chufangao/CTO huggingface dataset:
Clinical trial NCT03756285: Safety and Tolerability Study of AZD4831 in Patients With Heart Failure.
Official title: A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre, Phase 2a Study to Assess Target Engagement, Safety and Tolerability of AZD4831 in Patients With Heart Failure With Preserved Ejection Fraction (HFpEF)
Acronym: SATELLITE
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A decision was made to stop the study early when AstraZeneca evaluated the available data and it was considered that completing the study would provide limited additional information and unlikely to change the study conclusions.
Enrollment: 41.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-11
Primary completion date: 2020-05-07
Completion date: 2020-05-07
Limitations and caveats: Due to premature study termination, the statistical assumptions for the study design according to the Clinical Study Protocol could not be fulfilled, therefore, no statistical conclusions can be made based on primary or secondary efficacy objectives. Statistical significance could not be evaluated for any efficacy objectives and the p-values presented are viewed as nominal.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT02757443: Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
Official title: Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients: a Single-center Randomised Double-blind Placebo-controlled Exploratory Pilot Clinical Trial
Acronym: PRISE
Sponsor: Meshalkin Research Institute of Pathology of Circulation (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 120.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-30
Primary completion date: 2021-04-30
Completion date: 2021-05-31
Plan to share individual participant data: YES
Clinical trial NCT05147415: Study of Tesomet With Open-label Extension in Subjects With Hypothalamic Obesity (HO)
Official title: A Phase 2b, Double-blind, Randomized, Placebo-controlled, Dose-finding, Multi-center, 36-week Safety and Efficacy Study With Open-label Extension (OLE) Period of Tesomet in Subjects With Hypothalamic Obesity
Sponsor: Saniona (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Due to financial considerations Sponsor is unable to complete the trial and assess the planned objectives/endpoints. No subjects have been randomized to treatment in the clinical trial and the decision therefore has no safety concern for patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-11-11
Primary completion date: 2022-12-09
Completion date: 2022-12-09
Plan to share individual participant data: YES
IPD sharing description: The Sponsor will consider requests from qualified researchers for access to TM008 study materials
IPD time frame: Following completion of Tesomet clinical development
Clinical trial NCT02908685: A Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy (SMA) Participants
Official title: A Two Part Seamless, Multi-Center Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of Risdiplam (RO7034067) in Type 2 and 3 Spinal Muscular Atrophy Patients
Acronym: SUNFISH
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 231.0 (ACTUAL)
Number of arms: 6.0
Start date: 2016-10-19
Primary completion date: 2019-09-06
Completion date: 2023-10-02
Clinical trial NCT03832114: Study on Efficacy and Safety of LNP023 in C3 Glomerulopathy Patients Transplanted and Not Transplanted
Official title: An Open-label, Non-randomized Study on Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LNP023 in Two Patient Populations With C3 Glomerulopathy
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-20
Primary completion date: 2021-04-23
Completion date: 2021-04-23
Baseline population: For all analysis sets, patients were analyzed according to study drug received for Cohort A and B. Safety analysis set included all patients that received any study drug. PK analysis set included all patients with available PK data and no protocol deviations with relevant impact on PK data.
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 NCT04382625: Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial
Official title: Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial
Sponsor: Kootenai Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Secondary to other study results, suspended for a scientific review
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-31
Primary completion date: 2022-01-01
Completion date: 2022-06-01
Plan to share individual participant data: NO
Clinical trial NCT04614025: Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19
Official title: A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Severe COVID-19
Sponsor: Pluristem Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients.
Enrollment: 23.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-19
Primary completion date: 2021-08-04
Completion date: 2023-02-07
Plan to share individual participant data: NO
Clinical trial NCT04857840: Randomized Study of Extended Treatment With Firibastat in Treatment-Resistant Hypertension (REFRESH)
Official title: A Phase 3, Double-blind, Placebo-controlled and Open-label Efficacy and Long-term Safety Study of Firibastat (QGC001) Administered Orally, Once Daily, for Up to 48 Weeks in Patients With Difficult-to-treat/Resistant Hypertension.
Acronym: REFRESH
Sponsor: Quantum Genomics SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: No Efficacy demonstrated inn the QGC001-3QG1 study
Enrollment: 419.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-05
Primary completion date: 2023-01-09
Completion date: 2023-01-09
Plan to share individual participant data: NO
Clinical trial NCT05966584: A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
Official title: RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Limited amount of eligible participants
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-07-06
Primary completion date: 2024-08-02
Completion date: 2024-08-02
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT04496999: HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.
Official title: HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt; a Phase I Study.
Acronym: HDMM
Sponsor: Insel Gruppe AG, University Hospital Bern (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Insufficient recruitment
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-13
Primary completion date: 2022-09-09
Completion date: 2022-09-09
Plan to share individual participant data: YES
Clinical trial NCT05238844: A Study of Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection
Official title: A Phase 2a Randomized, Double-blinded, Placebo-controlled, Multi Center, Dose Ranging Study of the Safety and Efficacy of ATI-2173 and Vebicorvir in Combination With Tenofovir Disoproxil Fumarate in Subjects With Chronic Hepatitis B Virus Infection
Sponsor: Antios Therapeutics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor stopped due to partner collaboration ending
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-11
Primary completion date: 2022-05-25
Completion date: 2022-05-25
Plan to share individual participant data: NO
Clinical trial NCT03641326: Sunitinib in Sarcomas of the Central Nervous System
Official title: Phase II Clinical Trial of Sunitinib in Sarcomas of the Central Nervous System
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor accrual
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-02-21
Primary completion date: 2021-04-02
Completion date: 2021-04-02
Limitations and caveats: National Institutes of Health (NIH) clinical center is a quaternary care facility where we rely heavily on self-referrals and outside physician referrals for accrual. Competing trials at NIH and outside institutions have shifted interest from this study and physicians are not referring patients for this study. Consequently, we have had low accrual.
