A Phase 3, single-arm, open-label extension study to evaluate the safety of finerenone in addition to standard of care, in pediatric heart failure patients, from birth to 18 years of age, with left ventricular systolic dysfunction (LVSD)

Date Added
August 28th, 2026
PRO Number
Pro00149200
Researcher
Katerina Boucek

List of Studies

Keywords
Heart, Pediatrics
Summary

The FIORELLO study is for pediatric patients who 1) Have heart failure and left ventricular systolic dysfunction associated with dilated cardiomyopathy or congenital heart disease and 2) Have successfully completed the FIORE trial. Study participants will receive the study drug finerenone, which has not yet been FDA approved for this specific pediatric population. The study will last 9 months and the objective is to show that finerenone in addition to standard of care is safe when given long-term to pediatric patients with left ventricular systolic dysfunction.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
8437928317
wakefies@musc.edu

PALMS-HF: Post-Acute Longitudinal Monitoring System for Heart Failure in Rural Populations

Date Added
August 26th, 2026
PRO Number
Pro00151094
Researcher
Michele Esposito

List of Studies

Keywords
Heart
Summary

This is a pilot study that will be performed to assess whether a series of once weekly in-home visits over a month (total of 4 visits) after discharge from a hospital with a heart failure diagnosis can help reduce re-hospitalization rates. To accomplish this, subjects will perform a once weekly telehealth visit with a heart failure provider and the following will be completed: symptom questionnaires, blood work, and a video of the neck veins to document physical exam once weekly during the study period. The videos and labs will be sent to the remote care team, who can use this data to manage the subject's medications. The study team will collect information regarding the study participant's frequency of hospital readmissions following enrollment.

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

Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion with Lenacapavir (LEN)

Date Added
August 25th, 2026
PRO Number
Pro00150000
Researcher
Hayley Berry

List of Studies

Keywords
HIV / AIDS
Summary

The primary objective of this study is to evaluate real-life persistence on lenacapavir (LEN) pre-exposure prophylaxis (PrEP) at W52 in diverse clinical settings in the US.

This is a non-interventional study where information is being gathered about how individuals decide if and when to use pre-exposure prophylaxis for HIV prevention over a 2-year period, and when they do, how consistently individuals use pre-exposure prophylaxis and specific kinds of pre-exposure prophylaxis, like lenacapavir. Participants must be at least 18 years or older and willing and able to comply with all study requirements.

Institution
MUSC
Recruitment Contact
Jamila Williams
843-792-1088
keithja@musc.edu

A Phase 1, Randomized, Double-Blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Novel Pneumococcal Vaccine in Children

Date Added
August 21st, 2026
PRO Number
Pro00147750
Researcher
Robert Clifford

List of Studies


Keywords
Children's Health, Vaccine
Summary

This trial is testing V118C in infants and toddlers.

V118C is an experimental vaccine. Vaccines help to prevent illness by teaching the body's immune system how to fight infections. The immune system is a network of organs and cells that fight infections. If it works, V118C may prevent an illness called pneumococcal disease. This is an illness caused by certain germs. These germs can cause infections, some of which may be serious, in the ears, nose, lungs, blood, or brain.

This trial will compare V118C to a vaccine called PCV20. PCV20 is approved to prevent pneumococcal disease in infants and toddlers.

Institution
MUSC
Recruitment Contact
Matthew Thomas
8438702225
thommatt@musc.edu

Microplastics in Orthodontics: Detection, Characterization, and Patient Safety – A Pilot Project

Date Added
August 20th, 2026
PRO Number
Pro00150386
Researcher
Vaibhav Gandhi

List of Studies

Keywords
Dental
Summary

This study explores whether clear aligners used in orthodontic treatment release very small plastic particles, known as microplastics, into the mouth. While aligners are made from safe medical-grade plastics, everyday use such as chewing, temperature changes, and saliva exposure may cause the material to gradually wear down. We will collect saliva samples from patients before starting aligner treatment and after several months of use to see if these particles can be detected. Advanced laboratory techniques will be used to identify and analyze any plastic particles present.

Our preliminary findings suggest that small plastic-related compounds may already be present in patients wearing aligners, but this study aims to confirm and better understand this in real clinical conditions. The goal is to determine how much exposure may occur and what types of materials are involved. This information will help improve the safety of orthodontic materials and guide future recommendations for both patients and providers.

