Hauppauge

Researchers are looking for new ways to treat neovascular age-related macular degeneration (NVAMD). Available standard (usual) treatments for NVAMD, such as aflibercept, may not work for every person. Researchers want to learn if a trial medicine called tiespectus (also called MK-8748 or EYE201) can treat NVAMD. The goal of this trial is to learn if tiespectus works as well as aflibercept to treat NVAMD.

Researchers are evaluating the safety, tolerability, and effectiveness of Pumitamig alone or combined with Ipilimumab or Cabozantinib in adults with advanced Renal Cell Carcinoma (RCC). This phase 1/2 study includes participants with locally advanced or metastatic RCC, including clear cell and non-clear cell types, to better understand treatment options for this condition. The trial aims to assess both side effects and tumor response over an extended period. Participants receive specified doses of Pumitamig alone or in combination with Ipilimumab or Cabozantinib on scheduled days during the study. Nivolumab is also involved as part of the treatment regimen. The study is open-label, randomized, and multi-center, allowing comparison of these treatment approaches over time. The dosing schedules and combinations are carefully monitored throughout the trial. During the study, participants undergo evaluations for adverse events, including serious side effects, dose-limiting toxicities, and events leading to discontinuation or death, monitored up to about two years after treatment ends. Researchers also measure tumor responses using established criteria (RECIST v1.1). Safety and treatment effects are tracked closely to provide comprehensive data on these therapies for advanced RCC.

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.

Researchers are studying the safety and performance of Motiva Implants®, silicone gel-filled breast implants used for breast augmentation and revision procedures. This prospective, non-randomized, multicenter study collects data before surgery, during the operation, and annually for up to 10 years. The study also compares the incidence of connective tissue disease signs and symptoms in participants with Motiva implants to a control group undergoing other aesthetic surgeries. Participants receive either Motiva Implants® during breast augmentation or revision surgeries or undergo other aesthetic procedures like liposuction, rhinoplasty, or face-lifts in the control group. The study includes monitoring of implant performance and safety, with some participants possibly undergoing CT, ultrasound, or MRI evaluations if recommended. Participants agree to return explanted devices to the sponsor, and they must follow all study requirements throughout the study period. During the 10 years of follow-up, participants have yearly assessments to gather operative and postoperative data. Researchers evaluate safety and effectiveness, tracking any signs of connective tissue diseases and other outcomes related to the implants or aesthetic procedures. The study monitors participant health and implant status through imaging and clinical evaluations to provide long-term safety information.

Researchers are evaluating how skin conditions related to cancer or cancer treatments affect the overall well-being of cancer patients and survivors. These skin issues are common and can either be caused directly by the cancer or result as side effects from cancer therapies. The study aims to better understand patients' feelings about their skin conditions and explore ways to improve treatment approaches for these skin problems. Participants will complete one or more questionnaires designed to measure the impact of skin conditions on quality of life. These dermatology-specific quality of life tools include various versions tailored for adults, children, family members, or caregivers. If treatment for the skin condition is needed, patients will be asked to complete the same questionnaire during follow-up visits to track changes over time. Throughout the study, participants will be asked to fill out quality of life assessments up to five years to monitor their experiences with skin conditions linked to cancer. The research team will collect and analyze these responses to evaluate how these dermatologic issues affect patients and their families. Informed consent procedures will be observed, especially for minors and caregivers involved in the study.