Eisenach

Researchers are studying the real-world effectiveness, safety, and patient experience 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 patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily insulin injection, in adults with type 1 diabetes. The study aims to see how well insulin icodec controls blood sugar when combined with insulin aspart, compared to the daily insulin glargine combined with insulin aspart. This phase 3 study is designed to assess the efficacy and safety of these insulin regimens over a period of about 26 weeks. Participants are randomly assigned to receive either weekly subcutaneous injections of insulin icodec with 2 to 4 daily doses of insulin aspart or daily subcutaneous injections of insulin glargine with 2 to 4 daily doses of insulin aspart. Both groups use insulin aspart multiple times daily as part of their treatment. The study includes monitoring during the 26-week treatment period. During the study, participants will have their blood sugar control measured, including changes in HbA1c levels from the start to week 26. Researchers will also track time spent within target blood sugar ranges, episodes of low blood sugar, insulin doses, and changes in body weight. Safety and blood sugar levels will be closely monitored throughout the study period. The total participation duration is about 8.5 months from screening to study end.

Researchers are evaluating how well the once-weekly injectable insulin icodec compares to daily injectable basal insulins in managing blood sugar levels in adults with type 2 diabetes. The study focuses on insulin-nave adults who need to start basal insulin treatment and aims to understand how these different insulin schedules affect diabetes control over about 13 months. Participants will be randomly assigned to receive either the weekly subcutaneous injections of insulin icodec or daily subcutaneous injections of basal insulin analogues such as insulin glargine, insulin detemir, or insulin degludec. The study follows approved and available insulin treatments to compare the effectiveness of once-weekly versus once-daily dosing in real-world clinical practice. During the trial, participants will have their blood sugar control measured mainly by changes in glycated hemoglobin HbA1c from the start to week 52. Additional assessments include treatment satisfaction, adherence questionnaires, treatment burden, and monitoring of severe low blood sugar episodes. Insulin doses and whether participants meet individualized HbA1c targets will also be tracked. The study includes regular visits over approximately one year to monitor these outcomes and ensure participant safety.

Researchers are studying metastatic colorectal carcinoma mCRC patients who have a specific BRAFV600E mutation, which is linked to poorer outcomes compared to those without it. This mutation leads to shorter survival times after initial treatments, prompting the need for new therapy combinations. This research aims to observe how the drugs encorafenib and cetuximab work together in real-world settings for patients who have already received prior systemic therapies. This non-interventional, prospective, longitudinal study focuses on patients treated with encorafenib plus cetuximab following prior systemic therapy. The study collects data on treatment effectiveness, safety, and quality of life among a broader patient population in Germany, Austria, and Switzerland. Patients may have started treatment up to three months before joining the study or plan to start soon, and the study observes their outcomes without influencing treatment decisions. Participants will be monitored through data collection on their disease and treatment profiles, including patient and physician assessments, adverse events, and treatment details. The main outcome measured is overall survival at 12 months after starting treatment. Additional information gathered includes treatment duration, dose intensity, interruptions, and patient-reported quality of life using questionnaires. Safety and tolerability are also evaluated throughout treatment, with follow-up averaging nine months.

Researchers are studying adults with type 2 diabetes, high blood pressure, and established cardiovascular disease who do not have a history of heart failure. The study aims to find out whether taking a medicine called vicadrostat together with empagliflozin can help reduce the risk of heart-related problems compared to taking a placebo with empagliflozin. This is a phase III trial sponsored by Boehringer Ingelheim evaluating the safety and effects of this combined treatment. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets, while the other group takes placebo tablets that look like vicadrostat plus empagliflozin. All participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. The study treatment is taken once daily for a period ranging from two and a half years up to four years and three months. During the study, participants visit the study site regularly where doctors collect health information and take blood samples. The doctors track any cardiovascular events and monitor participants for any side effects. The main outcome measured is the time until the first cardiovascular death or heart failure event over a period of up to 51 months. Several other heart and kidney-related outcomes are also evaluated throughout the study.

Researchers are investigating the use of low stable pressure pneumoperitoneum, applied with the AirSeal Insufflator, during colorectal surgery to improve recovery. This international prospective cohort study focuses on patients undergoing minimally invasive colorectal surgery for benign or malignant conditions. The goal is to shorten hospital stays, reduce postoperative pain, and lower opioid use by optimizing the early rehabilitation program after surgery. The study observes patients undergoing laparoscopic or robotic colorectal resections performed under low stable pressure pneumoperitoneum with the AirSeal device. It aims to evaluate the influence of this approach alongside other factors such as anesthesia management and surgical techniques on postoperative outcomes. This observational study does not alter standard surgical care but collects data on recovery parameters and complications. Participants will be monitored from the time of surgery through hospitalization, with maximum follow-up of 30 days post-surgery. Researchers will assess length of hospital stay, pain levels 24 hours after surgery, opioid consumption, surgical and medical complications, and the impact of different minimally invasive approaches and anesthesia methods. The study is expected to help optimize postoperative recovery after colorectal surgery by understanding the benefits of low-pressure pneumoperitoneum.

Researchers are observing the real-world clinical experience of men with metastatic castration-resistant prostate cancer mCRPC who are treated with the combination of olaparib and abiraterone. The study aims to describe patient characteristics, previous treatments, and clinical outcomes in patients who either have not been exposed to novel hormonal agents NHA or have prior NHA exposure before starting olaparib plus abiraterone therapy. This observational study is sponsored by AstraZeneca and plans to enroll patients over a two-year period. The study follows patients from the time they begin treatment with olaparib and abiraterone after the study site is activated. No experimental treatments are assigned since this is an observational study. Researchers will collect data on treatments received before and after starting the combination therapy, focusing on those treated in routine clinical practice. Patients will be observed without intervention to capture real-world outcomes. Participants will be followed for up to one year after the last patient joins the study. Researchers will assess the time until patients stop the combination treatment and the time until they begin a new therapy. Data collected will include patient demographics, clinical characteristics, and treatment history. The study involves reviewing medical information and monitoring treatment patterns and outcomes over time, without additional procedures or interventions required from participants.

Researchers are evaluating the use of venetoclax in people with Chronic Lymphocytic Leukemia CLL in a real-life setting. This observational study aims to understand the effectiveness, health-related costs, and participant-reported outcomes for those receiving venetoclax alone or combined with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed by their doctors according to local clinical practice and labels. Participants with CLL are observed while receiving venetoclax either as a single treatment or in combination with one of four other medications rituximab, obinutuzumab, ibrutinib, or acalabrutinib. The choice of treatment is determined by the physician and follows approved local guidelines. The study groups include those on venetoclax alone and those on venetoclax combined with each of the other drugs. During the study, participants responses to the treatment are monitored, focusing on the percentage achieving the best overall response within up to 12 months. Researchers also assess health economic costs and collect participant-reported outcomes. The study follows participants over time without changing their treatment and continues until December 2030, with data collected during regular care visits.