chufangao/CTO huggingface dataset:
Clinical trial NCT03273257: Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)
Official title: A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance
Sponsor: International CTEPH Association (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was stopped due to slower than expected recruitment and the additional limitations on clinical research imposed by the COVID-19 pandemic, both of which made study completion within a reasonable timeframe appear unlikely.
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-17
Primary completion date: 2020-05-05
Completion date: 2020-05-05
Baseline population: All participants who received at least one dose of randomized study drug
Limitations and caveats: The study was terminated after enrolling only 14 out of 88 planned patients, due to slower than expected recruitment and the additional limitations on clinical research imposed by the COVID-19 pandemic. No firm conclusions can be drawn based on the study data due to the limited sample size.
Plan to share individual participant data: NO
IPD sharing description: IPD sharing is not foreseen
Clinical trial NCT01400607: Neocartilage Implant to Treat Cartilage Lesions of the Knee
Official title: Randomized Controlled Trial to Evaluate the Efficacy of a Neocartilage Implant in the Management of ICRS Grade 3 to 4 Articular Cartilage Lesions of the Knee
Sponsor: ISTO Technologies, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Poor enrollment
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-07-31
Primary completion date: 2020-09-30
Completion date: 2020-09-30
Clinical trial NCT05366296: Safety, Reactogenicity, and Immunogenicity Study of a Lyophilized COVID-19 mRNA Vaccine
Official title: A Randomized, Observer-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of One Dose Booster by A Lyophilized COVID-19 mRNA Vaccine in Adults Aged 18 to 60 Years
Sponsor: Wuhan Recogen Biotechnology Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: business stragety
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-31
Primary completion date: 2022-09-30
Completion date: 2023-01-31
Plan to share individual participant data: NO
IPD sharing description: There is not a plan to make individual participant data (IPD) available
Clinical trial NCT04960397: Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine
Official title: A Phase 1b, Double-Blind, Randomized, Dose-Escalating, Age De-Escalating, Placebo-Controlled Study to Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine Delivered Intranasally In a Healthy Pediatric Population 6 Months Through 17 Years of Age.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of product and funding.
Enrollment: 140.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-09-10
Primary completion date: 2024-04-12
Completion date: 2024-04-12
Clinical trial NCT04750278: A Phase 2/3 Study to Evaluate FP-025 in Patients With Severe to Critical COVID 19
Official title: A Phase 2/3, Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of FP-025 in Patients With Severe to Critical COVID 19 With Associated Acute Respiratory Distress Syndrome (ARDS)
Sponsor: Foresee Pharmaceuticals Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Study stopped at interim analysis point, due to lack of study subjects to recruit.
Enrollment: 90.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-06
Primary completion date: 2022-04-18
Completion date: 2022-04-18
Baseline population: Patients with COVID-19 acute respiratory distress syndrome who met the inclusion criteria of the protocol.
Plan to share individual participant data: NO
Clinical trial NCT04897880: A Study of Panobinostat in Pediatric Patients With Solid Tumors Including MRT/ATRT
Official title: A Phase II Study of Panobinostat in Pediatric, Adolescent and Young Adult Patients With Solid Tumors Including Osteosarcoma, Malignant Rhabdoid Tumor/Atypical Teratoid Rhabdoid Tumors and Neuroblastoma
Acronym: NORTH
Sponsor: Australian & New Zealand Children's Haematology/Oncology Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Drug supply
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-01-09
Primary completion date: 2024-05-08
Completion date: 2024-05-08
Clinical trial NCT05035576: A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
Official title: A Randomized, Adaptive Design, Proof of Concept, Single Dose Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
Sponsor: Optinose US Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-01
Primary completion date: 2021-11-30
Completion date: 2021-11-30
Clinical trial NCT03199040: Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy
Official title: A Randomized Phase 1 Trial of Neoantigen DNA Vaccine Alone vs. Neoantigen DNA Vaccine Plus Durvalumab in Triple Negative Breast Cancer Patients Following Standard of Care Therapy
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Drugs/equipment unavailable and insufficient funding
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-23
Primary completion date: 2022-11-21
Completion date: 2023-05-01
Plan to share individual participant data: NO
Clinical trial NCT04933617: Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas
Official title: Phase 1 Study of Copanlisib With Dose-adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated early because copanlisib was removed from the market by the Food and Drug Administration (FDA) and the manufacturer.
