Bernau Bei Berlin

This observational study aims to gather clinical data on the safety and performance of the NEXUS Aortic Arch Stent Graft System and the Custom-Made NEXUS DUO Aortic Arch Stent Graft System for treating aortic aneurysms. It focuses on assessing early mortality, safety outcomes, device failure, and procedural and hospitalization information in patients treated according to standard care. The study includes participants who have been implanted with these devices since February 2019 or are indicated for implant according to device instructions. Participants will receive treatment as part of their usual care without additional interventions from the study. The study design includes two arms and collects data prospectively or retrospectively in an open-label, multi-center setting. Follow-up will continue for up to five years to monitor long-term safety and device performance. During the study, researchers will collect information on mortality within 30 days, safety throughout the study period, and any device failures. Clinical data, hospitalization details, and procedural outcomes will be recorded. Participants must provide informed consent and be available for follow-up visits, with ongoing assessment of their health status and renal function as deemed necessary by their physician.

This research aims to collect data on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in repairing mitral valve problems, specifically mitral regurgitation and mitral insufficiency. The study focuses on patients who have undergone transcatheter mitral valve repair, evaluating how well these devices improve mitral regurgitation, functional status, and quality of life in a real-world, postmarket setting. Participants will receive treatment using the Edwards PASCAL and PASCAL Precision Transcatheter Valve Repair Systems for mitral valve repair. This study does not involve randomization or comparison groups but follows patients after their valve repair procedure to monitor outcomes. The devices are used according to approved indications after careful patient selection by a Heart Team. During the study, participants will attend follow-up visits where researchers will assess safety by tracking major adverse events within 30 days and evaluate effectiveness through changes in mitral regurgitation severity measured by echocardiography at discharge or seven days post-procedure. The study also monitors improvements in functional status and quality of life over time, requiring participants to complete all scheduled tests and visits to provide comprehensive data on the devices' performance.

Researchers are evaluating the real-world effectiveness of nemolizumab for treating moderate-to-severe atopic dermatitis (AD) in adolescents and adults. This study is a prospective, multicenter, non-interventional trial that aims to measure treatment outcomes through physician assessments and patient-reported outcomes over approximately 12 months. The goal is to understand how nemolizumab works in routine clinical practice, focusing on physician evaluations and patient experiences at Month 6. Treatment with nemolizumab is determined solely by the participant's physician before joining the study, with no extra visits, procedures, or lab tests beyond standard care. The study does not define a specific visit schedule; instead, visits follow routine medical practice to collect data systematically. A sub-study in Germany and the UK will have participants complete daily questionnaires on itch severity, sleep disturbance, and pain from Day -1 to Day 14 remotely, without requiring clinic visits. Participants will be involved in routine clinical visits where physician assessments and patient-reported outcome measures will be gathered. Key outcomes measured include the Investigator Global Assessment (IGA) and the Peak Pruritus Numerical Rating Scale (PP NRS) at Month 6. The study observes participant responses and safety under normal care conditions, with data collection lasting about a year to evaluate nemolizumab's effectiveness in everyday treatment settings.

Researchers are evaluating the effectiveness of BHV-7000 in treating adults with refractory focal onset epilepsy, a condition where seizures originate in specific areas of the brain and have not responded to previous treatments. This Phase 2/3 trial aims to assess the safety, tolerability, and ability of BHV-7000 to reduce seizure frequency in participants who continue to have seizures despite using anti-seizure medications. The study follows classification criteria set by the International League Against Epilepsy and includes participants aged 18 to 75 years. Participants will be randomly assigned to receive either BHV-7000 at doses of 50 mg or 75 mg once daily, or a matching placebo, in a double-blind setup where neither participants nor researchers know which treatment is given. The treatment period focuses on monitoring changes in seizure frequency over 28-day averages from baseline through weeks 8 to 16. The study design includes careful control and comparison to evaluate the investigational drug's impact. During the study, participants will keep accurate seizure diaries to track their seizures. Researchers will measure changes in the average number of seizures over 28-day periods as the primary outcome. Safety and tolerability will also be monitored closely. The study requires participants to be currently treated with one to three anti-seizure medications and to meet specific epilepsy criteria. Overall participation includes screening, treatment, and follow-up to assess the drug's effects and participant safety.

Researchers are evaluating the effect of balcinrenone/dapagliflozin compared with dapagliflozin alone on cardiovascular death and heart failure events in patients with chronic heart failure and impaired kidney function who recently experienced a heart failure event. This is a Phase III, international, randomized, double-blind, parallel-group, active-controlled study involving approximately 700 sites in about 40 countries. Participants will be randomly assigned in a 1:1:1 ratio to receive one of three treatments once daily: a capsule of balcinrenone/dapagliflozin 15 mg/10 mg with a placebo tablet, a capsule of balcinrenone/dapagliflozin 40 mg/10 mg with a placebo tablet, or a dapagliflozin 10 mg tablet with a placebo capsule. The study is event-driven, with an estimated average duration of 22 months that includes a screening period, a 20-month blinded treatment phase, and a one-month follow-up on open-label dapagliflozin. During the study, participants will be monitored for the time to first occurrence of cardiovascular death, heart failure hospitalization, or heart failure events without hospitalization over approximately 38 months. Assessments include clinical evaluations, laboratory tests, and safety monitoring throughout the study and follow-up period to track treatment effects and patient outcomes.