chufangao/CTO huggingface dataset:
Clinical trial NCT05088460: A Study to Examine the Effects of the Leptin Receptor (LEPR) Agonist Antibody REGN4461 in Adult Patients With Familial Partial Lipodystrophy (FPLD)
Official title: A Randomized Double-Blind Placebo-Controlled Study of the LEPR Agonist Antibody REGN4461 for the Treatment of Metabolic Abnormalities in Patients With Familial Partial Lipodystrophy
Acronym: LEAP
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 20.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-02-28
Primary completion date: 2023-12-13
Completion date: 2024-04-18
Plan to share individual participant data: YES
IPD sharing description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD time frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification
IPD access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
Clinical trial NCT05655598: TAS-116 Plus Palbociclib in Breast and Rb-null Cancer
Official title: Phase Ib IIT of Heat Shock Protein 90 Inhibitor TAS-116 Combined with Cyclin-dependent Kinase 4/6 Inhibitor Palbociclib in Advanced Breast Cancer Progressing on Palbociclib & Treatment-refractory Solid Tumors with Retinoblastoma Deficiency
Sponsor: Brown University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Lack of accrual
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2023-09-12
Primary completion date: 2024-08-05
Completion date: 2024-08-05
Plan to share individual participant data: NO
Clinical trial NCT00274937: Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Official title: Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Sponsor: Children's Oncology Group (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 111.0 (ACTUAL)
Number of arms: 2.0
Start date: 2006-02-20
Primary completion date: 2014-12-31
Completion date: 2022-09-30
Limitations and caveats: Data was and never will never be collected for Outcome Measure #2 and Outcome Measure #3. Funding was not obtained and results will never be reported for Outcome Measure #4.
Clinical trial NCT03279081: Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Participants With Crohn's Disease (CD)
Official title: A Phase-III, Randomized, Double-blind, Parallel-group, Placebo-controlled, International, Multicentre Study to Assess Efficacy and Safety of Cx601, Adult Allogeneic Expanded Adipose-derived Stem Cells (eASC) for the Treatment of Complex Perianal Fistula(s) in Patients With Crohn's Disease Over a Period of 24 Weeks and a Follow-up Period up to 52 Weeks
Acronym: ADMIRE-CD-II
Sponsor: Takeda (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 568.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-09-15
Primary completion date: 2023-01-23
Completion date: 2023-07-26
Baseline population: The Intent-to-treat (ITT) Analysis Set included all randomized participants regardless of their being treated or not and regardless of their having any postbaseline efficacy measurements or not.
Plan to share individual participant data: YES
IPD sharing description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Clinical trial NCT00072462: Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
Official title: International Breast Cancer Intervention Study II (IBIS-II) (DCIS)
Acronym: IBIS-II DCIS
Sponsor: Queen Mary University of London (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 2980.0 (ACTUAL)
Number of arms: 2.0
Start date: 2003-09-30
Primary completion date: 2015-12-31
Completion date: 2021-05-31
Limitations and caveats: This CTIMP trial, which recruited between 03 Mar 2003 and 08 Feb 2012, formally ended on 31 May 2021.
Clinical trial NCT04531176: EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial
Official title: An ObEsity-centric Approach With and Without Anti-obesity Medications ComPared to the Usual-care ApprOach to Management of Patients With Obesity and Type 2 Diabetes in an Employer Setting: A Pragmatic Randomized Controlled Trial
Acronym: EMPOWER-T2D
Sponsor: The Cleveland Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: After an unplanned yet IRB approved interim analysis, it was found that there was not a significant difference between the 3 arms of the study. The study was closed due to futility. All Patients are off study and this study will not resume.
