Immenstadt Im Allgau

Accidental hypothermia occurs when the body's core temperature drops below normal levels, often due to incidents like snow sports accidents, near drowning, or exposure to cold urban environments. Severe accidental hypothermia, with body temperature below 28°C, is rare but usually fatal in over half of cases. The International Hypothermia Registry aims to collect extensive data worldwide to better understand the causes, treatment, and outcomes of accidental hypothermia to improve care and survival rates. The study collects information through a registry that includes data from both prehospital and hospital settings, covering various treatments and rewarming methods used for patients with accidental hypothermia. It welcomes both prospective and retrospective case entries without restrictions on the year of occurrence or patient age, gender, or health conditions. The registry records a wide range of patient details to assess factors influencing survival and neurological outcomes. Participants' data will be gathered through detailed questionnaires containing demographic, clinical, treatment, and outcome information, recorded on a secure database called REDCap. Researchers will analyze factors like patient temperature at presentation, trauma status, cardiac arrest occurrence, and the type and speed of rewarming methods to identify predictors of survival and complications after rewarming. The study continues through completion, with an average follow-up of about one year for outcome measurement.

Researchers are studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.