Pediatrics Biorepository to Support Cardiology Clinical Research

Date Added
April 9th, 2023
PRO Number
Pro00124741
Researcher
Eric Graham

List of Studies


Keywords
Cardiovascular, Heart
Summary

This proposal is to contribute to data registry and sample bank called Pediatrics Biorepository for Cardiology Clinical Research. Samples collected in this study may be used for future research which plan to advance the state of science in the hopes to develop new ways to diagnose and treat children affected with heart conditions.

Institution
MUSC
Recruitment Contact
Eric Graham
843-792-9570
grahamem@musc.edu

RANDOMIZED PHASE III TRIAL OF MFOLFIRINOX +/- NIVOLUMAB VS. FOLFOX +/- NIVOLUMAB FOR FIRST-LINE TREATMENT OF METASTATIC HER2-NEGATIVE GASTROESOPHAGEAL ADENOCARCINOMA

Date Added
April 6th, 2023
PRO Number
Pro00128202
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer/Gastrointestinal
Summary

This study is for patients with cancer in the stomach, esophagus, or gastroesophogeal junction. The study is being done to see if by adding a third chemotherapy drug to the usual combination of two chemotherapy drugs is better or worse than the usual approach for treatment.

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

Attention and Development in Infancy

Date Added
April 6th, 2023
PRO Number
Pro00127823
Researcher
Jessica Bradshaw

List of Studies

Keywords
Autism, Infant
Summary

Early intervention for infants and toddlers with or at an elevated likelihood for autism spectrum disorder can promote developmental skills and improve lifelong outcomes. Yet, many children with ASD are not diagnosed until after age 3. In order to improve early detection of ASD, we are investigating very early predictors of social communication challenges in infants as young as 1 week to 4 months of age.

This research study examines how the development of attention and motor skills in the first year of life is associated with the emergence of social and communication skills in three groups of infants: infants who are first born or who have a sibling with no developmental delays, infants who have an older sibling diagnosed with autism spectrum disorder, and infants who were born preterm.

Institution
USC
Recruitment Contact
Elizabeth Dixon
8039938356
esdlab@sc.edu

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-escalation, Proof-of-Concept Study Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetics of INT-787 in Subjects with Severe Alcohol-Associated Hepatitis

Date Added
April 6th, 2023
PRO Number
Pro00124137
Researcher
Don Rockey

List of Studies


Keywords
Alcohol, Liver
Summary

To evaluate the efficacy of an investigational medication (INT-787) as assessed by disease progression in severe alcohol-associated hepatitis (sAH).

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

A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults with Locally Advanced Head and Neck Squamous Cell Carcinoma (The ENDURE Trial)

Date Added
April 6th, 2023
PRO Number
Pro00123953
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer/Head & Neck
Summary

For patients with head and neck cancer, delays starting adjuvant radiation therapy are common, disproportionately burden racial minorities, and contribute to poor survival and racial disparities in mortality. However, effective therapies to improve the delivery of timely, equitable, guideline-adherent adjuvant radiation therapy are lacking. We have developed a navigation-based multilevel intervention to enhance care coordination, communication, and key cancer care delivery processes that could provide the first effective treatment in this population, thereby improving survival, decreasing racial disparities in outcomes, and developing new standards of clinical care.

Institution
MUSC
Recruitment Contact
Jessica McCay
843-791-0719
mccayj@musc.edu

Advancing Couple and Family Alcohol Treatment through Patient-Oriented Research and Mentorship

Date Added
April 4th, 2023
PRO Number
Pro00127577
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol
Summary

Intimate partner violence (IPV) is a serious public health problem that results in significant health and economic burdens including mortality, morbidity, and poor treatment outcomes. A well-developed field of research suggests that alcohol misuse and posttraumatic stress disorder (PTSD) can lead to IPV. Individuals with PTSD and/or problematic drinking behaviors are at risk for IPV because of several factors that are common symptoms of PTSD. Because individuals with PTSD often drink alcohol to "self-medicate" or cope with distressing PTSD symptoms, PTSD co-occurs with alcohol misuse and alcohol use disorder at extraordinarily high rates. However, few studies have examined the combined effects of alcohol misuse and PTSD on any form of violence.

