Garden City

Researchers are evaluating the effect of three different doses of the drug leflutrozole on semen quality in men, focusing on whether it can improve sperm count and overall testicular function. This Phase 2 clinical trial also aims to assess the safety of leflutrozole compared to a placebo, exploring any medical problems that may arise during treatment. Participants will be randomly assigned to receive one of three doses of leflutrozole or a placebo, taken orally once a week for 16 weeks. The study is double-blind and placebo-controlled, with treatments given in parallel groups. Visits to the clinic are scheduled every 4 weeks for checkups and testing throughout the 16-week treatment period. During the study, participants will provide semen samples to evaluate changes in total motile sperm count and semen volume. Blood tests will be conducted to measure hormone levels and monitor safety. Researchers will track any side effects and overall health, with the main outcome measured as the change in total motile sperm count from baseline to the end of treatment at 16 weeks.

Researchers are investigating the effects of multiple doses of vosoritide and comparing its therapeutic dose to human growth hormone (hGH) in children with idiopathic short stature (ISS). This Phase 2 study aims to understand how these treatments influence growth in this population. After an initial observation period of at least 6 months to measure baseline growth, participants are randomly assigned to receive either vosoritide, placebo, or hGH (the latter only in the United States). Those in the vosoritide and placebo groups undergo up to 6 months of randomized treatment, followed by open-label vosoritide until they reach near-final adult height or at least age 16 for females or 18 for males. Participants assigned to hGH receive open-label treatment for a minimum of 4 years. Throughout the study, safety is carefully monitored with clinical and imaging assessments focused on hips and lower extremities, as well as watching for hypotension, fractures, and slipped capital femoral epiphysis. An independent Data Monitoring Committee reviews safety data regularly. Study visits include a treatment completion visit about 4 weeks after the last dose, and follow-up assessments may continue annually through the end of the study. Key outcome measures include changes in annualized growth velocity at 6 months and changes in height and height Z-score after 4 years.

This research investigates dry eye disease by evaluating the safety and effectiveness of a fixed-dose combination of lifitegrast and perfluorohexyloctane given twice daily. The study is a 4-week, randomized, double-masked, parallel-group, active-controlled, multicenter trial focusing on improving signs and symptoms of dry eye disease. Participants must have a history of dry eye disease in both eyes for at least six months and meet specific symptom and sign criteria at screening and baseline. Participants will be assigned to one of several groups receiving topical eye drops for four weeks: the fixed-dose combination of lifitegrast and perfluorohexyloctane, lifitegrast alone, perfluorohexyloctane alone, or a vehicle drop without active ingredients. Each treatment is administered as an eye drop twice daily. The study compares these treatments to assess their impact on dry eye disease. Throughout the study, participants will undergo assessments including corneal fluorescein staining to measure changes from baseline at day 29. They will be monitored for adherence and safety, with evaluations of visual acuity and ocular health. The total participation time is approximately four weeks, during which researchers will track changes in dry eye disease signs and symptoms to evaluate treatment effects.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Researchers are collecting baseline growth data in children with idiopathic short stature (ISS) to better understand their growth patterns. This observational study includes children diagnosed with ISS who meet specific height and growth criteria, aiming to gather detailed growth measurements and related variables over time. The study does not involve any treatment interventions but focuses on monitoring growth changes in children who may or may not be receiving human growth hormone (hGH) therapy. Participants include those who have never received hGH and those currently on treatment. The study observes growth parameters such as height, height Z-score, BMI, and BMI Z-score every six months. Participants are involved in regular assessments every six months, continuing up to 15 years. These evaluations measure annualized growth velocity, standing height, height Z-score, BMI, and BMI Z-score to track their growth progress. The study relies on ongoing monitoring to understand growth changes in children with ISS over an extended period.

Researchers are evaluating the safety and eye effectiveness of a corticosteroid insert called Dextenza combined with an antibiotic and a nonsteroidal anti-inflammatory drug (NSAID) given inside the eye during cataract surgery. This study compares this "dropless" treatment approach to the standard method of using eye drops after surgery in patients having cataract operations on both eyes. The goal is to see which method better controls post-operative eye pain and inflammation. This randomized, self-controlled study involves 50 participants who will receive the Dextenza insert and intracameral medications in one eye during surgery, while the other eye, operated on two weeks later, will receive the standard eye drop regimen. The standard therapy includes topical moxifloxacin, ketorolac, and prednisolone acetate drops given before and after surgery at specified frequencies and durations. Each participant serves as their own control by receiving both treatments in different eyes. Participants will be monitored closely for pain and inflammation control after each surgery, with the main outcome measured by patient preference on the 28th day after the second eye surgery. The study includes detailed assessments, including clinical exams and safety monitoring throughout the treatment periods. Total study participation involves visits around the surgeries and follow-up to assess treatment effects and safety.

