The purpose of this research study is to see if IgPro10 (the study medication) is effective and tolerated when administered to adults with diffuse cutaneous systemic sclerosis (dcSSc) who have skin thickness involvement throughout their body. The study medication is administered intravenously through an IV. There are approximately 22 scheduled visits to the study site to complete assessments, in addition to a Follow-Up phone call. Your participation will last for approximately 80 weeks.
COVID-19 testing involves collection of swabs from nasopharyngeal cavities where the SARS-CoV-2 virus replicates. Many other commensal and pathogenic microbes may be found in the same host niche. Collectively, these microbes are called the microbiome. We hypothesize that the colonizing microbiome at the time of diagnosis may provide leads for early stratification of cases into risk categories, future clinical manifestations of the disease, and insights into treatment strategies.
This is a 2-year, longitudinal, observational study of adult patients (ages 18 and above) being treated for moderate to severe plaque psoriasis.
Patients being prescribed or initiating medical therapy with a new biologic drug (such as risankizumab, guselkumab, brodalumab, tildrakizumab, ixekizumab, adalimumab, etanercept, ustekinumab, secukinumab, certilizumab pegol, infliximab, or apremilast) for the treatment of plaque psoriasis will be eligible for enrollment. The study will be conducted to gather data from enrolled patients' electronic health records, prospective physician-reported information provided by the patients' dermatologists, and information collected from questionnaires and surveys completed by the enrolled patients.
Patients will be screened and enrolled at a regularly scheduled clinic visit. Retrospective medical records from patients who provide consent/assent and meet all inclusion and exclusion criteria will be obtained by the research site. Records will include but will not be limited to: hospitalizations, emergency room visits, procedures, and medical costs. Physician reported outcomes will be recorded at regularly scheduled visits. Patients will also be asked to complete patient reported outcome (PRO) surveys and questionnaires to record data regarding demographics, clinical characteristics of psoriatic disease, comorbidities, family history, occupation and lifestyle factors, use of PsO support programs, contact information, concomitant medication use, medication side effects, and symptom characteristics.
During the follow-up period, the research site will prospectively submit the research subjects' medical records approximately every 3 to 12 months, for up to 2 years. Patients will be asked to complete PRO surveys electronically at regular intervals during this follow-up period.
The purpose of this study is to find out more information about the study drug iloprost for the treatment of symptomatic Raynaud's phenomenon (RP) attacks in people with scleroderma. A Raynaud's attack is defined as one where you notice at least one color change of your finger(s) (blue, white, or red) associated with at least one symptom (pain, numbness, tingling, and/or discomfort of the finger[s]). Your participation in this study will last approximately 9 weeks and will include 8 visits to the study center and 1 phone call from the study staff.
Scleroderma (systemic sclerosis) is a chronic autoimmune disease, characterized by dysregulation of immune cells in the blood and subsequent fibrosis and vascular dysfunction, associated with significant mortality and morbidity, disproportionately affecting women and African Americans, and without satisfactory treatments. Monocytes, a type of blood immune cells, are critically involved, but the mechanisms responsible for their deregulation in scleroderma remain largely unknown. The goal of this project is to understand how the regulation of monocytes differs between scleroderma and healthy individuals. Volunteers will be asked to provide a blood sample, for which modest compensation will be provided. This is not a drug study.
The goal of this study is to learn more about lupus (Systemic Lupus Erythematosus; SLE), which affect African-Americans more than other groups. The purpose of this study is to understand what role microbes living in the intestine (called microbiota) have in causing lupus. This study will include males and females of all ethnic backgrounds who have SLE, individuals who have immediate family members with SLE, and unrelated healthy volunteers. For subject recruitment, CCCR/MCRC databases including the longitudinal SLE in Gullah Health (SLEIGH) study as well as the chart review will be used to screen for eligibility. The study is sponsored by the National Institutes of Health.
It is important to understand multiple personal-level factors that impact disease risks and outcomes to determine the most effective ways to establish precise medical strategies to prevent, diagnose, and treat chronic health conditions and diseases. This is especially important among minority and underserved populations that would benefit from more tailored healthcare approaches. This study will develop and assess strategies for circulating evidence about precision medicine and improving precision medicine approaches.
Often considered as related diseases, systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) are severe autoimmune disorders characterized, among other, by dysregulation of immune cells in the blood. The roles of different immune cells in SLE and SSc remain unclear. It is of increasing importance to characterize specific immune cells and define their impact on autoimmune disease, which may lead to new therapies. The goal of this study is to identify blood immune cells associated with SLE and SSc.
This study is for patient that have been diagnosed with suspected lower respiratory tract infection. The purpose of this study is to evaluate a new test that may be able to find more lung infections than current tests can. This new test is called next-generation sequencing and looks in respiratory secretions for bacteria, viruses, fungi, and other organisms that may cause infection. We hope to learn more about the usefulness of this new test in identifying infections.