GBM AGILE Trial

Date Added
January 21st, 2020
PRO Number
Pro00089802
Researcher
Scott Lindhorst

List of Studies


Keywords
Brain Tumor, Glioblastoma
Summary

Glioblastoma adaptive, global, innovative learning environment or GBM AGILE trial is to identify effective therapies and improve survival for a type of brian cancer called glioblastoma (GBM) and to match effective therapies with adult patients with newly diagnosed or recurring glioblastoma. Eligible participants will have a 50/50 chance of taking either standard therapy medications or a medication not yet approved by the FDA called regorafenib during their standard of care treatment for GBM.

Institution
MUSC
Recruitment Contact
John Keller
843-792-2209
Kellej@musc.edu

Phase II Trial of the Immune Checkpoint Inhibitor Nivolumab in Patients With Select Rare CNS Cancers

Date Added
March 16th, 2021
PRO Number
Pro00107606
Researcher
Scott Lindhorst

List of Studies


Keywords
Cancer/Brain
Summary

This study is for patients with rare Central Nervous (brain or spine) tumors. The purpose of this study is to determine whether the experimental drug, nivolumab can shrink tumors in patients with rare Central Nervous System (brain or spine) tumors or increase the time it takes for these tumors to grow or spread throughout the body.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

WATCHMAN FLX versus NOAC for EMbolic ProtectION in the management of patients with Non-Valvular Atrial Fibrillation (CHAMPION-AF)

Date Added
April 26th, 2022
PRO Number
Pro00116671
Researcher
Loren Morgan

List of Studies

Keywords
Cardiovascular, Heart, Vascular
Summary

This study will compare WATCHMAN FLXTM ("DEVICE") to a category of OAC called non-vitamin K antagonist oral anticoagulation, also known as NOACs ("CONTROL"). NOAC medications include Pradaxa® (dabigatran), Eliquis® (apixaban), Xarelto® (rivaroxaban), or Savaysa® (edoxaban).The study will research the safety and effectiveness of the WATCHMAN FLXTM device compared to treatment with NOAC therapy to determine if it works for patients with your type of atrial fibrillation who require treatment for potential blood clot formation (thrombus) in the LAA.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-255-2927
sheriods@musc.edu

PK Papyrus Covered Coronary Stent System

Date Added
July 26th, 2022
PRO Number
Pro00119783
Researcher
Michael Foster

List of Studies

Keywords
Cardiovascular
Summary

The PK Papyrus Covered Coronary Stent System is a Humanitarian Use device (HUD) approved for the use of acute perforation in native coronary vessels or coronary bypass grafts in vessels 2.4-5.0mm in diameter. In an emergency situation, PK Papyrus may be used emergently outside its' approved indications if a patient has a life threatening condition that needs immediate treatment and no generally acceptable alternative treatment for the condition exists.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-255-2927
sheriods@musc.edu

REBYOTA™ for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study

Date Added
August 8th, 2023
PRO Number
Pro00130739
Researcher
Scott Curry

List of Studies


Keywords
Bowel, Infectious Diseases
Summary

This is a prospective observational cohort study that will create a patient registry by collecting data on patients who receive REBYOTA to prevent recurrence of Clostridioides difficile infection (CDI). The registry will include data about CDI episodes, CDI related symptoms, healthcare resource utilization (i.e., hospitalizations and re-admissions) and this data will be collected up to 6-months after receiving REBYOTA™.

Institution
MUSC
Recruitment Contact
Alicia Hartley
843-792-4100
hartleal@musc.edu

LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu

REACT-AF: The Rhythm Evaluation for Anticoagulation with Continuous Monitoring of Atrial Fibrillation

Date Added
February 3rd, 2024
PRO Number
Pro00132508
Researcher
Venkateshwar Gottipaty

List of Studies

Keywords
Cardiovascular, Heart
Summary

This research is being done to assess whether it is safe and effective to stop oral anticoagulation medications (a blood-thinning medication) during prolonged periods of normal heart rhythm in participants with infrequent episodes of atrial fibrillation (AF).

You may qualify for this study if you have a history of atrial fibrillation (AF) and are currently taking an oral anticoagulant (a blood-thinning medication). You will be randomized to one of two groups: Control Group or Study Intervention Group.

If you are randomized to the Control group, you will be asked to stay on your previously prescribed oral anticoagulant. If you are randomized to the Study Intervention group, you will be asked to take the oral anticoagulant for 30 days only if a prolonged episode of AF is detected on an AF-sensing Apple smartwatch you will be provided.

Institution
MUSC Health Columbia Medical Center
Recruitment Contact
Jacqueline Sheriod-Scott
803-254-3278
sheriods@musc.edu



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