The goal of this early feasibility study is to gain initial insight into the basic safety and performance of transluminal (through the blood vessels) implantation of the PASCAL System's implant (composed of man-made materials). We are trying to evaluate the safety and performance of the PASCAL System with Optimal Medical Therapy (OMT) (also known as…
Early Age-Related Hearing Loss Investigation (EARHLI) is a study to obtain information on how a hearing aid-based intervention can prevent cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Age-related hearing loss (ARHL) is the third most common chronic condition in older adults. The…
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood…
The purpose of this study is to learn more about the mechanisms of hearing loss, specifically to learn how abnormalities in the brain may produce certain experiences that are common in patients with hearing loss. Individuals with hearing loss will be compared to individuals with normal hearing.
The Edwards Cardioband Tricuspid Valve Reconstruction FIT valve repair system is a prospective, single arm, multi-center study to evaluate the safety and performance of the Cardioband Tricuspid System. The Edwards Cardioband Tricuspid Valve Reconstruction System is intended for patients with tricuspid regurgitation deemed to be potential candidates for…
The purpose of this study is to determine if the use of immunotherapy nivolumab and the targeted therapy cabozantinib prior to removal of the kidney will increase the number subjects who are without any visible kidney cancer in their body at some point during the course of treatment. The study will also evaluate the changes that nivolumab and cabozantinib…
The purpose of this study is to study two experimental drugs called canakinumab and spartalizumab produced by Novartis to see if: It is safe and feasible to give canakinumab and spartalizumab prior to radical nephrectomy; canakinumab and spartalizumab can kill cancer cells and bring immune cells into the kidney cancer when given to human subjects prior to…
This is a prospective, single-arm, multi-center, early feasibility study. This research study is for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the heart's tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart…
This is a research study for patients who have Tricuspid Regurgitation (TR), a condition that occurs when the three leaflets of the hearts tricuspid valve do not close properly causing blood to leak backward with each heartbeat. Since some of the blood leaks backward, the heart has to pump more blood with each beat to push the same amount of blood forward.…
Axitinib (AG-013736) is an investigational (experimental) drug that is being studied in patients with metastatic pheochromocytoma/paraganglioma. The main goal of this study is to find out if axitinib is able to stop tumors from growing, or shrink tumors in patients with this type of cancer.
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the intervention works in treating a specific disease. Investigational means that the intervention is being studied. The Food and Drug Administration (FDA) has approved Nivolumab as treatment for…
This study will test whether cabozantinib in combination with nivolumab plus ipilimumab is more effective (works better) than nivolumab plus ipilimumab alone in treating patients with advanced kidney cancer who have not received prior treatment for their cancer. This study will also examine how safe cabozantinib is in combination with nivolumab plus…
Cisplatin is a chemotherapy medicine that is used to treat a variety of cancers. At high total (cumulative) doses it can be associated with progressive and irreversible hearing loss. The purpose of this study is see if injections of OTO-104 can protect against hearing loss associated with cisplatin therapy in the treatment of cancer. OTO-104 contains an…
We are doing this study to test a drug called MGD009. MGD009 is like an antibody, which is a protein in your blood that helps get rid of germs in your body. MGD009 is made to attach to cancer cells and to T-cells, which are a part of your immune system. Certain T cells have the ability to kill other cells, including cancer cells. By attaching to cancer…
Acute inner ear hearing loss is the sudden onset of hearing loss, usually in one ear, without any known cause. Acute hearing loss can permanently destroy some of the hair cells (that govern the sense of hearing) and / or hearing nerve in the inner ear.The drug AM-111 has been developed to protect the hearing cells and nerve following sudden inner ear…
This study is for patients who have renal cell carcinoma (RCC; a type of kidney cancer) and are at a high risk of disease coming back (disease recurrence) following either nephrectomy (surgical procedure to remove all or part of a kidney) or metastasectomy (removal of cancerous growth that has spread away from your kidney). The purpose of this study is to…
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate…