Understanding how cooperation persists despite the advantage of selfish behavior remains a central challenge in evolutionary dynamics. Classical models of public goods dilemmas predict dominance of defectors, yet natural and social systems often sustain cooperation. We study an eco-evolutionary public goods game on complex networks where cooperators and defectors diffuse at different rates. When the isolated system is in a defector-dominated coexistence regime, faster dispersal of defectors than cooperators leads to a symmetry-breaking transition that produces localized clusters of cooperators. In heterogeneous networks, nodes with higher connectivity become significantly more likely to exhibit cooperative dominance. A degree-based mean-field reduction supports this result by showing that network connectivity controls an effective coupling strength proportional to node degree, thereby producing a bifurcation that separates defector-dominated and cooperative states. We also address why not all hubs become cooperative by means of a multistability analysis. These results reveal how asymmetric mobility and heterogeneous connectivity jointly promote cooperation in structured populations.
The establishment of BUMN (State-Owned Enterprises) involved in the management of state-owned enterprises aims to contribute to national economic development and state revenue, provide high-quality goods and services to meet the needs of the community, and become a pioneer in business fields that have not been widely managed by the private sector. Problems related to losses in BUMN occur due to negligence and mismanagement by the Board of Directors. Eliminating criminal liability for directors who cause losses to BUMN can create opportunities for crimes and criminal acts that further cause losses to BUMN. The importance of this study is to analyze the limits of directors' actions that cannot be punished criminally and this study aims to evaluate the institutional consequences of violations committed by directors in BUMN. The enactment of Law Number 1 of 2025 concerning State-Owned Enterprises, which states that the Board of Directors is not a state administrator, has sparked debate over the legal accountability of the Board of Directors. The research method used focusses on the legal norms, rules, and principles found in legislation or other legal sources. This research approach uses a case study approach aimed at analysing the rules and their application, as well as the sanctions imposed. The entire data will be analysed to find solutions to the existing problems. The research results explain that legal liability, whether criminal, civil, or administrative, can be applied as long as the Board of Directors is proven to have committed the act. Harmonisation of laws related to the management of BUMN must be carried out, particularly concerning the status of BUMN as legal subjects equal to other legal subjects, namely individuals and private corporations, to ensure legal certainty in the application of the law regarding the legal accountability of the Board of Directors.
Accurate prediction of drug permeation through the stratum corneum is crucial for efficient preclinical development of topical formulations. In this study we investigated the suitability of two different stratum corneum-mimicking barriers (SCMBs) as predictive tools for evaluating the performance of topical formulations. For this purpose, we investigated hydrogels containing respectively three different APIs, i.e., caffeine, diclofenac, and ibuprofen as model formulations. Prior to in vitro permeation studies, the rheology, spreadability and swelling properties of the gels were characterized. Drug release kinetics were also investigated, following the USP dissolution test for semisolids. In vitro permeation studies across SCMBs highlighted the predominant role of API molecular properties on the permeation across lipid-based barriers, particularly API partitioning/hydrophilicity and molecular size. Interestingly, the results highlighted the crucial role of the lipid composition of the SCMB and, specifically, the ceramides content, in the API permeation kinetics. Ex vivo permeation studies evidenced distinct differences in permeation behavior between SCMBs and biological skin models, where the latter showed higher barrier resistance and lower permeation, in line with their more complex structural organization. Overall, the two artificial membranes tested represent reliable and predictive systems for early-stage topical formulation screening.
Sleep is a critical physiological process essential for overall brain health. Recent research shows that the glymphatic system is a key player in facilitating the metabolic waste clearance. However, the continuous real-time monitoring of brain water dynamics during sleep remains substantially challenging. Here, we introduce a soft, wearable near-infrared spectroscopy (NIRS) system to detect brain water dynamics potentially linked to glymphatic activity. The device features an integration of multi-wavelength LEDs and photodetectors. The in vivo study with multiple human subjects captures the device's overnight sleep monitoring in a natural home environment, revealing continuous changes in brain water dynamics across different sleep stages. Our results support the link between sleep stage-dependent water dynamics and glymphatic activity. Spectral analysis identifies several physiological rhythms during sleep, including respiration, heart rate, and oscillations linked to slow-wave activity. These advancements significantly enhance the NIRS system's potential for a deeper understanding of brain health.
