Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits

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

This study compares the effectiveness of in-person versus virtual delivery of an evidence-based intervention to reduce rates of postpartum emergency department visits. 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 Health Kershaw Medical Center
Recruitment Contact
Isabella Dubnicka
843-998-5635
hear4mamas@musc.edu

Comparing Standard of Care Versus a Technology-Based Approach To Reduce Postpartum Emergency Department Visits

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

This study compares the effectiveness of in-person versus virtual delivery of an evidence-based intervention to reduce rates of postpartum emergency department visits. 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 Health Columbia Medical Center
Recruitment Contact
Isabella Dubnicka
843-998-5635
hear4mamas@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, connective tissue, blood, 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 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
echosc@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)

Product Surveillance Registry (PSR) Aortic, Peripheral, and Venous (APV) Protocol Synopsis

Date Added
October 24th, 2023
PRO Number
Pro00126447
Researcher
Lindsey Korepta

List of Studies

Keywords
Vascular
Summary

The purpose of this registry is to collect safety data in patients undergoing aortic aneurysm repair, peripheral vascular intervention, hemodialysis access intervention or peripheral embolization with an eligible Medtronic market-released product(s), including but not limited to balloon catheters, peripheral or carotid stents, stet grafts, and coils, in a real-world setting.

Institution
MUSC
Recruitment Contact
Morgan Overstreet
8437928896
overstrm@musc.edu

Alpha-1 Foundation Therapeutic Development Network

Date Added
October 23rd, 2023
PRO Number
Pro00132722
Researcher
Charlie Strange

List of Studies


Keywords
Liver, Lung, Non-interventional, Pulmonary, Rare Diseases
Summary

The Alpha-1 Foundation Therapeutic Development Network (TDN) aims to make it easier to design and carry out clinical trials that enhance the treatment of patients with Alpha-1 Antitrypsin Deficiency (AATD). To achieve this, the TDN will establish a network of clinical trial centers that have enough patients to gather a comprehensive database of clinical and genetic information. This data will be crucial in determining the criteria for including or excluding participants in the trials and in recruiting suitable subjects.

Specifically, this study will enroll participants by in person or remote consent who will allow collection of medical records to be entered into an Alpha-1 TDN database. Participants will then be invited to future clinical trials.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles for Hospitalized Patients with Moderate-to-Severe ARDS: A Phase III Clinical Trial

Date Added
October 19th, 2023
PRO Number
Pro00132554
Researcher
Andrew Goodwin

List of Studies


Keywords
Critical Care
Summary

This study is a multicenter, randomized, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of ExoFlo for the treatment of moderate-to-severe ARDS (Acute Respiratory Distress Syndrome). The purpose of this study is to research and evaluate the safety and efficacy of intravenous (IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles, ExoFlo, as treatment for Moderate-to-Severe ARDS. Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles is an investigational drug created from human bone marrow being studied for the treatment of moderate-to-severe ARDS. This is a research study that will involve monitoring oxygen and inflammation levels after taking the investigational product and assessing the safety of the investigational product. The experimental treatment is a biologic product called Bone Marrow Mesenchymal Stem Cell (bmMSC)-Derived Extracellular Vesicles Allograft Product ExoFlo, which is purified from the bone marrow of a healthy well-screened individual. Participants will receive either 15mL of the investigational product with 85 mL of normal saline or 100 mL of normal saline only (placebo). The expected duration of participation in the study is a maximum of 61 days, which includes 1-day screening prior to treatment and 60 days following the first treatment.

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

Fontan Udenafil Exercise Longitudinal Assessment Trial (the FUEL-2 Study)

Date Added
October 2nd, 2023
PRO Number
Pro00130325
Researcher
Andrew Atz

List of Studies


Keywords
Adolescents, Cardiovascular, Drug Studies, Pediatrics
Summary

This will be a 26-week, prospective, multicenter, randomized, double-blind, placebo-controlled safety and efficacy study of udenafil 87.5 mg tablets versus placebo (both taken twice daily in adolescent subjects who have had the Fontan procedure. The primary efficacy endpoint will be change from baseline at 26 weeks in peak minute oxygen consumption [VO2] (mL/kg/min).

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8317
wakefies@musc.edu

Invasive Mechanical Ventilation (IMV) Strategies Domain

Date Added
September 27th, 2023
PRO Number
Pro00131378
Researcher
Andrew Goodwin

List of Studies


Keywords
Critical Care
Summary

This study is part of what is called a platform study. This platform study, called the "PRACTICAL" study is designed so that various interventions can be evaluated at the same time against standard therapy. This allows researchers to compare these newer interventions to each other as well as to the established usual practice and helps them explore different ways to potentially improve the management of lung injury. Within the platform study there are various different sub-studies that have their own interventions and procedures. This domain sub-study is the "Mechanical Ventilation Study" and it is a multi-centre, randomized, open-label trial that will evaluate multiple ventilation strategies in comparison to conventional lung-protective ventilation in patients with acute hypoxemic respiratory failure (AHRF). This domain will enroll perpetually, as interventions are added, continued, or discontinued. Researchers for this study are looking for different types of ventilation strategies (ways that the ventilators control settings can be adjusted) that may be the most helpful for people in their recovery, while also reducing lung damage caused by the ventilator.

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



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