The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to it...The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.展开更多
In 1999, the first International Maritime Confere- nce on Design for Safety was successfully held in Glasgow, UK as a WEGEMT Euro Conference with the sponsorship of the European Commission. Respo- nding to the expecta...In 1999, the first International Maritime Confere- nce on Design for Safety was successfully held in Glasgow, UK as a WEGEMT Euro Conference with the sponsorship of the European Commission. Respo- nding to the expectation from the world maritime safety community, the second was held in 2004 in Japan. The third and fourth were held in USA, 2007 and Italy, 2010, respectively. This year the Design for Safety conference including a single event of the 4th Workshop on Risk-Based Approaches in the Marine Industries will be held in Shanghai on November 25- 27, 2013. The conference is organized by Shanghai Jiao Tong University and is co-organized/sponsored by Marine Design and Research Institute of China （MARIC） and China Classification Society （CCS~.展开更多
BACKGROUND Due to the increasing rate of thyroid nodules diagnosis,and the desire to avoid the unsightly cervical scar,remote thyroidectomies were invented and are increasingly performed.Transoral endoscopic thyroidec...BACKGROUND Due to the increasing rate of thyroid nodules diagnosis,and the desire to avoid the unsightly cervical scar,remote thyroidectomies were invented and are increasingly performed.Transoral endoscopic thyroidectomy vestibular approach and trans-areolar approaches(TAA)are the two most commonly used remote approaches.No previous meta-analysis has compared postoperative infections and swallowing difficulties among the two procedures.AIM To compared the same among patients undergoing lobectomy for unilateral thyroid carcinoma/benign thyroid nodule.METHODS We searched PubMed MEDLINE,Google Scholar,and Cochrane Library from the date of the first published article up to August 2025.The term used were transoral thyroidectomy vestibular approach,trans areolar thyroidectomy,scarless thyroidectomy,remote thyroidectomy,infections,postoperative,inflammation,dysphagia,and swallowing difficulties.We identified 130 studies,of them,30 full texts were screened and only six studies were included in the final meta-analysis.RESULTS Postoperative infections were not different between the two approaches,odd ratio=1.33,95%confidence interval:0.50-3.53,theχ2 was 1.92 and the P-value for overall effect of 0.57.Similarly,transient swallowing difficulty was not different between the two forms of surgery,with odd ratio=0.91,95%confidence interval:0.35-2.40;theχ2 was 1.32,and the P-value for overall effect of 0.85.CONCLUSION No significant statistical differences were evident between trans-oral endoscopic Mirghani H.Infections and swallowing difficulty in scarless thyroidectomy WJCC https://www.wjgnet.com 2 January 6,2026 Volume 14 Issue 1 thyroidectomy vestibular approach and trans-areolar approach regarding postoperative infection and transient swallowing difficulties.Further longer randomized trials are needed.展开更多
In the past fifteen years, the attention of ship safety treatment as an objective rather than a constraint has started to sweep through the whole maritime industry. The risk-based ship design （RBD） methodology, advo...In the past fifteen years, the attention of ship safety treatment as an objective rather than a constraint has started to sweep through the whole maritime industry. The risk-based ship design （RBD） methodology, advocating systematic integration of risk assessment within the conventional design process has started to takeoff. Despite this wide recognition and increasing popularity, important factors that could potentially undermine the quality of the results come from both quantitative and qualitative aspects during the risk assessment process. This paper details a promising solution by developing a formalized methodology for risk assessment through effective storing and processing of historical data combined with data generated through first-principle approaches. This method should help to generate appropriate risk models in the selected platform （Bayesian networks） which can be employed for decision making at design stare.展开更多
In the era of big data,the dual risk-based damage associated with personal information leakage presents unique challenges.The unrealistic nature of objective risk-based damage without benchmarks and the high threshold...In the era of big data,the dual risk-based damage associated with personal information leakage presents unique challenges.The unrealistic nature of objective risk-based damage without benchmarks and the high threshold for determining subjective risk-based damage have become obstacles for information subjects seeking compensation.Traditional approaches to supporting risk-based damage are inadequate in the realm of personal information.The theoretical support and compensation mechanisms for dual risk-based damage to personal information need re-exploration.The information subject’s control over the value of personal information assets based on the right to know forms the theoretical basis for objective risk-based damage.Additionally,the independence of mental suffering and the relaxation of the“serious”standard allow for a broader interpretation of subjective risk-based damage.In addressing claims by information subjects,first,courts need to assess and quantify the level of risk-based damage;second,legislation should introduce a statutory compensation system to define the range of personal information asset value,with a focus on the fault of personal information processors in civil liability;finally,establishing a special representative litigation mechanism can effectively address collective disputes over personal information infringement and alleviate the litigation burden on information subjects.展开更多
In the USA,risk-based decision making has not been a common approach to tunnel safety in the past,but this is changing,as concepts such as“equivalency”in the NFPA 502 framework gain acceptance in the USA and elsewhe...In the USA,risk-based decision making has not been a common approach to tunnel safety in the past,but this is changing,as concepts such as“equivalency”in the NFPA 502 framework gain acceptance in the USA and elsewhere.In other regions,in particular in Europe,risk assessment techniques have been used for nearly two decades in many jurisdictions as an additional tool to complement the application of prescriptive guidelines and support decisions related to tunnel safety.After some initial difficulties these methods are meanwhile a well-established element of tunnel safety management.There are several tools available which have been practically applied and further developed over years,such as the Austrian tunnel risk model TuRisMo,or the PIARC owned DG-QRAM model.Whereas TuRisMo is a holistic,system-based model,which is best suited to quantify and assess fire risk and associated mitigation measures,DG-QRAM focusses on the risks related to the transport of hazardous materials.Depending on the objectives and the scope of the investigation and the regulatory environment,tunnel risk assessment tools are in use for different purposes,mainly to demonstrate a sufficient level of safety and to decide on and select(additional)risk mitigation measures.The international experience substantiates that the general approach is flexible and that the methods and tools are mature and can be applied for different problems in different environments.First case studies like the risk study on conditions and permissibility of the transport of hazardous materials through the Eisenhower-Johnson-Memorial Tunnel in Colorado demonstrate the applicability of a risk-based concept for decision making in the US-American environment.展开更多
