Treatment of Drug-resistant Adult and Pediatric Primary Focal Segmental Glomerulosclerosis Using the LIPOSORBER® LA-15 System

Date Added
January 10th, 2017
PRO Number
Pro00059528
Researcher
Katherine Twombley

List of Studies


Keywords
Blood Disorders, Kidney, Pediatrics
Summary

A device called the "Liposorber LA-15 System" has been approved by the United States Food and Drug Administration for treating kids with focal segmental
glomerulosclerosis (FSGS). The "Liposorber LA-15 System" can only be used if other treatment options, like drugs, don't work or can't be used, but the kidneys are still working okay. It can also be used if the subject has had a kidney transplant and the FSGS comes back after the transplant. Although the Liposorber System can be used for FSGS, we are not sure how well the Liposorber System works. So, we are doing this study to find out how well the treatment works.

In this research study, there will be up to 5 children who have FSGS enrolled at MUSC. Subjects will come back for up to 12 treatments over 9 weeks and then 5 visits to their study doctor over the next 2 years.

Institution
MUSC
Recruitment Contact
Katherine Twombley
843-792-8904
twombley@musc.edu

INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure (INVESTED)

Date Added
October 18th, 2016
PRO Number
Pro00059616
Researcher
Bhavadharini Ramu

List of Studies


Keywords
Cardiovascular, Heart, Vaccine
Summary

INVESTED is a multi-site trial comparing high-dose (60 μg per vaccine viral strain) trivalent influenza vaccine to standard-dose (15 μg per viral strain) quadrivalent influenza vaccination for up to three influenza seasons in high-risk cardiovascular disease patients with a history of myocardial infarction in the previous 12 months OR history of heart failure hospitalization in the previous 24 months. Subjects will be randomly assigned to receive either the high-dose or standard-dose vaccine.

Institution
MUSC
Recruitment Contact
Ricardo Cantu
843-792-8894
cantur@musc.edu

The HEART Pathway: a learning health system project, translating evidence to practice across the Carolinas

Date Added
October 14th, 2016
PRO Number
Pro00059813
Researcher
Christine Carr

List of Studies


Keywords
Coronary Artery Disease, Heart
Summary

Current care patterns for patients with acute chest pain fail to provide optimal quality and value. To avoid missing acute
coronary syndrome (ACS), emergency physicians hospitalize >50% of patients who present to the Emergency Department with
chest pain. However, <10% are ultimately diagnosed with ACS, and this pervasive overtriage
costs $1013
billion annually.
The HEART Pathway, which was developed at Wake Forest Baptist Health (WFBH), is designed to improve care for patients with
chest pain. It uses a validated clinical decision aid and serial troponin measures to provide realtime
decision support to providers.
In our prior studies, the HEART Pathway decreased hospitalizations, stress testing, and hospital length of stay, without
increasing adverse events. These studies led to a learning health system project in collaboration with insurers, in which the
HEART Pathway was fully integrated into the WFBH EHR. Preliminary results demonstrate further reductions in hospitalizations
and stress testing. Given WFBH's success with the HEART Pathway, the next logical step is regional dissemination.
This project will leverage Carolinas Collaborative infrastructure to collect data specific to the HEART Pathway from all 4 health
systems, establishing rates of healthcare utilization and ACS outcomes for Emergency Department patients with chest pain in
the Carolinas. In addition, we will engage key stakeholders at each health system to develop an implementation strategy. This
proposal builds on our prior work and will provide pilot data essential for a larger grant application that will support rigorous
testing and implementation of the HEART Pathway across Carolinas Collaborative health systems.

Institution
MUSC
Recruitment Contact
Christine Carr
843-792-5038
carrc@musc.edu

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

Date Added
June 23rd, 2016
PRO Number
Pro00056522
Researcher
Frances Woodard

List of Studies


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

Comparative Effectiveness of Pulmonary Embolism Prevention after Hip and Knee Replacement: Balancing Safety and Effectiveness

Date Added
April 19th, 2016
PRO Number
Pro00053742
Researcher
Vincent Pellegrini

List of Studies


Keywords
Drug Studies, Joint
Summary

PEPPER is a randomized study comparing the three most commonly used blood thinners in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The blood thinners being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

Institution
MUSC
Recruitment Contact
Monica Baczko
843-792-8169
baczko@gmail.com

Intacs Inserts-Prescription Inserts for Treatment of Patients with Keratoconus (HDE)

Date Added
November 17th, 2015
PRO Number
Pro00046816
Researcher
Karolinne Rocha

List of Studies


Keywords
Vision/ Eye
Summary

Intacs® Corneal Implants is a FDA Humanitarian Use Device (HUD) designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus.

Institution
MUSC
Recruitment Contact
Carol Bradham
843-792-2338
bradhamc@musc.edu

Observational Study for Pediatric Rheumatic Diseases: The CARRA Registry

Date Added
November 3rd, 2015
PRO Number
Pro00048606
Researcher
Natasha Ruth

List of Studies


Keywords
Arthritis, Autoimmune disease, Fibromyalgia, Lupus, Pediatrics, Rheumatoid, Sarcoidosis, Scleroderma
Summary

The purpose of this study is to create and maintain a registry, which is a database (a searchable collection of information) about children, adolescents and young adults with pediatric onset of rheumatic diseases. This data may help in the evaluation of the safety and benefit of medications that are prescribed to patients who have rheumatic diseases.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-8317
wakefies@musc.edu

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation

Date Added
October 13th, 2015
PRO Number
Pro00048303
Researcher
Praneeth Baratam

List of Studies

Keywords
Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for patients that have been diagnosed with acute myelogenous leukemia (AML) . The investigational drug in this study is AG-120. The purpose of this study is to identify and test the highest dose of AG-120 that can be given safely. Participants can expect to be in the study for as long as the study doctor feels it is in the participants best interest.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

Operant down-conditioning of the soleus H-reflex in spastic hemiparesis after stroke

Date Added
October 6th, 2015
PRO Number
Pro00048307
Researcher
Aiko Thompson

List of Studies


Keywords
Nervous System, Rehabilitation Studies, Stroke
Summary

Reflexes are important parts of our movements. When reflexes are not working well, movements are clumsy or even impossible. After stroke, reflex responses may change. Researchers have found that people can learn to increase or decrease a reflex response with training. Recently, we have found that rats and people with partial spinal cord injuries can walk better after they are trained to change a spinal cord reflex. Thus, learning to change a reflex response may help people recover after a nervous system injury. In this study, we aim to examine whether learning to change a spinal reflex through operant conditioning training can improve movement function recovery in people after stroke or other damage to the nervous system.

Institution
MUSC
Recruitment Contact
Blair Dellenbach
843-792-6313
stecb@musc.edu

Apathy in Dementia Methylphenidate Trial 2 (ADMET 2)

Date Added
September 23rd, 2015
PRO Number
Pro00043151
Researcher
Jacobo Mintzer

List of Studies


Keywords
Aging, Alzheimers, Brain
Summary

With this research study, we want to learn if methylphenidate (Ritalin® and others) helps people with Alzheimer's disease and apathy (lack of interest or concern for things that others find moving or exciting).

Institution
MUSC
Recruitment Contact
Allison Lapp
843-724-2302
Allison.Lapp@rsfh.com



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