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-24
Primary completion date: 2023-11-30
Completion date: 2023-11-30
Plan to share individual participant data: YES
IPD sharing description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All large- scale genomic sequencing data will be shared with subscribers to the database of Genotypes and Phenotypes (dbGaP).
IPD time frame: Clinical data available during the study and indefinitely. Genomic data are available once genomic data are uploaded per protocol Genomic Data Sharing (GDS) plan for as long as database is active.
IPD access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI). Genomic data are made available via the database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Clinical trial NCT04283526: Study of Select Combinations in Adults With Myelofibrosis
Official title: A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Combinations in Adult Patients With Myelofibrosis
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: This study was cancelled before enrolling any patients for business related reasons.
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-11-30
Primary completion date: 2024-04-11
Completion date: 2024-04-11
Plan to share individual participant data: NO
Clinical trial NCT04525014: RRx-001 Given With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors
Official title: A Phase 1 Trial of RRx-001 in Combination With Irinotecan and Temozolomide for Pediatric Patients With Recurrent or Progressive Malignant Solid and Central Nervous System Tumors
Acronym: PIRATE
Sponsor: EpicentRx, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low Enrollment
Enrollment: 2.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-01-26
Primary completion date: 2024-07-29
Completion date: 2024-07-29
Plan to share individual participant data: NO
Clinical trial NCT03528564: Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia
Official title: A Randomized Double-Blinded Phase II Study to Determine Treatment Protocol for Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia
Acronym: HOPE-Hb
Sponsor: Unity Health Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The primary reasoning is that we were unable to demonstrate feasibility, prior to and because of the impact of COVID on our research programs.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-01
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02033278: Infusion Intracoronary of Mononuclear Autologous Adult no Expanded Stem Cells of Bone Marrow on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.
Official title: Multicenter Phase IIb Clinical Trial, Double-blind, Randomized, Controlled Placebo for to Assess the Efficacy of Intracoronary Infusion of Autologous Adult Stem Cells Mononuclear Marrow Unexpanded on Functional Recovery in Patients With Idiopathic Dilated Cardiomyopathy and Heart Failure.
Sponsor: Andalusian Network for Design and Translation of Advanced Therapies (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low recruitment rate, bibliographic evidence of lack of efficacy
Enrollment: 27.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-01-06
Primary completion date: 2018-10-19
Completion date: 2020-04-21
Clinical trial NCT02636803: Study of the Efficacy of Oxfendazole Compared to Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
Official title: An Open Comparative Study of the Efficacy of Different Doses of Oxfendazole Compared to Single Dose Albendazole in the Treatment of Trichuris Trichiura Infection in Adults
Sponsor: Johns Hopkins Bloomberg School of Public Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: not going to be conducted
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-11-30
Primary completion date: 2020-08-31
Completion date: 2021-02-28
Plan to share individual participant data: YES
IPD sharing description: posting to CT.gov and publication
Clinical trial NCT03683277: IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic
Official title: Multicenter Open Label Phase 2 Single Arm Study of Ixazomib, Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Characterized With Genomic Abnormalities of Adverse Adverse Prognostic
Acronym: IFM2014-01
Sponsor: Intergroupe Francophone du Myelome (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Recruitment issue, 26 patients enrolled instead of 70 initially planned
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-03
Primary completion date: 2022-12-31
Completion date: 2023-02-10
Clinical trial NCT05556265: A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Alopecia Areata
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study to Evaluate Clinical Efficacy and Safety of Deucravacitinib (BMS-986165) in Participants With Alopecia Areata
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Business objectives have changed
Enrollment: 94.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-11-08
Primary completion date: 2024-01-06
Completion date: 2024-05-16
Plan to share individual participant data: YES
IPD sharing description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
IPD time frame: See plan description
IPD access criteria: See plan description
Clinical trial NCT03782532: Efficacy and Safety Study of Dupilumab in Patients With Persistent Asthma
Official title: A Randomized, Double Blind, Placebo-controlled, Parallel-group Phase 3 Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 486.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-25
Primary completion date: 2022-05-21
Completion date: 2022-05-21
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 NCT03163784: SHIFT: Studying HIV Immunology After Fecal Transplant
Official title: SHIFT: Studying HIV Immunology After Fecal Transplant
Acronym: SHIFT
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The study closed because of shifting research priorities and interests.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-06-30
