Multi-risk instruments for emergency response: a multi-hazard and multi-risk assessment of the European Union's Solidarity and Emergency Aid Reserve.

Natural hazard-related disasters are on the rise and have significant impacts on the public and private sector. Different mechanisms and instruments exist on the pan-European level to deal with them, including the European Union Solidarity Fund (EUSF). Recently, the EUSF expanded its scope to incorporate public health emergencies and merged with the Emergency Aid Reserve to become the Solidarity and Emergency Aid Reserve. It therefore became a multi-hazard and multi-risk instrument to assist countries during the emergency phase of disasters. As different types of hazards and risks are drawing from the same fund there is concern about what capitalisation levels have to be assumed to make it sustainable. Hence, it is important to understand to which hazards and risks the fund is most exposed and whether there are regional differences within Europe. To address these issues, this paper takes a risk-based approach and estimates the capitalisation levels needed for major hazards and risks, noting regional differences across Europe.

A cluster randomised trial of a rational emotive behavior therapy (REBT) program and a mindfulness-acceptance-commitment (MAC) program, with South African adolescent rugby players.

Until recently, research examining the application of Rational Emotive Behavior Therapy (REBT) in sports settings was virtually absent in South Africa. Despite the growing evidence of REBT's potential as a psychological intervention in Western nations, its use within the multicultural and sports-fervent context of South Africa remains unexplored. Moreover, limited research has addressed the impact of REBT on rugby players, with only a few case studies being reported. The current experiment employs a cluster randomised trial (CRT) to compare the effects of a 7-week preferential REBT program with a 7-week Mindfulness-Acceptance-Commitment (MAC) program on irrational beliefs, competitive anxiety and subjective performance, among adolescent South African rugby players. We also include a wait-list control group who received neither REBT nor MAC. Results indicate that athletes receiving REBT reported greater improvements in irrational beliefs, anxiety, and subjective performance, while that athletes receiving MAC also reported some improvements in anxiety. This study highlights the potential of REBT as a valuable psychological intervention in the context of South African adolescent rugby players.

A Novel Method to Assess Healing of Segmental Bone Defects using the Induced Membrane Technique.

OBJECTIVE: Clinical concerns exist regarding the quality of bony consolidation in the context of the induced membrane technique. This study evaluates the clinical process of bone grafting in the second stage of induced membrane bone union in patients with tibial bone defects to infer the possibility of non-union and establish a reliable and effective evaluation method combined with computed tomography (CT) to assess fracture healing. METHODS: Patients with tibial bone defects who underwent the induced membrane technique at our hospital between February 2017 and February 2020 were retrospectively analyzed. The Hounsfield unit (HU) values of the patients were evaluated at different times during the second stage of bone grafting. Bone healing at the boundary value of the 120 HU output threshold (-1024 HU-3071 HU) was directionally selected, and the changes in the growth volume of union (new bone volume [selected according to HU value]/bone defect volume) were compared with analyzing individual class bone union. Method 1 involved X-rays revealing that at least three of the four cortices were continuous and at least 2 mm thick, with the patient being pain free. For Method 2, new bone volume (selected according to HU value/bone defect volume) at the stage was compared with analyzing individual class healing. Receiver operating characteristic curve analysis was used for Methods 1 and 2. RESULTS: A total of 42 patients with a segmental bone defect with a mean age of 40.5 years (40.5 ± 8.3 years) were included. The relationship between bone graft volume and time variation was analyzed by single factor repeated variable analysis (F = 6.477, p = 0.016). Further, curve regression analysis showed that the change in bone graft volume over time presented a logarithmic curve pattern (Y = 0.563 + 0.086 × ln(X), Ra2 = 0.608, p = 0.041). ROC curve analysis showed that Method 2 is superior to Method 1 (AUC: 86.3% vs. 68.3%, p < 0.05). CONCLUSION: The induced membrane technique could be used to treat traumatic long bone defects, with fewer complications and a higher healing rate. The proposed imaging grading of HU (new bone volume/bone defect volume) can be used as a reference for the quality of bony consolidation with the induced membrane technique.

