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Non stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. This was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. A total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. The novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up. • DCB may be preferable when PCI with a stent is not desirable, such as for in-stent restenosis, side branch and small vessels • Sirolimus DCB may be a safe and effective alternative for the treatment of de novo and restenotic coronary lesions • New drug-release technology for DCB with microsphere-based drug release offers a more robust and controlled drug delivery [ABSTRACT FROM AUTHOR]

Objectives: Exertional-heat stress generates a thermoregulatory strain that exacerbates splanchnic hypoperfusion and sympathetic drive, but the effects on gastrointestinal function are poorly defined. The study aimed to determine the effects of exertional-heat stress on gastric myoelectrical activity, orocecal transit time (OCTT), and gastrointestinal symptoms (GIS).Design: Randomised cross-over study.Methods: Endurance runners (n = 16) completed 2 h of running at 60 % V̇O2max in 35 °C (HOT) and 22 °C (TEMP) ambient conditions. Surface electrogastrography (cEGG) was recorded pre- and post-exercise to determine gastric myoelectrical activity, a lactulose challenge was used to determine OCTT, and GIS were recorded using a modified visual analogue scale tool.Results: Post-exercise Tre [HOT:38.8(38.5 to 39.0)°C and TEMP:38.1(37.8 to 38.4)°C] and Δ Tre [HOT:2.2(2.0 to 2.4)°C and TEMP:1.5(1.2 to 1.8)°C] was higher on HOT compared to TEMP (p < 0.001). Normal gastric myoelectrical cycle frequency reduced (p = 0.010) on HOT [-11.7(-20.8 to -2.6)%], but this decrease did not differ (p = 0.058) from TEMP [-2.7(-8.3 to 3.0)%]. Bradygastria increased post-exercise on both trials (HOT:11.3(2.3 to 20.4)%, p = 0.030; and TEMP:7.4(2.1 to 12.6)%, p = 0.009). OCTT did not differ between trials (p = 0.864) with transit response classified as very slow on both HOT (99(68 to 131)min) and TEMP (98(74 to 121)min). GIS incidence was higher on HOT (88 %) compared to TEMP (81 %), in accordance with greater total-GIS and upper-GIS severity (p = 0.005 and p = 0.033, respectively).Conclusions: Running for 2 h at 60 % V̇O2max in either hot or temperate ambient conditions instigates perturbations in myoelectrical activity and OCTT, with GIS incidence and severity greater in hot conditions. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to determine the impact of running and cycling exercise modalities on the magnitude of exercise-induced gastrointestinal syndrome (EIGS) and associated gastrointestinal symptoms (GIS).Design: Parallel group trial design.Methods: Twenty-eight endurance athletes (male n = 14, female n = 14) completed 2 h running at 55 % of maximal oxygen uptake or cycling at 55 % of maximal aerobic power in Tamb 35 °C and 22 % RH. Pre- and post-exercise blood samples were collected and analysed for markers of intestinal epithelial integrity perturbations (i.e., plasma intestinal fatty acid protein (I-FABP), soluble (s)CD14, and lipopolysaccharide binding protein (LBP)) and systemic inflammatory cytokines (i.e., plasma IL-1β, TNFα, IL-10, and IL-1ra). GIS were assessed pre-exercise and every 10 min during exercise.Results: Exercise-associated Δ for plasma I-FABP (191 and 434 pg‧ml-1) and LBP (-1228 and 315 ng‧ml-1) did not differ between running and cycling, respectively; however for sCD14 was higher (p = 0.030) on cycling (116 ng‧ml-1) vs running (96 ng‧ml-1). There were no differences in absolute pre- and post-exercise systemic inflammatory cytokine concentration, with large individual variation observed. Exercise-associated plasma TNF-α, (p = 0.041) and IL-10 (p = 0.019) responses were greater in running than cycling, but did not lead to a greater systemic inflammatory response profile (p = 0.305) between running (5.0arb.units) and cycling (-2.5arb.units). Although greater GIS incidence occurred in running (44 %) compared with cycling (25 %), there was no difference between groups for GIS severity.Conclusions: When running and cycling exercise is performed with similar duration, intensity, ambient conditions, and with confounder control, the exercise modality does not substantially impact the magnitude of EIGS or associated GIS severity. [ABSTRACT FROM AUTHOR]

