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.
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)).
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.
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.
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.
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.
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.
The Zilver® Vena™ Venous Stent is intended to treat obstruction (blockage/narrowing) of the iliofemoral (groin/pelvis) veins. The purpose of this study is to assess the ability of the device to maintain an open iliofemoral vein in the groin/pelvis.
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.