Bone Fracture Healing under the Intervention of a Stretchable Ultrasound Array.

Ultrasound treatment has been recognized as an effective and noninvasive approach to promote fracture healing. However, traditional rigid ultrasound probe is bulky, requiring cumbersome manual operations and inducing unfavorable side effects when functioning, which precludes the wide application of ultrasound in bone fracture healing. Here, we report a stretchable ultrasound array for bone fracture healing, which features high-performance 1-3 piezoelectric composites as transducers, stretchable multilayered serpentine metal films in a bridge-island pattern as electrical interconnects, soft elastomeric membranes as encapsulations, and polydimethylsiloxane (PDMS) with low curing agent ratio as adhesive layers. The resulting ultrasound array offers the benefits of large stretchability for easy skin integration and effective affecting region for simple skin alignment with good electromechanical performance. Experimental investigations of the stretchable ultrasound array on the delayed union model in femoral shafts of rats show that the callus growth is more active in the second week of treatment and the fracture site is completely osseous healed in the sixth week of treatment. Various bone quality indicators (e.g., bone modulus, bone mineral density, bone tissue/total tissue volume, and trabecular bone thickness) could be enhanced with the intervention of a stretchable ultrasound array. Histological and immunohistochemical examinations indicate that ultrasound promotes osteoblast differentiation, bone formation, and remodeling by promoting the expression of osteopontin (OPN) and runt-related transcription factor 2 (RUNX2). This work provides an effective tool for bone fracture healing in a simple and convenient manner and creates engineering opportunities for applying ultrasound in medical applications.

Inequality in Forensic Medicine in India: The Current Scenario and Way Forward.

Background Forensic Medicine (FM) is one of the core specialties of medicine in India, which serves as a bridge between medical science and India's justice delivery systems. Although FM experts play a crucial role in handling medicolegal cases, there is an increasing deficit of FM experts in India. This may be due to the inadequate postgraduate (PG) seats across the states and the low uptake of PG seats in FM. This study was conducted to explore the current status of PG seats along with the Forensic Medicine Toxicology (FMT)/FM index across Indian states. Methodology In this cross-sectional study, data on the number of PGs in FMT/FM and the institutes offering PG courses in FMT/FM were searched on the official website of the National Medical Commission. The data available on the website until November 2023 were incorporated. The FMT/FM index was calculated at the national and state levels, and the states were graded based on the national FMT/FM index. Results The national FMT/FM PG trainee index was 0.054. Considering this as the reference value, grading of the FMT/FM PG trainee index was done as the highest (1.159 to 0.308), higher than the nation (0.054 but less than 0.308), lower than the nation (0.054 but higher than 0.00), and zero. Among all the states and union territories, Andaman & Nicobar, Arunachal Pradesh, Dadra and Nagar Haveli, Jammu & Kashmir, Lakshadweep, Mizoram, Nagaland, Sikkim, and Ladakh had zero FMT/FM PG index due to non-availability of any PG seats for FMT/FM. In total, 20 states had an FMT/FM PG index higher than India's FMT/FM PG index headed by Pondicherry (1.159), followed by Chandigarh (0.429) and Goa (0.308). Conclusions PG seats were highly deficient in several states, which is more likely to affect justice delivery in the future across these states. This study has a few limitations, as we did not explore the actual intake of these PG seats across different states. We anticipate a lower intake of PG seats due to factors such as low demand, fewer job opportunities, and monetary gain. However, this needs further exploration in future studies.

Integration of Postbiotics in Food Products through Attenuated Probiotics: A Case Study with Lactic Acid Bacteria in Bread.

