Plauen

Researchers are evaluating the persistence of two treatments, upadacitinib UPA and tumor necrosis factor inhibitors TNFi, in adults with moderate to severe active rheumatoid arthritis RA. This observational study is conducted in Germany with about 678 participants across roughly 80 sites. The purpose is to compare how long participants continue their prescribed treatment under real-world conditions over time. Participants will receive either UPA or TNFi treatment as prescribed by their doctors, following local labels and standard care practices. Treatment decisions were made before joining the study and are independent of recruitment. The study will observe participants for up to 24 months to assess retention rates on these treatments. During the study, participants will be monitored regularly according to local care standards. Researchers will collect data on how long participants stay on their assigned treatment, focusing on retention rates over approximately 24 months. Study participation may last up to two years, with recruitment expected to take about 24 months, resulting in a total study duration of about 48 months.

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

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 performing percutaneous coronary intervention PCI on all significant blockages in patients with non-ST-segment elevation myocardial infarction NSTEMI and multivessel coronary artery disease is better than treating only the main culprit lesion. This open-label, randomized, controlled, multicenter trial aims to compare these two approaches to understand which provides better outcomes for patients with this heart condition. Participants will be randomly assigned to one of two groups. One group will receive optimal medical therapy and PCI only on the culprit lesion, with no further intervention on other blockages unless certain emergency criteria occur. The other group will receive complete revascularization of all significant non-culprit lesions, either during the initial procedure, hospitalization, or within 45 days after the initial PCI. During the study, participants will be followed for an average of two years to monitor outcomes including cardiovascular death, rehospitalization for heart attacks, and other heart-related events. Researchers will also assess quality of life and complications such as bleeding, stroke, and kidney injury at various time points. The study involves regular evaluations and aims to gather comprehensive data to determine the best treatment strategy for these patients.

Researchers are gathering real-world clinical data from women with primary advanced FIGO stage III or IV or recurrent endometrial cancer who are treated with first-line chemotherapy regimens combining Carboplatin, Paclitaxel, and Durvalumab CPD. This observational study focuses on patients receiving maintenance therapy with durvalumab alone or durvalumab combined with olaparib, depending on their tumors DNA mismatch repair status. The aim is to evaluate treatment outcomes including effectiveness, safety, and patient-reported experiences after chemotherapy. Participants receive first-line CPD chemotherapy followed by maintenance therapy tailored to their tumor characteristics patients with DNA mismatch repair deficient tumors receive durvalumab maintenance, while those with proficient status receive both durvalumab and olaparib maintenance. Treatment decisions are made as part of routine care in collaboration with their doctors, independent of the study. The study observes patients who achieve disease control after chemotherapy, tracking their ongoing treatments according to approved guidelines. During the study, participants complete questionnaires to report their quality of life and health status over time. Researchers monitor time to next treatment and progression-free survival at 12 months, as well as the duration of maintenance therapy and chemotherapy phases, and timing between treatments. Safety and real-world usage of therapies are assessed up to 46 months. The study spans multiple centers in Germany and aims to better understand characteristics of patients benefiting from these treatments in everyday clinical practice.

Researchers are examining how three major heart conditionsheart failure, coronary artery disease, and atrial fibrillationare currently treated in everyday clinical practice. This observational registry study collects standardized patient data and outcomes to better understand healthcare use and how these diseases and their treatments interact. The study follows guidelines set by the International Consortium for Health Outcomes Measurement to ensure consistent and meaningful tracking of patient experiences and results. The study includes hospitalized patients diagnosed with any of the three heart conditions. There is no specific intervention or treatment assigned by the study instead, it observes how patients are treated in real-world clinical settings. Patients are grouped based on their diagnosis of heart failure, coronary artery disease, or atrial fibrillation. The research team collects data during hospital stays and follows patients over time to monitor health outcomes and treatment effects. Participants will have their health status and outcomes tracked through regular assessments over periods of 6, 12, and 18 months. These evaluations include measurements of all-cause and cardiovascular mortality, rates of hospital readmissions, length of hospital stay, quality of life surveys, side effects related to medications, and adherence to treatments. The study also monitors complications from therapies and the associated costs, providing a detailed view of patient experiences and health outcomes in real-world care over time.