Impact of Rule 11 on the European Medical Software Landscape: Analysis of EUDAMED and Further Databases Three Years After MDR Implementation.

Medicine is increasingly supported by software, with digital health technologies offering innovative ways to capture insights and drive therapies. Globally, medical device software must follow regulatory processes based on risk classification. The introduction of MDR represents a significant shift in risk-based classification for Medical Devices in Europe, including classification Rule 11 for software, which has caused significant discussions among European regulators.

Pediatric eosinophilic fasciitis: similarities and differences with adult forms.

The purpose of this study was to identify pediatric eosinophilic fasciitis, which is an extremely rare condition, in order to describe their clinical, paraclinical, and therapeutic characteristics. We made a call for observations via societies for pediatric rheumatology in France and surrounding countries and collected clinical and paraclinical data of the cases fulfilling the diagnostic criteria. Eight patients under 18 years of age with confirmed eosinophilic fasciitis followed between April 2004 and July 2022 in France, Germany, Italy, and Spain were included.

Chromatin environment-dependent effects of DOT1L on gene expression in male germ cells.

The H3K79 methyltransferase DOT1L is essential for multiple aspects of mammalian development where it has been shown to regulate gene expression. Here, by producing and integrating epigenomic and spike-in RNA-seq data, we decipher the molecular role of DOT1L during mouse spermatogenesis and show that it has opposite effects on gene expression depending on chromatin environment. On one hand, DOT1L represses autosomal genes that are devoid of H3K79me2 at their bodies and located in H3K27me3-rich/H3K27ac-poor environments.

Mechanical properties of modern restorative "bioactive" dental materials - an in vitro study.

This study aimed at assessing the mechanical properties and degradation of commercial bioactive materials. The bioactive materials (Activa Bioactive Restorative, Beautifil Flow Plus F00, F03, Predicta Bulk Bioactive) and composite resin Filtek Supreme Flow were submitted to flexural and diametral tensile strength tests (FS, DTS), modulus of elasticity (ME) evaluation, and analysis of aging in 70% ethanol and saliva on their hardness and sorption. The results for DTS ranged from 33.

On the enhancement of the efficiency of concentrated solar power plants using nanofluids based on a linear silicone fluid and Pt nanoparticles.

To reduce greenhouse emissions and producing electricity with the smallest environmental impact, developing solar power technology is one of the most important milestones to achieve. Thus, to improve the efficiency of the concentrated solar power (CSP) plants, with lower environmental impact, is of great interest. This work reports the development of nanofluids, a colloidal suspension of nanomaterials in a fluid, based on an environment-friendly base fluid for improving the performance of the heat transfer process in CSP plants.

Direct collaboration between hospitals and NGOs, an essential tool to reinforce linkage to care in people living with HIV.

With the aim of improving access and engagement to healthcare in people living with HIV (PLHIV), in 2022 Gregorio Marañón Hospital and the NGO COGAM developed a circuit for recruitment and referral to hospital. Program targeted PLHIV who were neither receiving antiretroviral treatment (ART) nor on medical follow-up (FU); but also, individuals at risk who underwent screening tests at the NGO and, if positive, were referred for confirmation. The result was an increase in annual new PLHIV seen in hospital by reaching a population who were, essentially, young men (94% male, median age 30 years), migrants (95%) with recent diagnosis of HIV (median 5 years) and who were recently arrived in Spain (median 5 months).

Digital quantum simulation of cosmological particle creation with IBM quantum computers.

We use digital quantum computing to simulate the creation of particles in a dynamic spacetime. We consider a system consisting of a minimally coupled massive quantum scalar field in a spacetime undergoing homogeneous and isotropic expansion, transitioning from one stationary state to another through a brief inflationary period. We simulate two vibration modes, positive and negative for a given field momentum, by devising a quantum circuit that implements the time evolution.

Nanoscale nonlocal thermal transport and thermal field emission in high-current resonant tunnel structures.

We present a nonlinear model of thermal field emission in resonant tunneling nanostructures with multiple barriers and potential wells, based on an accurate determination of the quantum potential shape and a rigorous solution of the Schrödinger equation, while considering thermal balance. The model applies to vacuum and semiconductor resonant tunnel diode and triode structures with two and three electrodes and to the general case of two-way tunneling with electrode heating. The complete balance of heat release and transfer is accounted for, with heat transport considered ballistic.

Enhanced phosphorus weathering contributed to Late Miocene cooling.

Late Miocene climate evolution provides an opportunity to assess Earth's climate sensitivity to carbon cycle perturbation under warmer-than-modern conditions. Despite its relevance for understanding the climate system, the driving mechanisms underlying profound climate and carbon cycle changes - including the enigmatic Late Miocene cooling from 7 to 5.4 million years ago - remain unclear.

α-Copaene is a potent repellent against the Asian Citrus Psyllid Diaphorina citri.

The Asian Citrus Psyllid (ACP), Diaphorina citri, severely threatens citrus production worldwide by transmitting the greening (= Huanglongbing)-causing bacterium Candidatus Liberibacter asiaticus. There is growing evidence that the push-pull strategy is suitable to partially mitigate HLB by repelling ACP with transgenic plants engineered to produce repellents and attracting the vector to plants with a minimal disease transmission rate. Species that pull ACP away from commercial citrus plants have been identified, and transgenic plants that repel ACP have been developed.

A catalogue of land-based adaptation and mitigation solutions to tackle climate change.