The study examines the integration of postbiotics in food products through the use of attenuated probiotics, specifically lactic acid bacteria (LAB) in bread. Postbiotics, non-viable microorganisms or their metabolites, offer health benefits similar to probiotics without the risks associated with live bacteria. This research evaluates the regulatory aspects and safety of LAB in sourdough bread production, highlighting their historical and significant use in Europe before 1997. The study includes microbial quantification and Next-Generation Sequencing (NGS) to identify LAB in traditional sourdough, comparing them with historical and current EFSA Qualified Presumption of Safety (QPS) lists. Findings show that the LAB present in sourdough have been extensively and safely used in bread making, supporting their classification as non-novel foods under EU regulations. The stability and consistency of LAB metabolites in sourdough bread are also confirmed, ensuring quality and safety in each batch. The study concludes that LAB in sourdough, when inactivated through bread-making processes, are not considered novel foods, aligning with historical, scientific, and regulatory evidence.

Case Studies of a Simulation Workflow to Improve Bone Healing Assessment in Impending Non-Unions.

Background: The healing potential of a fracture is determined by mechanical and biological factors. Simulation-based workflows can help assess these factors to assist in predicting non-unions. The aim of this study was the introduction of two use cases for a novel patient-specific simulation workflow based on clinically available information. Methods: The used software is an extension of the "Ulm Bone Healing model" and was applied in two cases with non-union development after fracture fixation to show its principal feasibility. The clinical and radiographic information, starting from initial treatment, were used to feed the simulation process. Results: The simulation predicted non-union development and axial deviation in a mechanically driven non-union. In the case of a biological non-union, a slow, incomplete healing course was correctly identified. However, the time offset in callus bridging was discordant between the simulation and the distinctly slower healing response in the clinical case. Conclusions: The simulation workflow presented in the two clinical use cases allowed for the identification of fractures at risk for impending non-union immediately after the initial fixation based on available clinical and radiographic information. Further validation in a large non-union cohort is needed to increase the model's precision, especially in biologically challenging cases, and show its validity as a screening instrument.

Identification and validation of miR-29b-3p and LIN7A as important diagnostic markers for bone non-union by WGCNA.

Bone non-union is a common fracture complication that can severely impact patient outcomes, yet its mechanism is not fully understood. This study used differential analysis and weighted co-expression network analysis (WGCNA) to identify susceptibility modules and hub genes associated with fracture healing. Two datasets, GSE125289 and GSE213891, were downloaded from the GEO website, and differentially expressed miRNAs and genes were analysed and used to construct the WGCNA network. Gene ontology (GO) analysis of the differentially expressed genes showed enrichment in cytokine and inflammatory factor secretion, phagocytosis, and trans-Golgi network regulation pathways. Using bioinformatic site prediction and crossover gene search, miR-29b-3p was identified as a regulator of LIN7A expression that may negatively affect fracture healing. Potential miRNA-mRNA interactions in the bone non-union mechanism were explored, and miRNA-29-3p and LIN7A were identified as biomarkers of skeletal non-union. The expression of miRNA-29b-3p and LIN7A was verified in blood samples from patients with fracture non-union using qRT-PCR and ELISA. Overall, this study identified characteristic modules and key genes associated with fracture non-union and provided insight into its molecular mechanisms. Downregulated miRNA-29b-3p was found to downregulate LIN7A protein expression, which may affect the healing process after fracture in patients with bone non-union. These findings may serve as a prognostic biomarker and potential therapeutic target for bone non-union.

Commodity risk assessment of Prunus avium plants from United Kingdom.

The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as 'High risk plants, plant products and other objects'. This Scientific Opinion covers plant health risks posed by plants of Prunus avium possibly grafted on rootstocks of either P. avium, P. canescens, P. cerasus, P. pseudocerasus or their hybrids imported from the UK, taking into account the available scientific information, including the technical information provided by the UK. All pests associated with the commodities were evaluated against specific criteria for their relevance for this opinion. Three quarantine pests Scirtothrips dorsalis, tobacco ringspot virus and tomato ringspot virus), one protected zone EU quarantine pest (Bemisia tabaci (European population), and three non- regulated pests (Colletotrichum aenigma, Eulecanium excrescens and Takahashia japonica) that fulfilled all relevant criteria were selected for further evaluation. The risk mitigation measures proposed in the technical Dossier from the UK were evaluated, taking into account the possible limiting factors. For these pests, expert judgement is given on the likelihood of pest freedom, taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The degree of pest freedom varies among the pests evaluated, with Colletotrichum aenigma being the pest most frequently expected on the imported potted plants. The Expert Knowledge Elicitation indicated with 95% certainty that between 9971 and 10,000 plants per 10,000 would be free from the above-mentioned fungus.

