Study design for development of novel safety biomarkers of drug-induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case–control study

A lack of biomarkers that detect drug-induced liver injury (DILI) accurately continues to hinder early- and late-stage drug development and remains a challenge in clinical practice. The Innovative Medicines Initiative’s TransBioLine consortium comprising academic and industry partners is developing a prospective repository of deeply phenotyped cases and controls with biological samples during liver injury progression to facilitate biomarker discovery, evaluation, validation and qualification.In a nested case–control design, patients who meet one of these criteria, alanine transaminase (ALT) ≥ 5 × the upper limit of normal (ULN), alkaline phosphatase ≥ 2 × ULN or ALT ≥ 3 ULN with total bilirubin > 2 × ULN, are enrolled. After completed clinical investigations, Roussel Uclaf Causality Assessment and expert panel review are used to adjudicate episodes as DILI or alternative liver diseases (acute non-DILI controls). Two blood samples are taken: at recruitment and follow-up. Sample size is as follows: 300 cases of DILI and 130 acute non-DILI controls. Additional cross-sectional cohorts (1 visit) are as follows: Healthy volunteers (n = 120), controls with chronic alcohol-related or non-alcoholic fatty liver disease (n = 100 each) and patients with psoriasis or rheumatoid arthritis (n = 100, 50 treated with methotrexate) are enrolled. Candidate biomarkers prioritised for evaluation include osteopontin, glutamate dehydrogenase, cytokeratin-18 (full length and caspase cleaved), macrophage-colony-stimulating factor 1 receptor and high mobility group protein B1 as well as bile acids, sphingolipids and microRNAs. The TransBioLine project is enabling biomarker discovery and validation that could improve detection, diagnostic accuracy and prognostication of DILI in premarketing clinical trials and for clinical healthcare application

Mobility in a Globalised World 2016

The term mobility has different meanings in the following science disciplines. In economics, mobility is the ability of an individual or a group to improve their economic status in relation to income and wealth within their lifetime or between generations. In information systems and computer science, mobility is used for the concept of mobile computing, in which a computer is transported by a person during normal use. Logistics creates by the design of logistics networks the infrastructure for the mobility of people and goods. Electric mobility is one of today’s solutions from engineering perspective to reduce the need of energy resources and environmental impact. Moreover, for urban planning, mobility is the crunch question about how to optimise the different needs for mobility and how to link different transportation systems. In this publication we collected the ideas of practitioners, researchers, and government officials regarding the different modes of mobility in a globalised world, focusing on both domestic and international issues

Study design for development of novel safety biomarkers of drug-induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case–control study

A lack of biomarkers that detect drug-induced liver injury (DILI) accurately continues to hinder early- and late-stage drug development and remains a challenge in clinical practice. The Innovative Medicines Initiative’s TransBioLine consortium comprising academic and industry partners is developing a prospective repository of deeply phenotyped cases and controls with biological samples during liver injury progression to facilitate biomarker discovery, evaluation, validation and qualification. In a nested case–control design, patients who meet one of these criteria, alanine transaminase (ALT) ≥ 5 × the upper limit of normal (ULN), alkaline phosphatase ≥ 2 × ULN or ALT ≥ 3 ULN with total bilirubin > 2 × ULN, are enrolled. After completed clinical investigations, Roussel Uclaf Causality Assessment and expert panel review are used to adjudicate episodes as DILI or alternative liver diseases (acute non-DILI controls). Two blood samples are taken: at recruitment and follow-up. Sample size is as follows: 300 cases of DILI and 130 acute non-DILI controls. Additional cross-sectional cohorts (1 visit) are as follows: Healthy volunteers (n = 120), controls with chronic alcohol-related or non-alcoholic fatty liver disease (n = 100 each) and patients with psoriasis or rheumatoid arthritis (n = 100, 50 treated with methotrexate) are enrolled. Candidate biomarkers prioritised for evaluation include osteopontin, glutamate dehydrogenase, cytokeratin-18 (full length and caspase cleaved), macrophage-colony-stimulating factor 1 receptor and high mobility group protein B1 as well as bile acids, sphingolipids and microRNAs. The TransBioLine project is enabling biomarker discovery and validation that could improve detection, diagnostic accuracy and prognostication of DILI in premarketing clinical trials and for clinical healthcare application

