The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.

Objective To compare the gut fungal composition between gout patients and healthy individuals through high-throughput sequencing of ribosomal DNA internal transcribed spacer 1(ITS1).Methods Gout patients and healthy volunteers who visited our hospital from January 2023 to December 2024 were enrolled in this study.Then based on established medical guidelines,the gout patients were categorized into 3 groups:Group H(asymptomatic hyperuricemia,n=14),Group G(acute gouty arthritis,n=14),and Group I(intercritical period of gouty arthritis,n=15),and the healthy individuals were assigned into Group N(n=9).Fecal samples were collected from all the participants to undergo ITS1 sequencing analysis.The differences in diversity and composition of gut mycobiome,and FunGuild-derived fungal functions and nutritional status were compared among the 4 groups,and the correlation between the gut mycobiome and clinical indicators was analyzed.Results There were no significant differences in baseline features such as gender,age,glomerular filtration rate(GFR),and levels of serum creatinine(SCr)and serum urea among Group N and other gout groups,but obvious differences were observed in body mass index(BMI),erythrocyte sedimentation rate,and levels of C-reactive protein(CRP),serum uric acid(SUA),and IL-1β and IL-6(P<0.05).In terms of gut fungal diversity,ITS1 analysis showed there were no statistical differences in α-diversity or the principal coordinate analysis(PCoA)of β-diversity among the groups.However,as gout progressed,significant changes were observed in β-diversity indices,indicating a shift in the gut fungal community composition with disease advancement(P<0.05).The phyla Ascomycota,Basidiomycota,and Mucoromycotina were the dominant fungal phyla in all groups.Compared with the other 3 gout groups,the abundance of Pichia was significantly increased in Group N(P<0.05),that of Saccharomyces was in Group H(P<0.05),and that of Starmerella was in Group G(P<0.05).Correlation analysis between the gut mycobiome and clinical indices indicated that the relative abundance of Starmerella was significantly positively correlated with IL-1β(P<0.01)and IL-6(P<0.05).The relative abundance of Pichia was significantly positively correlated with IL-1β and IL-6 levels(P<0.05),and negatively correlated with serum urea level(P<0.05),and the relative abundance of Saccharomyces was negatively correlated with IL-1β and IL-6 levels(P<0.05).Conclusion There exist significant alterations in both the diversity and composition of gut fungi among patients with gout at various stages.Notably,the fluctuations in the relative abundance of Starmerella,Pichia and Saccharomyces appear to correlate with key clinical indicators.

Objective To construct an automatic segmentation model to segment female urine control anatomy on MRI images based on deep learning methods in order to improve the segmentation efficiency and accuracy.Methods A dataset comprising 49 female pelvic floor muscle MRI images[30 women with varying degrees of pelvic organ prolapse(POP)and 19 healthy individuals],obtained from Faculty of Biomedical Engineering and Medical Imaging in Army Medical University,was used for model training and testing.The dataset was split into a training set(17 normal cases and 22 POP cases)and a testing set(4 normal cases and 6 POP cases)in a ratio of 8∶2.The training set was used to train UNet,UNet+++,Dense UNet,and UNet++models separately,and then input into each network.The model achieving the highest testing accuracy was selected as the backbone network.Results Under the training of UNet,UNet+++,Dense UNet,and UNet++,the 4 models achieved average Dice similarity coefficients of 61.82%,57.94%,57.63%,and 62.76%,respectively,for the segmentation of 5 anatomical structures(compressor urethrae,urethra sphincter body,bladder wall,bladder cavity and urethra submucosa).The corresponding Intersection over Union(IoU)score was 49.74%,46.59%,46.07%,and 49.44%,while the accuracy rate was 61.74%,55.03%,59.23%,and 61.91%,respectively for the 4 models.Notably,UNet++consistently outperformed UNet,UNet+++,and Dense UNet across the 3 metrics,indicating that UNet++achieved the highest overall segmentation accuracy.Conclusion In UNet,UNet++,Dense UNet and UNet++for automatic segmentation of 5 female urine control anatomical elements,UNet++achieves the best overall segmentation accuracy.

