chufangao/CTO huggingface dataset:
Clinical trial NCT02523768: Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment
Official title: Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment
Acronym: PIRAT
Sponsor: Centre Hospitalier Universitaire de Saint Etienne (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Difficulties for recruting patients
Enrollment: 117.0 (ACTUAL)
Number of arms: 2.0
Start date: 2011-01-08
Primary completion date: 2020-01-24
Completion date: 2020-02-24
Plan to share individual participant data: NO
Clinical trial NCT02755597: A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy
Official title: A Phase 3, Multicenter, Randomized, Double Blind Study of Bortezomib and Dexamethasone in Combination With Either Venetoclax or Placebo in Subjects With Relapsed or Refractory Multiple Myeloma Who Are Sensitive or Naïve to Proteasome Inhibitors
Acronym: Bellini
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 291.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-07-11
Primary completion date: 2021-03-15
Completion date: 2022-08-15
Baseline population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Clinical trial NCT01889186: A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion
Official title: A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 158.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-06-27
Primary completion date: 2020-10-28
Completion date: 2020-12-15
Baseline population: All treated participants: all participants who received at least one dose of ABT-199 in either the Main Cohort or Safety Expansion Cohort
Plan to share individual participant data: YES
IPD sharing description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT03646916: Intraoperative Dexamethasone and Its Effect on Hyperglycemia
Official title: Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients
Sponsor: Ascension Health (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lack of patients
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-15
Primary completion date: 2020-12-31
Completion date: 2020-12-31
Clinical trial NCT03761030: L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults
Official title: Targeting Dopaminergic Mechanisms of Slowing to Improve Late Life Depression
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The project end date was reached prior to the full sample enrollment
Enrollment: 51.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-09
Primary completion date: 2021-09-08
Completion date: 2021-09-08
Limitations and caveats: Data collected in the trial have been presented as required but are considered unreliable.
Plan to share individual participant data: NO
Clinical trial NCT03515941: Postoperative Chemoradiation or Chemotherapy After Preoperative Chemotherapy for Gastric Cancers
Official title: A Pilot Study in Gastric Cancer of Assignment to Postoperative Chemoradiation or Chemotherapy Based Upon Surgical Lymph Node Assessment After Preoperative Chemotherapy, With Gene Assay as Correlate of Biologic Response
Acronym: GABLE
Sponsor: Baylor College of Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: The PI has decided to close the study due to the outdated study design.
Enrollment: 6.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-22
Primary completion date: 2020-03-17
Completion date: 2020-06-18
Clinical trial NCT02897830: Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Plus Lenalidomide Maintenance in Multiple Myeloma
Official title: Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and Extended Consolidation Followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients ≤65 Years Eligible for High Dose Therapy
Acronym: IFM2014-03
Sponsor: University Hospital, Toulouse (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: negatives results
Enrollment: 46.0 (ACTUAL)
Number of arms: 1.0
Start date: 2016-08-05
Primary completion date: 2018-11-30
Completion date: 2020-08-31
Plan to share individual participant data: NO
Clinical trial NCT03234153: Neoadjuvant Immunotherapy With Durvalumab and Tremelimumab for Bladder Cancer Patients Ineligible for Cisplatin
Official title: Neoadjuvant Immunotherapy With Durvalumab in Combination With Tremelimumab in Patients With Muscle-invasive Bladder Cancer Ineligible for Cisplatin-based Chemotherapy.
Acronym: NITIMIB
Sponsor: Insel Gruppe AG, University Hospital Bern (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: low accrual
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-07-15
Primary completion date: 2019-11-08
Completion date: 2020-05-18
Clinical trial NCT02792192: Safety and Pharmacology Study of Atezolizumab Alone and in Combination With Bacille Calmette-Guérin (BCG) in High-Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) Participants
Official title: A Phase Ib/II, Open-Label Study of the Safety and Pharmacology of Atezolizumab Administered With or Without Bacille Calmette-Guérin in Patients With High-Risk Non-Muscle-Invasive Bladder Cancer
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated early as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Enrollment: 24.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-06-13
Primary completion date: 2020-09-29
Completion date: 2020-09-29
Baseline population: Participants were enrolled only in Cohort 1 of this study. The Sponsor decided to stop further enrollment for Cohorts 2 and 3 after the enrollment of 24 participants in Cohort 1 (BCG-unresponsive cohort), as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Limitations and caveats: Participants were enrolled only in Cohort 1 of this study. The Sponsor decided not to enroll participants in Cohorts 2 and 3 after the enrollment of 24 patients in Cohort 1 (BCG-unresponsive cohort), as the study had met its goals of providing preliminary safety and efficacy information for atezolizumab monotherapy alone and in combination with BCG in NMIBC.
