chufangao/CTO huggingface dataset:
Clinical trial NCT04227704: Ketamine to Prevent PPD After Cesarean
Official title: Postpartum Depression After Cesarean Delivery: Ketamine as a Preventative Intervention: A Feasibility Pilot-study
Acronym: PoCKet
Sponsor: Washington University School of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 25.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-11-12
Primary completion date: 2021-08-09
Completion date: 2021-08-09
Plan to share individual participant data: NO
Clinical trial NCT02908165: Randomized Phase II Trial of Chemoembolization and Sorafenib
Official title: Randomized Phase II Trial of Chemoembolization and Sorafenib: Comparison Between Continuous and Sequential Treatment Regimens
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: A future study will be taking place using the same patient population.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-30
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Plan to share individual participant data: NO
Clinical trial NCT03580005: A 6-week Study to Evaluate the Safety and Efficacy of Quillichew ERCT in 4-5 Year Old Children With ADHD.
Official title: A Phase 4, Double-blind, Randomized, Parallel Group, Placebo-controlled Study Of The Efficacy And Safety Of Quillichew (Methylphenidate Hydrochloride (Hcl)) Extended Release Chewable Tablets (Erct) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (Adhd)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The study was cancelled prior to the enrollment of any participants.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-10-31
Primary completion date: 2021-10-12
Completion date: 2021-10-12
Plan to share individual participant data: YES
IPD sharing description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Clinical trial NCT04677829: Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)
Official title: Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Trial to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Intravenous PNT001 in Hospitalized Patients With Traumatic Brain Injury (TBI)
Sponsor: Pinteon Therapeutics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was terminated due to administrative, non-safety related reasons.
Enrollment: 1.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-03-29
Primary completion date: 2021-04-12
Completion date: 2021-04-12
Plan to share individual participant data: NO
Clinical trial NCT02596971: A Study of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus (+) Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Participants With Follicular Lymphoma (FL) or Rituximab + CHOP in Participants With Diffuse Large B-Cell Lymphoma (DLBCL)
Official title: A Phase IB/II Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Either Obinutuzumab Plus Bendamustine or Obinutuzumab Plus CHOP in Patients With Follicular Lymphoma or Rituximab Plus CHOP in Patients With Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 91.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-12-22
Primary completion date: 2018-04-11
Completion date: 2020-05-08
Baseline population: 3 populations for the Atezo-G-Benda cohort: safety, efficacy, and pharmacokinetic (PK). All participants (n = 42) in Atezo-G-Benda cohort included in safety and positron emission tomography (PET) evaluable populations. Two participants were excluded from efficacy evaluable population due to diagnosis of relapsed/ refractory follicular lymphoma (r/r FL). All 42 FL participants in Atezo-G-Benda cohort included in PK evaluable population.
Limitations and caveats: Development of the atezolizumab combination treatment was discontinued as there was insufficient evidence regarding the additive efficacy of this therapy.
Clinical trial NCT04104919: Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Mastectomy in Patients With High PCS Scores
Official title: A Phase 2 Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Intrathecal Preoperative Administration of Brivoligide Injection in Patients With a Pain Catastrophizing Scale Score ≥16 Undergoing Mastectomy With Immediate Tissue Expander or Implant Placement
Sponsor: Adynxx, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study Initiation delayed due to COVID 19
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-31
Primary completion date: 2022-01-31
Completion date: 2022-02-28
Plan to share individual participant data: NO
Clinical trial NCT03220399: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2
Official title: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers
Sponsor: NVP Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Decided to stop drug development
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-01
Primary completion date: 2020-03-28
Completion date: 2020-07-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04089904: Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma
Official title: A Phase II Trial of Neoadjuvant Pembrolizumab for Resectable Early Stage Gastroesophageal Adenocarcinoma
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low accrual.
