A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Compensated Cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Date Added
July 23rd, 2024
PRO Number
Pro00136269
Researcher
Don Rockey

List of Studies


Keywords
Liver
Summary

Evaluate the effect of pegozafermin compared to placebo in reducing the risk of clinical outcomes measured as a composite endpoint

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
843-876-8439
blanke@musc.edu

Cardiac Surgery Recovery in Infants Using Neoneur Feeding System

Date Added
July 19th, 2024
PRO Number
Pro00137012
Researcher
Frances Woodard

List of Studies


Keywords
Heart, Pediatrics
Summary

This study will evaluate the association between feeding recovery and clinical assessment of infant behaviors as measured in a brief survey to assess irritability, ability to be soothed, alertness, non-nutritive sucking, and muscle tone. Forty infants will be recruited from the PCICU-CSD at MUSC. This data will be assessed using the Neoneur Feeding System to create a model of feeding recovery.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-876-5203
alsarral@musc.edu

A Phase 2 Study of Alisertib in Patients with Extensive Stage Small Cell Lung Cancer

Date Added
July 11th, 2024
PRO Number
Pro00135995
Researcher
Christopher Rangel

List of Studies

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

In this study, researchers are testing a drug called Alisertib in people with a specific type of lung cancer that has spread extensively. These patients have already undergone the first round of treatment, but unfortunately, their cancer has started growing again. The drug alisertib works by targeting certain molecules involved in cell division, which are often overactive in cancer cells.

Patients will take alisertib as pills twice a day for a week, followed by a break. To manage side effects, they'll also receive another medication to support their blood cell production. Throughout the study, researchers will closely monitor how much alisertib is in the patients' blood and how they're responding to treatment.

The study will continue until patients either see their cancer progress, experience intolerable side effects, or decide to leave the study. Even if the cancer spreads to the brain during the study, patients might still be able to continue treatment if it's deemed helpful by their doctor. This research hopes to find out if alisertib can offer a new option for people whose lung cancer has come back after initial treatment.

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

Establishing Normative Reference Values for Pressure and Impedance-Derived Swallow Metrics for High-Resolution Pharyngeal Manometry

Date Added
July 9th, 2024
PRO Number
Pro00136546
Researcher
Ashli O'Rourke

List of Studies


Keywords
Healthy Volunteer Studies
Summary

The purpose of this research study is to establish normal reference values for metrics used during high-resolution pharyngeal manometry (HRPM). HRPM is a test that measures pressures in the pharynx (throat) during swallowing. In this study, healthy adults who do not have a swallowing problem will undergo a single procedure that involves placing a small catheter in the nose and pharynx to measure pressure while swallowing liquids and foods. A single, one-hour visit is required for study participation. The HRPM procedure will take approximately 10 minutes. Participants will be compensated for their time and effort.

Institution
MUSC
Recruitment Contact
Kate Davidson
(843) 410-9682
vscresearch@musc.edu

Rapid Onsite Cytopathologic Evaluation for Improved Molecular Marker Testing via Endobronchial Ultrasound Bronchoscopy - A Randomized Controlled Trial

Date Added
July 3rd, 2024
PRO Number
Pro00128969
Researcher
Christopher Gilbert

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

In this study, all eligible study participants will have a clinically indicated reason to undergo a bronchoscopy procedure, using a EBUS-TBNA scope, before enrolling in the study. EBUS-TBNA stands for "endobronchial ultrasound-guided transbronchial needle aspiration" which is a procedure to collect lymph node tissue from within the lungs by inserting a flexible tube-like camera through the mouth, then down into the lungs.

After providing consent to participate in this study, each subject will be randomly assigned (by chance, like the flip of a coin) to either have or not have a cytopathology technologist (person who looks at samples under a microscope) in the room during your bronchoscopy, and then randomly assigned again (by chance, like the flip of a coin) to either have your tissue specimen prepared with clot or liquid preparation. Clot preparation is placing the tissue biopsy in a gel prior to being viewed under a microscope, whereas liquid preparation is placing the tissue biopsy in a liquid prior to being viewed under a microscope.

It is important to note that, by participating in this study, subjects will still receive the standard of care with a proven track record for obtaining lymph node tissue.

