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The protective role against SARS-CoV-2 infection by the third booster dose of mRNA vaccines in cancer patients with solid malignancies is presently unknown. We prospectively investigated the occurrence of COVID-19 in cancer patients on active therapy after the booster vaccine dose.Cancer patients on treatment at the Center for Immuno-Oncology (CIO) of the University Hospital of Siena, Italy, and health care workers at CIO who had received a booster third dose of mRNA vaccine entered a systematic follow-up monitoring period to prospectively assess their potential risk of SARS-CoV-2 infection. Serological and microneutralization assay were utilized to assess levels of anti-spike IgG, and of neutralizing antibodies to the SARS-CoV-2 Wild Type, Delta and Omicron variants, respectively, after the booster dose and after negativization of the nasopharyngeal swab for those who had developed COVID-19.Ninety cancer patients with solid tumors on active treatment (Cohort 1) and 30 health care workers (Cohort 2) underwent a booster third dose of mRNA vaccine. After the booster dose, the median value of anti-spike IgG was higher (p = 0.009) in patients than in healthy subjects. Remarkably, 11/90 (12%) patients and 11/30 (37%) healthy subjects tested positive to SARS-CoV-2 infection during the monitoring period. Similar levels of anti-spike IgG and of neutralizing antibodies against all the investigated variants, with geometric mean titers of neutralizing antibodies against the Omicron being the lowest were detected after the booster dose and after COVID-19 in both Cohorts.The occurrence of SARS-CoV-2 infection we observed in a sizable proportion of booster-dosed cancer patients and in healthy subjects during the Omicron outbreak indicates that highly specific vaccines against SARS-CoV-2 variants are urgently required.

Diabetic foot syndrome (DFS) is a complex disease. The best outcomes are reported with the multi-disciplinary team (MDT) approach, where each member works collaboratively according to his/her expertise. However, which health provider should act as the team leader (TL) has not been determined. The TL should be familiar with the management of diabetes, related complications and comorbidities. He/she should be able to diagnose and manage foot infections, including prompt surgical treatment of local lesions, such as abscesses or phlegmons, in an emergent way in the first meeting with the patient. According to the Organization for Economic Co-operation and Development (OECD) reports, Italy is one of countries with a low amputation rate in diabetic patients. Many factors might have contributed to this result, including 1)the special attention directed to diabetes by the public health system, which has defined diabetes as a "protected disease", and accordingly, offers diabetic patients, at no charge, the best specialist care, including specific devices, and 2)the presence of a network of diabetic foot (DF) clinics managed by diabetologists with medical and surgical expertise. The health care providers all share a "patient centred model" of care, for which they use their internal medicine background and skills in podiatric surgery to manage acute or chronic needs in a timely manner. Therefore, according to Italian experiences, which are fully reported in this document, we believe that only a skilled diabetologist/endocrinologist should act as a TL. Courses and university master's degree programmes focused on DF should guarantee specific training for physicians to become a TL.

In many species, males produce sounds to attract a female. In a chorus, males actively adjust their acoustic production depending on the presence and number of mating rivals. Plasticity in signal features might then be advantageous as males could tune their signalling activity to the contest intensity. However, the ability to exhibit plastic behaviour might be constrained and interindividual variation in plasticity can occur. In this field study, we examined the influence of body mass and social environment on the signal expression of male bushcrickets, Poecilimon veluchianus veluchianus. We tested whether differences in signal features of rivals of different body mass and number led to changes in the competition pressure perceived by focal males and, consequently, in their acoustic responses. We used the first principal component from a principal component analysis, reflecting verse duration, duty cycle and syllable number, as a measure of acoustic output. We found that the rivals' acoustic output depended only on their number, being higher for two rivals than one. However, the response of heavy focal males depended on the rivals' body mass. Contrary to what we expected, heavy males produced shorter verses with fewer syllables when competing against two heavy rivals than when competing against one or two light rivals or one heavy rival. Facing light competitors, heavy focal males responded more to two rivals than to one. In contrast, light focal males did not vary their signal features depending on competition conditions. These results indicate that body mass and social context drive interindividual variation in the capacity of P. v. veluchianus males to adjust their signal features to competition levels. We compare these findings with those previously obtained on congeneric species and discuss the outcomes' similarities and discrepancies. Lastly, we provide suggestions for future studies of socially induced plasticity in sexually selected acoustic signal features. (C) 2019 The Association for the Study of Animal Behaviour. Published by Elsevier Ltd. All rights reserved.

