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Web Intelligence and Intelligent Agent Technology Workshops (WI-IAT)

作者： Pablo Pico-Valencia Juan A. Holgado-Terriza Programming and Development of Software Department Pontificia Univ Católica del Ecuador Esmeraldas Software Engineering Department Universidad de Granada

ISBN: (纸本)9781509047727

The Internet of Things (IoT) is a current approach which aims to act on pervasive environments for connecting smart objects. These objects are capable to sense their own environment, interacting and cooperating with other devices. However, the IoT also requires to perform coordination actions that devices cannot carry out with the embedded electronic. In order to create smarter collaborative systems, the Internet of Agents (IoA) approach arises as an alternative for providing information and services to other objects, systems and people, and to initialize actions if necessary. In this paper, a semantic model of public agent contracts based on OWL ontologies enriched with Open Linked Data has been proposed as a fundamental way to describe standard collaborative units that can interact in a social context. The overarching ontology we have named IoA-OWL takes into account functional and non-functional aspects organized in six profiles such as agent, context, model, service, social, and object.

关键词： Open linked data Internet of agents Internet of things Ontology Contract

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Author Correction: Anchoring cortical granules in the cortex ensures trafficking to the plasma membrane for post-fertilization exocytosis

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Nature communications 2019年第1期10卷 2926页

作者： Edgar-John Vogt Keizo Tokuhiro Min Guo Ryan Dale Guanghui Yang Seung-Wook Shin Maria Jimenez Movilla Hari Shroff Jurrien Dean Laboratory of Cellular and Developmental Biology NIDDK National Institutes of Health Bethesda MD 20892 USA. Charité - Universitätsmedizin Berlin Augustenburger Platz 1 13353 Berlin Germany. Department of Genome Editing Institute of Biomedical Science Kansai Medical University 2-5-1 Shinmachi Hirakata Osaka 573-1010 Japan. Section on High Resolution Optical Imaging NIBIB National Institutes of Health Bethesda MD 20892 USA. Bioinformatics and Scientific Programming Core Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health Bethesda MD 20892 USA. Department of Cell Biology and Histology Medical School University of Murcia IMIB 30100 Murcia Spain. Advanced Imaging and Microscopy Resource National Institutes of Health Bethesda MD 20892 USA. Laboratory of Cellular and Developmental Biology NIDDK National Institutes of Health Bethesda MD 20892 USA. jurrien.dean@nih.gov.

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

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DOP024 Vedolizumab clinical and post-marketing safety experience of opportunistic infections

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S41-S41页

作者： Ng, S.C. Palo, W. Blake, A. Rana-Khan, Q. Bhayat, F. Chinese University of Hong Kong Department of Medicine and Therapeutics Hong Kong Hong Kong Takeda Development Center Americas Inc. Global Statistics and Statistical Programming Deerfield United States Takeda Development Center Europe Ltd Global Pharmacovigilance London United Kingdom Takeda Pharmaceutical International AG Singapore Emerging Markets Medical Affairs Singapore Singapore Takeda Development Centre Europe Ltd Global Pharmacovigilance London United Kingdom

Background:The risk of opportunistic infections (OIs) in IBD increases after treatment with biologics (OR: 1.90) [1]. Vedolizumab (VDZ), a humanised monoclonal antibody, targets α4β7 integrin and selectively blocks gut-specific lymphocyte trafficking. Gut selectivity could be associated with a lower risk of infections compared with anti-TNFα agents, which cause systemic immunosuppression. We assessed the frequency of OIs with VDZ treatment in clinical trials and the post-marketing (PM) ***:Safety data from GEMINI 1 and 2 (VDZ vs placebo, in ulcerative colitis [UC] and Crohn's disease [CD], respectively), the ongoing GEMINI open-label extension (OLE) study (VDZ only, UC and CD; data cut-off: 19 May 2015) and the VDZ Global Safety Database (May 2014 – 30 September 2016) were assessed. OI events were identified from a comprehensive list of MedDRA terms that are generally regarded as ***:Seven OIs were reported in GEMINI 1 and 2 (N=1731); all received VDZ (n=1434). OIs includedClostridium difficilecolitis (n=5); cytomegalovirus (CMV) colitis (n=1) and CMV infection (n=1). One event was serious; one (non-serious) led to discontinuation. 51 patients had OIs in GEMINI OLE (N=2243; TPY=5430; Table 1);C. difficilecolitis was most frequent (n=26; serious: n=11; non-serious: n=15). In the context of ∼72,140 patient-years of VDZ therapy in the PM setting, 127 OI events were reported in 124 patients (serious: 59 events; non-serious: 68 events); the most frequently reported OI wasC. difficileinfection (74 events; 25 serious, 49 non-serious; Table 2). 2 patients had fatal OIs:Pneumocystis jirovecipneumonia in a patient with immunosuppression due to long-term high-dose steroid use, and unspecified OI in a steroid-refractory graft versus host disease patient (off-label use). In the PM setting, VDZ treatment was continued in most patients with OI events (66%).Conclusions:Clinical trial and PM data showed that OIs were infrequent with VDZ. The most common OI wasC.

