Herford

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.

This observational registry studies the use of the CytoSorb device, a sorbent hemoperfusion system, in real-world critical care settings for patients with serious conditions such as septic shock, acute respiratory distress syndrome, trauma, and other life-threatening illnesses. The goal is to create a comprehensive data repository and reporting system to monitor and improve patient care quality when using this device in intensive care units. Participants will be those who have planned or actual use of the CytoSorb 300 mL device. The study collects data on the devices use without assigning specific treatments, serving as a scientific resource to evaluate outcomes like ICU and hospital mortality. This registry includes patients receiving the device in various critical care scenarios, excluding certain uses like antithrombotic removal or intraoperative cardiac surgery applications. During the study, data about patient outcomes through ICU discharge or hospital discharge will be collected and analyzed, typically over an average of 7 to 14 days. This includes monitoring ICU mortality and in-hospital mortality. The registry aims to support ongoing assessment of the devices use by gathering real-world patient information over time to help improve care practices in critical care environments.

Researchers are evaluating the use of a new device called the pressure microcatheter to measure the severity of coronary artery lesions in patients with stable coronary artery disease or stabilized non-ST elevation acute coronary syndrome ACS. This trial compares clinical outcomes of patients guided by the pressure microcatheter versus those guided by the conventional pressure wire during percutaneous coronary intervention PCI. The study aims to determine if the pressure microcatheter strategy is not worse than the pressure wire strategy for clinical decision making. Participants will be randomly assigned to receive PCI guided by either the pressure microcatheter or the pressure wire. After an angiographically successful PCI, patients will either undergo fractional flow reserve FFR-guided stent optimization using the assigned device or receive standard care treatment. The interventions are compared in four groups pressure microcatheter with optimization, pressure wire with optimization, pressure microcatheter with standard care, and pressure wire with standard care. Participants will be followed in hospital initially, then at 12 months, and yearly up to five years to monitor clinical outcomes. The study involves collecting data on major adverse cardiac events MACE, procedural times, resource use during hospitalization, post-PCI FFR measurements, and rates of symptoms and complications. This follow-up aims to assess safety, effectiveness, and long-term results of the two guidance strategies.

This research aims to evaluate the long-term outcomes, performance, and ongoing safety of the BIOMONITOR III and its possible successors in everyday clinical use. It focuses on patients with conditions such as tachycardia, atrial fibrillation, syncope, bradycardia, or cryptogenic stroke. The study is designed as an observational registry, allowing additional scientific investigations with minimal extra effort for participants and study sites. Participants will receive a BIOTRONIK Implantable Cardiac Monitor ICM and will use the CardioMessenger device to support the BIOTRONIK Home Monitoring system. The registry monitors patients under routine clinical care without introducing experimental treatments or interventions. Data collection includes the insertion procedure and success rate of the device, as well as the time taken to reach a relevant diagnosis starting from device implantation. Throughout the study, participants will be observed during their regular clinical care visits. Researchers will collect information on device performance, safety, and diagnostic timelines. The study will continue until August 30, 2027, tracking patient outcomes over this extended period. Participation involves consenting to the use of home monitoring technology and agreeing to data collection related to the implanted device and clinical events.

Researchers are studying patients 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 the impact of this treatment on patients health-related quality of life HRQoL at various stages, including before treatment, during treatment, and after disease progression. Patients will receive lutetium 177Lu vipivotide tetraxetan in treatment cycles lasting about 6 weeks each, with up to 6 cycles total as guided by local treatment labels. Data collection points include before treatment begins if eligible, the first administration date, throughout treatment, at the end of treatment EoT, and during follow-up up to one year after the last treatment. During the study, patients will complete questionnaires to assess quality of life and pain levels, and clinical data such as progression and survival will be recorded. Researchers will monitor changes in scores from baseline through one year after treatment ends. Follow-up data collection depends on availability and may continue for up to a year post-treatment. The study is sponsored by Novartis Pharmaceuticals and focuses on real-world patient experiences.

Researchers are monitoring the clinical performance and short-term safety of Resorbable Magnesium Scaffolds RMS used in patients with symptomatic coronary artery disease. This registry follows the ESCEACTS guideline and observes RMS use in real-world settings without additional medical exclusion criteria beyond the devices intended instructions for use. The devices studied include Magmaris and Freesolve, both designed to improve the luminal diameter in the treatment of new native coronary artery lesions. The scaffold size is matched to the vessel diameter, and lesion length is limited to the scaffold length. The study collects data on these devices as they are used according to their approved instructions. Participants will be followed to assess the primary outcome of Target Lesion Failure within 12 months after device implantation. The registry collects clinical information during routine care to evaluate device performance and safety over time. The study started in November 2020 and will continue through May 2030.