OAD monotherapy|To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy|To evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D)|To compare the results of OAD monotherapy in different groups of patients | AstraZeneca|Bristol-Myers Squibb | Research Site, Arkhangelsk, Russian Federation|Research Site, Astrakhan, Russian Federation|Research Site, Barnaul, Russian Federation|Research Site, Chelyabinsk, Russian Federation|Research Site, Izhevsk, Russian Federation|Research Site, Joshkar-Ola, Russian Federation|Research Site, Kazan, Russian Federation|Research Site, Khemerovo, Russian Federation|Research Site, Kirov, Russian Federation|Research Site, Kurgan, Russian Federation|Research Site, Moscow, Russian Federation|Research Site, Nizhni Novgorod, Russian Federation|Research Site, Perm, Russian Federation|Research Site, Petrozavodsk, Russian Federation|Research Site, Rostov-on-Don, Russian Federation|Research Site, Samara, Russian Federation|Research Site, Seversk, Russian Federation|Research Site, Smolensk, Russian Federation|Research Site, St-Peterburg, Russian Federation|Research Site, Tomsk, Russian Federation|Research Site, Tyumen, Russian Federation|Research Site, Ufa, Russian Federation|Research Site, Yaroslavl, Russian Federation | |
| Dance and Movement Therapy in Patients With Schizophrenia | Schizophrenia|Negative Symptoms in Schizophrenia|Disabilities Mental|Dance Therapy | Other: Dance and Movement Therapy (DMT) | The Scale for the Assessment of Negative Symptoms (SANS)|Disability Evaluation Schedule (WHO-DAS-II) | Amasya University | |
| Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants | Relapsing Remitting Multiple Sclerosis | Drug: Natalizumab | Overall Disease-Free Status at Month 12|Clinical Disease-Free Status at Month 12 in Comparison to the Previous Year|Annualized Relapse Rate at Month 12 in Comparison to the Previous Year|Overall Disease-Free Status at Months 24, 36 and 48|Clinical Disease-free Status Every 6 Months|Annualized Relapse Rate (ARR)|Change From Baseline in Sustained Expanded Disability Status Scale (EDSS) Score (24-week Sustained)|MRI measures: T2, T1, T1 with Gadolinium (Gd)|Cognitive Impairment Using Symbol Digit Modalities Test (SDMT)|Change From Baseline in Ability to Work and Productivity as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire|Quality of life (QoL) Assessed Using Fatigue Severity Scale|QoL assessed using Multiple Sclerosis Functional Composite (MSFC) Test|QoL Assessed Using Beck Depression Inventory, 2nd Edition (BDI-II)|QoL Assessed Using Multiple Sclerosis Impact Scale (MSIS-29) | Biogen | Research Site, Amadora, Portugal|Research Site, Angra do Heroismo, Portugal|Research Site, Aveiro, Portugal|Research Site, Braga, Portugal|Research Site, Coimbra, Portugal|Research Site, Faro, Portugal|Research Site, Funchal, Portugal|Research Site, Guimaraes, Portugal|Research Site, Leiria, Portugal|Research Site, Lisboa, Portugal|Research Site, Loures, Portugal|Research Site, Matosinhos, Portugal|Research Site, Penafiel, Portugal|Research Site, Porto, Portugal|Research Site, Santa Maria da Feira, Portugal|Research Site, Setubal, Portugal|Research Site, Viana do Castelo, Portugal|Research Site, Vila Nova de Gaia, Portugal |
| Delayed Diagnosis of Multiple Sclerosis, Treatment Initiation and Non-adherence in Upper Egypt | Multiple Sclerosis, Relapsing-Remitting | time to diagnosis of multiple sclerosis|time to disease modifying treatment initiation|rate of adherence to disease modifying treatment among MS patients|determine factors related to delayed diagnosis of MS|frequency of depression as a factor related to DMT adherence|frequency of fatigue as a factor related to DMT adherence|frequency of sleep disturbances as a factor related to DMT adherence|treatment satisfaction as a factor related to DMT adherence | doaa mokhtar mahmoud|Assiut University | Assiut University, Assiut, Egypt|South valley University, Qena, Egypt | |
| Extension Study of NS-089/NCNP-02 in DMD | Duchenne Muscular Dystrophy (DMD) | Drug: NS-089/NCNP-02 | Incidence of adverse events|Expression of dystrophin protein (Western blot)|Percentage of exon 44-skipped mRNA of dystrophin|North Star Ambulatory Assessment (NSAA)|Time to stand test|Time to run/walk 10 meters test|Six-minute walk test/Two-minute walk test|Timed Up & Go test|Quantitative muscle strength assessment|Performance of Upper Limb test|Change in serum creatine kinase concentration from baseline | Nippon Shinyaku Co., Ltd. | Kagoshima University Hospital, Kagoshima, Japan|National Center of Neurology and Psychiatry, Tokyo, Japan |
| Exploring the Immune Response to SARS-CoV-2 modRNA Vaccines in Patients With Secondary Progressive Multiple Sclerosis (AMA-VACC) | Secondary Progressive Multiple Sclerosis | Drug: BAF312|Drug: Baseline disease modifying therapies (DMTs) | Percentage of participants achieving seroconversion after receiving a modRNA vaccine|SARS-CoV-2 serum functional antibody levels over time|T-cell response to modRNA vaccines over time|Number of treatment emergent adverse events, serious adverse events and COVID-19 infections | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Mittweida, Sachsen, Germany|Novartis Investigative Site, Bogen, Germany|Novartis Investigative Site, Chemnitz, Germany|Novartis Investigative Site, Dresden, Germany|Novartis Investigative Site, Düsseldorf, Germany|Novartis Investigative Site, Neuburg an der Donau, Germany|Novartis Investigative Site, Pforzheim, Germany|Novartis Investigative Site, Regensburg, Germany|Novartis Investigative Site, Ruelzheim, Germany|Novartis Investigative Site, Ulm, Germany |
| Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS | Multiple Sclerosis, Relapsing-Remitting | Drug: Early Highly Effective Therapies Group|Drug: Escalation Therapies Group | Brain volume loss, baseline to month 36|Brain volume loss, month 6 to month 36|Proportion of participants with progression|Change in MSIS-29, baseline to 36 months|Change in Neuro-QOL, baseline to 36 months | The Cleveland Clinic|University of Nottingham | University of Colorado-Anschutz Medical Campus, Aurora, Colorado, United States|University of Minnesota, Minneapolis, Minnesota, United States|Mayo Clinic, Rochester, Minnesota, United States|Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, Nevada, United States|University of Buffalo, Buffalo, New York, United States|University Rochester Medical Center, Rochester, New York, United States|University of Cincinnati, Cincinnati, Ohio, United States|Cleveland Clinic, Cleveland, Ohio, United States|Ohio Health, Columbus, Ohio, United States|UT-Austin, Austin, Texas, United States|Baylor College of Medicine, Houston, Houston, Texas, United States|UTHealth-Houston, Houston, Texas, United States|University of Virginia, Charlottesville, Virginia, United States|Virginia Commonwealth University, Richmond, Virginia, United States|University of Wisconsin-Madison, Madison, Wisconsin, United States|University Hospitals Coventry and Warwickshire, Coventry, England, United Kingdom|Frimley Park, Frimley, England, United Kingdom|The Leeds Teaching Hospitals NHS Trust, Leeds General Infirmary, Leeds, England, United Kingdom|University Hospitals Leicester, Leicester, England, United Kingdom|Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, England, United Kingdom|University College London Hospitals NHS Foundation Trust, University College Hospital, London, England, United Kingdom|Salford Royal NHS Foundation Trust, Salford Hospital, Manchester, England, United Kingdom|Oxford University Hospitals NHS Foundation Trust, John Radcliffe Hospital, Oxford, England, United Kingdom|University Hospitals Plymouth NHS Trust, Derriford Hospital, Plymouth, England, United Kingdom|Sheffield Teaching Hospitals, Sheffield, England, United Kingdom|University Hospitals of North Midlands, Stoke, England, United Kingdom|Royal Infirmary of Edinburgh, Edinburgh, Scotland, United Kingdom|Cardiff and Vale University Local Health Board, University Hospital of Wales, Cardiff, Wales, United Kingdom|Aneurin Bevan Local Health Board Headquarters, Royal Gwent Hospital, Newport, Wales, United Kingdom|Swansea Bay University Local Health Board, Morriston Hospital, Swansea, Wales, United Kingdom|Nottingham University Hospitals NHS Trust, Queens Medical Centre, Nottingham, United Kingdom |
| Hibiscus Sabdariffa and Centella Asiatica in the Treatment of Anemia by Iron Deficiency | Iron Deficiency Anemia | Drug: Herbal medicine|Drug: Iron | Hemoglobin | Casa Espirita Terra de Ismael|University of Sao Paulo | Laboratorio M. F. Teixeira, Monte Santo de Minas, Minas Gerais, Brazil |
| A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720 | Multiple Sclerosis|Relapsing-Remitting | Drug: Fingolimod | Mean Patient-Reported Treatment Satisfaction Questionnaire for Medication Scores (TSQM-9)|Mean Patient-reported Health-related Quality-of-life With Fingolimod (Short Form Health Survey: SF-36). | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Altunizade, Turkey|Novartis Investigative Site, Ankara, Turkey|Novartis Investigative Site, Ankara, Turkey|Novartis Investigative Site, Atakum / Samsun, Turkey|Novartis Investigative Site, Bursa, Turkey|Novartis Investigative Site, Fatih / Istanbul, Turkey|Novartis Investigative Site, Izmir, Turkey|Novartis Investigative Site, Kocaeli, Turkey|Novartis Investigative Site, Mecidiyekoy/Istanbul, Turkey|Novartis Investigative Site, Trabzon, Turkey|Novartis Investigative Site, Uskudar / Istanbul, Turkey |
| Biogen Multiple Sclerosis Pregnancy Exposure Registry | Multiple Sclerosis|Exposure During Pregnancy | Drug: Dimethyl fumarate|Drug: Peginterferon beta-1a | Pregnancy Loss|Live Birth | Biogen | Research Site, Cambridge, Massachusetts, United States|Research Site, Box Hill, Victoria, Australia|Research Site, Cambridge, Massachusetts, Canada|Research Site, Bron CEDEX, Cedex, France|Research Site, Bochum, Nordrhein Wesfalen, Germany|Research Site, Dublin, Ireland|Research Site, Firenze, Italy|Research Site, Genova, Italy|Research Site, Milano, Italy|Research Site, Palermo, Italy|Research Site, Roma, Italy|Research Site, Białystok, Poland|Research Site, Madrid, Spain|Research Site, Malaga, Spain|Research Site, Salford, Greater Manchester, United Kingdom |
| Impact of Fingolimod Adherence on Outcomes | Multiple Sclerosis | Drug: Fingolimod | Number of Multiple Sclerosis (MS) relapses|Number of Multiple Sclerosis-related inpatient admission|Number of Multiple Sclerosis-related Emergency Room (ER) visits|All-cause total (medical plus pharmacy) health care costs|All-cause medical health care costs|All-cause total (medical plus pharmacy) health care costs excluding fingolimod | Novartis Pharmaceuticals|Novartis | Novartis Investigational Site, East Hanover, New Jersey, United States |
| Effects of Ocrevus in Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ocrelizumab|Drug: Platform | Dynamic Gait Stability|Gait speed|Step length|Step width|Step time|Cadence|Stability index|Swing index|Lower limb muscle strength|Lower limb muscle activity|Multiple Sclerosis Functional Composite|Expanded Disability Status Scale|Total cerebral T2 lesion volume|Prospective falls | Georgia State University|Multiple Sclerosis Center of Atlanta | Georgia State University, Atlanta, Georgia, United States|Multiple Sclerosis Center of Atlanta, Atlanta, Georgia, United States |
| ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis | Advanced Multiple Sclerosis|Progressive Multiple Sclerosis | Drug: Cladribine (MAVENCLAD®)|Drug: Placebo | The 9-HPT peg speed (tasks/second) at 24 months|9-HPT proportion of patients who do not deteriorate at 24 months|Change over 24 months of the study in clinical outcome measure: EDSS|Change over 24 months of the study in clinical outcome measure: ARAT|Change over 24 months of the study in clinical outcome measure: ABILHAND|Change over 24 months of the study in clinical outcome measure: T25ftWT|Change over 24 months of the study in clinical outcome measure: SLCVA|Change over 24 months of the study in clinical outcome measure: MSIS-29v2|Change over 24 months of the study in clinical outcome measure: SDMT|Change over 24 months of the study in clinical outcome measure: NFI-MS|Change over 24 months of the study in clinical outcome measure: EuroQoL EQ-5D-5L|Change over 24 months of the study in clinical outcome measure: WPAI-GH|Safety/occurrence of adverse events|Preventing loss of brain volume|Preventing loss of spinal cord cross sectional area|Preventing new focal demyelinating lesions and T2 burden of disease increase.|Preventing new hypo-intense lesions ("black holes") on T1 weighted MRI|Degree of unblinding | Queen Mary University of London|National Institute for Health Research, United Kingdom|Merck Serono Limited, UK|Multiple Sclerosis Society of Great Britain & Northern Ireland|National Multiple Sclerosis Society USA|Barts & The London NHS Trust | Queens University Belfast (Belfast Health and Social Care Trust), Belfast, United Kingdom|University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham, Birmingham, United Kingdom|Cardiff University Hospital, Cardiff, United Kingdom|Anne Rowling Clinic, University of Edinburgh, Edinburgh, United Kingdom|Queen Elizabeth University Hospital Glasgow, Glasgow, United Kingdom|University Hospital Hairmyres, NHS Lanarkshire, Glasgow, United Kingdom|Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom|Walton Centre NHS Trust, Liverpool, United Kingdom|Royal London Hospital, London, United Kingdom|Royal Free London NHS Foundation Trust, London, United Kingdom|Queen's Hospital (Havering and Redbridge University Hospitals NHS Trust), London, United Kingdom|St George's University Hospitals NHS Foundation Trust, London, United Kingdom|Luton and Dunstable Hospital, Luton, United Kingdom|Salford Royal Hospital NHS Trust, Manchester, United Kingdom|Nottingham University Hospital (Nottingham University Hospitals NHS Trust), Nottingham, United Kingdom|University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom|Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom|University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom|Morriston Hospital, Swansea, Swansea, United Kingdom |
| Evaluation of the Efficacy of Descemet Membrane Transplantation for the Treatment of Fuchs' Endothelial Dystrophy | Fuchs' Endothelial Dystrophy | Other: Descemet Membrane Transplantation | Central Endothelial Cell Density|Visual acuity | Singapore National Eye Centre | Singapore National Eye Centre, Singapore, Singapore |
| Tysabri Observational Cohort Study - Multiple Sclerosis (MS) Registries | Progressive Multifocal Leukoencephalopathy | Biological: Tysabri | Prospective and Retrospective Analyses: Number of Participants with Confirmed Progressive Multifocal Leukoencephalopathy (PML)|Prospective and Retrospective Analyses: Number of Participants with Serious Adverse Events of Other Serious Opportunistic Infections (OIs) | Biogen | Research Site, Cambridge, Massachusetts, United States |
| Psilocybin Cancer Anxiety Study | Cancer | Drug: Psilocybin|Drug: Niacin | HADS Anxiety|State-Trait Anxiety Inventory (STAI) State|STAI State|HADS Depression|STAI Trait|Death Anxiety Scale|Death Transcendence Scale|Hopelessness|Demoralization Scale|QoL Physical Health Scale|QoL Psychological Scale|QoL Social Relationships Scale|QoL Environment Scale | NYU Langone Health | NYU College of Dentistry Bluestone Center for Clinical Research, New York, New York, United States |
| Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial | Multiple Sclerosis, Relapsing-Remitting | Other: Early Aggressive Therapy or Traditional Therapy | Time to sustained disability progression|Change in Overall Burden of MS|Patient-Determined Disease Steps (PDDS)|Multiple Sclerosis Functional Composite (MSFC) Composite Score|Timed 25 Foot Walk Test|Nine-hole Peg Test|Paced Auditory Serial Addition Test (PASAT)|Low contrast visual acuity|Patient-reported incomplete relapse recovery|Neurologic exam-based incomplete relapse recovery|Cognition using Symbol Digit Modality Test (SDMT)|Multiple Sclerosis Impact Scale (MSIS-29)|Quality of Life in Neurological Disorders (Neuro-QoL): Anxiety Subscale|Quality of Life in Neurological Disorders (Neuro-QoL): Depression Subscale|Quality of Life in Neurological Disorders (Neuro-QoL): Fatigue Subscale|Quality of Life in Neurological Disorders (Neuro-QoL): Upper Extremity Function|Quality of Life in Neurological Disorders (Neuro-QoL): Lower Extremity Function|Quality of Life in Neurological Disorders (Neuro-QoL): Cognitive Function|Quality of Life in Neurological Disorders (Neuro-QoL): Positive Affect/Well-being|Quality of Life in Neurological Disorders (Neuro-QoL): Sleep Disturbance|Quality of Life in Neurological Disorders (Neuro-QoL): Ability to Participate in Social Roles and Activities|Quality of Life in Neurological Disorders (Neuro-QoL): Satisfaction with Social Roles and Activities|Quality of Life in Neurological Disorders (Neuro-QoL): Stigma|Employment status|Marital status|Serious Adverse Events (SAEs)|Adverse event resulting in a decision to change disease-modifying therapy|Severe COVID-19 Infection | Johns Hopkins University|Patient-Centered Outcomes Research Institute | University of Alabama at Birmingham, Birmingham, Alabama, United States|The University of South Alabama, Mobile, Alabama, United States|St. Joseph's Hospital & Medical Center - Barrow Neurological Institute, Phoenix, Arizona, United States|Dignity Health Medical Foundation, Carmichael, California, United States|Cedars-Sinai Medical Center, Los Angeles, California, United States|University of California, Los Angeles, Los Angeles, California, United States|University of California, San Diego, San Diego, California, United States|University of California, San Francisco, San Francisco, California, United States|Christiana Care Health Services, Inc., Newark, Delaware, United States|Georgetown University, Washington, District of Columbia, United States|University of Florida, Gainesville, Florida, United States|University of Miami, Miami, Florida, United States|University of South Florida Health, Tampa, Florida, United States|Rush University Medical Center, Chicago, Illinois, United States|The University of Kansas Medical Center (KUMC), Kansas City, Kansas, United States|University of Louisville, Louisville, Kentucky, United States|Norton Neurology MS Services, Louisville, Kentucky, United States|University of Maryland, Baltimore, Baltimore, Maryland, United States|The Johns Hopkins Hospital, Baltimore, Maryland, United States|Massachusetts General Hospital, Boston, Massachusetts, United States|University of Massachusetts Medical School, Worcester, Massachusetts, United States|University of Michigan, Ann Arbor, Michigan, United States|Wayne State University, Detroit, Michigan, United States|Mayo Clinic, Rochester, Minnesota, United States|Billings Clinic, Billings, Montana, United States|Advanced Neurology Specialists, Great Falls, Montana, United States|University of Nebraska Medical Center, Omaha, Nebraska, United States|Hackensack University Medical Center, Hackensack, New Jersey, United States|RWJBarnabas Health Multiple Sclerosis Comprehensive Care Center, Livingston, New Jersey, United States|New York University School of Medicine, New York, New York, United States|Icahn School of Medicine at Mount Sinai, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|University of Rochester Medical Center, Rochester, New York, United States|Stony Brook University, Stony Brook, New York, United States|Novant Health Neurology and Sleep, Charlotte, North Carolina, United States|University of Cincinnati, Cincinnati, Ohio, United States|OhioHealth Research Institute, Columbus, Ohio, United States|Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States|Providence Health and Services - Oregon, Portland, Oregon, United States|Geisinger Clinic, Danville, Pennsylvania, United States|Allegheny Health Network Research Institute, Pittsburgh, Pennsylvania, United States|Vanderbilt Comprehensive MS Center, Nashville, Tennessee, United States|Baylor Scott and White Health, Dallas, Texas, United States|The University of Texas Southwestern Medical Center, Dallas, Texas, United States|Central Texas Neurology Consultants, Round Rock, Texas, United States|University of Utah, Salt Lake City, Utah, United States|The University of Vermont and State Agricultural College, Burlington, Vermont, United States|Blacksburg Neurology, Christiansburg, Virginia, United States|Neurology Consultants of Tidewater, Norfolk, Virginia, United States|Swedish Health Services, Seattle, Washington, United States|University of Washington, Seattle, Washington, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States |
| Longitudinal Data Collection in Pediatric and Adult Patients With Spinal Muscular Atrophy in Latin America | Spinal Muscular Atrophy | Describe the natural history of the disease (5q SMA in patients in Latin America) in a real-life context.|Disease characteristics at first diagnosis. | Hospital Israelita Albert Einstein|Biogen | Hospital Italiano de Buenos Aires, Buenos Aires, Caba, Argentina|Hospital de Pediatria J.P.Garrahan, Buenos Aires, Caba, Argentina|Private office, Buenos Aires, Rivadavia 4951 PB 2 Caballito, Argentina|Clínica Universitaaria Reina Fabiola, Córdoba, Argentina|Hospital Pediátrico Humberto Notti, Mendoza, Argentina|HUPES - Escola Bahiana de Medicina e Saúde Pública, Salvador, BA, Brazil|UFMG - Universidade Federal de Minas Gerais - Hospital das Clínicas, Belo Horizonte, MG, Brazil|Hospital Infantil Pequeno Príncipe, Curitiba, Paraná, Brazil|Instituto de Puericultura e Pediatria Martagão Gesteira da UFRJ, Rio De Janeiro, RJ, Brazil|HCPA - Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil|Unicamp - Hospital de Clínicas da Universidade Estadual de Campinas, Campinas, SP, Brazil|Hospital Israelita Albert Einstein, São Paulo, SP, Brazil|Instituto da Criança do Hospital das Clínicas de São Paulo - FMUSP, São Paulo, SP, Brazil|Clinica Las Condes, Santiago, Chile|Instituto Roosevelt Pontifícia Universidade Javeriana, Bogotá, Colombia|Hospital Pablo Tobon Uribe, Medellín, Colombia|Hospital Infantil de México Federico Gómez, Ciudad de mexico, Mexico|Hospital Christus Muguerza Alta Especialidade, Monterrey, Mexico|Centro de Rehabilitación e inclusión Infantil Teletón Estado de Mexico - Fundación Teletón Mexico, Tlalnepantla, Mexico|Centro Hospitalario Pereira Rossell, Facultad de Medicina- Universidad de la Republica, Montevideo, Uruguay | |
| Prospective Stratification of Infectious Risks in Multiple Sclerosis | Multiple Sclerosis | Other: MS-adapted AWIS questionnaire (MS-AWIS)|Other: infection diary (MS-AWIS diary) | AWIS RTI score|infection diary score|Comparison of infection scores between patients receiving Disease Modifying Therapies (DMTs) and those who do not receive DMTs | University Hospital, Basel, Switzerland|Swiss Multiple Sclerosis Society|Bangerter-Rhyner Stiftung|Center for Chronic Immunodeficiency (CCI) in Freiburg, Germany | University Hospital Basel, Department of Neurology, Basel, Switzerland |
| Natalizumab Temporary Discontinuation Study | Multiple Sclerosis | Other: Natalizumab discontinuation | Number of recorded infections including viral opportunistic infection|Saturation percentage of α4β1integrin receptors on the surface of lymphocytes|Number gadolinium-enhancing lesions|Absolute changes in gadolinium-enhancing and T2-weighted lesion volume between timepoints|Sum of new and enlarging T2-weighted lesions|Number of clinical relapses|Expanded Disability Status Scale (EDSS) score | University at Buffalo | Buffalo Neuroimaging Analysis Center, Buffalo, New York, United States|Jacobs Neurological Institute, Buffalo, New York, United States |
| Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod (FTY720) | Annual Relapse Rate (ARR)|Time to First Relapse|Change From Baseline in Expanded Disability Status Scale (EDSS) Score|Change From Baseline in Cerebral Volume|Percentage of Participants With Mild, Moderate or Severe Relapse|Percentage of Relapse-free Participants|Mean Number of T2 Active Lesions | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, East Gosford, New South Wales, Australia|Novartis Investigative Site, Kanwal, New South Wales, Australia|Novartis Investigative Site, Liverpool, New South Wales, Australia|Novartis Investigative Site, New Lambton Heights, New South Wales, Australia|Novartis Investigative Site, Sydney, New South Wales, Australia|Novartis Investigative Site, Auchenflower, Queensland, Australia|Novartis Investigative Site, Adelaide, South Australia, Australia|Novartis Investigative Site, Box Hill, Victoria, Australia|Novartis Investigative Site, Fitzroy, Victoria, Australia|Novartis Investigative Site, Melbourne, Victoria, Australia|Novartis Investigative Site, Parkville, Victoria, Australia|Novartis Investigative Site, Nedlands, Western Australia, Australia|Novartis Investigative Site, Bedford Park, Australia|Novartis Investigative Site, Brisbane Queensland, Australia|Novartis Investigative Site, Geelong VIC, Australia|Novartis Investigative Site, Ferrol, A Coruna, Spain|Novartis Investigative Site, Córdoba, Andalucia, Spain|Novartis Investigative Site, Granada, Andalucia, Spain|Novartis Investigative Site, Malaga, Andalucia, Spain|Novartis Investigative Site, Sevilla, Andalucia, Spain|Novartis Investigative Site, Sevilla, Andalucia, Spain|Novartis Investigative Site, Oviedo, Asturias, Spain|Novartis Investigative Site, Santander, Cantabria, Spain|Novartis Investigative Site, Albacete, Castilla La Mancha, Spain|Novartis Investigative Site, Valladolid, Castilla Y Leon, Spain|Novartis Investigative Site, Leon, Castilla Y León, Spain|Novartis Investigative Site, Badalona, Catalunya, Spain|Novartis Investigative Site, Barcelona, Catalunya, Spain|Novartis Investigative Site, Barcelona, Catalunya, Spain|Novartis Investigative Site, Tarragona, Cataluña, Spain|Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain|Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain|Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain|Novartis Investigative Site, La Coruna, Galicia, Spain|Novartis Investigative Site, Palma De Mallorca, Islas Baleares, Spain|Novartis Investigative Site, Las Palmas de Gran Canaria, Las Palmas De G.C, Spain|Novartis Investigative Site, Pamplona, Navarra, Spain|Novartis Investigative Site, Barakaldo, Pais Vasco, Spain|Novartis Investigative Site, Bilbao, Pais Vasco, Spain|Novartis Investigative Site, Barcelona, Spain|Novartis Investigative Site, Las Palmas de Gran Canaria, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Santa Cruz de Tenerife, Spain |
| A Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of IMS001 in Subjects With Multiple Sclerosis | Multiple Sclerosis | Biological: IMS001 | Safety and tolerability | ImStem Biotechnology|Rho, Inc. | Shepherd Center, Atlanta, Georgia, United States|UMass Memorial Medical Center, Worcester, Massachusetts, United States|Rocky Mountain MS Clinic, Salt Lake City, Utah, United States |
| Adherence in Pediatric Multiple Sclerosis | Multiple Sclerosis | Behavioral: Motivational Interview|Other: Video Attention Control | Change in Level of Adherence in Subjects (Objective Measure)|Change in Level of Adherence in Subjects (Parent- and Patient-Reported): MSTAQ|Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Morisky|Change in Level of Adherence in Subjects (Parent- and Patient-Reported): Parental Involvement|Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): PedsQL|Quality of Life and Psychosocial Outcomes (Parent- and Patient-Reported): MSNQ | The Hospital for Sick Children|National Multiple Sclerosis Society|Loma Linda University|University of Pittsburgh|Children's Hospital of Philadelphia|Boston Children's Hospital|Baylor College of Medicine|University of Alabama at Birmingham|Mayo Clinic|University of Colorado, Denver|University of California, San Francisco|Washington University School of Medicine|Alberta Children's Hospital|The Cleveland Clinic|DeltaQuest Foundation | University of Alabama, Birmingham, Alabama, United States|Loma Linda University, Loma Linda, California, United States|The Regents of the University of California, San Francisco, San Francisco, California, United States|University of Colorado at Denver, Denver, Colorado, United States|Boston Children's Hospital, Boston, Massachusetts, United States|Mayo Clinic, Rochester, Minnesota, United States|Washington University, Saint Louis, Missouri, United States|Cleveland Clinic, Cleveland, Ohio, United States|The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, United States|Baylor College of Medicine, Houston, Texas, United States|Alberta Children's Hospital, Calgary, Alberta, Canada|The Hospital for Sick Children, Toronto, Ontario, Canada |
| Delphinus SoftVue Prospective Case Collection - ARM 1 | Breast Neoplasms | Device: Routine Full-Field Digital Mammography|Device: Routine Digital Breast Tomosynthesis|Device: Automated Whole Breast Ultrasound | No Breast Cancer|Breast Cancer | Delphinus Medical Technologies, Inc. | USC Keck School of Medicine, Los Angeles, California, United States|Mount Sinai Medical Center, Miami Beach, Florida, United States|SouthCoast Imaging, Savannah, Georgia, United States|Beaumont Dearborn Breast Care Center, Dearborn, Michigan, United States|Karmanos Cancer Institute, Detroit, Michigan, United States|Mercy Imaging Services, Washington, Missouri, United States|Elizabeth Wende Breast Care, Rochester, New York, United States|UNC Breast Imaging Center, Chapel Hill, North Carolina, United States|Weinstein Imaging Associates, Pittsburgh, Pennsylvania, United States|Ascension St. Elizabeth, Radiology Associates of the Fox Valley, Appleton, Wisconsin, United States |
| The Multiple Sclerosis Continuous Quality Improvement (MSCQI) Collaborative | Multiple Sclerosis | Other: Quality Improvement | Disease modifying therapy utilization|Clinical outcome for Depression|Clinic Outcome for Anxiety|Clinic Outcomes on Cognitive Function|Clinic Outcomes on mobility|Clinic Outcomes on fine motor skills and activities of daily living|Clinic Outcomes on stigma associated with MS|Clinic Outcomes on ability to participate in social roles and activities|Clinic Outcomes on satisfaction with social roles and activities|Clinic Outcomes for sleep disturbance|Clinic Outcomes for communication|Clinic Outcomes for Vitamin D levels in MS patients|Clinic Outcomes for fatigue|Clinic Outcomes for assesment of patient health status|Clinic Outcomes for satisfaction of treatment by medication|Clinic Outcomes for the effects of MS on the patient|Clinic Outcomes for the presence of a MS relapse|Clinic Outcomes reporting of MS patient daily symptoms|Medical History|Hospitalization|Demographic information|Medication|MRI utilization|Exercise|System level measure the patient experience for ambulatory care.|System level measure of Health Care Quality | Dartmouth-Hitchcock Medical Center|MGH Multiple Sclerosis Clinic|University of Vermont Multiple Sclerosis Center|Neurology Associates Multiple Sclerosis Center of Greater Orlando|Concord Hospital | Neurology Associates of Greater Orlando, Maitland, Florida, United States|Massachusetts General Hospital Multiple Sclerosis Center, Boston, Massachusetts, United States|Concord Hospital, Concord, New Hampshire, United States|University of Vermont Multiple Sclerosis Center, Burlington, Vermont, United States |
| COMparison Between All immunoTherapies for Multiple Sclerosis. | Relapsing-remitting Multiple Sclerosis | Drug: Rituximab | Confirmed disease progression in patients with Expanded Disability Status Scale (EDSS) ≤2.5 at baseline|Confirmed disease progression in patients with EDSS ≥2.5 at baseline|Disease-related impact on daily life|Risk and side effect assessments|Occurence of Serious Adverse Reactions|Annual relapse rate|Number of Contrast-enhancing lesions (CEL)|Increase in EDSS|Proportion of patients with at least 1 step increase in EDSS|Proportion of patients with No Evidence of Disease Activity (NEDA) -2|Proportion of patients with NEDA-3|Levels of Neurofilament-Light chain (NFL) in serum|Brain atrophy rate|Time on drug|Treatment satisfaction|Quality of life assessments|Fatigue|Health economy|Occurrence of Anti-drug antibodies (ADA)|Employment rate|Severity assessments of COVID-19 in MS|Severity assessments of COVID-19 in MS in relation to DMD | Karolinska Institutet|Patient-Centered Outcomes Research Institute|Kaiser Foundation Research Institute | Fredrik Piehl, Stockholm, Sweden |
| Observational Study to Characterize Real-world Clinical Outcomes With Relapsing-remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis | Proportion of participants relapsed at 12 months in participants treated with DMF|Proportion of participants relapsed at 12 months treated with index therapy in the overall population as well as the subgroup of MS participants who were naïve to DMTs and were diagnosed with MS within 3 years of starting the index therapy|ARR at 12 months in participants treated with index therapy in the overall population as well as in the matched cohorts|Proportion of relapsed participants with one or more MS-related hospitalizations during the 12 months following treatment initiation in participants treated with index therapy in the overall population and the matched cohorts|Proportion of relapsed participants requiring treatment with intravenous corticosteroids during the 12 months following treatment initiation in participants treated with index therapy in the overall participant population and the matched cohorts | Biogen | Research Site, Homewood, Alabama, United States|Research Site, Gilbert, Arizona, United States|Research Site, Hanford, California, United States|Research Site, Modesto, California, United States|Research Site, Santa Ana, California, United States|Research Site, Aurora, Colorado, United States|Research Site, Danbury, Connecticut, United States|Research Site, Hartford, Connecticut, United States|Research Site, Jacksonville, Florida, United States|Research Site, Port Orange, Florida, United States|Research Site, Savannah, Georgia, United States|Research Site, Avon, Indiana, United States|Research Site, Franklin, Indiana, United States|Research Site, Muncie, Indiana, United States|Research Site, Overland Park, Kansas, United States|Research Site, Boston, Massachusetts, United States|Research Site, Boston, Massachusetts, United States|Research Site, Wellesley, Massachusetts, United States|Research Site, Golden Valley, Minnesota, United States|Research Site, Amherst, New York, United States|Research Site, New Hyde park, New York, United States|Research Site, New York, New York, United States|Research Site, Patchogue, New York, United States|Research Site, Raleigh, North Carolina, United States|Research Site, Cleveland, Ohio, United States|Research Site, Columbus, Ohio, United States|Research Site, Columbus, Ohio, United States|Research Site, Medford, Oregon, United States|Research Site, Portland, Oregon, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Pittsburgh, Pennsylvania, United States|Research Site, Dallas, Texas, United States|Research Site, Houston, Texas, United States|Research Site, Mansfield, Texas, United States|Research Site, Round Rock, Texas, United States|Research Site, Salt Lake City, Utah, United States|Research Site, Norfolk, Virginia, United States|Research Site, Tacoma, Washington, United States|Research Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina|Research Site, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina|Research Site, Rosario, Santa Fe, Argentina|Research Site, Rosario, Santa Fe, Argentina|Research Site, Ciudad Autonoma Buenos Aires, Argentina|Research Site, Cordoba, Argentina|Research Site, Salta, Argentina|Research Site, New Lambton Heights, New South Wales, Australia|Research Site, Box Hill, Victoria, Australia|Research Site, Heidelberg, Victoria, Australia|Research Site, Melbourne, Victoria, Australia|Research Site, Burnaby, British Columbia, Canada|Research Site, St. John, New Brunswick, Canada|Research Site, Halifax, Nova Scotia, Canada|Research Site, Cambridge, Ontario, Canada|Research Site, Guelph, Ontario, Canada|Research Site, Chicoutimi, Quebec, Canada|Research Site, Gatineau, Quebec, Canada|Research Site, Greenfield Park, Quebec, Canada|Research Site, Osijek, Croatia|Research Site, Varazdin, Croatia|Research Site, Brno, Czech Republic|Research Site, Hradec Kralove, Czech Republic|Research Site, Hradec Kralove, Czech Republic|Research Site, Jihlava, Czech Republic|Research Site, Olomouc, Czech Republic|Research Site, Ostrava-Poruba, Czech Republic|Research Site, Pardubice, Czech Republic|Research Site, Prague 5, Czech Republic|Research Site, Teplice, Czech Republic|Research Site, Libourne Cedex, Gironde, France|Research Site, Toulouse cedex 9, Haute Garonne, France|Research Site, Le Mans cedex 9, Sarthe, France|Research Site, Le Chesnay Cedex, Yvelines, France|Research Site, Freiburg, Baden Wuerttemberg, Germany|Research Site, Pforzheim, Baden Wuerttemberg, Germany|Research Site, Stuttgart, Baden Wuerttemberg, Germany|Research Site, Bamberg, Bayern, Germany|Research Site, Potsdam, Brandenburg, Germany|Research Site, Kassel, Hessen, Germany|Research Site, Oldenburg, Niedersachsen, Germany|Research Site, Osnabrueck, Niedersachsen, Germany|Research Site, Stade, Niedersachsen, Germany|Research Site, Bochum, Nordrhein Westfalen, Germany|Research Site, Düsseldorf, Nordrhein Westfalen, Germany|Research Site, Gelsenkirchen, Nordrhein Westfalen, Germany|Research Site, Hagen, Nordrhein Westfalen, Germany|Research Site, Siegen, Nordrhein Westfalen, Germany|Research Site, Sprockhoevel, Nordrhein Westfalen, Germany|Research Site, Kandel, Rheinland Pfalz, Germany|Research Site, St. Ingbert, Saarland, Germany|Research Site, Leipzig, Sachsen, Germany|Research Site, Kiel, Schleswig Holstein, Germany|Research Site, Berlin, Germany|Research Site, Berlin, Germany|Research Site, Hamburg, Germany|Research Site, Budapest, Hungary|Research Site, Debrecen, Hungary|Research Site, Eger, Hungary|Research Site, Esztergom, Hungary|Research Site, Kecskemet, Hungary|Research Site, Nyiregyhaza, Hungary|Research Site, Cagliari, Italy|Research Site, Catania, Italy|Research Site, Napoli, Italy|Research Site, Napoli, Italy|Research Site, Badalona, Barcelona, Spain|Research Site, Santiago de Compostela, La Coruña, Spain|Research Site, Vigo, Pontevedra, Spain|Research Site, Alicante, Spain|Research Site, Cordoba, Spain|Research Site, Madrid, Spain|Research Site, Malaga, Spain|Research Site, Sevilla, Spain|Research Site, Lausanne, Switzerland|Research Site, Lugano, Switzerland|Research Site, Truro, Cornwall, United Kingdom|Research Site, Exeter, Devon, United Kingdom|Research Site, Chelmsford, Essex, United Kingdom|Research Site, Romford, Essex, United Kingdom|Research Site, London, Greater London, United Kingdom|Research Site, Glasgow, Strathclyde, United Kingdom|Research Site, Chertsey, Surrey, United Kingdom | |
| Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis. | Relapsing Remitting Multiple Sclerosis | Drug: Fingolimod|Drug: Disease Modifying therapy | Participant Retention Rate Over 12 Months|Primary and Secondary Reasons for Discontinuation From Randomized Treatment: Randomized Set|Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Oral Test) by Visit (Randomized Treatment / Randomized Phase)|Change From Baseline of Symbol Digit Modalities Test (SDMT) Scores (Written Test) by Visit (Randomized Treatment / Randomized Phase)|Percent Change From Baseline in Brain Volume From Month 12 to Last Visit (Randomized)|Number of Satisfied Participants Per Medication Satisfaction Questionnaire (MSQ) Score | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Cullman, Alabama, United States|Novartis Investigative Site, Phoenix, Arizona, United States|Novartis Investigative Site, Sun City, Arizona, United States|Novartis Investigative Site, Tucson, Arizona, United States|Novartis Investigative Site, Sherwood, Arkansas, United States|Novartis Investigative Site, Fullerton, California, United States|Novartis Investigative Site, Oceanside, California, United States|Novartis Investigative Site, San Francisco, California, United States|Novartis Investigative Site, Walnut Creek, California, United States|Novartis Investigative Site, Basalt, Colorado, United States|Novartis Investigative Site, Boulder, Colorado, United States|Novartis Investigative Site, Denver, Colorado, United States|Novartis Investigative Site, Denver, Colorado, United States|Novartis Investigative Site, Fort Collins, Colorado, United States|Novartis Investigative Site, Fairfield, Connecticut, United States|Novartis Investigative Site, New London, Connecticut, United States|Novartis Investigative Site, Dover, Delaware, United States|Novartis Investigative Site, Atlantis, Florida, United States|Novartis Investigative Site, Bradenton, Florida, United States|Novartis Investigative Site, Delray Beach, Florida, United States|Novartis Investigative Site, Hollywood, Florida, United States|Novartis Investigative Site, Jacksonville, Florida, United States|Novartis Investigative Site, North Palm Beach, Florida, United States|Novartis Investigative Site, Plantation, Florida, United States|Novartis Investigative Site, Pompano Beach, Florida, United States|Novartis Investigative Site, Port Charlotte, Florida, United States|Novartis Investigative Site, Port Orange, Florida, United States|Novartis Investigative Site, Saint Petersburg, Florida, United States|Novartis Investigative Site, Sarasota, Florida, United States|Novartis Investigative Site, Sarasota, Florida, United States|Novartis Investigative Site, Tallahassee, Florida, United States|Novartis Investigative Site, Tampa, Florida, United States|Novartis Investigative Site, West Palm Beach, Florida, United States|Novartis Investigative Site, Atlanta, Georgia, United States|Novartis Investigative Site, Columbus, Georgia, United States|Novartis Investigative Site, Decatur, Georgia, United States|Novartis Investigative Site, Suwanee, Georgia, United States|Novartis Investigative Site, Flossmoor, Illinois, United States|Novartis Investigative Site, Northbrook, Illinois, United States|Novartis Investigative Site, Anderson, Indiana, United States|Novartis Investigative Site, Indianapolis, Indiana, United States|Novartis Investigative Site, Indianapolis, Indiana, United States|Novartis Investigative Site, Des Moines, Iowa, United States|Novartis Investigative Site, Overland Park, Kansas, United States|Novartis Investigative Site, Wichita, Kansas, United States|Novartis Investigative Site, Hawesville, Kentucky, United States|Novartis Investigative Site, Lexington, Kentucky, United States|Novartis Investigative Site, Madisonville, Kentucky, United States|Novartis Investigative Site, Alexandria, Louisiana, United States|Novartis Investigative Site, Baton Rouge, Louisiana, United States|Novartis Investigative Site, New Orleans, Louisiana, United States|Novartis Investigative Site, Annapolis, Maryland, United States|Novartis Investigative Site, Fulton, Maryland, United States|Novartis Investigative Site, New Bedford, Massachusetts, United States|Novartis Investigative Site, North Dartmouth, Massachusetts, United States|Novartis Investigative Site, Springfield, Massachusetts, United States|Novartis Investigative Site, Watertown, Massachusetts, United States|Novartis Investigative Site, Worcester, Massachusetts, United States|Novartis Investigative Site, Kalamazoo, Michigan, United States|Novartis Investigative Site, Traverse City, Michigan, United States|Novartis Investigative Site, Nixa, Missouri, United States|Novartis Investigative Site, North Kansas City, Missouri, United States|Novartis Investigative Site, Saint Louis, Missouri, United States|Novartis Investigative Site, Las Vegas, Nevada, United States|Novartis Investigative Site, Las Vegas, Nevada, United States|Novartis Investigative Site, Las Vegas, Nevada, United States|Novartis Investigative Site, Flemington, New Jersey, United States|Novartis Investigative Site, Teaneck, New Jersey, United States|Novartis Investigative Site, Toms River, New Jersey, United States|Novartis Investigative Site, Albuquerque, New Mexico, United States|Novartis Investigative Site, Albany, New York, United States|Novartis Investigative Site, Amherst, New York, United States|Novartis Investigative Site, Bronx, New York, United States|Novartis Investigative Site, Kingston, New York, United States|Novartis Investigative Site, Latham, New York, United States|Novartis Investigative Site, New York, New York, United States|Novartis Investigative Site, Patchogue, New York, United States|Novartis Investigative Site, Asheville, North Carolina, United States|Novartis Investigative Site, Charlotte, North Carolina, United States|Novartis Investigative Site, Charlotte, North Carolina, United States|Novartis Investigative Site, Greensboro, North Carolina, United States|Novartis Investigative Site, Greenville, North Carolina, United States|Novartis Investigative Site, Raleigh, North Carolina, United States|Novartis Investigative Site, Salisbury, North Carolina, United States|Novartis Investigative Site, Winston-Salem, North Carolina, United States|Novartis Investigative Site, Grand Forks, North Dakota, United States|Novartis Investigative Site, Akron, Ohio, United States|Novartis Investigative Site, Bellevue, Ohio, United States|Novartis Investigative Site, Canton, Ohio, United States|Novartis Investigative Site, Cincinnati, Ohio, United States|Novartis Investigative Site, Columbus, Ohio, United States|Novartis Investigative Site, Dayton, Ohio, United States|Novartis Investigative Site, Toledo, Ohio, United States|Novartis Investigative Site, Oklahoma City, Oklahoma, United States|Novartis Investigative Site, Oklahoma City, Oklahoma, United States|Novartis Investigative Site, Eugene, Oregon, United States|Novartis Investigative Site, Greensburg, Pennsylvania, United States|Novartis Investigative Site, Hershey, Pennsylvania, United States|Novartis Investigative Site, Pittsburgh, Pennsylvania, United States|Novartis Investigative Site, Cranston, Rhode Island, United States|Novartis Investigative Site, Indian Land, South Carolina, United States|Novartis Investigative Site, Spartanburg, South Carolina, United States|Novartis Investigative Site, Spartanburg, South Carolina, United States|Novartis Investigative Site, Cordova, Tennessee, United States|Novartis Investigative Site, Knoxville, Tennessee, United States|Novartis Investigative Site, Nashville, Tennessee, United States|Novartis Investigative Site, Colleyville, Texas, United States|Novartis Investigative Site, Houston, Texas, United States|Novartis Investigative Site, Lubbock, Texas, United States|Novartis Investigative Site, North Richland Hills, Texas, United States|Novartis Investigative Site, Plano, Texas, United States|Novartis Investigative Site, Round Rock, Texas, United States|Novartis Investigative Site, San Antonio, Texas, United States|Novartis Investigative Site, Orem, Utah, United States|Novartis Investigative Site, Alexandria, Virginia, United States|Novartis Investigative Site, Norfolk, Virginia, United States|Novartis Investigative Site, Vienna, Virginia, United States|Novartis Investigative Site, Bothell, Washington, United States|Novartis Investigative Site, Seattle, Washington, United States|Novartis Investigative Site, Tacoma, Washington, United States|Novartis Investigative Site, Morgantown, West Virginia, United States|Novartis Investigative Site, Neenah, Wisconsin, United States|Novartis Investigative Site, Guaynabo, Puerto Rico |
| Safety Study to Evaluate Immune Response of Vaccines in Participants With Relapsing Forms of Multiple Sclerosis Who Receive Ozanimod Compared to Non-Pegylated Interferon (IFN)-β or No Disease Modifying Therapy | Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting | Biological: Tetanus, diphtheria, and acellular pertussis vaccine|Biological: Pneumococcal polysaccharide vaccine|Biological: Seasonal influenza vaccine | Proportion of participants with serologic response to tetanus toxoid|Tetanus|Pneumococcus|Safety of concomitant vaccine administration in participants taking ozanimod | Celgene | Stanford University, Palo Alto, California, United States|Colorado Springs Neurological Associates, Colorado Springs, Colorado, United States|Hartford Healthcare CT, Southington, Connecticut, United States|University of Florida Health, Gainesville, Florida, United States|University of Florida Health, Gainesville, Florida, United States|Neurostudies Inc, Port Charlotte, Florida, United States|Neurostudies Inc, Port Charlotte, Florida, United States|Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS, Port Orange, Florida, United States|Accel Research Sites - Brain and Spine Institute of Port Orange - ERN - PPDS, Port Orange, Florida, United States|University of Chicago Medicine, Chicago, Illinois, United States|University of Chicago Medicine, Chicago, Illinois, United States|Consultants In Neurology, Northbrook, Illinois, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|University Of Kansas Medical Center, Kansas City, Kansas, United States|CPFCC Neurology Research Dept., Overland Park, Kansas, United States|CPFCC Neurology Research Dept., Overland Park, Kansas, United States|Neuromedical Clinic of Central LA, Alexandria, Louisiana, United States|Neuromedical Clinic of Central LA, Alexandria, Louisiana, United States|Neurology Center of New England P.C., Foxboro, Massachusetts, United States|Neurology Center of New England P.C., Foxboro, Massachusetts, United States|Michigan State University MS Clinic, East Lansing, Michigan, United States|Shapiro Center for MS at the Minneapolis Clinic of Neurology, Minneapolis, Minnesota, United States|Neurology Associates PC, Lincoln, Nebraska, United States|Jersey Shore MS Center, Neptune, New Jersey, United States|Jersey Shore MS Center, Neptune, New Jersey, United States|Holy Name Hospital, Teaneck, New Jersey, United States|South Shore Neurology Associates, Inc, Patchogue, New York, United States|South Shore Neurology Associates, Inc, Patchogue, New York, United States|Asheville Neurology Specialists PA, Asheville, North Carolina, United States|Asheville Neurology Specialists PA, Asheville, North Carolina, United States|Lake Norman Neurology, Mooresville, North Carolina, United States|NeuroScience Research Center, LLC, Canton, Ohio, United States|Velocity Clinical Research - Cleveland - ERN - PPDS, Cleveland, Ohio, United States|Thomas Jefferson University - Clinical Research Institute, Philadelphia, Pennsylvania, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|Sanford Health, Sioux Falls, South Dakota, United States|Hope Neurology MS Center, Knoxville, Tennessee, United States|Hope Neurology MS Center, Knoxville, Tennessee, United States|Central Texas Neurology Consultants PA, Round Rock, Texas, United States|MultiCare Institute for Research and Innovation, Tacoma, Washington, United States|MultiCare Institute for Research and Innovation, Tacoma, Washington, United States|Vaught Neurological Services, PLLC, Crab Orchard, West Virginia, United States|Vaught Neurological Services, PLLC, Crab Orchard, West Virginia, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States|St. Josef Hospital, Bochum, Germany|Dresden University Clinic, Dresden, Germany|Local Institution - 206, Mannheim, Germany|Nervenärztliche Gemeinschaftspraxis Neuroplus, Mannheim, Germany|Universitätsklinik Rostock, Rostock, Germany |
| Inhibition of CArbonic Anhydrase in Combination With Platinum and Etoposide-based Radiochemotherapy in Patients With Localized Small Cell Lung Cancer | Small Cell Lung Cancer | Drug: acetazolamide in combination with platinum and etoposide-based radiochemotherapy | To identify the Tolerated Maximum Dose (DMT) and Recommended Dose (DR) of acetazolamide in combination with radiotherapy combined with platinum and etoposide chemotherapy|To determine the overall tolerance of the association acetazolamide and radiochemotherapy|To evaluate the effectiveness of the treatment|To identify predictive factors for response to acetazolamide|To evaluate progression-free survival at 24 months|To evaluate overall survival at 24 months|To determine the compliance of acetazolamide|To evaluate the quality of life | Centre Antoine Lacassagne | Centre Antoine Lacassagne, Nice, France |
| A 2 Stage Trial of Lenalidomide (REV) in Asymptomatic Ovarian Cancer Patients With Increasing CA 125 in Late Relapse | Ovarian Cancer Recurrent | Drug: Lenalidomide | Efficacy of lenalidomide as single agent, then DMT of lenalidomise with carboplatin and pegylated liposomal doxorubicin|Safety profile of lenalidomide as single agent, then in combination | ARCAGY/ GINECO GROUP | Hopital Tenon, Paris, France |
| Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought | Healthy | Drug: Psilocybin|Drug: Placebo | Difference between drug conditions in the frequency of word use during free association tasks|Sensitivity in distinguishing old versus newly presented visual stimuli|Accuracy in the remote associates task as assessed by total correct number of trials|Accuracy in the alternative uses task|Alpha band power in EEG record|Reliability of whole-brain response while watching videos | Johns Hopkins University | Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States |
| Psilocybin Therapy for Depression in Bipolar II Disorder | Bipolar II Disorder | Drug: Psilocybin therapy | Safety and tolerability of psilocybin therapy for depression in BD II|Recruitment rate|Retention rate|Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II|Treatment Satisfaction of study procedures|Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II|Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II|Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II|Patient reported effects of psilocybin therapy on depressive symptoms symptoms in people with Bipolar II (exploratory)|Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory)|Effects of psilocybin therapy on sleep quality in people with Bipolar II (exploratory)|Effects of psilocybin therapy on quality of life in people with Bipolar II (exploratory)|Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory)|Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory)|Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory)|Subjective effects of psilocybin therapy in people with Bipolar II | University of California, San Francisco | University of California, San Francisco, San Francisco, California, United States |
| Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease | Parkinson Disease|Depression|Anxiety | Drug: Psilocybin therapy | Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD|Recruitment rate|Retention rate|Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD|Effects of psilocybin therapy on depression in people with PD (exploratory)|Effects of psilocybin therapy on anxiety in people with PD (exploratory)|Effects of psilocybin therapy on self-reported apathy (exploratory)|Effects of psilocybin therapy on self-reported depression (exploratory)|Effects of psilocybin therapy on self-reported lower extremity function (exploratory)|Effects of psilocybin therapy on self-reported Upper Extremity Function (exploratory)|Effects of psilocybin therapy on self-reported Cognitive Function (exploratory)|Effects of psilocybin therapy on self-reported Fatigue (exploratory)|Effects of psilocybin therapy on self-reported Concern with Death and Dying (exploratory)|Effects of psilocybin therapy on self-reported Social Roles and Activities (exploratory)|Effects of psilocybin therapy on self-reported Positive Affect and Well-Being (exploratory) | Joshua Woolley, MD/PhD|University of California, San Francisco | University of California, San Francisco, San Francisco, California, United States |
| Multiple Sclerosis Outcome Determination Evaluating Real Differences After TimE | Relapsing Remitting Multiple Sclerosis | Other: Clinical assessment | Mean Expanded Disability Status Scale (EDSS) score at prospective assessment.|Proportion experiencing (serious) adverse events in first 9-10 years after diagnosis|Proportion attaining Expanded Disability Status Scale (EDSS) 3.0, 4.0 and 6.0|Mean change in Expanded Disability Status Scale (EDSS) between treatment groups|Mean scores on patient reported outcome measure Multiple Sclerosis Impact Scale -29 (MSIS-29) at prospective assessment|Mean Brief International Cognitive Assessment for MS (BICAMS) score at prospective assessment|Mean 9-Hole Peg Test (9-HPT) at prospective assessment | NHS Greater Glasgow and Clyde|Biogen | Clinical Research Facility, Glasgow, United Kingdom |
| Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder | Major Depressive Disorder|Alcohol Use Disorder | Drug: Psilocybin|Drug: Placebo | Change from baseline in grid-version of the Hamilton Depression Rating Scale (GRID-HAMD) score|Change from baseline in percentage of days abstinent as measured by the Time Line Follow Back (TLFB) assessment|Change from baseline in percentage of days of heavy drinking as measured by the TLFB assessment|Change from baseline in gamma-glutamyl transferase (GGT)|Change from baseline in the percentage of carbohydrate deficient transferrin relative to total transferrin concentration (%CDT)|Change from baseline in the ratio of aspartate transaminase to alanine transaminase (AST/ALT)|Change from baseline in Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR) score|Change from baseline in State Trait Anxiety Index (STAI) score|Change from baseline in percentage of days abstinent as measured by the TLFB assessment|Change from baseline in GGT|Change from baseline in %CDT|Change from baseline in AST/ALT ratio | Johns Hopkins University | Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States |
| COVID-19 Vaccine Response in Treated MS Patients | Multiple Sclerosis|Healthy | Other: Blood draw | Primary endpoint|Secondary endpoint 1|Secondary endpoint 2|Secondary endpoint 3|Secondary endpoint 4|Secondary endpoint 5 | Brigham and Women's Hospital | Brigham MS Center, Boston, Massachusetts, United States |
| Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action | Fibromyalgia | Drug: Psilocybin|Behavioral: Therapeutic support | Lempel-Ziv complexity (LZc)|The Brief Experiential Avoidance Questionnaire (BEAQ)|MRI|Patient reported outcome measures|Physiology: Heart rate, body temperature, accelerometry|Qualitative interviews | Imperial College London | Imperial College London, London, United Kingdom |
| Anti-inflammatory Status in DM2 Treated Patients | Diabetes Mellitus, Type 2 | Drug: Metformin / alogliptin Oral Product|Drug: Metformin / Pioglitazone Pill|Drug: triple therapy | inflammatory miRNA|side effects|body weight|Waist values|drug interaction|Fasting blood glucose|HbA1c levels|liver function|cell count|lipid metabolism/atheroscelorisis | University of Catanzaro | ASP Catanzaro, Catanzaro, Italy |
| The Effect of Intraneural Facilitation Therapy on Diabetic Patients With Peripheral Neuropathy | Diabetic Neuropathy | Other: Intraneural Facilitation|Other: Sham | Pain Quality Assessment Scale|Limits of Stability|Zeno Walkway|Sensory organization test (SOT) | Loma Linda University | Loma Linda University, Loma Linda, California, United States |
| Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors | Diabetes Mellitus, Type 2 | Drug: Degludec|Drug: Glargine U300 | Changes from baseline in glucose variability|Changes from baseline in oxidative stress|Changes from baseline in arterial stiffness after treatment|Changes from baseline in total cholesterol|Changes from baseline in triglycerides|Changes from baseline in LDL|Changes from baseline in HDL|Changes from baseline in WBC|Changes from baseline in RBC|Changes from baseline in platelets|Changes from baseline in hemoglobin|Changes from baseline in hematocrit|Changes from baseline in MCV|Changes from baseline in liver enzymes|Changes from baseline in LDH|Changes from baseline in ALP|Changes from baseline in CRP | University of Split, School of Medicine|Pavle Vrebalov Cindro|Jonatan Vuković|Darko Modun|Božo Smajić|Gordan Kardum|Tina Tičinović Kurir|Doris Rušić|Ana Šešelja Perišin|Josipa Bukić | Klinički bolnički Centar Split, Split, Croatia |
| A Single-blinded, Controlled, Multi-centre Study of Effects of Exercise in Participants With Multiple Sclerosis | Exercise | Change of muscle strength|Changes of speed of walking | Biogen|Biogen Idec A/S | Coordinating Research Site, NSW, Australia|Research Site, Odense, Denmark|Research Site, Sønderborg, Denmark|Research Site, Vejle, Denmark|Research Site, Jyväskylä, Finland|Research Site, Oulu, Finland|Research Site, Pori, Finland|Research Site, Seinäjokï, Finland|Research Site, Hamilton, New Zealand|Research Site, Drammen, Norway|Research Site, Ullevål, Norway|Research Site, Gothenburg, Sweden|Research Site, Stockholm, Sweden|Research Site, Ängelholm, Sweden | |
| Psychopharmacology of Psilocybin in Cancer Patients | Depressive Symptoms|Anxiety|Cancer | Drug: psilocybin | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.|HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | Johns Hopkins University|Heffter Research Institute | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Campus, Baltimore, Maryland, United States |
| Methylprednisolone During the Switch Between Natalizumab and Fingolimod | Multiple Sclerosis | Drug: Methylprednisolone|Drug: Placebo|Drug: natalizumab (NTZ)|Drug: fingolimob (FTY) | efficacy of high dose methylprednisolone compared to that of a placebo|comparison of the number of new T2 or gadolinium enhanced lesions on MRI in the 2 treatment groups|comparison of the number of MS relapses during the 6 months after natalizumab discontinuation, in the 2 treatment groups|potential correlations between previous MS activity and the risk of relapse or inflammatory rebound on MRI after natalizumab discontinuation|adverse effects of high dose oral prednisolone|use of methylprednisolone once every 4 weeks during the switch between natalizumab and fingolimod in patients with MS | University Hospital, Clermont-Ferrand | CHU Clermont-Ferrand, Clermont-Ferrand, France |
| Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM | Multiple Sclerosis | Drug: Ocrelizumab | Proportion of patients discontinuing the treatment with ocrelizumab in the last 12 months after inclusion|Multiple sclerosis phenotype|Gender|Age at study entry | Hospital Italiano de Buenos Aires | Juan Ignacio Rojas, Buenos Aires, Argentina|Juan Ignacio Rojas, Buenos Aires, Argentina|Juan Ignacio Rojas, Buenos Aires, Argentina|Edgard Carnero, Buenos Aires, Argentina |
| Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409 | Relapsing Remitting Multiple Sclerosis | Drug: alemtuzumab GZ402673 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs)|Number of Participants With Infusion-Associated Reactions (IAR)|Number of Participants With Adverse Events of Special Interest (AESI)|Number of Participants With Potentially Clinically Significant Laboratory Abnormalities|Annualized Relapse Rate|Proportion of Participants Who Were Relapse Free|Change From Baseline in Expanded Disability Status Scale (EDSS) Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54 and 60|Brain Magnetic Resonance Imaging (MRI) Assessment: Number of Gadolinium Enhancing (Gd-enhancing) Lesions Per MRI Scan|Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New or Enlarged T2 Lesions Per MRI Scan|Brain Magnetic Resonance Imaging (MRI) Assessment: Number of New T1 (and New Hypointense T1) Lesions Per MRI Scan|Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T1 Lesions at Months 12, 24, 36, 48, and 60|Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Volume of T2 Lesions at Months 12, 24, 36, 48, and 60|Brain Magnetic Resonance Imaging (MRI) Assessment: Percent Change From Baseline in Brain Parenchymal Fraction (BPF) at Month 12, 24, 36, 48, and 60|Change From Baseline in Self-reported Quality of Life (QoL) as Assessed by the Medical Outcome Study (MOS) 36-Item Short-Form Health Survey (SF-36): Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores at Month 12, 24, 36, 48, and 60|Change From Baseline in Functional Assessment of Multiple Sclerosis (FAMS) Score at Month 12, 24, 36, 48, and 60|Change From Baseline in European Quality of Life -5 Dimension (EQ-5D) Score: Utility Scores at Month 12, 24, 36, 48, and 60|Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Scores at Month 12, 24, 36, 48, and 60|Modified Healthcare Resource Utilization Questionnaire (HRUQ): Number of Participants Who Reported Change in Employment Situation, Availing of Sick Leaves, Admissions and Stays in Hospital, Rehabilitation Centers or Nursing Homes Due to Multiple Sclerosis|Modified HRUQ: Number of Participants Who Reported Other Changes/Changes in Lifestyle Due to Multiple Sclerosis|Health Related Productivity Questionnaire (HRPQ): Number of Participants Reporting Current Employment Status (Part Time/Full Time/Not Employed) Due to Multiple Sclerosis|HRPQ: Total Scheduled Working Hours and Number of Hours Missed From Work Due to Multiple Sclerosis|HRPQ: Percentage Impact on Work Output Due to Multiple Sclerosis|HRPQ: Total Scheduled Household Chores Hours; Number of Hours Missed From Household Chores Due to Multiple Sclerosis|HRPQ: Percentage Impact on Work Output for Household Chores Due to Multiple Sclerosis|HRPQ: Duration of Disease (in Months) Since Development of Multiple Sclerosis|HRPQ: Number of Participants Who Reported Impact on Work Due to Multiple Sclerosis | Genzyme, a Sanofi Company|Sanofi | Investigational Site Number 1086, Cullman, Alabama, United States|Investigational Site Number 1031, Phoenix, Arizona, United States|Investigational Site Number 1171, Phoenix, Arizona, United States|Investigational Site Number 1090, Tucson, Arizona, United States|Investigational Site Number 1040, Berkeley, California, United States|Investigational Site Number 1152, Fullerton, California, United States|Investigational Site Number 1093, Pasadena, California, United States|Investigational Site Number 1027, Fort Collins, Colorado, United States|Investigational Site Number 1078, Jacksonville, Florida, United States|Investigational Site Number 1059, Maitland, Florida, United States|Investigational Site Number 1173, Sarasota, Florida, United States|Investigational Site Number 1034, Sunrise, Florida, United States|Investigational Site Number 1005, Tampa, Florida, United States|Investigational Site Number 1049, Tampa, Florida, United States|Investigational Site Number 1008, Northbrook, Illinois, United States|Investigational Site Number 1001, Fort Wayne, Indiana, United States|Investigational Site Number 1024, Indianapolis, Indiana, United States|Investigational Site Number 1017, Des Moines, Iowa, United States|Investigational Site Number 1022, Kansas City, Kansas, United States|Investigational Site Number 1083, Lenexa, Kansas, United States|Investigational Site Number 1039, Lexington, Kentucky, United States|Investigational Site Number 1021, Louisville, Kentucky, United States|Investigational Site Number 1061, Wellesley, Massachusetts, United States|Investigational Site Number 1028, Worcester, Massachusetts, United States|Investigational Site Number 1025, Ann Arbor, Michigan, United States|Investigational Site Number 1020, Detroit, Michigan, United States|Investigational Site Number 1054, Traverse City, Michigan, United States|Investigational Site Number 1084, Kansas City, Missouri, United States|Investigational Site Number 1092, Saint Louis, Missouri, United States|Investigational Site Number 1073, Teaneck, New Jersey, United States|Investigational Site Number 1014, Albuquerque, New Mexico, United States|Investigational Site Number 1081, Mineola, New York, United States|Investigational Site Number 1026, New York, New York, United States|Investigational Site Number 1160, Patchogue, New York, United States|Investigational Site Number 1015, Rochester, New York, United States|Investigational Site Number 1053, Syracuse, New York, United States|Investigational Site Number 1095, Chapel Hill, North Carolina, United States|Investigational Site Number 1082, Winston-Salem, North Carolina, United States|Investigational Site Number 1035, Cleveland, Ohio, United States|Investigational Site Number 1058, Uniontown, Ohio, United States|Investigational Site Number 1067, Oklahoma City, Oklahoma, United States|Investigational Site Number 1097, Allentown, Pennsylvania, United States|Investigational Site Number 1057, Providence, Rhode Island, United States|Investigational Site Number 1163, Cordova, Tennessee, United States|Investigational Site Number 1055, Franklin, Tennessee, United States|Investigational Site Number 1009, Knoxville, Tennessee, United States|Investigational Site Number 1042, Nashville, Tennessee, United States|Investigational Site Number 1018, Houston, Texas, United States|Investigational Site Number 1002, Round Rock, Texas, United States|Investigational Site Number 1046, San Antonio, Texas, United States|Investigational Site Number 1037, Vienna, Virginia, United States|Investigational Site Number 1068, Seattle, Washington, United States|Investigational Site Number 03208, Caba, Argentina|Investigational Site Number 2013, Auchenflower, Australia|Investigational Site Number 2001, Heidelberg, Australia|Investigational Site Number 2011, Hobart, Australia|Investigational Site Number 2012, Kogarah, Australia|Investigational Site Number 2003, Melbourne, Australia|Investigational Site Number 2002, Parkville, Australia|Investigational Site Number 2005, Southport, Australia|Investigational Site Number 2009, Sydney, Australia|Investigational Site Number 2006, Westmead, Australia|Investigational Site Number 5005, Bruxelles, Belgium|Investigational Site Number 5004, Esneux, Belgium|Investigational Site Number 5001, Leuven, Belgium|Investigational Site Number 3006, Porto Alegre, Brazil|Investigational Site Number 3002, Recife, Brazil|Investigational Site Number 3001, São Paulo, Brazil|Investigational Site Number 3003, São Paulo, Brazil|Investigational Site Number 1102, Calgary, Canada|Investigational Site Number 1105, Gatineau, Canada|Investigational Site Number 1104, Greenfield Park, Canada|Investigational Site Number 1109, Kingston, Canada|Investigational Site Number 1110, London, Canada|Investigational Site Number 1101, Ottawa, Canada|Investigational Site Number 1106, Vancouver, Canada|Investigational Site Number 4803, Brno, Czechia|Investigational Site Number 4804, Hradec Kralove, Czechia|Investigational Site Number 4801, Praha 2, Czechia|Investigational Site Number 4802, Teplice, Czechia|Investigational Site Number 5302, Aarhus N, Denmark|Investigational Site Number 5301, København Ø., Denmark|Investigational Site Number 4602, Berlin, Germany|Investigational Site Number 4607, Dresden, Germany|Investigational Site Number 4634, Frankfurt am Main, Germany|Investigational Site Number 4622, Hamburg, Germany|Investigational Site Number 4605, Hannover, Germany|Investigational Site Number 4609, Hennigsdorf, Germany|Investigational Site Number 4608, München, Germany|Investigational Site Number 4610, Rostock, Germany|Investigational Site Number 4613, Wermsdorf, Germany|Investigational Site Number 5501, Ramat Gan, Israel|Investigational Site Number 5505, Tel Aviv, Israel|Investigational Site Number 4112, Cagliari, Italy|Investigational Site Number 4102, Gallarate (VA), Italy|Investigational Site Number 4106, Orbassano (TO), Italy|Investigational Site Number 4110, Roma, Italy|Investigational Site Number 3105, Chihuahua, Mexico|Investigational Site Number 3102, Mexico, Mexico|Investigational Site Number 4202, Sittard-Geleen, Netherlands|Investigational Site Number 4902, Krakow, Poland|Investigational Site Number 4901, Lodz, Poland|Investigational Site Number 4903, Lublin, Poland|Investigational Site Number 4904, Poznan, Poland|Investigational Site Number 4905, Warszawa, Poland|Investigational Site Number 6009, Kazan, Russian Federation|Investigational Site Number 6001, Moscow, Russian Federation|Investigational Site Number 6005, Moscow, Russian Federation|Investigational Site Number 6003, Moscow, Russian Federation|Investigational Site Number 6006, Nizhny Novgorod, Russian Federation|Investigational Site Number 6010, Pyatigorsk, Russian Federation|Investigational Site Number 6002, Saint-Petersburg, Russian Federation|Investigational Site Number 6004, Saint-Petersburg, Russian Federation|Investigational Site Number 6008, Saint-Petersburg, Russian Federation|Investigational Site Number 6013, Samara, Russian Federation|Investigational Site Number 6016, Ufa, Russian Federation|Investigational Site Number 4301, Barcelona, Spain|Investigational Site Number 4303, Madrid, Spain|Investigational Site Number 4305, Málaga, Spain|Investigational Site Number 4304, Sevilla, Spain|Investigational Site Number 4701, Göteborg, Sweden|Investigational Site Number 4702, Umeå, Sweden|Investigational Site Number 6102, Kharkov, Ukraine|Investigational Site Number 6104, Kiev, Ukraine|Investigational Site Number 6103, Lviv, Ukraine|Investigational Site Number 4004, Bristol, United Kingdom|Investigational Site Number 4001, Cambridge, United Kingdom|Investigational Site Number 4005, Cardiff, United Kingdom|Investigational Site Number 4006, London, United Kingdom|Investigational Site Number 4008, Salford, United Kingdom|Investigational Site Number 4007, Sheffield, United Kingdom |
| NUTRACORE, Glycaemic Index and Appetite | Hyperglycemia|Hyperglycemia, Postprandial|Appetitive Behavior|Hyperinsulinism|Consumer Preference | Dietary Supplement: Same intervention for both groups: glycaemic index assessment of 3 biscuits recipes|Dietary Supplement: Crossover: Recipe 4 before recipe 5|Dietary Supplement: Crossover: Recipe 5 before recipe 4 | Blood Glucose|COEQ (Control of Eating Questionnaire)|Ghrelin|GLP-1|Insulin|C-Peptide|Leptin|Glycated Hemoglobin (Hb1ac)|Customer preference and satisfaction | Azienda Ospedaliero Universitaria Maggiore della Carita|Polo AgriFood - Miac Scpa|Albertengo Panettoni | : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont, Novara, Italy |
| PRuDENTE; Diabetes Prevention Via Exercise, Nutrition and Treatment | Diabetes Mellitus, Type 2|Prediabetic State | Drug: Metformin|Behavioral: Lifestyle intervention | Diabetes. measured by HbA1c and Fasting blood glucose (FBG)|Lifestyle modifications by decreasing adiposity indicators|Caloric intake|Physical Activity|Implementation process outcomes at the clinic level. Using a questionnaire|Implementation process outcomes at the clinician level. Using a questionnaire|Implementation process outcomes patient level. Assess via questionnaire|Cost-utility of Metformin. Measured using cost per QALYS | Instituto Nacional de Salud Publica, Mexico|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|Ministry of Health, Mexico City|University of California, San Francisco | Centros de Salud. Secretaría de Salud Ciudad de México, Mexico City, Mexico |
| Periodontal Treatment and Metabolic Control in Type 2 Diabetic Patients | Type 2 Diabetes Mellitus|Periodontal Disease | Procedure: non-surgical periodontal treatment|Procedure: Supragingival biofilm control | Changes in HbA1c and serum inflammatory markers of inflammation after periodontal intervention | University of Sao Paulo|Federal University of São Paulo | School of Dentistry - University of São Paulo, São Paulo, Brazil |
| Tolerability and Quality of Life Study in Participants Who Switched to Avonex Pen | Relapsing-Remitting Multiple Sclerosis|Clinical Isolated Syndrome (CIS)|Multiple Sclerosis | Device: interferon beta-1a | Change from baseline to month 4 in injection site tolerability as measured on a composite visual analogue scale (VAS) score ranging from 0-100|Change from baseline to month 12 in injection site tolerability as measured on a composite VAS score|Change from baseline in the VAS score of systemic tolerability|The percentage of participants still on Avonex Pen|Quality of Life as assessed by the change in Short Form (SF) Health Survey, SF-36 scores|The percentage of missed injections|Change in Fatigue Scale for Motor and Cognitive functions (FSMC) score | Biogen | Research Site, Brno, Czech Republic|Research Site, Hradec Králové, Czech Republic|Research Site, Jihlava, Czech Republic|Research Site, Plzeň, Czech Republic|Research Site, Praha, Czech Republic|Research Site, Teplice, Czech Republic|Research Site, Bienne, Switzerland|Research Site, Langenthal, Switzerland|Research Site, Lugano, Switzerland|Research Site, Sion, Switzerland|Research Site, Wil, Switzerland |
| A NIS Evaluating Injectable Treatments in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Other: ofatumumab|Other: glatiramer acetate|Other: interferon β1 | Proportion of patients who continue to receive their first-line treatment|Impact of first-line treatment on health economy|Fatigue Symptoms and Impact Questionnaire-RMS|Patient Health Questionnaire 8 [PHQ-8]|Generalized Anxiety Disorder Scale 7 [GAD-7]|MS Treatment Concerns Questionnaire [MSTCQ]|Expanded disability status scale (EDSS)|Time to onset of confirmed disability progression (CDP)|Proportion of patients with confirmed disability progression (CDP)|Time to onset of confirmed disability improvement (CDI)|Proportion of patients with CDI|Number of T1 Gd-enhancing lesions per brain|Number of new or enlarging T2 lesions|Proportion of patients with no evidence of disease activity (NEDA3) upon discretion of the investigator.|Proportion of patients with no clinical disease activity and no discontinuation of current treatment due to AEs|Annualized relapse rate|Time to first relapse|Proportion of relapse free patients|Number of patients and reasons for discontinuation of treatment|Proportion of patients who continue to receive their subsequent treatment|Reasons for and number of treatment interruptions per patient|Duration of treatment interruptions per patient|Number of patients with treatment interruptions|Proportion of drug-related adverse events (AEs)|Persistence of drug-related adverse events (AEs)|Specific safety assessment of injection related AEs|Proportion of participants discontinuing treatment due to insufficient effectiveness (lack of efficacy) or tolerability/safety reasons | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Bamberg, Bavaria, Germany|Novartis Investigative Site, Untermeiting, Bayern, Germany|Novartis Investigative Site, Schwetzingen, BW, Germany|Novartis Investigative Site, Hannover, Lower Saxony, Germany|Novartis Investigative Site, Essen, Nordrhein-Westfalen, Germany|Novartis Investigative Site, Muenster, Northwest, Germany|Novartis Investigative Site, Altmark, Sachsen-Anhalt, Germany|Novartis Investigative Site, Altenburg, Germany|Novartis Investigative Site, Altenholz, Germany|Novartis Investigative Site, Alzey, Germany|Novartis Investigative Site, Bad Homburg, Germany|Novartis Investigative Site, Bamberg, Germany|Novartis Investigative Site, Bergneustadt, Germany|Novartis Investigative Site, Berlin, Germany|Novartis Investigative Site, Berlin, Germany|Novartis Investigative Site, Berlin, Germany|Novartis Investigative Site, Boblingen, Germany|Novartis Investigative Site, Bochum, Germany|Novartis Investigative Site, Bonn, Germany|Novartis Investigative Site, Bremen, Germany|Novartis Investigative Site, Chemnitz, Germany|Novartis Investigative Site, Dortmund, Germany|Novartis Investigative Site, Dresden, Germany|Novartis Investigative Site, Dresden, Germany|Novartis Investigative Site, Duisburg, Germany|Novartis Investigative Site, Düsseldorf, Germany|Novartis Investigative Site, Erbach, Germany|Novartis Investigative Site, Essen, Germany|Novartis Investigative Site, Essen, Germany|Novartis Investigative Site, Frankfurt, Germany|Novartis Investigative Site, Fulda, Germany|Novartis Investigative Site, Gelsenkirchen, Germany|Novartis Investigative Site, Gladenbach, Germany|Novartis Investigative Site, Hagen, Germany|Novartis Investigative Site, Hamburg, Germany|Novartis Investigative Site, Ingelheim, Germany|Novartis Investigative Site, Itzehoe, Germany|Novartis Investigative Site, Kaiserslautern, Germany|Novartis Investigative Site, Koln, Germany|Novartis Investigative Site, Köln, Germany|Novartis Investigative Site, Mannheim, Germany|Novartis Investigative Site, Marburg, Germany|Novartis Investigative Site, Minden, Germany|Novartis Investigative Site, München, Germany|Novartis Investigative Site, Neuburg an der Donau, Germany|Novartis Investigative Site, Osnabrück, Germany|Novartis Investigative Site, Pforzheim, Germany|Novartis Investigative Site, Regensburg, Germany|Novartis Investigative Site, Remscheid, Germany|Novartis Investigative Site, Rostock, Germany|Novartis Investigative Site, Ruelzheim, Germany|Novartis Investigative Site, Siegen, Germany|Novartis Investigative Site, Stuttgart, Germany|Novartis Investigative Site, Stuttgart, Germany|Novartis Investigative Site, Wolfratshausen, Germany |
| TRUST Study of Adolescent Weight Self-Management | Adolescent Obesity | Behavioral: TRUST Intervention|Behavioral: Enhanced Usual Care | Body Mass Index|Eating|Physical Activity|Sleep | University Hospitals Cleveland Medical Center|Case Western Reserve University | Case Western Reserve University, Cleveland, Ohio, United States |