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P442 Incidence of pneumonia and other respiratory tract infections with vedolizumab treatment for inflammatory bowel disease: clinical trial experience

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S301-S302页

作者： Feagan, B. Bhayat, F. Khalid, J.M. Palo, W. Blake, A. Shetzline, M. Travis, S. Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada Takeda Development Centre Europe Ltd Global Pharmacovigilance London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom Takeda Development Center Americas Inc. Global Statistics and Statistical Programming Deerfield United States Takeda Development Center Europe Ltd Global Pharmacovigilance London United Kingdom Takeda Pharmaceuticals International Co. Clinical Science GI Cambridge United States University of Oxford Translational Gastroenterology Unit Nuffield Department of Medicine Oxford United Kingdom

Background:Vedolizumab (VDZ) is a humanised monoclonal antibody that binds to α4β7integrin and selectively blocks gut-specific lymphocyte trafficking. Although upper respiratory tract infections (URTIs) have been reported with VDZ [1] its gut selectivity may reduce the risk of respiratory tract infections (RTIs), including pneumonia, compared with therapies producing systemic immunosuppression (e.g. anti-tumour necrosis factor-alpha [TNFα] agents). We aimed to determine the incidence of RTIs associated with VDZ treatment in the clinical trial ***:Safety data from VDZ phase 3 randomised controlled trials (RCTs) in ulcerative colitis (UC; GEMINI 1) and Crohn's disease (CD; GEMINI 2) and a phase 3 open-label extension (OLE; C13008 ongoing study in both UC and CD) were used to calculate the incidence of lower RTIs (LRTIs), including pneumonia, and URTIs using the MedDRA High Level Terms “lower respiratory tract and lung infections” and “upper respiratory tract infections”. A Cox proportional hazards model was used to identify potential predictors of these AEs for the pooled GEMINI 1 and 2 ***:Of 1731 patients in the pooled RCT population and 2243 patients in the OLE, mean (SD) ages were 37.9 (12.7) years and 39.1 (13.2) years, respectively; 43% and 50%, respectively, had disease duration ≥7 years; and 57% and 59%, respectively, had prior anti-TNFα therapy. In the RCTs, the rate of LRTIs, including pneumonia, was similar in the VDZ and placebo groups (Table 1). Rates of LRTIs were higher for VDZ-treated patients with CD than with UC. Most LRTI and URTI AEs were not serious and did not result in treatment discontinuation. Predictors of increased incidence of LRTIs were identified as being a current or former smoker, female sex and prior anti-TNFα therapy (Table 2). Predictors of URTIs were: being a current smoker, concomitant narcotic use and prior anti-TNFα ***:In this post hoc analysis, VDZ treatment of IBD was not associated with

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DOP026 Sustained remission with vedolizumab in patients with moderately to severely active ulcerative colitis: a GEMINI 1 post hoc analysis of week 14 remitters

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S42-S43页

作者： Stallmach, A. Bokemeyer, B. Axler, J. Curtis, R. Ehehalt, R. Feagan, B. Geransar, P. James, A. Kaviya, A. Khalid, J.M. Wolf, D. Schreiber, S. University hospital Jena Department of Internal Medicine IV Jena Germany Gastroenterology Practice Private practice Minden Germany TDDA (Toronto Digestive Disease Associates Inc.) Toronto Canada Takeda Development Centre Europe Ltd Global Medical Affairs London United Kingdom Praxis für Gastroenterologie Gastroenterology Heidelberg Germany Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada Takeda Pharmaceuticals International AG Global Medical Affairs Zurich Switzerland Takeda Development Centre Europe Ltd Global Statistics and Statistical Programming London United Kingdom Takeda Development Centre Europe Ltd Clinical Development London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom Atlanta Gastroenterology Associates Emory Saint Joseph's Atlanta United States University Hospital Schleswig-Holstein Institute for Clinical Molecular Biology Kiel Germany

