Albany

This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups: one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone; the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.

Researchers are evaluating the safety and effects of disitamab vedotin for treating adults with advanced breast cancer that is difficult to treat and has spread in the body. The study focuses on patients whose tumors express HER2 and who have previously received treatment for their advanced breast cancer. This open-label, non-randomized study is sponsored by Pfizer and includes multiple groups based on HER2 and hormone receptor status. All participants will receive disitamab vedotin as an intravenous infusion every two weeks at the study clinic. The treatment continues until either the participant or doctor decides to stop, which may be due to cancer progression, side effects, or personal choice. After stopping treatment, participants will have follow-up visits about every six weeks, followed by phone calls every twelve weeks to monitor their health. During the study, participants will attend visits every two weeks for treatment and assessments. Researchers will evaluate tumor response, duration of response, disease control, progression-free survival, overall survival, and drug levels in the blood. Safety will be monitored for up to two years, and participants can expect regular checkups and tests throughout the study period, which may last up to three years.

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.