Wolfenbuttel

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are studying whether performing percutaneous coronary intervention (PCI) on all significant blocked arteries (multivessel complete PCI) is better than treating only the artery causing the current heart attack (culprit-lesion only PCI) in patients with non-ST-segment elevation myocardial infarction (NSTEMI) who have blockages in multiple heart arteries. This trial is designed as a prospective, randomized, controlled, and open-label study conducted at multiple centers to compare these two treatment approaches for people with NSTEMI and multivessel coronary artery disease. Participants will be assigned to one of two groups: one receiving PCI only on the artery responsible for the heart attack (culprit-lesion revascularization), and the other receiving PCI on all significant blockages in the heart arteries (complete PCI). The procedures involve opening blocked arteries using standard catheter-based techniques. The study will monitor participants over an estimated average of two years to evaluate outcomes. During the study, researchers will track the combined rate of cardiovascular death or rehospitalization for a new heart attack as the primary outcome. Participants will be followed closely for up to two years, with regular assessments and medical monitoring to capture these events. This approach aims to determine which PCI strategy leads to better long-term heart health and fewer complications.