Causes and Consequences of Preschooler's Digital Media Use: The Role of Sleep, Physical Activity, Sedentary Behavior and Social Emotional Health

Date Added
December 15th, 2023
PRO Number
Pro00133829
Researcher
Bridget Armstrong

List of Studies

Keywords
Children's Health, Disease Prevention, Healthy Volunteer Studies, Mental Health, Non-interventional, Pediatrics
Summary

Children spend more time than ever using screens — increasingly on portable digital media devices like tablets and smartphones, but our understanding about how these devices impact health is lagging. This project proposes to uncover how patterns of digital media use are formed and maintained and examine how those patterns predict mental health and cardiovascular health risk over time. The novel forms of media measurement used in this project – including passive mobile sampling, ecological momentary assessment and accelerometry – will allow us to uncover the unique and complex ways in which digital media impacts health behaviors.

Institution
USC
Recruitment Contact
Michal Talley
8032501730
BA12@mailbox.sc.edu

CORD clamping among neonates with Congenital Heart Disease

Date Added
December 11th, 2023
PRO Number
Pro00131976
Researcher
Sinai Zyblewski

List of Studies


Keywords
Heart, Pediatrics, Pregnancy
Summary

A randomized clinical trial study that compares 2 different timepoints to clamp the cord at birth. The study involves babies with heart disease born between 37 0/7- 41 6/7 weeks of pregnancy. Doctors will clamp the umbilical cord around 30 seconds (between 1-<60 seconds) after birth vs. around 120 seconds (between 60-<180 seconds) after birth. Doctors consider both treatment groups to be "usual care." A goal of this study is to find out which umbilical cord clamping timepoint is best for babies with heart disease.

Institution
MUSC
Recruitment Contact
Layla Al Sarraf
843-901-4153
alsarral@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
Layla Al Sarraf
843-876-5203
alsarral@musc.edu

Identification of Facilitators and Barriers for the Management of Pediatric Asthma within School-based Clinics: A Mixed Methods Approach

Date Added
September 16th, 2023
PRO Number
Pro00130502
Researcher
Katherine Chike-Harris

List of Studies


Keywords
Asthma, Pediatrics
Summary

Pediatric asthma is not well controlled in SC and it's important to understand the facilitators and barriers to asthma care, especially in rural and underserved populations. Though school-based clinics provide quality asthma care to pediatric patients and has been shown to increase asthma control and decreased unnecessary health care utilization (i.e., emergency room), enrollment continues to be low. To identify and understand the facilitators and barriers to asthma care within school-based clinics, it is important to query caregivers (parents, grandparents, foster parents, legal guardians) and providers (doctors, APPs) to elicit their thoughts and opinions. This study will include caregiver and provider surveys and individual interviews to collect and analyze these thoughts and opinions.

Institution
MUSC
Recruitment Contact
Katherine Chike-Harris
843-792-4649
chikehar@musc.edu

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Baricitinib in Children from 6 Years to Less than 18 Years of Age with Alopecia Areata

Date Added
September 11th, 2023
PRO Number
Pro00126611
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

This is a Phase 3, placebo-controlled, randomized, double-blind research study evaluating the efficacy, safety, and PK of baricitinib in children from 6 years to less than 18 years of age with severe alopecia areata. The study is divided into 4 periods: a 5-week screening period, a 36-week double-blind treatment period, an approximately 2-year long-term extension period, and a 4-week posttreatment follow-up period. If the subject meets all eligibility criteria they will be randomized to receive either baricitinib high dose, baricitinib low dose, or placebo for 36 weeks. Participants will then be transitioned into the long-term extension treatment period. Subjects will attend 18 clinic visits for up to 145 weeks.

Institution
MUSC
Recruitment Contact
Madeline Richmond
8437921436
richmoma@musc.edu

Cold Atmospheric Plasma Device for the Treatment of Molluscum Contagiosum and Verruca Vulgaris in Pediatric Patients - Open-Label Extension Study

Date Added
June 6th, 2023
PRO Number
Pro00127338
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@ musc

Neurobehavioral and Immune Effects of Citicoline in Youth Alcohol Use Disorder

Date Added
June 6th, 2023
PRO Number
Pro00128800
Researcher
Lindsay Squeglia

List of Studies


Keywords
Adolescents, Alcohol, Brain, Drug Studies, Pediatrics, Psychiatry, Substance Use
Summary

This study is testing citicoline as a possible medication to treat alcohol use disorder. Youth (ages 16-22) will be randomly assigned to receive either citicoline (2000mg per day) and or a placebo for four weeks.

All participants will receive brief counseling from a trained clinician and will undergo a brain scan and cognitive testing at the beginning and end of the treatment.

Participants must provide informed consent and youth under 18 must have parental consent to participate. The full study will last approximately one month.

Compensation is available to those who qualify.

Institution
MUSC
Recruitment Contact
Cori Herring
843-792-8207
herrinco@musc.edu

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients with Severe Eosinophilic Asthma (DOMINICA)

Date Added
June 6th, 2023
PRO Number
Pro00126684
Researcher
Kelli Williams

List of Studies


Keywords
Allergy, Asthma, Pediatrics
Summary

The main purpose of this study is to see if taking benralizumab is effective in treating Severe Eosinophilic Asthma in patients 6 to 17 years old compared with placebo. Benralizumab is administered through a subcutaneous injection (shot). Participation in the study is divided into two parts. The first part will last up to 16 weeks or until an asthma attack or flare is experienced. The second part will last up to two years.

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

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Date Added
May 2nd, 2023
PRO Number
Pro00125254
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Brain, Pediatrics
Summary

This study is for patients that have been diagnosed with relapsed/refractory neuroblastoma. The investigational drug given is eflornithine (DFMO) along with etoposide. DFMO is the investigational drug being used along with etoposide for treatment of neuroblastoma. Participants will undergo a number of standard tests and research-related procedures before being able to enroll in this study. Some risks include but are not limited to: fewer red and white blood cells, diarrhea, abdominal pain, loss of appetite, skin rash, seizure, difficulty swallowing and blurred vision. Participants can expect to be on this study for approximately 2 years. Participants will then be followed for up to 5 years after study completion.

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

An Open-Label Extension Study of BPN14770 in Subjects with Fragile X Syndrome

Date Added
May 1st, 2023
PRO Number
Pro00125951
Researcher
Caroline Buchanan

List of Studies

Keywords
Genetics, Pediatrics, Rare Diseases
Summary

This is an OLE study for subjects completing from one of two double-blind clinical
trials. Subjects must have completed the Week 13 visit from one of these two parent
clinical trials to be eligible for this OLE.

Institution
Self Regional Healthcare
Recruitment Contact
Caleb Hinzman
864-672-6912
chinzman@ggc.org



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