Brandenburg An Der Havel

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 investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety and effectiveness of two drugs, eltrekibart and mirikizumab, in adults with moderately to severely active ulcerative colitis (UC). This study is a phase 2 trial lasting about 4 to 5 years, aiming to understand how well these treatments work alone or together for this chronic condition. Participants will receive either eltrekibart alone, mirikizumab alone, a combination of both, or a placebo. The treatments are administered as drugs, and the study includes a screening period of up to 35 days before enrollment. The total participation time for each person is approximately 69 weeks, which includes the screening and treatment periods. During the trial, participants will be closely monitored to assess the percentage who achieve clinical remission by week 12. Researchers will conduct regular evaluations, which may include medical assessments and questionnaires, to track the safety and effects of the treatments. The study emphasizes careful follow-up to ensure participant safety and to gather detailed information about the therapies over the entire study duration.

Researchers are studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.

Researchers are developing and validating a new questionnaire called the CFAbd-Score to assess and measure abdominal symptoms in people with cystic fibrosis (CF), a genetic disease affecting multiple organs and shortening life expectancy. This study follows FDA guidelines for patient-reported outcome measures (PROMs) and includes CF patients, their families, and CF care professionals in its stepwise development. The goal is to create a reliable and valid tool that reflects abdominal involvement in CF across different age groups and to test its applicability in various CF centers and countries. The study involves creating and testing the CFAbd-Score questionnaire to evaluate its reliability, consistency, reproducibility, and responsiveness by comparing CF patients with age-matched healthy controls. Additional tools being developed include a daily symptom diary (CFAbd-day2day) for ongoing assessment and a version of the questionnaire tailored for children under 12 years old (CFAbd-kid). The research also explores possible links between abdominal symptoms and fecal inflammatory markers. Participants will complete the questionnaires and diaries repeatedly to assess their abdominal symptoms. Researchers will analyze the internal consistency, construct validity, and reproducibility of the tools, as well as their responsiveness compared to healthy participants. The study lasts up to seven years, during which it will also evaluate cross-generational use and translate the questionnaire into other languages. This comprehensive approach aims to provide a CF-specific method for daily and clinical assessment of abdominal symptoms.

This research aims to explore the role of Digital Navigators (DN) in helping general practitioners, outpatient psychiatrists, psychologists, and their patients use digital mental health apps (DiGAs) and incorporate them into treatment. The study focuses on understanding the acceptance, expectations, and potential benefits of Digital Navigators, including their impact on patients' psychological health, digital health literacy, and technical skills. It targets patients with mental disorders who have access to smartphones and basic digital skills. Trained medical team members, primarily medical assistants, become Digital Navigators through a specialized training program adapted from Harvard Medical School. These Digital Navigators support treatment teams in selecting and integrating suitable digital health applications and assist patients over a 12-week period to find and use appropriate mental health apps. The intervention includes guidance through the DiGAnavigator.de website and ongoing support to enhance adherence and ease the burden on healthcare providers. Participants undergo assessments before and after the 12-week support period, measuring digital health literacy focused on information retrieval and interactive skills, as well as attitudes and expectations toward Digital Navigators. Researchers also evaluate implementation challenges and the effects on patients and professionals using standardized scales. The study includes interviews, focus groups, and surveys to capture digital skills, willingness to change, and illness severity. The goal is to establish sustainable training for Digital Navigators in mental health care.

Researchers are evaluating the effectiveness and safety of obefazimod compared to a placebo in adults with moderately to severely active Crohn's Disease who have not responded well or are intolerant to conventional or advanced treatments. The study is a Phase 2b trial and includes three treatment phases: a 12-week Induction Phase, a 40-week Maintenance Phase, and a 48-week Extension Phase. The main goals are to assess how well obefazimod controls disease activity and its safety over these periods. Participants will receive either obefazimod or a matching placebo once daily, preferably in the morning with food. The trial includes an initial 12-week treatment to induce response, followed by a 40-week maintenance period to sustain results. Those who complete these phases may enter a 48-week Extension Phase to further evaluate the long-term safety and tolerability of obefazimod compared to placebo. During the study, participants will undergo regular assessments including clinical evaluations of disease activity using the Crohn's Disease Activity Index and endoscopic scoring at various time points up to week 52. Safety is monitored throughout, especially during the Extension Phase with checks for adverse events, blood tests, and other laboratory evaluations at scheduled visits. Overall, participation may last over a year, with careful monitoring of treatment effects and safety.

Perioperative complications after colorectal cancer surgery are a major cause of postoperative illness and death. Current risk tools do not fully capture the complex biological and imaging factors that affect individual patient risk. The KIA-Korekt study evaluates whether artificial intelligence (AI) using three types of medical imaging can better predict these complications in colorectal cancer patients. It includes both a retrospective group of about 750 patients treated from 2011 to 2021 and a prospective group of about 210 patients recruited from 2026 to 2028. The study uses AI to analyze digital histopathology images, preoperative CT and MRI scans, and multiplex tissue imaging including immunohistochemistry and mass cytometry. Each imaging type is analyzed separately using advanced machine learning methods and then combined with multimodal approaches. The predicted outcomes include complications such as anastomotic leakage, wound infection, sepsis, ICU admission, and death within 30 days after surgery. Participants are involved through analysis of existing tissue slides and imaging data from their surgeries. The study applies deep learning and radiomic techniques to extract features from these images and links them with clinical outcomes. Researchers will measure how well the AI models predict postoperative complications within 30 days. The study includes quality control steps and detailed biological correlation analyses, with results shared in scientific publications and conferences.

Researchers are evaluating the effectiveness and safety of combining carboplatin, paclitaxel, bevacizumab, and niraparib compared to carboplatin and paclitaxel followed by niraparib alone in women newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase III international, multicenter, randomized open trial focuses on patients with specific advanced stages of these cancers who have undergone or plan to undergo surgery and chemotherapy. The study aims to see if adding bevacizumab to the treatment improves progression free survival. All participants first receive one cycle of chemotherapy with carboplatin and paclitaxel. Based on tumor BRCA testing, patients are then randomly assigned to one of two groups: one group receives five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years; the other group receives the same chemotherapy combined with bevacizumab, continuing bevacizumab for up to one year and niraparib daily for up to three years. Treatment schedules follow a three-week cycle. Participants will be closely monitored throughout the trial with frequent assessments to track progression free survival until either 586 events occur or three years after the last patient joins, whichever happens first. The study includes detailed safety evaluations, laboratory tests, and patient questionnaires. To participate, women must meet specific health criteria, including performance status and organ function, and agree to follow study procedures for up to three years of treatment and observation.