Informing and engaging all actors in the land sector, including land-owners and managers, researchers, policy-makers and citizens, on the most effective sustainable land-based solutions and behavioural changes is a key strategy for achieving climate change adaptation and mitigation targets at the global as well as at EU and local level. One requisite to support actors in the land sector is to provide them publicly available, reliable and ready-to-use information related to the implementation of Land-based Adaptation and Mitigation Solutions (LAMS). Here we introduce a LAMS catalogue, a collection of meaningful quantitative and qualitative information on 60 solutions characterised according to a set of specifications (e.

Experience with the implementation of central venous catheters by medical oncologists in a non-surgical setting.

Totally implantable central venous catheters (CVCs) are widely used in the management of patients with malignant diseases. Conventionally, port implantations were carried out by general surgeons and vascular radiologists. In recent years, the medical staff of the Medical Oncology department at the Central University Hospital of Asturias (HUCA) has developed a simplified methodology for the routine implantation of these devices.

Can a single coastal tide gauge help predict internal solitary wave activity offshore.

Internal solitary waves (ISWs) propagate in stratified waters, enhancing diapycnal mixing, sediment and mass transport on shelves. They have typical wavelengths of hundreds of meters and tens of minutes periods, requiring high resolution and high frequency measurements for their sampling. But such in-situ measurements are scarce and ISWs remain largely unpredictable.

Contact lenses for visual rehabilitation in post-keratoplasty eyes: A systematic review.

Purpose: To evaluate the role of contact lenses (CLs) in visual rehabilitation following keratoplasty.

Methods: Four databases, including PubMed, Scopus, Web of Science, and Embase were systematically searched for studies published between January 2010 and July 2023. Visual outcomes, daily wearing duration, subjective comfort, rate and etiology of CL discontinuation, corneal endothelial cell density, central corneal thickness, and complications were extracted.

Epidemiology of colistin resistance mediated by mcr-1 in carbapenemase-producing Enterobacterales in Ecuador in three periods from 2016 to 2022.

Carbapenemase-producing Enterobacterales (CPE) have increased in the last decade. In low-income countries, colistin is considered a last resort antimicrobial to treat CPE infections, whose most worrisome mechanism of resistance is MCR-1 production. This study aims to understand the epidemiology of colistin resistance in CPE in the region, through the surveillance of the mcr-1 gene in CPE isolates in Ecuador.

Habit of physical-sports practice and the healthy lifestyle among Spanish adults from 22 to 72 years of age.

Background: Physical-sports habits in adulthood constitute one of the predictors of physical, psychological and social health within healthy lifestyles.

Methods: The Acquired Healthy Lifestyle Assessment Scale was applied to a sample of 788 subjects between the ages of 22 and 72 and the dimension that makes up physical-sports practice habits was analyzed.

Results: 74.

[Translated article] Toxicity of the FOLFOX-6 regimen, with or without 5-fluorouracil bolus, in metastatic colorectal cancer.

Objective: Standard treatment of metastatic colorectal cancer includes oxaliplatin and 5-fluorouracil in continuous infusion. Although FOLFOX-6 is the reference combination, it is aggressive and has high toxicity. Variants such as the TTD regimen, which does not include folinic acid or 5-fluorouracil bolus, are used.

Skin and soft tissue infections in people migrating by sea to the Canary Islands, Spain.

Introduction: People migrating to the Canary Islands by sea frequently suffer from potentially severe skin and soft tissue infections (SSTIs) for which optimal empirical antibiotic therapy is not well defined.

Methods: This descriptive retrospective observational study assess a case series of newly arrived maritime migrants to the Canary Islands who were diagnosed with clinical and microbiological SSTIs and admitted to the Nuestra Señora de La Candelaria Hospital in Tenerife between January 2020 and December 2023. Clinical data, bacterial species, resistance profiles, and choice of empirical treatments were analysed.

[Quality of organizations and the system: It is not the same].

Governance and management, two terms that are barely understood, are precisely defined, and measured. They explain a very important part of the difference between countries, systems, and organizations. Also, in healthcare.

The role of nutritional vitamin D in CKD-MBD in children and adults with CKD, on dialysis and after kidney transplantation - a European consensus statement.

Vitamin D deficiency is common in patients with chronic kidney disease (CKD) and associates with poor outcomes. Current clinical practice guidelines recommend supplementation with nutritional vitamin D as for the general population. However, recent large-scale, clinical trials in the general population failed to demonstrate a benefit of vitamin D supplementation on skeletal or non-skeletal outcomes, fueling a debate on the rationale for screening for and correcting vitamin D deficiency, both in non-CKD and CKD populations.

MAdPHOS, a P-Stereogenic Aminodiphosphane Ligand with Adamantyl Groups: Synthesis, NH/PH Tautomerism, and Rhodium and Nickel Complexes.

A novel chiral ligand, named MAdPHOS, bearing a P-stereogenic phosphane and a diadamantyl phosphane linked by a NH bridge has been synthesized. This bulky, C-symmetric, PNP ligand has been prepared from enantiopure -butylmethyl aminophosphane and was obtained as a crystalline solid. The NH/PH tautomerism, air-stability, and σ-donor capacity of MAdPHOS have been assessed herein.

Ischaemia-reperfusion time differences in ST-elevation myocardial infarction in very young patients: a cohort study.

Introduction: ST-elevation myocardial infarction (STEMI) is one of the most prevalent presentations in young patients. It is essential to emphasise that each minute of delay in providing medical care is negatively correlated to the patient's prognosis. The present study was carried out to evaluate the ischaemia-reperfusion times in patients ≤40 years of age versus individuals >40 years of age and their association with mortality and major adverse cardiac event (MACE) over the long term.