A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Efficacy, Safety, and Tolerability of JBT-101 in Systemic Lupus Erythematosus (Protocol ALE09) Save

Date Added
July 18th, 2017
PRO Number
Pro00063016
Researcher
Diane Kamen
Keywords
Autoimmune disease, Drug Studies, Inflammation, Lupus
Summary

This double-blinded placebo-controlled research study is being done to test the effectiveness, safety, and tolerability of the experimental drug JBT-101 in patients with systemic lupus erythematosus (SLE). We will see if JBT-101 taken by mouth stops inflammation and how well JBT-101 is tolerated. The study will evaluate whether JBT-101 will decrease the pain associated with active arthritis or tendonitis in SLE subjects. JBT-101 is manufactured entirely from chemicals and its structure is similar to the end product of a chemical in marijuana. This drug was designed to have the known anti-inflammatory properties of marijuana without the effects on brain function and mood.

Institution
MUSC
Recruitment Contact
Traeannah Chisolm
843-792-4296
chisoltr@musc.edu

The Influence of Colorectal Cancer Risk Factors within Normal Colonic Mucosa and Colon Polyps: A Feasibility Study Save

Date Added
January 17th, 2017
PRO Number
Pro00060146
Researcher
Kristin Wallace
Keywords
Cancer, Cancer/Gastrointestinal, Colonoscopy, Disease Prevention, Immune System, Inflammation, Minorities
Summary

The purpose of the study is to determine the feasibility of enrolling patients, obtaining colorectal cancer risk factor data via an in-person questionnaire, and procuring three types of biologic samples (normal mucosa biopsies, a salvia sample, and polyp tissue (if applicable)).

Institution
MUSC
Recruitment Contact
Bridgette Blankenship
8438762445
blanke@musc.edu

Alpha1-Antitrypsin (AAT) Enhances Islet Autograft Survival Save

Date Added
May 17th, 2016
PRO Number
Pro00053906
Researcher
Hongjun Wang
Keywords
Diabetes, Inflammation, Insulin
Summary

The purpose of this study is to test whether treatment with a drug called alpha 1 antitrypsin (AAT, Prolastin, Grilfols, Inc.) can reduce the chance of getting diabetes in a specific situation. Sometimes patients have their pancreas gland removed for pain. Since the pancreas makes insulin from cells called islet cells, these are removed from the pancreas and returned to the body to try decrease the chance of diabetes. The only participants invited to this study are those individuals getting ready to have the pancreas surgery.

Institution
MUSC
Recruitment Contact
Stefanie Owczarski
843-876-4305
owczarsm@musc.edu

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial of IMO-8400 in Patients with Dermatomyositis. Save

Date Added
April 26th, 2016
PRO Number
Pro00054009
Researcher
Katherine Ruzhansky
Keywords
Drug Studies, Inflammation, Muscle, Rare Diseases, Skin
Summary

Subjects are being asked to volunteer for this research study because they have been diagnosed with Dermatomyositis (DM). This study will test the safety and effectiveness of the investigational new drug, IMO-8400. Subjects will receive a subcutaneous injection of the study drug or placebo once a week for up to 24 weeks during the study. Subjects will complete a total of 27 visits over the course of 32 weeks. After the baseline visit, subjects will have the option of having a visiting nurse (who has been trained in the protocol and approved by the Sponsor) conduct the intervening weekly study visits 2-25 outside of the clinic (e.g., at your home or workplace) rather than coming in to clinic for injections.

Institution
MUSC
Recruitment Contact
Christine Hudson
843-792-3790
hudsoncm@musc.edu

Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence Save

Date Added
June 2nd, 2015
PRO Number
Pro00043450
Researcher
Teresa Kelechi
Keywords
Aging, Circulation, Diabetes, Inflammation, Skin, Vascular
Summary

Individuals with venous leg and diabetic foot ulcers often find these ulcers take a long time to heal and when they do, sometimes they come back. These ulcers can be quite painful making it hard to work, sleep and go about one's day to day activities. You will be asked to do a self-care routine of taking the temperature of the skin where the leg or foot ulcer just healed with a special thermometer and applying a small cooling gel patch over this skin. We want to know if this routine will prevent the ulcer from coming back, help you to become more active, and improve the quality of your life.

Institution
MUSC
Recruitment Contact
Margaret Prentice
843 792 4771
prenticm@musc.edu

Expression patterns of micro RNA in severe sepsis Save

Date Added
December 16th, 2014
PRO Number
Pro00039618
Researcher
Hongkuan Fan
Keywords
Inflammation, Vascular
Summary

Blood samples from patients admitted to the intensive care unit with a severe infection (sepsis) will be analyzed for markers of gene regulation called micro RNA. Micro RNA levels will be compared between patients with sepsis, patients with other non-septic critical illness and healthy individuals. Micro RNA levels will be analyzed to determine if they correlate with hospitalization outcomes.

Institution
MUSC
Recruitment Contact
Melissa Spears
843-792-2072
coole@musc.edu

Regulation of Inflammatory T Cells and Neuroprotection by Calpain Inhibition in MS Save

Date Added
March 4th, 2014
PRO Number
Pro00028348
Researcher
Narendra Banik
Keywords
Inflammation, Multiple Sclerosis
Summary

A number of veterans suffer from multiple sclerosis (MS), a devastating and debilitating disease for which there is not cure or significant treatment. The only therapy available is immunomodulatory, but does not treat the neurodegeneration. The studies proposed in this application will develop therapeutic strategies and identify a drug that ameliorates inflammation as well as neurodegeneration in the disease. Thus, the effect of this drug will not only help veterans with MS, but will also benefit individuals with the disease in general.

Institution
MUSC
Recruitment Contact
Elizabeth Kau
789-6450
elizabeth.kau2@va.gov

Racial Disparities in Sepsis: The Role of Immunological Heterogeneity Save

Date Added
June 18th, 2013
PRO Number
Pro00025452
Researcher
Andrew Goodwin
Keywords
Ethnicity and Disease, Genetics, Inflammation, Minorities
Summary

Disparities in sepsis incidence and outcomes have been identified between blacks and whites. While some of these disparities can likely be attributed to socio-demographic factors including socio-economic status, education level, and access to healthcare, existing data suggests that other factors, including biological differences, may contribute to the observed disparities. The innate immune system is an integral component of the body's mechanism for fighting off infection and has been identified as a site for numerous racial heterogeneities. The RADIUS study seeks to identify both black and white patients admitted in an intensive care unit with sepsis. A single blood sample will be collected from each enrolled subject to be used for quantitative analysis of cytokine levels as well as for genotyping for a specific single nucleotide polymoprhism. These cytokines and the polymorphism are related to the innate immune system response to infection. Simultaneously, clinical and demographic information will be recorded from each enrolled subject so that cytokine levels and polymorphism presence can be correlated with clinical outcomes while controlling for socio-demographic variables.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@musc.edu

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