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…
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 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 test an investigational device called the Echopulse for treatment of breast fibroadenomas in women. Fibroadenomas are benign (noncancerous) breast tumors. These lumps can occur alone, in groups, or as a complex of lumps together. Sometimes women feel these in the breast when doing regular self-breast exams, or they may be…
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.…
We are asking you to participate in a research study to learn if different ways of doing routine anesthesia and patient care before, during and after abdominal surgery can reduce breathing problems. The total time of the study is 3 months with daily visits by a member of our study team while you are in the hospital and 3 short follow-up calls after you…
The experimental drug being investigated in this study is called rucaparib. Rucaparib is being developed by Clovis Oncology, Inc. (the Sponsor), a biopharmaceutical company with headquarters in the United States (US). Rucaparib (trade name: Rubraca) is a medicine that is approved in the European Union (EU) and the US for use in certain types of ovarian…
This is a Phase 1/2 multicenter study of VX15/2503 in pediatric patients and young adults with solid tumors which have come back or have not responded to standard therapy. The study treatment is considered experimental because VX15/2503 is not approved by the United States (US) Food and drug Administration (FDA) for treating pediatric patients and young…
The study drug (TSR-042) in this study is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. The Study Drug is designed to help your immune system by attaching to a protein called PD-1 and stopping one of the signals that keeps your immune system from recognizing the cancer. This may help your immune system…
You are being asked to be part of this study because you have been diagnosed with a bulge or aneurysm in your iliac arteries, the vessels that supply blood to the lower half of your body. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk…
The study is designed to evaluate the safety and effectiveness of the InSpace device as a primary surgical treatment for a full thickness Massive Rotator Cuff Tears (MRCT) in comparison to Partial Repair of a full thickness MRCT performed during an arthroscopic procedure.
The purpose of this research study is to compare the safety and effectiveness of two drug-eluting stents that are used to open the blocked or narrowed blood vessel of the leg in patients with Peripheral Artery Disease (PAD): the ELUVIA Stent and the Zilver PTX Stent.
Thepurposeof the study is to test whether or not QPI-1002 could be used to lessen or prevent acute kidney injury after heart surgery. Another purpose is to better understand the safety of QPI-1002.
SY-1365 is an investigational drug that stops the function of a protein known as CDK7. Previous workhas shown that CDK7 is necessary for some cancers to grow. Therefore, SY-1365 could be used to slow down the growth of cancer. This research study is being done to understand the highest tolerated dose of SY-1365, and to assess the safety of SY-1365 in…
The purpose of this study is to evaluate the short-term (1 year) and long-term (5 and 10 year) safetyand effectiveness of the JOURNEY II CR Total Knee System in patients with degenerative joint disease of the knee requiring primary total knee replacement. Clinical, radiographic, and health economic outcomes will be evaluated.