Worldwide trends in population-based survival for children, adolescents, and young adults diagnosed with leukaemia, by subtype, during 2000–14 (CONCORD-3): analysis of individual data from 258 cancer registries in 61 countries

Background: Leukaemias comprise a heterogenous group of haematological malignancies. In CONCORD-3, we analysed data for children (aged 0–14 years) and adults (aged 15–99 years) diagnosed with a haematological malignancy during 2000–14 in 61 countries. Here, we aimed to examine worldwide trends in survival from leukaemia, by age and morphology, in young patients (aged 0–24 years). Methods: We analysed data from 258 population-based cancer registries in 61 countries participating in CONCORD-3 that submitted data on patients diagnosed with leukaemia. We grouped patients by age as children (0–14 years), adolescents (15–19 years), and young adults (20–24 years). We categorised leukaemia subtypes according to the International Classification of Childhood Cancer (ICCC-3), updated with International Classification of Diseases for Oncology, third edition (ICD-O-3) codes. We estimated 5-year net survival by age and morphology, with 95% CIs, using the non-parametric Pohar-Perme estimator. To control for background mortality, we used life tables by country or region, single year of age, single calendar year and sex, and, where possible, by race or ethnicity. All-age survival estimates were standardised to the marginal distribution of young people with leukaemia included in the analysis. Findings: 164 563 young people were included in this analysis: 121 328 (73·7%) children, 22 963 (14·0%) adolescents, and 20 272 (12·3%) young adults. In 2010–14, the most common subtypes were lymphoid leukaemia (28 205 [68·2%] patients) and acute myeloid leukaemia (7863 [19·0%] patients). Age-standardised 5-year net survival in children, adolescents, and young adults for all leukaemias combined during 2010–14 varied widely, ranging from 46% in Mexico to more than 85% in Canada, Cyprus, Belgium, Denmark, Finland, and Australia. Individuals with lymphoid leukaemia had better age-standardised survival (from 43% in Ecuador to ≥80% in parts of Europe, North America, Oceania, and Asia) than those with acute myeloid leukaemia (from 32% in Peru to ≥70% in most high-income countries in Europe, North America, and Oceania). Throughout 2000–14, survival from all leukaemias combined remained consistently higher for children than adolescents and young adults, and minimal improvement was seen for adolescents and young adults in most countries. Interpretation: This study offers the first worldwide picture of population-based survival from leukaemia in children, adolescents, and young adults. Adolescents and young adults diagnosed with leukaemia continue to have lower survival than children. Trends in survival from leukaemia for adolescents and young adults are important indicators of the quality of cancer management in this age group

