chufangao/CTO huggingface dataset:
Clinical trial NCT04173325: Feasibility and Safety Study of Nivolumab With Irinotecan for Small Cell Lung Cancer
Official title: Phase I Feasibility and Safety Study of Nivolumab in Combination With Irinotecan in Relapsed or Refractory Small Cell Lung Cancer (SCLC) Followed by Maintenance Nivolumab
Sponsor: Augusta University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Closed by the IRB 5/26/22 due to non-compliance
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-01-06
Primary completion date: 2022-05-26
Completion date: 2022-05-26
Clinical trial NCT02623699: An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)
Official title: A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB067 Administered to Adult Subjects With Amyotrophic Lateral Sclerosis and Confirmed Superoxide Dismutase 1 Mutation
Acronym: VALOR (Part C)
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 176.0 (ACTUAL)
Number of arms: 12.0
Start date: 2016-01-20
Primary completion date: 2021-07-16
Completion date: 2021-07-16
Baseline population: Intention-to-Treat (ITT) populations for parts A, B, and C included all randomized participants who received at least 1 dose or a part of 1 dose of study treatment (BIIB067 or placebo) in Parts A, B, and C respectively. The demographics data reported for Part B arm groups included only the unique participants who were enrolled directly into Part B of the study.
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
Clinical trial NCT04187144: Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
Official title: A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
Sponsor: GlaxoSmithKline (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1606.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-23
Primary completion date: 2022-12-01
Completion date: 2022-12-01
Baseline population: Participants randomly assigned to the study treatment were included in the ITT population.
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 NCT05081986: Repeated iTBS Cycloserine Motor Plasticity
Official title: Motor Plasticity Enhancement of Spaced iTBS Trains: a Randomized, Placebo-controlled, Crossover Trial of D-cycloserine.
Sponsor: University of Calgary (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-18
Primary completion date: 2021-10-06
Completion date: 2022-02-23
Plan to share individual participant data: NO
Clinical trial NCT05087992: A Study to Find the Best Dose of BI 905711 in Combination With Chemotherapy and to Test Whether This Dose Helps People With Advanced Gastrointestinal Cancers
Official title: A Phase Ia/Ib, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Combination With Chemotherapy Followed by Expansion Cohorts in Patients With Advanced Gastrointestinal Cancers
Sponsor: Boehringer Ingelheim (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 13.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-11-24
Primary completion date: 2023-10-23
Completion date: 2023-11-14
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 NCT03199053: Study to Evaluate Safety and Efficacy of Dapagliflozin and Saxagliptin in Patients With Type 2 Diabetes Mellitus (T2DM) Aged 10 to Below 18 Years Old
Official title: A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial With a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in Pediatric Patients With Type 2 Diabetes Mellitus Who Are Between 10 and Below 18 Years of Age
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 256.0 (ACTUAL)
Number of arms: 5.0
Start date: 2017-10-11
Primary completion date: 2023-02-01
Completion date: 2024-01-03
Baseline population: Randomised Participants Data Set: consisted of all randomised participants who receive at least one dose of study medication during the treatment period.
Limitations and caveats: Due to legal dispute, the source documents could not be accessed for 11 participants at 1 site. All data from this site were excluded as documented in the statistical analysis plan.
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 rerefer 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 NCT01851083: Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury
Official title: A Phase 2 Multicenter Trial of Pediatric Autologous Bone Marrow Mononuclear Cells (BMMNCs) for Severe Traumatic Brain Injury (TBI)
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-08-31
Primary completion date: 2020-09-16
Completion date: 2020-10-12
Clinical trial NCT04747470: Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors
Official title: A Phase 1b Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583, a FLT3 Agonist Fc Fusion Protein, in Subjects With Advanced Solid Tumors
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision to prematurely discontinue the study, following an internal safety assessment of the molecule, GS-3583.
