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Claudia Omarini,1 Patrizia Palumbo,2 Annarita Pecchi,3 Stefano Draisci,3 Sara Balduzzi,4 Cecilia Nasso,1 Monica Barbolini,1 Chrystel Isca,1 Alessandro Bocconi,1 Luca Moscetti,1 Silvia Galetti,5 Giovanni Tazzioli,6 Pietro Torricelli,3 Stefano Cascinu,1 Federico Piacentini1 1Division of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 2Division of Clinical Nutrition and Metabolism, Department of Specialist Medicines, University Hospital of Modena, Modena, Italy; 3Department of Radiology, University Hospital of Modena, Modena, Italy; 4Statistics Unit, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 5Division of Clinical Nutrition and Metabolism, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Modena, Italy; 6Department of General Surgery and Surgical Specialities, University Hospital of Modena, Modena, ItalyCorrespondence: Claudia OmariniDivision of Medical Oncology, Department of Medical and Surgical Sciences for Children & Adults, University Hospital of Modena, Via Del Pozzo 71, Modena 41122, ItalyTel +39 059 4222845Email claudia.omarini@gmail.comBackground: Fat tissue is strongly involved in BC tumorigenesis inducing insulin resistance, chronic inflammation and hormonal changes. Computed tomography (CT) imaging instead of body mass index (BMI) gives a reliable measure of skeletal muscle mass and body fat distribution. The impact of body composition parameters (BCPs) on chemosensitivity is still debated. We examined the associations between BCPs and tumor response to neoadjuvant chemotherapy (NC) in patients treated for operable breast cancer (BC).Methods: A retrospective review of BC patients treated with NC in Modena Cancer Center between 2005 and 2017 was performed. BCPs, such as subcutaneous fat area (SFA), visceral fat area (VFA), lumbar skeletal muscle index (LSMI) and liver-to-spleen (L/S) ratio were calculated by Advance workstation (General Electric), software ADW server 3.2 or 4.7. BMI and BCPs were correlated with pathological complete response (pCR) and survival outcomes.Results: 407 patients were included in the study: 55% with BMI < 25 and 45% with BMI ≥ 25. 137 of them had pre-treatment CT scan imagines. Overweight was significantly associated with postmenopausal status and older age. Hormonal receptor positive BC was more frequent in overweight patients (p

As wind turbine technology proceeds towards the development of more advanced and complex machines, modelling tools with fidelity higher than the ubiquitous Blade Element Momentum (BEM) method are needed. Among them, the Actuator Line Method (ALM) stands out in terms of accuracy and computational cost. Moving from this background, an advanced ALM method has been developed within the commercial solver CONVERGE®. As elements of novelty, this tool features a Lagrangian method for sampling the local inflow velocity and a piece-wise smearing function for the force projection process. Various sub-models for both Horizontal Axis Wind Turbines (HAWTs) (e.g. the Shen tip loss correction) and Vertical Axis Wind Turbines (VAWTs) (e.g. the MIT dynamic stall model) has also been included. Aim of the research is to address the new challenges posed by modern machines. HAWTs are in fact getting larger and larger, shifting the research focus on the interaction of increasingly deformable blades with the atmosphere at the micro- and mesoscale level. VAWTs on the other hand, whose popularity has arisen in the last years, thanks to their advantages in non-conventional applications, e.g. floating offshore installations, are extremely complex machines to study, due to their inherently unsteady aerodynamics. The approach has been validated on selected test cases, i.e. the DTU 10MW turbine and a real 2-blade H-rotor, for which both high-fidelity CFD and experimental data are available.

The use of vertical-axis turbines is raising interest in the field of hydropower production from rivers or water channels, where suitable mass flows are available, without the need of high water jumps or large construction sites. Although many optimization studies on vertical-axis turbines have been carried out for wind applications, lesser examples exist in the technical literature regarding hydrokinetic turbines. In the latter case, the best trade-off between power output and low structural stress is more dependent on the fluid dynamic loadings rather than the inertial loadings, due to the higher fluid density and lower rotation speed. The present work shows the results of an industrial study case application, in which the design of a traditional three-blade Darrieus rotor has been adapted for operating in water flows via hydrokinetic technology. Some specific design rules will be discussed, showing the different concepts adopted for the machine layout in order to achieve the best efficiency and performance. Multiple geometrical parameters of the rotor configuration were involved during the analysis: the number of rotor blades, i.e. two or three blades, the rotor’s shape, i.e. traditional H-shape or unconventional L-shape, and the use of power augmentation systems. The analysis of the numerical results was focused on the following output targets: maximum power coefficient, optimal tip speed ratio (TSR), rotor thrust, blade normal force and the upstream and downstream flow field influence. The outcome of the study shows how the best configuration differs from the common solutions for wind application. Moreover, a high power enhancement can be achieved while guaranteeing a good compromise in terms of structural loads.

