Clinical Research Directory

Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases

Background: Viral infections such as COVID-19 may lead to flare-ups in people with systemic autoimmune diseases (SAD). These infections may also change the function of their immune system and/or cause problems with their blood vessels. Researchers want to learn how people with SAD respond to treatments or vaccines for COVID-19. Objective: To understand how COVID-19 affects inflammation, the immune system, and blood vessels in adults and children with autoimmune diseases. Eligibility: People ages 15 and older who have been diagnosed with an autoimmune disease or are a healthy volunteer Design: Participants will have a screening visit. This will include: Medical history and physical exam EKG Chest x-ray COVID-19 test. A swab will be put in the participant s nose or the back of their mouth. Blood and urine tests Participants will be placed into 1 of 4 groups: 1. Those with previously documented COVID-19 infection or COVID vaccination 2. Those with a recently known COVID-19 exposure or vaccination 3. Those with no known COVID-19 exposure or vaccination 4. Those who developed an acute COVID-19 infection Depending on their group, participants will have 1 to 5 more visits. These will occur over 12 to 18 months. Visits may include: FDG PET/CT scan. Participants will lie in a doughnut-shaped machine. The machine creates pictures of the body. For the scan, they will have a radioactive substance injected into their arm through an IV. Kidney function tests Non-invasive vascular studies test. These tests are similar to what it feels like to have blood pressure checked.

The RheumSafer Study: Improving Medication Appropriateness in People With Rheumatic Conditions

The goal of this prospective observational quality improvement study is to determine if a physician tool, MedSafer, combined with educational brochures for patients, can help to reduce the use of 'potentially inappropriate medications' (PIMs) in adults aged 60 and over with rheumatic conditions and polypharmacy (taking 5 or more regular medications). Researchers will follow participants during usual rheumatic disease care. They will compare the rate of PIM deprescribing (stopping medications or reducing the dose) before and after the introduction of the following interventions: * MedSafer reports provided to treating physicians * EMPOWER consumer brochures provided to participants Participants will complete 4 study visits over 18-20 months during which researchers will collect information on medication changes, serious adverse events (emergency visits or hospitalizations), and quality of life.

Prophylactic Tranexamic Acid Reduces Postpartum Hemorrhage

Postpartum hemorrhage (PPH) is the most significant leading cause of pregnancy-related mortality in high-risk cesarean delivery women. Systemic autoimmune diseases are associated with adverse pregnancy outcomes (APOs), including PPH, preeclampsia, thromboembolism, abortion, and intrauterine growth restriction. The incidence of PPH in women with systemic lupus erythematosus has been reported to be as high as 34%. Prevention of PPH is the key to reduce complications in high-risk women. In recent years, a large number of clinical studies have confirmed that the early preventive use of tranexamic acid(TXA) can reduce the amount of blood loss, the need for additional uterine contraction agents, the risk of blood transfusion, and maternal adverse outcomes, and do not increase the risk of thromboembolic events, which can be used to prevent PPH. However, the study population of TXA is mainly low-risk puerpera, and there is still a lack of relevant research on TXA used in pregnant women with systemic autoimmune diseases. The purpose of this study was to evaluate the safety and efficacy of TXA in preventing postpartum hemorrhage after cesarean delivery in women with systemic autoimmune disease, as well as the maternal and neonatal risks associated with systemic autoimmune disease, to provide evidence for clinical practice and further research.