chufangao/CTO huggingface dataset:
Clinical trial NCT04541225: Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
Official title: Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults With Recurrent or Refractory High-grade Gliomas and Solid Tumors
Sponsor: Nuvation Bio Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 74.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-08
Primary completion date: 2022-08-31
Completion date: 2022-08-31
Clinical trial NCT05205668: Study of F-652 in Subjects With Corona Virus Disease 2019 (COVID-19) Pneumonia
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of F-652 in Subjects With COVID-19 Pneumonia
Sponsor: EVIVE Biotechnology (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Compound development plan changed
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-04-08
Primary completion date: 2022-04-08
Completion date: 2023-04-08
Plan to share individual participant data: NO
Clinical trial NCT03859570: Pentoxifylline in Lupus Nephritis
Official title: A Multicenter, Double-blind, Placebo-controlled, Randomized Trial of Pentoxifylline or Placebo in Addition to Standard of Care for Treatment of Proteinuria in Patients With Lupus Nephritis.
Acronym: Pentoxifylline
Sponsor: MetroHealth Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Study not selected to receive funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-01
Primary completion date: 2021-12-31
Completion date: 2022-12-31
Clinical trial NCT04161391: Study of TPX-0046, A RET/SRC Inhibitor in Adult Subjects With Advanced Solid Tumors Harboring RET Fusions or Mutations
Official title: A Phase 1/2 Study of TPX-0046, A Novel Oral RET/SRC Inhibitor in Adult Subjects With Advanced/Metastatic Solid Tumors Harboring Oncogenic RET Fusions or Mutations
Sponsor: Turning Point Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Adverse change in the risk/benefit.
Enrollment: 41.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-06
Primary completion date: 2023-05-22
Completion date: 2023-05-22
Limitations and caveats: As the study enrollment will close prior to completing Phase 1 dose escalation, the Phase 1 food effect substudy, Phase 1 dose expansion, and Phase 2 activities will not take place.
Plan to share individual participant data: NO
Clinical trial NCT05139901: Usefulness of DORNASE in COVID-19 on HFNO
Official title: Usefulness of DORNASE (Pulmozyme®) in Patients With COVID-19 Respiratory Insufficiency on High-Flow Oxygen Therapy
Sponsor: University Medical Centre Ljubljana (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to the Omicron version of SARS-CoV-2 the COVID-pneumonia patients ran out
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-01
Primary completion date: 2023-02-22
Completion date: 2023-02-22
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04603937: A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
Official title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Secondary to Treatment-naïve Diabetic Macular Edema (DME)
Acronym: GLIMMER
Sponsor: Kodiak Sciences Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study did not meet primary endpoint
Enrollment: 459.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2023-04-27
Completion date: 2023-08-31
Baseline population: Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment.
Plan to share individual participant data: NO
Clinical trial NCT05725343: A Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer
Official title: A Phase III Prevention Trial of Canakinumab in Subjects at High Risk for Lung Cancer _ CANAL Study
Acronym: CANAL
Sponsor: Mario Negri Institute for Pharmacological Research (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Novartis has decided to terminate the trial due to the recent results made available from the Novartis CANOPY A study (CACZ885T2301), this decision is not related to any safety data for Canakinumab
Enrollment: 350.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-03
Primary completion date: 2022-04-03
Completion date: 2022-09-21
Plan to share individual participant data: NO
Clinical trial NCT02851004: Special Combination of BBI608 and Pembrolizumab
Official title: A Phase Ib/II Study of BBI608 in Combination With Pembrolizumab in Patients With Metastatic Colorectal Cancer
Sponsor: National Cancer Center Hospital East (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: On the request of the investigational drug provider. No subjects were newly enrolled in the additional cohort as they were preparing to resume enrollment in the additional cohort. Currently, it is preparing the creation of clinical study report.
