Eisenach

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 efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus T2DM who are already being treated with insulin and other glucose-lowering medications. This Phase III study focuses on adults with T2DM who have had the condition for at least 90 days and meet certain health criteria. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are taken orally once daily. The study treatment period lasts up to 40 weeks, during which participants continue their background insulin and glucose-lowering medications. During the study, participants will have regular assessments to monitor changes in blood sugar control, including Hemoglobin A1c HbA1c, body weight, blood pressure, and insulin dose. Researchers will also track safety, side effects, and tolerability. The main outcome is the change in HbA1c from baseline to Week 40. Overall, participation involves visits for monitoring and evaluations over approximately 40 weeks.

Researchers are evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection. This study focuses on adults with type 1 diabetes to see how well the weekly insulin controls blood sugar when combined with insulin aspart, which is taken 2 to 4 times daily. The trial aims to assess blood sugar control over about 8.5 months. Participants will be randomly assigned to receive either insulin icodec once a week with insulin aspart daily or insulin glargine once a day with insulin aspart daily. Both insulins are given as subcutaneous injections. The study is designed as a parallel comparison to evaluate the effects of these insulin regimens on blood sugar control. During the study, participants will have regular assessments including blood tests to measure HbA1c and glucose levels, monitoring of hypoglycemic episodes, and tracking of insulin doses and body weight. The primary outcome is the change in HbA1c from baseline to week 26. Secondary outcomes include time spent in target glucose ranges and frequency of low blood sugar events. The study will last about 8.5 months with ongoing monitoring to evaluate treatment effects and safety.

Researchers are evaluating how well once-weekly insulin icodec maintains blood sugar levels compared to daily basal insulin injections in adults with type 2 diabetes. The study focuses on people who need to start basal insulin treatment after using other glucose-lowering medications. This phase 4 trial aims to assess insulin icodecs effectiveness in real-world clinical practice over about 13 months. Participants will be randomly assigned to receive either weekly subcutaneous injections of insulin icodec or daily subcutaneous injections of basal insulin analogues such as insulin glargine, detemir, or degludec. The study compares these two insulin regimens as part of standard type 2 diabetes care. Treatment continues during the 52-week period to monitor blood sugar control and treatment satisfaction. Throughout the study, participants will undergo assessments including measuring changes in glycated hemoglobin HbA1c from baseline to week 52. They will also complete questionnaires on treatment adherence, satisfaction, and burden, and researchers will track severe hypoglycemia episodes and insulin doses. The trial spans about 13 months, providing thorough monitoring of treatment impact and safety in daily clinical use.

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 evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

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 conducting a prospective, observational study to describe the real-world clinical experience of patients with metastatic castration-resistant prostate cancer mCRPC treated with a combination of olaparib and abiraterone. The study aims to assess clinical outcomes in patients who are either new to novel hormonal agents NHA-naive or have been previously exposed to these agents before starting olaparib plus abiraterone treatment. Patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone will also be documented. Participants will be observed from the start of their olaparib plus abiraterone treatment, with no investigational interventions administered by the study team, reflecting real-world treatment usage. The study plans to enroll patients for up to two years and will follow each patient for one year after the last patient begins treatment. The primary outcome measured is the time to treatment discontinuation within 12 months, along with secondary outcomes such as the time to the first subsequent therapy within 24 months. During the study, participants clinical data, treatment histories, and outcomes will be collected and analyzed. There are no specific study visits or procedures imposed beyond routine clinical care. Safety and treatment adherence will be monitored through observational data. Participants are expected to be involved for the duration of their treatment and follow-up, which may extend to approximately three years from enrollment start to last follow-up.

Researchers are observing adults with Chronic Lymphocytic Leukemia CLL who are receiving the drug venetoclax, either alone or combined with other medications such as rituximab, obinutuzumab, ibrutinib, or acalabrutinib. The study aims to understand how these treatments work in real-life settings, focusing on the effectiveness, costs related to health economics, and outcomes reported by the patients themselves. Participants receive venetoclax as prescribed by their doctors following local medical guidelines. They may receive it alone or alongside one of the other drugs mentioned. This study does not assign treatments but observes patients as they undergo therapy according to routine clinical practice across several countries. During the study, participants are monitored for their response to treatment, with the main focus on the best overall response rate within 12 months. Researchers collect data on health outcomes, costs, and patient experiences to better understand the impact of these therapies. The study spans several years, allowing long-term observation of treatment effects and outcomes.