Leveraging Technology to Reduce Disparities and Improve Early Detection of and Timely Care for Postpartum Complications

Date Added
November 7th, 2023
PRO Number
Pro00130902
Researcher
Constance Guille

List of Studies


Keywords
Mental Health, Minorities, Obstetrics and Gynecology, Post Partum Depression, Pregnancy, Psychiatry, Women's Health
Summary

The purpose of the study is to learn if a program for newborn mom's can improve detection of complications after delivery and help women get medical care quickly and easily. Participants will be asked to complete a survey at the time of enrollment and at 4 additional times. All surveys can be completed via cell-phone or email. All women will be followed for 1-year after delivery. Women that enroll will be assigned to one of two groups: usual in person care OR usual in-person care PLUS a text message-based program that will ask about sign and symptoms of complications that may occur after delivery. If there is a concern, a care coordinator will call on the phone to discuss options and help refer to care if needed. Participants will be paid for their time in completing surveys.

Institution
MUSC
Recruitment Contact
Katie Tremont
843-792-5958
tremontk@musc.edu

A Phase 2 Multicenter, Randomized, Double-blind, Placebocontrolled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TTI-101 in Participants with Idiopathic Pulmonary Fibrosis

Date Added
November 6th, 2023
PRO Number
Pro00132082
Researcher
Rachana Krishna

List of Studies


Keywords
Interstitial Lung Disease (ILD)
Summary

This multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical
study is designed to evaluate the safety and tolerability of 3 dose levels of TTI-101 vs placebo in participants with idiopathic pulmonary fibrosis (IPF). a screening period of up to 28 days, 100 participants will be randomly assigned to receive 1 of 3 dose levels of TTI-101 (25 participants per dose level) or matching placebo (25 participants). Enrollment will be stratified by current use of nintedanib. The assigned study drug will be self-administered orally in tablet form twice daily (BID) with a glass of water after a meal. Once randomized, each participant will maintain their current standard of care supportive medications, including cough treatment, medications for symptom relief or quality of life improvements, oxygen therapy where indicated, respiratory physiotherapy, and treatment of comorbidities. Following randomization, all participants will enter the 12-week, double-blind treatment period.

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

A RANDOMIZED PHASE II TRIAL OF NIVOLUMAB AND IPILIMUMAB COMPARED TO NIVOLUMAB MONOTHERAPY IN PATIENTS WITH DEFICIENT MISMATCH REPAIR SYSTEM RECURRENT ENDOMETRIAL CARCINOMA

Date Added
November 6th, 2023
PRO Number
Pro00131158
Researcher
Brian Orr

List of Studies

Keywords
Cancer/Gynecological
Summary

This study is for subjects with endometrial cancer has spread to other parts of your body and/or has not responded to previous treatment(s). The study is being done to see if combining two immunotherapy drugs, nivolumab and ipilimumab, more effective in shrinking their cancer and preventing its growth than single drug immunotherapy with nivolumab alone. The subject can expect to be in this study for up to 24 months.

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

Efficacy and safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4mg) once-weekly compared to tirzepatide 15 mg s.c. once-weekly in participants with obesity

Date Added
November 1st, 2023
PRO Number
Pro00131916
Researcher
Patrick O'Neil

List of Studies


Keywords
Drug Studies, Obesity, Weight Control
Summary

An 81-week clinical research study to compare the effect on body weight loss of CagriSema 2.4 mg vs. tirzepatide (known as Mounjaro) 15 mg weekly, along with a reduced-calorie diet and increased physical activity in participants with obesity.
The medicines are injected subcutaneously (under the skin) once a week.

Institution
MUSC
Recruitment Contact
Mary Harley
843-792-5428
harleyma@musc.edu

Pediatrics Biorepository for Neurosurgery

Date Added
November 1st, 2023
PRO Number
Pro00126218
Researcher
Ramin Eskandari

List of Studies


Keywords
Brain
Summary

The goal of this study proposal is to develop a biorepository which will collect and store central nervous system (CNS) tissue or cerebral spinal fluid (CSF) for future research. This material will be collected from children with CNS conditions or defects. This will be a very useful resource to scientists who work to develop new approaches to prevent and treat conditions that affect children's brains and nervous systems.

