Boblingen

This observational study follows patients with relapsing multiple sclerosis RMS who are being treated with approved injectable or selected oral disease-modifying therapies DMTs in Germany. The study is non-interventional and open-label, designed to collect real-world data on treatment and disease progression over several years. It aims to understand how patients continue their baseline treatments and how these treatments impact various health and quality of life measures. Participants receive routine medical care with approved injectable or oral DMTs such as ofatumumab, interferon b21, glatiramer acetate, teriflunomide, dimethyl fumarate, or diroximel fumarate. The study includes two cohorts with up to approximately two years of prospective observation each, with an optional extension allowing up to four years total. Treatment decisions and monitoring follow the patients usual care and physicians discretion, including routine visits and telemedicine options. During the study, participants provide medical history, complete questionnaires, and have data collected on disability status, MRI findings, relapses, and laboratory tests. Researchers assess treatment continuation rates, fatigue, anxiety, depression, quality of life, lesion counts, and relapse rates at multiple time points. Safety and treatment interruptions are also documented. Follow-up is flexible and based on standard care procedures, with data collection occurring throughout the observational periods.

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.

This trial studies adults aged 55 to 90 who have psychosis linked to Alzheimers Disease. It is a Phase 3, 38-week, randomized, double-blind, placebo-controlled outpatient study. Its main goal is to assess how well KarXT capsules prevent relapse of psychosis compared to placebo. Additional goals include evaluating time to treatment discontinuation or relapse, and monitoring safety and tolerability. Participants receive either KarXT capsules at various doses or placebo capsules. The study involves a randomized assignment and is conducted under quadruple masking. The treatment period lasts 38 weeks during which KarXT or placebo is taken three times daily. Assessments continue up to approximately 42 weeks to monitor adverse events and other safety measures. Throughout the study, participants attend outpatient visits for evaluations including cognitive tests, assessments of psychosis severity, caregiver reports, lab tests, vital signs, and safety monitoring. Researchers measure relapse timing, treatment discontinuation, neuropsychiatric symptoms, movement scales, weight, and signs related to heart and urinary health. Safety is closely tracked with various assessments until about week 42.

Researchers are evaluating the safety and effectiveness of KarXT in adults aged 55 to 90 with mild to severe Alzheimers Disease who experience moderate to severe psychosis related to this condition. This Phase 3 trial aims to study KarXT compared to a placebo to better understand its impact on psychotic symptoms associated with Alzheimers. Participants will be randomly assigned to receive either KarXT or a placebo at specified doses on certain days. The study lasts up to 14 weeks, during which changes in psychosis symptoms, as measured by the Neuropsychiatric Inventory-Clinician Hallucinations and Delusions score, will be closely monitored. Additional assessments include cognitive tests and monitoring for side effects. During the trial, participants will undergo regular evaluations including symptom ratings, cognitive tests such as the Mini-Mental State Examination, laboratory tests, and safety monitoring. Researchers will track any adverse events and changes in mental and physical health. The study aims to provide detailed information about how KarXT affects psychosis and cognition in Alzheimers disease over the treatment period.

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 studying the effects of a nutritional intervention combining ketogenic medium-chain triglycerides kMCT and B-vitamins on cognitive function in older adults diagnosed with mild cognitive impairment MCI. This randomized, double-blind, placebo-controlled trial aims to evaluate how this nutritional approach impacts cognitive performance over a 12-month period. The study is sponsored by Socit des Produits Nestl and involves multiple centers and countries. Participants will be randomly assigned to receive either BrainXpert, a dietary supplement containing 15 g of kMCT and B-vitamins in powder form, or a placebo consisting of a calorie-equivalent, non-ketogenic high-oleic acid sunflower oil powder. Both are provided in sachetstickpack format without preservatives, flavors, sweeteners, or colorants. The intervention is administered daily during the study period. During the trial, participants and their informants will attend clinic visits at baseline, 12 months, and 18 months. Cognitive function will be assessed using tools such as the Preclinical Alzheimers Cognitive Composite PACC, Montreal Cognitive Assessment MoCA, Wechsler Memory Scale, and Mini-Mental State Examination MMSE. Safety and tolerability will also be monitored throughout the 12 months. The study includes adherence assessments and requires participants to comply with study procedures and medication restrictions.

Triple negative breast cancer TNBC is a type of breast cancer that lacks certain receptors and tends to have a poor prognosis and aggressive behavior. The study focuses on patients with low-risk, early-stage TNBC stage I-II node-negative who generally have better outcomes, but still face significant clinical challenges. Researchers are evaluating neoadjuvant therapies to improve treatment strategies for this group, especially comparing sacituzumab govitecan alone versus its combination with pembrolizumab. Participants will receive neoadjuvant treatment for 12 weeks, either sacituzumab govitecan alone or combined with pembrolizumab. Sacituzumab govitecan is given intravenously at 10 mgkg on Days 1 and 8 every 21 days, while pembrolizumab is administered intravenously at 200 mg every three weeks. Depending on their response after 12 weeks, some patients may continue treatment for an additional 6 weeks before surgery. Patients who achieve a complete response may not require further systemic treatment, while those with residual disease may receive additional chemotherapy as decided by their investigator. Throughout the study, participants will be closely monitored with various assessments including pathological evaluation at surgery and invasive disease-free survival measured after three years. Other outcomes include overall survival and quality of life assessments. Safety and response will be regularly evaluated to guide treatment decisions. The trial aims to enroll adult women with early-stage TNBC and will continue through September 2029, with detailed follow-up planned to capture long-term outcomes.

This research focuses on people with psychosis linked to Alzheimers Disease who have completed earlier studies CN012-0026, CN012-0027, or CN012-0056. It is a Phase 3 global, multicenter, open-label extension study lasting 52 weeks that aims to evaluate the long-term safety and tolerability of KarXT in this population. Participants will receive KarXT capsules containing Xanomeline and Trospium Chloride. The study includes various dosing levels ranging from 202 mg to 66.76.67 mg taken three times daily. This open-label extension follows completion of previous studies and continues for up to 54 weeks from the initial dose, including a 14-day safety follow-up after the final dose. During the study, participants will be monitored for treatment-emergent adverse events and serious adverse events. Safety assessments include clinical evaluations throughout the treatment and 14 days after the last dose. The total participation time is approximately one year, allowing researchers to understand long-term effects of KarXT in this group.

Researchers are investigating the combination of ribociclib and standard adjuvant endocrine therapy ET to assess its effect on invasive breast cancer-free survival iBCFS in adults with hormone receptor-positive HR, HER2-negative early breast cancer at Anatomic Stage Groups III, IIB, and a subset of IIA. This phase IIIb, open-label, single-arm study involves patients close to typical clinical practice settings to better understand the treatments efficacy and safety. Participants receive ribociclib 400 mg orally once daily on days 1 to 21 of each 28-day cycle, alongside daily ET for 36 months, approximately 39 cycles. ET options vary by menopausal status and sex, including letrozole, anastrozole, or exemestane for postmenopausal women, and the same drugs combined with goserelin or leuprolide injections for preperimenopausal women and men. The treatment period starts with the first dose of ribociclib and ends 30 days after the last dose, followed by a safety follow-up call. During the study, participants undergo screening before treatment begins. After completing treatment, they enter a follow-up period lasting until death, withdrawal, loss to follow-up, or up to 48 months after the last participant starts treatment. Researchers monitor outcomes including iBCFS at 3 years, adverse events, various survival measures, dose intensity, treatment discontinuation timing, and quality of life assessments up to approximately 6 years. Safety follow-up is conducted 30 days post-treatment to ensure participant well-being.

Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.