Aging Neural Systems and Communication Difficulties

Date Added
August 2nd, 2024
PRO Number
Pro00135808
Researcher
Kenneth Vaden

List of Studies


Keywords
Aging, Brain, Hearing
Summary

As people get older, understanding speech in a noisy environment can become more difficult. The MUSC Hearing Research Program is seeking healthy adults between 25 and 89 years of age to participate in a research study to investigate the connection between listening difficulties and the brain. Payment is provided for participation and scheduling is flexible. The study involves two visits. Participants must be able to complete an MRI. Please contact us if you would like to participate in this research or learn more about our study.

Institution
MUSC
Recruitment Contact
Kenneth Vaden
8437922774
vaden@musc.edu

RELIANCE: A phase 1, randomized, double-blinded, placebo-controlled, trial evaluating the long-term safety and tolerability of Imatinib for the treatment of Lymphangioleiomyomatosis (LAMP-2 Trial)

Date Added
July 30th, 2024
PRO Number
Pro00136539
Researcher
Charlie Strange

List of Studies


Keywords
Kidney, Lung, Pulmonary, Rare Diseases, Women's Health
Summary

The purpose of this medical research study is to evaluate the safety and effectiveness of a new medication called imatinib mesylate in the treatment of Lymphangioleiomyomatosis (LAM). LAM is a rare disease in which abnormal cells (called LAM cells) grow out of control. Over time, LAM cells destroy healthy lung tissue and cause respiratory disease or failure.

Many patients with LAM are currently treated with a medication called sirolimus (rapamycin). Sirolimus slows the growth of LAM cells.

Imatinib mesylate (hereafter called imatinib) is approved by the Food and Drug Administration (FDA) for the treatment of some cancers that share common pathways with LAM cells. Laboratory studies suggest that imatinib could completely block the growth of LAM cells through initiation of targeted cell death.

An important purpose of this research is to determine the safety of imatinib in people with LAM. This study will also evaluate the short-term effectiveness of imatinib. Participants will be randomized to receiving imatinib (study medication) or placebo (no treatment) for the 180 day duration of participation. The study is being conducted at the Medical University of South Carolina and at Columbia University in New York (CUMC). Each site will enroll 10 participants.

Institution
MUSC
Recruitment Contact
Mary Hayden
(843) 792-8438
blantonm@musc.edu

Biomarker Modulation and the Inhibition of Natural Killer Type 1 (NKT1) Cells by Oral GRI-0621 in Patients with Idiopathic Pulmonary Fibrosis (IPF)

Date Added
July 29th, 2024
PRO Number
Pro00136739
Researcher
Aravind Menon

List of Studies

Keywords
Interstitial Lung Disease (ILD)
Summary

This is a Phase 2a, randomized, double-blind, multi-center, placebo-controlled, parallel-design, 2-arm study. This study will be conducted in approximately 20 centers globally, in subjects with IPF. Participation will last for about 18 weeks and include about 12 study clinic visits with the Study Doctor and/or study staff. This study will take place over approximately a year. The study will investigate a single dose level of GRI-0621 of 4.5mg compared with placebo, following once daily oral administration for 12 weeks. Approximately 36 subjects with IPF will be randomized in a 2:1 ratio for GRI-0621 4.5mg or Placebo. The study consists of a Screening Period, a Treatment Period and a Safety Follow-Up Period. The Screening Period will be conducted within 4 weeks prior to randomization, and is comprised of at least two separate in-clinic visits to assess eligibility.
Concurrently, a BAL Sub-Study will be conducted, for up to 12 eligible subjects (across various centers). The objective of the Sub-Study is to examine the role of NKT cells in fibrotic lung disease.

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

Patient reported outcomes in patients with nontuberculous mycobacterial pulmonary disease

Date Added
July 29th, 2024
PRO Number
Pro00133747
Researcher
Patrick Flume

List of Studies


Keywords
Lung, Pulmonary
Summary

Nontuberculous mycobacteria (NTM) cause a chronic pulmonary infection associated with cough, fatigue, and shortness of breath. Our primary objectives are to better understand the trajectory of patient-reported outcomes (PROs), e.g.
respiratory symptoms and health-related quality of life (HRQoL), across the entire disease course and measure toxicity and tolerability using patient-reported symptomatic adverse events in treated patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).

