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This deliverable reports the results of the activities carried out by M18 in Task 2.5 of WP2 of the iPRODUCE project. In this deliverable, it is presented an overview of the main EU survey findings. It also provides an overview of the proposed social manufacturing framework. It includes the structure that local cMDFs and ecosystems can adapt to. Finally, it presents the interconnection between the software components in relation to the user perspective is illustrated.

The deliverable D2.6 “iPRODUCE Social Manufacturing Vision and Reference Model I” by month 9, focuses on strengthen iPRODUCE vision on how social manufacturing framework can work in the consumer goods sectors. In particular, the D2.6 regards the fusion and synthesis of the outputs from T2.1-T2.4 in the form of a position paper and: Provides the proposed social manufacturing framework, the identified stakeholders, their main needs and the drivers for their participation to social manufacturing, the business, operational, and technical challenges that they face as well as which existed methods, functions, services & tools they use under co-creation activities. Includes the structure that local cMDFs and ecosystems can adopt, the scope of their federation, the governance principles they can apply as well as the intellectual property management, data management and ethics, occupational health and safety issues that have to consider. Presents the reference models for digital manufacturing platforms and the iPRODUCE reference architecture model approach. Presents the iPRODUCE platform main components description and the high functional view of their architecture. Also, in this section is described how these robust digital components will address the business, operational and technical challenges that appeared within a social manufacturing framework. The D2.6 is the first version of the documentation of the Social Manufacturing Reference Model and Framework Evolution. This document will be enriched by the second version on month 18 by D2.7 “iPRODUCE Social Manufacturing Vision and Reference Model II” and the last version on month 36 by D2.8 “iPRODUCE Social Manufacturing Vision and Reference Model III”. The D2.6 is a public document (PU) and is, therefore, intended for the European Commission, the iPRODUCE Project Officer, the members of the iPRODUCE consortium, the members of other national and H2020-funded projects, as well as, the research and industry more widely, and even the general public.

SummaryBackground Single-centre studies show that alexithymia, defined as difficulty in recognizing and describing emotions, is more prevalent among psoriasis patients than in the general population. However, its prevalence and the consequences of the association between alexithymia and psoriasis are unclear. Objectives The primary objective of this study was to determine the prevalence of alexithymia, as defined by a score ≥61 in the 20-item Toronto Alexithymia Scale (TAS-20), in a large sample of patients who had plaque psoriasis for ≤10 years and were eligible for phototherapy or systemic treatment. The secondary objectives were to investigate the relationship between alexithymia and the clinical and psychological aspects of psoriasis. Methods Data were collected in the framework of an observational, multicenter, international study, the EPidemiological Study In Patients With Recently DiagnosEd PSOriasis (EPIDEPSO), aiming at investigating the prevalence of alexithymia and other psychosocial comorbidities in psoriasis patients with ≤10 years disease duration. Results The prevalence of alexithymia within a cohort of 670 patients was 24.8% (95%CI: 21.7-28.2). Patients with alexithymia had a higher burden of psoriasis, including significant impairment of quality of life, higher levels of anxiety and depression, a higher risk of alcohol dependency and impairment of work productivity, compared to patients without alexithymia. Conclusion It is important to identify alexithymic patients with psoriasis in clinical practice as they suffer from a higher disease burden and have a lower ability to express their feelings. This article is protected by copyright. All rights reserved.

The skin is the most common organ of involvement during the course of lupus erythematosus (LE). The literature data concerning the dermatoscopic patterns of the different clinical variants of cutaneous LE (CLE), namely chronic (CCLE), subacute (SCLE), and acute (ACLE), are scarce. To determine the dermatoscopic spectrum of CLE and to correlate the dermatoscopic features with the histological findings. This was a retrospective, observational, multicenter, cohort study. We evaluated the dermatoscopic features in a cohort of patients diagnosed with CLE. Furthermore, we investigated their frequency per clinical subtype and correlated them with the anatomic alterations. We included 79 patients. The most prevalent dermatoscopic features of CCLE included follicular plugs (86.4%, P

