Changes in Optic Nerve Sheath Diameter in Preeclamptic patients with Severe Features by Neurologic Criteria versus Diagnosis Without Neurologic Criteria, Compared to Controls. Save

Date Added
November 7th, 2018
PRO Number
Pro00078977
Researcher
Mary Sterrett
Keywords
Central Nervous System, Hypertension/ High Blood Pressure, Non-interventional, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Preeclamptic patients will have an ultrasound done of their eyes, to look at the size of the nerve behind the eye. We will also recruit women without preeclampsia to be a comparison group.

Institution
MUSC
Recruitment Contact
Mary Sterrett
8434940554
sterretm@musc.edu

VITROS® Immunodiagnostic Products hs Troponin I US Sample Collection Protocol Save

Date Added
May 8th, 2018
PRO Number
Pro00076320
Researcher
Gary Headden
Keywords
Cardiovascular, Heart, Non-interventional
Summary

Roughly 8-10 million patients complaining of chest pain come to an Emergency Department (ED) annually in the United States. Quickly determining if you are having a heart attack is critical for improving your chances of survival. Cardiac troponin is a protein that is used as a biomarker (biological marker) to indicate damage to the heart muscle. Cardiac troponin lab tests that are currently used in the United States do not have the ability to detect low levels of troponin. There are more sensitive troponin tests that are primarily used outside the US, that are able to detect lower levels of cardiac troponin within 90-180 minutes instead of 5 or 6 hours. This allows for the early identification of individuals at a higher risk for heart damage and these patients benefit from early diagnosis and treatment. Delaying the treatment of a heart attack increases the chance of dying or being permanently disabled. This study will collect blood samples from people coming to the Emergency Department complaining of chest pain in order to measure this troponin lab test's ability to accurately detect troponin levels.

Institution
MUSC
Recruitment Contact
Robert Houck
843-792-3576
houckr@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
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

Key informant interviews to facilitate development of adherence tools in solid organ transplant Save

Date Added
March 15th, 2018
PRO Number
Pro00075735
Researcher
Nicole Pilch
Keywords
Heart, Kidney, Liver, Lung, Non-interventional, Transplant
Summary

A sample of patients will be drawn from a cross-sectional cohort of pre- and post-abdominal and cardiothoracic transplant recipients from March 2018 through May 2018. 10 to 15 minute key informant interviews will be conducted with patients to ascertain their views and perceptions related to adherence pre- and post-transplant and use of technolgy. This data will be used to educate the transplant community about adherence from the patient's perspective.

Institution
MUSC
Recruitment Contact
Nicole Pilch
843-792-3702
weimert@musc.edu

Community Talking Circles: Qualitative Research to Document Patient Needs Save

Date Added
November 30th, 2017
PRO Number
Pro00068865
Researcher
Philip Smeltzer
Keywords
Education, Environmental Factors, Healthy Volunteer Studies, Language, Minorities, Non-interventional, Writing
Summary

Focus groups or talking circles are formed in community neighborhoods to facilitate input on common patient experiences. Insights on patient perceptions related to physician office visits and after visit self care are obtained in groups of 8-12 participants.

Institution
MUSC
Recruitment Contact
Philip Smeltzer
843-792-6637
smeltzerp@musc.edu

Evaluation of the CytoRADx SystemTM as a Biodosimeter for Special Human Populations Save

Date Added
July 14th, 2017
PRO Number
Pro00067066
Researcher
Gary Headden
Keywords
Blood Disorders, Children's Health, Environmental Factors, HIV / AIDS, Non-interventional, Pediatrics
Summary

This is a study to develop a test for radiation exposure in the event of a nuclear event such as the detonation of a nuclear device or widespread radiation exposure. We will collect blood samples from a variety of different types of human subjects whose current medical status could possibly have an effect on the results of the test, such as trauma, burns, infections or a damaged immune system or young children. The goal is to ensure that these conditions do not affect the results of the test.

