Routine Cardiac Screening in Sarcoidosis Patients Save

Date Added
August 20th, 2019
PRO Number
Pro00090373
Researcher
Walter James

List of Studies

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Keywords
Lung, Pulmonary, Sarcoidosis
Summary

This is a trial for cardiac sarcoidosis in patients seen during routine clinical care who have not been clinically suspected to have cardiac sarcoidosis according to conventional criteria. The addition of echocardiogram and ambulatory ECG to usual clinical follow-up will be compared. This is a multicenter study, coordinated by the Foundation for Sarcoidosis Research. Up to 12 sites in the US and Europe will participate. Each site will enroll 50 consecutive consenting individuals to a total of 600 enrolled subjects in a randomized trial of additional screening versus usual care.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

Registry for Advanced Sarcoidosis (ReAS) Save

Date Added
August 13th, 2019
PRO Number
Pro00090539
Researcher
Walter James

List of Studies

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Keywords
Lung, Pulmonary, Sarcoidosis
Summary

The purpose of this research study registry is to identify patients with advanced sarcoidosis. This is an observational research study, which means you will not take study medication(s). The study will determine how many and how often patients are diagnosed with advanced disease in sarcoidosis clinics. The study will determine how many and how often patients are diagnosed with advanced disease in sarcoidosis clinics. This study will look at genetic markers; determine the risk factors for advanced sarcoidosis and the natural course of symptoms in advanced disease. You will be in the research study for approximately 36 months (3 years)and will be seen every 6 (six) months during the research study.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Multiple Ascending Dose Study of Intravenous ATYR1923 in Patients with Pulmonary Sarcoidosis Save

Date Added
January 22nd, 2019
PRO Number
Pro00084946
Researcher
Walter James

List of Studies

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Keywords
Lung, Pulmonary, Sarcoidosis
Summary

This study is being done to learn more about the safety of the drug ATYR1923, to see if taking this drug ATYR1923 will allow you to reduce your steroid dose, and to find out more about the effects of different doses of this drug on the lungs of people who have pulmonary sarcoidosis. This study will also look at how the body responds to the drug. These things will be measured by taking samples of your blood, through medical examinations performed by your study doctor, by lung function tests and by reviewing images of your lungs. This study also includes taking blood samples for biomarkers, antibodies, and tryptase and complement levels. A skin lesion biopsy portion of the study is optional. Participation will last up to 28 weeks. You will have a total of 7 study site clinic visits and 8 telephone contacts during the treatment period.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Multicenter, Open-Label Study To Estimate The Effect Sizes Of HRCT Endpoints In Response To Glucocorticoid Induction Therapy In Subjects With Pulmonary Sarcoidosis Save

Date Added
September 25th, 2018
PRO Number
Pro00081796
Researcher
Walter James

List of Studies

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Keywords
Lung, Pulmonary, Sarcoidosis
Summary

The purpose of this study is to compare an imaging procedure called high-resolution computed tomography (HRCT) against the standard pulmonary function tests (PFTs) to see if HRCT is better at showing if the standard glucocorticoid treatment is working. This study also includes testing of blood samples for biomarkers which are measurable indicators of the severity or presence of some disease state. The maximum time you will be in the study is 3 months. During this time, you will need to visit the study site 6 times for 6 site study visits. This study will enroll subjects with a diagnosis of pulmonary sarcoidosis at stage II or III who have shortness of breath (dyspnea) and have not received prednisone or prednisolone (glucocorticoids) treatment or other sarcoidosis therapy within the last three months.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Phase 4 Multicenter, Randomized, Double Blind, Placebo Controlled Pilot Study to Assess the Efficacy and Safety of H.P. Acthar® Gel in Subjects with Pulmonary Sarcoidosis Save

Date Added
June 26th, 2018
PRO Number
Pro00078345
Researcher
Walter James

List of Studies

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Keywords
Lung, Pulmonary, Sarcoidosis
Summary

The purpose of this research study is to find out if Acthar works well in and is safe when you use it as part of the treatment for your Pulmonary Sarcoidosis. This research study will collect additional data as to the effectiveness and safety of Acthar in treating Pulmonary Sarcoidosis, and will examine how the study drug acts in the body and how well it manages your symptoms. Participation could last for approximately 56 weeks. This will include a Screening Period that will last up to 4 weeks, a double-blind treatment period of about 6 months when neither you nor your study doctor will know if you are taking Acthar or placebo, an open-label treatment period of about 6 months, and a follow-up visit at about 4 weeks after the last dose of the study drug. The study plan includes coming to the study doctor's research center at least 12 times if you participate throughout the whole study duration of 56 weeks or 9 times if you participate only in the double-blind period.
Approximately 100 people will participate in this study.

