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…
This is a prospective multicenter study whose purpose is to establish the safety and effectiveness of the Edwards SAPIEN 3 and SAPIEN 3 Ultra valves with Commander delivery system in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification (which is a progressive loss of function of the mitral valve due to…
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 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 is a randomized controlled trial (RCT) that will compare the clinical outcome of MitraClip device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team. In this trial,…
The study is designed to compare the safety and effectiveness of the PASCAL System to the MitraClip System for reduction of degenerative mitral regurgitation.
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…
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…
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 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 study is designed to look at the safety and performance of The Intrepid TMVR System using transfemoral transseptal access (TF). TF is a procedure that requires access to the femoral vein by an incision in the lower limb between the knee and the hip. The study population is for patients with severe, symptomatic mitral regurgitation (MR), a condition…
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…
The Millipede Feasibility Study is a prospective, open-label, single-arm study to assess the safety and feasibility of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation. The Millipede Annuloplasty Ring System is a novel transcatheter, fully adjustable, complete annuloplasty repair device for the treatment…
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…
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 trial is a non-randomized, prospective, multi-center early feasibility study to evaluate the safety and performance of the AccuCinch system in patients with Heart Failure and Reduced Ejection Fraction HFrEF
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…
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 evaluate a new device to treat patients who may benefit from the repair of their mitral heart valve due to mitral regurgitation. The device is called the Edwards Cardioband System (Edwards Cardioband System or the device). The device is investigational in the United States but has been approved in Europe. This clinical study…
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.…