Iserlohn

Researchers are evaluating the safety, tolerability, and therapeutic effects of BNT113 combined with pembrolizumab compared to pembrolizumab alone as a first-line treatment for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma HNSCC positive for human papilloma virus 16 HPV16 and expressing the protein PD-L1 with a combined positive score of 1 or higher. This is an open-label, multi-site, Phase IIIII clinical trial consisting of two parts an initial safety run-in phase and a randomized phase. In the safety run-in phase Part A, patients receive BNT113 in combination with pembrolizumab to confirm safety and tolerability at selected dose levels. The randomized phase Part B compares BNT113 combined with pembrolizumab against pembrolizumab monotherapy. Treatments are given by intravenous injection or infusion and continue for up to 24 months. An optional pre-screening phase allows tumor samples to be tested for HPV16 DNA and PD-L1 expression before the main trial screening. Participants will be closely monitored throughout the study. Assessments include safety evaluations, tumor response, and survival outcomes such as overall survival and progression-free survival. Tumor tissue samples must be provided for testing. Researchers will measure treatment-emergent adverse events, response rates, duration of response, and disease control. The study may last up to 48 months, with ongoing safety and efficacy monitoring during and after treatment.

This research aims to describe the real-world medical care of patients with atrial fibrillation who undergo cardiac surgical ablation. It seeks to answer important questions about the reasons for surgery, the types of surgical and ablation procedures used, safety during and after the procedure, effectiveness in preventing atrial fibrillation recurrence, and the medical treatments patients receive afterward. Participants in this observational study have atrial fibrillation treated by cardiac surgical ablation. The study observes how often different surgical approaches and left atrial appendage interventions are used. It also tracks safety events such as major bleeding and adverse cardiac events during hospital stays and over the long term. During the study, researchers monitor participants for up to 12 months to record major bleeding events, cardiac complications, and procedural success. Data collected includes treatment details, hospital stay outcomes, and follow-up results to evaluate safety and effectiveness. The total participation duration and follow-up extend to at least one year after surgery.