Enrollment: 74.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-09-01
Primary completion date: 2022-08-15
Completion date: 2023-08-04
Baseline population: Individual participants who were randomized to each arm of the study
Plan to share individual participant data: NO
Clinical trial NCT05027594: Ph I Study in Adult Patients With Relapsed or Refractory Multiple Myeloma
Official title: A Phase I Dose Escalation Study of NMS-03597812, a PERK Inhibitor, in Adult Patients With Relapsed or Refractory Multiple Myeloma
Sponsor: Nerviano Medical Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The decision is not based on emerging safety or efficacy concerns but on strategic reasons related to the changing and competitive treatment options in Multiple Myeloma
Enrollment: 5.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-09-09
Primary completion date: 2023-08-08
Completion date: 2024-01-08
Clinical trial NCT04922424: Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
Official title: Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: not funded
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-09-30
Primary completion date: 2023-08-31
Completion date: 2023-08-31
Clinical trial NCT05356897: Tucatinib Combined with Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study
Official title: 3T: a Phase II Single Arm Open Label Study of Tucatinib Combined with Trastuzumab and TAS-102 in Molecularly Selected Patients with HER2+ Metastatic Colorectal Cancer
Sponsor: Academic and Community Cancer Research United (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: no sites were regulatory ready and the SC took the study to a different group.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2023-10-31
Primary completion date: 2024-09-17
Completion date: 2024-09-17
Clinical trial NCT05679388: A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients
Official title: A Phase Ib Study of Extending Relugolix Dosing Intervals Through Addition of the CYP3A4 and Pg-P Inhibitor Itraconazole or Ritonavir in Prostate Cancer Patients
Sponsor: University of Chicago (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Terminated by the PI
Enrollment: 60.0 (ACTUAL)
Number of arms: 5.0
Start date: 2023-02-13
Primary completion date: 2024-08-05
Completion date: 2024-08-05
Clinical trial NCT03199976: Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Official title: Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
Sponsor: Helsinki University Central Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Subjects in the Salbutamol group discontinued the intervention more often due to troublesome respiratory symptoms
Enrollment: 80.0 (ACTUAL)
Number of arms: 3.0
Start date: 2016-04-20
Primary completion date: 2020-11-18
Completion date: 2020-11-18
Limitations and caveats: Early termination leading to small numbers of subjects analyzed.
Plan to share individual participant data: NO
IPD sharing description: Deidentified individual participant data will not be made available.
Clinical trial NCT03666728: A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
Official title: An Open-label, Single-arm, Multi-center, Phase 2 Study to Evaluate SHR-1210 Combination With BP102 in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Whose PD-L1 Positive and EGFR/ALK Wild Type.
Sponsor: Jiangsu HengRui Medicine Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: changes in the R\&D strategy
Enrollment: 5.0 (ACTUAL)
Number of arms: 1.0
Start date: 2018-11-30
Primary completion date: 2020-03-11
Completion date: 2020-03-11
Clinical trial NCT05194839: A Phase 2b Study to Evaluate RIST4721 in Palmoplantar Pustulosis (PPP)
Official title: A Randomized, Double-blind, Placebo-controlled, Dose Ranging Phase 2 Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Palmoplantar Pustulosis
Sponsor: Aristea Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Due to safety findings in ongoing Phase 2 trials.
Enrollment: 79.0 (ACTUAL)
Number of arms: 3.0
Start date: 2022-01-05
Primary completion date: 2023-02-13
Completion date: 2023-03-06
Plan to share individual participant data: NO
Clinical trial NCT01772472: A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
Official title: A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1487.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-04-03
Primary completion date: 2018-07-25
Completion date: 2024-05-23
Baseline population: The intent-to-treat (ITT) population was defined as all participants enrolled in the study regardless of whether or not they received any study drug.
Clinical trial NCT05430854: Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
Official title: An Open-Label Extension Study To Evaluate The Long- Term Safety And Tolerability Of Daxdilimab (Hzn-7734) In Subjects With Systemic Lupus Erythematosus
Acronym: RECAST SLE OLE
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor Decision
Enrollment: 155.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-06-01
Primary completion date: 2023-10-31
Completion date: 2023-10-31
Baseline population: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
Plan to share individual participant data: NO
Clinical trial NCT03382925: Does Low-does Cervical Epidural Lidocaine Cause Transient Weakness?
Official title: Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized
Sponsor: University of Utah (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Not enough cervical interlaminar patients who meet criteria in order to meet recruitment goals.
Enrollment: 16.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-12-20
Primary completion date: 2019-08-19
Completion date: 2020-08-19
Limitations and caveats: Early termination leading to low enrollment which ended up being the greatest limitation.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03818256: A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
Acronym: GRATITUDE
Sponsor: Corcept Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 71.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-12-04
Primary completion date: 2022-06-17
Completion date: 2022-07-06
Baseline population: All enrolled patients
Plan to share individual participant data: NO
Clinical trial NCT03796650: Fecal Transplantation for Primary Clostridium Difficile Infection
Official title: COmparative Effectiveness of IntestinaL MicrobiOta Versus VaNcomycin for Primary C. Difficile Infection - RandomiZEd Trials
Acronym: COLONIZE
Sponsor: Oslo University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Pre-specified non-inferiority criterion met at interim analysis.
Enrollment: 104.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-07-17
Primary completion date: 2024-04-02
Completion date: 2024-04-02
Plan to share individual participant data: UNDECIDED
IPD sharing description: The trial adheres to data sharing policies of the ICMJE. Data sharing is considered for each request by the principal investigators. Data sharing is not granted if they overlap with planned analyses. Data sharing requires all approvals by relevant authorities. Costs for data sharing will not be covered by the study group.
