Examining the association between psychosocial factors and adherence to a home exercise program for upper extremity recovery in Veteran stroke survivors

Date Added
November 18th, 2022
PRO Number
Pro00124150
Researcher
Gabrielle Scronce

List of Studies

Keywords
Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Research shows that exercising at home can improve arm and hand movement after a stroke. Unfortunately, it can be hard to exercise enough to make a difference in arm and hand movement after stroke. In this study, we will try to determine things that make it easy or hard for Veterans to exercise their arm and hand after a stroke. In this study, we will recruit Veteran stroke survivors who have difficulty using their arm and hand after a stroke. First, we will administer surveys and questionnaires to get Veteran stroke survivors' perspectives on their self-confidence, mood, sleep, and more. Then, we will ask them to track their home exercise using a wearable movement tracker (like a smart watch). Then, Veteran stroke survivors will meet with a researcher to talk about their experience doing home exercise and why they think it was easy or hard to do.

Institution
MUSC
Recruitment Contact
Gabrielle Scronce
334-590-6943
gabrielle.scronce@va.gov

Low-Interventional Cohort Study of Myocarditis/Pericarditis Associated With COMIRNATY in Persons Less Than 21 Years of Age

Date Added
November 16th, 2022
PRO Number
Pro00124654
Researcher
Kimberly McHugh

List of Studies


Keywords
Coronavirus, Heart, Pediatrics
Summary

This is a low-interventional cohort study to determine cardiac and non-cardiac long-term outcomes of persons <21 years of age with myocarditis/pericarditis after the administration of COMIRNATY, compared with similarly aged persons with myocarditis/pericarditis associated with COVID-19, including MIS-C.

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

REAL Answers (Registry Expansion Analysis to Learn Answers)

Date Added
November 16th, 2022
PRO Number
Pro00124358
Researcher
Hermes Florez

List of Studies

Keywords
Anxiety, Blood Disorders, Cardiovascular, Genetics, Hypertension/ High Blood Pressure, Pain, Stroke, Stroke Recovery
Summary

Over 2400 people who have sickle cell disease and are between the ages of 15 and 45 have been enrolled into the National Registry (SCDIC-I) of patients with Sickle Cell Disease (SCD). A rich resource of natural history data, the SCDIC-I Registry has longitudinal data collected yearly since 2016 from patient surveys (e.g. self reported pain incidences, sleep, barriers to care, experiences during and after pregnancy), medical record abstraction (e.g. medications, transfusion history, co-morbidities) and laboratory results. The 150 patients (or 1200 among the 8 sites) will be selected from both MUSC adult and pediatric SCD clinics starting at 12 years of age; those not previously enrolled in the SCDIC National Registry will be offered the possibility to enroll in SCDIC-II.
We will look at the following:
1- Compare the effect of new SCD medications – crizanlizumab, voxelotor, and L-glutamine – on clinical outcomes in individuals with SCD.
2 - Identify genetic and genomic predictors of response to crizanlizumab, voxelotor, and L-glutamine
3 - Integrate study data into the CureSCi metadata catalog (MDC) to enhance future cross-study analyses.

Institution
MUSC
Recruitment Contact
Jayla Moss
843-792-4653
mossjay@musc.edu

Characterizing Lower Extremity Neurophysiological Responses to Sensory Augmentation after Stroke

Date Added
November 1st, 2022
PRO Number
Pro00124079
Researcher
Jasmine Cash

List of Studies

Keywords
Stroke, Stroke Recovery
Summary

Following stroke, communication between brain areas and to the lower limbs can be compromised, leading to impairments in walking ability. Paired associative stimulation (PAS), a method of non-invasive brain stimulation, is thought to be a useful tool in understanding the relationship between different parts of the brain, and functional ability. However, PAS protocols have not been optimized for use post-stroke. The purpose of this research study is to determine the reliability and effectiveness PAS. This study involve individuals >6 months after having a stroke.

Institution
MUSC
Recruitment Contact
Jasmine Cash
9804282997
cashja@musc.edu

PCORI 1: Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

Date Added
November 1st, 2022
PRO Number
Pro00123833
Researcher
Constance Guille

List of Studies


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

The purpose of the study is to compare a text message based mental health and substance use screening and referral to treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online surveys. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Institution
MUSC Health Florence Medical Center
Recruitment Contact
Edie Douglas
843-792-5958
douglaed@musc.edu

PCORI 1: Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

Date Added
November 1st, 2022
PRO Number
Pro00123833
Researcher
Constance Guille

List of Studies


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

The purpose of the study is to compare a text message based mental health and substance use screening and referral to treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online surveys. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Institution
MUSC Health Lancaster Medical Center
Recruitment Contact
Edie Douglas
843-792-5958
douglaed@musc.edu

PCORI 1: Improving Maternal Mental Health & Substance Use Disorder Screening and Treatment

