Protection against Emboli during caRotid artery stenting using a Neuroguard IEP® Direct 3-in-1 delivery system comprised oF a pOstdilation balloon, integRated eMbolic filter, and A Novel Carotid stEnt III

Date Added
February 26th, 2024
PRO Number
Pro00132178
Researcher
Adam Tanious

List of Studies

Keywords
Vascular
Summary

To evaluate the safety and effectiveness of direct carotid access for stenting using
the Neuroguard IEPĀ® Direct System in subjects at elevated risk for adverse events
following carotid endarterectomy (CEA).

Institution
MUSC
Recruitment Contact
Hannah Culpepper
8437927244
culpepph@musc.edu

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC)

Date Added
February 26th, 2024
PRO Number
Pro00130418
Researcher
Don Rockey

List of Studies


Keywords
Digestive System, Drug Studies, Hepatology, Liver, Rare Diseases
Summary

The main goal of this study is to evaluate how well taking oral elafibranor 80 mg daily works, compared to a placebo, in reducing or preventing the occurrence of death, liver transplant, worsening of liver disease, and liver disease-related complications in adults with PBC.

Institution
MUSC
Recruitment Contact
Joshua Inman
(843) 876-4303
inmanj@musc.edu

A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Efficacy and Safety of NS-229 in the Treatment of Eosinophilic Granulomatosis With Polyangiitis

Date Added
February 23rd, 2024
PRO Number
Pro00133321
Researcher
Kathleen Maksimowicz-McKinnon

List of Studies

Keywords
Autoimmune disease, Drug Studies, Inflammation, Rare Diseases, Vasculitis
Summary

The purpose of this study is to test whether a drug called NS-229 (the study drug) is a potential treatment for patients with Eosinophilic Granulomatosis With Polyangiitis (EGPA).

NS-229 is an investigational drug that is provided in an oral pill form. An investigational drug is not approved by The US Food and Drug Administration. It can only be used in a research study like this one. In this study, NS-229 will be compared with a placebo (dummy drug), having no active drug in it. This is a randomized study, meaning that you will be assigned by chance (like flipping a coin) to receive either the study drug or placebo. The study is also double-blinded study, meaning you and your study doctor will not know what you are receiving, the NS-229 or placebo.

The study is sponsored by a NS Pharma, Inc. Participation in the study will require 12 visits to the MUSC main campus over approximately 8 months. Visits are much like the your standard of care and include the following procedures: blood draw, urine collection, physician-led assessments of your disease (for example physical exam and medical history review), tests to assess your lung function and health (Pulmonary Function Test (PFT) and spirometry, health questionnaires. You will also be asked to complete a daily diary regarding your medication use and vasculitis symptoms.

Compensation is available for participation

Institution
MUSC
Recruitment Contact
Kathleen Maksimowicz-McKinnon
843-792-0066
maksimow@musc.edu

Randomized, Placebo-Controlled, Multi-Site Trial of Extended-Release Naltrexone Injection/Bupropion XL Tablets in the Treatment of Methamphetamine Use Disorder

Date Added
February 14th, 2024
PRO Number
Pro00135002
Researcher
Susan Sonne

List of Studies


Keywords
Drug Studies, Substance Use
Summary

This study is designed to evaluate the safety and effectiveness of using a combination of two different medications (extended release naltrexone and bupropion) compared to matching placebo (an inactive substance) in the treatment of methamphetamine use disorder. Participants will undergo screening, and if eligible, will receive study medications along with brief medication management for twelve weeks, with follow up visits at weeks 14 and 16. The total study duration is around 19 weeks.

Institution
MUSC
Recruitment Contact
Elizabeth Chapman
864.898.2992
chapmanb@musc.edu

A Phase 3, Multi-Center, Randomized, Double-Blind Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults with Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy

Date Added
February 13th, 2024
PRO Number
Pro00134508
Researcher
Jessica Atkins

List of Studies

Keywords
Drug Studies, Heart
Summary

This study is enrolling subjects with non-obstructive hypertrophic cardiomyopathy (nHCM). nHCM is typically a genetic condition in which the main pumping chamber of the heart (called the left ventricle) becomes abnormally thickened and stiff, which makes it harder for the ventricle to fill and pump out enough blood. This study involves the investigational medication Aficamten, which means it is not approved for commercial use by the Food and Drug Administration. (FDA) Aficamten is designed to reduced excessive heart pumping function. This is a randomized study which means all subjects are assigned to receive either Aficamten or placebo. Subjects have a 50:50 chance of being assigned to either group, but will not know which group they are assigned. Placebo looks like the medication but does not have any active ingredients in it. Study procedures include exercise testing, echocardiograms (ultrasound test of the heart), blood work, questionnaires and genetic testing. Study risks include risks associated with the study medication including decreased heart pumping, nausea, headache and dizziness. There are also study procedure related risks, and the risk of loss of confidentiality. There may be no benefit but the information learned may benefit others in the future. Study participation will last between 10.5 and 19 months and include up to 13 visits to the study site. Visits will generally last 2-3 hours.

Institution
MUSC
Recruitment Contact
Ellie Cutright
843-876-5011
cutrighe@musc.edu

Replacing Invasive Cystoscopy with Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance

Date Added
February 12th, 2024
PRO Number
Pro00134992
Researcher
Robert Grubb

List of Studies


Keywords
Bladder, Cancer
Summary

The purpose of this research is to determine whether bladder cancer monitoring can be improved by replacing some cystoscopy procedures with investigational urine testing. Specifically, we are examining whether there are any differences in urinary symptoms, discomfort, number of invasive procedures, anxiety, complications, cancer recurrence or cancer progression when some cystoscopy procedures are replaced with urine testing.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
8438760630
jenkijn@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Inhalation of Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH)

Date Added
February 12th, 2024
PRO Number
Pro00134528
Researcher
Rahul Argula

List of Studies


Keywords
Pulmonary Hypertension
Summary

This Phase 3 study, comprising a double-blind, placebo-controlled treatment period of up to 48 weeks, will assess the efficacy and safety of seralutinib versus placebo when added to background PAH disease-specific medication in adult PAH subjects who are WHO FC II or III. The primary objective of the study is to assess the efficacy of seralutinib relative to placebo with a primary endpoint of change from baseline to Week 24 in 6MWD.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@musc.edu

A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immunooncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma.

Date Added
February 12th, 2024
PRO Number
Pro00133635
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Pediatrics
Summary

This study is for patients that have been diagnosed with early-stage (Stage I or II) Hodgkin lymphoma (HL)(cHL). The main purpose of this study is to compare the effects, good and/or bad, of brentuximab vedotin and nivolumab (Bv-NIVO) against standard therapy for people with HL to find out which is better. Participants can expect to be in the study for up to 54 months.

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

Phase III Randomized Trial of Immunotherapy with or without Consolidative Radiotherapy for Oligometastatic Head and Neck Squamous Cell Carcinoma

Date Added
February 12th, 2024
PRO Number
Pro00132402
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck
Summary

In this study, the participants will take pembrolizumab for 24 months or get pembrolizumab plus a course of radiation therapy for 24 months until the cancer progresses. After the study treatment is finished, the study doctor will continue to follow the participants condition for a total of 3 years. Some risks in this study is that pembrolizumab with radiation may not be as good as the usual approach for cancer shirking or stabilizing. Some risks associated with pembrolizumab and radiation which are reduction in blood counts, mouth or throat pain and difficulty swallowing. The potential benefit of this study is that radiation and chemotherapy/pembrolizumab can be effective at shrinking or stabilizing the cancer. The purpose of this study is to compare using pembrolizumab with radiation to pembrolizumab without radiation.

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

A Phase 3 randomized, placebo-controlled, double-blind program to evaluate efficacy and safety of upadacitinib in adult and adolescent subjects with severe alopecia areata

Date Added
February 7th, 2024
PRO Number
Pro00132680
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy and safety of upadicitinib in adults and adolescents with severe alopecia areata. Participation in this research study will take approximately 168 weeks with 17 visits in that time. This research study includes three phases; a screening phase, treatment phase, and a follow-up phase. The length of the screening period varies from 1 to 35 days, depending on therapies that must be washed out or discontinued before initiation of treatment. Patients who meet all eligibility criteria will be randomized to receive upadicitinib or placebo for the first 24 weeks. At week 24, all patients will receive upadicitinib until week 160. The post-treatment follow-up visit will occur approximately 30 days after the last study drug dose.

Institution
MUSC
Recruitment Contact
Devyn Spino
843-876-2281
spino@musc.edu



-- OR --