No studies have been conducted to analyze the impact of serum uric acid (UA) levels on the outcome of atrial fibrillation (AF) patients. We aimed to evaluate the effect of hyperuricemia (HU) on the prognosis of AF. Consecutive patients who consulted our emergency room for an episode of AF, already known or newly diagnosed, between January 1, 2010, and December 31, 2015 (n=2017) were enrolled. After applying exclusion criteria, 1772 patients were included. Serum UA levels in the 6 months before or after the date of the episode were recorded and classified into quartiles: Q1 (n=443) serum UA levels <4.6 mg/dL; Q2 (n=430) 4.6-5.6 mg/dL; Q3 (n=435) 5.7-6.9 mg/dL; and Q4 (n=464) ≥7 mg/dL. Two groups were differentiated: patients without HU (Q1-Q3) and those with HU (Q4). The mean follow-up was 3.7 ± 1.4 years. The primary endpoint was all-cause mortality during follow-up. Mortality during follow-up in the bivariate analysis was higher (p < 0.001) in patients with HU (52.1 %) compared to those without it (35.3 %), confirming multivariate Cox analysis of HU as an independent risk factor for death [hazard ratio 1.89 (1.59-2.25)]. Kaplan-Meier survival analysis showed a shorter survival time in patients with HU (log-rank test, p<0.001). Cox analysis confirmed significant differences in the risk of heart failure (30 % vs. 22 %) in patients with HU. HU is independently associated with an increased risk for all-cause mortality and hospitalization for heart failure in patients with AF. [ABSTRACT FROM AUTHOR]

This paper presents the development, implementation, and validation of a macro-element suitable for the linear analysis of innovative 3D plug-and-play joints between tubular columns and lightweight steel truss-girders. The macro-element is based on the component method, accounts for the three-dimensional interaction between the tube faces, and its components have a clear physical meaning. Simplified procedures are developed for the closed-form computation of the stiffness matrix of the macro-element based on the geometric and mechanical properties of the nodal zone. This facilitates practical application in everyday design scenarios. Furthermore, the macro-element's architecture is implemented in the framework of OpenSees as a standalone beam-to-column joint finite element. Validation of the conceptual design is accomplished through parametric studies, comparing its performance with models generated in higher-order finite element commercial software, Abaqus. This research offers a valuable resource for the linear analysis and design of innovative 3D plug-and-play joint connections in structural engineering, enhancing efficiency and reliability in construction practices. • Created a macro-element for linear analysis of innovative plug-and-play steel joints. • Accounted for 3D tube face interactions in component-based macro-element design. • Implemented the macro-element as a stand-alone beam-to-column joint FE in a software. • Validated the beam-to-column joint FE against higher-order FE models. [ABSTRACT FROM AUTHOR]

Objective: To evaluate whether circulating cardiac troponin I (cTnI) levels are associated with worst outcomes in patients with atrial fibrillation (AF).Methods: Consecutive patients visiting the emergency room (ER) with a new episode of a previously diagnosed AF or a new diagnosis of AF during ER admission between January 1st, 2010 and December 31st, 2015, were enrolled in the study (n = 2617). After applying exclusion criteria and eliminating repeated episodes, 2013 patients were finally included. Of these, 1080 patients with at least one cTnI measurement in the ER were selected and classified into 4 groups according to cTnI quartiles: Q1 (n = 147) cTnI <10 ng/L (Group 1); Q2 (n = 254): 10-19 ng/L (Group 2); Q3 (n = 409): 20-40 ng/L (Group 3); and Q4 (n = 270): cTnI >40 ng/L (Group 4). The median follow-up period was 47.8 ± 32.8 months. The primary endpoint was all-cause death during the follow-up.Results: A higher mortality was found in group 4 compared with the other groups (58.9% vs. 28.5%, respectively, p < 0.001), along with, hospitalizations (40.4% vs. 30.7%, p = 0.004), and readmissions due to decompensated heart failure (26.7% vs. 2.5%, p = 0.002). The probability of survival without AF recurrences was lower in the Q4 (p = 0.045). Moreover, cTnI levels >40 ng/L (Q4) were an independent risk factor of death (HR, 2.03; 95% CI, 1.64-2.51; p < 0.001).Conclusion: The assessment of cTnI at ER admission could be a useful strategy for risk stratification of patients diagnosed with AF by identifying a subgroup with medium-term to long-term increased risk of adverse events and mortality. [ABSTRACT FROM AUTHOR]

