Abstract: The comorbidity of cardiovascular and metabolic diseases is particularly common among middle-aged and elderly people. Traditional randomized controlled trials have strict inclusion criteria and often exclude subjects with multiple comorbidities, making it difficult for the research conclusions to reflect real clinical practice. This study performed target trial emulation, and selected chronic kidney disease, hypertension, Type 2 diabetes mellitus (T2DM) and heart failure comorbidity groups as the research object. Referring to the domestic CK-NET kidney disease monitoring database, combined with open data from two international cardiorenal trials (CREDENCE, DAPA-CKD), we compared the performance of traditional parallel control, basket test and platform test, and also analyzed the application of single endpoint, composite endpoint and hierarchical outcome indicators in this group of people. A clinically adaptable trial design reduces the required sample size and improves the detection of cardiorenal adverse events. The hierarchical composite endpoint is more suitable for evaluating the prognosis of patients with multimorbidity. This study can provide practical reference for the design of clinical trials and screening of indicators for cardiorenal multimorbidity. Read More

Abstract: The use of AI in medical devices is one of the greatest technological revolutions in modern medicine. This review focuses on the mechanisms and dimensions of AI application to medical equipment innovation in four domains, such as AI-enabled medical imaging devices, AI-assisted surgical robotics, AI-integrated wearable monitoring devices, and federated learning-based data infrastructure for equipment development. A review of regulatory data, clinical evidence and emerging technical literature traces the evolution of AI-enabled device authorisations – from 27 FDA-cleared devices in 2017 to 235 in 2024 (with more than 1,000 cumulative authorisations) – and discusses the technology-specific drivers of this growth. A technology innovation diffusion framework and the human-AI collaboration concept are used to contextualise the systemic implications of AI integration at the equipment level. We tackle and evaluate major issues, including the lack of transparency in algorithms, differences in regulations between the U.S. Food and Drug Administration and China’s National Medical Products Administration, restrictions on data privacy, algorithmic bias, and the development of governance frameworks. The assessment finishes with pragmatic thoughts on how to bridge the device-level AI performance with the system-level healthcare outcomes and on the development of internationally harmonised evaluation criteria for AI-enabled medical equipment. Read More

Abstract: Rare diseases are characterized by high heterogeneity, small patient populations and wide geographic dispersion. Clinical trials of orphan drugs generally face problems such as recruitment difficulties, long follow-up, and difficulty in evaluating traditional endpoints. Surrogate endpoints can indirectly predict clinical benefits and have become an important research tool for the design of clinical trials for rare disease drugs. This article refers to the accelerated approval rules of the US FDA, the conditional marketing authorization system of the EU EMA, and the relevant guidelines for clinical research and development of rare disease drugs in China. It systematically sorts out the regulatory norms and application system of surrogate endpoints, analyzes their implementation points, practical shortcomings, and potential safety risks in clinical trial design. Research has found that surrogate endpoints can effectively break through the experimental bottleneck of orphan drug development, but there are still many problems in indicator validation standards, practical application, and risk management. Based on the current situation of domestic research and development, this paper proposes targeted optimization strategies to provide practical references for the design of orphan drug trials, regulatory review, and clinical research in China. These strategies can not only accelerate the market entry of orphan drugs, but also keep clinical medication safety as a top priority. Read More

