chufangao/CTO huggingface dataset:
Clinical trial NCT03198234: Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders
Official title: Use of T-allo10 Cell Infusions Combined With Mismatched Related or Mismatched Unrelated Hematopoietic Stem Cell Transplantation (HSCT) for Hematologic Malignancies
Acronym: T-allo10
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of Enrollment
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-08-30
Primary completion date: 2021-11-11
Completion date: 2021-11-11
Baseline population: Cohort 1 was completed, and Cohort 2 enrolled two participants before closing due to feasibility.
Limitations and caveats: Early termination led to a small number of participants analyzed.
Plan to share individual participant data: NO
IPD sharing description: There is no plan to share the individual participant data.
Clinical trial NCT05144360: Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension
Official title: National, Multicenter, Randomized, Double-blind, Triple-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Atenas Association in the Treatment of Type II Diabetes Mellitus and Hypertension
Acronym: ATENAS
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Strategy review
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-08-31
Primary completion date: 2024-07-31
Completion date: 2024-11-30
Clinical trial NCT03922750: A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
Official title: A Trial Comparing NNC0148-0287 C (Insulin 287) Versus Insulin Glargine U100, Both in Combination With Metformin, With or Without DPP4 Inhibitors and With or Without SGLT2 Inhibitors, in Basal Insulin Treated Subjects With Type 2 Diabetes Mellitus
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 154.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-05-09
Primary completion date: 2019-12-19
Completion date: 2020-01-27
Baseline population: The full analysis set 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 NCT03957096: A Safety Study of SGN-CD47M in Patients With Solid Tumors
Official title: A Phase 1 Study of SGN-CD47M in Patients With Advanced Solid Tumors
Sponsor: Seagen Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision based on portfolio prioritization
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-17
Primary completion date: 2020-09-14
Completion date: 2020-09-14
Clinical trial NCT04250805: Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
Official title: Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy
Acronym: GASTROXY
Sponsor: Centre Hospitalier Universitaire de Saint Etienne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Difficulties in recruiting patients
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-27
Primary completion date: 2024-01-23
Completion date: 2024-01-23
Plan to share individual participant data: NO
Clinical trial NCT04160195: T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma
Official title: T Cells Expressing Fully-human Anti-CD19 and Anti-CD20 Chimeric Antigen Receptors for Treating B-cell Malignancies and Hodgkin Lymphoma
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The original principal investigator left the National Institutes of Health (NCI) and the decision was made to close the study to enrollment.
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-20
Primary completion date: 2021-06-11
Completion date: 2021-06-11
Baseline population: No participants were enrolled on group 2 because the study was stopped. The chimeric antigen receptor (CAR) gene used in this study is prone to recombination events and is therefore not stable.
Plan to share individual participant data: YES
IPD sharing description: Human data will be shared as follows: Coded, linked data in a National Institutes of Health-funded or approved repository. Coded, linked data in the Biomedical Translational Research Information System (BTRIS). And coded, linked or identified data with approved outside collaborators under appropriate agreements.
IPD time frame: Data will be shared before publication and at the time of publication or shortly thereafter indefinitely.
IPD access criteria: Data will be shared through ClinicalTrials.gov, BTRIS, approved outside collaborators under appropriate individual agreements, and publication and/or public presentations.
Clinical trial NCT04404361: PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer
Official title: A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Pacritinib Plus Standard of Care Versus Placebo and Standard of Care in Hospitalized Patients With Severe COVID-19 With or Without Cancer
Sponsor: CTI BioPharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: decision to close enrollment early
Enrollment: 200.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-22
Primary completion date: 2021-09-21
Completion date: 2021-09-21
Clinical trial NCT03694522: A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer
Official title: FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1
Acronym: FIGHT
Sponsor: Five Prime Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 155.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-14
Primary completion date: 2020-09-23
Completion date: 2022-05-13
Baseline population: The intent-to-treat (ITT) population includes all participants who were randomized in the study.
