Big Rapids

Researchers are evaluating disitamab vedotin, alone or combined with pembrolizumab, to treat HER2-expressing urothelial cancer that has either spread locally and cannot be removed or has metastasized throughout the body. This phase 2 clinical trial aims to assess how well these treatments work and how safe they are for participants with this type of advanced cancer. The study includes several groups receiving either disitamab vedotin alone given intravenously every two weeks or in combination with pembrolizumab administered intravenously on the first day of each six-week cycle. Different cohorts represent variations in prior treatment history and tumor HER2 expression levels. The trial also includes specific cohorts in Japan and evaluates both monotherapy and combination therapy approaches, with treatment continuing for about two years. Participants will undergo regular assessments including tumor measurements by imaging using standardized criteria, monitoring for side effects, laboratory tests, heart function evaluations, and analysis of drug levels in the body. Safety and response to treatment will be tracked during the treatment period lasting up to two years, with an overall study duration of about three years to observe outcomes such as survival and disease control.

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.

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 eye's 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.

Researchers are evaluating the outcomes of two treatments for lumbar spinal stenosis with neurogenic claudication (LSS with NC) in Medicare beneficiaries. This observational study compares the rates of surgical and minimally invasive interventions, as well as any harms, occurring within 24 months after receiving either the MILD procedure or Interspinous Process Decompression (IPD). The study uses Medicare claims data starting from patients treated on or after January 1, 2017, and continues enrollment until the sponsor stops it. The study groups include Medicare patients who underwent the MILD procedure, which involves a partial decompression performed under fluoroscopic image guidance through the removal of tissue and bone at the symptomatic spinal level. The control group consists of Medicare patients treated with Interspinous Process Decompression during the same enrollment period. Both groups are monitored for reoperation and harms for 24 months following their initial treatment. Participants are included based on Medicare claims with the study's NCT number, which automatically enrolls them without requiring prior consent. Researchers will analyze Medicare claims data to track surgical or minimally invasive interventions and any complications related to the initial procedure over two years. The study does not involve direct patient visits or interventions and is exempt from Institutional Review Board oversight. The total follow-up duration for outcome measurement is 24 months after the index procedure.

Researchers are studying a new medicine called PF-08634404 to see how well it works for adults with colorectal cancer that has spread to other parts of the body. This trial aims to find out if combining PF-08634404 with approved chemotherapy helps compared to using another approved medicine, Bevacizumab, combined with chemotherapy. The study is a phase 3, double-blind, randomized trial focused on treatment-nafve participants with metastatic colorectal cancer. Participants will be randomly assigned to one of two groups: one group will receive PF-08634404 plus chemotherapy, and the other will receive Bevacizumab plus chemotherapy. Both treatments are given through intravenous (IV) infusions at a clinical site. Treatments are given in cycles, and participants can continue treatment as long as it is helping and side effects are manageable. During the study, participants will have regular visits for treatment, health checks, and tests. After stopping treatment, there will be a final visit about 30 to 37 days later to evaluate health and side effects. Follow-up will continue every 12 weeks by phone, in person, or by reviewing health records. The study is expected to last about 33 months per participant. Researchers will measure outcomes like progression-free survival and overall survival over approximately 4 years, along with response rates, duration of response, quality of life, and safety assessments.