Early Age-Related Hearing Loss Investigation (EARHLI) is a study to obtain information on how a hearing aid-based intervention can prevent cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD/ADRD). Age-related hearing loss (ARHL) is the third most common chronic condition in older adults. The…
Pancreatic cancer is a deadly disease and the best hope for improving the chances of survival is to find it early. Some patients, called "high risk", have an inherited predisposition to pancreatic cancer. Certain medical centers have started programs where "high risk patients" undergo testing, such as receiving imaging scans, to look for…
The purpose of this study is to learn more about the mechanisms of hearing loss, specifically to learn how abnormalities in the brain may produce certain experiences that are common in patients with hearing loss. Individuals with hearing loss will be compared to individuals with normal hearing.
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…
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 to evaluate how safe and effective the NanoKnife System is at treating Stage 3 pancreatic adenocarcinoma. This is registry study and therefore, the NanoKnife System is not being used for study purposes. The safety and efficacy of this system will be evaluated by comparing survival rates, pain ratings, and number of adverse…
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…
The purpose of this study is to learn which treatment works best in patients with pancreatic cancer. The study explores multiple treatment combinations. A study drug called atezolizumab may be combined with other drugs such as cobimetinib, PEGPH20, and BL-8040. Patients may also be assigned to receive standard chemotherapy treatment.
The purpose of this study is to find out which doses of talimogene laherparepvec (T-Vec) can be given safely to patients with pancreatic cancer that is either too big to be taken out by surgery or has spread to other parts of the body. The study will also see if T-Vec can cause tumor shrinkage or prevent its growth. To find out which doses are safe, all…
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.
Cisplatin is a chemotherapy medicine that is used to treat a variety of cancers. At high total (cumulative) doses it can be associated with progressive and irreversible hearing loss. The purpose of this study is see if injections of OTO-104 can protect against hearing loss associated with cisplatin therapy in the treatment of cancer. OTO-104 contains an…
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 research study is being conducted to see if a new treatment using a study drug called Olaparib given after platinum based chemotherapy treatments can reduce the risk of pancreatic cancer from growing back. Participants will receive either Olaparib or placebo (no contains active medication) and will stay on the research study for as long as they are not…
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…
The purpose of this study is to test whether GVAX pancreas vaccine and CRS-207 together are safe and work better than chemotherapy to treat individuals with advanced pancreatic cancer who have received at least one prior chemotherapy treatment for metastatic cancer. This study will also look at whether CRS-207 alone is safe and works better than…
Acute inner ear hearing loss is the sudden onset of hearing loss, usually in one ear, without any known cause. Acute hearing loss can permanently destroy some of the hair cells (that govern the sense of hearing) and / or hearing nerve in the inner ear.The drug AM-111 has been developed to protect the hearing cells and nerve following sudden inner ear…
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.
The purpose of this research is to find out whether it is safe to use a virus to deliver a new gene to the inner ear of people with hearing loss. This is a kind of gene therapy which involves gene transfer. Once the genetic material and vector are surgically administered to you, it is not possible to remove these agents. The study is designed to evaluate…
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…