Clinical trial NCT04272333: Intratumoral Microdosing of Motolimod in HNSCC
Official title: A Phase 0 Study Using the CIVO® Platform to Evaluate Intratumoral Microdoses of Motolimod Singly and in Combination With Nivolumab in Patients With Head and Neck Cancer
Sponsor: Presage Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: Partner Termination
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-10-15
Primary completion date: 2022-03-25
Completion date: 2022-03-25
Plan to share individual participant data: NO
Clinical trial NCT04084444: Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients
Official title: Efficacy and Safety of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients: A Multicenter, Randomized, Double-blind, Dose-finding, Placebo-controlled Study
Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 151.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-12-25
Primary completion date: 2022-07-05
Completion date: 2022-07-05
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03426267: Evaluation of Efficacy and Safety of SDN-037
Official title: A Randomized, Double-Masked, Parallel Group, Multicenter, Study To Evaluate Efficacy And Safety of SDN -037 Twice Daily Compared With Vehicle For The Treatment Of Inflammation And Pain Associated With Ocular Surgery.
Sponsor: Sun Pharma Advanced Research Company Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 325.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-28
Primary completion date: 2020-03-05
Completion date: 2020-03-05
Baseline population: modified intent-to-treat population
Plan to share individual participant data: NO
Clinical trial NCT04347980: Dexamethasone Treatment for Severe Acute Respiratory Distress Syndrome Induced by COVID-19
Official title: Dexamethasone Combined With Hydroxychloroquine Compared to Hydroxychloroquine Alone for Treatment of Severe Acute Respiratory Distress Syndrome Induced by Coronavirus Disease 19 (COVID-19): a Multicentre, Randomised Controlled Trial
Acronym: DHYSCO
Sponsor: Centre Chirurgical Marie Lannelongue (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: ANSM RECOMMANDATION
Enrollment: 5.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-17
Primary completion date: 2020-08-07
Completion date: 2020-08-07
Plan to share individual participant data: YES
IPD sharing description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
IPD time frame: Beginning 3 months and ending 24 months following article publication
IPD access criteria: Researchers who provide a methodologically sound and proposal. Data are available for 24 months and request should be addressed by email
Clinical trial NCT04622774: First-in-Human Study of IMGC936 in Patients With Advanced Solid Tumors
Official title: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation and Expansion Study of IMGC936 (Anti-ADAM9 Antibody Drug Conjugate) in Patients With Advanced Solid Tumors
Sponsor: ImmunoGen, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 56.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-26
Primary completion date: 2023-12-31
Completion date: 2023-12-31
Clinical trial NCT03892044: Duvelisib and Nivolumab in Treating Patients With Richter Syndrome or Transformed Follicular Lymphoma
Official title: A Phase I Study of Duvelisib in Combination With Nivolumab for Patients With Richter's Syndrome and Transformed Follicular Lymphoma
Sponsor: Ohio State University Comprehensive Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 7.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-11-05
Primary completion date: 2024-02-14
Completion date: 2024-02-14
Plan to share individual participant data: NO
Clinical trial NCT04228666: A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Alzheimer's Disease
Official title: A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-adMSCs) for the Treatment of Alzheimer's Disease
Sponsor: Hope Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Due to COVID 19 Pandemic
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-03-01
Primary completion date: 2022-02-01
Completion date: 2022-02-01
Plan to share individual participant data: NO
Clinical trial NCT03319784: Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
Official title: A Randomized Single Blinded Prospective Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
Sponsor: Milton S. Hershey Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: never initiated
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-09-05
Primary completion date: 2020-09-05
Completion date: 2020-10-05
Clinical trial NCT02649439: Prostvac in Patients With Biochemically Recurrent Prostate Cancer
Official title: Prostvac in Patients With Biochemically Recurrent Prostate Cancer
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 97.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-12-22
Primary completion date: 2019-03-28
Completion date: 2022-10-01
Plan to share individual participant data: NO
Clinical trial NCT05120375: Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients in China
Official title: A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT6021 as Mono Therapy or in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Sponsor: Bio-Thera Solutions (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Based on the disclosed global research data on the same target drugs, the company has carefully considered and decided to terminate the project to optimize the existing research pipeline.
