Herford

Researchers are evaluating the clinical utility of serum neurofilament light (sNfL) as a prognostic marker for disease activity in patients with relapsing multiple sclerosis (MS). This prospective, multicenter, observational, non-interventional study in Germany aims to understand how sNfL values can influence patient management and treatment decisions. The study focuses on patients treated with category 1 disease-modifying therapies (DMTs) who have incorporated sNfL testing into their care. Participants will either continue their current category 1 DMT, which includes therapies such as dimethylfumarate, glatiramer acetate, interferon beta, and teriflunomide, or switch to ofatumumab based on their physician’s clinical judgment. There is no treatment allocation by the study itself. Data collection will cover up to 24 months, and the frequency of visits and assessments will follow routine clinical practice without a fixed protocol. During the study, baseline and follow-up data will be gathered according to standard care recommendations, including clinical evaluations and sNfL measurements. Researchers will monitor the proportion of patients with high sNfL levels over time to assess disease activity. The observational period is flexible and guided by the treating physician, with no additional diagnostic or monitoring procedures beyond standard care. Participants will be followed for up to two years to better understand how sNfL influences treatment management in relapsing MS.

This research aims to assess how satisfied people with Multiple Sclerosis (MS) are after receiving subcutaneous (under the skin) injections of ocrelizumab over a period of 12 months. The study focuses on participants diagnosed with relapsing-remitting MS (RMS) or primary progressive MS (PPMS) according to 2017 McDonald criteria, who are starting ocrelizumab treatment for the first time. The main goal is to understand participant satisfaction using a special questionnaire designed for subcutaneous therapy administration. Participants will receive ocrelizumab as an injection under the skin, with the exact dosing and schedule determined by their treating physician following local medical guidelines. This observational study does not change standard care but monitors patients throughout their treatment with ocrelizumab. During the study, participants will complete the Therapy Administration Satisfaction Questionnaire for subcutaneous treatment after 12 months to measure their satisfaction. Researchers will also observe and record any relevant clinical information. The total study duration for each participant is 12 months, during which their experience and outcomes with ocrelizumab are carefully tracked.

This registry collects data on the use of the CytoSorb device, a sorbent hemoperfusion system, in real-world critical care settings. It aims to provide a comprehensive, scientific resource to monitor and enhance the quality of patient care for critically ill patients suffering from conditions such as septic shock, acute respiratory distress syndrome, trauma, and other severe illnesses. Participants will have planned or actual use of the CytoSorb 300 mL device during their critical care treatment. The registry includes patients treated with this device in various critical conditions, excluding certain specific uses such as antithrombotic removal only or intraoperative cardiac surgery use. Data collection focuses on how the device is used and its impact in diverse critical care scenarios. Throughout the study, researchers will track patient outcomes including mortality during ICU stay and in-hospital mortality. The average follow-up for ICU mortality is about 7 days, and for hospital mortality about 14 days. The registry gathers detailed information to support ongoing evaluation and improvement of care for critically ill patients receiving CytoSorb therapy.

Researchers are evaluating the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold in patients with coronary artery disease. This post-market study aims to assess the scaffold's performance in treating new coronary lesions in patients who have evidence of myocardial ischemia and are suitable candidates for angioplasty and stenting. The study focuses on patients who meet specific lesion criteria and are willing to comply with follow-up evaluations. Participants will receive treatment with the Fantom scaffold for de novo coronary lesions that meet detailed baseline criteria, including lesion size, vessel diameter, and absence of certain complications. The scaffold is designed to be placed in native coronary arteries with stenosis of 50% or more but less than 100%. The study includes only lesions that can be covered by a single scaffold and excludes lesions with severe complications or unsuitable vessel characteristics. During the study, participants will undergo follow-up evaluations to monitor the target lesion failure over 12 months. Researchers will assess safety and effectiveness by tracking clinical outcomes and complications related to the treated coronary lesions. The study involves ongoing monitoring to ensure patient safety and adherence to the protocol throughout the follow-up period.