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-11
Primary completion date: 2023-03-11
Completion date: 2023-03-11
Clinical trial NCT03035058: Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease
Official title: A Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-02-28
Primary completion date: 2020-09-30
Completion date: 2021-01-31
Clinical trial NCT04315051: A Trial of Safety/Efficacy of Test Article in Patients With Interdigital T. Pedis
Official title: Clinical Trial Protocol DBI-204 Double-Blind, Randomized, Placebo Controlled Trial of the Safety and Efficacy of DBI-001 Gel in Patients With Interdigital Tinea Pedis
Sponsor: DermBiont, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Covid- 19 has shut the clinic
Enrollment: 39.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-12
Primary completion date: 2020-06-30
Completion date: 2020-06-30
Clinical trial NCT05284604: Mesenchymal Stem Cells for Age-Related Frailty
Official title: A Pilot Study of Mesenchymal Stem Cells as Novel Therapy for Age-Related Frailty in Veterans
Acronym: MESCAFY
Sponsor: VA Office of Research and Development (FED)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Insufficient funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-01-31
Primary completion date: 2023-01-31
Completion date: 2023-01-31
Plan to share individual participant data: NO
IPD sharing description: MEDVAMC will not provide unrestricted, open public access to large scale health related datasets because of re-identification concerns and the obligation to protect Veterans' private information. However, controlled public access will be provided to the greatest extent possible under specific DUAs or other written agreements, and open access will be provided to the final datasets underlying peer-reviewed publications (aggregated data that can be released with privacy and confidentiality risks).
Clinical trial NCT04868045: Study of Resistance to Thyroid Hormone After Long-term Exposure in People With Thyroid Cancer
Official title: Evaluation of The Development of Central Resistance to Thyroid Hormone After Prolonged Exposure to Excess Thyroid Hormone in Thyroid Cancer Patients
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-27
Primary completion date: 2023-02-15
Completion date: 2023-02-15
Plan to share individual participant data: YES
IPD sharing description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Clinical trial NCT03941873: A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) or Gastric/Gastroesophageal Junction Cancer (GC/GEJC)
Official title: A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib as Monotherapy and in Combination With Tislelizumab in Patients With Unresectable Locally Advanced or Metastatic HCC or GC/GEJC
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 111.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-02-28
Primary completion date: 2023-03-31
Completion date: 2023-03-31
Plan to share individual participant data: YES
Clinical trial NCT04382924: Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease
Official title: A Randomized Open Label Phase 2b/3 Study of the Safety and Efficacy of NP-120 (Ifenprodil) for the Treatment of Hospitalized Patient With Confirmed COVID-19 Disease
Sponsor: Algernon Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 168.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-08-05
Primary completion date: 2020-12-24
Completion date: 2021-01-26
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04235036: Ibrutinib and Rituxan for Chronic GVHD
Official title: Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B Cell Depleting Therapy With Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus-Host Disease
Sponsor: Northside Hospital, Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Low Recruitment
Enrollment: 19.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-12-16
Primary completion date: 2022-12-23
Completion date: 2022-12-23
Plan to share individual participant data: NO
Clinical trial NCT03587142: Buspirone for Early Satiety and Symptoms of Gastroparesis
Official title: Buspirone for Early Satiety and Symptoms of Gastroparesis: A Multicenter, Randomized, Placebo-Controlled, Double-Masked Trial (BESST)
Acronym: BESST
Sponsor: Johns Hopkins Bloomberg School of Public Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 96.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-27
Primary completion date: 2022-04-15
Completion date: 2022-04-30
Plan to share individual participant data: YES
IPD sharing description: The study will comply with the NIH Data Sharing Policy. The data will be first de-identified so that no individual participant identifiers will be included in the dataset (no names, addresses, dates, comments, etc). If a characteristic is an extreme value for this population, then those values will be categorized into one frequency group. If a CSR has multiple versions, then all data will be recoded into the format of the most current form version. A random unique identification number will be substituted for the unique BESST identification number. If a clinical item was obtained from surveys with restrictions due to licensing, then that data will be excluded. The data will be shared in 2 stages: the first will be the analytic datasets to produce the primary outcome paper. For this dataset, the documentation will include analytic code. The full dataset by CSR will be provided in the second stage.
