chufangao/CTO huggingface dataset:
Clinical trial NCT04622254: Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)
Acronym: ULTRA II
Sponsor: Merz North America, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 368.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-11-12
Primary completion date: 2021-06-16
Completion date: 2022-07-08
Baseline population: The full analysis set (FAS) included all randomized subjects.
Plan to share individual participant data: NO
Clinical trial NCT05536037: Metformin for the Prevention of Oral Cancer in Patients With Oral Premalignant Lesions
Official title: Metformin Chemoprevention of Oral Premalignant Lesions
Sponsor: Thomas Jefferson University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Slow accrual
Enrollment: 4.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-04
Primary completion date: 2024-03-16
Completion date: 2024-03-16
Clinical trial NCT03277352: INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Official title: A Phase 1/2 Safety and Efficacy Study of INCAGN01876 in Combination With Immune Therapies in Subjects With Advanced or Metastatic Malignancies
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The study was terminated due to emergent data from another study and unrelated to safety.
Enrollment: 10.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-11-21
Primary completion date: 2020-07-01
Completion date: 2020-07-01
Baseline population: The Full Analysis Set (FAS) includes all subjects enrolled in the study who received at least 1 dose of INCAGN01876, pembrolizumab, or epacadostat.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03276780: Nicotine Replacement Therapy (NRT) Sampling and Selection to Increase Medication Adherence
Official title: NRT Sampling and Selection to Increase Medication Adherence
Acronym: NRT
Sponsor: University of Alabama at Birmingham (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-05-03
Primary completion date: 2020-05-31
Completion date: 2020-10-31
Plan to share individual participant data: NO
Clinical trial NCT04808882: ANTIcoagulation in Severe COVID-19 Patients
Official title: ANTIcoagulation in Severe COVID-19 Patients: a Multicenter, Parallel-group, Open-label, Randomized Controlled Trial
Acronym: ANTICOVID
Sponsor: Assistance Publique - Hôpitaux de Paris (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 353.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-04-14
Primary completion date: 2022-01-10
Completion date: 2022-03-13
Plan to share individual participant data: NO
IPD sharing description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Clinical trial NCT04695652: A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult
Official title: A Phase II, Prospective, Double-blinded, Multi-Center, Multi-Regional Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901
Acronym: COVID-19
Sponsor: Medigen Vaccine Biologics Corp. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 3854.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-30
Primary completion date: 2021-05-15
Completion date: 2021-10-29
Clinical trial NCT04827589: Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria
Official title: A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of Tirabrutinib in Subjects With Antihistamine-Resistant Chronic Spontaneous Urticaria
Sponsor: Gilead Sciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Development program terminated
Enrollment: 0.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-07-31
Primary completion date: 2022-04-30
Completion date: 2022-09-30
Plan to share individual participant data: NO
Clinical trial NCT05518279: Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures
Official title: Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures: A Prospective, Randomized, Double-blinded, Placebo Controlled Trial
Sponsor: Henry Ford Health System (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: Could not work out internal logistics
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-09-30
Primary completion date: 2021-08-31
Completion date: 2021-09-30
Plan to share individual participant data: NO
Clinical trial NCT03304379: Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
Official title: Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip
Acronym: FACT OA2
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1650.0 (ACTUAL)
Number of arms: 4.0
Start date: 2017-10-26
Primary completion date: 2019-12-13
Completion date: 2020-11-09
Clinical trial NCT03469492: Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose
Official title: Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study
Sponsor: Yale University (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-18
Primary completion date: 2020-03-20
Completion date: 2020-03-20
Clinical trial NCT03646344: Heme Arginate in Transplantation Study
Official title: Heme Arginate in Transplantation Study - a Multi-centre Blinded Parallel-group Randomised Trial of Heme Arginate Versus Placebo to Reduce Delayed Graft Function in Kidney Transplant Recipients
Acronym: HOT2
Sponsor: University of Edinburgh (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: COVID
Enrollment: 47.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-03-12
Primary completion date: 2020-03-17
Completion date: 2021-02-23
Plan to share individual participant data: YES
IPD sharing description: Following publication of the primary paper, a de-identified individual participant data set will be submitted to a data archive for sharing purposes. Access to this data set will be under a controlled access model in line with ECTU policies at that time.
Clinical trial NCT04086472: Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)
Official title: A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Participants Inoculated With Experimental Respiratory Syncytial Virus
Sponsor: Merck Sharp & Dohme LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 80.0 (ACTUAL)
Number of arms: 5.0
Start date: 2019-10-28
Primary completion date: 2020-03-22
Completion date: 2020-08-14
Plan to share individual participant data: YES
IPD sharing description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Clinical trial NCT04353206: Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure
Official title: A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to COVID-19
Sponsor: Cedars-Sinai Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: TERMINATED 
Why stopped: The initiation of the expanded access program for convalescent plasma.
