Safety of the human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in adolescents aged 12-15 years : Interim analysis of a large community-randomized controlled trial

This community-randomized controlled trial was initiated to assess the overall and herd effects of 2 different human papillomavirus (HPV) immunization strategies in over 80,000 girls and boys aged 1215 y in 33 communities in Finland (ClinicalTrials.gov NCT00534638). Overall, 14,838 adolescents received HPV-16/18 vaccine (2,440 boys and 12,398 girls) and 17,338 received hepatitis-B virus (HBV) vaccine {9,221 boys and 8,117 girls). In an interim analysis, vaccine safety was assessed by active monitoring and surveillancece via health registry linkage. Active monitoring showed that the HPV-16/18 vaccine has acceptable safety and reactogenicity in boys. In all study participants, the observed incidences (per 100,000 person-years) of serious adverse events (SAEs) possibly, related to vaccination were 54.3 (95% Confidence Interval [CI]: 34.0-82.1) in the HPV-16/18 group and 64.0 (95% CI: 43.2-91.3) in the HBV group. During the follow-up period for this interim analysis, the most common new-onset autoimmune diseases (NOADs; with incidence rate >= 15 per 100,000) in any group based on hospital discharge registry (HILMO) download were ulcerative colitis, juvenile arthritis, celiac disease insulin-dependent diabetes mellitus (IDDM) and Crohn's disease. No increased NOAD incidences were observed in HPV-16/18 vaccine recipients compared to HBV vaccine recipients. In both the SAE possibly related- and HILMO-analyses, a lower incidence of IDDM was observed in HPV-16/18 vaccinees compared to HBV vaccinees (relative risks, 0.26 [95% CI: 0.03-1.24] and 0.16 [95% CI: 0.03-0.55], respectively).Peer reviewe

Risk of spontaneous abortion and other pregnancy outcomes in 15–25 year old women exposed to human papillomavirus-16/18 AS04-adjuvanted vaccine in the United Kingdom

AbstractBackgroundWe assessed the risk of spontaneous abortion (SA) after inadvertent exposure to HPV-16/18-vaccine during pregnancy using an observational cohort design.MethodsThe study population included women aged 15–25 years registered with the Clinical Practice Research Datalink General Practice OnLine Database in the United Kingdom (UK), who received at least one HPV-16/18-vaccine dose between 1st September 2008 and 30th June 2011. Exposed women had the first day of gestation between 30 days before and 45 days (90 days for the extended exposure period) after any HPV-16/18-vaccine dose. Non-exposed women had the first day of gestation 120 days–18 months after the last dose. SA defined as foetal loss between weeks 1 and 23 of gestation (UK definition).ResultsThe frequency of SA was 11.6% (among 207 exposed) and 9.0% (632 non-exposed), women: hazard ratio (HR) adjusted for age at first day of gestation 1.30 (95% confidence interval: 0.79–2.12). Sensitivity analysis per number of doses administered (−30 to +45-day risk period) showed a HR for SA of 1.11 (0.64–1.91) for 18/178 women with one dose during the risk period versus 2.55 (1.09–5.93) in 6/29 women with two doses within a 4–5 weeks period. The proportion of pre-term/full-term/postterm deliveries, small/large for gestational age infants, and birth defects was not significantly different between exposed and non-exposed women. Results were consistent using a (United States) SA definition of foetal loss between weeks 1–19 and/or the extended risk period.ConclusionThere was no evidence of an increased risk of SA and other adverse pregnancy outcomes in young women inadvertently HPV-16/18-vaccinated around gestation. Nevertheless, women who are pregnant or trying to become pregnant are advised to postpone vaccination until completion of pregnancy

Quantitative analysis of CT-perfusion parameters in the evaluation of brain gliomas and metastases

