This study is evaluating the safety and effectiveness of the experimental treatment named AB-1002. The purpose of this study is to look at the safety and feasibility of delivery of adeno-associated virus (AAV) through the coronary arteries into the heart in participants with heart failure and non-ischemic cardiomyopathy. An experimental treatment is another option for care for your disease that is still being tested and is not yet approved by the Food and Drug Administration (FDA).

Participation in this study is expected to last one year and include up to 18 visits. Study related procedures include the following heart related testing: study drug infusion, electrocardiograms (ECG), a test to show the heart's electrical activity, echocardiogram (Echo), a test that uses ultrasound to capture moving images of the heart, cardiopulmonary stress test, sample collection including blood, urine, tissue, nasal mucus, saliva, semen, and stool, questionnaires, physical exams, and at least an overnight stay in the hospital. You will also need to take medications to suppress your immune system.

There are risks associated with this study. Risks associated with gene therapy include an immune response that may cause inflammation in the liver, heart or other organs. It may damage your red blood cells, cause a low platelet count or cause the formation of small blood clots. There are also risks related to the study procedures including bleeding associated with the heart biopsy, risks related to drawing blood, risks of radiation, and loss of confidentiality. There may be no benefit to you but knowledge gained from this study may benefit others with heart failure and non-ischemic cardiomyopathy in the future.

The purpose of this research study is to see how effective the use of copper Cu 64 PSMA I&T Injection is in imaging prostate cancer tumors for staging of men with newly diagnosed intermediate or high risk prostate cancer who are planned to have radical prostatectomy with pelvic lymph node dissection. Three hundred twenty-three (323) patients are planned for enrollment in this Phase 3 study, at approximately 60 sites in the U.S. and Europe. Copper Cu 64 PSMA I&T Injection is an investigational imaging agent, given to you via IV injection, that may make tumors from prostate cancer show up better during a nuclear medicine imaging scan. The imaging scan is a type of nuclear medicine imaging test, which means it uses a radioactive drug and a special camera to create pictures of your tumor(s). Copper Cu 64 PSMA I&T Injection is investigational in the United States which means that the U.S. Food and Drug Administration (FDA) has not yet approved it.

You are invited to volunteer in this clinical research study because you have been diagnosed with tricuspid valve regurgitation.

The type of research study you are being asked to join is called an Early Feasibility Study. This means the device and procedure you are receiving (the treatment) have not been previously studied in humans, and that you will be among the first patients in the world to undergo this treatment. The Device you are receiving is not approved by the United States Food and Drug Administration and its safety and effectiveness are unknown.

Participants will undergo right heart catheterizations, computed tomography (CT) scans without iodinated contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits. You will have a screening right heart catheterization (RHC) to check the pressures and function of your heart. The research procedure and placement of the TRIcares Topaz Transfemoral Tricuspid heart Valve (Topaz Tricuspid Valve) will be placed in a hybrid operating room. This procedure is done by entering a vein in your groin known as the femoral vein. The purpose of this device is to eliminate the regurgitation or leaking in the tricuspid valve of the heart to help reduce the symptoms caused by this leaky valve.

The most common risks associated with the research procedure are those related to the right heart catheterization (RHC) and Topaz Tricuspid valve procedure. Major risks include bleeding and damage to the heart or surrounding blood vessels. There are no known benefits of the research device. There may be possible benefits from the research procedure including improvement in quality of life or a decrease in the symptoms caused by tricuspid regurgitation. The information that we obtain from your participation in this study will help us learn more about how safe and effective this approach is in treating the symptoms of individuals similar to yourself.

The goal of this study is to determine if an investigational product (a substance not approved by the US Food and Drug Administration) made from mesenchymal stromal cells (MSC) and taken as a single subcutaneous injection, is safe and well tolerated in individuals with active lupus while also receiving standard of care treatment for their lupus.

The MSCs used in this trial are cells that were obtained from the umbilical cords of healthy donors having an elective Caesarean section and who have been screened to be sure that they are free of any infectious diseases.

Participation in the study will take about 9 visits and 2 telephone calls over a period of 7 months. With participation, compensation is available.

At study visits you will have blood and urine labs collected, physical exam/lupus specific assessments, and be asked to complete a questionnaire. These procedures are much like those completed at your routine standard of care visits with your rheumatologist.

The risks to study participation are that only a few hundred people worldwide have been treated with MSCs. So far, there have been no serious side effects when MSCs have been used. Potential risks could however include an allergic reaction to the cells, development of infection, or MSCs changing into cancer cells.

Prior to any use of the MSC injection, participants will have a thorough review of the study and given an opportunity to consider their options and have all questions/concerns answered. A screening visit will be completed to ensure that participation is appropriate - participant safety is a priority of the study.

This research study primarily aims to determine if BT8009 alone and when given in combination with pembrolizumab works against urothelial cancer for patients who previously received treatment for their locally advanced or metastatic cancer.
This research study also aims to understand the side effects of BT8009 when given alone and in combination with pembrolizumab.
The study drug BT8009 is investigational (i.e., experimental). An investigational drug is one that has not been approved by the Regulatory Authority to treat a certain condition or illness or a certain type of patient.

This is a pivotal Phase 3, global, randomized, double-blinded, placebo-controlled, multicenter study to evaluate efficacy and safety of lutikizumab in subjects 16 years of age and older with moderate to severe HS. The study comprises a 35-day Screening Period, a 16-week placebo-controlled double-blinded period (Period 1), a 36-week double-blinded extension (Period 2), and a 10-week (70 days) Follow-Up Period after last study drug dosing or an option to enter a separate long term extension study.

This study tests a mobile app that aims to reduce alcohol use and risky sexual behavior.

Interested individuals will complete an online screener to see if they are eligible. Eligible participants will complete six mobile sessions over the course of about 45 days.

The first and the last session will be completed via video conference with a member of the research staff. The second through fifth sessions are completed independently on the mobile app. Sessions involve survey questionnaires, clinical interviews, and computerized tasks. Participants will be compensated for completed study sessions.

The purpose of this research is to assess a group-based telehealth parenting program for child ages 2-6 years old with a neurodevelopmental diagnosis and behavior problems. Families will complete an online intake assessment, 6 group-based telehealth PCIT sessions, and an online post intervention assessment. Families will be compensated for their time.

This study is for subjects that have been diagnosed with advanced high grade serious ovarian cancer. The investigational drug used in this study is Sovilnesib. The main purpose of this study is to is to establish the recommended phase 2 dose, which will be considered the optimal dose, of Sovilnesib. Additionally, this study will examine the safety, tolerability and preliminary efficacy of Sovlinesib. The total time you will be on the study treatment will depend on if you have any unwanted side effects and how your cancer is responding to treatment.

The purpose of this study is to evaluate the safety and efficacy of the study drug ZILRETTA (Triamcinolone Acetonide, extended release) compared to a placebo (saline solution). The study drug is administered through an ultrasound-guided injection to the affected shoulder. 66.6 percent of participants will receive Zilretta and 33 percent will receive placebo.
The study Drug ZILRETTA, is currently FDA-approved for knee osteoarthritis and is being investigated in this study for treatment of shoulder osteoarthritis. The study population consists of adults 50-80 years of age who have been diagnosed with Osteoarthritis of the shoulder by x-ray. The study has 9 study visits over 24-week's and will include, but is not limited to a questionnaire, medical examination, shoulder x-ray and blood draws. Each visit should last less than 1 hour, depending on the procedures performed. The most common side effects of the study drug are joint pain, headaches, upper respiratory infections, back pain, joint swelling, and cold symptoms.