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 purpose of this study is to determine whether using LY4052031 in a type of cancer that may have tumor cells that express a protein called Nectin-4 is safe and how well the cancer responds to the study drug. LY4052031 has not been approved by the US Food and Drug Administration (FDA). This is a first in human study and all of the risks are not fully…
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 lower the chance of your bladder cancer growing or spreading by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual therapy? The usual approach for patients who are not in a study is treatment with Transurethral surgery of bladder tumor (…
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…
This study will develop a data registry of patients diagnosed with uveal melanoma (UM). This registry will provide data that will be used to support the development of novel therapies for this disease. In this study, we are focused on trying to better understand how uveal melanoma behaves and how it is treated at different medical centers around the country.
This study is for patients who have bladder cancer that has not invaded muscle tissue and who have been treated with one or more surgical resections and Bacillus Calmette-Guerin or BCG, which was directly given into the bladder before. The main purpose of this trial is to show that durvalumab is safe when given alone, in combination with BCG treatments, and…
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…
We are doing this research to find out the safety, toxicity, and efficacy of intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of non-muscle-invasive urothelial carcinoma of the bladder that has recurred despite BCG use. The purpose of finding the maximum tolerable dose is important for future use of the drug, so as to provide the…
This is a Phase 1 study (the first time this treatment is being tested in humans) of an anti-cancer study drug called as PF-07225570. This study drug works on stimulating certain cells in the immune system. The study will test different doses that increase (dose escalation) and at the appropriate time, additional patients will be enrolled to evaluate this…
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 research study will investigate an experimental, unapproved drug that will be given two different ways; as an injection in the bladder wall after bladder tumor resection surgery (or TURBT) and then as an intravesical instillation (fluid inserted in the bladder by catheter) right after the injection. The purpose of this study is to find the dose which…
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…
This study is being conducted to evaluate the performance of the AssureMDx test for the detection of bladder cancer in patients presenting with hematuria.
This research study is being done to see if the study drug, IMCgp100, works and is safe as treatment for subjects with uveal melanoma who also test positive for HLA-A*0201. In this study IMCgp100 will be compared to three standard treatments: dacarbazine (a chemotherapy drug), ipilimumab (an immunotherapy drug), or pembrolizumab (an immunotherapy drug).…
The purpose of this study is to find out what effects, good and/or bad, intermittent dosing of the medication Selumetinib will have on you and your uveal melanoma. Selumetinib is a medication that blocks (or turns off) MEK, a protein activated in some uveal melanoma cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop your cancer from growing.
The purposes of this clinical study are: To evaluate the safety and tolerability of up to 2 drug release periods of GemRIS for up to 7 days per drug release period To evaluate the pharmacokinetics (the study of the bodily absorption, distribution, metabolism, and excretion of the drug) of gemcitabine and a gemcitabine-related metabolite (product after…
This is a Phase I study of a weekly intra-patient escalation dose regimen with IMCgp100 in patients with metastatic uveal melanoma (mUM). To help decide whether or not patients can take part in a research study looking at a new form of treatment for advanced uveal melanoma, their blood need to first be tested to determine their Human Leukocyte Antigen (HLA…
The study is part of a research program to assess the efficacy of the drug nab-rapamycin, a biologic mTOR inhibitor. The purpose of the study is to assess the response rate, as well as, the safety of administering nab-rapamycin in combination with gemcitabine directly into the bladder in an effort to treat bladder cancer. The study seeks to determine if…
This research is being done to study the effects, safety, and tolerability of the study drugs Nivolumab and Urelumab when given to people with advanced bladder cancer that has spread into the muscle tissue, also called Muscle-Invasive Urothelial Carcinoma of the Bladder (MIBC). Specifically, this research study will have participants either take Nivolumab…
The purpose of the treatment part of the study is to find out what effects drug crizotinib has, good and/or bad on people with "high risk" uveal melanoma after surgery or radiation for the eye. It is thought that giving crizotinib to patients with "high risk" uveal melanoma can lower the chance the cancer will come back. Uveal melanoma…
The purpose of this study is to test how well the drug works, safety, and side effects of the experimental drug called BMS-986205. BMS-986205 will be added to another cancer medicine called nivolumab plus chemotherapy for participants who have bladder cancer that has grown into the muscle wall of the bladder. These drugs will be compared to just…
The purpose of this study is evaluate the benefits and safety of using the combination of drugs, AEB071 and BYL719 to treat patients with an advanced form of uveal melanoma. The study will have two parts. The first part twill test different dose levels of each drug.Once the highest safe dose level is found, another group of patients will be treated at that…
This clinical trial is for patients who have cancer of the urinary system (urothelial cancer, including cancer of the bladder, renal pelvis, ureter or urethra) that has spread to nearby tissues or to other areas of the body who have already been treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). This clinical trial uses an…
The purpose of this study is to look at a new treatment for non-muscle-invasive bladder cancer. This new form of paclitaxel, a drug currently used by injection into a vein to treat various types of cancer, is designed to be instilled (injected) into the urinary bladder with a catheter (tube) placed into your bladder through your urethra (the opening where…
You are invited to join voluntarily in a clinical research study to find out if the drug LXS196 alone or in combination with HDM201 is safe and has beneficial effects in people who have metastatic uveal melanoma. The purpose of this study is to determine the highest dose of LXS196 that can be given safely without unacceptable side effects as a single drug…