Cardiovascular diseases(CVDs)remain the leading cause of morbidity and mortality worldwide,necessitating innovative diagnostic and prognostic strategies.Traditional biomarkers like C-reactive protein,uric acid,troponi...Cardiovascular diseases(CVDs)remain the leading cause of morbidity and mortality worldwide,necessitating innovative diagnostic and prognostic strategies.Traditional biomarkers like C-reactive protein,uric acid,troponin,and natriuretic peptides play crucial roles in CVD management,yet they are often limited by sensitivity and specificity constraints.This narrative review critically examines the emerging landscape of cardiac biomarkers and advocates for a multiple-marker approach to enhance early detection,prognosis,and risk stratification of CVD.In recent years,several novel biomarkers have shown promise in revolutionizing CVD diagnostics.Gamma-glutamyltransferase,microRNAs,endothelial microparticles,placental growth factor,trimethylamine N-oxide,retinol-binding protein 4,copeptin,heart-type fatty acid-binding protein,galectin-3,growth differentiation factor-15,soluble suppression of tumorigenicity 2,fibroblast growth factor 23,and adrenomedullin have emerged as significant indicators of CV health.These biomarkers provide insights into various pathophysiological processes,such as oxidative stress,endothelial dysfunction,inflammation,metabolic disturbances,and myocardial injury.The integration of these novel biomarkers with traditional ones offers a more comprehensive understanding of CVD mechanisms.This multiple-marker approach can improve diagnostic accuracy,allowing for better risk stratification and more personalized treatment strategies.This review underscores the need for continued research to validate the clinical utility of these biomarkers and their potential incorporation into routine clinical practice.By leveraging the strengths of both traditional and novel biomarkers,precise therapeutic plans can be developed,thereby improving the management and prognosis of patients with CVDs.The ongoing exploration and validation of these biomarkers are crucial for advancing CV care and addressing the limitations of current diagnostic tools.展开更多
The progressive loss of dopaminergic neurons in affected patient brains is one of the pathological features of Parkinson's disease,the second most common human neurodegenerative disease.Although the detailed patho...The progressive loss of dopaminergic neurons in affected patient brains is one of the pathological features of Parkinson's disease,the second most common human neurodegenerative disease.Although the detailed pathogenesis accounting for dopaminergic neuron degeneration in Parkinson's disease is still unclear,the advancement of stem cell approaches has shown promise for Parkinson's disease research and therapy.The induced pluripotent stem cells have been commonly used to generate dopaminergic neurons,which has provided valuable insights to improve our understanding of Parkinson's disease pathogenesis and contributed to anti-Parkinson's disease therapies.The current review discusses the practical approaches and potential applications of induced pluripotent stem cell techniques for generating and differentiating dopaminergic neurons from induced pluripotent stem cells.The benefits of induced pluripotent stem cell-based research are highlighted.Various dopaminergic neuron differentiation protocols from induced pluripotent stem cells are compared.The emerging three-dimension-based brain organoid models compared with conventional two-dimensional cell culture are evaluated.Finally,limitations,challenges,and future directions of induced pluripotent stem cell–based approaches are analyzed and proposed,which will be significant to the future application of induced pluripotent stem cell-related techniques for Parkinson's disease.展开更多
Deep learning algorithms have been rapidly incorporated into many different applications due to the increase in computational power and the availability of massive amounts of data.Recently,both deep learning and ensem...Deep learning algorithms have been rapidly incorporated into many different applications due to the increase in computational power and the availability of massive amounts of data.Recently,both deep learning and ensemble learning have been used to recognize underlying structures and patterns from high-level features to make predictions/decisions.With the growth in popularity of deep learning and ensemble learning algorithms,they have received significant attention from both scientists and the industrial community due to their superior ability to learn features from big data.Ensemble deep learning has exhibited significant performance in enhancing learning generalization through the use of multiple deep learning algorithms.Although ensemble deep learning has large quantities of training parameters,which results in time and space overheads,it performs much better than traditional ensemble learning.Ensemble deep learning has been successfully used in several areas,such as bioinformatics,finance,and health care.In this paper,we review and investigate recent ensemble deep learning algorithms and techniques in health care domains,medical imaging,health care data analytics,genomics,diagnosis,disease prevention,and drug discovery.We cover several widely used deep learning algorithms along with their architectures,including deep neural networks(DNNs),convolutional neural networks(CNNs),recurrent neural networks(RNNs),and generative adversarial networks(GANs).Common healthcare tasks,such as medical imaging,electronic health records,and genomics,are also demonstrated.Furthermore,in this review,the challenges inherent in reducing the burden on the healthcare system are discussed and explored.Finally,future directions and opportunities for enhancing healthcare model performance are discussed.展开更多
This article provides a comprehensive analysis of the study by Hou et al,focusing on the complex interplay between psychological and physical factors in the postoperative recovery(POR)of patients with perianal disease...This article provides a comprehensive analysis of the study by Hou et al,focusing on the complex interplay between psychological and physical factors in the postoperative recovery(POR)of patients with perianal diseases.The study sheds light on how illness perception,anxiety,and depression significantly influence recovery outcomes.Hou et al developed a predictive model that demonstrated high accuracy in identifying patients at risk of poor recovery.The article explores the critical role of pre-operative psychological assessment,highlighting the need for mental health support and personalized recovery plans in enhancing POR quality.A multidisciplinary approach,integrating mental health professionals with surgeons,anesthesiologists,and other specialists,is emphasized to ensure comprehensive care for patients.The study’s findings serve as a call to integrate psychological care into surgical practice to optimize outcomes for patients with perianal diseases.展开更多
Objective: To explore the effect of Health Action Process Approach (HAPA) theory in patients with type D personality psoriasis. Methods: A total of 66 patients with type D personality psoriasis admitted to the dermato...Objective: To explore the effect of Health Action Process Approach (HAPA) theory in patients with type D personality psoriasis. Methods: A total of 66 patients with type D personality psoriasis admitted to the dermatology department of a top-three hospital in Jingzhou City from November 2022 to July 2023 were selected and divided into control group and test group with 33 cases in each group by random number table method. The control group received routine health education, and the experimental group received health education based on the HAPA theory. Chronic disease self-efficacy scale, hospital anxiety and depression scale and skin disease quality of life scale were used to evaluate the effect of intervention. Results: After 3 months of intervention, the scores of self-efficacy in experimental group were higher than those in control group (P P Conclusion: Health education based on the theory of HAPA can enhance the self-efficacy of patients with type D personality psoriasis, relieve negative emotions and improve their quality of life.展开更多