Plan to share individual participant data: NO
Clinical trial NCT01828112: LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
Official title: A Phase III, Multicenter, Randomized, Open-label Study of Oral LDK378 Versus Standard Chemotherapy in Adult Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer Who Have Been Treated Previously With Chemotherapy (Platinum Doublet) and Crizotinib
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 231.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-06-28
Primary completion date: 2016-01-26
Completion date: 2023-11-10
Baseline population: The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned by randomization.
Limitations and caveats: Although 116 patients were randomized to the Chemotherapy arm, 3 did not receive study drug and were excluded form the Safety set.
Plan to share individual participant data: UNDECIDED
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 NCT05169931: Clinical Efficacy of Amniotic Membrane Extract Eye Drops in Dry Eye Treatment
Official title: Clinical Efficacy of Amniotic Membrane Extract Eye Drops in Dry Eye Treatment
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Lack of funding/support
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-01-31
Primary completion date: 2022-04-30
Completion date: 2022-05-31
Plan to share individual participant data: NO
Clinical trial NCT02399462: Acthar for Treatment of Post-transplant FSGS
Official title: Acthar for Treatment of Post-transplant FSGS
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Funding terminated prematurely
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-03-31
Primary completion date: 2021-07-31
Completion date: 2021-07-31
Plan to share individual participant data: NO
Clinical trial NCT03208244: DAA Treatment in Donor HCV-positive to Recipient HCV-negative Heart Transplant
Official title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Protocol transitioned to standard of care, no funding available to support research work
Enrollment: 40.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-09
Primary completion date: 2021-04-20
Completion date: 2021-04-28
Baseline population: Number of subjects initiating treatment with DAA
Limitations and caveats: Protocol was terminated prior to completion, primarily due to lack of resources (research staffing and funding) and clinical team moving HCV+ donor to HCV- recipient transplants to standard of care.
Plan to share individual participant data: YES
IPD sharing description: Anticipate to share coded data with collaborators
IPD time frame: Anticipate data would be available to share within 6 months after the final patient completes the study.
IPD access criteria: Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.
Clinical trial NCT06082843: A Study to Test Whether Avenciguat Helps People With Liver Cirrhosis and High Blood Pressure in the Portal Vein (Main Vessel Going to the Liver) Who Had Bleeding in the Esophagus or Fluid Accumulation in the Belly
Official title: Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Investigate the Effects of One Dose (Up-titration to a Fixed Dose Regimen) of Oral BI 685509 on Portal Hypertension After 8 Weeks Treatment in Patients With Clinically Significant Portal Hypertension (CSPH) in Decompensated Cirrhosis After Their First Decompensation Event, Who Are Stabilized CTP 5-7
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company decision
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-01-03
Primary completion date: 2024-05-30
Completion date: 2024-05-30
Plan to share individual participant data: YES
IPD sharing description: Once the criteria in section 'time frame frame' 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 NCT05878704: Study of GBT021601 in Participants With Renal Impairment
Official title: A Phase I, Open-Label, Single-Dose, Non-Randomized, Parallel Group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of GBT021601, an Oral Hemoglobin S Polymerization Inhibitor, in Adult Participants With Renal Impairment
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business decision to terminate the trial after the completion of Part 1: Cohort 1 (severe renal impairment). The decision to terminate the trial was not due to any potential safety concerns.
Enrollment: 8.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-06-29
Primary completion date: 2024-07-29
Completion date: 2024-07-29
Plan to share individual participant data: NO
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 NCT03129100: A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
Official title: A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis
Sponsor: Eli Lilly and Company (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 773.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-05-09
Primary completion date: 2020-05-26
Completion date: 2021-05-27
Baseline population: All randomized participants from extension period (period 2).