Date Added
November 1st, 2022
PRO Number
Pro00123833
Researcher
Constance Guille

List of Studies


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

The purpose of the study is to compare a text message based mental health and substance use screening and referral to treatment program, called Listening to Women and Pregnant and Postpartum People (LTWP), to standard of care in-person mental health and substance use screening to look at rates of treatment attendance and retention in treatment. Participation would involve completing online surveys. You may be eligible to participate if you are age 18-45 years, are pregnant and entering prenatal care in one of MUSC's OB clinics, and attended a prenatal appointment at an MUSC clinic.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-5958
douglaed@musc.edu

A Multicenter Randomized Controlled Trial of Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia

Date Added
November 1st, 2022
PRO Number
Pro00122683
Researcher
Puja Elias

List of Studies


Keywords
Cancer/Gastrointestinal, Esophagus, Non-interventional, Surgery
Summary

The study will compare the effectiveness of endoscopic surveillance and endoscopic eradication therapy (EET) for the management of Barrett's esophagus (BE) and low-grade dysplasia (LGD).

Institution
MUSC
Recruitment Contact
Collins Ordiah
8438761912
ordiah@musc.edu

Characterizing the Natural History of Fragile X Syndrome to Inform the Development of Intervention Outcome Measures

Date Added
October 10th, 2022
PRO Number
Pro00123125
Researcher
Caroline Buchanan

List of Studies

Keywords
Genetics, Non-interventional, Rare Diseases
Summary

This project is an extension of the CDC-funded FORWARD (Fragile X Online Registry With Accessible Research Database) study. From its inception in 2010, the goal of the FORWARD study has been to characterize the natural history of fragile X syndrome (FXS). This current extension project is known as FORWARD-MARCH (Multiple Assessments for Research CHaracterization) because it will include multiple assessments to characterize behavioral, adaptive, and cognitive function in greater depth and thereby further improve understanding of the natural history of FXS. FORWARD-MARCH continues the mission of FORWARD to better understand the natural history of FXS in order to improve the lives of children and adolescents with FXS and the lives of their families. FORWARD-MARCH will also better define trajectories of development in FXS that will be useful in understanding the long-term effects of an intervention relative to the natural history of FXS.

FORWARD-MARCH builds upon the foundation of the FORWARD study. The FORWARD study included 24 participating FXS specialty clinics throughout the US that are members of the FXCRC (Fragile X Clinical & Research Consortium). The FORWARD study worked closely with the Centers for Disease Control and Prevention (CDC), the National Fragile X Foundation (NFXF), and other stakeholders in the FXS community. FORWARD-MARCH will also involve a contractor, Chickasaw Nation Industries (CNI), funded through a contract with the CDC. CNI will assist in data collection and management.

Between September 2022 and August 2026, FORWARD-MARCH expects to enroll at least 600 individuals with fragile X syndrome who were born between 2003-2017. The majority of these individuals will already be FORWARD study participants, enabling researchers to conduct longitudinal analyses incorporating previously collected data. Cognitive, behavioral, and adaptive function will be assessed using parent or caregiver-completed surveys and in-person clinical assessments. After completion of data collection, deidentified data will be securely maintained at CDC and will be an important long-term resource for analyses of the natural history of FXS.

Previous phases of the FORWARD study, conducted between 2012 and 2022, have received IRB review and approval by the institutions of each participating clinic. These previous phases of the study did not require review by a CDC IRB, as CDC had no participant contact and did not have access to personal identifying information (PII). The extension of the FORWARD study covered in this protocol (FORWARD-MARCH, 2022-2026) will continue to be reviewed and approved by the institutions of each participating clinic conducting data collection. However, review and approval are also being sought from the CDC IRB because PII will be maintained on CDC servers and because CDC's contractor, CNI, will regularly have access to PII and interact directly with study participants. A reliance agreement allowing CNI to rely on CDC's IRB is being developed and will be executed before data collection is begun. To clarify which aspects of the protocol involve CDC and CNI staff (rather than just clinic staff), sections 3,4 and 5 of this protocol document each end with a subsection that specifically focuses on the role of CDC and CNI staff.

Institution
Self Regional Healthcare
Recruitment Contact
Caleb Hinzman
8646726912
chinzman@ggc.org

Identification of Differences in Verb Learning between Late Talkers and Typically Developing Children

Date Added
October 4th, 2022
PRO Number
Pro00123522
Researcher
Sabrina Horvath

List of Studies

Keywords
Language, Pediatrics, Speech Disorders
Summary

This study explores the best way to teach two-year-old toddlers new verbs, and whether there are differences in what is best between late talkers and typically developing children. In a series of two, one-hour visits, children will watch videos on an eye-tracker, which will capture their face and gaze patterns. This data will be analyzed to see how children are making sense of what they are hearing. In one task, we ask whether it is better for children to hear a new verb before they see the action it denotes, or whether it is better to see the new action before hearing the verb. In the second task, we consider how quickly children are able to make sense of the language they hear, and whether this has any relationship to how they learn new verbs (Task 1). Results will help shape new clinical interventions for late talkers.

Institution
MUSC
Recruitment Contact
Sabrina Horvath
843-792-9363
horvaths@musc.edu



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