Establishing a comprehensive mechanism for the initiation and review of investigator-initiated trial(IIT) plays an important role in ensuring the scientific validity of clinical research and improving research quality.Since 2021, Zhongshan Hospital affiliated to Fudan University had actively explored improvements in the project management of IIT. The hospital had established a standardized grading review management process, developed an integrated clinical research management system, established a three-level clinical research training system, built a methodological support platform, and formulated research plan templates, gradually formed a standardized grading project approval review management mode. As of February 2024, the hospital had completed 400 quick reviews and more than 400 expert letter reviews based on the integrated clinical research management system. The efficiency and quality of IIT project approval had been improved. At the same time, over 40 academic salons and forums had been held, cultivating a group of young clinical research talents, providing data management training for more than 30 clinical departments, and promoting the improvement of the quality of research protocol. In the future, hospitals should further optimize their information systems, expand the influence of their training systems, enhance the capabilities of their methodological support platforms, and improve the efficiency of the application of clinical research protocol templates, so as to escort the establishment and implementation of high-quality clinical research projects and provide references for other hospitals′ IIT project management.

The non-invasive brain-computer interface (BCI) has gradually become a hot spot of current research, and it has been applied in many fields such as mental disorder detection and physiological monitoring. However, the electroencephalography (EEG) signals required by the non-invasive BCI can be easily contaminated by electrooculographic (EOG) artifacts, which seriously affects the analysis of EEG signals. Therefore, this paper proposed an improved independent component analysis method combined with a frequency filter, which automatically recognizes artifact components based on the correlation coefficient and kurtosis dual threshold. In this method, the frequency difference between EOG and EEG was used to remove the EOG information in the artifact component through frequency filter, so as to retain more EEG information. The experimental results on the public datasets and our laboratory data showed that the method in this paper could effectively improve the effect of EOG artifact removal and improve the loss of EEG information, which is helpful for the promotion of non-invasive BCI.
Humans ; Electrooculography/methods* ; Artifacts ; Brain-Computer Interfaces ; Algorithms ; Electroencephalography/methods* ; Signal Processing, Computer-Assisted

Objective:To explore the risk factors influencing the prognosis for patients with hepatocellular carcinoma (HCC) recurrence after liver transplantation and summarize the relevant diagnostic and therapeutic experiences.Methods:The clinicopathological features with diagnosis and treatment plan of 102 recurrent HCC patients fulfilling the Fudan Criteria were compared for survival rate (univariate analysis) and independent prognostic indicators were obtained by Cox multivariate analysis.Results:The 1/3/5-year overall survival rates were 92.2%, 48.6% and 34.6% and the 1/3/5-year survival rates with tumor were 63.2%, 31.0% and 16.7% respectively. Cox regression analysis indicated that patient age, whether tumor can be surgically resected or not and personalized diagnostic & therapeutic plan based upon targeted therapy were independent prognostic factors affecting the overall survival rates and survival rates with tumor.Conclusions:Although HCC recurrence and metastasis after liver transplantation seriously influence patient prognosis, satisfactory outcomes may be obtained for some patients through active, effective and precise managements.

Objective To study the MRI findings of superficial siderosis of the central nervous system(SSCNS)and to improve the understanding of SSCNS imaging features.Methods MRI images of 21 cases were retrospectively reviewed.MRI plain scan (T1WI,T2WI)and diffusion weighted imaging(DWI)were performed in all patients;T2* weighted angiography(SWAN)scan was performed in 8 patients.Results On T1WI of 21 cases,only 4 cases showed infratentorial superficial siderosis which appeared as linear hypointense signal in sulci cerebelli and around brainstem.On T2WI of 21 cases,18 cases presented with linear hypointense signal on cerebral surface.On DWI of 21 cases,20 cases showed linear hypointense signal on cerebral surface,and the other one case showing negative signal on DWI presented hypointense signal on SWAN.On SWAN of 8 cases,more lesions were found in more regions.Conclusion SSCNS has characteristic findings on MRI.SWAN is sensitive to superficial siderosis.MRI is a reliable method for the assessment of SSCNS.

Objective To investigate the effect of Er-Chen-Er-Huang diet therapy on the visual acuity and the fundus of the patients with the wet age-related macular degeneration after the intravitreal injection of ranibizumab.Methods Fifty-eight patients (fifty-eight eyes) with the wet age-related macular degeneration (w-AMD) who were treated with the intravitreal injection of ranibizumab from June 2015 to August 2016 were included. They were divided into the control group (n=29) and the observation group (n=29) according to the random number table. The patients in the control group was fed with the normal diet. The patients in the observation group was supplemented with Er-Chen-Er-Huang diet. The ETDRS score, the CRT thickness, and the CNV lesion leakage control of the patients in two groups were observed after the three-month follow-up. Results One month after the treatment, the ETDRS score of the patients in the control group was (34.44±5.04), and the score of the patients in the observation group was (33.60±5.42). There was no significant difference between the two groups (t=1.054,P=0.297). Three months after the treatment, the ETDRS score of the patients in the control group was (39.60±4.41), which was significantly lower compared to the observation group (42.16±3.77)(t=2.207,P=0.032). One month after the treatment, the CRT thickness of the patients inthe control group was (346.36±48.87)μm. The CRT thickness of the patients in the observation group was (340.16±51.08)μm. There was no significant difference between the 2 groups (t=0.439,P=0.663).Three months after the treatment, the CRT thickness of the patients in the control group was (318.96±45.22)μm, which was significantly thicker compared to the observation group (286.28±44.62)μm(t=-2.572,P=0.013). The total effective rate of the CNV lesion leakage control of the patients in the observation group was 88.0%, which was significantly higher compared with 64.0% of the control group (P<0.05).Conclusions The intravitreal injection of ranibizumab combined with the diet therapy has a more obvious and longer effect on the improvement of the patients'visual acuity,the alleviation of the macular oedema and the occlusion of the CNV leakage than the only intravitreal injection of ranibizumab.

