This study is looking for patients who have been diagnosed with advanced non–small cell lung cancer (NSCLC) that have certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C). This study is being conducted to determine how well participants respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of this type of cancer getting worse and improves participants survival (i.e., increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. It is anticipated that participants will be enrolled in this study for approximately 5 and a half years. There will be a total of approximately 15 visits to the study site during the study depending on how well participants tolerate or respond to the study drug. The visits will take several hours each and will take place approximately every 3 weeks.

We will gather feedback from healthcare providers and pregnant or up to two years postpartum adult women to better understand their needs and experiences related to traumatic stress and alcohol use during pregnancy. We will conduct focus groups with maternal health and mental health professionals, as well as conduct 60-minute interviews along with a survey/questionnaire with pregnant women who are experiencing both alcohol-related challenges and trauma-related symptoms. What we learn from these conversations will help us tailor services to address the unique needs of women during pregnancy and the postpartum period.

This is a treatment plan to provide recombinant Bacillus Calmette-Guérin (rBCG) to patients with bladder cancer who are eligible to receive TICE® BCG and may benefit from its use. The treatment plan will end if the product is approved for use in the United States or if a Food and Drug Administration (FDA) clinical trial proves rBCG treatment to be ineffective. The drug is not currently FDA approved for bladder cancer.

Subjects will receive rBCG. They will have tests, exams and procedures that are part of standard of care (SoC) and for treatment plan purposes. Participants will receive treatment based on TICEBCG protocol at their local institutions.

This study is enrolling patients with severe tricuspid regurgitation. Tricuspid regurgitation happens when your heart's tricuspid valve does not close tightly. The study will look at the safety and function of the investigational VDyne Transcatheter Tricuspid Replacement System (VDyne System). The VDyne System (Study Device) is experimental, which means it is not approved by the Food and Drug Administration (FDA), or any other relevant regulatory authority for commercial use. The VDyne System consists of an artificial heart valve and tools to place the valve into your heart. The VDyne Valve is designed to replace your tricuspid heart valve without open-heart surgery.

This study is randomized, meaning you will be assigned by chance to receive either the Study Device or the EVOQUE system, which is commercially approved by the FDA. The EVOQUE System is approved for use in the European Union (EU) (CE Mark) and the US (FDA).

Participation in this study will last about 5 years and include about 11 visits. Study related procedures included in these visits are physical exams, questionnaires, walking and moving from sitting to standing tests, blood tests, electrical measure of your heart's performance, ultrasound imaging of your heart, insertion of a thin tube to measure pressures through a blood vessel and monitor blood flow through your heart, and X-rays.

There are risks associated with the study such as: bleeding, injury to the system that controls your heartbeat, movement of the VDyne Valve from its implanted location, irritation of your esophagus, pain, inflammation, and skin/tissue injury. There are also risks related to study procedures such as other risks related with putting you to sleep for the procedure (general anesthesia) or other study related testing risks and the loss of confidentiality. Not all risks are known at known at this time. There may be benefit to you, although this cannot be guaranteed, but the information gained from you being in this study may benefit others with this condition in the future

The PRE-EMPT study is designed to identify people who may have early signs of heart disease even though they are considered to be at low risk for heart problems. Participants will undergo specialized heart scans to look for plaque buildup in the arteries that supply blood to the heart. Individuals found to have early plaque may be invited to participate in a treatment phase of the study. In this phase, participants will receive either study medications (rosuvastatin and/or colchicine) or placebo tablets and will also receive support for healthy lifestyle behaviors through a digital health platform. Patients will be randomized to one for four treatment groups. Researchers will follow participants for approximately two years to determine whether these treatments and lifestyle interventions can slow or reduce plaque buildup in the heart arteries. Information gained from this study may help improve strategies for detecting and treating early heart disease in the future.

This study will compare the efficacy and safety of SD-101-6.0 cream with SD-101-0.0 (placebo) in approximately 80 patients with Epidermolysis Bullosa (EB), including Simplex, Recessive Dystrophic, and JEB-nH subtypes. Patients will apply SD-101-6.0 or placebo topically once daily to the entire body for 60 days. Each patient will have one target wound that is 21 days or older and 10–50 cm² in size selected at baseline. The primary goal is to determine how many patients in each treatment group achieve complete closure of the target wound (skin re-epithelialization without drainage) by Month 1.

Patients will return for follow-up visits around Days 14, 30, and 60 to assess wound healing using the ARANZ SilhouetteStar™ device, with the target wound measured at each visit until it is documented as closed. Secondary assessments include changes in total wound burden based on body surface area (BSA), itching, and incidence of skin infections across the entire body. Itching will be evaluated at multiple time points but will not be recorded as an adverse event. Patients who complete this trial may be eligible to enroll in an open-label extension study (SD-008) to receive active treatment. Safety will be monitored through adverse event reporting, tolerability assessments, and physical examinations, with urine pregnancy testing performed at the investigator's discretion.

This study is for patients that have been diagnosed with platinum-resistant, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study is testing and investigational drug called INCB123667. "Investigational" means it has not been approved by the United States Food and Drug Administration (FDA). The primary purpose of this study is to evaluate the efficacy and safety of INCB123667 in terms of objective response rate (ORR) as assessed by an independent review committee (IRC). The drug is given to participants orally. Participants can expect to be on this study for approximately 24 months.

This study is being conducted to determine how well participants with stage IV or advanced stage IIIB/C nonsquamous non-small cell lung cancer (NSCLC), that has certain biomarkers (negative for PD-L1, and positive for KRAS p.G12C) respond to treatment with chemotherapy (carboplatin and pemetrexed) combined with either sotorasib or pembrolizumab. The study will determine whether sotorasib and chemotherapy reduces the risk of your cancer getting worse and improves your survival (i.e. increases the chance of you living longer) compared to the current standard treatment with pembrolizumab and chemotherapy. In this study, participants will be screened and if they meet criteria will be enrolled into the main study and assigned, by chance, into one of 2 groups. You will have an equal chance of taking sotorasib platinum doublet combination chemotherapy or pembrolizumab platinum doublet combination chemotherapy. It is hoped that the information gained from the study will help refine future chemotherapy programs.

Up to 40% of people who want to reduce their drinking have thought about suicide. However, currently there are no treatments that create a plan to manage cravings for alcohol and to manage suicide ideation. This study consists of three studies: Study 1 aims to conduct interviews with adults with lifetime alcohol misuse and thoughts of suicide and with providers who have worked with patients with alcohol misuse. The interviews obtain feedback on a newly developed brief (single appointment) treatment for alcohol craving and thoughts of suicide. Study 2 aims to pilot test the single-appointment treatment and 1 week of text messages with adults with recent alcohol misuse and recent thoughts of suicide. Adults will provide feedback in a brief interview. Study 3 aims to test the single-appointment treatment and 4 weeks of text messages with adults with recent alcohol misuse and recent thoughts of suicide. Specifically, different types of text messages will be tested.

This study is to compare the usual treatment (radiation plus temozolomide alone) to using the study treatment (usual treatment plus the study drug, vorasidenib). The addition of the study drug, vorasidenib, to the usual treatment could shrink or stabilize your cancer. The study drug is FDA (Food and Drug Administration approved. The study drug will be given orally. The study will randomize (the computer will pick the group that the participant will be enrolled in) participant to Group 1 or Group 2. Participants can expect to be on the trial for 10 years or more. There will 4 participants enrolled locally.