chufangao/CTO huggingface dataset:
Clinical trial NCT03777982: Conventional Androgen Deprivation Therapy (ADT) With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and ADT
Official title: A Randomized Phase III Study - Conventional Androgen Deprivation Therapy With or Without Abiraterone Acetate + Prednisone and Apalutamide Following a Detectable PSA After Radiation and Androgen Deprivation Therapy
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: PI is terminating the study due to slow/low accrual
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-20
Primary completion date: 2024-02-13
Completion date: 2024-02-13
Baseline population: Those who initiate the treatment
Plan to share individual participant data: YES
IPD sharing description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor-Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
IPD time frame: Data can be shared no earlier than 1 year following the date of publication.
IPD access criteria: Requests may be directed to: \[contact information for Sponsor-Investigator or designee\].
Clinical trial NCT03355573: A Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Official title: A Multicenter, Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of Bimekizumab in Subjects With Ankylosing Spondylitis
Acronym: BE AGILE 2
Sponsor: UCB Pharma (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 255.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-28
Primary completion date: 2022-10-19
Completion date: 2022-10-19
Plan to share individual participant data: NO
Clinical trial NCT04035603: Multimodal Cue Exposure Therapy for Smoking Cessation
Official title: Multimodal CET for Smoking Cessation Augmented With D-cycloserine
Sponsor: Boston University Charles River Campus (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Never received funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-01
Primary completion date: 2021-01-31
Completion date: 2021-01-31
Plan to share individual participant data: YES
IPD sharing description: One year after publication of the primary aims from this project the primary and fully de-identified IPD will be made available by the investigators on CD for other researchers providing documented IRB consent from their institution.
IPD time frame: One year after publication of primary aims
IPD access criteria: Institutional IRB approval
Clinical trial NCT04410991: Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)
Official title: A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis
Acronym: GEMINI 2
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 899.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-11
Primary completion date: 2024-07-16
Completion date: 2024-07-16
Plan to share individual participant data: YES
IPD sharing description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Clinical trial NCT03937999: Bezlotoxumab as Secondary Prophylaxis for C. Difficile in High-risk Hospitalized Patients Exposed to Antibiotics.
Official title: A Pragmatic Trial of Secondary Prophylaxis With Bezlotoxumab to Prevent C. Difficile Relapse Among Hospitalized Adults Receiving Antibiotics.
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow enrollment due to COVID19 , change in practice with standardized use of oral vancomycin prophylaxis
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-30
Primary completion date: 2022-05-15
Completion date: 2022-05-15
Baseline population: Only 1 participant was enrolled in the study (control group). Study terminated early due to lack of enrollment
Plan to share individual participant data: NO
Clinical trial NCT03922100: Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML
Official title: A Phase I/II Study of NMS-03592088, a FLT3, KIT and CSF1R Inhibitor, in Patients With Relapsed or Refractory AML or CMML
Sponsor: Nerviano Medical Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Study stopped due to strategic reasons. The decision is not based on specific safety findings as the safety observed in the phase II part of the study is in line with what was reported in the phase I part.
Enrollment: 63.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-03
Primary completion date: 2024-08-29
Completion date: 2024-08-29
Clinical trial NCT04467905: ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2
Official title: Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients With Atrial Fibrillation.
Sponsor: Milestone Pharmaceuticals Inc. (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 69.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-19
Primary completion date: 2023-08-03
Completion date: 2023-08-10
Baseline population: Safety/mITT Population
Plan to share individual participant data: NO
Clinical trial NCT04807517: Buspirone Treatment of Anxiety in Williams Syndrome
Official title: Buspirone for the Treatment of Anxiety in Williams Syndrome
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-08-01
Primary completion date: 2023-09-11
Completion date: 2023-09-11
Clinical trial NCT04484493: Corticosteroid Nasal Spray in COVID-19 Anosmia
Official title: Role of Corticosteroid Nasal Spray in Recovery of Smell Sensation in COVID-19 Patients
Sponsor: Benha University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-08
Primary completion date: 2020-10-25
Completion date: 2020-11-03
Plan to share individual participant data: NO
Clinical trial NCT03521570: Intensity-Modulated Radiation Therapy & Nivolumab for Recurrent or Second Primary Head & Neck Squamous Cell Cancer
Official title: Phase II Study of IMRT Re-Irradiation With Concurrent/Adjuvant Nivolumab in Patients With Locoregionally Recurrent or Second Primary Squamous Cell Cancer of the Head and Neck
Sponsor: Emory University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 62.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-06-28
Primary completion date: 2022-07-25
Completion date: 2023-09-07
Clinical trial NCT01724346: Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Official title: An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)
Sponsor: Pharmacyclics LLC. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 269.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-12-03
Primary completion date: 2023-08-18
Completion date: 2023-08-18
Plan to share individual participant data: YES
IPD sharing description: Requests for access to individual participant data from clinical studies conducted by Pharmacyclics LLC, an AbbVie Company, can be submitted through Yale Open Data Access (YODA) Project site at the following link.
