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

Adolescents' Weight Management- Is there an app for that? Save

Date Added
March 22nd, 2017
PRO Number
Pro00063390
Researcher
Christine Sangiovanni
Keywords
Adolescents, Nutrition, Obesity, Pediatrics, Weight Control
Summary

Interviews of adolescents 13-17 years old in rural and urban areas of South Carolina will be conducted to identify which weight management apps adolescents think are easy to use, engaging and motivating, and fit their needs for help with managing weight. Features that adolescents prefer will be gathered and health care providers can use this information to recommend immediately available, engaging, and helpful resources for weight management.
Our long-term goal is to optimize the use of mobile apps as beneficial and readily accessible resources to assist primary care providers in the management of overweight/obese adolescents. However, prior to determining if an app is efficacious or even feasible, adolescents? preferences for app features need to be assessed.
The objective of this research is to determine which features of apps adolescents think appeal or detract from the acceptability and usability of weight management apps. Our central hypothesis is that adolescents will prefer to use some apps more than others and this will most likely be due to the preferred specific features available in certain apps, such as goal setting and social connection with friends, peers, or providers.

Institution
MUSC
Recruitment Contact
Christine SanGiovanni
843-876-8671
sangiova@musc.edu

An Open-Label, Long-Term Safety Study of A Long-acting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone Deficiency The VISTA Study: Versartis Long-Term Safety Study of Somavaratan Save

Date Added
February 28th, 2017
PRO Number
Pro00060869
Researcher
Deborah Bowlby
Keywords
Pediatrics
Summary

This study is designed as a long-term safety study and is a multi-center, parallel dose, open-label study assessing long-term somavaratan administration. It is open to subjects completing a somavaratan clinical study in children with GHD, as well as up to 200 new treatment na

Institution
MUSC
Recruitment Contact
Amanda Blue
843-792-1005
blueae@musc.edu

Treatment of Drug-resistant Pediatric Primary Focal Segmental Glomerulosclerosis Using the Liposorber® LA-15 System Save

Date Added
January 10th, 2017
PRO Number
Pro00059528
Researcher
Katherine Twombley
Keywords
Blood Disorders, Kidney, Pediatrics
Summary

A device called the ?Liposorber LA-15 System? has been approved by the United States Food and Drug Administration for treating kids with focal segmental
glomerulosclerosis (FSGS). The ?Liposorber LA-15 System? can only be used if other treatment options, like drugs, don?t work or can?t be used, but the kidneys are still working okay. It can also be used if the subject has had a kidney transplant and the FSGS comes back after the transplant. Although the Liposorber System can be used for FSGS, we are not sure how well the Liposorber System works. So, we are doing this study to find out how well the treatment works.

In this research study, there will be up to 5 children who have FSGS enrolled at MUSC. Subjects will come back for up to 12 treatments over 9 weeks and then 5 visits to their study doctor over the next 2 years.

Institution
MUSC
Recruitment Contact
Katherine Twombley
843-792-8904
twombley@musc.edu

A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention Save

Date Added
December 13th, 2016
PRO Number
Pro00058654
Researcher
Andrew Atz
Keywords
Cardiovascular, Drug Studies, Pediatrics
Summary

This is a prospective, randomized, open-label, Phase II, multi-center clinical trial for pediatric subjects with congenital or acquired heart disease who are on blood thinners. Subjects will be assigned by chance (2:1) to apixaban,vitamin K antagonist or low molecular weight heparin.

Recruitment will start first for subjects 2 years old to less than 18 years old. Recruitment for subjects from 0 to less than 2 years of age will be delayed until study data from the 2 to less than 18 years of age is analyzed.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

Pathogen Identification in Pediatric Hematopoietic Stem Cell Transplant Patients with Suspected Lower Respiratory Tract Infection Save

Date Added
December 6th, 2016
PRO Number
Pro00060294
Researcher
Michelle Hudspeth
Keywords
Adolescents, Children's Health, Immune System, Lung, Pediatrics, Transplant
Summary

This study is for patient that have been diagnosed with suspected lower respiratory tract infection. The purpose of this study is to evaluate a new test that may be able to find more lung infections than current tests can. This new test is called next-generation sequencing and looks in respiratory secretions for bacteria, viruses, fungi, and other organisms that may cause infection. We hope to learn more about the usefulness of this new test in identifying infections.

Institution
MUSC
Recruitment Contact
Thomas Hortman
864-792-9579
hortman@musc.edu

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