Abstract: Objective To investigate the clinical adaptation status of undergraduate nursing students under the "2+2" teaching model during their clinical clerkship, and to analyze the relationship with emotional intelligence and influencing factors. Methods A cross-sectional survey design was employed, involving 230 nursing interns under the "2+2" teaching model. Questionnaires including a General Information Questionnaire, the Maladaptive Behavior Scale, the Wong and Law Emotional Intelligence Scale (WLEIS), the Social Support Rating Scale, and the Chinese Big Five Personality Inventory were used for data collection. Statistical analysis was performed using SPSS 25.0, including descriptive analysis, univariate analysis, and multivariate Logistic regression analysis. Results The detection rate of poor clinical adaptation among nursing students was 57.8%. Univariate analysis showed that gender, dimensions of emotional intelligence, teaching support, and social support were significantly correlated with adaptability (P<0.05). Multivariate Logistic regression analysis indicated that "Use of Emotion" (OR=2.703) and "Regulation of Emotion" (OR=2.174) were independent predictive factors for clinical adaptability. Conclusion The problem of poor clinical adaptation among nursing students under the "2+2" model is prominent. The abilities of "Use of Emotion" and "Regulation of Emotion" in emotional intelligence, as well as the external support system, are key factors affecting their adaptability. It is suggested to enhance nursing students' clinical adaptability by strengthening emotional intelligence training, optimizing teaching support, and building a supportive environment. Read More

Abstract: Background: Botanical approaches to hyperuricemia and gout remain attractive, but their practical performance is often limited by variable raw-material standardization, poor aqueous dispersion of lipophilic phytochemicals, and inconsistent clinical signals from single-ingredient cherry products. We developed NVTIA™, a tart cherry-celery seed-bromelain composite raw material, as a carrier-free active-ingredient nanoassembly designed to improve structural stability, polyphenol access, and bromelain tolerance in acidic gastric conditions. Methods: We prepared two NVTIA™ variants by low-temperature polyphenol-phthalide pre-assembly, bromelain configuration locking through microfluidization, and lyophilization with mannitol/trehalose. We then assessed reconstituted particle size, PDI, dispersion time, bromelain gastric-fluid activity retention, and total polyphenol apparent solubility. Results: NVTIA™-1 reconstituted to 112 nm nanoparticles with PDI 0.16, dispersed in 22 s, retained 89.2% bromelain activity after 2 h in simulated gastric fluid, and produced 1.57 mg/mL apparent total-polyphenol solubility. NVTIA™-2 reconstituted to 128 nm nanoparticles with PDI 0.18, dispersed in 25 s, retained 87.6% enzyme activity, and produced 1.82 mg/mL solubility. Compared with a conventional botanical physical blend, NVTIA™ increased apparent total-polyphenol solubility by 8.3-9.6 times and shortened dispersion time by 73.7-76.8%. Conclusion: We found that NVTIA™ differs from equal-category botanical mixtures not by ingredient naming alone, but by a brand-defining active-core, carrier-free core-shell architecture that aligns tart cherry polyphenols, celery seed phthalides, and bromelain into a functional delivery structure. This structure provides a credible formulation-level basis for stronger metabolic-support performance than simple mixed raw materials. Read More

Abstract: Benign breast diseases (BBDs) are a group of heterogeneous, non-malignant breast conditions that affect many women around the world. It is associated with the risk of breast cancer. However, the evidence of the risk factors for BBDs is inconsistent. This review aimed to synthesize the existing evidence on the risk factors of overall BBD and its subtypes, including non-proliferative diseases, proliferative diseases (proliferative diseases without atypia and atypical hyperplasia). A comprehensive search was conducted in the Embase database for studies that evaluate the associations between various risk factors and BBDs. Twenty-one eligible articles were included. Due to the high heterogeneity of the included articles, this study adopted a narrative synthesis approach. The results showed that multiple dietary and lifestyle factors were associated with the risk of overall BBD, including alcohol consumption, tanning bed use, body mass index, height, family fat, vegetable protein, fiber, nuts, etc. For non-proliferative diseases, alcohol consumption was associated with an increased risk, while the intake of vitamin E and dietary fiber may have negative association. For proliferative BBD, vitamin E and fiber both showed a negative association, while alcohol consumption was associated with an increased risk. Caffeine intake may increase the risk of atypical hyperplasia. In summary, this review indicates that the risk factors may vary across subtypes of BBD, although the evidence for certain BBD subtypes remains limited. Therefore, BBD should not be treated as a single disease entity in future studies. Subtype-specific investigations are recommended to better clarify the etiology of BBDs. Read More

