Multiple Patient Program for Lamprene® (clofazimine) for the treatment of Non-Tuberculous Mycobacterial (NTM) Infections

Date Added
March 21st, 2017
PRO Number
Pro00065207
Researcher
Patrick Flume

List of Studies


Keywords
Nontuberculous mycobacteria (NTM)
Summary

LampreneĀ®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. LampreneĀ®/Clofazimine is approved by FDA (the U.S Food and Drug Administration) for the treatment of leprosy. It is being tested in non-Novartis clinical studies for drug resistant tuberculosis and non-tuberculous mycobacteria (NTM).

If you have been diagnosed with NTM, then your doctor may decide that this infection can be treated with LampreneĀ®/Clofazimine. This medicine is provided to you in an expanded access program. This means that this medicine is not registered for the treatment of NTM, but it can be used in special situations where there are no other possible treatments. For example, this may be because you have a type of Mycobacterial infection that is resistant or failed to respond optimally to other drugs, or because you have had side effects that prevent the use of other drugs.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
8437920965
recruitment@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

The benefits of acute aerobic exercise on neuroplastic potential in depression

Date Added
April 5th, 2016
PRO Number
Pro00050872
Researcher
Ryan Ross

List of Studies

Keywords
Depression, Exercise, Mental Health, Nervous System
Summary

Aerobic exercise training has positive effects on depression severity and mood in individuals with depression. The effects of single sessions of aerobic exercise may also provide some short-term benefits in depression. It is believed that a reduction in depression severity may be facilitated by changes in the nervous system, however this has yet to be examined. Although aerobic exercise has beneficial effects for those with depression it is unclear as to why this may occur. Therefore the goal of our project is to better understand the effect of a single session of aerobic exercise on the nervous system, physiology, and mood in depression.

Institution
MUSC
Recruitment Contact
Ryan Ross
862-377-8208
rossre@musc.edu

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

IntacsĀ® 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 (RitalinĀ® 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

Operant Conditioning of Spinal Reflexes in Youth

Date Added
August 4th, 2015
PRO Number
Pro00046453
Researcher
Aiko Thompson

List of Studies


Keywords
Nervous System, Rehabilitation Studies, Spinal Cord
Summary

Reflexes are important parts of our movements. When reflexes are not working well, movements are clumsy or even impossible. Researchers have found that people can learn to increase or decrease a reflex response with training. Recently, we have found that rats with 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. We are currently studying effects of spinal cord reflex training (e.g., a knee jerk reflex) in people in early adulthood. We hope that the results of this study will help us develop spinal reflex training as a new treatment to help people in early adulthood recover better after spinal cord injury or other damage to the nervous system.

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



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