The PEOPLE trial aimed to identify new immune biomarkers in negative and low programmed death-ligand 1 (PD-L1) (0%-49%) advanced non-small-cell lung cancer (aNSCLC) patients treated with first-line pembrolizumab. Here we report the main outcomes and the circulating immune biomarkers analysis.The primary endpoint of this phase II trial was the identification of immune biomarkers associated with progression-free survival (PFS). Overall survival (OS), objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and safety were secondary endpoints. Absolute cell counts for 36 subsets belonging to innate and adaptive immunity were determined by multiparametric flow cytometry in peripheral blood at baseline and at first radiologic evaluation. An orthoblique principal components-based clustering approach and multivariable Cox regression model adjusted for clinical variables were used to analyze immune variables and their correlation with clinical endpoints.From May 2018 to October 2020, 65 patients were enrolled. After a median follow-up of 26.4 months, the median PFS was 2.9 months [95% confidence interval (CI) 1.8-5.6 months] and median OS was 12.1 months (95% CI 8.7-17.1 months). The ORR was 21.5%, DCR was 47.7% and median DoR was 14.5 months (95% CI 6.4-24.9 months). Drug-related grade 3-4 adverse events were 9.2%. Higher T cell and natural killer (NK) cell count at baseline and at the first radiologic evaluation were associated with improved PFS, DCR and OS. On the contrary, higher myeloid cell count at baseline or at the first radiologic evaluation was significantly associated with worse OS and DCR.Circulating immune biomarkers can contribute to predict outcomes in negative and low PD-L1 aNSCLC patients treated with first-line single-agent pembrolizumab.

Males of several animals, including insects, use acoustic signals to attract a sexually receptive conspecific partner. In the orthopteran chorusing genus Poecilimon (Tettigoniidae), male signalling as well as female preference can be related to male body condition and to the social environment. Song is thought to be an honest signal of male quality, and song characteristics are therefore often important for sexual and social selection. At the same time, signal expression is plastic and this plasticity depends on the quality of the individual signaller, the acoustic components preferred by females and rivals' body condition and proximity. Using the bushcricket species Poecilimon ampliatus as a model, we investigated how both internal (body condition) and external (level of competition) factors affected the expression of temporal song characteristics. We show that both factors significantly affected acoustic signalling activity: when competing against light rivals, heavy males adjusted the characteristics of their songs to different social conditions. However, light males competing against a heavy rival showed less plasticity in their acoustic signals across social conditions. During the most escalated competition, heavier males increased their acoustic signal investment up to the maximum level, signalling with longer verses and higher duty cycles, in comparison to all other treatments. Body condition and the social environment affected male acoustic signal activity, which suggests that these factors mediate the allocation of resources for signalling and different strategies adopted in competition. The adaptive plasticity of acoustic signals in this species raises new questions about the potential role that this process could play in natural choruses, where more than two competitors are signalling simultaneously.

Background Randomized controlled trials (RCTs) in the field of diabetes have limitations inherent to the fact that design, setting, and patient characteristics may be poorly transferrable to clinical practice. Thus, evidence from studies using routinely accumulated clinical data are increasingly valued. Aims We herein describe rationale and design of the DARWIN-T2D (DApagliflozin Real World evIdeNce in Type 2 Diabetes), a multicenter retrospective nationwide study conducted at 50 specialist outpatient clinics in Italy and promoted by the Italian Diabetes Society. Data synthesis The primary objective of the study is to describe the baseline clinical characteristics (particularly HbA1c) of patients initiated on dapagliflozin from marketing authorization approval to the end of 2016. Secondary and exploratory objectives will evaluate the changes in glycaemic and extraglycaemic efficacy parameters after initiation of dapagliflozin or after initiation of comparator glucose lowering medications (DPP-4 inhibitors, gliclazide extended release, and long-acting GLP-1 receptor agonists). An automated software will extract relevant data from the same electronic chart system at all centres, thereby minimizing data treatment and human intervention. Conclusion The study is expected to collect an enormous dataset of information on dapagliflozin- and comparator-using patients. After study completion, the Italian Diabetes Society will launch an open crowdsourcing call on the DARWIN-T2D database, challenging diabetes researchers to apply their ideas and approaches to address new unmet needs and knowledge gaps in diabetes. We believe this will move DARWIN-T2D to the next generation of real world studies.

To provide data on hospitalization and incidence rates of Charcot neuroarthropathy (CN) and its relation to lower limbs' amputations/revascularizations in population with diabetes of Italy as well as of one of its regions (Tuscany).Hospitalizations with CN diagnosis (codes ICD-9-CM: 7130, 7135, 7138) have been recorded in people with diabetes over years 2003-2013 in Italy and 2008-2015 in Tuscany. Amputations, peripheral vascular disease, revascularizations and infections were likewise evaluated.Between 2003 and 2013 CN hospitalizations were very infrequent in Italy ranging between 14×100,000 and 11×100,000 patients with diabetes. In Tuscany they declined to a minimum of 7×100,000 patients in 2015, after a previous increase to a maximum of 22×100,000 (p=NS for both). Yearly CN incidence remained constant in Italy, declining in Tuscany to a minimum of 3.4×100,000 diabetic patients in 2015 (p=0.047). CN patients were younger and with longer length of hospital stay than those with non-Charcot diabetic foot (p0.05 for both). Amputation and infection rates were manifold higher in CN patients than in those with non-Charcot diabetic foot, while the revascularization rate was similar in both.Over last decade, in Italy and Tuscany yearly CN incidence and hospitalization rates concerned only a small percentage of patients, remaining constant over years and declining in Tuscany in the last couple of years. CN was significantly associated to younger age, longer hospital stay and greater risk of amputations and infections while the need of revascularization was similar to that of non-Charcot diabetic foot.

Objective Women with diabetes have a greater excess risk for cardiovascular diseases (CVD) than men. This study was aimed at clarifying whether this effect is lifelong or more evident in some life-periods. Methods The effect of diabetes and gender on the risk of first ever hospitalization for acute myocardial infarction (AMI), ischemic stroke (IS), congestive heart failure (CHF), lower extremity amputations (LEA) or any of these major cardiovascular events (MACE) have been evaluated by a Cox-hazard model, over years 2008–2012 querying administrative databases of a cohort living in Tuscany, Italy. Results Comparing subjects with diabetes to those without it the overall age-adjusted excess risk was higher in women than in men for AMI and MACE and higher in men for LEA, with no difference for IS or CHF. In women the excess risk for AMI and MACE started earlier (46 yr) and lasted until age of more than 85 yr, while ‘risk-windows’ opened later and had a shorter duration for CHF (56–65 yr) and IS (66–75 yr). Conclusion Diabetic women have a significant diabetes-associated excess of CVD risk, except for LEA, with a ‘risk window’ opening earlier and lasting longer for AMI and MACE, later and with a shorter duration for IS and CHF.

Pottery is of fundamental importance for understanding archaeological contexts. However, recognition of ceramics is still a manual, time-consuming activity, reliant on analogue catalogues created by specialists, held in archives and libraries. The ArchAIDE project worked to streamline, optimise, and economise the mundane aspects of these processes, using the latest automatic image recognition technology, while retaining key decision points necessary to create trusted results. The project has developed two complementary machine-learning tools to propose identifications based on images captured on site. One method relies on the shape of the fracture outline of a sherd; the other is based on decorative features. For the outline-identification tool, a novel deep-learning architecture was employed, integrating shape information from points along the inner and outer surfaces. The decoration classifier is based on relatively standard architectures used in image recognition. In both cases, training the classifiers required tackling challenges that arise when working with real-world archaeological data: the paucity of labelled data; extreme imbalance between instances of the different categories; and the need to avoid neglecting rare types and to take note of minute distinguishing features of some forms. The scarcity of training data was overcome by using synthetically-produced virtual potsherds and by employing multiple data-augmentation techniques. A novel way of training loss allowed us to overcome the problems caused by under-populated classes and non-homogeneous distribution of discriminative features.

