Weiden In Der Oberpfalz

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 investigates the effectiveness and safety of two treatment combinations for people with relapsed or refractory multiple myeloma who have received one to three prior treatments and were previously treated with lenalidomide. It compares mezigdomide, bortezomib, and dexamethasone MeziVd against pomalidomide, bortezomib, and dexamethasone PVd to see which is better for this condition. The study is a Phase 3, randomized, open-label trial sponsored by Celgene. Participants receive either the MeziVd combination or the PVd combination, with specified doses given on certain days according to the study plan. These treatments are given as drugs, and participants are randomly assigned to one of these two groups to compare their effects. The study will continue for up to approximately five years to evaluate long-term outcomes. During the study, participants will be monitored regularly through various assessments including measuring disease progression, survival, response to treatment, and quality of life using specific questionnaires EORTC QLQ-C30 and QLQ-MY20. Blood samples may be checked for drug levels, and adverse events will be tracked. The main focus is progression-free survival, measured from randomization until disease worsening or death. Participants health and responses will be followed for up to five years, with ongoing visits and evaluations throughout this period.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Researchers are investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

Researchers are evaluating the efficacy and safety of intravenously administered fosfomycin in treating severely infected patients across Europe. This prospective, multicenter, non-interventional study focuses on infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis or central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections covered by national guidelines. Patients receive fosfomycin intravenously according to the respective national Summary of Product Characteristics SmPC. The study is observational and does not involve randomization or placebo. It includes monitoring during treatment and follow-up periods, with evaluations up to six months for treatment outcomes and up to one year for osteomyelitis follow-up. The study documents clinical and microbiological cure rates, clinical improvements, and sodium and potassium serum levels during hospital stays. Participants are assessed for clinical success at multiple points, including initial response within 7 days, end of treatment up to 6 months, test of cure, and follow-up up to one year for osteomyelitis. Safety monitoring includes daily recording of adverse events, serious adverse events, adverse drug reactions, and deaths during treatment and follow-up. The study tracks dropouts due to treatment failure or adverse events. Overall, participation duration varies depending on treatment and follow-up schedules.

Researchers are collecting retrospective data to evaluate the safety, performance, and clinical benefits of the Hi-Fatigue G Bone Cement used in total knee and hip replacements with Zimmer Biomet implants. The study aims to confirm implant survivorship and clinical outcomes by analyzing radiological images and patient-reported measures over time. This observational study focuses on patients who have already undergone primary total knee or hip arthroplasty with this specific bone cement. The study includes patients who received primary total knee or hip replacements using Hi-Fatigue G Bone Cement combined with Zimmer Biomet implants. Data collection involves radiological evaluations at various time points following the hospitals standard care, focusing on radiolucent lines around the implant components at 5 years. The study also monitors implant survivorship, safety by tracking adverse events related to the implant or procedure, and gathers information on the cementing technique and handling when available. Participants will have their radiographic images reviewed from enrollment through 5 years after surgery. Patient-reported outcome measures PROMs will be collected to assess clinical benefits, along with monitoring any implant removals or adverse events. The study relies on standard hospital follow-up visits and evaluations, including X-rays and clinical scores, to gather comprehensive data on the implants performance and patient experience. Total participation time spans from enrollment to the 5-year postoperative follow-up.

This research investigates GLSI-100 immunotherapy in people with HER2neu positive breast cancer who are at high risk for their cancer returning. It focuses on participants who have completed both neoadjuvant and postoperative adjuvant standard treatments. The study is Phase 3, randomized, double-blinded, and placebo-controlled, involving subjects who are HLA-A*02 positive as well as an open-label group of non-HLA-A*02 positive subjects. The goal is to evaluate the treatments impact on invasive breast cancer-free survival over a median follow-up of 4 years. Participants receive 6 primary immunization injections of GLSI-100 or placebo intradermally once a month for the first 6 months, followed by 5 booster injections spaced 6 months apart, totaling 11 injections over 3 years. There are three groups one receiving placebo 0.9% normal saline, one receiving GLSI-100 immunotherapy in HLA-A*02 positive subjects, and an open-label arm for non-HLA-A*02 positive subjects receiving GLSI-100 under the same schedule. During the study, participants undergo regular monitoring and assessments including invasive disease-free survival, distant disease-free survival, overall survival, and quality of life questionnaires at baseline and up to 36 months. Researchers track safety and treatment effects over a median 4-year follow-up. The study continues until December 2031, aiming to provide comprehensive data on long-term outcomes and quality of life for participants receiving these treatments.

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 observing the real-world effects and patient experiences of trastuzumab deruxtecan T-DXd treatment in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This prospective, non-interventional study takes place in multiple centers in Germany and aims to collect patient-reported outcomes along with safety and efficacy data during routine clinical practice. Approximately 800 patients will be enrolled, divided evenly between HER2-positive and HER2-lowultralow cohorts. Participants will receive T-DXd treatment as prescribed by their doctors according to the approved product guidelines SmPC. Treatment and visit schedules are determined by the treating physician and are not fixed by the study protocol. Patients will also be informed about using a digital healthcare application DiGA during the study. The study includes two cohorts based on HER2 status, both receiving T-DXd in routine care. During the study, participants will be followed to measure the time until their next treatment or death, assessed for up to 60 months from the first T-DXd dose. Quality of life will be evaluated using questionnaires at six months after baseline. Patient safety and treatment effects will be monitored through data collected in routine clinical visits. The total participation period may extend up to eight years, allowing for long-term observation of treatment outcomes in real-world settings.

Researchers are studying metastatic pancreatic ductal adenocarcinoma PDA in adults who have not been previously treated for this condition. The trial evaluates the effect of adding SBP-101, a small molecule polyamine metabolic inhibitor, to the standard chemotherapy regimen of gemcitabine and nab-paclitaxel. This randomized, double-blind, placebo-controlled, multicenter study aims to assess overall survival and other important outcomes in about 600 patients. Participants will receive either SBP-101 combined with nab-paclitaxel and gemcitabine or a placebo with the same chemotherapy drugs. The treatments are given as injections, and the study includes two groups one experimental arm receiving SBP-101 plus chemotherapy and one control arm receiving placebo plus chemotherapy. The safety and effectiveness of treatments will be monitored throughout the trial by an independent committee. During the study, patients will be followed for overall survival up to 100 weeks or until death. Researchers will also measure progression-free survival, responses seen on scans, and quality of life. Assessments include imaging with CT or MRI, blood tests, and monitoring of side effects. Participants must consent to the study and meet specific health criteria, and safety will be closely observed throughout the trial period.