chufangao/CTO huggingface dataset:
Clinical trial NCT03361137: Study of Emicizumab Prophylaxis in Participants With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures
Official title: A Phase IV, Multicenter, Single-Arm, Open-Label Study of Emicizumab Prophylaxis in Patients With Hemophilia A With or Without Inhibitors Undergoing Minor Surgical Procedures
Sponsor: Genentech, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The Sponsor decided to terminate the study early for several reasons (low enrollment, limited variety of surgery types, and available scientific data).
Enrollment: 14.0 (ACTUAL)
Number of arms: 5.0
Start date: 2018-06-28
Primary completion date: 2020-03-13
Completion date: 2020-03-13
Limitations and caveats: No definitive efficacy conclusions were drawn due to study limitations that included early enrollment termination, limited number of participants enrolled, and evaluation in only 2 minor surgical procedure types.
Clinical trial NCT03175367: Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 272.0 (ACTUAL)
Number of arms: 7.0
Start date: 2017-11-10
Primary completion date: 2020-05-22
Completion date: 2020-12-14
Clinical trial NCT03493464: BR55 in Characterization of Ovarian Lesions
Official title: BR55 Contrast Enhanced Ultrasound (CEUS) in Characterization of Ovarian Lesions
Sponsor: Bracco Diagnostics, Inc (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor decision; expiration of available study agent due to long recruitment timeline.
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-12-13
Primary completion date: 2021-04-15
Completion date: 2021-07-31
Baseline population: All participants enrolled and dosed in the study who provided demographic information.
Plan to share individual participant data: NO
Clinical trial NCT02404935: Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
Official title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
Acronym: TIME
Sponsor: UNICANCER (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 139.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-11-22
Primary completion date: 2020-11-01
Completion date: 2021-10-25
Clinical trial NCT03965091: A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of the Efficacy and Safety of Fremanezumab for Treatment of Patients With Fibromyalgia
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Met pre-specified criteria for futility at interim analysis
Enrollment: 189.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-07-31
Primary completion date: 2022-01-19
Completion date: 2022-01-19
Baseline population: The intent-to-treat (ITT) analysis set included all randomized participants.
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 study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Clinical trial NCT04944992: A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)
Official title: A Phase 2a, Randomized, Active-Comparator-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Individuals With Nonalcoholic Fatty Liver Disease
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 145.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-08-04
Primary completion date: 2022-10-19
Completion date: 2022-10-19
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT05557110: Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL
Official title: A Multicenter, Single-arm, Open-end Study of Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Philadelphia Chromosome Negative Acute B Lymphoblastic Leukemia
Sponsor: The First Affiliated Hospital of Soochow University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 35.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-09-08
Primary completion date: 2024-01-05
Completion date: 2024-03-31
Plan to share individual participant data: NO
Clinical trial NCT05387239: Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
Official title: Safety and Effectiveness of VL-PX10 + VL-P22 Treatment on Pulmonary Fibrosis Secondary to Covid-19
Sponsor: Vitti Labs, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: Sponsor request
Enrollment: 20.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2022-11-30
Primary completion date: 2024-11-30
Completion date: 2024-12-31
Clinical trial NCT03969212: Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households
Official title: A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 4176.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-10
Primary completion date: 2024-05-10
Completion date: 2024-05-10
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)
Clinical trial NCT03371498: Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome
Official title: Procollagen-3 Driven Corticosteroids for Persistent Acute Respiratory Distress Syndrome
Acronym: ProCoCo
Sponsor: Assistance Publique Hopitaux De Marseille (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Insufficient recruitment of eligible patients.
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-12-27
Primary completion date: 2023-11-29
Completion date: 2023-11-29
Plan to share individual participant data: NO
Clinical trial NCT04084158: A Study of Toripalimab Combined With Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma.
