chufangao/CTO huggingface dataset:
Clinical trial NCT04357028: Measles Vaccine in HCW
Official title: Effectiveness of Measles Vaccine in Health Care Professionals During COVID-19 Outbreak (Randomized Controlled Trial)
Acronym: MV-COVID19
Sponsor: Kasr El Aini Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Failure of subject recruitment
Enrollment: 200.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2020-07-13
Primary completion date: 2020-12-31
Completion date: 2021-01-01
Plan to share individual participant data: NO
Clinical trial NCT01682616: A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Official title: A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 49.0 (ACTUAL)
Number of arms: 1.0
Start date: 2012-07-25
Primary completion date: 2022-06-23
Completion date: 2022-06-23
Plan to share individual participant data: NO
Clinical trial NCT03106454: Ovulation Incidence in Oral Contraceptive Users
Official title: Ovulation Incidence in Oral Contraceptive Users
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: Investigator leave of absence
Enrollment: 58.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2014-08-31
Primary completion date: 2024-01-31
Completion date: 2024-01-31
Plan to share individual participant data: NO
Clinical trial NCT04564833: Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
Official title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery (The START Study)
Acronym: START
Sponsor: Renibus Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 152.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-08-04
Primary completion date: 2022-11-09
Completion date: 2023-02-03
Plan to share individual participant data: NO
Clinical trial NCT04495374: Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy
Official title: Use of Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy: Evaluation of Postoperative Pain and Opioid Consumption
Sponsor: Universidade Federal de Alfenas (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to an atypical health scenario caused by the COVID-19 pandemic
Enrollment: 58.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-02
Primary completion date: 2020-09-09
Completion date: 2020-09-30
Limitations and caveats: Failure to monitor patients 24 hours after surgery to assess parameters such as chronic pain and home opioid consumption. All patients admitted to the study underwent abdominal hysterectomy, a surgery known to have higher pain rates, which makes it impossible for the results found to be used as a basis for patients undergoing laparoscopic hysterectomy or other types of surgery.
Plan to share individual participant data: NO
Clinical trial NCT04790786: UPMC OPTIMISE-C19 Trial, a COVID-19 Study
Official title: The UPMC OPtimizing Treatment and Impact of Monocolonal antIbodieS Through Evaluation for COVID-19 Trial
Acronym: OPTIMISE-C19
Sponsor: University of Pittsburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Emergency Use Authorizations for monoclonal antibodies withdrawn
Enrollment: 4571.0 (ACTUAL)
Number of arms: 5.0
Start date: 2021-03-10
Primary completion date: 2022-06-16
Completion date: 2022-06-16
Limitations and caveats: Results are presented before any prespecified statistical trigger was reached. Lack of patient-level variant data limited ability to assess comparative effectiveness relative to variant strains. The EHR eligibility screen identified most, but not all, EUA risk factors and could not identify if a patient was asymptomatic or severely ill. Finally, vaccination status was unable to be ascertained for this cohort which may impact effectiveness of monoclonal antibody therapy.
Plan to share individual participant data: YES
IPD sharing description: De-identified participant-level data underlying the results reported in journal articles, subject to appropriate security controls, may be available for sharing with other researchers.
IPD time frame: Relevant data may be available 1 year following publication
IPD access criteria: Data access is subject to a methodologically sound proposal and the necessary data sharing agreements.
Clinical trial NCT03910244: Pomalidomide for the Treatment of Bleeding in HHT
Official title: Pomalidomide for the Treatment of Bleeding in Hereditary Hemorrhagic Telangiectasia
Acronym: PATH-HHT
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 145.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-17
Primary completion date: 2023-09-08
Completion date: 2023-09-08
Plan to share individual participant data: YES
IPD sharing description: The DCC will prepare de-identified data files for sharing. A final data sharing plan will be developed with NHLBI and the study Steering Committee. The data can be provided in SAS data sets and export files and documentation will be in PDF format.~The first level of data sharing will be with trial investigators. In addition, the DCC will be responsible for sharing study data with outside researchers, if approved by NHLBI and the SC.
IPD time frame: Data will be made available to investigators 6 months after closed data sets for the trial have been prepared for final analysis or 1 month after results of the protocol are published in a peer-reviewed journal.
IPD access criteria: A data request form will be developed to collect information deemed necessary by the SC and NIH, including applicant name, organization, and purpose of research. Investigators will submit the request form, Data Distribution Agreement, and IRB approval to designated DCC staff. The SC or its designated Committee will review each application, and if the requestor meets established criteria for access to the data and provides the required documents, the requested data sets and associated documentation will be disseminated by a mode agreed upon by the SC in accordance with NHLBI policy.