Researchers are evaluating the use of a new device called the pressure microcatheter compared to the traditional pressure wire in guiding treatment decisions and optimizing percutaneous coronary intervention (PCI) for patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome. This Phase 4, multicenter, randomized, open-label trial aims to see if clinical outcomes with the pressure microcatheter are not worse than those with the pressure wire. The pressure microcatheter is designed to provide similar physiological measurements while being easier to use during the procedure. Participants will be randomly assigned to one of four groups: pressure microcatheter guided strategy with incremental optimization (PIOS MC), pressure wire guided strategy with incremental optimization (PIOS PW), pressure microcatheter guided strategy with standard care, or pressure wire guided strategy with standard care. Each group will receive PCI guided by their assigned device, followed by either the incremental optimization strategy or standard care treatment as described. The study device is used during the PCI procedure to measure lesion severity and help guide treatment. During the study, patients will be monitored in the hospital and followed up at 12 months, then yearly for up to five years. Researchers will compare major adverse cardiac events (MACE) occurring within 12 months between the two device strategies. Assessments will include clinical evaluations and tracking of outcomes related to heart health and procedure success. This long-term follow-up will help determine the safety and effectiveness of using the pressure microcatheter compared to the pressure wire in guiding PCI.

This research aims to assess the long-term outcomes, performance, and safety of the BIOMONITOR III implantable cardiac monitors (ICMs) and their possible successors in real-life clinical settings. The study also serves as a platform for additional scientific and regulatory investigations with minimal extra effort for both clinical sites and patients. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, and cryptogenic stroke. Participants will receive a BIOTRONIK Implantable Cardiac Monitor and use the CardioMessenger device as part of the BIOTRONIK Home Monitoring system. The study observes routine clinical care with these devices and may include submodules for further research. The timeline includes monitoring the time to diagnosis starting from the device insertion. Throughout the study, participants will be regularly monitored using the implanted device and home monitoring technology. Researchers will track outcomes related to device performance, safety, and the time it takes to reach relevant diagnoses. Participants provide informed consent and agree to use the home monitoring system during the study period, contributing to long-term data collection and safety assessment.

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) who are starting treatment with lutetium (177Lu) vipivotide tetraxetan. This observational study aims to describe routine clinical practice and how this treatment affects patients' health-related quality of life (HRQoL) from before treatment through to post-progression. The study collects detailed data on patient well-being, symptom changes, and disease progression over time. Patients will receive lutetium (177Lu) vipivotide tetraxetan as determined by their doctors according to local guidelines. Treatment cycles last about 6 weeks, and patients may receive up to 6 cycles. Data is collected at key points including before treatment starts, on the first day of treatment, during each treatment cycle, at the end of treatment, and during follow-up visits. This approach helps capture the full patient experience with this therapy in real-world settings. During the study, participants complete various questionnaires assessing quality of life, cancer symptoms, and pain levels. Researchers also monitor clinical progression, radiographic changes, prostate-specific antigen (PSA) levels, and survival outcomes for up to one year after treatment ends. This comprehensive data collection aims to provide insights into treatment impact, symptom control, and overall patient health over time.

Researchers are conducting a registry to study the performance and short-term safety of Resorbable Magnesium Scaffolds (RMS) in patients with coronary artery disease. This registry follows the ESC/EACTS guidelines and evaluates these devices in real-world use based on their intended instructions without additional medical exclusion criteria. The study involves the use of two types of RMS devices, Magmaris and Freesolve, which are designed to improve the diameter of native coronary artery lesions in patients with symptomatic coronary artery disease. These devices are used where the vessel size matches the scaffold size, and the lesion length is shorter than the scaffold length. Participants will be monitored according to the registry protocols, focusing on outcomes such as Target Lesion Failure over 12 months. The study observes the clinical use and safety of these devices in typical treatment settings without additional restrictions. Patient follow-up and data collection occur throughout the study duration to assess device performance.