Enrollment: 13.0 (ACTUAL)
Number of arms: 11.0
Start date: 2021-03-25
Primary completion date: 2022-11-07
Completion date: 2022-11-07
Baseline population: The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Plan to share individual participant data: NO
Clinical trial NCT02774291: Anti-NY ESO-1 mTCR Peripheral Blood Lymphocytes
Official title: Pilot Study of Adoptive Cell Transfer for the Treatment of Metastatic Cancer That Expresses NY-ESO-1 Using Lymphodepleting Conditioning Followed by Infusion of Anti-NY ESO-1 Murine TCR-Gene Engineered Lymphocytes
Sponsor: Albert Einstein College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Due to lack of accrual the study was formally terminated on 01-JUL-2020. Primary Completion and Study Completion Dates have been revised based accordingly based on respective definitions
Enrollment: 3.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-04-20
Primary completion date: 2020-07-01
Completion date: 2020-08-04
Plan to share individual participant data: NO
Clinical trial NCT04516941: CorONa Virus edoxabaN ColchicinE (CONVINCE) COVID-19
Official title: Efficacy and Safety of Edoxaban and or Colchicine for Patients With SARS-CoV-2 Infection Managed in the Out of Hospital Setting
Acronym: CONVINCE
Sponsor: Insel Gruppe AG, University Hospital Bern (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient rate of patient accrual and newly available scientific evidence
Enrollment: 60.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-01-21
Primary completion date: 2022-08-31
Completion date: 2022-08-31
Plan to share individual participant data: NO
Clinical trial NCT02454933: Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours
Official title: A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of AZD9291 in Combination With MEDI4736 Versus AZD9291 Monotherapy in Patients With Locally Advanced or Metastatic Epidermal Growth Factor Receptor T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Received Prior Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy (CAURAL)
Acronym: CAURAL
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-07-15
Primary completion date: 2017-08-21
Completion date: 2023-06-21
Baseline population: The safety analysis set consisted of all subjects who received at least one dose of randomised treatment.
Limitations and caveats: Subject enrolment was terminated early on 29 September 2015 after higher than anticipated incidence of interstitial lung disease-like events in subjects receiving osimertinib + durvalumab in a separate Phase Ib open-label study D5160C00006 (TATTON).
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
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 rerefer 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 deidentified 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 NCT03170115: Induction Chemotherapy Plus Chemoradiotherapy With or Without Aspirin in High Risk Rectal Cancer
Official title: Phase II Randomized Study of Induction Chemotherapy Followed by Chemoradiotherapy With or Without Aspirin in High Risk Locally Advanced Rectal Cancer
Acronym: ICAR
Sponsor: Instituto Nacional de Cancer, Brazil (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Aspirin added to chemoradiotherapy was safe but did not improve response to total neoadjuvant treatment. The study was closed due absence of benefit.
Enrollment: 25.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-30
Primary completion date: 2020-01-17
Completion date: 2020-01-17
Plan to share individual participant data: NO
Clinical trial NCT03518567: Behavioral Economic Analysis of Demand for Marijuana
Official title: Behavioral Economic Analysis of Demand for Marijuana
Sponsor: Brown University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 133.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-10-15
Primary completion date: 2021-05-24
Completion date: 2021-05-24
Clinical trial NCT04981717: A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat
Official title: A Randomized, Double-Blind, Placebo-Controlled Study in Cat-Allergic Patients With Allergic Rhinitis Who Live With a Cat to Assess the Efficacy and Safety of Anti-Fel d 1 Antibodies During Natural Cat Exposure in the Home
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 446.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-30
Primary completion date: 2023-01-04
Completion date: 2023-04-24
Limitations and caveats: The study met prespecified interim futility criteria for CSMS and TNSS, therefore, an efficacy analysis was not performed for the primary and secondary endpoints as specified in the protocol
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: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Clinical trial NCT04727151: TAC T-cells for the Treatment of HER2-positive Solid Tumors
Official title: A Phase 1/2 Trial Investigating the Safety and Efficacy of Autologous TAC T Cell Monotherapy, and TAC T Cells in Combination With Pembrolizumab, in Relapsed HER2-Positive Solid Tumors
Acronym: TACTIC-2
Sponsor: Triumvira Immunologics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study terminated by Sponsor for commercial reasons
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-19
Primary completion date: 2023-12-17
Completion date: 2024-03-25
Plan to share individual participant data: NO
Clinical trial NCT04208386: A Study to Evaluate the Effect of Hepatic Impairment on JNJ-73763989
Official title: A Phase 1, Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of JNJ-73763989
Sponsor: Janssen Sciences Ireland UC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 16.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-01-08
Primary completion date: 2020-07-20
Completion date: 2020-07-20
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT02848001: A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-risk Myelodysplastic Syndromes
Official title: A Phase 1, Open-label, Dose Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Trial terminated because of lack of efficacy in the short term acute phase.