Paola Ferri,1 Matteo Guadi,1 Luigi Marcheselli,1 Sara Balduzzi,1 Daniela Magnani,1 Rosaria Di Lorenzo2 1Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, 2Department of Mental Health, AUSL di Modena, Service of Psychiatric Diagnosis and Treatment, Modena, Italy Background: Shift work is considered necessary to ensure continuity of care in hospitals and residential facilities. In particular, the night shift is one of the most frequent reasons for the disruption of circadian rhythms, causing significant alterations of sleep and biological functions that can affect physical and psychological well-being and negatively impact work performance.Objectives: The aim of this study was to highlight if shift work with nights, as compared with day work only, is associated with risk factors predisposing nurses to poorer health conditions and lower job satisfaction.Methods: This cross-sectional study was conducted from June 1, 2015 to July 31, 2015 in 17 wards of a general hospital and a residential facility of a northern Italian city. This study involved 213 nurses working in rotating night shifts and 65 in day shifts. The instrument used for data collection was the “Standard Shift Work Index,” validated in Italian. Data were statistically analyzed.Results: The response rate was 86%. The nurses engaged in rotating night shifts were statistically significantly younger, more frequently single, and had Bachelors and Masters degrees in nursing. They reported the lowest mean score in the items of job satisfaction, quality and quantity of sleep, with more frequent chronic fatigue, psychological, and cardiovascular symptoms in comparison with the day shift workers, in a statistically significant way.Conclusion: Our results suggest that nurses with rotating night schedule need special attention due to the higher risk for both job dissatisfaction and undesirable health effects. Keywords: shift work, night work, health, sleep disorders, job satisfaction, nurses

The paper analyses the efficacy of digital platforms for deliberative and participatory democracy in enhancing democracy. After examining the concepts of deliberative and participatory democracy (§IA), particularly their meaning from a legal standpoint and their relation to representative and direct democracy (§IB), the study introduces the broader concept of ‘digital democratic innovations’ (§IC) and adopts a classification framework (§II). Then, the current legal framework of e-participation in Italy, Germany, France, and the EU is analysed (§III). This comparative analysis sets the stage for a detailed examination of five digital platforms operating at both local and national levels, which serve as case studies. Through a systematic evaluation of the key features of these platforms, the paper classifies those platforms according to the classification framework (§IVA-E). It also assesses the quality of citizen participation facilitated by each digital democratic innovation exploring two indicators: the meaningfulness of participation and the extent of digital deliberation (§IVF). In drawing conclusions, the paper also suggests potential avenues for further legal research into digitised civic participation (§V).

The actuator line method (ALM) is increasingly being preferred to the ubiquitous blade element momentum (BEM) approach in several applications related to wind turbine simulation, thanks to the higher level of fidelity required by the design and analysis of modern machines. Its capability to resolve blade tip vortices and their effect on the blade load profile is, however, still unsatisfactory, especially when compared to other medium-fidelity methodologies such as the lifting line theory (LLT). Despite the numerical strategies proposed so far to overcome this limitation, the reason for such behavior is still unclear. To investigate this aspect, the present study uses the ALM tool developed by the authors for the ANSYS® Fluent® solver (v. 20.2) to simulate a NACA0018 finite wing for different pitch angles. Three different test cases were considered: high-fidelity blade-resolved computational fluid dynamics (CFD) simulations (to be used as a benchmark), standard ALM, and ALM with the spanwise force distribution coming from blade-resolved data (frozen ALM). The last option was included to isolate the effect of force projection, using three different smearing functions. For the postprocessing of the results, two different techniques were applied: the LineAverage sampling of the local angle of attack along the blade and state-of-the-art vortex identification methods (VIMs) to outline the blade vortex system. The analysis showed that the ALM can account for tip effects without the need for additional corrections, provided that the correct angle of attack sampling and force projection strategies are adopted.