Three biochars were produced using sawdust from waste biomass, via a simple pyrolysis thermal conversion at 450, 650, and 850 °C (BC450, BC650, and BC850), without any activation process. These materials, together with vegetal and mineral commercial activated carbons (VAC and MAC), were characterized for their elemental composition, Brunauer–Emmett–Teller surface area, t-plot microporosity and Barrett-Joyner-Halenda mesoporosity. Moreover, iodine, phenol and methylene blue porosity indexes were measured. The materials were also evaluated for their pH of the point of zero charge, as well as near-surface chemical composition and surface functionality by means of X-ray photoelectron and Fourier-transform infrared spectroscopy. Ash content, water-extractable metals and polycyclic aromatic hydrocarbons (PAHs) were also determined. BC650 showed a much higher surface area (319 m2 g−1) compared to BC450 (102 m2 g−1), as well as an increase in aromatization and the residual presence of functional polar groups. BC850 exhibited a loss of polar and aromatic groups, with the dominance of graphitic carbon and the highest value of surface area (419 m2 g−1). Biochars comply with the EN 12915-1/2009 limits for metal and PAH release in water treatment. Biochars and MAC were tested using Langmuir and Freundlich isotherms for the sorption in real effluent wastewater of a mixture of 14 branched ethoxylated 4-t-octyl and 4-nonylphenols, as well as 4-t-octyl and 4-nonylphenol, the latter representing persistent, endocrine disrupting contaminants, widespread in the effluents from wastewater treatment plants and listed as priority/priority hazardous substances in the Directive 2013/39/EU. Biochars showed a lower sorption efficiency compared to MAC. The best performance was found for BC650 towards the alkylphenols (9–13 times less efficient than the MAC). Considering the lower market price of biochar compared to MAC (estimated as at least 16 times less expensive by a small market survey), the former can be considered more competitive than the latter.

The aim of this research was to evaluate the natural durability of different wood species against marine organisms in the Messina strait to determine the most durable wood species for the replacement of wooden docks. The wood species tested were Bilinga/Opepe (Nauclea diderrichii Merril), Okan (Cylicodiscus gabunensis Taub (Harms), Demerara Greenheart (Ocota rodiaei Mez) and Azobe (Lophira alata Banks ex Gaertn), the current wood species used for docks. Scots Pine (Pinus sylvestris L.) was used for reference controls. The assessment was performed in accordance with EN 275 combined with a software for image acquisition called Nis D3.22. From the results of this experiment, it can be seen that Bilinga and Okan can well replace the current utilization of Azobe for wooden banking in the Sicilian strait. The Nis D3.22 software distinguished slight differences not perceived by the human eye in the assessment described in EN 275. These differences, which were lost in visual assessment associated with the wide nominal durability classes of EN 275, can contribute to the choice of wood species that are not suitable for their purpose, so the improvement of the assessment due to image analysis might be important even from an economic point of view.

To evaluate the effect of diabetes by gender on the peak-risk of first-ever-ischemic stroke and its recurrence.Administrative datasets including all hospital discharges for ischemic stroke (N = 43,332) in the diabetic (N = 207,568) and non-diabetic (N = 2,808,554) population of the Tuscany region, Italy were used to calculate Hazard ratios (HR) after Cox-regression, of first-ever and recurrent ischemic strokes, between 2005 and 2011.Overall, diabetes increased the HR of first-ever ischemic stroke by about 50% in both genders. However, this risk significantly declined with age and was higher in women aged 55-74 yr than in men of the same age (HR; 95% CI: 1.392; 1.228-1.579 in age-class 55-64 yr and 1.203; 1.110-1.304 in age class 65-74 yr; p0.001). Diabetes also increased the adjusted risk of three-year-stroke recurrence (N = 5,998) in women, independently of age, whereas this was the case in men70 yr.Diabetes is associated with increased risk of ischemic stroke although it declines with age though at lower rate among women than men. Moreover, diabetic women have greater risk of recurrence than in men70 yrs old, supporting a high-risk "time-window" in postmenopausal-elderly diabetic women.

