Annandale

Ovarian cancer is a serious health concern with the highest death rate among gynecological cancers. Currently, a definitive diagnosis can only be made after surgery, as reliable tests to distinguish cancerous from benign ovarian abnormalities before surgery are lacking. Cleo Diagnostics has developed a new blood test measuring five biomarkers to better differentiate between benign and malignant ovarian conditions, showing promising results compared to the standard CA125 test. The study is evaluating the Cleo Diagnostics (CleoDX) Ovarian Adnexal Mass Score Test System. This diagnostic test analyzes five substances in the blood to provide a score indicating the likelihood of cancer in patients with an ovarian mass who require surgery. The test aims to help doctors make more informed decisions about surgery and patient care by improving pre-surgical cancer risk assessments. Participants will provide blood samples for the CleoDX test before surgery. Researchers will analyze the results after completing patient recruitment and continue for up to 12 months or until August 2026. The main outcome measured is the calculation of the CleoDX adnexal mass score. The study focuses on improving patient outcomes by identifying those with malignant conditions who need specialist care.

Researchers are investigating how bone mineral density changes during long-term treatment with the relugolix combination tablet in premenopausal women aged 18 to 50 who have heavy menstrual bleeding caused by uterine fibroids or moderate to severe pain related to endometriosis. This Phase 3B, single-arm, open-label study aims to assess the safety and effects of up to 48 months (4 years) of continuous treatment, followed by a 1-year post-treatment follow-up period. Participants will receive a daily fixed-dose tablet containing relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg. Bone mineral density will be monitored every 6 months using dual-energy X-ray absorptiometry during treatment. Some women who completed a prior related study may join for 3 years of treatment under this protocol. After treatment ends or if stopped early, participants will be followed for 1 year with bone density checks at 6 and 12 months. Women in the study will have regular physical, gynecological, and laboratory assessments to monitor health and treatment effects. Researchers will measure the percentage change from baseline in bone mineral density at the lumbar spine after 48 months of treatment. Safety and health status will be closely observed throughout the treatment and follow-up periods to understand the long-term impact of the relugolix combination tablet on bone health.

Researchers are evaluating if a modified form of metaxalone 640 mg can reduce pain in adults aged 18 to 80 years who experience new low back or leg pain due to acute lumbosacral musculoskeletal conditions, including spinal stenosis and sciatica. This is a double-blind, randomized, placebo-controlled Phase 4 study comparing the active drug to a look-alike placebo. The purpose is to measure changes in pain and how it affects physical activity and sleep over one week. Participants will be randomly assigned to receive either metaxalone 640 mg oral tablets along with standard care or a placebo that looks the same but contains no active drug. The study consists of an initial pilot phase followed by a larger phase with more participants to confirm results. Treatments are taken as oral tablets, and participants continue their usual care. During the study, participants will complete surveys on Day 1 before starting treatment and again on Day 7 to report pain levels, pain quality, and how pain affects their physical activity and sleep. Researchers will monitor changes in pain using a Numeric Pain Scale from Day 1 to Day 7. Participants must be able to respond to text or email reminders for surveys. The total study duration for each participant is 7 days of treatment and follow-up.

Researchers are evaluating LMN-201, an oral medication made from dried spirulina engineered to target Clostridioides difficile, in adults recently diagnosed with C. difficile infection (CDI). This Phase 2/3 study focuses on assessing the safety, tolerability, and effectiveness of LMN-201 in preventing CDI recurrence when given alongside standard antibiotic therapy. Participants include adults diagnosed within the past 7 days and scheduled to receive up to 28 days of standard antibiotics such as fidaxomicin, metronidazole, or vancomycin. Participants are randomly assigned to receive either LMN-201 or a placebo that looks identical. LMN-201 works by binding and neutralizing C. difficile toxin B and includes an enzyme that destroys the bacteria’s cell wall. The treatment period involves taking these oral capsules during the course of antibiotic therapy. The study is double-blind and placebo-controlled, ensuring neither participants nor researchers know who receives LMN-201 or placebo. During the study, participants will undergo monitoring to track their response, including assessments up to 16 weeks after starting therapy to determine who achieves a global cure. Researchers will collect data on safety, tolerability, and recurrence rates. Participants must be able to take oral medication, use a smartphone, and commit to all study procedures. Safety follow-up and adherence to treatment schedules are part of the study process, which aims to gather comprehensive information on LMN-201’s potential benefits and risks.