Official title: A Phase II, Randomized, Open Label, Multi-center Design Study of Toripalimab Given Before and After Concurrent Chemoradiotherapy in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Sponsor: Zhejiang Cancer Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: SUSPENDED 
Why stopped: combination arm delevelped significant poor prognosis
Enrollment: 100.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2019-09-07
Primary completion date: 2021-12-30
Completion date: 2021-12-30
Plan to share individual participant data: NO
Clinical trial NCT03933007: Relation Between Blood Concentration of Colchicine and Response to Colchicine Treatment in Gout Flare
Official title: Comparison of Maximum Blood Concentrations of Colchicine Between Responders and Non-responders to Colchicine Treatment During Gout Flare
Acronym: COMpARE
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: faillure of recrutement
Enrollment: 26.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-09-10
Primary completion date: 2019-10-10
Completion date: 2024-02-28
Clinical trial NCT03081117: Intranasal Insulin for the Treatment of HAND
Official title: Clinical Trial of Intranasal Insulin for the Treatment of HIV-associated Neurocognitive Disorder (HAND)
Sponsor: Johns Hopkins University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: On 3/15/2020 study visits were suspended due to COVID-19 pandemic. With safety concerns surrounding COVID-19 and difficulty recruiting, the investigators decided to close enrollment 10/16/2020 after interim data were reviewed by the DSMB and NIH.
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-01
Primary completion date: 2020-05-20
Completion date: 2020-10-16
Plan to share individual participant data: NO
Clinical trial NCT03413891: Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
Official title: Tranexamic Acid To Reduce Bleeding in Patients Treated With New Oral Anticoagulants Undergoing Dental Extraction
Acronym: EXTRACT-NOAC
Sponsor: Universitaire Ziekenhuizen KU Leuven (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Advice from DSMB
Enrollment: 222.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-07
Primary completion date: 2020-03-19
Completion date: 2020-03-19
Baseline population: All randomized patients except those who were lost to follow-up or who had a protocol violation were included in the full analysis set.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05074992: A Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma
Official title: A Phase II Trial of Neoadjuvant Therapy in Patients With Newly Diagnosed Glioblastoma
Acronym: NeAT Glio
Sponsor: University College, London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Support withdrawn from drug company supplying IMP
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-08-24
Primary completion date: 2023-05-02
Completion date: 2023-05-02
Plan to share individual participant data: NO
Clinical trial NCT03435250: Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Official title: A Phase 1 Study of AG-270 in the Treatment of Subjects With Advanced Solid Tumors or Lymphoma With Homozygous Deletion of MTAP
Sponsor: Servier (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Strategic reasons
Enrollment: 123.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-03-04
Primary completion date: 2023-04-20
Completion date: 2023-04-20
Plan to share individual participant data: YES
IPD sharing description: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.~Access can be requested for all interventional clinical studies:~* used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).~* where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.~In addition, access can be requested for all interventional clinical studies in patients:~* sponsored by Servier~* with a first patient enrolled as of 1 January 2004 onwards~* for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
IPD time frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
IPD access criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Clinical trial NCT03971422: A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 200.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-06-03
Primary completion date: 2021-08-31
Completion date: 2021-10-26
Baseline population: Baseline Characteristics refers to the Randomized Set (RS) which consisted of all study participants who were randomized and analyzed according to the treatment assigned instead of the actual treatment received.
Plan to share individual participant data: YES
IPD sharing description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
IPD time frame: Data from this study may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
IPD access criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Clinical trial NCT04730804: A Study of ALXN1830 in Healthy Adult Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of Subcutaneous ALXN1830 in Healthy Participants
Sponsor: Alexion Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Sponsor decision to terminate program
Enrollment: 34.0 (ACTUAL)
Number of arms: 6.0
Start date: 2021-03-17
Primary completion date: 2021-12-14
Completion date: 2022-01-04
Baseline population: The Safety Set included all participants who received at least 1 dose of study drug.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04880278: Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder
Official title: Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder
Sponsor: New York State Psychiatric Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: The Principal Investigator is no longer at the Institution and a request for early termination of the grant supporting the study was submitted to NIH.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-03-01
Primary completion date: 2024-05-08
Completion date: 2024-05-08
Plan to share individual participant data: NO
Clinical trial NCT03432676: Epacadostat and Pembrolizumab in Treating Participants With Advanced Pancreatic Cancer
Official title: Single-Arm, Phase II Proof of Concept Study of IDO-1 Inhibitor Epacadostat in Combination With Pembrolizumab in Advanced Pancreatic Cancer With Chromosomal Instability/Homologous Recombination Repair Deficiency (HRD)
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Incyte (supporter of the study) is no longer going to support the study.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-07-31
Primary completion date: 2020-04-30
Completion date: 2021-04-30
Clinical trial NCT04309734: Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
Official title: A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
Sponsor: Atea Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawn prior to study initiation.