| AttackMS - Treatment of People With Inflammatory Demyelination Suggestive of MS, or Definite MS, at First Presentation | Multiple Sclerosis|Clinically Isolated Syndrome of Demyelination | Drug: Tysabri Injectable Product|Drug: Placebo | To establish whether there is efficacy superiority of Tysabri® over placebo at 12 weeks in facilitating remyelination of previously demyelinated CNS lesions, as measured by MRI lesion magnetization transfer ratio (MTR).|To establish whether there is a difference between participants receiving Tysabri® or placebo at 24 weeks in P100 latency measured using visually evoked potentials (VEP).|To establish whether there is a difference between participants receiving Tysabri® or placebo at 24 weeks in number and occurrence of adverse events.|To establish whether there is a difference between participants receiving Tysabri® or placebo at 24 weeks in facilitating remyelination of previously demyelinated CNS lesions using Magnetisation transfer ratio (MTR).|To establish whether there is a difference between participants receiving Tysabri® or placebo at 24 weeks in protecting limb function.|To establish whether there is a difference between participants receiving Tysabri® or placebo at 24 weeks in Retinal nerve fibre layer and ganglion cell + inner plexiform (GCIP) layer thickness measured using optical coherence tomography (OCT). | Queen Mary University of London | |
| Accurate Diagnosis of Multiple Sclerosis Using PET/MR | Multiple Sclerosis | Diagnostic Test: 18F-florbetapir PET+MRSI | Distribution Volume Ratio (DVR)|Change from Baseline DVR at 6 months|Change from Baseline DVR at 1 year|Standardized Uptake Value Ratio (SUVR)|Change from Baseline SUVR at 6 months|Change from Baseline SUVR at 1 year|N-acetyl aspartate (NAA) quantification|Change from Baseline NAA at 6 months|Change from Baseline NAA at 1 year | Ruijin Hospital | Shanghai Ruijin Hospital, Shanghai, China |
| Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis | Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting|Multiple Sclerosis, Secondary Progressive | Combination Product: Extracorporeal Photopheresis|Combination Product: MS standard of care | Tolerability to ECP procedures (Group A patients)|Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)|Tolerability to TEAEs, AESIs, and SAEs|Clinical improvement (25-foot walk)|Clinical improvement (9-hole peg test)|Clinical improvement (36-Item Short Form Survey)|Clinical improvement (EDSS baseline low score)|Clinical improvement (EDSS baseline high score)|Occurrence of clinical relapse at any point in the study|Immune response profile (cellular)|Immune response profile (humoral) | Abu Dhabi Stem Cells Center | Abu Dhabi Stem Cells Center, Abu Dhabi, United Arab Emirates |
| Early Arthroscopic Partial Meniscectomy(APM) | Meniscus Tear | Procedure: early APM|Procedure: delayed APM | Knee KOOS score|IKDC score|waist circumstance|SBP|DBP|TC|TG|LDL|HDL|FBG|BMI|K-L grade|pain score|symptoms score|activities of daily living score|function in sport and recreation score|knee related quality of life score | The First People's Hospital of Jingzhou | First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China |
| Multiple Sclerosis-Simvastatin Trial 2 | Secondary Progressive Multiple Sclerosis (SPMS) | Drug: Simvastatin|Drug: Placebo | Time to confirmed disability progression between simvastatin and placebo arm based on change in EDSS scores compared to baseline.|Response rate on the patient reported outcome form Multiple Sclerosis Walking Scale-12 version 2 (MSWS-12v2)|Response rate on the patient reported outcome form Multiple Sclerosis Impact Scale-29 version 2 (MSIS-29v2)|Cost effectiveness of intervention|Change in time taken to complete 25-Foot Timed Walk (T25FW)|Change in time taken to complete 9 hole peg test (9HPT)|Evaluating change in degree of disability based on the modified Rankin scale (mRS)|Difference in the number and severity of multiple sclerosis related relapse events between treatment groups|Change in visual function based on the Sloan Low Contrast Visual Acuity (SLCVA)|Difference in patient reported quality of life based on the EuroQoL Health Related Quality of Life - 5 Dimensions - 5 Levels (EQ-5D 5L) scores|Change in a modified Multiple Sclerosis Functional Composite scores|Change in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)|Change in cognitive impairment based on Symbol Digit Modalities Test (SDMT) scores|Evaluating the time to disability progression based on a secondary composite progression outcome measure|Change in fatigue as measured by the Chalder Fatigue Scale|Change in rates of service utilisation as measured by the Client Service Receipt Inventory (CSRI) questionnaire | University College, London|University of Edinburgh|Queen Mary University of London|London School of Hygiene and Tropical Medicine|University of Leeds|The Leeds Teaching Hospitals NHS Trust|Imperial College Healthcare NHS Trust | Belfast City Hospital, Belfast, United Kingdom|Royal Sussex County Hospital, Brighton, United Kingdom|Addenbrooke's Hospital, Cambridge, United Kingdom|University Hospital of Wales, Cardiff, United Kingdom|The Anne Rowling Regenerative Neurology Clinic, Edinburgh, United Kingdom|Royal Devon and Exeter Hospital, Exeter, United Kingdom|The Queen Elizabeth University Hospital, Glasgow, United Kingdom|Leeds General Infirmary, Leeds, United Kingdom|The Leeds Teaching Hospital, Leeds, United Kingdom|The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom|Queen's Hospital, Barking, Havering and Redbridge University Hospitals, London, United Kingdom|King's College Hopsital, London, United Kingdom|Charing Cross Hospital, London, United Kingdom|University College London Hospital, London, United Kingdom|Salford Royal Hospital, Manchester, United Kingdom|Royal Victoria Infirmary, Newcastle Upon Tyne, United Kingdom|Nottingham Teaching Hospitals, Nottingham, United Kingdom|Queen's Medical Centre, Nottingham, United Kingdom|John Radcliffe Hospital, Oxford, United Kingdom|Derriford Hospital, Plymouth, United Kingdom|Poole Hospital, Poole, United Kingdom|Royal Hallamshire Hospital, Sheffield, United Kingdom|University Hospital of North Staffordshire, Stoke-on-Trent, United Kingdom|Morriston & Neath Port Talbot Hospitals (Abertawe Bro Morgannwg University Local Health Board), Swansea, United Kingdom |
| Melatonin in Patients With Multiple Sclerosis (MS). | Relapsing Remitting Multiple Sclerosis | Drug: 3 mg Melatonin|Drug: 5 mg Melatonin | Changes in urine melatonin levels|Modified Fatigue Impact Scale (MFIS)|Serum melatonin level|Multiple Sclerosis Impact Scale-29 (MSIS-29)|Pittsburgh Sleep Quality Index (PSQI)|Relapse Rate|Patient Determined Disease Steps - Performance Scale (PDDS-PS) | Providence Health & Services | Providence MS Center, Portland, Oregon, United States |
| Sitagliptin Treatment in Diabetic COVID-19 Positive Patients | Covid19 | Drug: Retrospective case-control analysis | Clinical parameter of acute lung disease|Death|Biochemical parameter of acute lung disease | University of Milan|Papa Giovanni XXIII Hospital|IRCCS Policlinico S. Matteo|Humanitas Hospital, Italy|Ospedale dell'Angelo, Venezia-Mestre|University of Pavia | ASST FBF-Sacco P.O. Sacco, Milan, MI, Italy|Papa Giovanni XXIII Hospital, Bergamo, Italy|Ospedale dell'Angelo, Venezia-Mestre, Mestre, Italy|Humanitas Hospital, Milan, Italy|University of Pavia, Pavia, Italy|IRCCS Policlinico S. Matteo, Pavia, Italy |
| Single Ascending Dose Study With BPL-003 in Healthy Subjects | Pharmacokinetics in Healthy Adults | Drug: BPL-003|Other: Placebo | Percentage of subjects with treatment emergent AEs (TEAES)|Peak plasma concentration (Cmax)|Time to reach Cmax (tmax)|Area under the plasma concentration- time curve | Beckley Psytech Limited | Hammersmith Medicines Research, London, United Kingdom |
| Natalizumab in Preventing Post-partum Relapses in Multiple Sclerosis | Multiple Sclerosis | Drug: Natalizumab | Annualized Relapse Rate (ARR)|Confirmed (12 week) EDSS change|AUC-EDSS changes|Change in MRI|Time to first relapse|Percent of relapse free patients|Percent of patient that discontinued their DMT | State University of New York at Buffalo | SUNY Buffalo, Buffalo, New York, United States |
| Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors | Distress|Depression|Grief | Drug: Psilocybin|Behavioral: Modified brief Supportive Expressive Group Therapy | Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0|Subject Recruitment and Retention|Change From Baseline in Demoralization Scale-II at End-of-treatment|Change From Baseline in Demoralization Scale-II at 3-month Follow-up|Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment|Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up|Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment|Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up|Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug | Joshua Woolley|Heffter Research Institute|River Styx Foundation|Usona Institute|Stupski Foundation|University of California, San Francisco | University of California, San Francisco, San Francisco, California, United States |
| Best Available Therapy Versus Autologous Hematopoetic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) | Relapsing Multiple Sclerosis|Relapsing Remitting Multiple Sclerosis|Secondary Progressive Multiple Sclerosis | Procedure: Autologous Hematopoietic Stem Cell Transplantation|Biological: Best Available Therapy (BAT) | Multiple Sclerosis (MS) Relapse-Free Survival|Number of Multiple Sclerosis (MS) Relapses Per Year|The Occurrence of Any Evidence of Multiple Sclerosis (MS) Disease Activity or Death From Any Cause|The Occurence of Confirmed Disability Worsening by the Kurtz Expanded Disability Status Scale (EDSS)|The Occurrence of Confirmed Disability Improvement by the Kurtz Expanded Disability Status Scale (EDSS)|Whole Brain Volume Change from Pre-Randomization Visit to the follow-up evaluations|Change in Serum Neurofilament Light Chain (NfL) Concentration|The Occurrence of Death From Any Cause: All-Cause Mortality|Proportion of Participants who Experience a Serious Adverse Event (SAE)|Proportion of Participants with a Grade 3 or Higher Infection|Proportion of Participants with Progressive Multifocal Leukoencephalopathy (PML)|Time to Neutrophil Engraftment Among Autologous Hematopoietic Stem Cell Transplantation (AHSCT) Recipients|Proportion of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) Recipients Who Experience Primary or Secondary Graft Failure | National Institute of Allergy and Infectious Diseases (NIAID)|Immune Tolerance Network (ITN)|Blood and Marrow Transplant Clinical Trials Network|PPD|Rho Federal Systems Division, Inc. | Stanford Multiple Sclerosis Center, Palo Alto, California, United States|Rocky Mountain Multiple Sclerosis Center, University of Colorado School of Medicine, Aurora, Colorado, United States|University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States|University of Minnesota Multiple Sclerosis Center, Minneapolis, Minnesota, United States|Mayo Clinic, Rochester, Minnesota, United States|John L. Trotter Multiple Sclerosis Center, Washington University School of Medicine in St. Louis, Saint Louis, Missouri, United States|Washington University, Saint Louis, Missouri, United States|Baird Multiple Sclerosis (MS) Center, Kaleida Health, Buffalo, New York, United States|Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Siinai, New York, New York, United States|Rochester Multiple Sclerosis Center, University of Rochester, Rochester, New York, United States|Duke University Medical Center, Durham, North Carolina, United States|University of Cincinnati (UC) Waddell Center for Multiple Sclerosis, Cincinnati, Ohio, United States|Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic, Cleveland, Ohio, United States|Multiple Sclerosis Center, Oregon Health & Science University, Portland, Oregon, United States|Penn Comprehensive MS Center, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States|University of Texas Southwestern Medical Center: Division of Multiple Sclerosis and Neuroimmunology, Dallas, Texas, United States|Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center, Houston, Texas, United States|Virginia Commonwealth University Multiple Sclerosis Treatment and Research Center, Richmond, Virginia, United States|Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States|Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, Washington, United States|Multiple Sclerosis Center at Northwest Hospital, Seattle, Washington, United States|Imperial College Healthcare NHS Trust, London, United Kingdom |
| Understanding Daily Fluctuations in Self-Regulation | Impulsive Behavior|Self-Regulation | Behavioral: Assessment only | Impulsivity | Northwell Health|Cornell University|Sage Bionetworks | Center for Addiction Services and Personalized Interventions Research (CASPIR), Great Neck, New York, United States |
| Research Study for Rare Pathogenic Mutations Causing Type 2 Diabetes and Complications | Diabete Type 2 | Diagnostic Test: search for rare pathogenic mutations | pathogenic mutations causing type 2 diabetes | University of Liege|EGID, Lille | Marjorie Fadeur, Liège, Belgium |
| Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes | Diabetes Mellitus, Type 2 | Drug: Insulin LISPRO | fasting plasma glucose after insulin therapy | Sun Yat-sen University | endocrinology department of the first affiliated hospital of Sun Yat-sen University, Guangzhou, Guangdong, China |
| Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive|Multiple Sclerosis, Secondary Progressive | Drug: ibudilast|Drug: Placebo oral capsule | Covariate-adjusted Mean Rate of Change in Brain Atrophy Over 96 Weeks as Measured by Brain Parenchymal Fraction (BPF).|Percentage of Participants With Adverse Events.|Diffusion Tensor Imaging (DTI) in Descending Pyramidal White Matter Tracts|Magnetization Transfer Ratio (MTR) Imaging in Normal-appearing Brain Tissue|Retinal Nerve Fiber Layer as Measured by Optical Coherence Tomography (OCT). | MediciNova|National Institutes of Health (NIH)|National Institute of Neurological Disorders and Stroke (NINDS)|National Multiple Sclerosis Society | University of Alabama at Birmingham, Birmingham, Alabama, United States|University of California Davis, Davis, California, United States|University of California Los Angeles, Los Angeles, California, United States|University of Colorado Denver, Denver, Colorado, United States|University of Miami Miller School of Medicine, Miami, Florida, United States|Emory University, Atlanta, Georgia, United States|Northwestern University, Evanston, Illinois, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|Massachusetts General Hospital, Boston, Massachusetts, United States|Brigham and Women's Hospital, Boston, Massachusetts, United States|Washington University School of Medicine in St Louis, Saint Louis, Missouri, United States|Montefiore Medical Center, Bronx, New York, United States|University at Buffalo, The State University of New York, Buffalo, New York, United States|Cornell Medical College, New York, New York, United States|Columbia University Medical Center, New York, New York, United States|University of Rochester, Rochester, New York, United States|University at Stony Brook, The State University of New York, Stony Brook, New York, United States|University at Upstate, The State University of New York, Syracuse, New York, United States|University of Cincinnati, Department of Neurology, Cincinnati, Ohio, United States|Cleveland Clinic, Cleveland, Ohio, United States|Ohio State University, Columbus, Ohio, United States|Oregon Health and Science University, Portland, Oregon, United States|University of Pittsburgh, Pittsburgh, Pennsylvania, United States|Vanderbilt University, Nashville, Tennessee, United States|University of Texas Southwestern Medical Center, Dallas, Texas, United States|University of Utah, Salt Lake City, Utah, United States|University of Virginia Charlottesville, Charlottesville, Virginia, United States|Swedish Medical Center - Seattle, Seattle, Washington, United States |
| Remotely Supervised Exercise Program in Individuals With Type 2 Diabetes | Diabetes Mellitus, Type 2 | Other: Remote Exercise Group|Other: Group control | Glycaemic control|Systolic blood pressure|Diastolic blood pressure|Capillary blood glucose|Lower limb strength|Upper limb strength|Agility and dynamic balance|Aerobic capacity|Flexibility|Quality of life (QOL) will be verified using the EUROHIS-QOL 8-item index|Sleep quality will be verified using the Pittsburgh Sleep Quality Index Self-report Questionnaire|Depressive symptoms|Emotional stress related to diabetes|Physical activity levels|Eating habits|Subjective perception of well-being | Federal University of Pelotas | Federal University of Pelotas, Pelotas, Brazil, Pelotas, Rio Grande Do Sul, Brazil |
| Long-term Follow-up of Fingolimod Phase II Study Patients | Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis | Other: Assessments arm | Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)|Number of Participants With Disability Progression|Number of Participants With EDSS <4 or <6|Number of Participants Not Using a Wheelchair or Being Bedridden|Number of Participants Classified as Secondary Progressive MS (SPMS)|Percentage of Participants With First Use of an Ambulatory Device|Percentage of Participants With First Use of a Wheelchair|Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)|Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score|Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score|Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score|Total Volume in T2 Lesion|Change From Baseline in Total Volume of T2 Lesion|Third Ventricle Diameter|Change From Baseline in Third Ventricle Diameter|Percentage Brain Volume Change (PBVC)|Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Ottawa, Ontario, Canada|Novartis Investigative Site, Toronto, Ontario, Canada|Novartis Investigative Site, Montreal, Quebec, Canada|Novartis Investigative Site, Montreal, Quebec, Canada|Novartis Investigative Site, Copenhagen, Denmark|Novartis Investigative Site, Glostrup, Denmark|Novartis Investigative Site, Lille, France|Novartis Investigative Site, Marseille, France|Novartis Investigative Site, Würzburg, Germany|Novartis Investigative Site, Genova, GE, Italy|Novartis Investigative Site, Milano, MI, Italy|Novartis Investigative Site, Roma, RM, Italy|Novartis Investigative Site, Gallarate, VA, Italy|Novartis Investigative Site, Warszawa, Poland|Novartis Investigative Site, Warszawa, Poland|Novartis Investigative Site, Coimbra, Portugal|Novartis Investigative Site, Lisboa, Portugal|Novartis Investigative Site, Malaga, Andalucia, Spain|Novartis Investigative Site, Sevilla, Andalucia, Spain|Novartis Investigative Site, Barcelona, Catalunya, Spain|Novartis Investigative Site, L'Hospitalet de Llobregat, Catalunya, Spain|Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Basel, Switzerland|Novartis Investigative Site, Zuerich, Switzerland|Novartis Investigative Site, Newcastle Upon Tyne, United Kingdom |
| Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression | Major Depression | Drug: Ayahuasca|Drug: placebo | HAM-D effect at D7|MADRS effect at D1, D2 and D7|Response rate at D7 (HAM-D)|Response rate at D1, D2 and D7 (MADRS)|Remission rate at D7 (HAM-D)|Remission rate at D1, D2 and D7 (MADRS) | Universidade Federal do Rio Grande do Norte|University of Sao Paulo | Draulio B de Araujo, Natal, Rio Grande do Norte, Brazil |
| Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS | Multiple Sclerosis, Relapsing-Remitting | Other: Multiparametric assessment | Predictors of disease evolution|evaluation of evolutionary patterns of cognitive status (impaired vs non impaired)/changes from baseline|baseline predictors of future cognitive impairment|alteration in strategic white matter tracts at the early stages of RRMS, in patients with and without cognitive impairment|predictive role of mEPS in predicting future disability | University Hospital of Mont-Godinne|Saint-Luc University Hospital | CHU UCL Namur site Godinne, Yvoir, Namur, Belgium |
| Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063) | Multiple Sclerosis | Drug: RPC-1063 | Proportion of subjects with an increase in raw score of ≥ 4 points or 10% from baseline (improved)|Proportion of subjects with a decrease in raw score of ≥ 4 points or 10% from baseline (worsened)|Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)|Proportion of subjects with an increase in raw score of ≥ 3 points from baseline|Proportion of subjects with a decrease in raw score of ≥ 3 points from baseline|Change from baseline in Symbol Digit Modalities Test (SMDT)|Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes|Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years|GdE lesion volume over 3 years|Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3|Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3|Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)|Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS)|Fatigue Severity Scale (FSS)|Multiple Sclerosis Quality of Life-54 (MSQOL-54)|Hospital Anxiety and Depression Scale (HADS)|Annualized relapse rate (ARR)|Timed 25-foot Walk (T25W)|Nine-hole Peg Test (9-HPT)|Expanded Disability Status Scale (EDSS)|Adverse Events (AEs) | Celgene | Neurological Institute of Alabama, Birmingham, Alabama, United States|Neurological Institute of Alabama, Birmingham, Alabama, United States|North Carolina Neurology Association P.C, Cullman, Alabama, United States|North Carolina Neurology Association P.C, Cullman, Alabama, United States|University of South Alabama, Mobile, Alabama, United States|University Of South Alabama, Mobile, Alabama, United States|Multiple Sclerosis Center of Arizona, Phoenix, Arizona, United States|Multiple Sclerosis Center of Arizona, Phoenix, Arizona, United States|Multiple Sclerosis Center of California, Laguna Hills, California, United States|SC3 Research - Pasadena, Pasadena, California, United States|SC3 Research - Pasadena, Pasadena, California, United States|UC Davis Medical Center, Sacramento, California, United States|University of Colorado, School of Medicine - Hepatology Clinic - Anschutz, Aurora, Colorado, United States|Colorado Springs Neurological Associates, Colorado Springs, Colorado, United States|Colorado Springs Neurological Associates, Colorado Springs, Colorado, United States|Advanced Neurosciences Research, LLC, Fort Collins, Colorado, United States|Advanced Neurosciences Research, LLC, Fort Collins, Colorado, United States|Georgetown University Hospital, Washington, District of Columbia, United States|Georgetown University Hospital, Washington, District of Columbia, United States|Neurology Offices of South Florida, Boca Raton, Florida, United States|Neurology Offices of South Florida, Boca Raton, Florida, United States|Vero Beach Neurology and Research Institute, Vero Beach, Florida, United States|Vero Beach Neurology and Research Institute, Vero Beach, Florida, United States|Meridian Clinical Research, LLC - Savannah, Savannah, Georgia, United States|Meridian Clinical Research, LLC - Savannah, Savannah, Georgia, United States|Northwest Neurology, Ltd, Hoffman Estates, Illinois, United States|Consultants In Neurology, Northbrook, Illinois, United States|Fort Wayne Neurological Center, Fort Wayne, Indiana, United States|Fort Wayne Neurological Center, Fort Wayne, Indiana, United States|Acellacare US Inc, Ames, Iowa, United States|Acellacare US Inc, Ames, Iowa, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|University Of Kansas Medical Center, Kansas City, Kansas, United States|NeuroMedical Clinic of Central Louisiana, Alexandria, Louisiana, United States|NeuroMedical Clinic of Central Louisiana, Alexandria, Louisiana, United States|Detroit Medical Center, Detroit, Michigan, United States|Detroit Medical Center, Detroit, Michigan, United States|Henry Ford Health System, Detroit, Michigan, United States|Henry Ford Health System, Detroit, Michigan, United States|Washington University School Medicine - CAM- Neuroscience Center, Saint Louis, Missouri, United States|Washington University School Medicine - CAM- Neuroscience Center, Saint Louis, Missouri, United States|The MS Center for Innovations in Care, Saint Louis, Missouri, United States|The MS Center for Innovations in Care, Saint Louis, Missouri, United States|Advanced Neurology Specialists, Great Falls, Montana, United States|South Jersey MS Center, Audubon, New Jersey, United States|Holy Name Hospital, Teaneck, New Jersey, United States|Holy Name Hospital, Teaneck, New Jersey, United States|Dent Neurologic Institute, Amherst, New York, United States|UBMD Neurology, Buffalo, New York, United States|Stony Brook Neurosciences Institute - Neurology Associates of Stony Brook, East Setauket, New York, United States|Stony Brook Neurosciences Institute - Neurology Associates of Stony Brook, East Setauket, New York, United States|NYU Langone Medical Center, New York, New York, United States|NYU Langone Medical Center, New York, New York, United States|Weill Cornell Medical College, New York, New York, United States|South Shore Neurology Associates, Inc, Patchogue, New York, United States|South Shore Neurology Associates, Inc, Patchogue, New York, United States|University of North Carolina, Chapel Hill, North Carolina, United States|University Of North Carolina, Chapel Hill, North Carolina, United States|Guilford Neurologic Research, PA, Greensboro, North Carolina, United States|Guilford Neurologic Research, PA, Greensboro, North Carolina, United States|Lake Norman Neurology, Mooresville, North Carolina, United States|Lake Norman Neurology, Mooresville, North Carolina, United States|Raleigh Neurology Associates PA, Raleigh, North Carolina, United States|University of Cincinnati - Gardner Neuroscience Institute, Cincinnati, Ohio, United States|University of Cincinnati - Gardner Neuroscience Institute, Cincinnati, Ohio, United States|University Hospitals of Cleveland, Cleveland, Ohio, United States|University Hospitals of Cleveland, Cleveland, Ohio, United States|UC Health, LLC, Dayton, Ohio, United States|Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States|Thomas Jefferson University - Clinical Research Institute, Philadelphia, Pennsylvania, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, United States|Temple University - Lewis Katz School of Medicine, Philadelphia, Pennsylvania, United States|University of Pittsburgh Medical Center Magee Womens Hospital, Pittsburgh, Pennsylvania, United States|Advanced Neurosciences Institute, Franklin, Tennessee, United States|Advanced Neurosciences Institute, Franklin, Tennessee, United States|Hope Neurology MS Center, Knoxville, Tennessee, United States|Hope Neurology MS Center, Knoxville, Tennessee, United States|Baylor Research Institute - Dallas Clinical Trials Office, Dallas, Texas, United States|Central Texas Neurology Consultants PA, Round Rock, Texas, United States|Central Texas Neurology Consultants PA, Round Rock, Texas, United States|Neurology Center of San Antonio, San Antonio, Texas, United States|Neurology Center of San Antonio, San Antonio, Texas, United States|Meridian Clinical Research, LLC - Norfolk, Norfolk, Virginia, United States|Meridian Clinical Research, LLC - Norfolk, Norfolk, Virginia, United States|Evergreen Hospital Muiltiple Sclerosis Center, Kirkland, Washington, United States|Evergreen Hospital Muiltiple Sclerosis Center, Kirkland, Washington, United States|Virginia Mason Medical Center, Seattle, Washington, United States|Virginia Mason Medical Center, Seattle, Washington, United States|Inland Northwest Research, Spokane, Washington, United States|Inland Northwest Research, Spokane, Washington, United States|MultiCare Institute for Research and Innovation, Tacoma, Washington, United States|MultiCare Institute for Research and Innovation, Tacoma, Washington, United States|Marshall University School of Medicine, Huntington, West Virginia, United States|WVU Neurology, Morgantown, West Virginia, United States|WVU Neurology, Morgantown, West Virginia, United States|University of Wisconsin, Madison, Wisconsin, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, United States|Local Institution - 203, London, Ontario, Canada|London Health Sciences Centre, London, Ontario, Canada|Ottawa Hospital, Ottawa, Ontario, Canada|St. Michael's Hospital, Toronto, Ontario, Canada|Local Institution - 206, Montreal, Quebec, Canada|Universite de Montreal, Montreal, Quebec, Canada|Local Institution - 207, Halifax, Canada|Maritime Neurology, Halifax, Canada|San Juan MS Center, Guaynabo, Puerto Rico|San Juan MS Center, Guaynabo, Puerto Rico |
| Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients. | Multiple Sclerosis|Relapsing Multiple Sclerosis|Advancing Multiple Sclerosis | Drug: Siponimod | Number of patients with treatment emergent adverse events|Number of patients satisfied with treatment as measured by Treatment Satisfaction Questionnaire for Medication|Change in Heart Rate from baseline|Treatment persistence with Siponimod | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Birmingham, Alabama, United States|Novartis Investigative Site, Cullman, Alabama, United States|Novartis Investigative Site, Tucson, Arizona, United States|Novartis Investigative Site, Fresno, California, United States|Novartis Investigative Site, Fullerton, California, United States|Novartis Investigative Site, Irvine, California, United States|Novartis Investigative Site, Colorado Springs, Colorado, United States|Novartis Investigative Site, Denver, Colorado, United States|Novartis Investigative Site, Fort Collins, Colorado, United States|Novartis Investigative Site, Boca Raton, Florida, United States|Novartis Investigative Site, Bradenton, Florida, United States|Novartis Investigative Site, Maitland, Florida, United States|Novartis Investigative Site, Miami, Florida, United States|Novartis Investigative Site, Ocala, Florida, United States|Novartis Investigative Site, Oldsmar, Florida, United States|Novartis Investigative Site, Orlando, Florida, United States|Novartis Investigative Site, Ormond Beach, Florida, United States|Novartis Investigative Site, Sarasota, Florida, United States|Novartis Investigative Site, Sunrise, Florida, United States|Novartis Investigative Site, Tampa, Florida, United States|Novartis Investigative Site, Vero Beach, Florida, United States|Novartis Investigative Site, Flossmoor, Illinois, United States|Novartis Investigative Site, Indianapolis, Indiana, United States|Novartis Investigative Site, Lexington, Kentucky, United States|Novartis Investigative Site, Lexington, Kentucky, United States|Novartis Investigative Site, Lexington, Kentucky, United States|Novartis Investigative Site, Rockville, Maryland, United States|Novartis Investigative Site, Clinton Township, Michigan, United States|Novartis Investigative Site, Saint Louis, Missouri, United States|Novartis Investigative Site, Las Vegas, Nevada, United States|Novartis Investigative Site, Hackensack, New Jersey, United States|Novartis Investigative Site, Asheville, North Carolina, United States|Novartis Investigative Site, Greensboro, North Carolina, United States|Novartis Investigative Site, Raleigh, North Carolina, United States|Novartis Investigative Site, Cincinnati, Ohio, United States|Novartis Investigative Site, Cleveland, Ohio, United States|Novartis Investigative Site, Oklahoma City, Oklahoma, United States|Novartis Investigative Site, Philadelphia, Pennsylvania, United States|Novartis Investigative Site, Willow Grove, Pennsylvania, United States|Novartis Investigative Site, Greer, South Carolina, United States|Novartis Investigative Site, Indian Land, South Carolina, United States|Novartis Investigative Site, Cordova, Tennessee, United States|Novartis Investigative Site, Johnson City, Tennessee, United States|Novartis Investigative Site, Round Rock, Texas, United States|Novartis Investigative Site, San Antonio, Texas, United States|Novartis Investigative Site, Falls Church, Virginia, United States|Novartis Investigative Site, Kirkland, Washington, United States|Novartis Investigative Site, Seattle, Washington, United States|Novartis Investigative Site, Spokane, Washington, United States|Novartis Investigative Site, Tacoma, Washington, United States|Novartis Investigative Site, Waukesha, Wisconsin, United States|Novartis Investigative Site, Guaynabo, Puerto Rico |
| Pilot Trial of Domperidone in Relapsing-Remitting Multiple Sclerosis (RRMS) | Multiple Sclerosis, Relapsing-Remitting | Drug: Domperidone | Measures of repair within enhancing T1 MRI lesions|Number and type of adverse events over the 16 week treatment period.|Serum Prolactin Levels at both 6 and 16 weeks | University of Calgary|Alberta Innovates Health Solutions | Calgary MS Clinic at Foothills Medical Centre, Calgary, Alberta, Canada |
| App Based Dexterity Training in Multiple Sclerosis | Multiple Sclerosis | Behavioral: App Dexterity|Behavioral: Theraband | AMSQ, Arm Function in Multiple Sclerosis Questionnaire (AMSQ)|Nine Hole Peg Test (9HPT)|Multiple Sclerosis Impact Scale 29 (MSIS 29)|Coin Rotation Task (Kamm et al. 2012) | Luzerner Kantonsspital|University Hospital Inselspital, Berne | Luzerner Kantonsspital, Luzern, Switzerland |
| Safety and Efficacy Study of NVC-422 on Bacteriuria in Catheterized Patients | Asymptomatic Bacteriuria | Drug: sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate | Evaluate the safety and antimicrobial effect (and its duration) of NVC-422 in urine following bladder instillation in chronically catheterized subjects with bacteriuria|Assess urine concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation|Assess plasma concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation | NovaBay Pharmaceuticals, Inc. | Michael E. Debakey V.A. Medical Center, Houston, Texas, United States |
| Role of Simvastatin in Relapsing-Remitting Multiple Sclerosis | Simvastatin Multiple Sclerosis | Drug: Simvastatin in relapsing remitting multiple sclerosis | EDSS|Response rate on the patient reported outcome form Multiple Sclerosis Walking Scale-12 version 2|Change in time taken to complete 25-Foot Timed Walk|Change in time taken to complete 9 hole peg test|modified Rankin scale|Change in frontal lobe function based on Frontal Assessment Battery (FAB) scores | Assiut University | |
| Calorie Restricted Diet and Exercise | Metabolic Syndrome | Behavioral: calorie restricted diet and exercise | KOOS|IKDC|subscales of the KOOS pain|KOOS symptoms|KOOS activity of daily living|sport and recreational function|knee related quality of life|SBP|DBP|BMI|weight|HDL|LDL-C|TG|TC|FBG|WC | The First People's Hospital of Jingzhou | First Affiliated Hospital of Jinzhou Medical University, Jinzhou, Liaoning, China |
| Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study | Nicotine Dependence | Drug: Psilocybin-assisted treatment|Drug: Nicotine Replacement Therapy (NRT) | Urinary cotinine|Breath CO|MRI scanning | Johns Hopkins University|Beckley Foundation|Heffter Research Institute | Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States|Neuroimaging Research Branch, NIDA-IRP, Baltimore, Maryland, United States |
| Exploratory Study of NS-089/NCNP-02 in DMD | Duchenne Muscular Dystrophy | Drug: NS-089/NCNP-02 | Adverse event and adverse drug reaction [Safety and Tolerability]|Expression of dystrophin protein|NSAA|TTSTAND|TTRW|6MWT and 2MWT|TUG|PUL|Detection of exon 44-skipped mRNA of dystrophin in muscle tissue|NS-089/NCNP-02 concentration of the blood plasma|Serum Creatine kinase concentration | National Center of Neurology and Psychiatry, Japan|Nippon Shinyaku Co., Ltd. | National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan |
| Exploratory Study of NS-065/NCNP-01 in DMD | Duchenne Muscular Dystrophy | Drug: NS-065/NCNP-01 | Safety and tolerability (adverse event and adverse drug reaction)|Expression of dystrophin protein|Detection of exon53 skipped mRNA of dystrophin|NS-065/NCNP-01 concentration of the blood plasma|NS-065/NCNP-01 concentration of the urine|Serum Creatine kinase concentration | National Center of Neurology and Psychiatry, Japan|Nippon Shinyaku Co., Ltd. | National Center of Neurology and Psychiatry, Kodaira, Tokyo, Japan |
| Patient Real-world Clinical, Neurological, Tolerability, and Safety Outcomes for Tecfidera® and Rebif® | Relapsing-remitting Multiple Sclerosis | Drug: Rebif|Drug: Tecfidera | NEDA-2|Clinical differences between the two treatment groups|Neurological differences between two treatment groups|Proportion of individuals within each treatment group who discontinued, stratified by reason | IMS HEALTH GmbH & Co. OHG|EMD Serono | Alabama Neurology Associates, Birmingham, Alabama, United States|Colorado Springs Neurological Associates, Colorado Springs, Colorado, United States|Savannah Neurology Specialists, Savannah, Georgia, United States|Northshore University, Evanston, Illinois, United States|OSF Multi-specialty Group d/b/a Illinois Neurological Institute, Peoria, Illinois, United States|St Elizabeths/ Dragonfly Research, Brighton, Massachusetts, United States|Lahey Clinic, Burlington, Massachusetts, United States|Minneapolis Clinic of Neurology, Golden Valley, Minnesota, United States|Washington university, Saint Louis, Missouri, United States|University of Nebraska Medical Center, Lincoln, Nebraska, United States|University of Buffalo Clinical and Translational research Center, Buffalo, New York, United States|Neurological Associates of Long Island, Lake Success, New York, United States|Onsite Clinical Solutions, Charlotte, North Carolina, United States|Raleigh Neurology Associates, Raleigh, North Carolina, United States|Dayton Center for Neurological Disorders, Centerville, Ohio, United States|Oak Clinic-Multiple Sclerosis, Uniontown, Ohio, United States|Providence St. Vincent Medical Center, Portland, Oregon, United States|The university of Texas Health Science Center at San Antonio, San Antonio, Texas, United States|University of Vermont, Burlington, Vermont, United States|Blacksburg Neurology, Christiansburg, Virginia, United States|MultiCare Health System, Tacoma, Washington, United States|Neuroscience Group, Neenah, Wisconsin, United States|Centre Hospitalier de l'Universite de Montreal, Montréal, Quebec, Canada |
| The Effects of Intrathecal Dexmedetomidine on Spinal Anesthesia Using Diluted Low-Dose Bupivacaine for Transurethral Resection of Prostate in Elderly | Benign Prostatic Hypertrophy | Drug: spinal anesthesia | Evaluation of efficacy of DXM-bupivacaine|Comparison of the degree of the postoperative analgesic effect | Yonsei University | Severance Hospital, Seoul, Korea, Republic of |
| Randomized Comparative Study of Sleeve Gastrectomy Versus MGB and SASI Bypass , Randomized Study | Diabetes Mellitus Type 2 in Obese | Other: metabolic surgery | excess weight loss|Resolution of diabetes | tarek mahdy|Mansoura University | |
| Short-term B-cell Depletion in Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Time to return of disease activity after the third month post-first-infusion|Change in disability as assessed by Expanded Disability Status Scale (EDSS)|Quality of life measure as assessed by Neuro-QoL Computer Adaptive Test (CAT) | Johns Hopkins University|National Multiple Sclerosis Society | Johns Hopkins University, Baltimore, Maryland, United States |
| Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators | Healthy | Drug: Moderately-high dose of psilocybin|Drug: Moderately-low dose of psilocybin|Drug: Very-low dose of psilocybin|Drug: Placebo | Persisting Effects Questionnaire|Hood Mysticism Scale|States of Consciousness Questionnaire|fMRI Resting State Functional Connectivity | Johns Hopkins University | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| Nivolumab Role in the Treatment of Patients With Refractory or Relapse Multiple Myeloma | Multiple Myeloma | Drug: Nivolumab|Drug: Pomalidomide|Drug: Dexamethasone|Drug: Elotuzumab | Safety of Nivolumab: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | PETHEMA Foundation|Celgene|Bristol-Myers Squibb|Adknoma Health Research, S.L. | ICO Badalona, Badalona, Spain|Hospital Clinic, Barcelona, Spain|Hospital Universitario Virgen de las Nieves, Granada, Spain|Hospital Universitario de Canarias, Las Palmas de Gran Canaria, Spain|Hospital Ramón y Cajal, Madrid, Spain|Hospital Universitario 12 de octubre, Madrid, Spain|Hospital Morales Messeguer, Murcia, Spain|Hospital Central de Asturias, Oviedo, Spain|Hospital Son Llatzer, Palma de Mallorca, Spain|Clinica Universidad de Navarra, Pamplona, Spain|Hospital Universitario de Salamanca, Salamanca, Spain|Complejo Hospitalario Regional Virgen del Rocío, Sevilla, Spain |
| Covid-19 Vaccine Immune Response in Multiple Sclerosis | Multiple Sclerosis | Other: Blood Test 1|Other: Blood Test 2 | Blood titres of Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche in MS patients compared with healthy volunteers 12 months from date of first dose of Covid-19 vaccine|Blood titres of Anti-SARS-CoV-2 S1/S2/N IgG antibody Roche in MS patients compared with healthy volunteers 18 months from date of first dose of Covid-19 vaccine|T-SPOT® COVID SARS-CoV-2 test status in MS patients compared with healthy volunteers 12 months from date of first dose of Covid-19 vaccine|T-SPOT® COVID SARS-CoV-2 test status in MS patients compared with healthy volunteers 18 months from date of first dose of Covid-19 vaccine|Type and timing of DMT in MS patients|Type and timing of Covid-19 vaccine in MS patients compared with healthy volunteers|Participant-reported PCR positive Covid-19 infection/s in MS patients compared with healthy volunteers|Covid-19 vaccine-related serious adverse events in MS patients compared with healthy volunteers|Demographics of MS patients compared with healthy volunteers|Co-morbidity status of MS patients compared with healthy volunteers | University Hospitals of North Midlands NHS Trust | University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, United Kingdom |
| Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients | Obesity|Iron Deficiency | Procedure: Sleeve gastrectomy for morbid obesity | The intestinal absorption of iron | Assistance Publique - Hôpitaux de Paris | Hôpital Louis Mourier, Colombes, Ile De France, France |
| Exercise Therapy in Multiple Sclerosis | Multiple Sclerosis | Other: Physical Therapy | Changes in clinical disability (EDSS)|Changes in clinical disability: Multiple Sclerosis Functional Composite (MSFC)|Changes in visual disability|Changes in Mood-depressive trait|Changes in Mood-anxiety trait|Neurophysiological assessment|Changes in autonomic function|Changes in T cell function|Electrophysiological evaluation | IRCCS San Raffaele|Neuromed IRCCS | IRCCS San Raffele Pisana, Roma, RM, Italy |
| Psilocybin Therapy for Chronic Low Back Pain | Chronic Low-back Pain | Drug: Psilocybin therapy with Zolpidem and Modafinil|Drug: Psilocybin therapy with Zolpidem|Drug: Psilocybin therapy with Modafinil|Drug: Psilocybin therapy with Placebo | Change in pain interference|Change in average pain intensity|Change in clinical depressive symptom severity|Change in depressive symptom severity | Joshua Woolley, MD/PhD|University of California, San Francisco | |
| Neuroprotection and Repair in Optic Neuritis | Multiple Sclerosis|Optic Neuritis | Drug: Minocycline | Retinal nerve fibre layer|Other functional and structural optic nerve recovery measures | University of Calgary|Neuroscience Canada | |
| Profile of Adherence to Therapy and Interventions to Promote Adherence in MS | Multiple Sclerosis | Behavioral: Behavioral Intervention | Adherence to therapy by assessment of remaining pills/medication claims electronic records|Adherence to therapy according to ProMas|Adherence to therapy according to MS-TAQ|Improvement in quality of life | Carmel Medical Center | MS Clinic, Carmel Medical Center, Haifa, Israel |
| Effects of Hallucinogens and Other Drugs on Mood and Performance | Healthy | Drug: Hallucinogens and psychoactive substances | Rating of "Drug Liking" on the End of Day Questionnaire|Hallucinogen Rating Scale | Johns Hopkins University | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| Delphinus SoftVue Prospective Case Collection - ARM 2 | Breast Neoplasms | Other: Non-Interventional|Device: Automated Whole Breast Ultrasound | No Breast Cancer|Breast Cancer | Delphinus Medical Technologies, Inc. | USC Keck School of Medicine, Los Angeles, California, United States|Mount Sinai Medical Center, Miami Beach, Florida, United States|SouthCoast Imaging, Savannah, Georgia, United States|Beaumont Dearborn Breast Care Center, Dearborn, Michigan, United States|Karmanos Cancer Institute, Detroit, Michigan, United States|Mercy Imaging Services, Washington, Missouri, United States|Elizabeth Wende Breast Care, Rochester, New York, United States|UNC Breast Imaging Center, Chapel Hill, North Carolina, United States|Weinstein Imaging Associates, Pittsburgh, Pennsylvania, United States|Ascension St. Elizabeth, Radiology Associates of the Fox Valley, Appleton, Wisconsin, United States |
| The Effect of Exercise on Strength and Mobility and Corresponding CNS Plasticity in Multiple Sclerosis Patients | Multiple Sclerosis | Other: specifically design 6 month resistance training program|Behavioral: 6 months weight resistance and balance program | Determine activation differences in the neural regions serving motor function using MEG in a group of MS patients, comparing MS affected portions of the brain versus non-affected.|Determine effect of a 6 month resistance and balance program on activation in sensorimotor brain areas using MEG, and correlate changes in these neural indices with those of specific movement and balance. | University of Nebraska|Biogen | UNMC, Omaha, Nebraska, United States |
| A-dmDT390-bisFv(UCHT1) Immunotoxin Therapy for Patients With Cutaneous T-Cell Lymphoma (CTCL) | T-cell Lymphomas|T-cell Leukemia|Sezary Syndrome|Mycosis Fungoides|Cutaneous T-cell Lymphoma (CTCL) | Biological: A-dmDT390-bisFv(UCHT1) | Remission status (complete, partial, stable disease, progressive disease) | Angimmune LLC|James Graham Brown Cancer Center|M.D. Anderson Cancer Center|Scott and White Hospital & Clinic|University of Texas Southwestern Medical Center|Yale University | Yale University School Of Medicine Recruiting, New Haven, Connecticut, United States|James Graham Brown Cancer Center, Louisville, Kentucky, United States|University of Texas Southwestern Medical Center, Dallas, Texas, United States|University of Texas MD Anderson Cancer Center, Houston, Texas, United States|Scott and White Hospital & Clinic, Temple, Texas, United States |
| 4D-710 in Adult Patients With Cystic Fibrosis | Cystic Fibrosis Lung | Biological: 4D-710 | Incidence and severity of adverse events | 4D Molecular Therapeutics | University of Alabama Child Health Research Unit, Birmingham, Alabama, United States|National Jewish Health, Denver, Colorado, United States|University of Kansas Medical Center, Kansas City, Kansas, United States|Boston Children's Hospital, Boston, Massachusetts, United States|Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States|Nationwide Children's Hospital, Columbus, Ohio, United States|Penn State Health, Hershey, Pennsylvania, United States|The Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States|Virginia Commonwealth University Health System, Richmond, Virginia, United States |
| 4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration | Neovascular (Wet) Age-Related Macular Degeneration | Biological: 4D-150 IVT|Biological: Aflibercept IVT | Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant changes in safety parameters|Time to receiving the first supplemental aflibercept injection|Percentage of subjects requiring supplemental aflibercept injections over 52 weeks|Number of supplemental aflibercept injections over 52 weeks|Change from baseline in BCVA over time (up to 52 weeks) as assessed using the ETDRS Visual Acuity Chart|Change from baseline in central subfield thickness (CST) over time (up to 52 weeks) measured by spectral domain optical coherence tomography (SD-OCT) | 4D Molecular Therapeutics | California Retina Consultants, Oxnard, California, United States|Vitreo Retinal Associates, Gainesville, Florida, United States|Florida Eye Associates, Melbourne, Florida, United States|Retina Vitreous Associates of Florida, Tampa, Florida, United States|Cumberland Valley Retina Consultants, Hagerstown, Maryland, United States|Sierra Eye Associates, Reno, Nevada, United States|Austin Clinical Research, Austin, Texas, United States|Retina Consultants of Texas, Houston, Texas, United States|Valley Retina Institute, PA, McAllen, Texas, United States|Retina Consultants of Texas, The Woodlands, Texas, United States |
| Impact of Pumps on Internal Thoracic Arteries (IPITA) | Coronary Disease | Diagnostic Test: vascular reactivity of internal thoracic arteries | Myography|Superoxide detection and confocal microscopy|Immunochemistry|Quantitative real time transcription-polymerase chain reaction (RT-PCR) analysis|Blood sampling and biochemical analysis | University Hospital, Angers | |
| The Effect of Covid-19 on the Disease Course of Multiple Sclerosis :Belgian Lessons Learned From Rocky I to Rocky IV | COVID-19 | The investigators hereby aim to answer the question whether COVID-19 affects the progression of clinical disability in MS|vaccination status and progression MS | Marie D'hooghe|National MS Center Melsbroek | Nationaal MS center, Melsbroek, Vlaams Brabant, Belgium | |
| 4D-125 in Patients With X-Linked Retinitis Pigmentosa (XLRP) | X-Linked Retinitis Pigmentosa | Biological: 4D-125 IVT Injection|Other: Observational | Primary outcome measure | 4D Molecular Therapeutics | University of Colorado, Aurora, Colorado, United States|Vitreo Retinal Associates, Gainesville, Florida, United States|University of Michigan Kellogg Eye Center, Ann Arbor, Michigan, United States|Columbia University Medical Center/Edward Harkness Eye Institute, New York, New York, United States|Duke University Eye Center/Dept. of Ophthalmology, Durham, North Carolina, United States|Casey Eye Institute, Oregon Health and Science University, Portland, Oregon, United States|Retina Foundation of the Southwest, Dallas, Texas, United States|University of Utah John A. Moran Eye Center, Salt Lake City, Utah, United States |
| Acute Study of Effect of Ultrasound Vagus Nerve Stimulation on Glycemia | Diabetes Mellitus, Type 2 | Device: Ultrasound Vagus Nerve Stimulation (DECIMA) | Change in blood glucose Area Under the Curve (AUC, mg/dL ● hours) from baseline to 3 hours after an Oral Glucose Tolerance Test (OGTT) with Ultrasonic Vagus Nervous Stimulation (uVNS).hyperglycemia|Change in whole blood lipospolysaccharide-induced TNF-Alpha (pg/mL) production from base line to 4 hours post stimulation. | Aucta Technologies, Inc.|STATKING Clinical Services | Cognitive Clinical Trials, LLC, Scottsdale, Arizona, United States |
| Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED) | Diabetes Mellitus, Type II | Drug: Sitagliptin (MK0431)|Drug: Placebo/Glipizide 5 mg|Drug: Metformin|Drug: Pioglitazone | Change From Baseline in Hemoglobin A1C (A1C) at Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24|Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 | Merck Sharp & Dohme LLC | |
| Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients | Multiple Sclerosis | Drug: MetFORMIN 1000 Mg Oral Tablet|Drug: Interferon beta-1a | Change in IL17 in both arms as measured by ELISA.|Percentage of Quality of Life deterioration in both arms measured by MSQOL-54.|Change in IL22 in both arms as measured by ELISA.|Malondialdehyde in both arms as measured by Colorimetric tests.|Degree of remyelination visualized by MRI, it depends on clinician's overview.|Degree of disability assessed by Expanded Disability Status Scale. | German University in Cairo | Nasser Institute for Research and Treatment, Cairo, Egypt |
| Neurophysiological Assessment in Patients With Multiple Sclerosis | Multiple Sclerosis|Demyelinating Disease|Inflammatory Disease | Other: Neurophysiological assessment|Other: clinical assessment | Changes of Global cortico-cortical myelination|Changes of the Cortical-cortical coherence|Changes of the Local cortical-cortical myelination (motor)|Changes of the Trans-callosal axonal myelination|Changes of Interhemispheric signal propagation (iSP)|Changes of TMS-EEG measurement of the functional integrity of the grey matter:|Changes of TMS-EMG measurement of the functional integrity of the grey matter:|Changes of clinical outcome measures|Changes of the Multiple Sclerosis Functional Composite (MSFC)|Changes of radiological outcome measures|Changes of magnetic resonance imaging (MRI) number of lesions in T2 | University of Roma La Sapienza | |
| Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf | Relapsing Multiple Sclerosis | Other: Ofatumumab|Other: Ocrelizumab | Expanded Disability Status Scale (EDSS)|Magnetic Resonance Imaging (MRI) activity|Volume of T2 lesions|Number of relapses in the past 12 months|Baseline ARR (Annualized Relapse Rates)|Time since MS diagnosis|Time since first MS symptom|Percentage of participants with previous DMTs|Time from diagnosis to start of treatment|Number of previous DMT treatment|Line of previous DMT treatment|Type of previous DMT|Percentage of participants with comorbidities|Percentage of participants by number of comorbidities|Percentage of smoking participants|Percentage of alcohol intake participants|Percentage of patients by employment status|Percentage of participants by monthly income|Percentage of participants by educational level|Percentage of participants by ethnicity|Percentage of patients by frequency preference|Percentage of patients by route of administration|Percentage of participants by type of coverage|Treatment Satisfaction Questionnaire for Medicines (TSQM)|Total number of visits|Number of visits to clinics|Reason for out patient department (OPD) visit|Number and reason of ER visits|Number and reason of hospitalizations|Length of hospital stay|proxy costs for each visit | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Dubai, United Arab Emirates |
| UW Psilocybin Pharmacokinetics Study | Healthy | Drug: Psilocybin | Determine the concentrations of psilocin following escalating doses of psilocybin|Characterize any non-linearity in the pharmacokinetics of psilocybin and psilocin.|Determine the effect of kidney function on psilocin pharmacokinetics.|Characterize the incidence and severity of adverse events associated with escalating doses of psilocybin in normal adults. | University of Wisconsin, Madison | University of Wisconsin, School of Pharmacy, Madison, Wisconsin, United States |
| Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: FMP30 Donor Stool|Procedure: Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool|Other: Observational Control | Subjects who complete the study protocol|Change in fecal microbiota|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]|Induction of T regulatory or Th2 cells and/or reduction of Th1 or Th17 cells|Plasma CD19+ B cell count percentages|Plasma CD20+ B cell count percentages|Plasma CD19+ B cell absolute count|Plasma CD20+ B cell absolute count|Measurement of Serum Immunoglobulin Levels|Incidence of new T2/FLAIR lesions|Measurement of T2/FLAIR lesion volume|Number of T2/FLAIR lesions|Total Gadolinium Enhancing Lesions | Jeffrey Gelfand|University of California, San Francisco | UCSF Multiple Sclerosis Center, San Francisco, California, United States |
| Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine | Multiple Sclerosis, Relapsing-Remitting|Vaccine Response Impaired | Biological: Most recent vaccine to seasonal influenza | Proportion who achieve seroprotection|Fraction with 2-fold increase of HI titers|Fraction with 4-fold increase of HI titers|Seroconversion rate|Mean antibody titers|Cellular immune responses|Serum immunoglobulin subtypes|Influenza infections | Heinrich-Heine University, Duesseldorf | Medical Faculty, Heinrich-Heine-University, Duesseldorf, Northrhine-Westphalia, Germany |
| Sema 4A as a Marker for Inflammatory Disease in Multiple Sclerosis | Relapsing Multiple Sclerosis|Multiple Sclerosis | Diagnostic Test: Cerebrospinal and Blood Serum Semaphorin 4A Levels | Blood Serum Semaphorin 4A Levels|Cerebrospinal Fluid Semaphorin 4A Levels|Correlation between Semaphorin 4A levels and Demyelination and Axonal Degeneration | Providence Health & Services|Milton S. Hershey Medical Center|Bristol-Myers Squibb | Providence St. Vincent Medical Center, Portland, Oregon, United States |
| miR-142-3p as Potential Biomarker of Synaptopathy in MS | Multiple Sclerosis|Spasticity | Procedure: lumbar puncture and blood withdrawal|Procedure: Intermittent theta burst stimulation (iTBS) therapeutic protocol for spasticity | CSF concentration of miR-142-3p|CSF concentration of soluble molecules|Clinical disability assessment by Progression Index calculation for correlation analysis with CSF-miR-142-3p levels|Clinical disability assessment by MSFC calculation for correlation analysis with CSF-miR-142-3p levels|Neuroradiological assessment for correlation analysis with CSF-miR-142-3p levels|Neurophysiological assessments for correlation analysis with CSF-miR-142-3p levels|Statistical correlation of miR-142-3p levels in MS CSF with disease and neurophysiological parameters|Statistical correlation of miR-142-3p levels in MS CSF with patient's responsiveness to disease modifying therapies (DMTs).|Genotyping of SNPs in SLC1A3 and MIR-142 genes for correlation analysis with disease parameters|Lower limb spasticity assessment by H/M amplitude ratio for the therapeutic TMS substudy|Lower limb spasticity assessment by MAS score for the therapeutic TMS substudy|Statistical correlation of response to iTBS treatment with MS-significant SNPs of both SLC1A3 and MIR-142. | Neuromed IRCCS | IRCCS Neuromed, Pozzilli, Isernia, Italy |
| Risk Perception in Multiple Sclerosis | Multiple Sclerosis | Other: High Efficacy Therapy (HET)|Other: Non High Efficacy Therapy (Non-HET) | Proportion of patients who were switched based on risk perception (infections, malignancies, others)|Number of patients with ranking of the frequency of switches due to risk perception|Proportion of patients who switched due to lack of efficacy|Proportion of patients who changed treatment group versus patients who continued in the same treatment group|Number of relapses|Expanded Disability Status Scale (EDSS)|Age|Gender|Number of patients: Employment status|Number of patients with Initial MS diagnosis|Number of patients with Current MS diagnosis|Number of patients with previous disease modifying treatment | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, East Hanover, New Jersey, United States |
| Observational Study of the Effect of Ozanimod on Fatigue in Multiple Sclerosis Patients | Fatigue|Multiple Sclerosis | Drug: Ozanimod | Three-months change in Modified Fatigue Impact Scale (MFIS) score|Three-months change in Chalder Fatigue Scale (CFS) score|Three-months change in Fatigue Severity Scale (FSS) score|Three-months change in NeuroQOL-fatigue questionnaire score|Visual Analog Scale (VAS) for fatigue score|Three-months change in NeuroQOL-cognitive function questionnaire score | Brigham and Women's Hospital|Bristol-Myers Squibb | |
| Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | Multiple Sclerosis | Drug: Teriflunomide | Treatment Satisfaction Questionnaire for Medication (TSQM) Version 1.4 - Assessment of Global Satisfaction Subscale Score With Teriflunomide Treatment at Week 48|Change From Baseline in TSQM Scores in Participants Switching From Another Disease Modifying Therapy (DMT) at Week 4 and Week 48|Change From Week 4 in TSQM Scores in Naïve Participants to Week 48|Change From Baseline in Disease Progression Using Patient Determined Disease Steps (PDDS) Score at Week 48|Change From Baseline in Multiple Sclerosis Performance Scale (MSPS) Score at Week 24 and Week 48|Annualized Treated Relapse Rate|Time to Relapse: Kaplan-Meier Estimates of the Probability of Treated Relapse at Week 4, Week 24 and Week 48|Change From Baseline in Cognition Measured by Symbol Digit Modalities Test (SDMT) Score at Week 48|Overview of Adverse Events (AEs)|Percentage of Participants With Treatment Compliance of ≥80% During the Study Treatment Period|Duration of Teriflunomide Treatment Exposure|Change From Baseline in Multiple Sclerosis International Quality of Life (MusiQoL) Score at Week 48|Change From Baseline in Stern Leisure Activity Scale at Week 48|Expanded Disability Status Scale (EDSS) Score at Baseline and Week 48 | Sanofi | Investigational Site Number 840077, Birmingham, Alabama, United States|Investigational Site Number 840007, Cullman, Alabama, United States|Investigational Site Number 840087, Phoenix, Arizona, United States|Investigational Site Number 840114, Phoenix, Arizona, United States|Investigational Site Number 840080, Scottsdale, Arizona, United States|Investigational Site Number 840032, Tucson, Arizona, United States|Investigational Site Number 840021, Phoenix, Arkansas, United States|Investigational Site Number 840018, Fullerton, California, United States|Investigational Site Number 840037, Fullerton, California, United States|Investigational Site Number 840108, Long Beach, California, United States|Investigational Site Number 840014, Newport Beach, California, United States|Investigational Site Number 840019, Oceanside, California, United States|Investigational Site Number 840097, Boulder, Colorado, United States|Investigational Site Number 840040, Colorado Springs, Colorado, United States|Investigational Site Number 840046, Denver, Colorado, United States|Investigational Site Number 840016, Englewood, Colorado, United States|Investigational Site Number 840094, Fort Collins, Colorado, United States|Investigational Site Number 840024, Bradenton, Florida, United States|Investigational Site Number 840089, Clearwater, Florida, United States|Investigational Site Number 840055, Coconut Creek, Florida, United States|Investigational Site Number 840104, Hialeah, Florida, United States|Investigational Site Number 840101, Miami Lakes, Florida, United States|Investigational Site Number 840011, Ormond Beach, Florida, United States|Investigational Site Number 840059, Sarasota, Florida, United States|Investigational Site Number 840008, St. Petersburg, Florida, United States|Investigational Site Number 840081, Sunrise, Florida, United States|Investigational Site Number 840002, Atlanta, Georgia, United States|Investigational Site Number 840075, Macon, Georgia, United States|Investigational Site Number 840012, Fort Wayne, Indiana, United States|Investigational Site Number 840010, Indianapolis, Indiana, United States|Investigational Site Number 840034, Louisville, Kentucky, United States|Investigational Site Number 840047, Rockport, Maine, United States|Investigational Site Number 840107, Foxboro, Massachusetts, United States|Investigational Site Number 840030, Springfield, Massachusetts, United States|Investigational Site Number 840073, Clinton Township, Michigan, United States|Investigational Site Number 840068, Golden Valley, Minnesota, United States|Investigational Site Number 840098, Golden Valley, Minnesota, United States|Investigational Site Number 840086, Chesterfield, Missouri, United States|Investigational Site Number 840058, St. Louis, Missouri, United States|Investigational Site Number 840026, Lincoln, Nebraska, United States|Investigational Site Number 840020, Henderson, Nevada, United States|Investigational Site Number 840049, Freehold, New Jersey, United States|Investigational Site Number 840044, Toms River, New Jersey, United States|Investigational Site Number 840100, East Setauket, New York, United States|Investigational Site Number 840005, New York, New York, United States|Investigational Site Number 840064, NY, New York, United States|Investigational Site Number 840071, Schenectady, New York, United States|Investigational Site Number 840091, Staten Island, New York, United States|Investigational Site Number 840045, Syracuse, New York, United States|Investigational Site Number 840084, Asheville, North Carolina, United States|Investigational Site Number 840078, Charlotte, North Carolina, United States|Investigational Site Number 840042, Raliegh, North Carolina, United States|Investigational Site Number 840105, Sanford, North Carolina, United States|Investigational Site Number 840074, Wilmington, North Carolina, United States|Investigational Site Number 840090, Winston Salem, North Carolina, United States|Investigational Site Number 840041, Bismarck, North Dakota, United States|Investigational Site Number 840003, Canton, Ohio, United States|Investigational Site Number 840009, Dayton, Ohio, United States|Investigational Site Number 840053, Monaca, Pennsylvania, United States|Investigational Site Number 840056, Philadelphia, Pennsylvania, United States|Investigational Site Number 840072, Cranston, Rhode Island, United States|Investigational Site Number 840048, Nashville, Tennessee, United States|Investigational Site Number 840035, Tullahoma, Tennessee, United States|Investigational Site Number 840060, Dallas, Texas, United States|Investigational Site Number 840052, Mansfield, Texas, United States|Investigational Site Number 840028, San Antonio, Texas, United States|Investigational Site Number 840070, Henrico, Virginia, United States|Investigational Site Number 840109, Richmond, Virginia, United States|Investigational Site Number 840017, Roanoke, Virginia, United States|Investigational Site Number 840054, Vienna, Virginia, United States|Investigational Site Number 840069, Spokane, Washington, United States|Investigational Site Number 840079, Morgantown, West Virginia, United States|Investigational Site Number 840038, Milwaukee, Wisconsin, United States|Investigational Site Number 840112, Milwaukee, Wisconsin, United States|Investigational Site Number 840076, Neenah, Wisconsin, United States|Investigational Site Number 040-001, Linz, Austria|Investigational Site Number 040-002, Wien, Austria|Investigational Site Number 056006, Brasschaat, Belgium|Investigational Site Number 056001, Bruxelles, Belgium|Investigational Site Number 056003, Edegem, Belgium|Investigational Site Number 056002, Kortrijk, Belgium|Investigational Site Number 056007, Leuven, Belgium|Investigational Site Number 056008, Liège, Belgium|Investigational Site Number 056009, Liège, Belgium|Investigational Site Number 056005, Melsbroek, Belgium|Investigational Site Number 124006, Cambridge, Canada|Investigational Site Number 124007, St. John, Canada|Investigational Site Number 152003, Concepcion, Chile|Investigational Site Number 152001, Santiago, Chile|Investigational Site Number 152005, Santiago, Chile|Investigational Site Number 246004, Hämeenlinna, Finland|Investigational Site Number 246005, Kuopio, Finland|Investigational Site Number 246006, Oulu, Finland|Investigational Site Number 246001, Turku, Finland|Investigational Site Number 246003, Turku, Finland|Investigational Site Number 250002, Agen Cedex, France|Investigational Site Number 250003, Aix En Provence, France|Investigational Site Number 250004, Albi, France|Investigational Site Number 250005, Amiens Cedex 1, France|Investigational Site Number 250006, Bayonne, France|Investigational Site Number 250007, Bordeaux, France|Investigational Site Number 250008, Caen, France|Investigational Site Number 250009, CAHORS Cedex 9, France|Investigational Site Number 250011, Chambery, France|Investigational Site Number 250012, Colmar, France|Investigational Site Number 250001, Dijon, France|Investigational Site Number 250015, GRENOBLE cedex, France|Investigational Site Number 250017, Le Mans Cedex 9, France|Investigational Site Number 250018, Lille Cedex, France|Investigational Site Number 250019, Limoges Cedex, France|Investigational Site Number 250020, Lyon Cedex 03, France|Investigational Site Number 250021, Marseille, France|Investigational Site Number 250022, Metz-Tessy, France|Investigational Site Number 250023, Montbeliard, France|Investigational Site Number 250024, MONTPELLIER Cedex 5, France|Investigational Site Number 250025, Mulhouse, France|Investigational Site Number 250026, Nancy, France|Investigational Site Number 250027, Nantes, France|Investigational Site Number 250028, Nimes, France|Investigational Site Number 250016, PARIS Cedex 13, France|Investigational Site Number 250029, PARIS Cedex 20, France|Investigational Site Number 250043, Pau, France|Investigational Site Number 250031, Quimper, France|Investigational Site Number 250032, Reims, France|Investigational Site Number 250033, Rouen, France|Investigational Site Number 250030, St Germain En Laye, France|Investigational Site Number 250035, Strasbourg, France|Investigational Site Number 250037, Toulouse, France|Investigational Site Number 250038, Tours, France|Investigational Site Number 250039, Valence Cedex 9, France|Investigational Site Number 250040, Valenciennes, France|Investigational Site Number 250013, VICHY Cedex, France|Investigational Site Number 276001, Bergisch-Gladbach, Germany|Investigational Site Number 276003, Berlin, Germany|Investigational Site Number 276004, Freiburg, Germany|Investigational Site Number 300002, Athens, Greece|Investigational Site Number 300001, Athens, Greece|Investigational Site Number 300005, Larissa, Greece|Investigational Site Number 300004, Thessaloniki, Greece|Investigational Site Number 380008, Ancona, Italy|Investigational Site Number 380009, Bari, Italy|Investigational Site Number 380002, Gallarate (VA), Italy|Investigational Site Number 380001, Milano, Italy|Investigational Site Number 380004, Milano, Italy|Investigational Site Number 380006, Napoli, Italy|Investigational Site Number 380005, Orbassano (TO), Italy|Investigational Site Number 578002, Bergen, Norway|Investigational Site Number 578003, Namsos, Norway|Investigational Site Number 578001, Oslo, Norway|Investigational Site Number 724002, Barcelona, Spain|Investigational Site Number 724010, Córdoba, Spain|Investigational Site Number 724008, Donostia, Spain|Investigational Site Number 724001, El Palmar (MURCIA), Spain|Investigational Site Number 724004, La Coruña, Spain|Investigational Site Number 724006, Santiago de Compostela, Spain|Investigational Site Number 724007, Valencia, Spain|Investigational Site Number 724005, Valladolid, Spain|Investigational Site Number 752001, Karlstad, Sweden|Investigational Site Number 752003, Kungsbacka, Sweden|Investigational Site Number 752002, Motala, Sweden|Investigational Site Number 826-005, Birmingham, United Kingdom|Investigational Site Number 826-003, Brighton, United Kingdom|Investigational Site Number 826-007, Glasgow, United Kingdom|Investigational Site Number 826-008, Leeds, United Kingdom|Investigational Site Number 826-010, Leicester, United Kingdom|Investigational Site Number 826-009, London, United Kingdom|Investigational Site Number 826-001, Norwich, United Kingdom|Investigational Site Number 826-006, Romford, United Kingdom|Investigational Site Number 826-004, Salford, United Kingdom |
| A Survey to Evaluate Early Experience From Patient and Care Partner on Injection and Device for KESIMPTA® Indicated for Multiple Sclerosis | Multiple Sclerosis | Other: Kesimpta | Proportion of respondents in top two rating categories for device satisfaction on use of KESIMPTA Sensoready|Proportion of patients by US region of residence|Proportion of patients by educational level|Patients Determined Disease Steps (PDDS)|General QoL|Proportion of patients by Multiple Sclerosis Phenotype|Proportion of patients with co-morbidities|Importance of healthcare provider (HCP) instructions for first injection|Proportion of participants with necessity of HCP at first injection|Level of anxiety with injections, in general|Proportion of patients performing preparation activities for injection|Proportion of participants by site of administration|Proportion of participants by individual medication as previous Disease Modifying Therapy (DMT)|Proportion of participants by reasons to switch from most recent therapy|Proportion of patients who are injection naïve or experienced|Proportion of participants by reasons for starting KESIMPTA|Proportion of patients agreeing with the attributes of the device Usability Characteristics during self-administration|Patient Confidence|Overall device satisfaction based on patient self-report and care partner report|Injection experience based on patient self-report or care partner report|Time for injection in minutes | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, East Hanover, New Jersey, United States |
| The MS-LINK™ Outcomes Study | Multiple Sclerosis | Patient-determined Disease Steps (PDDS) Scale Score|Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Fatigue Score|Patient Reported Outcomes Measurement Information System (PROMIS) Multiple Sclerosis (MS) Physical Function Score|Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Score|Patient Reported Outcomes Measurement Information System (PROMIS) MS Cognitive Function Score|Patient Health Questionnaire 9-Item (PHQ9) Score|Wasson Health Confidence Scale Score|Health-related Quality of Life Assessed by Centers for Disease Control and Prevention Health-Related Quality of Life Measure (CDC HRQoL-14)|Work Productivity and Activity Impairment Questionnaire-Multiple Sclerosis (WPAI-MS) Score|Number of Participants with Reasons for Discontinued Disease-Modifying Therapies (DMT)|Number of Participants with Current Use of Disease-Modifying Therapies (DMT)|Duration of Disease-Modifying Therapies (DMT) use|Number of Participants With Adherence to Treatment as Assessed by Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)|Occurrence of Relapses|Occurrence of Multiple Sclerosis (MS) Symptoms|Number of Utilization of Healthcare Resources by Participants|Well-being of Participant Assessed by Physical Activity Diary|Number of Participants with Response to Health Priorities and Goals|Expanded Disability Status Scale (EDSS) Score|Multiple Sclerosis Functional Composite (MSFC) Score|Timed 25-Foot Walk Test|9-Hole Peg Test (9HPT) Score|Paced Auditory Serial Addition Test (PASAT) Score|Symbol Digit Modalities Test (SDMT)|Processing Speed Test (PST)|Number of Participants with Magnetic resonance imaging (MRI) History|Number of Participants with History of Fall|Number of Participants with Adverse Events of Interest|Number of Participants with Symptoms of Coronavirus (COVID) | EMD Serono Research & Development Institute, Inc.|EMD Serono | Alabama Neurology Associates, Birmingham, Alabama, United States|Georgetown University, Washington, District of Columbia, United States|The Multiple Sclerosis Center of Atlanta, Atlanta, Georgia, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|The Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, United States|The University of Texas of Austin, Austin, Texas, United States | |
| Kesimpta® (Ofatumumab) in Swiss Multiple Sclerosis Patients - an Observational Study | Multiple Sclerosis | Other: Ofatumumab | Proportion of patients with no evidence of disease activity (NEDA-3)|Proportion of patients demonstrating NEDA-3|Proportion of patients demonstrating no evidence of disease activity in individual components of NEDA-3|Proportion of patients with previous DMT medication|Proportion of patients with clinical and MRI parameters|Proportion of Ofatumumab doses not completed|Proportion of participants with a cumulative treatment interruption of more than six months|Adherence to Ofatumumab|Proportion of patients permanently discontinuing Ofatumumab|Interdependency of adherence and clinical outcome in terms of NEDA-3|Treatment effect of Ofatumumab on the impact of multiple sclerosis as measured by MSIS-29|Treatment satisfaction with Ofatumumab as measured by TSQM-9 | Novartis Pharmaceuticals|Novartis | Novartis Investigative Site, Baden, Aargau, Switzerland|Novartis Investigative Site, Liestal, BL, Switzerland|Novartis Investigative Site, Zuerich, CHE, Switzerland|Novartis Investigative Site, Chur, GR, Switzerland|Novartis Investigative Site, Luzern, LU, Switzerland|Novartis Investigative Site, Sargans, Saint Gallen, Switzerland|Novartis Investigative Site, Wil, SG, Switzerland|Novartis Investigative Site, Zug, ZG, Switzerland|Novartis Investigative Site, Zurich, ZH, Switzerland|Novartis Investigative Site, Basel, Switzerland|Novartis Investigative Site, Bern, Switzerland|Novartis Investigative Site, Lausanne, Switzerland|Novartis Investigative Site, Lugano, Switzerland|Novartis Investigative Site, Luzern, Switzerland|Novartis Investigative Site, Luzern, Switzerland |
| Analysis of Lymphocyte Cell Surface Adhesion Marker Expression in Natalizumab Population With Active Control | Multiple Sclerosis | Quantitative Assessment of CD62L in MS Patients on Immunomodulatory Agents | John F. Foley, MD|Biogen|Elan Pharmaceuticals|Rocky Mountain MS Research Group, LLC | Rocky Mountain MS Clinic, Salt Lake City, Utah, United States | |
| Study Evaluating Kesimpta® Treatment Effects and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Other Disease Modifying Therapies | Multiple Sclerosis | Other: Ofatumumab | Reasons for recent therapy switch to ofatumumab|Proportion of missed ofatumumab doses|Number of patients by reasons for treatment interruptions|Number of treatment interruptions per patient|Duration of treatment interruptions per patient|Proportion of patient subgroups with and without 100% adherence depending on different characteristics|Proportion of patients permanently discontinuing ofatumumab during the study by reason for discontinuation|Proportion of patients permanently discontinuing ofatumumab during the study by planned next DMT|Change on Multiple Sclerosis Impact Scale 29 (MSIS-29) as compared to baseline in general and depending on reasons for treatment switch|Treatment Satisfaction Questionnaire for Medication (TSQM) 1.4 as compared to baseline in general and depending on reasons for treatment switch|Fatigue Scale for Motor and Cognitive Functions (FSMC) compared to baseline in general and depending on reasons for treatment switch|Percentage of patients with no clinical evidence of disease activity (NEDA)|Proportion of patients demonstrating the individual NEDA-3 components|The proportion of subjects discontinuing treatment due to insufficient effectiveness (lack of effectiveness) or tolerability/safety reasons|Number of participants with injection related AEs | Novartis Pharmaceuticals|Novartis | |
| Follow-up Study After 11 Years of Patients Who Were Included in the BENEFIT Trial (304747) With a First Demyelinating Event Suggestive of Multiple Sclerosis | Multiple Sclerosis | Procedure: Several diagnostic procedures | Time to First Relapse by Kaplan-Meier Estimates|Time to Clinically Definite Multiple Sclerosis (CDMS) Represented by Kaplan-Meier Estimates|Number of Subjects With Diagnosis of Multiple Sclerosis Within Eleven years after Clinically-Isolated Syndrome (CIS) According to McDonald 2001 and 2010 Criteria|Disease Course as Assessed at the Time of BENEFIT 11|Percentage of Subjects Converting to Secondary Progressive Multiple Sclerosis (SPMS)|Time to Secondary Progressive Multiple Sclerosis (SPMS) Represented by Kaplan-Meier Estimates|Expanded Disability Status Scale (EDSS) at Year 11|Number of Subjects With Confirmed and Sustained 1-point Expanded Disability Status Scale (EDSS) Progression at Year 11|Number of Subjects With Confirmed 2.5-point Expanded Disability Status Scale (EDSS) Progression at Year 11|Percentage of Subjects who Ever Reached a Disability Status Scale (DSS) 3 and 6|Disability Based Efficacy Domain: Time to Disability Status Scale (DSS) 3 by Kaplan-Meier Estimates|Disability Based Efficacy Domain: Time to Disability Status Scale (DSS) 6 by Kaplan-Meier Estimates|Multiple Sclerosis Functional Composite (MSFC) at Year 11|Multiple Sclerosis Severity Score (MSSS) at Year 11|Cognitive Function: Paced Auditory Serial Addition Test-3 (PASAT-3) at Year 11|Cognitive function: Symbol Digit Modalities Test (SDMT)|Relapse-Based Efficacy domain: Hazard Ratio for Recurrent Relapses|Relapse Based Efficacy Domain: Annualized Relapse Rate|Time to use of Ambulatory Device Represented by Kaplan-Meier Estimates|Time to Dependence of Ambulatory Device for Walking Represented by Kaplan-Meier Estimates|Number of Subjects With Wheelchair Use After 11 years|Education Status at Year 11|Living Conditions at Year 11|Employment Status at Year 11|Multiple Sclerosis Impact on Employment at Year 11|Resource Use: Hospitalization During Last 12 months|Resource Use: Visits to Other Specialists During Last 12 months|Resource Use Assessment Questionnaire: Help from Family/Regular Ambulatory Services|Resource Use Assessment Questionnaire: Additional Ambulatory Services During Relapse|Resource Use Assessment Questionnaire: Adaptions past 6 months|Patient-Reported Outcomes (PRO)-based Efficacy Domain: Center of Epidemiological Studies Depression Scale (CES-D) Total Score at Year 11|PRO-based Efficacy Domain: Fatigue Scale for Sensory and Motor Functions (FSMC)|Functional Assessment of Multiple Sclerosis (FAMS) Trial Outcome Index (TOI) at Year 11|Functional Assessment of Multiple Sclerosis (FAMS) Total Score at Year 11|PRO-based Efficacy Domain: European Quality of Life - 5 Dimensions (EQ-5D) Score at Year 11|European Quality of Life - 5 Dimensions (EQ-5D) Health-related quality of life (HRQoL) Score at Year 11|Number of Subjects who Started Second Line Therapy at Year 11|Number of Subjects who Started First Disease-Modifying Treatment (DMT) other than IFNB at Year 11|Magnet-Resonance Imaging (MRI): Number of Newly Active Lesions|Magnet-Resonance Imaging (MRI): Number of Lesions on T1- and T2-Weighted Scans|Magnet-Resonance Imaging (MRI): Volume of Lesions on T1- and T2-Weighted Scans|Magnet-Resonance Imaging (MRI): Normalized Brain Volume|Optical Coherence Tomography (OCT) Parameter - Retinal Nerve Fiber Layer (RNFL)|Optical Coherence Tomography (OCT) Parameter - Total Macular Volume (TMV)|Optical Coherence Tomography (OCT) Parameter - Pupillo Macular Bundle (PMB)|Optical Coherence Tomography (OCT) Parameter - Ganglion Cell Inner Plexiform Layer|Ophthalmological examination - Optic Nerve Head|Ophthalmological examination - Slit lamp Biomicroscopy|Ophthalmological examination - Visual Acuity|Number of Subjects with Vitamin D Intake | Bayer | Graz, Steiermark, Austria|Innsbruck, Austria|Bruxelles - Brussel, Belgium|Gent, Belgium|Leuven, Belgium|Liege, Belgium|Calgary, Alberta, Canada|London, Ontario, Canada|Ottawa, Ontario, Canada|Montreal, Quebec, Canada|Brno, Czech Republic|Hradec Kralove, Czech Republic|Ostrava-Poruba, Czech Republic|Praha 2, Czech Republic|Glostrup, Denmark|Oulu, Finland|Seinäjoki, Finland|Tampere, Finland|Turku, Finland|Bordeaux, France|Clermont ferrand, France|Dijon, France|Lille, France|Nice, France|Rennes, France|Toulouse, France|Ulm, Baden-Württemberg, Germany|München, Bayern, Germany|Regensburg, Bayern, Germany|Würzburg, Bayern, Germany|Hennigsdorf, Brandenburg, Germany|Gießen, Hessen, Germany|Marburg, Hessen, Germany|Offenbach, Hessen, Germany|Greifswald, Mecklenburg-Vorpommern, Germany|Göttingen, Niedersachsen, Germany|Düsseldorf, Nordrhein-Westfalen, Germany|Köln, Nordrhein-Westfalen, Germany|Mainz, Rheinland-Pfalz, Germany|Halle, Sachsen-Anhalt, Germany|Erfurt, Thüringen, Germany|Münster, Germany|Budapest, Hungary|Budapest, Hungary|Debrecen, Hungary|Szeged, Hungary|Jerusalem, Israel|Tel Hashomer, Israel|Orbassano, Torino, Italy|Gallarate, Italy|Milano, Italy|Padova, Italy|Pavia, Italy|Torino, Italy|Sittard, Netherlands|Bergen, Norway|Bydgoszcz, Poland|Krakow, Poland|Lodz, Poland|Lublin, Poland|Wroclaw, Poland|Coimbra, Portugal|Ljubljana, Slovenia|Sevilla, Andalucía, Spain|L'Hospitalet de Llobregat, Barcelona, Spain|Barcelona, Spain|Barcelona, Spain|Madrid, Spain|Málaga, Spain|Valencia, Spain|Göteborg, Sweden|Basel, Basel-Stadt, Switzerland|St. Gallen, Sankt Gallen, Switzerland|Bern, Switzerland|Sheffield, South Yorkshire, United Kingdom|Aberdeen, United Kingdom|Dundee, United Kingdom |
| Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in Multiple Sclerosis | Multiple Sclerosis|Covid19 | Geometric mean titers (GMT) of anti-SARS-CoV-2 spike IgG for each treatment at 8 weeks from initial vaccination dose|Proportion of participants with >4 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks|Proportion of participants with >2 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks|Median time from peak to complete absence of anti-SARS-CoV-2 IgG for each treatment arm|Proportion of spike-specific T-cells/Total T cells | St. Barnabas Medical Center | Saint Barnabas Medical Center, Livingston, New Jersey, United States | |
| Hypoglycemia- and Weight-related Quality of Life in Patients With Diabetes Mellitus Type 2 on Sulfonylurea Derivatives. | Diabetes Mellitus Type 2 | Hypoglycemic Fear Survey (HFS) questionnaire|Impact of Weight on Quality of Life (IWQOL-Lite) questionnaire|Diabetes Symptom Checklist (DSC-R) questionnaire,|Medication Adherence Report Scale (MARS-5) questionnaire|Investigator-asked Symptoms of Hypoglycemia, hypoglycemic events, weight, compliance | AstraZeneca | Research Site, Alkmaar, Netherlands|Research Site, Den Haag, Netherlands|Research Site, Edam, Netherlands|Research Site, Gorinchem, Netherlands|Research Site, Heerhugowaard, Netherlands|Research Site, Heiloo, Netherlands|Research Site, Hoogvliet, Netherlands|Research Site, Lichtenvoorde, Netherlands|Research Site, Limmen, Netherlands|Research Site, Maasbracht, Netherlands|Research Site, Noord-Scharwoude, Netherlands|Research Site, Poortvliet, Netherlands|Research Site, Rotterdam, Netherlands|Research Site, Spijkenisse, Netherlands|Research Site, Tuitjenhorn, Netherlands|Research Site, Vaassen, Netherlands|Research Site, Valkenswaard, Netherlands|Research Site, Voerendaal, Netherlands|Research Site, Volendam, Netherlands|Research Site, Wamel, Netherlands|Research Site, Zuid-Scharwoude, Netherlands|Research Site, Zutphen, Netherlands | |
| Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera | Multiple Sclerosis|Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl fumarate | Time to Absolute Lymphocyte Count (ALC) Reconstitution After Dimethyl Fumarate (DMF) Discontinuation|Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation|Time From DMF Initiation to Lymphopenia Assessed at Time of DMF Discontinuation|Percent Change in ALC Over Time From DMF Initiation to DMF Discontinuation or End of Study|Time From DMF Initiation to DMF Discontinuation|Percentage of Participants with Discontinuation of DMF Treatment|Percentage of Participants on DMF and/or After Discontinuation Reflecting Relapses and/or an Expanded Disability Status Scale (EDSS) Progression|Percentage of Participants with Serious Adverse Events (SAEs)|Percentage of Participants With Opportunistic or Serious Infections|Time to Occurrence of Lymphopenia During DMF Treatment Assessed in Association Between Demographic and Clinical Characteristics|Time to Lymphocyte Reconstitution After DMF Discontinuation Assessed in Association Between Demographic and Clinical Characteristics|Percent Change from Baseline in Absolute CD4+ Count|Percent Change from Baseline in Absolute CD8+ Count|Percent Change from Baseline in Absolute CD4+/CD8+ Ratio | Biogen | Research Site, Amiens, France|Research Site, Besançon, France|Research Site, Bordeaux, France|Research Site, Brest, France|Research Site, Caen, France|Research Site, Clermont-Ferrand, France|Research Site, Dijon, France|Research Site, Grenoble, France|Research Site, Lille, France|Research Site, Limoges, France|Research Site, Lyon, France|Research Site, Marseille, France|Research Site, Montpellier, France|Research Site, Nancy, France|Research Site, Nantes, France|Research Site, Nice, France|Research Site, Nîmes, France|Research Site, Poitiers, France|Research Site, Rennes, France|Research Site, Rouen, France|Research Site, Saint-Etienne, France|Research Site, Strasbourg, France|Research Site, Toulouse, France|Research Site, Tours, France|Research Site, Île-de-France - Bicêtre, France|Research Site, Île-de-France - Créteil, France|Research Site, Île-de-France - Poissy St-Germain, France|Research Site, Île-de-France - Pontoise, France|Research Site, Île-de-France - Rothschild, France|Research Site, Île-de-France - Saint-Antoine, France|Research Site, Île-de-France - Saint-Denis, France|Research Site, Île-de-France - Salpêtrière, France |
| To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer | Solid Tumours | Drug: Olaparib|Drug: Tamoxifen|Drug: Anastrozole|Drug: Letrozole|Procedure: Pharmacokinetic sampling | Effect of Olaparib on Exposure to Tamoxifen - Cmax ss|Effect of Tamoxifen on Exposure to Olaparib - Cmax ss|Effect of Olaparib on Exposure to Anastrozole - Cmax ss|Effect of Anastrozole on Exposure to Olaparib - Cmax ss|Effect of Olaparib on Exposure to Letrozole - Cmax ss|Effect of Letrozole on Exposure to Olaparib - Cmax ss|Effect of Olaparib on Exposure to Tamoxifen - AUC0-τ|Effect of Tamoxifen on Exposure to Olaparib - AUC0-τ|Effect of Olaparib on Exposure to Anastrozole - AUC0-τ|Effect of Anastrozole on Exposure to Olaparib - AUC0-τ|Effect of Olaparib on Exposure to Letrozole - AUC0-τ|Effect of Letrozole on Exposure to Olaparib - AUC0-τ | AstraZeneca | Research Site, Brussels, Belgium|Research Site, Edegem, Belgium|Research Site, Gent, Belgium|Research Site, Leuven, Belgium|Research Site, Liège, Belgium|Research Site, Wilrijk, Belgium|Research Site, Herlev, Denmark|Research Site, Bordeaux, France|Research Site, Amsterdam, Netherlands|Research Site, Utrecht, Netherlands|Research Site, London, United Kingdom|Research Site, Manchester, United Kingdom|Research Site, Newcastle Upon Tyne, United Kingdom|Research Site, Sutton, United Kingdom |
| Personality and Drug Use | No Conditions Study Focus on Substance Use and Personality | Other: Usage of drugs | Change in scores on Big Five Inventory (BFI-44)|Change in scores on Retrospective Personality Scale (RPS) | Psychedelic Data Society|Maastricht University|Quantified Citizen Technologies Inc. | |
| Personality and Drug Use (PDU) | Personality | Current Personality Profile|Changes in Personality Profile | Quantified Citizen Technologies Inc.|Maastricht University|Psychedelic Data Society | ||
| Epidemiology Study of Malaria Transmission Intensity in Africa | Malaria|Malaria Vaccines | Procedure: Blood sampling|Procedure: Assessment of body temperature | Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), for Each Survey|Number of Subjects With Plasmodium Falciparum (P. Falciparum) Parasitaemia (PFP), According to Annual Age for Children of 4 Years or Less, for Each Survey|Number of Subjects With Anemia and Severe Anemia for Each Survey|Number of Subjects With Anti-malarial Therapy in Survey 1, According to Parasite Density|Number of Subjects With Anti-malarial Therapy in Survey 2, According to Parasite Density|Number of Subjects With Anti-malarial Therapy in Survey 3, According to Parasite Density|Number of Subjects With Anti-malarial Therapy in Survey 4, According to Parasite Density|Mean Number of Days With Malaria Treatment at Survey 1|Mean Number of Days With Malaria Treatment at Survey 2|Mean Number of Days With Malaria Treatment at Survey 3|Mean Number of Days With Malaria Treatment at Survey 4|Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 1|Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 2|Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 3|Number of Subjects With Fever in the Last 24 Hours or at Visit During Survey 4|Mean Number of Days With Fever at Survey 1|Mean Number of Days With Fever at Survey 2|Mean Number of Days With Fever at Survey 3|Mean Number of Days With Fever at Survey 4|Axillary Temperature at Visit in Survey 1|Axillary Temperature at Visit in Survey 2|Axillary Temperature at Visit in Survey 3|Axillary Temperature at Visit in Survey 4|Number of Subjects Living in the Same House at Survey 1|Number of Subjects Living in the Same House at Survey 2|Number of Subjects Living in the Same House at Survey 3|Number of Subjects Living in the Same House at Survey 4|Mean Number of Subjects Living in the Same House at Survey 1|Mean Number of Subjects Living in the Same House at Survey 2|Mean Number of Subjects Living in the Same House at Survey 3|Mean Number of Subjects Living in the Same House at Survey 4|Number of Subjects by Localisation and Type of Location at Survey 1|Number of Subjects by Localisation and Type of Location at Survey 2|Number of Subjects by Localisation and Type of Location at Survey 3|Number of Subjects by Localisation and Type of Location at Survey 4|Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 1|Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 2|Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 3|Number of Subjects by House Construction Material Regarding Walls and Floor at Survey 4|Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 1|Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 2|Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 3|Number of Subjects Classified by House Construction Material Regarding Roof, Window/Eaves and Nets at Survey 4|Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 1|Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 2|Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 3|Number of Subjects Classified by House Information Regarding Main Source of the Drinking Water and Presence of Electricity at Survey 4|Number of Subjects With Malaria Prevention Measures (MPM) at Each Survey|Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 1|Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 2|Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 3|Number of Subjects With Plasmodium Species Other Than P. Falciparum at Survey 4|Number of Subjects With Serious Adverse Events (SAEs) Related to Study Procedure for Each Survey | GlaxoSmithKline|The PATH Malaria Vaccine Initiative (MVI) | GSK Investigational Site, Ouagadougou 01, Burkina Faso|GSK Investigational Site, Lambaréné, Gabon|GSK Investigational Site, Kintampo, Ghana|GSK Investigational Site, Kumasi, Ghana|GSK Investigational Site, Kisumu, Kenya|GSK Investigational Site, Lilongwe, Malawi|GSK Investigational Site, Dar-es-Salaam, Tanzania|GSK Investigational Site, Korogwe, Tanga, Tanzania |
| IVICA: Intravenous Iron in Colorectal Cancer Associated Anaemia | Anemia|Colorectal Neoplasm | Drug: Ferric carboxymaltose|Drug: Ferrous Sulphate | To determine if the use of intravenous ferric carboxymaltose can reduce the need for allogeneic blood transfusion compare to oral ferrous sulphate in patients with colorectal adenocarcinoma related anaemia|To determine differences in hemoglobin and hematinic markers between the groups.|To determine differences in hepcidin levels in relation to blood profile changes in participants in the intravenous group.|To determine differences in colonic mucosal expression of iron transport proteins, C-myc and NKD1 between the groups|To determine differences in postoperative outcomes between the groups.|To determine differences in anemia symptomatology response between groups. | Nottingham University Hospitals NHS Trust|National Institute for Health Research, United Kingdom | University Hospital Birmingham, Birmingham, West Midlands, United Kingdom|Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, West Midlands, United Kingdom|University Hospitals Bristol Foundation NHS Turst, Bristol, United Kingdom|Derby Hospital NHS Foundation Trust, Derby, United Kingdom|St James University Hospitals NHS Trust, Leeds, United Kingdom|University Hospitals of Leicester NHS Trust, Leicester, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom|Yeovil District Hospital NHS Foundation Trust, Yeovil, United Kingdom |
| Navigated Repetitive Transcranial Magnetic Stimulation for Parkinson's Disease With Depression or Cognitive Impairment | Parkinson Disease|Depression|Cognitive Impairment | Device: repetitive transcranial magnetic stimulation(rTMS) | Hamilton Depression Scale（HAMD）|Beck Depression Inventory（BDI）|Hamilton Anxiety Scale（HAMA）|Beck Anxiety Inventory（BAI）|Mini-mental State Examination（MMSE）|Montreal Cognitive Assessment Scale（MoCA）|Named test of the Aphasia Battery of Chinese|Similarity test|Symbol Digit modalities test（SDMT）|Verbal fluency test（VFT）|Logical memory test（LMT）|Delayed memory test（DMT）|Digit span test（DST）|Ten point clock test|Uniform Parkinson's Disease Rating Scale Ⅲ（UPDRSⅢ）|Modified Hoehn & Yahr scale（H-Y）|Activity of Daily Living Scale（ADL）|Parkinson's Disease Questionnaire（PDQ-39）|Pittsburgh Sleep Quality Index (PSQI)|Epworth Sleepiness Scale (ESS)|Parkinson's Disease Sleep Scale (PDSS-2) | Guangdong Provincial People's Hospital | Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China |
| Standardization and Optimization of TMS Protocols for the Treatment of PD With Depression or Cognitive Impairment | TMS Protocols in the Treatment of PD | Device: repetitive transcranial magnetic stimulation(rTMS) | Hamilton Depression Scale（HAMD）|Beck Depression Inventory（BDI）|Mini-mental State Examination（MMSE）|Montreal Cognitive Assessment Scale（MoCA）|Named test of the Aphasia Battery of Chinese|Similarity test|Symbol Digit modalities test（SDMT）|Verbal fluency test（VFT）|Logical memory test（LMT）|Delayed memory test（DMT）|Digit span test（DST）|Ten point clock test|Uniform Parkinson's Disease Rating Scale Ⅲ（UPDRSⅢ）|Modified Hoehn & Yahr scale（H-Y）|Time up and go test（TUG test）|Activity of Daily Living Scale（ADL）|Parkinson's Disease Questionnaire（PDQ-39）|Non-motor symptoms questionnaire(NMS-Q)|Pittsburgh Sleep Quality Index (PSQI)|Hamilton Anxiety Scale（HAMA）|Beck Anxiety Inventory（BAI） | Guangdong Provincial People's Hospital | Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China|Xuanwu Hospital, Capital Medical University, Beijing, Beijing, China|Beijing Hospital, Beijing, Beijing, China|Affiliated Union Hospital of Fujian Medical University, Fuzhou, Fujian, China|The Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong, China|Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China|Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China|First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China|Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China|Huashan Hospital, Fudan University, Shanghai, Shanghai, China |
| Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism | Nutrition Disorders | Dietary Supplement: Folic acid and iron supplementation|Dietary Supplement: Control group | folic acid concentrations at baseline|folic acid concentrations after 3 months of treatment|iron concentrations at baseline|iron concentrations after 3 months of treatment|blood pressure|body mass|body height|Body % fat|Body % muscle|ferritin at the baseline|ferritin after 3 months of treatment|hepcidin at the baseline|hepcidin after 3 months of treatment|homocysteine at the baseline|homocysteine after 3 months of treatment|total iron-binding capacity (TIBC) at the baseline|TIBC after 3 months of treatment|divalent metal transporter 1 (DMT1) gene polymorphisms|transferrin receptor 2 (TfR2) gene polymorphisms|proton-coupled folate transporter (PCFT) gene polymorphisms|reduced folate carrier (RFC) gene polymorphisms | Poznan University of Life Sciences | Poznan University of Life Sciences, Poznań, Poland |
| BENEFIT 15 Long-term Follow-up Study of the BENEFIT and BENEFIT Follow-up Studies | Multiple Sclerosis | Other: Brain MRI|Other: Blood sampling | Number of subjects with diagnosis of multiple sclerosis within fifteen years after Clinically-Isolated Syndrome (CIS) according to McDonald 2001 and 2010 criteria|Disease course since start of BENEFIT as assessed at the time of BENEFIT 15|Time to first relapse|Time to recurrent relapse|Annualized relapse rate|Time to conversion to Clinically-Definite Multiple Sclerosis (CDMS)|Time to conversion to Secondary Progressive Multiple Sclerosis (SPMS)|Expanded Disability Status Scale these scores (EDSS score) for disability assessed by the investigator during the neurological examination|Number of subjects with confirmed and sustained 1-point EDSS progression (Disability progression)|Number of subjects with confirmed 2.5-point EDSS progression (Disability progression)|Multiple Sclerosis Functional Composite (MSFC) score (Neurological status)|Paced Auditory Serial Addition Test (PASAT-3) score (Cognitive function)|Time to use of ambulatory device|Time to dependence on ambulatory device|Time to use of wheelchair|Employment status (Standardized questions)|Multiple sclerosis impact on employment|Resource use assessment questions: Help from family/regular ambulatory services|Resource use assessment questions: Additional ambulatory services during relapse|Resource use assessment questions: Adaptions (past 6 months)|Symbol Digit Modalities Test score (SDMT score)|Relation of SDMT and FSMC (Fatigue Scale for Motor and Cognitive Functions)|Relation of mental processing speed and MRI parameters|European Quality of life - 5 Dimensions Health-related Quality of life (EQ-5D HRQoL) score|European Quality of Life-5 Dimensions Visual Analog Scale (EQ-5D VAS) score|Functional Assessment of Multiple Sclerosis (FAMS score)|Fatigue Scale for Motor and Cognitive Functions (FSMC score)|Center of Epidemiological Studies for Depression (CES-D) score|Time to second line therapy|Time to first disease-modifying therapies (DMT) other than IFNB-1b | Bayer | Medizinische Universität Graz, Graz, Steiermark, Austria|Landeskrankenhaus - Universitätskliniken Innsbruck, Innsbruck, Austria|CU Saint-Luc/UZ St-Luc, Bruxelles - Brussel, Belgium|UZ Gent, Gent, Belgium|UZ Leuven Gasthuisberg, Leuven, Belgium|CHU de Liège, Liege, Belgium|Ottawa Hospital-General Campus, Ottawa, Ontario, Canada|CHUM - Hopital Hotel-Dieu, Montreal, Quebec, Canada|Montreal Neurological Hospital, Montreal, Quebec, Canada|Fakultni nemocnice Brno, Brno, Czechia|Fakultni Nemocnice Hradec Kralove, Hradec Kralove, Czechia|Fakultni nemocnice Ostrava, Ostrava-Poruba, Czechia|Vseobecna fakultni nemocnice v Praze, Praha 2, Czechia|Amtssygehuset Glostrup, Glostrup, Denmark|Tampereen yliopistollinen sairaala, keskussairaala, Tampere, Finland|Terveystalo Turku, Turku, Finland|Hôpital Pellegrin - Bordeaux, Bordeaux, France|Hopital general, Dijon, France|Hopital Roger Salengro, Lille, France|Hôpital Pasteur - Nice, Nice, France|Hôpital Pontchaillou, Rennes Cedex, France|Klinikum der Universität München Grosshadern, München, Bayern, Germany|Bezirksklinikum, Regensburg, Bayern, Germany|Krankenhaus Hennigsdorf, Hennigsdorf, Brandenburg, Germany|Universitätsklinik Gießen und Marburg GmbH, Marburg, Hessen, Germany|Sana Klinikum Offenbach GmbH, Offenbach, Hessen, Germany|Universitätsmedizin der Georg-August-Universität Göttingen, Goettingen, Niedersachsen, Germany|Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Nordrhein-Westfalen, Germany|Städt. Krankenhaus Martha-Maria Halle-Dölau gGmbH, Halle, Sachsen-Anhalt, Germany|HELIOS Klinikum Erfurt GmbH, Erfurt, Thüringen, Germany|Universitätsklinikum Charite zu Berlin, Berlin, Germany|Peterfy Sandor utcai Korhaz - Rendelointezet, Budapest, Hungary|Uzsoki Utcai Korhaz, Budapest, Hungary|Debreceni Egyetem Klinikai Kozpont, Debrecen, Hungary|Szent-Gyorgyi Albert Orvostudomanyi Egyetem, Szeged, Hungary|Hadassah Hebrew University Hospital Ein Kerem, Jerusalem, Israel|Ospedale San Raffaele, Milano, Lombardia, Italy|IRCCS Ist Neurologico Nazionale C.Mondino, Pavia, Lombardia, Italy|ASST Valle Olona, Varese, Lombardia, Italy|A.O.U. San Luigi Gonzaga, Torino, Piemonte, Italy|A.O.U. Città della Salute e della Scienza di Torino, Torino, Toscana, Italy|Helse Bergen HF Haukeland universitetssjukehus, Bergen, Norway|10 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ, Bydgoszcz, Poland|Szpital Uniwersytecki w Krakowie, Krakow, Poland|Szpital im. N. Barlickiego, Lodz, Poland|Samodzielny Publiczny Szpital Kliniczny nr 4, Lublin, Poland|Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego, Wroclaw, Poland|Instituto Português de Oncologia Francisco Gentil - Coimbra, Coimbra, Portugal|Hospital Universitario Virgen de la Macarena, Sevilla, Andalucía, Spain|Ciutat Sanitària i Universitària de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain|Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona, Spain|Hospital Clínic i Provincial de Barcelona, Barcelona, Spain|Hospital Regional de Málaga, Malaga, Spain|Hospital Universitari i Politècnic La Fe, Valencia, Spain|Sahlgrenska Universitetssjukhuset, Göteborg, Sweden|Universitätsspital Basel, Basel, Basel-Stadt, Switzerland|Inselspital Universitätsspital Bern, Bern, Switzerland|Royal Hallamshire Hospital, Sheffield, South Yorkshire, United Kingdom|Aberdeen Royal Infirmary, Aberdeen, United Kingdom|Ninewells Hospital, Dundee, United Kingdom|Charing Cross Hospital, London, United Kingdom |
| Dysport in Vulvodynia Phase II Study | Vulvodynia | Biological: Botulinum toxin type A|Drug: Placebo | Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the DB Treatment Period (Stage 1)|Mean Change From Baseline in Vaginal Dilator Induced Pain During the DB Treatment Period at Week 6 (Stage 2)|Mean Change From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point Numeric Rating Scale (NRS) During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 50% Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 30% Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 2-point Decrease From Baseline in Vaginal Dilator Induced Pain as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in the DTMS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in the Composite Score for the Vaginal Dilator Induced Pain and Dilator Size During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 50% Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 30% Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Number of Participants Who Reported at Least a 2-point Decrease From Baseline in Pain During Insertion of Vaginal Dilator Number 6 Size as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in Pain During Intercourse as Reported on an 11-point NRS During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Mean Change From Baseline in the Number of Intercourse Instances in Participants With Partners During the DB Treatment Period at Week 6 and Week 12 (Stage 1)|Use of Pain Rescue Medication Associated With Intercourse During the DB Treatment Period at Week 6 and Week 12 | Ipsen | James A. Simon, MD, PC, Washington, District of Columbia, United States|The Center for Vulvovaginal Disorders, Washington, District of Columbia, United States|New Age Medical Research Corporation, Miami, Florida, United States|University of Kansas Medical Center, Kansas City, Missouri, United States|Omaha OB-GYN Associates, PC, Omaha, Nebraska, United States|The Center for Vulvovaginal Disorders, New York, New York, United States|Women's Institute for Sexual Health (WISH), Nashville, Tennessee, United States|Seattle Women's: Health, Research, Gynecology®, Seattle, Washington, United States|Clinique de Santé des Femmes, Québec, Canada |
| Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS) | Relapsing-Remitting Multiple Sclerosis | Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets|Annualized Relapse Rate in the Year 1 After Treatment Initiation With Cladribine Tablets|Annualized Relapse Rate in the Year 2 After Treatment Initiation with Cladribine Tablets|Annualized Relapse Rate in the Year 3 After Treatment Initiation with Cladribine Tablets|Annualized Relapse Rate in the Year 4 After Treatment Initiation with Cladribine Tablets|Annualized Relapse Rate in the Year 5 After Treatment Initiation with Cladribine Tablets|Percentage of Participants Who Remain Relapse-Free in Each Year after Initiation of Cladribine Tablet Treatment|Percentage of Participants Who Remain Relapse-free up to 5 years After the Initation of Caldribine Tablets|Time from Cladribine Tablet Initiation to First Relapse|Percentage of Participants Who Discontinued Cladribine Tablets|Percentage of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) after Cladribine Tablets Discontinuation/Treatment Completion|Percentage of Participants with Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2|Percentage of Participants with Disability Progression Confirmed over 6 Months, Assessed by Expanded Disease Severity Scale (EDSS) at 2 Years after Cladribine Tablet Treatment Initiation|Number of Participants with Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany|Merck Serono Limited, an affiliate of Merck KGaA, Darmstadt, Germany | University Hospitals Coventry and Warwickshire- Neurology, Coventry, United Kingdom|NHS Lanarkshire Health Board- Department of Neurology, Glasgow, United Kingdom|Queen Elizabeth University Hospital, Glasgow, United Kingdom|University Hospitals of Leicester NHS Trust, Leicester, United Kingdom|Barking Havering and Redbridge University Hospitals NHS Trust, London, United Kingdom|University College London UCL, London, United Kingdom|Nottingham City Hospital (2655), Nottingham, United Kingdom|Salford Royal, Salford, United Kingdom | |
| An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device | Relapsing Multiple Sclerosis | Patient Adherence|Difference in patient adherence over time|Medication Possession Ratio|Adherence of patient subgroups|Patient Adherence in the UK versus Ireland|Device Comfort Settings | Merck KGaA, Darmstadt, Germany|Merck Serono Limited, UK | Please contact the, Merck KGaA Communication Center for recruiting locations, United Kingdom | |
| Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl Fumarate|Other: PSP | Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at 6 Months|Percentage of Participants with Oral Dimethyl Fumarate (DMF) Persistence at Both 1 Month and 3 Months|Percentage of Participant's with Adherence at 6 Months|Percentage of Participants by Reason of Oral Dimethyl Fumarate (DMF) Discontinuation at 3 Months and 6 Months|Percentage of Participants with Adverse Events (AEs)|Percentage of Participants with Adverse Events (AEs) Related to Treatment|Percentage of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation|Percentage of Participants with Adverse Events (AEs) of Interest|Participant's Anxiety at Inclusion and at 6 Months|Participant's Satisfaction Regarding Dimethyl Fumarate (DMF) Treatment at 6 Months|Participant's Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP)|Neurologists' Satisfaction Regarding their Participation in OroSEP Patient Support Program (PSP) | Biogen | Research site, Agen, France|Research Site, Agen, France|Research Site, Aix-en-Provence, France|Research Site, Albi, France|Research site, Albi, France|Research Site, Amiens, France|Research Site, Angoulême, France|Research site, Annecy, France|Research site, Antibes, France|Research Site, Antony, France|Research Site, Arras, France|Research Site, Bastia, France|Research site, Bayonne, France|Research Site, Belfort, France|Research Site, Bezannes, France|Research Site, Biarritz, France|Research Site, Bordeaux, France|Research site, Bordeaux, France|Research Site, Béziers, France|Research site, Carcassonne, France|Research Site, Challans, France|Research Site, Chatellerault, France|Research Site, Cholet, France|Research Site, Clamart, France|Research site, Cornebarrieu, France|Research Site, Créteil, France|Research site, Dax, France|Research Site, Dijon, France|Research Site, Dijon, France|Research site, Douai, France|Research Site, Eaubonne, France|Research Site, Gap, France|Research Site, Gonesse, France|Research Site, Grenoble Cedex 9, France|Research site, La Rochelle, France|Research site, La Seyne-sur-Mer, France|Research Site, Libourne, France|Research Site, Lille, France|Research Site, Lons-le-Saunier, France|Research Site, Lure, France|Research site, Lyon, France|Research Site, Melun, France|Research Site, Mont de Marsan Cedex, France|Research site, Montauban, France|Research Site, Montluçon, France|Research Site, Montpellier, France|Research Site, Montpellier, France|Research Site, Mornant, France|Research Site, Mornant, France|Research site, Muret, France|Research Site, Nice, France|Research site, Nimes, France|Research Site, Niort, France|Research Site, Nîmes, France|Research Site, Orléans, France|Research Site, Paris, France|Research Site, Paris, France|Research Site, Paris, France|Research Site, Paris, France|Research Site, Pau, France|Research Site, Perpignan, France|Research site, Pessac, France|Research site, Poissy, France|Research Site, Poitiers, France|Research Site, Quimper Cedex, France|Research Site, Rambouillet, France|Research Site, Roanne, France|Research Site, Roubaix, France|Research Site, Roubaix, France|Research Site, Saint-Quentin, France|Research Site, Soissons, France|Research site, Talence, France|Research Site, Toulon, France|Research Site, Toulon, France|Research Site, Toulouse cedex 9, France|Research Site, Tours, France|Research Site, Tours, France|Research Site, Troyes, France|Research Site, Valence, France|Research site, Vesoul Cedex, France|Research Site, Évreux, France |
| Cytarabine and Daunorubicin Hydrochloride or Idarubicin and Cytarabine With or Without Vorinostat in Treating Younger Patients With Previously Untreated Acute Myeloid Leukemia | Acute Myeloid Leukemia|Untreated Adult Acute Myeloid Leukemia | Procedure: Allogeneic Hematopoietic Stem Cell Transplantation|Drug: Cytarabine|Drug: Daunorubicin Hydrochloride|Drug: Idarubicin|Other: Laboratory Biomarker Analysis|Drug: Vorinostat | Event-free Survival (EFS)|Rate of Allogeneic HCT|Disease-free Survival (DFS) Among High Risk Patients|EFS of Arm I Compared to Arm II|Frequency and Severity of Toxicities | National Cancer Institute (NCI) | University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States|Anchorage Radiation Therapy Center, Anchorage, Alaska, United States|Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States|Alaska Oncology and Hematology LLC, Anchorage, Alaska, United States|Alaska Regional Hospital, Anchorage, Alaska, United States|Alaska Women's Cancer Care, Anchorage, Alaska, United States|Anchorage Oncology Centre, Anchorage, Alaska, United States|Katmai Oncology Group, Anchorage, Alaska, United States|Providence Alaska Medical Center, Anchorage, Alaska, United States|University of Arizona Cancer Center-Orange Grove Campus, Tucson, Arizona, United States|University of Arizona Cancer Center-North Campus, Tucson, Arizona, United States|The University of Arizona Medical Center-University Campus, Tucson, Arizona, United States|Yuma Cancer Center, Yuma, Arizona, United States|Mercy Cancer Center-Hot Springs, Hot Springs, Arkansas, United States|Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, United States|City of Hope Comprehensive Cancer Center, Duarte, California, United States|UC San Diego Moores Cancer Center, La Jolla, California, United States|Fremont - Rideout Cancer Center, Marysville, California, United States|UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States|Stanford Cancer Institute Palo Alto, Palo Alto, California, United States|University of California Davis Comprehensive Cancer Center, Sacramento, California, United States|Poudre Valley Hospital, Fort Collins, Colorado, United States|Hartford Hospital, Hartford, Connecticut, United States|Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States|Yale University, New Haven, Connecticut, United States|University of Florida Health Science Center - Gainesville, Gainesville, Florida, United States|Moffitt Cancer Center, Tampa, Florida, United States|Northside Hospital, Atlanta, Georgia, United States|Northside Hospital-Forsyth, Cumming, Georgia, United States|Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States|Saint Luke's Mountain States Tumor Institute, Boise, Idaho, United States|Kootenai Medical Center, Coeur d'Alene, Idaho, United States|Saint Luke's Mountain States Tumor Institute - Fruitland, Fruitland, Idaho, United States|Saint Luke's Mountain States Tumor Institute - Meridian, Meridian, Idaho, United States|Saint Luke's Mountain States Tumor Institute - Nampa, Nampa, Idaho, United States|Kootenai Cancer Center, Post Falls, Idaho, United States|Kootenai Cancer Clinic, Sandpoint, Idaho, United States|Saint Luke's Mountain States Tumor Institute-Twin Falls, Twin Falls, Idaho, United States|Saint Joseph Medical Center, Bloomington, Illinois, United States|Illinois CancerCare-Bloomington, Bloomington, Illinois, United States|Illinois CancerCare-Canton, Canton, Illinois, United States|Memorial Hospital of Carbondale, Carbondale, Illinois, United States|Illinois CancerCare-Carthage, Carthage, Illinois, United States|Centralia Oncology Clinic, Centralia, Illinois, United States|Mount Sinai Hospital Medical Center, Chicago, Illinois, United States|Northwestern University, Chicago, Illinois, United States|University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States|Cancer Care Center of Decatur, Decatur, Illinois, United States|Decatur Memorial Hospital, Decatur, Illinois, United States|Crossroads Cancer Center, Effingham, Illinois, United States|Illinois CancerCare-Eureka, Eureka, Illinois, United States|NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States|Illinois CancerCare-Galesburg, Galesburg, Illinois, United States|Western Illinois Cancer Treatment Center, Galesburg, Illinois, United States|NorthShore University HealthSystem-Glenbrook Hospital, Glenview, Illinois, United States|Hematology Oncology Associates of Illinois-Highland Park, Highland Park, Illinois, United States|NorthShore University HealthSystem-Highland Park Hospital, Highland Park, Illinois, United States|Presence Saint Mary's Hospital, Kankakee, Illinois, United States|Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States|NorthShore Hematology Oncology-Libertyville, Libertyville, Illinois, United States|Illinois CancerCare-Macomb, Macomb, Illinois, United States|Loyola University Medical Center, Maywood, Illinois, United States|Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States|Illinois Cancer Specialists-Niles, Niles, Illinois, United States|Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States|Radiation Oncology of Northern Illinois, Ottawa, Illinois, United States|Illinois CancerCare-Pekin, Pekin, Illinois, United States|OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center, Pekin, Illinois, United States|Methodist Medical Center of Illinois, Peoria, Illinois, United States|Illinois CancerCare-Peoria, Peoria, Illinois, United States|OSF Saint Francis Radiation Oncology at Peoria Cancer Center, Peoria, Illinois, United States|OSF Saint Francis Medical Center, Peoria, Illinois, United States|Illinois CancerCare-Peru, Peru, Illinois, United States|Valley Radiation Oncology, Peru, Illinois, United States|Illinois CancerCare-Princeton, Princeton, Illinois, United States|SwedishAmerican Regional Cancer Center/ACT, Rockford, Illinois, United States|Hematology Oncology Associates of Illinois - Skokie, Skokie, Illinois, United States|North Shore Medical Center, Skokie, Illinois, United States|Central Illinois Hematology Oncology Center, Springfield, Illinois, United States|Southern Illinois University School of Medicine, Springfield, Illinois, United States|Springfield Clinic, Springfield, Illinois, United States|Memorial Medical Center, Springfield, Illinois, United States|Cancer Care Specialists of Illinois-Swansea, Swansea, Illinois, United States|Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States|Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States|IU Health Central Indiana Cancer Centers-East, Indianapolis, Indiana, United States|Franciscan Health Indianapolis, Indianapolis, Indiana, United States|Reid Health, Richmond, Indiana, United States|McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa, United States|McFarland Clinic PC-Boone, Boone, Iowa, United States|Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States|Mercy Cancer Center-West Lakes, Clive, Iowa, United States|Alegent Health Mercy Hospital, Council Bluffs, Iowa, United States|Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States|Mercy Medical Center - Des Moines, Des Moines, Iowa, United States|University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States|McFarland Clinic PC-Jefferson, Jefferson, Iowa, United States|McFarland Clinic PC-Marshalltown, Marshalltown, Iowa, United States|Siouxland Regional Cancer Center, Sioux City, Iowa, United States|Mercy Medical Center-Sioux City, Sioux City, Iowa, United States|Saint Luke's Regional Medical Center, Sioux City, Iowa, United States|Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States|Cancer Center of Kansas - Chanute, Chanute, Kansas, United States|Cancer Center of Kansas - Dodge City, Dodge City, Kansas, United States|Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States|Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States|Cancer Center of Kansas-Independence, Independence, Kansas, United States|University of Kansas Cancer Center, Kansas City, Kansas, United States|Cancer Center of Kansas-Kingman, Kingman, Kansas, United States|Lawrence Memorial Hospital, Lawrence, Kansas, United States|Cancer Center of Kansas-Liberal, Liberal, Kansas, United States|Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States|Cancer Center of Kansas - McPherson, McPherson, Kansas, United States|Cancer Center of Kansas - Newton, Newton, Kansas, United States|Menorah Medical Center, Overland Park, Kansas, United States|Saint Luke's South Hospital, Overland Park, Kansas, United States|Cancer Center of Kansas - Parsons, Parsons, Kansas, United States|Kansas City NCI Community Oncology Research Program, Prairie Village, Kansas, United States|Cancer Center of Kansas - Pratt, Pratt, Kansas, United States|Cancer Center of Kansas - Salina, Salina, Kansas, United States|Cancer Center of Kansas - Wellington, Wellington, Kansas, United States|Associates In Womens Health, Wichita, Kansas, United States|Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States|Cancer Center of Kansas - Wichita, Wichita, Kansas, United States|Via Christi Regional Medical Center, Wichita, Kansas, United States|Wesley Medical Center, Wichita, Kansas, United States|Wichita NCI Community Oncology Research Program, Wichita, Kansas, United States|Cancer Center of Kansas - Winfield, Winfield, Kansas, United States|Flaget Memorial Hospital, Bardstown, Kentucky, United States|Commonwealth Cancer Center-Corbin, Corbin, Kentucky, United States|Oncology Hematology Care Inc-Crestview, Crestview Hills, Kentucky, United States|Saint Joseph Radiation Oncology Resource Center, Lexington, Kentucky, United States|Saint Joseph Hospital East, Lexington, Kentucky, United States|University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States|Jewish Hospital, Louisville, Kentucky, United States|Saints Mary and Elizabeth Hospital, Louisville, Kentucky, United States|Jewish Hospital Medical Center Northeast, Louisville, Kentucky, United States|Jewish Hospital Medical Center South, Shepherdsville, Kentucky, United States|Baton Rouge General Medical Center, Baton Rouge, Louisiana, United States|Hematology/Oncology Clinic LLP, Baton Rouge, Louisiana, United States|West Jefferson Medical Center, Marrero, Louisiana, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, United States|Harold Alfond Center for Cancer Care, Augusta, Maine, United States|Eastern Maine Medical Center, Bangor, Maine, United States|Lafayette Family Cancer Center-EMMC, Brewer, Maine, United States|Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States|Tufts Medical Center, Boston, Massachusetts, United States|Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States|Brigham and Women's Hospital, Boston, Massachusetts, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, United States|Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States|Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States|Bronson Battle Creek, Battle Creek, Michigan, United States|Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, United States|Beaumont Hospital-Dearborn, Dearborn, Michigan, United States|Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States|Saint John Hospital and Medical Center, Detroit, Michigan, United States|Green Bay Oncology - Escanaba, Escanaba, Michigan, United States|Weisberg Cancer Treatment Center, Farmington Hills, Michigan, United States|Genesys Hurley Cancer Institute, Flint, Michigan, United States|Hurley Medical Center, Flint, Michigan, United States|Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, United States|Mercy Health Saint Mary's, Grand Rapids, Michigan, United States|Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States|Green Bay Oncology - Iron Mountain, Iron Mountain, Michigan, United States|Allegiance Health, Jackson, Michigan, United States|Borgess Medical Center, Kalamazoo, Michigan, United States|Bronson Methodist Hospital, Kalamazoo, Michigan, United States|West Michigan Cancer Center, Kalamazoo, Michigan, United States|Sparrow Hospital, Lansing, Michigan, United States|Saint Mary Mercy Hospital, Livonia, Michigan, United States|Mercy Health Mercy Campus, Muskegon, Michigan, United States|Assarian Cancer Center, Novi, Michigan, United States|Saint Joseph Mercy Oakland, Pontiac, Michigan, United States|Lake Huron Medical Center, Port Huron, Michigan, United States|Spectrum Health Reed City Hospital, Reed City, Michigan, United States|Saint Mary's of Michigan, Saginaw, Michigan, United States|Providence Hospital-Southfield Cancer Center, Southfield, Michigan, United States|Munson Medical Center, Traverse City, Michigan, United States|Saint John Macomb-Oakland Hospital, Warren, Michigan, United States|Fairview Ridges Hospital, Burnsville, Minnesota, United States|Mercy Hospital, Coon Rapids, Minnesota, United States|Fairview-Southdale Hospital, Edina, Minnesota, United States|Unity Hospital, Fridley, Minnesota, United States|Hutchinson Area Health Care, Hutchinson, Minnesota, United States|Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States|Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States|Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States|Hennepin County Medical Center, Minneapolis, Minnesota, United States|Health Partners Inc, Minneapolis, Minnesota, United States|New Ulm Medical Center, New Ulm, Minnesota, United States|North Memorial Medical Health Center, Robbinsdale, Minnesota, United States|Mayo Clinic, Rochester, Minnesota, United States|Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States|Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States|Regions Hospital, Saint Paul, Minnesota, United States|United Hospital, Saint Paul, Minnesota, United States|Saint Francis Regional Medical Center, Shakopee, Minnesota, United States|Lakeview Hospital, Stillwater, Minnesota, United States|Ridgeview Medical Center, Waconia, Minnesota, United States|Rice Memorial Hospital, Willmar, Minnesota, United States|Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States|University of Mississippi Medical Center, Jackson, Mississippi, United States|Central Care Cancer Center-Carrie J Babb Cancer Center, Bolivar, Missouri, United States|Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, United States|CoxHealth Cancer Center, Branson, Missouri, United States|Saint Francis Medical Center, Cape Girardeau, Missouri, United States|Southeast Cancer Center, Cape Girardeau, Missouri, United States|University of Missouri - Ellis Fischel, Columbia, Missouri, United States|Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States|Centerpoint Medical Center LLC, Independence, Missouri, United States|Capital Region Medical Center-Goldschmidt Cancer Center, Jefferson City, Missouri, United States|Freeman Health System, Joplin, Missouri, United States|Mercy Hospital-Joplin, Joplin, Missouri, United States|Saint Luke's Hospital of Kansas City, Kansas City, Missouri, United States|Heartland Hematology and Oncology Associates Incorporated, Kansas City, Missouri, United States|Research Medical Center, Kansas City, Missouri, United States|Saint Luke's East - Lee's Summit, Lee's Summit, Missouri, United States|Liberty Radiation Oncology Center, Liberty, Missouri, United States|Delbert Day Cancer Institute at PCRMC, Rolla, Missouri, United States|Saint John's Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States|Heartland Regional Medical Center, Saint Joseph, Missouri, United States|Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States|Washington University School of Medicine, Saint Louis, Missouri, United States|Missouri Baptist Medical Center, Saint Louis, Missouri, United States|Mercy Hospital Saint Louis, Saint Louis, Missouri, United States|Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, United States|Mercy Hospital Springfield, Springfield, Missouri, United States|CoxHealth South Hospital, Springfield, Missouri, United States|Missouri Baptist Sullivan Hospital, Sullivan, Missouri, United States|Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills, Missouri, United States|Billings Clinic Cancer Center, Billings, Montana, United States|Saint Vincent Healthcare, Billings, Montana, United States|Montana Cancer Consortium NCORP, Billings, Montana, United States|Saint Vincent Frontier Cancer Center, Billings, Montana, United States|Bozeman Deaconess Hospital, Bozeman, Montana, United States|Saint James Community Hospital and Cancer Treatment Center, Butte, Montana, United States|Benefis Healthcare- Sletten Cancer Institute, Great Falls, Montana, United States|Great Falls Clinic, Great Falls, Montana, United States|Saint Peter's Community Hospital, Helena, Montana, United States|Kalispell Regional Medical Center, Kalispell, Montana, United States|Montana Cancer Specialists, Missoula, Montana, United States|Saint Patrick Hospital - Community Hospital, Missoula, Montana, United States|Community Medical Hospital, Missoula, Montana, United States|CHI Health Saint Francis, Grand Island, Nebraska, United States|Heartland Hematology and Oncology, Kearney, Nebraska, United States|CHI Health Good Samaritan, Kearney, Nebraska, United States|Saint Elizabeth Regional Medical Center, Lincoln, Nebraska, United States|Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States|Hemotology and Oncology Consultants PC, Omaha, Nebraska, United States|Alegent Health Bergan Mercy Medical Center, Omaha, Nebraska, United States|Alegent Health Lakeside Hospital, Omaha, Nebraska, United States|Creighton University Medical Center, Omaha, Nebraska, United States|University of Nebraska Medical Center, Omaha, Nebraska, United States|Midlands Community Hospital, Papillion, Nebraska, United States|Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States|Saint Joseph's Regional Medical Center, Paterson, New Jersey, United States|University of New Mexico Cancer Center, Albuquerque, New Mexico, United States|Roswell Park Cancer Institute, Buffalo, New York, United States|North Shore University Hospital, Manhasset, New York, United States|Long Island Jewish Medical Center, New Hyde Park, New York, United States|Northwell Health/Center for Advanced Medicine, New Hyde Park, New York, United States|Mount Sinai Hospital, New York, New York, United States|University of Rochester, Rochester, New York, United States|Cancer Care of Western North Carolina, Asheville, North Carolina, United States|Mission Hospital-Memorial Campus, Asheville, North Carolina, United States|Mountain Radiation Oncology, Asheville, North Carolina, United States|Asheville Hematology-Oncology Associates, Asheville, North Carolina, United States|Hope Women's Cancer Centers-Asheville, Asheville, North Carolina, United States|Transylvania Regional Hospital, Brevard, North Carolina, United States|Duke University Medical Center, Durham, North Carolina, United States|Angel Medical Center, Franklin, North Carolina, United States|Park Ridge Hospital Breast Health Center, Hendersonville, North Carolina, United States|Kinston Medical Specialists PA, Kinston, North Carolina, United States|McDowell Hospital, Marion, North Carolina, United States|Blue Ridge Regional Hospital, Spruce Pine, North Carolina, United States|Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, North Carolina, United States|Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States|Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States|Summa Barberton Hospital, Barberton, Ohio, United States|Miami Valley Hospital South, Centerville, Ohio, United States|Oncology Hematology Care Inc-Eden Park, Cincinnati, Ohio, United States|Oncology Hematology Care Inc-Mercy West, Cincinnati, Ohio, United States|Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States|Oncology Hematology Care Inc - Anderson, Cincinnati, Ohio, United States|Oncology Hematology Care Inc-Kenwood, Cincinnati, Ohio, United States|The Jewish Hospital, Cincinnati, Ohio, United States|Bethesda North Hospital, Cincinnati, Ohio, United States|Oncology Hematology Care Inc-Blue Ash, Cincinnati, Ohio, United States|TriHealth Cancer Institute-Westside, Cincinnati, Ohio, United States|TriHealth Cancer Institute-Anderson, Cincinnati, Ohio, United States|Case Western Reserve University, Cleveland, Ohio, United States|MetroHealth Medical Center, Cleveland, Ohio, United States|Cleveland Clinic Foundation, Cleveland, Ohio, United States|Grandview Hospital, Dayton, Ohio, United States|Good Samaritan Hospital - Dayton, Dayton, Ohio, United States|Miami Valley Hospital, Dayton, Ohio, United States|Samaritan North Health Center, Dayton, Ohio, United States|Dayton NCI Community Oncology Research Program, Dayton, Ohio, United States|Oncology Hematology Care Inc-Healthplex, Fairfield, Ohio, United States|Blanchard Valley Hospital, Findlay, Ohio, United States|Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States|Wayne Hospital, Greenville, Ohio, United States|Kettering Medical Center, Kettering, Ohio, United States|Springfield Regional Cancer Center, Springfield, Ohio, United States|Springfield Regional Medical Center, Springfield, Ohio, United States|Upper Valley Medical Center, Troy, Ohio, United States|Wright-Patterson Medical Center, Wright-Patterson Air Force Base, Ohio, United States|Greene Memorial Hospital, Xenia, Ohio, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States|Natalie Warren Bryant Cancer Center at Saint Francis, Tulsa, Oklahoma, United States|Warren Clinic Oncology-Tulsa, Tulsa, Oklahoma, United States|Saint Charles Health System, Bend, Oregon, United States|Clackamas Radiation Oncology Center, Clackamas, Oregon, United States|Providence Oncology and Hematology Care Southeast, Clackamas, Oregon, United States|Bay Area Hospital, Coos Bay, Oregon, United States|Providence Milwaukie Hospital, Milwaukie, Oregon, United States|Providence Newberg Medical Center, Newberg, Oregon, United States|Providence Willamette Falls Medical Center, Oregon City, Oregon, United States|Providence Portland Medical Center, Portland, Oregon, United States|Providence Saint Vincent Medical Center, Portland, Oregon, United States|Oregon Health and Science University, Portland, Oregon, United States|Geisinger Medical Center, Danville, Pennsylvania, United States|Ephrata Cancer Center, Ephrata, Pennsylvania, United States|Ephrata Community Hospital, Ephrata, Pennsylvania, United States|Adams Cancer Center, Gettysburg, Pennsylvania, United States|Cherry Tree Cancer Center, Hanover, Pennsylvania, United States|Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States|Lewistown Hospital, Lewistown, Pennsylvania, United States|Drexel University School of Medicine, Philadelphia, Pennsylvania, United States|University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States|WellSpan Health-York Cancer Center, York, Pennsylvania, United States|WellSpan Health-York Hospital, York, Pennsylvania, United States|AnMed Health Cancer Center, Anderson, South Carolina, United States|Medical University of South Carolina, Charleston, South Carolina, United States|Saint Francis Hospital, Greenville, South Carolina, United States|Gibbs Cancer Center-Pelham, Greer, South Carolina, United States|Carolina Blood and Cancer Care Associates PA-Lancaster, Lancaster, South Carolina, United States|Carolina Blood and Cancer Care Associates PA, Rock Hill, South Carolina, United States|Spartanburg Medical Center, Spartanburg, South Carolina, United States|MGC Hematology Oncology-Union, Union, South Carolina, United States|Memorial Hospital, Chattanooga, Tennessee, United States|Vanderbilt-Ingram Cancer Center Cool Springs, Franklin, Tennessee, United States|Pulmonary Medicine Center of Chattanooga-Hixson, Hixson, Tennessee, United States|Vanderbilt Breast Center at One Hundred Oaks, Nashville, Tennessee, United States|Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States|Memorial GYN Plus, Ooltewah, Tennessee, United States|Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston, Texas, United States|Ben Taub General Hospital, Houston, Texas, United States|M D Anderson Cancer Center, Houston, Texas, United States|Michael E DeBakey VA Medical Center, Houston, Texas, United States|American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork, Utah, United States|Sandra L Maxwell Cancer Center, Cedar City, Utah, United States|Logan Regional Hospital, Logan, Utah, United States|Intermountain Medical Center, Murray, Utah, United States|McKay-Dee Hospital Center, Ogden, Utah, United States|Utah Valley Regional Medical Center, Provo, Utah, United States|Dixie Medical Center Regional Cancer Center, Saint George, Utah, United States|Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, United States|LDS Hospital, Salt Lake City, Utah, United States|Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, United States|University of Vermont College of Medicine, Burlington, Vermont, United States|Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States|Providence Regional Cancer System-Aberdeen, Aberdeen, Washington, United States|Cancer Care Center at Island Hospital, Anacortes, Washington, United States|Swedish Cancer Institute-Eastside Oncology Hematology, Bellevue, Washington, United States|PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States|Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, United States|Harrison Medical Center, Bremerton, Washington, United States|Highline Medical Center-Main Campus, Burien, Washington, United States|Providence Regional Cancer System-Centralia, Centralia, Washington, United States|Swedish Medical Center-Edmonds, Edmonds, Washington, United States|Saint Elizabeth Hospital, Enumclaw, Washington, United States|Providence Regional Cancer Partnership, Everett, Washington, United States|Saint Francis Hospital, Federal Way, Washington, United States|Swedish Cancer Institute-Issaquah, Issaquah, Washington, United States|Kadlec Clinic Hematology and Oncology, Kennewick, Washington, United States|Seattle Cancer Care Alliance at EvergreenHealth, Kirkland, Washington, United States|Providence Regional Cancer System-Lacey, Lacey, Washington, United States|Saint Clare Hospital, Lakewood, Washington, United States|PeaceHealth Saint John Medical Center, Longview, Washington, United States|Skagit Valley Hospital, Mount Vernon, Washington, United States|Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, United States|Harborview Medical Center, Seattle, Washington, United States|Minor and James Medical PLLC, Seattle, Washington, United States|Pacific Gynecology Specialists, Seattle, Washington, United States|Swedish Medical Center-Ballard Campus, Seattle, Washington, United States|Fred Hutchinson Cancer Research Center, Seattle, Washington, United States|Kaiser Permanente Washington, Seattle, Washington, United States|Swedish Medical Center-First Hill, Seattle, Washington, United States|University of Washington Medical Center, Seattle, Washington, United States|United General Hospital, Sedro-Woolley, Washington, United States|Providence Regional Cancer System-Shelton, Shelton, Washington, United States|Rockwood Clinic Cancer Treatment Center-Valley, Spokane Valley, Washington, United States|Cancer Care Northwest - Spokane South, Spokane, Washington, United States|Rockwood Cancer Treatment Center-DHEC-Downtown, Spokane, Washington, United States|Evergreen Hematology and Oncology PS, Spokane, Washington, United States|Rockwood Clinic, Spokane, Washington, United States|Franciscan Research Center-Northwest Medical Plaza, Tacoma, Washington, United States|Northwest Medical Specialties PLLC, Tacoma, Washington, United States|PeaceHealth Southwest Medical Center, Vancouver, Washington, United States|Compass Oncology Vancouver, Vancouver, Washington, United States|Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, United States|Wenatchee Valley Hospital and Clinics, Wenatchee, Washington, United States|North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima, Washington, United States|Providence Regional Cancer System-Yelm, Yelm, Washington, United States|Marshfield Clinic Cancer Center at Sacred Heart, Eau Claire, Wisconsin, United States|Sacred Heart Hospital, Eau Claire, Wisconsin, United States|Green Bay Oncology at Saint Vincent Hospital, Green Bay, Wisconsin, United States|Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States|Green Bay Oncology Limited at Saint Mary's Hospital, Green Bay, Wisconsin, United States|Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States|UW Cancer Center Johnson Creek, Johnson Creek, Wisconsin, United States|Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States|University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States|Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States|Bay Area Medical Center, Marinette, Wisconsin, United States|Marshfield Clinic, Marshfield, Wisconsin, United States|Marshfield Medical Center, Marshfield, Wisconsin, United States|Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States|Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States|ProHealth D N Greenwald Center, Mukwonago, Wisconsin, United States|Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States|ProHealth Oconomowoc Memorial Hospital, Oconomowoc, Wisconsin, United States|Green Bay Oncology - Oconto Falls, Oconto Falls, Wisconsin, United States|Marshfield Clinic at James Beck Cancer Center, Rhinelander, Wisconsin, United States|Marshfield Clinic-Rice Lake Center, Rice Lake, Wisconsin, United States|HSHS Saint Nicholas Hospital, Sheboygan, Wisconsin, United States|Marshfield Clinic Cancer Care at Saint Michael's Hospital, Stevens Point, Wisconsin, United States|Green Bay Oncology - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States|ProHealth Waukesha Memorial Hospital, Waukesha, Wisconsin, United States|UW Cancer Center at ProHealth Care, Waukesha, Wisconsin, United States|Marshfield Clinic-Wausau Center, Wausau, Wisconsin, United States|Marshfield Clinic - Weston Center, Weston, Wisconsin, United States|Saint Clare's Hospital, Weston, Wisconsin, United States|Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States|Rocky Mountain Oncology, Casper, Wyoming, United States|Big Horn Basin Cancer Center, Cody, Wyoming, United States|Billings Clinic-Cody, Cody, Wyoming, United States|Welch Cancer Center, Sheridan, Wyoming, United States|Tom Baker Cancer Centre, Calgary, Alberta, Canada|The Moncton Hospital, Moncton, New Brunswick, Canada|Atlantic Health Sciences Corporation-Saint John Regional Hospital, Saint John, New Brunswick, Canada|QEII Health Sciences Centre/Nova Scotia Health Authority, Halifax, Nova Scotia, Canada|CIUSSSEMTL-Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada|Allan Blair Cancer Centre, Regina, Saskatchewan, Canada |
| Investigation of the Effect of Ocrelizumab on Peripheral Lymphocyte Immunophenotypes With Suppressive Capacity in MS | Multiple Sclerosis | Drug: Ocrelizumab | Change from baseline in T cell capacity achieved by eliminating B cells as measured by flow cytometry.|Change from baseline in T cell function achieved by eliminating B cells as measured by flow cytometry.|Correlation between changes in T and B cell capacity and function during course of ocrelizumab therapy.|Clinical improvement|Changes in T cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry.|Changes in B cells in case of relapse or infection after vaccination during ocrelizumab treatment by flow cytometry. | Dr Recai Turkoglu|Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital|Haydarpasa Numune Training and Research Hospital | Health Sciences University Istanbul Haydarpaşa Numune Training and Research Hospital, Neurology Department, Istanbul, Uskudar, Turkey |
| Characterizing the Use of Ofatumumab in a Real World Setting | Relapsing Multiple Sclerosis | Other: ofatumumab | Part I and II: Proportion of doses not completed within three days of the expected date|Part I and II: Proportion of doses not completed within +/- 14 days of the expected date|Part I: Proportion of doses not completed within three days of the expected date|Part I: Proportion of doses not completed within 14 days of the expected date|Part I: Proportion of participants with a treatment interruption of more than six months during maintenance|Part I: Proportion of participants discontinued within three months of the intial dose|Part I: Proportion of participants discontinued within 12 months of the intial dose.|Part I: Proportion of doses not completed within three days of the expected date for individual patient sub-groups|Part II: Proportion of doses not completed within 14 days of the expected date|Part II: proportion of participants discontinued within 18 months of the intial dose|Part II: Change in work productivity measured by the Work Productivity and Activity Impairment (WPAI) questionnaire|Part II: Change in generic health status as measured by the EQ5D|Part II: Change in fatigue as measured by the Fatigue Scale for Motor and Cognitive Function (FSMC).|Part II: Assessment of treatment satisfaction as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM1.4)|Part II: Proportion of self administration|Part II: Proportion of patients initiating ofatumumab who are treatment naïve|Part II: Change in Expanded Disability Status Scale (EDSS)|Part II: Annualized relapse rate|Part II: Number of T1 Gd-enhancing lesions per MRI scan|Part II: Number of new or enlarging T2 lesions on MRI|Percentage brain volume change | Novartis Pharmaceuticals|Novartis | |
| Single Ascending Dose Study With 5-MeO-DMT in Healthy Subjects | Pharmacokinetics in Healthy Adults | Drug: 5-MeO-DMT|Other: Placebo | Percentage of subjects with treatment emergent AEs (TEAES)|Peak plasma concentration (Cmax)|Time to reach Cmax (tmax)|Area under the plasma concentration- time curve | Beckley Psytech Limited | King's College London, London, United Kingdom |
| Pharmacokinetics of GH001 in Healthy Volunteers | Healthy Volunteers | Drug: 5 Methoxy N,N Dimethyltryptamine|Drug: Placebo | The pharmacokinetic (PK) parameters derived from laboratory assay results of the systemic levels of 5-MeO-DMT and bufotenine|Safety: Adverse Event (AE) reporting|Safety: Frequency of clinically significant changes from baseline in electrocardiogram (ECG) recording|Safety: Frequency of clinically significant changes from baseline in vital signs measurement|Safety: Frequency of clinically significant changes from baseline in safety laboratory tests of blood and urine|Safety: Frequency of clinically significant changes from baseline in Peak Flow Respirometry|Safety: Frequency of clinically significant changes from baseline in level of sedation|Safety: Change from baseline in Clinician Administered Dissociative States Scale (CADSS)|Safety: Assessment of Subject-Discharge readiness|Mental Health: Change from baseline in Brief Psychiatric Rating Scale (BPRS)|Mental Health: Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)|Pharmacodynamic assessment: The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale|Pharmacodynamic assessment: 30-Question Mystical Experience Questionnaire (MEQ30)|Pharmacodynamic assessment: Challenging Experiences Questionnaire (CEQ)|Pharmacodynamic assessment: Duration of the psychoactive effects (PsE)|Cognitive Function: Change from baseline in Psychomotor Vigilance Task (PVT)|Cognitive Function: Change from baseline in Auditory Verbal Learning Test (AVLT)|Cognitive Function: Change from baseline in Spatial Working Memory (SWM) task|Cognitive Function: Change from baseline in Digit Symbol Substitution Task (DSST) | GH Research Ireland Limited | GH Research Clinical Trial Site, Groningen, Netherlands |
| Safety of GH001 in Healthy Volunteers | Healthy Volunteers | Drug: 5 Methoxy N,N Dimethyltryptamine | The safety and tolerability of GH001|The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale | GH Research Ireland Limited | Clinical Trial Site, Maastricht, Netherlands |
| Clinical Study of GH001 in Depression | Treatment Resistant Depression|Major Depressive Disorder|Depression | Drug: 5 Methoxy N,N Dimethyltryptamine | Phase 1: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13.|Phase 2: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)|Phase 1: The effects of GH001 on the severity of depression evaluated by the Montgomery-Asberg Depression Rating Scale (MADRS)|Phase 2: The safety and tolerability of GH001 as a combined measure of outcomes 5 to 13 | GH Research Ireland Limited | Clinical Trial Site, Maastricht, Netherlands |
| Personality and Drug Use | No Conditions Study Focus on Substance Use and Personality | Other: Usage of drugs | Change in scores on Big Five Inventory (BFI-44)|Change in scores on Retrospective Personality Scale (RPS) | Psychedelic Data Society|Maastricht University|Quantified Citizen Technologies Inc. | |
| Personality and Drug Use (PDU) | Personality | Current Personality Profile|Changes in Personality Profile | Quantified Citizen Technologies Inc.|Maastricht University|Psychedelic Data Society |
CT World - Ayahuasca
CT World - Ayahuasca.csv
| Title | Conditions | Interventions | Outcome Measures | Sponsor/Collaborators | Locations |
|---|---|---|---|---|---|
| Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression | Major Depression | Drug: Ayahuasca|Drug: placebo | HAM-D effect at D7|MADRS effect at D1, D2 and D7|Response rate at D7 (HAM-D)|Response rate at D1, D2 and D7 (MADRS)|Remission rate at D7 (HAM-D)|Remission rate at D1, D2 and D7 (MADRS) | Universidade Federal do Rio Grande do Norte|University of Sao Paulo | Draulio B de Araujo, Natal, Rio Grande do Norte, Brazil |
| Entheogen Resurgence | Psychedelic Experiences | Other: self-reported entheogen use | Entheogen Use in Naturalistic Retreat & Therapeutic Settings | Vireo Health | Vireo Health of New York, Queens, New York, United States |
| Personality and Drug Use | No Conditions Study Focus on Substance Use and Personality | Other: Usage of drugs | Change in scores on Big Five Inventory (BFI-44)|Change in scores on Retrospective Personality Scale (RPS) | Psychedelic Data Society|Maastricht University|Quantified Citizen Technologies Inc. | |
| Personality and Drug Use (PDU) | Personality | Current Personality Profile|Changes in Personality Profile | Quantified Citizen Technologies Inc.|Maastricht University|Psychedelic Data Society |
CT World - Ibogaine
CT World - Ibogaine.csv
| Title | Conditions | Interventions | Outcome Measures | Sponsor/Collaborators | Locations |
|---|---|---|---|---|---|
| Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification | Drug Dependence|Drug Use Disorders|Opioid Dependence | Drug: Ibogaine Hydrochloride | Methadone dose|Adverse events|Cardiovascular effects | International Center for Ethnobotanical Education, Research, and Service|Multidisciplinary Association for Psychedelic Studies|University Rovira i Virgili|Universidad Autonoma de Madrid|Hospital Universitari Sant Joan de Reus|University of Sao Paulo | Hospital Universitari Sant Joan, Reus, Tarragona, Spain |
| Ibogaine in the Treatment of Alcoholism: a Randomized, Double-blind, Placebo-controlled, Escalating-dose, Phase 2 Trial | Alcoholism | Drug: Ibogaine Hydrochloride | Time without using alcohol|Subjective effects|Biomarkers|Cardiovascular effects | University of Sao Paulo|Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.|Conselho Nacional de Desenvolvimento Científico e Tecnológico|International Center for Ethnobotanical Education, Research, and Service | Ribeirão Preto Medical School, Ribeirão Preto, São Paulo, Brazil |
| A Study of Oral Ibogaine in Opioid Withdrawal | Opiate Withdrawal Syndrome | Drug: DMX-1002|Drug: Placebo | Stage 2 - Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) average score from Day 2 to Day 6|Stage 2 - Subject completion status at Day 6 (key secondary endpoint)|Stage 2 - Objective Opiate Withdrawal Scale of Handelsman (OOWS Handelsman) average score from Day 2 to Day 6|Stage 2 - Subject completion status at Day 30|Stage 2 - Time to drop-out through Day 30|Stage 2 - Daily subject-rated Visual Analog Scale for Efficacy (VAS-E) score from Day 2 to Day 6 and at Day 30|Stage 2 - Clinician-rated daily Clinical Global Impression - Improvement (CGI-I) score from Day 2 to Day 6|Stage 2 - Hamilton Depression Rating Scale (HAM-D) score at Day 6 and Day 30|Stage 2 - Proportion of subjects requiring clonidine for relief of withdrawal symptoms up to Day 6 | DemeRx IB, Inc.|MAC Clinical Research|ERT: Clinical Trial Technology Solutions|Hammersmith Medicines Research | MAC Clinical Research Manchester (Early Phase Unit), Neuroscience Centre of Excellence, Manchester, Greater Mancherster, United Kingdom|Hammersmith Medicines Research (HMR) Limited, London, United Kingdom |
| Personality and Drug Use | No Conditions Study Focus on Substance Use and Personality | Other: Usage of drugs | Change in scores on Big Five Inventory (BFI-44)|Change in scores on Retrospective Personality Scale (RPS) | Psychedelic Data Society|Maastricht University|Quantified Citizen Technologies Inc. | |
| Personality and Drug Use (PDU) | Personality | Current Personality Profile|Changes in Personality Profile | Quantified Citizen Technologies Inc.|Maastricht University|Psychedelic Data Society |
CT World - LSD
CT World - LSD.csv
| Title | Conditions | Interventions | Outcome Measures | Sponsor/Collaborators | Locations |
|---|---|---|---|---|---|
| Effects of SERT Inhibition on the Subjective Response to LSD in Healthy Subjects | Healthy | Drug: Paroxetine|Drug: Lysergic Acid Diethylamide|Drug: Placebo | 5 dimensions of altered state of consciousness (5D-ASC) total OAV score|Visual Analog Scales (VAS) good effect rating|Adjective mood rating scale (AMRS)|States of consciousness questionnaire (SCQ)|Spiritual Realm Questionnaire (SRQ)|Psychological Insight Questionnaire (PIQ)|Blood pressure|Heart rate|Body temperature|Plasma concentrations of paroxetine|Plasma concentrations of LSD|HTR gene expression|Changes in the electrocardiogram (ECG) | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| Effects of LSD on Neuroplasticity in Healthy Subjects | Healthy | Drug: Lysergic Acid Diethylamide | Change in motor evoked potential amplitude after paired associative stimulation (PAS)|Change in auditory event-related potential (ERP) amplitude after tetanic stimulation|Plasma and serum levels of brain-derived neurotrophic factor (BDNF)|Motor learning ability | University of Fribourg | University of Fribourg, Fribourg, FR, Switzerland |
| LSD Base and LSD Tartrate Bioequivalence and Bioavailability in Healthy Subjects | Healthy | Drug: Lysergic Acid Diethylamide Base oral drinking solution|Drug: Lysergic Acid Diethylamide Base solid orodispersible film|Drug: Lysergic Acid Diethylamide Tartrate oral drinking solution|Drug: Lysergic Acid Diethylamide Tartrate intravenous administration|Other: LSD Placebo | LSD plasma AUC|LSD Cmax|Bioavailability of LSD base|Bioavailability of LSD tartrate|Acute subjective effects I|Acute subjective effects II|Acute subjective effects III|Acute subjective effects IV|Autonomic effects I|Autonomic effects II|Autonomic effects III|Bioavailability of orodispersible film|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Personality Inventory (FPI-R)|Saarbrücker Personality Questionnaire (SPF)|HEXACO personality inventory|Defense Style Questionnaire (DSQ-40)|Absence of tolerance|Appreciation Scale (AS)|Subjective well-being I|Subjective well-being II|Subjective well-being III | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| Effects of MDMA Co-administration on the Response to LSD in Healthy Subjects | Healthy | Drug: Lysergic Acid Diethylamide|Drug: 3,4-methylenedioxymethamphetamine|Other: LSD Placebo|Other: MDMA Placebo | Acute subjective effects I|Acute subjective effects II|Acute subjective effects III|Autonomic effects I|Autonomic effects II|Autonomic effects III|Plasma levels of LSD|Plasma levels of MDMA|Plasma levels of blood-derived neurotrophic factor (BDNF)|Plasma levels of oxytocin|Psychological Insight Questionnaire|States of Consciousness Questionnaire|Spiritual Realms Questionnaire|Effect moderation through personality traits I|Effect moderation through personality traits II|Effect moderation through personality traits III|Effect moderation through personality trait IV|Effect moderation through personality trait V | University Hospital, Basel, Switzerland | University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland |
| Effect of Ketanserin After LSD Administration | Healthy | Drug: Lysergic Acid Diethylamide|Drug: Ketanserin Placebo|Drug: Ketanserin | Duration of subjective response|Extent of subjective response|Plasma concentrations of LSD|Plasma concentrations of Ketanserin|5 dimensions of altered state of consciousness (5D-ASC) profile total score|Adjective mood rating scale (AMRS)|States of consciousness questionnaire (SCQ)|Blood pressure|Heart rate|Body temperature|Pupil diameter|Elliot Humility Scale (EHS)|Jankowski Humility Scale (JHS)|Arnett Inventory of Sensation Seeking (AISS-d)|Freiburger Persönlichkeitsinventar (FPI)|Saarbrücker Persönlichkeitsfragebogen (SPF)|Defense Style Questionnaire (DSQ-40) | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| Lysergic Acid Diethylamide (LSD) as Treatment for Cluster Headache | Cluster Headache | Drug: Lysergic Acid Diethylamide|Drug: Placebo | Change in frequency of the cluster headache attacks|Change in intensity of the cluster headache attacks|Episode abortion|Change in duration of attacks|Time to first attack after completion of pulse regimen|Cumulative time with headache|Change in cluster period duration and interval between cluster periods|Number of attacks requiring abortive medication|Number of Attack-associated autonomic symptoms|Quality of life assessed by questionnaires: 36-item short-form health survey (SF-36)|Quality of life assessed by questionnaires: 5-level EuroQoL-5D (EQ-5D-5L)|Quality of life assessed by questionnaires: Headache Impact Test (HIT-6)|Acute autonomic effects assessed by blood pressure|Acute autonomic effects assessed by heart rate|Acute autonomic effects assessed by body temperature|Adverse Events|Acute psychological effects assessed by questionnaire Visual analogue scales (VAS)|Acute psychological effects assessed by SCQ|Acute psychological effects assessed by questionnaire 5-dimensions of altered states of consciousness|Persisting effects attributed to the LSD experience|Change of attack frequency at the end of the study compared with baseline|Change of attack intensity at the end of the study compared with baseline|Change in attack frequency before and after pulse regimen|Change in attack intensity before and after pulse regimen | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| LSD Treatment for Persons With Alcohol Use Disorder | Alcohol Use Disorder (AUD) | Drug: LSD|Drug: Active placebo | Percent heavy drinking days|Days to first heavy drinking day|Days to first drinking day|Percent days abstinent|Drinks per drinking day|Craving|Carbohydrate-deficient transferrin|General health|Adverse consequences of alcohol use|Impulsivity|Depression|Anxiety|Persisting effects | Felix Mueller|University of Bern|University Hospital, Geneva|University Hospital, Basel, Switzerland | University Hospital of Psychiatry, University of Basel, Basel, Switzerland|University Hospital of Psychiatry, University of Bern, Bern, Switzerland|Service d'Addictologie, Hôpitaux Universitaires de Genève, Geneve, Switzerland |
| Minidosing Lysergic Acid Diethylamide (LSD) for Chronic Cluster Headache | Chronic Cluster Headache | Drug: LSD tartrate|Drug: Placebo | Mean change in weekly attack frequency, across treatments groups.|Mean change in weekly attack frequency across, treatments|50% responder and remission rate in week 3, across treatment groups|50% responder and remission rate in week 8, across treatment groups|Mean change in mean headache attack duration per week, across treatment groups|Mean change in mean headache attack severity, across treatment groups|Mean change in number of abortive medication use, across treatment groups|Rescue treatment|Patient Global Impression of Change (PGIC)|EuroQoL EQ-5D-5L|Hospital Anxiety and Depression Score (HADS)|Pharmacokinetic (PK)-pharmacodynamic (PD) modelling|Success of masking of intervention assignment|Alcohol consumption | Canisius-Wilhelmina Hospital|ZonMw: The Netherlands Organisation for Health Research and Development|Radboud University Medical Center|Leiden University Medical Center | |
| LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders | Patients|Anxiety Disorders | Drug: LSD|Drug: Placebo | Reduction in anxiety assessed by questionnaires|Reduction in Depression assessed by questionnaires|Reduction of psychopathological symptoms assessed by questionnaires|Sustained Response assessed by questionnaires | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, BS, Switzerland|Private Practice P.Gasser, Solothurn, SO, Switzerland |
| LSD Therapy for Persons Suffering From Major Depression | Major Depressive Disorder | Drug: LSD | Change in depressive symptomatology assessed by questionnaire compared with active placebo | University Hospital, Basel, Switzerland|Department of Psychiatry Basel (UPK Basel; Prof. Dr. med. Stefan Borgwardt) | Universitäre Psychiatrische Kliniken, Basel, Basel-Stadt, Switzerland |
| Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin | Healthy | Drug: LSD|Drug: Psilocybin | Altered states of consciousness|Subjective effects assessed by VAS|Subjective effects assessed by AMRS scales|Psychotomimetic effects|Mystical-type experiences assessed by SCQ|Mystical-type experiences assessed by MS scales|Effects on emotion processing|Autonomic effects assessed by heart rate|Autonomic effects assessed by blood pressure|Autonomic effects assessed by body temperature | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| Psychological, Physiological, Endocrine, and Pharmacokinetic Effects of LSD in a Controlled Study | Healthy | Drug: Placebo|Drug: LSD | Subjective / psychological effects of LSD|Physiological effects of LSD|Endocrine response of LSD|Pharmacokinetics of LSD|Effect of LSD on prepulse inhibition|Tolerability of LSD|Long-term psychological effects of LSD|Genetic Polymorphisms|Effects on social cognition and empathy | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Basel-Stadt, Switzerland |