Background:Social anxiety is prevalent among adolescents and severely impacts their mental health and social functioning.This study aims to explore the underlying mechanisms and subgroup differences in adolescent soci...Background:Social anxiety is prevalent among adolescents and severely impacts their mental health and social functioning.This study aims to explore the underlying mechanisms and subgroup differences in adolescent social anxiety to provide a theoretical basis for targeted interventions.Methods:3025 Chinese adolescents(Meanage=13.91±1.60 years;47%male)completed self-report measures of physical activity,core self-evaluation,and social anxiety.Variable-centered analyses employed PROCESS Model 4 with 5000 bootstrap samples;covariates were gender,grade,and place of residence.Person-centered analyses used latent profile analysis in Mplus 8.3 to identify subgroups based on social anxiety item profiles.Results:Variable-centered analyses showed that physical activity had a significant negative association with social anxiety(β=−0.224,p<0.001)and a significant positive association with core self-evaluation(β=0.471,p<0.001);core self-evaluation partially mediated this relationship,accounting for 30%of the total effect.Person-centered analyses revealed an optimal two-profile solution:a low social anxiety profile(89.6%)and a high social anxiety profile(10.4%).The high social anxiety profile reported significantly lower physical activity and lower core self-evaluation than the low social anxiety profile.Conclusions:This study integrates variable-centered and person-centered evidence,identifies physical activity and core self-evaluation as key modifiable factors in reducing social anxiety,providing a theoretical basis for targeted and differentiated interventions.展开更多
BACKGROUND The root of mesentery dissection is one of the critical maneuvers,especially in borderline resectable pancreatic head cancer.Intra-abdominal chyle leak(CL)including chylous ascites may ensue in up to 10%of ...BACKGROUND The root of mesentery dissection is one of the critical maneuvers,especially in borderline resectable pancreatic head cancer.Intra-abdominal chyle leak(CL)including chylous ascites may ensue in up to 10%of patients after pancreatic resections.Globally recognized superior mesenteric artery(SMA)first approaches are invariably performed.The mesenteric dissection through the inferior infracolic approach has been discussed in this study emphasizing its post-operative impact on CL which is the cornerstone of this study.AIM To assess incidence,risk factors,clinical impact of CL following root of mesentery dissection,and the different treatment modalities.METHODS This is a retrospective study incorporating the patients who underwent dissection of the root of mesentery with inferior infracolic SMA first approach pancreat-oduodenectomy for the ventral body and uncinate mass of pancreas in the Department of Gastrointestinal and General Surgery of Kathmandu Medical College and Teaching Hospital from January 1,2021 to February 28,2024.Intraop-erative findings and postoperative outcomes were analyzed.RESULTS In three years,ten patients underwent root of mesentery dissection with inferior infracolic SMA first approach pancreatoduodenectomy.The mean age was 67.6 years with a male-to-female ratio of 4:5.CL was seen in four patients.With virtue of CL,Clavien-Dindo grade Ⅱ or higher morbidity was observed in four patients.Two patients had a hospital stay of more than 20 days with the former having a delayed gastric emptying and the latter with long-term total parenteral nutrition requirement.The mean operative time was 330 minutes.Curative resection was achieved in 100%of the patients.The mean duration of the intensive care unit and hospital stay were 2.55±1.45 days and 15.7±5.32 days,respectively.CONCLUSION Root of mesentery dissection with lymphadenectomy and vascular resection correlated with occurrence of CL.After complete curative resection,these were managed with total parenteral nutrition without adversely impacting outcome.展开更多
BACKGROUND Laparoscopic hepatectomy has been widely accepted for the treatment of liver tumors.Compared with open surgery,it provides a reduced hospital stay,less intraoperative blood loss,less trauma,and fewer incisi...BACKGROUND Laparoscopic hepatectomy has been widely accepted for the treatment of liver tumors.Compared with open surgery,it provides a reduced hospital stay,less intraoperative blood loss,less trauma,and fewer incisional infections,without affecting tumor outcomes.However,lesions in the right lobe of the liver are deep and obstructed by the ribs,making exposure difficult and increasing the degree of surgical difficulty;thus,liver tumors in the deep right lobe pose technical challenges in standard laparoscopic surgery.AIM To investigate the safety and efficacy of laparoscopic retroperitoneal partial hepatectomy for liver tumors.METHODS The clinical data of 72 patients who underwent laparoscopic retroperitoneal partial hepatectomy for liver tumors between January 2018 and December 2024 at the First People’s Hospital of Yunnan Province were analyzed.Of the 72 patients included,34 were male and 38 were female,with ages ranging from 34 years to 72 years(median age,45 years).The tumors were all located in the right lobe of the liver,with 30 cases in segment S6,27 cases in segment S7,and 15 cases in segment S8;the mean tumor diameter was 7.5±3.4 cm.The postoperative tumor indices,liver function,and postoperative complications were analyzed to evaluate the clinical efficacy of laparoscopic partial hepatectomy via the retroperitoneal approach.RESULTS The surgeries were successfully completed in all patients,and conversion to open surgery was required in 10 patients.The mean operative time,blood loss,drain retention time,and length of postoperative hospital stay were 140±30 minutes,150±46 mL,3.8±1.2 days,and 8.3±5.3 days,respectively.Liver function tests returned to normal in all patients within two weeks of surgery.Fifteen patients developed atelectasis and pleural effusion and were managed with incision and drainage and antibiotics.Two patients developed uncomplicated minimal ascites,and the remaining patients had no perioperative complications,such as abdominal hemorrhage,infection,liver failure,bile leakage,and other adverse events.All patients were successfully treated.CONCLUSION Laparoscopic retroperitoneal partial hepatectomy is a safe and effective approach for right hepatic space-occupying lesions,particularly in segments S6,S7,and S8,with fewer postoperative complications,less trauma,and faster recovery times.This procedure provides a new surgical access for resection of deep tumors in the right lobe of the liver and has clear clinical implications.展开更多