AERO – A prototype for electric wheelchair distance sensors

Aus dem Behindertenbericht von 2008 (Bundesministerium für Arbeit, Soziales und Konsumentenschutz, 2009) geht hervor, dass von den 50.000 Rollstuhlnutzer*innen, 9,7% elektrische Rollstühle benutzen. Ein Rollstuhl kann je nach Herstellung und Einsatzgebiet bis zu 200kg haben. Daher ist eine sichere Steuerung wichtig. Die Masterarbeit befasst sich mit der Frage wie mittels Sensoren und Raspberry Pi ein kostengünstiges und leicht einsetzbares System für die Abstandserfassung bei elektrischen Rollstühlen gestaltet werden kann. Durch Expert*innen-Interviews und eine Diskussionsrunden wurde herausgefunden, welche Schwierigkeiten beim eigenständigen Fahren auftreten und infolgedessen wie das Abstandsensoren System am besten gestaltet werden soll. Basierend auf diesen analysierten Ergebnissen wurde der Prototyp AERO, Abstandssensoren für Elektro-Rollstühle, entwickelt, der Feedback zu der Entfernung von Gegenständen liefert. Der fertiggestellte Prototyp wurde den Expert*Innen vorgeführt und Rückmeldungen dazu eingeholt. Es wurde ein System entwickelt welches eine Audionotifikation, entweder ein Pieps-Geräusch oder einen gesprochenen Text wiedergibt. Zusätzlich wird der gemessene Abstand auch in einem visuellen Feedback dargestellt. Die Expert*innen fassten das dargebotene Feedback und die Umstellmöglichkeit dessen als positiv auf. Ein Abstandssensor System wie AERO weise ein Nutzungspotential für die betroffenen Personen auf. Durch AERO könnten unsichere Personen beim Elektro-Rollstuhlfahren unterstützt werden, aber auch Gefahrenquellen besser identifiziert werden. Die Weiterverfolgung eines solchen Systems, sodass es ein Medizinprodukt daraus entsteht oder von Rollstuhlherstellern übernommen wird wäre eine künftige Option.In Austria 50.000 people need a wheelchair for their mobility. From those 9.7 % are in need of an electric wheelchair. Depending on the model, an electric wheel chair can weigh up to 200 kg. Therefore, it is important for the users to navigate their vehicle safely; otherwise it might cause accidents. This thesis focuses on developing an economic and flexible usable system to detect obstacles surrounding the electric wheelchair. Experts were interviewed, concerning the difficulties driving an electric wheelchair and the possible applications of a system like AERO. Based on this data the prototype was developed. Afterwards it was presented to the experts again and evaluated. AERO was developed to give a beeping and voice audio notification. Furthermore, a display shows the distances graphically. In the evaluation the experts were pleased with the possibility of switching between the feedbacks with ease or turning it off altogether. They also saw the potential usage for affected people. It is possible to help an insecure person to gain confidence or reduce dangerous situations and therefore accidents. To use AERO commercially it is necessary to make it a medical device. In addition the manufacturers could, in the future, incorporate it into their vehicles.vorgelegt von: Melanie HacklWien, FH Campus Wien, Masterarb., 201

Neue Medien im Kindergarten

Neuen Medien, wie Fernsehen, Smartphone, Tablet, Computer und Internet, haben sich in den letzten Jahren rasant weiterentwickelt und bieten heute eine große Vielfalt an Möglichkeiten. Dadurch sind sie auch ein fester Bestandteil der (früh)kindlichen Lebenswelt geworden. Für eine zeitgemäße Unterstützung der frühkindlichen Entwicklung im Kindergarten spielen daher Medienerziehung und -bildung eine zunehmend bedeutende Rolle, um den Kindern einen kompetenten Umgang mit den Medien ihres Alltages nahe zu bringen. Daraus ergeben sich sowohl neue Anforderungen an die didaktische Gestaltung von medienpädagogischen Bildungsprozessen, als auch an die Qualifizierungen des pädagogischen Personals.In dieser Arbeit wird auf die Begriffe der Mediensozialisation, Medienpädagogik, Medienerziehung und -bildung und auf die Entwicklung von Medienkompetenz eingegangen. Der Fokus liegt dabei auf der Übertragbarkeit und Umsetzung im Kindergarten, also der Altersgruppe der Null- bis Sechsjährigen. Auch der gesetzliche Kinder- und Jugendmedienschutz wird in die Betrachtungen einbezogen. Daraus werden Ziele und Konzepte für die Arbeit mit Neuen Medien abgeleitet und einige didaktische Methoden dargestellt. Als Beispiel für den gezielten Medieneinsatz im Kindergarten wird der Computer heran gezogen. Zuletzt wird die Rolle der PädagogInnen im Prozess der Medienbildung beschrieben.The availability and the possibilities of New Media like television, smartphone, tablet, PC and internet rapidly increased in the last few years. Today those devices are not only present in the everyday life of young children but often used by themselves. Hence, media education gets increasingly important for an up-to-date early childhood education which should enable children to be competent users of New Media. Thereof result new needs governing media-educational processes and the qualifications of pedagogues in kindergartens.In this thesis outlines the concepts of media socialization, media-pedagogy, media education and the development of media competence with respect to young children from 0 to 6 years and the kindergarten. The outcome of this is the definition of goals and methods for the didactic use of New Media in the kindergarten. As an example serves the applicability of PC`s. Finally, the role of the pedagogues in media education is defined.vorgelegt von Melanie HacklAbweichender Titel laut Übersetzung der Verfasserin/des VerfassersZsfassungen in dt. und engl. SpracheGraz, Univ., Masterarb., 2015(VLID)33638