| A Double-blind, Placebo-controlled Study to Evaluate Very Low Dose LSD in Healthy Volunteers Aged 55-75 Years | Healthy Volunteers | Drug: Lysergic acid diethylamide (LSD) 5µg|Drug: Lysergic acid diethylamide (LSD) 10µg|Drug: Lysergic acid diethylamide (LSD)20 µg|Drug: Placebo | To evaluate the safety and tolerability of very low dose LSD|To evaluate the pharmacokinetics of very low dose LSD - Variation of plasma concentration over time|To evaluate the pharmacokinetics of very low dose LSD - Maximum Peak concentration of drug|To evaluate the pharmacokinetics of very low dose LSD - Half life of drug|To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on cognition.|To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Acute subjective effects.|To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on the characteristics of altered states of consciousness assessed by questionnaire|To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Balance tracking|To evaluate the pharmacodynamic (PD) and cumulative effect of very low dose LSD on Proprioception | Eleusis Therapeutics | |
| Lysergic Acid Diethylamide (LSD)-Assisted Psychotherapy in People With Illness-related Anxiety | Anxiety | Drug: 200 mcg LSD|Drug: 20 mcg LSD|Behavioral: Therapy | Baseline State-Trait Anxiety Inventory (STAI)|Primary Endpoint State-Trait Anxiety Inventory (STAI) | Multidisciplinary Association for Psychedelic Studies | Private Practices of Peter Gasser MD, Solothurn, Switzerland |
| Sodium Lactate and Brain Relaxation (LSD) | Sodium Lactate|Intracranial Hypertension|Brain Relaxation | Drug: Sodium Lactate|Drug: Mannitol 20% Infusion | Quality of brain relaxation|Necessity for "rescue" therapy|Electrolytes alterations|Changes of lactatemia|Volume of post operative brain edema|Glasgow Coma Scale|Extubation|Neurological recovery|Protein S100-β|Neuron-Specific Enolase (NSE)|Glial Fibrillary Acid Protein (GFAP)|Morbidity|Mortality|Karnofsky performance scale | Centre Hospitalier Universitaire de Besancon | CHU de Besançon, Besancon, France |
| Comparative Acute Effects of LSD, Psilocybin and Mescaline | Healthy | Drug: LSD|Drug: Psilocybin|Drug: Mescaline|Other: Placebo | 5 Dimensions of Altered States of Consciousness (5D-ASC)|fMRI resting state functional connectivity (RSFC)|Visual Analog Scale (VAS)|States of Consciousness questionnaire (SCQ)|Blood pressure|Heart rate|Body temperature|Pupil size|Drug plasma levels|Oxytocin levels|Blood-derived neurotrophic factor (BDNF)|Renal clearance values|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Persönlichkeitsinventar (FPI)|Saarbrücker Persönlichkeitsfragebogen (SPF)|Adjective Mood Rating Scale (AMRS)|Mysticism Scale (MS)|Elliot Humility Scale (EHS)|Jankowski Humility Scale (JHS)|Arnett Inventory of Sensation Seeking (AISS-d) | University Hospital, Basel, Switzerland | University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland |
| MR Antagonist and LSD1 | Hypertension|Mineralocorticoid Excess | Drug: Eplerenone|Drug: Amlodipine | 24-hour systolic ambulatory blood pressure | Brigham and Women's Hospital | Brigham and Women's, Boston, Massachusetts, United States |
| Phase 1 Trial of the LSD1 Inhibitor SP-2577 (Seclidemstat) in Patients With Advanced Solid Tumors | Advanced Solid Tumors | Drug: SP-2577 Seclidemstat | Safety and tolerability of SP-2577|Determine the maximum tolerated dose of SP-2577|Characterization of pharmacokinetics of SP-2577 (area under the concentration time profile)|Characterization of pharmacokinetics of SP-2577 (time to maximum plasma concentration)|Characterization of pharmacokinetics of SP-2577 (maximum plasma concentration)|Characterization of pharmacokinetics of SP-2577 (half-life)|Characterization of pharmacokinetics of SP-2577 (clearance rate)|Characterization of pharmacokinetics of SP-2577 (volume of distribution)|Efficacy parameter: overall response rate of SP-2577|Efficacy parameter: duration of response of SP-2577|Efficacy parameter: progression-free survival of SP-2577|Changes in serum hemoglobin F concentrations|Changes in the molecular signatures of the tumor | Salarius Pharmaceuticals, LLC | HonorHealth, Scottsdale, Arizona, United States|Sarcoma Oncology Research Center, Santa Monica, California, United States |
| Hematology, IMG-7289, LSD1 (Lysine-Specific Demethylase 1) Inhibitor, Essential Thrombocythemia (ET), Ph 2 | Thrombocythemia, Essential | Drug: IMG-7289 | The proportion of patients who achieve complete hematologic remission | The University of Texas Health Science Center at San Antonio|Imago BioSciences,Inc. | Mays Cancer Center, San Antonio, Texas, United States |
| Role of the Serotonin 5-HT2A Receptor in LSD-induced Altered States of Consciousness (LDR-Study) | Healthy | Drug: LSD|Drug: Placebo | Altered states of consciousness|Subjective effects|Psychotomimetic effects|Mystical-type experiences|Autonomic effects | University Hospital, Basel, Switzerland | University Hospital, Basel, Switzerland |
| Neuronal Correlates of Altered States of Consciousness | Healthy | Drug: LSD|Drug: Placebo | fMRI brain activity|Physiological effects (Association of alterations in consciousness and autonomic nervous system reactions (blood pressure, heart rate, pupil size)|Plasma hormone levels (Associations of alterations in consciousness with plasma hormone levels) | University Hospital, Basel, Switzerland | University Hospital, Basel, Switzerland |
| Assessment of [18F]MNI-1054 as a Marker for LSD1 | Healthy Volunteers (HV) | Drug: [18F]MNI-1054 | Average and standard deviation across subjects of the variability ((test - retest) / average(test, retest) ) as well as the intraclass correlation (ICC). | Invicro | Invicro, New Haven, Connecticut, United States |
| Large Scale Demonstrator, Webportal Diabetes | Diabetes Mellitus Type 2 | Behavioral: Web portal | Health Related Quality of Life|Well-being Index: WHO-5 questionnaire|Diabetes-related distress|Assessing self-efficacy|Evaluation of general practice|Clinical parameters | Henk Bilo, MD|Isala|University Medical Center Groningen|Medical Research Foundation, The Netherlands | Isala Clinics, Zwolle, Netherlands |
| IMG-7289 in Patients With Myelofibrosis | Myelofibrosis|Post-polycythemia Vera Myelofibrosis (PPV-MF)|Post-essential Thrombocythemia Myelofibrosis (PET-MF)|Primary Myelofibrosis (PMF) | Drug: IMG-7289 | Incidence of treatment-emergent adverse events, and changes in physical examination, vital signs and laboratory parameters [safety and tolerability]|Drug Concentration (performed in Phase 1/2a only)|Spleen Volume | Imago BioSciences,Inc. | University of Michigan, Ann Arbor, Michigan, United States|Royal Adelaide Hospital, Adelaide, South Australia, Australia|Universitatsklinikum Essen, Essen, Germany|Azienda Ospedaliero Universitaria Careggi, Florence, Italy|Guy's and St Thomas' Hospitals, London, United Kingdom |
| A Rollover Protocol to Allow for Continued Access to the LSD1 Inhibitor Seclidemstat (SP-2577) | Ewing Sarcoma|Myxoid Liposarcoma|Desmoplastic Small Round Cell Tumor|Extraskeletal Myxoid Chondrosarcoma|Angiomatoid Fibrous Histiocytoma|Clear Cell Sarcoma|Myoepithelial Tumor|Low Grade Fibromyxoid Sarcoma|Sclerosing Epithelioid Fibrosarcoma | Drug: Seclidemstat | Length of time receiving study treatment|Number of patients enrolled through study completion|Evaluate safety & tolerability utilizing the most current version of CTCAE|Evaluate anti-tumor activity based upon imaging studies according to RECIST v1.1 | Salarius Pharmaceuticals, LLC | Sarcoma Oncology Center, Santa Monica, California, United States |
| The Role of 5-HT2A Receptor in the Perception of Self and Personal Meaning in Healthy Volunteers | Healthy | Drug: Placebo|Drug: LSD|Drug: Ketanserin | fMRI brain activity (BOLD signal)|associations between personality traits, subjective experiences, and mood changes and the changes in BOLD signal|repeated assessment of subjective effects with validated questionnaires | Psychiatric University Hospital, Zurich | Center for Psychiatric Research, Department of Psychiatry, Psychotherapy and Psychosomatic, Psychiatric Hospital, University of Zurich, Zurich, Switzerland |
| Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects | Respiratory Muscle Function | Drug: Levosimendan | Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves|Fatiguability of the diaphragm | University Medical Center Nijmegen|Orion Corporation, Orion Pharma | University Medical Center Nijmegen, Nijmegen, Gelderland, Netherlands |
| A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After Single-Dose Oral Administration in Healthy Participants | Healthy Volunteers | Drug: TAK-418|Drug: [18F]MNI-1054 (radiotracer) | Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models At Baseline Scan on Day -1|Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 1|Quantitative Estimates of Binding of [18F]MNI-1054 Based on PET Radiotracer Kinetic Models on Day 2|Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 1|Percent Enzyme Occupancy Based on Quantitative Estimates of Binding for TAK-418 on Day 2|Cmax: Maximum Observed Plasma Concentration for TAK-418|AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-418|AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418|ED50 PET Enzyme Occupancy|Number of Participants Reporting One or More Adverse Events (AEs) and Serious Adverse Events (SAEs)|Number of Participants With Clinically Significant Abnormal Laboratory Values|Number of Participants With Clinically Significant Abnormal Vital Signs | Takeda | Invicro, A Konica Minolta Company, New Haven, Connecticut, United States |
| Clinical Trial of SP-2577 (Seclidemstat) in Patients With Relapsed or Refractory Ewing or Ewing-related Sarcomas | Ewing Sarcoma|Myxoid Liposarcoma|Sarcoma,Soft Tissue|Desmoplastic Small Round Cell Tumor|Extraskeletal Myxoid Chondrosarcoma|Angiomatoid Fibrous Histiocytoma|Clear Cell Sarcoma|Primary Pulmonary Myxoid Sarcoma|Myoepithelial Tumor|Sclerosing Epithelioid Fibrosarcoma|Fibromyxoid Tumor | Drug: Seclidemstat|Drug: Cyclophosphamide|Drug: Topotecan | Safety and tolerability of seclidemstat (SP-2577) as a single agent and in combination with topotecan and cyclophosphamide measured by dose limiting toxicities and adverse events according to CTCAE version 5.0|Determine the maximum tolerated dose of SP-2577 as determined by dose limiting toxicities measured according to CTCAE version 5.0|Characterization of the pharmacokinetics of SP-2577 as measured by peak plasma concentration|Characterization of the pharmacokinetics of SP-2577 as measured by area under the curve|Characterization of the pharmacokinetics of SP-2577 as measured by apparent clearance of seclidemstat|Characterization of the pharmacokinetics of SP-2577 as measured by median half-life|Food effects on the pharmacokinetics of SP-2577 as measured in both fasted and fed populations, primarily measured by apparent clearance.|Anti-tumor activity as measured according to RECIST 1.1 criteria based upon radiological assessments. | Salarius Pharmaceuticals, LLC|National Pediatric Cancer Foundation | Children's Hospital Los Angeles, Los Angeles, California, United States|Sarcoma Oncology Research Center, Santa Monica, California, United States|Mayo Clinic, Jacksonville, Florida, United States|Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States|H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, United States|Mayo Clinic, Rochester, Minnesota, United States|Washington University, Saint Louis, Missouri, United States|Memorial Sloan Kettering Cancer Center, New York, New York, United States|Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States|The Research Institute at Nationwide Children's Hospital, Columbus, Ohio, United States|Oregon Health Sciences University, Portland, Oregon, United States|Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States|MD Anderson Cancer Center, Houston, Texas, United States|Oncology Consultants, Houston, Texas, United States|Virginia Cancer Specialists, Fairfax, Virginia, United States|University of Washington, Seattle, Washington, United States |
| IMG-7289, With and Without ATRA, in Patients With Advanced Myeloid Malignancies | Acute Myeloid Leukemia|Myelodysplastic Syndrome | Drug: IMG-7289|Drug: All-trans retinoic acid | Safety and tolerability as measured by monitoring of adverse events, changes in physical examinations, vital signs and laboratory parameters|Pharmacokinetic parameters as measured by acute and steady state sampling|The adequacy of the treatment regimen in producing a pharmacodynamic effect as measured by the IWG/Cheson response criteria | Imago BioSciences,Inc. | Royal Adelaide Hospital, Adelaide, South Australia, Australia |
| A Study of Orally Administered JBI-802, an LSD1/HDAC6 Inhibitor, in Patients With Advanced Solid Tumors | Locally Advanced Solid Tumor|Metastatic Solid Tumor | Drug: JBI-802 | Maximum-Tolerated Dose (MTD)|Investigator-Assessed ORR (Part 2)|Incidence of AEs|Cmax: Maximum Plasma Concentration JBI-802|Tmax: Time of Maximum Plasma Concentration JBI-802|Clast: Last Observed (quantifiable) Plasma Concentration in units of ng/mL JBI-802|AUC(0-last): Area Under the Concentration-time Curve from Dosing (time 0) to Time of Last Measured Concentration JBI-802|AUC(0-t) (partial AUC): Area Under the Concentration-time Curve from Dosing (time 0) to Time t JBI-802|Vd/F: Apparent Volume of Distribution During Terminal Phase (Vz/F) After Oral Administration calculated as (CL/F)/ Ke|CL/F: Apparent Oral Clearance (CL/F) computed as Dose/AUC|t½: The Apparent Terminal Elimination Half-life JBI-802|Investigator-Assessed Overall Response Rate (ORR) (Part 1)|Duration of Response (DOR)|PFS: Progression Free Survival|OS: Overall Survival|PSA 50 Response Rate in Patients with Prostate Cancer | Jubilant Therapeutics Inc. | Sarah Cannon Research Institute at HealthOne, Denver, Colorado, United States|The Christ Hospital, Cincinnati, Ohio, United States|Tennessee Oncology, PLLC, Nashville, Tennessee, United States|NEXT Virginia, LLC, Fairfax, Virginia, United States |
| Effect of a Low Starch Diet in Patients With Ankylosing Spondylitis | Spondyloarthritis|Ankylosing Spondylitis | Behavioral: Low Starch Diet (LSD)|Behavioral: General healthy eating | Change in intestinal Klebsiella|Change in mean erythrocyte sedimentation rate (ESR)|Change in mean C-reactive protein (CRP)|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|Bath Ankylosing Spondylitis Function Index (BASFI)|Ankylosing Spondylitis Disease Activity Score (ASDAS)|Bath Ankylosing Spondylitis Patient Global Score (BAS-G)|Ankylosing Spondylitis Quality of Life (ASQoL)|Euro Quality of Life-5D (EQ-5D)|Change in Short Form (36) Health Survey (SF-36)|Change in ASAS response criteria|Change in pain, fatigue and stiffness by patient's Visual analogue scale (VAS)|Individual evolution of intestinal Klebsiella|Change in Weight|Change in body mass index (BMI)|Change in body composition|Quantification of the average starch intake through 24h dietary recall | Universidade do Porto|Portuguese Institute of Rheumatology|Centro de Investigação Interdisciplinar Egas Moniz | Instituto Português de Reumatologia, Lisboa, Portugal |
| Brain Derived Neurotropic Factor Response to Aerobic Exercise Intensity in Depressive Patients. | Depressive Disorder|Depressive Disorder, Major | Behavioral: High aerobic intensity training (HIT)|Behavioral: Long slow distance training (LSD) | Change in serum brain derived neurotropic factor (BDNF)|Change in affective symptoms|Change in state of anxiety.|Change in subjective exercise experience|Maximal oxygen uptake|Maximal Heart rate | St. Olavs Hospital|Norwegian University of Science and Technology | St.Olavs university Hospital, Departement of Østmarka, Trondheim, Norway |
| Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing | Healthy | Drug: LSD|Drug: MDMA|Drug: Amphetamine|Drug: Placebo | Emotional enhancement as determined by fMRI|fMRI brain activity|Resting State fMRI|Effect Modulation by personality traits (assessed with questionnaires),|Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)|Effect Modulation by genetic polymorphisms (determined by genotyping of each subject) | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Basel Stadt, Switzerland |
| Study of Sensitization of Non-M3 AML Blasts to ATRA by Epigenetic Treatment With Tranylcypromine (TCP) | Acute Myeloid Leukemia|Myelodysplastic Syndrome | Drug: tranylcypromine|Drug: all-trans retinoic acid|Drug: cytarabine | MTD determination of TCP in combination with fixed-dose of ATRA and with fixed-dose Cytarabine;|Objective best response|Overall survival (OS) | Michael Luebbert|University Hospital Freiburg | Universitätsklinikum Heidelberg, Heidelberg, Baden-Wuerttemberg, Germany|Universitätsklinik Düsseldorf, Medical School Duesseldorf, Düsseldorf, Germany|Universitätsklinikum Frankfurt Main, Medical School Frankfurt, Frankfurt Main, Germany|Universitätsklinikum Freiburg, Medical School Freiburg, Freiburg, Germany|Klinikum München rechts der Isar, Medical School Munich rechts der Isar, München, Munich, Germany|Universitätsklinikum Tübingen, Medical School Tuebingen, Tübingen, Tuebingen, Germany |
| Bomedemstat in Patients With Polycythemia Vera | Polycythemia Vera | Drug: bomedemstat | Incidence of treatment-emergent adverse events|Incidence of patients who achieve a reduction of hematocrit|Evaluate the duration of change in hematocrit|Pharmacodynamics of bomedemstat on platelet count|Pharmacodynamics of bomedemstat on WBC|Incidence of thrombotic and hemorrhagic events|Incidence of spleen volume reduction|Incidence of disease progression|Evaluate pharmacokinetics: maximum plasma concentration (Cmax) of bomedemstat|Evaluate pharmacokinetics: exposure of bomedemstat|Evaluate pharmacokinetics: half life of bomedemstat|Evaluate the change in patient reported symptoms on the MFSAF|Evaluate the change in patient reported symptoms on the PGIC|Evaluate duration of change in patient-reported symptom burden | Imago BioSciences,Inc. | |
| IMG-7289 in Patients With Essential Thrombocythemia | Essential Thrombocythemia | Drug: IMG-7289 | The safety of IMG-7289 when administered to patients with essential thrombocythemia|The efficacy of IMG-7289 when administered to patients with essential thrombocythemia | Imago BioSciences,Inc. | Local Institution, Jacksonville, Florida, United States|Local Institution, Ann Arbor, Michigan, United States|Local Institution, New York, New York, United States|Local Institution, Durham, North Carolina, United States|Cleveland Clinic, Cleveland, Ohio, United States|Local Institution, Pittsburgh, Pennsylvania, United States|Local Institution, Seattle, Washington, United States|Local Institution, Herston, Brisbane, Australia|Local Institution, Camperdown, New South Wales, Australia|Local Institution, St Leonards, New South Wales, Australia|Local Institution, Southport, Queensland, Australia|Royal Adelaide Hospital, Adelaide, South Australia, Australia|Local Institution, Clayton, Victoria, Australia|Department of Hematology and Stem Cell Transplantation, West German Cancer Center (WTZ), Essen, Germany|Local Institution, Jena, Germany|Local Institution, Hong Kong, Hong Kong|Local Institution, Alessandria, Italy|Local Institution, Bologna, Italy|CRIMM; Centro Ricerca e Innovazione delle Malattia Mieloproliferative, Azienda ospedaliera Universitaria Careggi, Florence, Italy|Local Institution, Varese, Italy|Local Institution, Auckland, New Zealand|Middlemore Hospital, Auckland, New Zealand|Local Institution, London, United Kingdom|Guys and St Thomas Hospital, London, United Kingdom|Local Institution, London, United Kingdom|Local Institution, Oxford, United Kingdom |
| Autologous Transplantation of Cultivated Limbal Stem Cells on Amniotic Membrane in Limbal Stem Cell Deficiency (LSD) Patients | Limbal Stem Cell Deficiency | Procedure: Cultured limbal stem cells Transplantation | Snellen visual acuity|corneal epithelial integrity and stability|Impression cytology|Extent of retarding recurrent neovascularisation | Royan Institute|Small Business Developing Center|Labafi Nejad Eye Research Center | Royan Institute, Tehran, Iran, Islamic Republic of|Labbafinejad Ophthalmic Research Center, Tehran, Iran, Islamic Republic of |
| Assessment of the Biodistribution and Safety of [18F]MNI-1054 | Healthy Volunteers | Drug: [18F]MNI-1054 | Assessment of body organ distribution in Healthy Subjects | Invicro | Invicro, New Haven, Connecticut, United States |
| Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers | SCCOHT|Ovarian Clear Cell Tumor|Ovarian Endometrioid Adenocarcinoma|Endometrial Cancer | Drug: SP-2577|Drug: Pembrolizumab | Incident of AEs|Incident of DLTs|Overall Response Rate|Disease Control Rate|Duration of Response|Duration of Stable Disease|Progression Free Survival|Overall Survival|Plasma Concentration of SP-2577|ctDNA in blood and other body fluids|Target Inhibition in Tumor Biopsies | HonorHealth Research Institute|Merck Sharp & Dohme LLC|Salarius Pharmaceuticals, LLC | HonorHealth Research Institute, Scottsdale, Arizona, United States |
| IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) | Essential Thrombocythemia|Polycythemia Vera | Drug: IMG-7289 | Hematologic Response Rates|Incidence of Treatment-Related Toxicity|Change in Total Symptom Score (TSS) as Measured by the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF)|Change in Mutational Allele Burden|Change in Spleen Size in Centimeters|Change in Fibrosis Score | Terrence J Bradley, MD|Imago BioSciences,Inc.|University of Miami | University of Miami, Miami, Florida, United States |
| Safety and Efficacy of Low Dose MM-120 for ADHD Proof of Concept Trial | ADHD|Attention Deficit Disorder | Drug: MM-120|Other: Placebo | Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms|Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms|Number of patients who experience a decrease in the Clinical Global Impressions Scale (CGI-S)|Changes in patient self-assessment of Adult attention-Deficit/Hyperactivity Disorder (ADHD) symptoms|Changes in patient self-assessment of Adult Attention-Deficit/Hyperactivity Disorder(ADHD) symptoms | Mind Medicine, Inc. | Maastricht University, Maastricht, Netherlands|University Hospital Basel, Basel, Switzerland |
| Evaluation of Lysine-Specific Demethylase 1 | Hypertension | Drug: Para-aminohippuric Acid|Drug: Angiotensin II | Evaluating for the mechanisms by which genetic variants in the LSD1 gene contribute to salt-sensitive hypertension and cardiovascular disease | Brigham and Women's Hospital | Brigham and Women's Hospital, Boston, Massachusetts, United States |
| Mood Effects of Serotonin Agonists | Healthy | Drug: Lysergic Acid Diethylamide | Change From Baseline in Profile of Mood States (POMS) | University of Chicago | Matthew Bona, Chicago, Illinois, United States|University of Chicago, Chicago, Illinois, United States |
| A Phase I Dose Escalation Study of GSK2879552 in Subjects With Acute Myeloid Leukemia (AML) | Leukaemia, Myelocytic, Acute | Drug: GSK2879552|Drug: ATRA | Part 1: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|Part 1: Number of Participants With Dose Limiting Toxicities (DLT)|Part 1: Number of Participants With AE Leading to Dose Reductions or Delays|Part 1: Number of Participants With Withdrawals Due to Toxicities|Number of Participants With Clinical Chemistry Parameters Changes From Baseline With Respect to the Normal Range|Number of Participants With Clinical Chemistry Toxicity Grade Changes From Baseline|Number of Participants With Hematology Parameters Change From Baseline With Respect to the Normal Range|Number of Participants With Hematology Toxicity Grade Changes From Baseline|Part 1: Number of Participants With Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)|Part 1: Number of Participants With Change From Baseline in Heart Rate|Part 1: Number of Participants With Change From Baseline in Temperature|Part 1: Number of Participants With Change From Baseline in Respiratory Rate|Part 1: Number of Participants With Abnormal Electrocardiograms (ECGs) Findings|Part 1: Number of Participants With Abnormal Physical Examinations|Part 2: Objective Response Rate of Participants|Part 1: Area Under the Plasma Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and From Time Zero (Pre-dose) Extrapolated to Infinite Time [(AUC(0-inf)] After Single Dose Administration|Part 1: AUC Over the Dosing Interval (0-tau) After Single Dose Administration|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration [AUC(0-t)] and AUC Over the Dosing Interval (0-tau) After Repeated Administration|Part 1: Maximum Observed Plasma Concentration (Cmax) of GSK2879552|Part 1: Apparent Terminal Phase Half-life (t½)|Part 1: Time of Occurrence of Cmax (Tmax) of GSK2879552|Part 1: Accumulation Ratio for GSK2879552|Part 1:Time Invariance|Part 1:Percentage of Participants With Objective Response|Part 1: AUC(0-t), AUC (0-tau) and AUC(0-inf) of ATRA|Part 1: Cmax of ATRA|Part 1: Apparent Terminal Phase Half-life (t½) of ATRA|Part 1: Time of Occurrence of Cmax (Tmax) of ATRA|Part 2: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)|Part 2: Number of Participants With AE Leading to Dose Reductions or Delays|Part 2: Number of Participants With Withdrawals Due to Toxicities|Part 2: Number of Participants With Abnormal Clinical Chemistry Parameters|Part 2: Number of Participants With Abnormal Hematology Parameters|Part 2: Number of Participants With Abnormal Vital Signs|Part 2: Number of Participants With Abnormal Electrocardiogram (ECG) Findings|Part 2: Number of Participants With Abnormal Physical Examinations|Part 2: Clearance (CL) of GSK2879552 for Part 2|Part 2: Volume of Distribution of GSK2879552 for Part 2|Number of Participants With Abnormal Covariates: Part 2|Duration of Response: Part 2|Time to Time to Response: Part 2|Progression-free Survival: Part 2 | GlaxoSmithKline | GSK Investigational Site, Augusta, Georgia, United States|GSK Investigational Site, Bronx, New York, United States|GSK Investigational Site, Bronx, New York, United States|GSK Investigational Site, New York, New York, United States|GSK Investigational Site, Houston, Texas, United States|GSK Investigational Site, Melbourne, Victoria, Australia|GSK Investigational Site, Toronto, Ontario, Canada|GSK Investigational Site, Toronto, Ontario, Canada |
| In Utero Enzyme Replacement Therapy for Lysosomal Storage Diseases | MPS I|MPS II|MPS IVA|MPS VI|Mps VII|Gaucher Disease, Type 2|Gaucher Disease, Type 3|Pompe Disease Infantile-Onset|Wolman Disease | Drug: Aldurazyme (laronidase) | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.|Number of participants to receive the full initial, weight-based dose of enzyme replacement therapy through the fetal umbilical vein, and subsequent doses throughout the pregnancy.|Number of participants with the presence and levels of glycosaminoglycans (GAGs) in urine.|The number of participants with improvement or resolution of hydrops (if present).|Number of participants that show measured levels of antibodies against the enzyme. | University of California, San Francisco|Duke University | University of California, San Francisco, California, United States |
| Extension of Study HGT-SAN-055 Evaluating Administration of rhHNS in Patients With Sanfilippo Syndrome Type A (MPS IIIA) | Sanfilippo Syndrome | Biological: rhHNS-10 mg|Biological: rhHNS-45 mg|Biological: rhHNS-90 mg | Number of Participants With Treatment Emergent Adverse Events (TEAEs) And Treatment Emergent Serious Adverse Events (TESAEs)|Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity|Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs)|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs)|Number of Participants With Postive Anti-rhHNS Antibody Status in Serum by Recombinant Human Heparan N-Sulfatase (rhHNS)|Number of Participants With Positive Anti-rhHNS Antibody Status in Cerebrospinal Fluid (CSF) by Recombinant Human Heparan N-Sulfatase (rhHNS)|Change From Baseline in Bayley Scales of Infant Development Third Edition (BSID-III) at Month 103|Change From Baseline in Bayley Scales of Infant Development Third Edition (BSID-III)/Kaufman Assessment Battery for Children Second Edition (KABC-II) Age-Equivalent Scores at Month 103|Change From Baseline in Developmental Quotient (DQ) Using Bayley Scales of Infant Development Third Edition (BSID-III) and Kaufman Assessment Battery for Children Second Edition (KABC-II) at Month 103|Change From Baseline in Vineland Adaptive Behavioral Scales Second Edition (VABS-II) at Month 103|Change From Baseline in Cerebrospinal Fluid (CSF) Total Heparan Sulfate Levels at Month 103|Change From Baseline in Urine Glycosaminoglycan (GAG) Levels at Month 103|Change From Baseline in Brain Magnetic Resonance Imaging (MRI) at Month 103 | Shire|Takeda | Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands|St. Mary's Hospital, Manchester, United Kingdom |
| Study of TCP-ATRA for Adult Patients With AML and MDS | Acute Myelogenous Leukemia|Myelodysplastic Syndromes|Leukemia | Drug: Tranylcypromine|Drug: Tretinoin | Rate of Toxicity in Study Participants Receiving TCP/ATRA Combination Therapy|Rate of Preliminary Efficacy of TCP/ATRA Combination Therapy|Pharmacokinetics (PK) effects of TCP in plasma when combined with ATRA|Pharmacodynamic (PD) effects of TCP in peripheral blood and bone marrow when combined with ATRA. | University of Miami|Women's Cancer Association|Gabrielle's Angel Foundation | University of Miami, Miami, Florida, United States |
| Screening of Lysosomal Storage Disorders Diseases in Minority Groups | Lysosomal Storage Diseases | Diagnostic Test: Enzyme assay and molecular sequencing | Enzyme activity analysis to identify subjects with Lysosomal storage disorders|Genotypic analysis of subjects with abnormal enzyme activity | Lysosomal and Rare Disorders Research and Treatment Center, Inc. | LDRTC, Fairfax, Virginia, United States |
| Investigation of GSK2879552 in Subjects With Relapsed/Refractory Small Cell Lung Carcinoma | Carcinoma, Small Cell | Drug: GSK2879552 | Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs|Part 1: Number of Participants With Dose Limiting Toxicities (DLT)|Part 1: Number of Participants With Dose Reduction or Delays|Part 1: Number of Participants Withdrawn Due to Toxicities|Part 1: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline|Part 1: Number of Participants With Change in Hematology Toxicity Grade From Baseline|Part 1:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug|Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters|Part 1: Number of Participants With Abnormal Findings Undergoing Physical Examinations|Part 2: Number of Participants Achieving Disease Control Rate at Week 16|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2879552|Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK2879552|Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2879552|Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2879552|Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2879552|Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2879552|Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2879552|Part 1: Accumulation Ratio Following Administration of GSK2879552|Part 1: Time Invariance Ratio Following Administration of GSK2879552|Part 1: Number of Participants Achieving Disease Control Rate at Week 16|Part 1 :Median Effective Dose (ED50) of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose|Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax|Part 1: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)|Part 2: Number of Participants With SAEs and Non-SAEs|Part 2: Number of Participants With DLTs|Part 2: Number of Participants With Dose Reduction or Delays|Part 2: Number of Participants Withdrawn Due to Toxicities|Part 2: Number of Participants With Change in Clinical Chemistry Toxicity Grade From Baseline|Part 2: Number of Participants With Change in Hematology Toxicity Grade From Baseline|Part 2:Number of Participants With Critical Changes in Values of Vital Signs in Response to Drug|Part 2: Number of Participants With Abnormal Findings for ECG Parameters|Part 2: Number of Participants With Abnormal Findings Undergoing Physical Examinations|Part 2: Clearance Following Administration of GSK2879552|Part 2: Volume of Distribution Following Administration of GSK2879552|Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Dose|Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and Cmax|Part 2: ED50 of GSK2879552 With Respect to Platelet Nadir as Percent Change From Baseline and AUC (0 to Infinity)|Part 2: Duration of Response|Part 2: Progression Free Survival (PFS)|Part 2: Percentage of Participants Achieving CR and PR | GlaxoSmithKline | GSK Investigational Site, Saint Louis, Missouri, United States|GSK Investigational Site, Columbus, Ohio, United States|GSK Investigational Site, Nashville, Tennessee, United States|GSK Investigational Site, Villejuif cedex, France|GSK Investigational Site, Barcelona, Spain|GSK Investigational Site, Madrid, Spain|GSK Investigational Site, Madrid, Spain|GSK Investigational Site, Málaga, Spain |
| Extension Study of Bomedemstat (IMG-7289) in Patients With Myeloproliferative Neoplasms | Thrombocythemia, Essential|Primary Myelofibrosis | Drug: Bomedemstat | Number of Patients with Treatment-Emergent Adverse Events and Serious Adverse Events|Number of Patients with Clinically Significant Change from Baseline in One or More Vital Signs|Number of Patients with Clinically Significant Changes from Baseline in One or More Laboratory Parameters|Myelofibrosis (MF) Patients Only: Change from Baseline in Spleen Volume|Essential Thrombocythemia (ET) Patients Only: Change from Baseline in Platelet Counts Compared to Baseline | Imago BioSciences,Inc. | University of Miami Leonard M. Miller, Miami, Florida, United States|University of Michigan, Ann Arbor, Michigan, United States|UMPC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States|Universittsklinikum Essen, Essen, Germany|Queen Mary Hospital, Hong Kong, Hong Kong|Ospedale di Circolo-a Fondazione Macchi, Varese, VA, Italy|Azienda Ospedaliera SS. Antonio, Alessandria, Italy|Azienda Ospedaliero Universitaria di Bologna, Pavia, Italy|Guy's and Saint Thomas' NHS Foundation Trus, London, United Kingdom |
| Safety, Tolerability, Ascending Dose and Dose Frequency Study of rhHNS Via an IDDD in MPS IIIA Patients | Mucopolysaccharidosis (MPS) | Biological: Recombinant human heparan N-sulfatase (rhHNS) | Number of Treatment Emergent Serious Adverse Events (SAE)|Number of Treatment Emergent Adverse Events (TEAE)|Summary of Anti-rhHNS Antibody Status in Cerebrospinal Fluid (CSF) by Recombinant Human Heparan N-Sulfatase (rhHNS) Dose Group|Summary of Anti-rhHNS Antibody Status in Serum by Recombinant Human Heparan N-Sulfatase (rhHNS) Dose Group|Number of Participants With Intrathecal Drug Device (IDDD) Failures at Week 26|Change From Baseline in Developmental Quotient (DQ) Using Bayley Scales of Infant Development Third Edition (BSID III) and Kaufman Assessment Battery for Children Second Edition (KABC II) at Week 22|Change From Baseline in Four Point Scoring System/Total Disability Score (FPSS/TDS) at Week 22 and Week 26 (EOS)|Change From Baseline in Sanfilippo Behavioral Rating Scale (SBRS) at Week 22 and Week 26 (EOS)|Change From Baseline in Developmental Quotient (DQ) Using Vineland Adaptive Behavioral Scales Second Edition (VABS-II) at Week 22|Change From Baseline in Movement Assessment Battery for Children Second Edition (MABC-2) at Week 26 (EOS)|Change From Baseline in Quality of Life (QoL) Using Child Health Questionnaire™ Parent Form 50 (CHQ-PF50) Questions at Week 22 and Week 26 (EOS)|Change From Baseline in Quality of Life (QoL) Using Infant Toddler Quality of Life Questionnaire™ (ITQOL) at Week 22 and Week 26 (EOS)|Change From Baseline in Quality of Life (QoL) Using Child Health Questionnaire™ Child Form 87 (CHQ-CF87) at Week 26 (EOS)|Change From Baseline in Quality of Life (QoL) Using Children's Sleep Habits Rating Scale at Week 22 and Week 26 (EOS)|Number of Participants With Accumulation of Recombinant Human Heparan N-Sulfatase (rhHNS) in Cerebrospinal Fluid (CSF) at Week 22|Change From Baseline in Concentration of Heparan Sulfate and Heparan Sulfate Derivatives in Cerebrospinal Fluid (CSF) at Week 6, 10, 14, 18, 22 and 26(EOS)|Change From Baseline in Brain Magnetic Resonance Imaging (MRI) at Week 22|Change From Baseline in Mean Auditory Brainstem Response (ABR) at Week 22|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Latencies|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Amplitudes|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Amplitude Ratio|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Log Transformed Latencies|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Log Transformed Amplitude|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Square-root Transformed Latencies|Change From Baseline in Auditory Brainstem Response (ABR) at Week 22: Square-root Transformed Amplitude | Shire|Takeda | Emma Children's Hospital, Academic Medical Center, Amsterdam, Netherlands|St. Mary's Hospital, Manchester, United Kingdom |
| Daily Living Activities and Exercise Capacity in Lipid Storage Diseases | Lipid Storage Disease | 6 minutes walking test|Activity limitation (ACTIVLIM) questionnaire|Rivermead mobility index|Hand held dinamometer | Istanbul University|Biruni University | Istanbul University, Istanbul, Turkey | |
| Molecular and Cellular Mechanisms of Lysosomal Storage Diseases | Lysosomal Storage Disorders | Correlating genetic mutations with clinical signs and symptoms|Associated Immune Pathophysiology | O & O Alpan LLC | Lysosomal and Rare Disorders Research and Treatment Center, Inc (LDRTC), Fairfax, Virginia, United States | |
| Role of the Serotonin 5-HT2A Receptor in Mescaline-induced Altered States of Consciousness | Healthy | Drug: Placebo|Drug: Mescaline 100mg|Drug: Mescaline 200mg|Drug: Mescaline 400mg|Drug: Mescaline 800mg|Drug: Mescaline 800mg + Ketanserin 40mg | Altered States of Consciousness|Extent of subjective response over time|Subjective mood ratings|Subjective experiences of spiritual phenomenons|States of Consciousness|Mystical-type experiences|Blood pressure|Heart rate|Body temperature|Pupil size|Mescaline concentrations in the blood|Mescaline concentrations in the urine|Effects on brain-derived neurotrophic factor (BDNF)|Effects on inflammatory cytokines|Effects on oxytocin|Emotional effects|Effect moderation through personality traits I|Effect moderation through personality traits II|Effect moderation through personality traits III|Effect moderation through personality traits IV|Effect moderation through personality traits V|Psychological insight|Effects on life satisfaction, well-being and appreciation I|Effects on life satisfaction, well-being and appreciation II|Effects on life satisfaction, well-being and appreciation III|Effects on life satisfaction, well-being and appreciation IV|Incidence of Adverse Events before and during each study session|Incidence of Adverse Events during each study session|Electrical activity of the heart | University Hospital, Basel, Switzerland | University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland |
| Gene Therapy for Metachromatic Leukodystrophy (MLD) | Lysosomal Storage Disease|Metachromatic Leukodystrophy | Genetic: OTL-200 Gene Therapy | Improvement of GMFM score|Increase of residual ARSA activity|Conditioning regimen-related safety|Conditioning regimen-related toxicity|The short-term safety and tolerability of lentiviral-transduced cell infusion|The long-term safety of lentiviral-transduced cell infusion|The absence of immune responses against the transgene (immunoblot analyses).|Improvement in the NCV Index for ENG and in the total score for MR|Transduced cell engraftment|IQ measurement above 55 | Orchard Therapeutics|Ospedale San Raffaele | Ospedale San Raffaele - Telethon Institute for Gene Therapy (OSR-TIGET), Milan, Italy |
| Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study | Healthy | Drug: N,N-Dimethyltryptamine (54 mg)|Drug: N,N-Dimethyltryptamine (108 mg)|Drug: N,N-Dimethyltryptamine (162 mg)|Drug: N,N-Dimethyltryptamine (216 mg)|Drug: Placebo|Drug: N,N-Dimethyltryptamine (108 mg) + dose titration | Altered states of consciousness profile (5D-ASC)|Subjective effect ratings over time|AMRS|MEQ43|Spiritual Realms Questionnaire|Blood pressure|heart rate|body temperature|Plasma level DMT|Plasma level of oxytocin|Plasma level of cortisol|Plasma level of BDNF|Plasma level of Prolactin|Urine recovery of DMT|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Personality Inventory (FPI-R)|Saarbrücker Personality Questionnaire (SPF)|Elliot Humility Scale (EHS)|Defense Style Questionnaire (DSQ-40)|Jankowski Humility Scale (JHS)|Psychological insight (PIQ) | University Hospital, Basel, Switzerland | |
| Phase I/II Trial of ATRA and TCP in Patients With Relapsed or Refractory AML and no Intensive Treatment is Possible | AML | Drug: Tranylcypromine|Drug: Tretinoin | Analysis of the cumulative response rate (CR,CRp, CRi, PR)|number of participants with adverse events as a measure of safety and tolerability|overall survival|treatment effects of promotor genes | Martin-Luther-Universität Halle-Wittenberg | Universitaetsklinikum Halle, Halle, Germany |
| A Natural History Study of Aspartylglucosaminuria | Aspartylglucosaminuria|Aspartylglucosamidase (AGA) Deficiency|Lysosomal Storage Diseases | Neuropsychological Testing|Ophthalmological Evaluation|Visual Evoked Potential (VEP)|Brainstem Auditory Evoked Response (BAER)|Magnetic Resonance Imaging (MRI)/Magnetic Resonance Spectroscopy (MRS)|Adaptive functioning: Vineland Adaptive Behavior Scales, 3rd Ed|Language: Expressive One-Word Picture Vocabulary Test, 4th Ed, Receptive One-Word Picture Vocabulary Test, 4th Ed, NEPSY, 2nd Ed|Motor: NIH Toolbox Early Childhood Motor Battery or NIH Toolbox Motor Battery, 6 Minute Walk Test, Beery-Buktenica Development | Neurogene Inc. | University of Texas Southwestern, Dallas, Texas, United States | |
| Safety and Effect of Oral RVX000222 in Subjects With Fabry Disease | Fabry Disease | Drug: RVX000222 | Adverse events|Changes in clinical laboratory parameters|Change in Alkaline Phosphatase|Changes in key markers of Chronic Kidney Disease-Bone Mineral Disease (CKD-BMD)|Changes in key markers of inflammation|Changes in markers of alpha-galactosidase (a-GAL A) deficiency|Initial uptake and steady-state level of RVX000222 | Resverlogix Corp | Queen Elizabeth II Health Sciences Centre, Victoria General Site, Halifax, Nova Scotia, Canada |
| Software Application for Low-Sodium Diet Trial (SALT) | Kidney Stone|Hypernatriuria | Behavioral: Standard dietary counseling|Behavioral: Mobile app | Mean change in score of Knowledge of Low Sodium Diet Questionnaire|Mean change in twenty four hour urinary sodium levels|Exploratory within-group assessment of application usage in the intervention group | University of Rochester | University of Rochester, Rochester, New York, United States |
| OTL-200 in Patients With Late Juvenile Metachromatic Leukodystrophy (MLD) | Lysosomal Storage Diseases|Metachromatic Leukodystrophy | Genetic: OTL-200 | Change from baseline in ARSA activity levels in Cerebrospinal Fluid (CSF)|Change from baseline in neuronal metabolite ratio of N-acetyl-aspartate (NAA) to creatine (Cr) in white matter regions of the brain | Orchard Therapeutics|Ospedale San Raffaele | Ospedale San Raffaele - Telethon Institute for Gene Therapy (OSR-TIGET), Milan, Italy |
| A Study to Assess the Safety, Tolerability, and Efficacy of Long-term SOBI003 Treatment in Pediatric MPS IIIA Patients | Sanfilippo Syndrome Type A (MPS IIIA) | Drug: SOBI003 | Safety as Measured by Adverse Events Frequencies (by Type and Severity)|The Observed SOBI003 Serum Concentration Immediately Before the Start of Infusion of SOBI003|The Observed SOBI003 Serum Concentration at the End of Infusion of SOBI003|The Time of the End of the Infusion of SOBI003|The Maximum Observed Serum Concentration of SOBI003|The Time at Which the Maximum Serum Concentration of SOBI003 is Observed|The Minimum Observed Serum Concentration of SOBI003|Clearance|Area Under the SOBI003 Serum Concentration-time Curve From Time 0 to168 Hours|The Half-life|SOBI003 Concentration in Cerebrospinal Fluid|Number of Patients Having Anti-drug Antibodies in Serum|Number of Patients Having Anti-drug Antibodies in Cerebrospinal Fluid|Change From Baseline in Heparan Sulfate Concentration in Cerebrospinal Fluid|Change From Baseline in Heparan Sulfate Levels in Serum|Change From Baseline in Heparan Sulfate Levels in Urine|Change From Baseline in Neurocognitive Development Quotient|Change From Baseline in Age-equivalence Score|Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.|Change From Baseline in Age-equivalence Score as Assessed Either by the BSID-III, Cognitive Subtest, or the KABC-II.|Age-equivalence Score as Assessed by VABS-II|Change From Baseline in Age-equivalence Score as Assessed by VABS-II|Change From Baseline in Gray Matter Volume|Pediatric Quality of Life Inventory (PedsQL™) Total Score|Change From Baseline in Pediatric Quality of Life Inventory (PedsQL™) Total Score|PedsQL™ Family Impact Module Total Score|Change From Baseline in PedsQL™ Family Impact Module Total Score | Swedish Orphan Biovitrum | Children´s Hospital and research center, Oakland, California, United States|University of North Carolina hospitals, Chapel Hill, North Carolina, United States|Gazi University Hospital, Ankara, Turkey |
| A Study to Assess the Safety and Tolerability of SOBI003 in Pediatric MPS IIIA Patients | Sanfilippo Syndrome Type A (MPS IIIA) | Drug: SOBI003 | Safety as Measured by Adverse Events Frequencies (by Type and Severity)|The Observed Serum Concentration Immediately Before the Start of Infusion of SOBI003|The Observed Serum Concentration at the End of Infusion of SOBI003|The Time of the End of the Infusion of SOBI003|The Maximum Observed Serum Concentration of SOBI003|The Time at Which the Maximum Serum Concentration of SOBI003 is Observed|The Minimum Observed Serum Concentration of SOBI003|Clearance|Area Under the Serum Concentration-time Curve From Time 0 to 168 Hours|The Half-life|SOBI003 Concentration in Cerebrospinal Fluid|Number of Patients Having Anti-drug Antibodies in Serum|Patients Having Anti-drug Antibodies in Cerebrospinal Fluid|Change From Baseline in Heparan Sulfate Levels in Cerebrospinal Fluid|Change From Baseline in Heparan Sulfate Levels in Serum|Change From Baseline in Heparan Sulfate Levels in Urine|Change From Baseline in Neurocognitive Development Quotient|Change From Baseline in Age-equivalence Score|Change From Baseline in Age-equivalence Score as Assessed by VABS-II|Change From Baseline in Gray Matter Volume|Change From Baseline in Pediatric Quality of Life Inventory (PedsQL™) Total Score|Change From Baseline in PedsQL™ Family Impact Module Total Score | Swedish Orphan Biovitrum | Childrens's Hospital and Research Center, Oakland, California, United States|University of North Carolina Hospitals, Chapel Hill, North Carolina, United States|University Medical Center Hamburg-Eppendorf, Hamburg, Germany|Gazi University Hospital, Ankara, Turkey |
| A Safety and Efficacy Study of Cryopreserved OTL-200 for Treatment of Metachromatic Leukodystrophy (MLD) | Lysosomal Storage Disease|Metachromatic Leukodystrophy | Genetic: OTL-200 | Change in Gross Motor Function Measure (GMFM) score|Change in Gross Motor Function Classification (GMFC)-MLD score|Change in neurological examinations|Change in Nerve Conduction Velocity (NCV)|Change in total score for brain magnetic resonance (MR) imaging|Change in neurocognitive function (Intelligence Quotient [IQ])|Engraftment measured by percent Lentiviral (LV) positive clonogenic progenitors in bone marrow|Vector copy number (VCN) level in bone marrow mononuclear cells|VCN level in peripheral blood mononuclear cell (PBMCs)|Change in ARSA activity in total PBMCs|Change in ARSA activity in PB CD15+ cells|Change in ARSA activity in PB CD14+ cells|Change in ARSA activity in cerebrospinal fluid (CSF)|Safety and tolerability as measured by recording of adverse events (AEs)|Safety and tolerability as measured by number of subjects not achieving hematological recovery by Day 60 (i.e., engraftment failure)|Safety and tolerability as measured by number of subjects with incidences and titers of antibodies against ARSA|Safety and tolerability as measured by number of subjects with abnormal clonal proliferation (ACP)|Safety and tolerability as measured by number of subjects with replication competent lentivirus (RCL) | Orchard Therapeutics|Ospedale San Raffaele | Ospedale San Raffaele - Telethon Institute for Gene Therapy (OSR-TIGET), Milan, Italy |
| Cellular Pharmacodynamics of Small Molecules in Lysosomal Storage Disorders | Lysosomal Storage Diseases | Effect on enzyme activity|Effect on substrate accumulation|Effect on autophagy-lysosomal pathway|Effect on mitochondrial functions|Effect on immune and inflammatory response | Lysosomal and Rare Disorders Research and Treatment Center, Inc. | LDRTC, Fairfax, Virginia, United States | |
| Observational Study to Evaluate Neurodevelopmental Status in Pediatric Patients With Hunter Syndrome (MPS II) | Mucopolysaccharidosis (MPS)|Hunter Syndrome | Neurodevelopmental parameters of cognitive function over time in pediatric patients with MPS II|Neurodevelopmental parameters of adaptive function over time in pediatric patients with MPS II|Reported adverse events|Medication usage|Quality of life | Shire|Takeda | Childrens Hospital & Research Center Oakland, Oakland, California, United States|Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States|University of North Carolina Division of Genetics and Metabolism, Chapel Hill, North Carolina, United States|Hospital Universitario Austral, Pilar, Buenos Aires, Argentina|Instituto Nacional De Pediatria, Mexico City, Mexico|Hospital Infantil Universitario, Madrid, Spain|Central Manchester University Hospitals NHS Foundation Trust Willink Biochemical Genetics Unit, St. Mary's Hospital, Manchester, M13 9wl, United Kingdom | |
| National Lysosomal Acid Lipase Deficiency Study | Cholesteryl Ester Storage Disease | Frequency of Cholesteryl Ester Storage Disease in children who have unexplained transaminase elevation for more than 3 months and/or organomegaly and/or hepatosteatosis unrelated to obesity and/or cryptogenic fibrosis and cirrhosis|Identify demographic and clinical features of Cholesteryl Ester Storage Disease | Ankara University|Alexion Pharmaceuticals | Ankara University School of Medicine, Ankara, Turkey | |
| EARLY MOBILIZATION OF INTUBETED PATIENTS IN THE INTENSİVE CARE UNİT AND THE EFFECTS OF EARLY MOBILIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS | Intensive Care Unit Acquired Weakness|Intensive Care, Intubated Patient, Early Mobilization, Mobilization, Respiratory Pattern | Other: MOBILIZATION | EARLY MOBILIZATION OF INTUBE PATIENTS AND THE EFFECTS OF EARLY MOBLIZATION ON RESPIRATORY PATTERN AND PATIENT HEMODYNAMICS | Okan University | Gürkan ÇAMOK, Istanbul, İ̇stanbul, Turkey |
| Azacitidine Combined With Pembrolizumab and Epacadostat in Subjects With Advanced Solid Tumors (ECHO-206) | Solid Tumors|Advanced Malignancies|Metastatic Cancer | Drug: Azacitidine|Drug: Pembrolizumab|Drug: Epacadostat|Drug: INCB057643|Drug: INCB059872 | Part 1 and 2 : Number of Participants With Treatment Emergent Adverse Events|Part 1 and 2: Objective Response Rate Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)|Parts 1 and 2: Percentage of Responders Determined by Immunohistochemistry|Parts 1 and 2: Progression-free Survival Based on RECIST v1.1.|Parts 1 and 2: Duration of Response Based on RECIST v1.1 | Incyte Corporation | City of Hope National Medical Center, Duarte, California, United States|University of California San Diego, La Jolla, California, United States|The University of Chicago, Chicago, Illinois, United States|University of Pennsylvania Health System, Philadelphia, Pennsylvania, United States|Sarah Cannon, Nashville, Tennessee, United States|Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States|MD Anderson Cancer Center, Houston, Texas, United States|University of Washington, Seattle, Washington, United States|Vall D Hebron Univ, Barcelona, Spain|Univ De Navarra, Pamplona, Spain|University College London Hospitals (Uclh), London, United Kingdom|Churchill Hospital, Oxford, United Kingdom |
| Establishment of Biomarkers for Fabry Disease | Fabry Disease | Other: Fluorescein angiography | Presence of specific findings commonly associated with Fabry's disease using neuroretinal examination|Capillary perfusion abnormalities in optic nerve and retina | Ohio State University|Genzyme, a Sanofi Company | Eye and Ear Institute, Columbus, Ohio, United States |
| Prevalence of New Psychoactive Substances Use | Addiction | the prevalence of new psychoactive substance abuse among outpatient of addiction management clinic and patients admitted to addiction management unit of neurology and psychiatry department at Assiut university hospital. | Assiut University | ||
| Complement Activation in the Lysosomal Storage Disorders | Fabry Disease|Gaucher Disease|Niemann-Pick Disease, Type C|Lysosomal Storage Diseases | Diagnostic Test: Complement measurements | Change in soluble C5b-9|Other complement biomarkers | Melbourne Health|Sanofi | The Royal Melbourne Hospital, Melbourne, Victoria, Australia |
| Acute Effect of Mirror Therapy on Rehabilitation of Paretic Upper Extremity After Chronic Stroke | Stroke | Other: Mirror Therapy|Other: Control Intervention | Change Movement Cycle Time (MCT)|Change Index of Curvature (IC)|Change Average Jerk (AJ)|Change Mean Movement Velocity (MMV)|Change Adjusting Sway (AS)|Change Range of motion|Change Manual dexterity|Change Spasticity of paretic upper extremity | Federal University of Health Science of Porto Alegre | Federal University of Health Sciences of Porto Alegre, Porto Alegre, RS, Brazil |
| GENetic & Immunologic Abnomalies in Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Genetic: Blood sampling | New genes identification|Immunological genotype and clinical abnormalities correlation | Hospices Civils de Lyon | Service d'hématologie / oncologie pédiatrique - CHU, Angers, France|Néphrologie Pédiatrique - CHU Besançon, Besançon, France|Hôpital Femme Mère Enfant, Bron, France|Service de Néphrologie Pédiatrique, Clermont Ferrand, France|Service de pédiatrie - CHU Fort de France, Fort De France, France|Service de Néphrologie et Rhumatologie Pédiatrique, Grenoble, France|Service de Rhumatologie Pédiatrique - Hôpital de Bicêtre, Le Kremlin Bicêtre, France|Service de médecine interne - Centre de référence des maladies rares, Lille, France|Service de néphrologie, endocrinologie, maladie métabolique et hématologie bénigne pédiatriques - Hôpital Jeanne de Flandre, Lille, France|édiatrie générale, urgences et maladies infectieuses, Hôpital Salengro, Lille, France|Service de Néphrologie - Hôpital Edouard Herriot, Lyon, France|Centre de néphrologie et de transplantation rénale - Hôpital de la conception, Marseille, France|Service de médecine infantile- Hôpital Nord, Marseille, France|Service de médecine interne - Hôpitaux privés de Metz, Metz, France|ervice d'urgence et post-urgences pédiatriques - CHU Arnaud de Villeneuve, Montpellier, France|Service médecine infantile 2, Nancy, France|Service de néphrologie pédiatrique - CHU de Nantes, Nantes, France|Service d'immunologie et rhumatologie pédiatrique - Centre de référence de maladies rhumatologiques et inflammatoires rares en pédiatrie-Hôpital Necker-Enfants malades, Paris, France|Service de médecine interne - Hôpital Saint Antoine, Paris, France|Service de pédiatrie générale - Hôpital Robert-Debré, Paris, France|Médecine Interne Adulte - Centre Hospitalier Lyon Sud, Pierre-Bénite, France|Service de Rhumatologie - Centre Hospitalier Lyon Sud, Pierre-Bénite, France|Service pédiatrie grands enfants-adolescents - CHU Hôpital Sud, Rennes, France|Hôpital Nord, Saint Etienne, France|Service de Pédiatrie Générale - CHU Réunion, Saint Pierre, France|Service de néphrologie - médecine interne - Hypertension pédiatrique - Hôpital des enfants, Toulouse, France |
| Mirror Therapy in Sensorimotor Recovery of Paretic Upper Extremity After Chronic Stroke | Stroke | Other: Mirror therapy intervention and control intervention | Motor function of the paretic upper extremity|Sensory function of the paretic upper extremity|Manual dexterity|Palmar grip strength|Spasticity of paretic upper extremity|Pain of paretic upper extremity|Level of functional disability|Quality of life after stroke: The Stroke Impact Scale 3.0 | Federal University of Health Science of Porto Alegre | Caren Luciane Bernardi, Porto Alegre, RS, Brazil |
| The Selection of Pregnancy for Patients After Tubal Ectopic Pregnancy Treatment | Tubal-preserving Treatment of Tubal Ectopic Pregnancy|Tubal Pregnancy|Pregnancy Preparation | Other: No intervention. | Rate of tubal pregnancy within12 months in both groups of patients.|Rates of pregnancy and miscarriage within 12 months in both groups of patients. | Shanghai First Maternity and Infant Hospital|Shanghai Seventh People's Hospital|Shanghai Zhoupu Hospital|Shanghai Pudong Hospital | Shanghai First Maternity and Infant Hospital, Shanghai, Shanghai, China |
| The "Motoric Cognitive Risk" Syndrome in the Quebec Population | Cognition Disorders in Old Age|Dementia | Other: Summarize of participants' characteristics using means and standard deviations or frequencies and percentages | MCR syndrome criteria|Cognitive decline and impairment|Covariates | Jewish General Hospital | Jewish General Hospital, Montréal, Quebec, Canada |
| Psychological Concomitants of Morquio Syndrome (The MAP Study) | Morquio Disease|Mucopolysaccharidosis IV | ASEBA Self-Report|Brief Pain Inventory|SF-36 | Nadia Ali, PhD|BioMarin Pharmaceutical|Emory University | Emory University, Decatur, Georgia, United States | |
| A Study of INCB059872 in Relapsed or Refractory Ewing Sarcoma | Relapsed Ewing Sarcoma | Drug: INCB059872 | Number of adverse events|Objective response rate|Cmax of INCB059872|tmax of INCB059872|t½ of INCB059872|Cl/F of INCB059872 | Incyte Corporation | UCLA Jonsson Comprehensive Cancer, Los Angeles, California, United States|Mayo Clinic Jacksonville - PPDS, Jacksonville, Florida, United States|Columbia University Medical Center, New York, New York, United States|St. Jude Children's Research Hospital, Memphis, Tennessee, United States|MD Anderson Cancer Center, Houston, Texas, United States|Istituto Ortopedico Rizzoli, Bologna, Italy|Policlinico Sant'orsola-Malpighi, Bologna, Italy|Ospedale Pediatrico Bambino Gesu IRCCS, Rome, Italy|Hospital Universitario Vall d'Hebron, Barcelona, Spain|Hospital Clínico San Carlos, Madrid, Spain|The Christie NHS Foundation Trust, Manchester, United Kingdom |
| Fetal Umbilical Cord Blood (UCB) Transplant for Lysosomal Storage Diseases | Lysosomal Storage Diseases|Inborn Errors of Metabolism | Biological: ALD-601 | To determine whether immune tolerance and donor cell engraftment can be achieved through first trimester injection of donor cells to fetus's diagnosed with lethal LSDs.|Safety and feasibility of fetal intrap.|Donor chimerism for neonate at birth and 7 days post delivery.|Establishment of threshold enzyme levels in neonate at birth and 7 days post delivery.|Donor chimerism for mother post delivery and 1 year post date of birth. | Joanne Kurtzberg, MD|Aldagen|Duke University | Duke University Medical Center Pediatric Blood and Marrow Transplant, Durham, North Carolina, United States|Duke University Medical Center, Durham, North Carolina, United States |
| A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease | Sickle Cell Disease | Drug: INCB059872 | Safety and tolerability of INCB059872 assessed by monitoring frequency, duration, and severity of adverse events|Change in fetal hemoglobin (HbF) from baseline|Cmax of INCB059872|AUC0-t of INCB059872 | Incyte Corporation | Acevedo Clinical Research Associates, Miami, Florida, United States|Advanced Pharma, Miami, Florida, United States|Vita Health and Medical Center, Tamarac, Florida, United States|University of Illinois at Chicago, Chicago, Illinois, United States|Boston University, Boston, Massachusetts, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Blood Centers of Wisconsin, Milwaukee, Wisconsin, United States |
| Effects of Hallucinogens and Other Drugs on Mood and Performance | Healthy | Drug: Hallucinogens and psychoactive substances | Rating of "Drug Liking" on the End of Day Questionnaire|Hallucinogen Rating Scale | Johns Hopkins University | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| MCR Syndrome in Quebec : Results From NuAge Study | Motoric Cognitive Risk Syndrome|Aging Disorder | Other: Data analysis | prevalence of MCR syndrome|Cognitive decline and impairment|Covariates|Biological characteristics|Genetic approach | Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal | CRIUGM, Montréal, Quebec, Canada |
| Predictive Value of Intraoperative Indocyanine Green Clearance Test After Partially Blood Flow Blocking in Postoperative Liver Reserve | Predictive Value of ICG Clearance Measurement During Selective Hepatic Vascular Trial Clamping on Remnant Liver Function After Anatomic Liver Resection | Diagnostic Test: Indocynine green clearance test | PHLF|MELD score|Clavien-Dindo grade | Fudan University | Fudan University Shanghai Cancer Center, Shanghai, China |
| SNPs in the DNase 1 Gene Impair Its Activity and Are Increased in a STE-ACS Patient Cohort Compared to Healthy Controls | ST Elevation Myocardial Infarction | Other: Blood draw | Frequency of SNPs of the DNase 1 and DNase gamma genes in the STE-ACS patient population compared to healthy controls|Correlation of SNPs of the DNase 1 and gamma gene with DNase activity|Correlation of SNPs with major adverse cardiac events|Correlation of DNAse activity with major adverse cardiac events|Correlation of SNPs with DNA-Histone complex levels|Correlation of SNPs with MPO-DNA complex levels|Correlation of SNPs with dsDNA levels|Netosis quantification in STE-ACS patients and healthy controls | Medical University of Vienna | |
| The Effects of Dry Needling on Patients With Knee Pain | Patellofemoral Pain Syndrome|Anterior Knee Pain Syndrome | Procedure: Dry Needling|Procedure: Sham Dry Needling|Other: Physical Therapy | Change from Baseline Anterior Knee Pain Scale (AKPS) score to 3 weeks|Change from Baseline Numeric Pain Rating Scale (NPRS) score to 3 weeks|Change from Baseline Lateral step-down (LSD) test score to 3 weeks|Change from Baseline Isometric knee and hip peak torque values to 3 weeks|Change from Baseline Lower Extremity Functional Scale (LEFS) score to 3 weeks|Change from Baseline Pressure Pain Threshold to 3 weeks | Ohio State University | The Ohio State University Wexner Medical Center, Columbus, Ohio, United States |
| Bronchi Dilation in Polynesian Patients: Monocentric Retrospective Study | Polynesian Bronchiectasis | Describe the detailed phenotype of bronchi dilation in the Polynesian population|Highlighting indirect arguments for a genetic cause | Centre Hospitalier Intercommunal Creteil | ||
| Comparing the Digestion of Milk With Different Beta-casein Protein Content by Dairy Intolerant Persons | Dairy Intolerance | Other: Lactose free milk|Other: Jersey milk|Other: High A1 β-casein milk|Other: High A2 β-casein milk | Differences in AUC ΔH2 concentrations|Differences within each of the symptom categories | Purdue University | Purdue University, West Lafayette, Indiana, United States |
| Pro-inflammatory Role of Blood Platelets in Critically Ill Patients With Septic Shock. | Septic Shock | Other: Septic shock|Other: Systemic Inflammatory Response Syndrome | Plasma concentration|Neutrophil Extracellular Traps formation|Markers of platelet activation and severity of organ failure|Markers of platelet activation and inflammatory markers|Markers of platelet activation and ISTH score|Markers of platelet activation and platelet count|Markers of platelet activation on ICU mortality|Levels of platelet activation markers | University Hospital, Bordeaux|MSD France | Hôpital Saint Louis, Paris, France|Hôpital Haut Lévêque, Pessac, France |
| Seclidemstat and Azacitidine for the Treatment of Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia-0|Chronic Myelomonocytic Leukemia-1|Chronic Myelomonocytic Leukemia-2|Myelodysplastic Syndrome|Recurrent Chronic Myelomonocytic Leukemia|Recurrent Myelodysplastic Syndrome | Drug: Azacitidine|Drug: Seclidemstat | Overall response rate|Incidence of adverse events|Overall survival|Duration of response|Leukemia free survival|Relapse-free survival | M.D. Anderson Cancer Center | M D Anderson Cancer Center, Houston, Texas, United States |
| Lysine-specific Demethylase 1 and Salt-sensitivity in Humans | Healthy Subjects | Other: Aldosterone response to AngII LS|Other: Renal blood flow response to salt|Other: Vascular Stiffness | Aldosterone response to angiotensin II|Renal blood flow response to dietary salt|Vascular stiffness response to angiotensin II | Brigham and Women's Hospital | Brigham and Women's Hospital, Boston, Massachusetts, United States |
| A Phase Ib Study of Stereotactic Body Radiotherapy (SBRT) Plus Sorafenib in Patients With Unresectable Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | Drug: Sorafenib|Radiation: Stereotactic radiotherapy | Number of Participants with Adverse Events as a Measure of Safety and Tolerability|Number of patients with local response|Time from the start of the treatment until the criteria for overall disease progression is met or death occurs.|Time from start of treatment until death from any cause or date of last patient contact. | Indiana University | Indiana University, Indianapolis, Indiana, United States |
| The 400m-walk-test for Stable Coronary Patients | Chronic Coronary | Other: Walk-tests | Measurement of intra-class correlation coefficient (ICC)|A variance analysis (ANOVA)|Univariate analysis | Centre Hospitalier Universitaire Dijon | CHU Dijon, Dijon, France |
| Mood Effects of Serotonin Agonists Extended | Healthy | Drug: Placebo|Drug: Serotonin agonist | Profile of Mood States | University of Chicago | Matthew Bona, Chicago, Illinois, United States |
| An Early Phase Study of Abraxane Combined With Phenelzine Sulfate in Patients With Metastatic or Advanced Breast Cancer | Metastatic Breast Cancer | Drug: Nanoparticle albumin-bound paclitaxel|Drug: Phenelzine Sulfate | Dose-Limiting Toxicity (DLT) events|Abraxane Cmax|Abraxane Tmax|Abraxane Half-life|Abraxane AUC|Nardil Cmax|Nardil Tmax|Nardil Half-life|Nardil AUC|Circulating Tumour Cell (CTC) burden|PDL1 expressing Circulating Tumour Cell (CTC) burden|HER2 expressing Circulating Tumour Cell (CTC) burden|FFPE Tumour cells burden|FFPE Stoma cells burden|FFPE Cancer Stem Cells (CSC) burden | EpiAxis Therapeutics|The Canberra Hospital|Southern Medical Day Care Centre|Liverpool Cancer Therapy Centre | Canberra Region Cancer Centre, Canberra, Australian Capital Territory, Australia|Liverpool Cancer Therapy Centre, Sydney, New South Wales, Australia|Southern Medical Day Care Centre, Wollongong, New South Wales, Australia |
| Differential Responses to Drugs and Sweet Tastes | Bipolar II Disorder | Drug: Placebo oral capsule|Drug: d-amphetamine 10 mg oral capsule|Drug: d-amphetamine 20 mg oral capsule | Addiction Research Center Inventory (ARCI-A) | University of Chicago | University of Chicago Medical Center - Human Behavioral Pharmacology Lab, Chicago, Illinois, United States|University of Chicago, Chicago, Illinois, United States |
| A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users | Alzheimer's Disease|Huntington's Disease | Drug: dimebon|Drug: placebo|Drug: alprazolam | Balance of Effects- Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|Balance of Effects- Overall Drug Liking VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|Balance of Effects- Take Drug Again VAS: Peak Effect (Maximum Effect [Emax])|Balance of Effects- Good and Bad Effects VAS: Peak Effect (Maximum Effect [Emax]) and Minimum Effect (Emin)|Balance of Effects- Subjective Drug Value (SDV): Maximum Effect (Emax)|Positive Effects- Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG): Maximum Effect (Emax)|Positive Effects- Good Drug Effects: Peak Effect (Maximum Effect [Emax])|Positive Effects- High VAS: Peak Effect (Maximum Effect [Emax])|Negative Effects- Bad Drug Effects: Peak Effect (Maximum Effect [Emax])|Negative Effects- Addiction Research Center Inventory (ARCI) Lysergic Acid Diethylamide (LSD): Maximum Effect (Emax)|Sedative Effects- Addiction Research Center Inventory (ARCI) Pentobarbital Chlorpromazine Group (PCAG): Maximum Effect (Emax)|Sedative Effects- Alertness/Drowsiness: Minimum Effect (Emin)|Other Subjective Effects- Any Drug Effects: Peak Effect (Maximum Effect [Emax])|Other Subjective Effects- Drug Similarity|Other Subjective Effects- Addiction Research Center Inventory (ARCI) Benzedrine Group (BG): Maximum Effect (Emax) and Minimum Effect (Emin) | Pfizer|Medivation, Inc. | |
| An Open-Label, Dose-Escalation/Dose-Expansion Safety Study of INCB059872 in Subjects With Advanced Malignancies | Solid Tumors and Hematologic Malignancy | Drug: INCB059872|Drug: all-trans retinoic acid (ATRA)|Drug: azacitidine|Drug: nivolumab | Safety and tolerability of INCB059872 in monotherapy and in combination with other therapies as measured by the frequency, duration, and severity of adverse events (AEs) in participants, and determine recommended dose(s) for further study|Tumor response rates in subjects with measurable disease|Maximum observed plasma concentration (Cmax) of INCB059872|Area under the single-dose plasma concentration-time curve (AUC0-t) of INCB059872 | Incyte Corporation | University of Alabama, Birmingham, Alabama, United States|Moores UCSD Cancer Center, La Jolla, California, United States|UCLA Medical Center, Los Angeles, California, United States|Northwestern University, Chicago, Illinois, United States|University of Kansas Center for Research, Inc., Kansas City, Kansas, United States|Roswell Park Cancer Institute, Buffalo, New York, United States|Columbia University, New York, New York, United States|Oregon Health Science University, Portland, Oregon, United States|University of Pennsylvania, Philadelphia, Pennsylvania, United States|Vanderbilt University, Nashville, Tennessee, United States|University of Texas MD Anderson Cancer Center, Houston, Texas, United States|Institut Jules Bordet, Brussel, Belgium|Netherland Cancer Institute, Amsterdam, Netherlands|VU Medical Center, Amsterdam, Netherlands|Erasmus MC, Rotterdam, Netherlands |
| Clinical Trial to Evaluate the Safety of PT150 (Formerly ORG34517) When it is Taken Concurrently With Alcohol | Alcohol Dependence|Alcohol Interaction | Drug: PT150|Other: Beverage | Change in Breath-alcohol levels (BALs) - Cmax|Change in Breath-alcohol levels (BALs) - Tmax|Change in Breath-alcohol levels (BALs) - AUC|Change in blood pressure|Change in Heart Rate (Pulse)|Change in ECG abnormalities|Change in Positive Affect score from the Positive and Negative Affect Schedule (PANAS)|Change in Negative Affect score from the Positive and Negative Affect Schedule (PANAS)|Change in Alcohol Urge Questionnaire (AUQ) score|Change in Biphasic Alcohol Effects Scale (BAES) Sedative effects|Change in Biphasic Alcohol Effects Scale (BAES) Stimulant effects|Change in Addiction Research Center Inventory (ARCI) score - Pentobarbital-Chlorpromazine-Alcohol Group Scale|Change in Addiction Research Center Inventory (ARCI) score - Amphetamine Scale|Change in Addiction Research Center Inventory (ARCI) score - Morphine-Benzedrine Group (MBG) Scale|Change in Addiction Research Center Inventory (ARCI) score - LSD Scale|Change in Addiction Research Center Inventory (ARCI) score - Benzedrine Group Scale|Differences in the adverse events|Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Total Recall Score|Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Delayed Recall Score|Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Percent Retained Score|Cognitive Assessment - Hopkins Verbal Learning Task-Revised (HLVT-R) Discrimination Index Score|Cognitive Assessment - Dual n-Back (DNB) auditory trial accuracy score|Cognitive Assessment - Dual n-Back (DNB) visual trial accuracy score|Cognitive Assessment - Dual n-Back (DNB) auditory reaction time|Cognitive Assessment - Dual n-Back (DNB) visual reaction time|Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of commission score|Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of ommission score|Cognitive Assessment - Continuous Performance Task-2 (CPT) errors of perseveration score|Cognitive Assessment - Continuous Performance Task-2 (CPT) reaction time|Psychomotor Assessment - One Legged Stand (OLS)|Psychomotor Assessment - Walk and Turn (WAT) | Pop Test Oncology LLC|Pharmacotherapies for Alcohol and Substance Use Disorders Alliance|Congressionally Directed Medical Research Programs|Michael E. DeBakey VA Medical Center|Baylor College of Medicine|University of California, San Diego | Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas, United States |
| Investigating Lysosomal Storage Diseases in Minority Groups | Lysosomal Storage Disorders|Gaucher Disease|Fabry Disease|Pompe Disease|Niemann-Pick Disease | Number of patients identified with lysosomal storage disorders | O & O Alpan LLC | O&O Alpan, LLC, Fairfax, Virginia, United States | |
| Bomedemstat and Maintenance Immunotherapy for Treatment of Newly Diagnosed Extensive Stage Small Cell Lung Cancer | Extensive Stage Lung Small Cell Carcinoma|Limited Stage Lung Small Cell Carcinoma | Drug: Bomedemstat|Biological: Atezolizumab | Incidence of dose limiting toxicity (DLT)|Progression free survival|Incidence of adverse events|Overall survival | University of Washington|National Cancer Institute (NCI)|Imago BioSciences,Inc. | Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States |
| A Safety and Efficacy Study of CC-90011 in Combination With Nivolumab in Subjects With Advanced Cancers | Neoplasms | Drug: CC-90011|Drug: Nivolumab | Overall response rate|Adverse Events (AEs)|Duration of response|Progression-free survival|Time to Response|Time to first subsequent therapy | Celgene | Augusta University - Georgia Cancer Center, Augusta, Georgia, United States|Investigative Clinical Research of Indiana, LLC, Indianapolis, Indiana, United States|Local Institution - 102, Indianapolis, Indiana, United States|Local Institution - 106, New York, New York, United States|Memorial Sloan-Kettering Cancer Center - David H. Koch Center for Cancer Care, New York, New York, United States|Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States|Piedmont Hematology Oncology Associates, Winston-Salem, North Carolina, United States|Gabrail Cancer Center Research, Canton, Ohio, United States|Local Institution - 105, Canton, Ohio, United States|Local Institution - 104, Cleveland, Ohio, United States|University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States|Local Institution - 109, Pittsburgh, Pennsylvania, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States|Brooke Army Medical Center Francis Street Medical Center, Fort Sam Houston, Texas, United States|Local Institution - 107, Fort Sam Houston, Texas, United States|Local Institution - 110, Houston, Texas, United States|Millennium Oncology, Houston, Texas, United States|Local Institution - 111, Fairfax, Virginia, United States|Virginia Cancer Specialists, PC, Fairfax, Virginia, United States|Hopital Louis Pradel, Lyon Cedex, France|Local Institution - 156, Lyon Cedex, France|Hospital Le Timone, Marseille Cedex 5, France|Local Institution - 153, Marseille Cedex 5, France|Hospital Pontchaillou, Rennes, France|Local Institution - 154, Rennes, France|CHU Nantes Hopital Nord Laennec, Saint-Herblain, France|Local Institution - 151, Saint-Herblain, France|Gustave Roussy, Villejuif CEDEX, France|Local Institution - 152, Villejuif CEDEX, France|Centro di Riferimento Oncologico, Aviano, Italy|Local Institution - 301, Aviano, Italy|Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.), Meldola, Italy|Local Institution - 306, Meldola, Italy|Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy|Local Institution - 303, Milan, Italy|Local Institution - 305, Roma, Italy|Policlinico Universitario Campus Biomedico Di Roma, Roma, Italy|Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy|Local Institution - 304, Verona, Italy|Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz, Poland|Local Institution - 451, Lodz, Poland|Instytut Centrum Zdrowia Matki Polki, Lodz, Poland|Local Institution - 452, Lodz, Poland|Local Institution - 454, Poznan, Poland|Med Polonia Sp. z o.o. NSZOZ, Poznan, Poland|Local Institution - 453, Warsaw, Poland|Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland|Hospital Universitari Germans Trias i Pujol Can Ruti, Badalona (Barcelona), Spain|Local Institution - 351, Badalona (Barcelona), Spain|Hospital Quiron Barcelona, Barcelona, Spain|Local Institution - 355, Barcelona, Spain|Hospital Universitari Vall d'Hebron, Barcelona, Spain|Local Institution - 356, Barcelona, Spain|Complejo Universitario La Coruna, La Coruna, Spain|Local Institution - 361, La Coruna, Spain|Insular-Maternal and Child University Hospital Complex, Las Palmas de Gran Canaria, Spain|Local Institution - 359, Las Palmas de Gran Canaria, Spain|Clinica Universidad de Navarra, Madrid, Spain|Local Institution - 358, Madrid, Spain|Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain|Local Institution - 353, Madrid, Spain|Hospital Universitario 12 de Octubre, Madrid, Spain|Local Institution - 357, Madrid, Spain|Hospital Puerta de Hierro, Majadahonda, Madrid, Spain|Local Institution - 360, Majadahonda, Madrid, Spain|Clinica Universidad de Navarra, Pamplona, Spain|Local Institution - 352, Pamplona, Spain|Hospital General de Valencia, Valencia, Spain|Local Institution - 362, Valencia, Spain|Hospital Universitari i Politecnic La Fe de Valencia, Valencia, Spain|Local Institution - 354, Valencia, Spain|Clatterbridge Centre for Oncology NHS Trust, Bebington, Wirral, United Kingdom|Local Institution - 254, London, United Kingdom|The Royal Marsden Hospital, London, United Kingdom|Local Institution - 251, Manchester, United Kingdom|The Christie NHS Foundation Trust, Manchester, United Kingdom|Local Institution - 255, Sutton-Surrey, United Kingdom|Royal Marsden Hospital, Sutton-Surrey, United Kingdom |
| Bioresorbable Polymer ORSIRO Versus Durable Polymer RESOLUTE ONYX Stents | Coronary Artery Disease|Angina Pectoris|Unstable Angina Pectoris|Acute Coronary Syndrome|Coronary Stenosis|Coronary Restenosis | Device: Orsiro|Device: Resolute Onyx | Target vessel failure (TVF)|Death at 1 and 2 year follow-up|Myocardial infarction at 1 and 2 year follow-up|Revascularization at 1 and 2 year follow-up|Stent thrombosis at 1 and 2 year follow-up|Target lesion failure (TLF) at 1 and 2 year follow-up|Major adverse cardiac events (MACE) at 1 and 2 year follow-up|Patient oriented composite endpoint (POCE) at 1 and 2 year follow-up|Major Bleeding at 1 and 2 year follow-up | Thorax Centrum Twente | CHU Charleroi, Charleroi, Belgium|Jessa Ziekenhuis, Hasselt, Belgium|Rambam, Haifa, Israel|Haga Ziekenhuis, Den Haag, Zuid Holland, Netherlands|Rijnstate Hospital, Arnhem, Netherlands|Treant Zorggroep, Emmen, Netherlands|Medisch Spectrum Twente, Enschede, Netherlands |
| A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C | Niemann-Pick Disease, Type C | NP-C clinical disease severity|Quality of life questionnaire (EQ-5D-Y)|Ultrasonographic evaluation of liver and spleen|Oxysterol|NPC clinical symptoms|NPC protein|Safety Parameters | KemPharm Denmark A/S | University Hospital Copenhagen (Rigshospitalet), Copenhagen, Denmark|CHU de Montpellier, Montpellier, France|Hôpital Trousseau, Paris, France|Villa Metabolica Mainz, Mainz, Germany|Klinikum der Universistat, Munchen, Munich, Germany|Istituto Carlo Besta (Milano), Milan, Italy|Azienda Ospedaliera San Gerardo, Monza, Italy|Università Federico II, Napoli, Italy|Ospedale Pediatrico Bambino Gesù, Rome, Italy|Azienda Ospedaliero-Universitaria "Santa Maria della Misericordia", Udine, Italy|The Children´s Memorial Istitute Warsaw, Warsaw, Poland|Hospital Vall D'Hebron, Barcelona, Spain|Hospital Quirón, Zaragoza, Spain|Inselspital, University Hospital Bern, Bern, Switzerland|Birmingham Children's Hospital, Birmingham, United Kingdom|Great Ormond Street Hospital, London, United Kingdom | |