IPD time frame: The analytic datasets to produce the primary result manuscript will be submitted within one year of publication of the primary result manuscript. The full clinical dataset for all Clinical Study Reports (CSRs) without proprietary restrictions will be submitted within 2 years of the primary result manuscript publication. This data will be available publicly indefinitely.
IPD access criteria: An investigator interested in acquiring BESST study data should contact the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository at https://www.niddkrepository.org/search/study/ and apply to obtain the data required for their study.
Clinical trial NCT03088709: Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide
Official title: Safety, Efficacy and Feasibility of Haploidentical Stem Cell Transplantation (Haplo-SCT) Using Post-Transplant Cyclophosphamide (PTCy) as an Alternative Donor Source for Patients Who Lack a Matched Sibling/Unrelated Donor Options
Sponsor: Loyola University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Poor accrual
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-01-18
Primary completion date: 2022-01-31
Completion date: 2022-01-31
Plan to share individual participant data: NO
Clinical trial NCT05898828: Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer
Official title: Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With Entinostat and Nivolumab as Adjuvant Therapy Following Chemoradiation Therapy With or Without Surgery for Locally Advanced Esophageal Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2024-08-02
Primary completion date: 2024-08-02
Completion date: 2024-08-02
Plan to share individual participant data: YES
IPD sharing description: .All IPD recorded will be shared upon request.
IPD time frame: Data from this study may be requested from other researchers after the trial has been completed and closed.
IPD access criteria: Data from this study may be requested by contacting the PI.
Clinical trial NCT04425902: Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults
Official title: Effects of GSK3640254 on the Single-Dose Pharmacokinetics of Probe Substrates (Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin) in Healthy Subjects
Sponsor: ViiV Healthcare (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-12-16
Primary completion date: 2021-03-10
Completion date: 2021-03-10
Baseline population: Safety Population consisted of all participants who received at least 1 dose of study medication.
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on ViiV's data sharing criteria can be found at: https://viivhealthcare.com/about-viiv/corporate-ethics-compliance/commitment-to-data-transparency/
IPD time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
Clinical trial NCT03809663: A Dose Ranging Placebo-Controlled Double-Blind Study to Evaluate the Safety and Efficacy of Tezepelumab in Atopic Dermatitis
Official title: A Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Tezepelumab Alone or Combined With Topical Corticosteroids in Moderate-to-Severe Atopic Dermatitis
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Tezepelumab as a monotherapy in atopic dermatitis did not reach the targeted efficacy level pre-established for this patient population.
Enrollment: 251.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-03-15
Primary completion date: 2020-05-12
Completion date: 2020-12-22
Baseline population: Full analysis set (FAS): All randomized participants in Part A.
Limitations and caveats: Enrollment of Part A of this study was completed as of 27 July 2020. The study was terminated prior to the enrollment of any participants into Part B.
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 NCT02960113: Scopolamine Patch and Acupressure Point P6 Stimulation for Reduction of Nausea and Vomiting During Cesarean Section
Official title: Is the Application of Scopolamine Patch With or Without Intra-operative Acupressure Point P6 Stimulation More Effective Than Intra-operative Acupressure Point P6 Stimulation Alone?
Sponsor: Rutgers, The State University of New Jersey (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 240.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-05-31
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Plan to share individual participant data: NO
Clinical trial NCT04631601: Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Official title: A Master Protocol Evaluating the Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Amgen made a business decision to discontinue all AMG 160 clinical trials. This decision is not related to safety.
Enrollment: 65.0 (ACTUAL)
Number of arms: 11.0
Start date: 2021-01-15
Primary completion date: 2023-10-23
Completion date: 2023-10-23
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 NCT02478710: Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia
Official title: Aerosolized Antibiotics in the Treatment of Ventilator Associated Pneumonia: A Pilot Study
Acronym: AAINTVAP
Sponsor: Wright State University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-30
Primary completion date: 2017-02-28
Completion date: 2022-07-31
Limitations and caveats: Data was not collected for the Secondary Outcomes.
Plan to share individual participant data: NO