Wilhelmshaven

Researchers are evaluating asthma control, health-related quality of life (HRQL), lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in a real-life clinical setting in Germany. This prospective, non-interventional, single-arm, multicenter study aims to observe these outcomes over a 52-week period to better understand benralizumab's impact outside of randomized clinical trials. Patients prescribed benralizumab according to label and local reimbursement criteria will be followed for up to 52 weeks. The study will monitor asthma control using the Asthma Control Test (ACT) and the Asthma Impairment and Risk Questionnaire (AIRQ®) at various timepoints. Health-related quality of life will be assessed with the mini Asthma Quality of Life Questionnaire (miniAQLQ) at baseline and routine follow-up visits. Patients will also track and report their weekly asthma medication intake using either paper-based or electronic diaries throughout the study. Participants will complete questionnaires every 4 weeks and record medication intake weekly. Researchers will measure changes in ACT scores, proportions of responders, and reductions in inhaled corticosteroid doses from baseline to weeks 12, 24, and 52. Safety and health outcomes will be observed under routine clinical care. This study includes adults aged 18 to 120 years with severe eosinophilic asthma who can understand study instructions and provide informed consent.

Researchers are evaluating the use of Vagus Nerve Stimulation (VNS) Therapy as an additional treatment for patients with difficult to treat depression, including those with treatment resistant depression. This study focuses on individuals diagnosed with unipolar or bipolar disorder experiencing chronic or recurrent depression who have not responded well to standard psychiatric treatments. The diagnosis and any associated conditions are confirmed using the Mini International Neuropsychiatric Interview (MINI). Patients will receive an implant of the VNS Therapy System, which includes an implantable generator, lead, and external programming system designed to stimulate the vagus nerve. Enrollment is planned for up to 500 patients across about 80 sites worldwide, with a baseline visit scheduled between 1 and 6 weeks before device implantation. After implantation, participants will be followed for at least 36 months and up to 60 months, with the study ending once the last participant completes 36 months of follow-up. During the study, participants will attend outpatient clinic visits regularly and complete various evaluations as outlined in the study protocol. Researchers will measure outcomes such as the reduction in depression severity using the Montgomery Åsberg Depression Rating Scale (MADRS), looking for at least a 50% decrease from baseline to 12 months after implant. The study aims to assess the short, mid, and long-term effectiveness and efficiency of VNS Therapy as an adjunctive treatment for this patient population.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

Researchers are evaluating the treatment and disease progression in men with recurrent or metastatic prostate cancer through a long-term registry study. The study includes patients with four distinct prostate cancer conditions: biochemical recurrence after surgery or radiation, non-metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer. Each group is studied independently during different time periods to better understand their treatment courses and disease outcomes. There is no specific treatment assigned by the study. Instead, patients receive care according to the usual medical practice at their treatment centers. Treatments may vary and are decided by each patient's doctor. Data is collected at routine visits after enrollment, then every 3 or 6 months, and whenever therapy changes. This includes recording treatments, disease status, quality of life questionnaires (FACT-P and EQ-5D-5L), and collection of biomaterial. Participants will be involved in regular follow-up visits where their disease progression and therapy details are documented. The study monitors therapy frequencies and patterns for an average of 7 years. Researchers assess these long-term outcomes along with quality of life and other clinical data to better understand prostate cancer management in real-world settings.

Researchers are evaluating the effectiveness and safety of a subcutaneous cladribine treatment for patients with hairy cell leukemia who need therapy. This study focuses on patients who are either untreated or have only been pretreated with alpha-interferon. It aims to assess remission rates four months after treatment and whether a second cycle benefits those with a non-optimal response, defined by residual disease or partial remission. Participants receive cladribine 0.14 mg/kg as a subcutaneous bolus injection once daily for five consecutive days. If the response after the first cycle is not optimal, patients may receive a second cycle of the drug to improve their remission status. This treatment approach is being studied in a Phase 2/3 clinical trial setting. During the study, remission status is evaluated four months after the first treatment cycle. Patients undergo assessments to detect residual disease in bone marrow and peripheral blood. Researchers monitor the rate of complete remissions and any treatment-related toxicities. The overall health, laboratory tests, and disease markers are regularly checked throughout the study period to ensure safety and to measure the treatment's impact.