Institution
MUSC
Recruitment Contact
Daniel Larimore
(843) 792-6890
larimord@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 Save

Date Added
January 2nd, 2018
PRO Number
Pro00073886
Researcher
Constance Guille

List of Studies


Profiles_link
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. We are investigating a 3 day treatment for depression which may be more acceptable for this population. We further hope to characterize the ant-depressant effect of this protocol in order to design a larger trial.

Institution
MUSC
Recruitment Contact
James Fox
843-792-2123 pgr 14687
foxj@musc.edu

Neural Determinants of Age-Related Change in Auditory-Visual Speech Processing Save

Date Added
September 24th, 2017
PRO Number
Pro00070971
Researcher
James Dias

List of Studies

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Keywords
Aging, Brain, Central Nervous System, Ears, Healthy Volunteer Studies, Hearing, Language, Minorities, Vision/ Eye
Summary

Older adults typically have trouble identifying the speech they hear, especially in noisy environments. Fortunately, compared to younger adults, older adults are better able to compensate for difficulties identifying the speech they hear by recruiting the visual system. However, the extent to which older adults can benefit from visual input, and how this influence relates to age-related changes in brain structure and function, have not been thoroughly investigated. The general purpose of this study is to determine how age-related changes in brain structure and function affect how well people hear and see. This study seeks participants with normal hearing to mild hearing loss, who also have normal or corrected-to-normal vision.

Institution
MUSC
Recruitment Contact
James Dias
(843) 792-3921
diasj@musc.edu

Investigation of the Efficacy of Antimycobacterial Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial Save

Date Added
June 22nd, 2017
PRO Number
Pro00067313
Researcher
Walter James

List of Studies

Silhouette
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

You are being asked to take part in this research study because you have been diagnosed with pulmonary sarcoidosis. Sarcoidosis is a disease that can affect the lungs, skin and other organs of the body. Sarcoidosis also involves immune cells which fight bacteria. The purpose of this study is to see if using specific antibiotics will help these immune fighting cells get rid of bacterial proteins and how the antibiotics affect respiratory (breathing) function. The antibiotics used in this study are Levaquin, Ethambutol, Azithromycin, and either Rifampin or Rifabutin. You will by chance be assigned either these medicines or a placebo (an inactive substance).

Institution
MUSC
Recruitment Contact
Kelly French
843-792-3169
frenchke@musc.edu

Imaging Framework for Testing GABAergic/glutamatergic Drugs in Bipolar Alcoholics Save

Date Added
April 4th, 2017
PRO Number
Pro00064964
Researcher
James Prisciandaro

List of Studies


Profiles_link
Keywords
Alcohol, Depression, Mental Health, Psychiatry, Substance Use
Summary

This study examines the effects of the medication gabapentin and the supplement n-acetylcysteine among individuals with Bipolar Disorder who regularly drink alcohol. Participants in this study will take gabapentin, n-acetylcysteine, and matched placebo (one at a time) for 5 days each. There are 8 study visits, including 3 MRI scans.

Institution
MUSC
Recruitment Contact
Sara Hix
843-792-0572
hixs@musc.edu

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFECTS OF BEMPEDOIC ACID (ETC-1002) ON THE OCCURRENCE OF MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH, OR AT HIGH RISK FOR, CARDIOVASCULAR DISEASE WHO ARE STATIN INTOLERANT Save

Date Added
February 28th, 2017
PRO Number
Pro00062003
Researcher
James Thomas

List of Studies


Profiles_link
Keywords
Cardiovascular, Cholesterol
Summary

Research study looking for participants with, or at high risk for, cardiovascular disease (CVD). This study is being carried out to see if a new investigational drug called bempedoic acid provides cardiovascular benefits and decreases the risks of future cardiac events when taken by patients who are not able to take a type of medication called statins. The study may require up to 15 visits to the clinic over a period of five years.

Institution
MUSC
Recruitment Contact
Della MacNicholas
843-876-5012
macnichd@musc.edu

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