Objectives: The study aimed to examine if the α-diversity and relative abundance of the gastrointestinal bacterial taxa is associated with the response magnitude of markers characteristic of exercise-induced gastrointestinal syndrome in response to exertional-heat stress.Design: Cross-sectional.Methods: Twenty-two endurance-trained athletes completed 2h running at 60% V.O2max in hot ambient conditions (35.2°C, 25% relative humidity). Faecal samples were collected pre-exercise to determine bacterial taxonomy by 16S rRNA amplicon sequencing (Illumina MiSeq platform). Data were processed using the QIIME2 pipeline (v2019.1) establishing taxonomic classification with >95% confidence using SILVA. Pre- and post-exercise blood samples were used to determine plasma I-FABP and cortisol concentrations, and systemic inflammatory response profile. Markers of physiological and thermoregulatory strain, and gastrointestinal symptoms were measured every 10min during exercise. Associations were determined by partial correlation controlled for body mass variables.Results: Positive associations between Tenericutes (r(18)=0.446, p=0.049) and Verrucomicrobia (r(18)=0.450, p=0.046) phylum, Akkermansiaceae (r(18)=0.486, p=0.030) and Ruminococcaceae (r(18)=0.449, p=0.047) family and aligned genus groups with I-FABP were observed. Whilst, associations between Faecalibacterium (r(12)=0.668, p=0.009) and Ruminoclostridium-9 (r(12)=-0.577, p=0.031) genus with systemic inflammatory profile were observed. Association between bacterial phyla, family, and genus groups were also observed for gastrointestinal symptoms and markers of thermoregulatory strain (r(18) >0.400, p<0.05).Conclusions: The relative abundance of several commensal bacterial groups showed modest favourable (i.e., low perturbations) or detrimental associations with the magnitude of gastrointestinal integrity perturbations and symptoms, and potentially influences body temperature change, in response to exertional-heat stress. [ABSTRACT FROM AUTHOR]

• A mixed model was built to assess the effect of liver fluke on carcass weight of cattle. • The carcass weight of non-infected cattle is higher than that of infected cattle. • Differences in carcass weights were observed mostly at younger ages (up to 30 months). • The difference observed in the 23–30 month age range was estimated as 6.34 kg. • Carcasses with liver fluke also had worse conformation scores and poorer fat scores. Although fasciolosis is a relatively common disease, the productive and economic losses resulting from cattle with chronic fasciolosis are unclear. This paper aims to investigate the effect of fasciolosis on the parameters of carcass quality and discuss the hypothesis that the effects on weight differ among age ranges of cattle. For this, we analysed abattoir data of 30,151 bovines, from 928 farms, slaughtered in Uruguay in 2016, of which 33.9% (95% confidence interval (CI): 27.3–41.1%) had Fasciola hepatica (liver fluke). A mixed model was built to assess whether the effect of fasciolosis on weight differs depending on the age range, using the interaction term 'age* F. hepatica '. The effect on the carcass parameters was tested using a proportional logistic regression. The interaction of age and F. hepatica was statistically significant (P < 0.001). Differences in carcass weights between infected and non-infected animals were observed mostly at younger ages (up to 30 months), with the highest difference observed in the 23–30 months age range (estimated marginal mean difference of 6.34 kg). Overall, the presence of F. hepatica was positively associated with poor conformations and lower fat scores of carcasses (P < 0.001). The carcasses of cattle infected with F. hepatica had 0.16 times greater odds of having worse conformation scores than carcasses of cattle without F. hepatica (proportional odds ratio (POR) = 1.16; 95% CI: 1.07–1.26). Similarly, carcasses of cattle with F. hepatica had 0.30 times (POR = 1.30, 95% CI: 1.23–1.39) greater odds of having poorer fat scores than carcasses of cattle without F. hepatica. Therefore, infection with F. hepatica is associated with poorer carcass quality parameters and lower weights, and the effect on weight differs across age ranges. [ABSTRACT FROM AUTHOR]

A detailed delineation of flood-prone areas over large regions represents a challenge that cannot be easily solved with today's resources. The main limitations lie in algorithms and hardware, but also costs, scarcity and sparsity of data and our incomplete knowledge of how inundation events occur in different river floodplains. We showcase the implementation of a data-driven web application for regional analyses and detailed (i.e., tens of meters) mapping of floodplains, based on (a) the synthesis of hydrogeomorphic features into a morphological descriptor and (b) its classification to delineate flood-prone areas. We analysed the skill of the descriptor and the performance of the mapping method for European rivers. The web application can be effectively used for delineating flood-prone areas, reproducing the reference flood maps with a classification skill of 88.59% for the 270 major river basins analysed across Europe and 84.23% for the 64 sub-catchments of the Po River. • Progress in hydrogeomorphic flood hazard mapping is presented. • A cloud-based web application for data-driven hydrogeomorphic flood hazard mapping is implemented. • The GFI classifier displayed strong discerning capabilities for mapping flood-prone areas in Europe. • Flood-prone areas for the whole Europe are computed and evaluated for different return periods using the proposed web application. [ABSTRACT FROM AUTHOR]

