Vero Beach

Researchers are evaluating disitamab vedotin alone or combined with pembrolizumab to treat urothelial cancer that expresses HER2. This study focuses on participants with locally advanced or metastatic urothelial cancer that cannot be removed by surgery. It aims to assess how well the drug works and to monitor the side effects experienced by participants. Participants receive disitamab vedotin intravenously every 2 weeks, either alone or with pembrolizumab given by intravenous infusion on Day 1 of each 6-week cycle. The study includes multiple cohorts receiving different combinations or monotherapy treatments. The treatment period and monitoring last approximately 2 years, with ongoing assessments of drug effects and safety. During the study, participants undergo regular evaluations including imaging scans to measure tumor response, laboratory tests, electrocardiograms to monitor heart function, and assessments of side effects. Researchers measure treatment response using established cancer evaluation criteria and track survival and disease control over about 3 years. Participants are closely monitored for adverse effects and blood levels of the drugs to understand how the treatments behave in the body.

Glaucoma is a leading cause of blindness worldwide, second only to cataracts. This research evaluates the safety and effectiveness of the XEN63 gel stent implanted using two different surgical methods ab interno inside the eye and ab externo outside the eye. The study focuses on patients with glaucoma that is not controlled by medication or previous surgery, assessing adverse events and intraocular pressure over time. Participants will be assigned to one of two groups. One group will receive the XEN63 gel stent implanted via the ab interno approach, while the other group will have it implanted via the ab externo approach. The implantation happens on Day 1, and participants will be followed for 12 months to monitor outcomes. During the study, participants will attend regular visits at hospitals or clinics to assess safety and the stents effect on glaucoma. Medical assessments and eye examinations will be conducted to measure intraocular pressure and monitor adverse events. The primary outcomes include the proportion of participants achieving a significant reduction in intraocular pressure and the number experiencing adverse events over the 12-month period.

Researchers are comparing two forms of long-acting drugs, cabotegravir ultra long-acting CAB ULA plus rilpivirine ultra long-acting RPV ULA versus cabotegravir long-acting CAB LA plus rilpivirine long-acting RPV LA, in adults and adolescents who have HIV and are already virologically suppressed on antiretroviral therapy ART. The study aims to evaluate the effectiveness, safety, and tolerability of these treatments in maintaining viral suppression. Participants are randomly assigned to receive either the CAB ULA plus RPV ULA combination or the CAB LA plus RPV LA combination. Both interventions involve administering these drugs as long-acting injectable treatments. The study is conducted as a phase III trial with parallel groups, where participants continue their assigned treatment regimen throughout the study period. During the trial, participants are monitored regularly to assess their HIV viral load, specifically tracking the percentage of participants with plasma HIV-RNA levels at or above 50 copiesmL at month 11. Additional measures include evaluating virologic failure, drug-related adverse events, and resistance to the study drugs up to month 23. Researchers also track immune cell counts and drug concentrations over time. The total duration of participation extends through to the study completion date, with ongoing safety and efficacy assessments.

Researchers are evaluating the effects of remibrutinib compared to continuous ocrelizumab treatment in people living with relapsing multiple sclerosis RMS. This Phase 3b study aims to provide data on the efficacy, safety, and tolerability of remibrutinib when patients switch from ocrelizumab. The trial is randomized, open-label, and conducted across multiple centers globally, including the USA. Participants in the study are assigned to either switch to remibrutinib tablets taken orally or continue with ocrelizumab administered via infusion or injection at standard doses. The study includes a Core Part lasting up to 24 months, during which these treatments are compared. Those completing the Core Part may enter an Extension Part lasting up to 24 months, where all participants receive remibrutinib in an open-label format. Throughout the study, participants will undergo regular monitoring including MRI scans to measure new or enlarging T2 lesions and assessments for disease activity and adverse events. The main outcome is the annualized rate of new or enlarging T2 lesions during the Core Part, with continued evaluations during the Extension Part. Safety and tolerability are closely monitored, and total participation can last up to 48 months.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.

Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.

Researchers are evaluating the efficacy and safety of Adagrasib alone and in combination with pembrolizumab for patients with advanced or metastatic non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study includes a Phase 2 portion that assesses these treatments in patients with various PD-L1 tumor proportion scores TPS and a Phase 3 portion that compares Adagrasib plus pembrolizumab to pembrolizumab alone in patients with higher PD-L1 TPS 50%. The goal is to understand how these treatments work as first-line therapy in this patient population. Treatment involves Adagrasib administered orally twice daily BID either alone or combined with pembrolizumab, which is given intravenously at 200 mg every three weeks. Phase 2 includes three cohorts based on PD-L1 status and treatment type, while Phase 3 randomly assigns patients to receive either the combination or pembrolizumab alone. Patients with unresectable or metastatic squamous or nonsquamous NSCLC are included, with specific brain metastases criteria for Phase 3 participants. Participants will be monitored over periods of up to 22 months in Phase 2 and 36 months in Phase 3. Assessments include measuring treatment efficacy, safety, pharmacokinetics, quality of life, and tumor response using RECIST 1.1 criteria. Regular evaluations involve imaging, clinical exams, and patient-reported outcomes. The study aims to provide detailed information on treatment tolerability and effectiveness during and after therapy.