Bad Mergentheim

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 evaluating insulin icodec, a once-weekly insulin injection, compared to insulin glargine, a once-daily injection, in adults with type 1 diabetes. The study aims to see how well weekly insulin icodec controls blood sugar levels compared to daily insulin glargine when both are combined with insulin aspart. This phase 3 study will last about 26 weeks, or roughly 8.5 months. Participants will receive either insulin icodec or insulin glargine, both given as subcutaneous injections. All participants will also use insulin aspart as a subcutaneous injection. The study compares these two insulin regimens to assess their effects on blood sugar control over the 26-week period. During the study, researchers will monitor changes in glycosylated hemoglobin (HbA1c) from the start of the study to week 26. Participants will follow the study protocol including self-measured plasma glucose profiles. Safety and efficacy will be evaluated throughout the treatment period to understand the impact of the insulin regimens on blood sugar control and participant health.

Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.

Cholangiocarcinoma is a rare and aggressive bile duct cancer with limited treatment options and a poor outlook. This study investigates the use of ivosidenib, a targeted IDH1 inhibitor, which was approved in May 2023 by the European Medicines Agency for adults with locally advanced or metastatic cholangiocarcinoma carrying an IDH1 R132 mutation, who have already received at least one prior systemic therapy. The study aims to collect real-world data on the effectiveness, safety, and impact on quality of life of ivosidenib treatment. Ivosidenib will be given to patients according to the current prescribing information (SmPC). This is a prospective, multicenter, observational study conducted in Germany, enrolling a broad patient population receiving ivosidenib as part of routine care. Treatment is not assigned by the study but is observed in real-world settings, allowing for the collection of comprehensive data on this therapy. Participants will be monitored for up to 38 months to measure progression-free survival, among other outcomes. Data on quality of life and safety will also be collected. Patients will provide informed consent, and those opting into the patient-reported outcomes module will complete assessments in German. The study will provide valuable insights into how ivosidenib performs outside of clinical trials.

People with diabetes often face higher risks of mental health problems such as distress, depression, anxiety, and eating disorders, which can lower quality of life and worsen blood sugar control. This research explores the complex relationships between mental health and glucose levels in diabetes, aiming to identify patient subgroups with different patterns of mental health and glycemic control. The study builds on previous work using advanced methods to monitor daily psychological factors and glucose continuously, aiming to develop a personalized approach to mental health care in diabetes. The study uses a precision medicine approach by collecting extensive data from over 1,800 people with diabetes, including clinical interviews for mental disorders, continuous glucose monitoring, and repeated daily assessments of mental health factors via ecological momentary assessment (EMA). Participants complete surveys and provide data every six months, including questionnaires about well-being, diabetes distress, and other psychosocial factors. The research team applies machine learning to analyze the data and create digital twin models, virtual representations of individuals that simulate mental health and glucose outcomes to guide personalized treatment decisions. Participants are involved in regular clinical interviews, continuous glucose monitoring, EMA periods lasting 14 days, and online surveys every six months over a long-term observation period. The study measures the incidence and remission of mental health disorders, changes in depressive and anxiety symptoms, eating behaviors, diabetes distress, and glycemic control through both lab tests and glucose monitoring devices. Safety and accuracy of the digital twin predictions will be validated using follow-up data and a subsample of participants undergoing repeat diagnostic interviews, supporting future improvements in personalized diabetes care.

Researchers are studying the use of venetoclax in people with chronic lymphocytic leukemia (CLL) to understand how effective it is and to assess the costs and patient-reported outcomes when used in real-life medical settings. The study looks at venetoclax given alone or combined with rituximab, obinutuzumab, ibrutinib, or acalabrutinib, based on doctors' decisions and local treatment guidelines. Participants receive venetoclax therapy as prescribed by their physician, which may include the drug alone or along with one of the mentioned combination treatments. The study follows patients in Austria, Germany, and Switzerland, observing how the treatments are used in everyday practice without altering the prescribed therapy. During the study, participants are monitored for up to 12 months to measure the percentage who achieve the best overall response rate (ORR) to treatment. Researchers also collect data on health economics and patient experiences to better understand the impact of these therapies in routine care.