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

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

Multicentre, randomised, double-blind, placebo-controlled, 48-week, Phase III trial to evaluate the efficacy and safety of survodutide administered subcutaneously in participants with overweight or obesity and presumed or confirmed non-alcoholic steatohepatitis (NASH)

Date Added
July 23rd, 2024
PRO Number
Pro00134740
Researcher
Don Rockey

List of Studies


Keywords
Drug Studies, Liver, Obesity, Weight Control
Summary

The purpose of this study is to test whether survodutide helps people living with obesity or overweight and with a confirmed or presumed liver disease called non-alcoholic steatohepatitis (NASH) to reduce liver fat and to lose weight

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438768436
blanke@musc.edu

SAINT NEUROMODULATION SYSTEM FOR THE TREATMENT OF DEPRESSION IN AN INPATIENT SETTING

Date Added
July 23rd, 2024
PRO Number
Pro00126985
Researcher
Mark George

List of Studies


Keywords
Depression, Mental Health, Suicide
Summary

This is an inpatient clinical trial of a new form of transcranial magnetic stimulation with 10 treatments/day for 5 days, called SAINT. It is jointly funded by the NIH and a TMS company, MAGNUS. It is being done at 5 enrolling sites in the US, with total sampe of 100. Depressed and suicidal inpatients will have an MRI scan, then 5 days of treatment, and then a followup MRI scan. Outcome measures are depression and suicide ratings, as well as MRI changes. It is randomized and double blind, so some patients will not be getting active TMS. Importantly this is an adjunctive treatment study on top of all routine clinical treatments.

Institution
MUSC
Recruitment Contact
Morgan Dancy
843-876-5141
maddoxm@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

An Open-Label Prospective Multicenter Study to Evaluate Safety and Tolerability of Dry Powder Inhaled Treprostinil in Pulmonary Hypertension – ASCENT Study

Date Added
July 17th, 2024
PRO Number
Pro00136738
Researcher
Rachana Krishna

List of Studies


Keywords
Drug Studies, Interstitial Lung Disease (ILD), Pulmonary Hypertension
Summary

Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861, the study drug, in subjects who have World Health Organization (WHO) Group 1 & 3 Pulmonary Hypertension. The purpose of this research study is to evaluate the long-term safety and tolerability of LIQ861 in patients with WHO Group 3 Pulmonary Hypertension associated with interstitial lung disease (PH-ILD). The investigational form of Treprostinil in this study is called LIQ861, it is delivered to your lungs using a hand-held device called a dry powder inhaler (DPI). Dose levels may be adjusted by the Study Doctor between 26.5 micrograms to 318 micrograms based on your PH-ILD symptoms. The study will include approximately 60 subjects and participation will last 52 weeks.

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

Biomarker-Driven Radiation Dose Reduction after TORS in Patients with HPV-Positive Oropharyngeal Cancer

Date Added
July 16th, 2024
PRO Number
Pro00137408
Researcher
Bhishamjit Chera

List of Studies

Keywords
Cancer, Cancer/Head & Neck, Men's Health, Women's Health
Summary

This study is designed to learn more about how swallowing function works after completing reduced dose radiation after surgery. If decided to take part in this study, participants will go through a screening period, treatment period, and follow-up period. During the screening period following signing of consent form participants will be evaluated for screening criteria and the initiation of radiotherapy within 28 days of signing the consent form. During treatment period some participants will receive reduced-dose radiotherapy and others will receive standard of care radiotherapy. In the follow up period participants will have visits every 3-6 months. Participation in this study may last up to two years. The swallowing function will be quantified using the MD Anderson Dysphagia index composite score 1 year after surgery. Some serious risk related to this study is that the reduced amount of radiation may not be as effective at curing this cancer compared to the standard dose. The most common risks and discomforts expected in this study are pain and swelling at the site of blood draw that may last several days. The main risk of this study is the increased risk of relapse. There may not a benefit from joining the study. The head and neck cancer may improve while on this study but it may not, and it may even get worse. It will also help inform how well this reduced dose works at curing this type of cancer. The study results may be used to help others in the future.

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



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