eACT (epilepsy: Adherence in children and technology) Save

Date Added
May 4th, 2019
PRO Number
Pro00087259
Researcher
Janelle Wagner

List of Studies

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Keywords
Children's Health, Epilepsy, Pediatrics
Summary

The aim of this multi-site study is to evaluate the effectiveness of mHealth intervention strategies for improving anti-epileptic drug adherence in caregivers of young children with epilepsy. A 2-month baseline period will be followed by two stages. In Stage 1 (3-months), caregivers will received either 1) a mHealth education module and automated digital reminders or 2) the mHealth education module, automated digital reminders, and individualized adherence feedback based. In Stage 2 (2-months), caregivers will either receive 1) continued individualized adherence feedback or 2) individualized adherence feedback and a mHealth problem-solving module. The primary outcome is electronically-monitored adherence. Secondary outcomes include seizure severity/frequency, quality of life and healthcare utilization.

Institution
MUSC
Recruitment Contact
Millie Griffin
843-792-4653
grifm@musc.edu

Fear regulation, executive functioning, and child trauma exposure: A study on psychological risk and resilience in youth Save

Date Added
January 4th, 2019
PRO Number
Pro00082705
Researcher
Ashley Howell

List of Studies

Silhouette
Keywords
Children's Health, Mental Health
Summary

The purpose of this study is to gain a better understanding of how stressful life experiences and learning styles impact threat reactivity in childhood. Children that experience highly stressful situations are at risk for diverse mental health concerns, including anxiety and depressive disorders and PTSD.There may be certain periods of time in development that this risk is heightened. By studying the mechanisms underlying threat response, we hope to better predict short-term and long-term effects of stress and trauma in youth, as well as inform and improve clinical care.

Institution
MUSC
Recruitment Contact
Ashley Howell
843-792-2946
howeash@musc.edu

AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF DUPILUMAB IN PATIENTS ?6 MONTHS TO <18 YEARS OF AGE WITH ATOPIC DERMATITIS Save

Date Added
November 13th, 2018
PRO Number
Pro00076016
Researcher
Lara Wine lee

List of Studies

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Keywords
Children's Health, Skin
Summary

This is a clinical research trial that will evaluate whether an investigational drug called dupilumab (given by injection) is safe and effective in children with severe atopic dermatitis.

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
dermresearch@musc.edu

Detecting the Pathophysiology that Drives Fontan-associated Liver Disease Save

Date Added
October 5th, 2018
PRO Number
Pro00077466
Researcher
Joshua Kurtz

List of Studies

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Keywords
Adolescents, Cardiovascular, Children's Health
Summary

The purpose of this study is to evaluate causes and risk factors for liver disease in those whom have 1) undergone the Fontan procedure or 2) whom have dilated cardiomyopathy.

Participants in this study will have a blood sample collected, undergo cardiac magnetic resonance imaging (CMR), a liver magnetic resonance imaging (MRI), shear wave ultrasound elastography (SWE), echocardiography, liver Doppler ultrasound, and an exercise stress test. Participants medical records will be reviewed to collect information on previous medical procedures. Participation is complete once all imaging studies and blood sample have been collected.

This is not a treatment study; if one chooses not to participate, s/he will continue to undergo regularly scheduled clinical procedures.

Institution
MUSC
Recruitment Contact
Joshua Kurtz
843-834-0972
kurtzj@musc.edu

A PHASE 2/3 STUDY INVESTIGATING THE PHARMACOKINETICS, SAFETY, AND EFFICACY OF DUPILUMAB IN PATIENTS AGED ?6 MONTHS TO <6 YEARS WITH SEVERE ATOPIC DERMATITIS Save

Date Added
May 8th, 2018
PRO Number
Pro00074957
Researcher
Lara Wine lee

List of Studies

Silhouette
Keywords
Children's Health, Skin
Summary

This study is being conducted to determine how safe and effective an investigational drug called dupilumab (REGN668) is in reducing the signs and symptoms of eczema. This drug is investigational in that it is not yet approved by government agencies, such as the US Food and Drug Administration (FDA) for the treatment of children. Dupilumab is, however, approved by the FDA for the treatment of AD in adult patients.
Your child's participation in this study will require 8 visits to the study center over 3 months.

As part of this study, your child will have a physical exam, blood testing and an electrocardiogram or electrical testing of the heart performed. They will also be given the study drug (dupilumab).

