Efficacy of Surgery in Treating Children with Idiopathic Constipation who are "Refractory to Medical Management" Save

Date Added
February 3rd, 2016
PRO Number
Pro00042654
Researcher
James Glasser
Keywords
Autism, Children's Health, Digestive System, Nutrition, Pain, Surgery
Summary

There are three operations that can be offered to children with idiopathic constipation refractory to medical management:
1. insertion of a tube into the cecum or the appendix for antegrade enemas.
2. removal of the sigmoid colon (if it is redundant).
3. removal of the rectum and sigmoid colon, if they are grossly dilated.
The later two options are difficult operations that carry the risk of an anastomotic leak that may be life threatening. Is it justified to assume this risk in treating a benign disease?

Institution
Palmetto
Recruitment Contact
Martin Durkin
803-434-6963
martin.durkin@palmettohealth.org

Gendered Racial Factors in Girls? Self-Regulation, Drug, and Behavior Disparities Save

Date Added
February 2nd, 2016
PRO Number
Pro00051830
Researcher
Colleen Hallidayboykins
Keywords
Adolescents, Children's Health, Education, Healthy Volunteer Studies, Mental Health, Minorities, Substance Use, Women's Health
Summary

The purpose of this study is to understand factors contributing to managing emotions, behavior problems, and substance use among girls. Middle school adolescent girls will be asked about their thoughts and feelings about themselves and their ethnic group, perceptions, and discrimination. They will also report on their behavior and substance use. Their reactions to recent incidents of unfair treatment or disciplinary action will also be assessed.

Institution
MUSC
Recruitment Contact
Jennifer Powell
843-876-0567
smithjl@musc.edu

Validation of the Pediatric Sensory Modality Assessment and Rehabilitation Technique (SMART) Save

Date Added
December 1st, 2015
PRO Number
Pro00048514
Researcher
Cynthia Dodds
Keywords
Brain, Children's Health, Hearing, Vision/ Eye
Summary

The purpose of this project is to study validity of a newly developed pediatric tool, the Pediatric Sensory Modality Assessment and Rehabilitation Techniques (SMART), which will measure cognitive awareness for children with severe brain damage. Thirty children, between the ages of 3-21 years, with physician-documented severe brain damage and considered medically stable are needed for this study. Recruitment flyers will be disseminated at iHope (school serving children with severe disabilities) in NY, NY, MUSC and the greater Charleston area community to recruit parents/legal guardians of children with severe brain damage. Once parental/legal guardian and physician consents are in place, participants will be evaluated using the Pediatric SMART 5 times within 10 days. The Pediatric SMART is made up of 5 domains that are olfactory, visual, auditory and vestibular, gustatory, and tactile. Test administration requires approximately 1 hour and can be completed in settings convenient for parents/legal guardians. The potential benefit to study participants is that the findings from the Pediatric SMART may identify sensory and motor strengths of participants. Knowledge of these strengths may enhance current rehabilitation and treatment plans, which may lead to functional improvements; although, this cannot be guaranteed. It is a goal of this study to evaluate Pediatric SMART validity. Once validity has been substantiated for the Pediatric SMART by means of further study, future children with severe brain injury, being evaluated with the Pediatric SMART, may have rehabilitation and treatments opportunities that are better informed, leading to greater improvement in functional and participatory outcomes.

Institution
MUSC
Recruitment Contact
Cynthia Dodds
843-792-5731
doddscb@musc.edu

Role of White Matter Tracts and Gray Matter Centers in X-linked MCT8 Transporter Deficiency, Assessed by Dedicated Magnetic Resonance Imaging and Clinical Correlation Save

Date Added
November 3rd, 2015
PRO Number
Pro00048044
Researcher
Maria Matheus
Keywords
Adolescents, Brain, Children's Health, Healthy Volunteer Studies, Pediatrics
Summary

The purpose of the study is to assess and qualify the clinical phenotype as well as adequately classify the motor component of the X-linked MCT8 transporter deficiency syndrome by performing neurological exams and MRI imaging of subjects with the MCT8 transporter deficiency and MRI imaging of age matching control patients. A total of 12 well-documented MCT8 deficiency patients and 20 age matching control subjects are expected to be recruited over a two year period fo this proposed study.

Institution
MUSC
Recruitment Contact
Corie Lynn
843-792-8874
lynnc@musc.edu

A PROSPECTIVE OBSERVATIONAL ANALYSIS OF NEAR VISION IN MONOFOCAL PSEUDOPHAKIC CHILDREN Save

Date Added
August 12th, 2015
PRO Number
Pro00037499
Researcher
Marion Wilson
Keywords
Children's Health, Pediatrics, Vision/ Eye
Summary

We propose a prospective observational analysis of near visual acuity and stereopsis in pseudophakic children. Visual acuity analysis will be standardized based on age per PEDIG protocols. Results will be stratified by age and by monocular versus binocular surgery. Children will be assessed in their appropriate corrective lenses to control for myopia as a confounding factor. Refractive error will be measured to optimize visual acuity measurement and assess for the potential role of astigmatism in preservation of near visual function.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Analysis of genetic variant and treatment based variations in infants at risk for retinopathy of prematurity (ROP) Save

Date Added
July 31st, 2015
PRO Number
Pro00041164
Researcher
Richard Saunders
Keywords
Children's Health, Genetics, Infant, Vision/ Eye
Summary

Infants born early who are in the neonatal intensive care unit will be included if they meet national guidelines for retinopathy of prematurity (ROP) screening exams. Informed consent will be given to the parent(s) or legal guardians. 1.5-2 ml of blood will be drawn from a vein when the child is enrolled in the study and may be drawn again if the child requires treatment of eye disease. A cheek swab will also be obtained. These biologic samples will be shipped overnight to the University of Utah for genetic analysis. Analysis will determine if a change in gene expression causes retinopathy of prematurity. Infants enrolled in the study will be followed clinically per established ROP screening guidelines. They will not require additional study exams.

