chufangao/CTO huggingface dataset:
Clinical trial NCT04936971: Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response
Official title: Effect of the Introduction of mTor Inhibitors in the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response to Control Viral Replication in Kidney Transplant Patients
Acronym: ACTIVA
Sponsor: Hospital Universitari de Bellvitge (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Impossibility to perform tests (elispot) of the study due to change of location of laboratory
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-30
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Clinical trial NCT02527681: Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics
Official title: An Open-label Study to Evaluate the Single-dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged up to 3 Months Undergoing Treatment With Systemic Antibiotics
Sponsor: Basilea Pharmaceutica (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: on July 07, 2020 due to slow enrollment; there were no safety concerns.
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-11-22
Primary completion date: 2020-02-25
Completion date: 2020-02-25
Clinical trial NCT02728037: Magnesium-Based Trigger Point Injections for Relief of Chronic Myofascial Pelvic Pain
Official title: Randomized Control Trial of Magnesium-Based Trigger Point Injections vs. Lidocaine-Only Trigger Point Injections for Relief of Chronic Myofascial Pelvic Pain
Sponsor: Queen's University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low Enrollment, Adoption of investigational treatment into standard practice at our center.
Enrollment: 38.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-04-30
Primary completion date: 2020-03-31
Completion date: 2020-04-30
Clinical trial NCT03443869: Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 601.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-03
Primary completion date: 2022-04-05
Completion date: 2022-04-05
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05152641: Study to Evaluate Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study Investigating the Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery
Sponsor: BioAge Labs, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The program priority for execution of this clinical trial changed prior to enrollment of the first patient. The study was not withdrawn due to any safety concerns.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2022-04-30
Primary completion date: 2023-04-30
Completion date: 2024-07-31
Clinical trial NCT03850509: Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Trial to Assess the Efficacy and Safety of Orally Administered OPS-2071 for 12 Weeks in Subjects With Crohn's Disease Showing Symptoms of Active Inflammation Despite Ongoing Treatment
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 3.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-02-25
Primary completion date: 2020-05-22
Completion date: 2020-05-22
Baseline population: The Randomized Set included all participants who were randomized into this trial.
Plan to share individual participant data: YES
IPD sharing description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD time frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD access criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com
Clinical trial NCT03533946: Rucaparib in Nonmetastatic prOstAte With BRCAness
Official title: A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating BRCAness Genotype (ROAR)
Acronym: ROAR
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: New standard of care for study participant population
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-20
Primary completion date: 2023-01-12
Completion date: 2023-01-12
Plan to share individual participant data: NO
Clinical trial NCT03186209: Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
Official title: A Multicentre, Randomised, Double-blind, Parallel Group, Placebocontrolled, Phase 3 Efficacy and Safety Study of Benralizumab (MEDI-563) Added to Medium to High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist in Patients With Uncontrolled Asthma.
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 695.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-07
Primary completion date: 2023-01-30
Completion date: 2023-01-30
Baseline population: Full analysis set, all participants who were randomized and received at least one investigational product (IP), Benralizumab or Placebo.
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 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 NCT02774460: The Precision Hypertension Care Study
Official title: The Precision Hypertension Care Study
Acronym: PHYSIC
Sponsor: Uppsala University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 280.0 (ACTUAL)
Number of arms: 7.0
Start date: 2017-02-20
Primary completion date: 2021-06-11
Completion date: 2021-06-11
Clinical trial NCT03908255: Branched-chain Amino Acid Supplementation for Hepatocellular Carcinoma
Official title: Impact of Branched-chain Amino Acid Supplementation on Quality of Life and Overall Survival in Patients Receiving Liver Directed Therapy for Hepatocellular Carcinoma
Acronym: BCAA in HCC
Sponsor: Louisiana State University Health Sciences Center in New Orleans (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Dr. Marshall left UMC and LSU Health Sciences Center.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-06-01
Primary completion date: 2022-12-30
Completion date: 2023-12-30
Plan to share individual participant data: YES
IPD sharing description: Individual participant data may be shared in collaboration with the current investigators for future studies in which branched chain amino acids for treatment of liver disease are studied in a similar manner to this protocol. All collected data may be made available after local Institutional Review Board authorization, de-identification through a secure method of data transfer (encrypted file sharing) and kept on a secure server.
IPD time frame: The time frame for data sharing will begin after initial publication and will extend for 5 years.~After this point, data will be purged from secured servers and will no longer be available for sharing.
IPD access criteria: A request for data will be made through the principal investigator of this study, who is responsible for data storage. Requests will be made to local Institutional Review Boards prior to de-identified data release.
