The investigator-initiated trials （IIT）， as a widely existing form of clinical research both domestically and internationally， have attracted the attention of governments around the world due to the potential legal risks and issues they may cause， and the trend of legal supervision has gradually strengthened. The legal regulation of IIT in China is still in its early stages， with numerous legal issues that need to be clarified and sorted out. Based on the domestic and international legal reviews of IIT， this paper systematically sorted out the current situation of legal supervision of IIT in China and examined the existing issues， including weak legislative rules， incomplete regulatory systems， imperfect protection rules for research participants and informed consent systems， inadequate regulation of conflicts of interest management， and lax legal supervision of ethical review. Furthermore， this paper proposed suggestions for legal regulation of IIT from three perspectives， including strengthening legislation and emphasizing regulation， improving the mechanism for protecting research participants’ rights and interests， and balancing the legalization of IIT and the scientific development of clinical research， with a view to providing references for legal regulatory paths of IIT in China.

AIM:Given the uncertain impact of osmotic pressure on embryoid body(EB)differentiation,this study aimed to investigate the effects of increased osmotic pressure on EB differentiation and explore the potential relation-ship between this process and cadherin.METHODS:Polhethylene glycol 300(PEG 300)was used to increase the os-motic pressure of the culture medium used for cultivating EBs under both high osmotic pressure and standard culture condi-tions.The experimental design included a control group,an experimental group(hypertonic group),groups treated with varying concentrations of PEG 300,and an experimental group treated with an inhibitor.Western blot,RT-qPCR,AM/PI staining,CCK-8,and immunocytochemical staining was used to analyze the cell viability and the expression of CDH1 and CDH2 markers of the three germ layers,and pluripotency markers within the EBs.RESULTS:Hypertonicity did not af-fect cell viability.Significant differences were observed in the expression of the cadherin proteins CDH1 and CDH2 in EBs between the experimental and control groups;however,no cleartrend towards an EMT shift was observed.Specifically,CDH2 expression was significantly down-regulated in experimental group,showing a clear correlation with variations in os-motic pressure.Moreover,compared with control group,pluripotency markers in the EBs from experimental group exhibited significantly higher expression levels from the 2nd day to the 5th day.A substantial increase in the expression of mesoder-mal markers was also observed;however,a downward trend was observed for ectodermal markers in experimental group.Intervention using SB431542,which up-regulates CDH2 expression by affecting TGF-β signaling,reversed the expression trend of mesodermal and ectodermal markers in experimental group.CONCLUSION:Elevated osmotic pressure appears to enhance the mesodermal differentiation efficiency in EBs,possibly correlating with CDH1 and CDH2 changes induced by osmotic pressure.Therefore,this study emphasizes the significant role of osmotic pressure in stem cell applications.

Objective:To explore the effect of combining hand-brain perception training with hand-brain motor training based on mirror neuron theory on the recovery of upper limb function after a stroke.Methods:A group of 105 stroke survivors with upper limb dysfunction were randomly divided into a hand-brain perception (HP) group, a hand-brain motor (HM) group, and a combination (C) group, each of 35. In addition to conventional rehabilitation treatment (including exercise therapy, occupational therapy and physical factor therapy), the HP and HM groups were given hand-brain perception training and hand-brain motor training respectively, while group C was provided with both. Before the intervention and after 4 weeks, the upper limb motor functioning of all of the participants was assessed using the simplified version of the Fugl-Meyer upper limb motor function scale (FMA-UE). Sensory functioning was quantified using the tactile Semmes Weinstein monofilament examination (SWME), and the modified Barthel index (MBI) was used to quantify the participants′ ability in the activities of daily living.Results:After the intervention the average FMA-UE, MBI and SWME scores of all three groups had improved significantly, with group C′s average FMA-UE and MBI scores significantly better than the other two groups′ averages. The average SWME score of group C was then significantly better than that of group HM.Conclusions:Hand-brain perception combined with hand-brain motor training based on mirror neuron theory can further promote the recovery of upper limb sensory and motor functioning of stroke survivors., Such therapy is worthy of clinical promotion and application.