The benefit provided by hearing devices often differs between laboratory evaluations and real-world conditions, due to low signal-to-noise ratio (SNR) in adaptive speech tests and differences in head movement behavior between laboratory evaluations and real conversations. This study aimed to investigate whether SNR improvement provided by a spatial filter can be measured during free conversation in virtual reality (VR) and to compare this SNR improvement with the benefit measured using a speech test with two spatially separated talkers in the same VR. Two experimental conditions were tested in 11 normal-hearing participants. Condition 1 involved free conversations between a participant and two confederates represented by avatars, and Condition 2 utilized an adaptive speech test with two speakers, presented by the same avatars. Acoustic simulations were used to render speech signals, background noise and room acoustics. A spatial filter with two levels of selectivity was simulated in VR using the participant's actual dynamic head orientation. Acoustic measures of the benefit of the spatial filter were derived from these simulated signals. The benefit was higher when measured in free conversations than in the speech test. Additionally, participants were found to move their heads closer to active speakers during free conversation than during the speech test. Furthermore, SNR in free conversations was closer to SNRs typical of conversational environments. These findings suggest that the effectiveness of hearing devices can be evaluated through conversations in VR at more realistic SNRs. Consequently, this approach may improve the ecological validity of hearing aid research outcomes.
The experience of forced migration, along with post-migration stressors, can elevate the risk of poor sexual health outcomes among young people. Despite this, little evidence is available on the sexual health needs, behaviors, and healthcare utilization of young male forced migrants in Sweden and elsewhere. This study aims to explore the attitudes, perceived knowledge, experiences, and needs of young Eritrean, Afghan, and Syrian men regarding condom use, Sexually Transmitted Infections (STIs), transactional sex, and sexual healthcare utilization. In this qualitative study, semi-structured interviews were undertaken with 32 young male forced migrants (former unaccompanied minors, refugees, and asylum seekers) ages 16 to 28. The data were analyzed using qualitative content analysis. Three broad themes and eight categories emerged from the analysis: 'Gaps in STI knowledge and ambiguity towards condom use as an STI prevention strategy'; 'knowing it is illegal to pay for sex in Sweden, yet feeling ambivalent towards transactional sex'; 'school, female partners, and trust in healthcare providers eased challenges in sexual health communication and access'. This study highlights important sexual health needs among the study population, emphasizing the value of school-based sexuality education in improving knowledge, including condom use. Female partners also played a key role in facilitating communication, STI testing, and service utilization. To address these needs, school-based interventions should be strengthened to include safer sexual practices, communication skills, and increased awareness of sexual health services. Programs should also provide practical guidance on accessing sexual healthcare and youth-friendly clinics. Main findings: Our findings highlight STI knowledge gaps, ambiguous attitudes towards condom use and transactional sex, as well as challenges related to sexual health communication and navigating access to sexual health care and information within our study population.Added knowledge: Attending school-based sexuality education and having a female partner with sexual health awareness facilitated sexual communication, STI testing, condom use, and the utilization of sexual health care. While various barriers to accessing care in general were identified, those who visited youth clinics perceived the services and staff more positively.Global health impact for policy and action: It is vital that sexual and reproductive health and rights interventions for young male forced migrants address aspects such as safe sexual practices, effective sexual communication, transactional sex, and navigating sexual health care. Furthermore, these interventions should integrate practical skill-building elements regarding access to care and information to better address the specific needs of this population.
Dental caries is a multifactorial, dynamic disease leading to the demineralization and loss of tooth structure. Traditionally, it is treated with mechanical removal of the carious tooth structure and restoration with a restorative material, requiring specialized skills and equipment. Young children, patients with physical or intellectual disabilities, elderly patients, and patients living in remote communities are disproportionately affected because of greater difficulty accessing and undergoing operative dental procedures. The purpose of this narrative review is to explore the use of silver diamine fluoride as an alternative or adjunct tool in clinical practice for treating and preventing dental caries. This review was conducted from July 2022 to May 2025. Three electronic databases-PubMed, Cochrane Library, and Ovid Medline-were searched using the keywords silver diamine fluoride, SDF, fluoride, access to care, caries risk, restorative material, and caries prevention. Opinion articles and those not published in English were excluded from consideration. The literature search returned 74 articles, including qualitative studies, case studies, randomized clinical trials, systematic reviews, and meta-analyses. Silver diamine fluoride was found to be effective in treating cavitated and non cavitated lesions caused by dental caries. With proper case selection and follow up, silver diamine fluoride is