Pforzheim

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.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

This research aims to evaluate participant satisfaction with subcutaneous ocrelizumab treatment in people with Multiple Sclerosis MS over a 12-month period. It will also investigate changes in neurofilament light chain NfL protein levels, a marker related to MS disease activity, and explore correlations between NfL levels and various clinical and imaging factors. The study is observational and follows participants who are starting ocrelizumab SC as part of their routine MS care. Participants will receive ocrelizumab as a subcutaneous injection according to their physicians discretion and local clinical practice. The study observes participants for up to 12 months to assess treatment satisfaction using the Therapy Administration Satisfaction Questionnaire for Subcutaneous administration TASQ-SC and other satisfaction questionnaires. Blood samples will be collected at baseline, month 6, and month 12 to measure NfL protein levels and other biomarkers. The study also monitors MS relapses, disability scores, and adverse events during this period. Throughout the 12 months, participants will undergo assessments of treatment satisfaction at multiple time points, including after the first injection, 6 months, and 12 months. Clinical evaluations, questionnaires, and blood tests will be conducted to track disease activity and participant experience. Researchers will measure satisfaction levels, changes in NfL concentrations, relapse rates, disability progression, and safety events. The study is designed to provide real-world data on patient experience and biomarker changes with subcutaneous ocrelizumab treatment in MS.

Researchers are evaluating the safety and performance of the Zimmer Nexel Total Elbow device when used for primary or revision total elbow replacement. This study aims to confirm how well the device works and its safety by analyzing standard scoring systems, X-rays, and records of any adverse events. The study includes patients with various elbow conditions such as joint destruction, arthritis, instability, and fractures who require total elbow arthroplasty. Participants receive the Nexel Total Elbow device either as part of a primary or revision surgery. The study includes both retrospective patients who already had the device implanted and prospective patients who will receive it during the trial. The devices performance is assessed by measuring pain, function, implant survival, patient health status, and radiographic success over time. During the study, participants undergo scheduled follow-up evaluations to monitor outcomes and safety. Researchers collect information on device survivorship over a 10-year period using clinical assessments, imaging, and adverse event reports. The study involves non-randomized single-group participation without masking, with ongoing monitoring until study completion in 2036.

Significant tricuspid regurgitation TR is common in elderly patients and often leads to right heart failure RHF with limited treatment options. Surgical intervention carries high risk due to factors like advanced age and organ dysfunction. This observational study aims to assess the safety and performance of the TriClip device, a percutaneous treatment designed specifically for TR, in critically ill patients at high or prohibitive surgical risk. Participants will receive a percutaneous edge-to-edge repair of the tricuspid valve using the TriClip system. This single-arm, open-label, prospective registry evaluates real-world outcomes in patients with symptomatic severe TR despite medical therapy. The study follows patients over time to monitor procedural success and clinical benefits of the TriClip device. During the study, participants will be monitored at 12 months for procedural success, changes in quality of life, functional capacity, and major organ system function. The trial collects data on safety and effectiveness in a real-world setting, helping to understand how TriClip therapy impacts patients with right heart failure and tricuspid valve disease over the short and longer term.

Researchers are investigating the real-world use and effects of ovarian function suppression OFS combined with endocrine therapy in pre- and perimenopausal women with breast cancer who have low genomic risk according to MammaPrint testing. The study aims to understand differences in treatment outcomes based on menopausal status, chemotherapy use, and endocrine therapies, with a focus on adherence and quality of life over time. This observational registry will collect data to provide insights into treatment paths, outcomes, and factors influencing prognosis in these patients. Participants receive standard-of-care endocrine therapy with or without ovarian suppression and may have received chemotherapy based on clinical decisions and genomic risk assessments. The registry observes various treatment approaches in a real-world setting, including management of ovarian function, and follows patients for up to 10 years. Quality of life assessments occur regularly during the first five years, and treatment adherence is monitored throughout the study period. During the study, participants medical data including baseline characteristics, treatment details, relapse information, and quality of life questionnaires will be collected at multiple time points. Researchers will evaluate outcomes such as distant recurrence-free interval, disease-free survival, overall survival, and endocrine response over 5 to 10 years. The long-term follow-up allows for detailed monitoring of treatment adherence and correlation of genomic and clinicopathological markers with patient outcomes.

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.

This research aims to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems used in primary anatomic shoulder arthroplasty. It is a multicenter, prospective, non-controlled post market surveillance study focusing on patients with shoulder conditions such as osteoarthritis, fractures, rheumatoid arthritis, and other degenerative joint diseases. The study evaluates safety by monitoring adverse events and measures clinical benefits including pain, function, quality of life, and radiographic parameters. Participants will receive the Zimmer Biomet Total Shoulder Arthroplasty System, including the Alliance Glenoid implant, as part of their primary total shoulder arthroplasty procedure. The study does not include a control group and involves long-term follow-up to assess the devices performance and safety. The primary endpoint is improvement in the American Shoulder and Elbow Surgeons ASES shoulder score at 2 years, with secondary endpoints including adverse event frequency, quality of life assessments EQ-5D-5L, and radiographic performance over 10 years. During the study, participants will be monitored for clinical outcomes such as pain relief, shoulder function, and quality of life through standardized assessments and imaging studies. Follow-up visits will continue up to 10 years to track safety and device performance. Researchers will collect data on adverse events and changes in radiographic parameters to evaluate long-term effects. Participants are expected to complete all required follow-up assessments and provide informed consent before joining.