Brandenburg An Der Havel

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 combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. 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 given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

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 the safety and effectiveness of the drugs eltrekibart and mirikizumab in adults with moderately to severely active ulcerative colitis UC, a chronic inflammatory bowel disease. This Phase 2 study aims to find out how these treatments work alone or in combination to improve UC symptoms and health. The study is sponsored by Eli Lilly and Company and will last about 4 to 5 years, including screening. Participants will be randomly assigned to receive one of several treatments eltrekibart with a placebo, mirikizumab with a placebo, both drugs together, or placebo alone. The study is double-blinded, meaning neither the participants nor the researchers know which treatment is given to ensure unbiased results. The treatment period includes dosing with the study drugs or placebo, and participants will be monitored for safety and response. Participants will be involved in the trial for around 69 weeks, including a screening period of up to 35 days before starting treatment. Throughout the study, they will undergo assessments to measure clinical remission, response, endoscopic improvement, and quality of life using questionnaires. Blood samples will be taken to study drug levels, and researchers will monitor safety and disease activity regularly. The main outcome is the percentage of participants achieving clinical remission at Week 12, with additional measures assessed up to Week 52.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Atrial fibrillation is the most common heart rhythm disorder, increasing the risk of blood clots forming in the heart, especially in the left atrium. These clots can cause strokes if they travel to the brain. Patients with atrial fibrillation who have had an intracranial bleed bleeding in the brain are often treated with blood thinners to prevent stroke, but these medications can increase bleeding risk. This study compares two treatment methods to prevent strokes in such patients blood thinners and a device that closes off the left atrial appendage of the heart. The study randomly assigns participants to one of two groups. One group receives a device called Watchman or Watchman FLX to close the left atrial appendage through a minimally invasive procedure, followed by short-term blood thinning medication. The other group receives standard oral blood thinners as per current guidelines. Only approved drugs and devices are used. The trial aims to provide data to help doctors manage patients with atrial fibrillation who have experienced brain bleeds. Participants are followed for up to three years after randomization. Researchers monitor for events such as death from cardiovascular causes, stroke, systemic embolism, and bleeding episodes. Assessments include imaging during the procedure and regular follow-up visits to track health outcomes. The main measure is event-free survival without these complications. This long-term follow-up helps evaluate the safety and effectiveness of each treatment approach in preventing strokes and bleeding.

This research aims to develop, validate, and evaluate a new questionnaire called the CFAbd-Score to assess and measure abdominal symptoms in patients with cystic fibrosis, a genetic disease affecting multiple organs and shortening life expectancy. The study follows FDA guidelines to create patient-reported outcome measures PROMs specifically for cystic fibrosis and includes patients, their families, and healthcare professionals across different countries. The goal is to better understand abdominal involvement in cystic fibrosis and improve symptom tracking. The study involves developing a multimodal questionnaire assessing abdominal symptoms, evaluating its reliability, reproducibility, and responsiveness by comparing results between cystic fibrosis patients and age-matched healthy controls. It also includes creating related tools a daily symptom diary for patients and a version for children under 12 years old. The questionnaire will be adapted and tested in multiple countries and languages, with assessments of its relationship to clinical markers and ultrasound findings. Participants will complete the CFAbd-Score questionnaire and related diaries over a period of up to 7 years. The study will collect data on abdominal symptoms, genotype, clinical history, and laboratory results. The research team will monitor symptom patterns and evaluate changes related to new therapies. Healthy volunteers matched by age will also participate to provide comparison data. This long-term observational study will help refine symptom measurement tools and improve abdominal symptom assessment in cystic fibrosis care.

Researchers are evaluating how Digital Navigators DN can assist general practitioners, outpatient psychiatrists, psychologists, and their patients in using digital mental health apps DiGAs and integrating them into treatment. The study aims to understand the opportunities and barriers to implementing DNs, acceptance and expectations towards them, and their effects on patients psychological health and digital literacy. Medical assistants and other medical team employees receive training to become Digital Navigators. These trained navigators support treatment teams in selecting and integrating suitable mental health apps and accompany patients for 12 weeks to help them find and use an appropriate app. The study includes a preliminary phase with interviews and focus groups, followed by DN training and a 12-week intervention period with 48 patients. Participants undergo assessments before and after the 12-week intervention to measure digital health literacy, acceptance and expectations of Digital Navigators, psychological health, and digital competence. Data collection involves interviews, focus groups, and validated scales to evaluate symptom severity and treatment effects. The study also evaluates implementation barriers and aims to establish accredited DN training for sustainable use.