A Phase 2a randomized, double-blind, placebo-controlled proof-of-concept study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of SION-719 when added to physician-prescribed Trikafta™ in people with cystic fibrosis who are homozygous for the F508del mutation

Date Added
November 20th, 2025
PRO Number
Pro00147883
Researcher
Christina Mingora

List of Studies

Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this research study is to assess if the study drug SION-719 is safe and well-tolerated in people with cystic fibrosis who are already taking Trikafta, understand the effect of SION-719 on the body by measuring chloride levels, and to learn how the body absorbs, distributes, and gets rid of the study drug in people with cystic fibrosis. This study is a placebo controlled cross-over study with two study treatment periods, and participants will take part in both study treatment periods. Participants will be assigned either study drug or placebo. Participants will remain on standard dose of physician-prescribed Trikafta throughout the study. This study will be approximately 16 weeks, or 112 days long.

Institution
MUSC
Recruitment Contact
Rohini Rao
8437926109
recuitment@musc.edu

Right Ventricular Function, Hepatic Metabolic Function, and Relationship to RV-PA Coupling in Patients with Tricuspid Regurgitation

Date Added
November 18th, 2025
PRO Number
Pro00148059
Researcher
Nicholas Amoroso

List of Studies


Keywords
Heart
Summary

This study is enrolling two different groups of individuals. The first group are those individuals referred for right heart catheterization (RHC), which is a procedure performed to check heart pressure taken inside the heart. The second group of individuals are those who have tricuspid regurgitation (TR) (blood that leaks due to improper valve closure) and are undergoing tricuspid valve intervention to correct the regurgitation. The RHC group will be referred to as the control group and the tricuspid intervention group will be the treatment group in this study. This study involves collecting existing medical records on both groups, as well as an arterial (from an artery) blood sample and venous (from a vein) blood sample from the vein that carries blood away from the liver. The control group will not involve any additional procedures or follow up. The TR population will perform a 6 minute hall walk test before their tricuspid valve intervention and again during the six month post procedure follow up. The TR group will also have repeat arterial and venous blood collection at the six month follow up. The TR group will have data collected for up to two years post tricuspid valve intervention.

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

Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Platinum Refractory Disease

Date Added
November 18th, 2025
PRO Number
Pro00147980
Researcher
John Kaczmar

List of Studies


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

The purpose of this study is to test whether adding cetuximab to standard of care (pembrolizumab) is more effective in shrinking tumor size and increasing survival when compared to being treated with pembrolizumab alone. This study seeks to find if this approach is the same, better, or worse than standard of care for returning or spreading head and neck cancer after previous treatment.

Treatment and follow up for this study may be up to 5 years. The procedures include blood tests, CT or MRI scans, and chemotherapy. Risks include tiredness, anemia, constipation, loss of appetite, joint stiffness, cough, swelling and redness of the skin.

You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future. Both drugs, pembrolizumab and cetuximab, are already individually approved by the FDA for use in head and neck cancers. However, the benefit of combining the two drugs is being investigated in this study and this study approach is not FDA approved.

There will be about 158 people taking part in this study, approximately 4 subjects will be enrolled at MUSC.

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

Hypofractionated Radiotherapy with a Focal Microboost for High-Risk and Locally Advanced Prostate Cancer

Date Added
November 18th, 2025
PRO Number
Pro00147655
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary
Summary

This study is for adult men with previously untreated prostate cancer. The purpose of this study is to evaluate the safety and effectiveness of the combination of two emerging treatment techniques (hypofractionated radiotherapy with microboost technique). Participation will include standard of care visits along with questionnaires and blood draws completed for research purposes. There is optional banking of blood and prostate biopsy tissue which will not require extra biopsies. Participation in this study is anticipated to last approximately 6 weeks with follow up every three months for two years then twice yearly for years 3-5.

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

Saline Enhanced Radiofrequency (SERF) Needle Ablation for Refractory VT

Date Added
November 18th, 2025
PRO Number
Pro00147339
Researcher
Jeffrey Winterfield

List of Studies


Keywords
Cardiovascular, Heart
Summary

This study is testing a new treatment for people with a dangerous heart rhythm problem called ventricular tachycardia (VT). VT can cause the heart to beat too fast, leading to fainting, heart failure, or even sudden death. Some people continue to have VT even after taking medicines and undergoing standard ablation procedures. For these patients, current treatment options are very limited.

The investigational treatment uses the Thermedical Ablation System with the Durablate™ catheter. This device delivers both heat and saline (salt water) deep into the heart muscle to target the areas causing abnormal rhythms. The goal is to safely and effectively reduce or eliminate VT episodes in patients who have not responded to other therapies.

