ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials， promote clinical trial progress， and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials， analyzing the advantages and challenges of decentralized drug clinical trials， and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review， and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility， applicability， and rationality， the adequacy of informed consent， the protection of rights and interests and privacy of subjects， as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties， pay attention to the rights and interests of subjects， and gradually promote the implementation of decentralized drug clinical trials.

ObjectiveGliomas in the motor functional area can damage the corticospinal tract (CST), leading to motor dysfunction. Currently, there is a lack of unified methods for evaluating the extent of CST damage, especially in patients with high surgical risk where the minimum distance from the lesion to the CST is less than 10 mm. This study aims to further clarify the classification method and clinical significance of CST morphological changes in these patients. MethodsThis retrospective study analyzed 109 high-risk functional area glioma patients who underwent neurosurgical treatment with preoperative diffusion tensor imaging (DTI) imaging and intraoperative neurostimulation guidance between 2014 and 2024. All patients had a lesion-to-tract distance (LTD) of less than 10 mm between the CST and the lesion. Preoperative DTI evaluation of CST involvement-induced morphological changes were reviewed. Patients were divided into 3 groups: 17 cases (15.6%) with symmetric CST morphology compared to the healthy side (CST symmetry), 48 cases (44.0%) with significant CST morphology changes compared to the healthy side (CST deformation), and 44 cases (40.4%) with CST overlap with the tumor (CST overlap). Then we classified patients according to preoperative assessment of tumor-induced morphological changes, and analyze postoperative motor function for each category. ResultsPostoperative pathology showed a significantly higher proportion of high-grade gliomas (HGG) in the CST overlap group compared to the other two groups (P=0.001). Logistic regression analysis showed that CST overlap was a predictor of HGG (P=0.000). The rate of total tumor resection in the CST deformation group and overlap group was lower than in the CST symmetric group (P=0.008). There was a total of 41 postoperative hemiplegic patients, with 4 cases (23.5%) in the CST symmetric group, 11 cases (22.9%) in the CST deformation group, and 26 cases (59.1%) in the CST overlap group. CST overlap with the tumor predicted postoperative hemiplegia (P=0.016). Two-way ANOVA analysis of the affected/healthy side and CST morphology groups showed significant main effects of CST grouping and healthy-affected side (P=0.017 and P=0.010), with no significant interaction (P=0.31). The fractional anisotropy (FA) value in the CST overlap group and the affected side was lower. A decrease in the FA value on the affected side predicted postoperative hemiplegia (sensitivity 69.2%, specificity 71.9%). ConclusionWe have established a method to predict postoperative hemiplegia in high-risk motor functional area glioma patients based on preoperative CST morphological changes. CST overlap leads to a decrease in CST FA values. This method can be used for precise patient management and aid in accurate preoperative surgical planning.

Aim To investigate the effect of Xuefu Zhuyu decoction on transforming growth factor-β1(TGF-β1 ) -induced endothelial-to-mesenchymal transition (EndMT) of pulmonary microvascular endothelial cells ( PMVEC), and further analyze the mechanism related to the TGF-β1/Smad signaling pathway. Method To construct an EndMT cell model, PMVEC was treated with TGF-β1 (5 μg · L

Non-small cell lung cancer(NSCLC)is a highly lethal malignant tumor that poses a serious threat to human health.Traditional methods for tumor diagnosis and treatment have many limitations.However,circulating tumor DNA(ctDNA)detection,a kind of liquid biopsy technology,has gained widespread attention in the field of NSCLC personalized therapy and monitoring due to its non-invasive,convenient,and comprehensive sensitivity.This article will review the latest research progress of ctDNA detection in the clinical diagnosis and treatment of NSCLC in recent years,including its applications in early screening,disease diagnosis,tumor mutation monitoring,treatment efficacy evaluation,and prognosis assessment.

Objective To investigate the correlation between uterine globulin associated protein 1(UGRP1)and Fas mediated apoptosis pathway in hashimoto thyroiditis(HT).Methods The expression of UGRP1 in thyroid cells of normal people and HT patients was detected by immunohistochemistry(IHC).FRTL-5 cells were transfect-ed by plasmids in vitro,and control group,UGRP1 group,Fas group were established respectively.Real-time fluo-rescent quantitative reverse transcription PCR(RT-qPCR)was used to detect the expression of Fas and UGRP1 mRNA in each group.Results UGRP1 expression was positive in thyroid cells of HT patients and negative in that of normal people.There were no significant differences between control group and UGRP1 group in Fas gene ex-pression(1.085 0±0.124 9 vs 1.021 0±0.113 9).Compared with the control group,the expression of UGRP1 gene increased significantly in Fas group(P＜0.000 1,5.807 0±0.323 2 vs 0.752 7±0.076 0).Conclusion The high expression of UGRP1 in HT may be related to apoptosis pathway mediated by Fas.