Plan to share individual participant data: NO
Clinical trial NCT04762875: MGTA-145 + Plerixafor in the Mobilization of HSCs for Allogeneic Transplant in Hematologic Malignancies
Official title: A Phase II Study Evaluating the Safety and Efficacy of MGTA-145 in Combination With Plerixafor for the Mobilization and Transplantation of HLA-Matched Donor Hematopoietic Stem Cells in Recipients With Hematological Malignancies
Sponsor: Ensoma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: This study was voluntarily terminated due to a business decision not to proceed and not due to any safety issue
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-06-16
Primary completion date: 2021-09-14
Completion date: 2022-03-14
Plan to share individual participant data: NO
Clinical trial NCT03668119: A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
Official title: A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
Acronym: CheckMate 848
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 212.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-31
Primary completion date: 2022-05-03
Completion date: 2023-08-02
Plan to share individual participant data: NO
Clinical trial NCT04454398: Study to Evaluate STI-1499 (COVI-GUARD) in Patients With Moderate COVID-19
Official title: A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-1499 (COVI-GUARD™) in Hospitalized Patients With Moderate COVID-19
Sponsor: Sorrento Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Difficulty recruiting
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-30
Primary completion date: 2021-01-31
Completion date: 2021-01-31
Clinical trial NCT03695380: A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
Official title: A Phase Ib Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab, To Patients With Advanced Platinum-sensitive Ovarian Cancer
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 77.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-09
Primary completion date: 2023-07-12
Completion date: 2023-07-12
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Clinical trial NCT04871711: Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema
Official title: A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 1)
Acronym: DELTA 1
Sponsor: LEO Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 487.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-10
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Plan to share individual participant data: YES
IPD sharing description: De-identified IPD can be made available to researchers in a closed environment for a specified period of time.
IPD time frame: Data is available to request after results of the trial are available on leopharmatrials.com
IPD access criteria: Data-sharing is subject to approved scientifically sound research proposal and signed data-sharing agreement.
Clinical trial NCT04370873: MK-5475 in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD) (MK-5475-006)
Official title: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Pulmonary Hypertension Associated With COPD
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-05
Primary completion date: 2022-01-12
Completion date: 2022-01-12
Baseline population: One participant in Part 1 also participated in Part 2. That participant is counted only in Part 1 for baseline characteristics.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03831113: Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy
Official title: Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: poor recruitment
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-13
Primary completion date: 2022-12-22
Completion date: 2022-12-22
Limitations and caveats: This portion of the study was terminated due to poor recruitment and poor compliance of recruited subjects
Plan to share individual participant data: NO
Clinical trial NCT03726515: CART-EGFRvIII + Pembrolizumab in GBM
Official title: Phase 1 Study of EGFRvIII-Directed CAR T Cells Combined With PD-1 Inhibition in Patients With Newly Diagnosed, MGMT-Unmethylated Glioblastoma
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-11
Primary completion date: 2021-02-27
Completion date: 2021-02-27
Clinical trial NCT03162510: Biweekly SOLAR, as First-line C/T in Pts With Gastric, Pancreatic and Biliary Cancers
Official title: An Phase I Dose-Escalation Study of Biweekly Abraxane in Combination With Oxaliplatin and Oral S-1/LV (SOLAR Regimen) as First-line Chemotherapy in Patients With Advanced Gastric, Pancreatic and Biliary Cancers
Acronym: SOLAR
Sponsor: National Health Research Institutes, Taiwan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-26
Primary completion date: 2021-06-07
Completion date: 2022-01-31
Plan to share individual participant data: NO
Clinical trial NCT02680574: Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)
Official title: Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)
Sponsor: Akebia Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1725.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-02-29
Primary completion date: 2020-06-18
Completion date: 2020-07-31
Plan to share individual participant data: NO
Clinical trial NCT04677426: 129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
Official title: 129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study
Sponsor: University of Kansas Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor withdrew Funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-01
Primary completion date: 2022-08-01
Completion date: 2022-08-01
Plan to share individual participant data: NO
Clinical trial NCT01757535: Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia in Complete Remission
Acronym: QUAZAR AML-001
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 472.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-04-24
Primary completion date: 2019-07-15
Completion date: 2024-06-18
Baseline population: The intent to treat (ITT) population includes participants who were randomized, regardless of whether they received treatment or not.
Clinical trial NCT04383691: A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression
Official title: A Randomized, 6-Week, Multicenter, Double-Blind, Placebo-Controlled, Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression
Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Company's business decision
Enrollment: 124.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-11
Primary completion date: 2022-12-23
Completion date: 2022-12-23
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share IPD.
Clinical trial NCT03733132: Metformin Effect on Brain Function in Insulin Resistant Elderly People
Official title: Metformin Effect on Brain Function in Insulin Resistant Elderly People
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 40.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-15
Primary completion date: 2023-04-05
Completion date: 2023-04-05
Plan to share individual participant data: NO
Clinical trial NCT06110494: A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment
Official title: A New Clinical Use of Ferumoxytol Nanoparticles: An Antibiofilm Treatment
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-13
Primary completion date: 2022-03-10
Completion date: 2022-03-10
Limitations and caveats: we emphasize the limitation of our clinical study. Limitations include the small sample size
Plan to share individual participant data: YES
IPD sharing description: Only the participants chart numbers were collected during the study. The study protocol, statistical analysis plan and informed consent form will be published as supporting information with the final manuscript
IPD time frame: the supporting information will be available with the publication