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Found 6 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating the safety, tolerability, and effectiveness of the drug Pumitamig alone or combined with Ipilimumab or Cabozantinib in adults with advanced Renal Cell Carcinoma RCC. This study focuses on participants with locally advanced, unresectable, or metastatic RCC, including both clear cell and non-clear cell types in the initial phase, and only clear cell RCC in later phases. The trial is conducted in phases 1 and 2 to gather detailed information about these treatments. Participants receive specified doses of Pumitamig, Ipilimumab, and Cabozantinib according to study group assignments. The study uses a randomized, parallel design with multiple experimental arms to compare these treatments alone or in combination. Participants may be assigned to one of several groups receiving different drug combinations, with dosing schedules specified by the protocol. During the study, participants undergo regular safety monitoring for adverse events and serious adverse events for up to approximately two years after treatment ends. Effectiveness is assessed by measuring tumor response using established criteria and tracking progression-free survival and duration of response over time. The study includes ongoing evaluations and follow-up visits to observe treatment impact and monitor participant health until the studys completion in 2031.
Actively Recruiting
Researchers are studying children aged 4 to 7 years with amblyopia to compare two treatments watching dichoptic movies or shows using the Luminopia headset versus patching the fellow eye. The goal is to see if the Luminopia headset treatment used one hour per day, six days per week, is not worse than patching for two hours per day, seven days per week, in improving vision in the amblyopic eye over 26 weeks. This phase 3 randomized trial evaluates changes in distance visual acuity as the primary outcome. Participants will be randomly assigned to one of two groups. One group uses the Luminopia headset to watch dichoptic content for one hour daily which can be split into shorter sessions six days a week, wearing optical correction if needed. The other group uses an eye patch on the fellow eye for two hours daily also split into shorter sessions seven days a week, with optical correction as needed. After 26 weeks, those initially in the patching group who still have significant vision difference may be offered the Luminopia treatment and followed for an additional 26 weeks. Throughout the study, participants will undergo clinical assessments at 13 and 26 weeks, with follow-up visits at 39 and 52 weeks for those switching to Luminopia. Researchers will measure changes in distance visual acuity in the amblyopic eye, tracking treatment effects over time. Parents will maintain communication with the study team, and participants will continue using required spectacles or contact lenses. The total study duration varies up to 52 weeks depending on treatment response and group assignment.
Actively Recruiting
Researchers are evaluating dichoptic treatments for children aged 8 to 12 years with amblyopia, a condition affecting vision. This phase 3 randomized trial compares two types of virtual reality-based dichoptic therapy, Luminopia and Vivid Vision, against continued use of optical correction alone. The study aims to understand how these treatments impact vision improvement, specifically measuring changes in the amblyopic eyes visual acuity. Participants are randomly assigned to one of three groups Luminopia, involving watching dichoptic movies or shows using a headset for 1 hour daily six days a week Vivid Vision, playing dichoptic video games with a headset for about 25 minutes daily six days a week or continuing optical correction with glasses or contact lenses alone. Those initially assigned to optical correction alone who show limited improvement after 18 weeks may be re-randomized to receive one of the dichoptic therapies, with follow-up visits extending to 36 weeks. During the study, participants attend clinical assessments at 9 and 18 weeks after starting treatment, with additional visits at 27 and 36 weeks for some. Researchers measure visual acuity changes in the amblyopic eye using the logMAR scale and assess quality of life related to vision through a pediatric eye questionnaire. The study includes monitoring adherence to treatment, willingness to wear the headset and optical correction, and safety considerations throughout the 18 to 36-week participation period.
Actively Recruiting
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.
Actively Recruiting
Researchers are evaluating a new medicine called PF-08634404 combined with chemotherapy for adults with colorectal cancer that has spread to other parts of the body. The study aims to understand how well this new combination works compared to an existing treatment using Bevacizumab with chemotherapy. The study is a phase 3, double-blind, randomized trial focusing on treatment effectiveness and safety in participants who have not received prior systemic therapy for metastatic disease. Participants are randomly assigned to one of two groups. One group receives PF-08634404 with chemotherapy, and the other group receives Bevacizumab with chemotherapy. Both treatments are given through intravenous IV infusions in cycles. Treatment continues as long as it helps and side effects are manageable. Treatments are administered at clinical sites by trained staff. Participants will have regular visits for treatment, health evaluations, and various tests. After stopping treatment, there is a follow-up visit about 30 to 37 days later to review health and side effects. Further follow-up occurs every 12 weeks by phone, in person, or via health record review to monitor health status and any new treatments. The study duration for each participant is approximately 33 months. Researchers will measure progression-free survival, overall survival, response rates, quality of life, and monitor safety throughout the study.