an effective agent for arresting dental caries. Its use by more clinicians because of its effectiveness, safety, low cost, and ease of use can help alleviate some of the challenges faced by certain patient populations. Further research should be undertaken to assess the effectiveness of silver diamine fluoride on adult teeth as well as for dental caries prevention. La carie dentaire est une maladie multifactorielle dynamique qui entraîne la déminéralisation des dents et la compromission de la structure dentaire. Traditionnellement, son traitement consiste en l’excavation mécanique de la structure dentaire atteinte et la restauration de la dent à l’aide d’un matériau de réparation, ce qui nécessite des compétences et un équipement spécialisés. Les jeunes enfants, les patients ayant une déficience physique ou intellectuelle, les patients âgés et les patients vivant dans des collectivités éloignées sont touchés de façon disproportionnée en raison de la difficulté accrue à accéder aux procédures dentaires nécessaires. Cette revue narrative explore l’utilisation du fluorure diamine d’argent comme outil de rechange ou d’appoint dans la pratique clinique pour traiter et prévenir les caries dentaires. Cette revue a été réalisée de juillet 2022 à mai 2025. Les recherches ont été menées dans trois bases de données électroniques — PubMed, Cochrane Library et Ovid Medline — à l’aide des mots-clés silver diamine fluoride, SDF, fluoride, access to care, caries risk, restorative material, et caries prevention. Les articles d’opinion et les articles publiés dans une langue autre que l’anglais ont été exclus de la revue. La recherche documentaire a permis de cerner 74 articles, notamment des études qualitatives, des études de cas, des essais cliniques randomisés, des revues systématiques et des méta-analyses. Le fluorure diamine d’argent s’est révélé efficace dans le traitement des lésions avec cavité et sans cavité causées par les caries dentaires. Avec une sélection et un suivi appropriés des cas, le fluorure diamine d’argent est un agent efficace pour enrayer les caries dentaires. Son adoption par un plus grand nombre de cliniciens en raison de son efficacité, sa sécurité, son faible coût et sa facilité d’utilisation peut contribuer à l’atténuation de certains défis auxquels font face des populations de patients particulières. Des recherches additionnelles devront être menées pour évaluer l’efficacité du fluorure diamine d’argent chez les adultes et sa capacité à prévenir les caries dentaires.
To map and synthesize the available evidence on the use of Auracast technology in hearing aids (HA), in the context of auditory accessibility in public environments. This scoping review followed the Joanna Briggs Institute (JBI) and PRISMA-ScR guidelines. The PCC framework was adopted (Population: individuals with hearing loss using HA; Concept: Auracast technology; Context: public environments). The search strategy was based solely on the keyword "Auracast" and applied to a defined time window from June 2022 (the official launch of Auracast) to April 2025. Information sources included scientific databases (PubMed, Scopus, IEEE Xplore, Dimensions Analytics) and gray literature sources (Google Scholar, websites of HA manufacturers, professional associations, and institutional repositories such as OSF and OpenGrey). Study selection and data extraction were conducted independently and blindly by two reviewers, with disagreements resolved by consensus. A total of 348 records were identified. After removing duplicates and applying eligibility criteria, 17 studies were included in the final synthesis. The available evidence suggests that Auracast could improve accessibility and autonomy in public settings, particularly when integrated with HA. However, most studies were technical or descriptive, lacking robust clinical evaluations. Auracast is an emerging innovation in auditory accessibility. Nevertheless, further empirical studies are needed to assess its effectiveness in educational, healthcare, and transportation settings. Large-scale adoption will depend on technical, financial, and social factors, especially in low-infrastructure contexts. Mapear e sintetizar as evidências disponíveis sobre o uso da tecnologia Auracast em dispositivos eletrônicos de amplificação sonora (DEAS), no contexto da acessibilidade auditiva em ambientes públicos. A revisão seguiu as diretrizes do Joanna Briggs Institute (JBI) e do PRISMA-ScR. Foi utilizada a estrutura PCC (População: indivíduos com perda auditiva usuários de DEAS; Conceito: tecnologia Auracast; Contexto: ambientes públicos). A busca foi realizada em abril de 2025 e abrangeu o período de junho de 2022 a abril de 2025, utilizando o termo “Auracast” como palavra-chave. As fontes de informação incluíram bases de dados científicas (PubMed, Scopus, IEEE Xplore, Dimensions Analytics) e fontes de literatura cinzenta (Google Acadêmico, sites de fabricantes de DEAS, associações profissionais e repositórios institucionais, como o OSF e o OpenGrey). A seleção e extração dos dados foram realizadas por dois revisores independentes e cegados, com resolução de conflitos por consenso. Foram identificados 348 registros. Após a remoção de duplicatas e a aplicação dos critérios de elegibilidade, 17 publicações foram incluídas na síntese final. As evidências disponíveis apontam para o potencial do Auracast em promover maior acessibilidade e autonomia em espaços coletivos, especialmente quando integrado a DEAS. Entretanto, as publicações encontradas são predominantemente técnicas ou descritivas, com escassez de avaliações clínicas robustas. O Auracast representa uma inovação emergente no campo da acessibilidade auditiva, mas ainda são necessários estudos empíricos que avaliem sua eficácia em ambientes educacionais, de saúde e de transporte. A adoção em larga escala dependerá de fatores técnicos, financeiros e sociais, especialmente em contextos com infraestrutura limitada.
