Advanced Fibrosis Detection and a Predictive Diagnostic Model for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care

Date Added
July 3rd, 2025
PRO Number
Pro00145783
Researcher
Andrew Schreiner

List of Studies


Keywords
Diabetes, Liver, Obesity
Summary

This proposal evaluates the implementation of a novel, non-interruptive, electronic health record alert for metabolic dysfunction-associated steatotic liver disease (MASLD) fibrosis risk assessment in primary care patients with MASLD using a stepped wedge, cluster randomized design. We will evaluate the clinical outcome of advanced liver fibrosis detection and the implementation outcomes of adoption, penetration, fidelity, and sustainability. This work will generate generalizable data to dramatically enhance MASLD management in primary care.

Institution
MUSC
Recruitment Contact
Chloe Cooper
843-876-0448
coopechl@musc.edu

A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors

Date Added
July 3rd, 2025
PRO Number
Pro00145386
Researcher
Theodore Gourdin

List of Studies


Keywords
Cancer, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Lung, Drug Studies, Liver, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with recurrent, progressive as well as advanced, metastatic hepatocellular carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma (HNSCC) or non-small cell lung cancer (NSCLC). The study is testing an investigational drug called DB-1311. Investigational means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of the study is to determine the recommended phase II dose of DB-1311 in combination with BNT327 or DB-1311 in combination with DB-1305 by assessing the safety and tolerability. The drug is given to participants by IV infusion. Participants in this study can expect to be in this study for 72 months.

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

Complementary Options for Symptom Management In Cancer (COSMIC): Assessing Benefits and Harms of Cannabis and Cannabinoid Use Among a Cohort of Cancer Patients Treated in Community Oncology Clinics

Date Added
July 3rd, 2025
PRO Number
Pro00145053
Researcher
Erin McClure

List of Studies


Keywords
Cancer, Men's Health, Women's Health
Summary

The study is for patients that have been diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung. The study will examine the association between cannabis and/or cannabinoid use and cancer-related symptoms assessed monthly for one year in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung. 40 participants will be enrolled locally. Participants can expect to remain in the study for 12 months.

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

Infant feeding intentions and risk for breastfeeding attrition among women living with HIV

Date Added
July 3rd, 2025
PRO Number
Pro00142019
Researcher
Britton Gibson

List of Studies

Keywords
Obstetrics and Gynecology
Summary

This is a research study among women living with HIV about their choices in how they feed their infants and the different factors that contribute to those decisions, as well as how those decisions change after giving birth and as their baby grows. This study includes surveys at 2 different time points- once while still pregnant, once approximately 4-6 weeks postpartum. We hope to gain understanding on womens choices about breastfeeding while living with HIV.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@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

Neuromodulation + Prolonged Exposure Therapy: Evaluation of a Technology-Enhanced, Entirely Remote 2-Week Integrated Treatment for Pain and PTSD

Date Added
July 1st, 2025
PRO Number
Pro00144178
Researcher
Ronald Acierno

List of Studies

Keywords
Anxiety, Military, Pain
Summary

The purpose of this study is to see how well the combination of home-based transcranial direct current stimulation (tDCS) and prolonged exposure (PE) works in treating people with chronic pain (e.g., pain related to fibromyalgia, lower back pain, arthritis) and posttraumatic stress disorder (PTSD).

Participants must be a Veteran or Active-Duty service member with a diagnosis of PTSD and chronic musculoskeletal pain. Participants will receive 10 sessions of PE over 2 weeks (called Massed PE) and 10 sessions of tDCS.

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

GSR DEFINE– US Cohort

Date Added
June 24th, 2025
PRO Number
Pro00145266
Researcher
Thomas Todoran

List of Studies


Keywords
Heart, Hypertension/ High Blood Pressure
Summary

This registry is enrolling subjects who are indicated for renal denervation to treat high blood pressure that has remained high despite treatment. Renal denervation is a procedure where a catheter (a thin, flexible plastic tube with four electrodes near the end) is placed inside the blood vessels that go to the kidneys. Heat is delivered through the electrodes to disable the nerve activity and lower the blood pressure.

Participation in this registry will last about 1-3 years and include 3-6 visits depending on how often your doctor typically conducts follow up visits. Data will be collected including medical history, medications, blood pressure readings, labs, from the procedure and from any complications if applicable. There is a risk of loss of confidentiality and there may be risks that are not known. There may be no direct benefit but the information learned may help others in the future.

Institution
MUSC
Recruitment Contact
Deborah Everidge
843-792-2944
adamsde@musc.edu

A Phase II Study of Ribociclib And Endocrine Treatment of Physician s Choice for Locoregional Recurrent Resected Hormone Receptor Positive HER2 Negative Breast Cancer

Date Added
June 24th, 2025
PRO Number
Pro00144995
Researcher
Abirami Sivapiragasam

List of Studies

Keywords
Cancer, Drug Studies
Summary

The purpose of this study is to find out if adding a drug called ribociclib to the usual hormone therapy drugs can lower the chance of your breast cancer coming back again. This study is for patients with locoregional, recrrent, resected hormonone receptor positive HER2 negative breast cancer. Endocrine therapy has already been approved by the FDA for your type of cancer. Ribociclib has already been approved by the FDA for your type of cancer that has not been removed by surgery or has spread to other parts of the body.

Receiving ribociclib with endocrine therapy is still being studied and to yet approved by the FDA. Ribociclib is taken as a pill and endocrine therapy is taken as an injection. Participants will receive ribociclib with endocrine therapy for up to 3 years and can receive endocrine therapy alone for an additional two years after stopping ribociclib. Participants can remain on the study for up to 5 years.

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

A Phase 3, Randomized, Double-Blinded, Placebo -Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)

Date Added
June 24th, 2025
PRO Number
Pro00144738
Researcher
Daniel Steinberg

List of Studies


Keywords
Drug Studies, Heart
Summary

This study is enrolling participants with calcific aortic valve stenosis (CAVS) which is a heart valve disease. Blood pumped out of the heart goes through the aortic valve, and in CAVS, calcium builds up causing the valve to thicken over time so it is not able to open as much or as easily and over time this restricts blood flow. This study involves an investigational medication called ataciguat which is being studied to see how well it can slow the progression of CAVS. Investigational means it has not been approved for commercial use by the Food and Drug Administration (FDA). Ataciguat is taken by mouth daily.

Participation in this study will last about 3 years and include about 14 visits. Study procedures include collection of medical data, physical exams, electrocardiogram (ECG - a recording of your heart's electrical activity), bloodwork, echocardiogram (ultrasound test of the heart), CT scan, questionnaires and home monitoring of your blood pressure and heart rhythm.

Risks related to ataciguat include headache, nausea, abdominal pain, diarrhea and dizziness. Study procedure risks include radiation risks, risks of drawing blood and loss of confidentiality.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-792-5037
drain@musc.edu

NRG-GU013: The Phase III ‘High Five Trial' Five Fraction Radiation for High-Risk Prostate Cancer

Date Added
June 20th, 2025
PRO Number
Pro00145135
Researcher
David Marshall

List of Studies


Keywords
Cancer, Cancer/Genitourinary, Men's Health, Prostate
Summary

This study is for patients that have been diagnosed with prostate cancer. This study will compare metastasis-free survival, determined using conventional imaging, between men with high-risk prostate cancer randomized to ultrahypofractionation (stereotactic body radiation therapy [SBRT]) to those randomized to moderate hypofractionation and conventional fractionation. Participants can expect to remain in the study for 11 years and 10 months.

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



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