Background:Sustained remission is a key therapeutic goal in ulcerative colitis (UC). Vedolizumab (VDZ) was more effective than placebo as induction and maintenance therapy in patients (pts) with moderately to severely active UC in the GEMINI 1 study (NCT00783718). This post hoc analysis assessed sustained remission during the maintenance phase of GEMINI ***:Analyses included pts enrolled in GEMINI 1, who received 6 weeks (wks) of induction with placebo or VDZ and entered 46 wks of maintenance continuing placebo or VDZ, respectively; eligible pts could then enrol into an open-label extension (OLE) to receive VDZ every 4 wks. The primary aim was to assess sustained remission (remission at Wks 26, 38 and 52) in pts who achieved remission at Wk 14. Remission was defined as 1) clinical remission (partial Mayo Score [PMS] ≤2 points with no individual subscore >1 point) or 2) rectal bleeding subscore =0. For the analyses, pts who received VDZ maintenance, discontinued before Wk 52 and then entered the OLE had missing maintenance data imputed using OLE ***:In total, 620 pts received VDZ (Wk 6 responders and non-responders) and 149 received placebo throughout GEMINI 1. Patient characteristics were broadly similar between treatment groups. From Wk 4 onwards, a significantly higher proportion of pts receiving VDZ were in clinical remission versus placebo in the overall and anti-TNF-naïve populations; significance was achieved at Wk 26 in the anti-TNF failure population. At Wk 14, 203 (33%) pts receiving VDZ and 30 (20%) pts receiving placebo were in clinical remission based on PMS, and 293 (47%) pts receiving VDZ and 43 (29%) pts receiving placebo were in remission based on rectal bleeding subscore. Of pts in remission at Wk 14, the VDZ group had a higher proportion of pts with sustained remission versus placebo according to both PMS and rectal bleeding definitions (Table); significance was reached in both the overall and anti-TNF-naïve populations, and a simila

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Durability of alirocumab effect: Data from an open-label extension to the ODYSSEY program for patients with heterozygous familial hypercholesterolemia

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Annales d'Endocrinologie 2017年第4期78卷 301-301页

作者： M. Farnier G.K. Hovingh G. Langset R. Dufour M. Baccara-Dinet C. Din-Bell G. Manvelian J.R. Guyton Lipid clinic – Point Médical Dijon France Department of Vascular Medicine Academic Medical Center Amsterdam The Netherlands Lipid Clinic Oslo University Hospital Oslo Norway Institut de recherches cliniques de Montréal Université de Montréal Montréal QC Canada Clinical Development R&D Sanofi Montpellier France Biostatistics and Programming Sanofi Chilly-Mazarin France Regeneron Pharmaceuticals Tarrytown NY USA Duke University Medical Center Durham NC USA

Purpose To evaluate the overall durability of the effect of alirocumab in patients with heterozygous familial hypercholesterolemia (HeFH) using data from the ODYSSEY open-label extension (OLE) of four phase 3 trials (FHI, FHII, LONG-TERM, HIGH-FH) assessing long-term efficacy and safety for up to 40 months. Methods Patients received alirocumab 75 mg (FHI, FHII, LONG-TERM) or 150 mg (HIGH-FH) once every 2 weeks. From Week 12, dose adjustment of alirocumab was allowed as per investigator's clinical judgement. Results A total of 985 patients (mean age 54.4 years, 55.8% male) were included in OLE safety population. At OLE enrollment, 978 patients were receiving statins with 627 other lipid-lowering therapy. At the time of analysis, 938 patients had completed ≥ 1 year of treatment; 5.7% had discontinued treatment (2.2% due to adverse events). Of those who started OLE on 75 mg dose, 537/909 (59.1%) were maintained on that dose throughout. At Week 48 of OLE, the mean LDL-C was 79.7 mg/dL, a mean reduction of 46.9% compared with baseline levels of the parent studies. Other lipid changes included reductions at Week 48 in non-high density lipoprotein cholesterol (40.3%), total cholesterol (29.7%), lipoprotein(a) (25.6%), and apolipoprotein B (37.5%). Overall, 762/985 (77.4%) patients reported treatment-emergent adverse events during OLE (up to 73 weeks). Injection site reactions reported by 49 patients (5.0%) were mild and self-limited. Conclusion In this OLE study of patients with HeFH, alirocumab demonstrated a durable and robust treatment effect, yielding a 47% reduction in LDL-C at Week 48 compared with baseline levels.

