chufangao/CTO huggingface dataset:
Clinical trial NCT04201743: An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
Official title: A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Injection Comparing Two Doses (1 mL and 2mL Injection) in the Treatment of Osteoarthritis of the Knee
Sponsor: Illinois Center for Orthopaedic Research and Education (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Resources limited secondary to COVID-19 pandemic.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-03-30
Primary completion date: 2021-06-30
Completion date: 2021-12-31
Plan to share individual participant data: NO
Clinical trial NCT04426695: Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
Official title: A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Hospitalized Patients With COVID-19
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 2252.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-10
Primary completion date: 2021-05-07
Completion date: 2021-10-22
Baseline population: The full analysis set (FAS) included all randomized participants who received at least one dose (full or partial) of the study drug.
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., Food and Drug Administration (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 NCT05845359: Intraoperative Methadone for Postoperative Pain Control
Official title: Randomized Control Study on the Effectiveness of Intraoperative Methadone on Postoperative Pain Control
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: IRB approval never received
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-09-30
Primary completion date: 2024-02-29
Completion date: 2024-02-29
Plan to share individual participant data: NO
Clinical trial NCT03983395: Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer
Official title: A Phase 1/2, Open-Label, Dose-Escalation Study of ISB 1302 in Subjects With HER2-Positive Metastatic Breast Cancer
Sponsor: Ichnos Sciences SA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated during Part 1 (dose escalation), and Part 2 (expansion) of the study was not initiated. This study was voluntarily terminated due to a business decision not to proceed with the ISB 1302 asset, and not due to any safety issue.
Enrollment: 1.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-04-08
Primary completion date: 2020-07-24
Completion date: 2020-07-24
Plan to share individual participant data: NO
Clinical trial NCT03049449: T Cells Expressing a Fully-Human Anti-CD30 Chimeric Antigen Receptor for Treating CD30-Expressing Lymphomas
Official title: Anti-CD30 CAR T Cells With Fully-human Binding Domains for Treating CD30-expressing Lymphomas Including Anaplastic Large Cell Lymphomas
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-03-17
Primary completion date: 2022-01-26
Completion date: 2022-01-26
Baseline population: 2 participants who had baseline data collected and were enrolled but not treated, is reported here.
Plan to share individual participant data: YES
IPD sharing description: We will share coded, linked data in an National Institutes of Health (NIH)-funded or approved public repository. Coded, linked data in Biomedical Translational Research Information System (BTRIS).
IPD time frame: Data will be shared before publication. And at the time of publication or shortly thereafter.
IPD access criteria: An National Institutes of Health (NIH)-funded or approved public repository - Clinical Trials.gov, Biomedical Translational Research Information System (BTRIS), and publication and/or presentations.
Clinical trial NCT04466904: Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM
Official title: A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 42.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-12
Primary completion date: 2021-05-28
Completion date: 2021-05-28
Clinical trial NCT03700723: Comparison of the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Official title: Multicenter, Single-Blinded, Randomized, Comparator-Controlled Noninferiority Trial to Compare the Efficacy & Safety of Resusix With FP24 in Patients With Acquired Coagulopathy
Sponsor: Entegrion, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Convenience of Government Funding Sponsor
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-14
Primary completion date: 2020-04-15
Completion date: 2020-04-15
Clinical trial NCT03273153: A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma
Official title: A Phase III, Open-Label, Multicenter, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: This study was terminated due to benefit/risk analysis.
Enrollment: 446.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-11
Primary completion date: 2019-04-15
Completion date: 2021-02-19
Clinical trial NCT03185819: Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Participants Assessed to be at Imminent Risk for Suicide
Official title: A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 147.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-10-05
Primary completion date: 2023-03-31
Completion date: 2023-03-31
Baseline population: All baseline characteristics were analyzed on the safety analysis set which included all randomized participants who received at least one dose of DB study drug.
Clinical trial NCT03394027: ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma
Official title: A Phase 2 Study of ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-01-17
Primary completion date: 2021-03-18
Completion date: 2021-10-07
Plan to share individual participant data: YES
IPD sharing description: All IPD recorded in the medical record will be shared with intramural investigators upon request. In addition, all large scale genomic sequencing data will be shared with subscribers to 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 database of Genotypes and Phenotypes (dbGaP) through requests to the data custodians.
Clinical trial NCT03121586: Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Official title: A 52-Week, Open-Label, Extension Study of Pimavanserin for the Adjunctive Treatment of Schizophrenia
Sponsor: ACADIA Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Enrollment: 996.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-31
Primary completion date: 2024-06-30
Completion date: 2024-06-30
Plan to share individual participant data: NO
Clinical trial NCT03008915: Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
Official title: Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
Sponsor: Columbia University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-01-31
Primary completion date: 2018-07-31
Completion date: 2020-10-31
Baseline population: All participants
Plan to share individual participant data: NO
Clinical trial NCT03097107: Evaluate the Safety and Efficacy of Saroglitazar Mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm, 12-week Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 1, 2 and 4 mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL
Sponsor: Zydus Therapeutics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Management decision to suspend the study due to recruitment issues
Enrollment: 124.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2017-04-06
Primary completion date: 2023-12-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
IPD sharing description: See above.
Clinical trial NCT06216561: Intraperitoneal LSTA1 in CRS-HIPEC
Official title: A Phase I Trial of Intraperitoneal LSTA1 in Patients Undergoing Cytoreductive Surgery and HIPEC for Peritoneal Surface Malignancy
Sponsor: University of California, San Diego (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: closed early due to low (0) accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-11-30
Primary completion date: 2024-06-24
Completion date: 2024-06-24
Clinical trial NCT05901467: Recall by Genotype: Neuropeptide Stimulation
Official title: Recall by Genotype: Neuropeptide Stimulation
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study team no longer has access to GnRH. The study has been altered to account for this change and is no longer a clinical trial.
