Erding

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 collecting data on patients diagnosed with BCR-ABL 1-negative myeloid neoplasms, a type of blood cancer classified by the WHO in 2008 and 2016. The study aims to register many patients at participating centers to better understand the disease by analyzing biological features and clinical outcomes, including quality of life. The research also focuses on identifying prognostic and predictive markers by correlating disease characteristics with patient results. Participants will be part of a registry study where samples such as bone marrow aspirates, blood, plasma, buccal swabs, and occasionally skin biopsies are collected and stored. Morphologic and genetic analyses will be performed on these samples. There is no intervention treatment; instead, the study gathers extensive clinical and biological data over time to support research. During the study, patients' clinical characteristics, quality of life, and outcome data will be assessed using specific questionnaires and defined clinical variables. Researchers will monitor treatment decisions, response to therapy, survival rates, and progression-free survival for up to 25 years. This long-term follow-up allows comprehensive tracking of the disease course and patient well-being.

Researchers are evaluating the effectiveness, safety, and economic benefits of coronary lithotripsy compared to other procedures like cutting or super high pressure balloon angioplasty and ablative methods in treating severely calcified coronary artery lesions. The study focuses on patients with coronary artery disease who have severe calcification in their coronary arteries, aiming to improve the preparation and treatment of these blockages. This is a randomized, multicenter clinical trial assessing these different methods to better understand their benefits in lesion treatment. Participants receive either intravascular lithotripsy (IVL) using balloons with a burst pressure of up to 18 atmospheres or standard non-IVL methods such as special high pressure, super high pressure, cutting balloons, and ablative procedures for treating severely calcified lesions. The trial compares these treatment groups to assess additional benefits of coronary lithotripsy. Treatments are performed during the interventional procedure aimed at opening narrowed coronary arteries. During the study, participants are monitored for major cardiac and cerebrovascular events up to 12 months after randomization. Researchers will collect data on the combined endpoint of these serious events to evaluate the treatments' outcomes. Participants must meet specific eligibility criteria and provide informed consent. The study aims to provide insights into the best treatment approaches for patients with severe coronary artery calcification, with follow-up extending over one year after treatment.