European survey: citizens' attitudes on personalized medicine, genetic testing and health data sharing - design and delivery.

In the transformative landscape of healthcare, personalized medicine emerges as a pivotal shift, harnessing genetic, environmental and lifestyle data to tailor medical treatments for enhanced outcomes and cost efficiency. Central to its success is public engagement and consent to share health data amidst rising data privacy concerns. To investigate European public opinion on this paradigm, we executed a comprehensive cross-sectional survey to capture the general public's views on personalized medicine and data-sharing modalities, including digital tools and electronic records. The survey was distributed in eight major European Union countries and the results aim at guiding future policymaking and trust-building measures for secure health data exchange. This article delineates our methodological approach, whereby survey findings will be expounded in subsequent publications.

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Are we tackle ready? Cross-sectional video analysis of match tackle characteristics in elite women's Rugby Union.

The tackle contest is the most common and most injurious match contact event in rugby and is an indicator of performance. Tackle Ready is World Rugby's tackle technique education program. Limited research has characterized the tackle contest in women's rugby. The purpose of this study is to: (1) identify the match situational characteristics, ball-carrier and tackler technical actions demonstrated in elite women's Rugby Union and (2) to determine the extent to which Tackle Ready recommended tackle techniques were exhibited. Technical characteristics for 1500 tackle events in the 2022-2023 Women's Six Nations Championship were visually assessed according to a predefined coding framework and the Tackle Ready program. Tackles lacked full completion (0.2%) of the 22 coded Tackle Ready techniques with 47% of the recommended techniques demonstrated in each tackle on average (range 15%-98%). A high proportion of tackles involved two defenders (48%), approaching ball-carriers from the side (38%) or oblique angles (39%), in an upright position (30%), and with initial contact made with the arm (51%). Incorrect pre-contact head positioning and head placement upon contact accounted for 50% and 15% of tackles, respectively, and there was a mean of 14 (95% CI 11-18) head and neck contacts to a tackler and 18 (95% CI 14-22) head and neck contacts to a ball-carrier per game. Targeted interventions to encourage adoption of recommended techniques are needed to reduce tackle-related injury risk in women's rugby. This study provides valuable context for future discussion across law enforcement, coach education and gender-specific tackle coaching in the women's game.

Food-based domestic violence and anemia among women in sexual unions in Nigeria: the effect of urbanization.

In 2019, 1.74 billion people worldwide had anemia. In Nigeria, women of reproductive age are the most affected. Domestic violence affects the anemia prevalence, but few studies have examined the influence of urbanization on women in heterosexual unions (currently married, and cohabiting between). Using the social determinants of health framework, we argue that food-based violence and anemia vary among women residing in rural and urban areas. We used the Chi-square test and logistic regression to analyze the 2018 Nigeria Demographic and Health Survey records (n = 10,499). The study showed that anemia occurs more among women in rural (66%) than in urban (34%) areas. In rural areas, anemia was 29% higher among women who approved food-based domestic violence (OR: 1.29, CI 1.15-1.57) than those who did not. In urban areas, food-based domestic violence was not significantly associated with anemia. This study emphasizes the urgent need for culturally sensitive maternal health interventions aimed at re-orienting individuals and families on violence in rural areas.

Reconstruction of gap non-union tibia with composite use of extramedullary fixation and bone transport by monorail fixator: a prospective case series.

