chufangao/CTO huggingface dataset:
Clinical trial NCT02617589: An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
Official title: A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT (Tumor O-6-methylguanine DNA Methyltransferase) Glioblastoma (CheckMate 498: CHECKpoint Pathway and Nivolumab Clinical Trial Evaluation 498)
Acronym: CheckMate 498
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 560.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-01
Primary completion date: 2019-01-17
Completion date: 2022-03-04
Baseline population: Baseline characteristics were summarized using all randomized subjects (all enrolled subjects who were randomized to any treatment arm)
Clinical trial NCT03151408: An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia
Official title: A Phase III, Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Of Pracinostat In Combination With Azacitidine In Patients ≥18 Years With Newly Diagnosed Acute Myeloid Leukemia Unfit For Standard Induction Chemotherapy
Sponsor: Helsinn Healthcare SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The IDMC recommended to stop the study prematurely due to a lack of efficacy.
Enrollment: 406.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-23
Primary completion date: 2020-08-20
Completion date: 2020-08-20
Limitations and caveats: Results of the interim analysis (OS curves crossing at about 300 days) demonstrated futility according to the planned threshold and concluded that it was unlikely to meet the primary endpoint compared to the control group at the final analysis. Based on this outcome, the decision taken was to discontinue the recruitment of patients and terminate the study.
Clinical trial NCT05477498: Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction
Official title: Iron Substitution With Ferric Carboxymaltose as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction: A Prospective, Double-blind, Randomized, Placebo-controlled Trial
Acronym: IRON-HFpEF
Sponsor: Cantonal Hosptal, Baselland (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Principal Investigator left institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-01
Primary completion date: 2022-08-31
Completion date: 2022-12-31
Plan to share individual participant data: YES
IPD sharing description: Patient-level anonymised datasets can be requested after completion of all planned analyses and publications from the study centre (anticipated by mid 2022). Public access to the study protocol will be granted by publishing it in a scientific journal.
Clinical trial NCT04674748: To Assess the Safety, Tolerability and Pharmacokinetics of INCB086550
Official title: A Phase 1 Study Exploring the Safety, Tolerability, and Pharmacokinetics of INCB086550 in Japanese Participants With Advanced Solid Tumors
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated early due to a business decision.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-02-03
Primary completion date: 2022-05-13
Completion date: 2022-05-13
Plan to share individual participant data: YES
IPD sharing description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Clinical trial NCT04575766: A Study of FT-7051 in Men With MCRPC
Official title: A Phase 1 Study of FT-7051 in Men With Metastatic Castration-Resistant Prostate Cancer
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 25.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-30
Primary completion date: 2022-11-08
Completion date: 2022-11-15
Clinical trial NCT03376321: A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Study terminated early (date of study termination decision: 28 August 2020) as a result of the outcome of the pre-planned Interim Analysis.
Enrollment: 334.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-03
Primary completion date: 2020-03-31
Completion date: 2020-04-30
Baseline population: The safety set (or all participants treated) includes all participants who received at least one dose of study drug and were analyzed by treatment arm as treated.
Limitations and caveats: As the study was terminated early after a pre-planned interim analysis which showed futility, the Sponsor decided not to perform the complete analysis planned per protocol. Hence, data was collected and analyzed for safety and selected efficacy parameters only.
Clinical trial NCT03912259: Evaluation of Dupilumab in Chinese Adult Patients With Moderate to Severe Atopic Dermatitis
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate-to-severe Atopic Dermatitis
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 165.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-19
Primary completion date: 2020-02-14
Completion date: 2020-02-14
Baseline population: Analysis was performed on Intent-to-treat (ITT) population which consisted of all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT04536532: Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Official title: A Single-center, Randomized, Double-blind, Single and Multiple Dosing, Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
Sponsor: Sunshine Lake Pharma Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Company decision to discontinue trial
Enrollment: 52.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-10-09
Primary completion date: 2023-03-12
Completion date: 2023-03-12
Clinical trial NCT04280705: Adaptive COVID-19 Treatment Trial (ACTT)
Official title: A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1062.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-21
Primary completion date: 2020-05-21
Completion date: 2020-05-21
Clinical trial NCT03065218: 99mTc Sestamibi Scans In Thyroglobulin Positive Scan Negative Differentiated Thyroid Cancer (DTC) Patients
Official title: Evaluation of 99mTc Sestamibi Scans In Patients Who Have Differentiated Thyroid Cancer, Elevated Serum Thyroglobulin Levels, and Negative Diagnostic Imaging Studies
Sponsor: Medstar Health Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Insufficient recruitment
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-10-31
Primary completion date: 2021-02-15
Completion date: 2021-02-15
Baseline population: Patients who met study inclusion criteria.