Clinical trial NCT00410956: Floxuridine and Dexamethasone as a Hepatic Arterial Infusion and Bevacizumab in Treating Patients With Primary Liver Cancer That Cannot be Removed by Surgery
Official title: A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Bevacizumab (A Monoclonal Antibody to Vascular Endothelial Growth Factor-A), in Patients With Unresectable Primary Hepatic Malignancy
Sponsor: Memorial Sloan Kettering Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2007-05-09
Primary completion date: 2024-05-07
Completion date: 2024-05-07
Clinical trial NCT03867851: Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation
Official title: Open, Randomized, Active Comparator-controlled, Multi-Center Study to Evaluate Safety and Efficacy of IBsolvMIR® in Islet Transplantation
Sponsor: TikoMed AB (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Slow patient recruitment
Enrollment: 7.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-02-08
Primary completion date: 2024-05-13
Completion date: 2024-05-13
Plan to share individual participant data: NO
Clinical trial NCT03702621: Comparing Liposomal Bupivacaine Versus Standard Bupivacaine in Colorectal Surgery
Official title: Liposomal Bupivacaine Versus Standard Bupivacaine Hydrochloride In Colorectal Surgery
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-30
Primary completion date: 2020-03-13
Completion date: 2020-03-13
Clinical trial NCT03895099: New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
Official title: Feasibility and Efficacy of a New Ovarian Stimulation Regimen With RANDom Start, Use of Corifollitropin Alpha and Progestin Protocol for Oocyte donorS
Acronym: RANDOS
Sponsor: Centre Hospitalier Intercommunal Creteil (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 110.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-09-04
Primary completion date: 2023-10-30
Completion date: 2023-10-30
Plan to share individual participant data: NO
Clinical trial NCT04485052: Efficacy and Safety Evaluation of IBI188 in Combination With Demethylating Agents in Treatment of Patients With Acute Myeloid Leukemia
Official title: A Phase Ib Study Evaluating the Safety and Efficacy of IBI188 in Combination With Demethylating Agents in Subjects With Acute Myeloid Leukemia
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Why stopped: Pause for changes in development strategies
Enrollment: 222.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2020-09-25
Primary completion date: 2024-06-30
Completion date: 2024-12-31
Clinical trial NCT02637076: Xyrem and Brain Dopamine in Narcolepsy
Official title: Does Xyrem Influence Brain Dopamine in Patients With Narcolepsy? A PET Imaging Investigation
Sponsor: Centre for Addiction and Mental Health (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 17.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-01-31
Primary completion date: 2020-01-23
Completion date: 2020-01-23
Clinical trial NCT05409183: Effectiveness of CRD-740 in Heart Failure
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects With Chronic Heart Failure (CARDINAL-HF)
Acronym: CARDINAL-HF
Sponsor: Cardurion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Part A of the study was successfully concluded. Part B of the study was discontinued in favor of redesigned new studies.
Enrollment: 60.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-26
Primary completion date: 2023-05-02
Completion date: 2023-07-25
Plan to share individual participant data: NO
Clinical trial NCT04483700: Study to Evaluate the Efficacy and Safety of Filgotinib in Participants With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Filgotinib in Subjects With Active Ankylosing Spondylitis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drug Therapy
Acronym: SEALION2-NAÏVE
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Development program terminated
Enrollment: 0.0 (ACTUAL)
Number of arms: 5.0
Start date: 2020-12-31
Primary completion date: 2022-10-31
Completion date: 2024-06-30
Plan to share individual participant data: NO
Clinical trial NCT04761601: First in Human Study of UCT-01-097 in Participants With Advanced Solid Tumors
Official title: A Phase 1, First in Human, Dose-Escalation Study of UCT-01-097 in Participants With Advanced Solid Tumors
Sponsor: 1200 Pharma, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Stopped for strategic business reasons. The decision to stop the study was not connected to any safety concerns, or new risk associated with the study product, intervention, or procedures.
Enrollment: 32.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-03-03
Primary completion date: 2024-02-19
Completion date: 2024-02-29
Plan to share individual participant data: NO
Clinical trial NCT02739542: Assessment of Tecfidera® in Radiologically Isolated Syndrome (RIS)
Official title: Multi-center, Randomized, Double-blinded Assessment of Tecfidera® in Extending the Time to a First Attack in Radiologically Isolated Syndrome (RIS) (ARISE)
Acronym: ARISE
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 87.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-03-19
Primary completion date: 2021-03-31
Completion date: 2021-03-31
Plan to share individual participant data: NO
Clinical trial NCT04534283: A Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib.
Official title: A Phase 2 Basket Trial of an ERK1/2 Inhibitor (LY3214996) in Combination With Abemaciclib for Patients Whose Tumors Harbor Pathogenic Alterations in BRAF, RAF1, MEK1/2, ERK1/2, and NF1.