Introduction: Non-union is a complex, multifactorial orthopaedic problem that requires multiple treatment modalities for its management. It can result from infection, segmental bone loss, soft-tissue loss, and associated host factors. External fixators as management of gap non-union are bulky and give rise to a number of complications In our study, we have described a technique where we have used extramedullary fixation in the form of a tibial locking plate and transportation of part of the tibial bone after corticotomy by a monorail fixator. Materials and Methods: The procedure was done in two stages where internal and external fixation was done after creating a gap at the non-union site. The bone was transported after corticotomy and fixed to the internal fixation device in the second stage. The external fixator was removed in the second stage and the patient was then followed up till the bony union. The evaluation was done by functional and radiological assessment along with the complications noted with the described procedure. Results: Ten patients were enrolled in the study with a mean age of 33 years. The mean age of the patients was 33.7 ± 11.32 years with a mean size of the defect was 4.8 ± 1.7 cm. At 30 weeks out of nine patients, three patients had excellent and six had good functional results on the Association of Surgeons for Application and Methodology of Ilizarov (ASAMI) scale. The composite Musculoskeletal Tumor Society (MSTS) score was 76.66 % at the end of 30 weeks of follow-up. The mean time of consolidation was 134.4 days, whereas the mean union time was 145 days from index surgery. Ankle stiffness was the most common complication affecting 50% of the patients. Following closely was pin tract infection, which was present in 40% of the patients. According to Paley's classification, there were 11 obstacles, two problems and none were true complications. Conclusion: The integrated fixation is both safe and effective and has the advantage of early removal of the external fixator and a low complication rate as compared to use of a bulky conventional fixator alone. Moreover, it gives protection to the regenerated bone for a long period. So, this technique can be recommended for the management of segmental tibial defects.

Effectiveness of smoking cessation intervention based on the ABC Approach in patients with TB.

SETTING: Urban setting in the Philippines. OBJECTIVE: To assess the effectiveness of the ABC Approach developed by The Union as a tobacco-smoking cessation intervention for TB patients at a primary healthcare level in an urban setting in the Philippines. DESIGN: We set up an intervention group whose patients with TB received the ABC approach and a control group of patients with TB receiving only routine health education in Manila, The Philippines. We collected smoking status and the domestic secondhand-smoking (SHS) status data from patients with TB at months 0, 2, 4, 6, 8, and 12. TB treatment outcome data were also collected. RESULTS: Patients with TB (n = 2,174) were enrolled upon TB registration. Smoking rates were consistently low in the intervention group (3.9% vs. 8.7% at Month 6). The odds ratios of both tobacco-smoking status and domestic SHS status in the intervention group were significantly lower than those in the control group (tobacco-smoking status: P < 0.001, domestic SHS status: P < 0.01). TB treatment success rates were similar between the groups (85.0% vs. 87.3%; P = 0.201). CONCLUSION: The ABC approach successfully reduced tobacco-smoking rates, maintained low domestic SHS rates and TB treatment success rates in the Philippines.

CADRE: Cadre urbain aux Philippines. OBJECTIF: Évaluer l'efficacité de l'approche ABC développée par L'Union en tant qu'intervention de sevrage tabagique pour les patients atteints de TB au niveau des soins de santé primaires en milieu urbain aux Philippines. MÉTHODE: Nous avons mis en place un groupe d'intervention dont les patients atteints de TB ont reçu l'approche ABC et un groupe témoin de patients atteints de TB ne recevant qu'une éducation sanitaire de routine à Manille, aux Philippines. Nous avons recueilli des données sur le statut tabagique et le statut de tabagisme passif (SHS, pour l'anglais « secondhand-smoking ¼) domestique des patients atteints de TB aux mois 0, 2, 4, 6, 8 et 12. Des données sur les résultats du traitement de la TB ont également été recueillies. RÉSULTATS: Les patients atteints de TB (n = 2 174) ont été recrutés lors de l'enregistrement de la TB. Les taux de tabagisme étaient constamment faibles dans le groupe d'intervention (3,9% contre 8,7% au 6e mois). Les rapports de cotes du tabagisme et du statut SHS canadien dans le groupe d'intervention étaient significativement inférieurs à ceux du groupe témoin (tabagisme : P < 0,001, statut SHS national : P < 0,01). Les taux de réussite du traitement de la TB étaient similaires entre les groupes (85,0% contre 87,3% ; P = 0,201). CONCLUSION: L'approche ABC a permis de réduire les taux de tabagisme, de maintenir de faibles taux nationaux de SHS et de taux de réussite du traitement de la TB aux Philippines.