Clinical trial NCT02055963: Minocycline for Postsurgical Symptom Reduction in Head and Neck Cancer
Official title: Minocycline for Reduction of Symptom Burden After Surgery in Patients With Head and Neck Malignancy: A Randomized Study
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Early termination due to the protocol lack of progress in improving accrual rate
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-05-06
Primary completion date: 2022-08-11
Completion date: 2022-08-11
Limitations and caveats: Early termination due to the protocol lack of progress in improving accrual rate.
Clinical trial NCT03649841: Antiandrogen Therapy, Abiraterone Acetate, and Prednisone With or Without Neutron Radiation Therapy in Treating Patients With Prostate Cancer
Official title: Radiation Enhancement of Local and Systemic Anti-Prostate Cancer Immune Responses
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Terminated due to low accrual.
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-06-29
Primary completion date: 2022-09-01
Completion date: 2023-02-01
Limitations and caveats: Early termination due to poor patient accrual leading to small numbers of subjects analyzed.
Plan to share individual participant data: NO
Clinical trial NCT04134091: The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
Official title: A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Acronym: NASH
Sponsor: Lipocine Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 56.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-08-27
Primary completion date: 2021-06-24
Completion date: 2021-06-24
Baseline population: All randomized participants.
Clinical trial NCT03762564: Study With Paclitaxel +/- Ramucirumab in Patients With Squamous-cell Carcinoma of the Esophagus After Prior Therapy
Official title: A Randomized, Multicenter Open Label Phase II Trial of Paclitaxel + Ramucirumab Versus Paclitaxel Alone in Patients With Squamous-cell Carcinoma of the Esophagus, Refractory or Intolerant to Combination Therapy With Fluoropyrimidine and Platinum-based Drugs - The RAMOS STUDY
Acronym: RAMOS
Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 21.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-08
Primary completion date: 2022-07-04
Completion date: 2022-11-25
Plan to share individual participant data: NO
IPD sharing description: No IPD will be shared
Clinical trial NCT04184518: Durvalumab (MEDI4736) Plus Cediranib in Patients With Metastatic Uveal Melanoma
Official title: Phase II, Open-Label Study of Preliminary Efficacy of Durvalumab (MEDI4736) in Combination With Cediranib in Patients With Metastatic Uveal Melanoma
Acronym: CEDUVEAL-M
Sponsor: Grupo Español Multidisciplinar de Melanoma (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: The Cediranib producer laboratory decided to stop the development of this product.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-05-31
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03235739: Ancillary Effects of Oral Naloxegol (Movantik)
Official title: Ancillary Effects of Oral Naloxegol (Movantik)
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 136.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-10-01
Primary completion date: 2021-05-31
Completion date: 2022-05-23
Plan to share individual participant data: NO
IPD sharing description: Data to be provided in aggregate without patient identifiers
Clinical trial NCT03912337: Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine
Official title: Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine Who Have Previously Failed 1 or More Migraine Preventive Treatments.
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Terminated \[Study would not complete enrollment target until 2026 with results available in 2027. The information will not be useful at that time.\]
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-04
Primary completion date: 2021-07-28
Completion date: 2021-07-28
Baseline population: The respective full analysis set consisted of all participants who were randomized in the study through traditional study sites or decentralized clinical trial sites (DCTS).
Limitations and caveats: The study was terminated early due to slow enrollment and the impact of COVID-19 on the work productivity study endpoints, beyond normal operational disruptions.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
Clinical trial NCT02914600: Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease
Official title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease
Acronym: DIVERSITY LTE
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: development program for filgotinib for participants with Crohn's disease has been stopped
Enrollment: 1188.0 (ACTUAL)
Number of arms: 3.0
Start date: 2017-03-17
Primary completion date: 2023-08-01
Completion date: 2023-08-01
Baseline population: Safety analysis set included all participants who took at least 1 dose of study drug in this study.
Limitations and caveats: The results of DIVERSITY 1 study with filgotinib in participants with moderate to severely active CD failed to meet the co-primary endpoints of clinical remission and endoscopic response for filgotinib 100 mg q.d. and 200 mg q.d. in the study. After analyzing all available data from the DIVERSITY 1 and DIVERSITY long term extension (LTE) studies, the sponsor decided not to pursue extension of the filgotinib indication for CD and decided to terminate the DIVERSITY LTE study.