Introduction: Leukocytosis and particularly neutrophilia are usually caused by acute infection, inflammation, and myeloproliferative neoplasms. However, leukocytosis can also occur in patients with malignancy either due to bone marrow metastases or in the context of a paraneoplastic syndrome. Case Presentation: An 86-year-old female was admitted to our hospital due to marked leukocytosis (white blood cells [WBC] >40,000/μL), neutrophilia, and monocytosis. She was afebrile and reported hoarseness and mild difficulty swallowing. Upon physical examination, lung auscultation revealed inspiratory wheezing and a non-tender mass was observed in the anterior midline of the neck. Blasts and immature WBC were not found, and polymerase chain reaction for the detection of BCR/ABL gene was negative. A mass (5.4 cm in diameter) of abnormal parenchymal composition with calcifications occupying the right lobe, was seen on thyroid ultrasound. Cytology, after fine-needle aspiration, showed an anaplastic thyroid carcinoma (ATC). The cervical and chest computed tomography scan revealed a low-density lesion with calcifications that shifts and presses the trachea and multiple lung nodular lesions bilaterally. Since the case was inoperable and the airway was severely obstructed, a DUMON stent was placed. Biopsy of specimens from the trachea lesion revealed a tumor with significant atypical cells and focal squamoid features. The patient's WBC increased to 72,470/μL. Additionally, interleukin-6 (IL-6) was markedly elevated (20.2 pg/mL). The patient passed away due to respiratory arrest 55 days after her initial admission. Discussion: Excessive leukocytosis in a patient, having excluded infectious disease and myelodysplastic syndrome, could represent a manifestation of a paraneoplastic syndrome due to various cytokines secretion from the tumor. In our case, ATC synthesized and secreted IL-6, which seems to be the cause of severe leukocytosis. © 2020 European Thyroid Association Published by S. Karger AG, Basel.

Recent decentralization of electricity systems together with the decarbonization and several changing societal demands are giving rise to different application scenarios such as microgrids. A microgrid is a small-scale electrical system which consists of several loads and sources (conventional and renewables) that can either operate autonomously in a stand-alone mode or interconnected with the main grid. The design and development of such a smart microgrid in a university campus is proposed within the 3DMicroGrid project (funded through the ERANETMED European Union’s initiative). This paper reviews the main components and characteristics of similar microgrids developed around the world. Furthermore, this study provides the design guidelines, the main functionalities, the key components and the control architecture for developing the microgrid proposed by the 3DMicroGrid project. A simulation model has been developed and initial results are demonstrated for the operation of this microgrid. The recommendations and insights are replicable to any solar priority country for future microgrids pilots.

Background: limited data exist on transitioning patients with psoriasis from conventional systemic agents to biologics. Objectives: the TRANSIT study aimed to assess the efficacy and safety of two methotrexate-to-ustekinumab transition strategies. Methods: patients with moderate-to-severe psoriasis and inadequate methotrexate response were randomized 1 : 1 to receive ustekinumab with immediate (arm 1) or 4-week gradual (arm 2) methotrexate withdrawal. Patients weighing ≤ 100 kg or > 100 kg received ustekinumab 45 mg or 90 mg, respectively. The primary endpoint was the frequency of adverse events (AEs) at week 12. Secondary endpoints included additional safety, efficacy and patient-reported outcomes. We report the 12-week efficacy and safety results. Results: overall, 244 patients in arm 1 and 245 in arm 2 were randomized and received ustekinumab. Four patients per arm discontinued the trial by week 12. At week 12 in arms 1 and 2, respectively, 61% and 65% of patients experienced an AE, 2·9% and 2·4% had a serious AE, and 1·2% and 0·4% had an AE leading to ustekinumab discontinuation. In arms 1 and 2, respectively, median Psoriasis Area and Severity Index (PASI) score decreased from 15·2 and 15·4 at baseline to 2·9 and 2·8 at week 12; 58% and 62% of patients achieved a 75% reduction from baseline in PASI score (PASI 75) at week 12; median baseline Dermatology Life Quality Index fell from 8 and 9 at baseline to 1 (both arms) at week 16. Conclusions: ustekinumab was well tolerated and effective in patients who had an inadequate response to methotrexate. Both transition strategies resulted in similar week 12 safety and efficacy outcomes.

Background: There are limited long-term, ‘real-world’ data on ustekinumab, or the effect of dose adjustment in suboptimal responders. Objectives: We describe 52-week data from TRANSIT, which initiated ustekinumab by licensed regimen and investigated exploratory dose adjustment. Methods: Patients with moderate-to-severe psoriasis and inadequate methotrexate response received ustekinumab, with immediate or gradual methotrexate withdrawal. Outcomes were similar between treatment arms at week 12 (primary endpoint), so week 52 data were pooled. Patients weighing ≤ 100 kg or > 100 kg were administered ustekinumab 45 or 90 mg, respectively. Patients weighing ≤ 100 kg without 75% improvement in Psoriasis Area and Severity Index (PASI 75) response at weeks 28 or 40 received a dose adjustment to 90 mg. The primary analysis used observed data. Results: Overall, 391 and 98 patients received ustekinumab 45 and 90 mg, respectively. Forty-four patients (9%) discontinued before week 52 (0·4% due to adverse events). At week 52 (in the overall population), 369 patients (83%) achieved a PASI score ≤ 5, and 341 patients (77%) achieved PASI 75; the median PASI score decreased from 15 at baseline to 1·8. At weeks 28 and 40, 84 and 31 patients, respectively, did not achieve PASI 75 and received a dose adjustment; by week 52, 35/82 (43%) and 15/31 (48%) of these patients, respectively, achieved PASI 75 (two discontinued between weeks 28 and 40). Conclusions: Ustekinumab showed sustained 1-year efficacy and was well tolerated when initially administered according to label. Adjusting the ustekinumab dose to 90 mg may result in clinically meaningful improvement in response in patients weighing ≤ 100 kg with suboptimal initial response.

