The objective of the study is to evaluate the safety and efficacy of the JenaValve Pericardial TAVR system when treating patients with aortic regurgitation. Aortic Regurgitation is a condition that develops when the heart's aortic valve does close tightly, therefore the blood leaks back into the heart chamber. The JenaValve Pericardial TAVR system will…
The high incidence and variety of conduction disturbances post-TAVR represents a major challenge in the periprocedural management of TAVR recipients. Despite the growing body of knowledge on this topic, the large variability in the management of these complications has translated into a high degree of uncertainty regarding the most appropriate treatment of…
This prospective, multicenter trial is looking at the investigative device called the ACURATE Transcatheter Aortic Valve System for TAVR to see if it is safe and effective in treating patients with severe symptomatic native aortic stenosis. The ACURATE Transcatheter Aortic Valve System for TAVR is designed for iliofemoral access and delivery of a self-…
This study is being done to answer the following question: Can we increase the clinical complete response rate (tumor disappears by exam, endoscopy, and imaging) by adding a 3rd drug (irinotecan) to the standard chemotherapy regimens known as FOLFOX or CAPOX, given following long-course chemoradiation for patients with locally advanced rectal cancer? We are…
The purpose of this study is safety, tolerability and efficacy of a combined treatment of LBL-007 and tislelizumab in combination with bevacizumab and capecitabine. LBL-007 and tislelizumab has not yet been approved by the Food and Drug Administration (FDA). Bevacizumab and capecitabine are approved for use in colorectal cancer, but their use in combination…
Aortic stenosis (AS) or narrowing of the arteries remains one of the most common valvular diseases in the Western population requiring intervention. The deterioration of the aortic valve is more common in the older population and usually along with coronary artery disease (CAD) requires the need for treatment. This is a study that is collecting safety and…
The purpose of this study is to find out if the study medicine called EDIT-301 will help in the treatment of Severe Sickle Cell Disease (SCD) and how safe it is to be used in people. EDIT-301 (study medicine) is a new investigational therapy which uses the patient's own stem cells, modifies them by CRISPR technology, and infuses them back to the…
This is a prospective, multicenter, non-randomized, single-arm, open-label clinical study, sponsored by Pi-Cardia. Fifteen (15) patients with symptomatic severe Aortic Stenosis (narrowing of the aortic valve) who are considered operable but are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement…
The study is to determine whether aortic valve replacement is helpful for patients who have moderate-severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms. Subjects will be randomly assigned, l to one of two groups: (1) Treatment…
The purpose of this study is to determine if the study drugs, encorafenib, and cetuximab, taken in combination with pembrolizumab would improve compared to the outcome of pembrolizumab alone in study patients. Encorafenib and cetuximab target cancerous BRAF proteins and potentially slow down the growth of cancer cells. Pembrolizumab may help your immune…
The BNT122-01 research study is testing an investigational medication (RO7198457) for patients who have had surgery for Stage II and Stage III colorectal cancer. The study will look at the safety and effectiveness of an investigational medication for patients who have had surgery for Stage II (high risk) and Stage III colorectal cancer. It will study…
This research study is sponsored by ImmunogenX and The National Institutes of Health (NIH, Bethesda, MD). The objective of this study is to determine if the investigational product (latiglutenase) will help decrease symptoms in subjects with celiac disease while maintaining a gluten-free diet while undergoing periodic gluten exposure. In addition, this…
The purpose of this study is to learn about whether the study drug (PF-07209326) is safe and effective in people with sickle cell disease and learn about what the right dose is. We will look at drug levels in the blood, see how fast drug levels rise and fall, and what effects the drug has, all of which are known as the pharmacokinetics (PK) and…
This study evaluates whether the addition of immune therapy to usual FOLFOX chemotherapy in patients with deficient DNA mismatch repair stage III colon cancer can improve your outcome compared to FOLFOX alone. The immune therapy drug, atezolizumab, may allow your body's immune system to more effectively kill cancer cells in your body. One of the…
The purpose of this study is to compare the effects, good or bad, of the cancer immunotherapy combination treatments (CIT) combinations versus standard treatment on you and your colorectal cancer to find out which is better.
The study is to determine whether aortic valve replacement is helpful for patients who have severe, calcific, aortic stenosis (a narrowing of the aortic heart valve, where calcium has attached to the valve surface, resulting in obstructed blood flow) and do not have symptoms.
This study is being done to answer the following question: Does duloxetine (either 30 mg or 60 mg) prevent numbness, tingling, and/or pain caused by your colorectal cancer treatment with oxaliplatin? We are doing this study because we want to find out if duloxetine can prevent Oxaliplatin-Induced Peripheral Neuropathy (OIPN).
Deciphera Pharmaceuticals, LLC., the Sponsor of this study, is developing a drug called DCC-2618 to treat Gastrointestinal Stromal Tumors (GIST) that are growing because of changes in specific genes. Genes are the instructions that tell a part of your body called a cell what to do. Cancer changes the genes so that the instructions are no longer correct. DCC…
Studies have shown that cancer patients may be at high risk for financial problems because of the cost of treatment. These financial problems can be stressful and sometimes might cause patients to avoid or refuse treatment. This study will measure how often financial problems happen in patients with colorectal cancer, using questionnaires that collect…
The objective of this study is to collect outcome data on valve performance and a pre-specified TAVR care pathway. Transcatheter aortic valve replacement (TAVR) has been shown to be a safe and effective treatment for patients with severe aortic stenosis who are at extreme, high, or intermediate surgical risk. Since CoreValveTM became commercially approved…
The purpose of this research is to learn how to help parent youth pairs work together to help youth with sickle cell disease take hydroxyurea every day as a daily habit. This study is for children and teens ages 10-18 with Sickle Cell Anemia taking hydroxyurea, and their parents (or guardians). Many children and teens do not use hydroxyurea every day. Daily…
This study is being done to see if giving your child a lower dose of chemotherapy (drug therapy), than has been used historically in bone marrow transplant, to kill his/her own diseased cells before he/she receives a bone marrow transplant, will possibly result in the permanent control of your child's sickle cell disease. Patients will receive busulfan…