Plan to share individual participant data: YES
IPD sharing description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Clinical trial NCT04643691: Losartan and Spironolactone Treatment for ICU Patients With COVID-19 Suffering From ARDS
Official title: Benefit of Treatment With Losartan and Spironolactone on the Regulation of the Renin-angiotensin System in the Prognosis of Patients Infected With COVID-19 and Suffering From Acute Respiratory Distress Syndrome
Acronym: COVIDANCE
Sponsor: Assistance Publique Hopitaux De Marseille (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: due to an Urgent Security Measure
Enrollment: 78.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-11
Primary completion date: 2021-12-07
Completion date: 2021-12-07
Plan to share individual participant data: NO
Clinical trial NCT05041101: Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer
Official title: Phase Ib/II Study of Grapiprant (IK-007) and Eribulin Combination Treatment for Metastatic Inflammatory Breast Cancer (mIBC)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The sponsor terminated support for this study
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-11-04
Primary completion date: 2024-09-06
Completion date: 2024-09-06
Clinical trial NCT04774328: Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
Official title: A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
Sponsor: Concentric Analgesics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-09
Primary completion date: 2021-06-15
Completion date: 2021-06-15
Clinical trial NCT03608501: A Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-naive Multiple Myeloma (MM) Participants Non-eligible for Autologous Stem-cell Transplantation
Official title: An Open-Label, Single-Arm Phase II Study of Ixazomib, Thalidomide and Dexamethasone in Newly Diagnosed and Treatment-Naive Multiple Myeloma Patients Non-Eligible for Autologous Stem-Cell Transplantation
Acronym: IDEALL
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Business decision (no safety or efficacy concerns)
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-30
Primary completion date: 2021-06-30
Completion date: 2023-05-31
Plan to share individual participant data: YES
IPD sharing description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Clinical trial NCT04249583: Treatment of Moderate to Severe Glabellar Lines
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines
Acronym: READY-1
Sponsor: Galderma R&D (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 300.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-10
Primary completion date: 2020-08-07
Completion date: 2021-01-05
Plan to share individual participant data: NO
Clinical trial NCT04244058: Changes in Glutamatergic Neurotransmission of Severe TBI Patients
Official title: Evaluation of Pharmacologically-induced Changes in Excitatory Glutamatergic Neurotransmission of Severe TBI Patients
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: SUSPENDED 
Why stopped: Given CoVid-19 pandemic we could not recruit subjects/patients for the 1st year. Currently waiting for new sponsor to fulfill the aims.
Enrollment: 30.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2020-09-23
Primary completion date: 2023-05-30
Completion date: 2023-06-30
Plan to share individual participant data: YES
IPD sharing description: The proposed research will involve a small sample with deficits secondary to traumatic brain injury (i.e., vegetative state and minimally conscious state). These rare disorders are associated with distinguishing features that even with the removal of all identifiers it would be difficult if not impossible to protect the identities of subjects. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.~Data to be share will be 18F-FPEB raw data; CRS-R available data; anatomical data from the MRI.
IPD time frame: Data will be available from publication date up to 3 years.
IPD access criteria: Only under a data-sharing agreement.
Clinical trial NCT02207244: A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab for the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis With Randomized Withdrawal and Retreatment
Acronym: VOYAGE 2
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 992.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-11-03
Primary completion date: 2015-10-01
Completion date: 2020-07-01
Limitations and caveats: All participants were on guselkumab after Week 76; therefore, there was no concurrent control group within the study after Week 76.
Clinical trial NCT02479178: A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase 2 Study to Determine the Efficacy and Safety of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck
Acronym: iNSITE2
Sponsor: BIND Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Enrollment: 73.0 (ACTUAL)
Start date: 2015-06-30
Primary completion date: 2016-10-31
Completion date: 2020-01-31
Clinical trial NCT03546556: 18-FLT PET/MR Imaging to Predict Graft Failure and GVHD in Bone Marrow Transplant Patients
Official title: 18-FLT PET/MR Imaging to Predict Graft Failure and Graft Versus Host Disease in Bone Marrow Transplant Patients
Sponsor: UNC Lineberger Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Study terminated due to COVID-19 pandemic and not being able to perform PET/MR scans on participants.
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-01
Primary completion date: 2020-03-12
Completion date: 2020-03-12
Plan to share individual participant data: UNDECIDED
Clinical trial NCT00023504: Antibody Production in Immune Disorders
Official title: Evaluation of Immune Response to Vaccines in Primary Immune Disorders
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow/Insufficient accrual
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2002-06-13
Primary completion date: 2017-05-22
Completion date: 2021-10-14