Enrollment: 55.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-10-31
Primary completion date: 2020-02-03
Completion date: 2021-08-23
Plan to share individual participant data: NO
Clinical trial NCT05667662: Study to Evaluate Itraconazole Administered as Inhaled Dry Powder in Adults With Asthma and ABPA
Official title: Study to Evaluate the Effect of Dose and Duration of Treatment of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) on Safety, Tolerability, and Potential Outcomes in Adult Patients With ABPA
Sponsor: Pulmatrix Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 8.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-02-01
Primary completion date: 2024-02-27
Completion date: 2024-02-27
Clinical trial NCT03087058: Pharmacodynamic & Safety of Patiromer in Children & Adolescents (2-<18 Yrs) With Chronic Kidney Disease and Hyperkalemia
Official title: A Phase 2, Open-Label, Multiple Dose Study to Evaluate the Pharmacodynamic Effects, Safety, and Tolerability of Patiromer for Oral Suspension in Children and Adolescents 2 to < 18 Years of Age With Chronic Kidney Disease and Hyperkalemia
Acronym: EMERALD
Sponsor: Vifor Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated on 13 May 2022 due to a modification to the PIP/PSP
Enrollment: 23.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-07-07
Primary completion date: 2021-01-13
Completion date: 2021-04-30
Plan to share individual participant data: NO
Clinical trial NCT02922413: Panhematin for Prevention of Acute Attacks of Porphyria
Official title: Safety and Efficacy of Panhematin™ for Prevention of Acute Attacks of Porphyria
Sponsor: The University of Texas Medical Branch, Galveston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-10-30
Primary completion date: 2023-12-27
Completion date: 2023-12-27
Clinical trial NCT03738618: Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Trial Investigating the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Women Aged 35-42 Years Undergoing Assisted Reproductive Technology
Acronym: RITA-2
Sponsor: Ferring Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 588.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-29
Primary completion date: 2020-12-21
Completion date: 2020-12-21
Baseline population: The mITT analysis set comprised all randomized and exposed participants. Participants were analyzed according to planned treatment.
Clinical trial NCT03234465: Efficacy, Safety and Tolerability of AG013 in Oral Mucositis Compared to Placebo When Administered Three Times Per Day
Official title: A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Topically-applied AG013 for the Attenuation of Oral Mucositis in Subjects With Cancers of the Head and Neck Receiving Concomitant Chemoradiation Therapy
Sponsor: Oragenics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: No efficacy could be demonstrated, sponsor decided to prematurely end the study.
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-18
Primary completion date: 2020-03-31
Completion date: 2020-07-13
Plan to share individual participant data: NO
Clinical trial NCT04121208: MIcroglial Colony Stimulating Factor-1 Receptor (CSF1R) in Alzheimer's Disease
Official title: A Randomised, Placebo-controlled, Single-blind Study to Characterise the Biomarker Effects of the Colony Stimulating Factor-1 (CSF-1) Receptor Antagonist JNJ-40346527 in Participants With Mild Cognitive Impairment
Acronym: MICAD
Sponsor: University of Oxford (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Delayed due to COVID19. Study drug expired before could be used.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-07
Primary completion date: 2022-02-18
Completion date: 2022-02-18
Plan to share individual participant data: NO
IPD sharing description: Study terminated early after 2 participants recruited. No usable data, therefore no data will be shared.
Clinical trial NCT05429021: IMM-BCP-01 in Mild to Moderate COVID-19
Official title: A Randomized, Double-Blind, Placebo-Controlled, First-in-Human, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Viral Clearance of Single Ascending Doses of IMM-BCP-01 Administered Intravenously in Adults With Mild to Moderate COVID-19
Sponsor: Immunome, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision to discontinue the study based on strategic prioritization.
