Vero Beach

Researchers are evaluating the drug disitamab vedotin, alone or combined with pembrolizumab, to treat urothelial cancer that expresses HER2. This cancer is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The study aims to see how well the drug works and how safe it is for participants by monitoring side effects and treatment responses. Participants will receive disitamab vedotin through an intravenous (IV) infusion every two weeks. Pembrolizumab, when given, is administered by IV on the first day of each six-week cycle. The study includes several groups, called cohorts, each with different treatment histories and eligibility criteria. Treatment and evaluation may continue for about two years. During the study, participants will have regular tests including scans to measure tumor response, lab tests, heart function checks, and monitoring for adverse events. Researchers will also track drug levels in the blood and any changes in heart function. The study will assess confirmed tumor responses and safety outcomes over approximately two years, with close monitoring to understand how participants respond to the treatments and any side effects experienced.

Glaucoma, a leading cause of blindness worldwide, is the focus of this study evaluating the safety and effectiveness of a glaucoma gel stent called XEN63. This device is intended for patients with glaucoma whose intraocular pressure (IOP) remains uncontrolled despite medical or surgical treatments. The trial compares two implantation methods: ab interno (inside the eye) and ab externo (outside the eye), enrolling about 130 participants aged 45 years or older with glaucoma. Participants receive the XEN63 gel stent implanted either by the ab interno or ab externo approach on the first day of the study. They are then monitored regularly over 12 months to assess and compare the outcomes of each implantation method. The study takes place at approximately 32 sites across the United States. Throughout the 12-month follow-up, participants attend scheduled visits at hospitals or clinics where medical assessments and eye examinations evaluate the safety and effectiveness of the gel stent. Researchers measure the percentage of participants achieving at least a 20% reduction in IOP from baseline using the same or fewer IOP-lowering medications. They also track adverse events to monitor safety during the study period.

Researchers are evaluating the efficacy, safety, and tolerability of remibrutinib in people living with relapsing multiple sclerosis (RMS). This Phase 3b study compares remibrutinib after switching from ocrelizumab to continuous ocrelizumab treatment. It aims to provide important data on how well remibrutinib works and how safe and tolerable it is for patients with RMS. Participants are randomly assigned to receive either remibrutinib tablets taken daily or ongoing ocrelizumab infusions or injections at standard doses (600mg infusion or 920mg injection). The study includes an initial Core Part lasting up to 24 months, followed by an Extension Part lasting up to 24 months where eligible participants continue open-label treatment with remibrutinib. The study is conducted at multiple centers, including locations in the USA and worldwide. During the study, participants will be monitored regularly with assessments that include brain MRI scans to measure the annualized rate of new or enlarging T2 lesions. Researchers will also evaluate safety and tolerability throughout both study parts. Those completing the Core Part may join the Extension Part to continue receiving remibrutinib for long-term observation. The total study duration for participants can be up to 48 months.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

This research evaluates anonymous, previously collected medical data to review the outcomes of different treatment methods for chronic pain. The study is a retrospective review involving multiple centers and independent patient groups to compare results across various subgroups. The study examines clinical outcomes related to the use of spinal cord stimulation, radiofrequency (RF), and other implantable device systems from Boston Scientific and other manufacturers. Multiple cohorts will be analyzed based on the type of treatment system used. Participants' medical charts will be reviewed to measure response rates through approximately two years of follow-up. The study focuses on clinical results documented in patient records without any new treatment or intervention administered during the study.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.