Search Results (475)

Background/Objectives: To evaluate the safety of cholecystectomy in nonagenarians. Methods: In compliance with the PRISMA statement standards, a systematic review including random-effects meta-analysis and meta-regression models was conducted. All studies reporting postoperative outcomes in patients aged ≥90 undergoing cholecystectomy were included and analyzed. Results: Six studies (1223 patients) were included. The risk of 30-day mortality was 5.4% (95% CI 3.1–7.7); 30-day morbidity occurred in 22% (95% CI 11.3–32.8). The mean length of hospital stay was 11.5 days (95% CI 8.3–14.6). Postoperative mortality was not affected by male sex (coefficient: 0.028, p = 0.832), ASA status ≥ III (coefficient: 0.051, p = 0.309), cholecystitis as indication for cholecystectomy (coefficient: −0.166, p = 0.051), cholecystectomy in emergency setting (coefficient: −0.020, p = 0.425), laparoscopic (coefficient: −0.104, p = 0.09) or open approach (coefficient: 0.104, p = 0.09), and conversion to open surgery (coefficient: 0.043, p = 0.820). The GRADE certainty of evidence was low to moderate. Conclusions: Subject to selection bias and confounding by fitness, the available evidence suggests that cholecystectomy in highly selected nonagenarians with good performance status, who have passed robust preoperative fitness assessment tests, may be safe with an acceptable risk of morbidity and mortality. Full article

Background: Although early mobilization has been shown to improve clinical outcomes after intensive care unit (ICU)-acquired weakness, its implementation remains limited in routine clinical practice. This study aimed to evaluate the feasibility, safety, and preliminary clinical outcomes of a mobile application-based rehabilitation program in non-ambulatory patients during the early ward phase following ICU discharge. Methods: This prospective single-arm pilot trial included adult patients (≥19 years) who had received ICU care and demonstrated limited ambulatory function, defined as Functional Ambulatory Category (FAC) ≤3. Participants received an individualized, application-guided exercise program comprising two daily sessions over two weeks. Primary outcomes were programmatic feasibility, safety, and patient satisfaction. Rehabilitation compliance was quantified using application usage logs and categorized as high (≥50%) or low (<50%). Secondary functional outcomes, such as Medical Research Council Sum Score (MRC-SS), ICU Mobility Scale, FAC, muscle strength measures, health-related quality of life, and pain scores, were assessed at baseline, week 1, and week 2. Results: Of the 25 initially enrolled patients, 5 dropped out due to clinical status changes or transfers, yielding a retention rate of 80.0%. For the 20 analyzed patients (mean age 52.7 ± 13.9 years; 45% male), the overall mean rehabilitation compliance was 40.6%. No serious adverse events related to the intervention were reported, and overall patient satisfaction and application usability were high. Progressive increases in exercise intensity and training levels were observed throughout the intervention period. Significant improvements over time were found in MRC-SS, ICU Mobility Scale, FAC, grip strength, health-related quality of life, and pain scores (all p < 0.05). Although compliance-based recovery trajectories were confounded by small subgroup sizes and baseline clinical imbalance, exploratory analyses nonetheless identified statistically significant time × compliance interaction effects for MRC-SS and straight leg raise performance. Conclusions: This pilot study demonstrates that a mobile application-based rehabilitation program is a feasible and safe approach to implement in deconditioned patients after ICU discharge. These preliminary functional recovery trajectories provide encouraging signals, suggesting that this digital platform may serve as a potential adjunct to conventional care. Rigorous, randomized controlled trials are required to confirm its definitive clinical efficacy and scalability. Full article

This article revisits the debate on whether the Brussels Agreement and the Ohrid Agreement, including its Implementation Annex, are legally binding. It develops a three-test framework that separates international-law binding force from EU-law legal effects. Tests A and B adapt the International Court of Justice (ICJ) indicators of animus contrahendi and acceptance through subsequent conduct, acquiescence and silence. Test C examines whether the agreements produce legal effects through EU enlargement conditionality, monitoring and reporting. The analysis finds that the treaty status of both instruments remains contestable. The Brussels Agreement is textually specific, yet intent signals are mixed, practice remains reversible and treaty-type obligation structures are weak. The Ohrid Agreement is drafted in a more treaty-like register, but references to a future “legally binding agreement” and the politics of non-signature leave inter se binding force unsettled. Nonetheless, both agreements can produce EU legal effects. They operate as enlargement benchmarks that shape assessments of Serbia’s and Kosovo’s progress, while Commission reporting and standardised compliance indicators may indirectly bind EU institutions through consistency, equal treatment and legitimate expectations. Full article