Enrollment: 101.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-11-14
Primary completion date: 2023-04-11
Completion date: 2024-04-11
Clinical trial NCT05375253: Donor Enriched Activated NK Cell Infusion Post Haploidentical Stem Cell Transplant for Refractory Myeloid Malignancies
Official title: A Phase I Trial of Donor Enriched Activated NK (DEA-NK) Cell Infusion Post Haploidentical Stem Cell Transplant for Refractory Myeloid Malignancies
Sponsor: University of Nebraska (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: PI has left institution and is taking the study with him.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-04-12
Primary completion date: 2023-04-12
Completion date: 2023-04-12
Plan to share individual participant data: NO
Clinical trial NCT02883062: Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
Official title: Randomized Phase 2 Study of Neoadjuvant Chemotherapy, Carboplatin and Paclitaxel, With or Without Atezolizumab in Triple Negative Breast Cancer (TNBC)
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 67.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-02
Primary completion date: 2019-12-18
Completion date: 2020-12-20
Clinical trial NCT02657005: TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
Official title: A Phase 1 / 2, Dose Escalation Study of Intravenous TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
Sponsor: Oncternal Therapeutics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Enrollment: 85.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-31
Primary completion date: 2022-05-31
Completion date: 2022-06-30
Plan to share individual participant data: NO
Clinical trial NCT04345861: Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for COVID-19 Pneumonia (COVIDOC Trial)
Official title: Randomized Trial Assessing Efficacy and Safety of Hydroxychloroquine Plus Azithromycin Versus Hydroxychloroquine for Hospitalized Adults With COVID-19 Pneumonia
Acronym: COVIDOC
Sponsor: University Hospital, Montpellier (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: halted prematurely.
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-11
Primary completion date: 2021-02-09
Completion date: 2021-04-09
Plan to share individual participant data: NO
Clinical trial NCT03616574: First-in-human Study of CA102N Monotherapy and CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors
Official title: Phase 1,Two-part (Dose Escalation, Dose Expansion), Multicenter,Non-randomized,Open-label, Multiple Dose, First-in-human Study of CA102N Monotherapy and of CA102N Combined With Trifluridine/Tipiracil (LONSURF) in Subjects With Advanced Solid Tumors
Sponsor: Holy Stone Healthcare Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 37.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-04-09
Primary completion date: 2022-02-08
Completion date: 2022-03-01
Plan to share individual participant data: NO
Clinical trial NCT04430959: Candesartan as an Adjunctive Treatment for Bipolar Depression
Official title: A Pilot, Proof of Concept, Placebo-controlled Trial of Candesartan as an Adjunctive Treatment for Bipolar Depression
Sponsor: The University of Texas Health Science Center, Houston (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: The reason the study was withdrawn was due to lack of funds. In addition, the PI is moving to a different institution and it would not be feasible to proceed with the study under these circumstances.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2022-07-01
Completion date: 2022-09-01
Clinical trial NCT02031419: Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-cell Lymphoma and Follicular Lymphoma
Official title: A Phase 1B, Multi-Center, Open-Label Study of Novel Combinations of CC-122, CC-223, CC-292, and Rituximab in Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Replaced with another clinical trial.
Enrollment: 174.0 (ACTUAL)
Number of arms: 4.0
Start date: 2013-12-18
Primary completion date: 2023-12-12
Completion date: 2023-12-12
Clinical trial NCT04584684: Mouth Rinses for Inactivation of COVID-19
Official title: Antiviral Efficacy and Acceptability of Therapeutic Antiseptic Mouth Rinses for Inactivation of COVID SARS-2 Virus
Acronym: MOR
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The team decided to terminate the trial in order to start a new trial, unrelated to safety reasons
Enrollment: 128.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-12-18
Primary completion date: 2021-10-21
Completion date: 2021-10-21
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD time frame: following publication up to 1 year
IPD access criteria: Deidentified individual data that supports the results will be shared beginning following publication up to 1 year provided the investigator who proposes to use the data has approval from an IRB, IEC, or REB as applicable, and an executed data use/sharing agreement with UNC.