Institution
MUSC
Recruitment Contact
Adrian Modzik
843-792-8385
modzik@musc.edu

Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care Save

Date Added
May 7th, 2018
PRO Number
Pro00077156
Researcher
Lisa Knight

List of Studies

Keywords
Children's Health, Infant, Pediatrics
Summary

The majority of drugs administered to children are used off label and PK studies to define appropriate dosing are lacking across pediatric age groups. Challenges associated with clinical trials in children limit the ability to conduct PK and dosing trials in this population. Studies capitalizing on standard of care procedures have proven successful in characterizing the PK of drugs used in children. The purpose of this study is to characterize the PK of understudied drugs administered to children per standard of care as prescribed by their treating caregiver.
This study will serve as a tool to better understand drug exposure in children receiving drugs per standard of care. The data collected through this initiative will provide valuable PK and dosing information drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Institution
Palmetto
Recruitment Contact
Sarah Newman-Norlund
803-216-3377
Sarah.Newman-Norlund@uscmed.sc.edu

Comparison of Length of Stay for Infants with GBS Unknown Mothers with Adequate vs Inadequate Treatment Save

Date Added
April 6th, 2018
PRO Number
Pro00077255
Researcher
Rachel Sigrest

List of Studies

Keywords
Children's Health, Disease Prevention, Infant, Non-interventional, Obstetrics and Gynecology, Pediatrics, Pregnancy, Women's Health
Summary

The primary investigators/residents have noted during clinical rotations that a significant number of GBS unknown mothers at SRHS are being treated with intrapartum antibiotics even without the presence of risk factors, presumably to decrease postpartum/neonatal length of stay.
Our study, a retrospective chart review, will determine whether or not length of stay is affected by treating GBS unknown mothers with intrapartum antibiotics in the absence of the aforementioned risk factors.
Potential benefits include the cost-effectiveness of decreased length of stay for these patients as well as decreased exposure to nosocomial infections for neonates. However, antibiotic stewardship and patient safety are also considerations. Another potential option for these patients is rapid GBS testing with PCR which can provide results in 1-2 hours compared with 24-48 hours for the standard culture. PCR is not currently available at SMC.

Institution
Spartanburg
Recruitment Contact
Rachel Sigrest
8643800885
racheljames1985@gmail.com

A Phase 2, Prospective, Randomized, Open-label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus- Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopoietic Stem Cell Transplant Save

Date Added
February 27th, 2018
PRO Number
Pro00072922
Researcher
Michelle Hudspeth

List of Studies


Profiles_link
Keywords
Cancer, Cancer/Leukemia, Children's Health, Drug Studies, Men's Health, Women's Health
Summary

This study is for subjects who have been diagnosed with acute leukemia or myelodysplastic syndrome (MDS) and are a candidate for allogeneic hematopoietic stem cell transplant (HSCT). The study is being done to learn if adding defibrotide to the standard medicines for prevention of acute Graft-versus-Host Disease (aGvHD), which is called immunoprophylaxis, will help to prevent aGvHD better than using the usual immunoprophylaxis medicines alone. The investigational drug in this study is called Defibrotide. The duration of participation for each patient is approximately 6 months.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Effectiveness of continuous nebulization treatment of bronchodilation in patient admitted to PICU diagnosed with acute bronchiolitis Save

Date Added
February 15th, 2018
PRO Number
Pro00073193
Researcher
Sami Rishmawi

List of Studies

Keywords
Children's Health, Infant
Summary

Bronchiolitis is broadly defined as a clinical syndrome that occurs in children < 2 years of age and is characterized by upper respiratory symptoms followed by lower respiratory infection with inflammation, which results in wheezing and or crackles (rales). Bronchiolitis typically is caused by viruses. In ICU setting, the standard therapy of patient presents with acute bronchiolitis are bronchodilation medications. Recent recommendations of American Academy of Pediatrics stated that no evidence to support usage of any of bronchodilators,The goal of this study is validate the effectiveness of bronchodilators medications.

Institution
Spartanburg
Recruitment Contact
Sami Rishmawi
8642371109
srishmawi@srhs.com

The effect of povidone-iodine ophthalmic surgical prep solution on respiration in children undergoing strabismus surgery with general anesthesia. Save

Date Added
August 15th, 2017
PRO Number
Pro00067331
Researcher
Michelle Rovner

List of Studies


Profiles_link
Keywords
Children's Health, Pediatrics
Summary

This study is being done to study the effect of putting povidone-iodine ophthalmic or balanced saline solutions in the eye has on respirations during strabismus (eye alignment) surgery. Both of these solutions are FDA approved for use in this manner and will be done after patients are under anesthesia. The solution to be used is determined by randomization upon enrollment and will either be 3 drops of povidone-iodine ophthalmic solution in each eye (Group A) or 3 drops of BSS in each eye (Group B). The eye solution intervention period will take less than 5 minutes and will cause either only a slight delay or no delay in the surgical time. The only other intervention is the collection of data after induction (but just prior to IV insertion), as well as before and after the drops of eye solution are delivered.

Institution
MUSC
Recruitment Contact
Wanda Jones
8437921869
joneswr@musc.edu

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