chufangao/CTO huggingface dataset:
Clinical trial NCT04493216: A Dose-Range Finding Clinical Trial Study in Human Immunodeficiency Virus (HIV-1) Infected Treatment-Naive Adults
Official title: A Phase IIb, Randomized, Partially Blind, Active Controlled, Dose-range Finding Study of GSK3640254 Compared to a Reference Arm of Dolutegravir, Each in Combination With Nucleoside Reverse Transcriptase Inhibitors, in HIV-1 Infected Antiretroviral Treatment-naive Adults
Acronym: DOMINO
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company decision to stop compound development. The decision is not based on any safety or efficacy concerns. It reflects the company strategy for portfolio progression.
Enrollment: 161.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-11-18
Primary completion date: 2022-09-05
Completion date: 2023-05-29
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Clinical trial NCT04465877: Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
Official title: Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy
Sponsor: Akros Pharma Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 37.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-15
Primary completion date: 2021-02-17
Completion date: 2021-02-17
Plan to share individual participant data: NO
Clinical trial NCT02961114: Use of Autologous Adipose-Derived Stem/Stromal Cells (AD-cSVF) in Symptomatic Benign Prostate Hypertrophy
Official title: Use of Autologous Adipose-Derived Stem/Stromal Cells In Symptomatic Benign Prostate Hypertrophy
Acronym: SVF-BPN
Sponsor: Healeon Medical Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: COVID restrictions prevent patient enrollment or treatment. Clinical Trial facility is being closed due to viral limitations and loss of staff to perform
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-11-01
Primary completion date: 2022-12-31
Completion date: 2023-07-31
Plan to share individual participant data: YES
IPD sharing description: Annual Data Update to All Collaborators
Clinical trial NCT03582033: A Safety Study of SEA-BCMA in Patients With Multiple Myeloma
Official title: A Phase 1 Study of SEA-BCMA in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor: Seagen Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study closed due to portfolio prioritization
Enrollment: 83.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-01
Primary completion date: 2023-11-09
Completion date: 2023-11-09
Clinical trial NCT02998905: NOACs for Stroke Prevention in Patients With Atrial Fibrillation and Previous ICH
Official title: Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation and Previous Intracerebral Hemorrhage Study
Acronym: NASPAF-ICH
Sponsor: Population Health Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-26
Primary completion date: 2019-10-31
Completion date: 2020-02-18
Plan to share individual participant data: NO
Clinical trial NCT03645525: Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Official title: Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Acronym: IUMTB
Sponsor: Children's Hospital of Fudan University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The certification of cell-based treatment in the settings need to be updated.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-01
Primary completion date: 2022-10-30
Completion date: 2023-04-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05382819: A Safety, Tolerability and Preliminary Efficacy Study of FRTX-02 Capsules in Healthy Subjects and Subjects With Atopic Dermatitis
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Single and Multiple Ascending Doses of FRTX-02 in Healthy Subjects and Subjects With Atopic Dermatitis
Sponsor: Fresh Tracks Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Decision
Enrollment: 89.0 (ACTUAL)
Number of arms: 6.0
Start date: 2022-05-16
Primary completion date: 2023-02-08
Completion date: 2023-08-11
Plan to share individual participant data: NO
Clinical trial NCT02888041: Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?
Official title: Is There an Interest in Repeating the Vaginal Administration of Dinoprostone (Propess®), to Promote Induction of Labor of Pregnant Women at Term?
Acronym: RE-DINO
Sponsor: University Hospital, Limoges (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Not enough patients
Enrollment: 160.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-31
Primary completion date: 2022-04-23
Completion date: 2022-04-23
Plan to share individual participant data: NO
Clinical trial NCT03245840: Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE)
Official title: A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE)
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 133.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-05
Primary completion date: 2022-04-26
Completion date: 2022-04-26
Baseline population: The safety analysis set (SAS) consisted of all participants who received at least 1 dose of BOS.