Evaluation of how ankle joint mobility (AJM) can be useful in the identification of patients with diabetes at risk of foot ulcer (FU).Plantar and dorsal flexion of foot were evaluated using an inclinometer in 87 patients (54 type 2 and 33 type 1), and 35 healthy sex- and age-matched control subjects. Patients with diabetes were followed up for diagnosis of FU over the next 8 years and subsequently, patients were subdivided into: those without a history of FU (18 type 1 and 33 type 2), those who had a history of FU detected before baseline evaluation (14 type 2) and those who had history of first ulceration detected by the 8th year of the evaluation period (7 type 2).Aging and diabetes caused a significant reduction in mobility of each of the movements investigated (p0.001), whereas after adjusting for the confounding effect of age, diabetes specifically reduced plantar flexion (p0.0001). AJM was significantly lower in those with history of previous FU compared to all the other groups (p0.001). The first ulceration was detected in the same foot presenting lower AJM in 17 of the 22 subjects with diabetes with history of ulcer (77.27%).Diabetes and aging reduce AJM although diabetes seems to reduce plantar flexion to a more specific extent. Reduced AJM is mostly associated with a previous history of FU. The evaluation of AJM is a valid and reliable ulcer risk scale that indicates which foot is at higher ulcer risk.

“Plant Resources in the Palaeolithic” is a research project focused on the technologies for plant food processing as documented by use-wear traces and plant residue on grinding tools found in European sites. Many researchers have been involved in the project, which encompasses the fields of archaeology, botany and food processing technologies, within the context of the history of European Prehistoric societies. The first study was carried out on use-wear traces and plant remains recovered from grinding tools from the sites of Bilancino (Italy), Kostienki 16 (Russia) and Pavlov VI (Czech Republic), dating to the Middle-Upper Palaeolithic (Gravettian and Gorotsovian) around 28,000–30,000 cal BP. The results demonstrated that vegetable food processing and the production of flour was a common practice across Europe from at least 30,000 years ago and that flour, a high-energy food, was a component of the food economy of mobile hunter gatherers. Flour production and consumption imply multi-step processing from harvesting to cooking to obtain a suitable and digestible food, and that this was part of an Upper Paleolithic behavioural package. This paper presents new data from two Gravettian pestles, found at Grotta Paglicci – level 23a (Southern Italy) and at Dolni Vestonice I (Czech Republic), which furnish further information about plant exploitation and the technologies related to plant food processing.

Since the first description of the intradural removal of the anterior clinoid process, numerous refinements and modifications have been proposed to simplify and enhance the safety of the technique. The growing use of endoscopes in endonasal and transcranial approaches has changed the traditional management of many skull base lesions. We describe an endoscopic extradural anterior clinoidectomy and optic nerve decompression through a minimally invasive pterional port. Minimally invasive optic nerve decompression, with endoscopic extradural anterior clinoidectomy, through a pterional keyhole craniotomy was performed on five preserved cadaveric heads. The endoscopic pterional port provided a shorter and more direct route to the anterior clinoid region, and helped avoid unnecessary and extensive bone removal. An extradural approach helped minimize complications associated with infraction of the subdural space and allowed for the maintenance of visibility while drilling with continuous irrigation. Adequate 270 bone decompression of the optic canal was achieved in all specimens. Endoscopic extradural anterior clinoidectomy and optic nerve decompression is feasible through a single minimally invasive pterional port. 2013 Elsevier Ltd. All rights reserved.