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-06-27
Primary completion date: 2020-11-01
Completion date: 2020-11-01
Clinical trial NCT02152358: PTH - Preemptive Treatment for Herpesviridae
Official title: Efficacy of a Preemptive Treatment by Ganciclovir or by Aciclovir in ICU Patients Requiring Prolonged Mechanical Ventilation and Presenting a Viral Replication (CMV and/or HSV) - Prospective, Randomized, Double-blinded Multicenter Trial
Acronym: PTH
Sponsor: Assistance Publique Hopitaux De Marseille (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 317.0 (ACTUAL)
Number of arms: 4.0
Start date: 2014-02-05
Primary completion date: 2018-04-21
Completion date: 2023-04-05
Clinical trial NCT04252664: A Trial of Remdesivir in Adults With Mild and Moderate COVID-19
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir in Hospitalized Adult Patients With Mild and Moderate COVID-19.
Sponsor: Capital Medical University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: SUSPENDED 
Why stopped: The epidemic of COVID-19 has been controlled well at present, no eligible patients can be recruitted.
Enrollment: 308.0 (ESTIMATED)
Number of arms: 2.0
Start date: 2020-02-12
Primary completion date: 2020-04-10
Completion date: 2020-04-27
Plan to share individual participant data: UNDECIDED
Clinical trial NCT04666441: COVID-19 Study Assessing the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Adult Outpatients With SARS-CoV-2 Infection
Official title: A Phase 2 Study to Assess the Virologic Efficacy of REGN10933+REGN10987 Across Different Dose Regimens in Outpatients With SARS-CoV-2 Infection
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 1149.0 (ACTUAL)
Number of arms: 8.0
Start date: 2020-12-15
Primary completion date: 2021-03-04
Completion date: 2021-09-21
Baseline population: Randomized participants who received any study drug; based on the treatment received (as treated)
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: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Clinical trial NCT01676441: Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury
Official title: A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Chronic Spinal Cord Injury.
Sponsor: Pharmicell Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: sponsor decision (confidential)
Enrollment: 20.0 (ACTUAL)
Number of arms: 1.0
Start date: 2008-08-31
Primary completion date: 2021-03-04
Completion date: 2021-03-04
Clinical trial NCT02616185: A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
Official title: A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING DOSES OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN (VBIR) FOR PROSTATE CANCER (PF-06753512)
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Due to strategic evaluation of PF-06753512 (VBIR-1) within context of Pfizer's oncology portfolio, decision not based on any safety or regulatory concerns.
Enrollment: 91.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-12-30
Primary completion date: 2021-02-23
Completion date: 2021-02-23
Baseline population: All enrolled participants who received at least one dose of one of the components of the regimen.
Limitations and caveats: The study was terminated on 20 August 2020 by the sponsor. The decision to terminate this study was based on the results of a strategic evaluation of VBIR-1 within the current Pfizer oncology portfolio. This decision was not based on any safety or regulatory concerns with the treatment of participants with VBIR-1.
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 NCT04418661: Safety and Efficacy Study of SAR442720 in Combination With Other Agents in Advanced Malignancies
Official title: A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of SAR442720 in Combination With Other Agents in Participants With Advanced Malignancies
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Sponsor's decision not related to any safety concern
Enrollment: 65.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-06-09
Primary completion date: 2024-04-04
Completion date: 2024-04-04
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 NCT03174782: Peripheral Nerve Blocks for Major Lower Extremity Amputations
Official title: Peripheral Nerve Blocks for Major Lower Extremity Amputations
Sponsor: University of California, San Francisco (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: The study was terminated due to not enough power and research staff assistance.
Enrollment: 42.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-01
Primary completion date: 2021-04-27
Completion date: 2021-04-27
Plan to share individual participant data: NO
Clinical trial NCT04154826: Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease
Official title: Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease. Two Doses Phase II, Single Center, Open-label Trial
Acronym: IMPULSE-7
Sponsor: Revimmune (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: non convincing results
Enrollment: 8.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-30
Primary completion date: 2023-12-31
Completion date: 2024-03-30
Plan to share individual participant data: NO
Clinical trial NCT04563299: Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections
Official title: Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections
Acronym: DETeR
Sponsor: Retina Vitreous Associates of Florida (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Subject Enrollment
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-12-09
Primary completion date: 2023-02-14
Completion date: 2023-02-14
Plan to share individual participant data: NO
Clinical trial NCT04983901: PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN
Official title: An Investigator Initiated, Phase II Single-Center, Randomized, Open-Label, Prospective, Study To Determine The Impact Of Serial Procalcitonin On Improving Antimicrobial Stewardship And On The Efficacy, Safety, And Tolerability Of Imipenem-Cilastatin-Relebactam Plus/Minus Vancomycin Or Linezolid Versus Standard Of Care Antipseudomonal Beta-Lactams Plus/Minus Vancomycin Or Linezolid As Empiric Therapy In Febrile Neutropenic Adults With Cancer
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 100.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-09-14
Primary completion date: 2023-10-06
Completion date: 2023-10-06
Baseline population: Patients in Modified Intent-To-Treat (MITT) analysis set.