Enrollment: 5.0 (ACTUAL)
Number of arms: 8.0
Start date: 2022-02-17
Primary completion date: 2023-04-07
Completion date: 2023-04-07
Plan to share individual participant data: NO
Clinical trial NCT04411472: (Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI
Official title: A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI
Sponsor: AM-Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The Data Monitoring Committee (DMC) concluded that the pre-specified futility threshold was met and that there was no safety concern.
Enrollment: 676.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-02
Primary completion date: 2022-08-18
Completion date: 2022-08-18
Baseline population: Baseline characteristics are presented for the modified intent-to-treat population
Limitations and caveats: The trial was terminated early due to futility being reached for the primary endpoint of all cause mortality at day 28 at the interim analysis.
Clinical trial NCT02527434: Study of Tremelimumab in Patients With Advanced Solid Tumors
Official title: A Phase II, Multi-Center, Open-Label Study of Tremelimumab Monotherapy in Patients With Advanced Solid Tumors
Sponsor: AstraZeneca (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 64.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-11-02
Primary completion date: 2018-02-17
Completion date: 2023-03-28
Baseline population: Analysis was performed on the FAS (all treated patients who received at least 1 dose of tremelimumab monotherapy).
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 NCT03439254: Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Official title: A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
Acronym: REVERSE
Sponsor: Intercept Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 919.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-08-30
Primary completion date: 2022-09-08
Completion date: 2022-09-08
Baseline population: Intent-To-Treat (ITT) Population: included all randomized participants.
Clinical trial NCT02361346: Safety, PD & Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
Official title: Safety, Pharmacodynamics and Efficacy of MT-3724 for the Treatment of Patients With Relapsed or Refractory DLBCL
Acronym: MT-3724NHL001
Sponsor: Molecular Templates, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision following clinical hold
Enrollment: 38.0 (ACTUAL)
Number of arms: 9.0
Start date: 2015-02-28
Primary completion date: 2021-03-22
Completion date: 2021-03-22
Baseline population: Part 2 was analyzed as a single arm as data was not collected for each dose level separately. As no participants from Part 3 had shown a response and as potential risks outweighed benefits, the study was terminated and no participants entered Part 4.
Plan to share individual participant data: NO
Clinical trial NCT04430036: AGEN1884 Plus AGEN2034 Combined With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer
Official title: A Phase II Trial of Neoadjuvant AGEN1884 Plus AGEN2034 in Combination With Cisplatin-Gemcitabine for Muscle-Invasive Bladder Cancer Prior to Radical Cystectomy
Sponsor: The University of Texas Health Science Center at San Antonio (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: PI left the institution
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-10-14
Primary completion date: 2021-10-18
Completion date: 2022-03-14
Plan to share individual participant data: NO
Clinical trial NCT04961658: Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients
Official title: Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients
Acronym: AMETHYST
Sponsor: Northern Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Funding Decision
Enrollment: 11.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-08-11
Primary completion date: 2023-08-10
Completion date: 2024-01-08
Plan to share individual participant data: NO
Clinical trial NCT02041533: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer (CheckMate 026)
Official title: An Open-Label, Randomized, Phase 3 Trial of Nivolumab Versus Investigator's Choice Chemotherapy as First-Line Therapy for Stage IV or Recurrent PD-L1+ Non-Small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 541.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-03-27
Primary completion date: 2016-07-01
Completion date: 2022-05-27
Baseline population: All randomized participants
Clinical trial NCT03752099: To Evaluate Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
Official title: A Phase 1b/2 Study to Evaluate the Safety and Tolerability of VERU-111 in Men With Advanced Metastatic Castration Resistant Prostate Cancer
Sponsor: Veru Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Administrative decision
Enrollment: 80.0 (ACTUAL)
Number of arms: 6.0
Start date: 2019-01-18
Primary completion date: 2023-03-15
Completion date: 2023-03-15
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04236258: Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Official title: A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
Sponsor: Brigham and Women's Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 94.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-01-24
Primary completion date: 2021-06-30
Completion date: 2021-06-30
Limitations and caveats: The trial was conducted during the COVID pandemic which fundamentally changed the way patients interact with the medical system.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual participant data will be made available to other researchers for all primary and secondary outcomes as well as demographic data.
IPD time frame: The data will be available for approximately six months after the study's conclusion.
IPD access criteria: Data access requests will be reviewed by the internal Institutional Review Board.