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

Lamprene®/Clofazimine, is a product of the pharmaceutical company named Novartis Pharmaceuticals Corporation. Lamprene®/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 Lamprene®/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

An Open Label Study to Assess the Feasibility and Tolerability of Accelerated Theta Burst Repetitive Transcranial Magnetic Stimulation (iTBS-rTMS) for the Treatment of Post-Partum Depression

Date Added
January 2nd, 2018
PRO Number
Pro00073886
Researcher
Kevin Caulfield

List of Studies

Keywords
Depression, Post Partum Depression
Summary

This is an open-label study designed to investigate the feasibility and tolerability of a novel TMS treatment protocol to treat depression in women with post-partum depression. It is known that TMS can effectively treat depression. The FDA approved protocol lasts 6 weeks and is not feasible for many women with post-partum depression. In this study we are investigating 2 accelerated treatment delivery schedules: One in which patients receive treatments on 6 days over 3 weeks and one in which treatments are delivered on 5 days within 8. We are investigating the feasibility, tolerability, and credibility of both schedules which may be more acceptable for this population. We further hope to characterize the anti-depressant effect and durability of this protocol in order to design a larger trial.

Institution
MUSC
Recruitment Contact
Samantha LaPorta
843-792-8274
laporta@musc.edu

CureGN: Cure Glomerulonephropathy

Date Added
February 20th, 2018
PRO Number
Pro00072900
Researcher
Milos Budisavljevic

List of Studies


Keywords
Kidney
Summary

If you have a glomerular disease, have had kidney biopsy in the last 5 years, are not on dialysis, and have not had a kidney transplant or was previously enrolled in the NEPTUNE study, you may be eligible to take part in this research study. The purpose of this study is to gather a group of patients with glomerular disease to create a source of information along with your kidney biopsy slides, blood, and urine samples so that researchers can easily and effectively study glomerular disease.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

Prospective, observational, longitudinal study in pediatric patients with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not medically advisable

Date Added
December 20th, 2018
PRO Number
Pro00084090
Researcher
Lara Wine Lee

List of Studies


Keywords
Pediatrics, Skin
Summary

This study will assess the features of children, younger than 12 years old, with moderate to severe eczema, also known as atopic dermatitis, when their condition is not adequately controlled with topical therapies (creams or lotions) or when those therapies are not medically advisable.

This is not a treatment study. You and your child will complete questionnaires describing how their condition effects them. Information related to your child's illness will be collected by reviewing their medical chart and by assessments performed by the study team. Participation in this study will involve at least 12 visits that will take place over a period of 10 years.

The information collected in this study may lead to an improved understanding of your child's illness and may provide healthcare providers with important information for treating atopic dermatitis in the future.

Institution
MUSC
Recruitment Contact
Susannah Wakefield
843-792-5935
dermresearch@musc.edu

A Randomized Controlled Trial Comparing Monitored Anesthesia Care versus General Anesthesia with Transesophageal Echocardiography for Transcatheter Aortic Valve Replacement

Date Added
June 18th, 2019
PRO Number
Pro00088473
Researcher
George Whitener

List of Studies


Keywords
Cardiovascular, Heart, Surgery
Summary

This study is being done to evaluate the impact that monitored anesthetic care (MAC) versus general endotracheal anesthesia (GETA) has on hospital length of stay, rate of ICU admission, or procedural mortality. Also, we hope to determine if the use of Transesophageal Echocardiography (TEE) during GETA impacts device success and durability. Adult patients undergoing transfemoral approach TAVR for aortic valve stenosis may be eligible candidates for this study.

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

Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke

Date Added
August 6th, 2019
PRO Number
Pro00090790
Researcher
Na Jin Seo

List of Studies


Keywords
Aging, Exercise, Movement Disorders, Nervous System, Physical Therapy, Rehabilitation Studies, Stroke, Stroke Recovery
Summary

Hand disability after stroke has a profound negative impact on functional ability and independence. Hand therapy may be augmented with sensory stimulation for better outcomes. We have developed a novel sensory stimulation - unfelt vibration applied via a wristwatch. Participants will receive this novel stimulation with hand task practice therapy or therapy only to determine if use of this stimulation is better for recovery.

Institution
MUSC
Recruitment Contact
Kristen Coupland
8437927685
coupland@musc.edu

tDCS Combined with a Brief Cognitive Intervention to Reduce Perioperative Pain and Opioid Requirements in Veterans

Date Added
October 1st, 2019
PRO Number
Pro00091450
Researcher
Jeffrey Borckardt

List of Studies


Keywords
Brain, Joint, Mental Health, Military, Pain, Psychiatry, Surgery
Summary

The purpose of this study is to determine whether a new medical technology can help reduce post-operative total knee or hip pain when combined with a Cognitive-Behavioral intervention (CBI).

