Annandale

Ovarian cancer is a serious health concern with the highest death rate among gynecological cancers. Diagnosing ovarian cancer definitively requires surgery since current tests cannot reliably distinguish between benign and malignant ovarian abnormalities before surgery. Researchers are evaluating the Cleo Diagnostics CleoDX Ovarian Adnexal Mass Score Test System, which measures five blood biomarkers to better assess the likelihood of cancer in patients with ovarian masses needing surgery. This test aims to help doctors make more informed decisions about surgery and patient care by providing a more accurate pre-surgical cancer risk assessment. The study involves patients with ovarian cysts or adnexal masses identified by imaging who require surgery but have not yet undergone it. The CleoDX test analyzes blood samples to generate a score indicating cancer risk, and patients are categorized after surgery as having malignant or benign masses. The study compares the CleoDX test results to standard clinical assessments and post-surgical pathology to evaluate the tests accuracy and performance. Participants will provide blood samples before surgery, and their clinical and pathological information will be collected and analyzed. The primary outcome is the calculation of the CleoDX adnexal mass score, with secondary outcomes comparing the tests score to clinical and pathological findings. Data analysis will take place after patient recruitment, continuing for up to 12 months or until the study ends in August 2026. The study involves monitoring and evaluating the tests ability to predict cancer risk accurately before surgery.

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.

Researchers are evaluating the effectiveness of switching to injectable GS-3242 plus Lenacapavir LEN compared to continuing the oral medication Biktarvy bictegraviremtricitabinetenofovir alafenamide, BFTAF in adults with well-controlled HIV-1 infection. The study has two parts Part A focuses on people in treatment Groups 1, 2, and 3 at Week 35, while Part B focuses on Groups 4 and 3 at Week 26. This phase 2 trial aims to assess the efficacy of these treatments in virologically suppressed people with HIV-1. Participants are randomized to receive either oral loading doses of GS-3242 combined with LEN tablets followed by intramuscular IM injections of GS-3242 and LEN for up to 52 weeks, at different doses depending on the group, or to continue daily oral BFTAF for up to 52 weeks. Part B participants are enrolled non-randomized to receive oral loading doses and IM injections of GS-3242 and LEN at specific doses. The study compares these treatment approaches to evaluate viral control over specified time points. During the study, participants will have their HIV-1 RNA levels monitored at Week 26, Week 35, and Week 52 using the FDA Snapshot Algorithm to measure viral suppression. Additional assessments include CD4 cell counts, drug concentration levels in blood, and monitoring for treatment-emergent adverse events. The studys total duration extends up to 52 weeks for treatment and includes safety and efficacy evaluations at multiple time points.

Researchers are evaluating whether a modified version of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who have newly occurring low back or leg pain due to acute lumbosacral musculoskeletal conditions with spinal stenosis and sciatica. This study is a phase 4, double-blind, randomized, placebo-controlled trial designed to compare the effects of the active drug with a placebo. The goal is to understand the impact on pain levels, physical activity, and sleep interference. Participants will be randomly assigned to receive either metaxalone 640 mg capsules or inactive placebo capsules. Both treatments are taken orally every six hours for seven days alongside standard care. The study includes an initial pilot phase followed by a larger randomized phase to ensure proper evaluation with adequate participant numbers. During the study, participants will complete surveys on day 1 before starting treatment and again seven days later to report on pain amount and quality, as well as how pain affects their physical activities and sleep. Researchers will monitor changes in pain using the Numeric Pain Scale from day 1 to day 7. The total participation involves these assessments and treatment over the one-week period with attention to any safety or health changes.

Researchers are evaluating how well a long-acting injectable combination treatment of lenacapavir, teropavimab, and zinlirvimab works compared to continuing daily oral HIV treatment in adults with HIV-1 who already have their virus well controlled. The study focuses on virologically suppressed people with HIV-1 and aims to measure how many participants maintain viral suppression after one year of treatment. Participants in one group will receive an initial dose of oral and injectable lenacapavir along with intravenous infusions of teropavimab and zinlirvimab on Day 1, followed by self-administered oral lenacapavir on Day 2. Every 26 weeks, they will receive additional injections and infusions up to Week 92, with an option to continue in an extension phase. The other group will continue their stable oral antiretroviral therapy as prescribed, also with an option to switch to the injectable combination after Week 92. Throughout the study, participants will be monitored for viral load levels at Weeks 52 and 92 using FDA-approved methods, changes in CD4 T-cell counts, and the presence of antibodies against study drugs. Safety will be assessed by tracking adverse events and treatment discontinuations. Drug levels will also be measured at several timepoints. The study may last until March 2033, including the extension phase for those who continue treatment.