Enrollment: 9.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-06-03
Primary completion date: 2023-01-06
Completion date: 2023-01-06
Plan to share individual participant data: NO
Clinical trial NCT03099187: A Study of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing Interstitial Lung Disease
Official title: Multicenter, International, Double-blind, Two-Arm, Randomized, Placebo-controlled Phase II Trial of Pirfenidone in Patients With Unclassifiable Progressive Fibrosing ILD
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 253.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-15
Primary completion date: 2018-11-21
Completion date: 2020-01-10
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04811040: Study to Evaluate the Safety and Efficacy of Teropavimab and Zinlirvimab in Combination With Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection
Official title: A Phase 1b Randomized, Blinded, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Broadly Neutralizing Antibodies (bNAbs) GS-5423 and GS-2872 in Combination With Capsid Inhibitor Lenacapavir (GS-6207) in Virologically Suppressed Adults With HIV-1 Infection
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-04-08
Primary completion date: 2023-04-18
Completion date: 2023-10-17
Plan to share individual participant data: NO
Clinical trial NCT04325893: Hydroxychloroquine Versus Placebo in COVID-19 Patients at Risk for Severe Disease
Official title: Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study
Acronym: HYCOVID
Sponsor: University Hospital, Angers (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: decrease in number of eligible patients
Enrollment: 259.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-01
Primary completion date: 2020-06-18
Completion date: 2020-06-18
Clinical trial NCT05374538: VIC-1911 Monotherapy in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer
Official title: A Phase 1a/1b Study of Aurora Kinase A Inhibitor VIC-1911 Monotherapy and in Combination With Sotorasib for the Treatment of KRAS G12C-Mutant Non-Small Cell Lung Cancer
Sponsor: Vitrac Therapeutics, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 4.0 (ACTUAL)
Number of arms: 5.0
Start date: 2022-11-09
Primary completion date: 2023-08-26
Completion date: 2023-08-26
Plan to share individual participant data: NO
Clinical trial NCT03876119: Intraarterial Alteplase Versus Placebo After Mechanical Thrombectomy
Official title: CHemical OptImization of Cerebral Embolectomy in Patients With Acute Stroke Treated With Mechanical Thrombectomy (CHOICE) Trial
Acronym: CHOICE
Sponsor: Hospital Clinic of Barcelona (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 121.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-05
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual participant data on outcome measures will be published along with the main results of the trial.
IPD time frame: The data will become available after publication of main study results.
IPD access criteria: The IPD will be available from the Sponsor of the trial on reasonable request.
Clinical trial NCT04465916: Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD)
Official title: A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Oral FXR Modulator EYP001a Combined With Nucleos(t)Ide Analogues (NA) in Virologically Suppressed Chronic Hepatitis B Patients to Improve Functional Cure Rates
Sponsor: Enyo Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: DSMC reviewed results of 26 subjects. New randomizations were stopped. Already randomized subjects were followed up to W40.
Enrollment: 26.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-12
Primary completion date: 2021-06-17
Completion date: 2021-11-25
Clinical trial NCT04210986: Senolytic Drugs Attenuate Osteoarthritis-Related Articular Cartilage Degeneration: A Clinical Trial
Official title: Senolytic Drugs Attenuate Osteoarthritis-Related Articular Cartilage Degeneration: A Clinical Trial
Sponsor: Steadman Philippon Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-06
Primary completion date: 2023-01-05
Completion date: 2023-02-01
Baseline population: All randomized.
Plan to share individual participant data: NO
Clinical trial NCT05205447: Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants
Official title: A Phase 1, Two-part, Open-label, Fixed-sequence Study to Evaluate the Effects of Multiple Doses of Itraconazole and Carbamazepine on the Single-dose Pharmacokinetics of LY3410738 in Healthy Adult Subjects
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Data from part 2 no longer deemed necessary for this program.
Enrollment: 27.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-01-05
Primary completion date: 2022-04-12
Completion date: 2022-04-12
Plan to share individual participant data: NO
Clinical trial NCT03970382: A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors
Official title: A Phase 1a/1b, Open-label First-in-human Study of the Safety, Tolerability and Feasibility of Gene-edited Autologous NeoTCR-T Cells (NeoTCR-P1) Administered as a Single Agent or in Combination With Anti-PD-1 to Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor: PACT Pharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: SUSPENDED 
Why stopped: Business decision
Enrollment: 21.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-03
Primary completion date: 2022-08-12
Completion date: 2022-08-12
Plan to share individual participant data: NO
Clinical trial NCT04066478: Does DHEA IVF Outcomes in Poor Responders?
Official title: Does Dehydroepiandrosterone (DHEA) Improve IVF Outcomes in Poor Responders? A Randomised, Double-blind, Placebo Controlled Trial
Acronym: DHEA
Sponsor: Homerton University Hospital NHS Foundation Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: SUSPENDED 
Why stopped: Sponsor
Enrollment: 400.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2017-10-08
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Clinical trial NCT05022329: COVID-19 Vaccine Boosters in Patients With CKD
Official title: A Multi-Centre 12 Month Parallel-Group Randomized Control Trial of BNT162b2 Versus mRNA( Messenger Ribonucleic Acid) -1273 COVID-19 Vaccine Boosters in Chronic Kidney Disease and Dialysis Patients With Poor Humoral Response Following COVID-19 ( Corona Virus Disease of 2019)Vaccination
Acronym: BOOST KIDNEY
Sponsor: Sunnybrook Health Sciences Centre (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Trial participants became eligible to receive their 4th dose of the COVID-19 vaccine vaccine thus data collected from the 12 month follow-up after 3rd dose vaccine, as per current protocol, would not not be relevant to the study outcomes.