Plan to share individual participant data: NO
Clinical trial NCT03870763: Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Decision to stop the trial was based on long-term difficulties in fulfilling our enrolment commitments and changes in paediatric MS landscape which no longer support placebo-controlled trials.Decision to stop study was not based on safety concerns.
Enrollment: 11.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-03-19
Primary completion date: 2022-07-21
Completion date: 2022-07-21
Baseline population: Safety population included all participants who had received at least 1 dose of study treatment.
Limitations and caveats: The study was terminated because of long-term difficulties in fulfilling the enrolment commitments and changes in paediatric MS landscape which no longer support placebo-controlled trials. Decision to stop study was not based on safety concerns.
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT05223868: A Study of JNJ-77242113 in Participants With Moderate-to-severe Plaque Psoriasis
Official title: A Phase 2b Multicenter, Randomized, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of JNJ-77242113 for the Treatment of Moderate-to-Severe Plaque Psoriasis
Acronym: FRONTIER 1
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 255.0 (ACTUAL)
Number of arms: 6.0
Start date: 2022-02-03
Primary completion date: 2022-12-15
Completion date: 2022-12-15
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 NCT05808673: Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers
Official title: A Randomized, Double-blind, Parallel Controlled, Phase I Three-arm Study, Comparing the PK, PD, Safety, and Immunogenicity of Pre- and Post-change CMAB807X, Post-change CMAB807X and Xgeva® in Healthy Chinese Male Subjects
Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Changes in the company's production plan
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-02-28
Primary completion date: 2024-06-30
Completion date: 2024-07-31
Plan to share individual participant data: NO
Clinical trial NCT03574220: Pembrolizumab After Lung SBRT for Medically Inoperable Early Stage Non-small Cell Lung Cancer
Official title: A Pilot Study of Adjuvant Pembrolizumab After Lung Stereotactic Body Radiotherapy (SBRT) for Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Case Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: No accrual - closed by PRMC
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-19
Primary completion date: 2020-03-21
Completion date: 2020-03-21
Clinical trial NCT03579966: Long Term Safety Study of Amifampridine Phosphate in MuSK-MG (Muscle Specific Tyrosine Kinase Myasthenia Gravis)
Official title: Long Term Safety Study of Amifampridine Phosphate in Patients With MuSK Antibody Positive and AChR (Acetylcholine Receptor) Antibody Positive Myasthenia Gravis
Sponsor: Catalyst Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Lack of measure appropriate data (MG-ADL).
Enrollment: 63.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-11
Primary completion date: 2022-08-05
Completion date: 2022-08-05
Limitations and caveats: The study was terminated due to lack of measure appropriate data. The analysis of the MG-ADL score was removed in Statistical Analysis Plan (SAP), dated 21FEB2023.
Plan to share individual participant data: NO
Clinical trial NCT04046939: Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
Official title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects With Eosinophilic Asthma
Acronym: EXHALE-1
Sponsor: Knopp Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 534.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-08-15
Primary completion date: 2020-12-03
Completion date: 2021-03-02
Baseline population: Safety population: all subjects who were randomized and received at least 1 dose of study drug (placebo, dexpramipexole) during the Primary Assessment Period.
Plan to share individual participant data: NO
Clinical trial NCT04944784: A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official title: A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)
Acronym: COURAGE-ALS
Sponsor: Cytokinetics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The DMC recommended the trial be discontinued due to futility following a planned second interim analysis.