| A Study to Assess the Abuse Potential of Hydrocodone Extended-Release Tablet in Recreational Opioid Users | Drug Abuse | Drug: 45-mg hydrocodone bitartrate extended-release tablet (crushed or intact)|Drug: Placebo | Drug Liking and Effects Questionnaire (DLEQ)|Overall drug liking visual analog scale (VAS) score|Pharmacokinetic maximum observed (Cmax) plasma concentrations|Take drug again Visual Analog Scale|Price Value Assessment Questionnaire|Addiction Research Center Inventory (ARCI): Morphine Benzedrine Group (MBG) Subscale|Addiction Research Center Inventory (ARCI): Lysergic Acid Diethylamide (LSD) Subscale|Addiction Research Center Inventory (ARCI): Pentobarbital Chlorpromazine Alcohol Group (PCAG) Subscale|Pupillometry|Time to maximum observed drug concentration (tmax)|Area under the plasma concentration by time curve (AUC) from time 0 to maximum drug concentration time - Immediate release product|Area under the plasma concentration by time curve (AUC) from time 0 to maximum drug concentration time - Extended release product intact|Area under the plasma concentration by time curve (AUC) from time 0 to maximum drug concentration time - Extended release product crushed|Area under the plasma concentration by time curve (AUC) from time 0 to last measureable drug concentration|Area under the plasma concentration by time curve (AUC) from time 0 to infinity|Apparent plasma terminal elimination rate constant and associated elimination half-life | Cephalon|Teva Branded Pharmaceutical Products R&D, Inc. | Cephalon Investigational Site 001, Salt Lake City, Utah, United States|Cephalon Investigational Site 100, Toronto, Ontario, Canada |
| A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers | Fabry Disease | Drug: IV migalastat HCl|Drug: IV placebo|Drug: oral migalastat HCl | Plasma pharmacokinetics of migalastat|Safety and tolerability of migalastat|Urinary pharmacokinetics | Amicus Therapeutics | PRA International, Groningen, Netherlands |
| The Norwegian Addiction, Pain and Trauma Study | Chronic Pain|Post-traumatic Stress Disorder|Substance Use Disorders | Chronic pain (ICD-10)|European-Addiction Severity Index (EuropASI), Section E|The Stressful Life-Events Screening Questionnaire (SLESQ)|The PTSD Checklist for DSM-5 - short version (PCL-5 short)|Pain characteristics|The Brief Pain Inventory: Pain intensity|The Brief Pain Inventory: Pain interference|Other pain related questions (selfmade)|Opioid maintenance treatment (OMT) history (selfmade)|Subjective quality of life (QOL-1)|Demographics|Nicotine use | University Hospital, Akershus|Oslo University Hospital|Norwegian Center for Violence and Traumatic Stress Studies | Akershus University Hospital, Lørenskog, Norway|Oslo University Hospital, Oslo, Norway | |
| A Study of CC-90011 and Comparators in Participants With Prostate Cancer | Prostatic Neoplasms | Drug: CC-90011|Drug: Abiraterone|Drug: Prednisone | Assessment of androgen receptor (AR) level|Safety and tolerability assessed by Adverse events (AEs)|Safety and tolerability assessed by dose-limiting toxicities (DLTs)|Assessment of anti-tumor activity | Celgene | Memorial Sloan-Kettering Cancer Center, New York, New York, United States |
| BMN 110 US Expanded Access Program | Mucopolysaccharidosis IVA|Morquio A Syndrome|MPS IVA | Drug: BMN 110 | BioMarin Pharmaceutical | Birmingham, Alabama, United States|Little Rock, Arkansas, United States|Oakland, California, United States|Orange, California, United States|Aurora, Colorado, United States|Washington, District of Columbia, United States|Hollywood, Florida, United States|Miami, Florida, United States|Atlanta, Georgia, United States|Chicago, Illinois, United States|Louisville, Kentucky, United States|New Orleans, Louisiana, United States|Minneapolis, Minnesota, United States|Paterson, New Jersey, United States|Manhasset, New York, United States|New York, New York, United States|Portland, Oregon, United States|Philadelphia, Pennsylvania, United States|Pittsburgh, Pennsylvania, United States|Nashville, Tennessee, United States|Houston, Texas, United States|Salt Lake City, Utah, United States|Seattle, Washington, United States|Tacoma, Washington, United States|Santurce, Puerto Rico | |
| Efficacy and Safety Study of BMN 110 for Morquio A Syndrome Patients Who Have Limited Ambulation | Mucopolysaccharidosis IVA|Morquio A Syndrome|MPS IVA | Drug: BMN 110 | Percent Change From Baseline in Speed as Measured in Functional Dexterity Test (FDT)|Change From Baseline in Strength as Assessed by Grip and Pinch Test (GPT)|Percent Change From Baseline in Speed as Measured in Timed 25-Foot Walk Test (25FWT)|Percent Change From Baseline in Normalized Urine Keratan Sulfate (uKS) | BioMarin Pharmaceutical | Children's Hospital & Research Center Oakland, Oakland, California, United States|Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States|Universitätsklinikum Hamburg, Hamburg, Germany|University Medical Center Mainz, Center of Pediatric and Adolescent Medicine Villa Metabolica, Mainz, Germany|NIHR/Wellcome Trust Birmingham CRF, Queen Elizabeth Hospital, Birmingham, United Kingdom|Central Manchester University Hospitals NHS Foundation Trust, Manchester, United Kingdom|Salford Royal NHS Foundation Trust, Salford, United Kingdom |
| Safety and Exercise Study of Two Doses of BMN 110 for Morquio A Syndrome | Mucopolysaccharidosis IVA|Morquio A Syndrome|MPS IVA | Drug: BMN 110 | Safety Evaluation|6-minute Walk Test (6MWT)|3-minute Stair Climb Test (3MSCT)|Respiratory Function Test (MVV and FVC)|Normalized Urine Keratan Sulfate (uKS)|Cardiopulmonary Exercise Testing (CPET) - Duration of Exercise|Cardiopulmonary Exercise Testing (CPET) - Peak Workload|Cardiopulmonary Exercise Testing (CPET) - O2 Pulse|Cardiopulmonary Exercise Testing (CPET) - Aerobic Efficiency|Muscle Strength Testing (MST) - Knee Extension Test|Muscle Strength Testing (MST) - Knee Flexion Test|Muscle Strength Testing (MST) - Elbow Flexion Test|Adolescent Pediatric Pain Tool (APPT) - Pain Intensity | BioMarin Pharmaceutical | Oakland, California, United States|Chicago, Illinois, United States|New York, New York, United States|Houston, Texas, United States|Calgary, Alberta, Canada|Toronto, Ontario, Canada|Montreal, Quebec, Canada|Sherbrook, Quebec, Canada|Hamburg, Germany|Belfast, Northern Ireland, United Kingdom|Manchester, United Kingdom |
| Study of BMN 110 in Pediatric Patients < 5 Years of Age With Mucopolysaccharidosis IVA (Morquio A Syndrome) | Mucopolysaccharidosis IVA|Morquio A Syndrome|MPS IVA | Drug: BMN 110 | To Evaluate Safety and Tolerability of Infusions of BMN 110 at a Dose of 2.0 mg/kg/Week Over a 52-week Period in MPS IVA Subjects Less Than 5 Years of Age at Time of First Study Drug Infusion|Percent Change From Baseline to Week 52 in Urinary Keratan Sulfate Measures|Change From Baseline in Normalized Growth Rate Z-Scores | BioMarin Pharmaceutical | Oakland, California, United States|Manhasset, New York, United States|Monza, Italy|Taipei, Taiwan|Central Manchester, United Kingdom |
| Long-Term Efficacy and Safety Extension Study of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome) | Mucopolysaccharidosis IV A|Morquio A Syndrome|MPS IVA | Drug: BMN 110 - Weekly|Drug: BMN 110 - Every Other Week | Change From Baseline in 6-minute Walk (6MW) Test - ITT|Change From Baseline in 6-minute Walk (6MW) Test - MPP|Change From Baseline in 3-minute Stair Climb Test - ITT|Change From Baseline in 3-minute Stair Climb Test - MPP|Change From Baseline in Urine Keratan Sulfate - ITT|Change From Baseline in Urine Keratan Sulfate - MPP | BioMarin Pharmaceutical | Phoenix, Arizona, United States|Oakland, California, United States|Orange, California, United States|Wilmington, Delaware, United States|Washington, District of Columbia, United States|Orlando, Florida, United States|Honolulu, Hawaii, United States|Chicago, Illinois, United States|New York, New York, United States|Seattle, Washington, United States|Cordoba, Argentina|Campina Grande, Brazil|Porto Alegre, Brazil|Rio de Janeiro, Brazil|Montreal, Canada|Sherbrooke, Canada|Toronto, Canada|Bogota, Colombia|Copenhagen, Denmark|Lyon, France|Marseille, France|Paris, France|Paris, France|Mainz, Germany|Monza, Italy|Tokyo, Japan|Seoul, Korea, Republic of|Amsterdam, Netherlands|Oslo, Norway|Coimbra, Portugal|Lisbon, Portugal|Doha, Qatar|Riyadh, Saudi Arabia|Santiago de Compostela, Spain|Taipei, Taiwan|Ankara, Turkey|Belfast, United Kingdom|Birmingham, United Kingdom|Birmingham, United Kingdom|London, United Kingdom|London, United Kingdom|London, United Kingdom|Manchester, United Kingdom |
| A Double-Blind Study to Evaluate the Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome) | MPS IV A | Drug: BMN 110 Weekly|Drug: Placebo|Drug: BMN 110 Every Other Week | Change From Baseline in Endurance as Measured by the 6-minute Walk Test|Change From Baseline in Endurance as Measured by the 3-minute Stair Climb Test|Percent Change From Baseline in Urine Keratan Sulfate Normalized for Urine Creatinine | BioMarin Pharmaceutical | Oakland, California, United States|Wilmington, Delaware, United States|Washington, District of Columbia, United States|Chicago, Illinois, United States|New York, New York, United States|Seattle, Washington, United States|Cordoba, Argentina|Campina Grande, Brazil|Porto Alegre, Brazil|Montreal, Canada|Sherbrooke, Canada|Toronto, Canada|Bogota, Colombia|Copenhagen, Denmark|Lyon, France|Paris, France|Mainz, Germany|Monza, Italy|Tokyo, Japan|Seoul, Korea, Republic of|Amsterdam, Netherlands|Coimbra, Portugal|Doha, Qatar|Riyadh, Saudi Arabia|Taipei, Taiwan|Birmingham, United Kingdom|London, United Kingdom|Manchester, United Kingdom |
| A Study to Evaluate the Long-Term Efficacy and Safety of BMN 110 in Patients With Mucopolysaccharidosis IVA (Morquio A Syndrome) | MPS IV A|Mucopolysaccharidosis IVA|Morquio A Syndrome | Drug: BMN 110 | Safety Evaluation|Change From Baseline in Endurance as Measured by the 6-minute Walk Test During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Change in Baseline in Endurance as Measured by the 3 Minute Stair Climb During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change From Baseline in Urine Keratan Sulfate (uKS) Levels During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change From Baseline in Respiratory Function Test MVV During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100).|Percent Change From Baseline in Respiratory Function Test FVC During the Pilot Trial (MOR-002) and Current Extension Trial (MOR-100). | BioMarin Pharmaceutical | Birmingham, United Kingdom|Dumfries, United Kingdom|London, United Kingdom|Manchester, United Kingdom |
| A Study to Evaluate the Safety, Tolerability and Efficacy of BMN 110 in Subjects With Mucopolysaccharidosis IVA | MPS IV A | Drug: BMN 110 | Subject Incidence of Treatment Emergent AEs|Change From Baseline in 6MWT|Change From Baseline in 3MSCT|Percent Change From Baseline in uKS|Percent Change From Baseline in MVV|Percent Change From Baseline in FVC | BioMarin Pharmaceutical | Birmingham, United Kingdom|London, United Kingdom|Manchester, United Kingdom |
| A Clinical Assessment Study of Subjects With Mucopolysaccharidosis IVA (Morquio Syndrome) | MPS IV A|Mucopolysaccharidosis IVA|Morquio A Syndrome | Endurance|Respiratory Function | BioMarin Pharmaceutical | Oakland, California, United States|Chicago, Illinois, United States|Cordoba, Argentina|Porto Alegre, Brazil|Sao Paulo, Brazil|Montreal, Quebec, Canada|Lyon, France|Paris, France|Mainz, Germany|Monza, Italy|Amsterdam, Netherlands|Taipei, Taiwan|Birmingham, United Kingdom|London, United Kingdom|Manchester, United Kingdom | |
| Study in Healthy Recreational Polydrug Users to Measure the Abuse Potential of TC-5214 | Drug Abuse|Healthy | Drug: TC-5214|Drug: TC-5214 Placebo|Drug: Ketamine|Drug: Phentermine | Momentary Drug Liking VAS maximum effect (Emax)|Momentary Drug Liking VAS minimum effect (Emin)|Drug Liking VAS time-weighted mean (TWmean)|Overall Drug Liking VAS maximum effect ( Emax)|Overall Drug Liking VAS (Emin)|Overall Drug Liking VAS 10-hour mean score|Overall Drug Liking VAS 24-hour mean score|Take Drug Again VAS Emax|Take Drug Again VAS 10-hour mean score|Take Drug Again VAS 24-hour mean score|Subjective Drug Value Emax|Subjective Drug Value 10 hour mean score|Subjective Drug 24 hour mean scores|High VAS Emax|High VAS TWmean|Good Effects VAS Emax|Good Effects VAS TWmean|Addiction Research Center Inventory (ARCI) euphoria scale (MBG) Emax|Addiction Research Center Inventory (ARCI) euphoria scale (MBG) TWmean|Bad Effects VAS Emax|Bad Effects VAS TWmean|ARCI dysphoria scale (LSD) Emax|ARCI dysphoria scale (LSD) TWmean|ARCI sedation scale (PCAG) Emax|ARCI sedation scale (PCAG) TWmean|Alertness/Drowsiness VAS Emin (drowsiness)|Alertness/Drowsiness VAS TWmean|Any Effects VAS Emax|Any Effects VAS TWmean|Bowdle VAS Emax|Bowdle VAS TWmean|ARCI A scale Emax|ARCI A scale TWmean|ARCI Phentermine and Benzedrine Group scale (BG) Emax|ARCI Phentermine and Benzedrine Group scale (BG) TWmean | AstraZeneca | |
| Pilot Study of Entacapone for Methamphetamine Abuse | Methamphetamine Dependence | Drug: Entacapone|Drug: Methamphetamine|Drug: Placebo | Effect of Entacapone on Methamphetamine-induced Mood|Effect of Entacapone on Subjective Effects of Methamphetamine|Effect of Entacapone on Methamphetamine-induced Stimulation|Cognitive Function | Oregon Health and Science University|Portland VA Medical Center | Oregon Health & Science University, Portland, Oregon, United States |
| A Safety, Tolerability and Preliminary Efficacy Study of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia and Treatment-naïve Participants Not Eligible for Intensive Therapy | Leukemia, Myeloid | Drug: CC-90011|Drug: Venetoclax|Drug: Azacitidine | Adverse Events (AEs)|Recommended Phase 2 dose (RP2D)|Complete remission (CR) Rate|Complete remission with partial hematologic recovery (CRh) Rate|Overall response rate (ORR)|Duration of response (CR)|Duration of response (CR/CRh)|Duration of response (CR/ CRMRD-/ CRi/ PR/MLFS)|Event-free survival (EFs)_Part III Only|Overall survival (OS)_Part III Only|Minimal residual disease (MRD) Response Rate_Part II and III only|Minimal residual disease (MRD) Conversion Rate_Part II and III Only|Complete response with incomplete hematologic recovery (CRi) rate|Duration of response (CR/CRi) | Celgene | City of Hope, Duarte, California, United States|Local Institution - 110, Duarte, California, United States|Yale University School of Medicine, New Haven, Connecticut, United States|University of Miami Miller School of Medicine Jackson Memorial Hospital, Miami, Florida, United States|Winship Cancer Institute of Emory University, Atlanta, Georgia, United States|Northwestern University Medical Center, Chicago, Illinois, United States|Mount Sinai Medical Center, New York, New York, United States|Duke University Medical Center, Durham, North Carolina, United States|Cleveland Clinic, Cleveland, Ohio, United States|Ohio State University Medical CenterJames Cancer Hospital, Columbus, Ohio, United States|Baylor University Medical Center, Dallas, Texas, United States|The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States|Swedish Medical Center, Seattle, Washington, United States|Salzburger Landkliniken St. Johanns-Spital, Salzburg, Austria|Medical University of Vienna, Vienna, Austria|Krankenhaus Hietzing, Wien, Austria|ZNA Stuivenberg Centrumziekenhuis, Antwerpen, Belgium|UZ Gent, Gent, Belgium|CHU de Liege, Liege, Belgium|Hopital Aviecenne, BOBIGNY Cedex, France|CHRU Nantes, Nantes, France|Centre Hospitalier Lyon Sud - Hospices Civils de Lyon Groupement Hospitalier Sud, Pierre-Benite, France|Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France|Gustave Roussy, Villejuif CEDEX, France|Local Institution - 401, Villejuif CEDEX, France|Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi, Bologna, Italy|IRST Meldola, Meldola, Italy|Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milano, Italy|Ospedale Santa Maria Della Misericordia Di Perugia, Perugia PG, Italy|Haukeland University Hospital, Bergen, Norway|Oslo Universitetssykehus, Oslo, Norway|Hospital Universitari Vall d'Hebron, Barcelona, Spain|Hospital de Bellvitge, Barcelona, Spain|Hospital General Universitario Gregorio Marañon, Madrid, Spain|Hospital Universitario Virgen del Rocio - PPDS, Sevilla, Spain |
| PE PREMIER CHINA CLINICAL TRIAL | Atherosclerosis | Device: Percutaneous coronary intervention PROMUS PREMIER | Technical Success Rate|Target Lesion Revascularization (TLR) Rate|Target Lesion Failure (TLF) Rate|Target Vessel Revascularization (TVR) Rate|Target Vessel Failure (TVF) Rate|Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate|Cardiac Death Rate|Non-cardiac Death Rate|All Death Rate|Cardiac Death or MI Rate|All Death or MI Rate|All Death/MI/TVR Rate|Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)|Clinical Procedural Success Rate|In-stent and In-segment Percent Diameter Stenosis (%DS)|In-stent and In-segment Minimum Lumen Diameter (MLD)|Acute Gain|Longitudinal Stent Deformation (LSD) Rate | Boston Scientific Corporation | |
| Personality and Drug Use | No Conditions Study Focus on Substance Use and Personality | Other: Usage of drugs | Change in scores on Big Five Inventory (BFI-44)|Change in scores on Retrospective Personality Scale (RPS) | Psychedelic Data Society|Maastricht University|Quantified Citizen Technologies Inc. | |
| Personality and Drug Use (PDU) | Personality | Current Personality Profile|Changes in Personality Profile | Quantified Citizen Technologies Inc.|Maastricht University|Psychedelic Data Society | ||
| Reducing the Abuse Liability of Prescription Opioids | Addiction | Drug: Risperidone|Drug: Ziprasidone|Drug: Oxycodone | Evaluation of analgesic efficacy- Cold pressor|Evaluation of analgesic efficacy- Thumb pressor|Drug liking|Addiction Research Center Inventory test questionnaire|Profile of Mood States test questionnaire | The University of Texas Health Science Center at San Antonio | Westgate Pain Clinic, San Antonio, Texas, United States |
| Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of rhHNS Administration Via an IDDD in Pediatric Patients With Early Stage MPS IIIA Disease | Sanfilippo Syndrome | Drug: Recombinant human heparan N-sulfatase [rhHNS] | Number of Participants With Overall Response Using Bayley Scales of Infant Development Assessment Third Edition (BSID-III)|Number of Participants With Serious Adverse Events (SAE)|Number of Participants With Treatment Emergent Adverse Events (TEAEs)|Number of Participants With Positive Anti-recombinant Human Heparan-N-Sulfatase (rhHNS) Antibody in Serum at Week 48|Change From Baseline in Vineland Adaptive Behavior Scales Second Edition (VABS-II) Development Quotient (DQ) Score at Week 48|Change From Baseline in Development Quotient (DQ) Using Bayley Scales of Infant Development Assessment Third Edition (BSID-III) at Week 48|Change From Baseline in Total Cortical Grey Matter Volume at Week 48|Change From Baseline in Concentration of Glycosaminoglycan (GAG) in Cerebrospinal Fluid (CSF) at Week 48|Change From Baseline in Concentration of GAG in Urine at Week 48|Concentration of Recombinant Human Heparan-N-Sulfatase (rhHNS) in Cerebrospinal Fluid (CSF)|Maximum Observed Drug Concentration (Cmax) of Recombinant Human Heparan-N-Sulfatase (rhHNS) in Serum | Shire|Takeda | Los Angeles Biomedical Research, Torrance, California, United States|University of Minnesota Department of Pediatrics, Minneapolis, Minnesota, United States|University of North Carolina, Chapel Hill, North Carolina, United States|Hospital Universitario Austral A Unidad de Investigacion, Buenos Aires, Argentina|Chu Bicetre, Le Kremlin-Bicêtre, Paris, France|Universitätsklinikum Hamburg Eppendorf, Hamburg, Germany|U.O.S Malattie Metaboliche Rare Clinical Pediatrica, Monza, Italy|Academisch Medisch Centrum, Amsterdam, Netherlands|Hospital Vall D'Hebron, Barcelona, Spain|Great Ormond Street Hospital, London, United Kingdom |
| Individual Differences in the Response to Drugs | Healthy | Drug: THC|Drug: AMP|Drug: ALC|Drug: Placebo capsules|Drug: Placebo beverage | Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Capsule Administration|Change in General Drug Effects (Drug Effects Questionnaire) at 30 Minutes After Drink Administration|Change in General Drug Effects (Drug Effects Questionnaire) at 90 Minutes After Drink Administration|Change in General Drug Effects (Drug Effects Questionnaire) at 120 Minutes After Drink Administraion|Change in General Drug Effects (Drug Effects Questionnaire) at 150 Minutes After Drink Administration|Change in General Drug Effects (Drug Effects Questionnaire) at 180 Minutes After Drink Administration|Change in General Drug Effects (Drug Effects Questionnaire) at 210 Minutes After Drink Administration|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Capsule Administration|Change in Specific Drug Effects (Addiction Research Center Inventory) at 30 Minutes After Drink Administration|Change in Specific Drug Effects (Addiction Research Center Inventory) at 90 Minutes After Drink Administration|Change in Specific Drug Effects (Addiction Research Center Inventory) at 120 Minutes After Drink Administration|Change in Specific Drug Effects (Addiction Research Center Inventory) at 150 Minutes After Drink Administration|Change in Specific Drug Effects (Addiction Research Center Inventory) at 180 Minutes After Drink Administration|Change in Specific Drug Effects (Addiction Research Center Inventory) at 210 Minutes After Drink Administration | University of Chicago | |
| Y2Prevent: Preventing Drug Use and HIV Through Empowerment, Social Support and Mentorship (Y2P) | HIV|Drug Use | Behavioral: Y2Prevent | Sexual risk behaviors|Alcohol and illincit drug use|Illincit drug use|PrEP Uptake | Children's Hospital Los Angeles|National Institute on Drug Abuse (NIDA) | Children's Hospital Los Angeles, Los Angeles, California, United States |
| Caffeine and Cocaine | Cocaine Dependence | Drug: Caffeine 150 MG|Drug: Placebo|Drug: Amphetamine|Drug: Caffeine 300 MG | Visual Analog Scale Subjective Rating of Drug Effects|Systolic and Diastolic Blood Pressure|Heart Rate|Addiction Research Center Inventory Subjective Rating of Drug Effects|Drug Effects Questionnaire Rating of Subjective Ratings of Drug Effects|Probabalistic Feedback Selection Task|Saliva Caffeine and Paraxanthine Levels | Virginia Commonwealth University|National Institute on Drug Abuse (NIDA)|The University of Texas Health Science Center, Houston | The University of Texas Health Science Center, Houston, Houston, Texas, United States |
| Efficacy and Safety of Olanzapine in Patients With Borderline Personality Disorder | Borderline Personality Disorder | Drug: Olanzapine | To assess the efficacy of olanzapine therapy (5.0-10.0 mg/day) compared with placebo in patients with BPD,as defined by DSM-IV-TR criteria,|in improving overall symptomatology as measured by the last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment.|To assess the efficacy of olanzapine 2.5 mg/day compared with placebo in patients with BPD, as defined by DSM-IV-TR criteria|in improving overall symptomatology as measured by last observation carried forward (LOCF) mean change from baseline to endpoint in the ZAN-BPD total score for up to 12 weeks of double-blind treatment|to evaluate the level of functioning as measured by LOCF mean change from baseline to endpoint on the Sheehan Disability Scale (Work, Social Life,and Family Life/Home Responsibilities)total score|and individual scores(Work, Social Life,Family Life/Home Responsibilities, Days Lost, and Days Under Productive)|to assess the reduction of aggression, suicidality, and irritability as measured by the LOCF mean change from baseline to endpoint in the rating of the Overt Aggression Scale-Modified (OAS-M) total score|to assess the reduction of self-mutilation determined by the mean frequency of self-mutilation attempts as captured on the Lifetime Self-Destructiveness scale (LSDS), which will measure both frequency and nature of attempts|The frequency of self-mutilation for each patient will be calculated as the number of self-mutilations divided by the patient's total number of study drug exposure|(Self-mutilation is defined as deliberate physical self harm without the intent to commit suicide)|to assess the reduction of suicide attempts as determined by the mean frequency of suicide attempts.|The frequency of suicide attempts for each patient will be calculated as the number of suicide attempts divided by the patient's total number of days of study drug exposure|to assess the treatment of the core domains of BPD as assessed by LOCF mean change from baseline to endpoint in each of the four ZAN-BPD domain scores (cognitive disturbances,disturbed relationships,affective disturbances,and impulsivity)|to assess the following symptom domains (paranoid ideation, psychoticism, anxiety, depression, anger/hostility, interpersonal sensitivity, phobic anxiety, obsessive-compulsive, and somatization)on the Global Severity Index of the SCL-90-R|as determined by the LOCF mean change from baseline to endpoint|to evaluate the rate of response, time in response, and time to response. Levels of response are defined as a 30% and 50% reduction in the ZAN-BPD total score from baseline (Visit 2)|to assess the treatment of depressive mood symptoms as measured by LOCF mean change from baseline to endpoint in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)|to assess the resource utilization by frequency divided by the patient's total number of days of study drug exposure for days hospitalized for physical and psychological reasons,number of hospital admissions|or medical visits(emergency department, general and special care physicians, and other mental health care professionals|to evaluate the level of functioning in patients as measured by LOCF mean change from baseline to endpoint on the GAF|to assess the safety as measured by treatment-emergency adverse events (TEAE), change in vital signs and laboratory analytes, electrocardiograms and severity of any extrapyramidal symptoms (EPS)|The Simpson Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale will be used to measure EPS|The objectives of Study Period III (Open Label Extension Period are:|to assess the longer term safety of olanzapine for up to 12 additional weeks of therapy|as measured by TEAE, change in vital signs and laboratory analytes, ECG and severity of EPS.|to explore the efficacy of continued olanzapine treatment for up to 12 additional weeks of therapy|as measured by the ZAN-BPD total score, MADRS, Sheehan Disability Scale and LSDS|to assess resource utilization by frequency of divided by the patient's total number of days of study drug exposure for|days hospitalized for physical and psychological reasons, number of hospital admissions|or medical visits (emergency department, general and special care physicians or other mental health care professionals | Eli Lilly and Company | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, National City, California, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician, New Haven, Connecticut, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Indianapolis, Indiana, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Jackson, Mississippi, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Bronx, New York, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Memphis, Tennessee, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Houston, Texas, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Capital Federal, Buenos Aires, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, La Plata, Buenos Aires, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Villa Alberdi, Cordoba, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Buenos Aires, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Choroszcz, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Torun, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Bucuresti, Sector 4, Romania|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Istanbul, Capa, Turkey |
| Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse | Attention Deficit Disorder With Hyperactivity|Amphetamine-Related Disorders|Substance-Related Disorders | Drug: NRP104 | The difference in the time to maximum change from baseline in the Liking scale score (Question 2) from the Drug Rating Questionnaire - Subject (DRQS).|Maximum Liking score (Question 2 from DRQS) change from baseline|Question 1 and 3 from the DRQS|Question 1, 2 and 3 from the Drug Rating Questionnaire- Observer (DRQO)|Subscale of the ARCI (MBG, Amphetamine, BG, LSD and PCAG) (subject)|Street Value assessment Questionnaire (subject)|Treatment Enjoyment assessment Questionnaire (TEAQ) (subject)|Safety|Adverse events, laboratory tests, physical examination, vital signs and ECG will be collected to|assess the safety and tolerability of NRP104. | New River Pharmaceuticals | Johns Hopkins Bayview Medical Center, Clinical Studies Program, Baltimore, Maryland, United States |
| Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Drug Users | Abuse Potential Study | Drug: 200 mg almorexant|Drug: 400 mg almorexant|Drug: 1000 mg almorexant|Drug: 20 mg zolpidem|Drug: 40 mg zolpidem|Drug: placebo | Maximum effect (Emax) over 24 h post-dose for "At the moment" Drug Liking Visual Analogue Scale (VAS) score during each Treatment Visit|Minimum Effect (Emin) and Time-weighted mean effect (TWMean) over 24 h post-dose for "At the moment" Drug Liking VAS score during each Treatment Visit|Overall Drug Liking VAS score (Emax, Emin, and arithmetic mean effect of 8 h and 24 h post-dose assessments during each Treatment Visit)|Good/Bad Drug Effects VAS score (Emax, Emin, and TWMean over 24 h post-dose during each Treatment Visit)|Take Drug Again VAS score (Emax and arithmetic mean of 8 h and 24 h post-dose assessments during each Treatment Visit)|Subjective Drug Value (SDV) (Emax and arithmetic mean of 8 h and 24 h post-dose assessment during each Treatment Visit)|Feeling High VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)|Good Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)|Addiction Research Center Inventory (ARCI) Morphine Benzedrine Group (MBG) scale (Emax and TWMean over 24 h postdose during each Treatment Visit)|Bad Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)|ARCI Lysergic acid diethylamide (LSD) scale (Emax and TWMean over 24 h post-dose during each Treatment Visit|ARCI Pentobarbital Chlorpromazine Alcohol Group (PCAG) scale (Emax and TWMean over 24 h post-dose during each Treatment Visit)|Alertness/Drowsiness VAS score (Emin [drowsiness] and TWMean over 24 h post-dose during each Treatment Visit)|Bowdle VAS scores (Emax and TWMean over 24 h post-dose during each Treatment Visit)|Any Drug Effects VAS score (Emax and TWMean over 24 h post-dose during each Treatment Visit)|Drug Familiarity VAS score (Hour 12 during each Treatment Visit)|Drug Similarity VAS score (Hour 12 during each Treatment Visit) | Midnight Pharma, LLC | |
| The Canadian Underage Substance Use Prevention Trial | Substance Use Disorders|Adolescent Behavior|Adolescent Development | Behavioral: PreVenture Training (PTtT)|Behavioral: PreVenture Training+Implementation Facilitation | Effectiveness (primary outcome): Severity of substance use problems|Implementation Facilitation (primary outcome): Severity of substance use problems|Effectiveness (secondary outcome): Prevalence of binge drinking|Effectiveness (secondary outcome): Frequency of cannabis use|Effectiveness (secondary outcome): Frequency of non-medical prescription drug use|Effectiveness (secondary outcome): Frequency of illicit substance use|Implementation Facilitation (secondary outcome): Rate of interventions | St. Justine's Hospital|University of British Columbia|Center for Addiction and Mental Health|Dalhousie University|Canadian Institutes of Health Research (CIHR) | University of British Columbia Okanagan Campus, Kelowna, British Columbia, Canada|Dalhousie University, Halifax, Nova Scotia, Canada|Center for Mental Health and Addicitions, Toronto, Ontario, Canada|CHU Sainte-Justine Research Center, Montreal, Quebec, Canada |
| Social Media Intervention for Cannabis Use in Emerging Adults | Cannabis Use | Behavioral: Social Media Intervention | Frequency of Cannabis Use as Reported on the Timeline Follow-Back (TLFB)|Quantity of Cannabis Used as Reported on the Timeline Follow-Back (TLFB)|Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire Using Dichotomous Response Scale as Previously Described Throughout This Trial Registration.|Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire|Perceived Risk of Cannabis Use as Measured by 2 Modified Items From the Monitoring the Future Survey|Perceived Risk of Cannabis Use as Measured by Modified Items From the Monitoring the Future Survey|Peer Approval/Disapproval of Cannabis Use as Measured by Item Modified From Monitoring the Future Survey|Cannabis Impaired Driving as Measured by 5 Items From the Modified Young Adult Driving Questionnaire|Other Drug Use as Measured by Items Modified From Monitoring the Future Survey|Frequency of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB)|Quantity of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | University of Michigan|National Institute on Drug Abuse (NIDA) | University of Michigan, Ann Arbor, Michigan, United States |
| Ketamine to Improve Recovery After Cesarean Delivery - Part 1 | Obstetric Pain|Postpartum Depression|Breastfeeding|Pain, Acute|Pain, Chronic|Obstetric Anesthesia Problems|Drug Effect|Opioid Use | Drug: Ketamine | ketamine (AUC)|ketamine (M:P)|ketamine (AID)|S-ketamine|norketamine|hydroxyl-ketamine|hydroxynorketamine|Steady state (Css)|Half life (T1/2)|Volume of distribution|Milligram morphine equivalents (MME) (Part 2)|Static, dynamic, and affective VAS pain score|Dynamic acute pain|Vital Signs - blood pressure|Vital Signs - heart rate|Vital Signs - oxygen saturation|Vital Signs - respiratory rate|Sedation|Side effects | Grace Lim, MD, MS|University of Pittsburgh | UPMC Montefiore Hospital CTRC, Pittsburgh, Pennsylvania, United States|Emma Nowakowski, Pittsburgh, Pennsylvania, United States |
| Effects of Cannabidiol in Alcohol Use Disorder | Alcohol Use Disorder | Other: Placebo|Drug: Phytocannabinoid cannabidiol (CBD) | Number of Adverse Events|Mean Addiction Resource Center Inventory-Short Form (ARCI-SF) Score|Rey Auditory Verbal Learning Task (RAVLT) Score|Mental Rotation Task (MRT) Score|Time Reproduction Task (TRT) Score|Automated Operation Span Task (OSPAN) Score|Reading Span (RSpan) Score|Symmetry Span (SymSpan) Score|Rotation Span (RotSpan) Score|Change in Penn Alcohol Craving Scale (PACS) Score|Change in Beck Anxiety Inventory (BAI) Score|Change in Beck Depression Inventory-II (BDI-II) Score|Change in Alcohol Abstinence Self-Efficacy Scale (AASE): Temptation Subscale|Change in Alcohol Abstinence Self-Efficacy Scale (AASE): Confidence Subscale | NYU Langone Health|National Institutes of Health (NIH)|Tilray | New York University School of Medicine, New York, New York, United States |
| International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry | Gaucher Disease|Cerebroside Lipidosis Syndrome|Glucocerebrosidase Deficiency Disease|Glucosylceramide Beta-Glucosidase Deficiency Disease | ICGG Gaucher Registry: To provide the Gaucher medical community with recommendations for monitoring patients and to provide reports on patient outcomes to help optimize patient care|Gaucher Pregnancy Sub-registry: To track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy, such as ERT with imiglucerase | Genzyme, a Sanofi Company|Sanofi | Phoenix Children's Hospital-Site Number:840003, Phoenix, Arizona, United States|University of Arizona-Site Number:840015, Tucson, Arizona, United States|Arkansas Childrens Hospital-Site Number:840109, Little Rock, Arkansas, United States|University of Arkansas for Medical Sciences-Site Number:840113, Little Rock, Arkansas, United States|Tower Hematology/Oncology Medical Group-Site Number:840056, Beverly Hills, California, United States|University of California at Irvine-Site Number:840036, Irvine, California, United States|Southern California Permanente Medical Group-Site Number:840108, Los Angeles, California, United States|USC Health Sciences Center Dept of Genetics-Site Number:840082, Los Angeles, California, United States|Children's Hospital of Orange County-Site Number:840074, Orange, California, United States|Stanford Unviersity MC Dept of Genetics-Site Number:840022, Palo Alto, California, United States|UC Davis MIND Institute-Site Number:840010, Sacramento, California, United States|Kaiser Permanente Hospital-Site Number:840042, Sacramento, California, United States|Loma Linda University Children's Hospital-Site Number:840117, San Bernardino, California, United States|University of California at San Diego-Site Number:840007, San Diego, California, United States|University of California at San Francisco-Site Number:840051, San Francisco, California, United States|University of Colorado at Denver Genetics-Site Number:840068, Aurora, Colorado, United States|Yale-Site Number:840047, New Haven, Connecticut, United States|Children's National Medical Center-Site Number:840067, Washington, District of Columbia, United States|University Hematology Oncology-Site Number:840075, Coral Springs, Florida, United States|University of Florida Pediatrics Genetics-Site Number:840121, Jacksonville, Florida, United States|The Atwal Clinic-Site Number:840112, Jacksonville, Florida, United States|University Of Miami SOM-Site Number:840006, Miami, Florida, United States|University of Florida-Genetics-Site Number:840096, Tampa, Florida, United States|Pediatric Endocrine Associates-Site Number:840017, Tampa, Florida, United States|Emory University School of Medicine- Human Genetics-Site Number:840060, Decatur, Georgia, United States|Ann and Robert Lurie Children's Hospital-Site Number:840011, Chicago, Illinois, United States|Ann and Robert Lurie Children's Hospital-Site Number:840013, Chicago, Illinois, United States|Rush University Medical Center Genetics-Site Number:840079, Chicago, Illinois, United States|Indianapolis University School of Medicine-Site Number:840027, Indianapolis, Indiana, United States|University of Iowa-Site Number:840032, Iowa City, Iowa, United States|University of Louisville- Genetics-Site Number:840030, Louisville, Kentucky, United States|Tulane University Medical Center-Site Number:840001, New Orleans, Louisiana, United States|Ochsner Medical Center-Site Number:840120, New Orleans, Louisiana, United States|Maine Medical Center Pediatrics-Site Number:840064, Portland, Maine, United States|John Hopkins-Site Number:840044, Baltimore, Maryland, United States|Massachusetts General Hospital-Genetics-Site Number:840062, Boston, Massachusetts, United States|Boston Children's Hospital-Site Number:840092, Boston, Massachusetts, United States|University of Michigan Pediatrics-Site Number:840107, Ann Arbor, Michigan, United States|Children's Hospital of Michigan-Site Number:840066, Detroit, Michigan, United States|Infusion Associates-Site Number:840050, Grand Rapids, Michigan, United States|Children's Health Care-Site Number:840114, Minneapolis, Minnesota, United States|Children's Hospital and Clinics of Minnesota-Site Number:840046, Minneapolis, Minnesota, United States|University of Minnesota Medical Center Pediatrics-Site Number:840076, Minneapolis, Minnesota, United States|University of Missouri Health System Department of Genetics-Site Number:840031, Columibia, Missouri, United States|Children's Mercy Hospital- Pediatrics-Site Number:840063, Kansas City, Missouri, United States|Washington University of St. Louis-Site Number:840100, Saint Louis, Missouri, United States|University of Nebraska Medical Center- Pediatrics-Site Number:840084, Omaha, Nebraska, United States|Children's Specialty Center of Nevada-Site Number:840008, Las Vegas, Nevada, United States|Cooper Health Center-Site Number:840098, Camden, New Jersey, United States|Joseph M. Sanzari Children's Hospital-Site Number:840101, Hackensack, New Jersey, United States|Atlantic Health System-Site Number:840099, Morristown, New Jersey, United States|St. Peter's University Hospital-Site Number:840016, New Brunswick, New Jersey, United States|St. Joseph's Children's Hospital-Site Number:840057, Paterson, New Jersey, United States|Northwell Health-Site Number:840102, Manhasset, New York, United States|New York University School Of Medicine-Site Number:840040, New York, New York, United States|Metropolitan Hospital Center-Site Number:840110, New York, New York, United States|Mt. Sinai School of Medicine-Site Number:840005, New York, New York, United States|University of Rochester Medical Center SOM-Site Number:840105, Rochester, New York, United States|State University of New York-Site Number:840052, Syracuse, New York, United States|New York Medical College-Site Number:840039, Valhalla, New York, United States|Carolinas Medical Center Hospital-Site Number:840065, Charlotte, North Carolina, United States|Duke University Medical Center Genetics Dept-Site Number:840037, Durham, North Carolina, United States|-Site Number:840026, Cincinnati, Ohio, United States|UHCMC-Site Number:840119, Cleveland, Ohio, United States|Cleveland Clinic Foundation Pediatrics-Site Number:840048, Cleveland, Ohio, United States|Nationwide Children's Hospital-Site Number:840091, Columbus, Ohio, United States|LSD Data Registry Site LLC-Site Number:840094, Dublin, Ohio, United States|Oregon Health & Science University-Site Number:840080, Portland, Oregon, United States|Children's Hospital of Philadelphia HUP Medical Genetics-Site Number:840089, Philadelphia, Pennsylvania, United States|Children's Hospital of Philadelphia-Site Number:840034, Philadelphia, Pennsylvania, United States|University of Pittsburgh-Site Number:840023, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital Genetics-Site Number:840053, Providence, Rhode Island, United States|Greenwood Genetcs-Site Number:840055, Greenville, South Carolina, United States|Vanderbilt University Hospital-Pediatrics-Site Number:840049, Nashville, Tennessee, United States|Baylor Research Center-Site Number:840058, Dallas, Texas, United States|Cook Children's Health Care System-Site Number:840024, Fort Worth, Texas, United States|University of Utah Department of Medical Genetics-Site Number:840043, Salt Lake City, Utah, United States|University of Virginia School of Medicine-Pediatrics-Site Number:840078, Charlottesville, Virginia, United States|O&O Alpan, LLC-Site Number:840025, Fairfax, Virginia, United States|Children's Hospital of the Kings Daughters-Site Number:840072, Norfolk, Virginia, United States|Seattle Children's Hospital-Site Number:840028, Seattle, Washington, United States|University Of Washington Medical Center-Site Number:840059, Seattle, Washington, United States|Multicare Health System � Mary Bridge Childrens Hospital-Site Number:840115, Tacoma, Washington, United States|Children's Hospital of Wisconsin-Pediatrics-Site Number:840054, Milwaukee, Wisconsin, United States|Investigational Site Number :150661, Caba, Buenos Aires, Argentina|Investigational Site Number :032003, La Plata, Buenos Aires, Argentina|Investigational Site Number :151085, Sarandi, Buenos Aires, Argentina|Investigational Site Number :032012, Buenos Aires, Argentina|Investigational Site Number :154176, Corrientes, Argentina|Investigational Site Number :032011, Córdoba, Argentina|Investigational Site Number :151431, Camperdown, New South Wales, Australia|Investigational Site Number :151069, Westmead, New South Wales, Australia|Investigational Site Number :151491, Douglas, Queensland, Australia|Investigational Site Number :151010, Herston, Queensland, Australia|Investigational Site Number :151002, Adelaide, South Australia, Australia|Investigational Site Number :151725, Hobart, Tasmania, Australia|Investigational Site Number :151011, Clayton, Victoria, Australia|Investigational Site Number :151008, Parkville, Victoria, Australia|Investigational Site Number :151015, Murdoch, Western Australia, Australia|Investigational Site Number :150722, Antwerpen, Belgium|Investigational Site Number :151156, Brugge, Belgium|Investigational Site Number :150944, Brussel, Belgium|Investigational Site Number :152345, Brussel, Belgium|Investigational Site Number :151796, Bruxelles, Belgium|Investigational Site Number :150517, Bruxelles, Belgium|Investigational Site Number :154285, Edegem, Belgium|Investigational Site Number :151134, Gent, Belgium|Investigational Site Number :151668, Leuven, Belgium|Investigational Site Number :076007, Porto Alegre, Rio Grande Do Sul, Brazil|Investigational Site Number :076012, Campinas, Brazil|Investigational Site Number :076005, Campinas, Brazil|Investigational Site Number :076010, Curitiba, Brazil|Investigational Site Number :076001, Ribeirão Preto, Brazil|Investigational Site Number :076006, Rio de Janeiro, Brazil|Investigational Site Number :076002, São Paulo, Brazil|Investigational Site Number :076008, São Paulo, Brazil|Investigational Site Number :100001, Sofia, Bulgaria|Investigational Site Number :151164, Sofia, Bulgaria|Investigational Site Number :124014, Calgary, Alberta, Canada|Investigational Site Number :124002, Edmonton, Alberta, Canada|Investigational Site Number :124010, Vancouver, British Columbia, Canada|Investigational Site Number :124011, Vancouver, British Columbia, Canada|Investigational Site Number :124019, Winnipeg, Manitoba, Canada|Investigational Site Number :124022, Moncton, New Brunswick, Canada|Investigational Site Number :124024, Kingston, Ontario, Canada|Investigational Site Number :124005, Kingston, Ontario, Canada|Investigational Site Number :124021, London, Ontario, Canada|Investigational Site Number :124006, Toronto, Ontario, Canada|Investigational Site Number :124013, Toronto, Ontario, Canada|Investigational Site Number :124001, Sherbrooke, Quebec, Canada|Investigational Site Number :151787, Beijing, China|Investigational Site Number :153203-, Beijing, China|Investigational Site Number :152357, Guangzhou, China|Investigational Site Number :152358, Hangzhou, China|Investigational Site Number :152359, Hangzhou, China|Investigational Site Number :152356, Shanghai, China|Investigational Site Number :150899, Shanghai, China|Investigational Site Number :1910001, Zagreb, Croatia|Investigational Site Number :1910002, Zagreb, Croatia|Investigational Site Number :1910003, Zagreb, Croatia|Investigational Site Number :150809, Praha 2, Czechia|Investigational Site Number :151229, København, Denmark|Investigational Site Number :2140001, Santo Domingo, Dominican Republic|Investigational Site Number :5748, Alexandria, Egypt|Investigational Site Number :9889, Ash Sharqia, Egypt|Investigational Site Number :9888, Assuit, Egypt|Investigational Site Number :8345, Cairo, Egypt|Investigational Site Number :9829, Cairo, Egypt|Investigational Site Number :9830, Cairo, Egypt|Investigational Site Number :250015, ANGERS Cedex 01, France|Investigational Site Number :250004, Besancon, France|Investigational Site Number :250008, Bordeaux, France|Investigational Site Number :250005, Brest, France|Investigational Site Number :250014, BRON Cedex, France|Investigational Site Number :250002, Caen, France|Investigational Site Number :250001, CLICHY Cedex, France|Investigational Site Number :250003, Garches, France|Investigational Site Number :250009, LYON Cedex 03, France|Investigational Site Number :250011, MARSEILLE cdx 08, France|Investigational Site Number :2500013, Montpellier, France|Investigational Site Number :250006, NANTES Cedex 1, France|Investigational Site Number :250007, Paris, France|Investigational Site Number :250010, Paris, France|Investigational Site Number :250012, Rennes Cedex 2, France|Investigational Site Number :250018, Strasbourg, France|Investigational Site Number :250017, Toulouse, France|Investigational Site Number :250016, TOURS Cedex 9, France|Investigational Site Number :151686, Berlin, Germany|Investigational Site Number :150783, Düsseldorf, Germany|Investigational Site Number :154150, Gießen, Germany|Investigational Site Number :151369, Hamburg, Germany|Investigational Site Number :151368, Hamburg, Germany|Investigational Site Number :150031, Mainz, Germany|Investigational Site Number :150432, Oberhausen, Germany|Investigational Site Number :300002, Athens, Greece|Investigational Site Number :300004, Athens, Greece|Investigational Site Number :300003, Patras, Greece|Investigational Site Number :300001, Thessaloniki, Greece|Investigational Site Number :3480006, Budapest, Hungary|Investigational Site Number :3480003, Létavértes, Hungary|Investigational Site Number :3480007, Nyíregyháza, Hungary|Investigational Site Number :3480008, Székesfehérvár, Hungary|Investigational Site Number :356003, Ahmedabad, India|Investigational Site Number :356004, Jaipur, India|Investigational Site Number :356001, Kolkata, India|Investigational Site Number :356005, Mumbai, India|Investigational Site Number :3560006, Secunderabad, India|Investigational Site Number :356002, Vellore, India|Investigational Site Number :360001, Jakarta, Indonesia|Investigational Site Number :3760003, Haifa, Israel|Investigational Site Number :3760001, Jerusalem, Israel|Investigational Site Number :3760002, Petach-Tikva, Israel|Investigational Site Number :380008, Catania, Italy|Investigational Site Number :380009, Firenze, Italy|Investigational Site Number :380006, Genova, Italy|Investigational Site Number :380004, Milano, Italy|Investigational Site Number :380005, Modena, Italy|Investigational Site Number :380002, Monza (MB), Italy|Investigational Site Number :380011, Monza, Italy|Investigational Site Number :380010, Napoli, Italy|Investigational Site Number :380003, Padova, Italy|Investigational Site Number :380007, Roma, Italy|Investigational Site Number :380001, Udine, Italy|Investigational Site Number :153205, Abeno-ku, Osaka, Japan|Investigational Site Number :153204, Setagaya, Tokyo, Japan|Investigational Site Number :153203, Yonago-shi, Tottori, Japan|Investigational Site Number :153217, Chiba, Japan|Investigational Site Number :4000001, Amman, Jordan|Investigational Site Number :153178, Busan, Korea, Republic of|Investigational Site Number :153191, Daejeon, Korea, Republic of|Investigational Site Number :153225, Jeonnam, Korea, Republic of|Investigational Site Number :153180, Seoul, Korea, Republic of|Investigational Site Number :153196, Seoul, Korea, Republic of|Investigational Site Number :153192, Seoul, Korea, Republic of|Investigational Site Number :151149, Seoul, Korea, Republic of|Investigational Site Number :153212, Seoul, Korea, Republic of|Investigational Site Number :153222, Seoul, Korea, Republic of|Investigational Site Number :154148, Yangsan, Korea, Republic of|Investigational Site Number :154208, Yangsan, Korea, Republic of|Investigational Site Number :154225, Kuwait, Kuwait|Investigational Site Number :4220004, Beirut, Lebanon|Investigational Site Number :422001, Beirut, Lebanon|Investigational Site Number :422006, Douris, Lebanon|Investigational Site Number :4220002, Hazmieh, Lebanon|Investigational Site Number :154237, Vilnius, Lithuania|Investigational Site Number :458001, Jalan Pahang, Malaysia|Investigational Site Number :458002, Kuala Lumpur, Malaysia|Investigational Site Number :150149, Amsterdam, Netherlands|Investigational Site Number :151171, Amsterdam, Netherlands|Investigational Site Number :154264, Karachi, Pakistan|Investigational Site Number :154266, Lahore, Pakistan|Investigational Site Number :604001, Arequipa, Peru|Investigational Site Number :604002, Callao, Peru|Investigational Site Number :608001, Manila, Philippines|Investigational Site Number :150575, Warszawa, Poland|Investigational Site Number :620003, Coimbra, Portugal|Investigational Site Number :620004, Lisboa, Portugal|Investigational Site Number :620009, Ponta Delgada, Portugal|Investigational Site Number :151188, Cluj Napoca, Romania|Investigational Site Number :642002, Cluj Napoca, Romania|Investigational Site Number :642001, Cluj-Napoca, Romania|Investigational Site Number :643001, Moscow, Russian Federation|Investigational Site Number :643002, sait-Petersburg, Russian Federation|Investigational Site Number :682002, Al Mubarraz, Saudi Arabia|Investigational Site Number :682003, Jeddah, Saudi Arabia|Investigational Site Number :682004, Makkah, Saudi Arabia|Investigational Site Number :688001, Belgrade, Serbia|Investigational Site Number :688002, Belgrade, Serbia|Investigational Site Number :688003, Belgrade, Serbia|Investigational Site Number :688005, Belgrade, Serbia|Investigational Site Number :688004, Nis, Serbia|Investigational Site Number :702001, Singapore, Singapore|Investigational Site Number :703001, Bratislava, Slovakia|Investigational Site Number :154138, Johannesburg, South Africa|Investigational Site Number :710-003, Johannesburg, South Africa|Investigational Site Number :150346, Sandton, South Africa|Investigational Site Number :153237, Barcelona, Spain|Investigational Site Number :154147, Barcelona, Spain|Investigational Site Number :154146, La Coruna, Spain|Investigational Site Number :154163, Madrid, Spain|Investigational Site Number :154236, Madrid, Spain|Investigational Site Number :151524, Madrid, Spain|Investigational Site Number :153251, Madrid, Spain|Investigational Site Number :154199, Madrid, Spain|Investigational Site Number :154160, Madrid, Spain|Investigational Site Number :154119, Madrid, Spain|Investigational Site Number :154145, Sabadell, Spain|Investigational Site Number :154222, Santiago de Compostela, Spain|Investigational Site Number :153215, Sevilla, Spain|Investigational Site Number :153219, Sevilla, Spain|Investigational Site Number :154205, Valencia, Spain|Investigational Site Number :153213, Vigo, Spain|Investigational Site Number :154238, Zaragoza, Spain|Investigational Site Number :153216, Zaragoza, Spain|Investigational Site Number :154095, Borås, Sweden|Investigational Site Number :151726, Malmö, Sweden|Investigational Site Number :154092, Norrköping, Sweden|Investigational Site Number :157045, Bern, Switzerland|Investigational Site Number :154093, Chiayi, Taiwan|Investigational Site Number :152152, Hualien, Taiwan|Investigational Site Number :152246, Kaohsiung Hsien,, Taiwan|Investigational Site Number :152244, Kaohsiung, Taiwan|Investigational Site Number :151534, New Taipei City, Taiwan|Investigational Site Number :151500, Putz City, Chia-yi, Taiwan|Investigational Site Number :151179, Taichung City, Taiwan|Investigational Site Number :151181, Taichung, Taiwan|Investigational Site Number :153248, Tainan, Taiwan|Investigational Site Number :152153, Tainan, Taiwan|Investigational Site Number :151182, Taipei, Taiwan|Investigational Site Number :152321, Taipei, Taiwan|Investigational Site Number :152226, Taipei, Taiwan|Investigational Site Number :153158, Tao Yuan County, Taiwan|Investigational Site Number :764003, Bangkok, Thailand|Investigational Site Number :764004, Bangkok, Thailand|Investigational Site Number :764001, Bangkok, Thailand|Investigational Site Number :764005, Khon Kaen, Thailand|Investigational Site Number :792006, Adana, Turkey|Investigational Site Number :792005, Ankara, Turkey|Investigational Site Number :792001, Ankara, Turkey|Investigational Site Number :792002, Ankara, Turkey|Investigational Site Number :792004, Istanbul, Turkey|Investigational Site Number :792007, Izmir, Turkey|Investigational Site Number :792003, Malatya, Turkey|Investigational Site Number :7840001, Dubai, United Arab Emirates|Investigational Site Number :151340, Cambridge, Cambridgeshire, United Kingdom|Investigational Site Number :152287, Birmingham, United Kingdom|Investigational Site Number :154240, Birmingham, United Kingdom|Investigational Site Number :151123, London, United Kingdom|Investigational Site Number :151646, London, United Kingdom|Investigational Site Number :150303, London, United Kingdom|Investigational Site Number :150455, Manchester, United Kingdom|Investigational Site Number :152361, Salford, United Kingdom|Investigational Site Number :154212, Hanoi, Vietnam|Investigational Site Number :704002, Ho Chi Minh City, Vietnam | |
| Pompe Disease Registry Protocol | Glycogen Storage Disease Type II|Pompe Disease | Understanding of the variability, progression , identification and natural history of the manifestations of Pompe disease | Genzyme, a Sanofi Company|Sanofi | University Alabama at Birmingham-Site Number:840106, Birmingham, Alabama, United States|Barrow Neurological Institute-Site Number:840087, Phoenix, Arizona, United States|Phoenix Children's Hospital-Site Number:840003, Phoenix, Arizona, United States|University of Arizona-Site Number:840015, Tucson, Arizona, United States|Arkansas Childrens Hospital-Site Number:840109, Little Rock, Arkansas, United States|University of Arkansas for Medical Sciences-Site Number:840113, Little Rock, Arkansas, United States|University of California at Irvine-Site Number:840036, Irvine, California, United States|Loma Linda University- Genetics-Site Number:840070, Loma Linda, California, United States|Southern California Permanente Medical Group-Site Number:840108, Los Angeles, California, United States|USC Health Sciences Center Dept of Genetics-Site Number:840082, Los Angeles, California, United States|Children's Hospital Oakland-Site Number:840029, Oakland, California, United States|Children's Hospital of Orange County-Site Number:840074, Orange, California, United States|UC Davis MIND Institute-Site Number:840010, Sacramento, California, United States|Loma Linda University Children's Hospital-Site Number:840117, San Bernardino, California, United States|University of California at San Diego-Site Number:840007, San Diego, California, United States|University of California at San Francisco-Site Number:840051, San Francisco, California, United States|Stanford University Pediatrics-Site Number:840021, Stanford, California, United States|Children's Hospital IMD Clinic-Site Number:840069, Aurora, Colorado, United States|University of Colorado at Denver Genetics-Site Number:840068, Aurora, Colorado, United States|Yale-Site Number:840047, New Haven, Connecticut, United States|Children's National Medical Center-Site Number:840067, Washington, District of Columbia, United States|University of Florida-Genetics-Site Number:840012, Gainesville, Florida, United States|University of Florida Pediatrics Genetics-Site Number:840121, Jacksonville, Florida, United States|The Atwal Clinic-Site Number:840112, Jacksonville, Florida, United States|University Of Miami SOM-Site Number:840006, Miami, Florida, United States|University of Florida-Genetics-Site Number:840096, Tampa, Florida, United States|Emory University School of Medicine- Human Genetics-Site Number:840060, Decatur, Georgia, United States|Ann and Robert Lurie Children's Hospital-Site Number:840011, Chicago, Illinois, United States|Ann and Robert Lurie Children's Hospital-Site Number:840013, Chicago, Illinois, United States|Rush University Medical Center Genetics-Site Number:840079, Chicago, Illinois, United States|Indianapolis University School of Medicine-Site Number:840027, Indianapolis, Indiana, United States|University of Iowa-Site Number:840032, Iowa City, Iowa, United States|University Of Kansas Medical Center-Site Number:840020, Kansas City, Kansas, United States|University of Louisville- Genetics-Site Number:840030, Louisville, Kentucky, United States|Ochsner Medical Center-Site Number:840120, New Orleans, Louisiana, United States|Maine Medical Center Pediatrics-Site Number:840064, Portland, Maine, United States|John Hopkins-Site Number:840044, Baltimore, Maryland, United States|Massachusetts General Hospital-Genetics-Site Number:840062, Boston, Massachusetts, United States|Boston Children's Hospital-Site Number:840092, Boston, Massachusetts, United States|Baystate Health-Site Number:840002, Springfield, Massachusetts, United States|University of Michigan Pediatrics-Site Number:840107, Ann Arbor, Michigan, United States|Children's Hospital of Michigan-Site Number:840066, Detroit, Michigan, United States|Spectrum for Health-Site Number:840019, Grand Rapids, Michigan, United States|Infusion Associates-Site Number:840050, Grand Rapids, Michigan, United States|Children's Health Care-Site Number:840114, Minneapolis, Minnesota, United States|Children's Hospital and Clinics of Minnesota-Site Number:840046, Minneapolis, Minnesota, United States|University of Minnesota Medical Center Pediatrics-Site Number:840035, Minneapolis, Minnesota, United States|University of Minnesota Medical Center Pediatrics-Site Number:840076, Minneapolis, Minnesota, United States|University of Missouri Health System Department of Genetics-Site Number:840031, Columibia, Missouri, United States|Children's Mercy Hospital- Pediatrics-Site Number:840063, Kansas City, Missouri, United States|Washington University of St. Louis-Site Number:840100, Saint Louis, Missouri, United States|University of Nebraska Medical Center- Pediatrics-Site Number:840084, Omaha, Nebraska, United States|Children's Specialty Center of Nevada-Site Number:840008, Las Vegas, Nevada, United States|Cooper Health Center-Site Number:840098, Camden, New Jersey, United States|Hackensack University Medical Center-Site Number:840101, Hackensack, New Jersey, United States|Atlantic Health System-Site Number:840099, Morristown, New Jersey, United States|St. Peter's University Hospital-Site Number:840016, New Brunswick, New Jersey, United States|St. Joseph's Children's Hospital-Site Number:840057, Paterson, New Jersey, United States|Northwell Health-Site Number:840102, Manhasset, New York, United States|New York University School Of Medicine-Site Number:840040, New York, New York, United States|Metropolitan Hospital Center-Site Number:840110, New York, New York, United States|Mt. Sinai School of Medicine-Site Number:840005, New York, New York, United States|University of Rochester Medical Center SOM-Site Number:840105, Rochester, New York, United States|State University of New York-Site Number:840052, Syracuse, New York, United States|New York Medical College-Site Number:840039, Valhalla, New York, United States|Carolinas Medical Center Hospital-Site Number:840065, Charlotte, North Carolina, United States|Duke University Medical Center Genetics Dept-Site Number:840037, Durham, North Carolina, United States|Cincinnati Children's Hospital-Genetics-Site Number:840041, Cincinnati, Ohio, United States|UHCMC-Site Number:840119, Cleveland, Ohio, United States|Cleveland Clinic Foundation Pediatrics-Site Number:840048, Cleveland, Ohio, United States|Nationwide Children's Hospital-Site Number:840091, Columbus, Ohio, United States|LSD Data Registry Site LLC-Site Number:840094, Dublin, Ohio, United States|Oregon Health & Sciences University-Site Number:840080, Portland, Oregon, United States|Oregon Health & Science University-Site Number:840095, Portland, Oregon, United States|Oregon Health and Scinece University-Site Number:840038, Portland, Oregon, United States|Penn Hershey Medical Center-Site Number:840061, Hershey, Pennsylvania, United States|Children's Hospital of Philadelphia HUP Medical Genetics-Site Number:840089, Philadelphia, Pennsylvania, United States|Children's Hospital of Philadelphia-Site Number:840034, Philadelphia, Pennsylvania, United States|UPMC-Site Number:840014, Pittsburgh, Pennsylvania, United States|University of Pittsburgh-Site Number:840023, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital Genetics-Site Number:840053, Providence, Rhode Island, United States|Greenwood Genetcs-Site Number:840055, Greenville, South Carolina, United States|Vanderbilt University Hospital-Pediatrics-Site Number:840049, Nashville, Tennessee, United States|Baylor Research Center-Site Number:840058, Dallas, Texas, United States|Cook Children's Health Care System-Site Number:840024, Fort Worth, Texas, United States|University of Utah Department of Medical Genetics-Site Number:840043, Salt Lake City, Utah, United States|University of Virginia School of Medicine-Pediatrics-Site Number:840078, Charlottesville, Virginia, United States|O&O Alpan, LLC-Site Number:840025, Fairfax, Virginia, United States|Children's Hospital of the Kings Daughters-Site Number:840072, Norfolk, Virginia, United States|Seattle Children's Hospital-Site Number:840028, Seattle, Washington, United States|University Of Washington Medical Center-Site Number:840059, Seattle, Washington, United States|Multicare Health System � Mary Bridge Childrens Hospital-Site Number:840115, Tacoma, Washington, United States|Children's Hospital of Wisconsin-Pediatrics-Site Number:840054, Milwaukee, Wisconsin, United States|Investigational Site Number :152218, Caba, Buenos Aires, Argentina|Investigational Site Number :153194, Caba, Buenos Aires, Argentina|Investigational Site Number :153032, Buenos Aires, Argentina|Investigational Site Number :036013, Westmead, New South Wales, Australia|Investigational Site Number :151069, Westmead, New South Wales, Australia|Investigational Site Number :152096, Brisbane, Queensland, Australia|Investigational Site Number :154087, Herston, Queensland, Australia|Investigational Site Number :151002, Adelaide, South Australia, Australia|Investigational Site Number :151015, Murdoch, Western Australia, Australia|Investigational Site Number :150722, Antwerpen, Belgium|Investigational Site Number :154298, Brugge, Belgium|Investigational Site Number :150684, Bruxelles, Belgium|Investigational Site Number :056010, Bruxelles, Belgium|Investigational Site Number :152072, Edegem, Belgium|Investigational Site Number :152295, Gent, Belgium|Investigational Site Number :153179, Gosselies, Belgium|Investigational Site Number :151668, Leuven, Belgium|Investigational Site Number :152126, Leuven, Belgium|Investigational Site Number :076008, Porto Alegre, Rio Grande Do Sul, Brazil|Investigational Site Number :076003, Cuiabá, Brazil|Investigational Site Number :076011, Fortaleza, Brazil|Investigational Site Number :076009, Ribeirão Preto, Brazil|Investigational Site Number :076001, Rio de Janeiro, Brazil|Investigational Site Number :076002, São Paulo, Brazil|Investigational Site Number :076012, São Paulo, Brazil|Investigational Site Number :076004, São Paulo, Brazil|Investigational Site Number :076007, São Paulo, Brazil|Investigational Site Number :100001, Sofia, Bulgaria|Investigational Site Number :124014, Calgary, Alberta, Canada|Investigational Site Number :124002, Edmonton, Alberta, Canada|Investigational Site Number :124010, Vancouver, British Columbia, Canada|Investigational Site Number :124011, Vancouver, British Columbia, Canada|Investigational Site Number :124019, Winnipeg, Manitoba, Canada|Investigational Site Number :124022, Moncton, New Brunswick, Canada|Investigational Site Number :124007, Hamilton, Ontario, Canada|Investigational Site Number :124021, London, Ontario, Canada|Investigational Site Number :124006, Toronto, Ontario, Canada|Investigational Site Number :124004, Montreal, Quebec, Canada|Investigational Site Number :124018, Montreal, Quebec, Canada|Investigational Site Number :124001, Sherbrooke, Quebec, Canada|Investigational Site Number :152002, Punta Arenas, Chile|Investigational Site Number :152001, Santiago, Chile|Investigational Site Number :152380, Beijing, China|Investigational Site Number :153202, Beijing, China|Investigational Site Number :153203, Beijing, China|Investigational Site Number :152379, Guangzhou, China|Investigational Site Number :152381, Jinan, China|Investigational Site Number :152356, Shanghai, China|Investigational Site Number :152382, Shanghai, China|Investigational Site Number :170001, Bogota, Colombia|Investigational Site Number :1910001, Zagreb, Croatia|Investigational Site Number :1910002, Zagreb, Croatia|Investigational Site Number :150809, Praha 2, Czechia|Investigational Site Number :151229, København, Denmark|Investigational Site Number :250010, Bordeaux, France|Investigational Site Number :250012, Brest, France|Investigational Site Number :250003, BRON Cedex, France|Investigational Site Number :250007, BRON Cedex, France|Investigational Site Number :250009, Caen, France|Investigational Site Number :250015, GRENOBLE cedex, France|Investigational Site Number :250008, Lille Cedex, France|Investigational Site Number :250002, Marseille Cedex 05, France|Investigational Site Number :250017, NANCY Cedex, France|Investigational Site Number :250019, NANTES Cedex 1, France|Investigational Site Number :250005, Nice cedex 1, France|Investigational Site Number :250011, NIMES Cedex 9, France|Investigational Site Number :250001, PARIS Cedex 13, France|Investigational Site Number :250004, Paris, France|Investigational Site Number :250018, St Etienne, France|Investigational Site Number :250016, Strasbourg Cedex 2, France|Investigational Site Number :250014, Toulouse, France|Investigational Site Number :250006, Tours, France|Investigational Site Number :25013, Vannes Cedex, France|Investigational Site Number :152041, Berlin, Germany|Investigational Site Number :151686, Berlin, Germany|Investigational Site Number :152293, Berlin, Germany|Investigational Site Number :152234, Bochum, Germany|Investigational Site Number :152200, Bonn, Germany|Investigational Site Number :152108, Freiburg, Germany|Investigational Site Number :154150, Gießen, Germany|Investigational Site Number :152045, Halle (Saale), Germany|Investigational Site Number :154215, Hamburg, Germany|Investigational Site Number :150031, Mainz, Germany|Investigational Site Number :152075, München, Germany|Investigational Site Number :152299, Münster, Germany|Investigational Site Number :300001, Thessaloniki, Greece|Investigational Site Number :3480009, Debrecen, Hungary|Investigational Site Number :3480007, Nyíregyháza, Hungary|Investigational Site Number :3480011, Pécs, Hungary|Investigational Site Number :3480012, Székesfehérvár, Hungary|Investigational Site Number :356003, Ahmedabad, India|Investigational Site Number :356001, Kolkata, India|Investigational Site Number :3560004, Secunderabad, India|Investigational Site Number :356002, Vellore, India|Investigational Site Number :360001, Jakarta, Indonesia|Investigational Site Number :3760002, Beer Sheva, Israel|Investigational Site Number :3760001, Haifa, Israel|Investigational Site Number :3760003, Tel Aviv, Israel|Investigational Site Number :380008, Brescia, Italy|Investigational Site Number :380006, Cagliari, Italy|Investigational Site Number :380014, Ferrara, Italy|Investigational Site Number :380005, Firenze, Italy|Investigational Site Number :380004, Genova, Italy|Investigational Site Number :380013, Messina, Italy|Investigational Site Number :380016, Milano, Italy|Investigational Site Number :380007, Milano, Italy|Investigational Site Number :380009, Monza, Italy|Investigational Site Number :380010, Napoli, Italy|Investigational Site Number :380019, Napoli, Italy|Investigational Site Number :380002, Padova, Italy|Investigational Site Number :380011, Padova, Italy|Investigational Site Number :380003, Pavia, Italy|Investigational Site Number :380015, Roma, Italy|Investigational Site Number :380012, Roma, Italy|Investigational Site Number :380017, Torino, Italy|Investigational Site Number :380001, Udine, Italy|Investigational Site Number :392106, Sakyo-ku, Kyoto, Japan|Investigational Site Number :392105, Ginowan, Okinawa, Japan|Investigational Site Number :4000001, Amman, Jordan|Investigational Site Number :153178, Busan, Korea, Republic of|Investigational Site Number :153191, Daejeon, Korea, Republic of|Investigational Site Number :153225, Jeonnam, Korea, Republic of|Investigational Site Number :153180, Seoul, Korea, Republic of|Investigational Site Number :153196, Seoul, Korea, Republic of|Investigational Site Number :153192, Seoul, Korea, Republic of|Investigational Site Number :151149, Seoul, Korea, Republic of|Investigational Site Number :153176, Seoul, Korea, Republic of|Investigational Site Number :153212, Seoul, Korea, Republic of|Investigational Site Number :153222, Seoul, Korea, Republic of|Investigational Site Number :154148, Yangsan, Korea, Republic of|Investigational Site Number :154225, Kuwait, Kuwait|Investigational Site Number :4220004, Beirut, Lebanon|Investigational Site Number :4220002, Hazmieh, Lebanon|Investigational Site Number :458001, Jalan Pahang, Malaysia|Investigational Site Number :458002, Kuala Lumpur, Malaysia|Investigational Site Number :152029, Rotterdam, Netherlands|Investigational Site Number :154264, Karachi, Pakistan|Investigational Site Number :154266, Lahore, Pakistan|Investigational Site Number :608001, Manila, Philippines|Investigational Site Number :150575, Warszawa, Poland|Investigational Site Number :620008, Coimbra, Portugal|Investigational Site Number :620006, Lisboa, Portugal|Investigational Site Number :154099, Bucuresti, Romania|Investigational Site Number :643002, Moscow, Russian Federation|Investigational Site Number :682004, Makkah, Saudi Arabia|Investigational Site Number :682001, Qatif, Saudi Arabia|Investigational Site Number :6880001, Belgrade, Serbia|Investigational Site Number :702001, Singapore, Singapore|Investigational Site Number :703001, Bratislava, Slovakia|Investigational Site Number :154093, Chiayi, Taiwan|Investigational Site Number :152152, Hualien, Taiwan|Investigational Site Number :152246, Kaohsiung Hsien,, Taiwan|Investigational Site Number :152244, Kaohsiung, Taiwan|Investigational Site Number :151534, New Taipei City, Taiwan|Investigational Site Number :151500, Putz City, Chia-yi, Taiwan|Investigational Site Number :151179, Taichung City, Taiwan|Investigational Site Number :151181, Taichung, Taiwan|Investigational Site Number :153248, Tainan, Taiwan|Investigational Site Number :152153, Tainan, Taiwan|Investigational Site Number :151182, Taipei, Taiwan|Investigational Site Number :152321, Taipei, Taiwan|Investigational Site Number :152226, Taipei, Taiwan|Investigational Site Number :153158, Tao Yuan County, Taiwan|Investigational Site Number :764002, Bangkok, Thailand|Investigational Site Number :764003, Bangkok, Thailand|Investigational Site Number :764004, Bangkok, Thailand|Investigational Site Number :764001, Bangkok, Thailand|Investigational Site Number :764005, Khon Kaen, Thailand|Investigational Site Number :7840001, Dubai, United Arab Emirates|Investigational Site Number :151340, Cambridge, Cambridgeshire, United Kingdom|Investigational Site Number :152287, Birmingham, United Kingdom|Investigational Site Number :154240, Birmingham, United Kingdom|Investigational Site Number :152334, Cardiff, United Kingdom|Investigational Site Number :152156, Glasgow, United Kingdom|Investigational Site Number :151123, London, United Kingdom|Investigational Site Number :151646, London, United Kingdom|Investigational Site Number :150303, London, United Kingdom|Investigational Site Number :150455, Manchester, United Kingdom|Investigational Site Number :152087, Newcastle, United Kingdom|Investigational Site Number :150964, Salford, United Kingdom|Investigational Site Number :154212, Hanoi, Vietnam|Investigational Site Number :704002, Ho Chi Minh City, Vietnam | |