Researchers are evaluating the safety and immune response of a group B streptococcus (GBS) vaccine in healthy pregnant women and their babies in this Phase 3 randomized, placebo-controlled, double-blinded trial. The study includes pregnant women aged 49 or younger between 24 and 36 weeks of gestation with uncomplicated singleton pregnancies and no major fetal abnormalities. Participants must also have documented negative tests for HIV, syphilis, and hepatitis B during this pregnancy. The goal is to learn how the vaccine works and to monitor safety for both mothers and their infants. Participants will receive one injection of either the GBS6 vaccine or a saline placebo. Pregnant women will be followed for up to 14 months, including 6 months after delivery. Their babies will be followed for about 12 months after birth. A subset of infants will also receive routine vaccinations such as diphtheria toxoid-containing vaccines and pneumococcal vaccines according to their country's immunization schedule, with blood samples collected one month after completing primary and toddler booster doses. Mothers will be monitored for local and systemic reactions within 7 days after vaccination, adverse events through 1 month, and serious or medically attended events up to 6 months postpartum. Infants will be observed for adverse events from birth through at least one year, with serious and medically attended events tracked through 6 months. Researchers will also measure antibody levels in infants at birth to assess the vaccine's potential to protect against early and late onset GBS disease. Mothers will attend at least 3 to 4 study visits, some via telephone, to support ongoing safety and immunogenicity assessments.

Researchers are studying pancreatic cystic lesions to improve diagnosis using a special imaging technique called confocal laser endomicroscopy (nCLE). This study enrolls patients who are referred for endoscopic ultrasound (EUS) evaluation of pancreatic cysts and meet specific eligibility criteria. The goal is to assess the accuracy of diagnosing pancreatic cystic lesions and to better classify the risk of intraductal papillary mucinous neoplasms (IPMNs) over a 48-month period. Patients first undergo EUS-guided nCLE imaging, followed by EUS-guided fine needle aspiration (FNA) to collect cyst fluid. The fluid is analyzed for carcinoembryonic antigen (CEA) and cytology, along with molecular analysis as part of routine care. Based on results and multidisciplinary tumor board decisions, surgery may be performed when indicated. Surgical tissue analysis serves as the gold standard for confirming diagnosis, with most patients expected to have surgery after EUS. Participants will be closely monitored through imaging, fluid analysis, and histopathology to evaluate diagnostic accuracy and risk assessment. The study involves consent during clinic visits or before EUS, and follows patients for up to 48 months to measure outcomes. Safety and procedure tolerability are also observed throughout the study period.

Researchers are evaluating the use of Cxbladder Triage-Plus, a non-invasive urine-based test, to detect urothelial carcinoma (bladder cancer) in patients with microscopic or gross hematuria (blood in the urine). The study focuses on patients referred to urology and scheduled for cystoscopy, a standard but invasive procedure involving a camera inserted into the bladder to look for disease. Since cystoscopy can cause anxiety, pain, and other side effects, this study aims to validate a simpler test that could reduce the need for invasive procedures in patients with a low risk of disease. The study is a multicenter, observational trial enrolling up to 1000 subjects from US sites with microscopic hematuria (three or more red blood cells per high powered field) or visible blood in urine. Participants will undergo all standard care tests as clinically required, plus provide one urine sample either at home or in clinic within 90 days before or 10 weeks after their scheduled cystoscopy. The urine samples will be tested using Cxbladder Triage-Plus to assess its accuracy compared to standard cystoscopy. Results from the Cxbladder test will not be shared with patients or doctors during the study. Participants will provide urine samples and complete test request forms. Researchers will monitor and collect data including urine test results and cystoscopy findings to assess the performance of the Cxbladder test. The main goal is to confirm whether this test can effectively rule out disease in low-risk patients, identify those at higher risk, and potentially replace less sensitive urine tests. The study involves a single main evaluation period around cystoscopy, with data collection focused on diagnostic accuracy and patient characteristics.

Researchers are investigating the unique natural progression of blood sugar control, insulin sensitivity, and beta-cell function in obese adolescents who are at risk for developing type 2 diabetes. The study aims to deeply understand the biological and psychosocial factors that contribute to youth-onset type 2 diabetes by closely tracking these changes during puberty. This study involves observing a large group of young people at risk for type 2 diabetes as they go through puberty, without specific interventions. Researchers will collect detailed clinical, biochemical, and psychosocial data to characterize how dysfunctions develop and progress. There are no treatments or devices being tested; instead, the study focuses on detailed monitoring over time. Participants will undergo extensive assessments including biochemical tests, clinical evaluations, and psychosocial questionnaires. The main outcome is the development of type 2 diabetes over an average follow-up of 2.5 years. The study will carefully track changes in metabolic health and gather data that may help design future treatment and prevention strategies for youth at high risk of type 2 diabetes.