This new medical technology, is called transcranial direct current stimulation (tDCS), it uses a very small amount of electricity to temporarily stimulate specific areas of the brain thought to be involved in pain reduction. The electrical current passes through the skin, scalp, hair, and skull and requires no additional medication, sedation, or needles.

This study will investigate the effects of tDCS, the Cognitive-Behavioral (CB) intervention and their combination on pain among veterans following total knee arthroplasty (TKA) or total hip arthroplasty (THA). You may benefit in the form of decreased pain and opioid requirements following your knee or hip replacement surgery. However, benefit is only likely if you are randomized to one of the 3 (out of 4) groups.

This study hopes to determine the effects of these interventions and their combined effect on post-operative pain, opioid use and functioning during the 48-hour post-operative period following a total knee or hip replacement.

Institution
MUSC
Recruitment Contact
Georgia Mappin
(843) 789-7104
georgia.mappin@va.gov

Characterization of physiological changes induced through motor-evoked potential conditioning in people with spinal cord injury

Date Added
December 3rd, 2019
PRO Number
Pro00091457
Researcher
Aiko Thompson

List of Studies


Keywords
Central Nervous System, Nervous System, Rehabilitation Studies, Spinal Cord
Summary

We are currently recruiting volunteers who are interested in participating in a brain-spinal cord-muscle response training study that aims to better understand the changes that take place in the nervous system as a result of this type of training. After spinal cord injury, brain-to-muscle connections are often interrupted. Because these connections are important in movement control, when they are not working well, movements may be disturbed. Researchers have found that people can learn to strengthen these connections through training. Strengthening these connections may be able to improve movement control and recovery after injuries.

Research participants will be asked to stand, sit, and walk during the study sessions. Electrodes are placed on the skin over leg muscles for monitoring muscle activity. For examining brain-to-muscle connections, we use transcranial magnetic stimulation. The stimulation is applied over the head and will indirectly stimulate brain cells with little or no discomfort.

Participation in this study requires approximately three sessions per week for four months, followed by two to three sessions over another three months. Each session lasts approximately 1 hour. Participants will receive a mileage reimbursement.

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

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Immune-Mediated Inflammatory Skin Conditions

Date Added
December 3rd, 2019
PRO Number
Pro00093832
Researcher
Lara Wine Lee

List of Studies


Keywords
Skin
Summary

This is a 5-year, longitudinal, observational study of adult and pediatric patients (all ages) being treated for Immune-Mediated Inflammatory Skin Conditions. In addition to the study database, a biospecimen repository will be included in order to perform studies on biomarkers of response.

Patients being prescribed medical therapy for IMISC will be eligible for enrollment. Treatment algorithms will follow each site's local standard of care and no specific treatments, assessments, and/or laboratory tests will be dictated by enrollment in the main TARGET-DERM Program. Patients will be screened and enrolled at a regularly scheduled clinic visit. Up to three years of retrospective
medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, laboratory reports, clinic notes, telephone contact reports, medication lists, reasons for medication initiation and/or discontinuation, biopsy results, and imaging. Patients may
also be linked to external databases (such as patient support programs). Patients will also be asked to provide biological samples and complete patient reported outcome (PRO) surveys, although participation in these two portions is optional.

During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 6 to 12 months, for up to 5 years. Patients/legal representatives ("parent proxy") will be asked to complete PRO surveys at regular intervals during this follow-up period.

Institution
MUSC
Recruitment Contact
Courtney Rowley
843-792-9784
rowle@musc.edu

A Randomized Placebo-controlled Trial of Zoledronic Acid for Prevention of Fractures in Patients with Parkinson's Disease

Date Added
March 31st, 2020
PRO Number
Pro00095121
Researcher
Vanessa Hinson

List of Studies


Keywords
Parkinsons
Summary

This randomized clinical trial is designed to test the efficacy of ZA-5 mg in PD patients. This trial will also address barriers to treatment of patients with PD by providing rigorous evidence about whether ZA reduces fracture risk in patients with PD, simplifying treatment by giving ZA at home without extra medical visits and BMD testing, and overcoming poor persistence with oral therapies because one infusion may prevent bone loss for at least 2 years. The outcome of this trial will demonstrate how a home-based fracture prevention can reach older PD patients who would not otherwise receive treatment to reduce their high risk of fractures.

Institution
MUSC
Recruitment Contact
Timothy Sheehan
843-792-0372
sheehant@musc.edu



-- OR --