Lunen

This research aims to observe patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study collects data to understand how these treatments are used in routine care and their effects over time. It is an observational, non-interventional, multicenter, open-label study sponsored by Novartis Pharmaceuticals. Patients will be followed in two cohorts Cohort 1 includes patients starting or recently started on injectable DMTs, and Cohort 2 includes patients starting or recently started on either ofatumumab or other approved injectable or oral DMTs. The core observational period is up to two years, with an optional extension adding another two years, totaling up to about four years of observation. Treatment decisions are made independently by patients and their physicians, and no study-mandated treatment or monitoring is imposed. Participants will provide data through questionnaires and electronic case report forms, with medical history including disease duration, lab values, MRI results, and relapse information collected. Routine clinical care assessments and telemedicine visits may occur at the investigators discretion. The study measures include treatment continuation rates, disability scores, relapse rates, quality of life, fatigue, anxiety, depression, MRI lesion monitoring, and safety events, with follow-up visits scheduled as per standard care over the study period.

Researchers are evaluating the safety and performance of the Oncomagnetic Device, a portable wearable noninvasive magnetic device, in patients newly diagnosed with Glioblastoma Multiforme GBM. This non-randomized, multicenter, open-label clinical investigation uses an exposure-time escalation approach to understand how the device works over increasing durations of daily use. The study aims to provide important information on the devices clinical safety and effectiveness in this patient population. Participants will start using the Oncomagnetic Device for 4 hours per day. If no issues arise after 2 weeks, the daily use will increase to 6 hours, then to 8 hours after another 2 weeks without problems. If any device-related issues occur, the usage time may be reduced by 4 hours per day, with a minimum use of 2 hours daily, adjusted as needed. This personalized escalation continues throughout the study. During the study, participants will be monitored for safety and device performance for at least 6 months, with some evaluations extending up to 3 years. Assessments include clinical reviews and MRI scans to track disease status and any side effects. The main outcome is to assess safety within 6 months, while secondary outcomes focus on device performance over 6 months and up to 3 years. Participants must comply with all procedures and be available for the duration of the investigation.

Researchers are studying pre- and perimenopausal women with estrogen- andor progesterone-receptor-positive, HER2-negative early breast cancer who have intermediate to high clinical risk but low genomic risk of recurrence according to MammaPrint. This observational registry aims to understand the real-world use of ovarian function suppression OFS combined with endocrine therapy, especially in relation to chemotherapy use and secondary amenorrhea. The study also examines the impact of various clinical and genomic factors on treatment outcomes and quality of life. Participants receive standard-of-care treatments including endocrine therapy with or without ovarian function suppression and possibly chemotherapy, based on individual risk assessments. The registry collects data on treatment paths, adherence to therapy, and the use of ovarian function suppression over time. Quality of life is assessed regularly using specific questionnaires at multiple time points up to 5 years, and treatment adherence is monitored for up to 10 years. Throughout the study, researchers gather detailed baseline, treatment, and relapse information. They measure outcomes such as 5-year distant recurrence-free interval and monitor quality of life through validated questionnaires at intervals ranging from every 3 months in the first year to yearly up to 5 years. Long-term follow-up includes adherence tracking and evaluation of molecular and pathological markers over 10 years, providing insights into treatment effectiveness and patient well-being in real-world conditions.

Researchers are evaluating the safety and performance of the BeGraft Aortic balloon expandable covered Stent Graft System and the BeGraft Peripheral balloon expandable covered Stent Graft System in treating extensive aorto-iliac occlusive disease. This prospective, multi-center study focuses on using these devices in Covered Endovascular Reconstruction of Aortic Bifurcation CERAB procedures to treat this condition. The study aims to assess how well these stent graft systems work and their safety when implanted as covered stents in the affected arteries. The study involves using the BeGraft Aortic and BeGraft Peripheral covered stent graft systems during CERAB, a minimally invasive technique that rebuilds diseased aortic bifurcation and iliac arteries. These stents are introduced through arteries in the groin or arm to restore blood flow. The procedure uses up to three peripheral stents per limb and targets lesions with significant narrowing or blockage. The devices are evaluated without the need for chimney techniques, and specific sizing and placement criteria apply. Participants will undergo follow-up visits to assess outcomes such as freedom from needing additional treatment at 12 months and incidence of serious device-related adverse effects. Other evaluations include technical success, vessel patency, need for surgical conversion, patient-reported outcomes, clinical success, hemodynamic improvements, and safety monitored at various intervals up to 24 months. Participants must provide consent and attend scheduled follow-ups to track the stents performance and safety over time.