chufangao/CTO huggingface dataset:
Clinical trial NCT04115839: Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Psoriatic Arthritis Who Have an Inadequate Response or Are Intolerant to Biologic DMARD Therapy
Acronym: PENGUIN 2
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Development program terminated
Enrollment: 106.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-11-13
Primary completion date: 2021-01-04
Completion date: 2021-03-18
Baseline population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT02422615: Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
Official title: A Randomized Double-blind, Placebo-controlled Study of Ribociclib in Combination With Fulvestrant for the Treatment of Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer Who Have Received no or Only One Line of Prior Endocrine Treatment
Acronym: MONALEESA-3
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 726.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-09
Primary completion date: 2017-11-03
Completion date: 2023-01-11
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
Clinical trial NCT04162639: The Relationship Between Cadaveric Allograft Skin and HLA-Sensitivity in Burn Patients
Official title: The Relationship Between Cadaveric Allograft Skin and Human-leukocyte Antigens (HLA)-Sensitivity in Burn Patients
Sponsor: Virginia Commonwealth University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: PI is working on getting funding for the study and wishes to withdraw the study until that funding is secured.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-02-28
Primary completion date: 2023-02-28
Completion date: 2023-02-28
Plan to share individual participant data: NO
Clinical trial NCT04134468: MRI Effects of Pegvorhyaluronidase Alfa (PEGPH20) in Pancreatic Ductal Adenocarcinoma
Official title: UPCC 10219: Phase II Study Of Stromal Changes Detected By DCE- and DW-MRI In Response To PEGPH20 Combined With Chemotherapy In Subjects With Locally-Advanced Pancreatic Cancer
Sponsor: Abramson Cancer Center at Penn Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Halozyme halted development of PEGPH20 following Phase 3 failure.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-31
Primary completion date: 2021-02-11
Completion date: 2022-11-11
Plan to share individual participant data: NO
Clinical trial NCT01622868: Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer
Official title: Phase II Randomized Study of Whole Brain Radiotherapy/Stereotactic Radiosurgery in Combination With Concurrent Lapatinib in Patients With Brain Metastasis From HER2-Positive Breast Cancer - A Collaborative Study of NRG Oncology and KROG
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 143.0 (ACTUAL)
Number of arms: 2.0
Start date: 2012-12-06
Primary completion date: 2019-12-30
Completion date: 2022-05-20
Baseline population: Eligible participants
Clinical trial NCT04044651: Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma With Hepatitis B Virus Infection
Official title: A Randomized, Phase IIb Study of Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma (HCC) With Hepatitis B Virus (HBV) Infection
Sponsor: Sun Yat-sen University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Bristol-Myers Squibb company terminated this study
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-30
Primary completion date: 2021-03-30
Completion date: 2022-09-30
Clinical trial NCT04799431: Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colon and Pancreatic Ductal Cancer
Official title: A Pilot Study of a Neoantigen-Targeted Vaccine Combined With Anti-PD-1 Antibody for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Study never started
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-05-03
Primary completion date: 2023-05-03
Completion date: 2023-05-03
Plan to share individual participant data: NO
Clinical trial NCT02990338: Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients
Official title: A Phase 3 Randomized, Open-label, Multicenter Study Comparing Isatuximab (SAR650984) in Combination With Pomalidomide and Low-Dose Dexamethasone Versus Pomalidomide and Low-Dose Dexamethasone in Patients With Refractory or Relapsed and Refractory Multiple Myeloma
Acronym: ICARIA-MM
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 307.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-12-22
Primary completion date: 2018-11-22
Completion date: 2023-11-01
Baseline population: Analysis was performed on randomized population which included all participants with a signed informed consent and have been allocated a randomization number by the IRT, regardless of whether the participants was treated or not.
