Wilhelmshaven

Researchers are conducting a prospective observational study to examine asthma control, health-related quality of life HRQL, lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in routine clinical practice settings in Germany. The study aims to gather real-world evidence on these patients over a 52-week period. Participants will be treated with benralizumab as part of their standard care, and no additional treatment will be assigned by the study. Asthma control will be assessed using the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQae at various timepoints. Health-related quality of life will be measured using the mini Asthma Quality of Life Questionnaire miniAQLQ at baseline and follow-up visits. Patients will record their weekly asthma medication intake using either paper or electronic diaries throughout the study. During the study, participants will attend routine follow-up visits where investigators will collect clinical assessments and questionnaire data. Researchers will monitor changes in asthma control, lung function parameters, medication use, and patient-reported outcomes up to 52 weeks after the first dose of benralizumab. The primary outcomes include changes in ACT scores and inhaled corticosteroid use, while secondary outcomes cover remission criteria, lung function, biomarkers, exacerbation rates, and quality of life measures.

Researchers are evaluating the short, mid, and long-term clinical outcomes of Vagus Nerve Stimulation VNS Therapy as an additional treatment for patients with difficult to treat depression, including those with treatment resistant depression. The study focuses on adults diagnosed with unipolar or bipolar disorder who have chronic or recurrent depression that has not responded well to standard psychiatric treatments. Depression diagnosis and comorbid conditions will be confirmed using the Mini International Neuropsychiatric Interview MINI. Participants will receive a VNS Therapy System, which includes an implantable generator, lead, and external programming system for vagus nerve stimulation. The study will enroll at least 500 patients across up to 80 sites worldwide. Each participant will have a baseline visit 1 to 6 weeks before device implantation, followed by regular follow-ups for a minimum of 36 months and up to 60 months after implantation. During the study, participants will attend outpatient clinic visits to complete various evaluations and assessments. Researchers will measure depression symptoms using the Montgomery sberg Depression Rating Scale MADRS and other tools over an average of 4 years. They will also track quality of life, patient function, suicidality, cognition, anxiety, and changes in antidepressant treatments. Safety and tolerability will be monitored through the incidence of treatment-emergent adverse events.

Researchers are studying metastatic colorectal carcinoma mCRC patients who have a specific BRAFV600E mutation, which is linked to poorer outcomes compared to those without it. This mutation leads to shorter survival times after initial treatments, prompting the need for new therapy combinations. This research aims to observe how the drugs encorafenib and cetuximab work together in real-world settings for patients who have already received prior systemic therapies. This non-interventional, prospective, longitudinal study focuses on patients treated with encorafenib plus cetuximab following prior systemic therapy. The study collects data on treatment effectiveness, safety, and quality of life among a broader patient population in Germany, Austria, and Switzerland. Patients may have started treatment up to three months before joining the study or plan to start soon, and the study observes their outcomes without influencing treatment decisions. Participants will be monitored through data collection on their disease and treatment profiles, including patient and physician assessments, adverse events, and treatment details. The main outcome measured is overall survival at 12 months after starting treatment. Additional information gathered includes treatment duration, dose intensity, interruptions, and patient-reported quality of life using questionnaires. Safety and tolerability are also evaluated throughout treatment, with follow-up averaging nine months.

Researchers are conducting a prospective registry study to observe and document the treatment and disease progression in patients with recurrent and metastatic prostate cancer. The study includes four distinct patient groups based on disease status those with biochemical recurrence after local treatment, non-metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and metastatic castration-resistant prostate cancer. Each group is enrolled and followed independently over different time periods to understand the course of therapy and disease. The study does not prescribe any specific treatment but records routine care as decided by each patients physician. Data collection occurs during routine clinical visits at set intervals, including after enrollment, every 3 to 6 months, and when therapy changes occur. Standardized quality of life questionnaires FACT-P and EQ-5D-5L are completed, and biological samples are collected to support comprehensive assessment. Participants are followed long-term, with an average follow-up of seven years. Researchers document therapy patterns, disease management strategies, imaging assessments, patient-reported outcomes, treatment adherence, and adverse events throughout this period. The focus is on real-world data reflecting everyday clinical practice, enabling a detailed understanding of treatment effectiveness and disease progression in prostate cancer patients.

Researchers are evaluating the effectiveness and safety of a subcutaneous treatment using one cycle of cladribine for patients with hairy cell leukemia who need treatment. This study focuses on patients who are either untreated or have been previously treated only with alpha-interferon. The goal is to determine the rate of complete remission and to assess whether a second cycle of treatment benefits those with a non-optimal response, defined as detectable residual disease or partial remission four months after the initial treatment. Participants receive cladribine at a dose of 0.14 mgkg body weight administered subcutaneously as a bolus injection once daily for five consecutive days. After four months, remission status is evaluated. Patients showing non-optimal response may be considered for a second treatment cycle. This phase 23 trial is designed to optimize therapy for hairy cell leukemia by closely monitoring treatment response and toxicity. During the study, participants undergo evaluations including disease status assessment through bone marrow and blood tests, with a focus on remission rates four months post-treatment. Researchers track complete remission rates and monitor for residual disease. Safety is also monitored by assessing potential toxicities. Participants general health status and other laboratory tests are reviewed to ensure eligibility and ongoing suitability for treatment throughout the study period, which spans several months with follow-up assessments.