The reliable estimation of the cyclic behaviour of steel beam-to-column joints is essential for the safe design of steel structures under seismic loading. The T-stub is an essential component in steel beam-to-column joints. This paper presents the framework and implementation of a decoupled component model for the T-stub under cyclic loading. This decoupled model splits the single hysteretic spring representation of the T-stub into two separate hysteretic springs, one representing the quadrant where tensile forces are present and the other the quadrant with compressive forces. The results indicate that because of the degradation of the response of the T-stub with multiple loading cycles, the equivalence between the single spring model, and the decoupled double spring model is not trivial. Exact equivalence rules are proposed for the definition of the properties of the decoupled model. The accuracy of the model is validated by comparison with experimental test results. The decoupled model overcomes the problem of using a single spring to represent the T-stub in a steel joint that is not able to lead to correct results because it is unable to mobilize compressive forces in the T-stub as it occurs. • Development of a decoupled component model for T-stub under cyclic loading. • Demonstration of the error of using a coupled T-stub model. • The shape of the hysteretic curve is analysed qualitatively. • Decoupling the tension-compression cyclic behaviour is feasible. [ABSTRACT FROM AUTHOR]

Highlights • 3D experimental assessment of the behaviour of steel beam-to-column joints. • Assessment of interactions between a major and one and two minor axis joints. • Assessment of interactions between two minor axis joints. Abstract This work presents the experimental assessment of the joint behaviour of five steel beam-to-column end-plate joint configurations to assess (i) the effect of minor axis end plate joints in the behaviour of major axis end plate joints, and (ii) the interaction of two minor axis end plate joints. The experimental tests were performed with true size cruciform sub-frames specimens with boundary conditions intended to simulate unbraced frames. The sub-fames, with one to three beams, were loaded introducing multiple 3D stress states in the column unstiffened web, causing an interaction between the mechanical behaviour of two or three major and minor axis joints. The interactions were assessed in terms of the moment-rotation relations of joints, connections and column web. It was found that, for the slenderness of the column web tested, (i) the minor-axis joints have only a relevant influence on the stiffnesses of the major-axis joints and (ii) that, when two minor axis joints are present, their mutual interation increases both their stiffness and strength. [ABSTRACT FROM AUTHOR]

Abstract In this study, ent -kaurenoic acid derivatives were obtained by microbial transformation methodologies and tested against breast cancer cell lines (MCF-7). A multivariate quantitative-structure activity relationship (QSAR) analysis was performed taking into account both microbial transformation derivatives and other analogues previously reported in literature to give some insight into the main features behind the cytotoxic activity displayed by kaurane-type diterpenes against MCF-7 cells. The partial least square regression (PLS) method was employed in the training set and the best PLS model was built with a factor describing 69.92% of variance and three descriptors (log P , ε HOMO and ε HOMO–1) selected by the Ordered Predictors Selection (OPS) algorithm. The QSAR model provided reasonable regression (Q 2 = 0.64, R 2 = 0.72, SEC = 0.29 and SEV = 0.33). The model was validated by leave- N -out cross-validation, y-randomization and external validation (R 2 pred = 0.89 and SEP = 0.27). The selected descriptors indicated that the activity was mainly related to electronic parameters (HOMO and HOMO-1 molecular orbital energies), as well as to log P. These findings suggest that higher activity values are directly related with both higher log P and frontier orbital energy values. The positive relationship between these orbitals and the activity suggests that the ent -kaurenoic acid analogues interaction with the target involves charge displacement, which is entirely consistent with the literature. Based on these findings, three compounds were proposed and one of them was synthesized and tested. The experimental result confirmed the activity predicted by the model. Graphical abstract According to QSAR analysis, the activity of kaurenoic acid derivatives against MCF-7 breast cancer cells is related to the log P and to the energies of the HOMO and HOMO–1. Image 1 Highlights • Kaurenoic acid derivatives interact with MCF7 cells by charge transfer mechanism. • Higher activity against MCF-7 cells is related with both log P and frontier orbitals. • Kaurenoic acid derivatives were proposed to be synthetized based on the QSAR model. [ABSTRACT FROM AUTHOR]

Abstract Genipa americana L., commonly known as genipap, is a plant with economical and medicinal importance, and a promising source of bioactive compounds. Lectins are carbohydrate-binding proteins with several biotechnological applications. This study reports the isolation and characterization of a G. americana bark lectin (GaBL). A single chromatographic procedure on Sephacryl S-100 resulted in isolation of GaBL, a protein with native molecular weight of over 200 kDa and pI 4.02, whose hemagglutinating activity was inhibited by lactose and fetuin, not affected by ions (Ca2+ and Mg2+), and stable upon heating (303–393 K) as well as over the pH range 5–10. The highest activity was found at a temperature lower than 333 K and pH 5. The secondary structure was analyzed by circular dichroism and showed a prevalence of beta structures and unordered forms. GaBL was able to partially refold in acidic pH conditions when dissolved in PBS buffer at pH 7.4. In conclusion, GaBL was purified in milligram quantities with high stability against different conditions, and is a new biomaterial with potential biotechnological applications. [ABSTRACT FROM AUTHOR]

