This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.
Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards

Objective To explore a new pathogenic gene mutationin in COL4A3 and COL4A4 genes of a family with thin-basement-membrane nephropathy (TBMN), and explain its mechanism.Methods Genomic DNA was extracted from blood samples.Mutation screening for all the exons in COL4A3 and COL4A4 of the proband was carried out by direct PCR sequencing.The sequences of the proband were compared with standard sequences in GenBank.After identifying the mutation in COL4A4, screening for the mutation site in 200 healthy controls and the rest of family members were conducted.RNA sequence of the proband was analyzed by reverse transcription PCR and TA cloning.The positive clones were sequenced for RNA screening.Results There was a G to A mutation in the 1459 site of COL4A4 (c.1459+G ＞ A) in the proband, her mother, and the elder sister, whereas the mutation was not found in other family members and healthy people.RNA screening showed that the COL4A4 (c.1459+G ＞ A) mutation was a heterozygous substitution in position + 1 of exon 21, in the splicing region.This mutation leaded to eliminating of exon 21 from the COL4A4 mRNA, causing the exon 21 deletion and frameshift mutation following the exon 20 in its amino acids sequence.Conclusions It is described that COL4A4 (c.1459+G ＞ A) is a new pathogenic mutation in TBMN, which further help understanding the pathogenesis and clinical diagnosis of TBMN.

Abscess ; etiology ; Adult ; Humans ; Male ; Nasal Septum ; pathology ; Tooth, Impacted ; complications

The antibacterial peptide CM4 having potent antifungal activity on inhibitiong the cell wall regeneration of Saccharomyces cerevisiae protoplasts.When the peptide increased,the ratio of the regenerated colonies drop obviously.To study the antifungal mechanism of the antibacterial peptide,fluorescence\|labeled peptide mixted with the protoplast of yeast,then confocal laser scanning microscopy were performed.The results indicated that the peptides interactted with the protoplast membrane and damaged the structure of the membrane,then the permeation of protoplast changed.Finally the protoplasts with the peptide failed to regenerate the cell walls leading to killing the cell.

Talents constitute core resource in the development of healthcare sector. Based on the situation of the talent team in the Affiliated Hospital of Qingdao University, the authors systematically constructed the hierarchical and classified system for talent cultivation, centering on three key areas of talent cultivation, evaluation and assessment. The authors analyzed the achievements since the implementation in 2016, namely the innovation of talent evaluation, the construction of discipline echelon, and the communication and inter-departmental cooperation. At the same time, the authors further put forward targeted suggestions to promote the development of talent teams in terms of transforming the human resource management model, increasing policy support and funding, implementing refined management, and improving talent evaluation indicators by the levels and types.

Objective To investigate the clinical effects of liver transplantation including living related liver transplantation for Caroli's disease (CD). Methods Seven consecutive patients with diffused type of Caroli's disease had undergone liver transplantation (LT) from September 1999 to February 2007 in our single center. The clinical characteristics and survival of these patients were retrospectively reviewed. Results All 7 patients were diagnosed as Caroli's disease with diffused type which manifested recurrent cholangitis in clinical symptoms. Among them, 4 were female and 3 male.The mean age was 16 years old (ranging from 10 to 31 years old). Six patients were subjected to conservative therapy and only one patient had previously undergone cholecystectomy and T tube drainage before transplantation. In types of surgery, 4 patients accepted split liver transplantation with right liver lobe, two got whole liver transplantation and only one underwent living related liver transplantation. In two patients venovenous bypass was done during the operation. The mean duration of surgery was 9. 1 h. Post-transplant complications included pulmonary infection (3 cases), acute rejection (2 cases), pleural effusion (2 cases) and biliary leakage in the split section of donor liver (1 case). One patient died within 19 days caused by acute renal failure and multiple organs dysfunction.The rest six patients are alive without any signs of recurrence of protopathy and the longest survival time is 7 years. Conclusion Liver transplantation is a valuable treatment to Caroli's disease with diffused type. Due to the organ shortage, living related liver transplantation may own identical effects on LT.

Objective To discuss the influence of anatomical variations of the cystic duct on preoperative diagnosis and operational scheme for cholecystectomy. Methods A 47-year-old woman was admitted to our hospital with diagnosis of cholecystolithiasis. Ultrasonography suggested minimal intra- and extrahepatic ductal dilatation. Laboratory tests showed that serum levels of alanine aminotransferase, aspartate aminotransferase and alkaline phosphatase were 189 IU/L, 366 IU/L and 144 IU/L, respectively. In order to make a certain diagnosis, the patient received both magnetic resonance cholangiopancreatography (MRCP) and endoscopic retrograde cholangiopancreatography (ERCP). Results MRCP showed the bile duct slightly dilated with a shuttle shape figure and a lower signal with a strip form in it. MRCP could not confirm the quality of this signal and was doubtful of choledochus diaphragma. Subsequently, ERCP was applied to demonstrate that the cystic duct was collateral with the common hepatic duct when arriving into its left side and converged into the bile duct with a lower position, which was the reason for why MRCP misjudged the formation of choledochus diaphragma in the bile duct. Finally, the patient underwent open cholecystectomy. Conclusion There are some kinds of variations in the cystic duct including course, appearance and location of confluence. Combing MRCP with ERCP can significantly elevate the diagnostic accuracy of the cystic duct before operation, especially in those patients with doubtful diagnosis upon admission. To avoid biliary injury as much as possible, open cholecystectomy is superior to the laparoscopic cholecystectomy (LC)with regard to the patients suffering from cholecystolithiasis complicated with variation of the cystic duct.