| Fabry Disease Registry & Pregnancy Sub-registry | Fabry Disease | Fabry Registry: To evaluate the long-term safety and effectiveness of Fabrazyme®|Fabry Pregnancy Sub-registry: pregnancy outcomes, including complications and infant growth|Fabry Register: Monitor factors associated with the efficacy of Fabry disease treatments | Genzyme, a Sanofi Company|Sanofi | University of Alabama Birmingham- Nephrology-Site Number:840018, Birmingham, Alabama, United States|University of Alabama Birmingham- Nephrology-Site Number:840073, Birmingham, Alabama, United States|Phoenix Children's Hospital-Site Number:840003, Phoenix, Arizona, United States|University of Arizona-Site Number:840015, Tucson, Arizona, United States|Arkansas Childrens Hospital-Site Number:840109, Little Rock, Arkansas, United States|University of Arkansas for Medical Sciences-Site Number:840113, Little Rock, Arkansas, United States|University of California at Irvine-Site Number:840036, Irvine, California, United States|Southern California Permanente Medical Group-Site Number:840108, Los Angeles, California, United States|USC Health Sciences Center Dept of Genetics-Site Number:840082, Los Angeles, California, United States|UCLA School Of Medicine-Site Number:840088, Los Angeles, California, United States|Children's Hospital of Orange County-Site Number:840074, Orange, California, United States|Stanford Unviersity MC Dept of Genetics-Site Number:840022, Palo Alto, California, United States|UC Davis MIND Institute-Site Number:840010, Sacramento, California, United States|Kaiser Permanente Hospital-Site Number:840042, Sacramento, California, United States|Loma Linda University Children's Hospital-Site Number:840117, San Bernardino, California, United States|University of California at San Diego-Site Number:840007, San Diego, California, United States|University of California at San Francisco-Site Number:840051, San Francisco, California, United States|University of Colorado at Denver Genetics-Site Number:840068, Aurora, Colorado, United States|Yale-Site Number:840047, New Haven, Connecticut, United States|Children's National Medical Center-Site Number:840067, Washington, District of Columbia, United States|University Hematology Oncology-Site Number:840075, Coral Springs, Florida, United States|University of Florida Dept of Genetics-Site Number:840083, Gainesville, Florida, United States|University of Florida Pediatrics Genetics-Site Number:840121, Jacksonville, Florida, United States|The Atwal Clinic-Site Number:840112, Jacksonville, Florida, United States|University Of Miami SOM-Site Number:840006, Miami, Florida, United States|Children's Hospital Oakland-Site Number:840029, Oakland, Florida, United States|University of Florida-Genetics-Site Number:840096, Tampa, Florida, United States|Emory University School of Medicine- Human Genetics-Site Number:840060, Decatur, Georgia, United States|Ann and Robert Lurie Children's Hospital-Site Number:840013, Chicago, Illinois, United States|Rush University Medical Center Genetics-Site Number:840079, Chicago, Illinois, United States|Indianapolis University School of Medicine-Site Number:840027, Indianapolis, Indiana, United States|University of Iowa-Site Number:840032, Iowa City, Iowa, United States|University Of Kansas Medical Center-Site Number:840071, Kansas City, Kansas, United States|University of Louisville- Genetics-Site Number:840030, Louisville, Kentucky, United States|Ochsner Medical Center-Site Number:840120, Baton Rouge, Louisiana, United States|Tulane University Medical Center-Site Number:840001, New Orleans, Louisiana, United States|Maine Medical Center Pediatrics-Site Number:840064, Portland, Maine, United States|John Hopkins-Site Number:840044, Baltimore, Maryland, United States|Massachusetts General Hospital-Genetics-Site Number:840062, Boston, Massachusetts, United States|Brigham and Women's Hospital-Neurology-Site Number:840103, Boston, Massachusetts, United States|Boston Children's Hospital-Site Number:840092, Boston, Massachusetts, United States|Baystate Health-Site Number:840002, Springfield, Massachusetts, United States|University of Michigan Pediatrics-Site Number:840107, Ann Arbor, Michigan, United States|Children's Hospital of Michigan-Site Number:840066, Detroit, Michigan, United States|Spectrum for Health-Site Number:840019, Grand Rapids, Michigan, United States|Infusion Associates-Site Number:840050, Grand Rapids, Michigan, United States|Children's Health Care-Site Number:840114, Minneapolis, Minnesota, United States|Children's Hospital and Clinics of Minnesota-Site Number:840046, Minneapolis, Minnesota, United States|University of Minnesota Medical Center Pediatrics-Site Number:840076, Minneapolis, Minnesota, United States|University of Missouri Health System Department of Genetics-Site Number:840031, Columibia, Missouri, United States|Washington University of St. Louis-Site Number:840100, Saint Louis, Missouri, United States|Billings Clinic-Site Number:840118, Billings, Montana, United States|Shodair Children's Hospital-Site Number:840090, Helena, Montana, United States|University of Nebraska Medical Center- Pediatrics-Site Number:840084, Omaha, Nebraska, United States|Children's Specialty Center of Nevada-Site Number:840008, Las Vegas, Nevada, United States|Cooper Health Center-Site Number:840098, Camden, New Jersey, United States|Joseph M. Sanzari Children's Hospital-Site Number:840101, Hackensack, New Jersey, United States|Atlantic Health System-Site Number:840099, Morristown, New Jersey, United States|St. Peter's University Hospital-Site Number:840016, New Brunswick, New Jersey, United States|St. Joseph's Children's Hospital-Site Number:840057, Paterson, New Jersey, United States|Northwell Health-Site Number:840102, Manhasset, New York, United States|New York University School Of Medicine-Site Number:840040, New York, New York, United States|Icahn School of Medicine-Site Number:840080, New York, New York, United States|Metropolitan Hospital Center-Site Number:840110, New York, New York, United States|University of Rochester Medical Center SOM-Site Number:840105, Rochester, New York, United States|State University of New York-Site Number:840052, Syracuse, New York, United States|New York Medical College-Site Number:840039, Valhalla, New York, United States|Carolinas Medical Center-Site Number:840065, Charlotte, North Carolina, United States|Duke University Medical Center Genetics Dept-Site Number:840045, Durham, North Carolina, United States|Cincinnati Children's Hospital-Genetics-Site Number:840033, Cincinnati, Ohio, United States|UHCMC-Site Number:840119, Cleveland, Ohio, United States|Cleveland Clinic Foundation Pediatrics-Site Number:840048, Cleveland, Ohio, United States|Nationwide Children's Hospital-Site Number:840091, Columbus, Ohio, United States|Ohio State University Department of Genetics-Site Number:840097, Columbus, Ohio, United States|LSD Data Registry Site LLC-Site Number:840094, Dublin, Ohio, United States|Oregon Health & Science University-Site Number:840116, Portland, Oregon, United States|Oregon Health and Scinece University-Site Number:840038, Portland, Oregon, United States|Geisinger-Site Number:840111, Danville, Pennsylvania, United States|Penn State University Medical Center-Neurology-Site Number:840104, Hershey, Pennsylvania, United States|Children's Hospital of Philadelphia HUP Medical Genetics-Site Number:840089, Philadelphia, Pennsylvania, United States|Children's Hospital of Philadelphia-Site Number:840034, Philadelphia, Pennsylvania, United States|University of Pittsburgh-Site Number:840023, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital Genetics-Site Number:840053, Providence, Rhode Island, United States|Greenwood Genetcs-Site Number:840055, Greenville, South Carolina, United States|Vanderbilt University Hospital-Pediatrics-Site Number:840049, Nashville, Tennessee, United States|Baylor Research Center-Site Number:840058, Dallas, Texas, United States|Cook Children's Health Care System-Site Number:840024, Fort Worth, Texas, United States|University of Utah Department of Medical Genetics-Site Number:840043, Salt Lake City, Utah, United States|University of Virginia School of Medicine-Pediatrics-Site Number:840078, Charlottesville, Virginia, United States|O&O Alpan, LLC-Site Number:840025, Fairfax, Virginia, United States|Children's Hospital of the Kings Daughters-Site Number:840072, Norfolk, Virginia, United States|Seattle Children's Hospital-Site Number:840028, Seattle, Washington, United States|University Of Washington Medical Center-Site Number:840059, Seattle, Washington, United States|Multicare Health System � Mary Bridge Childrens Hospital-Site Number:840115, Tacoma, Washington, United States|Children's Hospital of Wisconsin-Pediatrics-Site Number:840054, Milwaukee, Wisconsin, United States|Investigational Site Number :153172, Caba, Buenos Aires, Argentina|Investigational Site Number :153032, Buenos Aires, Argentina|Investigational Site Number :153130, Buenos Aires, Argentina|Investigational Site Number :153194, Catamarca, Argentina|Investigational Site Number :032005, La Rioja, Argentina|Investigational Site Number :032004, Santa Fe, Argentina|Investigational Site Number :036013, Westmead, New South Wales, Australia|Investigational Site Number :151069, Westmead, New South Wales, Australia|Investigational Site Number :153063, Herston, Queensland, Australia|Investigational Site Number :151002, Adelaide, South Australia, Australia|Investigational Site Number :153040, Parkville, Victoria, Australia|Investigational Site Number :153090, Perth, Western Australia, Australia|Investigational Site Number :150722, Antwerpen, Belgium|Investigational Site Number :153133, Antwerpen, Belgium|Investigational Site Number :153001, Brussels, Belgium|Investigational Site Number :0560008, Brussel, Belgium|Investigational Site Number :150517, Bruxelles, Belgium|Investigational Site Number :151668, Leuven, Belgium|Investigational Site Number :154275, Liège, Belgium|Investigational Site Number :153100, Seraing, Belgium|Investigational Site Number :076008, Feira de Santana, Bahia, Brazil|Investigational Site Number :076005, Recife, Pernambuco, Brazil|Investigational Site Number :076002, Tapejara, Rio Grande Do Sul, Brazil|Investigational Site Number :076012, Florianopolis, Santa Catarina, Brazil|Investigational Site Number :076009, Brasília, Brazil|Investigational Site Number :076013, Campinas, Brazil|Investigational Site Number :076006, Cuiabá, Brazil|Investigational Site Number :076004, Curitiba, Brazil|Investigational Site Number :076011, Ourinhos, Brazil|Investigational Site Number :076001, São Paulo, Brazil|Investigational Site Number :076007, Uberlândia, Brazil|Investigational Site Number :153169, Sofia, Bulgaria|Investigational Site Number :100001, Sofia, Bulgaria|Investigational Site Number :124014, Calgary, Alberta, Canada|Investigational Site Number :124002, Edmonton, Alberta, Canada|Investigational Site Number :124010, Vancouver, British Columbia, Canada|Investigational Site Number :124011, Vancouver, British Columbia, Canada|Investigational Site Number :124019, Winnipeg, Manitoba, Canada|Investigational Site Number :124022, Moncton, New Brunswick, Canada|Investigational Site Number :124023, St. John's, Newfoundland and Labrador, Canada|Investigational Site Number :124008, Halifax, Nova Scotia, Canada|Investigational Site Number :124005, Kingston, Ontario, Canada|Investigational Site Number :124021, London, Ontario, Canada|Investigational Site Number :124006, Toronto, Ontario, Canada|Investigational Site Number :124009, Toronto, Ontario, Canada|Investigational Site Number :124013, Montreal, Quebec, Canada|Investigational Site Number :124001, Sherbrooke, Quebec, Canada|Investigational Site Number :152004, Antofagasta, Chile|Investigational Site Number :152001, Coquimbo, Chile|Investigational Site Number :152003, Iquique, Chile|Investigational Site Number :152002, Santiago, Chile|Investigational Site Number :152005, Vallenar, Chile|Investigational Site Number :153165, Beijing, China|Investigational Site Number :153163, Shanghai, China|Investigational Site Number :170001, Bogotá, Colombia|Investigational Site Number :1910001, Rijena, Croatia|Investigational Site Number :1910002, Zagreb, Croatia|Investigational Site Number :153126, Praha 2, Czechia|Investigational Site Number :153041, Copenhagen, Denmark|Investigational Site Number :151229, København, Denmark|Investigational Site Number :153106, Tartu, Estonia|Investigational Site Number :153024, Turku, Finland|Investigational Site Number :250005, Bordeaux, France|Investigational Site Number :250002, BRON Cedex, France|Investigational Site Number :250001, Garches, France|Investigational Site Number :250007, Lille, France|Investigational Site Number :250003, LIMOGES Cedex, France|Investigational Site Number :250006, Marseille, France|Investigational Site Number :250004, Saint Priest en Jarez, France|Investigational Site Number :250009, Strasbourg, France|Investigational Site Number :153013, Berlin, Germany|Investigational Site Number :154150, Gießen, Germany|Investigational Site Number :153147, Münster, Germany|Investigational Site Number :153011, Würzburg, Germany|Investigational Site Number :3480002, Budapest, Hungary|Investigational Site Number :3480003, Létavértes, Hungary|Investigational Site Number :3480005, Pécs, Hungary|Investigational Site Number :3480004, Sopron, Hungary|Investigational Site Number :356003, Ahmedabad, India|Investigational Site Number :356001, Kolkata, India|Investigational Site Number :3560004, Secunderabad, India|Investigational Site Number :356002, Vellore, India|Investigational Site Number :360001, Jakarta, Indonesia|Investigational Site Number :380002, Bassano Del Grappa (VI), Italy|Investigational Site Number :380004, Firenze, Italy|Investigational Site Number :380013, Firenze, Italy|Investigational Site Number :380005, Genova, Italy|Investigational Site Number :380009, Milano, Italy|Investigational Site Number :380006, Milano, Italy|Investigational Site Number :380003, Modena, Italy|Investigational Site Number :380010, Monza (MB), Italy|Investigational Site Number :380008, Napoli, Italy|Investigational Site Number :380007, Rimini, Italy|Investigational Site Number :380012, Roma, Italy|Investigational Site Number :380011, Torino, Italy|Investigational Site Number :380001, Udine, Italy|Investigational Site Number :380014, Vittoria (RG), Italy|Investigational Site Number :153201, Nangoku-shi, Kochi, Japan|Investigational Site Number :153205, Abeno-ku, Osaka, Japan|Investigational Site Number :153204, Setagaya, Tokyo, Japan|Investigational Site Number :153217, Chiba, Japan|Investigational Site Number :392007, Kobe-shi, Hyogo, Japan|Investigational Site Number :392006, Niigata, Japan|Investigational Site Number :153178, Busan, Korea, Republic of|Investigational Site Number :154246, Busan, Korea, Republic of|Investigational Site Number :153191, Daejeon, Korea, Republic of|Investigational Site Number :153228, Jeju-si, Korea, Republic of|Investigational Site Number :153225, Jeonnam, Korea, Republic of|Investigational Site Number :153180, Seoul, Korea, Republic of|Investigational Site Number :153196, Seoul, Korea, Republic of|Investigational Site Number :153192, Seoul, Korea, Republic of|Investigational Site Number :151149, Seoul, Korea, Republic of|Investigational Site Number :153188, Seoul, Korea, Republic of|Investigational Site Number :153212, Seoul, Korea, Republic of|Investigational Site Number :153222, Seoul, Korea, Republic of|Investigational Site Number :154273, Suwon-si, Korea, Republic of|Investigational Site Number :154148, Yangsan, Korea, Republic of|Investigational Site Number :154208, Yangsan, Korea, Republic of|Investigational Site Number :154225, Kuwait, Kuwait|Investigational Site Number :154244, Vilnius, Lithuania|Investigational Site Number :154652, Vilnius, Lithuania|Investigational Site Number :458001, Jalan Pahang, Malaysia|Investigational Site Number :458002, Kuala Lumpur, Malaysia|Investigational Site Number :151171, Amsterdam, Netherlands|Investigational Site Number :153004, Amsterdam, Netherlands|Investigational Site Number :153141, Bergen, Norway|Investigational Site Number :604002, Callao, Peru|Investigational Site Number :608001, Manila, Philippines|Investigational Site Number :150575, Warszawa, Poland|Investigational Site Number :620005, Lisboa, Portugal|Investigational Site Number :620001, Porto, Portugal|Investigational Site Number :154099, Bucuresti, Romania|Investigational Site Number :154164, Bucuresti, Romania|Investigational Site Number :153081, Cluj-Napoca, Romania|Investigational Site Number :643001, Moscow, Russian Federation|Investigational Site Number :643003, Nizhny Novgorod, Russian Federation|Investigational Site Number :643002, Saint-Peterburg, Russian Federation|Investigational Site Number :682002, Al Mubarraz, Saudi Arabia|Investigational Site Number :6880001, Novi Sad, Serbia|Investigational Site Number :702001, Singapore, Singapore|Investigational Site Number :703001, Bratislava, Slovakia|Investigational Site Number :705001, Slovenj Gradec, Slovenia|Investigational Site Number :154135, Barakaldo, Spain|Investigational Site Number :153067, Barcelona, Spain|Investigational Site Number :153237, Barcelona, Spain|Investigational Site Number :154147, Barcelona, Spain|Investigational Site Number :154204, Barcelona, Spain|Investigational Site Number :153077, Barcelona, Spain|Investigational Site Number :154123, Barcelona, Spain|Investigational Site Number :154146, La Coruna, Spain|Investigational Site Number :154159, La Coruna, Spain|Investigational Site Number :154136, Tarragona, Spain|Investigational Site Number :153213, Vigo, Spain|Investigational Site Number :153050, Göteborg, Sweden|Investigational Site Number :151484, Stockholm, Sweden|Investigational Site Number :154093, Chiayi, Taiwan|Investigational Site Number :152152, Hualien, Taiwan|Investigational Site Number :153088, Kaohsiung City, Taiwan|Investigational Site Number :152246, Kaohsiung Hsien,, Taiwan|Investigational Site Number :152244, Kaohsiung, Taiwan|Investigational Site Number :151534, New Taipei City, Taiwan|Investigational Site Number :151500, Putz City, Chia-yi, Taiwan|Investigational Site Number :151179, Taichung City, Taiwan|Investigational Site Number :151181, Taichung, Taiwan|Investigational Site Number :153248, Tainan, Taiwan|Investigational Site Number :152153, Tainan, Taiwan|Investigational Site Number :151182, Taipei, Taiwan|Investigational Site Number :152321, Taipei, Taiwan|Investigational Site Number :152226, Taipei, Taiwan|Investigational Site Number :153158, Tao Yuan County, Taiwan|Investigational Site Number :764003, Bangkok, Thailand|Investigational Site Number :764004, Bangkok, Thailand|Investigational Site Number :764001, Bangkok, Thailand|Investigational Site Number :764005, Khon Kaen, Thailand|Investigational Site Number :7840001, Dubai, United Arab Emirates|Investigational Site Number :151340, Cambridge, Cambridgeshire, United Kingdom|Investigational Site Number :154196, Belfast, United Kingdom|Investigational Site Number :152287, Birmingham, United Kingdom|Investigational Site Number :151123, London, United Kingdom|Investigational Site Number :151646, London, United Kingdom|Investigational Site Number :150303, London, United Kingdom|Investigational Site Number :150455, Manchester, United Kingdom|Investigational Site Number :152361, Salford, United Kingdom|Investigational Site Number :154212, Hanoi, Vietnam | |
| Mucopolysaccharidosis I (MPS I) Registry | Mucopolysaccharidosis I (MPS I) | To evaluate the long-term effectiveness of Aldurazyme | Genzyme, a Sanofi Company|Sanofi | Phoenix Children's Hospital-Site Number:840003, Phoenix, Arizona, United States|Arkansas Childrens Hospital-Site Number:840109, Little Rock, Arkansas, United States|Southern California Permanente Medical Group-Site Number:840108, Los Angeles, California, United States|USC Health Sciences Center Dept of Genetics-Site Number:840082, Los Angeles, California, United States|Children's Hospital of Orange County-Site Number:840074, Orange, California, United States|Stanford Unviersity MC Dept of Genetics-Site Number:840022, Palo Alto, California, United States|UC Davis MIND Institute-Site Number:840010, Sacramento, California, United States|Loma Linda University Children's Hospital-Site Number:840117, San Bernardino, California, United States|University of California at San Diego-Site Number:840007, San Diego, California, United States|University of California at San Francisco-Site Number:840051, San Francisco, California, United States|Children's Hospital IMD Clinic-Site Number:840069, Aurora, Colorado, United States|University of Colorado at Denver Genetics-Site Number:840068, Aurora, Colorado, United States|Yale-Site Number:840047, New Haven, Connecticut, United States|Children's National Medical Center-Site Number:840067, Washington, District of Columbia, United States|University of Florida Dept of Genetics-Site Number:840083, Gainesville, Florida, United States|University of Florida Pediatrics Genetics-Site Number:840121, Jacksonville, Florida, United States|The Atwal Clinic-Site Number:840112, Jacksonville, Florida, United States|University Of Miami SOM-Site Number:840006, Miami, Florida, United States|Children's Hospital Oakland-Site Number:840029, Oakland, Florida, United States|Pediatric Endocrine Associates-Site Number:840017, Tampa, Florida, United States|Emory University School of Medicine- Human Genetics-Site Number:840060, Decatur, Georgia, United States|Ann and Robert Lurie Children's Hospital-Site Number:840011, Chicago, Illinois, United States|Rush University Medical Center Genetics-Site Number:840079, Chicago, Illinois, United States|Indianapolis University School of Medicine-Site Number:840027, Indianapolis, Indiana, United States|University of Iowa-Site Number:840032, Iowa City, Iowa, United States|University of Louisville- Genetics-Site Number:840030, Louisville, Kentucky, United States|Ochsner Medical Center-Site Number:840120, New Orleans, Louisiana, United States|John Hopkins-Site Number:840044, Baltimore, Maryland, United States|Massachusetts General Hospital-Genetics-Site Number:840062, Boston, Massachusetts, United States|Boston Children's Hospital-Site Number:840093, Boston, Massachusetts, United States|Baystate Health-Site Number:840002, Springfield, Massachusetts, United States|University of Michigan Pediatrics-Site Number:840107, Ann Arbor, Michigan, United States|Children's Hospital of Michigan-Site Number:840066, Detroit, Michigan, United States|Children's Health Care-Site Number:840114, Minneapolis, Minnesota, United States|University of Minnesota Medical Center Pediatrics-Site Number:840076, Minneapolis, Minnesota, United States|Washington University of St. Louis-Site Number:840100, Saint Louis, Missouri, United States|University of Nebraska Medical Center- Pediatrics-Site Number:840084, Omaha, Nebraska, United States|Children's Specialty Center of Nevada-Site Number:840008, Las Vegas, Nevada, United States|Joseph M. Sanzari Children's Hospital-Site Number:840101, Hackensack, New Jersey, United States|Atlantic Health System-Site Number:840099, Morristown, New Jersey, United States|St. Peter's University Hospital-Site Number:840016, New Brunswick, New Jersey, United States|St. Joseph's Children's Hospital-Site Number:840057, Paterson, New Jersey, United States|Northwell Health-Site Number:840102, Manhasset, New York, United States|New York University School Of Medicine-Site Number:840040, New York, New York, United States|Metropolitan Hospital Center-Site Number:840110, New York, New York, United States|University of Rochester Medical Center SOM-Site Number:840105, Rochester, New York, United States|State University of New York-Site Number:840052, Syracuse, New York, United States|Duke University Medical Center Genetics Dept-Site Number:840037, Durham, North Carolina, United States|Cincinnati Children's Hospital-Genetics-Site Number:840041, Cincinnati, Ohio, United States|UHCMC-Site Number:840119, Cleveland, Ohio, United States|Nationwide Children's Hospital-Site Number:840091, Columbus, Ohio, United States|LSD Data Registry Site LLC-Site Number:840094, Dublin, Ohio, United States|Oregon Health & Science University-Site Number:840080, Portland, Oregon, United States|Children's Hospital of Philadelphia HUP Medical Genetics-Site Number:840089, Philadelphia, Pennsylvania, United States|Children's Hospital of Philadelphia-Site Number:840034, Philadelphia, Pennsylvania, United States|University of Pittsburgh-Site Number:840023, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital Genetics-Site Number:840053, Providence, Rhode Island, United States|Greenwood Genetcs-Site Number:840055, Greenville, South Carolina, United States|Baylor Research Center-Site Number:840058, Dallas, Texas, United States|University of Utah Medical Center-Site Number:840092, Salt Lake City, Utah, United States|University of Virginia School of Medicine-Pediatrics-Site Number:840078, Charlottesville, Virginia, United States|Children's Hospital of the Kings Daughters-Site Number:840072, Norfolk, Virginia, United States|Seattle Children's Hospital-Site Number:840028, Seattle, Washington, United States|University Of Washington Medical Center-Site Number:840059, Seattle, Washington, United States|Multicare Health System � Mary Bridge Childrens Hospital-Site Number:840115, Tacoma, Washington, United States|Children's Hospital of Wisconsin-Pediatrics-Site Number:840054, Milwaukee, Wisconsin, United States|Investigational Site Number :153032, Buenos Aires, Argentina|Investigational Site Number :153130, Buenos Aires, Argentina|Investigational Site Number :151069, Westmead, New South Wales, Australia|Investigational Site Number :152096, Brisbane, Queensland, Australia|Investigational Site Number :150944, Brussel, Belgium|Investigational Site Number :150517, Bruxelles, Belgium|Investigational Site Number :151668, Leuven, Belgium|Investigational Site Number :154008, Roeselare, Belgium|Investigational Site Number :076001, Porto Alegre, Rio Grande Do Sul, Brazil|Investigational Site Number :076007, Campinas, Brazil|Investigational Site Number :076004, Rio de Janeiro, Brazil|Investigational Site Number :076002, São Paulo, Brazil|Investigational Site Number :124014, Calgary, Alberta, Canada|Investigational Site Number :124002, Edmonton, Alberta, Canada|Investigational Site Number :124011, Vancouver, British Columbia, Canada|Investigational Site Number :124019, Winnipeg, Manitoba, Canada|Investigational Site Number :124022, Moncton, New Brunswick, Canada|Investigational Site Number :124021, London, Ontario, Canada|Investigational Site Number :124006, Toronto, Ontario, Canada|Investigational Site Number :124018, Montreal, Quebec, Canada|Investigational Site Number :124001, Sherbrooke, Quebec, Canada|Investigational Site Number :152003, Los Angeles, Chile|Investigational Site Number :152001, Talcahuano, Chile|Investigational Site Number :170001, Bogotá, Colombia|Investigational Site Number :1910001, Zagreb, Croatia|Investigational Site Number :150659, Praha 2, Czechia|Investigational Site Number :151229, København, Denmark|Investigational Site Number :818002, Cairo, Egypt|Investigational Site Number :818001, Cairo, Egypt|Investigational Site Number :250004, Bordeaux, France|Investigational Site Number :250001, BRON Cedex, France|Investigational Site Number :250002, Marseille Cedex 05, France|Investigational Site Number :250005, Paris Cedex 12, France|Investigational Site Number :250003, Paris, France|Investigational Site Number :250006, Vandoeuvre Les Nancy Cedex, France|Investigational Site Number :151368, Hamburg, Germany|Investigational Site Number :150031, Mainz, Germany|Investigational Site Number :3480005, Pécs, Hungary|Investigational Site Number :356003, Ahmedabad, India|Investigational Site Number :356001, Kolkata, India|Investigational Site Number :3560004, Secunderabad, India|Investigational Site Number :356002, Vellore, India|Investigational Site Number :360001, Jakarta, Indonesia|Investigational Site Number :154161, Dublin, Ireland|Investigational Site Number :380002, Ancona, Italy|Investigational Site Number :380004, Cusano Milanino, Italy|Investigational Site Number :380009, Firenze, Italy|Investigational Site Number :380003, Genova, Italy|Investigational Site Number :380007, Milano, Italy|Investigational Site Number :380005, Napoli, Italy|Investigational Site Number :380008, Padova, Italy|Investigational Site Number :380006, Roma, Italy|Investigational Site Number :380001, Udine, Italy|Investigational Site Number :392102, Nangoku-shi, Kochi, Japan|Investigational Site Number :392101, Setagaya, Tokyo, Japan|Investigational Site Number :154286, Changwon-si, Gyeongsangnam-do, Korea, Republic of|Investigational Site Number :153178, Busan, Korea, Republic of|Investigational Site Number :153191, Daejeon, Korea, Republic of|Investigational Site Number :153225, Jeonnam, Korea, Republic of|Investigational Site Number :153180, Seoul, Korea, Republic of|Investigational Site Number :153196, Seoul, Korea, Republic of|Investigational Site Number :153192, Seoul, Korea, Republic of|Investigational Site Number :151149, Seoul, Korea, Republic of|Investigational Site Number :153212, Seoul, Korea, Republic of|Investigational Site Number :153222, Seoul, Korea, Republic of|Investigational Site Number :154148, Yangsan, Korea, Republic of|Investigational Site Number :154225, Kuwait, Kuwait|Investigational Site Number :4220004, Beirut, Lebanon|Investigational Site Number :458001, Jalan Pahang, Malaysia|Investigational Site Number :458002, Kuala Lumpur, Malaysia|Investigational Site Number :151171, Amsterdam, Netherlands|Investigational Site Number :152029, Rotterdam, Netherlands|Investigational Site Number :154264, Lahore, Pakistan|Investigational Site Number :154266, Lahore, Pakistan|Investigational Site Number :608001, Manila, Philippines|Investigational Site Number :150575, Warszawa, Poland|Investigational Site Number :6200002, Coimbra, Portugal|Investigational Site Number :154177, Cluj Napoca, Romania|Investigational Site Number :643001, Moscow, Russian Federation|Investigational Site Number :643002, Moscow, Russian Federation|Investigational Site Number :682004, Makkah, Saudi Arabia|Investigational Site Number :682001, Qatif, Saudi Arabia|Investigational Site Number :702001, Singapore, Singapore|Investigational Site Number :703001, Bratislava, Slovakia|Investigational Site Number :7520001, Stockholm, Sweden|Investigational Site Number :154093, Chiayi, Taiwan|Investigational Site Number :152152, Hualien, Taiwan|Investigational Site Number :152246, Kaohsiung Hsien,, Taiwan|Investigational Site Number :152244, Kaohsiung, Taiwan|Investigational Site Number :151534, New Taipei City, Taiwan|Investigational Site Number :151500, Putz City, Chia-yi, Taiwan|Investigational Site Number :151179, Taichung City, Taiwan|Investigational Site Number :151181, Taichung, Taiwan|Investigational Site Number :153248, Tainan, Taiwan|Investigational Site Number :152153, Tainan, Taiwan|Investigational Site Number :151182, Taipei, Taiwan|Investigational Site Number :152321, Taipei, Taiwan|Investigational Site Number :153158, Tao Yuan County, Taiwan|Investigational Site Number :764002, Bangkok, Thailand|Investigational Site Number :764003, Bangkok, Thailand|Investigational Site Number :764004, Bangkok, Thailand|Investigational Site Number :764001, Bangkok, Thailand|Investigational Site Number :764005, Khon Kaen, Thailand|Investigational Site Number :7840001, Dubai, United Arab Emirates|Investigational Site Number :152287, Birmingham, United Kingdom|Investigational Site Number :154240, Birmingham, United Kingdom|Investigational Site Number :152156, Glasgow, United Kingdom|Investigational Site Number :151123, London, United Kingdom|Investigational Site Number :151646, London, United Kingdom|Investigational Site Number :150303, London, United Kingdom|Investigational Site Number :150455, Manchester, United Kingdom|Investigational Site Number :152361, Salford, United Kingdom|Investigational Site Number :154212, Hanoi, Vietnam|Investigational Site Number :704002, Ho Chi Minh City, Vietnam | |
| Dosing Intervals of Opioid Medication for Chronic Pain | Chronic Pain | Drug: Extended Release Opioid Formulation, Shortened Intervals|Drug: Extended Release Opioid Formulation, Standard intervals|Drug: Placebo oral tablet | Percentage of participants who complete both treatment periods and have evaluable Patient Global Impression and pharmacokinetic data|Patient Global Impression of Change|Numerical Pain Rating Scale|Brief Pain Inventory (Short Form)|Subjective Opioid Withdrawal Scale|Addiction Research Centre Inventory (ARCI) - short form|Profile of Mood States|Visual analogue scale - liking/high|Serum opioid concentrations|Peak plasma concentration (Cmax)|Time to peak plasma concentration (Tmax)|Area under the plasma concentration versus time curve (AUC)|Abuse liability quotient (AQ) | University Health Network, Toronto|Canadian Society of Hospital Pharmacists | University Health Network, Toronto, Ontario, Canada |
| A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure Which Aims to Evaluate Whether GRT0151Y is Likely to be Abused | Pain|Acute Pain | Drug: GRT0151Y 50 mg capsule|Drug: Hydromorphone IR 4 mg|Drug: Matching placebo | Overall Drug Liking|Subjective Drug Value (SDV)|Addiction Research Center Inventory (ARCI)|Drug Liking "at this moment"|Good Effects|Bad Effects|Any Effects|Subject-rated Opiate Agonist Scale (SROAS)|Observer-rated|Take Drug Again|Divided Attention test (DA) - Time over the road|Divided Attention test (DA) - Response latency|Divided Attention test (DA) - Target hits|Choice Reaction Time (CRT)|Pharmacokinetic parameter: AUC0-t|Pharmacokinetic parameter: Cmax|Pharmacokinetic parameter: tmax | Grünenthal GmbH | DecisionLine Clinical Research Corporation, Toronto, Ontario, Canada |
| Abuse Potential of Sativex | Evaluation of Abuse Potential of Sativex | Drug: Sativex|Drug: Placebo|Drug: Marinol | Comparison of Subjective Drug Value (SDV)(Balance of effects) between Marinol and Sativex|Comparison of Bipolar Drug Liking VAS (Balance of effects) between Marinol and Sativex|Comparison of Addiction Research Centre Inventory (ARCI) MBG (Positive effects) between Marinol and Sativex|Comparison of Balance of Effects VASs between Marinol and Sativex|Comparison of Positive Effects VASs between Marinol and Sativex|Comparison of Cannabinoid Effects between Marinol and Sativex|Comparison of Negative Effects Scores between Marinol and Sativex|Comparison of Other Effects Scores between Marinol and Sativex|Area under the concentration-time curve from 0 to 8.5 hours post-dose for plasma THC, CBD, and 11-hydroxy-THC.|Adverse Events | Jazz Pharmaceuticals | DecisionLine Clinical Research Corporation, Toronto, Ontario, Canada |
| Brief Alcohol Intervention for Adolescents Who Have Attempted Suicide | Suicide|Alcohol Drinking | Behavioral: motivational enhancement therapy | alcohol use|suicidal ideation | Boston Children's Hospital|American Foundation for Suicide Prevention | Boston Children's Hospital, Boston, Massachusetts, United States |
| ACT for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals | Methamphetamine Abuse|Methamphetamine-dependence | Behavioral: Acceptance Commitment Therapy | Feasibility of intervention|Acceptability of intervention|Changes in other substance use via the Timeline Followback (TLFB)|Changes in depression via the Patient Health Questionnaire-9 (PHQ-9)|Changes in anxiety via the Generalized Anxiety Disorder-7 (GAD-7)|Changes in trauma symptoms via the Trauma Screening Questionnaire (TSQ)|Changes in acceptance commitment skills via the Acceptance and Action Questionnaire [AAQ-2|Changes in cravings/urges for methamphetamine via the Brief Substance Craving Scale BSCS|Changes in quality of life, including well-being, relationships, social activities, personal fulfillment and recreation via the World Health Organization Quality of Life- BREF [WHOQOL-BREF]|Changes in safer drug use practices at the end of the study via semi-structured interviews|Barriers to engaging in the intervention using qualitative assessments at the end of study|Engagement in treatment|Changes in methamphetamine use via the timeline followback (TLFB)|Changes in methamphetamine use via urinalysis | Centre for Addiction and Mental Health | Centre for Addiction and Mental Health, Toronto, Ontario, Canada |
CT World - MDMA
CT World - MDMA.csv
| Title | Conditions | Interventions | Outcome Measures | Sponsor/Collaborators | Locations |
|---|---|---|---|---|---|
| Food Effects on Bioavailability of MDMA in Healthy Volunteers | Pharmacokinetics | Drug: MDMA | Area under the curve from dosing time to last measurement - Plasma concentration of MDMA|Area under the curve from dosing time to last measurement - Plasma concentration of active metabolite MDA | Multidisciplinary Association for Psychedelic Studies | Alliance for Multispecialty Research LLC, Knoxville, Tennessee, United States |
| Acute Effects of R- and S-MDMA in Healthy Subjects | Healthy | Drug: 3,4-methylenedioxymethamphetamine|Drug: S-3,4-methylenedioxymethamphetamine|Drug: R-3,4-methylenedioxymethamphetamine (125 mg)|Drug: R-3,4-methylenedioxymethamphetamine (250 mg)|Other: Placebo | Subjective effects I|Subjective effects II|Autonomic effects I|Autonomic effects II|Autonomic effects III|Adverse effects|Mood after study day I|Mood after study day II|Mood after study day III|Mood after study day IV|Plasma levels of cortisol|Plasma levels of prolactin|Plasma levels of oxytocin|Plasma levels of vasopressin|Plasma levels of S-MDMA|Plasma levels of R-MDMA|Plasma levels of S-MDA|Plasma levels of R-MDA|Additional subjective effects I|Additional subjective effects II|States of Consciousness Questionnaire|Spiritual Realms Questionnaire|Psychological Insight Questionnaire|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Personality Inventory (FPI-R)|Saarbrücker Personality Questionnaire (SPF)|HEXACO personality inventory|Defense Style Questionnaire (DSQ-40) | University Hospital, Basel, Switzerland | |
| Effects of MDMA Co-administration on the Response to LSD in Healthy Subjects | Healthy | Drug: Lysergic Acid Diethylamide|Drug: 3,4-methylenedioxymethamphetamine|Other: LSD Placebo|Other: MDMA Placebo | Acute subjective effects I|Acute subjective effects II|Acute subjective effects III|Autonomic effects I|Autonomic effects II|Autonomic effects III|Plasma levels of LSD|Plasma levels of MDMA|Plasma levels of blood-derived neurotrophic factor (BDNF)|Plasma levels of oxytocin|Psychological Insight Questionnaire|States of Consciousness Questionnaire|Spiritual Realms Questionnaire|Effect moderation through personality traits I|Effect moderation through personality traits II|Effect moderation through personality traits III|Effect moderation through personality trait IV|Effect moderation through personality trait V | University Hospital, Basel, Switzerland | University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland |
| Stanford Regulating Circuits of the Brain Study - MDMA | Healthy | Drug: MDMA | Reward circuit activation as assessed by functional magnetic resonance imaging|Behavioral responses on the WebNeuro computerized test battery assessing cognitive capacity|Self-reported responses as assessed by the 21-item Depression, Anxiety and Stress Scale (DASS)|Self-reported responses as assessed by the 29-item Rotter's Locus of Control (RLoC)|Self-reported responses as assessed by the 15-item Mini Brief Risk-Resilience Index for Screening (BRISC)|Self-reported responses as assessed by the 14-item Snaith-Hamilton Please Scale (SHAPS)|Self-reported responses as assessed by the 24-item Dimensional Apathy Scale (DAS)|Self-reported responses as assessed by the 18-item Motivation and Pleasure Scale Self-Report (MAP-SR)|Self-reported responses as assessed by the 17-item Dimensional Anhedonia Rating Scale (DARS)|Self-reported responses as assessed by the 94-item 5-Dimensional Altered States of Consciousness Rating Scale (DASC)|Self-reported responses as assessed by the 23-item Social Reward Questionnaire (SRQ)|Self-administered computerized task assessed by Multifaceted Empathy Test (MET)|Level of subjectively experienced intoxication, dissociation, and various mood and feelings as assessed by rating scale|Self-reported responses as assessed by the 23-item Clinician Administered Dissociative States Scale (CADSS)|Self-reported responses as assessed by a clinician on the 18-item Brief Psychiatric Rating Scale (BPRS)|Steroid hormone assay via saliva collection | Stanford University|National Institute on Drug Abuse (NIDA)|Multidisciplinary Association for Psychedelic Studies (MAPS) | Stanford Psychiatry and Behavioral Sciences Department, Palo Alto, California, United States |
| A Treatment Development Study of MDMA-Assisted Psychotherapy for PTSD | Post Traumatic Stress Disorder | Drug: MDMA | Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score|Change From Baseline to Midpoint (visit 6) in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score|Change From Baseline to 1 Month Follow up in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score|Change From Baseline to 3 Month Follow up in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score|Change From Baseline to Endpoint in PTSD Symptoms Checklist|Change From Baseline to Midpoint (Visit 6) in PTSD Symptoms Checklist|Change From Baseline to 1 Month Follow up in PTSD Symptoms Checklist|Change From Baseline to 3 Month Follow up in PTSD Symptoms Checklist|Change From Baseline to Endpoint in The Patient Health Questionnaire-9 Depression Symptoms|Change From Baseline to Midpoint (Visit 6) in The Patient Health Questionnaire-9 Depression Symptoms|Change From Baseline to 1 Month Follow up in The Patient Health Questionnaire-9 Depression Symptoms|Change From Baseline to 3 Month Follow up in The Patient Health Questionnaire-9 Depression Symptoms | Remedy|Multidisciplinary Association for Psychedelic Studies|Ryerson University | Remedy Institute, Toronto, Ontario, Canada |
| MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function | Pharmacokinetics|Hepatic Impairment | Drug: MDMA | Area under curve from dosing time to last measurement (AUC(0-t)) - MDMA|Area under curve from dosing time to last measurement (AUC(0-t) MDA|Peak MDMA (Cmax)|Peak MDA (Cmax)|Time to maximum (Tmax) MDMA|Time to maximum (Tmax) MDA|Area under curve from dosing time to infinity (AUC(0-infinity)) - MDMA|Area under curve from dosing time to infinity (AUC(0-infinity)) - MDA|90% CL between hepatic impaired and no hepatic impairment groups for AUC (0-t)|90% CL between hepatic impaired and no hepatic impairment groups for AUC (0-infinity)|90% CL between hepatic impaired and no hepatic impairment groups for Cmax|Change in QTcI - Baseline to 0.5 h post drug|Change in QTcI - Baseline to 2 h post-drug|Change in QTcI Baseline to 4 h post-drug|Change in QTcI Baseline to 6 h post-drug|Change in QTcI Baseline to 7 h post-drug|Change in QTcI Baseline to 1 d post-drug|Change in QTcI Baseline to 2 d post-drug|Change in QTcI Baseline to 3 d post-drug|Change in QTcI Baseline to 4 d post-drug|Pre-drug Systolic blood pressure (SBP)|Peak Systolic blood pressure (SBP)|Final systolic blood pressure (SBP)|Pre-drug Diastolic blood pressure (DBP)|Peak Diastolic blood pressure (DBP)|Final Diastolic blood pressure (DBP)|Pre-drug heart rate (HR)|Peak heart rate (HR)|Final heart rate (HR)|Pre-drug body temperature (BT)|Peak body temperature (BT)|Final body temperature (BT)|Number of AEs reported | Multidisciplinary Association for Psychedelic Studies | Alliance for Multispecialty Research, LLC., Knoxville, Tennessee, United States |
| The Effects of MDMA on Prefrontal and Amygdala Activation in PTSD. | Post Traumatic Stress Disorder | Drug: MDMA|Drug: Niacin | Changes in activation of mPFC, amygdala, and nucleus accumbens upon presentation of emotional faces.|Changes in PTSD symptoms, which will be measured by The Clinician-Administered PTSD Scale 5 (CAPS-5).|Changes in depression symptoms, which will be measured by The Beck Depression Inventory II (BDI-II).|Changes in sleep patterns, which will be measured by The Pittsburgh Sleep Quality Index (PSQI).|Changes in PTSD symptoms, which will be measured by The Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5).|Changes in personality traits, which will be measured by The NEO Personality Inventory - Revised (NEO PI-R).|Changes in mental states, which will be measured The 5-Dimensional Altered States of Consciousness Scale (5D-ASC).|Changes in growth following a traumatic event, which will be measured by The Post traumatic Growth Inventory (PTGI).|Changes in well-being, which will be measured by The Well-Being Inventory (WBI).|Changes in psychological inflexibility/experiential avoidance, which will be measured by The Acceptance and Action Questionnaire II (AAQ-II).|Changes in emotional regulation, which will be measured by The Emotion Regulation Questionnaire (ERQ).|Changes in cognitive and emotional empathy, which will be measured by the Multifaceted Empathy Test (MET).|Changes in the quality of specific relationships in terms of supportive and conflictual dynamics will be assessed with the Quality of Relationships Inventory (QRI)|Cognitive schemas about oneself and others, will be assessed by the Trauma and Attachment Beliefs Scale (TABS)|Brain injury will be assessed for with the CogState Neuropsychological Test|Moral injury, or the sense of distress due to contradiction of deeply-held beliefs due to a traumatic event, will be measured by the Moral Injury Events Scale (MIES)|Changes in concept and sense of existential meaning will be measured with the Purpose and Meaning scale (PIL)|Changes in depression symptoms, which will be measured Montgomery-Asberg Depression Rating Scale (MADRS). | Yale University | Connecticut Mental Health Center, New Haven, Connecticut, United States |
| Social Anxiety MDMA-Assisted Therapy Investigation | Social Anxiety Disorder | Drug: MDMA|Behavioral: Psychotherapy | Evaluate the effect of MDMA-assisted therapy on severity of social anxiety disorder symptoms, as measured by total score on the Liebowitz Social Anxiety Scale (L-SAS).|Evaluate the effectiveness of MDMA-assisted therapy for SAD in clinician-rated functional impairment, as measured by the mean change in item scores on the Sheehan Disability Scale (SDS).|Evaluate change in internalized shame as a potential process of change in MDMA-Assisted Therapy for SAD, as measured by mean change in Internalized Shame Scale (ISS) scores from pre- to post-treatment.|Evaluate change in acceptance of self-conscious emotions as a potential process of change in MDMA-Assisted Therapy for SAD, as measured by mean change in Acceptance of Shame and Embarrassment Scale (ASES) scores from pre- to post-treatment.|Evaluate change in subjective belonging as a potential process of change in MDMA-Assisted Therapy for SAD, as measured by mean change in Interpersonal Needs Questionnaire (INQ) - Thwarted Belongingness scores from pre- to post-treatment.|Evaluate change in self-concealment as a potential process of change in MDMA-Assisted Therapy for SAD, as measured by mean change in Hidden Self Scale (HSS) scores from pre- to post-treatment.|Evaluate change in self-compassion as a potential process of change in MDMA-Assisted Therapy for SAD, as measured by mean change in Self-Compassion Scale scores from pre- to post-treatment. | Jason B Luoma|Oregon Research Institute Center for Evaluation Services|Multidisciplinary Association for Psychedelic Studies|Portland Psychotherapy Clinic, Research, and Training Center | Portland Psychotherapy Clinic, Research, & Training Center, Portland, Oregon, United States |
| MDMA for Co-occurring PTSD and OUD After Childbirth | Stress Disorders, Post-Traumatic|Opioid Use Disorder | Drug: MDMA Assisted Therapy | PTSD|Opioid Use Disorder | University of New Mexico|Multidisciplinary Association for Psychedelic Studies | |
| Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study | PTSD | Drug: MDMA | Change in CAPS-5 Total Severity Score|Change in Sheehan Disability Scale (SDS) item scores | MAPS Europe B.V.|Multidisciplinary Association for Psychedelic Studies | NUDZ - National Institute of Mental Health, Klecany, Středočeský Kraj, Czechia|Klinik für Psychiatrie und Psychotherapie, Universitätsklinikum Hamburg-Eppendorf, Martinsried, Hamburg, Germany|Charité - Universitätsmedizin, Berlin Campus Benjamin Franklin, Berlin, Germany|Maastricht University, Dept of Neuropsychology and Psychopharmacology, Maastricht, Limburg, Netherlands|Stichting Centrum '45/Arq, Oegstgeest, Noord Holand, Netherlands|Sykehuset Østfold Hf, DPS Norder, Moss, Norway|Fundação de Anna de Sommer Champalimaud e Dr. Carlos Montez Champalimaud, Lisbon, Portugal|University Hospital of Wales - Research Facility, Cardiff, United Kingdom|The Institute of Psychiatry, Psychology and Neuroscience, London, United Kingdom |
| Bristol Imperial MDMA in Alcoholism Study | Alcohol Use Disorder | Drug: MDMA|Other: Psychotherapy | Safety and tolerability as measured by adverse event|Intensity of MDMA drug effect during MDMA-assisted psychotherapy sessions|Degree of psychological (subjective) distress (SUDS), participant and observer scores|Change in Vital signs during MDMA-assisted psychotherapy sessions: Heart Rate|Change in Vital signs during MDMA-assisted psychotherapy sessions: Temperature|Change in Vital signs during MDMA-assisted psychotherapy sessions: Systolic Blood pressure|Change in Vital signs during MDMA-assisted psychotherapy sessions: Diastolic Blood pressure|Subjective sleep following MDMA assisted psychotherapy|Mood rating during 7 days following MDMA assisted psychotherapy|Acceptability of MDMA-Assisted therapy program: questionnaire|Change in Drinking behaviour|Change in Quality of Life: SF-36|Change in Subjective Sleep Quality: PSQI|Change in psychosocial functioning: Short Inventory of Problems for Alcohol (SIP)|Change in psychosocial functioning: Generalized Anxiety Disorder 7 (GAD-7)|Change in psychosocial functioning: The Patient Health Questionnaire (PHQ-9)|Change in psychosocial functioning: Interpersonal reactivity Index (IRI)|Change in psychosocial functioning: The self compassion scale (SCS)|The Penn Alcohol Craving Scale|Obsessive Compulsive Drinking Scale|Prescribed medication use|Assessment of MDMA/Ecstasy use following MDMA-assisted therapy|Assessment of ability to collect follow-up data|Trauma History Questionnaire (THQ) | Imperial College London | Study Center: University of Bristol, Bristol, United Kingdom |
| A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD | PTSD | Drug: MDMA | Change from Baseline to Visit 16 in PCL-5 total score|Change from Baseline to Visit 16 in Sheehan Disability Scale (SDS) total score | Multidisciplinary Association for Psychedelic Studies | New School Research, Los Angeles, California, United States|San Francisco Insight and Integration Center, San Francisco, California, United States|UCSF, San Francisco, California, United States|Aguazul-Blue Water Inc., Boulder, Colorado, United States|Wholeness Center, Fort Collins, Colorado, United States|Trauma Research Foundation, Boston, Massachusetts, United States|NYU, New York, New York, United States|New York Private Practice, New York, New York, United States|Zen Therapeutic Solutions, LLC, Mount Pleasant, South Carolina, United States|University of Wisconsin - Madison, Madison, Wisconsin, United States|Numinus, Vancouver, British Columbia, Canada|Numinus, Montréal, Quebec, Canada |
| Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2) | Psychological Effects of Study Drug | Drug: MDMA|Behavioral: Psychotherapy | Change from Baseline in Self Compassion Scale (SCS) total score | Multidisciplinary Association for Psychedelic Studies | |
| Effects of MDMA-like Substances in Healthy Subjects | Healthy | Drug: 3,4-methylenedioxymethamphetamine|Drug: 3,4-methylenedioxyamphetamine|Drug: lysine-3,4-methylenedioxymethamphetamine|Drug: lysine-3,4-methylenedioxyamphetamine|Other: Placebo | Acute subjective effects I|Plasma levels of MDMA|Plasma levels of MDA|Acute Subjective effects II|Acute Subjective effects III|States of Consciousness Questionnaire|Psychological Insight Questionnaire|Autonomic effects I|Autonomic effects II|Autonomic effects III|Autonomic effects IV|Autonomic effects V|Plasma levels of oxytocin|Emotion processing I|Emotion processing II|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Personality Inventory (FPI-R)|Saarbrücker Personality Questionnaire (SPF)|HEXACO personality inventory|Defense Style Questionnaire (DSQ-40) | University Hospital, Basel, Switzerland | University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland |
| Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada) | Posttraumatic Stress Disorder | Drug: MDMA|Behavioral: Therapy | Change From Baseline to Primary Endpoint in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score|Baseline Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Scores|Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score|Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score|Baseline Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score|Primary Endpoint Sheehan Disability Scale (SDS for PTSD for MAPS) Total Score | Multidisciplinary Association for Psychedelic Studies | British Columbia Centre on Substance Abuse, Vancouver, British Columbia, Canada|Dr. Simon Amar, LLC, Montréal, Quebec, Canada |
| Evaluation of MDMA on Startle Response | Startle Response | Drug: Placebo|Drug: MDMA|Behavioral: Acoustic startle | EMG of right orbicularis oculi muscle|Systolic blood pressure pre-drug|Systolic blood pressure 45 min post-drug|Systolic blood pressure 1 h 15 min post-drug|Systolic blood pressure 1 h 45 min post-drug|Systolic blood pressure 3 h post-drug|Systolic blood pressure 4 h post-drug|Systolic blood pressure 5 h post-drug|Systolic blood pressure 6 h post-drug|Diastolic blood pressure pre-drug|Diastolic blood pressure 45 min post-drug|Diastolic blood pressure 1 h 15 min post-drug|Diastolic blood pressure 1 h 45 min post-drug|Diastolic blood pressure 3 h post-drug|Diastolic blood pressure 4 hours post-drug|Diastolic blood pressure 5 hours post-drug|Diastolic blood pressure 6 hours post-drug|Pulse pre-drug|Pulse 45 min post-drug|Pulse 1 h 15 min post-drug|Pulse 1 h 45 min post-drug|Pulse 3 h post-drug|Pulse 4 h post-drug|Pulse 5 h post-drug|Pulse 6 h post-drug|Body temperature pre-drug|Body temperature 45 minutes post-drug|Body temperature 1 h 15 minutes post-drug|Body temperature 1 h 45 minutes post-drug|Body temperature 3 hours post-drug|Body temperature 4 hours post-drug|Body temperature 5 hours post-drug|Body temperature 6 hours post-drug|Plasma oxytocin (OT) levels predrug|Plasma oxytocin (OT) levels 5 min post-drug|Plasma oxytocin (OT) levels 20 min post-drug|Plasma oxytocin (OT) levels 95 min post-drug|Plasma oxytocin (OT) levels 110 min post-drug|Plasma oxytocin (OT) levels 185 min post-drug|Plasma oxytocin (OT) levels 200 min post-drug|Plasma oxytocin (OT) levels 240 min post-drug|Plasma oxytocin (OT) levels 300 min post-drug | Multidisciplinary Association for Psychedelic Studies | Emory University, Atlanta, Georgia, United States |
| Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction | Healthy | Drug: MDMA|Drug: Placebo | Fear extinction measured by Skin conductance response|Fear extinction measured by Fear-potentiated startle|Plasma concentration of Oxytocin|Subjective effects measured by Visual analog scales|Autonomic effects measured by Blood pressure|Autonomic effects measured by Hearth rate|Autonomic effects measured by Body temperature|Subjective effects measured by State-trait anxiety inventory for state (STAI-S)|Plasma concentration of MDMA | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| Open Label Multi-Site Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD | PTSD | Drug: MDMA|Behavioral: Therapy | Change From Baseline to Visit 19 in CAPS-5 Total Severity Scores|Change From Baseline to Visit 19 in Adapted SDS Total Score | Multidisciplinary Association for Psychedelic Studies | New School Research LLC, North Hollywood, California, United States|San Francisco Insight and Integration Center, San Francisco, California, United States|University of California San Francisco, San Francisco, California, United States|Aguazul-Blue Water Inc., Boulder, Colorado, United States|Wholeness Center, Fort Collins, Colorado, United States|University of Connecticut, Farmington, Connecticut, United States|Ray Worthy Psychiatry LLC, New Orleans, Louisiana, United States|Trauma Research Foundation, Brookline, Massachusetts, United States|New York University, New York, New York, United States|Affective Care, New York, New York, United States|Zen Therapeutic Solutions, LLC, Mount Pleasant, South Carolina, United States|University of Wisconsin at Madison, Madison, Wisconsin, United States |
| MDMA-Assisted Therapy for Stress Disorders in Healthcare Workers | Post-Traumatic Stress Disorder|Adjustment Disorders | Drug: MDMA | Change from Baseline on symptoms of Post-Traumatic Stress based on the PTSD Checklist for DSM-5 (PCL-5) at Treatment Termination|Change from Baseline on symptoms of Adjustment Disorder based on the Adjustment Disorder New Module-20 (ADNM-20) at Treatment Termination | Willa Hall|Nautilus Sanctuary | |
| Effects of MDMA on Emotional and Social Memories | Healthy | Drug: MDMA|Drug: Placebo | Probability of Accurately Recalling Visual Stimuli|Probability of Accurately Recognizing Visual Stimuli | University of Chicago | |
| Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD | Posttraumatic Stress Disorder | Drug: 3,4-methylenedioxymethamphetamine | Change from Baseline in PTSD Checklist (adapted PCL-5) total score | Multidisciplinary Association for Psychedelic Studies | |
| Exploring Mechanisms of Action in MDMA-assisted Psychotherapy for PTSD | Posttraumatic Stress Disorder | Drug: Full dose MDMA | Change in brain activity measured via fMRI while listening to trauma scripts|Change in heart rate variability in response to trauma script|Change in Self Compassion Scale Score | Multidisciplinary Association for Psychedelic Studies | Offices of Michael Mithoefer, Mount Pleasant, South Carolina, United States |
| #NAME? | Metabolism|Interaction | Drug: MDMA | Concentrations of dextromethorphan in plasma and urine.|Concentrations of caffeine in plasma and urine.|Concentrations of MDMA and metabolites (influence of gender)|Concentrations of MDMA and metabolites (influence of genetics)|Effects of MDMA on physiological response. | Parc de Salut Mar|National Institute on Drug Abuse (NIDA) | IMIM-Hospital del Mar (Institut de Recerca Hospital del Mar), Barcelona, Spain |
| Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans | PTSD | Drug: MDMA|Behavioral: Therapy | Change in CAPS-5 Total Severity Score from Baseline to Visit 16|Change in Sheehan Disability Scale (SDS) from Baseline to Visit 16 | Multidisciplinary Association for Psychedelic Studies | |
| MDMA-Assisted Psychotherapy in Veterans With Combat-Related, Refractory PTSD | Post Traumatic Stress Disorder|Combat Stress Disorders | Drug: 3,4-methylenedioxymethamphetamine | Change in total score of CAPS-5 | VA Loma Linda Health Care System|Multidisciplinary Association for Psychedelic Studies | VA Loma Linda Health Care System, Loma Linda, California, United States |
| Influence of Bupropion on the Effects of MDMA | Healthy|Substance-related Disorders | Drug: MDMA|Drug: Bupropion|Drug: Placebo | Positive Mood Effects|Blood pressure(mmHg)during 10 hours|Neuroendocrine plasma levels|Drug plasma levels|Heart rate (bpm)|Body temperature|Effects on social cognition (emotion recognition and empathy)|Influence of genetic cytochrome P450 2D6 polymorphisms on the metabolism of MDMA | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Basel-Stadt, Switzerland |
| Circulating Oxytocin Changes in Response to the Oxytocin System Stimulator MDMA in Patients With Diabetes Insipidus and Healthy Controls | Diabetes Insipidus | Diagnostic Test: study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy)|Diagnostic Test: Control intervention: Placebo | area under the concentration time curve in oxytocin level|Peak change in oxytocin (OT) plasma level|Time course of plasma OT levels|Time course of plasma MDMA concentration|Time course of cortisol levels|Time course of prolactin levels|Time course of copeptin levels|Time course of adrenocorticotropic hormone (ACTH) levels|Subjective/emotional effects|Recognition of negative emotions in the face emotion recognition task (FERT)|Empathy in the multifaceted empathy task (MET)|Anxiety level with the State-Trait Anxiety Inventory (STAI)|Level of Alexithymia using the Toronto-Alexithymia-Scale 20 (TAS-20)|Level of depression using the Beck-Depressions-Inventory II (BDI-II)|Level of general physical & mental health using the short form health survey (SF-36) | University Hospital, Basel, Switzerland | University Hospital Basel, Endocrinology, Diabetes and Metabolism, Basel, Switzerland |
| Study of the Effects of MDMA/Ecstasy on Water Regulation, Sleep, and Cognition. | MDMA Discontinuation Syndrome | Drug: 3,4-methylenedioxymethamphetamine or Placebo | Time course, severity, and characteristics of MDMA discontinuation in experienced MDMA users given a known dose of MDMA|Relate observed discontinuation effects to sleep data: polysomnography, wrist actigraphy, and self-report sleep measures.|Assess the acute effects of MDMA on water and sodium homeostasis|Document the acute effects of MDMA on self-reported measures, including positive and negative arousal, autonomy, and sociability.|Document the acute effects of MDMA on behavioral measures of economic decision making.|Document the acute effects of MDMA on autobiographical speech and memory|Measure the effects of MDMA on ADMA | California Pacific Medical Center Research Institute | CPMC Addiction & Pharmacology Research Laboratory (APRL), San Francisco, California, United States |
| Pharmacological Interaction Between Carvedilol and Methylenedioxymethamphetamine (MDMA) | Mood Disorder|Substance-Related Disorders|Amphetamine-Related Disorders | Drug: 3,4-Methylenedioxymethamphetamine|Drug: carvedilol|Drug: placebo | Effect of carvedilol on the blood pressure response to MDMA|Effect of carvedilol on the subjective response to MDMA|Effect of carvedilol on neuroendocrine effects of MDMA|Effect of carvedilol on pharmacokinetics of MDMA | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| Pharmacological Interaction Between Clonidine and Methylenedioxymethamphetamine (MDMA) | Mood Disorder|Substance-Related Disorders|Amphetamine-Related Disorders | Drug: 3,4-Methylenedioxymethamphetamine|Drug: Clonidine|Drug: placebo | Effect of clonidine on the subjective response to MDMA|Effect of clonidine on cardiovascular effects of MDMA|Effect of clonidine on pharmacokinetics of MDMA|Effect of MDMA on clonidine pharmacokinetics|Tolerability of MDMA and clonidine|Effect of clonidine on neuroendocrine responses to MDMA | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| Pharmacological Interaction Between Pindolol and MDMA (3,4-Methylenedioxymethamphetamine) | Mood Disorder|Substance-Related Disorders|Amphetamine-Related Disorders | Drug: MDMA|Drug: Pindolol | Effect of pindolol on subjective response to MDMA|Effect of pindolol on physiological response to MDMA | University Hospital, Basel, Switzerland|Heffter Research Institute | Heffter Research Center, University Hospital of Psychiatry, Zurich, Switzerland |
| Effects of MDMA on Social and Emotional Processing | Drug Addiction | Drug: Within-subjects (MDMA)|Drug: Within-subjects (oxytocin)|Drug: Within-subjects (placebo) | Emotional Recognition (MDMA)|Emotional Recognition (Oxytocin)|Emotional Recognition (Placebo)|Subjective Response to MDMA (Ratings of 'Feel Drug')|Subjective Response to Oxytocin (Ratings of 'Feel Drug')|Subjective Response to Placebo (Ratings of 'Feel Drug')|Subjective Response to MDMA (Ratings of 'Feel High')|Subjective Response to Oxytocin (Ratings of 'Feel High')|Subjective Response to Placebo (Ratings of 'Feel High')|Subjective Response to MDMA (Ratings of 'Feel Sociable')|Subjective Response to Oxytocin (Ratings of 'Feel Sociable')|Subjective Response to Placebo (Ratings of 'Feel Sociable')|Cardiovascular Response to MDMA (Heart Rate)|Cardiovascular Response to Oxytocin (Heart Rate)|Cardiovascular Response to Placebo (Heart Rate)|Cardiovascular Response to MDMA (Systolic Blood Pressure)|Cardiovascular Response to Oxytocin (Systolic Blood Pressure)|Cardiovascular Response to Placebo (Systolic Blood Pressure)|Cardiovascular Response to MDMA (Diastolic Blood Pressure)|Cardiovascular Response to Oxytocin (Diastolic Blood Pressure)|Cardiovascular Response to Placebo (Diastolic Blood Pressure)|Motivation to Socialize (MDMA)|Motivation to Socialize (Oxytocin)|Motivation to Socialize (Placebo) | University of Chicago|National Institute on Drug Abuse (NIDA) | University of Chicago, Chicago, Illinois, United States |
| A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders | Anorexia Nervosa Restricting Type|Binge-Eating Disorder | Drug: MDMA|Behavioral: Non-directive Psychotherapy|Behavioral: Psychotherapy | Change in Eating Disorder Examination Interview (EDE) Global Score from Baseline to Visit 16 (Study Termination) | Multidisciplinary Association for Psychedelic Studies | |
| Role of Serotonin in Acute and Subacute MDMA Effects | MDMA Mechanism of Action | Drug: MDMA and citalopram|Drug: Placebo | To determine if administration of the selective serotonin reuptake inhibitor (SSRI) citalopram decreases the subacute (post 24hr) discontinuation effects of MDMA in experienced MDMA users given a modest dose of MDMA|To determine if administration of the SSRI citalopram decreases the acute (post 1 to 4hr) social and emotional and cognitive effects of MDMA | California Pacific Medical Center Research Institute | CPMC Research Institute, St.Luke's Hospital, San Francisco, California, United States |
| Interaction Between Duloxetine and 3,4-Methylenedioxymethamphetamine (MDMA, Ecstasy) | Mood Disorder|Substance-Related Disorders|Amphetamine-Related Disorders | Drug: 3,4-Methylenedioxymethamphetamine|Drug: Duloxetine|Drug: Placebo | Effect of duloxetine on the subjective response to MDMA|Effect of duloxetine on cardiovascular effects of MDMA|Effect of duloxetine on pharmacokinetics of MDMA|Effect of MDMA on duloxetine pharmacokinetics|Tolerability of MDMA and duloxetine|Effect of duloxetine on neuroendocrine responses to MDMA | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| MDMA-Assisted Cognitive-Behavioral Conjoint Therapy (CBCT) in Dyads in Which 1 Member Has Chronic PTSD | Posttraumatic Stress Disorder | Drug: MDMA|Behavioral: CBCT|Behavioral: Therapy | Baseline Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score|Primary Endpoint Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score|Baseline Pittsburgh Sleep Quality Index (PSQI)|Primary Endpoint Pittsburgh Sleep Quality Index (PSQI)|Baseline Patient Beck Depression Inventory-II (BDI-II)|Primary Endpoint Patient Beck Depression Inventory-II (BDI-II)|Baseline Patient Couples Satisfaction Index (CSI)|Primary Endpoint Patient Couples Satisfaction Index (CSI)|Baseline Partner Couples Satisfaction Index (CSI)|Primary Endpoint Partner Couples Satisfaction Index (CSI)|Baseline Trauma and Attachment Beliefs Scale (TABS)|Primary Endpoint Trauma and Attachment Beliefs Scale (TABS)|Baseline Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale|Primary Endpoint Emotion Regulation Questionnaire (ERQ) Reappraisal Subscale|Baseline Emotion Regulation Questionnaire (ERQ) Suppression Subscale|Primary Endpoint Emotion Regulation Questionnaire (ERQ) Suppression Subscale|Baseline Patient PTSD Checklist-5 (PCL-5)|Primary Endpoint Patient PTSD Checklist-5 (PCL-5)|Baseline Partner-rated PTSD Checklist-5 (PCL-5)|Primary Endpoint Partner-rated PTSD Checklist-5 (PCL-5) | Multidisciplinary Association for Psychedelic Studies | Offices of Michael Mithoefer MD, Mount Pleasant, South Carolina, United States |
| Emotional Effects of Methylphenidate and MDMA in Healthy Subjects | Healthy | Drug: 3,4-Methylenedioxymethamphetamine|Drug: Methylphenidate|Drug: Placebo | Subjective effect during 24 hours|Blood pressure (mmHg)during 10 hours|Neuroendocrine plasma levels during 10 hours|MDMA plasma levels during 24 hours|Heart rate (beats/min)) during 10 hours|Emotional and cognitive empathy|Prosocial behavior|Genetic polymorphisms | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Basel-Stadt, Switzerland |
| Pharmacological Interaction Between Doxazosin and Methylenedioxymethamphetamine (MDMA) | Mood Disorder|Substance-Related Disorders|Amphetamine-Related Disorders | Drug: 3,4-Methylenedioxymethamphetamine|Drug: Doxazosin|Drug: placebo | Systolic and diastolic blood pressure (mmHg) during 6 hours|Subjective effects during 6 hours|Neuroendocrine plasma levels during 6 hours|MDMA plasma levels during 6 hours|Genetic polymorphisms | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Switzerland |
| Effects of MDMA and Methylphenidate on Social Cognition | Social Cognition | Drug: 3,4-Methylenedioxymethamphetamine|Drug: Methylphenidate|Drug: Placebo | Effects on social cognition (emotion recognition and empathy)|Blood pressure (mmHg) and heart rate (beats per min)|Subjective effects|Neuroendocrine plasma levels|Drug plasma concentration | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Switzerland |
| A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD | Posttraumatic Stress Disorder | Behavioral: Behavioral: Psychotherapy|Drug: MDMA|Drug: Placebo | Change from Baseline in Clinician-Administered PTSD for DSM 5|Change from Baseline in Sheehan Disability Scale (adapted SDS) total score | Multidisciplinary Association for Psychedelic Studies | New School Research LLC, Los Angeles, California, United States|San Francisco Insight and Integration Center, San Francisco, California, United States|University of California San Francisco, San Francisco, California, United States|Aguazul-Blue Water Inc., Boulder, Colorado, United States|Wholeness Center, Fort Collins, Colorado, United States|Ray Worthy Psychiatry LLC, New Orleans, Louisiana, United States|Trauma Research Foundation, Boston, Massachusetts, United States|New York University, New York, New York, United States|New York Private Practice, New York, New York, United States|Zen Therapeutic Solutions, LLC, Mount Pleasant, South Carolina, United States|University of Wisconsin at Madison, Madison, Wisconsin, United States|Assaf Harofeh Research Fund, Be'er Ya'aqov, Israel|Sheba Fund for Health Services and Research, Tel HaShomer, Israel |
| Study Comparing Three Doses of MDMA Along With Therapy in Veterans With Posttraumatic Stress Disorder | Posttraumatic Stress Disorder | Drug: Low dose MDMA|Drug: Medium dose MDMA|Drug: Full dose MDMA|Behavioral: Therapy | Baseline Clinician-Administered PTSD Scale (CAPS-IV) Total Score|Primary Endpoint Clinician-Administered PTSD Scale (CAPS-IV) Total Score|Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to Primary Endpoint|Change in Global Assessment of Function (GAF) From Baseline to Primary Endpoint|Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint|Change in Beck Depression Inventory (BDI-II) From Baseline to Primary Endpoint|Change in Dissociative Experience Scale (DES-II) From Baseline to Primary Endpoint|Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Primary Endpoint|Change in Neuroticism-Extroversion-Openness Personality Inventory-Revised (NEO-PI-R) From Baseline to Primary Endpoint | Multidisciplinary Association for Psychedelic Studies | Offices of Michael Mithoefer, Mount Pleasant, South Carolina, United States |
| Neurobiology and Pharmacokinets of Acute MDMA Administration | Substance-Related Disorders | Drug: MDMA|Drug: (+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules | MDMA effects on human brain function and relationship between plasma MDMA concentrations and human brain function.|MDMA pharmacokinetics in various biological matrices. | National Institute on Drug Abuse (NIDA)|National Institutes of Health Clinical Center (CC) | National Institute on Drug Abuse, Biomedical Research Center (BRC), Baltimore, Maryland, United States |
| A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1) | Posttraumatic Stress Disorder | Behavioral: Therapy|Drug: MDMA|Drug: Placebo | Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-V (CAPS-5)|Change From Baseline to Primary Endpoint in Sheehan Disability Scale (SDS) Total Score | Multidisciplinary Association for Psychedelic Studies | New School Research LLT, North Hollywood, California, United States|San Francisco Insight and Integration Center, San Francisco, California, United States|University of California San Francisco, San Francisco, California, United States|Aguazul-Blue Water Inc., Boulder, Colorado, United States|Wholeness Center, Fort Collins, Colorado, United States|Ray Worthy Psychiatry LLC, New Orleans, Louisiana, United States|Trauma Research Foundation, Boston, Massachusetts, United States|New York University, New York, New York, United States|New York Private Practice, New York, New York, United States|Zen Therapeutic Solutions, LLC, Mount Pleasant, South Carolina, United States|University of Wisconsin at Madison, Madison, Wisconsin, United States|Providence Health Center, Vancouver, British Columbia, Canada|Dr. Simon Amar, Inc., Montreal, Quebec, Canada|Assaf Harofeh Research Fund, Be'er Ya'akov, Israel|Sheba Fund for Health Services and Research, Tel HaShomer, Israel |
| MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness | Anxiety | Drug: MDMA (125 mg)|Drug: Placebo|Behavioral: Therapy | Change in State Trait Anxiety Inventory (STAI) Trait Score From Baseline to Primary Endpoint|Baseline STAI Trait Score|Primary Endpoint STAI Trait Score|Change in STAI State Score From Baseline to Primary Endpoint|Change in Beck Depression Inventory-II (BDI-II) Score From Baseline to Primary Endpoint|Change in Global Assessment of Functioning (GAF) Score From Baseline to Primary Endpoint|Change in MADRS Score From Baseline to Primary Endpoint|Change in Pittsburgh Sleep Quality Inventory (PSQI) From Baseline to Primary Endpoint|Change in Posttraumatic Growth Inventory (PTGI) From Baseline to Primary Endpoint|Change in Functional Assessment of Chronic Illness Therapy Scale (FACIT) From Baseline to Primary Endpoint|Change in Death Attitudes Profile (DAP) From Baseline to Primary Endpoint|Change in Self-Compassion Scale (SCS) From Baseline to Primary Endpoint | Multidisciplinary Association for Psychedelic Studies | Offices of Philip Wolfson MD, San Anselmo, California, United States |
| Interaction Between Reboxetine and 3,4-Methylenedioxymethamphetamine: Pharmacodynamics (PD) and Pharmacokinetics (PK) | Mood Disorder|Substance-related Disorders|Amphetamine-related Disorders | Drug: MDMA|Drug: Reboxetine, 8 mg|Drug: Placebo | Effect of reboxetine on subjective responses to MDMA|Effect of reboxetine on physiological responses to MDMA|Effects of reboxetine on pharmacokinetics of MDMA|Tolerability of MDMA and reboxetine|Effect of reboxetine on neuroendocrine responses to MDMA | University Hospital, Basel, Switzerland | University Hospital, Basel, Switzerland |
| Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD | PTSD | Drug: MDMA|Behavioral: Psychotherapy | Change in CAPS-5 Total Severity Score from Baseline to Visit 12 for 2 Session Group|Change in CAPS-5 Total Severity Score from Baseline to Visit 16 for 3 Session Group|Change in Sheehan Disability Scale (SDS) from Baseline to Visit 12 for 2 Session Group|Change in Sheehan Disability Scale (SDS) from Baseline to Visit 16 for 3 Session Group | Multidisciplinary Association for Psychedelic Studies | James J. Peters VA Medical Center, Bronx, New York, United States |
| Additional MDMA-assisted Therapy for People Who Relapsed After MDMA-assisted Therapy Trial | Posttraumatic Stress Disorder | Drug: 3,4-methylenedioxymethamphetmine (MDMA)|Behavioral: Therapy | Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)|Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up|Clinician-Administered PTSD Scale (CAPS-IV)) at 12-month Follow-up|Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up|Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 12-month Follow-up | Multidisciplinary Association for Psychedelic Studies | Offices of Michael Mithoefer, Mount Pleasant, South Carolina, United States |
| Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults | Social Anxiety in Autistic Adults | Drug: Placebo|Drug: 75 mg to 125 mg MDMA|Behavioral: Psychotherapy | Liebowitz Social Anxiety Scale (LSAS) Total Score at Baseline|Liebowitz Social Anxiety Scale (LSAS) Total Score 1-Month Post Experimental Session 2|Change in Leibowitz Social Anxiety Scale (LSAS) Total Score From Baseline to 1-Month Post Experimental Session 2 | Multidisciplinary Association for Psychedelic Studies|Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Los Angeles Biomedical Research Institute, Torrance, California, United States |
| Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects | Healthy | Drug: 2-bromo-2,5-dimethoxyphenethylamine (10 mg)|Drug: 2-bromo-2,5-dimethoxyphenethylamine (20 mg)|Drug: 2-bromo-2,5-dimethoxyphenethylamine (30 mg)|Drug: 3,4-methylenedioxymethamphetamine|Drug: Psilocybin|Other: Placebo | Acute subjective effects I|Acute subjective effects II|Acute subjective effects III|Autonomic effects I|Autonomic effects II|Autonomic effects III|Plasma levels of 2C-B, MDMA, and psilocybin|Plasma levels of oxytocin|Plasma levels of Brain-derived neurotropic factor (BDNF)|Adverse effects|Urine Recovery|States of Consciousness Questionnaire|Spiritual Realms Questionnaire|Psychological Insight Questionnaire|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Personality Inventory (FPI-R)|Saarbrücker Personality Questionnaire (SPF)|HEXACO personality inventory|Defense Style Questionnaire (DSQ-40) | University Hospital, Basel, Switzerland | |
| Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD | Posttraumatic Stress Disorder | Drug: Placebo|Drug: 3,4-methylenedioxymethamphetamine|Behavioral: Psychotherapy | Change in Clinician-Administered PTSD Scale (CAPS-IV) Score | Multidisciplinary Association for Psychedelic Studies | Offices of Dr. Ingrid Pacey MBBS FRCP[C], Vancouver, British Columbia, Canada |
| Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study | Healthy|Substance-related Disorder|Mood Disorder | Drug: Methylphenidate|Drug: Modafinil|Drug: MDMA|Drug: Placebo | Effect on amygdala and striatum BOLD signal responses to emotional stimuli|Effects on cognitive performance and associated BOLD signal changes in frontal areas|Subjective effects|Neuroendocrine effects|Empathy and social behavior|Physiological effects of methylphenidate, modafinil, and MDMA|Genetic Polymorphisms|Pharmacokinetics of methylphenidate, modafinil, and MDMA | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Basel-Stadt, Switzerland |
| Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers | Psychological Effects of Study Drug | Drug: Lactose (inactive placebo)|Drug: 3,4-methylenedioxymethamphetamine | Profile of Mood States (POMS)|Interpersonal closeness measure|Brief Symptom Inventory (BSI)|Columbia Suicide Severity Rating Scale (adapted C-SSRS)|Neuroticism Extroversion Openness Personality Inventory|Blood pressure (SBP/DBP)|Heart rate (pulse)|Body temperature | Multidisciplinary Association for Psychedelic Studies | Aguazul Bluewater, Inc., Boulder, Colorado, United States|Santa Fe MDMA Therapy Training, LLC, Santa Fe, New Mexico, United States|Zen Therapeutic Solutions, Mount Pleasant, South Carolina, United States |
| Study of 3,4-Methylenedioxymethamphetamine-assisted Psychotherapy in People With Posttraumatic Stress Disorder | Posttraumatic Stress Disorder | Drug: 3,4-methylenedioxymethamphetamine (125 mg)|Drug: 3,4-methyelendioxymethamphetamine (25 mg)|Behavioral: Therapy | Change From Baseline to Primary Endpoint in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)|Change From Baseline to Primary Endpoint in Posttraumatic Stress Diagnostic Scale (PDS) | Multidisciplinary Association for Psychedelic Studies|Swiss Medical Association for Psycholytic Therapy | Offices of Peter Oehen MD, Biberist, Solothurn, Switzerland |
| A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD | Post Traumatic Stress Disorder | Drug: MDMA|Behavioral: Psychotherapy | Multidisciplinary Association for Psychedelic Studies | Luminous Healing Center, Santa Cruz, California, United States|Riverbird Clinic, Portland, Maine, United States|Sunstone Medical, PC, Rockville, Maryland, United States|Pearl Psychedelic Institute, Waynesville, North Carolina, United States | |
| Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD | Posttraumatic Stress Disorder | Drug: Comparative-dose (40mg) MDMA|Drug: Active Dose 2 (100 mg) MDMA|Drug: Active Dose 1 (125 mg) MDMA|Behavioral: Psychotherapy | Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score at Baseline (ITT)|Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score at One Month Post 2nd Experimental Session (ITT)|Change in Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) Total Severity Score From Baseline to One Month Post 2nd Experimental Session (ITT)|Beck Depression Inventory II (BDI-II) at Baseline (ITT)|Beck Depression Inventory II (BDI-II) at One Month Post 2nd Experimental Session (ITT)|Change in Beck Depression Inventory II (BDI-II) From Baseline to One Month Post 2nd Experimental Session (ITT)|Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to One Month Post 2nd Experimental Session (ITT) | Multidisciplinary Association for Psychedelic Studies | Offices of Marcela d'Otalora, Boulder, Colorado, United States |
| Randomized, Double-blind, Active Placebo-Controlled Pilot Study of MDMA-assisted Psychotherapy in People With Chronic PTSD | Posttraumatic Stress Disorder (PTSD) | Drug: Active Placebo Dose MDMA (25 mg)|Drug: Full Dose MDMA (125 mg)|Drug: Open Label Full Dose MDMA (125 mg)|Behavioral: Psychotherapy | Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to End of Stage 1|Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From End of Stage 1 to End of Stage 2|Change in Clinical Administered PTSD Scale (CAPS-IV) Total Score From Baseline to Long-Term Follow-Up|Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to End of Stage 1|Change in Beck Depression Inventory (BDI-II) Total Score From End of Stage 1 to End of Stage 2|Change in Beck Depression Inventory (BDI-II) Total Scores From Baseline to Long-Term Follow-Up|Change in Global Assessment of Functioning (GAF) Scale From Baseline to End of Stage 1|Change in Global Assessment of Functioning (GAF) Scale From End of Stage 1 to End of Stage 2|Change in Global Assessment of Functioning (GAF) Scale From Baseline to Long-Term Follow-Up|Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to End of Stage 1|Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From End of Stage 1 to End of Stage 2|Change in Posttraumatic Stress Diagnostic Scale (PDS) Symptom Severity Score From Baseline to Long-Term Follow-Up|Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to End of Stage 1|Change in Pittsburgh Sleep Quality Index (PSQI) From End of Stage 1 to End of Stage 2|Change in Pittsburgh Sleep Quality Index (PSQI) From Baseline to Long-Term Follow-Up | Multidisciplinary Association for Psychedelic Studies | Beer Yaakov Hospital, Be'er Ya'aqov, Israel |
| MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder | Posttraumatic Stress Disorder | Drug: 3,4-methylenedioxymethamphetamine|Drug: Lactose placebo pill|Behavioral: Therapy | Baseline Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)|Primary Endpoint Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV)|Change in Clinician-Administered PTSD Scale (CAPS-IV) From Baseline to 2-month Follow-up|Baseline Impact of Events Scale Revised (IES-R)|Primary Endpoint Impact of Events Scale Revised (IES-R)|Change in Impact of Events Scale Revised (IES-R) From Baseline to 2-month Follow-up | Multidisciplinary Association for Psychedelic Studies | Offices of Michael Mithoefer MD, Mount Pleasant, South Carolina, United States |
| Randomized Placebo-controlled Study of MDMA-assisted Therapy in People With PTSD - Israel | Posttraumatic Stress Disorder | Drug: 3,4-methylenedioxymethemphetmaine (MDMA_|Drug: 3,4-methylenedioxymethamphetamine | Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 2-month Follow-up|Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 6-month Follow-up|Change in Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV) at 12-month Follow-up | Multidisciplinary Association for Psychedelic Studies | Be'er Ya'akov Mental Health Center, Be'er Ya'aqov, Israel |
| Naturalistic Study Into the Hangover Effects of MDMA | Hangover | Utrecht Institute for Pharmaceutical Sciences | Utrecht University, Utrecht, Netherlands | ||
| Effects of Drugs on Responses to Brain and Emotional Processes | Autism Spectrum Disorder|Healthy | Drug: MDMA|Drug: Placebo oral tablet | Change in responses to affective touch | University of Chicago | University of Chicago, Chicago, Illinois, United States |
| MDMA-assisted Therapy in People With Anxiety Related to Advanced Stage Cancer | Anxiety Disorder|Cancer | Drug: Stage 1 Active Methylenedioxymethamphetamine|Drug: Stage 1 Low dose Methylenedioxymethamphetamine|Behavioral: Psychotherapy|Drug: Stage 2 Active Methylenedioxymethamphetamine | Spielberger State-Trait Anxiety Inventory (STAI)|Quality of Life - European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)|Anxiety - Hamilton Anxiety Rating Scale (HAM-A)|Quality of Life - Functional Assessment of Chronic Illness Therapy- Spiritual Well-being Scale (FACIT-Sp),Karnofsky Performance Rating Scale (KPRS), Memorial Symptom Assessment Scale (MSAS), Mini-Mental Status Exam (MMSE), Self-Expansiveness Level Form|Hamilton Depression Rating Scale (HAM-D)|Depression, Thoughts of Death - Schedule of Attitudes Toward Hastened Death (SAHD)|Daily Use of Anxiolytics - Daily Diary|Daily Experience of Pain - Visual Analog Pain Scale (VAPS)|The Hospital Anxiety and Depression Scale (HADS)|Daily Assessment of Anxiety - the Visual Analog Anxiety Scale (VAAS)|Beck Hopelessness Scale (BHI) | Brigham and Women's Hospital|Mclean Hospital | McLean Hospital, Belmont, Massachusetts, United States |
| Sustaining Remission From PTSD Using Tuned Vibroacoustic Stimulation (TVS) Following MDMA-Assisted Psychotherapy | Stress Disorders, Post-Traumatic | Device: Apollo Wearable | PTSD Checklist for DSM-5 (PCL-5)|Beck Depression Inventory II (BDI-II)|World Health Organization Health and Work Performance Questionnaire (HPQ Short form)|Alcohol Use Disorders Identification Test (AUDIT)|Drug Use Disorders Identification Test (DUDIT)|Chronic Pain Grade Scale (CPGS) | Apollo Neuroscience, Inc.|The Board of Medicine | Apollo Neuroscience, Inc., Pittsburgh, Pennsylvania, United States |
| Effect of Stimulant Drugs on Social Perception | Effects of MDMA on Healthy Human Volunteers | Drug: 3,4-Methylenedioxymethamphetamine|Drug: methamphetamine | Responses to affective touch | University of Chicago | University of Chicago, Chicago, Illinois, United States |
| Drug Effects on Interpersonal Interaction | Interaction, Social | Drug: MDMA|Drug: placebo oral tablet | Profile of Mood States | University of Chicago | University of Chicago, Chicago, Illinois, United States |
| Effects of Stimulants on Behavioral and Neural Markers of Social Motivation, Ability, and Neural Markers of Social Function | Stimulant Use|MDMA ('Ecstasy')|Social Behavior|Motivation | Drug: MDMA|Drug: Methamphetamine|Drug: placebo oral tablet | Profile of Mood States | University of Chicago | University of Chicago, Chicago, Illinois, United States |
| Investigation of Serotonin Neurotransmission in MDMA Users Using Combinated Dexfenfluramine Challenge and PET Imaging | Amphetamine-Related Disorders|Amphetamine Abuse | Drug: dexfenfluramine | Serotonin release capacity|Cognition|Prolactin and cortisol|Mood and mental state | University of Zurich | University Hospital of Psychiatry Zurich, Zurich, ZH, Switzerland |