Institution
MUSC
Recruitment Contact
Vaibhav Gandhi
843.792.4680
gandhiv@musc.edu

A Phase 1 Study of KTX-1001, an Oral, First-In-Class, Selective, and Potent MMSET Catalytic Inhibitor that Suppresses H3K36me2 in Patients With Relapsed and Refractory Multiple Myeloma

Date Added
August 19th, 2026
PRO Number
Pro00151980
Researcher
Anthony Dominick

List of Studies

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

This study is for patients that have been diagnosed with relapsed and refractory multiple myeloma (RRMM). This study is testing and investigational drug called KTX-1001. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to test the safety and tolerability of KTX-1001 and to find out how it is processed by the body. The drug is given to participants by mouth. Participants in this study can expect to be in this study until disease progression, unacceptable toxicity, or withdrawal from the study. The total duration of the study may be approximately 4 years.

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

SEAI T1-03: Improving Maternal Mental Health Screening Using Large Language Model-based Artificial Intelligence

Date Added
August 14th, 2026
PRO Number
Pro00152119
Researcher
Constance Guille

List of Studies


Keywords
Depression, Mental Health, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Substance Use, Women's Health
Summary

This study aims to improve the early identification of depression and substance use concerns during pregnancy and after childbirth by developing an artificial intelligence (AI) tool that uses information already collected in electronic health records. The goal is to help healthcare providers identify individuals who may be at risk for mental health or substance use problems earlier, allowing for timely support and treatment. Researchers will also work closely with patients, healthcare providers, and community partners to ensure the AI tool is trustworthy, easy to use, fair, and able to fit into routine healthcare settings.
The study includes two components. First, researchers will use existing electronic health record data from pregnant patients to develop and test an AI model that can predict the likelihood of depression or substance use concerns. Second, pregnant or postpartum individuals and obstetric healthcare providers will participate in a one-time virtual interview/focus group to share their perspectives on the use of AI in maternal healthcare. Feedback from these interviews/focus groups will help refine the AI tool and support its future implementation in clinical care.

Institution
MUSC
Recruitment Contact
Sarah Rowell
8542021117
smr300@musc.edu

Efficacy and safety of once-daily oral zenagamtide in participants with obesity (AMAZE 9)

Date Added
August 13th, 2026
PRO Number
Pro00151743
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

An 87-week clinical research study comparing zenagamtide in doses of 6mg, 12mg, 25mg, 50 mg or 2 x 50mg versus placebo, all administered as once-daily oral tablets as an adjunct to a reduced-calorie diet and increased physical activity, in participants with obesity.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

An Occupational Perspective of Menstrual Hygiene Management for Adults Living with Spinal Cord Injury: A Phenomenological Study

Date Added
August 13th, 2026
PRO Number
Pro00151678
Researcher
Jennifer Barnett

List of Studies

Keywords
Spinal Cord, Women's Health
Summary

This research study explores the experiences of adults with spinal cord injury (SCI) when managing menstrual hygiene. Recommendations for occupational therapy (OT) interventions to support participation are also included. Information will be gathered from each participant through a survey and a virtual interview. This study aims to answer the following questions: How do adults living with SCI manage menstrual hygiene? What challenges do they face? What role can OT play in supporting them?

Institution
MUSC
Recruitment Contact
Jennifer Barnett
864-888-7532
jhb203@musc.edu

Maturation of Arteriovenous Fistula with Automated Sonography Assessments (MAFASA) Trial

Date Added
August 13th, 2026
PRO Number
Pro00149409
Researcher
Adam Tanious

List of Studies

Keywords
Surgery, Vascular
Summary

The purpose of this research is to evaluate the safety and effectiveness of the EchoMark/EchoSure System for AVF (arteriovenous fistula) for assessing AV fistula maturation when used under a protocol of biweekly use as compared to the standard of care follow-up. Target subject population are subjects presenting with Stage 5 Chronic Kidney Disease (CKD5) or End Stage Renal Disease (ESRD) undergoing upper arm autologous arteriovenous fistula creation for hemodialysis access who are on dialysis or will imminently require dialysis (GFR <10).

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



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