Feasibility of Auricular Acupressure as an Adjunct Treatment for Neonatal Abstinence Syndrome (NAS) Save

Date Added
August 26th, 2019
PRO Number
Pro00089639
Researcher
Heather Jackson

List of Studies

Keywords
Children's Health, Obstetrics and Gynecology
Summary

This study will involve 12 babies who have been identified as at risk for withdrawal symptoms after birth. This study will test the feasibility of acupressure as an additional non-invasive, first line treatment for infants experiencing withdrawal symptoms. We will also send a voluntary survey out to the healthcare providers who cared for the infant (nurse, medical doctor, or advanced practice provider (nurse practitioner or physician assistant).

Institution
MUSC
Recruitment Contact
Heather J Jackson
6156910545
heather.jackson@vumc.org

Managing AsThma AnD Obesity Related Symptoms (MATADORS) study: An mHealth intervention to facilitate symptom self-management among youth Save

Date Added
August 8th, 2019
PRO Number
Pro00090560
Researcher
Michelle Nichols

List of Studies


Profiles_link
Keywords
Adolescents, Asthma, Children's Health, Depression, Obesity, Pain
Summary

Youth with one or more chronic diseases are at increased risk of further complications, disease, or even early death as they enter their adult years. Recent increases in both asthma and obesity among youth have led to high health care utilization, increased health-related complications, and expanded risks of subsequent cardiovascular disease burden. The research team will develop educational content in core areas (e.g., fatigue, physical activity) for Managing AsThma AnD Obesity Related Symptoms (MATADORS), an mHealth technology-enhanced nurse-guided intervention. Youth with asthma and obesity and their primary caregivers will participate in interviews to explore their perspectives on barriers, facilitators, needs, and preferences toward adopting health behaviors, medication adherence, disease awareness, symptom self-management behaviors, and utilization of a mobile smartphone platform. Additional details on content availability, delivery approaches, system needs, and functionality will be explored through semi-structured interview questions. Health care providers (physicians, nurses, nurse practitioners, dietitians, and respiratory and exercise therapists) will be invited to participate in interviews to seek their input on patient-caregiver needs, priority clinical focal areas, recommendations for symptom self-management, and preferences for intervention delivery. Interview findings will be used to inform intervention and app design. Providing youth with strategies to enhance symptom self-management may result in decreased symptom prevalence, improved quality of life, and long-term reduction of cardiovascular morbidity and mortality as they move into adulthood.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843-792-4771
prenticm@musc.edu

eACT (epilepsy: Adherence in children and technology) Save

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

List of Studies

Silhouette
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

Silhouette
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
Shahryar Chowdhury

List of Studies

Silhouette
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

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

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