Bautzen

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are evaluating treatments for patients with high-risk pulmonary embolism, a serious condition where blood clots block blood flow in the lungs. The trial compares early catheter-directed treatment plus conventional care against conventional care alone. This open-label, multicenter, randomized controlled trial aims to assess which approach better reduces mortality and severe complications within seven days. Participants are randomly assigned to one of two groups. One group receives conventional care following guidelines, including reperfusion treatments, with catheter-based intervention only if no improvement occurs. The other group undergoes catheter-interventional treatment within 60 minutes of randomization, using certified devices such as aspiration thrombectomy and local fibrinolytic therapy, possibly combined with ultrasound assistance. Sheaths used during the catheter procedures are removed shortly after treatment, and fibrinolytic drugs are prepared concurrently to avoid delays if needed. Throughout the study, researchers monitor participants closely, measuring outcomes like death from any cause, recurrent cardiac arrest, and shock within seven days. Secondary outcomes include mortality at 30 days, bleeding events, use of life support devices, heart function changes via echocardiography, ICU stay length, and time to stabilize blood flow. The trial is led by Leipzig Heart Science gGmbH and participants are followed up to assess these key health indicators.

Researchers are gathering real-world clinical data from women with primary advanced FIGO stage III or IV or recurrent endometrial cancer who are treated with first-line chemotherapy regimens combining Carboplatin, Paclitaxel, and Durvalumab CPD. This observational study focuses on patients receiving maintenance therapy with durvalumab alone or durvalumab combined with olaparib, depending on their tumors DNA mismatch repair status. The aim is to evaluate treatment outcomes including effectiveness, safety, and patient-reported experiences after chemotherapy. Participants receive first-line CPD chemotherapy followed by maintenance therapy tailored to their tumor characteristics patients with DNA mismatch repair deficient tumors receive durvalumab maintenance, while those with proficient status receive both durvalumab and olaparib maintenance. Treatment decisions are made as part of routine care in collaboration with their doctors, independent of the study. The study observes patients who achieve disease control after chemotherapy, tracking their ongoing treatments according to approved guidelines. During the study, participants complete questionnaires to report their quality of life and health status over time. Researchers monitor time to next treatment and progression-free survival at 12 months, as well as the duration of maintenance therapy and chemotherapy phases, and timing between treatments. Safety and real-world usage of therapies are assessed up to 46 months. The study spans multiple centers in Germany and aims to better understand characteristics of patients benefiting from these treatments in everyday clinical practice.