Objective:To explore the differences of physical activity levels between Chinese and British patients with cardiovascular disease (CVD) and its influencing factors.Methods:Based on the baseline survey of China Kadoorie Biobank (CKB) and United Kingdom Biobank (UKB), we identified the case and control group according to the self-reported disease history in the questionnaire. Metabolic equivalent of task, as the assessment of physical activity level, was graded according to the tertiles of specific ages and genders. Multiple logistic regression models were used to analyze the correlation between CVD status and physical activity levels.Results:We included 509 170 Chinese adults and 360 360 British adults in the analysis. After adjusting for multiple factors, we found a positive correlation between CVD patients and low physical activity levels in both CKB and UKB populations (CKB: OR=1.21, 95% CI:1.17-1.25; UKB: OR=1.24, 95% CI:1.20-1.28). There was a high correlation between the prevalence of CVD and low physical activity levels in males with CKB ( OR=1.33, 95% CI:1.27-1.40).Unlike the UKB population, as the length of CVD increased, the physical activity levels of CKB patients gradually approached that of the non-CVD population, and stroke was positively correlated with low physical activity levels ( OR=1.46, 95% CI:1.38-1.53). The decline in physical activity was more pronounced among CKB and UKB CVD patients with lower educational levels, current or former smokers or drinkers, and those with other chronic diseases. In CKB, there showed a high correlation between CVD disease and low physical activity levels in rural areas and non-retired populations. In UKB, there appeared a higher correlation between CVD disease and low physical activity levels in urban and non-working populations. Conclusions:The physical activity levels of CVD patients in both China and the UK were lower than that in non-CVD population. In addition to low-educated individuals, current or former smokers or drinkers, and those with other chronic diseases, it is critical to pay attention to the physical activity levels of rural, male, and non-retirees among Chinese patients.

Objective:To compare physical activity and its influencing factors in patients with chronic obstructive pulmonary disease (COPD) between China and the United Kingdom.Methods:We analyzed baseline data from China Kadoorie Biobank and the United Kingdom Biobank among COPD patients who were diagnosed with a one-second rate (FEV 1/FVC) less than 70%. Physical activity level was calculated as metabolic equivalent (MET) and divided into three levels: low, medium, and high, according to tertiles stratified by gender and age. Multiple logistic regression was used to estimate ORs and 95% CIs for COPD and Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade about physical activity level, and subgroup analysis was conducted. Results:A total of 506 073 Chinese adults and 231 884 British adults were included. After adjusting for potential confounders, COPD was associated with lower physical activity levels in both Chinese and British COPD patients, with OR (95% CI) of 1.07(1.03-1.10) and 1.03(1.01-1.06) compared with non COPD patients, respectively. The GOLD grade was inversely correlated with physical activity level, particularly in a dose-response manner in the CKB population (trend test P<0.001). The negative relationship was stronger among the elderly, people with less education and lower economic status, and those with a smoking or chronic disease history. Chinese rural COPD patients were at high risk of decline of physical activity. Conclusions:Physical activity is inversely related to COPD, with a dose-response connection to GOLD grade. Therefore, physical activity maintenance and improvement should be encouraged and promoted in COPD patients, especially in high-risk groups.

Under the background of " Internet+ medical treatment" and the continuous deepening of face recognition technology research, the face recognition industry has continued to mature, and face recognition has been initially applied in medical fields such as hospital management, auxiliary medical care, and epidemic prevention and control. At the same time, face recognition technology brings problems including error risk, technical cracking risk, privacy risk, equality risk, abuse risk, and other issues in practice, which seriously threaten the personal and property rights and interests of the public. On the basis of summarizing the specific application direction of face recognition technology in hospitals, the authors sorted out the legal regulation of face recognition in China, and proposed that it should be based on technology research and development, strengthen the " gatekeeper" responsibility of medical institutions, improve legal system and recommendations for strengthening judicial leadership in order to improve the legal regulations of face recognition technology, reduce the risk of infringement by medical institutions in the application of face recognition technology, and protect the legitimate rights and interests of citizens.

Objective: To understand the prevalence of low vision among Tujia and Han children and adolescents in Tujia inhabited areas, and to provide reference for the prevention and control of myopia in children and adolescents in minority areas. Methods: A cluster sampling of Tujia and Han primary school students from two primary schools in Lichuan City, Enshi Tujia and Miao Autonomous Prefecture, Hubei Province (2 466 Tujia and 971 Han) were selected for visual acuity assessment. Univariate χ 2 test and multivariate Logistic analysis were used. Low vision and associated factors between Tujia and Han nationality were compared. Results: The overall detection rate of low vision among children and adolescents in Tujia inhabited areas was 44.9%. There were differences in the degree of low vision in the left and right eyes of individuals, and the detection rate of low vision varied significantly by ethnic, gender and grade ( χ 2=22.10, 18.43, 19.06, 17.97 for the left eye, 17.52, 20.44, 21.49, 18.61 for the right eye, P < 0.05). There were many factors affecting low vision among children and adolescents in Tujia inhabited areas, overweight and obesity were negatively associated with low vision ( OR=1.81, 1.70, 95%CI=1.76-1.92, 1.66-1.82, P <0.01). Conclusion Low vision is highly prevalent in Tujia children and adolescents. Effective intervention measures should be taken to treat and prevent myopia in children and adolescents.