Dried blood spot (DBS) testing enables hepatitis C virus (HCV) testing in hard‑to‑reach patient populations but typically lacks full genotype and drug resistance information. This study evaluates a commercially available hybrid‑capture whole‑genome sequencing (WGS) workflow for HCV from DBS to determine suitability for clinical diagnostic and surveillance purposes. We analysed 147 DBS and 24 plasma samples known to be HCV‑RNA positive using the QIAGEN QIAseq xHYB HepC panel. Whole genome sequences were generated using an in-house custom designed iterative bioinformatic pipeline. We assessed coverage characteristics, genotyping accuracy, resistance‑associated mutation (RAM) detection, and analytical sensitivity to determine panel performance. WGS success rates were high for both DBS (95%) and plasma (96%). Genome enrichment was uniform across major HCV genotypes, with no systematic dropouts. Genotyping showed 100% concordance with reference laboratory results including for novel genotype 1 subtypes. RAMs were detected in 27% of samples assessed, with full concordance with reference laboratory results in those with known resistance profiles. Analytical sensitivity was calculated at < 7301 IU/ml for WGS with slightly poorer performance when assessing the NS5a gene in isolation. This protocol reliably generates high‑quality HCV genomes from DBS, enabling accurate genotype, subtype, and resistance profiling. This approach overcomes limitations of venous sampling in hard-to-reach populations and could support decentralised diagnostics and enhancing genomic surveillance in populations underserved by traditional healthcare pathways.
Bilateral cochlear implant (BiCI) users do not perform as well as typical hearing listeners when discriminating the direction of sound motion. This is likely due to the lack of synchronization between two independently operating sound processors. The use of bilaterally linked processors can improve the timing of electrical stimulation across the ears. However, these improvements are potentially counteracted by spectral peak-picking in sound coding strategies that may activate different electrodes across the ears, thereby reducing the fidelity of the binaural cues that BiCI users rely on for sound localization. To improve interaural synchrony, a bilateral peak-picking strategy that guarantees coordinated stimulation across the ears was developed and tested using the CCi-MOBILE, a bilaterally linked research processor. The auditory motion tracking abilities of nine BiCI users were measured using the bilateral peak-picking strategy and compared to performance with commercially available, unsynchronized processors. Results showed no effect of bilateral peak-picking. However, a small benefit was observed when tracking the range of motion of a sound when listening with bilateral synchronization which appears to be due to reduced interaural level difference changes with auditory motion. These findings suggest that dynamic auditory perception with BiCI may likely need bilaterally-synchronized hardware.
Anastomotic leakage (AL) remains a severe complication after colorectal surgery, increasing morbidity and mortality. Powered circular staplers may influence anastomotic healing through standardised compression and power distribution. This study aimed to compare clinical outcomes of powered versus manual circular staplers for transanal anastomoses. This retrospective single-centre cohort study included consecutive patients undergoing colorectal resection with transanal circular anastomosis between January 2022 and June 2025. Primary endpoint was the incidence of AL according to stapler type. To ensure comparability between groups, propensity score matching was performed. Among 333 patients, powered staplers were used in 69.1% and manual staplers in 30.9%. The overall AL rate was 15.0%. AL was significantly associated with higher BMI (28.1 vs. 26.6 kg/m²; p = .021), ASA ≥ 3 (64.0 vs. 46.0%; p = .019), diabetes mellitus (24.0 vs. 8.1%; p .001), open (34.0 vs. 19.1%) or converted surgeries (14.0 vs. 4.9%; p = .004) and greater intraoperative fluid administration (2548.1 vs. 2188.8 ml; p = .015). Most patients (72.1%) followed enhanced recovery concepts (FAST TRACK) with trend toward lower adherence in the AL cohort (n.s.).  After propensity score matching, AL occurred in 9.7% following powered circular stapling and 11.8% following manual circular stapling (n.s.). In this cohort, powered stapling devices were not associated with lower anastomotic leakage rates compared with manual staplers for transanal circular anastomosis in patients managed under modern minimally invasive and FAST TRACK concepts.