The Court of Justice of the European Union’s Grand Chamber judgement in Public.Resource.Org v Commission (“Malamud”) raises fundamental questions about the relationship between EU law and the European standardisation system. By holding that harmonised standards referenced in the Official Journal must be accessible to the public free of charge, the Court reaffirmed the principle that individuals must be able to know the norms governing their legal rights and obligations. While widely welcomed as a victory for transparency and the Rule of Law, the judgement poses significant challenges to the longstanding governance and funding model of European standardisation, which relies heavily on copyright-based revenues generated by European Standardisation Organisations and national bodies. This article examines the practical and institutional consequences of the Malamud ruling and explores viable compliance pathways for the EU standardisation system. After outlining the role of harmonised standards within the New Legislative Framework and their growing importance in regulatory regimes such as the Artificial Intelligence Act, it analyses the judgement’s implications for access to law and the copyright status of standards. The article then evaluates a range of implementation models, including Commission-hosted publication, read-only access portals, licencing buyouts, and expanded use of common specifications. It argues that a Commission-hosted publication model, supported by revised funding arrangements, offers the most coherent pathway to reconcile open access with the continued functioning of the European standardisation infrastructure, and proposes corresponding reforms to Regulation 1025/2012. Full article

Background/Objectives: Patients awaiting total hip arthroplasty (THA) may have a preoperative period for home-based exercise. However, the benefit of prehabilitation may depend on programme completion. This study assessed the association between compliance with home-based prehabilitation and postoperative course after THA, particularly hospital stay and self-assessed health status at discharge, and explored associations between compliance and changes in clinical and functional outcomes. Methods: In this prospective single-centre observational cohort pilot study, 40 adults scheduled for elective THA were included in a planned 60-day home-based prehabilitation programme as standard preoperative care. Assessments were performed before prehabilitation, preoperatively, and at discharge. Compliance was recorded using a daily checklist and expressed as a compliance index. Associations were analysed using non-parametric tests and Spearman correlation. Results: Median compliance index was 32.41%. Higher compliance was observed in participants reporting improvement or marked improvement at discharge than in those reporting slight improvement or no improvement (p = 0.0076). Compliance was inversely correlated with postoperative length of stay, median 6 days (rho = −0.593, p < 0.001). Compliance was lower in participants who reported pain during exercise (p = 0.0127). No significant associations were found between compliance and postoperative symptoms or changes in hip muscle strength, mechanical muscle properties, pain intensity, or functional test performance between baseline and preoperative assessments. Conclusions: Greater compliance with home-based prehabilitation was associated with shorter postoperative hospitalization and more favorable self-assessed health status at discharge. These findings support strategies to improve programme completion and minimize exercise-related pain. Full article

River Basin Management Plans (RBMPs) developed under the EU Water Framework Directive (WFD) assume stable monitoring, institutional continuity, and predictable implementation capacity—conditions that are undermined by war-driven uncertainty. This study assesses the feasibility of delivering the 2025–2030 RBMP in the Ukrainian Tisza sub-basin using a combined approach that integrates structured document analysis, a measure-level dataset derived from the Programme of Measures annexes, and a feasibility-screening framework linking expected environmental contribution, implementation dependency, and evidence readiness. The empirical basis covers 120 planned measures in a transboundary sub-basin with a large and heterogeneous surface-water portfolio. While surface-water monitoring remained operational in 2023, groundwater evidence was critically constrained because monitoring had been discontinued since 2018, and groundwater status and risk assessments had not been completed by the end of 2023. The analysis identifies a compliance-critical subset of high-contribution, high-dependency measures, particularly capital-intensive wastewater, monitoring, and groundwater-related interventions, whose implementation and verification are most vulnerable to wartime disruption. The study proposes an evidence-gap closure sequence and a verification-ready prioritisation logic for the 2025–2030 cycle, offering a transferable framework for stress-testing RBMP delivery in transboundary basins under high uncertainty. Full article