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 NCT03573544: This Study is to Evaluate Safe and Effective Treatment Dose of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Official title: A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
Sponsor: OBI Pharma, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: OBI-888 no longer fulfills our goal of developing cost-effective therapies for cancer patients
Enrollment: 54.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-07
Primary completion date: 2022-04-07
Completion date: 2022-04-07
Baseline population: The safety population consisted of all enrolled subjects who received at least 1 dose of study drug.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05590403: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
Official title: A Phase 3, Observer-blind, Randomized, Placebo-controlled Study to Evaluate the Non-inferiority of the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults ≥60 Years of Age
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1544.0 (ACTUAL)
Number of arms: 5.0
Start date: 2022-10-28
Primary completion date: 2023-03-13
Completion date: 2024-04-03
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, a key secondary endpoints and safety data 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 NCT05581719: A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy
Official title: A Phase 1/2a Study Evaluating Allocetra-OTS as Monotherapy or in Combination With Anti-PD-1 Therapy for the Treatment of Advanced Solid Tumor Malignancy
Sponsor: Enlivex Therapeutics RDO Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision
Enrollment: 14.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-11-15
Primary completion date: 2024-04-15
Completion date: 2024-04-15
Clinical trial NCT05512182: Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression
Official title: An Open Label, Single-Arm, Multi-Center Phase II Study to Evaluate the Efficacy of Triplet Combination With Pembrolizumab, Neratinib, and Paclitaxel as a Second Line Treatment in Recurrent/Advanced Gastric Cancer Having Somatic Human Epidermal Growth Factor Receptor Family (EGFR, HER2, HER3, HER4) Mutations or HER2 Amplification/Overexpression
Sponsor: Yonsei University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: No participants enrolled
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-15
Primary completion date: 2023-10-30
Completion date: 2023-10-30
Plan to share individual participant data: NO
Clinical trial NCT03440112: Modulation of GABA-A Receptors in Parkinson Disease-Transdermal Flumazenil Arm
Official title: Modulation of GABA-A Receptors and Axial Motor Impairments in Parkinson
Acronym: GABA-A
Sponsor: University of Michigan (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 34.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-01-29
Primary completion date: 2021-12-08
Completion date: 2021-12-08
Baseline population: Parkinson's disease patients age 50 years or older. Some, but not all, participants in the Clarithromycin arm were randomized, and only few completed study procedures because of premature termination of the trial due to an FDA safety risk warning of Clarithromycin, precluding any meaningful analysis. Consequently, this study arm was replaced by the transdermal Flumazenil arm.
Limitations and caveats: Our participants were predominantly male, which is often the case with Parkinson's disease (PD) patient population since PD is known to affect males at a greater rate. This means that our findings may not generalize as well to population of female PD patients.
Plan to share individual participant data: NO
Clinical trial NCT03777956: The Effect of Lacosamide in Peripheral Neuropathic Pain
Official title: The Effect of Lacosamide in Peripheral Neuropathic Pain: a Randomized, Double-blind, Placebo Controlled, Phenotype-stratified Study
Sponsor: Danish Pain Research Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: COVID 19 and recruitment problems
Enrollment: 63.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-15
Primary completion date: 2022-06-03
Completion date: 2022-06-03
Clinical trial NCT04309721: Perampanel in Focal Status Epilepticus
Official title: Efficacy of add-on PEramPanel in Focal Motor Status Epilepticus
Acronym: PEPSI
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Lack of inclusion
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-11-02
Primary completion date: 2022-11-02
Completion date: 2023-11-13
Clinical trial NCT05038800: A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002)
Official title: A Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of MK-0482 in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Business Reasons
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-26
Primary completion date: 2023-12-11
Completion date: 2023-12-11
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04952571: Combined Treatment of Camrelizumab and Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM)
Official title: An Exploratory Study on Camrelizumab Combined with Bevacizumab for Adult Patients with Recurrent Glioblastoma (GBM)
Sponsor: Beijing Sanbo Brain Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of funds
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-27
Primary completion date: 2022-12-31
Completion date: 2022-12-31
Plan to share individual participant data: NO
Clinical trial NCT03614728: Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents to Treat Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Official title: A Phase I/II Study to Investigate the Safety and Clinical Activity of GSK3326595 and Other Agents in Participants With Myelodysplastic Syndrome and Acute Myeloid Leukaemia
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Trial terminated due to internal review of clinical data in context of indication under investigation
Enrollment: 30.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-10-16
Primary completion date: 2022-01-11
Completion date: 2022-01-11
Baseline population: All Treated Population consisted of all participants who received at least one dose of GSK3326595 as monotherapy or at least one dose of both combination drugs as combination treatment. Data was not collected in Part 2 of the study as no participant was enrolled in Part 2.
