A randomized, double-blind, placebo-controlled, parallelgroup, Proof-of-Concept (PoC) study to assess the efficacy, safety and tolerability of itepekimab, in participants with non-cystic fibrosis bronchiectasis

Date Added
January 24th, 2025
PRO Number
Pro00142015
Researcher
Patrick Flume

List of Studies


Keywords
Bronchiectasis
Summary

This study is to evaluate an investigational study drug, itepekimab, for the treatment of bronchiectasis. The main purpose for this study is to assess the safety, efficacy, and tolerability of itepekimab in bronchiectasis in addition to the current background treatment you are receiving which may include bronchodilators, inhaled corticosteroids, mucolytics, and/or maintenance antibiotics. You will receive either the study drug or a placebo if you participate in this research. This study will include about 300 participants with bronchiectasis across approximately 20 countries worldwide.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@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

Preoperative 5-Day Radiotherapy for Soft Tissue Sarcoma: A Single Institution Phase II Trial

Date Added
January 21st, 2025
PRO Number
Pro00141818
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer
Summary

This study is for subjects that have been diagnosed with cancer in their
arm, leg, or trunk (the part of the body that involves the chest, abdomen,
and pelvis). The purpose of this research study is to preserve healthy
tissue around the cancer on the arm(s) and/or leg(s) using
hypofractionated radiotherapy, while treating the cancer and preventing
it from spreading to other areas of the body. This study will look at early side effects and effectiveness of preoperative 5-day hypofractionated radiotherapy. Active participation in the study will take about 12 visits and are completed once the participant has a 6-month post-operation visit.

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

Task-based synchronous electroencephalography and functional magnetic resonance imaging (EEG-fMRI) to explore neural representations of memory maintenance in the aging brain.

Date Added
January 21st, 2025
PRO Number
Pro00141769
Researcher
Kirstin-Friederike Heise

List of Studies

Keywords
Aging, Healthy Volunteer Studies
Summary

The purpose of this study is to better understand how practicing a new skill builds a stable memory and how this memory is maintained over time as one gets older. A better understanding how memories are controlled in healthy aging may help to develop better treatments for memory problems.
The study's main question is how the different brain regions communicate with each other when one is retrieving memories of a well-practiced skill. Specifically, when and where the brain waves that are related to skill memory are produced. The brief changes in the brain will be recorded with functional magnetic resonance imaging (fMRI), a medical technology that looks at blood flow in the brain. To assess electrical changes in the brain, the brain waves, electroencephalography (EEG) will be used. Combining EEG and fMRI will allow the precise detection of the exact location where the brain is active at any moment in time.
This study is conducted at the Medical University of South Carolina (MUSC). The study will take about one to two weeks and involves two visits to MUSC including an interview and combined brain recording and brain scan during task practice (EEG-fMRI) and up to 7 days of online skill practice at home. Volunteers in this research study must be free of any brain disease or brain injuries and have to be in good health status. Approximately 40 volunteers will take part in this study.

Institution
MUSC
Recruitment Contact
Kirstin-Friederike Heise
(843)792-3435
heisek@musc.edu

Frontier Study: A Multicentered Retrospective Chart Review of Non-Invasive Prenatal Testing for Inherited Monogenic Disorders, Rh Incompatibility and Common Aneuploidies

Date Added
January 21st, 2025
PRO Number
Pro00140738
Researcher
Eliza McElwee

List of Studies


Keywords
Obstetrics and Gynecology
Summary

This is a retrospective chart review study looking at the assessment of the clinical performance of single gene non-invasive prenatal screening and comparison to standard of care.

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-7525
paynej@,usc.edu

Establishment of ProNephro AKITM (NGAL) Cut off Value for Risk Assessment of Moderate to Severe Acute Kidney Injury in Adults (EPACRA-AKI)

Date Added
January 17th, 2025
PRO Number
Pro00139273
Researcher
Blaithin McMahon

List of Studies


Keywords
Kidney
Summary

The EPACRA- AKI study is a multicenter observational, non- interventional study, to determine actionable cut-off(s) for ProNephro AKITM (NGAL) assay to predict patients at risk for AKI in the general adult ICU population and subgroups of particular interest, such as sepsis or cardiac surgery patients.
Subject enrollment duration is anticipated for 12 months but might be extended or shortened depending on enrollment.