Limitations and caveats: The study was discontinued prematurely as per sponsor's decision.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT03751657: A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.
Official title: An Investigational Trial Comparing the Efficacy and Safety of Once Weekly NNC0148-0287 C (Insulin 287) Versus Once Daily Insulin Glargine, Both in Combination With Metformin, With or Without DPP-4 Inhibitors, in Insulin naïve Subjects With Type 2 Diabetes Mellitus
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 247.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-11-29
Primary completion date: 2019-12-16
Completion date: 2020-01-17
Baseline population: Full analysis set (FAS) included all randomised participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT03952325: Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC
Official title: A Multicenter, Phase 2 Study of Tesetaxel Plus Three Different PD-(L)1 Inhibitors in Patients With Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly and Non-Elderly Adult Patients With HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Acronym: CONTESSA TRIO
Sponsor: Odonate Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The Sponsor has discontinued the development of tesetaxel
Enrollment: 294.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-07-09
Primary completion date: 2021-06-23
Completion date: 2021-06-23
Clinical trial NCT03180294: Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer
Official title: Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer
Sponsor: NRG Oncology (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 230.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-05-31
Primary completion date: 2021-02-22
Completion date: 2021-02-22
Baseline population: Eligible participants
Clinical trial NCT02901067: STAT-STatin and Aspirin in Trauma
Official title: STAT (STatins and Aspirin in Trauma) Trial: A Phase II, Pragmatic, Prospective, Randomized, Double-blind, Adaptive Clinical Trial Examining the Efficacy of Statins and Aspirin in the Reduction of Acute Lung Injury and Venous Thromboembolism in Patients With Fibrinolysis Shutdown
Acronym: STAT
Sponsor: Denver Health and Hospital Authority (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID-19 pandemic and high proportion of patients meeting exclusion criteria.
Enrollment: 43.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-02-03
Primary completion date: 2021-05-24
Completion date: 2021-08-01
Clinical trial NCT04896632: Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants
Official title: A Randomized, Participant- and Investigator-blinded, Placebo-controlled, Single Ascending Dose and Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor's decision.
Enrollment: 64.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-13
Primary completion date: 2022-11-24
Completion date: 2022-11-24
Plan to share individual participant data: NO
Clinical trial NCT04332523: A Study of JNJ-53718678 in Participants With Hepatic Impairment
Official title: A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Pharmacokinetics of JNJ-53718678
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
Enrollment: 25.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-08-17
Primary completion date: 2022-03-16
Completion date: 2022-03-16
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency.~As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT02972294: HiFIT Study : Hip Fracture: Iron and Tranexamic Acid
Official title: HiFIT Study: Interest of Intravenous Iron and Tranexamic Acid to Reduce Transfusion in Hip Fracture Patients
Acronym: HiFIT
Sponsor: University Hospital, Angers (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: 1year inclusion hold due to PV new fact (Monofer hold for risk revaluation) DSMB Interim analysis : 1treatment with important transfusion risk reduction/inclusions issues (COVID)/sites change of practice if study continue=\>stop inclusions
Enrollment: 419.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-03-31
Primary completion date: 2021-09-16
Completion date: 2021-09-16
Plan to share individual participant data: NO
Clinical trial NCT02101385: Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer
Official title: A Phase II Randomized Controlled Trial of Genomically Directed Therapy After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer: Hoosier Oncology Group BRE12-158
Sponsor: Hoosier Cancer Research Network (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 193.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-04-03
Primary completion date: 2021-02-21
Completion date: 2022-09-09
Baseline population: This population includes all subjects who were enrolled and found eligible and evaluable for this trial.