In response to the common problems in college English writing teaching,such as the separation of learning and application,students’low interest in writing,and difficulties in expression,this paper,based on the theore...In response to the common problems in college English writing teaching,such as the separation of learning and application,students’low interest in writing,and difficulties in expression,this paper,based on the theoretical framework of the production-oriented approach(POA)proposed by Professor Wen Qiufang,designed and implemented a set of IELTS writing teaching plan.This plan takes“motivating,enabling,and assessing”as the core teaching process,and selects typical IELTS argumentative essay topics(such as food diversity)to create real communication scenarios.In the motivating stage,diverse inputs are used to stimulate students’interest and expose their language weaknesses;in the enabling stage,language knowledge,viewpoint generation,and text structure are focused on for targeted input and training;in the assessing stage,a combination of teacher-student cooperation and peer evaluation is adopted to guide students to identify and correct deficiencies in language use.The research results show that the POA model can effectively enhance students’writing interest,active learning awareness,and writing ability,particularly in overcoming vocabulary poverty and material shortages,as well as improving language accuracy and expression richness.This provides an operational theoretical basis and practical path for improving the teaching effect of IELTS writing.展开更多
Background:Dorsal approach is the potentially effective strategy for minimally invasive liver resection.This study aimed to compare the outcomes between robot-assisted and laparoscopic hemihepatectomy through dorsal a...Background:Dorsal approach is the potentially effective strategy for minimally invasive liver resection.This study aimed to compare the outcomes between robot-assisted and laparoscopic hemihepatectomy through dorsal approach.Methods:We compared the patients who underwent robot-assisted hemihepatectomy(Rob-HH)and who had laparoscopic hemihepatectomy(Lap-HH)through dorsal approach between January 2020 and December 2022.A 1:1 propensity score-matching(PSM)analysis was performed to minimize bias and confounding factors.Results:Ninety-six patients were included,41 with Rob-HH and 55 with Lap-HH.Among them,58 underwent left hemihepatectomy(LHH)and 38 underwent right hemihepatectomy(RHH).Compared with LapHH group,patients with Rob-HH had less estimated blood loss(median:100.0 vs.300.0 m L,P=0.016),lower blood transfusion rates(4.9%vs.29.1%,P=0.003)and postoperative complication rates(26.8%vs.54.5%,P=0.016).These significant differences consistently existed after PSM and in the LHH subgroups.Furthermore,robot-assisted LHH was associated with decreased Pringle duration(45 vs.60 min,P=0.047).RHH subgroup analysis showed that compared with Lap-RHH,Rob-RHH was associated with less estimated blood loss(200.0 vs.400.0 m L,P=0.013).No significant differences were found in other perioperative outcomes among pre-and post-PSM cohorts,such as Pringle duration,operative time,and hospital stay.Conclusions:The dorsal approach was a safe and feasible strategy for hemi-hepatectomy with favorable outcomes under robot-assisted system in reducing intraoperative blood loss,transfusion,and postoperative complications.展开更多
Metabolomics utilizes advanced analytical profiling techniques to comprehensively measure small molecules in cells,tissues,and biological fluids.Nutritional metabolomics studies in pigs have reported changes in hundre...Metabolomics utilizes advanced analytical profiling techniques to comprehensively measure small molecules in cells,tissues,and biological fluids.Nutritional metabolomics studies in pigs have reported changes in hundreds of metabolites across various sample types,including plasma,serum,urine,digesta,and feces,following dietary interventions.These findings can help identify biomarkers of gastrointestinal functionality and beyond,as well as investigate mechanistic interactions between diet,host,microbiome,and metabolites.This review aims to summarize the current literature on nutritional metabolomics in pigs and its use to investigate how different dietary approaches impact the gut health of pigs.Here,we critically assessed and categorized the impact of the main macronutrients-carbohydrates,proteins,and fats—along with feed additives such as amino acids,bile acids,and probiotics,as well as feeding strategies like creep feeding,milk replacer introduction,and time-restricted feeding,on the pig metabolome.Additionally,we discuss the potential modes of action of the key affected metabolites on pig gut health.展开更多
Enhancing the mechanical properties is crucial for polyimide films,but the mechanical properties(Young's modulus,tensile strength,and elongation at break)mutually constrain each other,complicating simultaneous enh...Enhancing the mechanical properties is crucial for polyimide films,but the mechanical properties(Young's modulus,tensile strength,and elongation at break)mutually constrain each other,complicating simultaneous enhancement via traditional trial-and-error methods.In this work,we proposed a materials genome approach to design and screen phenylethynyl-terminated polyimides for films with enhanced mechani-cal properties.We first established machine learning models to predict Young's modulus,tensile strength,and elongation at break to explore the chemical space containing thousands of candidate structures.The accuracies of the machine learning models were verified by molecular dynamics simulations on screened polyimides and experimental testing on three representative polyimide films.The performance advantages of the best-selected polyimides were analyzed by comparing well-known polyimides based on molecular dynamics simulations,and the structural rationale was revealed by"gene"analysis and feature importance evaluation.This work provides a cost-effective strategy for designing polyimide films withenhancedmechanical properties.展开更多
In recent years,the production-oriented approach has been applied in the field of teaching Chinese as a foreign language,providing a new perspective for language and cultural instruction.Currently,several issues exist...In recent years,the production-oriented approach has been applied in the field of teaching Chinese as a foreign language,providing a new perspective for language and cultural instruction.Currently,several issues exist in cultural teaching,such as the lack of in-depth cultural input,insufficient training in cross-cultural communication skills,and the over-stylization of cultural teaching in the classroom.The production-oriented approach offers a solution to these challenges.This paper seeks to introduce the production-oriented method into the teaching of Chinese culture as a foreign language,using silk culture as a case study for teaching design.The aim is to implement cultural teaching through a new instructional model and to promote the spread of Chinese silk culture.展开更多
文摘The quality system of any modern pharmaceutical company is the pharmaceutical quality system(PQS),which extends the GMP standards to all stages of the medicinal productslife cycle,from pharmaceutical development to its withdrawal from production.The principal difference between PQS and GxP rules from other quality systems is that the medicinal product,its safety and efficacy is put at the forefront.At the same time,PQS implies a process approach to all components that should be aimed at achieving the main goal—ensuring and guaranteeing the quality of the medicinal product for the end user(patient)—and should be based on the quality risk management system.An integral part of PQS,as well as the GxP rules adopted in the European Union and PIC/S,is a process for self-inspections and/or quality audits,which regularly appraises the effectiveness and applicability of the PQS.This publication is dedicated to the definition of self-inspections(internal audits)as one of the PQS’s processes.The article defines the main standard stages and develops a model of a risk-based approach to the self-inspections’planning in relation to processes of the pharmaceutical quality system.