| Abuse Liability and Human Pharmacology of Mephedrone | Amphetamine-Related Disorders | Drug: Mephedrone|Drug: 3,4-methylenedioxymethamphetamine|Drug: Placebo | Changes in blood pressure|Changes in euphoria-good effects|Area Under the Concentration-Time Curve (AUC 0-24h)|Number of Participants with Serious and Non-Serious Adverse Events|Elimination half-life|Changes in heart rate|Changes in pupil diameter|Changes in oral temperature | Parc de Salut Mar|Instituto de Salud Carlos III | Institut Hospital del Mar d'Investigacions Mèdiques-IMIM. Parc de Salut Mar., Barcelona, Spain |
| Functional Brain Imaging in Recreational Users of Ecstasy | Amphetamine-Related Disorders | Hadassah Medical Organization | Dept. of Nuclear Medicine, Hadassah Hospital, Ein Kerem, Jerusalem, Israel | ||
| Long-Term Safety and Effectiveness of Manualized MDMA-Assisted Therapy for the Treatment of Posttraumatic Stress Disorder | PTSD | Clinician Administered PTSD Scale for DSM-V (CAPS-5) Total Severity Score (actual or imputed) from the main study Baseline and Study Termination to assessment in the current LTFU study | Multidisciplinary Association for Psychedelic Studies | USCF, San Francisco, California, United States | |
| Abuse Potential and Human Pharmacology of Methylone | Substance Use|Healthy Subjects | Drug: Methylone|Drug: 3,4-methylenedioxymethamphetamine|Drug: Placebo | Change in blood pressure: Emax (peak/maximum effects) in blood pressure|Change in Heart rate: Emax (peak/maximum effects) in Heart rate|Change in Oral temperature: Emax (peak/maximum effects) in Oral temperature|Change in Pupil diameter: Emax (peak/maximum effects) in Pupil diameter|Change in Maddox Wing score (MW): Emax (peak/maximum effects)|Change in Intensity of effects: Emax (peak/maximum effects) in Intensity of effects|Change in High: Emax (peak/maximum effects) in High feeling|Change in Stimulated: Emax (peak/maximum effects) in Stimulated feeling|Change in Liking: Emax (peak/maximum effects) in Liking feeling|Change in global drug effects assessed with ARCI: Emax (peak/maximum effects) in global drug effects|Change in global drug effects assessed with VESSPA: Emax (peak/maximum effects) in global drug effects|Maximum plasma concentration (Cmax) of methylone|Maximum plasma concentration (Cmax) of MDMA|Time to reach maximum plasma concentration (Tmax) of methylone|Time to reach maximum plasma concentration (Tmax) of MDMA|Area under the concentration-time curve (AUC 0-24 h) of methylone in plasma concentrations|Area under the concentration-time curve (AUC 0-24 h) of MDMA in plasma concentrations|Maximum oral fluid concentration (Cmax) of methylone|Maximum oral fluid concentration (Cmax) of MDMA|Time to reach maximum oral fluid concentration (Tmax) of methylone|Time to reach maximum oral fluid concentration (Tmax) of MDMA|Area under the concentration-time curve (AUC 0-24h) of methylone oral fluid concentrations|Area under the concentration-time curve (AUC 0-24h) of MDMA oral fluid concentrations|Total amount methylone excreted in 24 h urine samples.|Total amount MDMA excreted in 24 h urine samples.|Total concentration of methylone present in sweat|Total concentration of MDMA present in sweat|Pharmacological class identification|Change in psychomotor vigilance task (PVT): Emax (peak/maximum effects)|Psychiatric evaluation using Young Mania Rating Scale (YMRS) | Germans Trias i Pujol Hospital|Fundació Recerca Institut Germans Trias i Pujol|Istituto Superiore di Sanità | Germans Trias i Pujol Hospital, Badalona, Barcelona, Spain |
| The NeXT Study; The Netherlands XTC Toxicity Study | Ecstasy (Drug)|N-Methyl-3,4-Methylenedioxymethamphetamine|Psychopathology | UMC Utrecht|Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|University of Amsterdam, Bonger Institute of Criminology|Erasmus Medical Center | Bonger Institute of Criminology, Amsterdam, NH, Netherlands|Academic Medical Center Amsterdam, Amsterdam, NH, Netherlands|University Medical Center Utrecht, Utrecht, Netherlands | ||
| Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing | Healthy | Drug: LSD|Drug: MDMA|Drug: Amphetamine|Drug: Placebo | Emotional enhancement as determined by fMRI|fMRI brain activity|Resting State fMRI|Effect Modulation by personality traits (assessed with questionnaires),|Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)|Effect Modulation by genetic polymorphisms (determined by genotyping of each subject) | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, Basel Stadt, Switzerland |
| Correlates of Anxiety Associated With a Life-threatening Illness | Anxiety | Other: fMRI | Changes in fMRI Blood Oxygen Level Dependent (BOLD) responses to emotional regulation task|Changes in fMRI Blood Oxygen Level Dependent (BOLD) resting state functional connectivity|Heart rate variability (HRV) during own versus other's anxiety script|Changes in fMRI BOLD response during dot probe task|Response time to dot probe task|Measure of compassion for self versus other | Multidisciplinary Association for Psychedelic Studies | University of California - Berkeley, Berkeley, California, United States |
| Addiction in Intensive Cardiac Care Units | Intensive Care Unit Syndrome|Drug Abuse|Substance-Related Disorders|Cardiovascular Events|Cardiac Disease | Other: urine test|Other: Fagerström questionnaire|Other: Exhaled carbon monoxide (CO) measurement | Prevalence of psychoactive drug use assessed by urine drug assay at the time of patient admission.|In-hospital major adverse events (MAE)|Duration of the hospitalization|Combined major adverse clinical events (MACE).|All cause mortality|The occurrence of cardiovascular events | Assistance Publique - Hôpitaux de Paris|Fondation Coeur et Recherche | CHU Lariboisière, APHP, Cardiology, Paris, Ile De France, France |
| Efficacy and Safety Study of Ryanodex as Adjuvant Treatment in Subjects With Psychostimulant Drug-Induced Toxicity (PDIT) | Drug Toxicity Psychotropic Agents Psychostimulants | Drug: Ryanodex (dantrolene sodium) for injectable suspension | Proportion of Subjects Who Achieved a Logistic Organ Dysfuction System (LODS) Total Score Less Than or Equal to 5|Proportion of Subjects Who Achieved a LODS Total Score Less Than or Equal to 5 at Other Planned Time Points. | Eagle Pharmaceuticals, Inc. | CrowdRx Medical Office- Moonrise Festival, Baltimore, Maryland, United States |
| Prevalence of New Psychoactive Substances Use | Addiction | the prevalence of new psychoactive substance abuse among outpatient of addiction management clinic and patients admitted to addiction management unit of neurology and psychiatry department at Assiut university hospital. | Assiut University | ||
| EA for PAAS: A pRCT | Substance Withdrawal Syndrome | Other: Electro-Acupuncture | Amphetamine Cessation Symptom Assessment|Visual Analog Scale|Hamilton Depression Scale|Hamilton Anxiety Scale|Pittsburgh Sleep Quality Index|36-item Short Form Health Survey | Chengdu University of Traditional Chinese Medicine | Affliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China |
| Effects of an 8-day Advanced Meditation, Samyama on Physical, Psychological and Spiritual Wellbeing ,and Associated Neural Mechanisms | Mental Health Wellness 1|Happiness|Depression|Consciousness, Level Altered|Ecstasy|Dietary Habits|Stress|Inflammatory Bowel Diseases | Other: Part A1: Survey|Other: Part A2: Sample collection|Other: Part B: | levels of Anandamide|Levels of Brain Derived Neurotrophic Factor (BDNF)|Transcriptome analysis|Epigenetic analysis (DNA methylation)|Microbiome analysis:|Gut Inflammation analysis:|Plasma lipidomic analyses: | University of Pittsburgh | Indiana University, Indianapolis, Indiana, United States |
| Understanding Substance Use and Incident HIV/STI Among Young Black MSM | HIV|Substance Abuse | Hazard ratio for HIV incidence and levels of alcohol, marijuana, cocaine, and ecstasy use|Incidence rates of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use|Proportion of recent sex partners who are additionally substance-use partners|Incidence rates of HIV|Event-level odds ratios between serodiscordant unprotected anal intercourse and self-reported alcohol, marijuana, cocaine, and ecstasy use|Incidence rates of sexually transmitted infections (rectal gonorrhea, rectal chlamydia, urethral gonorrhea, urethral chlamydia, syphilis)|Rate ratios between sexually transmitted infection (STI) incidence and levels of biomarker-detected and self-reported alcohol, marijuana, cocaine, and ecstasy use | Emory University|National Institute on Drug Abuse (NIDA) | Grady Health System, Atlanta, Georgia, United States|Grady Infectious Diseases Clinic (Ponce Clinic), Atlanta, Georgia, United States|The Ponce de Leon Center of the Grady Health System, Atlanta, Georgia, United States|AID Atlanta, Atlanta, Georgia, United States|Southside Medical Center, Atlanta, Georgia, United States|Rollins School of Public Health, Atlanta, Georgia, United States|SisterLove, Inc, Atlanta, Georgia, United States | |
| Characterization of the Prosocial and Prosexual Effects of GHB | Depressive Disorder, Major|Bipolar Disorder|Autistic Disorder | Drug: GHB 35 mg/kg p.o.|Drug: GHB 20 mg/kg p.o. | Sexual Arousal|Social Cognition and Behavior|Composite measure of Neuroendocrine Parameters|electroencephalography (EEG) activity|fMRI activity | University of Zurich|University of Regensburg|University of Salerno|University of Vienna|University of Freiburg | Hospital for Psychiatry, University of Zurich, Zurich, Switzerland |
| Effects of Hallucinogens and Other Drugs on Mood and Performance | Healthy | Drug: Hallucinogens and psychoactive substances | Rating of "Drug Liking" on the End of Day Questionnaire|Hallucinogen Rating Scale | Johns Hopkins University | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| Family and Adolescent Motivational Incentives for Leveraging Youth | Substance-Related Disorders | Behavioral: Functional Family Therapy|Behavioral: Motivational Enhancement Tx/Cognitive Behavioral Tx|Behavioral: Contingency Management | Urine Assays - NIDA 12 Test Panel|Timeline Followback semi-structured interview (TLFB) | Oregon Research Institute|Dartmouth College | Oregon Research Institute Center for Family and Adolescent Research, Albuquerque, New Mexico, United States |
| Identification of Psychoactive Substance Users in Young Adults (16 to 25 Years Old) Visiting the Emergency Department | Psychiatric Emergency|Drug Use | Consumption questionnaire and urinary strips to detect psychoactive substances users | Hospices Civils de Lyon | Hôpital Edouard Herriot, Lyon, France | |
| Therapy and Peer Support for Patients Taking Medication for Opioid Use Disorder | Opioid Use Disorder | Behavioral: Psychosocial treatment | Urinalysis-confirmed opioid use|Retention in Office-Based Buprenorphine Treatment|Quality of life assessment|Multidimensional problem severity|Urinalysis-confirmed use from other (non-opioid) drugs|ED utilization|Opioid overdose rates|Treatment satisfaction | Philadelphia College of Osteopathic Medicine|Boston University|Patient-Centered Outcomes Research Institute|Public Health Management Corporation|University of Pennsylvania | AtlantiCare, Atlantic City, New Jersey, United States|Care Clinic, Philadelphia, Pennsylvania, United States|Delaware Valley Community Health, Philadelphia, Pennsylvania, United States|Berks Community Health Center, Philadelphia, Pennsylvania, United States |
| Increasing Caregiver Engagement in Juvenile Drug Courts | Substance Abuse | Behavioral: Caregiver Contingency Management + Usual Drug Court Treatment|Behavioral: Usual Drug Court Treatment | Changes from baseline to 18 months post-baseline in Youth Urine Drug Screens (measured at 0, 3, 5, 6, 9, 12, and 18 months).|Changes from baseline to 18 months post-baseline in Youth Substance Use Frequency and Problems (measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 months).|Changes from baseline to 18 months post-baseline in Youth Arrests, Charges, and Convictions.|Changes from baseline to 18 months post-baseline in Youth Delinquent Behaviors (measured at 0, 3, 5, 6, 9, 12, and 18 months).|Changes from Baseline to 18 months post-baseline in caregiver reports on Youth Internalizing Symptoms and Externalizing Behaviors (measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 months).|Changes from Baseline to 18 months post-baseline in youth reports on Youth Internalizing Symptoms and Externalizing Behaviors (measured at 0, 1, 2, 3, 4, 5, 6, 9, 12, and 18 months).|Changes from baseline to post-treatment in Caregiver Substance Use Problems.|Changes from baseline to post-treatment in Caregiver Depressive Symptoms.|Changes from baseline to post-treatment in Therapist-Family Working Alliance (measured at 1, 2, 3, and 4 months, as well as post-treatment).|Changes from baseline to post-treatment in Caregiver Treatment Attendance and Activity Completion (measured at 1, 2, 3, and 4 months, as well as post-treatment).|Changes from baseline to the end of JDC involvement in Caregiver Attendance at JDC Sessions.|Rates of Treatment Completion.|Levels of Satisfaction with Treatment and JDC.|Changes from baseline to post-treatment in Caregiver Perceptions of Incentive Programs.|Changes from baseline to 36 months post-baseline in Therapist and JDC Personnel Perceptions of Incentive Programs (measured at 0, 12, 24, and 36 months).|Reports at post-treatment on Youth and Caregiver Attitudes Toward Incentive Programs.|Changes from baseline to 36 months post-baseline in Therapist and JDC Personnel Attitudes Toward Incentive Programs (measured at 0, 12, 24, and 36 months). | Medical University of South Carolina|National Institute on Minority Health and Health Disparities (NIMHD)|Wayne State University|Alliant International University|Baylor University | Montgomer County Juvenile Court, 380 West Second Street, Dayton, Ohio, United States|Nueces County Juvenile Court/Juvenile Treatment Court, Corpus Christi, Texas, United States |
| Clinical Trial to Evaluate Pharmacological Interactions Between γ-hydroxybutyrate (GHB) and Cobicistat | Pharmacokinetic Interactions|HIV | Drug: Cobicistat 150 MG|Drug: Placebo|Drug: GHB | concentration in plasma of GHB|Proportion of participants reporting adverse events.|physiological effects: blood pressure|physiological effects: heart rate|physiological effects : oxygen saturation|subjective effects of GHB -ARCI|subjective effects of GHB - Visual analog scale | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | José, Badalona, Barcelona, Spain |
| Mood Effects of Serotonin Agonists | Healthy | Drug: Lysergic Acid Diethylamide | Change From Baseline in Profile of Mood States (POMS) | University of Chicago | Matthew Bona, Chicago, Illinois, United States|University of Chicago, Chicago, Illinois, United States |
| A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls | Drug Abuse Prevention | Behavioral: RealTeen | 30-day alcohol and drug use | Columbia University|National Institute on Drug Abuse (NIDA) | Columbia University School of Social Work, New York, New York, United States |
| Preventing Drug Abuse Among Hispanic Adolescents | Drug Abuse | Behavioral: Prevention Program | Change in average number of drug abuse instances | Columbia University|National Institute on Drug Abuse (NIDA) | Columbia University Irving Medical Center, New York, New York, United States |
| Youth Drug Abuse Prevention in Kazakhstan | Drug Use | Behavioral: Kazakhstani Family Together|Behavioral: Usual Care Alone | Change in onset and 30-day alcohol and drug use from baseline to 6 months|Change in onset and sexual risk behaviors from baseline to 6 months | University of Chicago|National Institute on Drug Abuse (NIDA)|Columbia University | Columbia University Global Heath Research Center of Central Asia, Almaty, Kazakhstan |
| Youth Drug Abuse Family and Cognitive-Behavioral Therapy | Drug Abuse | Behavioral: Integrated Family and Cognitive-Behavioral Therapy|Other: Education | Marijuana use abstinence and frequency|Other drug use abstinence and frequency|Alcohol use abstinence and frequency|Legal involvement|Family functioning|Problem solving skill|Rational Beliefs|Learning Strategy Skill|Academic Achievement | University of Florida|National Institutes of Health (NIH) | Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States |
| Neurological Influences on Drug Prevention Intervention | Youths At-risk for Drug Use/Abuse | Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention|Other: Psychoeducation | Alcohol use abstinence and frequency|Marijuana use abstinence and frequency|Other drug use abstinence and frequency|Academic achievement|Family functioning|Learning Strategy Skill|Legal Involvement | University of Florida|National Institutes of Health (NIH)|Johns Hopkins University | Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States |
| Adolescents With Substance Use Disorders Transitioníng From Residential Treatment to the Community | Substance Use|Adolescent Behavior | Behavioral: Parenting Wisely+|Behavioral: Treatment as Usual | Change in Proportion of Days Used Outside of Controlled Environment|Change in Global Appraisal of Individual Needs - Quick Version (GAIN-Q3) Substance-Related Problems Scale|Count of Adolescents Testing Negative on Urine Screens | Brown University|Rhode Island Hospital|National Institute on Drug Abuse (NIDA) | Rosecrance Health Network, Rockford, Illinois, United States|Caritas ARTS Program, Cranston, Rhode Island, United States |
| Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder | Opioid-use Disorder|Opioid Withdrawal | Device: Sparrow Ascent Therapy System|Drug: Lofexidine|Drug: Extended-release injectable naltrexone | 14-Panel Urine Drug Screen|Self-Report of Drug Use|Clinical Opiate Withdrawal Scale (COWS)|Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop)|Opioid Craving Scale (OCS)|Proportion of patients who receive and tolerate an XR-NTX injection after acute detox treatment (Phase I) | Spark Biomedical, Inc.|Hazelden Betty Ford Foundation|Gaudenzia, Inc. | Hazelden Betty Ford Foundation, Rancho Mirage, California, United States|Gaudenzia, Inc., Baltimore, Maryland, United States|Hazelden Betty Ford Foundation, Center City, Minnesota, United States |
| Clinical Pharmacology of MDA [3,4-methylenedioxyamphetamine] | Healthy | Drug: MDA|Drug: Placebo | MDA will be metabolized to hydroxyamphetamine (HMA) and dihydroxyamphetamine (DHA) and will produce dose-dependent increases in neuroendocrine measures.|MDA will produce dose-dependent increases in self-report entactogen-like and stimulant like measures. | California Pacific Medical Center Research Institute|National Institute on Drug Abuse (NIDA)|University of California, San Francisco | CPMC Addiction & Pharmacology Research Laboratory (APRL), San Francisco, California, United States |
| Emergency Department-Initiated Buprenorphine Validation Network Trial | Opioid-use Disorder | Drug: CAM2038|Drug: Buprenorphine Sublingual Product | RCT Component: Patient engagement (yes/no) in formal addiction treatment at 7 days post randomization|RCT Component: Patient engagement (yes/no) in formal addiction treatment at 30 days post randomization|RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP at 7 days post randomization|RCT Component: Cost effectiveness of XR-BUP compared to SL-BUP at 30 days post randomization|RCT Component: Engagement in MOUD (yes/no) at 7 days post randomization|RCT Component: Self-reported days of illicit opioid use (past 7 days) at 7 days post randomization|RCT Component: Self-reported days (quantity) of illicit opioid use (past 7 days) at 7 days post randomization|RCT Component: Self-reported days (route of administration) of illicit opioid use (past 7 days) at 7 days post randomization|RCT Component: Craving scores at 7 days post randomization|RCT Component: Patient satisfaction with BUP at 7 days post randomization|RCT Component: Patient Engagement in MOUD (yes/no) at 30 days post randomization|RCT Component: Self-reported days of illicit opioid use (past 7 days) at 30 days post randomization|RCT Component: Self-reported days (quantity) of illicit opioid use (past 7 days) at 30 days post randomization|RCT Component: Self-reported days (route of administration) of illicit opioid use (past 7 days) at 30 days post randomization|RCT Component: Healthcare services utilization (past 30 days) regarding ED visits and hospitalizations at 30 days post randomization|RCT Component: Overdose Events at 30 days post randomization|BUP Implementation Component (ED): Change in the number of ED visits during which BUP is administered in the ED (prior 30 days)|BUP Implementation Component (ED): Change in the number of ED visits during which BUP is administered in the ED (prior 30 days )|BUP Implementation Component (ED): Change in the number of ED visits during which patients receive a prescription for BUP in the ED (prior 30 days )|BUP Implementation Component (ED): Change in the number of ED visits during which patients receive a prescription for BUP in the ED (prior 30 days)|BUP Implementation Component (ED): Change in the number of unique ED prescribers who are DATA 2000 X-waivered (prior 30 days)|BUP Implementation Component (ED): Change in the number of unique ED prescribers who administered BUP in the ED (prior 30 days)|BUP Implementation Component (ED): Change in the number of unique ED prescribers who are prescribing BUP from the ED (prior 30 days)|BUP Implementation Component (ED): Change in the percent adherence to the critical action checklist for ED-initiated SL-BUP and XR-BUP (prior 30 days)|BUP Implementation Component (ED): Change in the number of ED prescribers who fully adhere to the critical action checklist (prior 30 days)|BUP (XR and SL) Implementation Component (Community): Change in number of programs accepting patients into formal addiction treatment at 7 days following the ED visits|BUP (XR and SL) Implementation Component (Community): Change in number of formal systems (e.g., formal, informal, feedback) pathways in place for arranging referrals for ongoing MOUD.|BUP (XR and SL) Implementation Component (Community): Change in proportion of patients engaged in formal addiction treatment at 7 days following the ED visit|BUP (XR and SL) Implementation Component (Community): Change in proportion of patients engaged in MOUD at 7 days following the ED visit|Ancillary Component: Desire to Use post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Bad drug effects post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Changes in withdrawal severity at post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Pain at injection site post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Vital Signs (temperature) post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Vital Signs (blood pressure- systolic) post XR-BUP injection at ED Index Visit- (Day 0)|Ancillary Component: Vital Signs (diastolic blood pressure) post XR-BUP injection at ED Index Visit- (Day 0)|Ancillary Component: Vital Signs (pulse rate) post XR-BUP injection at ED Index Visit- (Day 0)|Ancillary Component: Vital Signs (respiratory rate) post XR-BUP injection at ED Index Visit- (Day 0)|Ancillary Component: Vital Signs (oxygen saturation) post XR-BUP injection at ED Index Visit- (Day 0)|Ancillary Component: Changes in withdrawal severity (COWS) at post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Changes in withdrawal severity (OOWS) at post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Changes in withdrawal severity (ARSW) at post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Pupillary diameter post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Provision of post Injection Medications post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Precipitated Withdrawal (yes/no) post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Local Tolerability post XR-BUP injection at ED Index Visit (Day 0)|Ancillary Component: Proportion of participants that experience clinician determined precipitated withdrawal within 1 hour of XR-BUP administration|Ancillary Component: Proportion of participants that experience a 5 or greater increase in COWS score within 4 hours of of XR-BUP administration|Ancillary Component: Proportion of participants that transition to moderate withdrawal (COWS 13-24) within 4 hours of XR-BUP administration|Ancillary Component: Daily Substance Use (Days 1-6 post injection)|Ancillary Component: Desire to Use (Days 1-6 post injection)|Ancillary Component: Presence of opioids, oxycodone, benzodiazepines, cocaine, methamphetamine, amphetamine, ecstasy (MDMA), marijuana (THC), barbiturate, methadone, buprenorphine and fentanyl (7 days post injection)|Ancillary Component: Opioid Withdrawal (7 days post injection)|Ancillary Component: Daily Substance Use (7 days post injection)|Ancillary Component: Desire to Use (7 days post injection)|Ancillary Component: Injection Site Reactions (7 days post injection)|Ancillary Component: Patient satisfaction with BUP (7 days post injection)|Ancillary Component: Health Services Utilization (7 days post injection)|Ancillary Component: Engagement in Treatment (7 days post injection)|Ancillary Component: Overdose Events (7 days post injection) | Yale University|National Drug Abuse Treatment Clinical Trials Network|The Emmes Company, LLC|Harvard Medical School (HMS and HSDM)|University of Pennsylvania|NYU Langone Health|Icahn School of Medicine at Mount Sinai|Alameda Health System|Weill Medical College of Cornell University | Valleywise Health, Phoenix, Arizona, United States|Highland Hospital, Oakland, California, United States|San Leandro Hospital, San Leandro, California, United States|Yale New Haven Health (Yale New Haven Hospital), New Haven, Connecticut, United States|Jackson Memorial Hospital, Miami, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|Grady Memorial Hospital, Atlanta, Georgia, United States|Northwestern Memorial Hospital, Chicago, Illinois, United States|University of Chicago Medicine, Chicago, Illinois, United States|Maine Medical Center, Portland, Maine, United States|Johns Hopkins Hospital, Baltimore, Maryland, United States|Detroit Receiving Hospital, Detroit, Michigan, United States|Henry Ford Hospital, Detroit, Michigan, United States|Hennepin County Medical Center, Minneapolis, Minnesota, United States|Barnes Jewish Hospital, Saint Louis, Missouri, United States|Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States|Presybterian Hospital, Albuquerque, NM, Albuquerque, New Mexico, United States|University of New Mexico Hospital, Albuquerque, New Mexico, United States|Bellevue Hospital, New York, New York, United States|Icahn School of Medicine, New York, New York, United States|Columbia University Irving Medical Center- NY Presbyterian, New York, New York, United States|Weill Cornell Medical College, New York, New York, United States|Upstate Medical University, Syracuse, New York, United States|Duke University, Durham, North Carolina, United States|Wake Forest School of Medicine, Winston-Salem, North Carolina, United States|Pennsylvania Presbyterian Medical Center/Hospital of UPENN, Philadelphia, Pennsylvania, United States|Temple University Hospital - Episcopal Campus, Philadelphia, Pennsylvania, United States|UPMC Mercy Hospital, Pittsburgh, Pennsylvania, United States|Rhode Island Hospital/The Miriam Hospital, Providence, Rhode Island, United States|Medical University of South Carolina, Charleston, South Carolina, United States|Vanderbilt University Medical Center, Nashville, Tennessee, United States|Parkland Memorial Hospital, Dallas, Texas, United States|University of Utah Hospital, Salt Lake City, Utah, United States|University of Washington Medical Center- Harborview/Montlake, Seattle, Washington, United States|West Virginia University - Berkeley Medical Center, Martinsburg, West Virginia, United States |
| The Norwegian Addiction, Pain and Trauma Study | Chronic Pain|Post-traumatic Stress Disorder|Substance Use Disorders | Chronic pain (ICD-10)|European-Addiction Severity Index (EuropASI), Section E|The Stressful Life-Events Screening Questionnaire (SLESQ)|The PTSD Checklist for DSM-5 - short version (PCL-5 short)|Pain characteristics|The Brief Pain Inventory: Pain intensity|The Brief Pain Inventory: Pain interference|Other pain related questions (selfmade)|Opioid maintenance treatment (OMT) history (selfmade)|Subjective quality of life (QOL-1)|Demographics|Nicotine use | University Hospital, Akershus|Oslo University Hospital|Norwegian Center for Violence and Traumatic Stress Studies | Akershus University Hospital, Lørenskog, Norway|Oslo University Hospital, Oslo, Norway | |
| Patient Doctor Lies | Patient Lying|Privacy Statements|Risk Statements|Benefit Statements|Patient Lie Detection | Behavioral: Benefit statement|Behavioral: Risk Statement|Behavioral: Privacy Statement|Behavioral: Benefit + Privacy|Behavioral: Risk + Privacy | Patient truthfulness - biometric mouse-movement distance|Patient truthfulness - biometric mouse-movement time|Patient truthfulness Weight - answer adjustment from -5 to 5 for each health question|Patient truthfulness Height - answer adjustment from -5 to 5 for each health question|Patient truthfulness Drink Alcohol - answer adjustment from -5 to 5 for each health question|Patient truthfulness Drug Activity - answer adjustment from -5 to 5 for each health question|Patient truthfulness Prescription Use - answer adjustment from -5 to 5 for each health question|Patient truthfulness Cigarette Smoking- answer adjustment from -5 to 5 for each health question|Patient truthfulness Exercise Activity- answer adjustment from -5 to 5 for each health question|Patient truthfulness Sexual Activity - answer adjustment from -5 to 5 for each health question|Gender | University of Utah | Brigham Young University, Provo, Utah, United States |
| Expanding the Potential of Couples HIV Testing: Adjunct Modules to Reduce Drug Use Among Vulnerable Male Couples | Substance Use|HIV Infections | Behavioral: Communication skills training video|Behavioral: Drug use module | Drug use frequency|Urine assay for drug use|CAS with casual partners|Bacterial STI's|Binge drinking|Syphilis infection|PrEP Uptake|PrEP adherence | Hunter College of City University of New York|National Institute on Drug Abuse (NIDA)|University of Michigan | University of Michigan, Ann Arbor, Michigan, United States|Hunter College, New York, New York, United States |
| Substance Use and Sexual Risk Reduction Intervention for Homeless Youth | Substance Use|Sexual Risk Behavior | Behavioral: Group MI risk reduction program | Change in substance use|Change in substance use intentions|Change in negative consequences from drinking|Change in use of drinking protective strategies|Change in number of different sex partners|Change in condom use|Change in substance use before or during sex|Change in HIV knowledge|Change in sex-related protective strategies|Change in sexual intentions|Change in HIV testing | RAND | My Friend's Place, Hollywood, California, United States|Safe Place for Youth, Venice Beach, California, United States |
| Implementation Research for Vulnerable Women in South Africa | HIV|Substance Abuse | Behavioral: Women's Health CoOp (WHC) | Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)|Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention|Implementation and Service Outcome: Adoption of the Women's Health CoOp (WHC) intervention|Implementation and Service Outcome: Adoption of the WHC intervention|Implementation and Service Outcome: Cost|Implementation and Service Outcome: Feasibility|Implementation and Service Outcome: Fidelity|Implementation and Service Outcomes: Sustainability|Antiretroviral Therapy (ART) Initiation and Adherence|Alcohol Use - self-reported frequency and amount|Alcohol Use|Substance Use|Substance use|Sexual Risk|Violence/Victimization|Sexual Communication|Relationship Power | RTI International|Kheth'Impilo | RTI International, Research Triangle Park, North Carolina, United States|Kheth'Impilo, Cape Town, South Africa |
| Clinical Evaluation of Safety and Tolerability of KDR2-2 Eye Drops in Healthy Volunteers With Pharmacokinetic Assessment | Corneal Neovascularization | Drug: KDR2-2|Drug: Placebo | Incidence of AE reporting for safety and tolerability (SDE)|Incidence of SAE reporting for safety and tolerability (SDE)|Body temperature for safety and tolerability (SDE)|Pulse rate for safety and tolerability (SDE)|Respiration rate for safety and tolerability (SDE)|Blood pressure for safety and tolerability (SDE)|Incidence of discomfort by clinical inquiring and observation for safety and tolerability (SDE)|Incidence of abnomal physical findings for safety and tolerability (SDE)|Visual acuity for safety and tolerability (SDE)|Intraocular pressure for safety and tolerability (SDE)|Incidence of abnomal extraocular and anterior segament findings for safety and tolerability (SDE)|White blood cell, red blood cell, platelet count, absolute neutrophils, monocytes , lymphocytes esoinophils and basophils (SDE)|Percentage of netrophils, monocytes, lymphocytes, eosinophils, basophils, hematocrit and mean cellular HGB concentration in hematology (SDE)|Mean cellulara HGB in hematology (SDE)|Mean cellular volume in hematology (SDE)|Hemoglobin in hematology (SDE)|Weight (SDE)|Akaline phosphatase, ALT, amylase, AST, creatine kinase, GGT and LDH in chemistry (SDE)|Serum chloride, potassium and sodium in chemistry (SDE)|Direct bilirubin, total bilirubin, urea nitrogen, calcium, cholesterol, creatinine, fasting glucose, triglycerides and uric acid in chemistry (SDE)|GFR estimate (Cockcroft-Gault) in chemistry (SDE)|Albumin, globulin, total protein in chemistry (SDE)|A/G ratio in chemistry (SDE)|Partial thromboplastin time, prothrombin time and thrombin time in coagulation (SDE)|Fibrinogen in coagulation (SDE)|International normalized ratio in coagulation (SDE)|Incidence of abnormal urine analysis by blood, glucose, ketones, leukocyte, protein, nitrite, bilirubin and urobilinogen in urine analysis (SDE)|PH in urine analysis (SDE)|Specific gravity in urine analysis (SDE)|Heart rate for safety and tolerability (SDE)|QRS wave interval, QT interval, QTC interval, PQ interval, P wave interval and RR interval for safety and tolerability (SDE)|QRS angle value for safety and tolerability (SDE)|QTCF value for safety and tolerability (SDE)|Satisfaction assessed by Ocular Surface Disease Index (OSDI) questionnaires for safety and tolerability (SDE)|Satisfaction assessed by National Eye Institute 25-Item Visual Function (NEI-VFQ25) questionnaires for safety and tolerability (SDE)|Incidence of AE reporting for safety and tolerability (RDE)|Incidence of SAE reporting for safety and tolerability (RDE)|Body temperature for safety and tolerability (RDE)|Pulse rate for safety and tolerability (RDE)|Respiration rate for safety and tolerability (RDE)|Blood pressure for safety and tolerability (RDE)|Incidence of discomfort by clinical inquiring and observation for safety and tolerability (RDE)|Incidence of abnomal physical findings for safety and tolerability (RDE)|Visual acuity for safety and tolerability (RDE)|Intraocular pressure for safety and tolerability (RDE)|Incidence of abnomal extraocular and anterior segament findings for safety and tolerability (RDE)|Incidence of abnormal findings from dilated fundus exam (RDE)|White blood cell, red blood cell, platelet count, absolute neutrophils, monocytes , lymphocytes esoinophils and basophils in hematology for safety and tolerability (RDE)|Percentage of netrophils, monocytes, lymphocytes, eosinophils, basophils, hematocrit and mean cellular HGB CON/MCHC in hematology (RDE)|Mean cellulara HGB in hematology (RDE)|Mean cellular volume in hematology (RDE)|Hemoglobin in hematology (RDE)|Weight (RDE)|Akaline phosphatase, ALT, amylase, AST, creatine kinase, GGT and LDH in chemistry (RDE)|Serum chloride, potassium and sodium in chemistry (RDE)|Direct bilirubin, total bilirubin, urea nitrogen, calcium, cholesterol, creatinine, fasting glucose, triglycerides and uric acid in chemistry (RDE)|GFR estimate (Cockcroft-Gault) in chemistry (RDE)|Albumin, globulin, total protein in chemistry (RDE)|A/G ratio in chemistry (RDE)|Partial thromboplastin time, prothrombin time and thrombin time in chemistry (RDE)|Fibrinogen in coagulation (RDE)|International normalized ratio in coagulation (RDE)|Incidence of abnormal urine analysis by blood, glucose, ketones, leukocyte, protein, nitrite, bilirubin and urobilinogen in urine analysis (RDE)|PH in urine analysis (RDE)|Specific gravity in urine analysis (RDE)|Heart rate for safety and tolerability (RDE)|QRS wave interval, QT interval, QTC interval, PQ interval, P wave interval and RR interval for safety and tolerability (RDE)|QRS angle value for safety and tolerability (RDE)|QTCF value for safety and tolerability (RDE)|Satisfaction assessed by Ocular Surface Disease Index (OSDI) questionnaires for safety and tolerability (RDE)|Satisfaction assessed by National Eye Institute 25-Item Visual Function (NEI-VFQ25) questionnaires for safety and tolerability (RDE)|AUC0-∞ in each SDE cohort|AUC0-t in each SDE cohort|Cmax in each SDE cohort|t1/2 in each SDE cohort|CL in each SDE cohort|Vd in each SDE cohort|AUC0-∞ in each RDE cohort|AUC0-t in each RDE cohort|Cmax in each RDE cohort|t1/2 in each RDE cohort|CL in each RDE cohort|Vd in each RDE cohort | Guangzhou HuiBoRui Biological Pharmaceutical Technology Co. Ltd|Parexel | Parexel International, Glendale, California, United States |
| Young Women's Health CoOp (Cooperative) in Cape Town | HIV|Substance Abuse | Behavioral: Young Women's Health CoOp (YWHC)|Behavioral: HIV Counseling/Testing | Unprotected intercourse among women|Alcohol use|Substance use|Victimization | RTI International|Medical Research Council, South Africa | RTI International, Research Triangle Park, North Carolina, United States |
| The Canadian Underage Substance Use Prevention Trial | Substance Use Disorders|Adolescent Behavior|Adolescent Development | Behavioral: PreVenture Training (PTtT)|Behavioral: PreVenture Training+Implementation Facilitation | Effectiveness (primary outcome): Severity of substance use problems|Implementation Facilitation (primary outcome): Severity of substance use problems|Effectiveness (secondary outcome): Prevalence of binge drinking|Effectiveness (secondary outcome): Frequency of cannabis use|Effectiveness (secondary outcome): Frequency of non-medical prescription drug use|Effectiveness (secondary outcome): Frequency of illicit substance use|Implementation Facilitation (secondary outcome): Rate of interventions | St. Justine's Hospital|University of British Columbia|Center for Addiction and Mental Health|Dalhousie University|Canadian Institutes of Health Research (CIHR) | University of British Columbia Okanagan Campus, Kelowna, British Columbia, Canada|Dalhousie University, Halifax, Nova Scotia, Canada|Center for Mental Health and Addicitions, Toronto, Ontario, Canada|CHU Sainte-Justine Research Center, Montreal, Quebec, Canada |
| Evaluation of the O'Neil Long Acting Naltrexone Implant in Opioid Dependent Persons | Opioid Use Disorder | Drug: naltrexone implant | Treatment Emergent Adverse Events (TEAEs)|Adverse Events of Special Interest (AESI)|Deaths|Serious Adverse Events (SAEs)|Adverse events (AEs) causing study discontinuation|Opioid overdose events|Laboratory abnormalities|Suicidality|Concomitant medications|AUC0-t of naltrexone|AUC0-t of 6-beta-naltrexol|AUC0-infinity of naltrexone|AUC0-infinity of 6-beta-naltrexol|Cmax of naltrexone|Cmax of 6-beta-naltrexol|Tmax of naltrexone|Tmax of 6-beta-naltrexol|Proportion of participants that maintain a minimum plasma concentration (13 weeks)|Proportion of participants that maintain a minimum plasma concentration (24 weeks)|Abstinence from drugs of abuse by UDS|Abstinence from drugs of abuse by Timeline Followback (TLFB)|Abstinence from alcohol|Opioid craving (VAS)|Opioid withdrawal (SOWS)|Opioid withdrawal (COWS)|Hamilton Depression Rating Scale (HDRS)|Brief Symptom Inventory 18 (BSI-18)|Quality of Life Score (QoL)|Treatment Satisfaction (TSQM-14) | Go Medical Industries Pty Ltd|National Institute on Drug Abuse (NIDA)|New York State Psychiatric Institute|Columbia University|The Emmes Company, LLC|University at Buffalo | |
| Personality and Drug Use | No Conditions Study Focus on Substance Use and Personality | Other: Usage of drugs | Change in scores on Big Five Inventory (BFI-44)|Change in scores on Retrospective Personality Scale (RPS) | Psychedelic Data Society|Maastricht University|Quantified Citizen Technologies Inc. | |
| Personality and Drug Use (PDU) | Personality | Current Personality Profile|Changes in Personality Profile | Quantified Citizen Technologies Inc.|Maastricht University|Psychedelic Data Society | ||
| iSTART: A Campus & Community Initiative for Services in Tec-health | Substance Use|Binge Drinking|Marijuana Use|Alcohol Drinking|Prescription Opioid Misuse|Illicit Drug Use | Behavioral: iSTART Web-app | Change from baseline alcohol use behavior at 3 months.|Change from baseline binge drinking at 3 months.|Change from baseline tobacco use at 3 months.|Change from baseline electronic vaping at 3 months.|Change from baseline marijuana use at 3 months.|Change from baseline non-prescribed prescription drug use at 3 months.|Change from baseline illicit drug use at 3 months.|Change from baseline behavioral intent at 3 months.|Change from baseline alcohol-specific outcomes at 3 months. | California State University, Northridge | California State University, Northridge, Northridge, California, United States |
| Conversion to Embeda With Rescue Trial | Chronic Disease|Pain | Drug: morphine sulfate and naltrexone hydrochloride (EMBEDA) | Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase|Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy|Duration to Titrate Participants to Stable Dose|Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy|Number of Titration Steps to Achieve Stable Dose|Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy|Percentage of Participants With Rescue Medications Usage During Titration|Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)|Investigator's Level of Satisfaction With the EMBEDA Conversion Guide | Pfizer | Adamsville Family Medicine, Adamsville, Alabama, United States|Office of David McLain, Birmingham, Alabama, United States|Monte Sano Clinical Research, LLC, Huntsville, Alabama, United States|Tennessee Valley Pain Consultants Properties, LLC, Huntsville, Alabama, United States|Sunbelt Research Group, LLC, Mobile, Alabama, United States|Office of Vaughn H. Mancha, Jr., PC, Montgomery, Alabama, United States|Dedicated Clinical Research, Goodyear, Arizona, United States|Dedicated Clinical Research, Inc, Phoenix, Arizona, United States|Redpoint Research, Phoenix, Arizona, United States|Anasazi Internal Medicine, PC, Phoenix, Arizona, United States|Cochise Clinical Research, Sierra Vista, Arizona, United States|Premiere Phamaceutical Research, LLC, Tempe, Arizona, United States|Quality of Life Medical and Research Center, LLC, Tucson, Arizona, United States|Ouachita Regional Pain Management, Hot Springs, Arkansas, United States|NEA Baptist Clinic, Jonesboro, Arkansas, United States|Hollis Family Medical Clinic, PLC, Paragould, Arkansas, United States|CSI Clinical Trials, Costa Mesa, California, United States|Global Wellness Medical Corporation, Foothill Ranch, California, United States|Chrishard Medical Group, Inglewood, California, United States|Triwest Research Associates LLC, La Mesa, California, United States|Pacific Coast Pain Management Center, Laguna Hills, California, United States|Valerius Medical Group and Research Center of Greater Long Beach, Inc., Long Beach, California, United States|LA Pain & Wellness Institute, Los Angeles, California, United States|Samaritan Center for Medical Research, Los Gatos, California, United States|Newport Beach Clinical Research Associates, Inc., Newport Beach, California, United States|Bayview Research Group, LLC, Paramount, California, United States|Pasadena Rehabilitation Institute, Pasadena, California, United States|Quality Control Research, Inc., Roseville, California, United States|Northern California Research, Sacramento, California, United States|Quality Control Research, Inc., Sacramento, California, United States|Rancho Santa Fe Medical Group, Inc., San Marcos, California, United States|Probe Clinical Research Corporation, Santa Ana, California, United States|Trinity Clinical Trials, Santa Ana, California, United States|Facility Medical Center, Upland, California, United States|Bayview Research Group, LLC, Valley Village, California, United States|Rocky Mountain Internal Medicine, PC, Aurora, Colorado, United States|Clinicos, LLC, Colorado Springs, Colorado, United States|Saint Luke's Medical Clinic, LLC, Fort Collins, Colorado, United States|ProHealth Physicians PC, Manchester, Connecticut, United States|Milford Physician Services, PC, Milford, Connecticut, United States|Orthopedic Research Institute, LLC, Boynton Beach, Florida, United States|Florida Research & Testing, LLC, Clearwater, Florida, United States|Omega Research Consultants, LLC, Debary, Florida, United States|Omega Research Consultants, LLC, DeBary, Florida, United States|West Florida Medical Associate, PA, Dunnellon, Florida, United States|International Research Associates, LLC, Hialeah, Florida, United States|Palm Springs Research Institute, Inc, Hialeah, Florida, United States|FPA Clinical Research, LLC, Kissimmee, Florida, United States|Clinical Research of Central Florida, Inc., Lakeland, Florida, United States|NextPhase Clinical Trials, Inc., Miami Beach, Florida, United States|Community Research Foundation, Inc., Miami, Florida, United States|New Horizon Research Center, Inc., Miami, Florida, United States|Harmony Clinical Research, Inc., North Miami Beach, Florida, United States|Office of Laszlo J. Mate, MD, PA, North Palm Beach, Florida, United States|Office of Richard E. Promin, MD, PA, Ocala, Florida, United States|Advent Clinical Research Centers, Inc., Pinellas Park, Florida, United States|Pain Management Strategies, Inc., Pompano Beach, Florida, United States|Sarasota Pain Medicine Research, LLC, Sarasota, Florida, United States|Stedman Clinical Trials, LLC, Tampa, Florida, United States|Clinical Research Center, LLC, Wellington, Florida, United States|Perimeter Institute for Clinical Research, Inc., Atlanta, Georgia, United States|Medical Research and Health Education Foundation, Inc., Columbus, Georgia, United States|Ialum Clinical Research, LLC, Decatur, Georgia, United States|Ialum Clinical Research, LLC, Stone Mountain, Georgia, United States|Herman Clinical Research, LLC, Suwanee, Georgia, United States|Centers for Pain Management, Tifton, Georgia, United States|Chicago Clinical Research Institute Inc., Chicago, Illinois, United States|Creve Coeur Family Practice, Creve Coeur, Illinois, United States|Office of Rebecca Knight, MD, Peoria, Illinois, United States|Josephson Wallack Munshower Neurology P.C., Indianapolis, Indiana, United States|Laporte County Institute for Clinical Research Inc., Michigan City, Indiana, United States|McKinley Research, LLC, Mishawaka, Indiana, United States|Accelovance, Inc., South Bend, Indiana, United States|Des Moines Orthopaedic Surgeons, PC, West Des Moines, Iowa, United States|The Pain Treatment Center of the Bluegrass, Lexington, Kentucky, United States|Healing Options, Louisville, Kentucky, United States|Four Rivers Clinical Research, Inc., Paducah, Kentucky, United States|Lakewood Family Practice, Russell Springs, Kentucky, United States|Diseasebusters, LLC, College Park, Maryland, United States|Office of Steven C. Miller, MD, Pikesville, Maryland, United States|Beacon Clinical Research, LLC, Brockton, Massachusetts, United States|Ronald J. Rapoport, MD, PC, Fall River, Massachusetts, United States|Boston Paincare Center, Inc., Waltham, Massachusetts, United States|Clarkston Medical Group, PC, Clarkston, Michigan, United States|Apex Medical Research, AMR, Inc., Flint, Michigan, United States|East Michigan Medical Associates, Flint, Michigan, United States|PCM Medical Services, PC, Lansing, Michigan, United States|Remedica LLC, Rochester, Michigan, United States|Michigan Lifestyle Change and Health Center, PC, Sterling, Michigan, United States|MAPS Applied Research Center, Inc., Edina, Minnesota, United States|MAPS Applied Research Center, Inc., Shakopee, Minnesota, United States|Anesthesia and Pain Control Services, Biloxi, Mississippi, United States|CRC of Jackson, LLC, Jackson, Mississippi, United States|Midsouth Anesthesia Consultants, PLLC, Southhaven, Mississippi, United States|Patterson Medical Clinic, Inc., Florissant, Missouri, United States|Quality Clinical Research Inc., Florissant, Missouri, United States|Primary Care Medicine, PC, Jefferson City, Missouri, United States|The Reiter Foundation, Inc., Anaconda, Montana, United States|Medical Pain Relief Clinic, Omaha, Nebraska, United States|Omaha Clinical Research, PC, Omaha, Nebraska, United States|Atco Medical Associates, PC, Atco, New Jersey, United States|Office of John V. Bernard, MD, Belvidere, New Jersey, United States|Central Jersey Medical Research Center, Inc., Elizabeth, New Jersey, United States|Center for Pain Management, Hackensack, New Jersey, United States|Advocare Heights Primary Care, Haddon Heights, New Jersey, United States|NJ Heart, LLC, Linden, New Jersey, United States|Spine and Pain Centers, PA, Shrewsbury, New Jersey, United States|Premier Research, Inc., Trenton, New Jersey, United States|Adirondack Medical Research Center, Glens Falls, New York, United States|Long Island Gastrointestinal Research Group LLP, Great Neck, New York, United States|Drug Trials America, Inc., Hartsdale, New York, United States|Office of Roger Kasendorf, DO, Long Beach, New York, United States|Family Health Medical Services PLLC, Mayville, New York, United States|New York Spine & Wellness Center, North Syracuse, New York, United States|North American Partners in Pain Management, LLP, Valley Stream, New York, United States|Carolina Clinical Research and Consulting, LLC, Asheboro, North Carolina, United States|Carolina Clinical Research and Consulting, LLC, Asheboro, North Carolina, United States|Joint and Muscle Research Institute, Inc., Charlotte, North Carolina, United States|Catawba Valley Internal Medicine, Hickory, North Carolina, United States|Profen Research Network at ECMA, Jacksonville, North Carolina, United States|The Center For Clinical Research, LLC, Winston-Salem, North Carolina, United States|Medical Frontiers, LLC, Carlisle, Ohio, United States|Valley Medical Research, Centerville, Ohio, United States|Hightop Medical Research Center, Cincinnati, Ohio, United States|Sentral Clinical Research Services, Cincinnati, Ohio, United States|Delaware Smith Clinic Research, Delaware, Ohio, United States|Medical Frontiers, LLC, Franklin, Ohio, United States|Jeffrey J. Haggenjos, DO, Inc., New Lexington, Ohio, United States|Whole Family Medical Care LLC, Perrysburg, Ohio, United States|Office of Jocelyn F. Shimek, DO, Salem, Ohio, United States|Office of James Lassiter, Tiffin, Ohio, United States|Health Research Institute, LLC, Oklahoma City, Oklahoma, United States|Office of Siavash Nael, MD, Inc., Oklahoma City, Oklahoma, United States|Associates of Medicine/John D. Williams, MD, PLLC, Stillwater, Oklahoma, United States|Portland Rheumatology Clinic, LLC, Lake Oswego, Oregon, United States|Office of Joseph E. Yankee, DO, PC, Milwaukie, Oregon, United States|Pennsylvania Pain Specialists, PC, Allentown, Pennsylvania, United States|Ware Medical Associates, PC, Aston, Pennsylvania, United States|Altoona Center for Clinical Research, PC, Duncansville, Pennsylvania, United States|Kandra, Fierer, Kuskin Associates, Ltd., Harrisburg, Pennsylvania, United States|Onuorah Umeh, M.D. P.C, Philadelphia, Pennsylvania, United States|Founders Research Corporation, Philadelphia, Pennsylvania, United States|Progressive Pain Solutions, LLC, Wind Gap, Pennsylvania, United States|Hartwell Research Group, LLC, Anderson, South Carolina, United States|Low Country Rheumatology, PA, Charleston, South Carolina, United States|Pharmacorp Clinical Trials, Inc., Charleston, South Carolina, United States|Internal Medicine of Greer Research LLC, Greer, South Carolina, United States|Clinical Research Authority, LLC, Murrells Inlet, South Carolina, United States|Trident Institute of Medical Research, LLC, North Charleston, South Carolina, United States|Low Country Pain Center, LLC, Orangeburg, South Carolina, United States|Brown Clinic, PLLP, Watertown, South Dakota, United States|Chattanooga Medical Research, LLC, Chattanooga, Tennessee, United States|Comprehensive Pain Specialists, Hendersonville, Tennessee, United States|Corsicana Medical Research, PLLC, Corsicana, Texas, United States|DCT - Genesis Neighborhood Research, LLC, Dallas, Texas, United States|Southwest Urgent Care Center, El Paso, Texas, United States|Westbury Medical Clinic, Houston, Texas, United States|Accurate Clinical Research, Inc., Houston, Texas, United States|Medstar Clinical Research, Houston, Texas, United States|Texas Medical Research Associates, LLC, San Antonio, Texas, United States|Hillcrest Family Health Center, Division of Clinical Research, Waco, Texas, United States|Hillcrest Family Health Center, Waco, Texas, United States|Progressive Clinical Research, LLC, Bountiful, Utah, United States|Sentara Medical Group, NDC Medical Center, Norfolk, Virginia, United States|Washington Center for Pain Management PLLC, Edmonds, Washington, United States|Pain Care, PLLC, Huntington, West Virginia, United States |
| Y2Prevent: Preventing Drug Use and HIV Through Empowerment, Social Support and Mentorship (Y2P) | HIV|Drug Use | Behavioral: Y2Prevent | Sexual risk behaviors|Alcohol and illincit drug use|Illincit drug use|PrEP Uptake | Children's Hospital Los Angeles|National Institute on Drug Abuse (NIDA) | Children's Hospital Los Angeles, Los Angeles, California, United States |
| Harnessing Placebo Effects in Methadone Treatment | Opioid-use Disorder|Opioid-Related Disorders | Behavioral: Open-Label Placebo (OLP) | Three-month dose of methadone|Treatment Retention|Total number of days retained in treatment|Mean number of days of self-reported drug use|Urine Testing- Quick-tox Screen|Craving assessment|Objective Opioid Withdrawal Scale (OOWS)|Subjective Opioid Withdrawal Scale (SOWS)|Pittsburgh Sleep Quality Inventory (PSQI)|World Health Organization Quality of Life - Brief (WHOQOL-BREF) Assessment | University of Maryland, Baltimore|University of Maryland, College Park | Maryland Methadone Treatment Center, Baltimore, Maryland, United States |
| Predicting Effective Adaptation to Breast Cancer to Help Women to BOUNCE Back | Breast Cancer | Behavioral: psychological questionnaires | Change in Resilience|Personality|Dispositional optimism|Sense of coherence|Change in Post traumatic stress disorder|Change in Positive outcome after trauma exposure|Change in Coping flexibility|Change in Cognitive coping strategies|Change in Dispositional mindfulness|Change in Mental adjustment to cancer|Change in Social support|Change in Family resilience|Change in Illness representation|Change in patients Self-efficacy in coping with cancer|Change in Depression and anxiety|Change in Quality of life assessed by EORTC-QLQ C30|Change in Quality of life in patients with breast cancer assessed by EORTC-QLQ BR23|Change in Fear of cancer recurrence|Change in Positive and negative affect|Change in Distress|Chronic illnesses|Genetic risk factors|Change in Menopausal status|Tumor biology|surgery type|Change in Performance status|Change in Ongoing oncological therapy|Change in the use of Psychotropic medication|Change in blood test|Age|Change in Level of education|Change in Marital status|Change in Weight|Change in Height|Change in Number of children|Change in Employment status|Change in number of sick days|Change in Flexible arrangements at work|Return to work|Change in monthly Income|Change in level of faith|Change in Number of professional support sessions|Change in family's work|Change in leisure activities|Change in domestic help|Change in Smoking habits|Change in alcohol consumption|Change in Drug use|Change in diet habits|Change in Physical exercise | European Institute of Oncology|Helsinki University Central Hospital|Hebrew University of Jerusalem|Fundacao Champalimaud|Foundation for Research and Technology - Hellas|Institute of Communications and Computer Systems, Athens, Greece|SINGULARLOGIC|NHG CONSULTING OY|Noona Healthcare | European Institute of Oncology, Milan, Italy |
| ACT for Methamphetamine Use Disorder in Women and Gender Non-Conforming Individuals | Methamphetamine Abuse|Methamphetamine-dependence | Behavioral: Acceptance Commitment Therapy | Feasibility of intervention|Acceptability of intervention|Changes in other substance use via the Timeline Followback (TLFB)|Changes in depression via the Patient Health Questionnaire-9 (PHQ-9)|Changes in anxiety via the Generalized Anxiety Disorder-7 (GAD-7)|Changes in trauma symptoms via the Trauma Screening Questionnaire (TSQ)|Changes in acceptance commitment skills via the Acceptance and Action Questionnaire [AAQ-2|Changes in cravings/urges for methamphetamine via the Brief Substance Craving Scale BSCS|Changes in quality of life, including well-being, relationships, social activities, personal fulfillment and recreation via the World Health Organization Quality of Life- BREF [WHOQOL-BREF]|Changes in safer drug use practices at the end of the study via semi-structured interviews|Barriers to engaging in the intervention using qualitative assessments at the end of study|Engagement in treatment|Changes in methamphetamine use via the timeline followback (TLFB)|Changes in methamphetamine use via urinalysis | Centre for Addiction and Mental Health | Centre for Addiction and Mental Health, Toronto, Ontario, Canada |
| Social Media Intervention for Cannabis Use in Emerging Adults | Cannabis Use | Behavioral: Social Media Intervention | Frequency of Cannabis Use as Reported on the Timeline Follow-Back (TLFB)|Quantity of Cannabis Used as Reported on the Timeline Follow-Back (TLFB)|Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire Using Dichotomous Response Scale as Previously Described Throughout This Trial Registration.|Consequences of Cannabis Use as Measured by the Marijuana Adolescent Consequences Questionnaire|Perceived Risk of Cannabis Use as Measured by 2 Modified Items From the Monitoring the Future Survey|Perceived Risk of Cannabis Use as Measured by Modified Items From the Monitoring the Future Survey|Peer Approval/Disapproval of Cannabis Use as Measured by Item Modified From Monitoring the Future Survey|Cannabis Impaired Driving as Measured by 5 Items From the Modified Young Adult Driving Questionnaire|Other Drug Use as Measured by Items Modified From Monitoring the Future Survey|Frequency of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB)|Quantity of Alcohol Consumption as Reported on the Timeline Follow-Back (TLFB) | University of Michigan|National Institute on Drug Abuse (NIDA) | University of Michigan, Ann Arbor, Michigan, United States |
| Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia | Alcohol and Substance-Related Mental Disorders | Behavioral: SBIRT|Behavioral: Treatment as usual | Difference in change in Alcohol Use Disorders Identification Test (AUDIT) score|Center for Epidemiologic Studies - Depression scale (CES-D)|Generalized Anxiety Disorder-7 scale (GAD-7)|Harvard Trauma Questionnaire (HTQ)|Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)|Sleep Scale for the Medical Outcomes Research Study | Columbia University | Mantapala Refugee Settlement, Nchelenge, Luapula, Zambia |
| A Phase 1 Study of HBI-3000 | Atrial Fibrillation | Drug: HBI-3000|Other: Placebo | Physical Examination (Safety and Tolerability)|Safety Labs (Safety and Tolerability)|Urinalysis (Safety and Tolerability)|Pulmonary Function Tests (Safety and Tolerability)|12-Lead ECG (Safety and Tolerability)|Holter ECG (Safety and Tolerability)|Telemetry ECG (Safety and Tolerability)|Vital Signs (Safety and Tolerability)|Adverse Events (Safety and Tolerability)|HBI-3000 Levels Over Time in Plasma (Cmax)|HBI-3000 Levels Over Time in Plasma (Tmax)|HBI-3000 Levels Over Time in Plasma (AUC(0-last))|HBI-3000 Levels Over Time in Plasma (AUC(0-inf))|HBI-3000 Levels Over Time in Plasma (AUC(0-24h))|HBI-3000 Levels Over Time in Plasma (AUC%extrap)|HBI-3000 Levels Over Time in Plasma (lambda-z)|HBI-3000 Levels Over Time in Plasma (T1/2)|HBI-3000 Levels Over Time in Plasma (CL)|HBI-3000 Levels Over Time in Plasma (CLr)|HBI-3000 Levels Over Time in Plasma (Vz)|HBI-3000 Levels Over Time in Plasma (Vss)|HBI-3000 Levels Over Time in Plasma (MRT)|HBI-3000 Levels Over Time in Urine (Ae)|HBI-3000 Levels Over Time in Urine (CumAe)|HBI-3000 Levels Over Time in Urine (%Ae)|HBI-3000 Levels Over Time in Urine (Cum%Ae) | HUYABIO International, LLC.|Quotient Clinical | Quotient Clinical, Nottingham, United Kingdom |
| Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments | COVID-19 Pandemic|Professional Stress | Other: Questionnaire | Prevalence of anxiety disorders|Measure the prevalence of post-traumatic stress disorder|Measure the prevalence of depressive episodes|Study the professional burnout syndrome|Study the the quality of life at work among staff|Study the use of psychostimulant substances (drugs, alcohol, drugs, tobacco) among the staff of accommodation facilities for old people and home help | Centre Hospitalier Charles Perrens, Bordeaux | Centre Hospitalier Charles Perrens, Bordeaux, France |
| MHealth Intervention of HIV and STDs Partner Notification for MSM | HIV/AIDS|Sexually Transmitted Diseases|Prevention | Behavioral: Health education, and regular HIV and STDs testing prompting service|Behavioral: Health status inquiry through app (partner notification) | HIV positive seroconversion rate (HIV incidence)|Additional cost of the intervention|Syphilis positive seroconversion rate (Syphilis incidence)|Hepatitis B positive seroconversion rate (Hepatitis B incidence)|Hepatitis C positive seroconversion rate (Hepatitis C incidence)|HIV and related diseases transmission among social networks|Testing adherence|Additional cost for finding per seroconversion|Frequency of utilization for each intervention/service|Satisfaction of the interventions and services|Knowledge of HIV and related STDs|Attitudes of HIV and STDs testing, safe sexual behaviors and partner notification|Sexual behaviors|Substance use behaviors|Psychological status|Referral rate of HIV and related STDs | National Institute on Drug Dependence, China|Man Wellness Center, Beijing, China | |
| Addressing Risk Through Community Treatment for Infectious Disease and Opioid Use Disorder Now (ACTION) Among Justice-involved Populations | Opioid Use Disorder|Infectious Disease|Risk Reduction Behavior|Substance Use|Substance Abuse|Stimulant Use Disorder | Behavioral: Patient Navigator|Behavioral: Mobile Health Unit | Time to post-release initiation of ART medication|Time to post-release initiation of PrEP medication|Proportion of participants that initiate PrEP|Proportion of participants prescribed PrEP at end of intervention.|PrEP adherence by dried blood spot (DBS) testing|PrEP adherence by urine sample analysis|PrEP adherence by self-report|PrEP adherence assessed by prescription refill data|Retention in HIV PrEP care|Change in HIV status|ART adherence by DBS testing|ART adherence by urine sample analysis|ART adherence by self-report|ART adherence by prescription refill|Retention in HIV ART care|HIV viral suppression|HIV Risk behaviors|Hepatitis C incidence|Hepatitis C linkage|Hepatitis C medication initiation via self-report|Hepatitis C medication initiation by prescription refill|Hepatitis C medication initiation by confirmation from provider|Hepatitis C medication completion by self-report|Hepatitis C medication completion by prescription refill|Hepatitis C medication completion by confirmation from provider|Hepatitis C sustained viral remission (SVR)|Hepatitis C re-infection|Opioid use|Number of opioid use days|Type of opioids used|Opioid abstinence|Substance use treatment participation|Linkage to medications for opioid use disorder (MOUD) via self report|Linkage to medications for opioid use disorder (MOUD) via community provider|MOUD retention by community provider|MOUD retention by self report|Substance use|Type of substances used|Substance use related overdoses at 6 months|Substance use related overdoses at 12 months | Yale University|National Institute on Drug Abuse (NIDA) | Yale School of Medicine, New Haven, Connecticut, United States|UT Southwestern, Dallas, Texas, United States|Texas Christian University, Fort Worth, Texas, United States |
| Project PRIDE (Promoting Resilience In Discriminatory Environments) | Human Immunodeficiency Virus|Sexually Transmitted Infections|Anxiety|Depression|Substance Use Disorders | Behavioral: Project PRIDE | Change in 60-Day Condomless Anal Sex in the Absence of PrEP from pre-test to 5 months|Salivary cortisol|60-Day Drug Use|60-Day Self-Reported Drug/Alcohol Use|Loneliness|Self Esteem|Coping|Racist Discrimination|Anti-Gay/Bisexual Discrimination|Gay/Bisexual Identity|Internalized Homonegativity|Anxiety|Depression|HIV|Gonorrhea|Chlamydia|Syphilis|60-Day Vaginal Sex|60-Day Oral Sex | University of Houston|National Institute on Drug Abuse (NIDA) | Avenue 360, University of Houston, Houston, Texas, United States |
| Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain | Chronic Noncancer Pain | Drug: oxycodone HCl and naltrexone HCl extended-release capsules | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Adverse Reactions|Number of Participants With Treatment Emergent (TE) Adverse Events (AEs) Based on Intensity|Percentage of Participants With Clinical Opiate Withdrawal Scale (COWS) Score|Subjective Opiate Withdrawal Scale (SOWS) Score | Pfizer | Avail Clinical Research, LLC, Deland, Florida, United States|Florida Institute of Medical Research, Jacksonville, Florida, United States|Drug Study Institute, Jupiter, Florida, United States|Ormond Medical Arts Pharmaceutical Research Center, Ormond Beach, Florida, United States|Peninsula Research, Inc., Ormond Beach, Florida, United States|Accord Clinical Research, Port Orange, Florida, United States|Sarasota Pain Medicine Research, Sarasota, Florida, United States|Clinical Research of West Florida, Tampa, Florida, United States|Center for Prospective Outcome Studies, Inc., Atlanta, Georgia, United States|Drug Studies America, Marietta, Georgia, United States|Georgia Institute for Clinical Research, LLC, Marietta, Georgia, United States|The Pain Treatment Center of the Bluegrass, Lexington, Kentucky, United States|Commonwealth Biomedical Research, Madisonville, Kentucky, United States|Crossroads Research, Owings Mills, Maryland, United States|DM Clinical Research, Springfield, Massachusetts, United States|MAPS Applied Research Center, Edina, Minnesota, United States|Mid-South Anesthesia Consultants, Southaven, Mississippi, United States|Healthcare Research, LLC, Hazelwood, Missouri, United States|Montana Neuroscience Institute, Missoula, Montana, United States|Comprehensive Clinical Research, Berlin, New Jersey, United States|Drug Trials America - New York, Hartsdale, New York, United States|New York Spine and Wellness Center, North Syracuse, New York, United States|Upstate Clinical Research Associates, Williamsville, New York, United States|Center for Clinical Research, LLC - Winston-Salem, Winston-Salem, North Carolina, United States|Columbus Clinical Research, Inc., Columbus, Ohio, United States|Allegheny Pain Management, PC, Altoona, Pennsylvania, United States|FutureSearch Trials of Neurology, Austin, Texas, United States|KRK Medical Research, Dallas, Texas, United States|Benchmark Research - Fort Worth, Fort Worth, Texas, United States|Quality Research, Inc., San Antonio, Texas, United States|Lifetree Clinical Research, Salt Lake City, Utah, United States|Hypothetest, LLC, Roanoke, Virginia, United States |
| Pilot Test of Parent-Focused Cannabis-Related Actions and Practices Intervention for Adolescent Marijuana Abuse | Cannabis Use Disorder, Mild|Cannabis Use Disorder, Moderate | Behavioral: Cannabis Actions and Practices Resource for Parents | Adolescent Marijuana Use-Adolescent Report|Perceptions of Harmfulness of Marijuana Use Adolescent Report (PMHU-A)|Cannabis-Specific Parenting Practices | Oregon Research Institute | Center for Family and Adolescent Research, Albuquerque, New Mexico, United States |
CT World - Psilocybin
CT World - Psilocybin.csv
| Title | Conditions | Interventions | Outcome Measures | Sponsor/Collaborators | Locations |
|---|---|---|---|---|---|
| Precision Functional Brain Mapping in Psilocybin | Psilocybin | Drug: Psilocybin|Drug: Methylphenidate | Functional Connectivity|Mystical Experiences|Personality Change | Washington University School of Medicine | Washington University, Saint Louis, Missouri, United States |
| Study of the Safety and Feasibility of Psilocybin in Adults With Methamphetamine Use Disorder | Methamphetamine Use Disorder|Substance-Related Disorders|Chemically-Induced Disorders|Substance Use Disorders|Stimulant-Use Disorder | Drug: Psilocybin | Incidence of serious adverse events associated with oral psilocybin|Number of participants who complete at least one dose of psilocybin|Number of participants who complete two-month follow-up visit|Changes in substance use|Functional changes in psychedelic and addiction-related neurocircuitry using functional magnetic resonance imaging. | University of Wisconsin, Madison|Revive Therapeutics, Ltd. | University of Wisconsin, Madison, Wisconsin, United States |
| Psilocybin for the Treatment of Veterans With Post-Traumatic Stress Disorder | PTSD|Stress Disorders, Traumatic|Stress Disorders, Post-Traumatic|Trauma and Stressor Related Disorders|Mental Disorder | Drug: Psilocybin | Type, severity, and frequency of Adverse Events (AEs) associated with psilocybin assisted therapy|Columbia Suicide Severity Rating Scale (C-SSRS)|PTSD Symptom Severity as measured by the Clinician Administered PTSD Scale-5 (CAPS-5)|PTSD Checklist for Diagnostic and Statistical Manual Diploma in Social Medicine-5 (PCL-5) | Ohio State University | Ohio State University Department of Psychiatry and Behavioral Health at the Davis Medical Research Center, Columbus, Ohio, United States |
| Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study | Alcohol Use Disorder (AUD) | Drug: Psilocybin | Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder|Feasibility: Proportion of participants who complete|Pharmacokinetic parameter of psilocin: Cmax|Pharmacokinetic parameter of psilocin: Tmax|Pharmacokinetic parameter of psilocin: AUC|Subjective effects of psilocybin: Intensity|Subjective effects of psilocybin: Mystical Experience|Subjective effects of psilocybin: Altered States of Consciousness|Subjective effects of psilocybin: Awe Experience|Subjective effects of psilocybin: Ego Dissolution|Change in craving|Change in self-efficacy|Change in mindfulness | Anders Fink-Jensen, MD, DMSci|The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet|Psychiatric Centre Rigshospitalet | Psychiatric Center Copenhagen, Rigshospitalet, Copenhagen, Denmark |
| Psilocybin-assisted CBT for Depression | Major Depressive Disorder | Drug: Psilocybin | Hamilton Depression Rating Scale|Global Assessment of Functioning|Treatment acceptability|Treatment feasibility | University of California, Los Angeles | |
| Bioavailability Study of Psilocybin in Normal Adults | Healthy | Drug: Oral Psilocybin|Drug: IV Psilocybin | Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin|Determine the concentration of psilocin following oral and IV administrations of psilocybin|Difference in the area under plasma concentration-time curve (AUC) between psilocybin administration methods.|Difference in the maximum concentration (Cmax) between psilocybin administration methods.|Difference in the time to maximum plasma concentration (Tmax) between psilocybin administration methods.|Characterize the incidence and severity of adverse events associated with doses of psilocybin in healthy adults|Suicidal ideation | University of Wisconsin, Madison|TRYP Therapeutics | University of Wisconsin, Madison, Wisconsin, United States |
| An Evaluation of Psilocybin's Effect on Cardiac Repolarization | QTc Interval | Drug: Psilocybin|Drug: Moxifloxacin|Drug: Micro-Crystalline Cellulose | Change from baseline (Day -1) QTcF (ΔΔQTcF) following up to 24 hours post administration of a supratherapeutic dose of psilocybin.|Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Usona Institute | Altasciences Clinical Kansas, Inc, Overland Park, Kansas, United States |
| Effects of Psilocybin in Obsessive Compulsive Disorder | Obsessive-Compulsive Disorder | Drug: Psilocybin | Change in The Yale Brown Obsessive Compulsive Scale (Y-BOCS) score|State-Trait Anxiety Inventory (STAI)|Beck Depression Inventory II (BDI-II)|Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | Johns Hopkins University | |
| Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease | Parkinson Disease|Depression|Anxiety | Drug: Psilocybin therapy | Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD|Recruitment rate|Retention rate|Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD|Effects of psilocybin therapy on depression in people with PD (exploratory)|Effects of psilocybin therapy on anxiety in people with PD (exploratory)|Effects of psilocybin therapy on self-reported apathy (exploratory)|Effects of psilocybin therapy on self-reported depression (exploratory)|Effects of psilocybin therapy on self-reported lower extremity function (exploratory)|Effects of psilocybin therapy on self-reported Upper Extremity Function (exploratory)|Effects of psilocybin therapy on self-reported Cognitive Function (exploratory)|Effects of psilocybin therapy on self-reported Fatigue (exploratory)|Effects of psilocybin therapy on self-reported Concern with Death and Dying (exploratory)|Effects of psilocybin therapy on self-reported Social Roles and Activities (exploratory)|Effects of psilocybin therapy on self-reported Positive Affect and Well-Being (exploratory) | Joshua Woolley, MD/PhD|University of California, San Francisco | University of California, San Francisco, San Francisco, California, United States |
| Psilocybin in Co-occuring Major Depressive Disorder and Borderline Personality Disorder | Borderline Personality Disorder|Major Depressive Disorder | Drug: Psilocybin | Montgomery-Asberg Depression Rating Scale (MADRS)|Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)|Clinical Global Impression - Severity scale (CGI-S)|Clinical Global Impression - Improvement scale (CGI-I) | University of Chicago|Usona Institute | University of Chicago, Chicago, Illinois, United States |
| Psilocybin Therapy for Depression in Bipolar II Disorder | Bipolar II Disorder | Drug: Psilocybin therapy | Safety and tolerability of psilocybin therapy for depression in BD II|Recruitment rate|Retention rate|Clinician-reported effects of psilocybin therapy on depressive symptoms in people with Bipolar II|Treatment Satisfaction of study procedures|Self-reported effects of psilocybin therapy on manic and/or psychotic symptoms in people with Bipolar II|Clinician-reported effects of psilocybin therapy on mania symptoms in people with Bipolar II|Clinician-reported effects of psilocybin therapy on suicidality symptoms in people with Bipolar II|Patient reported effects of psilocybin therapy on depressive symptoms symptoms in people with Bipolar II (exploratory)|Effects of psilocybin therapy on anxiety symptoms in people with Bipolar II (exploratory)|Effects of psilocybin therapy on sleep quality in people with Bipolar II (exploratory)|Effects of psilocybin therapy on quality of life in people with Bipolar II (exploratory)|Effects of psilocybin therapy on borderline personality disorder symptoms in people with Bipolar II (exploratory)|Effects of psilocybin therapy on adult attachment in people with Bipolar II (exploratory)|Effects of psilocybin therapy on participant-reported recovery in people with Bipolar II (exploratory)|Subjective effects of psilocybin therapy in people with Bipolar II | University of California, San Francisco | University of California, San Francisco, San Francisco, California, United States |
| A Study of Psilocybin for Major Depressive Disorder (MDD) | Depressive Disorder, Major | Drug: Psilocybin|Drug: Niacin | Change in central rater Montgomery-Asberg Depression Rating Scale (MADRS) total score from Baseline to post-dose Day 43|Change in central rater MADRS score from Baseline to post-dose Day 8|Change in on-site rater administered Sheehan Disability Scale (SDS) score from Baseline to post-dose Day 43|Sustained depressive symptom response defined as a ≥ 50% reduction from Baseline central rater MADRS score at all post-dose assessments|Sustained depressive symptom remission defined as a central rater MADRS total score ≤ 10 at all post-dose assessments | Usona Institute|The Emmes Company, LLC | University of California, San Francisco, San Francisco, California, United States|Pacific Neuroscience Institute, Santa Monica, California, United States|Yale University, New Haven, Connecticut, United States|Segal Trials, Lauderhill, Florida, United States|Emory University, Atlanta, Georgia, United States|Great Lakes Clinical Trials, Chicago, Illinois, United States|Johns Hopkins University, Baltimore, Maryland, United States|Hassman Research Institute, Berlin, New Jersey, United States|New York University School of Medicine, New York, New York, United States|Cedar Clinical Research, Draper, Utah, United States|University of Wisconsin - Madison, Madison, Wisconsin, United States |
| Psilocybin for Psychological and Existential Distress in Palliative Care | Depression, Anxiety|Distress, Emotional | Drug: Psilocybin | Recruitment Rate|Intervention Completion Rate|Follow-up Completion Rate|Number of Participants With Adverse Events - Change in Blood Pressure|Number of Participants With Adverse Events - Change in Heart Rate|Number of Participants With Adverse Events - Delirium|Number of Participants With Adverse Events - Serotonin Syndrome|Number of Participants With Adverse Events - Adverse Mood or Behaviour Change|Psychological Distress - Anxiety and Depression|Change in Psychological Distress - Anxiety and Depression|Psychological Distress - Anxiety, Depression, and Well-being|Change in Psychological Distress - Anxiety, Depression, and Well-being|Psychological Distress - Global Impression of Change|Dosing|Existential Distress|Death Anxiety|Participant Quality of Life|Wish to Die|Global Distress | Ottawa Hospital Research Institute|Bruyere Research Institute|The Ottawa Hospital|St. Joseph's Healthcare Hamilton|CHU de Quebec-Universite Laval|Centre de recherche du Centre hospitalier universitaire de Sherbrooke|Jewish General Hospital|William Osler Health System|Kingston Health Sciences Centre | |
| Investigating the Therapeutic Effects of Psilocybin in Treatment-Resistant Post-Traumatic Stress Disorder | Treatment Resistant Disorders|Post Traumatic Stress Disorder | Drug: Psilocybin | Primary efficacy of psilocybin using the 11-Dimension Altered States of Consciousness (11D-ASC) will assess|PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)|Subjective distress caused by traumatic events as measured by the Impact of Events Scale Revised (IES-R).|Symptoms of Psychopathology as measured by the Symptom Checklist 90-R (SC90-R).|Symptom severity, treatment response, and the efficacy of treatment studies of patients with mental disorders as measured by the Clinical Global Impression - Improvement (CGI-I)/ Clinical Global Impression - Severity (CGI-S).|Anxiety as measured by the Beck Anxiety Inventory (BAI).|Anxiety as measured by the State Trait Anxiety Inventory - Trait Version (STAI-T).|Depression as measured by the Beck Depression Inventory (BDI).|Depression as measured by the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR).|Impairments in daily living as measured by the Sheehan Disability Scale (SDS).|Addiction severity as measured by the Addiction Severity Index (ASI).|Body Mass Index (BMI) | Halucenex Life Sciences Inc.|Everest Clinical Research|KGK Science Inc. | Halucenex Life Sciences Inc., Windsor, Nova Scotia, Canada |
| The Safety and Efficacy of Psilocybin in Cancer Patients With Major Depressive Disorder | Major Depressive Disorder | Drug: Psilocybin | The Montgomery-Åsberg Depression Rating Scale (MADRS)|Quick Inventory of Depressive Symptomatology Self reported (QIDS-SR)|Maudsley Visual Analogue Scale (VAS) current|Maudley Visual Analogue Scale (VAS) Change.|Pain Visual Analogue Score (VAS)|Hamilton Anxiety Rating Scale-A (HAM-A)|State-Trait Anxiety Inventory (STAI)|National Institute of Health Healing Experience of All Life Stressors (NIH-HEALS)|Patient EQ-5D-5L|Caregiver Oncology Quality of Life Questionnaire (CarGOQol)|DS-II|5 Dimension Altered State of Consciousness (5D-ASC)|Sheehan Disability Score (SDS)|Scale To Assess Therapeutic Relationship: Patient (STAR-P)|Scale To Assess Therapeutic Relationship: Clinician. (STAR-C)|Changes in electrocardiographs. | Maryland Oncology Hematology, PA | Maryland Oncology Hematology PA, Rockville, Maryland, United States |