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P209 Long-term effectiveness and safety of vedolizumab in patients with ulcerative colitis: 5-year cumulative exposure of GEMINI 1 completers rolling into the GEMINI open-label extension studyGet access

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S182–S183页

作者： Loftus, E.V. Colombel, J.-F. Feagan, B. Vermeire, S. Sandborn, W. Sands, B. Danese, S. D'Haens, G. Kaser, A. Panaccione, R. Rubin, D. Shafran, I. O'Byrne, S. Geransar, P. James, A. Kaviya, A. Khalid, J.M. Mayo Clinic College of Medicine Gastroenterology and Hepatology Rochester United States Icahn School of Medicine at Mount Sinai Gastroenterology New York United States Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada University hospitals Leuven Department of clinical and experimental medicine Leuven Belgium University of California - San Diego Division of Gastroenterology La Jolla United States Icahn School of Medicine at Mount Sinai Division of Gastroenterology New York United States Humanitas University Italy Gastrointestinal Immunopathology Milan Italy University of Cambridge Division of Gastroenterology and Hepatology Cambridge United Kingdom University of Calgary Department of Medicine Calgary Canada University of Chicago Medicine Inflammatory Bowel Disease Center Section of Gastroenterology Hepatology and Nutrition Chicago United States Shafran Gastroenterology Research center Gastroenterology Winter Park United States Takeda Pharmaceuticals International AG Global Medical Affairs Zurich Switzerland Takeda Development Centre Europe Ltd Global Statistics and Statistical Programming London United Kingdom Takeda Development Centre Europe Ltd Clinical Development London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom

Background:Approval of vedolizumab (VDZ) for moderately to severely active ulcerative colitis (UC) was based on the phase 3 GEMINI 1 study. 【1】 The GEMINI open-label extension (OLE) trial is an ongoing study investigating the long-term safety of VDZ (NCT00790933). Here we report the 5-year exploratory analyses of effectiveness and safety in patients (pts) with UC who had completed GEMINI 1 and were enrolled in GEMINI ***:Analyses included pts who responded to VDZ induction at Week (Wk) 6 and had received VDZ maintenance (every 8 or 4 wks; data were combined) to Wk 52 of GEMINI 1, followed by VDZ every 4 wks in GEMINI OLE. Pts with 248 wks of cumulative VDZ treatment (data were collected from 22 May 2009 to 21 May 2015) were assessed for clinical response (decrease in partial Mayo Score 【PMS】 of ≥2 points and ≥25% change from baseline 【BL】, with an accompanying decrease in rectal bleeding subscore of ≥1 point from BL or absolute rectal bleeding subscore of ≤1 point), clinical remission (PMS of ≤2 with no individual subscore >1) and health-related quality of life (HRQoL), including IBD Questionnaire (IBDQ) and Euro Quality of Life-5D visual analogue scale (EQ-5D VAS). Safety was also ***:Of 247 pts in GEMINI 1 who responded to VDZ induction at Wk 6 and received VDZ in maintenance, 154 (62%) completed VDZ maintenance and were enrolled in GEMINI OLE (anti-TNFα-naïve n=107; anti-TNFα failure n=42). At the time of this analysis, 63 pts had completed 248 wks of cumulative VDZ treatment; 54 had discontinued (n=19 【35%】 due to lack of continued benefit) and 37 are ongoing (have not yet reached 248 wks of treatment). Of pts with data at Wk 248 (n=63), 98% had clinical response and 90% were in remission (Table). HRQoL improvements were observed at Wk 248, with mean change from BL IBDQ and EQ-5D-VAS scores of 58.7 and 24.0, respectively. In the safety population, 137 pts had adverse (AEs); 17 discontinued due to AEs. Serious AEs were reported in 44 pts (in

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The parameters impact on cutting forces and determination of regression function

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IOP Conference Series: Materials Science and Engineering 2016年第1期161卷

作者： T D Popovici Department of Manufacturing Engineering The faculty of Engineering and Management of Technological Systems University Politehnica Bucharest 313 Splaiul Independentei Sector 6 Bucharest Romania Department of CN Programming and Technology Research Romanian Research & Development Institute for Gas Turbine 220 D Iuliu Maniu Bd. Sector 6 Bucharest Romania

The aim of this paper is to present results of certain experiments related to material workability characteristics, taking into consideration its high quality features and large usability for special manufacturing. It is highly used in various industrial processes, such as aeronautics, petrochemical industry, chemical industry, etc. It was examined the influence of milling parameters upon the three dimensional cutting force and after it was determinate regression function.