Clinical trial NCT03399318: Aggressive Antipyretics for Fever Reduction in CNS Malaria
Official title: Aggressive Antipyretics in CNS Malaria: A Randomized-Controlled Trial Assessing Antipyretic Efficacy and Parasite Clearance Effects
Sponsor: University of Rochester (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 256.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-01-07
Primary completion date: 2022-12-02
Completion date: 2022-12-02
Baseline population: Eligible children were 24-132 months of age with evidence of P. falciparum infection, based upon a thick peripheral blood smear or rapid diagnostic test, and symptoms of CNS malaria including complicated seizures (multiple seizures, focal seizures or prolonged seizures lasting more than 15 minutes) or impaired consciousness
Plan to share individual participant data: NO
Clinical trial NCT02539303: Delivery of Yamani-15/5 Chemical Solution for PAD
Official title: In-vivo Demineralization of Calcific Peripheral Arterial Disease (PAD) Using Local Delivery of Yamani-15/5 Chemical Solution
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Unable to enroll subjects
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2015-08-31
Primary completion date: 2022-08-31
Completion date: 2023-08-31
Plan to share individual participant data: NO
Clinical trial NCT05006417: Botox for the Treatment of Recurrent Chronic Exertional Compartment Syndrome
Official title: OnabotulinumtoxinA (Botox) Effect on Pain and Function in Recurrent Chronic Exertional Compartment Syndrome: a Pilot Study
Sponsor: University of Wisconsin, Madison (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: issues with supplier of strength testing equipment, presumed to go out of business
Enrollment: 1.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-11-23
Primary completion date: 2022-11-23
Completion date: 2022-11-23
Plan to share individual participant data: NO
Clinical trial NCT04991688: A Prospective Pilot Study to Assess the Efficacy of BOTOX-A in Patients With Low Anterior Resection Syndrome (LARS>20) and Refractory Medical Treatment After Rectal Resection
Official title: A Prospective Pilot Study to Assess the Efficacy of Botox-A in Patients With Low Anterior Resection Syndrome (LARS>20) and Refractory Medical Treatment After Rectal Resection
Acronym: BOTOX-TME
Sponsor: University Hospital, Bordeaux (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Organizational difficulties
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-01
Primary completion date: 2023-01-07
Completion date: 2023-03-03
Plan to share individual participant data: NO
Clinical trial NCT03135652: Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation
Official title: Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation
Sponsor: Wuhan Union Hospital, China (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Inadequate patient enrollment
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-08-01
Primary completion date: 2021-06-01
Completion date: 2023-06-01
Clinical trial NCT01562626: Phase I/II Study of APS001F With Flucytosine and Maltose in Solid Tumors
Official title: A Phase I/II Safety, Pharmacokinetic, and Pharmacodynamic Study of APS001F With Flucytosine and Maltose for the Treatment of Advanced and/or Metastatic Solid Tumors
Sponsor: Anaeropharma Science, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: SUSPENDED 
Enrollment: 75.0 (ESTIMATED)
Number of arms: 1.0
Start date: 2012-09-30
Primary completion date: 2021-05-31
Completion date: 2021-05-31
Clinical trial NCT03073603: Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)
Official title: Discontinuation of Disease Modifying Therapies (DMTs) in Multiple Sclerosis (MS)
Acronym: DISCOMS
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 259.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-20
Primary completion date: 2021-08-31
Completion date: 2021-08-31
Limitations and caveats: Mostly white women; all participants in US; Relatively short follow-up (maximum 2 years); Most participants using older, injectable therapies for MS; Small numbers don't allow for significant subgroup analysis, eg not enough on high efficacy medications; Being a pragmatic study (real-world, insurance paid for MRI scans), and COVID pandemic resulted in more missing data than desirable; No brain volume data, a meaningful measure; No NfL or other serum or spinal fluid biomarker data.
Plan to share individual participant data: NO
Clinical trial NCT04938388: Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care
Official title: Comparison of Oral Semaglutide With Matched Oral Semaglutide Placebo as an Early Treatment for Latino Adults With Type 2 Diabetes Receiving Enhanced Lifestyle Care
Sponsor: Sansum Diabetes Research Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Principal Investigator no longer at study site.
Enrollment: 12.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-29
Primary completion date: 2023-02-16
Completion date: 2023-02-16