<p>Abstract</p> <p>Background</p> <p>The paper reports a quantitative analysis of the perfusion maps of 22 patients, affected by gliomas or by metastasis, with the aim of characterizing the malignant tissue with respect to the normal tissue. The gold standard was obtained by histological exam or nuclear medicine techniques. The perfusion scan provided 11 parametric maps, including Cerebral Blood Volume (CBV), Cerebral Blood Flow (CBF), Average Perfusion (P_mean) and Permeability-surface area product (PS).</p> <p>Methods</p> <p>The perfusion scans were performed after the injection of 40 ml of non-ionic contrast agent, at an injection rate of 8 ml/s, and a 40 s cine scan with 1 s interval was acquired. An expert radiologist outlined the region of interest (ROI) on the unenhanced CT scan, by using a home-made routine. The mean values with their standard deviations inside the outlined ROIs and the contralateral ROIs were calculated on each map. Statistical analyses were used to investigate significant differences between diseased and normal regions. Receiving Operating Characteristic (ROC) curves were also generated.</p> <p>Results</p> <p>Tumors are characterized by higher values of all the perfusion parameters, but after the statistical analysis, only the <it>PS</it>, <it>Pat</it>_{<it>Rsq </it>}(Patlak Rsquare) and <it>T</it>_{<it>peak </it>}(Time to Peak) resulted significant. ROC curves, confirmed both <it>Pat</it>_{<it>Rsq </it>}and <it>PS </it>as equally reliable metrics for discriminating between malignant and normal tissues, with areas under curves (AUCs) of 0.82 and 0.81, respectively.</p> <p>Conclusion</p> <p>CT perfusion is a useful and non invasive technique for evaluating brain neoplasms. Malignant and normal tissues can be accurately differentiated using perfusion map, with the aim of performing tumor diagnosis and grading, and follow-up analysis.</p

Energia renovável e impactos ambientais: construindo conhecimento sobre energia eólica com os estudantes do Ensino Médio em uma disciplina eletiva: Renewable energy and environmental impacts: building knowledge about wind energy with high School Students in an elective subject

O presente artigo apresenta uma fonte de energia renovável, a energia eólica, considerada um tipo de energia alternativa que atende as demandas da sociedade, garantindo uma produção de qualidade, assim como, uma redução aos impactos socioambientais decorrentes da geração e o consumo de eletricidade. A energia eólica aborda conceitos físicos relacionados à aplicação de energia cinética dos ventos no aproveitamento para geração de energia elétrica. As energias renováveis, em geral, vêm cada vez mais sendo utilizada pela sociedade em todo o mundo, deste modo, esta fonte de energia alternativa cresce constantemente devido a sua importância na contribuição de geração de energia limpa inesgotável. Assim, com o intuito de contribuir com o debate sobre esta temática, o trabalho desenvolvido teve o objetivo de apresentar o uso da energia eólica e seu potencial energético, explicando todo processo de distribuição e geração de eletricidade através de uma maquete que foi dimensionada, construída e apresentada pelos alunos de uma disciplina eletiva em Centro Educa Mais, escola de tempo integral. Trata-se de uma pesquisa descritiva, de natureza qualitativa, acerca do projeto desenvolvido em uma disciplina eletiva, realizada com os alunos do ensino médio, mais precisamente com as 1ª e 2ª séries, trabalhando a abordagem e o universo de significados que busca explicar a dinâmica das relações sociais e as percepções dos sujeitos e da situação investigada. Considerando o maior número de informações, tornando explícito o assunto investigado, foi aplicado à luz da Teoria da Aprendizagem Significativa de Ausubel (1963), Metodologia Ativa, com o aluno sendo o centro do objeto do processo de ensino-aprendizagem, aprendendo a fazer fazendo, protagonistas e autônomos com a consolidação do processo de conscientização de uma sociedade sustentável

Novel multicomponent organic-inorganic WPI/gelatin/CaP hydrogel composites for bone tissue engineering

