The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and TAK-700 plus radiation therapy with hormone therapy (androgen deprivation) and radiation therapy on patients with prostate cancer.
There are 2 treatment groups in this study. Group 1will receive hormone therapy plus radiation therapy only and Group 2 will receive hormone therapy and TAK-700 plus radiation therapy.
Subjects will receive hormone therapy for 24 months. Radiation will be given in 44 treatments over approximately 2 months. If the subject is in Group 2 they will take TAK-700 for 24 months. After the subject is finished receiving therapy, the study doctor will ask the subject to visit the office for follow-up exams every 6 months for 3 years and then once a year.
Systemic lupus erythematosus (lupus; SLE), Systemic Sclerosis (scleroderma; SSc) and Systemic Vasculitis (SV) are relatively rare rheumatic diseases that disproportionately impact the African American community, and particularly African American women. The causes of lupus, scleroderma and vasculitis are unknown, but thought to include both genetic and environmental factors. We are enrolling lupus, scleroderma, and vasculitis patients, and healthy control subjects. This is not a drug study. The purpose of this study is to better understand the factors that predispose people to develop lupus, scleroderma, and vasculitis. Information about medical, social and family history, medications, physical exam findings, and laboratory tests will be collected for analysis. This study will involve approximately 1360 volunteers.
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).
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.
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.
This Phase II clinical research study evaluates both the safety and effectiveness of an FDA-regulated medication presently in the initial stages of development for alcohol use disorder treatment (GET73), and will test whether GET73 alters brain chemicals and function, response to alcohol ingestion, and the desire for alcohol. Participants will be randomly assigned to one of two medication treatment groups (GET73 or placebo). Study medication will be taken for 8 days, with approximately 4 study visits, and a "bar-lab" procedure and 2 MRI brain imaging scans will be completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.
This research study evaluates the effects of anFDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.
The primary objective of this study is to evaluate the efficacy of namilumab in subjects with chronic pulmonary sarcoidosis (CPS). This study will include adult subjects who have been diagnosed with CPS for more than 6 months who are not well controlled by OCS and/or immunosuppressive therapy (IST). 100 total subjects are planned for this study. There will be a Double-blind treatment period of this study lasting approximately 26 weeks as well as an optional Open-Label Extension (OLE) Treatment Period which will extend the length of the study to approximately 64 weeks.
This is a multicenter, randomized, double-blind, placebo-controlled, study comparing the efficacy and safety of intravenous (IV) efzofitimod 3 mg/kg and 5 mg/kg versus placebo after 48 weeks of treatment. This study will enroll adults with histologically confirmed pulmonary sarcoidosis receiving stable treatment with oral corticosteroid (OCS), with or without immunosuppressant therapy. The duration of patient participation is up to 56 weeks, including a Screening period (up to 4 weeks), a Treatment period (48 weeks), and a Follow-up period (4 weeks).
This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.