A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants Save

Date Added
September 26th, 2017
PRO Number
Pro00066901
Researcher
Andrew Atz
Keywords
Children's Health, Drug Studies, Infant, Infectious Diseases, Lung, Pediatrics
Summary

This is a Randomized , Double blinded study to evaluate how effective a single dose of experimental drug called MEDI8897 is at preventing lung disease caused by RSV disease in healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days.This study also evaluate safety, tolerability and pharmacokinetics (PK) of MEDI8897 in healthy preterm infants compared with placebo.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
834-792-1213
choudhar@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

Self-Management for Families and Youth Living with Sickle Cell Disease - SMYLS Save

Date Added
September 2nd, 2017
PRO Number
Pro00062837
Researcher
Shannon Hudson
Keywords
Blood Disorders, Children's Health, Pediatrics
Summary

The purpose of this study is to find out whether a web-based intervention using a mobile device over a 12-week period is helpful in managing symptoms of Sickle Cell Disease in children, such as pain and fatigue and quality of life. For more information, please contact Shannon at 843-792-9379.

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

The effect of povidone-iodine ophthalmic surgical prep solution on respiration in children undergoing strabismus surgery with general anesthesia. Save

Date Added
August 15th, 2017
PRO Number
Pro00067331
Researcher
Michelle Rovner
Keywords
Children's Health, Pediatrics
Summary

This study is being done to study the effect of putting povidone-iodine ophthalmic or balanced saline solutions in the eye has on respirations during strabismus (eye alignment) surgery. Both of these solutions are FDA approved for use in this manner and will be done after patients are under anesthesia. The solution to be used is determined by randomization upon enrollment and will either be 3 drops of povidone-iodine ophthalmic solution in each eye (Group A) or 3 drops of BSS in each eye (Group B). The eye solution intervention period will take less than 5 minutes and will cause either only a slight delay or no delay in the surgical time. The only other intervention is the collection of data after induction (but just prior to IV insertion), as well as before and after the drops of eye solution are delivered.

Institution
MUSC
Recruitment Contact
Wanda Jones
8437921869
joneswr@musc.edu

A multicenter, Phase 3, randomized, open-label, active-controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks in prepubertal children with growth hormone deficiency (GHD) Save

Date Added
August 8th, 2017
PRO Number
Pro00062480
Researcher
Deborah Bowlby
Keywords
Pediatrics
Summary

This is a one year study comparing once a week subcutaneous long acting growth hormone with once a day growth hormone currently available commercially. All eligible subjects will be newly diagnosed, medically untreated growth hormone deficient children who have not yet entered puberty. A 2:1 randomization ratio will be used for the Transcon hGH treatment cohort and the daily rhGH treatment cohort, respectively. 150 subjects will be enrolled study-wide This study will be conducted in approximately 100 trial sites in approximately 20 countries in North and South America, Europe, Middle East and North Africa, and Oceania.

Institution
MUSC
Recruitment Contact
Amanda Blue
843-792-6807
blueae@musc.edu

A multicenter, multinational, randomized, double-blind, pharmacokinetic and pharmacodynamic (PK/PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Save

Date Added
July 25th, 2017
PRO Number
Pro00067181
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

This study is for pediatric patients that have been diagnosed with cancer and are receiving chemotherapy. The investigational drugs in this study are netupitant and palonosetron. The purpose of this study is to learn more about how well the combination of oral netupitant and oral palonosetron works in preventing nausea and vomiting associated with chemotherapy in children. Participation in the study will last for a maximum of 31 days, which includes a screening period up to 14 days before randomization (up to 7 days for patients aged less than 2 years), the day of enrollment/randomization, administration of study drugs and chemotherapy (Study Day 1), and the control visits (Study Days 2 to 5).

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

Evaluation of the CytoRADx SystemTM as a Biodosimeter for Special Human Populations Save

Date Added
July 14th, 2017
PRO Number
Pro00067066
Researcher
Gary Headden
Keywords
Blood Disorders, Children's Health, Environmental Factors, HIV / AIDS, Non-interventional, Pediatrics
Summary

This is a study to develop a test for radiation exposure in the event of a nuclear event such as the detonation of a nuclear device or widespread radiation exposure. We will collect blood samples from a variety of different types of human subjects whose current medical status could possibly have an effect on the results of the test, such as trauma, burns, infections or a damaged immune system or young children. The goal is to ensure that these conditions do not affect the results of the test.

Institution
MUSC
Recruitment Contact
Robert Houck
(843) 792-3576
houckr@musc.edu

Heart Failure in Single Right Ventricle Physiology: Pathologic Mechanisms and Novel Assessment Save

Date Added
July 5th, 2017
PRO Number
Pro00066472
Researcher
Shahryar Chowdhury
Keywords
Cardiovascular, Children's Health, Heart, Pediatrics
Summary

The goals of this study are to understand the mechanisms behind the development of heart failure in children born with complicated heart defects consisting of a functional single pumping chamber, improve the ability to objectively measure cardiac function in these patients and determine the relationship of these pathophysiologic mechanisms to outcomes.

Institution
MUSC
Recruitment Contact
Christine Perez Rosa
843-792-9454
perezaro@musc.edu

Protocol I1F-MC-RHCD Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Ixekizumab in Patients from 6 to Less than 18 Years of Age with Moderate-to-Severe Plaque Psoriasis Save

Date Added
June 27th, 2017
PRO Number
Pro00064844
Researcher
Lara Wine lee
Keywords
Drug Studies, Pediatrics, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called ixekizumab (given by injection) is safe and effective in children and young adults with moderate to severe plaque psoriasis. For more information, please call Abby Powell at (843) 792-6690.

Institution
MUSC
Recruitment Contact
Abby Powell
843-792-6690
powab@musc.edu

Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation Save

Date Added
May 23rd, 2017
PRO Number
Pro00066198
Researcher
Patrick Flume
Keywords
Cystic Fibrosis, Pediatrics, Pulmonary
Summary

The purpose of this study is to learn more about the safety and efficacy of the combination of tezacaftor/ivacaftor (TEZ/IVA) in subjects with CF who have previously discontinued Orkambi. Orkambi® is a combination of ivacaftor with another drug called lumacaftor. This study is being conducted to test whether combining ivacaftor with tezacaftor instead will improve symptoms of cystic fibrosis and cause fewer respiratory side effects.

Institution
MUSC
Recruitment Contact
Abbi Reed
843-792-1820
reedab@musc.edu

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