Bad Bevensen

The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.

This prospective observational study investigates the development of gastrointestinal (GI) symptoms in patients with anorexia nervosa (AN) and bulimia nervosa (BN) during multi-week inpatient weight rehabilitation. The study explores how the predominant nutritional strategy-flexitarian, vegetarian, or vegan-relates to changes in GI symptoms over the course of treatment. In addition to diet, the study examines how weight gain and other clinical, psychological, and demographic factors influence the trajectory of GI symptoms. Patients complete weekly questionnaires assessing GI symptoms as part of routine care at the Eating Disorder Center of the Klinik Lüneburger Heide, Germany. Further data are drawn from standard clinical assessments, including body weight, body composition, and psychometric instruments. The primary outcome is the change in GI symptom severity (measured via the GSRS score) from admission to discharge, analyzed in relation to dietary pattern and weight development. Secondary analyses will explore symptom progression over time, group differences between AN and BN, and predictors of GI symptom improvement, including dietary intake, baseline psychological status, symptom change, weight trajectory, and treatment duration. The study aims to recruit approximately 150 patients with AN and 35-40 with BN. Inclusion requires a diagnosis of AN (any subtype) or BN, age over 12 years, clinical stability, and the ability to provide informed consent. The findings aim to inform evidence-based dietary recommendations for individuals with eating disorders who experience significant GI symptoms during nutritional rehabilitation.

Approximately 540 participants will be randomized in a 2:1 ratio to receive an oral dose of levosimendan or placebo. Participants will be eligible for an open label extension (OLE) of 52-weeks.

The VISTA Nova Study will evaluate the safety, performance, and long-term durability of the Navitor valve in a real-world setting.