Improving Health Through Implementation of a Village-Based Complex Biogas System Save

Date Added
August 19th, 2014
PRO Number
Pro00034850
Researcher
Cynthia Swenson
Keywords
Children's Health, Disease Prevention, Men's Health, Women's Health
Summary

Lack of proper sanitation is one of the most significant and widespread health hazards in low and middle- income countries (LMIC). By the end of 2011, 2.5 billion people lacked access to hygienic means of personal sanitation. Further, 1 billion people (15% of the world’s population) lacked access to any facility and engaged in open defecation, a practice carrying enormous health risks. The problem is so widespread and life threatening that the United Nations identified improved sanitation in its millennium development goals for LMIC. One safe and environmentally sensitive solution that addresses the issue of human waste containment is a waste-to- energy system called a biogas system. Waste management biogas systems exist in Ghana but predominantly in large institutions; they have not been implemented in economically disadvantaged, rural communities (Bensah & Brew-Hammond, 2010). In fact, few sanitation systems of any kind exist in rural Ghana where the majority of the nation’s most economically disadvantaged live. The rural village of Okurase in the eastern region of Ghana and its supporting NGO have a longstanding relationship with MUSC. They propose to implement a biogas system that would reduce open defecation, reduce the use of charcoal and wood in cooking, and reduce the use of heavy chemicals in farming. A physicist and engineer have developed a method using a 3-prong approach that can be installed in the village. The Okurase Biogas System will include a private building with toilets. Human waste enters a chamber where it is converted to gas. This gas is harnessed as a dual energy source for cook stoves and organic fertilizer. The Chief and Elders of the village have embraced this technology and support its implementation. More information is needed to learn how to promote uptake of such a system by village residents. Therefore, in line with the overall goals for this village of developing a sustainable infrastructure to improve water, sanitation, health, economic self-sufficiency and food security in Okurase, the specific aims of this application are to: 1) determine the feasibility and acceptability of the biogas system; 2) assess the attitudes and knowledge of biogas technology over time; and, 3) determine factors that promote or preclude system sustainability.

Institution
MUSC
Recruitment Contact
Sarah Logan
843-693-2233
logans@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

The Role of Minimal Residual Disease Testing before and after Hematopoietic Cell Transplantation for Pediatric Acute Myeloid Leukemia Save

Date Added
May 6th, 2014
PRO Number
Pro00011017
Researcher
Michelle Hudspeth
Keywords
Adolescents, Cancer, Cancer/Leukemia, Children's Health, Infant, Pediatrics, Transplant
Summary

This study is being offerred to patients that have acute myelogenous leukemia (AML) which is a cancer of the blood and these patients are going to have a stem cell transplant. This study is looking to determine how accurate two different laboratory tests are at detecting residual, or small numbers of cancer cells in the body before and after stem cell transplant, as well as whether or not results of these two tests show how well a recipient might do after transplant.

Institution
MUSC
Recruitment Contact
Karen Rogers
843-792-2740
rogersk@musc.edu

A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients Save

Date Added
May 6th, 2014
PRO Number
Pro00017387
Researcher
Jennifer Jaroscak
Keywords
Cancer, Children's Health, Men's Health, Minorities, Pediatrics, Transplant, Women's Health
Summary

This study if for patients that have a blood disease and it's been determined that the best option for treating that blood disease is a cord blood transplant. Cord blood (CB) is blood that is taken from the umbilical cord and placenta of healthy newborn babies after childbirth. The cord blood collected from a newborn baby is called a cord blood unit. The United States Food and Drug Administration (FDA) considers cord blood to be a biological drug. These are considered “investigational” products. This study will evaluate the safety of administration of the investigational cord blood units by carefully documenting all infusion-related problems.

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

The Development and Preliminary Reliability Study of the Pediatric Sensory Modality Assessment and Rehabilitation Techniques (SMART) Save

Date Added
May 6th, 2014
PRO Number
Pro00034042
Researcher
Cynthia Dodds
Keywords
Brain, Children's Health, Hearing, Vision/ Eye
Summary

The purpose of this project is to develop and test preliminary reliability 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. Seven children, between the ages of 3-12 years, with physician-documented severe brain damage and considered medically stable are needed for this study. Recruitment flyers will be disseminated at 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 the preliminary Pediatric SMART reliability. Once reliability has been substantiated for the Pediatric SMART in further and future 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

GECHO Trial: Genetic Determinants of Congenital Heart Disease Outcomes Save

Date Added
May 6th, 2014
PRO Number
Pro00016329
Researcher
Andrew Atz
Keywords
Cardiovascular, Children's Health, Genetics, Heart, Pediatrics
Summary

Genetic Testing of neonates undergoing surgery for single ventricle cardiac defects (SVCD) and other congenital cardiac defects. DNA testing with an aim to identifying genetic factors that aid survival and recovery in SCD patients.

Genetic contribution to patient outcomes: Over the past two decades, there has been dramatic improvement in the survival and functional outcome of patients with all forms of congenital cardiac defects. Yet, there exists significant variability in outcomes that becomes more pronounced as the level of surgical intervention increases and the exposure to adverse hemodynamic conditions becomes more prolonged and more profound. This is particularly noticeable in the SCD patient group where there are continued high levels of mortality and levels of disability that can be quite severe. While these poor outcomes can on occasion be attributed to technical difficulties, complex cardiac anatomy or patient co-morbidities, more commonly they occur in patients that do not superficially appear to be any different than those that will ultimately have excellent outcomes. What is becoming increasingly apparent is that every patient differs in their ability to tolerate the challenges presented by the peri-operative environment. Therefore, significant improvements in outcomes may depend on identification of the genetic factors that place some patients at greater risk and designing treatment protocols to minimize those risks.

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

Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections (ABS01) Save

Date Added
April 1st, 2014
PRO Number
Pro00030944
Researcher
Andrew Atz
Keywords
Children's Health
Summary

The most commonly used drugs in infants with complicated intra-abdominal infections are not labeled for use in this population because safety and efficacy data are lacking. The proposed study will provide the safety information required for labeling. In addition, the PK of the study drugs has been or will be characterized in premature infants under an IND mechanism.

Institution
MUSC
Recruitment Contact
Hibah Al Nasiri
843-792-7857
alnasiri@musc.edu