A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Post-Operative Steroids after Sleep Surgery

Date Added
December 3rd, 2024
PRO Number
Pro00138969
Researcher
Mohamed Abdelwahab

List of Studies

Keywords
Pain, Sleep Disorders, Surgery
Summary

The purpose of this study is to study the effectiveness of steroids after sleep surgery in improving pain, reducing difficulties in swallowing, and reducing the amount of narcotic pain medication after surgery. This study also want to see what dosage of steroids, whether intravenous or oral, are more effective at reducing these symptoms and providing a more effective surgical procedure for your sleep apnea. Anyone planning to undergo sleep surgery for your obstructive sleep apnea at the recommendation of the Sleep Surgery Division here at MUSC is invited to participate in this study. The study will be using both intravenous and oral dexamethasone, a very common and widely used steroid. This steroid has been FDA approved for many medical indications.

Institution
MUSC
Recruitment Contact
Nicolas Poupore
843-792-8299
poupore@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease.

Date Added
December 27th, 2024
PRO Number
Pro00140678
Researcher
Kimberly Green

List of Studies

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

This study is for participants who have moderate or severe chronic graft-versus-host disease (cGVHD). cGVHD is a condition in which the healthy transplanted (graft) stem cells see the recipient's (host) cells as foreign and start to destroy them.
This Study is being done to learn the effects of the drug INCA034176 (also known as axatilimab) in combination with corticosteroids.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-9300
salzers@MUSC.edu

An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Treatment-Naive People With HIV-1

Date Added
December 30th, 2024
PRO Number
Pro00141056
Researcher
Eric Meissner

List of Studies


Keywords
HIV / AIDS
Summary

The main objective of this study is to test a once-weekly HIV medication regimen in persons who have not taken HIV treatment before. The goal is to see if taking a once a week pill combination (GS-1720 and GS-4182) works as well as taking a daily pill Biktarvy® (B/F/TAF). Participants will either take the weekly pill or continue with Biktarvy® for about 48 weeks or longer. The study will look at how well each option controls HIV levels.

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

A Phase 2, Global, Multicenter, Long-term Safety Study Designed to Assess the Safety and Tolerability of BHV-7000 in Subjects with Refractory Focal Onset Epilepsy

Date Added
January 24th, 2025
PRO Number
Pro00137514
Researcher
Zeke Campbell

List of Studies


Keywords
Epilepsy
Summary

This research study is being done to see the long term effectiveness and safety of a new drug called BHV-7000 as a possible treatment for focal seizures for patients who are taking anti-seizure medications (ASMs) and still experience seizures. You could be eligible to participate in the study if you completed the first double blind study successfully and your study doctor see's that you meet all the criteria for this study.

Institution
MUSC
Recruitment Contact
Robin Bulgarino
18437921115
bulgarino@musc.edu

ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101 (Clofazimine Inhalation Suspension) When Added to Guideline-Based Therapy in Participants with Pulmonary Nontuberculous Mycobacterial Infection (Part A) Followed by an Open-Label Extension (Part B)

Date Added
February 7th, 2025
PRO Number
Pro00136819
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

Part A of this study will compare the effects of Clofazimine Inhalation Suspension to placebo. The purpose of this study is to find out if Clofazimine Inhalation Suspension can treat NTM lung disease by getting rid of the bacteria from the lungs and to make sure that Clofazimine Inhalation Suspension is safe for use. The participant will continue with current treatment for NTM lung disease in this study. To test if the bacteria are gone from the lungs, sputum will be tested on a regular basis (every month) to see if the culture changes from positive to negative. Participants will be randomly assigned by chance (like drawing numbers from a hat) to either Clofazimine Inhalation Suspension or placebo.

After the participant completes the study treatment in Part A, they will be eligible to receive Clofazimine Inhalation Suspension in Part B.

Approximately 234 participants will take part in the study at approximately 120 sites globally.

