Hauppauge

Researchers are exploring new treatment options for neovascular age-related macular degeneration NVAMD, a condition affecting the eyes. This trial aims to compare a new medicine called tiespectus also known as MK-8748 or EYE201 with the standard treatment aflibercept to see if tiespectus works as well in treating NVAMD. The study includes adults aged 50 and older who have not previously received treatment for this condition. Participants will be randomly assigned to one of three groups tiespectus low dose, tiespectus high dose, or aflibercept. Those in the tiespectus groups will receive three initial injections every 4 weeks, followed by injections every 8 weeks up to week 48. After week 48, treatment will continue at intervals based on individual response until week 92. The aflibercept group will receive three initial injections followed by injections every 8 weeks until week 92. During the study, participants will have their vision tested using the Best-Corrected Visual Acuity BCVA score and their eye structure examined with imaging techniques. Researchers will monitor changes in vision over one year and track any side effects up to approximately 96 weeks. Participants will attend regular visits for treatment and assessments throughout the study period lasting about 92 weeks.

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.

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.

This research aims to evaluate the use and safety of Motiva Implants in people undergoing breast implant procedures. The study focuses on collecting and assessing safety and effectiveness data about these implants after they have been approved and are in general use. It includes participants who have primary breast augmentation, revision breast augmentation, or other aesthetic surgeries, with a focus on female patients aged 22 and older. Participants will receive Motiva Implants as part of their breast surgery or undergo other aesthetic procedures. The study is prospective and non-randomized, with data collected at baseline before surgery, during the operation, and annually for up to 10 years after surgery. Participants who have revision surgery or other aesthetic procedures without implants are also included as control groups to compare outcomes. During the study, participants will have various assessments including medical imaging such as CT, ultrasound, or MRI if medically advised. Researchers will monitor for connective tissue disease signs and symptoms, reproductive complications, cancer diagnoses, local complications, and patient satisfaction over 10 years. The impact of RFID on imaging will also be assessed. Participants will be followed for up to 10 years, providing long-term data on the safety and performance of Motiva Implants.

Researchers are evaluating how skin conditions linked to various types of cancer or cancer treatments affect the overall well-being of patients and survivors. These skin conditions can either be directly caused by cancer or arise as side effects from cancer therapies. The study aims to better understand patients feelings about their skin issues and to improve treatment approaches for these conditions in cancer patients. Participants in this observational study will have dermatologic conditions related to their cancer or its treatment and will be assessed and managed by their physician. Quality of Life QoL questionnaires specific to dermatology will be given to patients or their family members, spouses, or caregivers, depending on age and situation. These questionnaires may be completed at the initial visit and again at follow-up visits if treatment is needed. Treatment decisions are made by the physician and are not part of the study interventions. During the study, participants will fill out one or more dermatology-specific QoL instruments, such as Skindex, Dermatology Life Quality Index, or Functional Assessment of Cancer Therapy tools. The main measurement is the Quality of Life questionnaire collected over five years. This study will monitor how skin conditions impact patients lives and track changes through questionnaires without altering their medical care. Participation may last up to five years depending on follow-up needs.

Researchers are examining the effect of abelacimab compared to a placebo in patients with atrial fibrillation AF who are considered unsuitable for oral anticoagulation therapy. This Phase 3 study focuses on high-risk patients with AF to evaluate whether abelacimab can reduce the occurrence of ischemic stroke or systemic embolism. The study is led by Anthos Therapeutics, Inc. and aims to address treatment options in patients where traditional anticoagulation is deemed inappropriate. Participants are randomly assigned in equal numbers to receive either abelacimab 150 mg or a matching placebo by subcutaneous injection once a month. The study consists of three periods a screening period lasting up to 60 days, a double-blind treatment period that continues until at least 111 patients experience a primary endpoint event, and an end-of-treatment visit. Following this, participants may enter a 30-day follow-up or an optional open-label extension to receive abelacimab, depending on eligibility and regulatory approval. During the study, participants undergo assessments to monitor stroke, systemic embolism, and bleeding events, with the primary outcomes measured up to 30 months. Safety is tracked by recording bleeding events classified by the Bleeding Academic Research Consortium. Secondary outcomes include cardiovascular and all-cause mortality and other thrombotic events. The study also involves regular monitoring and follow-up visits to assess efficacy and safety throughout the treatment and observation periods.