Sponsor: Indiana University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of efficacy.
Enrollment: 16.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-05
Primary completion date: 2023-08-07
Completion date: 2023-08-07
Baseline population: All enrolled patients who received at least one dose of study treatment.
Limitations and caveats: Early termination leading to smaller number of patients enrolled than planned.
Clinical trial NCT03814109: Efficacy and Safety of Leningrado Association in the Treatment of Hypertension
Official title: Randomized, Double-blind, Triple-dummy, National, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Leningrado Association in the Treatment of Hypertension
Sponsor: EMS (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-04-30
Primary completion date: 2023-11-30
Completion date: 2024-01-31
Clinical trial NCT03452540: Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis
Official title: A Randomised, Double-Blind, Placebo-Controlled, Phase II Study to Assess the Efficacy and Safety of Orally Administered DS102 in Patients With Acute Decompensated Alcoholic Hepatitis.
Sponsor: Afimmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Company Decision
Enrollment: 9.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-28
Primary completion date: 2019-06-19
Completion date: 2020-03-31
Baseline population: The Full Analysis Set (FAS) included all patients who received at least one dose of investigational product. Patients were analysed according to the treatment they were assigned to, irrespective of what treatment they actually received.
Limitations and caveats: Early termination - The study was stopped at the end of the pilot phase (n=9) as the sponsor prioritised other therapeutic indications, so no patients were enrolled in the double-blind phase.
Clinical trial NCT03953170: Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
Official title: Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Funding ended
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-02
Primary completion date: 2022-11-25
Completion date: 2022-12-29
Plan to share individual participant data: NO
IPD sharing description: De-identified study data will be shared with study sponsor (Shire Human Genetics Therapies, Inc)
Clinical trial NCT04241159: Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults
Official title: A Small-Scale Study to Explore the Safety and Feasibility of Allogeneic Young Plasma Infusion in Older Adults Experiencing Disability Across the Spectrum of Frailty Syndrome
Sponsor: Wake Forest University Health Sciences (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Protocol required revisions and application was withdrawn from the IRB.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-31
Primary completion date: 2020-08-31
Completion date: 2020-08-31
Clinical trial NCT03728465: Evaluation of Safety and Efficacy of Patients With Four and More Symptomatic Brain Metastases of Melanoma
Official title: An Open Label Phase II Study to Evaluate Safety and Efficacy of Combined Treatment With Ipilimumab and Nivolumab in Patients With Four and More Symptomatic Brain Metastases of Melanoma
Sponsor: University Hospital Tuebingen (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of patients
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-04-10
Primary completion date: 2021-01-01
Completion date: 2021-01-01
Plan to share individual participant data: NO
Clinical trial NCT05096884: Post-Acute Sequelae of Coronavirus-19 (COVID-19) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study
Official title: Post-Acute Sequelae of Coronavirus-19 (COVID-19) With DysPnEA on ExertIon And Associated TaChycardia TrEatment Study
Acronym: PEACE
Sponsor: Hackensack Meridian Health (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-03-23
Primary completion date: 2023-09-12
Completion date: 2023-09-12
Plan to share individual participant data: NO
Clinical trial NCT03474614: Effect of Oral Propranolol on mRNA Expresssion in Symptomatic Cavernous Malformation
Official title: Effect of Oral Propranolol on mRNA Expression in Symptomatice Caavernous Malformation
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: lack of accrual
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-24
Primary completion date: 2021-02-11
Completion date: 2021-02-11
Plan to share individual participant data: NO
Clinical trial NCT02737306: A Study of Acute Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Stem-Cell Transplantation
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of PRO 140 for Prophylaxis of Acute Graft-Versus-Host Disease in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)
Acronym: GVHD
Sponsor: CytoDyn, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to lack of enrolment..
Enrollment: 11.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-05-14
Primary completion date: 2021-04-14
Completion date: 2021-09-30
Baseline population: The Intent-to-Treat (ITT) population is defined as the set of subjects who are randomized to PRO 140 or placebo. The ITT population will be the primary analysis population for the analysis of primary and secondary endpoints
Limitations and caveats: This study was stopped prior to completion due to lack of enrolment.
Plan to share individual participant data: NO
Clinical trial NCT03636555: Oxytocin Treatment for Alcohol Use Disorders
Official title: Intranasal Oxytocin Treatment for Alcohol Use Disorders: A Randomized, Placebo-Controlled Trial
Acronym: OT-ETOH-4
Sponsor: University of North Carolina, Chapel Hill (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: PI no longer employed at Institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-31
Primary completion date: 2022-09-30
Completion date: 2022-09-30
Plan to share individual participant data: YES
IPD sharing description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication.
IPD time frame: 9 to 36 months following publication
IPD access criteria: 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.