Plan to share individual participant data: NO
Clinical trial NCT03814798: Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency
Official title: A Multicenter, Randomized, Cross-over, Open-label Study to Evaluate IGSC 20% Flexible Dosing Including Daily Push Dosing In Treatment-Experienced Subjects With Primary Immunodeficiency (PI) and Evaluation of Loading/Maintenance IGSC 20% in Treatment-Naïve Subjects With PI
Sponsor: Grifols Therapeutics LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Due to the regulatory approval of the product in this indication, a large portion of the study becomes unnecessary.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-12-31
Primary completion date: 2020-09-30
Completion date: 2020-09-30
Plan to share individual participant data: NO
Clinical trial NCT04247282: Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection
Official title: A Sequential Window of Opportunity Trial of Anti-PD-L1/TGF-beta Trap (M7824 ) Alone and in Combination With TriAd Vaccine, and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection.
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-06-09
Primary completion date: 2021-08-24
Completion date: 2023-06-12
Baseline population: Baseline characteristic data collected for one participant that was enrolled but not treated is reported here.
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All large- scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
IPD time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Clinical trial NCT03459443: A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471
Official title: An Open-Label Phase 2 Proof-of-Concept Study in Patients With C3 Glomerulopathy (C3G) or Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN) Treated With ACH-0144471
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The reason for terminating study early was inconclusive efficacy results. No safety findings were identified.
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-20
Primary completion date: 2021-03-29
Completion date: 2021-03-29
Baseline population: All participants who received at least 1 dose of study drug during treatment period.
Plan to share individual participant data: YES
IPD sharing description: Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Clinical trial NCT05086276: FX-322 in Adults With Acquired Sensorineural Hearing Loss
Official title: A Phase 2, Prospective, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Multicenter Study to Evaluate the Efficacy of FX-322 Administered by Intratympanic Injection in Adults With Acquired Sensorineural Hearing Loss
Sponsor: Frequency Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 142.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-12
Primary completion date: 2022-12-30
Completion date: 2022-12-30
Baseline population: Full analysis set is defined as the subjects who met all inclusion criteria who received at least 1 dose of study drug. Note that 2 subjects who received FX-322 treatment were ultimately not included in the Full Analysis Set because, after they had been treated and as study assessments progressed, they were deemed to not meet the inclusion criteria for sensorineural hearing loss (SNHL) and were excluded from the FAS.
Clinical trial NCT04211922: Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Official title: A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor R\&D Strategy Adjustment
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-21
Primary completion date: 2022-10-11
Completion date: 2022-10-11
Clinical trial NCT04410523: Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
Official title: A 12-week, Multicenter, Randomized, Double-blind, Parallel-arm, Placebo-controlled Study to Assess the Efficacy and Safety of CSJ117, When Added to Existing Asthma Therapy in Patients ≥ 18 Years of Age With Severe Uncontrolled Asthma.
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Desicion
Enrollment: 335.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-09-09
Primary completion date: 2022-07-12
Completion date: 2022-09-06
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Clinical trial NCT04602221: A Study in Healthy Men to Test Whether BI 409306, BI 425809 or Lamotrigine Can Reverse the Memory Problems Caused by Ketamine
Official title: A Randomized, Placebo Controlled, Double-blind, Double-dummy Three-way Cross Over Trial to Investigate the Effect of BI 409306, BI 425809 and Lamotrigine on Ketamine-induced Cognitive Deficits in Healthy Male Subjects
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 18.0
Start date: 2020-12-01
Primary completion date: 2022-08-01
Completion date: 2022-08-12
Baseline population: Treated set (TS): The treated set included all subjects who were randomised and treated with at least one dose of Investigational medicinal product (IMP)/Placebo or ketamine.
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datasharing
Clinical trial NCT03532425: B/F/TAF vs Atripla Double-Blind Switch Study in HIV-1 Infected Adults
Official title: Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching From Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate to Bictegravir/ Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected Virologically Suppressed Adults
Sponsor: University of Alberta (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulties enrolling participants
Enrollment: 28.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-29
Primary completion date: 2020-08-03
Completion date: 2020-09-03
Plan to share individual participant data: NO