Borna

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 effectiveness of a commercial toothpaste containing a novel compound aimed at supporting a healthy oral microbiome in people with periodontitis. This multi-center controlled clinical study focuses on volunteers who receive professional tooth cleaning every 3 to 6 months during a non-treatment period between supportive periodontitis therapy sessions. The study aims to determine how well this toothpaste works when used at home. Participants will brush their teeth twice daily with the allocated toothpaste for three months. The toothpaste includes common ingredients like sodium fluoride and cleaning agents, plus a new compound designed to benefit the oral microbiome. The study involves monitoring the participants during this 3-month period while they maintain their usual professional tooth cleaning routine. During the study, participants will be assessed before and after the 3 months of toothpaste use to evaluate its efficacy. Researchers will collect data on oral health, including the presence of specific bacteria and plaque control. Participants will be monitored for safety and adherence, and the main outcome is the toothpastes effect on the oral microbiome after 12 weeks of use.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.

Researchers are gathering real-world clinical data from women with primary advanced FIGO stage III or IV or recurrent endometrial cancer who are treated with first-line chemotherapy regimens combining Carboplatin, Paclitaxel, and Durvalumab CPD. This observational study focuses on patients receiving maintenance therapy with durvalumab alone or durvalumab combined with olaparib, depending on their tumors DNA mismatch repair status. The aim is to evaluate treatment outcomes including effectiveness, safety, and patient-reported experiences after chemotherapy. Participants receive first-line CPD chemotherapy followed by maintenance therapy tailored to their tumor characteristics patients with DNA mismatch repair deficient tumors receive durvalumab maintenance, while those with proficient status receive both durvalumab and olaparib maintenance. Treatment decisions are made as part of routine care in collaboration with their doctors, independent of the study. The study observes patients who achieve disease control after chemotherapy, tracking their ongoing treatments according to approved guidelines. During the study, participants complete questionnaires to report their quality of life and health status over time. Researchers monitor time to next treatment and progression-free survival at 12 months, as well as the duration of maintenance therapy and chemotherapy phases, and timing between treatments. Safety and real-world usage of therapies are assessed up to 46 months. The study spans multiple centers in Germany and aims to better understand characteristics of patients benefiting from these treatments in everyday clinical practice.

Researchers are evaluating the effects of NORTASE42, a pancreatic enzyme treatment, compared to standard care in patients who have undergone gastrectomy, which involves removal of part or all of the stomach. The study focuses on how these treatments affect patients quality of life and weight over time. This Phase 3 trial is randomized and double-blinded to compare the two groups fairly. Participants will receive either 10 to 15 capsules of NORTASE42 or a placebo each day for six months. This treatment period allows researchers to assess the impact of the enzyme therapy after gastrectomy. The trial includes patients who had at least 50% of their stomach removed and excludes those with other conditions or treatments that could interfere. During the study, participants will be monitored for various health measures including disease-specific quality of life, weight, nutritional supplementation, blood levels of haemoglobin, proteins, glucose, cholesterol, and vitamins A, B12, D, E, and K. These assessments occur over the six-month treatment period to evaluate how the interventions affect overall health. Safety and compliance are also tracked throughout the trial.