Objective: To understand physical activity status of children and adolescents in Tujia inhabited areas, and to provide reference for the intervention model of physical activity of children and adolescents in minority areas. Methods: A cluster sample of 2 466 Tujia pupils from two primary schools in Lichuan City, Enshi Tujia and Miao Autonomous Prefecture of Hubei Province was selected to investigate physical activity status of Tujia pupils. The univariate χ 2 test was used to analyze the physical activity status of Tujia children and adolescents and its influencing factors. Results: The median duration of high intensity activity was 49.9 minutes/day in the last week, and 47.93% of participants met the physical activity standard( χ 2=80.47, P <0.01), the median duration of sitting was 396.1 minutes/day in the last week, and the qualified rate of screen time was 78.99%, and the differences of qualified rate between daystudents and residential students were of statistical differences( χ 2=35.12, P <0.01)). Conclusion The children and adolescents in the Tujia community are lack of physical activity. Therefore, it is necessary to take effective intervention measures to pay attention to the children and adolescents physical activity.

Objective: To investigate effectiveness of different intensities of basketball exercise on body compositions among obese junior middle school students, and to provide theoretical support for healthy weight loss among obese children and adolescents. Methods: From September to November 2020,a typical sampling method was used to select 48 obese junior middle school students were recruited from Wuhan Optical Valley Experimental Middle School according to body mass index(BMI), all the students were divided into high, moderate and low intensity basketball training group, as well as the control group, the 45 min per times basketball exercise intervention was administered three times per week for 12 weeks, while the control group did not received no intervention, body composition was assessed before and after intervention. Results: After 12 weeks of low intensity basketball exercise, the percentage of body fat of obese junior high school students after intervention was significantly higher than that before intervention[(32.16±2.26)% v.s. (34.33±2.35)%] ( t =3.52, P <0.05). There was no significant difference in other indexes body weight, body mass index, waist circumference, skeletal musclebetween before and after intervention ( t =2.31, 1.98, 1.26,-1.65, P >0.05). For moderate intensity basketball exercise group obdy weight, BMI, percentage of body fat and waist circumference showed statistical changes before and after intervention( t=3.44, 3.76, 6.56, 2.45, P <0.05). For high intensity basketball exercise group, all body composition indicators showed significant changes( t=4.14, 5.18, 11.26, 5.89, -2.56, P <0.05). Conclusion Twelve weeks of basketball exercise can effectively improve body composition of obese junior middle school students, with higher the intensity of exercise, the better the effectiveness.

Objective To investigate the potential therapeutic effect of luteolin on sepsis-induced ALI and the underlying mechanisms.Methods Total of 50 mice were randomly(random number) divided into five groups:a sham control group,a sepsis-induced ALI group,and three sepsis groups pre-treated with 20,40,and 80 mg/kg body weight luteolin.Mice in the treatment groups were pre-treated with luteolin at the respective oral dose two days before ALI induction.The lungs were isolated for histopathological examinations,and the bronchoalveolar lavage fluid (BALF) was collected for biochemical analyses.Results Luteolin significantly attenuated sepsis-induced ALI.Additionally,luteolin treatment decreased protein and inflammatory cytokine concentration and the number of infiltrated inflammatory cells in BALF compared with that in the non-treated sepsis mice.Pulmonary myeloperoxidase (MPO) activity was lower in the luteolin-pre-treated sepsis groups than in the sepsis group.The mechanism underlying the protective effect of luteolin on sepsis is related to the up-regulation of certain antioxidation genes,including inducible nitric oxide synthase (iNOS),cyclooxygenase-2 (COX-2),superoxide dismutases (SODs),and heme oxygenase 1 (HO-1),and the reduction of inflammatory responses through blockage of the activation of the nuclear factor (NF)-κB pathway.Conclusions Luteolin pre-treatment inhibits sepsis-induced ALI through its anti-inflammatory and antioxidative activity,suggesting that luteolin may be a potential therapeutic agent for sepsis-induced ALI.