Aalen

Researchers are conducting a prospective, multicenter, observational study in Germany to evaluate the clinical value and impact of serum neurofilament light sNfL as a prognostic marker for disease activity in patients with relapsing Multiple Sclerosis MS. The study focuses on patients who have received category 1 disease-modifying therapies DMTs and monitors routinely assessed sNfL values to better understand their role in patient management. Participants in the study either continue their current category 1 DMT treatment or switch to ofatumumab based on their physicians clinical judgment, independent of study enrollment. Category 1 DMTs include medications such as dimethylfumarate, diroximelfumarate, glatiramer acetate, interferon beta, and teriflunomide. Data will be collected over a maximum period of 24 months during routine clinical visits, with no specific protocol dictating observation frequency or diagnostic procedures. During the study, researchers will gather primary data including sNfL test results and track various outcomes like disease activity, treatment adherence, patient-reported fatigue, quality of life, and treatment satisfaction. Assessments will align with standard care practices and guidelines, and the study will measure outcomes at baseline, 12 months, and 24 months. The study aims to provide insights into the use of sNfL in clinical practice and its implications for managing relapsing MS.

Researchers are evaluating real-world patient characteristics, treatment methods, and long-term outcomes in people with symptomatic obstructive hypertrophic cardiomyopathy HCM in the United States and Europe. The study includes patients receiving mavacamten, other treatments, or no treatment due to intolerance or treatment failure. The US sub-study focuses on safety of mavacamten, while the European sub-study assesses both safety and effectiveness of mavacamten in everyday care. Participants may receive mavacamten or standard treatments like beta blockers, non-dihydropyridine calcium channel blockers, or disopyramide as prescribed by their doctors. The study observes these groups over time in routine clinical settings without altering their care. The study includes two main groups based on treatment type and monitors outcomes up to five years. Participants undergo evaluations including echocardiograms, heart function assessments using New York Heart Association NYHA class, left ventricular outflow tract gradient measurements, and patient-reported health questionnaires. Researchers also track heart failure events, arrhythmias, major cardiovascular events, hospitalizations, mortality, and biomarkers like NT-proBNP and cardiac troponin. Follow-up varies by region, lasting up to 18 months in Europe and up to 5 years in the United States.

Researchers are evaluating the safety, effectiveness, and quality of life for combining Abemaciclib with either an Aromatase Inhibitor or Fulvestrant in women with metastatic hormone receptor-positive, HER2-negative breast cancer. This Phase IV trial focuses on both pre- and postmenopausal patients receiving first-line treatment. A digital health app called CANKADO will be used to track side effects and patient-reported outcomes daily, alongside standard documentation. The study also aims to explore biomarkers to better understand treatment responses and resistance. Participants will receive either Abemaciclib combined with an Aromatase Inhibitor Anastrozole, Letrozole, or Exemestane taken orally twice daily plus daily Aromatase Inhibitor tablets every 24 hours in 28-day cycles, or Abemaciclib with Fulvestrant which is given as an injection on specific days within 28-day cycles. The two treatment groups are experimental and non-randomized, with no masking. The trial includes monitoring for side effects and quality of life throughout treatment. During the study, participants will regularly report side effects and global health status using questionnaires at multiple time points up to 24 months, including specialized breast cancer quality of life modules. Researchers will assess progression-free survival up to 48 months, as well as adverse events, hospitalizations, clinical benefit rate, overall survival, and tumor response. The use of the CANKADO app for side effect reporting is strongly recommended but not mandatory. Participants will be followed for safety and outcomes throughout the trial duration.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.