OBJECTIVE:To explore the protective effect and its mechanisms of Sinomenium acutum polysaccharide on mice with acute alcoholic liver injury. METHODS:60 mice were randomly divided into blank control group (normal saline),model group (normal saline),bifendate group (positive control,150 mg/kg) and S. acutum polysaccharide low-dose,medium-dose, high-dose groups(100,200,400 mg/kg),10 in each group,intragastrically administrated,once a day,for continual 7 d. 1 h af-ter last administration,mice received 50% ethanol (0.1 mL/10 g) intragastrically to induce acute alcoholic liver injury model ex-cept for those in blank control group. After 12 h,alanine aminotransferase(ALT),aspartate aminotransferase(AST)levels in se-rum,malondialdehyde(MDA),superoxide dismutase(SOD),glutathione(GSH),glutathione peroxidase(GSH-Px)levels in liv-er tissue of mice were determined;hematoxylin-eosin staining was conducted to observe the pathological changes in liver tissue;flow cytometry was used to detect the cell apoptosis rate. RESULTS:Compared with blank control group,mice in model group showed pathological changes in edema,disordered cell arrangement and local necrosis;ALT and AST levels in serum,MDA level in liver tissue and hepatocyte apoptotic rate were significantly increased,while the SOD,GSH and GSH-Px levels in liver tissue were significantly decreased,with statistical significances (P<0.01). Compared with model group,cell degeneration and necrosis degree of mice were improved in S. acutum polysaccharide medium-dose and high-dose groups;except for cell apoptosis rate of liver in S. acutum polysaccharide low-dose group was not decreased significantly,the above-mentioned indicators in other treatment groups were significantly improved(P<0.05 or P<0.01). CONCLUSIONS:S. acutum polysaccharide shows obvious protective effect on mice with acute alcoholic liver injury,its mechanism might re-late to anti-oxidation stress and inhibiting hepatocyte apoptosis.

Objective To study the influence of total flavonoids of hemerocallis fulva(TFHF) on hepatocyte apoptosis and related protein expression in mice with alcoholic hepatic injury.Methods A total of 40 mice were randomly divided into four groups:blank control,model control andsmall and high dose TFHF groups,10 cases in each group.The mice were given the continuous gavage administration for 7 d.Then the model group was given once gavage by 50％ ethanol 12.0 mL/kg after 1 h of the last administration.The blank control group was given the equal volume of distilled water.The activity levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in serum as well as the superoxide dismutase(SOD) activity and malondialdehyde (MDA) content in liver tissue hemogenate were detected.Hematoxylin and Eosin(HE) staining was performed for observing the pathological changes of the liver tissue.The flow cytometer was used to test the apoptosis ratio in hepatocyte suspension.The expressions of caspase-3,Bcl-2 and Bax protein were detected by Western blot.Results The various TFHF groups could decrease the activities of ALT and AST in serum (P＜0.05),while could decrease the MDA content in liver tissue hemogenate (P＜0.01) and increased the SOD activity;the liver tissue pathological examination showed that the high dose TFHF group could make the liver cell degeneration,alleviated the necrosis degree and relieved the pathological change of hepatic tissue;compared with the model group,the hepatocyte apoptosis rate in each TFHF group was decreased significantly;Western blotting results showed that the caspase-3 protein level in each TFHF group was decreased,expression of Bcl-2 protein was increased,whereas which of Bax protein was decreased and Bax/Bcl-2 ratio was reduced.Conclnsion TFHF has obvious protective effect on mice acute hepatic injury induced by ethanol,and can inhibit the hepatocyte apptosis,its action mechanism may be related to its antioxidation and regulation of caspase-3,Bcl-2 and Bax expression.

BACKGROUND:There is no effective treatment for muscle atrophy caused by peripheral nerve damage. Skeletal muscle cel s, a structural unit of muscle contraction, can be used for studies on muscle atrophy when cultured in vitro.
OBJECTIVE:To investigate the promotion effect of neuron-secreted factors on the growth of skeletal muscle cel s in vitro.
METHODS:Skeletal muscle cel s primary cultured in vitro were divided into two groups:experimental group with neuron-secreted factors, and control group with common culture medium, respectively. Afterwards, the number of skeletal muscle cel s and expression level of alpha actin were detected by hematoxylin-eosin staining and immunohistochemical staining, respectively.
RESULTS AND CONCLUSION:The number of skeletal muscle cel s and expression level of alpha actin in the experimental group were significantly higher than those in the control group (P<0.05). In conclusion, neuron-secreted factors have the ability of promoting the growth of skeletal muscle cel s and may be helpful for denervated muscle atrophy.