Medical device manufacturing requires strict quality control, reliable traceability, and compliance with regulatory requirements. In many cases, inspection activities are still carried out manually and production information is recorded separately, which can result in inconsistent defect detection and limited visibility of manufacturing performance. This paper presents the development and industrial implementation of an integrated closed-loop quality control architecture for a sterile single-use medical device assembly line, addressing the lack of integration between inspection, traceability, and control systems in existing manufacturing approaches. In the proposed approach, we combine radio-frequency identification, machine vision inspection, programmable logic control, and centralized production monitoring. RFID tags store the status of each unit at individual stations so that defective products cannot proceed to downstream operations. Machine vision systems verify component presence, detect missing parts, and confirm color-specific assembly requirements during production. The architecture was tested through implementation on an assembly line and evaluated with comparative pilot studies against a traditional manual inspection process. The upgraded line achieved scrap cost reductions of 52.77% and 53.23% while also improving inspection consistency and production traceability. The results demonstrate that integrating machine vision inspection with RFID traceability can significantly improve quality control and manufacturing efficiency in regulated medical device production. Full article

Nanocoating technology has emerged as a transformative strategy for enhancing the functional properties of food materials, packaging substrates, and food contact surfaces. This review explores the role of biopolymers as coating materials in nanocoating applications, with a particular focus on the food sector. Inorganic nanomaterials such as silver, titanium dioxide, zinc oxide, and silicon dioxide have been extensively studied for their antimicrobial, photocatalytic, and barrier-enhancing properties; however, concerns regarding toxicity and regulatory compliance continue to limit their direct food contact applications. Biopolymer-based nanocoatings present a safer and more sustainable alternative, offering biodegradability, biocompatibility, and GRAS (Generally Recognized as Safe) status. Key application areas reviewed include edible coatings for fresh and minimally processed fruits, vegetables, meat, cheese, and mushrooms; nanocoating of paper-based and polymeric packaging materials to improve gas barrier, mechanical, moisture resistance, and antimicrobial properties; nanocoating of glass or metal containers and active packaging systems, and nanocoating of food contact surfaces to prevent biofouling and microbial contamination. Recent studies confirm that biopolymer-based nanocoatings, particularly those based on chitosan, cellulose nanofibers, and alginate, can significantly extend shelf life, reduce weight loss, retard oxidation, and maintain sensory quality. Migration of nanomaterials from coatings into food systems is identified as a key safety concern. Challenges including scalability, coating durability, substrate compatibility, and incomplete toxicological profiling are critically discussed. This review underscores the need for standardized testing protocols, comprehensive regulatory frameworks, and continued research into durable, food-grade biopolymer nanocoatings as viable replacements for conventional synthetic coating systems in food preservation and packaging. Full article

Background: Conventional therapeutic and diagnostic approaches, despite improving clinical outcomes, remain limited by poor bioavailability, inadequate targeting, suboptimal pharmacokinetics, and systemic toxicity, particularly in complex diseases. To overcome this, nanomedicine has emerged as a transformative strategy, employing engineered nanoparticles to enhance drug stability, controlled release, targeted delivery, and diagnostic performance, thereby enabling theranostic applications. This review evaluates major nanoparticle platforms in therapy and diagnosis, comparing their mechanisms, applications, and challenges while highlighting their potential to advance precision medicine and theranostic strategies. Method: For providing the context and evidence, relevant literatures were sourced from Google Scholar, PubMed, and ScienceDirect using targeted keywords including “drug delivery,” “diagnostics,” “nanoparticles,” “nanomedicine,” “nano drug delivery,” “nanotheranostics,” “targeted therapy,” “controlled drug release,” “solid lipid nanoparticles (SLNs),” “lipid nano carriers (LNCs),” and “inorganic nanoparticles.” Although no strict time limit was applied during the literature search, clinical trial data were collected and analyzed up to January 2026. Given that clinical trial registries are continuously updated, the included trials represent the status at the time of data retrieval. However, it is pertinent to note that the earliest relevant studies appeared in 1973. Conclusions: This review highlights nanoparticle fundamentals, major material classes, mechanisms of action, and applications in targeted therapy, imaging, and theranostics. It also addresses translational barriers related to safety, scalability, biological complexity, and regulatory compliance. Overcoming these challenges through standardized characterization and interdisciplinary collaboration is crucial for clinical adoption. Future efforts should focus on AI-driven design, computational tools, smart nanomedicines, and advanced biosensing technologies to integrate nanoparticle-enabled precision diagnostics and therapy into routine clinical practice. Full article

