Hennigsdorf

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.

This research aims to assess how satisfied people with Multiple Sclerosis (MS) are after receiving subcutaneous (under the skin) injections of ocrelizumab over a period of 12 months. The study focuses on participants diagnosed with relapsing-remitting MS (RMS) or primary progressive MS (PPMS) according to 2017 McDonald criteria, who are starting ocrelizumab treatment for the first time. The main goal is to understand participant satisfaction using a special questionnaire designed for subcutaneous therapy administration. Participants will receive ocrelizumab as an injection under the skin, with the exact dosing and schedule determined by their treating physician following local medical guidelines. This observational study does not change standard care but monitors patients throughout their treatment with ocrelizumab. During the study, participants will complete the Therapy Administration Satisfaction Questionnaire for subcutaneous treatment after 12 months to measure their satisfaction. Researchers will also observe and record any relevant clinical information. The total study duration for each participant is 12 months, during which their experience and outcomes with ocrelizumab are carefully tracked.

Researchers are evaluating the effects of inclisiran compared to a placebo in people with serious heart conditions called acute coronary syndromes (ACS), including STEMI or NSTEMI. The study aims to learn about starting inclisiran treatment early after hospital admission to understand its impact on patients with ACS. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial with two parallel groups. Participants will be randomly assigned to receive either inclisiran sodium 300 mg or a placebo by subcutaneous injection. The first dose is given at randomization (Day 1) during the hospital stay, before discharge, and a second dose is administered on Day 90. The study includes a screening visit within 7 days of hospital admission, followed by randomization and baseline visit within those 7 days and before discharge. After randomization, participants enter a 150-day double-blind treatment period. Throughout the study, participants will have scheduled safety calls between visits and a safety follow-up call 30 days after the end of the treatment period. Researchers will measure the percent change in LDL cholesterol from baseline to Day 150. Screening and randomization visits occur during the hospital stay, and the overall study lasts 150 days, with close monitoring for safety and treatment effects.