Objective:To investigate the correlation between the annual professional proficiency test results and the theoretical examination score of completion assessment in standardized residency training, as well as the value of the annual professional proficiency test results in predicting whether a resident passes the theoretical examination of completion assessment.Methods:The residents who participated in the annual professional proficiency test of residency training in Affiliated Hospital 2 of Nantong University in 2019-2021 and the completion assessment of residency training in 2020-2022 were selected as subjects, and related data were collected, including sex, education background, personnel type, training specialty, the results of annual professional proficiency test, and the theoretical examination score of completion assessment. According to whether the resident passed the theoretical examination of completion assessment, they were divided into passed group and failed group. SPSS 19.0 was used to perform the chi-square test, the independent samples t-test, and the binary logistic regression analysis; the Pearson correlation coefficient was used for correlation analysis; the sensitivity analysis was represented by ROC curve. Results:Compared with the residents who passed the theoretical examination of completion assessment, the residents who did not pass the examination had a significant reduction in the proportion of the residents from our hospital and a significant increase in the proportion of the residents commissioned by foreign institutions ( χ 2=7.00, P=0.008). The passed group had a significantly higher national percentile of annual professional proficiency test score than the failed group (43.46%±26.61% vs. 23.40%±18.71%, t=6.02, P<0.001). The national percentile of annual professional proficiency test score was positively correlated with the theoretical examination score of completion assessment ( r=0.43, P<0.05). The source of residents commissioned by foreign institutions and the low percentile of annual professional proficiency test score were independent risk factors for failing the theoretical examination of completion assessment ( P=0.020 and P<0.001). The national percentile of annual professional proficiency test score had an area under the ROC curve of 0.73 (95% CI: 0.65-0.80) in predicting the outcome of theoretical examination and had a certain predictive value with a cut-off value of 15.1%. Conclusions:In addition to strengthening homogenization and professional base management for residency training, it is necessary to make full use of the results of annual professional proficiency test in standardized residency training and timely check the professional knowledge of the residents whose a national percentile of <15.1%, so as to effectively improve the pass rate of theoretical examination and the quality of training.

In recent years, the number of people living in short-term and long-term period in high-altitude has been continuously increasing, with over 81.6 million people living in areas with an altitude of ≥ 2, [KG*9]500 meters. In China, there are over 10 million people who frequently reside at high altitudes, and over 20 million people enter the plateau every year. The unique plateau climate has triggered a series of plateau related diseases, among which high altitude cerebral edema (HACE) is one of the most serious diseases. If patients are not treated promptly and appropriately, they may die from cerebral hernia within 24 hours. However, the exact mechanism of the development of HACE is not fully understood, which makes the clinical prevention and treatment of HACE challenging. Mesenchymal stem cells (MSC) and their exosomes (MSC-Exos) have the ability to repair damaged tissues and cells, resist oxidative stress, inhibit inflammatory reactions, and regulate autophagy, which may potentially become new drugs for preventing and treating HACE. This article elucidated the pathogenesis of high altitude brain edema and the potential roles of MSC and MSC-Exos based on relevant literatureat home and abroad, providing a theoretical basis for the prevention and treatment of HACE by MSC and MSC-Exos.

OBJECTIVE To investigate the components and metabolites of leaves of Cyclocarya paliurus in rats plasma. METHODS UHPLC-Q/TOF-MS method was applied to identify the components and metabolites of rat plasma. The prototype components and metabolites were analyzed in rats plasma of leaves of Cyclocarya paliurus water extract after intragastric administration by comparing the chromatograms of Cyclocarya paliurus, blank serum and drug-containing serum. RESULTS A total of 15 compounds including 6 prototype components and 9 metabolites were identified. The main prototype components in blood were caffeylquinic acid, flavonoids and saponins, and the metabolic pathways were methylation and hydroxylation. CONCLUSION This experiment showes that the prototype components absorbed into blood may be the potential bioactive components in leaves of Cyclocarya paliurus, providing a scientific basis for clarifying its material basis in pharmacodynamics.

