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…
The purpose of this study is to better understand the use of Valchlor in clinical practice. Other goals include describing the demographic and clinical characteristics of disease and health outcomes of patients treated with Valchlor. Participating in this study will not influence the usual care you receive from your doctor.
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 Phase III trial investigates if the incorporation of immunotherapy will improve progression-free survival (PFS) and maintain overall survival (OS) while simultaneously minimizing long-term morbidity and treatment-related mortality by reducing exposure to radiotherapy and high cumulative chemotherapy doses. The study will enroll patients ages 5 to 60…
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 is being done to determine if a study drug called lenalidomide can be combined with full doses of EPOCH chemotherapy for patients with Adult T-Cell Leukemia-Lymphoma (ATLL), and to define the highest dose and longest duration of lenalidomide that can be given safely in combination with EPOCH. EPOCH chemotherapy is a combination of five…
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 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 clinical trial is for patients diagnosed with carotid artery stenosis that are at high risk of a stroke. Carotid artery stenosis develops as a result of plaque buildup in the carotid artery. Over time plaque buildup creates a narrowing of the carotid artery, restricting the flow of blood. Thus, increasing the risk of stroke. In this research study the…
This is a 2-part, multicenter study of a study drug in pediatric and young adult patients with mature B-cell non-Hodgkin Lymphoma which has come back or has not responded to the standard therapy. The study treatment is considered an experimental because the study drug is not approved by the United States (US) Food and Drug Administration (FDA) for treating…
This is a phase 2 study to determine the efficacy and safety of Naloxone HCL Lotion 0.5% for the treatment of mycosis fungoides (MF) type of cutaneous T-cell lymphoma (CTCL). Selected subjects will have the study drug applied to determine its effect on reducing itchiness and any potential side effects. Naloxone has previously been approved for direct blood…
The purpose of this study is to see if study drug IMO-8400 is safe and effective in the treatment of patientswith relapsed or refractory Diffuse Large B-Cell Lymphoma following conventional treatment.Examples of conventional treatment are radiotherapy, immunotherapy, chemotherapy, orradioimmunotherapy. Patients are scheduled to participate in this study…
This is a phase 3 clinical trial to determine the efficacy of topical SGX301 (synthetic hypericin) in combination with visible light therapy on cutaneous T-cell lymphoma (CTCL). Selected subjects can participate in 3 cycles each consisting of a 6 week treatment period where a chosen lesion will be treated with the study ointment (twice a week) followed by…
The purpose of this study is to determine a safe dose by testingthe investigational product, AGS67E at different dose levels. Secondly, to test what effects, good and/or bad, it has on subjects with refractory or relapsed non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL) or hairy cell leukemia (HCL). We will also…
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…
You are being asked to participate in a research study because you have Cutaneous T-Cell Lymphoma/Mycosis Fungoides, and one of your symptoms is itching. This study is being done to assess the efficacy and safety of Naloxone HCL Lotion 0.5% compared to Vehicle Lotion for the treatment of itching in patients with mycosis fungoides (MF) which is a type of…
The purpose of this study is to gather information about the effectiveness and safety of as drug called brentuximab vedotin when given in combination with another drug called bendamustine for Hodgkin Lymphoma. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.…