Primary completion date: 2020-06-30
Completion date: 2022-06-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02941016: Vascular Inflammation and Cholesterol Lowering Therapy
Official title: Vascular Inflammation and Cholesterol Lowering Therapy
Sponsor: Rigshospitalet, Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Logistic reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-10-31
Primary completion date: 2020-10-31
Completion date: 2020-10-01
Clinical trial NCT04353284: Camostat Mesylate in COVID-19 Outpatients
Official title: The Effect of Camostat Mesylate on COVID-19 Infection in Ambulatory Patients: An Investigator-Initiated Randomized, Placebo-Controlled, Phase IIa Trial
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 70.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-09
Primary completion date: 2021-03-03
Completion date: 2021-04-22
Plan to share individual participant data: NO
Clinical trial NCT04234867: Study to Explore the Effect of Dapagliflozin and Stress in Adolescent and Adult Subjects With Type 1 Diabetes (T1D)
Official title: A Randomized, Double-Blinded, Placebo-controlled, Single-center Phase 1 Pilot Study to Explore the Effect of DAPAglifozin and Stress ( i.v. ACTH) on the Development of DKA After Insulin Withdrawal in Adolescent and Adult Subjects With T1D
Acronym: Dapa-Stress
Sponsor: Kinderkrankenhaus auf der Bult (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: slow recruitment
Enrollment: 2.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-05-18
Primary completion date: 2022-08-26
Completion date: 2022-08-26
Clinical trial NCT02781610: Standardized Treatment of Pulmonary Exacerbations II
Official title: Standardized Treatment of Pulmonary Exacerbations II (STOP2)
Acronym: STOP2
Sponsor: Seattle Children's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 982.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-06-30
Primary completion date: 2020-03-06
Completion date: 2020-03-06
Baseline population: Analysis for the ERR arms (ERR-10, ERR-14) was done on the per-protocol (PP) population. Analysis for the NERR arms (NERR-14, NERR-21) was done on the intent-to-treat (ITT) population. Caution: Analysis was not done on the combined total of all four treatment duration arms. Interpreting the total column is inappropriate for this study design.
Limitations and caveats: Analysis was not done on the combined total of all four treatment duration arms. Interpreting the total column within demographics is inappropriate for this study design.
Plan to share individual participant data: NO
Clinical trial NCT04202679: Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2)
Official title: A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 160.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-16
Primary completion date: 2021-08-30
Completion date: 2021-11-22
Baseline population: Analysis was performed on randomized population.
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 NCT03913702: Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement
Official title: Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial
Sponsor: The University of Texas Medical Branch, Galveston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Inadequate patient enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-09
Primary completion date: 2022-11-02
Completion date: 2022-11-02
Plan to share individual participant data: YES
IPD sharing description: At the end of this investigation, IPD-related results will be tabulated and submitted to clinicaltrials.gov to report. This would help evaluate the effects and safety of interventions administered.
IPD time frame: 20 weeks from the last patient enrollment
IPD access criteria: At the end of this investigation, all results will be tabulated and submitted to clinicaltrials.gov to report.
Clinical trial NCT05198843: Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body
Official title: Phase Ib/II Study of EPA-Based EphA2 Targeted Therapy for Patients With Metastatic Triple-Negative Inflammatory Breast Cancer
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Other - Poor accrual
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-08
Primary completion date: 2023-12-19
Completion date: 2023-12-20
Plan to share individual participant data: YES
IPD sharing description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Clinical trial NCT03943823: Postmenopausal Pessary Users: Estrogen Versus Trimosan
Official title: Postmenopausal Pessary Users: Estrogen Versus Trimosan
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulties in recruiting and retaining patients due to the COVID pandemic; lack of availability of study drug trimosan; lack of study personnel
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-07
Primary completion date: 2021-03-08
Completion date: 2021-04-08
Limitations and caveats: Early termination as a result of discontinuation of in-person research due to COVID-19 pandemic, as well as unavailability of study drug.
Plan to share individual participant data: NO
Clinical trial NCT04671355: TRIMBOW® and RELVAR® on Lung Stiffness Reduction Assessed Through Forced Oscillation Technique in Patients With COPD
Official title: A Phase IV, Open Label, Multicentre, Randomised, 2-way Cross-over Exploratory Clinical Trial Comparing TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on Lung Stiffness Reduction Assessed Through Area Under the Reactance Curve (AX) in COPD.
Sponsor: Chiesi Farmaceutici S.p.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Continuing delays due to COVID-19 pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-10-04
Primary completion date: 2021-12-22
Completion date: 2022-02-18
Plan to share individual participant data: YES
IPD sharing description: Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.~Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD access criteria: Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.