End-stage renal disease (ESRD) patients undergoing outpatient hemodialysis (HD) and home peritoneal dialysis (PD) are high risk population of severe and critical types caused by SARS-CoV-2 infection. In order to improve the quality of diagnosis and treatment in dialysis patients with SARS-CoV-2 infection, we wrote this recommendation for primary care clinicians. During the epidemic period of SARS-CoV-2 infection, all patients should be instructed to strengthen self-management. Once the SARS-CoV-2 infection was found in dialysis patients, early stratified management should be carried out within 72 hours after the first positive nucleic acid or antigen test results, which includes early antiviral therapy, early recognition, and transferring severe patients from community or primary hospital to a referral hospital promptly. Guidance for dietary and sports rehabilitation after SARS-CoV-2 infection should also be started as soon as possible.

China is stepping up its standardized management of investigator initiated trials(IIT)carried out by medical and health institutions, spotlighting the establishment and improvement of the quality control system of IIT projects than ever before. The authors retrieved official websites of clinical research related units of medical institutions and research institutes at home and abroad, and by means of literature review analyzed the current quality management of IIT projects at home and abroad. They found such setbacks as lack of quality management standards and norms, imperfect quality control mechanism, poor awareness of quality risk, insufficient quality supervision and poor quality control ability of clinical researchers. Based on the above, the paper made the following recommendations for building an IIT project quality control system in China: developing quality management standards and norms, setting up a systematic quality control mechanism(i.e., exploring a three-level quality control mode composed of the project team/department-hospital-national supervision institution/peer review expert team, and implementing the whole process quality control mechanism), strengthening policy guidance and system construction, and strengthening the standardized training of clinical researchers.

Objective:To explore the mechanism by which microRNA (miRNA) -1303 inhibits the proliferation and migration of renal cell carcinoma 786-O cells through targeted regulation of lysophosphatidic acid receptor 3 (LPAR3) expression.Methods:quantitative real-time polymerase chain reaction (qRT-PCR) was used to detect the relative expression of miR-1303 in renal cancer cell lines (A498, ACHN, 786-O, OS-RC-2) and normal renal tubular epithelial cells HK-2. The miR-1303 mimic and the negative control sequence were transfected into the renal cancer cells with the lowest expression of miR-1303, respectively, as the miR-1303 group and the negative control group. qRT-PCR detected the relative expression of miR-1303 in the two groups of cells. MTT method and Transwell migration experiment were used to detect cell proliferation and migration ability. RegRNA 2.0 predicted the target genes of miR-1303. The dual luciferase reporter gene detected the binding of miR-1303 to the target gene. qRT-PCR and Western blotting detected the relative expression of LPAR3. Measurement data were expressed as mean±standard deviation ( ± s), t-test was used for comparison between two groups, and one-way analysis of variance was used for comparison between multiple groups. Results:The expressions of miR-1303 in renal cancer cell lines A498, ACHN, 786-O, OS-RC-2 and normal renal tubular epithelial cells HK-2 were 0.51±0.04, 0.79±0.02, 0.21±0.04, 0.55±0.07 and 1.00±0.05, the expression of miR-1303 in renal cancer cell lines was lower than that in HK-2 ( P<0.05), and the relative expression in 786-O cells was the lowest ( F=29.50, P<0.01). Compared with the control group, the expression of miR-1303 in the experimental group was significantly increased [(1.00±0.01) vs (7.98±0.88), t=7.95, P<0.01]. The cell absorbance value of the experimental group was significantly lower than that of the control group ( P<0.05). The number of cell migration in the experimental group was significantly lower than that in the control group ( P<0.05). miR-1303 can bind to LPAR3 mRNA in a complementary pair ( P<0.01). Compared with the control group, the expression of LPAR3 mRNA in the 786-O cells of the experimental group was significantly reduced [(1.00±0.01) vs (0.23±0.03), t=23.56, P<0.01]. Conclusion:miR-1303 may inhibit the proliferation and migration ability of renal cancer 786-O cells by down-regulating the expression of LPAR3.