The present work focuses on the development of novel multicomponent organic‐inorganic hydrogel composites for bone tissue engineering. For the first time, combination of the organic components commonly used in food industry, namely whey protein isolate (WPI) and gelatin from bovine skin, as well as inorganic material commonly used as a major component of hydraulic bone cements, namely α‐TCP in various concentrations (0‐70 wt.%) was proposed. The results showed that α‐TCP underwent incomplete transformation to calcium‐deficient hydroxyapatite (CDHA) during preparation process of the hydrogels. Microcomputer tomography showed inhomogeneous distribution of the calcium phosphate (CaP) phase in the resulting composites. Nevertheless, hydrogels containing 30‐70 wt.% α‐TCP showed significantly improved mechanical properties. The values of Young's modulus and the stresses corresponding to compression of a sample by 50% increased almost linearly with increasing concentration of ceramic phase. Incomplete transformation of α‐TCP to CDHA during preparation process of composites provides them high reactivity in simulated body fluid during 14‐day incubation. Preliminary in vitro studies revealed that the WPI/gelatin/CaP composite hydrogels support the adhesion, spreading, and proliferation of human osteoblast‐like MG‐63 cells. The WPI/gelatin/CaP composite hydrogels obtained in this work showed great potential for the use in bone tissue engineering and regenerative medicine applications

A pragmatic approach to the use of inotropes for the management of acute and advanced heart failure: An expert panel consensus

Inotropes aim at increasing cardiac output by enhancing cardiac contractility. They constitute the third pharmacological pillar in the treatment of patients with decompensated heart failure, the other two being diuretics and vasodilators. Three classes of parenterally administered inotropes are currently indicated for decompensated heart failure, (i) the beta adrenergic agonists, including dopamine and dobutamine and also the catecholamines epinephrine and norepinephrine, (ii) the phosphodiesterase III inhibitor milrinone and (iii) the calcium sensitizer levosimendan. These three families of drugs share some pharmacologic traits, but differ profoundly in many of their pleiotropic effects. Identifying the patients in need of inotropic support and selecting the proper inotrope in each case remain challenging. The present consensus, derived by a panel meeting of experts from 21 countries, aims at addressing this very issue in the setting of both acute and advanced heart failure. (C) 2019 The Authors. Published by Elsevier B.V.Peer reviewe

Ladislao Mittner e la fondazione della germanistica a Ca' Foscari

In the form of a personal memoir, this essay outlines the work of the distinguished scholar Ladislao Mittner (1902-75) and the development of German studies at the University of Venice in the second half of the 20th century. Mittner arrived at Ca' Foscari in 1942 and took charge of German studies in the first Italian Faculty of Foreign Languages and Literatures (established in 1954), and became a point of reference for over thirty years. During these years, he decisively shaped the guidelines of the discipline at Ca' Foscari. Due to his own plurilingual Hapsburg roots, he considered a good command of languages pivotal. This is why he can also be considered a pioneer of the establishment of German language teaching as an independent subject from literature, which was not a self-evident truth at the time. However, he also underlined the importance of the literary text through very refined critical tools. He was an acute philologist and a broad-minded historian who, from the very beginning, added to the German courses such subjects as Germanic Philology, History of the German Language, Philosophy and Music of the German-speaking countries, transforming German studies in Italy into a modern and open-minded field of studies, far from just technical knowledge. From the beginning his vision of the German world was in a context of comparative cultures. Mittner's work provided the firm basis for the educational commitment required to meet the daily challenge of a multicultural Europe

Guest Molecule-Responsive Functional Calcium Phosphonate Frameworks for Tuned Proton Conductivity