Institution
MUSC
Recruitment Contact
Isabella Brookshire
8437920965
recruitment@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants with Immunoglobulin A Nephropathy (IgAN)

Date Added
February 12th, 2025
PRO Number
Pro00137540
Researcher
Anand Achanti

List of Studies


Keywords
Kidney
Summary

IgAN is a progressive condition that causes chronic kidney disease. Over time, some patients develop end-stage kidney disease (ESKD) requiring dialysis or kidney transplant.

The purpose of this study is to see if an investigational medication is safe and effective in the treatment of IgA nephropathy.

If you are eligible for the study and decide to participate, you will come to MUSC for study visits for about 3 years. These visits will involve blood and urine samples, questions about your health, EKGs, and physical exams. Participants will be randomized in a 1:1 ratio to receive either a weight-based IV infusion of ravulizumab or placebo for 106 weeks. Depending on your response to initial treatment, there is a possibility of additional treatment. An exploratory, open-label cohort of approximately 20 participants with eGFR 20-29 mL/min/1.73m2 may also be enrolled to expand the evidence of ravulizumab in participants with advanced kidney impairment at high risk for ESKD progression.

There is no guarantee that being in this study will help you. There is no cost to participate and compensation is available for the study visits.

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

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Date Added
March 5th, 2025
PRO Number
Pro00138827
Researcher
Alexander Coltoff

List of Studies

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

This phase 3 study is recruiting patients who have myelofibrosis who have never had a JAK inhibitor. This study will measure the safety and effectiveness of a tumor protein inhibitor treatment called navtemadlin combined with another tumor protein inhibitor called ruxolitinib. Navtemadlin is an "investigational" (not yet FDA approved) treatment, Ruxolitinib is FDA approved. The main purpose of the study is to see if navtemadlin combined with ruxolitinib is an effective treatment for myelofibrosis. The study will enroll approximately 180 patients with each patient initially receiving ruxolitinib. The study includes a screening period, run-in period, and a randomized (like flipping a coin) add-on period. The first two periods will be over the course of 18-24 weeks while the randomized add-on period is for those whose treatment with ruxolitinib is not effective enough and will last for a different amount of time for each patient. In the run-in period after screening, patients will take ruxolitinib at the dose determined by their study doctor for 18-24 weeks. If treatment with ruxolitinib alone is not effective, the participate will be randomized into one of two groups. In the randomized add-on period, participants will either receive ruxolitinib with navtemadlin 240 mg or a matching placebo (a pill that contains no medicine) daily for one week out of the 28-day cycle in combination with ruxolitinib at a dose determined by their study doctor. Patients in this group will continue treatment until disease progression, unacceptable toxicity, study closure, death, or withdrawal of consent. The main risk is that medical treatments often cause side effects. Patients may have none, some, or all of the side effects listed or not listed in the protocol, and they may be mild, moderate, or severe. There is no direct benefit for them in participating in this study.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8437929321
hcc-clinical-trials@musc.edu

Drowning Risks of Patients Presenting to the Pediatric Emergency Department at MUSC's Shawn Jenkins Children's Hospital

Date Added
March 11th, 2025
PRO Number
Pro00142153
Researcher
M. Titus

List of Studies


Keywords
Pediatrics
Summary

This study is seeking to assess two known risk factors of drowning, swimming ability and water safety knowledge, in parents of children and adolescents presenting to the pediatric emergency department using questionnaires.

By collecting this data, we hope to highlight factors that contribute to disparities in drowning rates in minority racial and ethnic groups and to aid local and federal governments in developing programs that effectively combat the number one cause of unintentional injury-associated death in children ages 1-4 years. This will also provide data that may help guide pediatricians in effective anticipatory guidance for families regarding water safety. All in the effort to minimize disparities in medicine and provide more equitable care to the patients that we see.

Institution
MUSC
Recruitment Contact
M. Titus
8434753656
titusda@musc.edu



-- OR --