About 130 patients will be enrolled at up to 25 hospitals in the U.S. and Canada. Participants will have the procedure and then be followed for six months with regular checkups to see if the treatment reduces their VT episodes and improves their quality of life. This study will help determine if the new system should be approved for wider clinical use.

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

NRG-CC015: Harnessing E-mindfulness Approaches for Ling After Breast Cancer - HEAL ABC

Date Added
November 18th, 2025
PRO Number
Pro00147298
Researcher
Dali Edwards

List of Studies

Keywords
Cancer, Cancer/Breast, Depression
Summary

This study is recruiting non-metastatic breast cancer survivors who were diagnosed between ages 18 and 51 and are currently 6 months to 5 years post-treatment. Eligible participants must have a score of 5–14 on the PHQ-8 depression screening tool. This study is testing a digital mindfulness meditation-based program. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). Participants will be randomly assigned (like drawing one number out of three at random) to one of three groups: (1) live online mindfulness classes over Zoom, (2) a specially designed mindfulness app, or (3) guided audio meditations. The primary purpose of this study is to determine if different ways of delivering digital mindfulness training can improve mental health and well-being in younger breast cancer survivors. The program is delivered either by live online sessions, through a mobile app, or by listening to guided meditation recordings. Participants can expect to be in this study for about 9 months, including a 6-week training program and questionnaires before, during, and after training. Participants will be enrolled for a duration of 9 months, and a total of 15 patients will be recruited locally over the course of 36 months.

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

A032302: Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

Date Added
November 14th, 2025
PRO Number
Pro00148191
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer/Genitourinary
Summary

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

Institution
MUSC
Recruitment Contact
maggie bentley
864-725-7125
margaret.bentley@selfregional.org

The Single Ventricle Outcomes Network (SV-ONE)

Date Added
November 14th, 2025
PRO Number
Pro00147843
Researcher
Frances Woodard

List of Studies


Keywords
Cardiovascular, Heart, Infant
Summary

SV-ONE represents the integration of NPC-QIC within the existing FON framework. As such, SV-ONE will engage in research and improvement efforts through the entire lifespan of patients with SVHD, including but not limited to those with a Fontan circulation. The larger objective of this study is to increase longevity and enhance the QoL by improving physical health and functioning, mental health and resilience, and neurodevelopment for individuals with SVHD and their families. A longer-term goal of SV-ONE will be to serve as a platform for research and improvement that will
accelerate advances, with the potential to nest clinical trials and to link to registries and programs,
nationally and internationally.

Institution
MUSC
Recruitment Contact
Frances Woodard
843-792-3292
klinefl@musc.edu

Paxillin expression in human liver

Date Added
November 14th, 2025
PRO Number
Pro00147117
Researcher
Karim Besir

List of Studies

Keywords
Liver
Summary

We wish to examine human liver to determine whether and to what extent paxillin is expressed (using immunohistochemistry). Existing liver specimens will be identified by ICD-10 search to identify patients with MASLD who have undergone liver biopsy within the last 5 years.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

Influence of Vocal Aging and Visual Cues on Listener Perception of Speaker Age

Date Added
November 14th, 2025
PRO Number
Pro00147043
Researcher
Cali Loblundo

List of Studies

Keywords
Aging, Healthy Volunteer Studies, Throat
Summary

This cross-sectional study aims to examine the impact of visual cues on listeners' perception of speaker age. Eligible speaking participants include adult males and females between the ages of 18–90 years old without voice or hearing disorders. Eligibility will be determined by research coordinators via patient demographic forms and validated voice and hearing assessments. Speaking participants will have two audio recordings taken: (1) sustained vowel sound and (2) reading of the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V), a standardized tool employed to evaluate the perceptual characteristics of voice quality across a wide age range. To develop the materials for the listening participants, CAPE-V audio recordings obtained from the speaking participants will be systematically paired with race and age-matched photographs obtained from a publicly available database. The finalized materials will encompass three experimental conditions: (1) audio only, (2) audio presented with a standardized photograph of an individual matched to the speaker's gender and age, and (3) audio presented with a standardized photograph of an individual matched for gender but differing in age. Naïve listening participants, blinded to the experimental conditions, will then be presented with these materials in a randomized order and asked to estimate the perceived ages of the speakers. Additionally, basic acoustic analyses of each sustained vowel sound recording (e.g., jitter, shimmer) will be conducted by a trained professional using the speech analysis software PRAAT.

Institution
MUSC
Recruitment Contact
Priyanka Shah
571-439-4745
shahpri@musc.edu



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