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

Gold-standard Measures of Diastolic Function in Single Ventricle Physiology Prior to Stage 3 Palliation: Correlations with Echocardiography and Relationship to Outcomes Save

Date Added
July 1st, 2014
PRO Number
Pro00034502
Researcher
Shahryar Chowdhury
Keywords
Cardiovascular, Children's Health, Heart, Pediatrics
Summary

In recent decades, the intense interest in the contribution of diastolic dysfunction to adult heart failure has resulted in a number of echocardiographic methods to evaluate diastolic function. To evaluate their accuracy, echocardiographic measurements of diastolic function have been validated with gold-standard measures derived from micromanometer pressure analysis in the adult heart failure population. However, no studies have assessed the accuracy of echocardiographic measures of diastolic function in the single ventricle population. Also, the relationship between echocardiographic measures of diastolic function and outcomes in the single ventricle population – an exercise necessary to determine their clinical usefulness - has not been investigated. The specific aims of this study seek to validate the accuracy and clinical utility of these non-invasive indices in the single ventricle population

Institution
MUSC
Recruitment Contact
Patricia Infinger
803-792-7857
infingep@musc.edu

A multicenter access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) for transplantation in pediatric and adult patients with hematologic malignancies and other indications Save

Date Added
June 17th, 2014
PRO Number
Pro00011805
Researcher
Robert Stuart
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

The primary purposes of this study are to:
•Provide access to cord blood units for recipients whose best choice for a cord blood unit(s) do not meet all FDA standards, but do meet standards set by the NMDP on this study.
•Assess how well and how quickly blood counts return to normal after transplant in recipients on this study.

Institution
MUSC
Recruitment Contact
Jessica Simons
843-792-2708
simonsjl@musc.edu

Prostaglandin Metabolites in Premature Infants Save

Date Added
June 3rd, 2014
PRO Number
Pro00033380
Researcher
Matthew Halliday
Keywords
Cardiovascular, Children's Health, Infant, Pediatrics
Summary

The patent ductus arteriosus (PDA) is a blood vessel that is essential to the life of a fetus while in the womb. However, the PDA can cause significant adverse effects on an infant after he/she is born if the PDA does not close in a matter of days to weeks. Current therapy to treat a PDA in infants inhibits a chemical in the body called prostaglandins which in turn causes constriction and closure of the PDA. Unfortunately the current therapy is not always effective and has significant side effects including damage to the kidneys. Our study will look at prostaglandin levels in the urine of infants before and after treatment to hopefully identify if there is a way to predict who will respond to the current therapy. We will also look at prostaglandin levels in infants who receive Tylenol (acetaminophen) to determine if acetaminophen could be used as a safe alternative to current medical therapy.

Institution
MUSC
Recruitment Contact
Matthew Halliday
843-819-3592
hallida@musc.edu

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