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DOP021 Long-term effectiveness and safety of vedolizumab in patients with Crohn's disease: 5-year cumulative exposure of GEMINI 2 completers rolling into the GEMINI open-label extension study

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Journal of Crohn's and Colitis 2017年第SUPPL_1期11卷 S39-S39页

作者： Vermeire, S. Loftus, E.V. Colombel, J.-F. Feagan, B. Sandborn, W. Sands, B. Danese, S. D'Haens, G. Kaser, A. Panaccione, R. Rubin, D. Shafran, I. O'Byrne, S. Geransar, P. Previtali, A. Khalid, J.M. Kaviya, A. University Hospitals Leuven Dpt of Gastroenterology Leuven Belgium Mayo Clinic College of Medicine Gastroenterology and Hepatology Rochester United States Icahn School of Medicine at Mount Sinai Gastroenterology New York United States Robarts Research Institute University of Western Ontario Robarts Clinical Trials London Canada University of California - San Diego Division of Gastroenterology La Jolla United States Icahn School of Medicine at Mount Sinai Division of Gastroenterology New York United States Humanitas University Italy Gastrointestinal Immunopathology Milan Italy Academic Medical Centre Dept. of Gastroenterology Amsterdam Netherlands University of Cambridge Division of Gastroenterology and Hepatology Cambridge United Kingdom University of Calgary Department of Medicine Calgary Canada University of Chicago Medicine Inflammatory Bowel Disease Center Section of Gastroenterology Hepatology and Nutrition Chicago United States Shafran Gastroenterology Research center Gastroenterology Winter Park United States Takeda Pharmaceuticals International AG Global Medical Affairs Zurich Switzerland Takeda Development Centre Europe Ltd Global Statistics and Statistical Programming London United Kingdom Takeda Development Centre Europe Ltd Evidence and Value Generation London United Kingdom Takeda Development Centre Europe Ltd Clinical Development London United Kingdom

Background:Vedolizumab (VDZ), a humanised monoclonal antibody that targets α4β7integrin, is approved for moderately to severely active Crohn's disease (CD) and ulcerative colitis. The GEMINI open-label extension (OLE) trial is an ongoing study investigating the long-term safety of VDZ (NCT00790933). Here we report the 5-year exploratory analyses of effectiveness and safety in patients (pts) with CD who had completed GEMINI 2 [1] and were enrolled in GEMINI ***:Analyses included pts who had responded to VDZ induction at Week (Wk) 6 and received VDZ maintenance (every 8 or 4 wks; data were combined) to Wk 52 of GEMINI 2, followed by VDZ every 4 wks in GEMINI OLE. Pts with 248 wks of cumulative VDZ treatment (data were collected from 22 May 2009 to 21 May 2015) were assessed for clinical response (decrease in Harvey–Bradshaw Index [HBI] of ≥3 points from baseline [BL]), clinical remission (HBI ≤4) and health-related quality of life (HRQoL), including IBD Questionnaire (IBDQ) and Euro Quality of Life-5D visual analogue scale (EQ-5D VAS). Safety was also ***:Of 308 pts in GEMINI 2 who responded to VDZ induction at Wk 6 and received VDZ in maintenance, 146 (47%) completed VDZ maintenance and were enrolled in GEMINI OLE (anti-TNFα-naïve n=81; anti-TNFα failure n=57). At the time of this analysis, 61 pts had completed 248 wks of cumulative VDZ treatment, 58 had discontinued (n=11 [19%] due to lack of continued benefit) and 27 are ongoing (have not yet reached 248 wks of treatment). Of pts with data at Wk 248 (n=61), 95% had clinical response and 89% were in remission (Table). HRQoL improvements were observed at Wk 248, with mean change from BL IBDQ and EQ-5D-VAS scores of 59.4 and 29.8, respectively. In the safety population, 134 pts had adverse events (AEs); 15 discontinued due to AEs. Serious AEs were reported in 41 pts (in 3 pts these were drug-related; 8 pts discontinued as a consequence of serious AEs). One death (not drug-related; motor accident)

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Information systems development projects and the simpt 2.0 case: How to turn an anticipated failure into a success

Information systems development projects and the simpt 2.0 c...

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IADIS International Conference on Information Systems 2013, IS 2013

作者： Federici, Tommaso Crisalli, Umberto Scerbo, Danilo Braccini, Alessio Maria University of Tuscia Viterbo Italy Department of Enterprise Engineering Tor Vergata University Rome Italy Direct.-General for Development of Territory Programming and International Projects Ministry of Infrastructures and Transports Rome Italy

ISBN: (纸本)9789728939830

This paper discusses the experience of the project for upgrading and extending a DSS of huge extent and complexity, devoted to transport management, which is still a neglected domain for IS research. This DSS belongs to an Italian Ministry and the project had the form of a public contract. For many reasons, this project was long-lasting and much troubled, and when approaching the testing phase it could have been considered failed. A case investigation through an action research reveals that drastic changes in project organization (actors composition and interaction), and in methodology (from waterfall to agile-like methods), adopted even in this late phase of the development process, contributed to turn an anticipated project failure into a success. © 2013 IADIS.

关键词： Information systems

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