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

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

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Lebrikizumab Compared to Placebo in Participants 6 Months to <18 Years of Age with Moderate-to-Severe Atopic Dermatitis

Date Added
December 8th, 2022
PRO Number
Pro00123135
Researcher
Lara Wine Lee

List of Studies


Keywords
Children's Health, Pediatrics, Skin
Summary

This study aims to evaluate the efficacy and safety of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment, compared with placebo, in pediatric participants with moderate-to-severe atopic dermatitis. Participants found to be eligible according to all of the study entry criteria will be randomly assigned in a 2:1 ratio to receive either lebrikizumab or placebo. This study can last up to 32 weeks, with 4 study periods. Screening Period: up to 4 weeks (≤30 days), TCS Standardization Period: 2 weeks, Treatment Period: 16 weeks, Post-Treatment Safety Follow-up Period: 12 weeks.

Institution
MUSC
Recruitment Contact
Mikayla DiDonato
8438762281
didonato@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

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

Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial (HIKO STEC Trial)

Date Added
May 11th, 2022
PRO Number
Pro00117570
Researcher
Christopher Pruitt

List of Studies


Keywords
Kidney, Pediatrics
Summary

This research study aims to learn more about children and adolescents who have a shiga toxin-producing E. coli (STEC) infection. E. coli is a type of bacteria found in the intestines. Although most types of E. coli are harmless, some produce toxins that can make children sick. This study will assess what type of treatment is best for this infection.

Institution
MUSC
Recruitment Contact
Christian Conley
843-792-1213
conelyc@musc.edu

Pediatric Acute Leukemia (PedAL) Screening Trial Developing New Therapies for Relapsed Leukemias

Date Added
March 11th, 2022
PRO Number
Pro00118800
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

This study is for patients that have been diagnosed with leukemia. This study is called a screening study and we are doing this study to find better ways to diagnose and treat leukemia in children, adolescents and young adults. Bone marrow, blood, and medical information about participant's cancer and treatment will be collected. Participants can expect to be on this study for 5 years.

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

A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

Date Added
February 23rd, 2022
PRO Number
Pro00118231
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with non-germinomatous germ cell tumor (NGGCT). The goal of this study is to see if radiation therapy (RT) to the spine and a portion of the brain works just as well as the standard treatment, which includes RT to the whole brain and spine, for people with NGGCT who agree to take part in this study, and whose disease responds well to induction chemotherapy, or who have no signs of disease following surgery. Participants can expect to receive treatment on this study for about 6 to 11 months, depending on which therapy they receive. After study completion, participants will continue to be followed for up to 10 years.

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



-- OR --