Institution
MUSC
Recruitment Contact
Robert Houck
(843) 792-3576
houckr@musc.edu

Investigating teleconsent to improve clinical research access in remote communities Save

Date Added
July 3rd, 2017
PRO Number
Pro00068715
Researcher
Jihad Obeid
Keywords
Healthy Volunteer Studies, Non-interventional
Summary

The objective of this proposal is to evaluate teleconsent, a novel telemedicine informed consent system, in order to study the advantages of teleconsent, the barriers to its adoption, and its impact on the informed consent process. The goal of this work is to improve the adoption of this technology and improve the overall research process, with reduction in travel burden on research participants and regulatory burden on clinical investigators. Facilitating enrollment into clinical trials will in turn accelerate the development of new treatments.

Institution
MUSC
Recruitment Contact
Nathan Wilson
843-792-8272
wilsonn@musc.edu

Sample Collection for Performance Evaluation for INNOVANCE® Free PS Ag* Save

Date Added
May 25th, 2017
PRO Number
Pro00064923
Researcher
Gary Headden
Keywords
Blood Disorders, Circulation, Non-interventional, Rare Diseases
Summary

Protein S is a protein that is very important to the blood clotting process. When people don't have enough Protein S they run the risk of developing blood clots. This study is collecting samples from people who may have abnormal Protein S levels in order to develop a new way of checking the Protein S levels. This test is looking specifically for FREE Protein S. The free protein S is Protein S that is not bound or "tied up" and is therefore more ready to do its job in the clotting process.

Institution
MUSC
Recruitment Contact
Robert Houck
843-792-3576
houckr@musc.edu

Implementation of a Prospective Financial Impact Assessment Tool in Patients with Metastatic Colorectal Cancer Save

Date Added
July 21st, 2016
PRO Number
Pro00057833
Researcher
James Bearden
Keywords
Cancer, Cancer/Gastrointestinal, Non-interventional
Summary

Studies have shown that cancer patients may be at high risk for financial problems because of the cost of treatment. These financial problems can be stressful and sometimes might cause patients to avoid or refuse treatment. We want to measure how often financial problems happen in patients with colorectal cancer, using questionnaires that collect information about finances and quality of life. In order to get a full picture of the financial impact of colorectal cancer, we also want to collect credit reports for all patients in this study.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

National Pediatric Cardiology Quality Improvement Collaborative (NPC-QIC) - A Collaborative Initiative to Improve Care of Children with Complex Congenital Heart Disease Save

Date Added
June 23rd, 2016
PRO Number
Pro00056522
Researcher
Frances Woodard
Keywords
Cardiovascular, Children's Health, Heart, Infant, Non-interventional
Summary

Transforming health care and outcomes for children with rare diseases is difficult within the current health care system. There is great variation in care delivery, inadequate and slow application of existing evidence, and ineffective use of available data to generate new knowledge. Individual care centers have inadequate numbers of patients for robust learning and improvement. In order to redesign the system, changes must take place at multiple levels, including the patient and family, clinician, practice and the network. The purpose of this project is to design, develop, and test further refinements to an improvement and research network focused on HLHS, the most severe congenital heart defect, and to use a registry to simultaneously improve clinical care, redesign care delivery systems and to conduct quality improvement, health services, outcomes, and comparative effectiveness research. The purpose of this initiative, specifically, is to improve care and outcomes for infants with HLHS by: 1) expanding the established NPC-QIC national registry to gather clinical care process, outcome, and developmental data on infants with HLHS between diagnosis and 12 months of age, 2) improving implementation of consensus standards, tested by teams, into everyday practice across pediatric cardiology centers, and 3) engaging parents as partners in improving care and outcomes. We utilize a quality improvement methodology, known as the adapted learning collaborative model, which expedites the implementation of tools and strategies that facilitate changes such as systematic care coordination, cardiovascular monitoring, and nutritional monitoring into every day practice. The NPC-QIC registry is used to document the impact of these changes on various care processes and outcomes (e.g., mortality rate, readmissions, and weight gain).

Institution
MUSC
Recruitment Contact
Frances Woodard
843-792-3292
klinefl@musc.edu

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