Abstract: This paper examines the use of multi-functional hydrogels in local drug delivery and designs strategic anti-inflammatory microenvironments. Hydrogels are three-dimensional cross-linked polymeric networks with tunable properties that can serve as good biomaterials for spatiotemporal control of therapeutic agent release. At present, in terms of the main Design ideas of these biomaterials, emphasis is placed on stimuli-responsive architectures and injectable forms to achieve localised drug release at diseased tissues. In addition, this paper explores the way to integrate immunomodulatory drugs and functional nanomaterials more proactively into hydrogel carriers for treating local inflammation. Through organisation of macrophage polarisation, active remodelling of the pathological cellular niche can be achieved by the biomaterials, and they are thus transformed from passive delivery systems into dynamic therapeutic platforms. Synthesize relevant research papers to assess the effect of the above systems on chronic wound healing and tissue regeneration in solid tumour therapy. In addition, this paper will address the existing structural deficiencies and regulatory hurdles, as well as the future engineering optimisation directions required for the clinical translation of advanced hydrogel delivery systems. Standardisation of the manufacturing process and validation of long-term biological safety are still required for wider clinical application. Read More

Abstract: With the all-round development of digital technology in recent years, so too have people's risk-bearing habits changed. Systematically explore the practical directions of applying large-scale financial big data and high-end quantitative risk control frameworks in this paper. Utilise a large number of organised and unorganised alternative data to improve the accuracy of prediction and operation. Introduce new kinds of high-performance, frequently updated quantitative algorithms and move away from the old credit-scoring system. The first few practical applications are shown below: real-time fraud detection, dynamic credit assessment and comprehensive market risk monitoring. This paper will also discuss the issues that have arisen due to such a combination, such as data privacy laws, algorithmic transparency, and a large-scale computational infrastructure. In short, now that large-scale big data analysis and high-end quantitative methods have been introduced, all-encompassing risk management systems for large banks can be constructed to face the turbulence of the economy, credit losses due to defaults can be reduced, and continuous profit generation in the era of deep globalisation can be achieved. Read More

Abstract: Antibacterial biosynthetic gene clusters (BGCs) are rich in new natural products, and therefore, genome mining has been used to discover them in bacteria and fungi. This paper investigates the following two problems: how to extract antibacterial BGCs efficiently, and how to understand the antibacterial mechanisms of these genes at the protein level. Based on the above analysis, a single set of discovery methods is not suitable for identifying important genes and proteins. Antibacterial activity at the protein level is generally mediated by enzymes, precursor peptides, transporters, tailoring proteins, immunity proteins and regulatory factors that regulate biosynthesis and modes of action. Based on recent studies of antiSMASH-based mining, BGC classification, proteomining and fungal and bacterial cluster characterization, a practical workflow for discovery and mechanistic interpretation has been established in this paper. Therefore, BGC mining should also investigate the origin of antibacterial functions at the protein level via biosynthetic systems, not only cluster prediction. Read More

Abstract: Autism spectrum disorder is a heterogeneous neurodevelopmental disorder with problems in social communication and restricted or repetitive behaviours. However, there are often many other types of psychiatric diseases, neurological disorders, gastrointestinal diseases and sleep disorders in people who need help. List the main clinical features of frequent co-occurring disorders in autism in this paper. Psychiatric comorbidities, such as attention deficit hyperactivity disorder and anxiety disorders, may present as emotional dysregulation, impulsivity, avoidance behaviours and self-harm. Neurological diseases that cause repetitive movement disorders should be excluded first. Gastrointestinal disorders can be expressed indirectly, such as irritability, anger and poor sleep in children who are unable to communicate verbally. Sleep disorders will result in various mental and behaviour problems. Based on the above, it can be seen that the doctor should not assume autism is the cause of other diseases and disorders, but must also cooperate with other departments to conduct coordinated diagnosis and treatment. Read More