Feasibility Trial of the iAmHealthy Intervention for Healthy Weight in Rural Children Recruited From Primary Care Clinics Save

Date Added
December 16th, 2019
PRO Number
Pro00094417
Researcher
James Roberts

List of Studies


Profiles_link
Keywords
Obesity
Summary

This feasibility trial is a multisite, randomized control trial of two different methods of identifying and recruiting participants into the I Am Healthy behavioral intervention. Children and caregivers in both arms will receive the usual care for all existing medical conditions throughout the trial period. they will also receive a monthly newsletter for six months. In addition to the newsletter, child/primary caregiver pairs in the I Am Healthy behavioral intervention arm will receive both group and individual counseling sessions. The trial intervention period will last for six months and will consist of 15 hours of group sessions and 11 hours of individual sessions for 26 contact hours. This falls within the 26-51 contact hour category, which is significantly more effective than the 6-25 contact hour category per the recent USPSTG guidelines. This feasibility trial will provide information toward the implementation of a fully powered multi-site randomized behavior intervention trial that will compare the effectiveness of the I Am Healthy behavioral intervention to a newsletter-only intervention for the treatment of obesity among rural and under served children and their primary caregivers.

Institution
MUSC
Recruitment Contact
Erin Dawley
843-792-8542
hintone@musc.edu

Routine Cardiac Screening in Sarcoidosis Patients Save

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

List of Studies

Silhouette
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

Silhouette
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 Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis Save

Date Added
June 25th, 2019
PRO Number
Pro00088593
Researcher
James C. Oates

List of Studies


Profiles_link
Keywords
Lupus
Summary

The purpose of this study is to see if a new medicine named BMS- 986165 will treat kidney inflammation caused by lupus (lupus nephritis). This study is a clinical trial?which is how new medicines are studied before they are approved by the FDA. This particular drug targets the JAK/STAT pathway to reduce autoimmunity and inflammation.

Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash, sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.

Current treatments for lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (for example prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.

Therefore, there is a need for new and effective treatments for lupus.

Institution
MUSC
Recruitment Contact
Jordan Fash
843-792-8997
fash@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

Silhouette
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 Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects with Systemic Lupus Erythematosus Save

Date Added
October 24th, 2018
PRO Number
Pro00077684
Researcher
James C. Oates

List of Studies


Profiles_link
Keywords
Autoimmune disease, Lupus, Skin
Summary

The purpose of this research study is to measure how well and how safe BMS-986165 is in treating patients with Systemic Lupus Erythematosus (SLE) and to determine the optimal dose level.

Lupus is an autoimmune disease, which means that your immune system not only attacks bacteria and viruses but also attacks your healthy cells and organs, affecting many parts of the body. Lupus can cause fever, joint pain, rash (redness of the skin), sensitivity of the skin to sunlight, as well as other symptoms, and may lead to inflammation and organ damage.

Current treatments for Lupus are mainly drugs that suppress the immune system such as cortisone-like drugs (such as prednisone) and cyclophosphamide (a potent drug sometimes used in treating certain types of cancer), and drugs commonly used to treat or prevent malaria (called antimalarials) such as hydroxychloroquine. Many of these treatments may have serious side effects if used for a long time.

Therefore, there is a need for new and effective treatments for Lupus.

Institution
MUSC
Recruitment Contact
Angela Robinson
843-792-6043
robia@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

Silhouette
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

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