Neglected Bicondylar Fracture of the Distal Humerus Treated With Total Elbow Arthroplasty.

A 69-year-old woman suffered a distal humerus fracture including the medial and lateral condyles. She received conservative treatment with a posterior arm splint at a local healthcare center where she was evaluated by a non-specialist physician. Eight months later, she presented to our department complaining about severe instability. An upper limb specialist examined the patient at the time, and after thoroughly explaining the condition, he suggested a surgical approach with total elbow arthroplasty (TEA), which was then performed. At the one-year follow-up, the patient had a full range of motion without any complications or pain complaints. TEA in neglected fractures of the distal humerus is a poorly researched topic in the field of upper limb surgery with only scarce literature available. In this case report, we present the excellent outcomes of the procedure performed on an elderly patient after non-union regaining her quality of life and suggest that TEA can be a viable solution in elderly patients with complicated or non-united elbow fractures.

Long-term impact of basin-wide wastewater management on faecal pollution levels along the entire Danube River.

The Danube River is, at 2857 km, the second longest river in Europe and the most international river in the world with 19 countries in its catchment. Along the entire river, faecal pollution levels are mainly influenced by point-source emissions from treated and untreated sewage of municipal origin under base-flow conditions. In the past 2 decades, large investments in wastewater collection and treatment infrastructure were made in the European Union (EU) Member States located in the Danube River Basin (DRB). Overall, the share of population equivalents with appropriately biologically treated wastewater (without disinfection) has increased from 69% to more than 85%. The proportion of tertiary treatment has risen from 46 to 73%. In contrast, no comparable improvements of wastewater infrastructure took place in non-EU Member States in the middle and lower DRB, where a substantial amount of untreated wastewater is still directly discharged into the Danube River. Faecal pollution levels along the whole Danube River and the confluence sites of the most important tributaries were monitored during four Danube River expeditions, the Joint Danube Surveys (JDS). During all four surveys, the longitudinal patterns of faecal pollution were highly consistent, with generally lower levels in the upper section and elevated levels and major hotspots in the middle and lower sections of the Danube River. From 2001 to 2019, a significant decrease in faecal pollution levels could be observed in all three sections with average reduction rates between 72 and 86%. Despite this general improvement in microbiological water quality, no such decreases were observed for the highly polluted stretch in Central Serbia. Further improvements in microbiological water quality can be expected for the next decades on the basis of further investments in wastewater infrastructure in the EU Member States, in the middle and lower DRB. In the upper DRB, and due to the high compliance level as regards collection and treatment, improvements can further be achieved by upgrading sewage treatment plants with quaternary treatment steps as well as by preventing combined sewer overflows. The accession of the Western Balkan countries to the EU would also significantly boost investments in wastewater infrastructure and water quality improvements in the middle section of the Danube. Continuing whole-river expeditions such as the Joint Danube Surveys is highly recommended to monitor the developments in water quality in the future.

Early Extrusion of an Anterior Odontoid Screw: A Case Report.

