RECOVER: A PRospective, Multi-cEnter, Randomized Controlled Blinded Trial DemOnstrating the Safety and Effectiveness of VNS Therapy® System as AdjunctivE Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression

Date Added
March 10th, 2020
PRO Number
Pro00095951
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Psychiatry
Summary

Depression is a very common disorder that is most often chronic or recurrent in nature. Many subjects do not respond adequately to an initial antidepressant treatment trial. Subjects who do not respond adequately to multiple therapeutic interventions are considered to have treatment-resistant depression (TRD). Among the treatment options for subjects with TRD is Vagus Nerve Stimulation (VNS) Therapy.This blinded, randomized, multicenter controlled study is intended to collect evidence that VNS Therapy as an adjunctive therapy improves health outcomes for patients with TRD.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

The Randomised Controlled Trial of Frontal and Temporal Electroconvulsive Therapy (ECT) for Severe Depression (The RAFT ECT Study)

Date Added
June 2nd, 2020
PRO Number
Pro00098725
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health
Summary

This is a research study to find out if a new form of electroconvulsive therapy (ECT) is as effective and safe as a current form. The new form of ECT is called Frontal (Ultrabrief Right Unilateral) ECT. If enrolled in this this study, participants will be randomly assigned (like flipping a coin) to receiving Frontal ECT or the current standard form of ECT called Temporal (Ultrabrief Right Unilateral) ECT.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

The MOOD study – external Combined Occipital and Trigeminal Nerve Stimulation (eCOT-NS) for the treatment of Major Depressive Disorder (MDD)

Date Added
October 20th, 2021
PRO Number
Pro00114373
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health
Summary

The purpose of this research is to evaluate whether the Relivion®DP device is safe and helpful in alleviating Major Depressive Disorder (MDD) symptoms. The research study includes up to 6 visits, each visit could be performed either at the clinic or remotely using digital means such as a video call or the use of another dedicated platform.In this research study the participant will randomly receive either an active device or a non-active (sham) device and the participant will be asked to preform daily treatments with the device for 8 weeks after which the participant will have the option to continue to an additional 8 week open-label extension with the active device.
We expect that the time commitment for taking part in this research will last up to 20 weeks (including the screening period).

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@musc.edu

BOLT: A Prospective, Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo® Aspiration System

Date Added
January 12th, 2022
PRO Number
Pro00115726
Researcher
Mathew Wooster

List of Studies


Keywords
Surgery, Vascular
Summary

The purpose of this study is to observe the safety and effectiveness of the Indigo Aspiration System. This study will help determine how study participants recover when the study device is used to remove the clot from the deep veins.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@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

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥65 Year-olds (PRIMARY)

Date Added
May 17th, 2022
PRO Number
Pro00119787
Researcher
Marc Katz

List of Studies


Keywords
Heart, Surgery
Summary

The purpose of this research is to compare the risks and benefits of two different procedures used to help patients with mitral valve regurgitation (also known as MR). MR is a condition where the valve does not close fully when it is supposed to, and some blood can then leak back into the left atrium instead of circulating to the rest of the body. The treatment options this study will compare are: (1) transcatheter edge-to-edge repair (abbreviated as TEER; which is a catheter procedure for repairing the mitral valve that doesn't require surgery to open up the heart) and (2) mitral valve repair surgery, which is an open-heart surgical procedure. There are no new or "experimental" procedures being tested in this study: both treatment options are well-established treatments and are regularly performed in patients who have MR.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in STANDARD RISK PATIENTS with SIGNIFICANT CAROTID ARTERY DISEASE (The ROADSTER 3 Study)

Date Added
January 12th, 2023
PRO Number
Pro00125673
Researcher
Antwana Wright

List of Studies

Keywords
Vascular
Summary

The study is to evaluate real world usage of the ENROUTE® Transcarotid Stent System when used with the ENROUTE® Transcarotid Neuroprotection System in patients with significant carotid artery disease who are at standard risk for adverse events from carotid endarterectomy (CEA). The devices used in the study are not investigational and have been approved for use by the Food and Drug Administration (FDA).

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

Multifaceted Intervention To Improve Graft outcome disparities in African American Kidney Transplants

Date Added
April 18th, 2023
PRO Number
Pro00127666
Researcher
David Taber

List of Studies


Keywords
Transplant
Summary

This is a randomized study to test a smartphone app that a pharmacist will use to help kidney transplant patients track their medications, blood pressures, and blood sugars if they have diabetes. The goal of this study is to improve care and outcomes in kidney transplant patients and, in particular, help African American patients have better outcomes after transplant.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
843-792-8896
overstrm@musc.edu

A Prospective, Single-arm, Multi-center, Open-label Trial Evaluating the Continuous Application of Prevena™ Therapy for up to 14 days

Date Added
April 20th, 2023
PRO Number
Pro00124286
Researcher
Thomas Curran

List of Studies


Keywords
Surgery
Summary

The purpose of this study is to demonstrate that the continuous use of negative pressure dressings for up to 14 days has similar benefits and risks to the continuous use for up to 7 days. The 3M study product being used in this study includes the PREVENA Plus Incision Management System with PREVENA Dressings (Peel & Place, Customizable and ARTHRO●FORM). The study product is considered investigational because it has not been approved by the FDA for continuous use for up to 14 days. It is currently approved for use for up to 7 days.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
(843) 792-8896

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)

Date Added
May 1st, 2023
PRO Number
Pro00127835
Researcher
Arman Kilic

List of Studies

Keywords
Heart, Surgery
Summary

There are two classes of drugs for preventing blood clots in patients with atrial fibrillation (AF), an irregular heartbeat, after cardiac surgery: antiplatelet drugs (like aspirin) and anticoagulants (blood thinners). This study aims to determine whether the addition of blood thinners to antiplatelet drugs will improve treatment outcomes in patients who develop AF after coronary artery bypass grafting (CABG) surgery.

In this study, you will be randomized (assigned to a group by chance--like flipping a coin) into one of 2 study groups; the assignment to receive the antiplatelet drug alone or the antiplatelet drug plus a blood thinner.

Before discharge from the hospital, you will undergo an electrocardiogram (ECG), which examines the electrical activity of your heart. At 1 and 2 months after randomization, you will receive a phone call from the study staff. At 3 months after randomization, you will return to the institution where you received your surgery for an in-person visit. At 6 months, you will receive a phone call from the study staff. Your total participation will be about 6 months.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
(843) 792-8896
overstrm@musc.edu



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