Objectives: The study aimed to determine the effects of temperature of ingested water during exertional-heat stress on gastrointestinal injury, symptoms and systemic inflammatory responses.Design: Randomised cross-over study.Methods: Twelve endurance runners completed 2h running at 60% v˙O2max in 35°C ambient temperature on three separate occasions, consuming 250±40mL water before and every 15min during running at either 0.4±0.4°C (COLD), 7.3±0.8°C (COOL), or 22.1±1.2°C (TEMP). Rectal temperature and gastrointestinal symptoms were recorded every 10min during exercise. Blood was collected pre, immediately and 1h post-exercise to determine plasma intestinal fatty-acid binding protein (I-FABP), cortisol, and inflammatory cytokine concentrations.Results: Compared to TEMP, COLD and COOL blunted the rise in rectal temperature (2.0±0.5°C vs. 1.6±0.4°C and 1.7±0.4°C, respectively; trial×time, p=0.033). I-FABP increased post-exercise (419%, p<0.001), with a trend for reduced I-FABP on COLD and COOL (mean reduction 460pgmL-1 and 430pgmL-1, respectively), compared to TEMP (p=0.066). No differences were observed between trials for gastrointestinal symptoms, albeit a trend for increased upper-gastrointestinal symptoms on TEMP (p=0.087) compared to COLD and COOL was observed. IL-6, IL-1β, IL-8, IL-10 and IL-1ra increased post-exercise (p<0.05); however no differences were observed between trials.Conclusions: COLD and COOL water ingestion during exertional-heat stress ameliorates thermoregulatory strain compared to TEMP. However, this appears to have no effect on cytokine profile and minimal effect on intestinal epithelial injury and gastrointestinal symptoms. [ABSTRACT FROM AUTHOR]

Accuracy may be dramatically reduced when the boundary domain is curved and numerical schemes require a specific treatment of the boundary condition to preserve the optimal order. In the finite volume context, Ollivier-Gooch and Van Altena (2002) has proposed a technique to overcome such limitation and restore the very high-order accuracy which consists in specific restrictions considered in the least-squares minimization associated to the polynomial reconstruction. The method suffers from several drawbacks, particularly, the use of curved elements that requires sophisticated meshing algorithms. We propose a new method where the physical domain and the computational domain are distinct and we introduce the Reconstruction for Off-site Data (ROD) where polynomial reconstructions are carried out on the mesh using data localized outside of the computational domain, namely the Dirichlet condition situated on the physical domain. A series of numerical tests assess the accuracy, convergence rates, robustness, and efficiency of the new method and show that the boundary condition is fully integrated in the scheme with a very high-order accuracy and the optimal convergence rate is achieved. [ABSTRACT FROM AUTHOR]

Objectives The purpose of this study was to evaluate the outcomes of the novel Fantom coronary bioresorbable scaffold at 6 months. Background The Fantom sirolimus-eluting bioresorbable scaffold incorporates a unique proprietary iodinated, polycarbonate copolymer of tyrosine analogs that is radiopaque, with thin struts (125 μm) that facilitate device delivery and precise target lesion treatment. Methods The 6-month outcomes and performance of the Fantom scaffold were evaluated in 117 patients with single de novo native coronary artery lesions of length ≤20 mm and reference vessel diameter 2.5 to 3.5 mm. The primary angiographic endpoint was mean late lumen loss at 6 months measured by quantitative coronary angiography. Procedural outcomes were categorized as short-term technical success, short-term procedural success, and clinical procedural success. The primary clinical endpoint was major adverse cardiac events at 6 months, the composite of cardiac death, myocardial infarction (MI), or clinically driven target lesion revascularization (TLR). Results Short-term technical success, short-term procedural success, and clinical procedural success were achieved in 96.6%, 99.1%, and 99.1% of patients, respectively. Mean 6-month in-stent late lumen loss was 0.25 ± 0.40 mm (n = 100). Binary restenosis was present in 2 patients (2.0%). Major adverse cardiac events within 6 months occurred in 3 patients (2.6%), including no deaths, 2 MIs, and 2 TLRs (1 patient had both an MI and TLR). Scaffold thrombosis occurred in 1 patient (0.9%). Conclusions The clinical results from 117 patients enrolled in cohort A of the multicenter FANTOM II (Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold) study demonstrate favorable 6-month outcomes of this novel device in the treatment of noncomplex coronary artery disease. [ABSTRACT FROM AUTHOR]