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-10-20
Primary completion date: 2024-05-29
Completion date: 2024-05-29
Plan to share individual participant data: NO
Clinical trial NCT05226533: Clinical Trials to Assess Safety and Efficacy of DWRX2003 Combination With Remdesivir in Moderate to Severe COVID-19 Patients.
Official title: A Phase 2, Double Blind, Randomized, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of DWRX2003 in Combination With Remdesivir Following Intramuscular Administration in Moderate-Severe COVID-19 Patients
Sponsor: Daewoong Pharmaceutical Co. LTD. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study stopped due to difficulties in patient recruitment
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-03-31
Primary completion date: 2022-12-16
Completion date: 2022-12-21
Plan to share individual participant data: NO
Clinical trial NCT04437199: Tricaprilin Phase 2 Pilot Study in Migraine
Official title: A 12-Week, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Participants With Migraine
Sponsor: Cerecin (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 83.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-17
Primary completion date: 2022-02-07
Completion date: 2022-02-07
Plan to share individual participant data: NO
Clinical trial NCT02028221: Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
Official title: Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
Sponsor: University of Arizona (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 151.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-03-07
Primary completion date: 2018-11-30
Completion date: 2022-06-14
Clinical trial NCT04270760: Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Official title: A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 281.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-07-28
Primary completion date: 2021-12-27
Completion date: 2022-11-08
Baseline population: Full Analysis Set (FAS): includes all randomized participants who received at least one dose of IP.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT02685709: Comparison of Oral Octreotide Capsules to Injectable Somatostatin Analogs in Acromegaly
Official title: A Phase 3, Randomized, Active Controlled Study to Evaluate Maintenance of Response, Safety and Patient Reported Outcomes in Acromegaly Patients Treated With Octreotide Capsules vs. Parenteral Somatostatin Receptor Ligands
Acronym: MPOWERED
Sponsor: Chiasma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 146.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-02-29
Primary completion date: 2020-10-31
Completion date: 2021-08-31
Baseline population: Acromegaly patients who previously tolerated and demonstrated a biochemical control on SRLs
Plan to share individual participant data: NO
Clinical trial NCT03488147: Whether Proton Pump Inhibitors, Administered Prior to or After Surgery, Can Reduce the Incidence and/or Severity of Difficulty Swallowing Foods and/or Liquids,Following Anterior Cervical Surgery
Official title: The Effect of Esomeprazole Magnesium on Incidence of Dysphagia Following Anterior Cervical Spine Surgery: A Prospective, Randomized, Double Blinded, Placebo-Controlled Study
Sponsor: Icahn School of Medicine at Mount Sinai (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Change in Investigational Drug Service policies resulting in the need to change the operational design of the overall protocol.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-07-31
Primary completion date: 2020-07-02
Completion date: 2020-07-02
Clinical trial NCT02625974: A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi
Official title: Prospective, Historically Controlled Study to Evaluate the Efficacy and Safety of a New Pediatric Formulation of Nifurtimox in Children Aged 0 to 17 Years With Chagas' Disease
Sponsor: Bayer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 330.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-27
Primary completion date: 2018-07-25
Completion date: 2021-08-10
Limitations and caveats: Abnormal findings on neurological examination by physical examination after Screening will be documented as AEs.
Clinical trial NCT03615924: Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease
Official title: A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing the Rate of Vaso-Occlusive Crises in Paediatric Patients With Sickle Cell Disease (HESTIA3)
Acronym: HESTIA3
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Recommendation from an independent data monitoring committee (DMC) and accepted by AstraZeneca.
Enrollment: 193.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-26
Primary completion date: 2020-08-13
Completion date: 2020-08-13
Baseline population: The Full Analysis Set (FAS) included all randomized participants regardless of treatment received.
Limitations and caveats: AstraZeneca took the decision to terminate the study early, following a recommendation from the independent Data Monitoring Committee. This early termination was not considered to have had an impact on the robustness of the study results.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.~Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Clinical trial NCT02777580: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Official title: STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction
Acronym: STREAM-2
Sponsor: KU Leuven (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 609.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-01
Primary completion date: 2022-10-13
Completion date: 2023-09-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04857138: A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors
Official title: An Open-Label, Multicenter, Dose-Escalation and Expansion, Phase I Study to Evaluate Safety, Pharmacokinetics, And Anti-Tumor Activity of RO7300490, A Fibroblast Activation Protein-α (FAP) Targeted CD40 Agonist, as Single Agent or in Combination With Atezolizumab in Participants With Advanced and/or Metastatic Solid Tumors
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-05-18
Primary completion date: 2024-01-18
Completion date: 2024-01-18
Clinical trial NCT02950558: Anesthesia for Pain After Ankle Fracture Surgery
Official title: Pilot Study: Extended Regional Anesthesia to Prevent Chronic Pain After Ankle Fracture Surgery
Sponsor: University of Cincinnati (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-29
Primary completion date: 2019-11-14
Completion date: 2020-06-19
Limitations and caveats: A problem encountered was that only 1 of the 6 subjects in the pump group received the full 5 days of treatment. The others discontinued using the pump early, primarily due to problems with catheter dislodgement/leakage. As specified in the statistical analysis plan, these subjects were all analyzed with intent-to-treat protocol and are included in the pump group data presented. Also, by chance, the distribution of males and females between the group was quite uneven.
Plan to share individual participant data: NO