8 research outputs found
Indoor Outdoor - Innovative tiergerechte Haltungsverfahren für die ökologische Schweine- und Rinderhaltung im Rahmen der geänderten EU-Öko-Verordnung
In organic cattle and pig husbandry, innovative, animal-friendly systems have been developed in which indoor and outdoor areas cannot be clearly separated. The outdoor and indoor areas should not only meet the EU-regulated minimum space requirements, but also allow the animals´ specific behaviour
Maize glutathione-dependent formaldehyde dehydrogenase: protein sequence and catalytic properties
Innovative tiergerechte Haltungsverfahren für die ökologische Schweine- und Rinder-haltung im Rahmen der geänderten EU-Öko-Verordnung (Verbundvorhaben)
In der ökologischen Rinder- und Schweinehaltung ist der Zugang zur Weide oder zum Auslauf obligatorisch. Daneben gibt es zunehmend innovative Systeme mit nicht klar getrennten Innen- und Außenbereichen, bei denen somit unklar ist, welche Abschnitte des Haltungsverfahrens als Stallfläche und welche als Außenfläche nach der EU-Öko-Verordnung anzurechnen sind. Trotz ausreichender Gesamtfläche kann es zu Unterschreitungen insbesondere der Flächenanforderungen im Stall kommen, ohne dass dies mit Nachteilen für die Tiere verbunden ist. Andererseits können solche offeneren Haltungsverfahren auch Vorteile in Bezug auf das Tierwohl bieten. Ziel des Projektes war es, unter Berücksichtigung der arteigenen Bedürfnisse von Rindern und Schweinen Haltungskriterien zu erarbeiten, mit denen unabhängig von der Aufteilung der verfügbaren Fläche auf den Innen- und Außenbereich beurteilt werden kann, ob die Anforderungen an eine besonders tiergerechte Haltung erfüllt werden. Unter breiter Expert:innen-Beteiligung wurden die Kriterien diskutiert und ihre Anwendbarkeit an Beispielen von Haltungsverfahren geprüft. In einem englischsprachigen Bericht wird der derzeitige Stand des Wissens zu den Bedürfnissen von Schwein und Rind mit besonderem Bezug zu Außenklimabedingungen und die abgeleiteten Haltungskriterien dargestellt und Beispiele innovativer, besonders tiergerechter Haltungsverfahren vorgestellt, die die erarbeiteten Kriterien erfüllen. Es wird der Schluss gezogen, dass bei den neuen, offeneren Haltungsverfahren die Unterscheidung zwischen Innen- und Außenflächen wenig aussagekräftig ist und stattdessen anhand der entwickelten Kriterien bewertet werden sollte, ob diese Verfahren Voraussetzungen für ein verbessertes Tierwohl bieten. In der Verordnung (EU) 2020/464 sollte es ermöglicht werden, im positiven Fall von den in Anhang I Teil I festgelegten Mindestflächen im Innen- und Außenbereich abzuweichen, soweit die geforderte Mindestgesamtfläche (Stall- und Außenfläche) geboten wird
Who is the gate keeper for treatment in a fertility clinic in Germany? -baseline results of a prospective cohort study (PinK study)-
Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia : a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study)
Altres ajuts: Professional medical writing assistance was provided by Fiona Boswell, PhD, and editorial assistance was provided by Katie Lay, MSc, at Caudex (Oxford, UK), funded by Biotest AG. Accovion GmbH, Eschborn, Germany (now Clinipace Worldwide, Morrisville, North Carolina, USA) provided study management services. We would like to thank all centers and staff involved in this study, and the patients and their families. Bernd H. Belohradsky, V. Marco Ranieri (Chair), Richard Strauss, and Gerhard W. Sybrecht monitored patient safety and data integrity as members of the DSMB.The CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing ~ 23% immunoglobulin (Ig) M, ~ 21% IgA, and ~ 56% IgG as add-on therapy for patients with severe community-acquired pneumonia (sCAP). In this double-blind, phase II study (NCT01420744), 160 patients with sCAP requiring invasive mechanical ventilation were randomized (1:1) to trimodulin (42 mg IgM/kg/day) or placebo for five consecutive days. Primary endpoint was ventilator-free days (VFDs). Secondary endpoints included 28-day all-cause and pneumonia-related mortality. Safety and tolerability were monitored. Exploratory post hoc analyses were performed in subsets stratified by baseline C-reactive protein (CRP; ≥ 70 mg/L) and/or IgM (≤ 0.8 g/L). Overall, there was no statistically significant difference in VFDs between trimodulin (mean 11.0, median 11 [ n = 81]) and placebo (mean 9.6; median 8 [ n = 79]; p = 0.173). Twenty-eight-day all-cause mortality was 22.2% vs. 27.8%, respectively (p = 0.465). Time to discharge from intensive care unit and mean duration of hospitalization were comparable between groups. Adverse-event incidences were comparable. Post hoc subset analyses, which included the majority of patients (58-78%), showed significant reductions in all-cause mortality (trimodulin vs. placebo) in patients with high CRP, low IgM, and high CRP/low IgM at baseline. No significant differences were found in VFDs and mortality between trimodulin and placebo groups. Post hoc analyses supported improved outcome regarding mortality with trimodulin in subsets of patients with elevated CRP, reduced IgM, or both. These findings warrant further investigation. Trial registration: NCT01420744. The online version of this article (10.1007/s00134-018-5143-7) contains supplementary material, which is available to authorized users
Efficacy and safety of trimodulin, a novel polyclonal antibody preparation, in patients with severe community-acquired pneumonia: a randomized, placebo-controlled, double-blind, multicenter, phase II trial (CIGMA study)
PURPOSE: The CIGMA study investigated a novel human polyclonal antibody preparation (trimodulin) containing ~ 23% immunoglobulin (Ig) M, ~ 21% IgA, and ~ 56% IgG as add-on therapy for patients with severe community-acquired pneumonia (sCAP). METHODS: In this double-blind, phase II study (NCT01420744), 160 patients with sCAP requiring invasive mechanical ventilation were randomized (1:1) to trimodulin (42 mg IgM/kg/day) or placebo for five consecutive days. Primary endpoint was ventilator-free days (VFDs). Secondary endpoints included 28-day all-cause and pneumonia-related mortality. Safety and tolerability were monitored. Exploratory post hoc analyses were performed in subsets stratified by baseline C-reactive protein (CRP; ≥ 70 mg/L) and/or IgM (≤ 0.8 g/L). RESULTS: Overall, there was no statistically significant difference in VFDs between trimodulin (mean 11.0, median 11 [n = 81]) and placebo (mean 9.6; median 8 [n = 79]; p = 0.173). Twenty-eight-day all-cause mortality was 22.2% vs. 27.8%, respectively (p = 0.465). Time to discharge from intensive care unit and mean duration of hospitalization were comparable between groups. Adverse-event incidences were comparable. Post hoc subset analyses, which included the majority of patients (58-78%), showed significant reductions in all-cause mortality (trimodulin vs. placebo) in patients with high CRP, low IgM, and high CRP/low IgM at baseline. CONCLUSIONS: No significant differences were found in VFDs and mortality between trimodulin and placebo groups. Post hoc analyses supported improved outcome regarding mortality with trimodulin in subsets of patients with elevated CRP, reduced IgM, or both. These findings warrant further investigation