chufangao/CTO huggingface dataset:
Clinical trial NCT03577028: Study of HPN424 in Patients With Advanced Prostate Cancer
Official title: A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN424 in Patients With Advanced Prostate Cancer Refractory to Androgen Therapy
Sponsor: Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Decision not to continue to the expansion portion of the study
Enrollment: 104.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-07-24
Primary completion date: 2023-02-27
Completion date: 2023-02-27
Baseline population: Safety Population. The study was terminated early, therefore the primary goal of the final data analysis was to look at dosing schedule rather than individual dose levels. The results displayed are shown broken out by dosing schedules and no analysis of specific dose levels was performed. This analysis is as outlined in the final Statistical Analysis Plan.
Clinical trial NCT03092895: A Study of SHR-1210 in Combination With Apatinib or Chemotherapy in Subjects With Advanced PLC or BTC
Official title: A Phase 2 Study of SHR-1210 (PD-1 Antibody) in Combination With Apatinib or Chemotherapy (FOLFOX4 or GEMOX) in Subjects With Advanced Primary Liver Cancer（PLC）or Biliary Tract Carcinoma (BTC)
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 157.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-27
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Plan to share individual participant data: NO
Clinical trial NCT04054973: L-arginine Study for Persistent Symptoms of Schizophrenia
Official title: An Open-label Feasibility Trial of Adjunctive L-arginine and Tetrahydrobiopterin Combination in Patients With Treatment Resistant Schizophrenia
Sponsor: University of Massachusetts, Worcester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study was unable to be started due to unavailability of study medication.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-11
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT05956509: Study of Intramuscular Injections of ABBV-950 to Assess Adverse Events and Change in Disease Activity in Adult Participants With Upper Limb Spasticity
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Efficacy, and Tolerability of ABBV-950 for the Treatment of Upper Limb Spasticity in Adult Post-Stroke Patients
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic considerations
Enrollment: 1.0 (ACTUAL)
Number of arms: 11.0
Start date: 2024-01-12
Primary completion date: 2024-06-02
Completion date: 2024-06-02
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT04376827: A Study of Guselkumab in Participants With Active Lupus Nephritis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Guselkumab in Subjects With Active Lupus Nephritis
Acronym: ORCHID-LN
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to enrollment challenges, J\&J Innovative Medicine decided to stop screening and terminate the study early. This decision was not based on a safety concern.
Enrollment: 33.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2023-02-01
Completion date: 2023-02-01
Limitations and caveats: Due to enrollment challenges, the Sponsor decided to stop screening of new participants and stop the study early. Since a small number of participants only entered the LTE phase than the planned enrollment count, some of the planned safety analyses were not performed for the LTE phase participants.
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 NCT05161481: A Study to Test Whether Two Different Doses of Avenciguat Help People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Live
Official title: Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Investigate the Effects of Two Doses (Up-titration to a Fixed Dose Regimen) of Oral BI 685509 on Portal Hypertension After 24 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Compensated Cirrhosis
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 80.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-02-03
Primary completion date: 2024-05-02
Completion date: 2024-06-12
Plan to share individual participant data: YES
IPD sharing description: Once the time frame criteria given under number 4 are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed Document Sharing Agreement.~Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD time frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
Clinical trial NCT04465760: Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy
Official title: A Phase II Study of Xisomab 3G3, a Monoclonal Antibody Preventing the Activation of FXI by FXIIa, for the Prophylaxis of Catheter-Associated Thrombosis
Sponsor: OHSU Knight Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Insufficient accrual rate
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-25
Primary completion date: 2021-10-05
Completion date: 2021-11-05
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.
Clinical trial NCT05375955: A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
Official title: A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF MULTIPLE DOSE LEVELS OF PF-07038124 OINTMENT FOR 12 WEEKS IN PARTICIPANTS 12 YEARS AND OLDER AND WITH MILD-TO-MODERATE ATOPIC DERMATITIS OR MILD-TO-SEVERE PLAQUE PSORIASIS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 263.0 (ACTUAL)
Number of arms: 7.0
Start date: 2022-09-26
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Baseline population: Safety analysis set included all participants randomly assigned to study intervention who received at least 1 dose of study intervention.
Plan to share individual participant data: YES
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT04268823: Clinical Study to Assess the Mode of Action of QBW251 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Subjects and Investigator Blinded, Placebo Controlled Parallel Group Study to Assess the Mode of Action of QBW251 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 54.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-10
Primary completion date: 2022-09-13
Completion date: 2022-09-20
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 NCT05943990: Study of GSK3845097 in Previously Treated Participants With Advanced Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
Official title: Assessment of Safety and Recommended Phase 2 Dose of Autologous T Cells Engineered With an Affinity-enhanced TCR Targeting NY ESO 1 and LAGE 1a, and Co-expressing the dnTGF-βRII (GSK3845097) in Participants With NY ESO 1 and/or LAGE 1a Positive Previously Treated Advanced (Metastatic or Unresectable) Synovial Sarcoma and Myxoid/Round Cell Liposarcoma
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to a change in GSK's R\&D priorities.
