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

Pulmonary Hemodynamics during Exercise - Research Network

Date Added
May 16th, 2019
PRO Number
Pro00087395
Researcher
Ryan Tedford

List of Studies


Keywords
Cardiovascular, Heart
Summary

Elevated pressures in the heart can represent a severe medical condition known as pulmonary hypertension. This can result in chronic right heart failure. An abnormal increase in this pressure during exercise may be represent an early stage of vascular lung disease. This study will investigate the prognostic implications of the measured pressures obtained during exercise while undergoing a right heart catheterization procedure based on a large scale multi-center approach by using retrospective and prospective analysis of hemodynamic data.

Institution
MUSC
Recruitment Contact
Brandon Sykes
843-876-5873
sykesb@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 Phase II Study of Metronomic and Targeted Anti-Angiogenesis Therapy for Children With Recurrent/Progressive Medulloblastoma

Date Added
September 1st, 2020
PRO Number
Pro00091939
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Brain, Brain Tumor, Cancer, Central Nervous System, Children's Health, Drug Studies, Pediatrics, Spinal Cord
Summary

This study is for patients with recurrent/progressive medulloblastoma, which is a type of childhood brain tumor. Participants in this study will receive intravenous (IV, into the veins) bevacizumab and intrathecal (into the spinal fluid) or intraventricular (into the fluid surrounding the brain) etoposide and cytarabine in combination with five oral (taken by mouth) chemotherapy drugs as a possible treatment for recurrent/progressive medulloblastoma. Total study duration is about 1 year and depending on how well a participant tolerates the medications and the response of the disease, the patient may continue the treatment after the first year.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trails@musc.edu

A Phase 3 Randomized Trial for Patients With De Novo AML Comparing Standard Therapy Including Gemtuzumab Ozogamicin (GO) to CPX-351 With GO, and the Addition of the FLT3 Inhibitor Gilteritinib for Patients With FLT3 Mutations

Date Added
September 25th, 2020
PRO Number
Pro00104024
Researcher
Jacqueline Kraveka

List of Studies


Keywords
Cancer, Pediatrics
Summary

This study is for patients that have been diagnosed with Acute Myelogenous Leukemia (AML). This study will compare standard chemotherapy using daunorubicin, cytarabine and gemtuzumab ozogamicin (GO) to chemotherapy using an experimental drug called CPX-351. CPX-351 is made up of daunorubicin and cytarabine. CPX-351 is made in a way that makes the drugs stay in the bone marrow longer and may be more effective. CPX-351 has been shown to be well-tolerated and effective against leukemia in adults and children. Participants can expect to receive treatment on this study for 6 months and followed for up to 10 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
HCC Clinical Trials Office843-792-9321
hcc-clinical-trials@musc.edu

Oxytocin to Enhance Integrated Exposure-Based Treatment of Co-occurring Alcohol Use Disorder and PTSD

Date Added
November 3rd, 2020
PRO Number
Pro00103198
Researcher
Sudie Back

List of Studies


Keywords
Alcohol, Mental Health, Military, Psychiatry, Stress Disorders
Summary

The purpose(s) of the research is to test a new medication in combination with a talk therapy for Veterans experiencing posttraumatic stress disorder (PTSD) and who may have alcohol use disorder (AUD). The study consists of 12 weekly therapy sessions. Once per week before each therapy session, an intranasal dose of investigational medication will be administered. The study also involves 3 and 6-month follow-up appointments and the administration of questionnaires at each visit.

Institution
MUSC
Recruitment Contact
Stacey Sellers
843-792-5807
sellersst@musc.edu



-- OR --