School zones in the United States require compliance of drivers to decreased speed limits during school start and end times, typically indicated by flashing beacons and warning signs. This study examined school zone safety by evaluating the effects of speed limit differentials on driver speeds in active school zones, the influence of roadway characteristics on driver behavior, and crash costs associated with school zones. The main goal was to attain a sustainable school zone safety policy. The analysis used speed observations from 378,506 vehicles, school and roadway characteristics, and crash data (2014 to 2018) across 18 study sites. Results showed that 85th-percentile speeds often exceeded posted speed limits during both active and passive school zone periods, with greater non-compliance being associated with larger speed limit differentials. Driver speeds were influenced by school zone status, vehicle type, time of day, traffic signals, street parking, and crosswalks. On average, speeds were 6.2 mph higher during passive periods than during active periods. However, high crash rates were observed during active school zone periods. Crashes during active periods resulted in average crash costs that were 52.5% lower than those during passive periods. The findings provide insights into human factors and mobility behavior in school zones, allowing transportation agencies to make informed and sustainable decisions for school zone design and safety. Full article

Background: Supplementation with long-chain omega-3 polyunsaturated fatty acids (LC n-3 PUFAs), particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), may mitigate exercise-induced muscle damage (EIMD) and enhance post-exercise recovery. However, the systematic reviews/meta-analyses evaluating these effects across populations and exercise models are limited and do not provide dosing recommendations. Objective: This systematic review and meta-analysis aimed to evaluate the effects of LC n-3 PUFA supplementation on key post-exercise recovery outcomes, including muscle soreness, muscle function, and muscle damage biomarkers in healthy adults. Methods: Following the PRISMA guidelines, a comprehensive search of PubMed, Scopus, and clinical trial registry databases was conducted (to January 2025). All studies that met the inclusion criteria underwent appropriate methodological quality assessments using established tools. The data were extracted for inputting into random-effects models, with effect sizes reported as Hedges’ g and 95% confidence intervals (CIs). Heterogeneity was assessed using the I² statistic. Results: Among the 2539 records, 43 studies met the inclusion criteria for the systematic review, and nine met the inclusion criteria for the meta-analysis. The effect of LC n-3 PUFA supplementation on recovery outcomes was equivocal, with significant methodological limitations noted across the literature. However, the meta-analysis of nine placebo-controlled, eccentric exercise trials demonstrated that LC n-3 PUFA supplementation significantly reduced delayed onset muscle soreness (DOMS) (Hedges’ g = −0.75; 95% CI: −1.14 to −0.36), creatine kinase (CK) (Hedges’ g = −0.40; 95% CI: −0.70 to −0.10), and muscle swelling (Hedges’ g = −0.45; 95% CI: −0.83 to −0.07), and significantly improved muscle strength (Hedges’ g = 0.45; 95% CI: 0.07 to 0.83) and range of motion (ROM) (Hedges’ g = 0.93; 95% CI: 0.33 to 1.53) at peak impairment compared with placebo. Conclusions: LC n-3 PUFA supplementation may support recovery from EIMD. However, due to the methodological limitations across the literature base it was not possible to assess effective dosing strategies. Future studies should address dose–response and duration requirements and incorporate objective assessments of omega-3 status (e.g., the Omega-3 Index [O3I] or comparable biomarkers) alongside standardized compliance measures. These approaches are necessary to determine effective dosing strategies and to test the relationship between omega-3 status and recovery outcomes. Full article

Background/Objectives: Micronutrient malnutrition, particularly deficiencies in calcium, vitamin D, iron, zinc, and iodine, remains a significant public health issue among school-aged children in Morocco. Processed cheese, such as “The Laughing Cow” (TLC), has potential as a vehicle for fortification due to its widespread consumption and accessibility. This study aimed to evaluate the impact of fortified TLC on micronutrient intake and adequacy relative to the Recommended Dietary Allowances (RDA), among Moroccan children aged 6–12 years, and to explore differences in effects by socioeconomic status (SES). Methods: Data from the Moroccan Household Budget Survey (2013–2014) included 9266 children (39.4% TLC consumers). Dietary intake was assessed using 24 h recalls, and nutrient composition was analyzed using Ciqual 2020 tables and specialized software. Fortification scenarios were modelled to estimate potential impacts on micronutrient intake and compliance with RDAs. Results: Under the modelling scenarios, consumption of one portion/day of fortified TLC significantly improved RDAs compliance for iron, iodine, and zinc (p < 0.05). There was also an increase in RDA compliance for calcium and vitamin D, but differences were not significant. The impact of fortification on micronutrient intake and RDA compliance increased with socioeconomic status. Consumers of more than one portion/day showed the highest compliance with RDAs (p < 0.001). Fortification effects were consistent across age subgroups. Conclusions: Fortifying processed cheese represents a feasible strategy to address micronutrient deficiencies among Moroccan schoolchildren. This study highlights the potential of targeted fortification programmes to improve public health outcomes, particularly in vulnerable populations. Further research is needed to optimize fortification approaches and ensure sustainability. Full article

