For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.

Objective To i nv estigate the clinical effect of shape-memory sawtooth-arm em bracing fixator in the management of periprosthetic femoral fracture.Methods Since1994, 21cases of periprosthet-ic femoral fractures had been treated in7hospitals with the shape-memory sawtooth-arm embracing fixator designed and developed b y the Ninth Peoples Hospital,Shanghai Second Medical University(SSMU ).Of the21cases,12were males and9were females,aging from42to83years old. Eighteen of the series ex peri-enced periprosthetic fracture at2weeks to10y ears after joint replacement the fractures were found as oblique,spi ral or comminuted with the fracture lines located between the lesser trochanter and a p oint 5cm distal to the end of prosthetic stem.The other three were revision c ases,in which2cases with osteoporosis had intraoperative spiral fracture and1 case had long segmental osteotomy for removal of the prostheses.One of the 21patients had Z-shaped femoral osteotomy,while the other20cases were clas sified into Jo hannson typeⅠfrac ture in4cases,typeⅡ9cases and typeⅢ7case s.All of them were complete fracture with dis-placement.In practice,the arm s of fixator were expanded firstly by immersing into the ice water to make the tempera ture of the device decrease to4~7℃.After reduction of the fracture ,the body of the fixator was placed on the tensile side of the femur,and th e temperature of the arms was raised with hot saline.With its shape memory ef fect,the sawtooth-arms began to close up and grasped the fracture fragments ti ghtly.Results Surgical process in all of the cases was smoothly done:the frac tures were stable after the fixation,and no ex-ternal fixation was required po stoperatively,except four cases underwent skin traction of the affected lim b for 2weeks.All the patients were able to walk with two crutches at2to4we eks after the operation.The post-operative follow-up lasted from1to7years, and no fracture re-displacement was found.The results of frac-ture healing were good while the functional recovery to the pre-operative level was achieved in the all se ries.Conclusion For periprosthetic femoral fracture,shape memo ry sawtooth-arm embracing fixator is a re liable device being implanted easily and offering stable fixation;it should be the treatment method of the first choice.

The treatment of liver fibrosis with TCM has become a hot spot for researches.TCM treatment has established a solid basis for the research and treatment of this disease.This article made an overview about the therapeutic methods of TCM in treating liver fibrosis,hoping to make a contribution to promote therapeutic level of treating this disease clinically.

For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results

Object To prepare and study a suitable carrier for paclitaxel in water. Methods Cetyl chitosan (CTCS), prepared by reacting chitosan (CS) with chlorocetane under alkaline condition, was soluble and spontaneously formed nanosphere about 100 nm in diameter. And the release in vitro from paclitaxel loaded CTCS nanosphere was measured in phosphate buffer solution (PBS, pH=7 4). Results The balanced release concentration of paclitaxel was deceased and half release time (t 1/2 ) was delayed with the increase of substitution degree of alkyl. Conclusion This kind of nanosphere is an excellent carrier for paclitaxel in water.

