A Phase 2, Double-Blind, Proof of Concept Study to Evaluate Mazdutide Compared with Placebo in Participants with Alcohol Use Disorder

Date Added
April 23rd, 2025
PRO Number
Pro00142519
Researcher
Sarah Book

List of Studies


Keywords
Substance Use
Summary

This is a 28-week-long treatment study for people with Alcohol Use Disorder who want to stop or cut down their drinking. The purpose of this study is to determine whether an investigational medication, Mazdutide, affects craving for alcohol and/or alcohol drinking while taking the study drug. Participants will be randomly assigned to Mazdutide or a matched placebo

Institution
MUSC
Recruitment Contact
Konstantin Voronin
843-792-4887
voronin@musc.edu

Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Date Added
April 22nd, 2025
PRO Number
Pro00144157
Researcher
William Albergotti

List of Studies

Keywords
Cancer/Skin, Drug Studies, Men's Health, Stage III, Stage IV, Women's Health
Summary

This phase III study evaluates whether cemiplimab can shrink or prevent the return of cancer when combined with the usual approach for skin cancer more effectively than the usual approach alone. This study will enroll adults diagnosed with stage III/IV cutaneous squamous cell carcinoma. If eligible to participate in this study participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the usual surgery used to treat this type of cancer. After surgery, they may get the usual type of radiation, depending on the results from the tumor tissue removed during surgery. Group 2 will receive cemiplimab before surgery every 3 weeks for up to 12 weeks. They may also receive radiation after surgery depending on the tumor tissue results from surgery. If treated with cemiplimab before surgery, then tumor tissue results will also determine whether or not they receive cemiplimab every 6 weeks for up to 24 weeks, after surgery, and radiation if given. Participants will be asked to complete quality of life questionnaires to understand how they are feeling during treatment and the effects of the treatment. Participants will be checked for sides effects 3 to 4 months for 2 years after treatment. After that, every 6 months for 1 year and then annually. The main risks are tiredness, diarrhea or constipation, nausea, rash or itching, change in thyroid function, and risk of progression of the cancer to require earlier surgery or to become inoperable. Alternatives to this treatment is standard of care surgery and radiation. The study benefit is cemiplimab may help in shrinking or stabilizing this type of skin cancer.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@musc.edu

A prospective, multicenter clinical trial of the TricValve® Transcatheter Bicaval Valve System in subjects with severe tricuspid regurgitation.

Date Added
April 22nd, 2025
PRO Number
Pro00143868
Researcher
Nicholas Amoroso

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

This study is enrolling subjects with tricuspid regurgitation, which is what occurs when the tricuspid heart valve on the right side of the heart does not close properly and blood leaks backwards. Over time this can lead to symptoms like shortness of breath and fluid build up in the legs, abdomen, and lungs. This study involves a new investigational device called the TricValve® Transcatheter Bicaval Valve system to treat the leaky valve. Investigational means it is not approved for commercial use by the Food and Drug Administration. (FDA) This study will last about 5 years and include about 11 visits. Study related procedures include physical exams, right heart catheterization (an invasive procedure to check pressures inside the heart), echocardiograms (ultrasound test of the heart), CT scan, blood work, questionnaires, hall walk test and procedure to place the device. Risks include those related to the device and procedure such as infection, failure of the device, worsening of your symptoms or other cardiac complications. There are also risks associated with study testing such as radiation risks, blood draw risks, loss of confidentiality and unknown risks. There is potential benefit to you and to others in the future from what is learned from this study.

Institution
MUSC
Recruitment Contact
Natalie Drain
843-876-5037
drain@musc.edu

Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" with the Lung: A Randomized Control Trial (KOURAGE)

Date Added
April 22nd, 2025
PRO Number
Pro00143675
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

This study is designed to help doctors understand how to safely - and at what dose – to give the study drug to patients suffering from acute kidney injury with accompanying acute hypoxic respiratory failure (AHRF). The study is testing Auxora (study drug) against placebo (a substance that has no medical effect).

Your chance of receiving a dose is 50% (for every 1 who receives placebo, 1 receives a dose of Auxora). This selection process is called randomization (like a ‘flip of a coin') and neither you nor your study doctor will know to which group you have been assigned. Every patient in the study will receive his/her dose of Auxora or placebo once a day, for 5 days in a row.

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

metaGENomic Sequencing to detect Infections in SOTR (Solid Organ Transplant Recipients): The mGENeSIS Registry

Date Added
April 22nd, 2025
PRO Number
Pro00143016
Researcher
Drew Charles

List of Studies

Keywords
Transplant
Summary

Examine current real-world utilization of mcfDNA using a multi-center retrospective registry. To achieve this aim, we will utilize a multi-center REDCap database to examine and summarize patient demographics and types of transplants where mcfDNA was used. We will classify cases based on common syndromes/indications for which mcfDNA is sent, timing of the test, and clinically relevant microbiologic yield of mcfDNA results.

Identify clinical predictors where mcfDNA outperforms CMT. We will analyze specific clinical syndromes where mcfDNA has higher yield compared to CMT including pneumonia, visceral abscesses, CNS infections, etc. We will also
identify specific pathogens that are more likely to be detected by mcfDNA earlier in the clinical course such as bartonella, syphilis, parasitic infections, and other atypical bacteria, mycobacteria, and fungi.

Analyze clinical impact of mcfDNA to assess whether the use of the test had a positive vs. negative vs. neutral impact on patient care using pre-specified definitions. Additionally, we will perform clinical adjudication of positive and
negative mcfDNA cases using standardized criteria and analyze effect of timing of test ordering on clinical impact.

Institution
MUSC
Recruitment Contact
Drew Charles
8437924549
charlesd@musc.edu

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects with Obesity or Overweight

Date Added
April 17th, 2025
PRO Number
Pro00142892
Researcher
Robert Malcolm

List of Studies


Keywords
Alcohol, Obesity, Weight Control
Summary

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of AUD in subjects with obesity or overweight.

Institution
MUSC
Recruitment Contact
Matthew Woodson
8437924442
woodsonm@musc.edu

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse (CAMPERR)

Date Added
April 9th, 2025
PRO Number
Pro00143358
Researcher
Gerard Silvestri

List of Studies


Keywords
Cancer
Summary

This study aims to develop a new blood test to detect and identify many different types of cancer, using a special technique that looks at tiny changes in your DNA. Some participants will be followed over time to see if this method can also find leftover cancer cells (after treatment), and if it could warn if the cancer comes back. However, this test still under development, so there are no results reported back to participants. The goal is to create a reliable tool that one day could help doctors diagnose and monitor cancer(s) more effectively.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

Sleep and Activity Habits of Inpatients with Chest Tubes: A Pilot Observational Trial

Date Added
April 9th, 2025
PRO Number
Pro00140546
Researcher
Christopher Gilbert

List of Studies

Keywords
Lung, Pulmonary
Summary

This is a non-invasive, observational study aiming to collect data on the impact chest tubes have on inpatients during their hospitalizations. Sleep and activity patterns, as well as select vital signs will be tracked using an MUSC-owned Apple Watch, which subjects will wear, and an MUSC-owned iPhone, for up to seven days during admission to the hospital. Each day, a study coordinator will visit subjects to collect a brief sleep survey. Participation may last up to 7 days while subjects are admitted and have a chest tube in place. Upon completion of the study, a study coordinator will collect the Apple Watch and iPhone for data analysis.

This pilot data will provide initial information on the feasibility of collecting and performing a larger study on the inpatient mobility, activity, and sleep.

Institution
MUSC
Recruitment Contact
Randal Neff
8437924557
Neffr@musc.edu



-- OR --