Virginia Beach

Researchers are working to create and use a comprehensive database focused on intracranial aneurysms (IA). This project collects and studies clinical history, imaging data, biological samples, and other information to understand factors linked to the formation and rupture of aneurysms. They aim to identify genetic, environmental, and anatomical markers, as well as evaluate outcomes from different treatment strategies and improve patient care protocols. Participants include patients with diagnosed aneurysms, both ruptured and unruptured, family members of affected individuals, and healthy volunteers. Data collected involves detailed clinical records, imaging scans like MRI angiography and CT angiography, and various biological samples such as blood, cerebrospinal fluid, saliva, and stool. Consent covers access to medical records, use of biological samples, and potential future research uses including genetic analyses. During the study, participants provide health and lifestyle information, imaging data, and biological samples. Researchers will monitor multiple long-term outcomes including disease progression, life expectancy, quality of life, neurological and cognitive status, and treatment effects over periods up to 20 years. Data confidentiality is maintained, and participants can withdraw at any time without affecting their medical care. The study aims to validate disease models and support advances in aneurysm management and research.

Researchers are evaluating new treatment options for people with high-risk non-muscle invasive bladder cancer (HR NMIBC), a type of bladder cancer that affects the inner lining of the bladder but has not spread to the muscle or beyond. This includes carcinoma in situ (CIS), a flat form of bladder cancer limited to the bladder's surface. The study aims to find out if adding intismeran autogene, an immune system-targeting treatment, to the standard Bacillus Calmette-Guerin (BCG) therapy can improve outcomes for people with HR NMIBC by helping the immune system attack the cancer more effectively. Participants are assigned to different groups. One group receives both intismeran autogene by intramuscular injection every three weeks for nine doses along with BCG treatment given once weekly for six weeks, followed by additional weekly doses at later weeks. Another group receives BCG alone on the same schedule, while a third group receives only intismeran autogene. The study compares these treatments to see if the combination improves survival without cancer growth, spread, or return. During the study, participants will be monitored for up to approximately five years to track event-free survival, recurrence-free survival, overall survival, and other outcomes. Researchers will also evaluate adverse events and treatment tolerability. Follow-up includes assessments at regular intervals to observe disease status and safety. The total participation time may last several years to gather long-term data on treatment effects.

Researchers are evaluating Xeomin injections as a treatment to prevent chronic migraine in adults. This Phase 3 clinical trial compares the change in monthly migraine days between participants receiving Xeomin injections and those receiving placebo injections. The study involves participants diagnosed with chronic migraine who meet specific migraine frequency criteria. Participants will receive four treatments approximately 12 weeks apart, with injections administered into muscles in the head and neck at specific points. The trial includes a placebo-controlled period with two Xeomin dose groups and a placebo group, followed by an extension period where all participants may receive Xeomin. Treatments involve Xeomin or placebo injections prepared by reconstitution with saline. The study lasts about 52 to 55 weeks, including a 4 to 5 week screening period and multiple visits. Four visits are on-site for treatments, while others are remote via phone or video call. Researchers will monitor changes in migraine days and headache days, use of acute migraine medication, and any treatment-related side effects. The primary outcome is the change in monthly migraine days from before treatment to six months after the first injection.

Researchers are studying the use of Xeomin injections to prevent episodic migraine by comparing its effects to placebo injections. The study focuses on adults with episodic migraine who experience a limited number of migraine and headache days per month. The main goal is to measure changes in the number of monthly migraine days after treatment. Participants receive Xeomin or placebo injections in muscles of the head and neck at specific points. The study includes two Xeomin dose groups and a placebo group, with an extension period where placebo participants may receive Xeomin. Four treatments are given roughly 12 weeks apart during a trial lasting about 52 to 55 weeks. Participants attend 14 visits over the course of the study, with the first, last, and four treatment visits conducted in person. The remaining visits occur remotely via phone or video call. Researchers monitor migraine frequency changes, medication use, and any treatment-related adverse events. The primary outcome is the change in monthly migraine days after six months of treatment.