Objective:To assess the current situation, advantages, and difficulties of standardized management in Investigator-Initiated Clinical Trials (IIT).Methods:This article summarized the requirements and policies for clinical research management, the development of clinical research domestically and internationally, the achievements and advantages of clinical research management development in China, and the main problems and difficulties with the standardized IIT management in China, and compiled the experiences and models of several medical institutions in IIT management.Results:While China has a large number of clinical medical publications and is ranked high in the world, the quality of the publications needs to be further improved. Domestic management requirements for IIT were gradually improving, providing a basis for medical institutions to implement standardized management throughout the lifecycle of IIT, and achieve certain progress. However, there were still challenges in the departmental divisions, the unification of management standards, whole-process management and quality control, the scientific review, high-risk project management, and registration.Conclusions:Drawing on the excellent experience of domestic medical institutions, measures including identifying a primary responsible department, establishing unified supervision and inspection standards, and implementing a whole life cycle management may help overcome the challenges in IIT management and improve the quality and efficiency of IIT management.

Interventions for endometriosis(EMs)include surgical excision of lesions and hormonal therapy,which usually have limited efficacy and adverse drug reactions.Traditional Chinese medicine(TCM)has the multi-component and multi-target characteristics,which can help patients achieve good clinical benefits by intervening in different parts of the disease.In this paper,we briefly discuss the modern pharmacology of Sanlang and Curcuma longa,and deeply summarize the possible mechanisms of action of TCM monomer and classical compound extracts and their active ingredients through signal pathways in inflammation,immune system,angiogenesis,hormone regulation,etc.,so as to provide theoretical bases for the clinical use of TCM monomers,drug-to-drug groups and compounds in the treatment of EMs.

Objective To investigate the risk factors of in-hospital mortality and establish a risk prediction model for patients receiving venoarterial extracorporeal membrane oxygenation(VA-ECMO).Methods We retrospectively collected the data of 302 patients receiving VA-ECMO in ICU of 3 hospitals in Guangdong Province between January,2015 and January,2022 using a convenience sampling method.The patients were divided into a derivation cohort(201 cases)and a validation cohort(101 cases).Univariate and multivariate logistic regression analyses were used to analyze the risk factors for in-hospital death of these patients,based on which a risk prediction model was established in the form of a nomogram.The receiver operator characteristic(ROC)curve,calibration curve and clinical decision curve were used to evaluate the discrimination ability,calibration and clinical validity of this model.Results The in-hospital mortality risk prediction model was established based the risk factors including hypertension(OR=3.694,95%CI:1.582-8.621),continuous renal replacement therapy(OR=9.661,95%CI:4.103-22.745),elevated Na2+ level(OR=1.048,95%CI:1.003-1.095)and increased hemoglobin level(OR=0.987,95%CI:0.977-0.998).In the derivation cohort,the area under the ROC curve(AUC)of this model was 0.829(95%CI:0.770-0.889),greater than those of the 4 single factors(all AUC<0.800),APACHE Ⅱ Score(AUC=0.777,95%CI:0.714-0.840)and the SOFA Score(AUC=0.721,95%CI:0.647-0.796).The results of internal validation showed that the AUC of the model was 0.774(95%CI:0.679-0.869),and the goodness of fit test showed a good fitting of this model(χ2=4.629,P>0.05).Conclusion The risk prediction model for in-hospital mortality of patients on VA-ECMO has good differentiation,calibration and clinical effectiveness and outperforms the commonly used disease severity scoring system,and thus can be used for assessing disease severity and prognostic risk level in critically ill patients.

Objective This study aimed to evaluate the associations of serum folate and/or vitamin B12 concentrations with obesity among Chinese children and adolescents. Methods A cross-sectional study was conducted including 3,079 Chinese children and adolescents,aged 6 to 17 years,from Jiangsu,China.Anthropometric indices,such as,children's body mass index(BMI),BMI z-scores,waist circumference,and waist-to-height ratio were utilized.Multivariable linear regression and generalized additive models were used to investigate the associations of serum folate and vitamin B12 levels with anthropometric indices and odds of obesity. Results We observed that serum vitamin B12 concentrations were inversely associated with all anthropometric indices and the odds of general obesity[odds ratio(OR)= 0.68;95%confidence interval(CI)= 0.59,0.78]and abdominal obesity(OR = 0.68;95%CI = 0.60,0.77).When compared to participants with both serum vitamin levels in the two middle quartiles,those with both serum folate and vitamin B12 levels in the highest quartile were less prone to general(OR = 0.31,95%CI = 0.19,0.50)or abdominal obesity(OR = 0.46,95%CI = 0.31,0.67).Conversely,participants with vitamin B12 levels in the lowest quartile alongside folate levels in the highest quartile had higher odds of abdominal obesity(OR = 2.06,95%CI = 1.09,3.91). Conclusion Higher serum vitamin B12 concentrations,but not serum folate concentrations,were associated with lower odds of childhood obesity.Children and adolescents with high levels of vitamin B12 and folate were less likely to be obese.