Introduction: The growing demand for traditional medicines and health supplements (TMHS) in Malaysia has raised concerns regarding microbial contamination in hard-shell capsule products. Despite regulatory oversight, recurring recalls highlight persistent non-compliance with Good Manufacturing Practice (GMP) standards. This study examines the risks of microbial contamination, recall patterns, and encapsulation practices among TMHS hard-shell capsule manufacturers in Malaysia. Methods: A cross-sectional approach was employed, comprising a review of regulatory guidelines, analysis of NPRA recall data from 2020 to 2024, and a structured survey of 86 TMHS manufacturers on equipment and production parameters. Results: Review of GMP guidance indicated that greater automation and reduced manual handling in capsule-filling processes help minimise microbial contamination. In line with this, TMHS products were recalled at a rate of 4.73%, more than 4 times the pharmaceutical recall rate (1.09%). Among the 245 TMHS recalls, 68 involved hard-shell capsule products that failed microbial testing, primarily total aerobic microbial count (73.53%). Additionally, manufacturers with 50–100 registered products had significantly higher odds of recall (OR = 10.0, 95% CI: 2.35–42.47). However, no significant associations were found between recall status and equipment type, capsule size, or production frequency. Conclusions: Microbial contamination remains a critical issue in TMHS hard-shell capsule products. Regulatory efforts should focus on medium-scale manufacturers and reinforce risk-based GMP adherence to enhance product safety and public health protection. Full article

The global exotic pet trade has expanded in recent decades, raising concerns related to animal welfare, biodiversity conservation, and compliance with international regulations. Reptiles and amphibians constitute a major component of this trade, yet information on species availability and trade practices at exotic pet fairs remains limited. The primary aim of this study was to identify the reptile and amphibian species offered for sale at an exotic pet fair in Warsaw, Poland. Secondary objectives were to assess the declared origin of the animals and the availability of information regarding their legal and conservation status. Photographic documentation of all exhibition tables was used to record species identity, number of individuals, and labeling practices. In total, 818 individuals representing 74 species from 31 families were recorded. Reptiles, particularly squamates, dominated the assemblage, while amphibians accounted for a smaller proportion of the animals offered. More than half of the individuals were labeled as captive-bred, whereas only a small fraction were identified as imported or wild-caught; however, information on origin was absent for nearly half of the animals. Over 50% of the recorded species were listed in Appendix II of the Convention on International Trade in Endangered Species of Wild Fauna and Flora, yet no visible information on legal or conservation status was provided at the point of sale. These findings indicate that inconsistent labeling limits transparency and informed decision-making by buyers. Full article

Background/Objectives: Iodine deficiency remains an important global public health concern. Although iodized salt is the primary strategy for iodine deficiency prevention, its effectiveness depends on adequate iodine concentrations in commercially available products. However, laboratory data on the iodine content of retail salt products in Hungary are currently lacking. Therefore, this study aimed to determine the iodine concentration of commercially available iodized table salts in Hungary and to assess their compliance with the WHO-recommended range of 20–40 ppm. Methods: Twenty different brands of iodized table salt were purchased from major retail outlets in Pécs, Hungary, representing the dominant food retail sector. According to product labels, ten salts were fortified with potassium iodate (KIO₃) and ten with potassium iodide (KI). Iodine concentrations were determined by iodometric titration following WHO-recommended laboratory methods. All measurements were performed in triplicate and expressed as mean values. In addition, a small exploratory wholesale micro-survey examined purchasing patterns of iodized and non-iodized salt in the regional supply chain. Results: Measured iodine concentrations varied substantially among products, ranging from 0 to 33.9 ppm. Overall, 65% of the analyzed salt samples contained less than 20 ppm iodine, while only 35% fell within the WHO-recommended range of 20–40 ppm. Notably, several products declared iodine concentrations below recommended levels on their labels. The wholesale micro-survey showed that ten times more iodized than non-iodized salt was ordered during the observation period. Conclusions: These results suggest that the presence of iodized salt on the market does not necessarily guarantee adequate iodine supply and highlight the potential relevance of considering iodine status during the differential diagnosis of hypothyroidism. Full article