文摘In 1999, the first International Maritime Confere- nce on Design for Safety was successfully held in Glasgow, UK as a WEGEMT Euro Conference with the sponsorship of the European Commission. Respo- nding to the expectation from the world maritime safety community, the second was held in 2004 in Japan. The third and fourth were held in USA, 2007 and Italy, 2010, respectively. This year the Design for Safety conference including a single event of the 4th Workshop on Risk-Based Approaches in the Marine Industries will be held in Shanghai on November 25- 27, 2013. The conference is organized by Shanghai Jiao Tong University and is co-organized/sponsored by Marine Design and Research Institute of China （MARIC） and China Classification Society （CCS~.
文摘BACKGROUND Due to the increasing rate of thyroid nodules diagnosis,and the desire to avoid the unsightly cervical scar,remote thyroidectomies were invented and are increasingly performed.Transoral endoscopic thyroidectomy vestibular approach and trans-areolar approaches(TAA)are the two most commonly used remote approaches.No previous meta-analysis has compared postoperative infections and swallowing difficulties among the two procedures.AIM To compared the same among patients undergoing lobectomy for unilateral thyroid carcinoma/benign thyroid nodule.METHODS We searched PubMed MEDLINE,Google Scholar,and Cochrane Library from the date of the first published article up to August 2025.The term used were transoral thyroidectomy vestibular approach,trans areolar thyroidectomy,scarless thyroidectomy,remote thyroidectomy,infections,postoperative,inflammation,dysphagia,and swallowing difficulties.We identified 130 studies,of them,30 full texts were screened and only six studies were included in the final meta-analysis.RESULTS Postoperative infections were not different between the two approaches,odd ratio=1.33,95%confidence interval:0.50-3.53,theχ2 was 1.92 and the P-value for overall effect of 0.57.Similarly,transient swallowing difficulty was not different between the two forms of surgery,with odd ratio=0.91,95%confidence interval:0.35-2.40;theχ2 was 1.32,and the P-value for overall effect of 0.85.CONCLUSION No significant statistical differences were evident between trans-oral endoscopic Mirghani H.Infections and swallowing difficulty in scarless thyroidectomy WJCC https://www.wjgnet.com 2 January 6,2026 Volume 14 Issue 1 thyroidectomy vestibular approach and trans-areolar approach regarding postoperative infection and transient swallowing difficulties.Further longer randomized trials are needed.
基金the financial support received by the University of Strathclyde in the form of a postgraduate research scholarship for the duration of the second author’s P hD studies
文摘In the past fifteen years, the attention of ship safety treatment as an objective rather than a constraint has started to sweep through the whole maritime industry. The risk-based ship design （RBD） methodology, advocating systematic integration of risk assessment within the conventional design process has started to takeoff. Despite this wide recognition and increasing popularity, important factors that could potentially undermine the quality of the results come from both quantitative and qualitative aspects during the risk assessment process. This paper details a promising solution by developing a formalized methodology for risk assessment through effective storing and processing of historical data combined with data generated through first-principle approaches. This method should help to generate appropriate risk models in the selected platform （Bayesian networks） which can be employed for decision making at design stare.
基金“A New Round of Reform and Reconstruction of the International Dis-pute Settlement Mechanism for Intellectual Property Rights and China’s Countermeasures”(Project Number 21BFX101),a 2021 General Project of the National Social Science Foundation of China。
文摘In the era of big data,the dual risk-based damage associated with personal information leakage presents unique challenges.The unrealistic nature of objective risk-based damage without benchmarks and the high threshold for determining subjective risk-based damage have become obstacles for information subjects seeking compensation.Traditional approaches to supporting risk-based damage are inadequate in the realm of personal information.The theoretical support and compensation mechanisms for dual risk-based damage to personal information need re-exploration.The information subject’s control over the value of personal information assets based on the right to know forms the theoretical basis for objective risk-based damage.Additionally,the independence of mental suffering and the relaxation of the“serious”standard allow for a broader interpretation of subjective risk-based damage.In addressing claims by information subjects,first,courts need to assess and quantify the level of risk-based damage;second,legislation should introduce a statutory compensation system to define the range of personal information asset value,with a focus on the fault of personal information processors in civil liability;finally,establishing a special representative litigation mechanism can effectively address collective disputes over personal information infringement and alleviate the litigation burden on information subjects.
