chufangao/CTO huggingface dataset:
Clinical trial NCT04205539: Lymphatic System Health in Alzheimer's Disease
Official title: Lymphatic System Health in Alzheimer's Disease
Sponsor: Neurological Associates of West Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Pending COVID-19 pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-10
Primary completion date: 2022-12-10
Completion date: 2023-12-31
Plan to share individual participant data: NO
IPD sharing description: Data from this study will not be made publicly available due to ethical and privacy concerns. Anonymized data will be available upon reasonable request from any qualified investigator.
Clinical trial NCT04614636: FT538 in Subjects With Advanced Hematologic Malignancies
Official title: A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma
Sponsor: Fate Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: This study was terminated by the Sponsor.
Enrollment: 42.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-17
Primary completion date: 2023-07-13
Completion date: 2023-08-08
Plan to share individual participant data: NO
Clinical trial NCT04452318: COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 3303.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-13
Primary completion date: 2021-10-04
Completion date: 2021-10-04
Plan to share individual participant data: YES
IPD sharing description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
IPD access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency \[EMA\], Pharmaceuticals and Medical Devices Agency \[PMDA\], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
Clinical trial NCT03572634: Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL
Official title: A Combined Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of TP-0903 in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)
Sponsor: Sumitomo Pharma America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Given the extensive time projected to conclude the study hypothesis, it is no longer feasible to include this study of TP-0903.
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-06-10
Primary completion date: 2020-01-21
Completion date: 2020-01-21
Limitations and caveats: The study was stopped early (21 January 2020) due to low enrollment.
Plan to share individual participant data: NO
Clinical trial NCT04247074: Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
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 Lateral Canthal Lines and Glabellar Lines Alone or in Combination
Acronym: READY-3
Sponsor: Galderma R&D (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 413.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-10
Primary completion date: 2020-10-02
Completion date: 2021-02-26
Clinical trial NCT03943147: An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Insufficient enrollment
Enrollment: 16.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-07-15
Primary completion date: 2020-10-29
Completion date: 2021-09-17
Baseline population: Baseline analysis population for Open Label MMF includes all participants that did not meet randomization criteria in Part B. Open Label MMF + BMS-986165 includes the participant that met the randomization criteria in Part B.
Limitations and caveats: Due to low enrollment, the Sponsor chose to terminate the study on 01-Jul-2021 and consequently there is limited data available from a single randomized participant. Due to lack of sufficient data, no formal statistical analyses of endpoints were conducted.
Clinical trial NCT04464629: Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
Official title: Assessing the Efficacy and Safety of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert, When Placed Within the Lower Eye Lid Canaliculus in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
Sponsor: Midwest Eye Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Poor enrollment
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-14
Primary completion date: 2023-01-25
Completion date: 2023-01-25
Plan to share individual participant data: NO
Clinical trial NCT05252520: A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants
Official title: A Phase 1 Open-label Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants Following Subcutaneous Administration
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The development of bermekimab in Immunology is stopped
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-05-01
Primary completion date: 2023-11-20
Completion date: 2023-11-20
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and 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 NCT01948297: Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations
Official title: A Phase I, Gene Alteration-based, Open Label, Multicenter Study of Oral Debio 1347 (CH5183284) in Patients With Advanced Solid Malignancies, Whose Tumours Have an Alteration of the FGFR 1, 2 or 3 Genes
Sponsor: Debiopharm International SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Enrollment: 77.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-08-31
Primary completion date: 2020-06-26
Completion date: 2020-06-26
Clinical trial NCT02967692: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma
Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
Acronym: COMBI-i
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 569.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-02-17
Primary completion date: 2020-08-11
Completion date: 2024-08-21
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 NCT03262935: SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
Official title: A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
Acronym: TULIP
Sponsor: Byondis B.V. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 437.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-15
Primary completion date: 2021-03-31
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT04545060: VIR-7831 for the Early Treatment of COVID-19 in Outpatients
Official title: A Phase II/III Randomized, Multi-center, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Monoclonal Antibody VIR-7831 for the Early Treatment of Coronavirus Disease 2019 (COVID-19) in Non-hospitalized Patients
Acronym: COMET-ICE
Sponsor: Vir Biotechnology, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 1057.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-27
Primary completion date: 2021-04-08
Completion date: 2021-09-02
Baseline population: All participants who were randomly assigned to study intervention in the study ( irrespective of whether they have been dosed)
Clinical trial NCT01996605: Efficacy of Spinal Oxytocin in Healthy Volunteers
Official title: Efficacy of Intrathecal Oxytocin in Human Volunteers
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Cessation of funding period prior to completion, due to slow recruitment during the pandemic
Enrollment: 20.0 (ACTUAL)
Number of arms: 3.0
Start date: 2014-01-02
Primary completion date: 2022-10-10
Completion date: 2022-10-10
Limitations and caveats: The study was powered for a sample size of 40 and was terminated early with a sample size of 20 due to slow recruitment and cessation of financial support.
Clinical trial NCT02722369: STUDY 15 - Comparing Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
Official title: A Phase II, Multicentre, Randomised Trial Comparing Combination Gemcitabine/Carboplatin and Hydroxychloroquine Versus Carboplatin/Etoposide Therapy Alone in Small Cell Lung Cancer (SCLC)
Sponsor: University College, London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low recruitment, lack of efficacy and increased adverse events in investigational arm.