Clinical trial NCT04952597: Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
Official title: A Phase 2, Multicenter, Randomized, 3-Arm, Open-Label Study to Investigate the Preliminary Efficacy and Safety of the Anti-TIGIT Monoclonal Antibody Ociperlimab (BGB-A1217) Plus Tislelizumab Plus Concurrent Chemoradiotherapy in Patients With Untreated Limited-Stage Small Cell Lung Cancer
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 126.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-07-15
Primary completion date: 2023-07-26
Completion date: 2023-07-26
Baseline population: The Intent-To-Treat (ITT) Analysis Set includes all randomized patients.
Plan to share individual participant data: YES
Clinical trial NCT04109547: A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes
Official title: China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only
Acronym: PIONEER 11
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 521.0 (ACTUAL)
Number of arms: 4.0
Start date: 2019-10-01
Primary completion date: 2021-09-23
Completion date: 2021-10-27
Baseline population: Full analysis set included all randomized participants.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT04780061: Dietary Supplements for COVID-19
Official title: Dietary Supplements to Reduce Symptom Severity and Duration in People With SARS-CoV-2: A Randomized, Double Blind, Placebo Controlled Clinical Trial
Sponsor: The Canadian College of Naturopathic Medicine (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Public PCR testing stopped in Ontario
Enrollment: 90.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-07-12
Primary completion date: 2022-05-03
Completion date: 2022-07-07
Baseline population: Participants only included if they began study treatments.
Limitations and caveats: Early termination leading to small number of subjects analyzed; Symptom severity and duration questionnaire not validated
Plan to share individual participant data: NO
Clinical trial NCT04315948: Trial of Treatments for COVID-19 in Hospitalized Adults
Official title: Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults
Acronym: DisCoVeRy
Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (OTHER_GOV)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1552.0 (ACTUAL)
Number of arms: 7.0
Start date: 2020-03-22
Primary completion date: 2022-07-09
Completion date: 2023-09-25
Plan to share individual participant data: YES
IPD sharing description: Study protocol and statistical analysis plan will be available. Systematic individual patient data sharing is not intended, but all requests for the trial's data will be considered by the French DisCoVeRy Trial Management Team.
IPD time frame: Study protocol and statistical analysis plan will be available from September 2020 with no time limit.~Other data will be available upon request after first publication of the results for at least 5 years
IPD access criteria: Study protocol and statistical analysis plan will be published. All requests for the trial's data will be considered by the French DisCoVeRy Trial Management Team that can be contacted via the principal investigator: florence.ader@chu-lyon.fr
Clinical trial NCT03733990: A Study to Evaluate Safety, Tolerability and Preliminary Efficacy of FP-1305 in Cancer Patients (MATINS)
Official title: A Phase I/II Open-Label, Three-Part, Dose-Finding and Separate Cohort Expansion Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Repeated Doses of CLEVER-1 Antibody FP-1305, in Subjects With Advanced Solid Tumours
Sponsor: Faron Pharmaceuticals Ltd (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 216.0 (ACTUAL)
Number of arms: 6.0
Start date: 2018-12-03
Primary completion date: 2023-09-06
Completion date: 2023-10-31
Plan to share individual participant data: NO
Clinical trial NCT03878719: Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
Official title: A Multicenter, Open-label Phase 1b Study of the Combination of Binimetinib and Encorafenib in Adolescent Patients With Unresectable or Metastatic BRAF V600-mutant Melanoma
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The trial was terminated early on 05 October 2022 due to non-feasibility and poor recruitment and not based on safety concerns.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-03
Primary completion date: 2022-08-19
Completion date: 2022-08-19
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 NCT05343754: Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum
Official title: Hyperbaric Oxygen Therapy for Pyoderma Gangrenosum As a New Treatment Strategy
Acronym: HOTPANTS
Sponsor: Erasmus Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Due to low recruitment
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-06-01
Primary completion date: 2024-01-14
Completion date: 2024-01-14
Plan to share individual participant data: NO
Clinical trial NCT04576988: A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy and Safety of Sotatercept Versus Placebo When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
Sponsor: Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 324.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-01-25
Primary completion date: 2022-08-26
Completion date: 2022-12-06
Baseline population: Of the 324 participants randomized in the study, one participant was randomized in error in placebo plus background PAH therapy arm and no data was collected on this participant. Per protocol, this participant was excluded from the study analysis.
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT03827044: Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Mutant Colon Cancer
Official title: POLEM:Avelumab Plus 5-FU Based Chemotherapy as Adjuvant Treatment for Stage 3 MSI-High or POLE Exonuclease Domain Mutant Colon Cancer: A Phase 3 Randomised Study
Acronym: POLEM
Sponsor: Royal Marsden NHS Foundation Trust (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: POLEM encountered significant recruitment challenges. With little prospect of recruiting to target the decision to close was made.
Enrollment: 30.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-08-31
Primary completion date: 2021-01-05
Completion date: 2022-01-05
Plan to share individual participant data: NO