文摘In the USA,risk-based decision making has not been a common approach to tunnel safety in the past,but this is changing,as concepts such as“equivalency”in the NFPA 502 framework gain acceptance in the USA and elsewhere.In other regions,in particular in Europe,risk assessment techniques have been used for nearly two decades in many jurisdictions as an additional tool to complement the application of prescriptive guidelines and support decisions related to tunnel safety.After some initial difficulties these methods are meanwhile a well-established element of tunnel safety management.There are several tools available which have been practically applied and further developed over years,such as the Austrian tunnel risk model TuRisMo,or the PIARC owned DG-QRAM model.Whereas TuRisMo is a holistic,system-based model,which is best suited to quantify and assess fire risk and associated mitigation measures,DG-QRAM focusses on the risks related to the transport of hazardous materials.Depending on the objectives and the scope of the investigation and the regulatory environment,tunnel risk assessment tools are in use for different purposes,mainly to demonstrate a sufficient level of safety and to decide on and select(additional)risk mitigation measures.The international experience substantiates that the general approach is flexible and that the methods and tools are mature and can be applied for different problems in different environments.First case studies like the risk study on conditions and permissibility of the transport of hazardous materials through the Eisenhower-Johnson-Memorial Tunnel in Colorado demonstrate the applicability of a risk-based concept for decision making in the US-American environment.
文摘Cardiovascular diseases(CVDs)remain the leading cause of morbidity and mortality worldwide,necessitating innovative diagnostic and prognostic strategies.Traditional biomarkers like C-reactive protein,uric acid,troponin,and natriuretic peptides play crucial roles in CVD management,yet they are often limited by sensitivity and specificity constraints.This narrative review critically examines the emerging landscape of cardiac biomarkers and advocates for a multiple-marker approach to enhance early detection,prognosis,and risk stratification of CVD.In recent years,several novel biomarkers have shown promise in revolutionizing CVD diagnostics.Gamma-glutamyltransferase,microRNAs,endothelial microparticles,placental growth factor,trimethylamine N-oxide,retinol-binding protein 4,copeptin,heart-type fatty acid-binding protein,galectin-3,growth differentiation factor-15,soluble suppression of tumorigenicity 2,fibroblast growth factor 23,and adrenomedullin have emerged as significant indicators of CV health.These biomarkers provide insights into various pathophysiological processes,such as oxidative stress,endothelial dysfunction,inflammation,metabolic disturbances,and myocardial injury.The integration of these novel biomarkers with traditional ones offers a more comprehensive understanding of CVD mechanisms.This multiple-marker approach can improve diagnostic accuracy,allowing for better risk stratification and more personalized treatment strategies.This review underscores the need for continued research to validate the clinical utility of these biomarkers and their potential incorporation into routine clinical practice.By leveraging the strengths of both traditional and novel biomarkers,precise therapeutic plans can be developed,thereby improving the management and prognosis of patients with CVDs.The ongoing exploration and validation of these biomarkers are crucial for advancing CV care and addressing the limitations of current diagnostic tools.
基金supported by Singapore National Medical Research Council(NMRC)grants,including CS-IRG,HLCA2022(to ZDZ),STaR,OF LCG 000207(to EKT)a Clinical Translational Research Programme in Parkinson's DiseaseDuke-Duke-NUS collaboration pilot grant(to ZDZ)。
文摘The progressive loss of dopaminergic neurons in affected patient brains is one of the pathological features of Parkinson's disease,the second most common human neurodegenerative disease.Although the detailed pathogenesis accounting for dopaminergic neuron degeneration in Parkinson's disease is still unclear,the advancement of stem cell approaches has shown promise for Parkinson's disease research and therapy.The induced pluripotent stem cells have been commonly used to generate dopaminergic neurons,which has provided valuable insights to improve our understanding of Parkinson's disease pathogenesis and contributed to anti-Parkinson's disease therapies.The current review discusses the practical approaches and potential applications of induced pluripotent stem cell techniques for generating and differentiating dopaminergic neurons from induced pluripotent stem cells.The benefits of induced pluripotent stem cell-based research are highlighted.Various dopaminergic neuron differentiation protocols from induced pluripotent stem cells are compared.The emerging three-dimension-based brain organoid models compared with conventional two-dimensional cell culture are evaluated.Finally,limitations,challenges,and future directions of induced pluripotent stem cell–based approaches are analyzed and proposed,which will be significant to the future application of induced pluripotent stem cell-related techniques for Parkinson's disease.
基金funded by Taif University,Saudi Arabia,project No.(TU-DSPP-2024-263).
文摘Deep learning algorithms have been rapidly incorporated into many different applications due to the increase in computational power and the availability of massive amounts of data.Recently,both deep learning and ensemble learning have been used to recognize underlying structures and patterns from high-level features to make predictions/decisions.With the growth in popularity of deep learning and ensemble learning algorithms,they have received significant attention from both scientists and the industrial community due to their superior ability to learn features from big data.Ensemble deep learning has exhibited significant performance in enhancing learning generalization through the use of multiple deep learning algorithms.Although ensemble deep learning has large quantities of training parameters,which results in time and space overheads,it performs much better than traditional ensemble learning.Ensemble deep learning has been successfully used in several areas,such as bioinformatics,finance,and health care.In this paper,we review and investigate recent ensemble deep learning algorithms and techniques in health care domains,medical imaging,health care data analytics,genomics,diagnosis,disease prevention,and drug discovery.We cover several widely used deep learning algorithms along with their architectures,including deep neural networks(DNNs),convolutional neural networks(CNNs),recurrent neural networks(RNNs),and generative adversarial networks(GANs).Common healthcare tasks,such as medical imaging,electronic health records,and genomics,are also demonstrated.Furthermore,in this review,the challenges inherent in reducing the burden on the healthcare system are discussed and explored.Finally,future directions and opportunities for enhancing healthcare model performance are discussed.
基金Supported by National Research Foundation of Korea,No.NRF-2021S1A5A8062526.
文摘This article provides a comprehensive analysis of the study by Hou et al,focusing on the complex interplay between psychological and physical factors in the postoperative recovery(POR)of patients with perianal diseases.The study sheds light on how illness perception,anxiety,and depression significantly influence recovery outcomes.Hou et al developed a predictive model that demonstrated high accuracy in identifying patients at risk of poor recovery.The article explores the critical role of pre-operative psychological assessment,highlighting the need for mental health support and personalized recovery plans in enhancing POR quality.A multidisciplinary approach,integrating mental health professionals with surgeons,anesthesiologists,and other specialists,is emphasized to ensure comprehensive care for patients.The study’s findings serve as a call to integrate psychological care into surgical practice to optimize outcomes for patients with perianal diseases.