The microbial safety of food additives is regulated under Japan's Specifications and Standards for Food Additives (JSFA), which includes detection tests for Salmonella. The current standard procedure in JSFA requires selective enrichment of Salmonella using tetrathionate (TT) and Rappaport-Vassiliadis (RV) broths with differing incubation temperatures: 43 ± 0.2℃ for TT broth under high microbial load conditions, 35 ± 2℃ for TT broth under low bacterial load conditions, and 42 ± 0.2℃ for RV broth. These distinct incubation requirements necessitate separate temperature control, thereby increasing the complexity of laboratory procedures. In this study, we evaluated the temperature-dependent enrichment behavior of Salmonella under a limited set of conditions relevant to the JSFA method. Salmonella enterica subsp. enterica serovars Abony and Typhimurium were inoculated into food additive products in lactose broth with or without Escherichia coli at 102, 1.3×105, and 1.3×106 CFU/sample as a competing bacterium. The inoculated mixtures were incubated at 35 ± 1℃ for 22 hr, after which aliquots (TT: 1 mL/RV: 0.1 mL) were inoculated into TT and RV broths and incubated at 42 ± 0.2℃ and 43 ± 0.2℃ for RV broth under none/low-level E. coli co-inoculation, whereas RV broth was incubated at 42 ± 0.2℃ under high-level E. coli co-inoculation, and at 35 ± 2℃, 42 ± 0.2℃, and 43 ± 0.2℃ for TT broth. The cultures were plated on selective agar to evaluate Salmonella recovery. For TT broth, no clear differences in recovery scores were observed among 35 ± 2℃, 42 ± 0.2℃, and 43 ± 0.2℃, regardless of E. coli co-inoculation. Under none/low-level E. coli co-inoculation, recovery after RV enrichment at 42 ± 0.2℃ and 43 ± 0.2℃ was comparable. In some food additive products, colonies were not recovered on one or more selective media in some replicate experiments; however, when three selective agars were used in parallel, the incubation temperature for TT broth did not markedly affect the overall test interpretation. The recovery of S. Typhimurium on some selective agars was reduced following incubation in RV broth containing food additives, protease and isoamylase co-inoculated with E. coli at high microbial loads. This suggests that high levels of bacterial contamination in certain food additive enzyme products, including protease and isoamylase, may suppress Salmonella recovery in RV broth. Further investigation using a broader range of contaminating microorganisms and food additive types is required to validate these findings.
Stroke remains a major cause of disability worldwide, with gait impairment affecting up to 80% of survivors and contributing to long-term dependence, fall risk, and reduced quality of life. In Saudi Arabia, stroke incidence is rising, with a significant burden on younger populations and disparities in access to post-stroke rehabilitation services. Conventional gait analysis tools rely on expensive, specialized laboratory equipment, which limits their availability in low-resource and rural settings. Recent advances in wearable sensor technologies, including inertial measurement units, pressure insoles, and electromyography systems, offer portable, scalable, and cost-efficient options for assessing gait in real-world environments. These systems can offer continuous monitoring, tele-rehabilitation, and personalized feedback, aligning with global shifts toward digital health oversight. This review explores the application of wearable sensor-based gait analysis in post-stroke rehabilitation, highlighting sensor modalities, clinical utility, implementation challenges, and opportunities, particularly in Saudi Arabia, to strengthen rehabilitation services and optimize patient outcomes.
Hyperpolarised magnetic resonance spectroscopy (HP-MRS) enables real-time, non-invasive assessment of metabolism by increasing signal sensitivity by more than four orders of magnitude compared with conventional magnetic resonance spectroscopy (MRS). This signal enhancement is achieved by preparing nuclear spin populations in a non-equilibrium state prior to measurement, generating a substrate with a transient strongly amplified signal that enables detection of rapid metabolic conversion in real time. Integration of HP-MRS with cell-based microfluidic disease models (engineered systems in which living cells are cultured within controlled microscale environments that mimic key aspects of tissue physiology) enables dynamic metabolic profiling in physiologically relevant settings. These models are typically implemented as organ-on-a-chip platforms, where microfabricated channels enable precise control over perfusion, nutrient delivery, oxygenation and cellular interactions. Combined HP-MRS and chip-based microfluidic platforms enable direct, non-destructive assessment of metabolic transformations, with applications in biomarker discovery, treatment response assessment and personalised medicine. This At a Glance article reviews recent advances in chip-based microfluidic systems that are integrated with HP-MRS platforms, including designs compatible with benchtop and high-field nuclear magnetic resonance systems together with clinical magnetic resonance imaging systems. Key challenges for this technology include constraints imposed by signal decay time, variability in polarisation levels, injection reproducibility and the lack of standardised data processing.
