This study is testing whether a new investigational medicine called frexalimab can safely and effectively prevent kidney transplant rejection compared to tacrolimus, a standard medication currently used after transplant. Participants will be randomly assigned to receive either frexalimab (given by injection every 4 weeks) or tacrolimus (taken as capsules…
The main goal of this clinical trial is to determine if an investigational medication called VEL101 is safe, well tolerated, and effective in people receiving a new kidney transplant. Participants will be randomly assigned to 2 different doses of VEL-101 or to tacrolimus, which is standardly used post-transplant to prevent rejection. Participants will be…
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 purpose of this study is to understand the interaction between two different medications, tacrolimus and Paxlovid (nirmatrelvir/ritonavir), in patients who have had a kidney transplant and are being treated by their doctor for COVID-19 infection. Tacrolimus is an oral medication that is used standardly in kidney transplant recipients to prevent…
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…
This is a 60-month adaptive to evaluate three siplizumab-based treatment regimens in kidney transplant recipients. The purpose of this research study is to see if the anti-rejection medications that patients normally take after transplant can be reduced or stopped completely by using several medications including the investigational drug siplizumab in the…
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…
Kidney transplant extends life, improves quality of life, and reduces healthcare costs. Unfortunately, there are not enough donated kidneys, so many people who need a transplant spend years on the waiting list. Kidneys from organ donors who have hepatitis C virus (HCV) are often thrown away, but these kidneys work well, and hepatitis C can be cured. The…
The purpose of this study is to determine if an investigational drug called tegoprubart (also known as AT1501) is safe and effective in preventing rejection in patients who are undergoing a kidney transplant for the first time. Participants will be randomly assigned to tegoprubart or standard treatment with tacrolimusat the time of transplant. If you have…
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…
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.
Kidney transplant patients are at a higher risk for bone fractures compared to the general population. We are doing a clinical trial to examine the effects of 12-months of treatment with denosumab, a monoclonal antibody against RANKL, on bone density and strength as determined by bone imaging and by non-invasive measures of bone activity from blood and…
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).
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…
Subjects who undergo a kidney transplant require long term use of anti-rejection (immunosuppressive)drugs to prevent their body's immune system from attacking and damaging the newly transplanted kidney (rejection).The purpose of this study is to evaluate benefits and risks of two combinations(regimens) of immunosuppressive therapies: Thymoglobulin…
The purpose of this research study is to see if an investigational drug, BB3, is safe and effective forincreasing the amount of urine that a transplanted kidney will produce. An investigational drugis one that is not approved by the United States Food and Drug Administration (FDA). BB3 is agrowth factor-like drug, which means that it can affect cell…
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…