文摘Objective: To explore the effect of Health Action Process Approach (HAPA) theory in patients with type D personality psoriasis. Methods: A total of 66 patients with type D personality psoriasis admitted to the dermatology department of a top-three hospital in Jingzhou City from November 2022 to July 2023 were selected and divided into control group and test group with 33 cases in each group by random number table method. The control group received routine health education, and the experimental group received health education based on the HAPA theory. Chronic disease self-efficacy scale, hospital anxiety and depression scale and skin disease quality of life scale were used to evaluate the effect of intervention. Results: After 3 months of intervention, the scores of self-efficacy in experimental group were higher than those in control group (P P Conclusion: Health education based on the theory of HAPA can enhance the self-efficacy of patients with type D personality psoriasis, relieve negative emotions and improve their quality of life.
基金The Ministry of Education of China supported this work under the Humanities and Social Sciences Research Project for Young Scholars(Grant No.20YJC890020).
文摘Background:Social anxiety is prevalent among adolescents and severely impacts their mental health and social functioning.This study aims to explore the underlying mechanisms and subgroup differences in adolescent social anxiety to provide a theoretical basis for targeted interventions.Methods:3025 Chinese adolescents(Meanage=13.91±1.60 years;47%male)completed self-report measures of physical activity,core self-evaluation,and social anxiety.Variable-centered analyses employed PROCESS Model 4 with 5000 bootstrap samples;covariates were gender,grade,and place of residence.Person-centered analyses used latent profile analysis in Mplus 8.3 to identify subgroups based on social anxiety item profiles.Results:Variable-centered analyses showed that physical activity had a significant negative association with social anxiety(β=−0.224,p<0.001)and a significant positive association with core self-evaluation(β=0.471,p<0.001);core self-evaluation partially mediated this relationship,accounting for 30%of the total effect.Person-centered analyses revealed an optimal two-profile solution:a low social anxiety profile(89.6%)and a high social anxiety profile(10.4%).The high social anxiety profile reported significantly lower physical activity and lower core self-evaluation than the low social anxiety profile.Conclusions:This study integrates variable-centered and person-centered evidence,identifies physical activity and core self-evaluation as key modifiable factors in reducing social anxiety,providing a theoretical basis for targeted and differentiated interventions.
文摘BACKGROUND The root of mesentery dissection is one of the critical maneuvers,especially in borderline resectable pancreatic head cancer.Intra-abdominal chyle leak(CL)including chylous ascites may ensue in up to 10%of patients after pancreatic resections.Globally recognized superior mesenteric artery(SMA)first approaches are invariably performed.The mesenteric dissection through the inferior infracolic approach has been discussed in this study emphasizing its post-operative impact on CL which is the cornerstone of this study.AIM To assess incidence,risk factors,clinical impact of CL following root of mesentery dissection,and the different treatment modalities.METHODS This is a retrospective study incorporating the patients who underwent dissection of the root of mesentery with inferior infracolic SMA first approach pancreat-oduodenectomy for the ventral body and uncinate mass of pancreas in the Department of Gastrointestinal and General Surgery of Kathmandu Medical College and Teaching Hospital from January 1,2021 to February 28,2024.Intraop-erative findings and postoperative outcomes were analyzed.RESULTS In three years,ten patients underwent root of mesentery dissection with inferior infracolic SMA first approach pancreatoduodenectomy.The mean age was 67.6 years with a male-to-female ratio of 4:5.CL was seen in four patients.With virtue of CL,Clavien-Dindo grade Ⅱ or higher morbidity was observed in four patients.Two patients had a hospital stay of more than 20 days with the former having a delayed gastric emptying and the latter with long-term total parenteral nutrition requirement.The mean operative time was 330 minutes.Curative resection was achieved in 100%of the patients.The mean duration of the intensive care unit and hospital stay were 2.55±1.45 days and 15.7±5.32 days,respectively.CONCLUSION Root of mesentery dissection with lymphadenectomy and vascular resection correlated with occurrence of CL.After complete curative resection,these were managed with total parenteral nutrition without adversely impacting outcome.
基金Supported by Yunnan Provincial Clinical Medicine Center for Digestive System Diseases,No.2024YNLCYXZX0132.
文摘BACKGROUND Laparoscopic hepatectomy has been widely accepted for the treatment of liver tumors.Compared with open surgery,it provides a reduced hospital stay,less intraoperative blood loss,less trauma,and fewer incisional infections,without affecting tumor outcomes.However,lesions in the right lobe of the liver are deep and obstructed by the ribs,making exposure difficult and increasing the degree of surgical difficulty;thus,liver tumors in the deep right lobe pose technical challenges in standard laparoscopic surgery.AIM To investigate the safety and efficacy of laparoscopic retroperitoneal partial hepatectomy for liver tumors.METHODS The clinical data of 72 patients who underwent laparoscopic retroperitoneal partial hepatectomy for liver tumors between January 2018 and December 2024 at the First People’s Hospital of Yunnan Province were analyzed.Of the 72 patients included,34 were male and 38 were female,with ages ranging from 34 years to 72 years(median age,45 years).The tumors were all located in the right lobe of the liver,with 30 cases in segment S6,27 cases in segment S7,and 15 cases in segment S8;the mean tumor diameter was 7.5±3.4 cm.The postoperative tumor indices,liver function,and postoperative complications were analyzed to evaluate the clinical efficacy of laparoscopic partial hepatectomy via the retroperitoneal approach.RESULTS The surgeries were successfully completed in all patients,and conversion to open surgery was required in 10 patients.The mean operative time,blood loss,drain retention time,and length of postoperative hospital stay were 140±30 minutes,150±46 mL,3.8±1.2 days,and 8.3±5.3 days,respectively.Liver function tests returned to normal in all patients within two weeks of surgery.Fifteen patients developed atelectasis and pleural effusion and were managed with incision and drainage and antibiotics.Two patients developed uncomplicated minimal ascites,and the remaining patients had no perioperative complications,such as abdominal hemorrhage,infection,liver failure,bile leakage,and other adverse events.All patients were successfully treated.CONCLUSION Laparoscopic retroperitoneal partial hepatectomy is a safe and effective approach for right hepatic space-occupying lesions,particularly in segments S6,S7,and S8,with fewer postoperative complications,less trauma,and faster recovery times.This procedure provides a new surgical access for resection of deep tumors in the right lobe of the liver and has clear clinical implications.
