This is an observational non-medication study. The purpose of this study is to understand the immune system in people who are at risk for developing systemic lupus erythematosus ("lupus" or "SLE"). The investigators hope to develop better ways to predict who will get lupus and possibly come up with ideas for new treatments that can prevent or treat the disease.
Participants will be asked to complete 4 annual study visits and monthly telephone contacts with the study team over the course of 3 years. Visits will include a physical exam, collection of blood and urine, and the completion of some surveys/questionnaires about your health and wellbeing. The monthly phone calls will be a brief contact to check on any changes in your health and should take no longer than 15 minutes to complete.
Compensation is available for participation.
Patients with chronic pancreatitis often suffer from severe abdominal pain that reduce their quality of life. The major purpose of this study is evaluate the safety and efficacy of an infusion of the patient's own stem cells to relieve chronic pain. The stem cells will be isolated from the patient's bone marrow and grown in the clean lab to be used for treatment. After infusion into the vein, the participant will be followed for 12 months to evaluate their pain and other outcomes.
This study is for patients with neuroendocrine carcinoma (NEC) originating outside of the lung. This study is being done to see if the combination of atezolizumab, an immunotherapy drug, with a platinum drug (cisplatin or carboplatin) and etoposide better or worse than a platinum drug and etoposide for patients with advance or metastatic neuroendocrine carcinoma originating outside the lung
The purpose of this study is to learn about the effects of an experimental treatment called E7386. This study is for patients with hepatocellular carcinoma, colorectal cancer, endometrial cancer, or other solid tumors. E7386 in combination with levantinib fight tumors by decreasing tumor density. The purpose of this study is to learn about the effects of an experimental treatment called E7386. E7386 is considered "experimental" because it has not been approved by the U.S. Food & Drug Administration (FDA) for the treatment of any disease. Levantinib is FDA approved and has been previously used to treat cancer, however, it is considered experimental in combination with E7386.
The study is being done to test the use of a drug called bromocriptine for women who have a condition called Peripartum cardiomyopathy or PPCM. PPCM means you have a weak heart after giving birth. The study will look at how the heart muscle improves in women taking bromocriptine compared to a group of women given a placebo or inactive pill. Bromocriptine is approved by the United States Food and Drug Administration (FDA) to treat irregular periods and other symptoms that result from having high blood levels of a substance called prolactin. It is not approved for use in usual care to treat PPCM. The follow up period will be about 3 years. The study will have an initial visit and then the follow -up visits will take place at one, three, six, and 12 months in the first year and visits by phone at 24 months and 36 months.
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.
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.
The Southeastern Consortium for Lung Cancer Health Equity (SC3), led by Dr. Robert A. Winn, assembles an outstanding interdisciplinary team of translational researchers positioned in the heart of the historical and current tobacco-producing region within the southeast. Collectively, SC3's investigative team has unparalleled experience in lung cancer screening, translational research in lung cancer health disparities, community outreach and engagement, and recruiting and retaining racial and ethnic minorities and individuals from other medically underserved groups using evidence-based strategies. As NCI-designated cancer centers, all three centers report high enrollment of underserved minorities onto interventional trials and are committed to reducing the substantial disparities found in lung cancer outcomes in their collective Black/African American and rural communities.
The study is for patients who have been diagnosed with non-squamous non-small cell lung cancer (NSCLC). The investigational drug in this study is ivonescimab (AK112). The study drug is an antibody, it blocks two proteins in the body that help cancer cells live, grow and spread. The study drug will be given in addition to pemetrexed and carboplatin. There are two groups that a participant may be assigned to, which group a subject is assigned on will be determined by type of cancer treatments that they have previously received. Treatment Group A will receive the study drug along with pemetrexed and carboplatin. Treatment Group B will receive placebo along with pemetrexed and carboplatin. The drugs will be given via an infusion. There is a 50% chance of being assigned to either group. Participation in the study will last about 36 months. The study consist of a screening visit, treatment visits, and a safety follow up visit.
The purpose of this study is to assess the feasibility and safety of modified surgical eyeglasses to view bevonescein intraoperatively and the safety of bevonescein as it shows nerve tissue in the body. Bevonescein is an investigational drug being developed to help doctors identify nerves within the body during surgery.
The drug is administered through a vein in the arm and into the blood stream.t Bevonescein then travels through the blood where it makes nerve tissue fluorescent so that it can then be detected by the modified surgical eyeglasses used in this study by a surgeon. This may help the surgeon (study doctor) to tell the difference between nerve tissue and other tissue during surgery. Bevonescein and the modified surgical eyeglasses that your surgeon will wear (ReVealTM 475) are considered investigational because they are not approved by the Food and Drug Administration (FDA) to help with the visualization of nerves during surgery Alternatives to this study can include to undergo surgery without the study drug.
The duration of this study is about 2 months. The procedures of this study include administration of the study drug once (500 mg), collection of blood and urine samples, and ECGs. Surgery will happened as planned by the study doctor but as part of the research, the surgeon will ear modified surgical eyeglasses to view nerves and may take pictures or video clips. The glasses are FDA cleared but the modified filter and its use in combination with bevonescein is considered experimental.
The most commonly expected risks of fluorescein are nausea, vomiting, and stomach discomfort. Because bevonescein is cleared through the urine, there may be a potential risk to the kidneys and renal (kidney) system. The most serious risks of fluorescein may include severe local tissue damage, anaphylaxis, convulsions, cardiac arrest, and death.