Enrollment: 486.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-08-16
Primary completion date: 2023-07-18
Completion date: 2023-07-18
Plan to share individual participant data: NO
Clinical trial NCT03059277: Intravitreal Alfibercept for Center Involved DME Previously Managed With Intravitreal Ranibizumab
Official title: Efficacy of Intravitreal Aflibercept Injection (IAI) Administered in a Treat and Extend Fashion in Patients With Center Involved Diabetic Macular Edema (DME) Previously Managed With 0.3 mg Intravitreal Ranibizumab
Sponsor: Southeast Clinical Research Associates, LLC (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Site investigator decided to not move forward with study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-01
Primary completion date: 2020-06-30
Completion date: 2020-09-30
Plan to share individual participant data: NO
IPD sharing description: Site will not be sharing IPD.
Clinical trial NCT04374539: Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial
Official title: Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial
Acronym: REP-COVID
Sponsor: Fundacion Clinic per a la Recerca Biomédica (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: inability to recruit more patients
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-29
Primary completion date: 2021-06-06
Completion date: 2021-06-29
Plan to share individual participant data: NO
Clinical trial NCT03745898: The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea
Official title: The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea (LOFT-HF)
Sponsor: Brigham and Women's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low feasibility of completion within the study period due to delayed site activation and slow participant accrual
Enrollment: 98.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-15
Primary completion date: 2022-06-17
Completion date: 2022-06-17
Baseline population: Recruitment incomplete due to early termination
Limitations and caveats: Study incomplete due to early termination
Plan to share individual participant data: YES
IPD sharing description: All relevant deidentified data will be deposited in Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) and the National Sleep Research Resource (NSRR)
Clinical trial NCT03580044: Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria
Official title: A PROSPECTIVE, RANDOMIZED,OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM- AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO -Β-LACTAMASE (MBL)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Recruitment of patients with serious infections caused by gram-negative bacteria producing MBL has been challenging. Date study terminated: 16-Dec-2022.
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-25
Primary completion date: 2023-01-23
Completion date: 2023-01-23
Baseline population: Intent to Treat (ITT) analysis set included all randomized participants regardless of receipt of study drug. Participants were analyzed according to the treatment to which they were randomized.
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 NCT04095858: Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005)
Official title: A Randomized, Double Blind, Placebo Controlled, Multi-center, Phase III Study of CD24Fc for Prevention of Acute Graft-Versus-Host Disease Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Acronym: CATHY
Sponsor: Oncoimmune, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-05
Primary completion date: 2021-11-05
Completion date: 2021-11-05
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04541485: To Evaluate Safety, Tolerability and Pharmacodynamics of DWRX2003 Against COVID-19 (in Philippines)
Official title: Phase I Study to Evaluate the Safety, Tolerability, and Pharmacodynamics (PD) of DWRX2003 (Niclosamide IM Depot) Injection Following Intramuscular Administration in COVID-19 Patients
Sponsor: Daewoong Pharmaceutical Co. LTD. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Enrolment was suspended since 09Dec2020 due to a lack of COVID-19 patients.
Enrollment: 2.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-12-04
Primary completion date: 2021-03-03
Completion date: 2021-03-23
Plan to share individual participant data: NO
Clinical trial NCT03532022: Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy
Official title: An Open-label, Randomized, Titration-blinded, Phase III Study of Efficacy, Safety and Tolerability Of Chronocort® Compared With Standard Glucocorticoid REeplacement Therapy in the Treatment of Participants Aged 16 Years and Over With Congenital Adrenal Hyperplasia
Acronym: RESTORE
Sponsor: Diurnal Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Protocol re-design required following EU Phase III results
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-04
Primary completion date: 2018-10-17
Completion date: 2021-07-09
Plan to share individual participant data: NO
Clinical trial NCT04088903: Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart Transplantation
Official title: A Phase 1 Study of Daratumumab for Reduction of Circulating Antibodies in Patients With High Allosensitization Awaiting Heart Transplantation
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Protocol changed to use subcutaneous rather than intravenous daratumumab.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-04-01
Primary completion date: 2023-04-01
Completion date: 2023-04-01
Plan to share individual participant data: NO