Detecting the Pathophysiology that Drives Fontan-associated Liver Disease Save

Date Added
October 5th, 2018
PRO Number
Pro00077466
Researcher
Joshua Kurtz
Keywords
Adolescents, Cardiovascular, Children's Health
Summary

The purpose of this study is to evaluate causes and risk factors for liver disease in those whom have 1) undergone the Fontan procedure or 2) whom have dilated cardiomyopathy.

Participants in this study will have a blood sample collected, undergo cardiac magnetic resonance imaging (CMR), a liver magnetic resonance imaging (MRI), shear wave ultrasound elastography (SWE), echocardiography, liver Doppler ultrasound, and an exercise stress test. Participants medical records will be reviewed to collect information on previous medical procedures. Participation is complete once all imaging studies and blood sample have been collected.

This is not a treatment study; if one chooses not to participate, s/he will continue to undergo regularly scheduled clinical procedures.

Institution
MUSC
Recruitment Contact
Joshua Kurtz
843-834-0972
kurtzj@musc.edu

PRACTICE: A Mobile Health Solution to Increase Homework Use and Adherence in Youth Mental Health Treatment Save

Date Added
September 4th, 2018
PRO Number
Pro00080487
Researcher
Brian Bunnell
Keywords
Children's Health, Mental Health
Summary

Youth receiving mental health treatment have better outcomes when homework, or between-session practice, is assigned by providers and completed by youth and caregivers between treatment sessions. Many providers struggle with assigning homework during treatment, and many families struggle with completing homework assignments.

In this project we will develop a mobile application, "PRACTICE," to help providers and patients with homework exercises during mental health treatment. After developing the app we will be asking providers and youth patients and their caregivers to test the app and provide us with feedback during a one-time, remote interview. Next we will be recruiting mental health providers and families to participate in a treatment trial where we will preliminarily evaluate the effectiveness of the app. This will include a typical course of best-practice treatment where some providers and families will be randomly assigned to receive treatment enhanced with the PRACTICE app. As a last part of this study, we will be interviewing providers, supervisors, and senior leaders at local community-based clinics to get their ideas on how best to implement the use of the PRACTICE app in community settings.

Institution
MUSC
Recruitment Contact
Brian Bunnell
8437924675
bunnellb@musc.edu

A PHASE 2/3 STUDY INVESTIGATING THE PHARMACOKINETICS, SAFETY, AND EFFICACY OF DUPILUMAB IN PATIENTS AGED ?6 MONTHS TO <6 YEARS WITH SEVERE ATOPIC DERMATITIS Save

Date Added
May 8th, 2018
PRO Number
Pro00074957
Researcher
Lara Wine lee
Keywords
Children's Health, Skin
Summary

This study is being conducted to determine how safe and effective an investigational drug called dupilumab (REGN668) is in reducing the signs and symptoms of eczema. This drug is investigational in that it is not yet approved by government agencies, such as the US Food and Drug Administration (FDA) for the treatment of children. Dupilumab is, however, approved by the FDA for the treatment of AD in adult patients.
Your child's participation in this study will require 8 visits to the study center over 3 months.

As part of this study, your child will have a physical exam, blood testing and an electrocardiogram or electrical testing of the heart performed. They will also be given the study drug (dupilumab).

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
modzik@musc.edu

Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care Save

Date Added
May 7th, 2018
PRO Number
Pro00077156
Researcher
Lisa Knight
Keywords
Children's Health, Infant, Pediatrics
Summary

The majority of drugs administered to children are used off label and PK studies to define appropriate dosing are lacking across pediatric age groups. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard of care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per standard of care as prescribed by their treating caregiver.
This study will serve as a tool to better understand drug exposure in children receiving drugs per standard of care. The data collected through this initiative will provide valuable PK and dosing information drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Institution
Palmetto
Recruitment Contact
Sarah Newman-Norlund
803-216-3377
Sarah.Newman-Norlund@uscmed.sc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF DUPILUMAB ADMINISTERED CONCOMITANTLY WITH TOPICAL CORTICOSTEROIDS IN PATIENTS, ?6 YEARS TO <12 YEARS OF AGE, WITH SEVERE ATOPIC DERMATITIS Save

Date Added
April 10th, 2018
PRO Number
Pro00075600
Researcher
Lara Wine lee
Keywords
Children's Health, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called dupilumab (given by injection) with corticosteroids is safe and effective in children with severe atopic dermatitis. Participation in the study will take about 13 visits to the clinic and 9 phone calls over a period of about 33 weeks.