文摘In response to the common problems in college English writing teaching,such as the separation of learning and application,students’low interest in writing,and difficulties in expression,this paper,based on the theoretical framework of the production-oriented approach(POA)proposed by Professor Wen Qiufang,designed and implemented a set of IELTS writing teaching plan.This plan takes“motivating,enabling,and assessing”as the core teaching process,and selects typical IELTS argumentative essay topics(such as food diversity)to create real communication scenarios.In the motivating stage,diverse inputs are used to stimulate students’interest and expose their language weaknesses;in the enabling stage,language knowledge,viewpoint generation,and text structure are focused on for targeted input and training;in the assessing stage,a combination of teacher-student cooperation and peer evaluation is adopted to guide students to identify and correct deficiencies in language use.The research results show that the POA model can effectively enhance students’writing interest,active learning awareness,and writing ability,particularly in overcoming vocabulary poverty and material shortages,as well as improving language accuracy and expression richness.This provides an operational theoretical basis and practical path for improving the teaching effect of IELTS writing.
基金supported by grants from the National Nat-ural Science Foundation of China(82173129)the Innova-tive and Entrepreneurial Talent Doctor of Jiangsu Province,China(JSSCBS20221872)。
文摘Background:Dorsal approach is the potentially effective strategy for minimally invasive liver resection.This study aimed to compare the outcomes between robot-assisted and laparoscopic hemihepatectomy through dorsal approach.Methods:We compared the patients who underwent robot-assisted hemihepatectomy(Rob-HH)and who had laparoscopic hemihepatectomy(Lap-HH)through dorsal approach between January 2020 and December 2022.A 1:1 propensity score-matching(PSM)analysis was performed to minimize bias and confounding factors.Results:Ninety-six patients were included,41 with Rob-HH and 55 with Lap-HH.Among them,58 underwent left hemihepatectomy(LHH)and 38 underwent right hemihepatectomy(RHH).Compared with LapHH group,patients with Rob-HH had less estimated blood loss(median:100.0 vs.300.0 m L,P=0.016),lower blood transfusion rates(4.9%vs.29.1%,P=0.003)and postoperative complication rates(26.8%vs.54.5%,P=0.016).These significant differences consistently existed after PSM and in the LHH subgroups.Furthermore,robot-assisted LHH was associated with decreased Pringle duration(45 vs.60 min,P=0.047).RHH subgroup analysis showed that compared with Lap-RHH,Rob-RHH was associated with less estimated blood loss(200.0 vs.400.0 m L,P=0.013).No significant differences were found in other perioperative outcomes among pre-and post-PSM cohorts,such as Pringle duration,operative time,and hospital stay.Conclusions:The dorsal approach was a safe and feasible strategy for hemi-hepatectomy with favorable outcomes under robot-assisted system in reducing intraoperative blood loss,transfusion,and postoperative complications.
基金the PIG-PARADIGM project,funded by the Novo Nordisk Foundation(Grant No.NNFSA210073688).
文摘Metabolomics utilizes advanced analytical profiling techniques to comprehensively measure small molecules in cells,tissues,and biological fluids.Nutritional metabolomics studies in pigs have reported changes in hundreds of metabolites across various sample types,including plasma,serum,urine,digesta,and feces,following dietary interventions.These findings can help identify biomarkers of gastrointestinal functionality and beyond,as well as investigate mechanistic interactions between diet,host,microbiome,and metabolites.This review aims to summarize the current literature on nutritional metabolomics in pigs and its use to investigate how different dietary approaches impact the gut health of pigs.Here,we critically assessed and categorized the impact of the main macronutrients-carbohydrates,proteins,and fats—along with feed additives such as amino acids,bile acids,and probiotics,as well as feeding strategies like creep feeding,milk replacer introduction,and time-restricted feeding,on the pig metabolome.Additionally,we discuss the potential modes of action of the key affected metabolites on pig gut health.
基金supported by the National Key R&D Program of China(No.2022YFB3707302)the National Natural Science Foundation of China(Nos.52394271 , 52394270).
文摘Enhancing the mechanical properties is crucial for polyimide films,but the mechanical properties(Young's modulus,tensile strength,and elongation at break)mutually constrain each other,complicating simultaneous enhancement via traditional trial-and-error methods.In this work,we proposed a materials genome approach to design and screen phenylethynyl-terminated polyimides for films with enhanced mechani-cal properties.We first established machine learning models to predict Young's modulus,tensile strength,and elongation at break to explore the chemical space containing thousands of candidate structures.The accuracies of the machine learning models were verified by molecular dynamics simulations on screened polyimides and experimental testing on three representative polyimide films.The performance advantages of the best-selected polyimides were analyzed by comparing well-known polyimides based on molecular dynamics simulations,and the structural rationale was revealed by"gene"analysis and feature importance evaluation.This work provides a cost-effective strategy for designing polyimide films withenhancedmechanical properties.
文摘In recent years,the production-oriented approach has been applied in the field of teaching Chinese as a foreign language,providing a new perspective for language and cultural instruction.Currently,several issues exist in cultural teaching,such as the lack of in-depth cultural input,insufficient training in cross-cultural communication skills,and the over-stylization of cultural teaching in the classroom.The production-oriented approach offers a solution to these challenges.This paper seeks to introduce the production-oriented method into the teaching of Chinese culture as a foreign language,using silk culture as a case study for teaching design.The aim is to implement cultural teaching through a new instructional model and to promote the spread of Chinese silk culture.
