Randomized Controlled Trial of MAGIcTouch - Sirolimus Coated BALloon Versus Standard Balloon Angioplasty in The Treatment of Below The Knee Arterial Disease

Date Added
April 1st, 2025
PRO Number
Pro00137869
Researcher
Adam Tanious

List of Studies

Keywords
Vascular
Summary

The purpose of this research is to evaluate the efficacy of a new investigational Sirolimus coated balloon device in the treatment of insufficient blood flow of legs (peripheral arterial disease, PAD).

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

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

A prospective, multicenter clinical trial of the TricValve® Transcatheter Bicaval Valve System in subjects with severe tricuspid regurgitation.

Date Added
April 22nd, 2025
PRO Number
Pro00143868
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.

Institution
MUSC
Recruitment Contact
Natalie Forrester
843-876-5037
drain@musc.edu

CONQUEST: Platform Clinical Study for Conquering Scleroderma: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2b Platform Clinical Study to Evaluate the Safety and Efficacy of Investigational Products in Participants with Interstitial Lung Disease Secondary to Systemic Sclerosis

Date Added
May 13th, 2025
PRO Number
Pro00135916
Researcher
Faye Hant

List of Studies


Keywords
Autoimmune disease, Drug Studies, Rare Diseases, Scleroderma
Summary

The CONQUEST study is a clinical trial for people with systemic sclerosis associated interstitial lung disease (SSc-ILD). The goal of the research study is to help potentially uncover new SSc-ILD treatment options. The study is sponsored by The Scleroderma Research Foundation and is currently working with 2 pharmaceutical companies to provide the investigational medications (Amlitelimab, a subcutaneous injection/shot and BI 1015550/Nerandomilast, a tablet taken by mouth). Study participation involves a main study which is collecting general information about your scleroderma health and well being and at the same time, a treatment study that is specific to the investigational drug that you are assigned.

An investigational or study drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study the ID will be compared with a placebo (dummy drug). The placebo will be a look like the ID but does not have any study drug in it. The comparison with the placebo helps to determine whether the effects seen in your body is because of the ID or not. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is double-blinded study, meaning you and your study doctor will not know if you are taking a study drug or placebo but you will know what treatment study you are assigned (Treatment Study A with Amlitelimab or Treatment Study B with BI 1015550/Nerandomilast).

Participation in the overall study will be approximately 60 weeks (4 weeks
Screening, 52 weeks Treatment Period, and 4 weeks Follow-up with visits to the MUSC main campus. Study visits are much like the visits that you have with our Rheumatologist as part of your routine care such as: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and skin thickness testing), tests to assess your pulmonary function and health (Pulmonary Function Test (PFT) and High Resolution Computed Tomography (HRCT)), electrocardiogram, as well as being asked to complete surveys/questionnaires.

Compensation is available with participation.

Institution
MUSC
Recruitment Contact
Miranda Irvin
843-792-8613
sclerodermaresearch@musc.edu

A pragmatic remote approach to improve transitions of care and retention in opioid use disorder treatment: Qualitative Interviews

Date Added
May 20th, 2025
PRO Number
Pro00141967
Researcher
Allison Smith

List of Studies


Keywords
Psychiatry, Substance Use
Summary

The primary objective of this proposal is to conduct surveys and qualitative interviews to get feedback from (1) stakeholders and (2) people with lived experience of opioid use and a related medical hospitalization, on the barriers and facilitators of new potential strategy of treatment. The potential proposed intervention we will ask questions about is the direct mailing medications for opioid use disorder (OUD) in an attempt to overcome many of the barriers that interfere with treatment retention (i.e. transportation). Qualitative interviews will be used to get feedback on the feasibility, appropriateness, and acceptability of mailing maintenance medications for OUD after a hospital discharge. In a future study, this feedback will be used to develop a protocol to test this method.

Institution
MUSC
Recruitment Contact
Allison Smith
843-792-0686
smithall@musc.edu

Validation of the Revised Clinician Administered PTSD Scale for DSM-5 (CAPS-5-R)

Date Added
June 16th, 2025
PRO Number
Pro00145011
Researcher
Ronald Acierno

List of Studies

Keywords
Mental Health
Summary

This is a research study to help see if a new interview for posttraumatic stress disorder (PTSD), called the Revised Clinician-Administered PTSD Scale for DSM-5, or the CAPS-5-R for short, is accurate and reliable for veterans. By doing this study, we hope to learn if the CAPS-5-R can be used in VA to diagnose PTSD. Participation will all be done remotely. Joining this study will involve (1) completing some questionnaire measures and (2) completing an interview remotely by videoconference over 2 days at most.

Participants must be Veterans, aged 18 or older in the Ralph H. Johnson VA Health Care System who have experienced trauma or at least one PTSD symptom.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

OPtimal Adult Heart Transplant Immunosuppression with MicroRNA Levels

Date Added
June 17th, 2025
PRO Number
Pro00145519
Researcher
Ryan Tedford

List of Studies


Keywords
Heart, Transplant
Summary

This study is looking at people who have recently had a heart transplant to see if a simple blood test can help doctors better understand how the immune system is doing. By checking tiny molecules called microRNAs in the blood, researchers hope to find a way to tell if a patient might have problems like infection or rejection of their new heart. The goal is to help adjust medications so patients stay healthier after their transplant. The study involves taking blood samples during regular doctor visits over three years, but it doesn't change any of the usual care the patients would already get.

Institution
MUSC
Recruitment Contact
Shaquanda Goodwine
843-876-5783
shr37@musc.edu

Can MEP conditioning improve corticospinal recruitment of motoneurons in chronic cervical SCI?

Date Added
July 1st, 2025
PRO Number
Pro00145581
Researcher
Aiko Thompson

List of Studies


Keywords
Movement Disorders, Rehabilitation Studies, Spinal Cord
Summary

The purpose of this research study is to examine the effect of a brain stimulation training to improve the function of brain-spinal cord- muscle connections.Because brain-to-muscle pathways are very important in our movement control, restoring function of these pathways may improve movement problems after injuries. Spinal cord injury causes damage to the brain-to-muscle connection. However, when the injury is "incomplete", there is a possibility that some of the brain-to-muscle pathways are still connected and may be trained to improve movement function. For examining brain-to-muscle pathways, we use a transcranial magnetic stimulator. We hope that the results of this research study will help us develop new treatments for people who have movement disabilities. This study will require about 42 visits over the first 14 weeks, and another 6 visits over an additional 3 months. Each visit will take about 1 ½ hours.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@musc.edu



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