The aim of the present study was to evaluate the efficiency of visual ELISA-PAG for early pregnancy diagnosis based on the presence of PAG (pregnancy-associated glycoprotein) using sheep blood serum. Experiment 1: 140 ewes were divided into three groups with different stages of pregnancy. In the first group, 41 pregnant ewes were sampled at 26, 28, 30, and 32 days of pregnancy; in the second group, 65 ewes (49 pregnant with 30 days and 16 non-pregnant) were sampled; in the third group, 34 non-pregnant ewes were sampled. Experiment 2: 10 pregnant ewes were sampled weekly from day 35 of gestation until day 70 post-partum to verify the total period in which PAG can be detected in the blood serum by the test. Transrectal ultrasound was used as a gold standard. The detection or non-detection of PAG was analyzed by the logistic model PROC GENMOD of SAS; differences were detected by the chi-squared test. In group 1, there were no differences between the results from 28, 30, and 32 days of gestation, but samples from 30 days were easier to interpret in comparison to 28 days, with a sensitivity of 97.56%. In the second group, using 65 sheep, visual ELISA-PAG showed 100% sensitivity and 93.75% specificity, which indicates the diagnosis of an animal as a false positive. In the third group, 97.06% of the sheep were confirmed as negative and 2.94% as positive, again indicating the presence of a false positive. In 100% of the sheep, the PAG remained in the blood circulation throughout the antepartum period until birth and seven days post-partum, declining thereafter. Based on our results, the visual ELISA-PAG is an effective method for the early diagnosis of pregnancy in sheep and can be performed from day 30 of gestation. [ABSTRACT FROM AUTHOR]

Objectives The primary objective of this study was to evaluate the safety and effectiveness of the Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold compared with the Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold in the treatment of stenotic target lesions located in native coronary arteries, ranging from ≥2.25 to ≤4.0 mm in diameter. Secondary objectives were to establish the medium-term safety, effectiveness, and performance of the Mirage device. Background The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns. Methods In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post–scaffold implantation at 6 and 12 months. Results Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was −0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = −0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: d post-procedure = 0.41, d 6 months = 1.00, d 12 months = 0.92). Angiographic median in-scaffold diameter stenosis was significantly different between study groups at 12 months (28.6% [IQR: 21.0% to 40.7%] for the Mirage, 18.2% [IQR: 13.1% to 31.6%] for the Absorb, d = 0.39). Device- and patient-oriented composite endpoints were comparable between the 2 study groups. Conclusions At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage. [ABSTRACT FROM AUTHOR]

Triple negative breast cancer (TNBC) accounts for 10-20% of cases in breast cancer. Despite recent advances in the treatment of hormonal receptor+ and HER2+ breast cancers, there are no targeted therapies available for TNBC. Evidence supports that most patients with TNBC express the transmembrane Epidermal Growth Factor Receptor (EGFR). However, early phase clinical trials failed to demonstrate significant activity of EGFR-targeted monoclonal antibodies and/or tyrosine kinase inhibitors. Here, we review the recent discoveries related to the underlying biology of the EGFR pathway in TNBC, clinical progress to date and suggest rational future approaches for investigational therapies in TNBC. [ABSTRACT FROM AUTHOR]

The venom of marine animals is a rich source of compounds with remarkable selectivity and functional diversity. Scorpaena plumieri is the most venomous fish in the Brazilian fauna and is responsible for relatively frequent accidents involving anglers and bathers. In humans, its venom causes edema, erythema, ecchymoses, anxiety, nausea, vomiting, and syncope. The venom is chemically characterized by Sp-CTx, a enzyme able to generate an initial endothelium-dependent relaxation response, followed by a contraction response. This study sought to investigate the proteolytic activities regarding vasopeptides angiotensin I and II. Both the venom and the epidermal mucus presented angiotensin conversion activity for angiotensin I, as well as a capacity to form Ang 1–7 directly via Ang I and II. Captopril (10 μM) and EDTA (1 mM) were able to abolish the converting activity of the venom and the epidermal mucus, representing the first description of a converting activity in S. plumieri venom and epidermal mucus. [ABSTRACT FROM AUTHOR]