Objective:To investigate and evaluate the anti-tumor activity of hydroxychloroquine ( HCQ) in vitro. Methods:CCK-8 assay was applied to detect the inhibitory effect of HCQ at different concentrations(4. 78, 9. 55, 19. 10, 38. 20,76. 40 μg?ml-1 ) on A549 cells, HepG2 cells, HT-29 cells, K562 cells, Hela cells and B16 cells. Absorbance was detected by a microplate reader, and then the inhibitory rate of the tumor cells and the IC50 was calculated. Results:Compared with those of the negative control group, the inhibitory rates of HCQ at different concentrations against the six tumor cells were all increased significantly in a dose-dependent manner (P<0. 01). The inhibitory rates of the tumor cells were all above 60% when the concentration reached 38. 20μg?ml-1. The IC50 was 26. 70(A549), 27. 47(HepG2), 5. 72(HT-29), 14. 03(K562), 20. 21(Hela) and 13. 62(B16) μg?ml-1, respectively. Conclusion:HCQ shows anti-tumor activity on several cancer cells in vitro. There may be a good application prospect for HCQ in the treatment of colorectal cancer, liver cancer, cervical cancer, melanoma and leukemia.

Objective To explore methods for performance appraisal of directors of municipal hospitals in Shanghai.Methods To assess the management performance of directors of 24 tertiary hospitals each year,measured by five dimensions of social satisfaction,management efficiency,capital operation,development sustainability and staff satisfaction,and 23 indexes.Results Implementation of the performance appraisal has witnessed constant improvement of patient satisfaction and quality of medical care,as well as rational control of medical expenses and cost.In 2014 for example,the cost of emergency/outpatients per visit at such hospitals were 312 yuan and 1 5 600 yuan per hospitalization respectively,with 7.6 days of stay in average.Also improved were service efficiency,clinical research output and hospital business performance in general.Conclusion Performance appraisal of directors of public hospitals proves an important means for guiding the hospitals to adhere to public welfare, consistent with the government medical institution operation target, and to strengthen internal management of such hospitals.

Objective To analyze the incidence of retinopathy of prematurity(ROP)among extreme-ly preterm infants,and to evaluate the treatment methods and effects among those with severe ROP.Methods A retrospective analysis was performed to analyze incidence of ROP in 96 cases of extremely preterm infants who were born at a gestational age of 〈28 weeks and survived beyond a postmenstrual age of at least 1 year from Apr 2006 to Oct 2013,and to analyze the treatment outcomes of photocoagulation and ranibizum-ab intravitreal injection among the infants with severe ROP.Results Fifty-six of 96 cases(58.33%)grew into ROP finally and 21 cases(21.88%)grew into severe ROP,2 cases(2.08%)grew into aggressive poste-rior ROP.Fifteen cases with severe ROP were treated with laser photocoagulation.Four cases with severe ROP were received ranibizumab intravitreal injection prior to photocoagulation.Two cases with severe ROP were only treated with ranibizumab intravitreal injection.The eyesight of 96 patients (100%)in this study were all preserved.Conclusion ROP screening should focus on extremely preterm infants because of higher incidence of ROP and severe ROP among them.The infants with severe ROP should be treated with laser photocoagulation in time.The infants in critical condition or with aggressive posterior ROP can be treated with ranibizumab injection.

Objective To summarize the experience in nursing children with pediatric advanced intraocular retinoblastoma treated with 23-gauge microinvasive vitrectomy. Methods Eleven infants (12 eyes) suffered from advanced intraocular (D or E) retinoblastoma and treated with 23-gauge microinvasive vitrectomy. Preoperative psychological nursing, postoperative complication nursing and follow-up nursing were performed. Results The retinal tumors was completely removed in all 12 eyes. After the follow-up of a half year, the conditions in 8 eyes were stable, and the tumors in 4 eyes recurred. Visual acuity in 4 eyes improved and that in 1 eye remained unchanged. Conclusions Microinvasive vitreous operation can effectively remove advanced intraocular retinoblastoma. Active efficient perioperative nursing plays an important role for the prevention of complications and promoting the recovery of affected eyes.

Objective To investigate the effects of diversified health education in screening of preemy retinopathy. Methods One hundred and eighty preterm newborns were collected and randomly divided into control group and observation group on average. The diversified health education was adopted in observation group and conventional health education was adopted in control group. The disease cognition and satisfaction questionnaire investigated in the parents of preemys, and compared after 6 months′ intervention. Results After diversified health education, the rate of mastering knowledge of disease from parents in the observation group was higher than that in control group (95. 6% vs 80. 0% ) while the degree of satisfaction from parents in observation group was higher than that of the control group (90. 0% vs 71. 1% ) ( χ2 = 8. 751, 14. 754;P < 0. 05). Conclusions The development of diversified health education can effectively improve the disease cognition and the degree of satisfaction from parents. It can also enhance the consciousness of ROP screening of the parents and play an active role in ROP prevention.