| Effects of Psilocybin in Post-Treatment Lyme Disease | Post-Treatment Lyme Disease|Chronic Lyme Disease|Lyme Disease, Chronic | Drug: Psilocybin | Change in multi-system symptom burden as assessed by the General Symptom Questionnaire (GSQ-30) score|Change in functional health and well-being as assessed by the Short Health Form, Version 2 (SF-36v2) score|Change in fatigue as assessed by the Fatigue Severity Scale (FSS) score|Change in pain as assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ) | Johns Hopkins University|Steven and Alexandra Cohen Foundation | Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States |
| The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression | Treatment Resistant Depression | Drug: Psilocybin | Improvement in depressive symptoms|Incidence of response|Incidence of remission|Improvement in Clinical Global Impression - Severity|Adverse Events | COMPASS Pathways | Kadima Neuropsychiatry Institute, La Jolla, California, United States|Sheaf House, Tallaght Hospital, Dublin, Ireland |
| Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder | Amphetamine-Related Disorders | Drug: Psilocybin|Behavioral: Treatment-as-usual | Acceptability|Proportion of patients who complete the intervention and follow-up|Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]|Methamphetamine Use, self-report|Methamphetamine Use, urine|Change from baseline in Sheehan Disability Scale (SDS) at end-of-intervention|Change from baseline in Sheehan Disability Scale at 60 day post-discharge follow-up|Change from baseline in Sheehan Disability Scale at 180 day post-discharge follow-up | Portland VA Research Foundation, Inc|Steven & Alexandra Cohen Foundation | Portland VA Health Care System, Vancouver, Washington, United States |
| UW Psilocybin Pharmacokinetics Study | Healthy | Drug: Psilocybin | Determine the concentrations of psilocin following escalating doses of psilocybin|Characterize any non-linearity in the pharmacokinetics of psilocybin and psilocin.|Determine the effect of kidney function on psilocin pharmacokinetics.|Characterize the incidence and severity of adverse events associated with escalating doses of psilocybin in normal adults. | University of Wisconsin, Madison | University of Wisconsin, School of Pharmacy, Madison, Wisconsin, United States |
| Efficacy and Safety of COMP360 Psilocybin Therapy in Anorexia Nervosa: a Proof-of-concept Study | Anorexia Nervosa | Drug: Psilocybin | Change from baseline in the Eating Disorder Examination (EDE) global score|Safety|Change from baseline in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)|Change from baseline in weight | COMPASS Pathways | Altman Clinical and Translational Research Institute, San Diego, California, United States|Sheppard Pratt Health System, Baltimore, Maryland, United States|New York State Psychiatric Institute, New York, New York, United States|Kings College London, Institute of Psychiatry, Psychology and Neurology, London, United Kingdom |
| The Effects of Psilocybin on Self-Focus and Self-Related Processing in Treatment Resistant MDD | Treatment-Resistant Major Depressive Disorder | Drug: Psilocybin | Change in Massachusetts General Hospital Rumination Questionnaire (MGH-RQ)|Change in Resting-State Functional Connectivity|Change in Self-Attribution Task performance|Change in Task-Based Activity during Self-Attribution Task|Change in Montgomery-Asberg Depression Rating Scale(MADRS)|Change in Quick Inventory of Depressive Symptomatology - 16 item (QIDSR-SR-16)|Change in Positive and Negative Affect Schedule (PANAS)|Change in Hamilton Depression Rating Scale - 17 item (HAM-D-17)|Change in Ruminative Response Scale (RRS)|Change in Rumination Reflection Questionnaire (RRQ)|Change in Penn State Worry Questionnaire (PSWQ)|Change in NEO-Five-Factor Inventory (NEO-FFI)|Change in Behavior Rating Inventory of Executive Function - Adult Version (BRIEF)|Change in Cognitive Flexibility Inventory (CFI)|Change in Emotional Faces Flanker Task|Change in Depression Implicit Attitudes Task (IAT) | Massachusetts General Hospital|COMPASS Pathways | Athinoula A. Martinos Center for Biomedical Imaging, Charlestown, Massachusetts, United States |
| Efficacy of Psilocybin in OCD: a Double-Blind, Placebo-Controlled Study. | Obsessive-Compulsive Disorder | Drug: Psilocybin (0.25mg/kg)|Drug: Niacin (250mg) | Changes in severity of OCD symptoms, which will be measured by The Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The Primary Outcome Measure will be collected at baseline and 48 hours, assessing change from baseline at 48 hours.|Acute Yale-Brown Obsessive-Compulsive Scale (A-YBOCS)|Changes in brain connectivity, which will be measured with functional Magnetic Imaging Resonance (fMRI).|Changes in depression symptoms, which will be measured by The Montgomery-Asberg Depression Scale (MADRS).|Changes in beliefs, which will be measured by The Brown Assessment of Beliefs Scale (BABS).|Changes in depression symptoms, which will be measured by The Becks Depression Inventory (BDI).|Changes in dysfunctional beliefs, which will be measured by The Obsessive Beliefs Questionnaire (OBQ-44).|Changes in OCD symptoms, which will be measured by The Obsessive-Compulsive Inventory - Revised (OCI-R).|Changes in OCD dimensions, which will be measured by The Obsessive-Compulsive Trait Core Dimensions Questionnaire (OC-TCDQ).|Changes in anxiety, which will be measured by State-Trait Anxiety Inventory (STAI).|Changes in quality of life, which will be measured by The Quality of Life Enjoyment & Satisfaction Questionnaire (Q-LESQ-SF).|Changes in experiential aspects of psilocybin, which will be measured by The Mystical Experience Questionnaire (MEQ).|Changes in subjects' behaviors and attitudes, which will be measured by The Community Observer Ratings of Changes in Subjects' Behavior and Attitudes (COM-R).|Changes in meaning of life, which will be measured by The Schedule for Meaning in Life Evaluation (SMiLE).|Challenging Experience Questionnaire (CEQ)|5-Dimension - Altered States of Consciousness (5D-ASC)|Changes in different dimensions of emotional experience, which will be measured by The Positive and Negative Affect Schedule Expanded Form (PANAS-X).|Changes of the effects of Psilocybin, which will be measured by The Persisting Effects Questionnaire (PEQ).|Changes in connection to nature, which will be measured by The Nature Relatedness Scale (NRS).|Changes in opinion towards pro-environmental behavior, which will be measured by The Pro-Environmental Behavior Scale (PEBS).|Changes in anthropomorphism, which will be measured by The Individual Differences in Anthropomorphism Questionnaire (IDAQ).|Changes in beliefs of mind-body dualism, which will be measured by The Mind-Body Dualism Scale (MBDS).|Change in interpersonal connectedness, which will be measured by The Inclusion of Others in Self Scale (IOS).|Change in moral relativism and idealism, which will be measured by The Ethical Positions Questionnaire (EPQ).|Changes in alcohol consumption, which will be measured by The Alcohol Use Disorders Identification Test (AUDIT).|Changes in urgent care and emergency room use, which will be measured by The Utilization of Facility and Emergent Care (UFEC).|Changes in drug-related problems, which will be measured by The Drug Use Disorders Identification Test (DUDIT).|Changes in tobacco use, motivation to quit, and dependence, which will be measured by The Self-reported Nicotine Use (SRNU).|Changes in sleep quality, which will be measured by The Pittsburgh Sleep Quality Index (PSQI).|Changes in readiness to change, which will be measured by The University of Rhode Island Change Assessment (URICA).|Changes in symptom severity and treatment response, which will be measured by The Clinical Global Impressions (CGI).|Changes in functional impairment, which will be measured by The Sheehan Disability Scale (SDS).|Changes in optimism and pessimism, which will be measured by The Life Orientation Test Revised (LOT-R).|Changes in OCD symptoms, which will be measured by The Padua Inventory of OCD symptoms. | Yale University|Heffter Research Institute | Connecticut Mental Health Center, New Haven, Connecticut, United States |
| Frontline Clinician Psilocybin Study | Burnout, Caregiver|Burnout, Professional|COVID-19|Depression|Post Traumatic Stress Disorder|Moral Injury | Drug: Psilocybin (Usona Institute)|Drug: Active placebo | Montgomery-Asberg Depression Rating Scale|Stanford Fulfillment Index|PTSD Checklist for DSM-5 (PCL5)|Moral injury symptom scale|Beck Depression Index | University of Washington | University of Washington, Seattle, Washington, United States |
| Psilocybin for Treatment-Resistant Depression | Treatment Resistant Depression | Drug: Psilocybin | Feasibility of the study based on participant retention|Feasibility of the study based on suicidal ideation and behaviour scores|Feasibility of the study based on adverse events|Montgomery-Åsberg Depression Rating Scale (MADRS) total score|Montgomery-Åsberg Depression Rating Scale (MADRS) response rate|Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate|McIntyre and Rosenblat Rapid Response Scale (MARRRS)|Patient Health Questionnaire 9-item (PHQ-9)|Clinical Global Impressions Scale (CGI)|Quick Inventory for Depressive Symptomatology, Self-Report, 16-item (QIDS-SR-16)|Columbia Suicide Severity Rating Scale (CSSRS)|Clinician-Administered Dissociative States Scale (CADSS), 23-item|Clinician-Administered Dissociative States Scale (CADSS), 6-item|Brief Psychiatric Rating Scale (BPRS)|Young Mania Rating Scale (YMRS)|Mystical Experiences Questionnaire (MEQ)|Sheehan Disability Scale (SDS)|EuroQol-5D 5-Level (EQ-5D-5L)|World Health Organization-5 Well-Being Index (WHO-5)|World Productivity and Impairment Questionnaire (WPAI)|Perceived Deficits Questionnaire - Depression - 5-Item (PDQ-5-D)|Digit Symbol Substitution Test (DSST)|Trail Making Test A (TMT-A)|Trail Making Test B (TMT-B)|Generalized Anxiety Disorder-7 (GAD-7)|Snaith-Hamilton Pleasure Scale (SHAPS)|Peripheral inflammatory and metabolic biomarkers | Brain and Cognition Discovery Foundation|Braxia Scientific Corp.|Usona Institute | Canadian Rapid Treatment Centre of Excellence (CRTCE), Mississauga, Ontario, Canada |
| Safety and Efficacy of Psilocybin for Body Dysmorphic Disorder | Body Dysmorphic Disorders | Drug: Psilocybin | Body Dysmorphic Disorder Modification of the Yale-Brown Obsessive Compulsive Disorder Scale | New York State Psychiatric Institute|COMPASS Pathways|University of California, Los Angeles | New York State Psychiatric Institute, 1051 Riverside Drive, New York, New York, United States |
| Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder | Alcohol Use Disorder | Drug: Psilocybin|Drug: Lactose | Change in percentage of heavy drinking days|Change in total alcohol consumption|Change in days of abstinence|Change in phosphatidyl-ethanol (PEth)|Change in Alcohol Use Disorders Identification Test (AUDIT)|Change in Penn Alcohol Craving Scale (PACS) score|Change in Alcohol Abstinence Self-efficacy Scale (AASE) score|Change in Fagerstrom Test for Nicotine Dependence (FTND)|Change in Drug Use Disorders Identification Test (DUDIT)|Change in Major Depression Inventory (MDI)|Change in Short-Form 36 (SF-36)|Change in Mindful Attention Awareness Scale (MAAS)|Change in Acceptance and Action Questionnaire (AAQ)|Change in NEO-Personality Inventory (NEO-PI=|Persisting Effects Questionnaire (PEQ)|Neuroplasticity and inflammation|Subjective effects of psilocybin: Subjective Drug Intensity (SDI)|Pharmacokinetics- and dynamics of psilocybin|Subjective effects of psilocybin: Mystical Experience Questionnaire (MEQ)|Subjective effects of psilocybin: 5-Dimensional Altered State of Consciousness scale (5D-ASC)|Subjective effects of psilocybin: Ego Dissolution Inventory (EDI)|Subjective effects of psilocybin: Emotional Breakthrough Inventory (EBI)|Subjective effects of psilocybin: Awe Experience Scale (AWE-S)|Brain imaging | Anders Fink-Jensen, MD, DMSci|The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet|Psychiatric Centre Rigshospitalet | |
| Effects of Psilocybin in Anorexia Nervosa | Anorexia Nervosa | Drug: Psilocybin | Change in Hospital Anxiety and Depression Scale (HADS) Score|Change in health related quality of life as assessed by the Eating Disorder Quality of Life Scale (EDQLS)|Change in Eating Disorder Examination Questionnaire (EDE-Q) score|Change in Eating Disorder Examination (EDE) score|Change in Body mass index (BMI)|Change in Anorexia Nervosa Stages of Change Questionnaire (ANSOCQ) score | Johns Hopkins University | Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States |
| Psilocybin for Treatment of Obsessive Compulsive Disorder | Obsessive-compulsive Disorder (OCD) | Drug: Psilocybin 100 mcg/kg|Drug: Psilocybin 300 mcg/kg|Drug: Lorazepam 1 mg | Acute effects on Obsessive-Compulsive symptom severity|Acute Incidence of Treatment Emergent Adverse Events|Repeated administration effects on Obsessive-Compulsive symptom severity|Long Term Incidence of Treatment Emergent Psychiatric Adverse Events|Changes in the magnitude of Error Related Negativity (an electroencephalographic biomarker of OCD)|Change in Depression Symptoms|Changes in functional connectivity between the Caudate Nucleus (CN) and Orbital Frontal Cortex (OFC) | University of Arizona | University of Arizona, Tucson, Arizona, United States |
| Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease | Depressive Symptoms|Depression|Alzheimer Disease|Mild Cognitive Impairment | Drug: Psilocybin | Change in Cornell Scale for Depression in Dementia (CSDD) score|Change in Quality of Life Alzheimer's Disease (QOL-AD) scale score | Johns Hopkins University | Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States |
| Effects of Repeated Psilocybin Dosing in OCD | Obsessive-Compulsive Disorder | Drug: Psilocybin | Change in Yale-Brown Obsessive-Compulsive Scale-Second Edition (Y-BOCS-II) Severity Scale total score from baseline at 4 days post-second dose|Change in Montgomery-Asberg Depression Scale (MADRS) total score from baseline at 4 days post-second dose|Change in Dimensional Obsessive-Compulsive Scale (DOCS) total score from baseline at 4 days post-second dose|Change in Obsessive Beliefs Questionnaire-44 (OBQ-44) total score from baseline at 4 days post-second dose|Change in Acceptance and Action Questionnaire for Obsessions and Compulsions (AAQ-OC) total score from baseline at 4 days post-second dose|Change in Tolerance of Uncontrollability Questionnaire (TOUQ) total score from baseline at 4 days post-second dose|Change in White Bear Suppression Inventory (WBSI) total score from baseline at 4 days post-second dose|Change in Difficulties in Emotion Regulation Scale (DERS) total score from baseline at 4 days post-second dose|Change in Southampton Mindfulness Questionnaire (SMQ) total score from baseline at 4 days post-second dose|Toronto Mindfulness Scale (TMS)|Set, Setting, and Intentions (SSI) Scale|Mystical Experience Questionnaire (MEQ)|Psychological Insight Questionnaire (PIQ)|Challenging Experience Questionnaire (CEQ)|Ego Dissolution Inventory (EDI)|Emotional Breakthrough Inventory (EBI)|Change in Self-Compassion Scale (SCS) total mean score from baseline at 4 days post-second dose|Change in Ten-Item Personality Inventory (TIPI) total score from baseline at 4 days post-second dose|Change in Persisting Effects Questionnaire (PEQ) subscale scores from 4 weeks post-second dose at 12 months post-second dose|Change in Alcohol Use Disorders Identification Test (AUDIT) total score from baseline at 4 weeks post-second dose|Change in Drug Use Disorders Identification Test (DUDIT) total score from baseline at 4 weeks post-second dose|Change in Fagerstrom Test for Nicotine Dependence (FTND) total score from baseline at 4 weeks post-second dose|Change in Sheehan Disability Scale (SDS) total score from baseline at 4 days post-second dose|Change in Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) percentage maximum score from baseline at 4 days post-second dose|Writing task|Columbia Suicide Severity and Risk Scale (C-SSRS) Since Last Visit version|Theoretical Orientation Profile Scale-Revised (TOPS-R)|Working Alliance Inventory-Short Revised (WAI-SR)|Change in Symptom Provocation Task (SPT) ratings from baseline at 4 days post-second dose|Stanford Expectations of Treatment Scale (SETS) | Yale University|Steven & Alexandra Cohen Foundation | Connecticut Mental Health Center, New Haven, Connecticut, United States |
| The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation | Treatment Resistant Depression|Suicidal Ideation | Drug: Psilocybin | Columbia-Suicide Severity Rating Scale (C-SSRS)|Montgomery-Åsberg Depression Rating Scale (MADRS)|Clinical Global Impression - Modified for Depression (CGI-D)|Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)|Concise Health Risk Tracking Self Report 12 Items (CHRT-SR) | Sheppard Pratt Health System|COMPASS Pathways | Sheppard Pratt Health System, Baltimore, Maryland, United States |
| Mood and Cognitive Effects of Psilocybin in Healthy Participants | Mood Disturbance|Mood Change|Sleep Disturbance|Drug Effect|Psychedelic Experiences|Health, Subjective|Psilocin Toxicity|Psilocybin Toxicity|Psilocybin Causing Adverse Effects in Therapeutic Use|Anxiety | Drug: Psilocybin|Drug: Inonotus Obliquus Whole Extract | Incidence of Adverse Events|Tolerability of doses with regard to reported hallucinogenic or unpleasant effects (Altered States of Consciousness Scale (5D-ASC), self-reported experience)|Assessments of physiological effects of psilocybin capsules | Optimi Health Corporation|University of Calgary | |
| Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors | Distress|Depression|Grief | Drug: Psilocybin|Behavioral: Modified brief Supportive Expressive Group Therapy | Number of Participants Who Experienced Treatment-related Adverse Events as Assessed by NIH Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0|Subject Recruitment and Retention|Change From Baseline in Demoralization Scale-II at End-of-treatment|Change From Baseline in Demoralization Scale-II at 3-month Follow-up|Change From Baseline in Inventory of Complicated Grief-Revised at End-of-treatment|Change From Baseline in Inventory of Complicated Grief at 3-month Follow-up|Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at End-of-treatment|Change From Baseline in Center for Epidemiologic Studies Depression Scale-Revised at 3-month Follow-up|Change in Average Score on Subscales of Group Questionnaire Pre-drug vs Post-drug | Joshua Woolley|Heffter Research Institute|River Styx Foundation|Usona Institute|Stupski Foundation|University of California, San Francisco | University of California, San Francisco, San Francisco, California, United States |
| Persisting Effects of Psilocybin | Healthy | Drug: Psilocybin | Amygdala Response to Stimuli in the Emotion Recognition Test|Change in Longitudinal Emotion and Mood Questionnaire Scores|Change in Emotional Functioning Task Accuracy|Change in Emotional Functioning Tasks Response Time (Milliseconds) | Johns Hopkins University|National Institute on Drug Abuse (NIDA) | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| Effects of Psilocybin on Electrophysiology and the Dynamic Content of Thought | Healthy | Drug: Psilocybin|Drug: Placebo | Difference between drug conditions in the frequency of word use during free association tasks|Sensitivity in distinguishing old versus newly presented visual stimuli|Accuracy in the remote associates task as assessed by total correct number of trials|Accuracy in the alternative uses task|Alpha band power in EEG record|Reliability of whole-brain response while watching videos | Johns Hopkins University | Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States |
| Investigating the Mechanisms of the Effects of Psilocybin on Visual Perception and Visual Representations in the Brain | Perception Disorders | Drug: Psilocybin | Amplitude and pattern of fMRI cortical responses|Perceptual measurements|Voxelwise modeling|Participant-reported Subjective Effects | University of California, Berkeley | University of California, Berkeley, Berkeley, California, United States |
| Psilocybin as a Treatment for Anorexia Nervosa: A Pilot Study | Anorexia Nervosa | Drug: Psilocybin | Readiness and Motivation Questionnaire (RMQ)|Eating Disorder Examination (EDE)|Eating Disorder Examination Questionnaire (EDE-Q)|Functional Magnetic Resonance Imaging (fMRI) | Imperial College London | Imperial College Hammersmith campus, London, United Kingdom |
| Evaluation of Psilocybin in Anorexia Nervosa: Safety and Efficacy | Anorexia Nervosa | Drug: Psilocybin | Incidence and occurrence of changes in AEs|Incidence of clinically important changes in ECG parameters|Incidence of clinically important changes in laboratory tests|Incidence of clinically significant changes in vital signs|Incidence of changes in the Columbia-Suicide Severity Rating Scale (C-SSRS) at each post-Baseline visit|Change in Eating Disorder Examination (EDE) scores for Dietary Restraint, Eating Concern, and Shape Concern|Change in weight (kg)|Change in trait anxiety and state anxiety total scores on the Spielberger State-Trait Anxiety Inventory (STAI)|Change in Physical Appearance State and Trait Anxiety Scale (PASTAS) trait total score and state score|Change in Body Image State Scale (BISS) total score|Change in Yale Brown Cornell Eating Disorder Scale (YBC-EDS-SRQ)|Change in Eating Disorder Inventory (EDI) total score|Change in Eating Disorder Examination Questionnaire Short Form (EDE-QS) total scores | University of California, San Diego|COMPASS Pathways | Altman Clinical and Translational Research Institute, La Jolla, California, United States |
| Psilocybin - Induced Neuroplasticity in the Treatment of Major Depressive Disorder | Major Depressive Disorder | Drug: Low Dose Psilocybin|Drug: Placebo|Drug: Medium Dose Psilocybin | Changes in electrical brain activity associated with neuroplasticity measured by Electroencephalography (EEG)|Changes in verbal memory [ Time Frame: One day and two weeks after each experimental session ]|Change in mood symptoms using the GRID-Hamilton Depression Rating Scale (GRID-HAM-D)|Change in mood symptoms using the Quick Inventory of Depressive Symptoms (QIDS-SR16) | Yale University|Heffter Research Institute | VA Connecticut Healthcare System, West Haven Campus, West Haven, Connecticut, United States |
| Psilocybin-facilitated Treatment for Chronic Pain | Fibromyalgia, Primary | Drug: Psilocybin|Drug: Dextromethorphan | Change in daily self-reported pain severity|Patient Global Impression of Change (PGIC)|Change in self-reported pain severity (Brief Pain Inventory [BPI])|Change in self-reported pain interference (Brief Pain Inventory [BPI]) | University of Alabama at Birmingham | |
| Psilocybin-assisted Therapy for Phantom Limb Pain | Phantom Limb Pain | Drug: Psilocybin|Drug: Placebo Niacin | Changes in Phantom Limb Pain Intensity|Change in Visual Analog Scale Pain ratings|Cerebral Blood Flow (CBF)|Brief Pain Inventory | University of California, San Diego | University of California, San Diego, San Diego, California, United States |
| Exploratory Study of Low Dose Psilocybin | Demoralization | Drug: Psilocybin|Drug: Placebo | Demoralization|Mystical Experience|Challenging Experience|PASAT|Trail Making|CPT-3 | University of Alabama at Birmingham|Diamond Therapeutics Inc. | |
| Psilocybin for the Treatment of Migraine Headache | Migraine Headache | Drug: High Dose Psilocybin|Drug: Low Dose Psilocybin|Drug: Placebo | Change in migraine headache days|Change in migraine attack frequency|Change in migraine attack duration|Change in pain intensity of migraine attacks|Change in intensity of nausea/vomiting during migraine attacks|Change in intensity of photophobia|Change in intensity of phonophobia|Change in migraine attack-related functional disability|Change in the use of abortive/rescue medication|Time to first migraine attack|Time to second migraine attack|Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module|Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale|Change in blood pressure|Change in heart rate|Change in peripheral oxygenation | Yale University | VA Connecticut Healthcare System, West Haven Campus, West Haven, Connecticut, United States |
| Effects of Psilocybin in Major Depressive Disorder | Major Depressive Disorder | Drug: Psilocybin | The GRID-Hamilton Depression Rating Scale (GRID-HAMD) | Johns Hopkins University | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| Psilocybin for Opioid Use Disorder in Patients on Methadone Maintenance With Ongoing Opioid Use | Opioid Use Disorder | Drug: Placebo|Drug: Psilocybin | Change in non-methadone opioid use as assessed by urine toxicology|Change in non-methadone opioid use as assessed by the Timeline Follow Back self report | Johns Hopkins University | |
| The Safety and Efficacy of Psilocybin in Participants With Type 2 Bipolar Disorder (BP-II) Depression. | Treatment Resistant Depression | Drug: Psilocybin | Montgomery-Asberg Depression Rating Scale (MADRS) | Sheppard Pratt Health System|COMPASS Pathways | Sam Rudow, Baltimore, Maryland, United States |
| Repeat Dosing of Psilocybin in Migraine Headache | Migraine Headache | Drug: Psilocybin|Drug: Placebo | Change in migraine attack frequency|Change in pain intensity of migraine attacks|Change in duration of migraine attacks|Change in intensity of photophobia (light sensitivity)|Change in intensity of phonophobia (noise sensitivity)|Average intensity of nausea/vomiting|Change in functional disability|Use of abortive/rescue medication|Time to first migraine attack|Migraine attack-free time|Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module|Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale|Change in blood pressure- Systolic|Change in blood pressure- Diastolic|Change in heart rate|Change in peripheral oxygenation|Change in peripheral calcitonin gene-related peptide (CGRP) levels|Change in pituitary adenylate cyclase-activating peptide (PACAP) levels | Yale University|Wallace Research Foundation | VA Connecticut Healthcare System, West Haven, Connecticut, United States |
| An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD) | Treatment Resistant Depression | Drug: Psilocybin | Montgomery Asberg Depression Rating Scale (MADRS) | Sheppard Pratt Health System|COMPASS Pathways | Stanford Exploratory Therapeutics Laboatory, Palo Alto, California, United States|VA Palo Alto Healthcare System/Stanford Medicine, Palo Alto, California, United States|Sheppard Pratt Health System, Baltimore, Maryland, United States |
| 5-HT2A Agonist Psilocybin in the Treatment of Tobacco Use Disorder | Tobacco Use Disorder | Drug: Psilocybin|Drug: Niacin | Potential Efficacy (Smoking Cessation)|Prolonged Abstinence|Cognitive control (Multi-Source Interference Task) at Screening (Visit 0)|Cognitive control (Multi-Source Interference Task) at Visit 5|Cognitive control (Multi-Source Interference Task) at Visit 6|Smoking Urges (Questionnaire on Smoking Urges; Factor 2) at Screening|Smoking Urges (Questionnaire on Smoking Urges; Factor 2) at Visit 5|Smoking Urges (Questionnaire on Smoking Urges; Factor 2) at Visit 6 | Johns Hopkins University|University of Alabama at Birmingham|New York University|National Institute on Drug Abuse (NIDA) | |
| Safety and Tolerability of Psilocybin in Post-Traumatic Stress Disorder | Post-Traumatic Stress Disorder | Drug: Psilocybin | Mean Peak Post-Administration Blood Pressure|Mean Peak Post-Administration Heart Rate|Mean Pre-Administration Suicide Ideation Scores (Columbia Suicide Severity Rating Scale - Severity Factor)|Mean Change in Suicide Ideation Scores (Columbia Suicide Severity Rating Scale - Severity Factor)|Mean Change in Clinician-Administered PTSD Scale for DSM-5 scores|Mean Change in PTSD Checklist Scores | Johns Hopkins University | |
| Pilot Study of Psilocybin-Assisted Therapy for Demoralization in Patients Receiving Hospice Care | Hospice|Psilocybin|Demoralization|Terminal Illness|Cancer-related Problem/Condition|Psychotherapy|Terminal Cancer|Cancer Terminal | Drug: Psilocybin|Behavioral: Psychotherapy | Number of participants screened per month|Number of participants enrolled per month|Average time delay from screening to enrollment|Mean number of sessions completed by enrolled participants|Proportion of planned assessments that are completed; duration of assessment visits|Duration of assessment visits|Mean score of acceptability ratings on Reactions to Research Participation Questionnaire Revised (RRPQR)|Safety Outcomes: Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by treating Investigator/PI (MD)|Safety Outcomes: Suicidal Risk as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)|Safety Outcomes: Delirium as assessed by Confusion Assessment Method (CAM)|Change in Global Quality Life Score as assessed by Functional Assessment of Chronic Illness Therapy - Palliative Care 14 (FACIT-Pal 14)|Change in Physical domain score as assessed by Edmonton Symptom Assessment System (ESAS)|Change in Physical domain score as assessed by PROMIS Pain Interference Scale (PIS)|Change in Hospital Anxiety and Depression Scale (HADS A and D) Score|Change in Life Attitude Profile - revised, Death acceptance subscale (LAP-R) Score|Change in Challenging Experience Questionnaire (CEQ) Score|Change in Social Isolation Scale (SIS) Score|Change in Spiritual Domain Score as assessed by Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 (FACIT-sp-12)|Change in Spiritual Domain Score as assessed by Schedule of Attitudes toward Hastened Death (SAHD)|Change in Spiritual Domain Score-Demoralization Scale (DS-II)|Change in Spiritual Domain Score Mystical Experience Questionnaire (MEQ-30)|Change in Caregiver- CarG OQoL Score | Yvan Beaussant|Oppenheimer Family Psychosocial Oncology and Palliative Care Research Grants|Usona Institute|Carey and Claudia Turnbull Family Foundation|Heffter Research Institute|George Sarlo Foundation|RiverStyx Foundation|Council on Spiritual Practices Fund at the San Francisco Foundation|Nikean Foundation|Jack Smith|Dana-Farber Cancer Institute | Care Dimensions, Danvers, Massachusetts, United States |
| Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms | Depressive Disorder, Major | Drug: Psilocybin + Placebo|Drug: Psilocybin + Escitalopram | functional magnetic resonance imaging (fMRI)|Quick Inventory of Depressive Symptomatology (QIDS-SR16) | Imperial College London|Alexander Mosely Charitable Trust | Imperial College Hammersmith campus, London, United Kingdom |
| Study of Psilocybin Enhanced Group Psychotherapy in Patients With Cancer | Cancer | Drug: Psilocybin | Number of adverse events (AEs) and serious adverse events (SAEs) characterized by severity|Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration|Number of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment.|Number of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness|Number of adverse events (AEs) and serious adverse events (SAEs) characterized by type|recruitment of patients with cancer diagnosis or hematologic malignancy|Enrollment of patients with a cancer diagnosis or hematologic malignancy|Consent of patients with a cancer diagnosis or hematologic malignancy|Number of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.|Number of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.|Number of adverse events (AEs) and serious adverse events (SAEs) characterized by type. | University of Utah|Usona Institute | Huntsman Cancer Institute, Salt Lake City, Utah, United States |
| Psilocybin Versus Ketamine in Treatment-Resistant Depression | Treatment Resistant Depression | Drug: Psilocybin|Drug: Ketamine Hydrochloride|Drug: Midazolam Ph. Eur 9.0 | Verification of the rapid antidepressant effect of Psilocybin compared to Ketamine using the Montgomery-Asberg Depression Rating Scale at 24 hours post administration|Comparing the response rate and duration of antidepressant effects of Psilocybin or Ketamine versus Midazolam (placebo)|Comparing the remission rate of depression after administration of Psilocybin or Ketamine versus placebo (Midazolam)|Comparing the time to return of depressive symptoms after administration of Psilocybin or Ketamine versus Midazolam (placebo)|Incidence of Treatment-Emergent Adverse Events|Comparing the response rate and duration of antidepressant effects of Psilocybin or Ketamine versus Midazolam (placebo) as rated by participants. | National Institute of Mental Health, Czech Republic|Czech Health Research Council|Czech Clinical Research Infrastructure Network | National Institute of Mental Health, Klecany, Czechia |
| Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients | Alcohol Use Disorder | Drug: Psilocybin|Drug: Placebo oral capsule | Changes in Time-Line Follow-Back|Brain|Empathy|Blood sample: Neural profile analysis|Blood sample: Epigenetic analysis|Blood sample: Markers of alcohol use | University of Zurich|Schweizerischer Nationalfonds | Psychiatrische Universitätsklinik Zürich, Zürich, Switzerland |
| Prophylactic Effects of Psilocybin on Chronic Cluster Headache | Cluster Headache | Drug: Psilocybin | Headache frequency|Resting state FC fMRI analyses|Proportion of reduced frequency|Headache intensity|Need of acute therapy|Sideeffects|Remission|Remission duration|SF-36|Preferred treatment|Mood|Sleep quality|Depressive symptoms|Stress | Gitte Moos Knudsen|Rigshospitalet, Denmark | Neurobiology Research Unit, Rigshospitalet, Copenhagen, Denmark |
| Effects of Psilocybin in Concussion Headache | Post-Traumatic Headache | Drug: Placebo oral capsule|Drug: Low Dose Psilocybin|Drug: High Dose Psilocybin | Acute change in pain intensity|Acute change in nausea/vomiting|Acute change in photophobia|Acute change in phonophobia|Acute change in functional disability|Time to first headache attack|Time to last headache attack|Change in headache attack frequency|Change in headache attack duration|Change in pain intensity of headache attacks|Change in intensity of nausea/vomiting during headache attacks|Change in intensity of photophobia during headache attacks|Change in intensity of phonophobia during headache attacks|Change in intensity of functional disability during headache attacks|Use of abortive/rescue medication|Headache attack-free time|Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module|Depression using Patient Health Questionnaire 9 (PHQ-9)|Suicide risk using the Columbia Suicide Severity Rating Scale (CSSRS)|Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale|Change in blood pressure|Change in heart rate|Change in peripheral oxygenation|Change in peripheral levels of calcitonin gene-related peptide (CGRP)|Change in peripheral levels of pituitary adenylate cyclase-activating peptide (PACAP) | Yale University | VA Connecticut Healthcare System, West Haven, Connecticut, United States |
| Psilocybin-facilitated Treatment for Cocaine Use | Cocaine-Related Disorders | Drug: Psilocybin|Drug: Diphenhydramine | The difference between the psilocybin and placebo groups in the percentage of days abstinent from cocaine, verified by urine drug screen.|The difference between the psilocybin and placebo groups in sustained/complete abstinence from cocaine, verified by urine drug screen.|The difference between the psilocybin and placebo groups in time to cocaine lapse.|The difference between the psilocybin and placebo groups in the severity of cocaine dependence.|The difference between the psilocybin and placebo groups in the severity of cocaine withdrawal symptoms.|The difference between the psilocybin and placebo groups in cocaine craving.|The difference between the psilocybin and placebo groups in situational cocaine abstinence self-efficacy.|The difference between the psilocybin and placebo groups in motivation to quit/remain abstinent, confidence in the ability to quit/remain abstinent, and perceived difficulty quitting/remaining abstinent.|The difference between the psilocybin and placebo groups in depression, anxiety, and stress.|The difference between the psilocybin and placebo groups in satisfaction with life.|The difference between the psilocybin and placebo groups in income, employment, and living situation.|The difference between the psilocybin and placebo groups in the percentage of days abstinent from alcohol.|The difference between the psilocybin and placebo groups in the percentage of days abstinent from heavy alcohol use.|The difference between the psilocybin and placebo groups in the percentage of days abstinent from tobacco.|The difference between the psilocybin and placebo groups in the percentage of days abstinent from cannabis. | University of Alabama at Birmingham | UAB Outpatient Clinical Research Unit, Birmingham, Alabama, United States |
| Psilocybin Treatment of Major Depressive Disorder With Co-occurring Alcohol Use Disorder | Major Depressive Disorder|Alcohol Use Disorder | Drug: Psilocybin|Drug: Placebo | Change from baseline in grid-version of the Hamilton Depression Rating Scale (GRID-HAMD) score|Change from baseline in percentage of days abstinent as measured by the Time Line Follow Back (TLFB) assessment|Change from baseline in percentage of days of heavy drinking as measured by the TLFB assessment|Change from baseline in gamma-glutamyl transferase (GGT)|Change from baseline in the percentage of carbohydrate deficient transferrin relative to total transferrin concentration (%CDT)|Change from baseline in the ratio of aspartate transaminase to alanine transaminase (AST/ALT)|Change from baseline in Quick Inventory of Depressive Symptomatology - Self Rated (QIDS-SR) score|Change from baseline in State Trait Anxiety Index (STAI) score|Change from baseline in percentage of days abstinent as measured by the TLFB assessment|Change from baseline in GGT|Change from baseline in %CDT|Change from baseline in AST/ALT ratio | Johns Hopkins University | Johns Hopkins Center for Psychedelic and Consciousness Research, Baltimore, Maryland, United States |
| Pragmatic Trial of Psilocybin Therapy in Palliative Care | Demoralization | Drug: Psilocybin|Drug: Ketamine | Change from Baseline on 16-item Demoralization Scale - II (DS-II) at Week 5|Change from Baseline on 16-item Demoralization Scale - II (DS-II) at Week 2|Odds of improvement from Baseline on Clinical Global Impression scale (CGI-I) for demoralization at Week 5.|Odds of improvement from Baseline on Clinical Global Impression scale (CGI-I) for demoralization at Week 2.|Odds of meeting criteria for demoralization on the Diagnostic Criteria for Psychosomatic Research-Revised (DCPR-R) at Week 5.|Odds of meeting criteria for demoralization on the Diagnostic Criteria for Psychosomatic Research-Revised (DCPR-R) at Week 2.|Change from Baseline on GRID Hamilton Rating Scale for Depression 6-item (GRID-HAMD-6) at Week 5.|Change from Baseline on GRID Hamilton Rating Scale for Depression 6-item (GRID-HAMD-6) at Week 2.|Change from Baseline on Patient Health Questionnaire-9 (PHQ-9) at Week 5.|Change from Baseline on Patient Health Questionnaire-9 (PHQ-9) at Week 2.|Change from Baseline on Generalized Anxiety Disorder-7 (GAD-7) at Week 5.|Change from Baseline on Generalized Anxiety Disorder-7 (GAD-7) at Week 2.|Change from Baseline on Functional Assessment of Chronic Illness Therapy-Palliative Care 14-item scale (FACIT-Pal-14) at Week 5.|Change from Baseline on Functional Assessment of Chronic Illness Therapy-Palliative Care 14-item scale (FACIT-Pal-14) at Week 2.|Change from Baseline on Functional Assessment of Chronic Illness Therapy-Spiritual Well-being 12-item scale (FACIT-Sp-12) at Week 5.|Change from Baseline on Functional Assessment of Chronic Illness Therapy-Spiritual Well-being 12-item scale (FACIT-Sp-12) at Week 2.|Change from Baseline on Hopelessness Assessment in Illness Questionnaire (HAI) at Week 5.|Change from Baseline on Hopelessness Assessment in Illness Questionnaire (HAI) at Week 2.|Relative risks for treatment-related, clinically significant adverse events | Charles S. Grob, M.D.|University of California, San Francisco|Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | |
| Pilot Trial of Visual Healing® in Psilocybin-assisted Therapy for Alcohol Use Disorder | Alcohol Use Disorder | Drug: Psilocybin plus Visual Healing Set and Setting|Drug: Psilocybin plus Standard Set and Setting | Feasibility: Recruitment Rate|Feasibility: Retention Rate|Tolerability: Number of Visual Healing segments viewed by participants|Safety/Tolerability: number of Adverse Events|Safety: Systolic Blood Pressure|Safety: Diastolic Blood Pressure|Safety: Heart rate|Tolerabilty: Spielberger State-Trait Anxiety Inventory -Short Form (STAI-SF) mean score|Safety: Challenging Experience Questionnaire (CEQ)|Safety: Questionnaire for Psychotic Experiences | Keith Heinzerling|Saint John's Cancer Institute | Pacific Treatment & Research in Psychedelics, Santa Monica, California, United States |
| Psilocybin and Depression | Severe Depression | Drug: Psilocybin|Drug: Ketamine (Ketalar) | The 16-Item Quick Inventory of Depressive Symptomatology (QIDS)|The Montgomery and Asberg Depression Rating Scale|Hamilton Depression Rating Scale | University of Helsinki|Dr. Tomi Rantamäki, Laboratory of Neurotherapeutics, Department of Biosciences, University of Helsinki|Dr. Robin Carthart-Harris and Prof. David Nutt, Imperial College London, UK | |
| The Effects of Psilocybin-Facilitated Experience on the Psychology and Effectiveness of Religious Professionals | Religious or Spiritual Problem | Drug: Psilocybin | Interim Questionnaire | NYU Langone Health | NYU Langone Medical Center/Tisch Hospital, New York, New York, United States |
| Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study | Nicotine Dependence | Drug: Psilocybin-assisted treatment|Drug: Nicotine Replacement Therapy (NRT) | Urinary cotinine|Breath CO|MRI scanning | Johns Hopkins University|Beckley Foundation|Heffter Research Institute | Behavioral Pharmacology Research Unit, Baltimore, Maryland, United States|Neuroimaging Research Branch, NIDA-IRP, Baltimore, Maryland, United States |
| Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe OCD | Obsessive-compulsive Disorder | Combination Product: psychotherapy assisted psilocybin | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS ) change from baseline|Obsessive-Compulsive Inventory-Revised (OCI-R) change from baseline|Obsessional Beliefs Questionnaire (OBQ-20) change from baseline|Beck Depression Inventory -II (BDI-II) change from baseline|Beck Anxiety Inventory (BAI) change from baseline|Mini International Neuropsychiatric Interview (M.I.N.I.) change from baseline|5-Dimension - Altered States of Consciousness (5D-ASC)|Mystical Experience Questionnaire (MEQ)|Emotional Breakthrough Inventory (EBI)|Persisting Effects Questionnaire (PEQ)|Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)|Community Observer Questionnaire | Beersheva Mental Health Center | |
| Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion | Healthy | Drug: Psilocybin | Interim Questionnaire | Johns Hopkins University | Behavioral Biology Research Center, Johns Hopkins Bayview, Baltimore, Maryland, United States |
| Pilot RECAP Study in Healthy Volunteers | Psychedelic Experiences|Amnesia | Drug: Psilocybin and Midazolam | Number of participants scoring >50 percent of normative scores on selected questions from the Altered States of Consciousness (ASC) questionnaire asked during the dosing session Day 0.|Number of participants scoring < 50 percent on post-dosing Day 1 of the mean normative score of ASC data from healthy volunteers administered the ASC questionnaire post-dosing|Accuracy on post-dosing Day 1 in recognizing ASC items asked during the dosing session Day 0 (number of correct versus distractor items)|Safety of psilocybin-midazolam co-administration assessed by number of adverse event incidences in each severity grade.|Safety of psilocybin-midazolam co-administration assessed by number of participants requiring medical attention due to adverse events|Safety of psilocybin-midazolam co-administration assessed by number of participants requiring psychiatric attention due to adverse events|Safety of psilocybin-midazolam co-administration assessed by number of participants leading to withdrawal from study due to adverse events|Safety of psilocybin-midazolam co-administration assessed by number of participants with severe adverse events|Safety of psilocybin-midazolam co-administration assessed by number of participants with new concomitant medication due to adverse events | University of Wisconsin, Madison | UWHealth, 600 Highland Avenue, Madison, Wisconsin, United States |
| Clinical, Neurocognitive, and Emotional Effects of Psilocybin in Depressed Patients - Proof of Concept | Depressive Disorder, Major | Drug: Psilocybine oral capsule|Drug: Placebo oral capsule | Montgomery Asberg Depression Scale|Beck Depression Inventory|Changes in BOLD signal over time as measured by fMRI|5 Dimensions- Altered States of consciousness(5D-ASC) | University of Zurich|Schweizerischer Nationalfonds | Psychiatrische Universitätsklinik Zürich, Zürich, Switzerland |
| Adjunctive Effects of Psilocybin and Buprenorphine | Opioid Use Disorder | Drug: Psilocybin with guided counseling | Safety Measured by Incidence and Severity of Adverse Events 24 hrs post-dose|Mean Change in Symptoms of Opioid Withdrawal Measured by COWS Instrument|Mean Change in Peripheral Capillary Oxygen|Mean Change in ECG|Change in Opioid Craving Scale (OCS) from baseline through end of study|Mystical Effects Questionnaire (MEQ) after each dose|Mean Number of Days of Participant Opioid Use via Time Line Follow Back (TLFB) | University of Wisconsin, Madison|Heffter Research Institute | University of Wisconsin, Madison, Wisconsin, United States |
| Psilocybin Combined With Multidisciplinary Palliative Care in Demoralized Cancer Survivors With Chronic Pain | Hematopoietic and Lymphoid Cell Neoplasm|Malignant Solid Neoplasm | Drug: Psilocybin|Behavioral: Psychotherapy|Other: Quality-of-Life Assessment|Other: Questionnaire Administration | Incidence Of Treatment-Related Medical Grade 3 Or Higher Or Psychiatric Grade 4 Or Higher|Evaluation of Feasibility Outcome To Assess Patient Retention in The Study | Emory University|National Cancer Institute (NCI) | Emory University/Winship Cancer Institute, Atlanta, Georgia, United States|Brain Health Center at Executive Park, Atlanta, Georgia, United States |
| Comparing the Effects of Psilocin and Psilocybin in Healthy Adults | Healthy | Drug: Psilocin|Drug: Psilocybin|Drug: Sublingual Psilocin | Physiological Effects|Psychological Effects|Adverse Effects | University of California, San Francisco|Filament Health | University of California, San Francisco, San Francisco, California, United States |
| Psilocybin Therapy for Chronic Low Back Pain | Chronic Low-back Pain | Drug: Psilocybin therapy with Zolpidem and Modafinil|Drug: Psilocybin therapy with Zolpidem|Drug: Psilocybin therapy with Modafinil|Drug: Psilocybin therapy with Placebo | Change in pain interference|Change in average pain intensity|Change in clinical depressive symptom severity|Change in depressive symptom severity | Joshua Woolley, MD/PhD|University of California, San Francisco | |
| Visual Surround Suppression and Perceptual Expectation Under Psilocybin | Perception Disturbance|Visual Suppression|Psychedelic Experiences | Drug: Psilocybin|Drug: Niacin | Psychophysical Discrimination Threshold|Difference in Event Related Potential Amplitude|Change in resting state brain activity|Change of white matter structural connectivity|Positive and Negative Affect Schedule (PANAS) Positive Scale|Positive and Negative Affect Schedule (PANAS) Negative Scale|Revised Mystical Experience Questionnaire (RMEQ-30)|Ego-Dissolution Inventory (EDI)|5 Dimensions of Altered States of Consciousness (5D-ASC)|Change in Serum Brain-Derived Neurotrophic Factor (BDNF)|Change in Serum C-Reactive Protein (CRP)|Change in Serum Transforming Growth Factor Beta-1 (TGFb-1)|Change in Serum Glial Fibrillary Acidic Protein (GFAP)|Change in Serum Tumor Necrosis Factor Alpha (TNFa)|Change in Serum Interleukin-1beta (IL-1b)|Change in Serum Interleukin-6 (IL-6)|Change in Serum Interleukin-10 (IL-10)|Change in Serum Interferon Gamma (IFNy)|Change in Serum Tumor Necrosis Factor Receptor 1 (TNF-R1)|Change in Serum Tumor Necrosis Factor Receptor 2 (TNF-R2)|Change in Serum S100 Calcium-Binding Protein B (S100B)|Change in Serum Ubiquitin C-Terminal Hydrolase L1 (UCHL-1) | University of Minnesota|Heffter Research Institute | University of Minnesota, Minneapolis, Minnesota, United States |
| Psilocybin Therapy in Advanced Cancer | Advanced Cancer | Drug: Psilocybin 25 mgs|Drug: Psilocybin 1 mg|Behavioral: Psychotherapy | Change in GRID-Hamilton Depression Rating Scale (GRID-HAMD-17) Score|Change in Hamilton Anxiety Scale Ham A (GRID-Ham-A)|Change in Hospital Anxiety and Depression Scale (HADS) - Depression Subscale Score|Change in Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale Score|Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score|Change in Functional Assessment of Chronic Illness Therapy-Spiritual well-being, 12-items (FACIT-Sp-12) Score|Change in Healing Experience of All Life Stressors (NIH-HEALS) Score|Changes in Demoralization scale (DS) Score|Change in Life Attitude Profile-Revised (LAP-R) Death Acceptance Scale Score|Mystical Experience Questionnaire-30 items (MEQ-30) Score | NYU Langone Health|National Cancer Institute (NCI) | University of Colorado Anschutz Medical campus (CU AMC), Aurora, Colorado, United States|NYU Langone Health, New York, New York, United States |
| Northwest Therapies Trauma Psilocybin Study Compassionate Use Study | Trauma, Nervous System | Drug: Trauma | GAF Score|BAM Score|PLC-5 Score | NWTraumatherapies|World Health Organization | Ross Allison NPI #1437519899 Administrator Of Study, Bozeman, Montana, United States |
| Naturalistic Study of Microdosing With Psilocybin | Cognitive Change|Creativity|Mood Change|Sleep | Drug: Psilocybin|Drug: Placebo | Resting state oscillations measured with EEG|Attention|Inhibitory control|Conscious access|Visual perception|Physical activity|Divergent thinking|Cognitive flexibility|Convergent thinking|Effect positive/negative affect and well-being|Effects on anxiety|Effects on personality|Concentration of psilocybin in the dried material | National Council of Scientific and Technical Research, Argentina | Instituto de Fisica de Buenos Aires (IFIBA), Buenos Aires, Argentina |
| The Effect of Psilocybin on MDD Symptom Severity and Synaptic Density | Major Depressive Disorder|Depression | Drug: Psilocybin|Drug: Niacin | Montgomery Åsberg Depression Rating Scale (MADRS)|[11C]UCB-J | Section for Affective Disorders; Northern Stockholm Psychiatry|Karolinska Institutet | Northern Stockholm Spychiatry Clinic, Stockholm, Sweden |
| Psilocybin in Depression Resistant to Standard Treatments | Treatment Resistant Depression | Combination Product: Psilocybin assisted therapy|Combination Product: Placebo assisted therapy | Montgomery Asberg Depression Rating Scale|Quick Inventory of Depressive Symptoms SR 16 | King's College London|South London and Maudsley NHS Foundation Trust | Clinical Research Facility, King's College Hospital, London, United Kingdom |
| Psilocybin in Patients With Fibromyalgia: EEG-measured Brain Biomarkers of Action | Fibromyalgia | Drug: Psilocybin|Behavioral: Therapeutic support | Lempel-Ziv complexity (LZc)|The Brief Experiential Avoidance Questionnaire (BEAQ)|MRI|Patient reported outcome measures|Physiology: Heart rate, body temperature, accelerometry|Qualitative interviews | Imperial College London | Imperial College London, London, United Kingdom |
| Psilocybin-assisted Psychotherapy for Treatment of Alcohol Use Disorder | Alcohol Use Disorder | Drug: Psilocybin | Timeline Follow-Back for Alcohol to assess change | Peggy C Nopoulos|University of Iowa | |
| Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence | Alcohol Dependence | Drug: Psilocybin | change in percent heavy drinking days | University of New Mexico|Heffter Research Institute | University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States |
| Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety | Anxiety | Drug: Psilocybin (drug)|Other: Active Niacin Placebo | Anxiety | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center|Heffter Research Institute | Harbor-UCLA Medical Center, Torrance, California, United States |
| Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators | Psilocybin|Hallucinogens|Pharmacologic Actions|Central Nervous System Agents|Therapeutic Uses|Psychotropic Drugs | Drug: psilocybin | Persisting Effects Questionnaire|Hood Mysticism Scale|States of Consciousness Questionnaire | Johns Hopkins University | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression | Treatment Resistant Depression | Drug: Psilocybin | Montgomery Asberg Depression Rating Scale (MADRS) | COMPASS Pathways | Kadima Neuropsychiatry Institute, La Jolla, California, United States|Altman Clinical and Translational Research Institute, University of California, San Diego, California, United States|Stanford Department of Psychiatry, Stanford, California, United States|Mood and Anxiety Disorders Program Emory University School of Medicine, Atlanta, Georgia, United States|Ray Worthy Psychiatry LLC, New Orleans, Louisiana, United States|Sheppard Pratt Health System, Baltimore, Maryland, United States|New York State Psychiatric Institute, New York, New York, United States|UT Center of Excellence on Mood Disorders, University of Texas Health Science Center, Houston, Texas, United States|Canadian Rapid Treatment Centre of Excellence, Mississauga, Ontario, Canada|Centre for Addiction and Mental Health, Toronto, Ontario, Canada|National Institute of Mental Health Czech Republic, Klecany, Czechia|Enhed for Psykiatrisk Forskning, Psykiatrien i Aalborg, Aalborg, Denmark|Charité - Universitätsmedizin Berlin, Department of Psychiatry and Psychotherapy, Campus Benjamin Franklin, Berlin, Germany|Tallaght University Hospital, Dublin, Ireland|Groningen University Medical Centre, Groningen, Netherlands|Leiden University Medical Centre, Leiden, Netherlands|Utrecht University Medical Centre, Utrecht, Netherlands|Unidade de Neuropsiquiatria, Centro Clinico Champalimaud, Lisboa, Portugal|Hospital de Dia Numancia, Barcelona, Spain|Institute Hospital del Mar of Medical Research (IMIM), Barcelona, Spain|Clinical Research and Imaging Centre, Bristol, Avon, United Kingdom|Wolfson Research Centre, Campus for Ageing and Vitality, Newcastle Upon Tyne, Tyne And Wear, United Kingdom|St. Pancras Clinical Research, London, United Kingdom|Kings College London, Institute of Psychiatry, Psychology and Neurology, London, United Kingdom|Greater Manchester Mental Health Foundation Trust, Manchester, United Kingdom |
| Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression | Treatment-resistant Depression | Drug: Psilocybin|Drug: Nicotinamide | Treatment Response (defined as a ≥ 50% drop in depressive symptom severity as measured by the Hamilton Rating Scale for Depression; HAM-D)|% change in HAM-D total score|Treatment response (≥ 50% drop) and % change in HAM-D total score|Treatment response (≥ 50% drop) and % change in the Beck Depression Inventory (BDI) - II | Central Institute of Mental Health, Mannheim|Charite University, Berlin, Germany|MIND Foundation gGmbH|German Federal Ministry of Education and Research|Usona Institute | Charité Berlin, Campus Mitte, Department of Psychiatry and Psychotherapy, Berlin, Germany|Central Institute of Mental Health (CIMH), Mannheim, Germany |
| Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma | Anxiety|Stage IV Melanoma | Drug: psilocybin | Hospital Anxiety and Depression Scale|Spielberger-State-Trait Inventory (STAI)|Hamilton Anxiety Rating Scale|Natural killer (NK) cell count|European Organization For Research and Treatment of Cancer; Quality of Life Questionnaire-C15|Hamilton Depression Rating Scale|Functional Assessment of Chronic Illness Therapy-spirituality | Multidisciplinary Association for Psychedelic Studies | Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States |
| Psilocybin for the Treatment of Cluster Headache | Cluster Headache | Drug: 0.143 mg/kg Psilocybin or 10 mg Psilocybin|Drug: 0.0143 mg/kg Psilocybin or 1 mg Psilocybin|Drug: Placebo | Time to first attack after completion of pulse regimen|Time to last attack after completion of pulse regimen|Change in frequency of attacks|Change in intensity of attacks|Change in duration of attacks|Change in cluster period duration compared to typical cluster period (episodic subjects only)|Difference in the change in cluster attack frequency between 1st and 2nd round|Difference in the change in cluster attack intensity between 1st and 2nd round|Difference in the change in the duration of attacks between 1st and 2nd round|Use of abortive/rescue medication|Attack-free time|Health-Related Quality of life|Psychedelic effects|Change in blood pressure|Change in heart rate|Change in peripheral oxygenation | Yale University|Heffter Research Institute|Cluster Headache-Trigeminal Autonomic Cephalalgia (CH-TAC), LLC | VA Connecticut Healthcare System, West Haven, Connecticut, United States |
| Psychopharmacology of Psilocybin in Cancer Patients | Depressive Symptoms|Anxiety|Cancer | Drug: psilocybin | GRID-HAM-D-17 -- Structured Interview Guide for the Hamilton Depression Scale.|HAM-A Assessed With the SIGH-A -- a Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A). | Johns Hopkins University|Heffter Research Institute | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Campus, Baltimore, Maryland, United States |
| Psilocybin Cancer Anxiety Study | Cancer | Drug: Psilocybin|Drug: Niacin | HADS Anxiety|State-Trait Anxiety Inventory (STAI) State|STAI State|HADS Depression|STAI Trait|Death Anxiety Scale|Death Transcendence Scale|Hopelessness|Demoralization Scale|QoL Physical Health Scale|QoL Psychological Scale|QoL Social Relationships Scale|QoL Environment Scale | NYU Langone Health | NYU College of Dentistry Bluestone Center for Clinical Research, New York, New York, United States |
| Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators | Healthy | Drug: Moderately-high dose of psilocybin|Drug: Moderately-low dose of psilocybin|Drug: Very-low dose of psilocybin|Drug: Placebo | Persisting Effects Questionnaire|Hood Mysticism Scale|States of Consciousness Questionnaire|fMRI Resting State Functional Connectivity | Johns Hopkins University | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| Phase 1b Study in Patients With Short-Lasting Unilateral Neuralgiform Headache Attacks (SUNHA) | Short Lasting Unilateral Neuralgiform Headache Attacks | Drug: Psilocybin | Percentage of patients with treatment emergent AEs (TEAES)|Treatment-related changes in Paired Associates Learning (PAL) scores and evaluation of dose response|Treatment-related changes in Spatial Working Memory (SWM) scores and evaluation of dose response|Treatment-related changes in Reaction Time Index (RTI) scores and evaluation of dose response|Treatment-related changes in Rapid Visual Information Processing (RVP) scores and evaluation of dose response|Change in frequency of headache attacks|Change in duration of headache attacks|Change in intensity of headache attacks | Beckley Psytech Limited | King's College London, London, United Kingdom |
| A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence | Alcohol Dependence | Drug: Psilocybin|Drug: Diphenhydramine|Behavioral: Motivational Enhancement and Taking Action (META) | Percent of Heavy Drinking Days|5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) Score|Penn Alcohol Craving Scale (PACS) Score|Alcohol Abstinence Self-Efficacy Scale (AASE) Score|Readiness Score|Percent of Days Abstinent|Number of Drinks Per Drinking Day|Number of Days to First Drinking Day|Number of Days to First Heavy Drinking Day|Short Inventory of Problems (SIP-2R) Score|Hamilton Anxiety Rating Scale (HAM-A) Score|Hamilton Depression Rating Scale (HAM-D) Score | NYU Langone Health|Heffter Research Institute|University of New Mexico | University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States|Clinical and Translational Science Institute, NYU Langone Medical Center, New York, New York, United States |
| PAPR: PAP + MBSR for Front-line Healthcare Provider COVID-19 Related Burnout | Depression|Burnout, Professional | Drug: Psilocybin|Behavioral: Mindfulness-Based Stress Reduction (MBSR) | Efficacy of MBSR + PAP vs. MBSR alone in reducing symptoms of depression, as measured by the QIDS-SR-16|Effect of MBSR + PAP vs. MBSR alone on participant reported symptoms of burnout as measured by the Maslach Burnout Inventory, MBI-HSS(MP).|Effect of MBSR+PAP vs. MBSR alone on symptoms of demoralization|Effect of MBSR + PAP vs. MBSR alone on symptoms of post-traumatic stress|Effect of MBSR + PAP vs. MBSR alone on participant reported quality of life.|Effect of MBSR + PAP vs. MBSR alone on measures of connectedness to self, other, and world|Storyline Health Integrative Assessment|State and Trait Mindfulness | University of Utah|Heffter Research Institute|Usona Institute | |
| Evaluation of Psilocybin (TRP-8802) in the Treatment of Binge Eating Disorder | Binge Eating Disorder | Drug: TRYP-0082|Behavioral: Psychotherapy | Assess the safety of a single dose of TRP 8802 in participants with BED during the TRP 8802 dosing session, and through 12 weeks following dosing|Evaluate the feasibility of inducing the psychedelic state with TRP 8802 in a BED population.|Determine the preliminary clinical activity and the effects of TRP 8802 in conjunction with psychotherapy on the frequency of binge eating episodes in a BED population through 4 weeks following dosing (i.e., Week 6)|Determine the preliminary clinical activity and the effects of TRP 8802 in conjunction with psychotherapy on weight-related indicators in a BED population through 4 weeks following dosing (i.e., Week 6) | TRYP Therapeutics | University of Florida, Gainesville, Florida, United States |
| The Neurobiological Effect of 5-HT2AR Modulation | Basic Science | Drug: Psilocybine|Drug: Ketanserin | Psilocin/ketanserin blood concentrations and 5-HT2A receptor occupancy (i.e., binding potential).|Effects of psilocybin on Cimbi-36 binding potential at baseline and at one and twelve weeks|Effects of psilocybin and ketanserin on brain function assessed with fMRI and PET|Effects of psilocybin on UCB-J binding potential at baseline and at one week|Effects of psilocybin on brain function assessed with fMRI at baseline and one month | Gitte Moos Knudsen|Rigshospitalet, Denmark | Neurobiology Research Unit, Rigshospitalet, Copenhagen, Denmark |
| Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin | Healthy | Drug: LSD|Drug: Psilocybin | Altered states of consciousness|Subjective effects assessed by VAS|Subjective effects assessed by AMRS scales|Psychotomimetic effects|Mystical-type experiences assessed by SCQ|Mystical-type experiences assessed by MS scales|Effects on emotion processing|Autonomic effects assessed by heart rate|Autonomic effects assessed by blood pressure|Autonomic effects assessed by body temperature | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
| Comparative Acute Effects of LSD, Psilocybin and Mescaline | Healthy | Drug: LSD|Drug: Psilocybin|Drug: Mescaline|Other: Placebo | 5 Dimensions of Altered States of Consciousness (5D-ASC)|fMRI resting state functional connectivity (RSFC)|Visual Analog Scale (VAS)|States of Consciousness questionnaire (SCQ)|Blood pressure|Heart rate|Body temperature|Pupil size|Drug plasma levels|Oxytocin levels|Blood-derived neurotrophic factor (BDNF)|Renal clearance values|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Persönlichkeitsinventar (FPI)|Saarbrücker Persönlichkeitsfragebogen (SPF)|Adjective Mood Rating Scale (AMRS)|Mysticism Scale (MS)|Elliot Humility Scale (EHS)|Jankowski Humility Scale (JHS)|Arnett Inventory of Sensation Seeking (AISS-d) | University Hospital, Basel, Switzerland | University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland |
| Palliadelic Treatment to Reduce Psychological Distress in Persons With Inoperable Pancreatobiliary Cancer | Pancreas Cancer|Biliary Tract Cancer|Psychological Distress | Drug: Psilocybin | Recruitment Rate|Retention Rate|Change in Patient Health Questionnaire-9 (PHQ-9) Depression Scale total score from Baseline to 1 week post-dose|Change in General Anxiety DIsorder-7 (GAD-7) total score from Baseline to 1 week post-dose|Change in Demoralization Scale (D-II) total score from Baseline to 1 week post-dose | Lou Lukas|Jim Young Pancreatic Cancer Research Memorial Fund|University of Nebraska | |
| Psilocybin and Spiritual Practice | Healthy | Drug: psilocybin|Behavioral: Intensity of support for spiritual practice|Behavioral: Number of sessions | Hood Mysticism Scale|States of Consciousness Questionnaire|Persisting Effects Questionnaire|Daily spiritual experiences scale|A battery assessing various measures of gratitude, forgiveness, religious coping, death attitude, life purpose, life satisfaction, and psychological functioning|Blood markers of stress and immune function|Brief symptom inventory|Visual effects questionnaire | Johns Hopkins University|Fetzer Institute|The CSP Fund of the San Francisco Foundation | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| Acute Effects of 2C-B Compared With MDMA and Psilocybin in Healthy Subjects | Healthy | Drug: 2-bromo-2,5-dimethoxyphenethylamine (10 mg)|Drug: 2-bromo-2,5-dimethoxyphenethylamine (20 mg)|Drug: 2-bromo-2,5-dimethoxyphenethylamine (30 mg)|Drug: 3,4-methylenedioxymethamphetamine|Drug: Psilocybin|Other: Placebo | Acute subjective effects I|Acute subjective effects II|Acute subjective effects III|Autonomic effects I|Autonomic effects II|Autonomic effects III|Plasma levels of 2C-B, MDMA, and psilocybin|Plasma levels of oxytocin|Plasma levels of Brain-derived neurotropic factor (BDNF)|Adverse effects|Urine Recovery|States of Consciousness Questionnaire|Spiritual Realms Questionnaire|Psychological Insight Questionnaire|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Personality Inventory (FPI-R)|Saarbrücker Personality Questionnaire (SPF)|HEXACO personality inventory|Defense Style Questionnaire (DSQ-40) | University Hospital, Basel, Switzerland | |
| Open-label Study to Assess the Safety and Efficacy of TRP-8802 With Psychotherapy in Adult Participants With Fibromyalgia | Fibromyalgia | Drug: TRP-8802|Behavioral: Psychotherapy | To assess the safety of TRP-8802 under the conditions of this trial measuring vital signs|To assess the safety of TRP-8802 under the conditions of this trial measuring Adverse Events | TRYP Therapeutics | University of Michigan - Functional MRI laboratory, Ann Arbor, Michigan, United States |
| Microdosing Psychedelics to Improve Mood | Persistent Depressive Disorder, Dysthymia | Drug: Psilocybin first|Drug: Placebo first | Change in Cornell Dysthymia Rating Scale (CDRS)|Change in Patient Health Questionnaire Somatic-Anxiety-Depression | Rotem Petranker|Nikean Foundation|University of Toronto | Psych Research, Toronto, Ontario, Canada |
| Effects of SERT Inhibition on the Subjective Response to Psilocybin in Healthy Subjects | Healthy | Drug: Escitalopram|Drug: Placebo oral capsule | 5 dimensions of altered state of consciousness (5D-ASC) profile total score|Visual Analog Scales (VAS)|Adjective mood rating scale (AMRS)|States of consciousness questionnaire (SCQ)|Mysticism scale (MS)|Eppendorf Schizophrenia Inventory (ESI)|Blood pressure|Heart rate|Body temperature|Pupil diameter|Plasma concentrations of escitalopram|Plasma concentrations of psilocin|HTR gene expression|Changes in the electrocardiogram (ECG) | University Hospital, Basel, Switzerland | University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland |
| The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder | Post Traumatic Stress Disorder | Drug: Psilocybin | Safety|Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) from baseline|Change in PTSD checklist for DSM-5 (PCL-5) from baseline|Change in Sheehan Disability Scale (SDS) total score from baseline | COMPASS Pathways | Icahn School of Medicine at Mount Sinai, New York, New York, United States|Kings College London, Institute of Psychiatry, Psychology and Neurology, London, United Kingdom |
| Long Term Follow Up Study to COMP 001 And COMP 003 Trials (P-TRD LTFU) | Treatment Resistant Depression | Long-term efficacy of psilocybin|Response, sustained response, remission and change in depression severity|Psychosocial functioning and to predict durability of response to antidepressant treatment|Functional impairment in work/school, social life, and family life.|Safety of Psilocybin | COMPASS Pathways | Kadima Neuropsychiatry Institute, La Jolla, California, United States|Altman Clinical and Translational Research Institute, University of California, San Diego, California, United States|Mood and Anxiety Disorders Program Emory University School of Medicine, Atlanta, Georgia, United States|UT Center of Excellence on Mood Disorders, University of Texas Health Science Center, Houston, Texas, United States|National Institute of Mental Health Czech Republic, Klecany, Czechia|Sheaf House, Tallaght Hospital, Dublin, Ireland|Groningen University Medical Centre, Groningen, Netherlands|Kings College London, Institute of Psychiatry, Psychology and Neurology, London, United Kingdom | |
| PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder | Major Depressive Disorder | Other: No intervention will be administered as part of this study. | Montgomery-Asberg Depression Rating Scale | Usona Institute | Segal Trials, Lauderhill, Florida, United States |
| Assessing the Efficacy of Micro-dosed Psilocybin on Reducing Anxiety & Depression Levels in Adults | Anxiety and Depression | Drug: PSIL428|Dietary Supplement: Oyster mushroom | Changes in Beck Anxiety Inventory BAI|Changes in Beck Depression Inventory 02 - BDI-II|Change in the European Quality of life 5 dimensions- EQ-5D|Cognitive flexibility, using the Stroop Color & Word Test (SCWT)|Changes in resilience using the Brief Resiliency Scale|Measurement of higher level cognitive processes using the Wisconsin Card Sorting Test|The incidence of adverse events|The severity of adverse events|Incidence of abnormal blood pressure|Incidence of abnormal heart rate|incidence of irregular heart rate|incidence of suicidal ideation using the Columbian Suicide Severity Rating Scale|Change in the number of steps|Changes in concomitant medication|Changes in volume of Alcohol|Changes in the number of cigarettes|Changes in the number of cannabis joints|Changes in other over the counter medication|Changes in Estradiol|Changes in Testosterone|Changes in Cortisol|Changes in Progesterone|Changes in Melatonin|Changes in DHEA (Dehydroepiandrosterone)|Changes in DHT(Dihydrotestosterone)|Changes in Androstenedione|Changes in Estrone | Wake Network, Inc.|Professor Roger Gibson Section of Psychiatry Faculty of Medical Sciences UWI | FMS Department of Psychiatry, Kingston, Jamaica |
| Characterization of Altered Waking States of Consciousness in Healthy Humans | Altered Waking States of Consciousness in Healthy Humans | Other: TMS/EEG | Assessment of change of the 'perturbational complexity index' (PCI) in psilocybin compared to placebo condition in healthy humans as indexed by TMS/EEG respones|Assessment of change of the learning rate in a probabilistic learning task in psilocybin compared to placebo condition|Assessment of change of the effect of psilocybin compared to placebo condition on all frequency bands of resting state EEG|Psychometric assessment of change of the sense of self, of perceptual alterations and of mood in psilocybin compared to placebo condition (1)|Psychometric assessment of change of the sense of self, of perceptual alterations and of mood in psilocybin compared to placebo condition (2)|Psychometric assessment of change of the sense of self, of perceptual alterations and of mood in psilocybin compared to placebo condition (3)|Psychometric assessment of change of the sense of self, of perceptual alterations and of mood in psilocybin compared to placebo condition (4) | University of Zurich | Psychiatrische Universitätsklinik Zürich, Zürich, Switzerland |
| Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self | Healthy | Drug: Placebo|Drug: Psilocybine | fMRI resting state activity (BOLD signal)|EEG measurement (ERPs)|Subjective effects will be assessed with the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)|Mood changes will be assessed with the Positive and Negative Affect Schedule (PANAS) | University of Zurich | |
| A Study of a Psilocybin Analog (CYB003) in Participants With Major Depressive Disorder | Major Depressive Disorder | Drug: CYB003|Behavioral: Psychotherapy|Drug: Placebo | Adverse Events|Resting 12 Lead ECG ventricular rate|Resting 12 Lead ECG PR interval|Resting 12 Lead ECG QRS duration|Resting 12 Lead ECG QT interval|Resting 12 Lead ECG QTcF|Holter monitoring|Columbia Suicide Severity Rating Scale (CSSRS) Lifetime version|Columbia Suicide Severity Rating Scale (CSSRS) Since Last Visit (SLV)|Mystical Experience Questionnaire (MEQ30)|5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)|Hallucinogen Rating Scale (HRS)|Persisting Effects Questionnaire (PEQ)|VAS Ratings of "Any Drug Effect"|Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from screening|Pharmacokinetic parameter of psilocin (Cmax)|Pharmacokinetic parameter of psilocin (AUC) | Cybin IRL Limited|Clinilabs Drug Development Corporation|Drug Safety Navigator | Clinilabs Drug Development Corporation, Eatontown, New Jersey, United States |
| Role of the Serotonin 5-HT2A Receptor in Mescaline-induced Altered States of Consciousness | Healthy | Drug: Placebo|Drug: Mescaline 100mg|Drug: Mescaline 200mg|Drug: Mescaline 400mg|Drug: Mescaline 800mg|Drug: Mescaline 800mg + Ketanserin 40mg | Altered States of Consciousness|Extent of subjective response over time|Subjective mood ratings|Subjective experiences of spiritual phenomenons|States of Consciousness|Mystical-type experiences|Blood pressure|Heart rate|Body temperature|Pupil size|Mescaline concentrations in the blood|Mescaline concentrations in the urine|Effects on brain-derived neurotrophic factor (BDNF)|Effects on inflammatory cytokines|Effects on oxytocin|Emotional effects|Effect moderation through personality traits I|Effect moderation through personality traits II|Effect moderation through personality traits III|Effect moderation through personality traits IV|Effect moderation through personality traits V|Psychological insight|Effects on life satisfaction, well-being and appreciation I|Effects on life satisfaction, well-being and appreciation II|Effects on life satisfaction, well-being and appreciation III|Effects on life satisfaction, well-being and appreciation IV|Incidence of Adverse Events before and during each study session|Incidence of Adverse Events during each study session|Electrical activity of the heart | University Hospital, Basel, Switzerland | University Hospital Basel, Clinical Trial Unit, Basel, BS, Switzerland |
| LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders | Patients|Anxiety Disorders | Drug: LSD|Drug: Placebo | Reduction in anxiety assessed by questionnaires|Reduction in Depression assessed by questionnaires|Reduction of psychopathological symptoms assessed by questionnaires|Sustained Response assessed by questionnaires | University Hospital, Basel, Switzerland | University Hospital Basel, Basel, BS, Switzerland|Private Practice P.Gasser, Solothurn, SO, Switzerland |
| Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study | Healthy | Drug: N,N-Dimethyltryptamine (54 mg)|Drug: N,N-Dimethyltryptamine (108 mg)|Drug: N,N-Dimethyltryptamine (162 mg)|Drug: N,N-Dimethyltryptamine (216 mg)|Drug: Placebo|Drug: N,N-Dimethyltryptamine (108 mg) + dose titration | Altered states of consciousness profile (5D-ASC)|Subjective effect ratings over time|AMRS|MEQ43|Spiritual Realms Questionnaire|Blood pressure|heart rate|body temperature|Plasma level DMT|Plasma level of oxytocin|Plasma level of cortisol|Plasma level of BDNF|Plasma level of Prolactin|Urine recovery of DMT|NEO-Five-Factor-Inventory (NEO-FFI)|Freiburger Personality Inventory (FPI-R)|Saarbrücker Personality Questionnaire (SPF)|Elliot Humility Scale (EHS)|Defense Style Questionnaire (DSQ-40)|Jankowski Humility Scale (JHS)|Psychological insight (PIQ) | University Hospital, Basel, Switzerland | |
| SRC Inhibition as a Potential Target for Parkinson's Disease Psychosis | Parkinson Disease Psychosis | Drug: Saracatinib|Drug: Placebo Oral Tablet | Difference between study drug and placebo in BOLD activity in the ventral visual stream during visual recognition vs. the control task measure using fMRI|Difference between study drug and placebo in BOLD activity in the occipito-temporal region during the visual processing task (Kanisza illusion)|Change in Mismatch negativity (MMN) in microvolts (mV) and connectivity with the posterior cingulate hub of the default mode network | King's College London|AstraZeneca|King's College Hospital NHS Trust | Mitul Mehta, London, Camberwell, United Kingdom |
| Effects of Hallucinogens and Other Drugs on Mood and Performance | Healthy | Drug: Hallucinogens and psychoactive substances | Rating of "Drug Liking" on the End of Day Questionnaire|Hallucinogen Rating Scale | Johns Hopkins University | Behavioral Pharmacology Research Unit, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States |
| ELE-101 Safety & Tolerability Study in Healthy Participants | Healthy Volunteers | Drug: ELE-101|Drug: ELE-101 Placebo | Percentage of participants with at least one safety event|Cmax: Maximum observed plasma concentration for ELE-101 and its metabolites|Tmax: Time to reach maximum plasma concentration (Cmax) for ELE-101 and its metabolites|AUCinf: Area under the plasma concentration-time curve from Time 0 to Infinity for ELE-101 and its metabolites|AUClast: Area under the plasma concentration-time curve from Time 0 to the time of the last quantifiable concentration for ELE-101 and its metabolites|AUC0-24: Area under the plasma concentration-time curve from Time 0 to 24 hours for ELE-101 and its metabolites|VZ: volume of distribution during the terminal disposition phase for ELE-101 and its metabolites|VZss: volume of distribution at steady state for ELE-101 and its metabolites|Cl: apparent total clearance from plasma for ELE-101 and its metabolites|MRTinf: mean residence time from Time 0 to Infinity for ELE-101 and its metabolites|t1/2: Terminal disposition phase half-life for ELE-101 and its metabolites|Dischargeability: Assessment of subject-discharge readiness|The dose related psychoactive effects of ELE-101 as evaluated by a Visual Analogue Scale | Eleusis Therapeutics | MAC Clinical Research, Liverpool, United Kingdom|MAC Clinical Research, Manchester, United Kingdom |
| Ketamine-Assisted PsychoTherapy ViAbility in Treating Cancer-related Emotional Distress | Cancer-related Problem/Condition|Depressive Symptoms|Anxiety Disorders | Drug: Ketamine 100 MG/ML | Percentage of population completing at least one KAP session.|Depression and Anxiety|Death and Dying Distress Scale (DADDS)|Mystical Experience Questionnaire (MEQ-30) | Northwell Health | |
| Personality and Drug Use | No Conditions Study Focus on Substance Use and Personality | Other: Usage of drugs | Change in scores on Big Five Inventory (BFI-44)|Change in scores on Retrospective Personality Scale (RPS) | Psychedelic Data Society|Maastricht University|Quantified Citizen Technologies Inc. | |
| Personality and Drug Use (PDU) | Personality | Current Personality Profile|Changes in Personality Profile | Quantified Citizen Technologies Inc.|Maastricht University|Psychedelic Data Society | ||
| The Canadian Underage Substance Use Prevention Trial | Substance Use Disorders|Adolescent Behavior|Adolescent Development | Behavioral: PreVenture Training (PTtT)|Behavioral: PreVenture Training+Implementation Facilitation | Effectiveness (primary outcome): Severity of substance use problems|Implementation Facilitation (primary outcome): Severity of substance use problems|Effectiveness (secondary outcome): Prevalence of binge drinking|Effectiveness (secondary outcome): Frequency of cannabis use|Effectiveness (secondary outcome): Frequency of non-medical prescription drug use|Effectiveness (secondary outcome): Frequency of illicit substance use|Implementation Facilitation (secondary outcome): Rate of interventions | St. Justine's Hospital|University of British Columbia|Center for Addiction and Mental Health|Dalhousie University|Canadian Institutes of Health Research (CIHR) | University of British Columbia Okanagan Campus, Kelowna, British Columbia, Canada|Dalhousie University, Halifax, Nova Scotia, Canada|Center for Mental Health and Addicitions, Toronto, Ontario, Canada|CHU Sainte-Justine Research Center, Montreal, Quebec, Canada |
| Effects of SERT Inhibition on the Subjective Response to LSD in Healthy Subjects | Healthy | Drug: Paroxetine|Drug: Lysergic Acid Diethylamide|Drug: Placebo | 5 dimensions of altered state of consciousness (5D-ASC) total OAV score|Visual Analog Scales (VAS) good effect rating|Adjective mood rating scale (AMRS)|States of consciousness questionnaire (SCQ)|Spiritual Realm Questionnaire (SRQ)|Psychological Insight Questionnaire (PIQ)|Blood pressure|Heart rate|Body temperature|Plasma concentrations of paroxetine|Plasma concentrations of LSD|HTR gene expression|Changes in the electrocardiogram (ECG) | University Hospital, Basel, Switzerland | Clinical Pharmacology & Toxicology, University Hospital Basel, Basel, Switzerland |