BACKGROUND: Systemic corticosteroids have been proposed for numerous indications and there are many claims that corticosteroids can reduce mortality in diverse conditions. METHODS: We performed an umbrella, agenda-wide review of the evidence on systemic corticosteroids and mortality, focusing primarily on large trials (defined as those with > 100 deaths) and meta-analyses. Searches were performed in PubMed and Cochrane Central Register of Controlled Trials (last update February 2011). We also examined whether spurious subset analyses may be responsible for claims of survival benefits in indications where only small trials had been available. RESULTS: Among 257 identified randomized trials with mortality data in their abstract, we found 14 large trials pertaining to 10 different indications. Although 10 of these 14 trials have reported statistically significant survival differences in subset analyses, none shows a nominally statistically significant (P < 0.05) decrease in death risk for any of the tested conditions when all deaths on all randomized patients are analysed. Meta-analyses for these conditions show statistically significant reductions in mortality only with antenatal corticosteroids for preterm labour (relative risk 0.77, 95% CI, 0.67-0.89) and in tuberculous meningitis (relative risk 0.78, 95% CI, 0.67-0.91). For conditions without any large trials, statistically significant reductions in mortality in meta-analyses were noted for Pneumocystis pneumonia (relative risk 0.54, 95% CI, 0.38-0.79) and alcoholic hepatitis (relative risk 0.63, 95% CI, 0.50-0.80). Many small trials that claim significant benefits, even those for classic indications such as typhoid fever and tetanus, have shown these benefits only in subset analyses. CONCLUSIONS: Corticosteroids have been documented to decrease mortality in some indications, in particular, antenatal use for preterm labour, tuberculous meningitis, Pneumocystis pneumonia, and alcoholic hepatitis. Many postulated benefits of corticosteroids on mortality may reflect 'vibration of treatment effects' leading to false-positive claims from spurious subset analyses and even for standard indications, such biases may have inflated the treatment effect estimates. More large trials are needed for serious, common conditions where use of corticosteroids is proposed. Eur J Clin Invest

INTRODUCTION: Black box warnings (BBWs) are the strongest medication-related safety warnings in a drug's labeling information and highlight major risks. Absence of a BBW or asynchronous addition of a BBW among same-class drugs could have major implications. METHODS: We identified the 20 top-selling drugs in 2008 (10 with BBWs and 10 without BBWs on their label) that belonged to different drug classes. We collected labeling information on all drugs belonging in these 20 classes, and recorded differences in the presence and timing of acquisition of BBWs for same-class drugs. RESULTS: Across the 20 evaluated drug classes, we identified 176 different agents, of which 7 had been withdrawn for safety reasons. The reasons for the withdrawals became BBWs in other same-class agents only in two of the seven cases. Differences were identified in 9 of the 20 classes corresponding to 15 BBWs that were not present in all drugs of the same class. The information for 10 of the 15 different BBWs were included in the labels of same-class drugs as simple warnings or text, while it was absent entirely in 5 BBWs. The median interval from the time the BBW had appeared in another drug of the same class was 66 months. DISCUSSION: Differences in BBW labeling in same-class drugs are common and shape impressions about the safety of similar agents. BBW labeling needs to become more systematic. J Gen Intern Med

This is the copy of the book chapter originally published in: Brömme, A., Busch, Ch. (ed.)(2011). Lecture Notes in Informatics, BIOSIG 2011, Proceedings - International Conference of the Biometrics Special Interest Group; 8.-9. September 2011 in Darmstadt. Bonn: Gesellschaft für Informatik. Reprinted with permission from Gesellschaft für Informatik. Increasing Passenger flow at Border Crossing Points is an important issue at today’s border crossing points (BCPs) of land, sea and airport. Group Access Control and utilizing biometrics information will help increase passenger throughput and reduce human error in handling passengers erroneously. Using multi modal information for (biometric) group id can provide more robust handling of passengers. On the other hand, connecting various BCPs will help solve some problems related to illegal entries from non-Schengen to Schengen space, laws and health. This paper presents the first relevant concepts and issues of using (biometric) group idea and connecting BCPs.