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.

The purpose of this study is to collect blood specimens and determine the levels of natriuretic peptides in the blood in patients that are presenting with a suspicion of new onset or worsening symptoms of heart failure. Blood specimens collected during this study will be used to support expanded development of a blood test that can help physicians diagnose heart failure.

The blood test (Access BNP Assay) being developed will measure natriuretic peptides that are released into the blood when the heart muscle is stretched and working too hard. This information is being used to develop a better blood test(s).

The purpose of this study is to test IMP1734 in humans for the first time and to assess the safety, tolerability, PK, PD, and anti-tumor activity of IMP1734 in patients with advanced solid tumors. The study will be conducted in 3 parts. Part 1 (dose escalation): Dose-escalation phase where the MTD (or MAD) will be
determined and safety, tolerability, PK, PD, and preliminary anti-tumor activity of IMP1734. Part 2 (dose optimization): Further evaluation of the safety, tolerability, PK, PD, and preliminary anti-tumor activity of selected dose levels of IMP1734. Part 3 (dose expansion): Efficacy, safety, and PK of IMP1734 with the dose(s) selected based on accumulated data will be assessed in either patients who have not received prior therapy with a PARPi containing treatment.

This study will enroll two groups of participants. The first group are those who participated in the RADIANCE CAP study, so have already undergone the renal denervation procedure. Those participants can enroll in this post approval study which will entail yearly follow up visits or telephone calls, blood pressure monitoring and questionnaires. The second group of participants are those scheduled to undergo a procedure called renal denervation for the treatment of high blood pressure that has not responded adequately to medications and lifestyle changes. Renal denervation is a procedure which uses a catheter (thin hollow tube) placed in the renal arteries (blood vessels that go to the kidneys) to deliver ultrasound energy. This energy will heat up a small area of tissue around the renal arteries to disable nerves that are surrounding the blood vessels as a way to help reduce blood pressure. Study visits include screening, procedure, discharge, months 1, 3, 6 and 12 then yearly for up to 5 years. Study procedures for this group includes blood work and urine studies, blood pressure monitoring, questionnaires, a follow up ultrasound of your kidneys and the blood vessels around the kidneys. Study related risks include loss of confidentiality, blood draw risks and unknown risks.

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.

This study involves an investigational drug called ALXN2220 for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Investigational means it is not yet approved for commercial use or sale by the Food and Drug Administration (FDA). ALXN2220 is intended to promote the elimination of ATTR deposits leading to symptom improvement.
All participants will be randomized, meaning assigned by chance, to receive ALXN2220 or placebo. A placebo looks like the study drug but contains no active medication. In this study, participants will have a 2 out of 3 chance, like drawing straws, of receiving the study drug and 1 out of 3 chance of receiving placebo. Neither the participants nor the study team or study doctor will know if they are assigned to receive the study drug or placebo. The study drug or placebo will be administered intravenously (IV), meaning into a vein in the arm, every four weeks.
Participation in this study will include a maximum of 56 visits over a maximum of 48 months. Study procedures include collection of vital signs, study drug infusion, physical exams, 12-lead electrocardiography, blood and urine collection, echocardiogram (ultrasound test of the heart), questionnaires, and some optional testing.

This is a Phase 3, 52-week, multi-center, double-blind, parallel-group, randomized withdrawal (RW), dose-up titration (DUT) extension study investigating the safety, tolerability, efficacy and durability of response of ritlecitinib (50 mg QD and 100 mg QD) in adult and adolescent (where permitted) participants with nonsegmental vitiligo following their participation in pivotal Study B7981040. The maximum duration of study participation is approximately 14 months, including a screening period up to 25 days, a 52-week treatment period, and a 4-week follow-up period.

The purpose of this study is to evaluate investigational treatments (study drug) for pancreatic adenocarcinoma following surgery in order to determine if any of these study treatments improve overall survival as compared to standard treatments. The goal is to determine the optimal dose level, safety, and tolerability for the study drug BNT321 in combination with mFOLFIRINOX. BNT321 is not FDA approved. mFOLFIRINOX is FDA approved by the U.S. Food and Drug Administration (FDA) to treat various cancers but may not be approved for your type of cancer. Treatment for this study may be up to 3 years. The procedures include blood and urine samples, questionnaires, infusions, and CT scans. Risks include diarrhea, nausea, vomiting, fatigue, headache, fever, and joint pain. You may or may not receive a direct benefit from participating in this trial, however, information learned from the trial may help other people in the future.

This Study will assess whether 20 mg of seltorexant compared with placebo as adjunctive therapy to an SSRI/SNRI antidepressant improves depressive symptoms in participants with MDD and insomnia who have had an inadequate response to current SSRI/SNRI antidepressant therapy.

Infants and young children are at increased risk for respiratory syncytial virus (RSV) infections because of their maturing immune system and lack of prior exposure to RSV. A genetically stable live-attenuated RSV vaccine (from the US National Institutes of Health) has been shown to be safe and immunogenic in RSV-seronegative children in Phase I studies. A Phase II study is ongoing to evaluate vaccine virus transmissibility to close contacts of study participants (VAD00014 study). Study VAD00004 will be initiated as part of the Phase III development of the RSVt vaccine. The objective of this study is RSVt clinical efficacy, while also further investigating the safety and immunogenicity of the RSVt vaccine in a global context. Vaccine efficacy against lower respiratory tract disease (LRTD) and upper respiratory tract disease (URTD) will be assessed separately, which will provide evidence of protection against RSV respiratory disease if efficacy against both LRTD and URTD is demonstrated.