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-10-31
Primary completion date: 2022-06-30
Completion date: 2022-09-30
Clinical trial NCT05767749: Split Face Study of the Duration of Local Anesthetics
Official title: Characterizing and Comparing the Duration of Local Anesthetic in Dermatologic Surgery
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 75.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-03-14
Primary completion date: 2023-07-31
Completion date: 2023-07-31
Baseline population: Participants were excluded from analysis if they withdrew from the study (1 participant), did not regain sensation bilaterally before leaving the study site (3 participants), or, if the time to regain sensation could not be accurately determined (1 participant).
Plan to share individual participant data: NO
Clinical trial NCT04323124: Study of Single and Multiple Ascending Doses of PF-07059013 in Healthy Adult Participants
Official title: A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE DOSE ESCALATION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07059013 AND OPEN-LABEL ASSESSMENT OF FOOD AND FORMULATION ON PHARMACOKINETICS OF PF-07059013 IN HEALTHY ADULT PARTICIPANTS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study was terminated as it did not demonstrate sufficient pharmacological effect. Termination was not related to safety reasons.
Enrollment: 61.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-07-17
Primary completion date: 2021-10-21
Completion date: 2021-10-21
Limitations and caveats: After the completion of the Part 1 and Part 2, due to failure to demonstrate sufficient pharmacologic effect in relation to the study PK and pharmacodynamic (PD) objectives in healthy participants as defined in the study protocol, the study was terminated prematurely. The decision to terminate the study was made while Part 3 was in progress (5 participants enrolled).
Plan to share individual participant data: NO
IPD sharing description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Clinical trial NCT05258721: Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on MGI, PI and BOP
Official title: Efficacy of ClōSYS® Sensitive Fluoride Toothpaste and ClōSYS® Sensitive Rinse Regimen on Plaque, Gingival Inflammation and Bleeding Upon Probing
Sponsor: Rowpar Pharmaceuticals, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 60.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-07-06
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Plan to share individual participant data: NO
Clinical trial NCT04069234: Study in Diabetes Mellitus Patients Without Prior Myocardial Infarction or Stroke Undergoing Elective Percutaneous Coronary Intervention.
Official title: 30-d Rand, Eval-blind, Controlled, Multi-centre, Parallel, ph III Study to Evaluate Effect of a Low Maint Dose Ticagrelor Regimen vs Standard Dose Clopidogrel on Coronary Flow Reserve in DM Patients With Impaired Microvascular Function Without Prior MI or Stroke Undergoing ePCI.
Acronym: AUGEAS
Sponsor: Region Skane (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Sponsor decided to stop the study due to commercial reasons.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-15
Primary completion date: 2021-10-15
Completion date: 2022-03-31
Clinical trial NCT04355169: A Study of Naldemedine in Participants Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Naldemedine in Patients Undergoing Surgeries That Include a Bowel Resection or Bowel Transection
Sponsor: Shionogi Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: This study was terminated before the planned sample size was enrolled due to very slow enrollment.
Enrollment: 2.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-11-06
Primary completion date: 2021-01-04
Completion date: 2021-01-04
Baseline population: This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Limitations and caveats: This study was terminated by the Sponsor. Due to study termination and only 2 participants being enrolled there are concerns regarding participant confidentiality, therefore no data are being reported.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04234477: Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial (AIRCRAFT)
Official title: Assessment of Intravenous Rate Control Response in Atrial Fibrillation Trial Pilot Study (AIRCRAFT)
Acronym: AIRCRAFT
Sponsor: Boston University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: The study was not IRB approved and there were anticipated challenges in recruiting participants.
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-12-31
Primary completion date: 2022-06-30
Completion date: 2022-06-30