This study will examine the effects of alcohol misuse and posttraumatic stress disorder (PTSD) on alcohol-related intimate partner violence (IPV). We will examine these associations among couples (N=70) in a controlled laboratory setting using validated, standardized methods in a 'real-world' settings using 28 days of ecological momentary assessment (EMA). EMA includes very short surveys (5 minutes or less) that participants respond to on a smartphone application. Participants will be asked to respond to these surveys in the morning and three additional times throughout the day.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu

Tracking Brain Biomarkers and Renormalization Associated with Antidepressant Transcranial Magnetic Stimulation Therapy

Date Added
April 4th, 2023
PRO Number
Pro00127417
Researcher
Andrew Manett

List of Studies


Keywords
Brain, Depression
Summary

The purpose of this study is to use magnetic resonance imaging (MRI) to take images of a participant's brain, and then apply an investigational way of processing the image, called Individualized Network-based Single-frame Coactivation Pattern Estimation ("INSCAPE") to measure participant's brain activity. This method uses a computer program to understand which parts of the brain communicate with each other and creates a map of the brain areas that are connected.

Participants being recruited in this study will include people planning to receive Transcranial Magnetic Stimulation ("TMS") for Major Depressive Disorder ("MDD"). Healthy participants are also being recruited. Images taken of depressed participants' brains will be compared to images of non-depressed participants' brains. Participation in this study will require three visits in which you will undergo MRI scans. The interval between each visits is about 3 weeks. Depressed participants will also complete mood assessments at several different intervals while they are receiving TMS for depression.

During each visit, MRI scans will require about 30 minutes of time in total. During the MRI scan, participants will need to stay still, relax, and keep eyes open in the scanner.

Institution
MUSC
Recruitment Contact
Andrew Manett
843-792-5716
manett@musc.edu

Self-Management for Youth Living with Sickle Cell Disease: SMYLS Multi-site Trial

Date Added
April 4th, 2023
PRO Number
Pro00127137
Researcher
Shannon Phillips

List of Studies


Keywords
Adolescents, Blood Disorders, Minorities, Pain, Pediatrics, Rare Diseases
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile app is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care for and manage their symptoms. 272 teens and adults with SCD will be enrolled in this study which is being conducted at the Medical University of South Carolina in Charleston SC., East Carolina University in Greenville NC., University of Miami in Miami FL., and the University of Alabama in Birmingham AL.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

Military Suicide Prevention Intervention Research (MSPIRE)

Date Added
April 4th, 2023
PRO Number
Pro00126830
Researcher
Ronald Acierno

List of Studies

Keywords
Military, Suicide
Summary

The purpose of this study is to compare the effectiveness of two psychological treatments for the reduction of suicide attempts among U.S. military personnel and veterans, and to identify the reasons why and how these treatments work.

Specifically, this study is looking at the efficacy of two interventions. The first intervention is Present Centered Therapy (PCT). This treatment has been shown to reduce depression, PTSD symptoms, and suicidal thoughts. The second intervention is Brief Cognitive Behavioral Therapy (BCBT). This treatment has also been shown to reduce depression, PTSD symptoms, and suicidal thoughts.

Both treatments involve a total of 12-16 sessions scheduled once or twice each week. Patients who have received either treatment have reported significant reductions in suicidal thoughts and psychological symptoms. These two treatments differ from each other with respect to the specific procedures and techniques used. The purpose of this study is to determine if one treatment works better than the other, or if they are equal to each other with respect to outcomes.

This study is only open to Veterans at the Ralph H. Johnson VA Health Care System and CBOCs or active duty military personnel in the Charleston, SC and Savannah, GA areas.

Institution
MUSC
Recruitment Contact
Stephanie Hart
843-789-6519
zeigls@musc.edu

An Electrophysiological Predictor of SSRI Response in Veterans with PTSD

Date Added
April 4th, 2023
PRO Number
Pro00124873
Researcher
Zhewu Wang

List of Studies


Keywords
Mental Health, Military, Psychiatry
Summary

By doing this study, we hope to learn if a brief screening method can predict which people are most likely to show a positive response to selective serotonin reuptake inhibitor (SSRI) medications. This brief screening method involves using electrodes attached to your scalp via a cap, to measure electrical brain activity in response to a series of loud tones.
Your participation in this research will last about 17-21 weeks if you decide to stay for the whole study.

Institution
MUSC
Recruitment Contact
Erica Cortes
843-829-2110 xt 1011
erica.cortes@va.gov



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