Bad Mergentheim

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 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.

Cholangiocarcinoma is a rare and aggressive bile duct tumor with poor outcomes and limited treatment options. Researchers are collecting real-world data on ivosidenib, an IDH1 inhibitor recently approved in Europe for adults with locally advanced or metastatic cholangiocarcinoma carrying an IDH1 R132 mutation who have undergone at least one prior systemic treatment. This observational study aims to evaluate ivosidenibs effectiveness, safety, and impact on quality of life in a broad patient population in Germany. Ivosidenib is given as monotherapy according to the current summary of product characteristics SmPC. The study follows patients receiving ivosidenib under routine clinical care without altering treatment decisions. It will gather data on treatment dosing, modifications, duration, and reasons for stopping treatment. Optional patient-reported outcomes PRO assessments are available for those who can participate in German. Participants are monitored during treatment and follow-up for up to 38 months from first patient in to last patient last visit. The study collects information on progression-free survival, overall survival, adverse events, quality of life related to cholangiocarcinoma, and physician treatment decisions. Data on prior therapies, concomitant medications, and subsequent cancer treatments are also recorded to assess real-world use and safety of ivosidenib.

Researchers are investigating mental health conditions such as distress, depression, anxiety, and eating disorders in people with diabetes. This study aims to use a personalized approach called precision mental health to identify subgroups of people with diabetes who share common patterns in the relationships between glucose levels and psychosocial factors. The goal is to develop a digital twin, a virtual model that can simulate and predict the course of mental health and blood sugar control to help guide more tailored diabetes care. Participants include over 1,800 people with type 1, type 2, or other specific types of diabetes. They continuously complete ecological momentary assessments EMA, which involve daily surveys about stress, mood, and diabetes distress, along with questionnaires every six months. Glucose levels are measured using continuous glucose monitoring CGM devices, and clinical interviews diagnose mental health disorders. Data on medication, complications, diet, physical activity, and metabolic measures like HbA1c are also collected to build comprehensive profiles. During the study, participants undergo repeated assessments every six months over a two-year period, including EMA, questionnaires, CGM data collection, and diagnostic interviews in a subset. Researchers analyze the complex interactions between metabolic, behavioral, and psychological data using machine learning to identify subgroups and validate the digital twins predictions. The main outcomes measured include the incidence and remission of mental disorders, diabetes distress, and glycemic control. This observational study will provide insights to support personalized mental health care in diabetes.

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.