This is a prospective, single-center, single-blind, two-arm, 1:1 randomized clinical trial. Patients who have undergone successful elective PCI will be screened with a lipid profile and eligible patients will be enrolled. Non-eligible patients will be enrolled in a registry. Randomization will be stratified by baseline LDL-C level and current statin therapy…
This is a Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design that will randomize about 1252 subjects at approximately 120 US and international centers. The study is looking to see if a device called the Impella device will improve the way the heart works as well as if health is improved as compared to…
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 primary objective is to demonstrate that physiologically-guided stenting using the Philips SyncVision iFR co-registration is superior with respect to clinical outcomes compared to PCI guided by angiography alone. Secondary objectives include: To evaluate the cost-effectiveness of physiology guidance with SyncVision compared to a standard of care PCI…
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…
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…
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 is trying to determine if using a Dynamic Coronary Roadmap (which is a software used along with an x-ray imaging system) reduces the total iodine contrast volume per Percutaneous Coronary Intervention (PCI) procedure compared to procedures performed without Dynamic Coronary Roadmap. This X-ray system provides imaging support while directing the…
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.
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).
This study has been designed to treat patient with coronary artery disease and demonstrate the superiority of the OCT device used to select and guide the stenting procedure when collecting images and flow measures inside the blocked artery.
This is a research study designed to look at the safety and effectiveness of the TriGUARD 3 cerebral embolic protection device in patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of the study is to assess whether the TriGUARD 3 can prevent death, stroke, more subtle signs of brain injury, and/or silent brain injury as measured…
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…
The purpose of this study is to collect data for evaluating VFR (Virtual Flow Reserve) in comparison with standard FFR (Fractional Flow Reserve) when patients undergo a percutaneous coronary intervention (PCI) to treat blockage or narrowing in the heart artery or arteries.
A study evaluating the placement of any guidewire beyond complex narrowed arteries that are relatively common in patients undergoing ballon angioplasty (a procedure where a balloon is used to stretch open narrowed arteries). At least one Teleflex guidewire and at least one Turnpike catheter is used. The guidewires and catheters that are being studied are…
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 Saranas Early Bird Bleed The Saranas study uses a device is called the Early Bird Bleed Monitoring System (EBBMS) and it is intended to provide physicians with an early indication of a potential internal bleeding complication due to vessel injury that may occur during the procedure before any symptoms present.
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…