Pharmacokinetics of Multiple Dose Methadone in Children Save

Date Added
December 2nd, 2014
PRO Number
Pro00029787
Researcher
Andrew Atz
Keywords
Children's Health, Drug Studies, Pediatrics
Summary

Selection of the correct drug dose is the most important decision in assuring optimal pharmacotherapy. Defining an optimal regimen requires a clear understanding of the drug’s PK, pharmacodynamics (PD), and for methadone, pharmacogenomic profiles. Understanding these characteristics for drugs used in children is imperative to determine optimal dose regimens across the pediatric age continuum.

Institution
MUSC
Recruitment Contact
Hibah Al Nasiri
843-792-0080
alnasiri@musc.edu

Pressure Volume Loop Analysis in Fontan Patients Save

Date Added
December 2nd, 2014
PRO Number
Pro00021772
Researcher
Ryan Butts
Keywords
Adolescents, Children's Health, Heart, Pediatrics
Summary

The goal of this study is to better understand single ventricle circulation after its final palliation, the Fontan procedure. Each specific aim of the project directly affects current knowledge and/or aids future research in this population. In regards to Aim1, a better understanding the impaired responses to stress in single ventricle circulation will help direct future research on ways to improve quality of life as well as help direct medical and surgical therapies in this population. In regards to Aim 2, the mechanism that leads to improved exercise capacity with PDE5 inhibition will be elucidated. These three aims all compliment the overall goal of understanding the mechanisms that lead to heart failure in this high risk population.

Institution
MUSC
Recruitment Contact
Ryan Butts
843-792-9146
butts@musc.edu

CureGN: Cure Glomerulonephropathy Network Save

Date Added
December 2nd, 2014
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 on dialysis, or 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 Patton
843-792-9454
tecklenb@musc.edu

Ketamine in Chronic Kid’s Pain Save

Date Added
November 4th, 2014
PRO Number
Pro00019935
Researcher
Amy-lee Bredlau
Keywords
Children's Health, Pain
Summary

We now know that oral ketamine is safe in children with chronic pain, but we do not know which dose (if any) has the potential to control chronic pain in children. This study is a randomized, placebo-controlled, double blinded study that is designed to select the most appropriate dosage of oral ketamine for development as a medicine for control of chronic pain in children. Once this dosage is selected, oral ketamine can be further developed for control of chronic pain in children.

Institution
MUSC
Recruitment Contact
Patricia Infinger
843-792-7857
infingep@musc.edu

Effectivness of Heliox as adjunct therapy with High Flow Nasal Cannula(HFNC) in Children with Respiratory Distress Save

Date Added
October 23rd, 2014
PRO Number
Pro00028732
Researcher
Mary Cantrell
Keywords
Asthma, Breathing, Children's Health, Pediatrics, Pulmonary
Summary

Children admitted to PICU with respiratory distress that require HFNC therapy will be eligible for entery. Patients will be randomly assigned into 2 arms of study. One arm will be standard oxygen therapy delivered via HFNC. Second arm will be HFNC with Heliox added. Patients heart rate, respiratory rate, O2 saturations, FIO2 and modified pulmonary Index score(mpis) distress score will be recorded at treatment intervals.

Institution
Spartanburg
Recruitment Contact
kim Cantrell
864-809-2875
mcantrell@srhs.com

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

Date Added
September 17th, 2014
PRO Number
Pro00011449
Researcher
Ilka Theruvath
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

A MULTICENTER, OBSERVATIONAL REGISTRY OF PEDIATRIC FEMALE PATIENTS WITH CENTRAL PRECOCIOUS PUBERTY RECEIVING SUPPRELIN® LA (HISTRELIN ACETATE), A HYDROGEL SUBCUTANEOUS IMPLANT PROTOCOL NO.: EN3326-403 Save

Date Added
September 8th, 2014
PRO Number
Pro00027444
Researcher
Deborah Bowlby
Keywords
Children's Health
Summary

This is a Phase IV multicenter, observational study of 100 pediatric female patients with CPP being treated with SUPPRELIN LA.Sites will extract relevant historical study information from the patients' medical charts and will enter data into an electronic data collection (EDC) system. Additional study information will be collected at the time of routine clinical visits (standard of care)and/or by telephone contact to obtain date of menses. (No study procedures are to be performed only data collection)

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

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

Date Added
September 2nd, 2014
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 4 Year Blinded-Outcomes Follow up Study of Patients Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-204 Save

Date Added
August 26th, 2014
PRO Number
Pro00029095
Researcher
Carol Wagner
Keywords
Children's Health, Infant
Summary

This is a multicenter 48-52 month blinded-outcomes follow up study of subjects who received stannsoporfin or placebo in clinical trial 64,185-204. This clinical trial consists of clinic visits over 4 year period. The developmental tools used in this trial will identify children who are developmentally delayed or at risk for delay.

Institution
MUSC
Recruitment Contact
Deanna Fanning
843-792-7021
fanningd@musc.edu

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

Date Added
August 5th, 2014
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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