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
cantur@musc.edu

Comparison of Length of Stay for Infants with GBS Unknown Mothers with Adequate vs Inadequate Treatment Save

Date Added
April 6th, 2018
PRO Number
Pro00077255
Researcher
Rachel Sigrest
Keywords
Children's Health, Disease Prevention, Infant, Non-interventional, Obstetrics and Gynecology, Pediatrics, Pregnancy, Women's Health
Summary

The primary investigators/residents have noted during clinical rotations that a significant number of GBS unknown mothers at SRHS are being treated with intrapartum antibiotics even without the presence of risk factors, presumably to decrease postpartum/neonatal length of stay.
Our study, a retrospective chart review, will determine whether or not length of stay is affected by treating GBS unknown mothers with intrapartum antibiotics in the absence of the aforementioned risk factors.
Potential benefits include the cost-effectiveness of decreased length of stay for these patients as well as decreased exposure to nosocomial infections for neonates. However, antibiotic stewardship and patient safety are also considerations. Another potential option for these patients is rapid GBS testing with PCR which can provide results in 1-2 hours compared with 24-48 hours for the standard culture. PCR is not currently available at SMC.

Institution
Spartanburg
Recruitment Contact
Rachel Sigrest
8643800885
racheljames1985@gmail.com

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth
Keywords
Cancer, Cancer/Leukemia, Children's Health, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

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

Effectiveness of continuous nebulization treatment of bronchodilation in patient admitted to PICU diagnosed with acute bronchiolitis Save

Date Added
February 15th, 2018
PRO Number
Pro00073193
Researcher
Sami Rishmawi
Keywords
Children's Health, Infant
Summary

Bronchiolitis is broadly defined as a clinical syndrome that occurs in children < 2 years of age and is characterized by upper respiratory symptoms followed by lower respiratory infection with inflammation, which results in wheezing and or crackles (rales). Bronchiolitis typically is caused by viruses. In ICU setting, the standard therapy of patient presents with acute bronchiolitis are bronchodilation medications. Recent recommendations of American Academy of Pediatrics stated that no evidence to support usage of any of bronchodilators,The goal of this study is validate the effectiveness of bronchodilators medications.

Institution
Spartanburg
Recruitment Contact
Sami Rishmawi
8642371109
srishmawi@srhs.com

Environmental Influences on Child Health Outcomes (ECHO) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Fetal Growth Study Save

Date Added
October 31st, 2017
PRO Number
Pro00070764
Researcher
John Vena
Keywords
Children's Health, Obesity
Summary

We will recruit mother-child pairs for participation in the study and both the mother and child will be considered study participants. However, in cases where it is not possible to recruit the mother, but the child is available to be in the study we will recruit the child with their parent or legal guardian providing consent for the child's participation in the study

Institution
MUSC
Recruitment Contact
JacKetta Cobbs
843-792-0450
echo-nfgs@musc.edu

A Family-Centered Self-Management Program for Young Children with Sickle Cell Disease: Phase II Save

Date Added
September 7th, 2017
PRO Number
Pro00068250
Researcher
Shannon Hudson
Keywords
Blood Disorders, Children's Health, Infant, Pediatrics
Summary

This study tests an intervention to help children with sickle cell disease ages 0-7 years and their families. The intervention is available on a smartphone or tablet, and includes an app for keeping track of symptoms and messaging with a health care provider. For more information, please contact Shannon at 843-792-9379.

Institution
MUSC
Recruitment Contact
Shannon Phillips
843-792-9379
phillipss@musc.edu

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