Brandenburg An Der Havel

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 studying the effects of combining baxdrostat with dapagliflozin in adults who have chronic kidney disease CKD and high blood pressure hypertension. This Phase III, international, multicenter, double-blind, placebo-controlled trial aims to evaluate whether this combination can reduce the risk of significant kidney function decline, kidney failure, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes a 4-week period where participants not already on SGLT2 inhibitors take dapagliflozin alone. Afterward, participants are randomly assigned to receive either baxdrostat with dapagliflozin or placebo with dapagliflozin. Those in the baxdrostat group may start on a lower dose and increase if needed. Treatment continues with regular visits scheduled at 2, 4, 8, 16, 34, and 52 weeks after randomization, followed by visits approximately every 4 months. If study medication is stopped early, participants continue dapagliflozin if possible and remain in the study for ongoing monitoring. During the trial, participants will have various assessments including kidney function tests, blood pressure measurements, and monitoring for heart and kidney events. The main outcome is to see if the combination reduces the risk of major kidney and heart problems over up to 37 months. Safety and tolerability will also be closely followed. The study will end once a set number of key health events have occurred, with a final visit planned for all participants to collect last data and ensure ongoing care.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus MACE-PLUS in adults with established atherosclerotic cardiovascular disease ASCVD or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis UC. This phase 2 study focuses on how these medications work alone or in combination for people who have had UC for at least three months and have not responded well or tolerated previous treatments. The trial is sponsored by Eli Lilly and Company and aims to improve treatment options for this condition. Participants may receive eltrekibart alone, mirikizumab alone, both drugs together, or placebos in various combinations. The study uses a randomized, double-blind design to compare these different treatment groups. The trial lasts about 69 weeks, including a screening period up to 35 days before enrollment. Treatments are administered throughout the study, with doses adjusted as needed to assess safety and effectiveness. During the trial, participants will undergo regular assessments including clinical remission rates at 12 and 52 weeks, endoscopic and histologic evaluations, and quality of life questionnaires. Blood tests will measure drug levels to monitor pharmacokinetics. Safety and response to treatment will be closely monitored throughout the study, which spans approximately 4 to 5 years in total. Participants will have multiple visits for evaluations to track their progress and any side effects.

Researchers are evaluating the efficacy and safety of several investigational long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter, proof-of-concept platform study aims to compare three monotherapy drugs and three combination therapies. The study is designed in two parts to explore these treatments in detail and to better understand their potential effects on UC. The study includes an initial open-label phase Part A where participants receive one of the three monotherapies to assess safety and early effectiveness. Following this, the randomized, placebo-controlled phase Part B will compare all six interventionsthree monotherapies and three combinationsagainst a placebo. These treatments include intravenous induction followed by subcutaneous maintenance dosing, and new treatment arms may be added over time, completing at different schedules. Participants will undergo endoscopy and histology assessments, with outcomes measured primarily by changes in the Robarts Histopathology Index and rates of clinical remission at 12 weeks. Additional measures include clinical response, endoscopic improvement, and histologic improvements up to 48 weeks. Safety and efficacy will be carefully monitored throughout the study, which is expected to continue until March 2028.

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.

Researchers are studying obefazimod to evaluate its effectiveness and safety as a treatment for adults with moderately to severely active Crohns disease who have not responded well or cannot tolerate conventional or advanced therapies. This Phase 2b trial compares obefazimod with a placebo to see if it can help control symptoms and improve disease activity. The study also aims to assess the long-term safety and tolerability of obefazimod during an extension period. The study includes three treatment phases a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. Participants receive one of four daily treatments obefazimod at doses of 50mg, 25mg, or 12.5mg, or a placebo. All treatments are taken once daily, ideally in the morning with food. The extension phase focuses on monitoring safety and tolerability compared to placebo. Participants will attend regular study visits for assessments including the Crohns Disease Activity Index and endoscopic scores to measure disease activity and response. Safety is monitored through adverse event reports and laboratory tests, including blood work for hematology, coagulation, and biochemistry at various weeks up to the end of the study. The total study duration spans several phases, allowing close observation of treatment effects and safety over time.

Researchers are studying how artificial intelligence AI can help predict complications after surgery for colorectal cancer CRC. The study focuses on improving risk prediction by combining different types of medical imaging data, including histopathology images, CT and MRI scans, and multiplex tissue imaging. This approach aims to better understand individual patient risks for complications such as wound infection, sepsis, and in-hospital mortality within 30 days after surgery. The study uses data from two groups a retrospective group of about 750 patients treated between 2011 and 2021, and a prospective group of about 210 patients recruited from 2026 to 2028. AI models analyze three types of imaging data separately and together to predict surgical risks. The study integrates digital histopathology images from tumour samples, radiology images from preoperative CT and MRI, and multiplex tissue imaging to examine immune and tissue characteristics. Participants provide consent for the prospective group, while retrospective data are anonymized. Researchers evaluate prediction accuracy of complications within 30 days after surgery, using measures like AUC-ROC and calibration plots. The study involves detailed imaging analysis, quality control, and statistical methods to assess model performance. Results will help understand links between imaging features and surgical outcomes, with findings shared in scientific publications and conferences.

Researchers are evaluating the effectiveness and safety of two treatment strategies for patients newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This international, multicenter, randomized, open Phase III trial compares carboplatinpaclitaxel chemotherapy followed by niraparib alone versus carboplatinpaclitaxel combined with bevacizumab followed by both bevacizumab and niraparib. The study includes patients with high-grade, non-mucinous, non-clear cell epithelial tumors at specific advanced stages who have had surgery or plan chemotherapy with interval debulking surgery. All patients receive an initial cycle of carboplatin and paclitaxel before randomization. After central testing of tumor BRCA status, participants are randomly assigned to one of two arms Arm 1 continues with five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years Arm 2 receives five cycles of carboplatin and paclitaxel plus bevacizumab, then maintenance bevacizumab for up to one year alongside daily niraparib for up to three years. This design aims to determine if adding bevacizumab improves outcomes over the standard treatment. Participants undergo frequent assessments including scans and laboratory tests to monitor progression-free survival and other health outcomes. Researchers also evaluate overall survival, time to additional therapies, treatment-related side effects, and quality of life up to several years after enrollment. Patients attend regular visits for treatment, monitoring, and completion of questionnaires, with safety follow-up 30 days after the last dose. The entire observation period can last up to 66 months after the last patient joins the trial.