1.The application of 3-D scanning in the diagnosis and evaluation of pectus excavatum
Hui WANG ; Fenghua WANG ; Wenyue SI ; Huiying LIANG ; Jianhua LIANG ; Jiahang ZENG ; Jue TANG ; Jianming LI ; Xiaohua GUO ; Huimin XIA ; Wei LIU
Chinese Journal of Thoracic and Cardiovascular Surgery 2018;34(5):284-287
Objective To investigate the application of 3-D scanning in the diagnosis and evaluation of pectus excava-tum.Methods From July 2016 to June 2017, chest CT concomitant 3-D scanning were performed in 90 pectus excavatum pa-tients before Nuss procudure.Another 30 cases underwent chest CT scanning for non-chest deformity causes were chosen as a control group.The transverse and anterior-posterior maximum diameter through the deepest point of chest wall deformity were measured.The surface topography index and Haller index were calculated respectively .Results There was a positive correla-tion between CT and 3-D scanning diameters of the transverse and anterior-posterior maximum diameters, and consistency rates were 94% and 82%, respectively.There was significant difference between pectus excavatum group 1.82 ±0.21 and control group 1.41 ±0.07 in the STI(P<0.001).There was a positive correlation between Haller index 5.12 ±3.36 and STI 1.82 ± 0.21, and consistency rate was 89%.The Delong's test showed no significant difference between ROC of HI and STI(Z =1.18, P=0.28).Conclusion 3-D scanning and STI of pectus excavatum is a validated alternative for CT and Haller index, especially in the infant and non-surgical treatment PE cases.
2.Compliance Risk Management of Investigator Initiated Trials on Children Rare Diseases: Medical Institution Perspective
Jingqi ZHANG ; Liandong ZUO ; Xueqi GAO ; Wenyue SI ; Rui LUO ; Qiang WU ; Wenhao ZHOU
JOURNAL OF RARE DISEASES 2025;4(1):132-138
There is a substantial unmet need for treatments in the field of pediatric rare diseases, and investigator initiated trial(IIT) provide a critical pathway for testing and developing new drugs or treatment strategies. However, healthcare institutions, when conducting such research, must address compliance risks related to project approval, contract management, data protection, and conflict of interest management. This study aims to analyze the particularities and challenges of IIT in pediatric rare diseases, review relevant regulations and regulatory requirements, and provide healthcare institutions with a reference framework for compliance risk management to maximize the benefits of IIT. Based on literature review, analysis of laws and regulations, practical work experience, and frameworks from other institutions, we summarize the unique aspects of pediatric rare disease IIT in terms of participant characteristics, innovative technologies, and organizational structures.On this basis, targeted compliance management recommendations are proposed, which include establishing a risk rating and full-cycle risk monitoring mechanism, a consent and ethical review mechanism tailored to pediatric participants, a robust contract management mechanism, a comprehensive data security management mechanism, and a multidisciplinary team and multi-channel compensation mechanism. The study concludes that healthcare institutions, funders, and other collaborating entities should implement compliance management in line with the characteristics of IIT to ensure the safety and effectiveness of research and facilitate innovation and development in the treatment of pediatric rare diseases.
3.Spinal Cord Stimulation Frequency Influences the Hemodynamic Response in Patients with Disorders of Consciousness.
Juanning SI ; Yuanyuan DANG ; Yujin ZHANG ; Yaxin LI ; Wenyue ZHANG ; Yi YANG ; Yue CUI ; Xiaoping LOU ; Jianghong HE ; Tianzi JIANG
Neuroscience Bulletin 2018;34(4):659-667
Spinal cord stimulation (SCS) is a promising technique for treating disorders of consciousness (DOCs). However, differences in the spatio-temporal responsiveness of the brain under varied SCS parameters remain unclear. In this pilot study, functional near-infrared spectroscopy was used to measure the hemodynamic responses of 10 DOC patients to different SCS frequencies (5 Hz, 10 Hz, 50 Hz, 70 Hz, and 100 Hz). In the prefrontal cortex, a key area in consciousness circuits, we found significantly increased hemodynamic responses at 70 Hz and 100 Hz, and significantly different hemodynamic responses between 50 Hz and 70 Hz/100 Hz. In addition, the functional connectivity between prefrontal and occipital areas was significantly improved with SCS at 70 Hz. These results demonstrated that SCS modulates the hemodynamic responses and long-range connectivity in a frequency-specific manner (with 70 Hz apparently better), perhaps by improving the cerebral blood volume and information transmission through the reticular formation-thalamus-cortex pathway.
Adolescent
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Adult
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Brain
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physiopathology
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Consciousness
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physiology
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Consciousness Disorders
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physiopathology
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therapy
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Female
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Hemodynamics
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physiology
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Humans
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Male
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Middle Aged
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Pilot Projects
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Spinal Cord
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physiopathology
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surgery
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Spinal Cord Stimulation
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methods
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Young Adult