Rudersdorf Bei Berlin

Researchers are evaluating how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

Researchers are studying adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) to understand why they choose certain treatments, why some switch to HyQvia from other therapies, and how satisfied they are with these treatments. The study also aims to assess the impact of CIDP on work productivity and daily activities, the signs and symptoms of CIDP, and collect information about any medical problems or side effects during HyQvia treatment. Additionally, it evaluates how effective HyQvia is in routine clinical care and monitors healthcare needs like emergency or hospital visits. This is a non-interventional study where participants receive treatment as determined by their doctors or clinics. Participants include both new users planning to switch to HyQvia within 6 weeks and current users who have recently started HyQvia treatment. Data collection involves medical record reviews, interviews at the start and end of the study, and questionnaires completed by participants. The study does not assign any specific treatment but observes the use of HyQvia in real-world settings. During the study, participants complete questionnaires measuring their treatment preferences, satisfaction, quality of life, disability, and work productivity at multiple times up to 12 months. Researchers also gather clinical information and monitor any side effects or healthcare interventions. Participants must be able to communicate in their local language if they take part in optional interviews. The study tracks outcomes and experiences related to HyQvia use for up to one year or until participants stop treatment or the study.

This research aims to explore the role of Digital Navigators (DN) in helping general practitioners, outpatient psychiatrists, psychologists, and their patients use digital mental health apps (DiGAs) and incorporate them into treatment. The study focuses on understanding the acceptance, expectations, and potential benefits of Digital Navigators, including their impact on patients' psychological health, digital health literacy, and technical skills. It targets patients with mental disorders who have access to smartphones and basic digital skills. Trained medical team members, primarily medical assistants, become Digital Navigators through a specialized training program adapted from Harvard Medical School. These Digital Navigators support treatment teams in selecting and integrating suitable digital health applications and assist patients over a 12-week period to find and use appropriate mental health apps. The intervention includes guidance through the DiGAnavigator.de website and ongoing support to enhance adherence and ease the burden on healthcare providers. Participants undergo assessments before and after the 12-week support period, measuring digital health literacy focused on information retrieval and interactive skills, as well as attitudes and expectations toward Digital Navigators. Researchers also evaluate implementation challenges and the effects on patients and professionals using standardized scales. The study includes interviews, focus groups, and surveys to capture digital skills, willingness to change, and illness severity. The goal is to establish sustainable training for Digital Navigators in mental health care.

Researchers are conducting the German Dementia Registry (DEMREG), a large national study in Germany that collects ongoing data from patients diagnosed with cognitive issues such as Subjective Cognitive Decline (SCD), Mild Cognitive Impairment (MCI), and early dementia from various causes. This registry aims to gather real-world, long-term information aligned with clinical guidelines to better understand the natural progression of dementia and differentiate between types like Alzheimer's and other dementias. The study also seeks to track biomarker changes and treatment patterns in routine healthcare settings, which may improve early diagnosis and treatment approaches for dementia. This is an observational registry study where no treatments are provided as part of the research. Instead, the study documents patients' usual care and medications while collecting additional data through questionnaires and tests related to early dementia. Data collection occurs during patient visits using an online platform, integrating clinical routine procedures and biomarker measurements such as cerebrospinal fluid and imaging results. The registry follows patients prospectively over time to monitor disease progression and biomarker changes. Participants and their family members provide informed consent and contribute data at baseline visits, with follow-up visits occurring annually for as long as possible. The registry gathers comprehensive clinical, biomarker, and questionnaire data to analyze dementia's natural history and healthcare practices in Germany. This ongoing data collection supports better understanding and potential improvements in dementia diagnosis and care. There is no maximum age limit for participation, and the registry includes both patients and involved family members.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.