Women's Aneurysm Research: Repair Immediately or Routine Surveillance: WARRIORS Trial- USA

Date Added
July 23rd, 2026
PRO Number
Pro00151293
Researcher
Jean Ruddy

List of Studies


Keywords
Surgery
Summary

This study is trying to find out whether early repair of small Abdominal Aortic Aneurysms (AAAs) in women improves health outcomes compared to routine monitoring. An AAA occurs when a section of the aorta in the abdomen weakens and bulges outward, resembling a balloon. This condition is serious because if the aneurysm ruptures, it can cause severe internal bleeding and can be fatal. This question is important because women with small AAAs may have a higher risk of rupture than men, and doctors are not yet sure whether early repair is better than standard monitoring. Surgical repair is the elective standard of care for aneurysms above 5.5cm in size. In our study we are evaluating if earlier repair (between 4.0- 5.4 cm) might be beneficial to women with abdominal aneurysms, but it is important to note that surgical repair involves risks and could lead to other complications, including death. These risks are discussed later in this form. There is also the possibility that you may need additional procedures, including open surgery.

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

A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)

Date Added
July 23rd, 2026
PRO Number
Pro00151187
Researcher
Russell Jenkins

List of Studies

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

This study is for adults diagnosed with advanced melanoma (a kind of skin cancer) that has spread or cannot be surgically removed. This study includes participants with advanced melanoma from any part of the body except the eye.

The main purpose of this research study is to learn if the study drug, brenetafusp (IMC-F106C), in combination with a standard therapy (nivolumab), works better than the standard therapy (nivolumab alone or in combination with relatlimab) at making tumors stop growing (or shrink). Nivolumab and relatlimab are FDA approved, however, the study drug, brenetafusp, is still being investigated and is not approved by the FDA.

Patients may participate in this study for up to 2 years. Procedures include CT, MRI, blood tests, drug administration, and regular visits with your doctor including follow-up study visits or phone calls. There will be about 680 people taking part in this study, approximately 5 patients will be enrolled at MUSC.

Risks include cytokine release syndrome, which could include flu-like symptoms such as nausea, vomiting, fever, tiredness, headache, chills, difficulty breathing and/or low blood pressure (symptoms may include dizziness or light headedness). Participants 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.

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

A Phase 3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol in Adults with an Open Label Study in Adolescents to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with Icotrokinra in Participants With Moderately to Severely Active Ulcerative Colitis

Date Added
August 3rd, 2026
PRO Number
Pro00149835
Researcher
Erin Forster

List of Studies


Keywords
Digestive System, Ulcerative colitis
Summary

This study aims to evaluate the clinical development program for icotrokinra in the treatment of adult participants with moderately to severely active UC. Icotrokinra may offer additional advantages beyond injectable antibody therapies and available
oral therapies for the treatment of patients with moderate to severely active UC due to its oral route of administration, high local exposure to GI tissues, and systemic activity. Overall, the program will evaluate icotrokinra treatment in a target of 822 adult and 60 adolescent participants through at least 52 weeks but participants can participate in a long-term extension for 4 years (total duration approximately 5 years).

Institution
MUSC
Recruitment Contact
Sydney Britton
(843) 792-1425
brittosy@musc.edu

The Effects of Self-Imagery Rescripting Paired with Transcutaneous Auricular Vagus Nerve Stimulation on Symptoms of Social Anxiety

Date Added
August 4th, 2026
PRO Number
Pro00151445
Researcher
Lisa McTeague

List of Studies


Keywords
Anxiety, Brain, Ears, Healthy Volunteer Studies, Mental Health
Summary

The purpose of this study is to better understand how ear stimulation techniques may impact how people think about themselves in social situations. The goal is to identify how the addition of ear stimulation can impact cognitive processes, including the ways that people think about themselves in social situations and attend to or process social information, that underly an activity known as "self-imagery rescripting." Eligible individuals who are between the ages of 18 and 65 years will complete a variety of activities after providing consent to study participation. These include: (1) completing questionnaires on the computer, (2) completing tasks similar to a video game on the computer, (3) having an electrode attached to their ear that will stimulate nerve activity, (4) completing an interview about how they feel in social situations, and (5) engaging in an activity during which they will be prompted about how they see themselves in social situations. Throughout these activities, participants also will be asked to wear a variety of sensors, bundled together in a cap for their head and individually on other parts of their body, that will collect information about brain activity, heart rate, and eye blinking. Participation in this research study is entirely voluntary and will last approximately 3 hours during a single session at the Medical University of South Carolina in Charleston. Participants will be compensated for their time.

There are some risks associated with this study. Some survey questions ask about personal thoughts and feelings. Ear stimulation may cause tingling sensations or irritation around the ear. Thinking and talking about how one sees themselves in social situations may be distressful.

There are no direct benefits to participants. This study will help researchers better understand how ear stimulation can improve the strategies that can help the way that people think about themselves in social situations.

Institution
MUSC
Recruitment Contact
Danielle Deros
(843) 792-8274
deros@musc.edu

A double blind, randomized, placebo-controlled exploratory trial to investigate the efficacy and safety of nerandomilast over 24 months when administered in individuals with interstitial lung abnormalities and a family history of pulmonary fibrosis to reduce the risk of worsening (DROP-FPF)

Date Added
August 6th, 2026
PRO Number
Pro00151414
Researcher
Aravind Menon

List of Studies

Keywords
Interstitial Lung Disease (ILD)
Summary

DROP-FPF is a clinical study that will assess whether an investigational medication called nerandomilast can reduce the risk of interstitial lung abnormalities (ILAs) or interstitial lung disease (ILD) getting worse over time. By learning more about people with early lung abnormalities, it may inform researchers how to reduce the risk of developing progressive pulmonary fibrosis.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
recruitment@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

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

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

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

Topical Minocycline Foam for Treatment of Confluent and Reticulated Papillomatosis (CARP)

Date Added
September 8th, 2026
PRO Number
Pro00140636
Researcher
Lara Wine Lee

List of Studies


Keywords
Drug Studies, Skin
Summary

This study will look at whether a topical medication called minocycline foam (AMZEEQ) can help treat confluent and reticulated papillomatosis (CARP), a skin condition that causes dark, scaly patches. We will also evaluate how safe the treatment is and how satisfied patients are with it. The study is open to participants ages 9 years and older.

Participants will apply minocycline foam to one side of the affected skin and a moisturizing cream (emollient) to the other side for 5 weeks. This allows us to compare the two treatments in the same person. After this period, participants may choose to continue using the minocycline foam on all affected areas.

During the study, participants will attend follow-up visits where photos of the skin will be taken and the condition of the skin will be evaluated. Participants will also complete brief surveys about how their skin condition affects their quality of life and how satisfied they are with the treatment. The research team will monitor treatment use and any side effects.

The goal of this study is to learn whether topical minocycline could be a safe and effective treatment option for CARP, potentially providing an alternative to oral antibiotics.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
610-715-4746
winelee@musc.edu



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