ABSTRACTWe present the characterization of geohazard-related features of the Ligurian Sea with the map of its physiographic domains (1:250,000 scale) and five maps (1:100,000 scale) of the morphological and morpho-bathymetric elements. These were realized in the framework of the MaGIC (Marine Geohazard along Italian Coasts) project, promoted by the Italian Civil Protection Department. The characterization of submarine geohazards along continental margins, together with mapping of marine geological features are critical for the management of coastal risks. Multibeam bathymetric data combined with high-resolution 2D reflection seismic data, allowed to identify and map the main tectono-sedimentary features related to mass movements along the Ligurian continental margin. A dense grid of seismic profiles allowed to improve the comprehension of the margin structure as well as its recent tectonic activity providing new insights concerning mass wasting processes and active tectonics relationships to plan further, focalized investigations in areas of maximum risk.

Summary: Background: Metastatic retroperitoneal lymph node dissection (LND) for nodal recurrence is applied for a variety of cancers, such as urological, gynaecological and rectal cancer. Precise localisation and resection of these lymph nodes (LNs) during surgery can be challenging, especially after previous radiotherapy or surgery. The objective of this study was to assess the added value of surgical navigation for targeted LND in the retroperitoneum. Methods: We performed an open-label randomised, controlled, phase 3 trial at the Netherlands Cancer Institute, Amsterdam. Eligible participants were over 18 years of age, scheduled for targeted retroperitoneal LND by laparotomy, with removal of one or more suspected (targeted) LN(s) as assessed by diagnostic imaging. Patients were randomised (1:1) between conventional LND and LND using surgical navigation, by means of a minimisation method stratified for tumour origin (urological, colorectal and other). For the surgical navigation, a digital 3D model of the patients' anatomy was created from diagnostic CT scans, including delineation of the targeted LN(s). The 3D model was linked to the patients’ position in the operation room. Using an electromagnetic tracking system, with a sterile tracked pointer, the actual position of the pointer was shown in the 3D model, enabling the surgeon to localize the targeted LN(s). The primary outcome of the study was the percentage of successful procedures. Success was defined as no residual target LN(s) visible on postoperative CT imaging. This study was registered with ClinicalTrials.gov, NCT05867095. Findings: From January 2017 to December 2020, 69 participants were included in the study, 35 (51%) in the conventional arm and 34 (49%) in the navigation arm. Four patients were not evaluable and excluded from further analysis; three in the conventional arm (patients withdraw from study participation), one in the navigation arm (discontinued surgery, misclassified diagnosis). According to intention-to-treat analysis, 50% (16/32) of the surgical procedures was successful in the conventional arm, versus 85% (28/33) in the surgical navigation arm (one-tailed p = 0.0028, 90% CI: 14%–56%). Using the Clavien-Dindo classification, the overall complication rate was comparable between the conventional arm and the navigation arm. Surgeons judged the surgical navigation setup as valuable, the median preference score to use surgical navigation was 3.7 (3.3–4.0) (scale 1–5), and the median system usability score was 75 (70–85) (scale 0–100). Interpretation: Surgical navigation allows for significantly better localisation and removal of target LN(s) in the retroperitoneum. Funding: This research was supported by the KWF-Alpe d'HuZes (NKI 2014-6596) and by an institutional grant of The Dutch Cancer Society and of the Dutch Ministry of Health, Welfare and Sport.

IntroductionAmong girls assessed for pubertal precocity, pelvic ultrasound (pUS) may represent a pivotal tool to predict the time expected to elapse between sonographic assessment and the onset of menarche (TUS-M). Accordingly, the present analysis is meant to define the statistical relationship between sonographic parameters and TUS-M, in order to identify the most reliable predictor of the timing of menarche.MethodsRetrospective, multicenter analysis. Girls assessed for sexual precocity and showing sonographic and clinical findings consistent with pubertal onset upon referral were considered eligible. Patients treated with GnRH analogues were excluded and only those who had subsequently achieved complete and spontaneous pubertal attainment and for whom the exact date of menarche was available were included. Overall, we enrolled 184 girls from five tertiary care Italian Centers.ResultsThe time elapsed (months) between baseline endocrine assessment and spontaneous achievement of menarche showed a negative statistically significant correlation (p