Clinical trial NCT02650713: A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors
Official title: An Open-Label, Multicenter, Dose Escalation and Expansion Phase Ib Study to Evaluate the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Patients With Locally Advanced and/or Metastatic CEA-Positive Solid Tumors
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 228.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-07
Primary completion date: 2020-01-13
Completion date: 2020-01-13
Clinical trial NCT04476992: Nitric Oxide Therapy for COVID-19 Patients With Oxygen Requirement
Official title: A Safety Study on the Use of Intermittent Versus Continuous Inhalation of NO in Spontaneous Breathing COVID-19 Patients
Acronym: NICOR
Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-24
Primary completion date: 2021-07-17
Completion date: 2021-09-17
Clinical trial NCT02294357: Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib
Official title: A Phase 2 Study of Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib
Sponsor: Oncotherapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Early termination due to the difficulties to enroll subjects.
Enrollment: 45.0 (ESTIMATED)
Number of arms: 5.0
Start date: 2014-12-31
Primary completion date: 2020-09-21
Completion date: 2020-09-22
Plan to share individual participant data: NO
IPD sharing description: Demographics and Clinical Responses
Clinical trial NCT03836053: Assessment of AMG 420 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Official title: A Phase 1b Multicenter, Open-label, Expansion Study to Assess the Safety and Efficacy of AMG 420 as Monotherapy in Subjects With Relapsed and/or Refractory Multiple Myeloma
Acronym: AMG420
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Amgen re-evaluated the portfolio and decided to discontinue clinical development activities for AMG 420.
Enrollment: 23.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-03-04
Primary completion date: 2022-04-21
Completion date: 2022-04-21
Baseline population: Safety analysis set includes all participants who enrolled and received at least 1 dose of AMG 420.
Limitations and caveats: The study was terminated early due to sponsor decision and long-term follow-up was cancelled.
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 (or other new use) 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, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. 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 link below.
Clinical trial NCT02508311: Albuterol to Improve Respiratory Strength in SCI
Official title: The Effect of an Oral Beta-2 Agonist on Respiratory Muscle Strength in SCI
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Our ability to test subjects with tetraplegia in this interventional study was interrupted by the COVID-19 pandemic. Our research pharmacist also informed us that oral albuterol is no longer being manufactured.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-01
Primary completion date: 2022-03-02
Completion date: 2023-02-28
Baseline population: 9 participants screened, 1 participant was eligible; however, the participant withdrew. No data collected.
Limitations and caveats: Inability to perform study during COVID-19. Albuterol repetabs are also no longer being manufactured.
Plan to share individual participant data: NO
IPD sharing description: IPD data is not available at this time.
Clinical trial NCT04344951: Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial
Official title: Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial
Acronym: HOPE
Sponsor: Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: No clinical efficacy against SARS-CoV-2 recorded
Enrollment: 29.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-04-06
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03527316: Effect of Methylenedioxymethamphetamine (MDMA) (Serotonin Release) on Fear Extinction
Official title: Effect of MDMA (Serotonin Release) on Fear Extinction
Acronym: MFE
Sponsor: University Hospital, Basel, Switzerland (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-18
Primary completion date: 2020-12-10
Completion date: 2020-12-24
Plan to share individual participant data: NO
Clinical trial NCT03906058: Anlotinib in Recurrent or Metastatic Nasopharyngeal Carcinoma Patients After Failure of no Less Than Second-line Therapy
Official title: Open-Label, Phase Ⅱ Study of Anlotinib Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma After Failure of no Less Than Second-line Chemotherapy or Targeted Therapy
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 39.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-29
Primary completion date: 2021-02-27
Completion date: 2022-04-30
Clinical trial NCT02660944: A Phase 2a of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Official title: A Phase 2a, Double-blind, Placebo-Controlled Study of RSLV-132 in Subjects With Systemic Lupus Erythematosus (SLE)
Sponsor: Resolve Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-03
Primary completion date: 2020-05-28
Completion date: 2020-08-10
Baseline population: All participants who received at least one dose of study treatment
Plan to share individual participant data: NO
Clinical trial NCT05177718: Natalizumab and Chronic Inflammation
Official title: Assessing the Effect of Natalizumab of Magnetic Resonance Imaging Measures of Blood Brain Barrier Permeability and Myelin Integrity
Sponsor: Vanderbilt University Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sponsor declined further support
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-16
Primary completion date: 2023-04-05
Completion date: 2023-04-05
Plan to share individual participant data: YES
IPD sharing description: Upon reasonable request from qualified investigators the PI will release all data listed below.