A rare clinical case presentation of complications due to 15-year previously Memokath stent placement.
Rigid thoracoscopy is an established diagnostic instrument for pleural diseases; however, it is limited by challenges related to manoeuvrability, patient comfort and operator learning curve. A novel dual-function semi-rigid thoracoscope with associated semi-rigid forceps has been engineered to integrate the diagnostic efficacy of rigid biopsy forceps with the ergonomic advantages of a semi-rigid system. The Dual-functIon Semi-rigid thoraCoscOpy Versus rigid thoracoscopy for the diagnosis of plEuRal disease trial was designed to evaluate whether this device achieves a diagnostic yield that is non-inferior to that of traditional rigid thoracoscopy. This study is designed as a prospective, randomised, open-label, controlled, non-inferiority trial. A cohort of 92 patients presenting with undiagnosed exudative pleural effusion across five centres in China will be randomly allocated to undergo pleural biopsy using either a dual-function semi-rigid thoracoscope or a conventional rigid thoracoscope. The primary endpoint of the study is the diagnostic yield. The key secondary endpoints include procedural analgesic requirements, specimen quality, operator-assessed device performance, postprocedural pain and safety. A non-inferiority margin of 10% will be applied, with analyses conducted on both the intention-to-treat and per-protocol populations. The study protocol was approved by the Ethics Committee of China-Japan Friendship Hospital (2026-KY-033). Written informed consent will be obtained from all participants before enrolment. The trial will be conducted in compliance with the Declaration of Helsinki and Good Clinical Practice guidelines. The results will be submitted for publication in a peer-reviewed journal. NCT07114783.
The withdrawal of traditional foreign suppliers and subsequent legalization of parallel importation, called upon to saturate market with necessary production, objectively created favorable conditions for penetration of counterfeit goods into medical sector, posing direct threat to health and life of population. In response to these challenges, the state authorities initiated launch of system of mandatory labeling for medical articles that conditioned actuality of considered topic. The article presents comprehensive analysis of phased implementation of mandatory labeling as key mechanism ensuring traceability of medical articles turnover. The article considers in detail chronology of introduction of mandatory requirements from initial registration of participants in the system "Honest Sign" and application of Data Matrix codes to step-by-step expansion of list of articles. The special attention is paid to analysis of technical aspects of labeling, including structure of identification code and practical tools for importers, such as information retrieval system for customs and logistics warehouses. Уход традиционных иностранных поставщиков и последующая легализация параллельного импорта, призванная насытить рынок необходимой продукцией, объективно создали благоприятные условия для проникновения в медицинский сектор фальсифицированных товаров, представляющих прямую угрозу здоровью и жизни населения. В ответ на эти вызовы государством был инициирован запуск системы обязательной маркировки медицинских изделий, чем обусловлена актуальность рассматриваемой темы. В статье проведен комплексный анализ поэтапного внедрения инструмента обязательной маркировки как ключевого механизма обеспечения прослеживаемости оборота медицинских изделий. В статье подробно рассмотрена хронология введения обязательных требований — от первоначальной регистрации участников в системе «Честный знак» и нанесения кодов Data Matrix до поэтапного расширения перечня товаров. Особое внимание уделено анализу технических аспектов маркировки, включая структуру кода идентификации и практические инструменты для импортеров, таких как поисковая система таможенных и логистических складов.