The reason for this research study is to determine whether rapid on-site cytopathologic evaluation, or the clot based method, can increase the chances of gathering adequate tissue for Next Generation Sequencing. Next generation sequencing is a test which detects molecular markers from tissue, or blood, samples and can provide possible treatment options for specific forms of lung cancer.

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

Combining rTMS & aerobic exercise to treat depression and improve post-stroke walking (RESTORATION)

Date Added
July 2nd, 2024
PRO Number
Pro00137804
Researcher
Chris Gregory

List of Studies


Keywords
Depression, Rehabilitation Studies, Stroke Recovery
Summary

We will determine if aerobic exercise (AEx) and/or repetitive transcranial magnetic stimulation (rTMS) are effective in treating symptoms of depression following stroke. This project is based on the idea that depression negatively affects the brain so that it doesn't change in the same way following treatment, the result being less effective recovery. We believe that effective treatment for depression will help improve how the brain in people with depression responds to other types of treatment. That is, effectively treating depression will enable individuals to better recover other forms of function following their stroke.

Institution
MUSC
Recruitment Contact
Alyssa Chesnutt
843-792-8171
hydar@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and the Decline in Kidney Function in Participants with Body Mass Index ≥ 27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease

Date Added
June 25th, 2024
PRO Number
Pro00136763
Researcher
Sheldon Litwin

List of Studies


Keywords
Cardiovascular, Kidney, Obesity, Stroke Recovery
Summary

Individuals with obesity and a history of heart or kidney-related disease will be eligible for participation. Study participants will have a 50:50 chance to be randomly assigned to either the treatment (retatrutide) or control (placebo) group. Retatrutide is currently considered an investigational medication as it has not been approved by the FDA for the treatment of obesity or any other medical condition at this time. Study participation will last approximately 5 years and begin with a screening period to ensure correct patient selection. Research clinic visits will occur every 4 weeks initially and then every 12 weeks. Some visits may be completed virtually through telehealth or by phone. Study procedures include but are not limited to: blood draws, questionnaires, self injection of study medication, medical history review, vital signs, and electrocardiogram. The medication will be injected subcutaneously once a week. The medication's purpose is to facilitate weight loss and decrease a subject's risk for heart or kidney related disease progression or events.

Institution
MUSC
Recruitment Contact
Elhaam Borhanian
843-792-5873
borhania@musc.edu

A MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF BIMEKIZUMAB COMPARED TO USTEKINUMAB IN CHILDREN AND ADOLESCENTS FROM 6 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Date Added
June 24th, 2024
PRO Number
Pro00136667
Researcher
Lara Wine Lee

List of Studies


Keywords
Adolescents, Skin
Summary

The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared to active control (ustekinumab) in children and adolescents (from 6 to <18 years of age) with moderate to severe plaque PSO. This study will consist of the following periods:
• Screening Period: up to 5 weeks
• Initial Treatment Period: 16 weeks
• Maintenance Period: 32 weeks
• OLE Period: 104 weeks
• SFU Period: 20 weeks after final dose of IMP
After the Screening Period of up to 5 weeks, eligible study participants will be randomized in a 2:1 ratio of bimekizumab to ustekinumab. Study participants will participate in a 16-week double-blinded Initial Treatment Period and continue into a 32-week double-blinded Maintenance Period. After completion of the Maintenance Period, study participants will be offered the opportunity to continue in a 104-week open label extension period and receive bimekizumab.

Institution
MUSC
Recruitment Contact
Kennedy McLeod
(843) 792-4091
mcleodke@musc.edu

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Date Added
June 24th, 2024
PRO Number
Pro00134737
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Hepatology, Liver
Summary

The purpose of this study is to evaluate the effect of pegozafermin compared to placebo to see how well pegozafermin might improve liver fibrosis after 52 weeks.

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768439
blanke@musc.edu

A Phase II Study of Fingolimod in Patients with Non-Small Cell and Small Cell Lung Cancer

Date Added
June 18th, 2024
PRO Number
Pro00137404
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Cancer/Other, Drug Studies, Lung, Men's Health, Women's Health
Summary

This study is for subjects that have been diagnosed with lung cancer and the disease has progressed on prior therapy. The purpose of the study is to determine the safety and efficacy of Fingolimod and whether it can aid in treatment against lung cancer tumors. Fingolimod is not FDA approved and is considered an investigational drug. Subjects can expect to be in this study for about 8 months, with routine visits occurring at MUSC.

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



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