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

A Phase 1b/2a Double Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-106 in Subjects Ages 18–75 with Generalized Myasthenia Gravis

Date Added
January 16th, 2025
PRO Number
Pro00136862
Researcher
Katherine Ruzhansky

List of Studies


Keywords
Autoimmune disease
Summary

Subjects ages 18–75 with generalized myasthenia gravis (MG) will be screened up to 42 days prior to enrollment into the clinical study. Note: If subjects are currently on a standard of care therapy, they will remain on their current standard of care therapy during the course of the clinical study at the discretion of the Investigator.
Subjects who meet all inclusion and no exclusion criteria after completing the Screening Visit will be enrolled in the clinical study.
Subjects will be randomized on Day 1 into the current cohort in a 2:1 ratio to receive two separate administrations of intravenous CNP-106 or Placebo (0.9% Sodium Chloride Injection USP) on Day 1 and Day 8. Investigational Product (IP) will be administered by IV infusion over approximately 3-4 hours using a graduated rate of infusion. Subjects will undergo medical observation in the clinic for acute AEs for 4 hours following infusion on Day 1 and Day 8.

Institution
MUSC
Recruitment Contact
Alison Line
8437922845
line@musc.edu

PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry

Date Added
January 14th, 2025
PRO Number
Pro00141768
Researcher
Rachel Kaplan

List of Studies

Keywords
Heart, Surgery
Summary

This study is enrolling subjects who are undergoing an atrial fibrillation ablation. Atrial fibrillation (AF) is a condition where the heart beats rapidly and irregularly. An ablation procedure can destroy the tissue in the heart that transmits the irregular electrical signals that cause the AF. The ablation procedure will use the PulseSelect™ PFA System which is approved by the Food and Drug Administration (FDA) and uses electroporation (electrical pulses) to destroy the heart tissue.

This study will last about 2 years and include up to 6 visits, some of which can be done virtually. Study procedures include data collection, questionnaires, electrocardiogram (ECG) - which is a tracing of the heart's electrical activity, echocardiogram (Echo) - which is an ultrasound test of the heart, and a Holter monitor - which is a wearable device that continuously records heart rhythm.

Institution
MUSC
Recruitment Contact
Cara Breunig
843-792-7519
breunig@musc.edu

A randomized, double-blind, double-dummy, placebo-controlled, multicenter, Phase 3 study assessing the efficacy, safety, and tolerability of 2 doses of remibrutinib over a 68-week treatment period in adult patients with moderate to severe hidradenitis suppurativa

Date Added
January 10th, 2025
PRO Number
Pro00141359
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

The research study determines if remibrutinib (study treatment) with two doses, dose A (10 mg b.i.d.) and dose B (25 mg b.i.d)., is safe and effective and can help adult patients with moderate to severe hidradenitis suppurativa (HS).

Institution
MUSC
Recruitment Contact
Neharika Talasila
843-792-6882
talasila@musc.edu

A Randomized Comparison of Cleerly Coronary Artery Disease Stage-Based Care Versus Risk Factor-Based Care for Primary Prevention of Cardiovascular Events

Date Added
January 7th, 2025
PRO Number
Pro00140945
Researcher
Marc-Andre Cornier

List of Studies

Keywords
Cardiovascular, Diabetes, Heart
Summary

This clinical research study is enrolling adults with diabetes, prediabetes or metabolic syndrome. The purpose of the study is to learn more about preventing cardiovascular disease. A heart CT scan will be done at screening and then 2 years later. Qualified participants will be randomly assigned to one of two groups. Participants in the usual care group, will continue to receive care from usual health care provider. In the personalized care group, participants will receive additional health care from a remote cardiologist led team which will individualize treatment based on Cleerly CAD staging results of the heart CT scan. Study is expected to last 3 1/2 years on average but could be 2 - 5 years. Participation is free.

Institution
MUSC
Recruitment Contact
Lori Spillers
843-876-0977
spillerl@musc.edu



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