Objectives This study sought to report the late multimodality imaging and clinical outcomes of the novel poly- l -lactic-acid–based DESolve novolimus-eluting bioresorbable coronary scaffold for the treatment of de novo coronary lesions. Background Bioresorbable scaffolds are an alternative to drug-eluting metallic stents and provide temporary vascular scaffolding, which potentially may allow vessel restoration and reduce the risk of future adverse events. Methods Overall, 126 patients were enrolled at 13 international sites between November 2011 and June 2012. The primary endpoint was in-scaffold late lumen loss at 6 months. Major adverse cardiac events, the main safety endpoint, were defined as the composite of cardiac death, target vessel myocardial infarction, or clinically indicated target lesion revascularization. All patients underwent angiography at 6 months. Serial intravascular ultrasound and optical coherence tomography were performed in a subset of patients. Results The scaffold device success rate was 97% (n = 122 of 126), and procedural success was 100% (n = 122 of 122). The major adverse cardiac event rate was 3.3% (n = 4 of 122) at 6 months and 7.4% (n = 9 of 122) at 24 months, including 1 probable stent thrombosis within the first month. At 6-month angiographic follow-up, in-scaffold late lumen loss was 0.20 ± 0.32 mm. Paired intravascular ultrasound analysis demonstrated a significant increase in vessel, lumen and scaffold dimensions between post-procedure and 6-month follow-up, and strut-level optical coherence tomography analysis showed full strut coverage in 99 ± 1.7%. Conclusions Our results showed favorable performance of the DESolve scaffold, effective inhibition of neointimal hyperplasia, and for the first time, early luminal and scaffold growth at 6 months with sustained efficacy and safety through 2 years. (Elixir Medical Clinical Evaluation of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System—The DESolve Nx Trial; NCT02086045 ) [ABSTRACT FROM AUTHOR]

Background: Wake-up stroke (WUS) represents 25% of all ischemic strokes. There is conflicting evidence concerning clinical severity, imaging characteristics, and outcome when WUS is compared with stroke of known time of onset. Our aim was to compare WUS patients with patients with ischemic stroke within the therapeutic window (STW) for thrombolysis. Methods: This is a retrospective hospital-based study of all consecutive patients hospitalized for acute ischemic stroke during 2013. Patients with STW, WUS, and WUS with computed tomography (CT)  at 3 hours or less after awakening (WUS≤3h) were selected for the study. The methods used include a review of clinical records, an independent quantification of early signs of ischemia on admission CT scan, and determination of functional outcome on follow-up. Results: Of 554 patients evaluated, 190 had STW, 113 had WUS (20.4%), and 25 had WUS≤3h. Among all WUS patients, 33.6% did not have any other formal contraindication for thrombolysis besides undetermined time of onset. WUS patients had demographic characteristics, vascular risk factors, and clinical severity similar to STW patients. Mild or absent early signs of ischemia on admission CT in WUS≤3h patients were similar to those in STW patients when adjusted for clinical severity (odds ratio [OR] = .50, 95% confidence interval [CI]=.17-1.47). Favorable prognosis in WUS≤3h was similar to STW when adjusted for age, clinical severity, and thrombolysis (OR = .53, 95% CI=.09-3.14). Conclusions: This study strengthens the evidence that clinical and early imaging characteristics of WUS patients are similar to those of patients with stroke who are eligible for thrombolysis based on the time window criteria, and patients with WUS do not have a worse short outcome. [ABSTRACT FROM AUTHOR]

In this work we successfully prepared sol–gel derived organic–inorganic hybrids by the incorporation of poly(2-hydroxyethyl methacrylate) and 3-methacryloxypropyltrimethoxysilane into a silica matrix. The obtained samples were examined by Fourier transform infrared spectroscopy (FTIR), thermogravimetry (TG), differential scanning calorimetry (DSC), Nitrogen adsorption tests, and Vickers microhardness measurements. The incorporation of PHEMA and P(HEMA-co-MPS) into silica gave rise to samples with smaller specific surface areas and pore volumes when compared to pure silica. It was observed that materials prepared with polymer additions above 40 wt% were virtually non-porous. These findings may be related to the blockage of silica pores by polymer chains in the hybrid materials. It seems that the initial addition of either PHEMA or P(HEMA-co-MPS) to silica caused a partial filling of its pore structure, leading to an increase of its microhardness. On the other hand, when these polymers are incorporated at concentrations above 20 wt% it may occur a partial rupture of the silica framework, which decreases the microhardness of the processed materials. In addition, the increase of the polymer loading led to large polymer domains in the prepared samples. However, this behavior was less pronounced for hybrids modified with MPS. [ABSTRACT FROM AUTHOR]

