Lunen

Researchers are evaluating various approved injectable and oral disease-modifying treatments (DMTs) in patients with relapsing multiple sclerosis (RMS) in Germany. This observational, non-interventional, multicenter, open-label study collects primary data prospectively over up to four years, alongside retrospective data. The study captures medical history, disease duration, laboratory values, disability scores (EDSS), MRI results, and relapse information to provide real-world insights into treatment use and outcomes. Patients receiving routine medical treatment with any approved injectable or selected oral DMTs—including ofatumumab, glatiramer acetate, interferon 21, teriflunomide, dimethyl fumarate, and diroximel fumarate—are enrolled without treatment allocation by the study. Two cohorts are observed: one treated primarily with injectable DMTs and another with injectable or oral DMTs. The core study period lasts about two years, with an optional extension providing an additional two years of observation, totaling up to four years. Follow-up visits and monitoring happen at the investigator's discretion and may include telemedicine. During the study, participants provide data through questionnaires and electronic case report forms. Routine clinical care procedures, such as diagnostic tests and monitoring, continue as usual. Researchers measure the proportion of patients continuing their baseline treatment at 24 months and collect ongoing clinical and imaging data. The study emphasizes real-world treatment patterns, safety, and disease activity over the extended follow-up period.

This clinical investigation is a non-randomized, multicenter, open-label, prospective pilot trial designed to evaluate the safety and performance of a wearable noninvasive magnetic device called the Oncomagnetic device in patients with newly diagnosed glioblastoma multiforme (GBM). The study focuses on patients who have undergone maximal safe tumor resection and have specific molecular and clinical characteristics, including unmethylated MGMT promoter status and good functional status. Participants will use the Oncomagnetic device, which delivers low-intensity oscillatory magnetic therapy, as part of an exposure-time escalation protocol. The device is portable and wearable, and the study aims to assess safety over a 6-month period. Standard radiotherapy is expected to be given unless contraindicated or refused by the participant. Throughout the study, participants will be monitored with pre-operative, post-surgical, and radiotherapy planning MRI scans. Investigators will review these images and evaluate clinical safety outcomes. Additional assessments include tracking corticosteroid use, Karnofsky Performance Status (KPS), and overall health status. The primary outcome is to assess the safety of the Oncomagnetic device over six months, with participants expected to comply with all study procedures and remain available for the study duration.

Researchers are studying pre- and perimenopausal women with estrogen- and/or progesterone-receptor-positive, HER2-negative early breast cancer who have an intermediate to high clinical risk but low genomic risk of recurrence based on MammaPrint4 testing. The study aims to understand the real-world use of ovarian function suppression (OFS) combined with endocrine therapy, with or without prior chemotherapy, and how secondary amenorrhea after chemotherapy might affect outcomes. It also focuses on treatment adherence and quality of life over time, given the importance of long-term endocrine treatment up to 10 years. The registry will follow patients receiving standard-of-care treatment, which may include endocrine therapy with or without ovarian function suppression, and potentially chemotherapy based on clinical decisions. Data on treatment choices, including the use of OFS and chemotherapy, will be collected along with tumor characteristics assessed by local pathology and genomic signatures. Quality of life assessments will be conducted at baseline and multiple time points up to five years, while treatment adherence and outcomes will be tracked over up to 10 years. Participants will provide baseline information including tumor and treatment details. Researchers will collect follow-up data on treatment adherence, quality of life using specific questionnaires, and disease outcomes such as the five-year distant recurrence-free interval. Monitoring will include hormonal status and clinical assessments to correlate treatment effects with genomic risk scores and clinical markers. The overall goal is to improve understanding of treatment patterns and outcomes in this specific breast cancer population under 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. These devices are studied for use in Covered Endovascular Reconstruction of Aortic Bifurcation (CERAB) procedures to treat extensive aorto-iliac occlusive disease. This prospective, multi-center, non-randomized clinical trial aims to assess these stent graft systems in patients with symptomatic peripheral artery disease affecting the aortic bifurcation. The study involves implanting the BeGraft Aortic and Peripheral covered stent graft systems during the CERAB procedure, a minimally invasive technique that rebuilds the diseased aortic bifurcation and iliac arteries. The stents are introduced through the groin or arm arteries to restore blood flow. The trial evaluates the devices' use without the need for additional chimney techniques, with specific sizing and placement criteria for the stents. Treatment includes using a maximum of three BeGraft Peripheral stents per limb in the iliac artery, with post-dilation if needed. Participants will be followed for at least 12 months after the procedure to assess outcomes such as freedom from clinically-driven target lesion revascularization and the incidence of serious adverse device effects. The study requires regular follow-up visits where clinical assessments and monitoring of safety and effectiveness will be conducted. Total participation duration includes pre-procedure screening, the intervention, and a 12-month follow-up period to evaluate the long-term performance and safety of the stent graft systems.