Odontoid fractures in the elderly typically require surgical intervention due to poor adaptability to conservative treatment. Anterior screw fixation, despite its high fusion rates under specific conditions, may lead to complications such as screw extrusion, as demonstrated in the case discussed, necessitating subsequent posterior cervical fusion. This study aimed to describe early extrusion of an anterior odontoid screw and the importance of caution and thorough postoperative assessment in elderly patients undergoing anterior screw fixation for odontoid fracture. A 73-year-old female patient with a history of ground-level fall and subsequent cervical pain was diagnosed with an odontoid type II fracture and underwent odontoid screw placement in June 2023. However, in August, follow-up imaging revealed screw displacement and a fracture of the posterior arch of the C1 vertebral, which was initially overlooked. After seeking a second opinion, a new surgical approach was decided, involving removal and replacement of the odontoid screw, posterior and posterolateral C1-C2 spinal instrumentation, arthrodesis, and fusion with the use of morselized allograft. The patient was discharged on postoperative day 3 with mild cervical pain, wearing a soft collar, and neurologically intact. Given the current literature, odontoid screw extrusion rates are still small but can come with enormous potential complications. Also, the present case is a reminder to always double-check preoperative imaging and recognize early failure/malpositioning of hardware.

Delayed Union and Nonunion: Current Concepts, Prevention, and Correction: A Review.

Surgical management of fractures has advanced with the incorporation of advanced technology, surgical techniques, and regenerative therapies, but delayed bone healing remains a clinical challenge and the prevalence of long bone nonunion ranges from 10 to 15% of surgically managed fractures. Delayed bone healing arises from a combination of mechanical, biological, and systemic factors acting on the site of tissue remodeling, and careful consideration of each case's injury-related, patient-dependent, surgical, and mechanical risk factors is key to successful bone union. In this review, we describe the biology and biomechanics of delayed bone healing, outline the known risk factors for nonunion development, and introduce modern preventative and corrective therapies targeting fracture nonunion.

Does vanillic acid affect fracture healing? An experimental study in a rat model of femur fracture.

BACKGROUND AND OBJECTIVES: We aimed to determine the effects of vanillic acid (VA) on fracture healing radiologically, histologically, immunohistochemically, and biomechanically using a rat femur open fracture injury model. METHODS: 32 male Wistar-Albino rats were used and divided into two groups: the study group (VA) and the control group. From the time they were operated on until they were sacrificed, the rats in the study group were given 100 mg/kg/day VA by oral gavage. After sacrification, the femurs were analyzed. RESULTS: It was observed that the Huo histological scoring was significantly higher in the VA group (p = 0.001), and the ratio of the amount of callus tissue compared to intact bone tissue was significantly higher. While no significant difference was observed in immunohistochemical H-scores in ColI antibody staining (p = 1.000), a borderline significant difference in favor of VA was observed in ColIII antibody staining (p = 0.078). In biomechanical analysis, failure load (N), total energy (J), maximum stress (MPa), and stiffness (N/mm) measurements were significantly higher in the VA group (p = 0.040, p = 0.021, p = 0.015, and p = 0.035, respectively). CONCLUSION: It has been observed that VA, with its antioxidative properties, increases fracture healing in rats, in which an open fracture model was created. We are hopeful that such an antioxidant, which is common in nature, will increase fracture healing. Since this study is the first to examine the effect of VA on fracture healing, further studies are needed.

Comparative analysis of GMO regulatory requirements for AAV vectors in the EU and Japan focusing on the shedding data and containment measures.

INTRODUCTION: Recombinant viral-based gene therapy products, such as those incorporating adeno-associated viruses (AAVs), fall under the category of genetically modified organisms (GMOs). The European Union (EU) countries and Japan must obtain environmental risk assessment (ERA) approval for the use of GMOs before starting any clinical trials. It has been reported that the development of GMO-containing products in these two regions encounters several regulatory obstacles due to the longer regulatory procedures and document preparation for ERA. AREAS COVERED: In this article, we comparatively analyzed the ERA document requirements in the EU and Japan for AAV-based recombinant medicinal products to highlight the differences in the context of potential future attempts of convergence. Additionally, we analyzed non-clinical and clinical shedding data requirements, which are key components of ERA reviews in the EU and Japan. Lastly, we compared the containment measures to minimize the spread of GMOs in the environment in the EU and Japan. EXPERT OPINION: Based on our comparative analysis, we present several policy recommendations of standardizing and simplifying the application materials and procedures for the ERA regulations on GMOs in the EU and Japan in the mid-, and long-term timeframe to achieve global regulatory convergence.