A Multi-Site Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention (BRIGHT) with Attention Control for the Management of Body Image-Related Distress Among Head and Neck Cancer Survivors

Date Added
August 2nd, 2022
PRO Number
Pro00110248
Researcher
Evan Graboyes

List of Studies


Keywords
Cancer/Head & Neck
Summary

Because head and neck cancer arises in cosmetically and functionally critical areas, head and neck cancer survivors suffer high rates of body image-related distress. Body image-related distress is a source of significant morbidity, contributing to stigmatization, social isolation, and worse quality of life. Unfortunately, effective therapies exist to manage body image-related distress among head and neck cancer survivors are lacking. We have developed a novel, scalable, tele-cognitive behavioral therapy intervention for head and neck cancer survivors with body image disturbance that could provide the first effective treatment in this population, thereby minimizing psychosocial morbidity, improving quality of life, and developing new standards of clinical care.

Institution
MUSC
Recruitment Contact
Evan Graboyes
843-791-0719
graboyes@musc.edu

Syntactic Bootstrapping in Toddlers

Date Added
August 2nd, 2022
PRO Number
Pro00122285
Researcher
Sabrina Horvath

List of Studies

Keywords
Language, Pediatrics, Speech Disorders
Summary

Learning new words is challenging for all toddlers, and it may be particularly challenging for toddlers who are late talkers. In this study, we ask whether late talkers use the same cues to figure out the meanings of new words as do their typically developing peers. Toddlers ages 2.0-2.5 will watch videos of people doing new actions and hear made-up words. An eye-tracking device will capture their face and their gaze patterns, and we will use this data to determine how they are making sense of the new words they are hearing. Results will provide insights into how toddlers learn new words and whether this process relates to toddlers' current language abilities.

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

Evaluating the specific role of endogenous opioids as the mechanism underlying tAN-based analgesia in healthy individuals

Date Added
September 6th, 2022
PRO Number
Pro00122762
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Healthy Volunteer Studies
Summary

This study is attempting to understand whether 30-minutes of a new ear stimulation technology can reduce pain in healthy individuals. Participants in this trial will attend two experimental visits, during which they will receive ear stimulation during the intravenous administration (I.V.) of either saline or naloxone. During each visit, the amount of thermal pain participants can tolerate will be determined before and after ear stimulation. Brain scans will also be collected before and after ear stimulation. Each visit should last about 3 hours.

Institution
MUSC
Recruitment Contact
Falon Sutton
843-792-9502
suttonf@musc.edu

Evaluating the Efficacy of Telehealth-Delivered Brief Family Involved Treatment (B-FIT) for Alcohol Use Disorder among Veterans

Date Added
September 6th, 2022
PRO Number
Pro00121552
Researcher
Julianne Flanagan

List of Studies


Keywords
Alcohol, Military, Stage II
Summary

Improving alcohol use disorder (AUD) treatment among Veterans is a national public health problem. The rate of AUD among Veterans is twice that of civilians, with up to 50% of Veterans having AUD. Family-based AUD programs are rarely undertaken in busy treatment clinics, and Veterans with problem drinking behavior or AUD are commonly excluded from couple therapies. As a result, there is a need to develop effective family AUD treatments that are both brief and highly accessible to Veterans.

The purpose of this study is to evaluate a new treatment add-on called Brief Family-Involved Treatment (B-FIT), which will be delivered via telehealth among Veterans engaged in alcohol-based treatment/therapy.

This study is an 12-week, Stage-II, open randomized controlled trial examining B-FIT in combination with treatment as usual, TAU (i.e., B-FIT + CBT treatment) as compared to TAU alone (i.e., CBT treatment). Veterans and their treatment companion (family member, partner, friend) will complete weekly assessments during the treatment phase in addition to 3 & 6 month follow-up assessments, all via telehealth.

Institution
MUSC
Recruitment Contact
Alexander Hannegan
843-7920608
alh324@musc.edu

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

A Pilot Trial of UrApp, a Novel Mobile Application for Childhood Nephrotic Syndrome Management

Date Added
October 4th, 2022
PRO Number
Pro00120040
Researcher
Katherine Twombley

List of Studies


Keywords
Kidney, Pediatrics
Summary

The purpose of this study is to learn how well a new mobile app helps families manage their child's nephrotic syndrome. We will be asking what parents think of the new app and how we can improve the design of the app. We will look for 60 parents to participate in the study, from 4 children's kidney clinics in the United States. The study will last 12 months. Participants will be asked to check their child's urine protein levels at home daily and answer surveys. If participants are randomly assigned to the mobile app study arm, they will be asked to use the app. The risks associated with participating in this study include loss of privacy and breach of confidentiality. There are no anticipated benefits to your child from participating in the study, but we hope that in the future the app will help families manage nephrotic syndrome. The alternative is to not participate in this study. Participants will be compensated for their participation in the study.

Institution
MUSC
Recruitment Contact
Christian Conley
843-792-1213
conleyc@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

Measurement-Based Stroke Tele- Occupational Therapy to Improve Community and Home Activity Performance

Date Added
December 15th, 2022
PRO Number
Pro00125524
Researcher
Michelle Woodbury

List of Studies


Keywords
Rehabilitation Studies, Stroke, Stroke Recovery
Summary

This small stroke rehabilitation study will test the feasibility of a new method to personalize a home exercise program for arm/hand recovery. The research study will last ~8 weeks. Participants will be included if they are adults who have experienced a stroke that has caused one arm/hand to become weak, are able to come to the MUSC main campus 3 times for ~2hr arm movement evaluations, and are willing and able to engage in 60 minute telerehabilitation video visits with an occupational therapist 1-2 times per week for 6 weeks. We anticipate that the results of this study will enable occupational therapists and stroke survivors to, together, design home exercise programs that are meaningful, motivating and effective.

Institution
MUSC
Recruitment Contact
Julianne Laura
843-985-1773
roseju@musc.edu

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Date Added
January 11th, 2023
PRO Number
Pro00123694
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Cancer/Other, Immune System
Summary

The purpose of this study is determine the optimal dose, efficacy and safety of an investigational drug (a new drug not yet approved by the U.S. Food and Drug Administration) in adults with Advanced Systemic Mastocytosis. The investigational drug is known as CGT9486 and will be taken daily orally. Participation in the study is expected to be approximately 6 years.

Institution
MUSC
Recruitment Contact
Natalie Naylon
8437925824
naylon@musc.edu

Examining Provider and Caregiver Perceptions of an Automated Clinical Support Tool to identify Child Risk in Primary Care

Date Added
February 12th, 2023
PRO Number
Pro00125560
Researcher
Hannah Espeleta

List of Studies

Keywords
Children's Health, Pediatrics
Summary

This study wants to understand how we can better identify children who have experienced or are at risk to experience child maltreatment. We will be interviewing caregivers of children and primary care providers (nurses, pediatricians, social workers) to understand their perspectives on screening for child safety risks in primary care settings. Interviews with providers will also focus on their feedback on a new tool to designed to detect child safety risks within health care settings. Findings will help inform best practice in integrated health care settings.

Institution
MUSC
Recruitment Contact
Hannah Espeleta
843-792-6098
espeleta@musc.edu



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