Objectives The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions. Background The BioFreedom (BFD) DCS incorporates a low-profile, stainless-steel platform, with a surface that has been modified to create a selectively microstructured abluminal surface that allows adhesion and further release of Biolimus A9 (Biosensors Europe SA, Morges, Switzerland). Methods A total of 182 patients (183 lesions) were randomized into a 1:1:1 ratio for treatment with BFD “standard dose” (BFD) or BFD “low dose” (BFD-LD) versus first-generation paclitaxel-eluting stents (PES) at 4 sites in Germany. Results Baseline and procedural characteristics were well matched. At 4-month angiographic follow-up (Cohort 1, n = 75), in-stent late lumen loss (LLL) was significantly lower with BFD and BFD-LD versus PES (0.08 and 0.12 mm vs. 0.37 mm, respectively; p < 0.0001 for BFD vs. PES, and p = 0.002 for BFD-LD vs. PES). At 12 months (Cohort 2, n = 107), in-stent LLL (primary endpoint) was 0.17 mm in BFD versus 0.35 mm in PES (p = 0.001 for noninferiority; p = 0.11 for superiority); however, the BFD-LD (0.22 mm) did not reach noninferiority (p = 0.21). At 5 years (175 of 182), there were no significant differences in major adverse cardiac events (23.8%, 26.4%, and 20.3%) and clinically indicated target lesion revascularization (10.8%, 13.4%, and 10.2%) for BFD, BFD-LD, and PES, respectively; also, there was no definite/probable stent thrombosis reported. Conclusions The BFD, but not the BFD-LD, demonstrated noninferiority versus PES in terms of in-stent LLL, a surrogate of neointimal hyperplasia, at 12-month follow-up. At 5 years, clinical event rates were similar, without occurrence of stent thrombosis in all groups. (BioFreedom FIM Clinical Trial; NCT01172119 ) [ABSTRACT FROM AUTHOR]

The design of efficient, simple, and easy to code, second-order finite volume methods is an important challenge to solve practical problems in physics and in engineering where complex and very accurate techniques are not required. We propose an extension of the original Frink’s approach based on a cell-to-vertex interpolation to compute vertex values with neighbour cell values. We also design a specific scheme which enables to use whatever collocation point we want in the cells to overcome the mass centre point restrictive choice. The method is proposed for two- and three-dimensional geometries and a second-order extension time-discretization is given for time-dependent equation. A large number of numerical simulations are carried out to highlight the performance of the new method. [ABSTRACT FROM AUTHOR]

Smart Grid (SG) is a relatively new subject in which intelligence comes from computer systems. Edge Computing (EC) processes data near the SG information source — potentially attenuating latency problems. While Internet of Things (IoT) collects, transmits and stores data, EC allows the employment of data analysis with Machine Learning (ML) at its edge. This work uses a systematic mapping methodology to encompass 15081 works related to four SGs technologies: data analysis, EC, IoT, and context awareness. With 37 works after the filtering process, this review revealed that most papers use one to three approaches, while only two use all four technologies. The results also indicate that EC has been extensively used in SG solutions, with 22 selected studies. Distinctively, only 9 works use context awareness, which may indicate a path for future developments in SG. The study also allowed the learning of 7 lessons that are presented in this paper. [Display omitted] • We review the state of the art related to smart grid computational techniques. • The paper covers internet of things, edge computing, and context-aware computing. • The work considers literature of the last decade through a well-defined methodology. • The study covers 15081 papers, answering one general and eight focused issues. • The paper proposes a taxonomy for smart grid Technologies. [ABSTRACT FROM AUTHOR]

Objectives: This study sought to perform clinical and imaging assessments of the DESolve Bioresorbable Coronary Scaffold (BCS). Background: BCS, which is drug eluting, may have potential advantages compared with conventional metallic drug-eluting stents. The DESolve system, designed to provide vessel support and neointimal suppression, combines a poly-l-lactic acid–based scaffold with the antiproliferative myolimus. Methods: The DESolve First-in-Man (A NON-RANDOMIZED, CONSECUTIVE ENROLLMENT EVALUATION OF THE DESolve MYOLIMUS ELUTING BIORESORBABLE CORONARY STENT IN THE TREATMENT OF PATIENTS WITH DE NOVO NATIVE CORONARY ARTERY LESIONS) trial was a prospective multicenter study enrolling 16 patients eligible for treatment. The principal safety endpoint was a composite of cardiac death, myocardial infarction, and clinically indicated target lesion revascularization. The principal imaging endpoint was in-scaffold late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 6 months. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging was performed at baseline and 6 months; multislice computed tomography (MSCT) was performed at 12 months. Results: Acute procedural success was achieved in 15 of 15 patients receiving a study scaffold. At 12 months, there was no scaffold thrombosis and no major adverse cardiac events directly attributable to the scaffold. At 6 months, in-scaffold LLL (by QCA) was 0.19 ± 0.19 mm; neointimal volume (by IVUS) was 7.19 ± 3.56%, with no evidence of scaffold recoil or late malapposition. Findings were confirmed with OCT and showed uniform, thin neointimal coverage (0.12 ± 0.04 mm). At 12 months, MSCT demonstrated excellent vessel patency. Conclusions: This study demonstrated the feasibility and efficacy of the DESolve BCS. Results showing low in-scaffold LLL, low % neointimal volume at 6 months, no chronic recoil, and maintenance of lumen patency at 12 months prompt further study. (DESolve First-in-Man; EudraCT number 2011-000027-32) [Copyright &y& Elsevier]