IPD time frame: \[per PDBP policy\]
IPD access criteria: \[per PDBP policy\]
Clinical trial NCT04040127: Residual Dental Pulp Tissue and Cord Blood Stem Cells
Official title: Effect of Residual Dental Pulp Tissue and Cord Blood Stem Cells on Regeneration of Dental
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Did not obtain IRB approval
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-01
Primary completion date: 2020-01-15
Completion date: 2020-02-28
Plan to share individual participant data: NO
Clinical trial NCT04504045: Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes
Official title: INFLAMMATION AND DRUG METABOLISM - Does the Effect of Drugs Decrease When Patients With Type 2 Diabetes Initiate Antidiabetic Treatment?
Sponsor: University of Southern Denmark (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Slow recruitment due to COVID-19, the study was stopped when recruited numbers fulfilled the pre-defined lower sample size.
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-09-01
Primary completion date: 2022-05-10
Completion date: 2022-05-10
Plan to share individual participant data: NO
IPD sharing description: Individual participant data cannot be shared due to general data protection regulation (GDPR).
Clinical trial NCT03376932: Effectiveness of Fluticasone Furoate/ Umeclidinium/ Vilanterol (FF/UMEC/VI) Using the Connected Inhaler System (CIS) as Compared With Fluticasone Proprionate/ Salmeterol (FP/SAL) Plus Tiotropium (TIO) in Inadequately Controlled Asthma
Official title: A Randomised Open-label Study to Compare the Effectiveness of the Fixed Dose Combination of FF/UMEC/VI (Using the Connected Inhaler System) With the Combination of FP/SAL Plus Tiotropium (Without the Connected Inhaler System) in Participants With Inadequately Controlled Asthma
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: withdrawn due to internal reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-01-18
Primary completion date: 2021-02-03
Completion date: 2021-02-03
Plan to share individual participant data: YES
IPD sharing description: IPD for this study will be made available via the Clinical Study Data Request site.
IPD time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints of the study
IPD access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
Clinical trial NCT04419493: A Study in Healthy Men to Compare 2 Different Formulations of Alteplase
Official title: Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 30.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-06-23
Primary completion date: 2021-06-21
Completion date: 2021-06-21
Baseline population: Treated set - part A (TS-A) included all subjects who were randomised and treated with at least 1 dose of the investigational medicinal product.~Treated set - part B (TS-B) included all subjects who had been randomised and treated with at least 1 dose of the investigational medicinal product.
Limitations and caveats: For study Part A three subjects underwent only one treatment period, thereafter the trial was put on-hold. Trial Part B was performed as planned. There were no important protocol deviations (IPDs). Each entered subject met all of the inclusion criteria and none of the exclusion criteria.
Plan to share individual participant data: NO
IPD sharing description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:~1. studies in products where Boehringer Ingelheim is not the license holder;~2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;~3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).~For more details refer to: https://www.mystudywindow.com/msw/datasharing
Clinical trial NCT03510455: BGJ398 for the Treatment of Tumor-Induced Osteomalacia
Official title: BGJ398 for the Treatment of Tumor-Induced Osteomalacia
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was stopped early due to a greater than expected incidence of ocular AEs and analysis of the data from the first 4 subjects indicating that the likelihood of permanent remission with this therapy was low.
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-27
Primary completion date: 2020-02-28
Completion date: 2020-05-04
Limitations and caveats: This study was terminated early due to a lack of efficacy in the first 4 patients and an unexpectedly high rate of ocular adverse events. As a result, only 4 patients were enrolled in this study. Because of the small sample size, we were unable to perform the planned statistical analysis, and instead the results are primarily descriptive.
Clinical trial NCT02914938: A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma
Official title: A Three-Arm Study of ME-401 Monotherapy in Subjects With Relapsed/Refractory CLL, SLL, or FL, of ME-401 in Combination With Rituximab in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination With Zanubrutinib in Subjects With Relapsed/Refractory CLL/SLL or B-cell NHL
Sponsor: MEI Pharma, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: discontinuation of zandelisib program
Enrollment: 97.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-10-31
Primary completion date: 2023-03-29
Completion date: 2023-03-29
Clinical trial NCT02968849: Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa
Official title: A Pivotal Phase 2b/3 Multisite, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALVAC-HIV (vCP2438) and Bivalent Subtype C gp120/MF59 in Preventing HIV-1 Infection in Adults in South Africa
Acronym: HVTN702
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 5404.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-10-26
Primary completion date: 2021-11-16
Completion date: 2021-11-16
Baseline population: Safety Cohort
Plan to share individual participant data: NO
Clinical trial NCT04373044: Baricitinib, Placebo and Antiviral Therapy for the Treatment of Patients With Moderate and Severe COVID-19
Official title: A Phase II Randomized Double-Blind Trial of Baricitinib or Placebo Combined With Antiviral Therapy in Patients With Moderate and Severe COVID-19
Sponsor: University of Southern California (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was terminated after the release of results of ACTT-2 (NCT04401579).
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-01
Primary completion date: 2021-05-12
Completion date: 2021-05-12