A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension

Date Added
August 28th, 2026
PRO Number
Pro00152132
Researcher
Thomas Uhde

List of Studies


Keywords
Drug Studies, Sleep Disorders
Summary

The 16-week main phase of the study is designed to assess the efficacy and safety of the once daily pitolisant, administered orally upon wakening, in comparison to a placebo. This study includes overnight sleep studies. The effects of HBS-301 on excessive daytime sleepiness, fatigue, and cataplexy (NT1 population only) will be examined.

After the main phase period, there is an option to be in the second part of the study, which will span 1 year. During this period, subjects will receive open label of the active drug, HBS-301.

Institution
MUSC
Recruitment Contact
Brooke Cameron
(843) 876-9262
camerobr@musc.edu

Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT)

Date Added
August 28th, 2026
PRO Number
Pro00151285
Researcher
Jacqueline Kraveka

List of Studies


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

This study is recruiting pediatric patients who have been diagnosed with Favorable Histology Wilms Tumor (FHWT). Wilms Tumor is the most common type of kidney cancer in children, and FHWT is the most common subtype. The goal of the study to improve outcomes within cohorts of FHWT patients with current long-term EFS rates at or below 80% and maintain outcomes despite therapy reduction within cohorts of FHWT patients with current long-term EFS rates at or above 84%. Common side effects of treatment in regards to this study include nausea, vomiting, hair loss, and fatigue (tiredness). Participants will receive the medications through an IV in their arm and orally. Study participation is expected to be approximately 5 years.

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

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

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

A Prospective, Multicenter, Observational Study Evaluating Serial T-ID Monitoring for the Prevention of CMV Disease and BK Virus–Associated Nephropathy Following Kidney Transplantation

Date Added
August 12th, 2026
PRO Number
Pro00150730
Researcher
Sakshi Vaishnav

List of Studies

Keywords
Surgery
Summary

This is a prospective, multicenter, observational study designed to evaluate the clinical utility and prognostic relevance of serial TRAC and T-ID monitoring in kidney transplant recipients under routine clinical care.

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

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer with RS25 (RxFINE-Low)

Date Added
August 11th, 2026
PRO Number
Pro00152292
Researcher
Dali Edwards

List of Studies

Keywords
Cancer, Cancer/Breast
Summary

The study compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk. Participants can expect to remain in the study for 10 years.

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



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