Long-term outcomes of paclitaxel-coated drug-coated balloons (DCBs) in patients with diabetes mellitus (DM) and infrainguinal peripheral arterial disease (PAD) are incompletely defined. In the current study, we evaluated 5-year outcomes in the diabetic cohort of BIOLUX P-III. BIOLUX P-III was a prospective, international, multicenter, post-market, single-arm study evaluating the Passeo-18 Lux DCB in routine practice. Between October 2014 and January 2017, 877 patients with infrainguinal lesions were treated at 47 centers, of whom 418 (47.7%) had DM. The primary clinical endpoint was 6-month freedom from major adverse events (MAEs), defined as freedom from procedure- or device-related death through 30 days, major target-limb amputation, or clinically driven target-lesion revascularization (CD-TLR). The primary performance endpoint was 12-month freedom from CD-TLR. Time-to-event outcomes were analyzed using Kaplan-Meier methods and the Log rank test. Among 877 treated patients, 418 had DM. Follow-up completion was 81.6%, 86.4%, 82.3%, and 31.3% at 6, 12, 24, and 60 months, respectively. At 5 years, freedom from MAE was lower in patients with DM than in those without DM (71.2% vs 74.7%; P = 0.0359), whereas freedom from CD-TLR was similar between groups (79.8% vs 79.6%; P = 0.535). Patients with DM also had lower overall survival (56.3% vs 73.8%; P < 0.0001), lower freedom from major target-limb amputation (92.4% vs 98.8%; P < 0.0001), and lower amputation-free survival (53.0% vs 73.6%; P < 0.0001). In this real-world registry, the Passeo-18 Lux DCB was associated with durable freedom from reintervention through 5 years, with similar CD-TLR rates in patients with and without DM. Patients with DM had poorer long-term survival and limb outcomes. However, these findings should be interpreted in the context of baseline between-group differences and limited 60-month follow-up (ClinicalTrials.gov number, NCT02276313). Peripheral arterial disease is a condition in which the blood vessels supplying the legs become narrowed or blocked. This can reduce blood flow, cause pain when walking, delay wound healing, and in severe cases increase the risk of amputation. People with diabetes are at especially high risk because they often have more severe artery disease and more other health problems that affect the heart, kidneys, and circulation. This study examined the long-term outcomes of a treatment called the Passeo-18 Lux drug-coated balloon in patients with leg artery disease. A drug-coated balloon is used during angioplasty to open narrowed arteries and deliver a medicine called paclitaxel to the artery wall to help reduce re-narrowing. We analyzed 877 patients treated in routine clinical practice, including 418 patients with diabetes, and followed outcomes for up to 5 years. We found that the need for repeat treatment of the same artery was similar in patients with and without diabetes. This suggests that the device performed well at the level of the treated artery over the long term. However, patients with diabetes had worse overall outcomes, including lower survival, higher rates of major amputation, and lower amputation-free survival. These findings suggest that, although the drug-coated balloon may provide durable treatment of the target lesion, long-term outcomes in patients with diabetes are also strongly influenced by the severity of their underlying disease and by other medical conditions. The results highlight the importance of not only restoring blood flow, but also providing ongoing wound care, diabetes management, cardiovascular risk reduction, and close multidisciplinary follow-up. The study has limitations. It was an observational registry rather than a randomized trial, the analyses were not adjusted for all baseline differences between groups, and follow-up was incomplete at 5 years. For these reasons, the findings should be interpreted with caution.
Objective: To track the growth of expressive vocabulary size in children with cochlear implantation (CI) over the first two years after activation, to compare the differences in expressive vocabulary development among different prosthesis configurations, and to establish milestones for expressive vocabulary development during this period. Methods: A total of 63 children (29 males, 34 females) who received CI before 30 months of age at the Department of Auditory Implantation, Shandong Provincial ENT Hospital, between October 2020 and December 2022 were enrolled. The mean age at CI activation was 16.0 months (SD=5.9). The Infant Checklist of the Early Vocabulary Inventory (EVI) for Putonghua was used to assess expressive vocabulary size at activation and 1, 3, 6, 9, and 12 months post-activation. The Toddler Checklist of the EVI was used at 18 and 24 months post-activation. Based on their hearing intervention mode, children were divided into three groups: unilateral CI (one CI, no contralateral