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, key secondary endpoints and safety data 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 NCT03396861: Treatment of Macular Edema After Cataract Surgery with Subconjunctival Aflibercept
Official title: Subconjunctival Aflibercept Injection for Pseudophakic Cystoid Macular Edema
Acronym: ACME
Sponsor: Tufts Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-22
Primary completion date: 2019-08-18
Completion date: 2020-01-02
Plan to share individual participant data: NO
Clinical trial NCT04071756: Topical Tazarotene Vs Placebo In Hand-Foot-Skin Reactions
Official title: A Phase II Randomized Double-Blind Trial of Topical Tazarotene 0.1% Gel Versus Placebo Gel for the Prevention of Regorafenib-Induced Hand-Foot-Skin Reaction
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Difficulty with patient recruitment
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-30
Primary completion date: 2021-06-12
Completion date: 2022-07-14
Limitations and caveats: This study was terminated prematurely on 7/14/2022 as there had been significant difficulty with patient recruitment.~This report includes data for eight (8) randomized participants. The first enrolled on December 30, 2019, and the last on July 28, 2020.
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD time frame: Data can be shared no earlier than 1 year following the date of publication
IPD access criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
Clinical trial NCT03742804: Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma
Official title: Pilot Phase 2 Study of Intratumoral G100 in Patients With Cutaneous T Cell Lymphoma
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study sponsor sold and the new company would not support the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-06-30
Primary completion date: 2019-12-31
Completion date: 2022-12-31
Clinical trial NCT02553915: Omega-3 Fatty Acids for Major Depressive Disorder With High Inflammation: A Personalized Approach
Official title: Omega-3 Fatty Acids for MDD With High Inflammation: A Personalized Approach
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-12-31
Primary completion date: 2018-07-13
Completion date: 2022-03-31
Baseline population: Adults with major depressive disorder, overweight, with elevated hsCRP at baseline.
Limitations and caveats: Smaller than projected sample due to challenges in recruitment led to smaller analyzable treatment arms. Results should be considered preliminary.
Plan to share individual participant data: NO
Clinical trial NCT05155085: A Study to Assess Subcutaneous Lirentelimab (AK002) in Atopic Dermatitis
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Lirentelimab in Adult Subjects With Moderate-to-Severe Atopic Dermatitis Inadequately Controlled by Topical Treatments
Acronym: ATLAS
Sponsor: Allakos Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: No longer pursuing development
Enrollment: 131.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-27
Primary completion date: 2023-12-18
Completion date: 2024-04-17
Baseline population: Baseline analysis is reported on the safety population of the main study period. Baseline information of OLE subjects is not reported since it is already captured as part of the main study population.
Plan to share individual participant data: NO
Clinical trial NCT04649060: Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma
Official title: A Randomized, Controlled, Open-Label Phase 3 Study of Melflufen in Combination With Daratumumab Compared With Daratumumab in Patients With Relapsed or Relapsed-Refractory Multiple Myeloma
Acronym: LIGHTHOUSE
Sponsor: Oncopeptides AB (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The sponsor decided to terminate the study due to financial issues following an FDA request for a partial clinical hold.
Enrollment: 54.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-21
Primary completion date: 2022-02-07
Completion date: 2022-02-07
Limitations and caveats: This study was put on clinical hold and later discontinued prematurely. Due to this, there is limited data available, and data cleaning was not done according to the original plan. Due to the early termination, the response assessments were done by investigators, not by an independent review committee.
Plan to share individual participant data: NO
Clinical trial NCT02790528: Statin Therapy In Patients With Vasospastic Angina
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina
Acronym: STAVA
Sponsor: Asan Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Funding issue
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-31
Primary completion date: 2023-06-30
Completion date: 2023-12-31
Plan to share individual participant data: NO
IPD sharing description: This is not a publicly funded trial.
Clinical trial NCT04015336: E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer
Official title: A Phase II Study of E7 TCR T Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Logistical challenges
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-07-06
Primary completion date: 2020-07-15
Completion date: 2020-07-15
Plan to share individual participant data: YES
IPD sharing description: Data will be shared as follows: 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), and identified or coded, linked data with approved outside collaborators under appropriate agreements.
IPD time frame: Before publication and at the time of publication or shortly thereafter.
IPD access criteria: Clinical Trials.gov, Biomedical Translational Research Information System (BTRIS), approved outside collaborators under appropriate individual agreements, and publication and/or public presentations.