Researchers are evaluating changes in bone mineral density in premenopausal women with heavy menstrual bleeding caused by uterine fibroids or moderate-to-severe pain from endometriosis. This Phase 3B, open-label study looks at the effects of continuous treatment with a relugolix combination tablet for up to 48 months (4 years), followed by a 1-year period to monitor bone health after stopping treatment. Participants will take a daily oral relugolix combination tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg for 4 years. Bone mineral density will be measured every 6 months using dual-energy X-ray absorptiometry (DXA). Some women who have completed a previous related study may join to complete 3 years of treatment. After treatment ends, bone density will be checked again at 6 months and 12 months during the follow-up year. Women in the study will have regular visits for bone density scans and health assessments, including physical and gynecological exams, lab tests, and vital signs. Researchers will track changes in bone density at the spine, hip, and femoral neck throughout treatment and follow-up. They will also monitor for any fractures or adverse events during the 4 years of treatment and the 1-year post-treatment period. Total participation can last up to 5 years including the follow-up.

This research aims to gather long-term safety information from men with prostate cancer who have previously been treated with enzalutamide in an earlier study sponsored by Astellas or Medivation. The study focuses on participants who are still benefiting from enzalutamide treatment after the primary analysis or evaluation period of their prior trial has ended. Participants will continue taking the same treatment they received in their previous study, including enzalutamide once daily. Depending on which prior study they were part of, some may also take additional medications like abiraterone acetate with prednisone, or leuprolide acetate every 12 weeks alongside enzalutamide. Any dose changes require medical approval. The study also continued as a post-marketing clinical study in South Korea after local drug approval. During the study, participants will visit their institution every 24 weeks to review any side effects, medications, and confirm eligibility to continue. They will return every 12 weeks to return and receive study medication if applicable. Researchers will collect and monitor all adverse events, including serious ones, from consent until study completion, up to 96 months. This allows for thorough long-term safety monitoring while participants follow their usual care.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid levels in adults with tophaceous gout. This Phase 3 study focuses on patients who have had gout for at least one year and have measurable tophi. The primary goal is to see how well dotinurad lowers uric acid by Week 24 compared with allopurinol. Participants will stop taking their current allopurinol and begin study-supplied allopurinol once daily through Week 76 or start dotinurad with a dose escalation from 1 mg daily in the first 4 weeks, to 2 mg daily for the next 8 weeks, and then 4 mg daily through Week 76. The study is randomized and double-blind, comparing these two treatments over this period. During the study, participants will have their serum uric acid levels measured at various points, including Week 24 and up to Week 80. Researchers will also monitor tophi response, gout flare rates, and safety outcomes such as adverse events. The total participation could last up to 80 weeks, with ongoing assessments to track treatment effects and tolerability.

Researchers are evaluating saruparib (AZD5305) combined with standard radiation therapy (RT) and androgen deprivation therapy (ADT) in men with high-risk or very high-risk localized or locally advanced prostate cancer who have a BRCA1 or BRCA2 gene mutation. The study aims to show saruparib's superiority compared to a placebo by measuring metastasis-free survival. This randomized, double-blind, placebo-controlled Phase III trial includes approximately 700 adult male participants with prostate adenocarcinoma and confirmed BRCA mutations. Participants will be randomly assigned to one of two groups: Cohort A includes those receiving saruparib or placebo with ADT (and abiraterone in Cohort B), after primary or salvage radiation therapy. Saruparib and placebo are given orally alongside standard ADT, with abiraterone and prednisone/prednisolone added for Cohort B participants. The study treatment is administered in cycles, and participants will be monitored for safety and effectiveness throughout the trial. During the study, participants will undergo scans including CT or MRI, bone scans, and PSMA-PET to confirm disease status. Researchers will assess metastasis-free survival over approximately 93 months and monitor overall survival up to about 11 years. Additional evaluations include progression-free survival, biochemical recurrence, urinary symptoms, physical function, and plasma drug concentrations. Safety will be closely monitored with an independent committee overseeing adverse events. Participants will be followed regularly until the study ends in 2036.

Researchers are evaluating the medication orforglipron in people who are obese or overweight and have osteoarthritis (OA) of the knee with pain. The study aims to understand how well and safely orforglipron works for this group. This phase 3 trial is sponsored by Eli Lilly and Company and participation will last about 74 weeks. Participants will be randomly assigned to receive either orforglipron or a placebo, both taken orally. The study includes two independent groups within the protocol, each with an orforglipron and placebo arm. Treatments are given once daily, and the trial is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo during the study. During the study, participants will have regular assessments including pain and physical function evaluations using the WOMAC score, body weight measurements, walking tests, and blood tests for inflammation markers. The main outcome is the change in knee pain from the start to week 72. Safety and drug levels in the blood will also be monitored. Participants may use allowed pain medications, and all assessments will help researchers understand the effects of orforglipron over the study period.