Gas evolution and flow patterns inside an alkaline electrolyzer cell strongly affect efficiency, although such effects have not been explored in detail to date. The present study aims to critically analyze the dependence of cell performance on the multiphase flow phenomena, defining some key metrics for its assessment using CFD. Six performance indicators, involving gas accumulation, bubble coverage, and flow uniformity, are applied to a 3D CFD model of an alkaline cathodic cell, and possible optimizations of the cell geometry are evaluated. The results demonstrate the complexity of defining the optimal indicator, which strictly depends on the case study and on the analysis at hand. For the cell analyzed herein, the parameters linked to the electrode volume fraction were indicated as the most influential on the cell efficiency, allowing us to define the best geometry case during the optimization. Furthermore, a sensitivity analysis was conducted, which showed that higher mass flow rates are generally preferable as they are linked to higher bubble removal. Higher current densities, allowing enhanced gas production, are instead associated with slightly lower efficiencies and stronger nonuniformity of the electrolyte flow inside the cell.

Anti T-lymphocyte globulin (ATLG) is used in hematopoietic stem cell transplantation (HSCT) to prevent graft-versus-host disease (GvHD) and graft failure. To date, insight in ATLG pharmacokinetics and -dynamics (PK/PD) is limited, and population PK (POPPK) models are lacking. In this prospective study, we describe ATLG POPPK using NONMEM® and the impact of ATLG exposure on clinical outcome and immune reconstitution in a homogeneous cohort of pediatric acute lymphoblastic leukemia (ALL) patients transplanted with a matched unrelated donor and receiving uniform ATLG dosing. Based on 121 patients and 812 samples for POPPK analysis, a two-compartmental model with parallel linear and non-linear clearance and bodyweight as covariate, best described the ATLG concentrationtime data. The level of ATLG exposure (day active ATLG day 16 8.2%, p

Down syndrome (DS) is the most common chromosomal disorder worldwide. Along with intellectual disability, endocrine disorders represent a remarkable share of the morbidities experienced by children, adolescents and young adults with DS. Auxological parameters are plotted on syndrome-specific charts, as growth rates are reduced compared to healthy age- and gender-matched peers. Furthermore, children with DS are at increased risk for thyroid dysfunctions, diabetes mellitus, osteopenia and obesity compared to general population. Additionally, male individuals with DS often show infertility, while women tend to experience menopause at an overall younger age than healthy controls. Given the recent outstanding improvements in the care of severe DS-related comorbidities, infant mortality has dramatically decreased, with a current average life expectancy exceeding 60 years. Accordingly, the awareness of the specificities of DS in this field is pivotal to timely detect endocrine dysfunctions and to undertake a prompt dedicated treatment. Notably, best practices for the screening and monitoring of pediatric endocrine disorders in DS are still controversial. In addition, specific guidelines for the management of metabolic issues along the challenging period of transitioning from pediatric to adult health care are lacking. By performing a review of published literature, we highlighted the issues specifically involving children and adolescent with DS, aiming at providing clinicians with a detailed up-to-date overview of the endocrine, metabolic and auxological disorders in this selected population, with an additional focus on the management of patients in the critical phase of the transitioning from childhood to adult care.

The large majority of patients with HER2-positive metastatic breast cancer (MBC) will eventually develop resistance to anti-HER2 therapy and die of this disease. Despite, relatively high levels of stromal tumor infiltrating lymphocytes (sTILs), PD1-blockade has only shown modest responses. Monalizumab targets the inhibitory immune checkpoint NKG2A, thereby unleashing NK- and CD8 T cells. We hypothesized that monalizumab synergizes with trastuzumab by promoting antibody-dependent cell-mediated cytotoxicity.In the phase II MIMOSA-trial, HER2-positive MBC patients were treated with trastuzumab and 750 mg monalizumab every two weeks. Following a Simon's two-stage design, 11 patients were included in stage I of the trial.Treatment was well tolerated with no dose-limiting toxicities. No objective responses were observed. Therefore, the MIMOSA-trial did not meet its primary endpoint.In summary, despite the strong preclinical rationale, the novel combination of monalizumab and trastuzumab does not induce objective responses in heavily pre-treated HER2-positive MBC patients.

In children with acute myeloid leukemia (AML) who lack an HLA identical sibling, the donor can be replaced with an HLA matched unrelated donor (MUD) or a haploidentical donor (haplo). We compared outcomes of patients