A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy with Immunooncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma.

Date Added
February 12th, 2024
PRO Number
Pro00133635
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Cancer/Lymphoma, Pediatrics
Summary

This study is for patients that have been diagnosed with early-stage (Stage I or II) Hodgkin lymphoma (HL)(cHL). The main purpose of this study is to compare the effects, good and/or bad, of brentuximab vedotin and nivolumab (Bv-NIVO) against standard therapy for people with HL to find out which is better. Participants can expect to be in the study for up to 54 months.

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

A Retrospective Follow-up Study of the Durability of Antiviral Therapy on Long-term Hearing and Neurodevelopmental Outcomes Among Patients Treated for Congenital Cytomegalovirus Infection as Infants or Toddlers

Date Added
December 18th, 2023
PRO Number
Pro00129725
Researcher
Stephen Thacker

List of Studies

Keywords
Pediatrics
Summary

Patients who previously had been treated with either intravenous ganciclovir or oral
valganciclovir as an infant or toddler, either as part of a previous Collaborative Antiviral Study Group (CASG) study or through routine clinical care at a current or former CASG study site, will be offered enrollment on this retrospective follow-up study.

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

Social Determinants of Health, Stress, Coping, and Quality of Life in Parents of Children with Congenital Heart Disease

Date Added
October 5th, 2023
PRO Number
Pro00131932
Researcher
Lianne Cole

List of Studies

Keywords
Cardiovascular, Children's Health, Heart, Mental Health, Pediatrics, Stress Disorders
Summary

This study will investigate the relationships among social determinants of health (SDOH), perceived stress, coping, and quality of life (QoL) in parents of children with congenital heart disease (CHD). Surveys will be administered to assess perceived stress, coping strategies, QoL, and SDOH. Semi-structured interviews with parents of children with CHD will explore parent experiences with CHD-related stressors, current use of coping strategies, SDOH barriers and facilitators to effective coping, and preferences for future interventions to reduce stress and facilitate coping.

Institution
MUSC
Recruitment Contact
Lianne Cole
336-207-8043
lianne.cole@childrens.harvard.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

An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency

Date Added
July 25th, 2023
PRO Number
Pro00130044
Researcher
Deborah Bowlby

List of Studies


Keywords
Pediatrics
Summary

Subjects entering this long-term safety extension (LTSE) study must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit and are eligible for continuation of treatment beyond Month 12, if applicable. Subjects may be enrolled into the LUM-201-02 study, having met all enrollment criteria, following successful completion of 12, 18, or 24 months of treatment in a pediatric LUM-201 GHD study.
Subjects who have met the AHV ≥ 6.7 growth criterion and have continued on treatment beyond the Month 12 visit in the LUM-201-01 trial may transition into the LUM-201-02 trial at Month 18 visit. For these subjects, AHV at Month 24 will be compared to AHV at Month 12, and if it is confirmed to be ≥ 80% of the Month 12 AHV, continued treatment with LUM-201 will be offered.

Institution
MUSC
Recruitment Contact
Terry Headley
843-792-4629
headleyt@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