Plan to share individual participant data: NO
Clinical trial NCT04274114: Treatment of Adults With Generalized Anxiety Disorder Using Glutamine
Official title: Efficacy of L-glutamine for the Treatment of Generalized Anxiety Disorder: a Randomized Controlled Trial
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Inhability to recruit further participants due to SARS-CoV-2 pandemics.
Enrollment: 38.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-18
Primary completion date: 2020-05-12
Completion date: 2020-05-12
Clinical trial NCT04541147: Opioid & Steroid Use Following Tonsillectomy in Pediatric Patients
Official title: A Randomized Control Trial of Post-operative Course of Oral Dexamethasone and Effect on Opioid Usage in Pediatric Tonsillectomies in a Tertiary Care Center
Sponsor: Duke University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Lack of funding
Enrollment: 24.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-04-14
Primary completion date: 2023-12-26
Completion date: 2023-12-26
Plan to share individual participant data: NO
Clinical trial NCT03871361: Abatacept in Patients With Birdshot HLA A29 Uveitis
Official title: Abatacept in Patients With Birdshot HLA A29 Uveitis: A Phase II Prospective 0pen Label Interventional Proof-of-Concept Study
Acronym: HLA-A29
Sponsor: Universitaire Ziekenhuizen KU Leuven (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 15.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-04-01
Primary completion date: 2022-01-01
Completion date: 2023-12-01
Plan to share individual participant data: NO
Clinical trial NCT04298918: A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Official title: A Phase lb/ll, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Decision to discontinue the study based on broader development and strategic prioritisation. The Sponsor concludes there is no benefit-risk impact on the CO41863 study.
Enrollment: 1.0 (ACTUAL)
Number of arms: 4.0
Start date: 2020-09-23
Primary completion date: 2021-02-04
Completion date: 2021-02-04
Baseline population: The study was terminated by the Sponsor. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Limitations and caveats: The study was terminated by the Sponsor. Only 1 participant was enrolled in this study. Based on the low enrolment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.
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 NCT05731492: A Study of Macitentan in Children Below 2 Years of Age
Official title: A Multicenter, Open-label, Single-arm Study to Assess the Pharmacokinetics and Safety of Macitentan in Children Aged 1 Month to <2 Years With Pulmonary Arterial Hypertension
Sponsor: Actelion (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Sponsor Decision
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2024-03-14
Primary completion date: 2024-04-01
Completion date: 2024-04-01
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 NCT02957097: Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
Official title: Gabapentin as a Pre-emptive Analgesic in Oral and Maxillofacial Surgical Procedures
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Original PI left institution and the PI who took over was not able to initiate the study so it was never started.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-30
Primary completion date: 2021-06-30
Completion date: 2021-07-31
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03649477: Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome
Official title: Phase 3, Randomized, Double-Blind, Placebo-Controlled, 8-week Clinical Study to Assess the Efficacy, Safety, and Tolerability, of Intranasal Carbetocin (LV-101) in Prader-Willi Syndrome (PWS) With Long Term Follow-Up (CARE-PWS)
Acronym: CARE-PWS
Sponsor: Levo Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 130.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-20
Primary completion date: 2020-05-13
Completion date: 2022-07-09
Limitations and caveats: The COVID-19 pandemic began affecting this study in early March 2020 by substantially impacting the ability to safely enroll clinical study subjects, by requiring remote visits and monitoring, and by dramatically changing daily routines and social environments in this sensitive PWS population. Levo held new screening and enrollment in March 2020, and subsequently closed screening and enrollment in May 2020, resulting in the enrollment of 130 subjects instead of the 175 subjects planned.
Plan to share individual participant data: NO
Clinical trial NCT04230330: Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma
Official title: A Pilot Study of Nivolumab in Combination With GDP (Gemcitabine, Dexamethasone, Cisplatin)/ L-asparaginase in Patients With Advanced Stage or Relapsed/ Refractory Natural-killer/ T-cell Lymphoma
Sponsor: National Cancer Centre, Singapore (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: PI has left the institution.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-12
Primary completion date: 2020-06-12
Completion date: 2020-06-12
Clinical trial NCT04760782: PTH Analog Type II Odontoid Fracture
Official title: Effect of PTH Analog on Union Rates of Type II Odontoid Fractures in Older Adults
Sponsor: University of Vermont (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated early due to low recruitment rate.
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-05-18
Primary completion date: 2023-08-14
Completion date: 2023-08-14
Limitations and caveats: Early termination due to recruitment barriers and slow recruitment rate. Insufficient statistical power for analyses with data collected before study termination.
Plan to share individual participant data: NO