4 research outputs found

    Einfluss der Blickrichtung auf die Verarbeitung von emotionalen Gesichtern bei Personen mit Sozialer Phobie: eine fMRT-Studie

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    Die vorliegende Arbeit untersuchte, ob direkte gegenüber abgewandter Blickrichtung in präsentierten Gesichtsstimuli zu unterschiedlicher Hirnaktivierung führt und ob dieses Aktivierungsmuster durch den Grad der sozialen Ängstlichkeit der Versuchsperson bzw. durch Stimulusvalenz moduliert wird. Je zwölf Sozialphobikern und gesunden Kontrollpersonen wurden während funktioneller MRT-Scans neutrale, zornige und freudige Gesichter mit abgewandtem oder direktem Blick gezeigt. Abgewandte gegenüber direkter Blickrichtung löste in beiden Gruppen stärkere Aktivierungen der Amygdala und des parahippocampalen Gyrus beidseits sowie des dorsomedialen präfrontalen Kortex und des anterioren cingulären Kortex aus, während die direkte Blickrichtung zu keiner signifikant höheren Aktivierung führte. Die Interaktion von Blickrichtung, Stimulusvalenz und Gruppe führte zu Effekten im orbitofrontalen Kortex, in der rechten Amygdala und im linken extrastriären Kortex, was unter anderem durch eine Hyperaktivierung bei Sozialphobikern durch zornige Bilder mit abgewandtem Blick bedingt war. Die stärkere Aktivierung bei allen Versuchspersonen durch abgewandte Blickrichtung könnte mit der größeren Ambivalenz oder Ungewohntheit dieses Stimulus assoziiert sein. Die durch zornige Gesichter mit abgewandtem Blick ausgelöste Reaktion bei Sozialphobikern könnte ein neuronales Korrelat von Hypersensitivität gegenüber Verachtung im Gesicht des Gegenübers darstellen, wobei der orbitofrontale Kortex eine besonders relevante Region zu sein scheint

    Mindfulness-Based Student Training Improves Vascular Variability Associated With Sustained Reductions in Physiological Stress Response

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    In today's fast-paced society, chronic stress has become an increasing problem, as it can lead to psycho-physiological health problems. University students are also faced with stress due to the demands of many courses and exams. The positive effects of mindfulness-based stress reduction (MBSR) on stress management and self-regulation have already been studied. We have developed a new mindfulness intervention tailored for students—the Mindfulness-Based Student Training (MBST). In this study, we present longitudinal results of the MBST evaluation. Biosignal analysis methods, including pulse wave variability (PWV), heart rate variability, and respiratory activity, were used to assess participants' state of autonomic regulation during the 12-week intervention and at follow-up. The progress of the intervention group (IGR, N = 31) up to 3 months after the end of MBST was compared with that of a control group (CON , N = 34). In addition, the long-term effect for IGR up to 1 year after intervention was examined. The analysis showed significant positive changes in PWV exclusively for IGR. This positive effect, particularly on vascular function, persists 1 year after the end of MBST. These results suggest a physiologically reduced stress level in MBST participants and a beneficial preventive health care program for University students

    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)

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    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)

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    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
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