Institution
MUSC
Recruitment Contact
Ramin Eskandari
(843) 876-0444
eskandar@musc.edu

A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections

Date Added
October 31st, 2023
PRO Number
Pro00132920
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus
Summary

The protocol aims to improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.

Trials within this protocol can be adaptive, will be randomized, and will have superiority as the primary objective. Comparisons in the trials may be between an unlicensed agent to a blinded placebo plus standard of care (SOC), between an approved off-label agent to a blinded placebo plus SOC, among several active interventions (blinded or non-blinded; i.e., a comparative effectiveness study), or among different treatment strategies.

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

A South Carolina ECHO Pregnancy Cohort

Date Added
October 31st, 2023
PRO Number
Pro00131971
Researcher
Kelly Hunt

List of Studies


Keywords
Children's Health, Environmental Factors, Pregnancy
Summary

The ECHO Cohort is a longitudinal prospective multi-site study aiming to understand how the environment and things that happen early in children's lives - even before they are born - affect their development, health, and well-being. This research program includes many study sites across the United States. ECHO will combine information about 20,000 pregnant participants, more than 50,000 children, and their families. With so many participants from across the country, researchers can answer important childhood health questions.

Institution
MUSC
Recruitment Contact
Erin Alsbrook
7038634359
wilkiee@musc.edu

3P-100-ILD-00 Early Feasibility Study Protocol: A Within-subject Device-setting Escalation Early Feasibility Study Evaluating the Safety, Tolerability, and Functionality of 3P-100, an Electric Nitric Oxide (NO) Ambulatory Production and Delivery System, Delivering Nitric Oxide for Inhalation to Subjects with Pulmonary Hypertension (PH) Accompanying Interstitial Lung Disease (ILD), PH-ILD

Date Added
October 31st, 2023
PRO Number
Pro00128998
Researcher
Rahul Argula

List of Studies


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

This is a multi-center early feasibility study evaluating the safety and tolerability of the 3P-100 device which creates and delivers iNO for the treatment of subjects with PH-ILD. All subjects will use the 3P-100 device and receive iNO via the 3P-100 device, aiming for ~4-4.5 hours of treatment. All subjects will remain on their prescribed Oxygen (O2). The study consists of an SV, an iNO treatment period at V1 (Day 0), and a Telephone Call at V1 + 1 Day for safety follow-up.

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

Investigate Host Gene Isoforms Contributing to HIV Persistence in Cocaine Users

Date Added
October 26th, 2023
PRO Number
Pro00131297
Researcher
Wei Jiang

List of Studies


Keywords
Drug Studies, HIV / AIDS
Summary

HIV infected cocaine users have uncontrolled viral levels and impaired immunity to control infection compared to HIV infected non-drug users. We ask the questions why cocaine use makes HIV infected cocaine users more sick than other patients. The goal is to improve immunity to control HIV infection in cocaine users. Both uninfected cocaine users and HIV-infected cocaine users are especially needed in this study.

Institution
MUSC
Recruitment Contact
Alicia Hartley
843-792-4100 (Alicia); 843-876-2457 (Wei)
hartleal@musc.edu (Alicia); jianw@musc.edu (Wei)

A multicenter, prospective, open-label study to evaluate the pharmacokinetics and safety of gadoquatrane in pediatric participants (from birth to <18 years) undergoing contrast-enhanced magnetic resonance imaging (CE-MRI)

Date Added
October 26th, 2023
PRO Number
Pro00128377
Researcher
Justin Chetta

List of Studies

Keywords
Children's Health, Infant
Summary

This is a Phase I (determine the safety of a drug) study that is looking at how long the contrast agent gadoquatrane stays in the plasma (part of blood not including red cells) after a single injection during an MRI in children aged 0-18 years. Gadoquatrane is an investigational drug, which means that it is not approved by the FDA. This study will be assessing the safety of gadoquatrane for up to 8 days following the administration of gadoquatrane at the MRI. Blood samples will be collected three times within the 8 hours following the MRI for analysis of how much gadoquatrane is left in the blood.

Institution
MUSC
Recruitment Contact
Samuel Bidwell
843-792-2305
bidwells@musc.edu



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