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

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
December 15th, 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

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

CureGN: Cure Glomerulonephropathy Network Save

Date Added
December 1st, 2015
PRO Number
Pro00038759
Researcher
Katherine Twombley
Keywords
Adolescents, Children's Health, Disease Prevention, Kidney, Minorities, Pediatrics, Transplant, Vaccine
Summary

Adult and Pediatric patients with glomerular disease:
Patients of all ages are needed to participate in a research study to investigate glomerular disease and create a worldwide database to help in the research and future treatment of this disease. To join this study, you must have a type of glomerular disease, have had a first kidney biopsy within the last 5 years, not be on dialysis, or not have had a kidney transplant.

The study is projected to last 4 years, and all study procedures will be done at regular clinic visits (between 1 and 3 yearly). Study procedures include filling out questionnaires and a blood draw at each visit.

Compensation is available for study participation.

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

National Validation of the PedsQL-Epilepsy Module Save

Date Added
October 20th, 2015
PRO Number
Pro00036854
Researcher
Janelle Wagner
Keywords
Adolescents, Children's Health, Epilepsy, Pediatrics
Summary

The aim of the current project is to validate the Epilepsy Module of a highly validated and utilized health-related quality of life (HRQOL) measure, the PedsQL™ 4.0. Approximately 400 participants will be recruited to participate in this study across four different sites, including MUSC. We will recruit 100 parent-child dyads at MUSC to complete self-report measures of HRQOL and behavioral functioning. Analyses will be conducted examining the relations between parent-proxy HRQOL and child HRQOL, as well as the relations between HRQOL and medical/demographic variables.

Institution
MUSC
Recruitment Contact
Janelle Wagner
843-792-4620
wagnerjl@musc.edu

Direct Measurement of Tissue Plasmin Activity in Infants and Children Undergoing Cardiothoracic Surgery - a Preliminary Feasibility Study Save

Date Added
September 9th, 2015
PRO Number
Pro00011449
Researcher
Marc Hassid
Keywords
Cardiovascular, Children's Health
Summary

Extensive blood loss and multiple blood transfusions are a major source of patient complications during and after infant cardiac surgery. The activation of the fibrinolytic system (an enzyme sytem that breaks down blood clots) during surgery is thought to be a main cause of blood clot instability in these patients. Although medications that inhibit this system are routinely used, they also display very variable efficacy and can cause serious side effects. The primary hypothesis of this study is that direct measurement of the activation status of the fibrinolytic system directly inside local tissue (e.g. muscle or wound surfaces) will enable physicians to better evaluate the blood clotting ability of a pediatric heart surgery patient and will substantially improve diagnostic accuracy and drug dosing, thereby reducing the observed side effects such as kidney injury and increased risk of thrombosis.

Institution
MUSC
Recruitment Contact
Peggy Edgerton
(843)792-1869
kotlowpe@musc.edu

Gene Discoveries in Subjects with Crohn?s Disease of African Descent Save

Date Added
September 1st, 2015
PRO Number
Pro00034427
Researcher
Jose Quiros
Keywords
Bowel, Children's Health, Crohn's Disease, Digestive System, Ethnicity and Disease, Genetics, Minorities, Pediatrics
Summary

A minimum of 1000 AA subjects with IBD will be recruited in the 4 year period; from Emory, Grady and Children?s Healthcare of Atlanta. And a total of 2500 patients form the collaborating institutions.

The primary investigative design will be a paired case-control study. This study will be similar to other IRB approved protocols in which DNA, serum, are collected from children and adults with and without IBD for the purpose of genotype analysis.

Institution
MUSC
Recruitment Contact
Mohammed Al Gadban
843-792-4837
algadban@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

Technology-Based Tools to Enhance Quality of Care in Mental Health Treatment Save

Date Added
August 4th, 2015
PRO Number
Pro00018673
Researcher
Kenneth Ruggiero
Keywords
Children's Health, Mental Health
Summary

Nearly 9 million U.S. children (1 in 8) meet criteria for at least one mental health disorder at any point in time. Effective treatments exist for these disorders, but children and families who seek services rarely receive them; mental health providers need more support in the delivery of these interventions to ensure that children and families are receiving the best quality care. This project aims to improve the delivery of best practices for families who seek mental health care by developing creative, technology-based resources for providers to enhance the care they already are providing.

Institution
MUSC
Recruitment Contact
Kathryn Soltis
792-7067
soltisk@musc.edu

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