We report the synthesis, structural characterization, and functionality of an open-framework hybrid that combines Ca2+ ions and the rigid polyfunctional ligand 5-(dihydroxyphosphoryl) isophthalic acid (PiPhtA). Ca-PiPhtA-I is obtained by slow crystallization at ambient conditions from acidic (pH≈3) aqueous solutions. It possesses a high water content (both Ca coordinated and in the lattice), and importantly, it exhibits water-filled 1D channels. At 75 °C, Ca-PiPhtA-I is partially dehydrated and exhibits a crystalline diffraction pattern that can be indexed in a monoclinic cell with parameters close to the pristine phase. Rietveld refinement was carried out for the sample heated at 75 °C, Ca-PiPhtA-II, using synchrotron powder X-ray diffraction data.All connectivity modes of the “parent” Ca-PiPhtA-I framework are retained in Ca-PiPhtA-II. Upon Ca-PiPhtA-I exposure to ammonia vapors (28% aqueous NH3) a new derivative is obtained (Ca-PiPhtA-NH3) containing 7 NH3 and 16 H2O molecules according to elemental and thermal analyses. Ca-PiPhtA-NH3 exhibits a complex X-ray diffraction pattern with peaks at 15.3 and 13.0 Å that suggest partial breaking and transformation of the parent pillared structure. Although detailed structural identification of Ca-PiPhtA-NH3 was not possible, due in part to nonequilibrium adsorption conditions and the lack of crystallinity, FT-IR spectra and DTA-TG analysis indicate profound structural changes compared to the pristine Ca-PiPhtA-I. At 98% RH and T = 24 °C, proton conductivity, σ, for Ca PiPhtA-I is 5.7 ×10−4 S·cm−1. It increases to 1.3 × 10−3 S·cm−1 upon activation by preheating the sample at 40 °C for 2 h followed by water equilibration at room temperature under controlled conditions. Ca-PiPhtA-NH3 exhibits the highest proton conductivity, 6.6 × 10−3 S·cm−1, measured at 98% RH and T = 24 °C. Ea for proton transfer in the above-mentioned frameworks range between 0.23 and 0.4 eV, typical of a Grothuss mechanism of proton conduction.Proyecto nacional MAT2010-1517

Photography-based taxonomy is inadequate, unnecessary, and potentially harmful for biological sciences

The question whether taxonomic descriptions naming new animal species without type specimen(s) deposited in collections should be accepted for publication by scientific journals and allowed by the Code has already been discussed in Zootaxa (Dubois & Nemésio 2007; Donegan 2008, 2009; Nemésio 2009a–b; Dubois 2009; Gentile & Snell 2009; Minelli 2009; Cianferoni & Bartolozzi 2016; Amorim et al. 2016). This question was again raised in a letter supported by 35 signatories published in the journal Nature (Pape et al. 2016) on 15 September 2016. On 25 September 2016, the following rebuttal (strictly limited to 300 words as per the editorial rules of Nature) was submitted to Nature, which on 18 October 2016 refused to publish it. As we think this problem is a very important one for zoological taxonomy, this text is published here exactly as submitted to Nature, followed by the list of the 493 taxonomists and collection-based researchers who signed it in the short time span from 20 September to 6 October 2016

Criminal Medical Experiments on the Skeletal System of the Lower Limbs Conducted on Polish Women – the Prisoners of Ravensbrück Concentration Camp and Their Consequences for the Quality of Life, Health and Later Functioning of the Patients Operated

Artykuł interdycyplinarnie przedstawia eksperymenty prowadzone przez niemieckich lekarzy w KL Ravensbrück na Polkach i ich wpływ na losy operowanych. Omówiono eksperymenty na kończynach dolnych: czyste kostne i septyczno-kostne. W oparciu o materiał dowodowy, ekspertyzy lekarskie i wspomnienia operowanych przedstawiono przebieg operacji i ich następstwa. Po wojnie eksperymenty te uznano za zbrodnie wojenne i przeciwko ludzkości. W zależności od stopnia okaleczenia podczas operacji oraz braku opieki pooperacyjnej i rehabilitacji, stresu wojennego, złych warunków obozowych u operowanych wystąpiło pogorszenie stanu zdrowia. Autorzy uznali doświadczenia za zbrodnicze eksperymenty medyczne. Dokonywali ich lekarze, ale z pogwałceniem etyki lekarskiej. Przeprowadzano je na zdrowych kobietach. Na skutek doświadczeń dochodziło do upośledzenia sprawności fizycznej, co prowadziło nawet do kalectwa. Ponadto wystąpił silny zespół stresu pourazowego, na który nałożyła się trauma poboozowa i krzywda związana z eksperymentami. Z racji dolegliwości chorobowych część kobiet została wyłączona z ról społecznych