Institution
MUSC
Recruitment Contact
Kinsey Shirer
843-792-2799
evanssa@musc.edu

Parents' perceptions of NCU discharge and infant readiness in transitional care Save

Date Added
May 18th, 2015
PRO Number
Pro00042954
Researcher
Bethany Carlos
Keywords
Children's Health, Pediatrics
Summary

Parents who have infants in the MUSC NCU will be asked to give their opinions about the discharge process as their infants transition from receiving hospital care to being cared for at home. The parents will complete surveys and interviews to offer their feedback. The parents' opinions will be compared with the infant's unexpected readmission to the hospital after discharge, if it occurred. Parents will also decide what is most important for a successful discharge of the infant. The factors that parents consider to be most important will also be compared to which factors nurses find to be important.

Institution
MUSC
Recruitment Contact
Bethany Carlos
803-556-8332
carlosb@musc.edu

Validation of the Residual Lesion Score for Congenital Heart Surgery Save

Date Added
April 14th, 2015
PRO Number
Pro00042799
Researcher
Eric Graham
Keywords
Children's Health, Heart, Infant, Pediatrics, Surgery
Summary

This multi-center prospective study will validate the RLS as a tool to predict early and mid-term outcomes for five common congenital cardiac operations. The RLS study will develop the first validated tool for measurement of residual lesions following congenital heart surgery. The proposed project will also lay the groundwork for future projects, facilitating continuous quality improvement in congenital heart surgery.

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

A Randomized Clinical Trial Comparing The Overall Adverse Event Rate Of Inguinal Hernia (IH) Repair Prior To NICU Discharge Versus IH Repair After NICU Discharge And Beyond 55 Weeks Post Conceptual Age In Premature Infants. Save

Date Added
March 17th, 2015
PRO Number
Pro00041985
Researcher
Aaron Lesher
Keywords
Children's Health, Surgery
Summary

The Hernia in Premies (HIP) Trial is a multi-site randomized clinical trial that is comparing two accepted treatment choices, surgery before or after neonatal intensive care unit (NICU) discharge, for inguinal hernia (IH) repair in premature infants. The reason we are doing this study is that surgeons and neonatologists currently do not know the best time to perform the hernia repair. Some providers recommend having the hernia fixed before discharge from the neonatal intensive care unit (NICU) and some believe waiting until after NICU discharge is better. Both treatments are standard options for IH repair in premature infants. Also, all babies that have IH repair receive anesthesia. We also do not know if the age of the child receiving anesthesia affects neurodevelopment. We are comparing the timing of anesthesia exposure between the two treatments (IH repair before or after NICU discharge) to help answer these questions.

By volunteering to take part in the HIP Trial, your child will be randomly assigned to have the operation before or after NICU discharge. This means that the timing of the repair operation will be determined by chance, like flipping a coin, and he/she has an equal chance of being treated before or after NICU discharge. We will be collecting information about your baby and the treatment that he or she receives, and how your baby recovers before and after the surgery. We will also collect information about your baby from clinic notes and results from your baby?s routine 2 year follow-up neurodevelopmental testing, where your child will be asked questions that measure cognitive, language, social and motor development. We will stop collecting information about your baby and your participation will end when your child is 2 years old. There are no extra medical tests or blood work being done for research purposes in the HIP trial.

Institution
MUSC
Recruitment Contact
Aaron Lesher
843-792-3853
leshera@musc.edu

A Randomized, Double-Blind, Efficacy and Safety Study of AR 14 (AZILSARTAN MEDOXOMIL) Treatment and Withdrawal, Followed by an Open-Label Extension, in Children 6 to Less Than 18 Years of Age With Hypertension Save

Date Added
January 13th, 2015
PRO Number
Pro00039004
Researcher
Melissa Henshaw
Keywords
Adolescents, Children's Health, Hypertension/ High Blood Pressure, Pediatrics
Summary

This research study is for children between 6 years and 18 years of age who have been diagnosed with hypertension, or high blood pressure. Hypertension or high blood pressure is when someone?s blood vessels, called arteries, tighten too much. The study lasts 12 months and could involve up to 17 study visits. Compensation is available.

The main purpose of this study is to find out if the study drug, Azilsartan medoxomil (also called AZM, TAK-491, or AR14) is effective in controlling blood pressure in children 6 to less than 18 years of age and to find out if it is safe and well tolerated in this age group compared to placebo. The safety and effectiveness of AZM in children less than 18 years of age have not yet been established and currently are under investigation in the age group 1 to 17 years. This means it does not currently have FDA approval for use in children and adolescents.

Another purpose of the study is to compare a drug called losartan potassium (Cozaar) to AZM. Cozaar is an FDA approved drug that is used to treat high blood pressure in adults and children

Institution
MUSC
Recruitment Contact
Anna Tecklenburg
843-792-9454
tecklenb@musc.edu

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