intervention), bimodal stimulation (one CI plus a hearing aid in the contralateral ear), and bilateral CI (CI in both ears). SPSS 23.0 was used for descriptive statistics of expressive vocabulary size at different time points, and R software was used to analyze differences in vocabulary growth rates among the three groups. Results: At 24 months post-activation, expressive vocabulary size ranged from 7 to 677 in the unilateral CI group, 252 to 702 in the bimodal group, and 38 to 686 in the bilateral CI group. All children in three groups produced their first expressive word at 6 months post-activation. The bilateral CI group reached the 10-word milestone at 9 months post-activation, whereas the bimodal and unilateral CI groups reached this milestone at 12 months. All three groups reached the 50-word milestone at 18 months. Both the bimodal and bilateral CI groups reached the 100-word milestone at 18 months, whereas the unilateral CI group reached this milestone at 24 months. There were significant differences in the growth rate of expressive vocabulary among the three groups. Both the bilateral CI group and the bimodal group showed significantly faster growth than the unilateral CI group (P<0.01 for both). No significant difference in vocabulary growth rate was found between the bilateral and bimodal groups (P=0.43). Conclusions: Expressive vocabulary size increases rapidly during the first two years after CI activation in Putonghua-speaking children. Both the bimodal and bilateral CI groups demonstrate faster developmental trajectories than the unilateral CI group. The expressive vocabulary milestones established for Putonghua-speaking children with CI during the first two years post-activation can help clinicians and parents set appropriate expectations. When bilateral cochlear implantation is not an option, the use of a hearing aid in the contralateral ear can promote expressive vocabulary development and help prevent language delays. 目的： 通过追踪人工耳蜗植入（cochlear implantation，CI）儿童开机2年内表达性词汇的数量，比较不同补偿模式下表达性词汇发展的差异，确立CI儿童开机0~2年表达性词汇发展的里程碑。 方法： 选取山东省耳鼻喉医院听觉植入科2020年10月至2022年12月期间63例在2.5岁前行CI手术的儿童，其中男性29例、女性34例，开机时年龄为（16.0±5.9）个月。分别在开机时及开机后1、3、6、9、12个月，使用普通话早期词汇量表（Early Vocabulary Inventory for Putonghua Chinese，EVI）中的婴儿版词表来评估CI儿童表达性词汇的数量，在开机18、24个月时使用EVI量表幼儿版评估其表达性词汇的数量。按照CI儿童的听力干预模式，将其分为三组：单侧CI组（一侧佩戴人工耳蜗，对侧未干预）、双模组（一侧佩戴人工耳蜗，一侧佩戴助听器）以及双侧CI组（双侧佩戴人工耳蜗）。应用SPSS 23.0软件对CI儿童开机后不同时间点的表达性词汇量进行描述性统计，使用R软件分析不同补偿模式之间词汇发展的差异。 结果： CI儿童开机2年时单侧CI组表达性词汇的数量为7~677个，双模组表达性词汇的数量为252~702个，双侧CI组表达性词汇的数量为38~686个。三组均在开机后6个月出现首个表达性词汇；双侧CI组在开机9个月时达到10个表达性词汇，而双模组和单侧CI组则在开机12个月时才达到10词；双模组和双侧CI组开机后18个月时达到100词的里程碑；单侧CI组在开机18个月时达到50词的里程碑，在开机24个月时才达到100词的里程碑。三组在表达性词汇量增长速度方面存在差异，双侧CI组和双模组的增长速度显著快于单侧CI组，差异有统计学意义（P值均<0.01），双侧CI组与双模组在词汇量增长速度方面差异无统计学意义（P=0.43）。 结论： CI儿童开机后2年内表达性词汇数量迅速增长，双模组和双侧CI组表现出比单侧CI组更快的发展水平。本研究建立的普通话CI儿童开机0~2年表达性词汇发展的里程碑，可以帮助临床医生和家长设定合理的期望值。在无法同时植入双侧人工耳蜗时，对侧耳佩戴助听器，可以促进表达性词汇的发展，预防语言发展的延迟。.
Stress urinary incontinence (SUI) is a prevalent condition that impairs quality of life; while midurethral sling (MUS) surgery is the standard treatment, intraurethral bulking injection offers a minimally invasive alternative. This study aimed to compare the efficacy and safety of intraurethral cross-linked hyaluronic acid/dextranomer (CLHA/Dx, DEXSUI®) injection with midurethral sling surgery in the treatment of stress urinary incontinence in women. This retrospective study included women who presented with stress urinary incontinence to İzmir Bakırçay University, Çiğli Training and Research Hospital between January 2024 and June 2025. Patients underwent either midurethral sling surgery or intraurethral CLHA/Dx (DEXSUI®) injection. Exclusion criteria included urge incontinence, urinary tract infection, and BMI > 35 kg/m². Quality of life was assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Urogenital Distress Inventory-6 (UDI-6), and Incontinence Quality of Life Questionnaire (I-QOL) questionnaires. Treatment success was defined by Patient Global Impression of Improvement (PGI)-I scores. Midurethral sling (MUS) was associated with significantly longer operative time (30.5 ± 7.8 vs. 11.4 ± 4.3 min, p < 0.001) and longer hospital stay (median 1 vs. 0 day, p < 0.001). At 1-month follow-up, complete dryness rates were similar (82.4% vs. 79.4%, p = 0.76). Both groups demonstrated significant improvement in ICIQ-SF, UDI-6, and Incontinence Quality of Life Questionnaire (I-QOL) scores compared with baseline (all p < 0.05), with slightly greater improvement observed in the MUS group; between-group differences were not statistically significant. Subgroup analysis by stress urinary incontinence (SUI) severity revealed consistently high dryness rates across mild, moderate, and severe categories, without significant intergroup differences. Intraurethral CLHA/Dx injection achieved clinical outcomes comparable to MUS, offering a less invasive alternative for SUI treatment.