OBJECTIVE: Explore the relationship between the pathogenic mutations of SLC26A4 gene and inner ear malformation, and analyze the feasibility of genetic testing to help current diagnosis in part of children with sensorineural hearing loss. METHOD: 2094 cases of children were detected by SLC26A4 with the method of DNA sequence. CT phenotypes of those children were classified according to the method proposed by Sennaroglu. We analyzed the relationship between the pathogenic mutations of gene and the CT phenotypes. RESULT: (1) 685 cases of inner ear malformations were found in 2094 cases of children with sensorineural hearing loss by CT examination (371 cases of cochlea malformation were consisted of the follow types of malformation. Michel deformity was 6 cases, cochlea aplasia was 8 cases, common cavity deformity was 12 cases, incomplete partition type I was 27 cases, cochlea hypoplasia was 30 cases and Mondini malformation was 288 cases); Vestibular aqueduct was 265 cases; Vestibular/semicircular canal/internal auditory canal were 49 cases, normal was 1409 cases. (2) The DNA sequence results revealed that 465 cases carried pathogenic mutations (Bi-allelic mutations) of SLC26A4 gene, among which 135 cases were homozygous, 330 cases were compound heterozygous. (3) Pathogenic mutations of SLC26A4 gene detected 100% (465/465) in the group related to vestibular aqueduct malformation. CONCLUSION The results suggest that pathogenic mutation of SLC26A4 gene is closely related to the CT phenotype of vestibular aqueduct malformation. Detecting of pathogenic mutations for hearing loss is binging the possibility to identify children with inner malformations at an early stage. As a consequence, it will improve the current diagnosis and therapeutical option.
Alleles ; Child ; Cochlea ; Deafness ; Ear, Inner ; abnormalities ; Genetic Testing ; Hearing Loss ; Hearing Loss, Sensorineural ; Humans ; Membrane Transport Proteins ; genetics ; Mutation ; Phenotype ; Semicircular Canals ; Sulfate Transporters ; Temporal Bone ; Vestibular Aqueduct ; Vestibule, Labyrinth

OBJECTIVE: Analyze the data of the patients with sensorineural hearing loss in China and study the classification and incidence of inner ear malformationsby the high-resolution computed tomography. METHOD: The investigation took a retrospective review of CT findings relating to the 2,747 cases of outpatients. The inner ear malformations diagnosed by CT were classified according to the methods proposed by Sennaroglu. RESULT: (1)843 cases of inner ear malformations were found in 2747 cases of patients with sensorineural hearing loss by CT examination. The incidence of inner ear malformation was 30.69%(843/2747). (2) The epidemiological information of 843 cases of inner ear malformation according to Sennaroglu's classification was as follows: cochlea was 52. 31%(441/843), simple vestibular aqueduct was 40.33%(340/843), simple vestibular/ semicircular canal/internal auditory canal were 7. 35%(62/843) of the group. (3) 441 cases of cochlea malformation were consisted of these types of malformation: Michel deformity was 1.13% (5/441), cochlear aplasia was 1. 81% (8/441), common cavity deformity was 3. 17% (14/441), incomplete partition type I was 8. 62% (38/441), cochlea hypoplasia was 9. 07% (40/441) and incomplete partition type II was 76. 19% (336/441) of the group. CONCLUSION The results suggested that 30. 69% cases of inner ear malformation can be found in patients with sensorineural hearing loss, which is more higher than reported by the high-resolution computed tomography. Sennaroglu's classification is instructively significant in investigating the status of inner ear malformations.
China ; Cochlea ; Ear, Inner ; abnormalities ; Hearing Loss, Sensorineural ; etiology ; Humans ; Outpatients ; Retrospective Studies ; Semicircular Canals ; Temporal Bone ; Tomography, X-Ray Computed ; Vestibular Aqueduct ; Vestibule, Labyrinth

Objective: To construct an eukaryotic expression plasmid containing gene coding for the hemagglutinin neuraminidase(HN) of Newcastle disease virus (NDV), and to study its mechanism and value in antitumor therapy. Methods: The HN cDNA was abtained from NDV with RT PCR and an eukaryotic expression vector of HN gene ( pcDNA3 HN ) was constructed. The antitumor effect was evaluated after injecting pcDNA3 HN into mice bearing B16 melanoma. Results: The HN cDNA of NDV was successfully cloned and pcDNA3 HN had a good expression in COS 7 cells. Animal experiments suggested that the pcDNA3 HN could significantly increase CTL and NK activity of tumor bearing mice. Conclusion:The eukaryotic expression plasmid containing the gene coding for the (HN) has the function of increasing CTL and NK activity of tumor bearing mice.

Self-designed experiments were used to study the effects on developing the students'ability and improving teaching quality.The results show that self-designed experiments can improve students'learning interest, motivation,coordination,and research capabilities.