Objective To explore the effect and mechanism of sodium hydrosulfide(NaHS)on cerebral cortical injury in rats with cerebral ischemia-reperfusion.Methods A total of 80 male SD rats were divided into a sham operation group,an NaHS group,an ischemia-reperfusion group,and an ischemia-reperfusion+NaHS group using a random number table method,with 20 rats in each group.The rats in the ischemia-reperfusion group and ischemia-reperfusion+NaHS group were used to prepare ischemia-reperfusion models.The rats in the ischemia-reperfusion+NaHS group were given 50 μmol·kg-1 NaHS intraperitoneally after cerebral ischemia,while the rats in the ischemia-reperfusion group were given an equal volume of physiological saline intraperitoneally after cerebral ischemia.The rats in the sham operation group and NaHS group only had vessels isolated but not occluded with threads.The rats in the NaHS group were given 50 μmol·kg-1 NaHS intraperitoneally after vascular detachment,while the rats in the sham operation group were given an equal volume of physiological saline intraperitoneally after vascular detachment.Twenty-four hours after modeling,the neurological deficits of rats in the four groups were evaluated by using the modified neurological severity score(mNSS),the cerebral infarction of rats in the four groups was observed aftertriphenyltetrazolium chloride staining,the levels of pro-inflammatory cytokines interleukin-1β(IL-1β)and interleukin-18(IL-18)in theischemiccerebralcortical tissues of rats in the four groups were detected by using enzyme-linked immunosorbent assay,the expression of nucleotide-binding oligomerization domain-like receptor protein 3(NLRP3)in the ischemic cerebral cortical tissues of rats in the four groups was detected by using Western blot,and the activity of microglia in the ischemic cerebral cortical tissues of rats in the four groups was detected by using immunofluorescence.Results The brain tissues of rats in the sham operation group and the NaHS group showed uniform orange red color,while the rats in the ischemia-reperfusion group and the ischemia-reperfusion+NaHS group had pale infarcted areas in the ischemic cerebral cortex and striatum.The cerebral infarction area of rats in the ischemia-reperfusion group and the ischemia-reperfusion+NaHS group were significantly larger than that in the sham operation group and the NaHS group,while the cerebral infarction area of rats in the ischemia-reperfusion+NaHS group was significantly smaller than that in the ischemia-reperfusion group(P＜0.05).The mNSS scores of rats in the ischemia-reperfusion group and the ischemia-reperfusion+NaHS group were significantly higher than those in the sham operation group and the NaHS group,while the mNSS score of rats in the ischemia-reperfusion+NaHS group was significantly lower than that in the ischemia-reperfusion group(P＜0.05).The relative expression levels of NLRP3 protein in the ischemic cerebral cortex of rats in the ischemia-reperfusion group and the ischemia-reperfusion+NaHS group were significantly higher than those in the sham operation group and the NaHS group,while the relative expression level of NLRP3 protein in the ischemic cerebral cortex of rats in the ischemia-reperfusion+NaHS group was significantly lower than that in the ischemia-reperfusion group(P＜0.05).The levels of IL-1β and IL-18 in the ischemic cerebral cortex of rats in the ischemia-reperfusion group and the ischemia-reperfusion+NaHS group were significantly higher than those in the sham operation group and the NaHS group,while the levels of IL-1β and IL-18 in the ischemic cerebral cortex of rats in the ischemia-reperfusion+NaHS group were significantly lower than those in the ischemia-reperfusion group(P＜0.05).The rats in both sham operation group and NaHS group showed normal morphology of microglia in the ischemic cerebral cortical area.Compared with the sham operation group and the NaHS group,the rats in the ischemia-reperfusion group showed a significant reduction in the protrusion of microglia in the ischemic cerebral cortical area and a significant increase in the brightness of microglial cell bodies,and the cells appeared as clumps,losing their normal morphology,with a higher proportion of activated microglia.Compared with the ischemia-reperfusion group,the rats in the ischemia-reperfusion+NaHS group showed an increase in the number of microglial processes in the ischemic cerebral cortex,with fewer activated microglia and significantly improved morphology.The total numbers of microglia in the ischemic cerebral cortex of rats in the ischemia-reperfusion group and theischemia-reperfusion+NaHS group were significantly lower than those in the sham operation group and the NaHS group,while the total number of microglia in the ischemic cerebral cortex of rats in the ischemia-reperfusion+NaHS group was significantly higher than that in the ischemia-reperfusion group(P＜0.05).Conclusion NaHS can significantly improve brain injury in ischemia-reperfusion rats by inhibiting the inflammatory response and microglial activation induced by NLRP3 and reducing the levels of pro-inflammatory cytokines IL-1β and IL-18.