Randomized Controlled Trial Comparing the Tolerability and Efficacy of Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant Recipients

Date Added
January 24th, 2023
PRO Number
Pro00125967
Researcher
David Taber

List of Studies


Keywords
Drug Studies, Transplant
Summary

The purpose of this study is to find out if there is a difference in how well the standard MUSC cytomegalovirus (CMV) prevention medicine works, compared to a different medicine, in preventing CMV infections in kidney transplant recipients who are at risk for this type of infection, while also assessing the tolerability of these two regimens. The two medication regimens being compared are valganciclovir (FDA approved to prevent and treat CMV infection) vs maribavir (FDA approved to treat CMV infection) plus acyclovir (FDA approved to prevent HSV infection).

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
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

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Date Added
July 5th, 2023
PRO Number
Pro00126590
Researcher
Marc Katz

List of Studies


Keywords
Cardiovascular, Surgery
Summary

This is an Investigational Device Exemption (IDE) clinical research trial (referred to also as a trial or a research trial) sponsored by AtriCure, Inc (the Sponsor) to learn whether the use of the AtriClip® LAA Exclusion System to close off your left atrial appendage (LAA) during your heart surgery will reduce the risk of stroke. The AtriClip has not been well studied or approved by the FDA for stroke prevention; therefore, this procedure is considered investigational.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

Product Surveillance Registry (PSR) Aortic, Peripheral, and Venous (APV) Protocol Synopsis

Date Added
October 24th, 2023
PRO Number
Pro00126447
Researcher
Mathew Wooster

List of Studies


Keywords
Vascular
Summary

The purpose of this registry is to collect safety data in patients undergoing aortic aneurysm repair, peripheral vascular intervention, hemodialysis access intervention or peripheral embolization with an eligible Medtronic market-released product(s), including but not limited to balloon catheters, peripheral or carotid stents, stet grafts, and coils, in a real-world setting.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

Comparison of Theta Burst versus 10 Hz Repetitive Transcranial Magnetic Stimulation for Craving in Smokers

Date Added
February 6th, 2024
PRO Number
Pro00121128
Researcher
Xingbao Li

List of Studies


Keywords
Brain, Healthy Volunteer Studies, Smoking
Summary

Smoking is one of the main public health problems. Smoking cessation is difficult because of nicotine dependence. Repetitive transcranial magnetic stimulation (rTMS) over the frontal head has shown to be effective in the reduction of cigarette consumption and craving. In this study, we will evaluate the efficiency of a new form of rTMS called intermittent theta-burst stimulation (iTBS) for smoking cessation.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843 8765-141
maddoxm@musc.edu

Prophylactic Intra-Operative Ventricular Arrhythmia Ablation in High-Risk LVAD Candidates (PIVATAL)

Date Added
June 12th, 2024
PRO Number
Pro00132289
Researcher
Arman Kilic

List of Studies

Keywords
Cardiovascular
Summary

The study will evaluate the effect of prophylactic intra-operative ventricular tachyarrhythmia ablation (VTA) at the time of left ventricular assist device (LVAD) implantation on post-implant total recurrent VTA events, after accounting for the competing risk of death, from discharge to an average follow-up of 18 months (with a minimum of 9 months) after LVAD implantation.

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

Research Evaluating Vagal Excitation and Anatomical Links

Date Added
June 13th, 2024
PRO Number
Pro00136451
Researcher
Mark George

List of Studies


Keywords
Depression, Epilepsy, Mental Health
Summary

This is an NIH sponsored trial across the US where patients who have been or will be implanted with cervical vagus nerve stimulation (VNS) are then tested in a variety of ways to determine the activity of the VNS on different organs in their body. This will involve implantation for those who qualify, and then two trips to the University of Minnesota for more extensive testing. The device, implantation and travel are all at no cost.

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

SAINT NEUROMODULATION SYSTEM FOR THE TREATMENT OF DEPRESSION IN AN INPATIENT SETTING

Date Added
July 23rd, 2024
PRO Number
Pro00126985
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Suicide
Summary

This is an inpatient clinical trial of a new form of transcranial magnetic stimulation with 10 treatments/day for 5 days, called SAINT. It is jointly funded by the NIH and a TMS company, MAGNUS. It is being done at 5 enrolling sites in the US, with total sampe of 100. Depressed and suicidal inpatients will have an MRI scan, then 5 days of treatment, and then a followup MRI scan. Outcome measures are depression and suicide ratings, as well as MRI changes. It is randomized and double blind, so some patients will not be getting active TMS. Importantly this is an adjunctive treatment study on top of all routine clinical treatments.

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



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