Enrollment: 72.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-14
Primary completion date: 2021-03-12
Completion date: 2021-03-12
Plan to share individual participant data: YES
IPD sharing description: On receipt of a request the recipient will consider the proposal, ensure relevant Chief Investigator/Trial Management Group are consulted and, if necessary, Trial Steering Committee and/or Cancer Trials Centre (CTC) Senior Management Group. Any shared data will be in an anonymised format
Clinical trial NCT04872608: A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer
Official title: ctDNA-guided Adaptive Therapy Escalation in ER+ MBC: A Phase 1b Study With Letrozole, Palbociclib and Onapristone ER
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: The sponsor closed the study due to discontinuing their onapristone program
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-09
Primary completion date: 2023-04-25
Completion date: 2023-04-25
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 NCT02798523: Genomic Responses of Human Immune and Non-Immune Cells to Glucocorticoids
Official title: Genomic Response of Human Immune and Non-Immune Cells to Glucocorticoids
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 33.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-24
Primary completion date: 2022-05-31
Completion date: 2022-11-14
Clinical trial NCT04253223: A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib
Official title: A Phase I/Ib Pilot Study to Determine the Safety and Efficacy of a Human Anti-glucagon Receptor Antibody (REMD-477) in Controlling Severe Hyperglycemia Due to Copanlisib in Patients With Relapsed or Refractory Lymphoma
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: poor accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-07
Primary completion date: 2021-05-05
Completion date: 2021-05-05
Plan to share individual participant data: NO
Clinical trial NCT03896581: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Official title: A Multicenter, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Acronym: BE COMPLETE
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 400.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-28
Primary completion date: 2021-12-08
Completion date: 2022-02-14
Baseline population: Baseline Characteristics refer to Randomized Set which consisted of all enrolled participants who had been randomized.
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT01847274: A Maintenance Study With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer
Official title: A Phase 3 Randomized Double-blind Trial of Maintenance With Niraparib Versus Placebo in Patients With Platinum Sensitive Ovarian Cancer.
Sponsor: Tesaro, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 596.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-06-21
Primary completion date: 2016-04-22
Completion date: 2021-12-26
Baseline population: The baseline analysis population was the intent-to-treat population, defined as all randomized participants with participants analyzed according to the study drug assigned via randomization
Plan to share individual participant data: NO
Clinical trial NCT02393183: The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease (TED)
Official title: The Effect of a New Antioxidant Combination (ASTED) on Mild Thyroid Eye Disease, a Placebo Controlled Randomized Clinical Trial
Sponsor: Iran University of Medical Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Do not access to the drug
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-15
Primary completion date: 2022-06-15
Completion date: 2022-12-15
Clinical trial NCT00001880: Stem Cell Transplantation for Metastatic Solid Tumors
Official title: Exploratory Study of Non-Myeloablative Allogeneic Stem Cell Transplantation and Donor Lymphocyte Infusions for Metastatic Neoplasms Refractory to Standard Therapy
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was closed early due to lack of accrual
Enrollment: 42.0 (ACTUAL)
Number of arms: 1.0
Start date: 1999-03-12
Primary completion date: 2008-08-14
Completion date: 2020-08-13
Clinical trial NCT03035812: Alkalinization by Urologists & Nephrologists
Official title: Prospective Evaluation of Oral Alkalinization by Urologists and Nephrologists: Evolution of the Extracellular Compartment
Acronym: AlcalUN
Sponsor: Club des Jeunes Néphrologues (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 156.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-02-01
Primary completion date: 2020-02-21
Completion date: 2020-02-21
Plan to share individual participant data: NO
Clinical trial NCT04242329: Surgery of Melanoma Metastases After Systemic Therapy
Official title: Surgery of Melanoma Metastases After Systemic Therapy - the SUMMIST Trial
Acronym: SUMMIST
Sponsor: Vastra Gotaland Region (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Not possible to recruit patients during COVID, and not possible to start enrolling after the pandemic.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-11
Primary completion date: 2023-09-03
Completion date: 2023-09-13
Plan to share individual participant data: NO
Clinical trial NCT04489628: Tele-health Enabled Clinical Trial for COVID-19
Official title: Tele-health Enabled Clinical Trial for COVID-19: Vitamin D as an Immunomodulator to Prevent Complications and Reduce Resource Utilization in Outpatients
Sponsor: University Hospitals Cleveland Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Unable to overcome hurdles to study recruitment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-01
Primary completion date: 2021-06-01
Completion date: 2021-06-01
Plan to share individual participant data: NO
Clinical trial NCT04302896: Development of a Urine-Based Point-of-Care Test for Adherence to Antiretroviral Drugs
Official title: APT-POCT-01: An Open Label, Pharmacokinetic Study of Plasma/Urine/Salivary Drug Concentrations Over Fourteen Days Following Drug Intake Cessation, In HIV-Uninfected Healthy Volunteers Dosing to Steady-state to Further Development of Point of Care Diagnostic Testing
Acronym: APTAMER
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-31
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Plan to share individual participant data: NO
Clinical trial NCT03949530: A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis
Official title: IDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor: Indalo Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-16
Primary completion date: 2020-03-29
Completion date: 2020-03-29