Enrollment: 268.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-09-30
Primary completion date: 2022-05-11
Completion date: 2022-11-15
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05142527: Study to Evaluate the Safety and Efficacy of a Monoclonal Antibody Cocktail for the Prevention of COVID-19
Official title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, and Efficacy of ADM03820 to Prevent Symptomatic COVID-19 in Adult Subjects
Sponsor: Resilience Government Services, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor withdrew study prior to initiation and no participants were enrolled.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-01-31
Primary completion date: 2024-01-31
Completion date: 2024-04-30
Clinical trial NCT01222559: Efficacy and Safety Study of co.Don Chondrosphere to Treat Cartilage Defects
Official title: Prospective, Randomised, Open Label, Multicentre Phase-III Clinical Trial to Compare the Efficacy and Safety of the Treatment With the Autologous Chondrocyte Transplantation Product co.Don Chondrosphere (ACT3D-CS) With Microfracture in Subjects With Cartilage Defects of the Knee With a Defect Size Between 1 an 4 cm2
Sponsor: co.don AG (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 102.0 (ACTUAL)
Number of arms: 2.0
Start date: 2010-10-31
Primary completion date: 2017-09-30
Completion date: 2020-02-29
Clinical trial NCT03313076: Vitamin D and n-3 Polyunsaturated Fatty Acids (PUFAs) to Prevent Chronic Pain Following Major Thermal Burn Injury
Official title: Pilot, Double-blind, Randomized Controlled, Multi-center Study of the Effects of Fish Oil and Vitamin D in the Prevention of Chronic Pain Following Major Thermal Burn Injury
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID-19 global pandemic, and study funding period ended 7/31/2020.
Enrollment: 24.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-07-19
Primary completion date: 2020-07-31
Completion date: 2020-07-31
Limitations and caveats: Early termination because of pandemic delays
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual data that supports the results will be shared on request provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina (UNC) independently.
IPD time frame: 12-36 months following publication
IPD access criteria: Deidentified individual data that supports the results will be shared provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC independently.
Clinical trial NCT02362958: A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer
Official title: Sun Yat-sen University Cancer Center
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 159.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-01-09
Primary completion date: 2020-05-31
Completion date: 2020-05-31
Plan to share individual participant data: NO
Clinical trial NCT03471182: Investigation of Cocaine Addiction Using mGluR5 PET and fMRI
Official title: Investigation of Cocaine Addiction Using mGluR5 PET and fMRI
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 32.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-02-26
Primary completion date: 2022-08-18
Completion date: 2022-08-18
Baseline population: In addition to participants enrolled in this study (N=17 CUD, N=8 HC-MRI), baseline characteristics are provided for the sample of comparison adults completing PET procedures (N=20 HC-PET) as part of other studies.
Limitations and caveats: This study was greatly impacted by a COVID-related suspension in research activities and subsequent restrictions on facility operations. This resulted in lower participation and study adjustments including the discontinuation of cocaine self-administration procedures, the use of historical HC-PET data, and the collection of an HC-MRI sample (no HC completed both PET and fMRI). These alterations limit the statistical power of primary outcomes and the ability to perform planned secondary analyses.
Plan to share individual participant data: YES
IPD sharing description: Consistent with NIH Grants Policy on Sharing of Unique Research Resources, including the Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Grants and Contracts (December, 1999), all research resources generated will be freely distributed, as available, to appropriate, qualified academic investigators for non-commercial research purposes. All data will be de-identified before sharing, using procedures in compliance with HIPPA and Yale Human Investigation Committee standards. No available data sets or supporting information will contain subject names, addresses or other specific personal identification.
IPD time frame: In accordance with institutional standards and guidelines, after termination of this study and completion of all analysis and publications, all data and screening information will be anonymized and kept in a secure fashion for the purpose of further analyses indefinitely unless prevailing University or Federal guidelines at the time require a change.
IPD access criteria: In accordance with institutional standards and guidelines, researchers must submit a requisition form that describes their specific hypotheses and details specific data or supporting information being requested. Requests will be reviewed by senior study personnel.