The purpose of this study is to evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in a patient population with symptomatic severe Aortic regurgitation ( a condition where the heart's aortic valve does not close tightly and allows some blood to leak back into the heart chamber) requiring replacement/repair of their native aortic valve that are at high risk for open surgical aortic valve replacement/repair (SAVR).
Your involvement in this study will last approximately 5 years from the time of your procedure. The visits include: Screening/Baseline, Procedure, Pre-Discharge, 1 month, 6 months and annualy for 5 years
This study is for subjects with Diffuse large B-cell lymphoma (DLBCL) that has gotten worse or come back after two or more treatments. This study is testing an "investigational" (not yet FDA approved drug) study drug called loncastuximab tesirine (ADCT-402). Treatment will be administered intravenously or via tablet depending on the subject's assigned treatment. The primary purpose of this study is to test whether the investigational drug combination of loncastuximab tesirine in combination with one of four other anti-cancer agents is a safe and effective treatment for relapsed or refractory B-cell Non-Hodgkin Lymphoma. Treatment will be assigned by a system in a sequence unless the subject has received the combination drug (the drug that is not locastuximab). This means the first enrolled subject will be assigned to arm C, the second to arm E, and so on. The subject will be seen approximately once a week during treatment, and may remain in the study for up to 3 years.
The purpose of this research is to compare the risks and benefits of two different procedures used to help patients with mitral valve regurgitation (also known as MR). MR is a condition where the valve does not close fully when it is supposed to, and some blood can then leak back into the left atrium instead of circulating to the rest of the body. The treatment options this study will compare are: (1) transcatheter edge-to-edge repair (abbreviated as TEER; which is a catheter procedure for repairing the mitral valve that doesn't require surgery to open up the heart) and (2) mitral valve repair surgery, which is an open-heart surgical procedure. There are no new or "experimental" procedures being tested in this study: both treatment options are well-established treatments and are regularly performed in patients who have MR.
This study is for men with prostate cancer that has come back after surgery. This study is being done to see if PET/CT scans help provide more tailored treatment recommendations and outcomes for men who have prostate cancer after radical prostatectomy (RP) and will adding focal, metastasis directed radiation treatment (e.g.., stereotactic radiation) and/or additional systemic therapy (e.g., apalutamide) to standard of care treatment help to delay progression of prostate cancer in men who have already had an RP and now have recurrence?
This study is for patients who have been diagnosed with breast cancer and their doctor has recommended that they receive radiation therapy after their mastectomy to reduce the risk of their breast cancer coming back. This study is being done to see if the severity of skin redness and peeling in the area of radiation can be reduced by applying Mepitel Film during radiation therapy.
This study is for adult male and female subjects that have been diagnosed with B-cell leukemias and lymphomas. In this research study, some of the subjects immune cells (called T cells) will be taken during a procedure called ‘apheresis', and genetically modified in the laboratory, in order to recognize a protein on the cancer cells. The investigational treatment in this study is called CD19-CD34t metabolically programmed CAR-T cells. The purpose of this study is to test whether these genetically CD19-CD34 CAR T-cells when re-introduced back into the body, will be able to safely and effectively attack the cancer cells. The investigators also want to determine the dose of genetically modified CD19-CD34 CAR T-cells which can be safely administered to subjects. Subjects can expect to be in this study for up to 15 years.
The need to advance knowledge and increase access to treatment for co-occurring posttraumatic stress disorder (PTSD) and substance use disorders (SUD) is a priority for service members and Veterans. PTSD and SUD often co-occur and are two of the most common and debilitating mental health disorders among service members and Veterans. However, few providers are trained in this approach and therefore are not prepared to deliver best practice care to Veterans who need integrated PTSD/SUD treatment.
This project will directly address this critical gap in provider training to improve the care of Veterans with comorbid PTSD/SUD, by providing development and testing of a web-based provider training course for concurrent treatment of PTSD and SUD Using prolonged exposure (COPE).
A large proportion of individuals with alcohol use disorder (AUD) also meet criteria
for posttraumatic stress disorder (PTSD). Trauma-focused, cognitive-behavioral therapy delivered alongside interventions for substance use disorders are most effective. Cognitive Processing Therapy (CPT) for PTSD and Relapse Prevention (RP) for AUD are two of the most widely used and effective treatments for these
conditions. The purpose of this study is to examine the CPT-RP, as compared to RP alone, in reducing (1) alcohol use frequency and quantity and (2) PTSD symptom severity among individuals with current AUD/PTSD.
This study is for men and women with HER2-positive salivary gland cancer (SGC) that has come back, spread outside of their salivary gland, or cannot be removed by surgery. This study is being done to find out if ado-trastuzumab emtansine (T-DM1) extends the length of time without the cancer getting worse compared to the usual approach.
This is a research study to find out if the study drug called BEAM-101 is safe and effective in the treatment of patients with severe Sickle cell disease (SCD). The study drug, BEAM-101 is a new investigational (experimental) therapy that is the first in human use of this drug.
The study medication uses patients' own stem cells that are harvested through apheresis (process where blood is removed, stem cells collected and blood is returned), changed by genetic modification, and transplanted back into the individual through intravenous infusion to treat severe SCD.
Participation in this study is expected to last approximately 24 months, starting at time of screening, through the collection of cells, transplantation of study drug, and 15-month follow-up period. Study visits during the screen and mobilization period will vary depending on the cell collection process, in other words, the mobilization and collection period could be 3 separate visits to harvest adequate stem cells. Subjects are then hospitalized for the conditioning period, transplantation of study drug and engraftment period (when blood counts return to normal). The follow up visits after discharge from the hospital will be monthly for the first 6 months, then every other month until 24 months post transplant period.
At the end of the 24 months, all participants will be asked to enroll in the long-term extension study for a duration of 13 years making the total follow-up period of 15 years.