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Christina Kunz,1 Doreen Luedtke,1 Anna Unseld,2 Alan Hamilton,3 Atef Halabi,4 Martina Wein,5 Stephan Formella6 1Translational Medicine and Clinical Pharmacology, 2Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH and Co KG, Biberach, Germany; 3Boehringer Ingelheim, Burlington, ON, Canada; 4CRS Clinical Research Services Kiel GmbH, Kiel, 5Drug Metabolism and Pharmacokinetics, Boehringer Ingelheim Pharma GmbH and Co KG, Biberach, 6Medicine Coordination, Boehringer Ingelheim Pharma GmbH and Co KG, Ingelheim, Germany Purpose: In two trials, the influences of hepatic and renal impairment on the pharmacokinetics of olodaterol, a novel long-acting inhaled β2-agonist for treatment of COPD, were investigated.Subjects and methods: The first trial included eight subjects with mild hepatic function impairment (Child–Pugh A), eight subjects with moderate impairment (Child–Pugh B), and 16 matched healthy subjects with normal hepatic function. The second trial included eight subjects with severe renal impairment (creatinine clearance

Masakazu Ichinose,1 Ayako Takizawa,2 Toshiyasu Izumoto,2 Yusuke Tadayasu,2 Alan L Hamilton,3 Christina Kunz,4 Yoshinosuke Fukuchi51Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan; 2Nippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan; 3Boehringer Ingelheim, Burlington, Ontario, Canada; 4Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany; 5Juntendo University School of Medicine, Tokyo, JapanBackground: Olodaterol is a novel long-acting β2-agonist with proven ≥24-hour duration of action in preclinical and clinical studies.Objective: This randomized, double-blind, placebo-controlled, parallel-group study evaluated the dose response of once-daily (QD) olodaterol based on bronchodilator efficacy, safety, and pharmacokinetics over 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD).Methods: All eligible patients were randomized to receive 2 µg, 5 µg, or 10 µg of olodaterol or placebo for 4 weeks via the Respimat® Soft Mist™ inhaler. The primary end point was the change from baseline in trough forced expiratory volume in 1 second (FEV1) after 4 weeks of olodaterol treatment. Secondary end points included trough FEV1 after 1 week and 2 weeks of treatment, FEV1 area under the curve from 0 hour to 3 hours (AUC0–3), peak FEV1 from 0 hour to 3 hours (peak FEV1), and corresponding forced vital capacity (FVC) responses. Rescue medication use, COPD symptoms, physician global evaluation, pharmacokinetics, and safety were also assessed.Results: A total of 328 patients with COPD were randomized to receive treatment. All olodaterol doses assessed in the study showed statistically significant increases in trough FEV1 compared to placebo at Day 29 (P

Training and prototype development in robotassisted surgery requires appropriate and safe environments for the execution of surgical procedures. Current dry lab laparoscopy phantoms often lack the ability to mimic complex, interactive surgical tasks. This work presents an interactive surgical phantom for the cholecystectomy. The phantom enables the removal of the gallbladder during cholecystectomy by allowing manipulations and cutting interactions with the synthetic tissue. The force-displacement behavior of the gallbladder is modelled based on retraction demonstrations. The force model is compared to the force model of ex-vivo porcine gallbladders and evaluated on its ability to estimate retraction forces.

Robotic assistance systems are being used more and more frequently in the operating room, with the goal to support surgeons and to automate parts of a procedure. The laparoscopic cholecystectomy is one of the most common procedures in Germany.We aim to automate the assistant grasp task in this procedure. To achieve this goal, first the grasp points on the gallbladder need to be determined. In this work, we therefore present a statistical shape model fitting to the gallbladder for grasp point determination. Gallbladder and liver point clouds are utilized as inputs. A registration algorithm is used to fit the shape model to the gallbladder mesh. The process is evaluated on three different datasets achieving a successful grasping point identification of 90% for artificially created gallbladders, 100% for our silicon phantom model, and 90% for ex-vivo organs.

BACKGROUND/OBJECTIVES: Considering the large number of children worldwide attending all-day schools, information on the effects of lunch on short-term cognitive performance is of public health relevance. However, only adult studies investigated this issue yet. Therefore, this study examined the impact of skipping lunch vs having lunch on children's cognitive functioning in the early afternoon. SUBJECTS/METHODS: Participants in this randomized crossover study with two groups were healthy 6th grade students of an all-day school in Gelsenkirchen, Germany. Group 1 skipped lunch on study day 1 and received an ad libitum lunch 1 week later on study day 2. The order for group 2 was vice versa. In the afternoon tonic alertness, visuospatial memory and selective attention were determined using a computerized test battery of the Vienna Test System. For continuous and discrete interval-scaled variables, treatment effect was estimated using the two sample t-test or the Wilcoxon rank-sum test, for discrete ordinal-scaled variables using generalized linear models. RESULTS: Data on 105 children (48% male;12.6±0.6 years) were analyzed. Except for tonic alertness there were no significant differences in cognitive functioning between the skipping lunch day and the having lunch day. The higher number of omission errors on the skipping lunch day lost significance when adjusting for multiple testing. CONCLUSIONS: In the first study on this topic lunch did not have relevant effects on children's cognitive functioning in the early afternoon. Future research needs to be done to figure out potential methodical and physiological explanations. doi: 10.1038/ejcn.2012.209 Keywords: child; attention; memory; diet; food services; schools, INTRODUCTION The long-standing National School Lunch Program of the US (1) and its nutrition standards (2) set an example for a well-organized provision of school meals with the objective of [...]