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-21
Primary completion date: 2022-10-24
Completion date: 2022-10-24
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Clinical trial NCT04491136: Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
Official title: A Multicenter, Interventional, Open-label and Single-arm Study to Investigate the Effect of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D
Acronym: RHYTHM
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 201.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-11-11
Primary completion date: 2023-06-08
Completion date: 2023-06-08
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 NCT04448834: Blincyto Amgen Acrotech BioPharma PH2 Blincyto Marqibo R/R Philadelphi CD19+ ALL
Official title: A Phase 2 Single Arm, Multicenter Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab (Blincyto) and Vincristine Sulfate Liposomal Injection (Marqibo) in Adult Subjects With Relapsed/Refractory Philadelphia Negative CD19+ Acute Lymphoblastic Leukemia
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study not moving forward
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-31
Primary completion date: 2023-06-01
Completion date: 2023-06-01
Plan to share individual participant data: NO
Clinical trial NCT02255305: FMT Versus Antimicrobials for Initial Treatment of Recurrent CDI
Official title: Fecal Microbiota Transplantation Versus Standard Medical Therapy for Initial Treatment of Recurrent Clostridium Difficile Infection
Sponsor: NorthShore University HealthSystem (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to personnel issues for finding and enrolling patients, performing appropriate follow-up and performing FMT procedure
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-01-31
Primary completion date: 2020-01-31
Completion date: 2020-01-31
Limitations and caveats: Study ended early due to personnel needed for study completion (enrollment, follow-up, FMT procedure) and did not reach enrollment goals.
Clinical trial NCT03585101: A Single-arm Evaluation of the Effect of HCV Treatment on Cardiovascular Disease Risk
Official title: A Single-arm Evaluation of the Effect of Elbasvir/Grazoprevir on Cardiometabolic Parameters in Patients With Hepatitis C Infection and Underlying Metabolic Disease
Acronym: HEART-C
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Funding no longer available
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-08-31
Primary completion date: 2019-06-30
Completion date: 2020-04-30
Plan to share individual participant data: NO
Clinical trial NCT04788511: Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
Official title: Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction
Acronym: STEP-HFpEF
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 529.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-16
Primary completion date: 2023-04-18
Completion date: 2023-04-18
Baseline population: Full analysis set (FAS) population included all the randomized participants for this trial.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT03404726: A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies
Official title: An Open-label, Multicenter Phase 1 Study to Characterize the Safety, Tolerability, Preliminary Antileukemic Activity, Pharmacokinetics, and Maximum Tolerated Dose or Pharmacological Active Dose of BAY2402234 in Patients With Advanced Myeloid Malignancies
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of sufficient clinical benefit
Enrollment: 40.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-03-29
Primary completion date: 2021-01-26
Completion date: 2021-01-26
Clinical trial NCT02960763: Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Official title: Optimizing Outcomes of Treatment-Resistant Depression in Older Adults
Acronym: OPTIMUM
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 742.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-02-24
Primary completion date: 2020-09-28
Completion date: 2021-09-01
Baseline population: In Participant Flow, Step 2 milestones shows numbers recorded for those who switched from Step 1 to Step 2, and the numbers for those who started Step 2 without having first participated in Step 1.~125 participants from the Step 1 arms (aripiprazole augmentation, bupropion augmentation, and switch to bupropion) also participated in Step 2.~A grand total of 742 unique participants were randomized in the study.
Plan to share individual participant data: YES
IPD sharing description: A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available through a Washington University in St. Louis (WUSTL) secure repository and registered at clinicaltrials.gov.
Clinical trial NCT03691779: Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Official title: A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age
Sponsor: Vertex Pharmaceuticals Incorporated (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 71.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-02
Primary completion date: 2020-08-07
Completion date: 2020-08-07
Baseline population: The analysis population included all enrolled participants who carry the intended CFTR allele mutation and received at least 1 dose of study drug in the respective part of the study.
Clinical trial NCT03467217: Losartan for the Treatment of Pediatric NAFLD
Official title: Losartan for the Treatment of Pediatric NAFLD (STOP-NAFLD): A Phase 2, Randomized, Placebo-Controlled Clinical Trial
Acronym: STOP-NAFLD
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Trial stopped for futility
Enrollment: 83.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-02
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: YES
IPD sharing description: This study will comply with the NIH Data Sharing Policy and Results information from this trial will be submitted to ClinicalTrials.gov and a public use database deposited with the NIDDK Central Repository.
IPD time frame: Data from this study may be requested from the NIDDK Central Repository (https://www.niddkrepository.org/search/study/) two years after the completion of the primary outcome.
IPD access criteria: Apply through the NIDDK Central Repository:
Clinical trial NCT02636946: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Sponsor: Allergan (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 144.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-24
Primary completion date: 2021-01-26
Completion date: 2021-01-26
Baseline population: Intent-to-treat (ITT) Population was defined as all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing, please refer to the link below.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT00896181: Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)
Official title: A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2008-12-10
Primary completion date: 2020-01-03
Completion date: 2020-12-31
Plan to share individual participant data: NO
Clinical trial NCT02973191: A Study to Determine Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-Cell Acute Lymphoblastic Leukemia
Official title: A Phase 2, Open-label, Multiple Cohort, Single-arm, Multi-center Trial to Determine the Safety, Feasibility and Efficacy of JCAR015 in Adult Subjects With B-cell Acute Lymphoblastic Leukemia.
Acronym: ORBIT
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Development of JCAR015 has been discontinued. No subjects were enrolled/treated under protocol JCAR015-ALL-001
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-12-20
Primary completion date: 2019-06-25
Completion date: 2021-01-24