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 study feasibility in extraction of calcific sign within pulmonary nodules with pattern classification.Meth-ods 49 cases with pulmonary nodules (benign in 16 and malignant in 33)confirmed by pathology or clinical follow-up were included in this study and all cases underwent chest CT examinations.CT images were interpreted double-blind by two associate chief radiolo-gists to draw a conclusion that there were any calcification within pulmonary nodules.Meanwhile,the calcifications in the regions of interest(ROI)on CT images were estimated with extraction of the sign of gray value,geometric and lung markings in ROI,and based on pattern classification algorithm at supporting vector machine(SVM).Results According to the results assessed by senior radiologists for classification within pulmonary nodules,the area under ROC curve was 0.95 which was extracted by automatic pat-tern classification algorithm,the extraction performance was stable(k=1),and was goodness fit with visual observation by doctors (k=0.939).Conclusion The ability of automatic pattern classification in detecting calcification within pulmonary nodules is about the same as that of visual assessment by senior doctors.

This experiment was based on a full-length SAMDC sequence from the drought stress induced cDNA library of Cleistogenes songorica.Two methods,absolute quantification and relative quantification,were used to analyze the gene expression under different tissue and drought stress treatment by real-time quantitaive PCR experiments and were compared each other,while CsSAMDC gene was used as a case.Leaves and roots tissue were sampled from the plants at 0,4,6,8,and 10 d of drought stress and 1 and 4 d after rewatering.The 2-CT method was used to analyze the relative changes in gene expression from quantitative real-time PCR experiments.A standard curve was generated by the purified plasmid DNA.The primer concentration in the realtime PCR was optimized.All absolute quatification data were normalized by the normalization factor from the most stable house-keeping genes in C.songorica.Relative quantification results using 2-CT method showed that CsSAMDC transcripts increased 5.93?0.71 fold in roots,down regulated 0.62?0.13 fold in leaves,under drought stress.Absolute quantification results showed that CsSAMDC transcripts up-regulated in roots significantly under drought stress as 1ong as 8 to 1 0 days after drought stress,while down-regulated in both roots and leaves after drought stress within 6 days and 1 to 4 days after rewatering,compared with control.CsSAMDC transcipt showed similar tendency of gene expression compared by using relative and absolute quantification methods.

Objective To explore the expression and the role of Toll-like receptor(TLR3 and TLR4) in rats with nephrotic syndrome induced by respiratory syncytial virus(RSV).Methods SD rats were inoculated intranasally and intraperitoneally with 6?106 plaque for-ming unit(PFU) RSV to construct RSV-induced nephropathy in rat model.Rats were anesthetized and blood was withdrawn from cardiac on day 4,14,30,60 after inoculation.The normal ones without intervention were set as control group.The renal histology was observed by light microscope and electron microscope.The urinary protein collected in 24 hours were measured.Meanwhile,the expressions of TLR3 and TLR4 were detected by indirect immunofluorescence staining and flow cytometry in peripheral blood mononuclear cells of rats.The results were analyzed by SPSS 13.0 softwore.Results After inoculation,the proteinuria increased and under the electron microscope the foot processes of glomerular epithelial cells were fused which resembled human minimal change nephrotic syndrome.Proteinuria reached the peak and the fusion of foot processes were most extensive in rats of RSV at 60 d.The expressions of TLR3 and TLR4 in each group of RSV-induced nephropathy in rat models were significantly higher than those in normal control group(Pa0.05).Conclusions TLR3 and TLR4 in peripheral blood mononuclear cells of RSV-induced nephropathy rat mo-dels had being significantly activated until 60 d after RSV inoculation.TLR signaling pathway may play an important role in nephrotic syndrome of rats induced by RSV.

Maca as one of the star products in the international health care market in recent years, had a wide range of application value and promoted to all over the world. However, the basic research of Maca was not deep, lack of systematic and clear efficacy studies. Market products hype its aphrodisiac effect, which greatly impact more systematic in-depth research and exploration. Therefore, this paper briefly summarizes advance research in recent years including the status quo of the resources, growth cultivation, phytochemical, pharmacological effect and other aspects, which can provide reference for rational development and utilization of Maca.
Animals ; Biomedical Research ; Humans ; Lepidium ; chemistry ; classification ; growth & development ; Plant Extracts ; chemistry ; metabolism ; pharmacology

Female ; Humans ; Infant, Newborn ; Mastocytosis, Systemic ; diagnosis ; pathology

Objective:To evaluate of the feasibility of low-dose CT(LDCT)in the reconstruction of three-dimensional(3D)model of maxillofacial hard and soft tissues.Methods:Lightspeed 16-slice spiral CT scanner was used to scan one adult cadaveric head specimens with conventional parameters(280 mA)and low dose parameters(200,150,100,50,35,25,15 and 5 mA)respectively;the 3D model of the hard and soft tissues were reconstructed with Mimics 10.01 software,and 3D comparison were carried on with Geomagic 11.0 software.A comparison of the surface morphology of the hard and soft tissues of the 3D models with different scanning parameters was made.Results:With the reduction of the tube current,the model surface became rough gradually.Compared with the 280 mA scan results,the model surface produced by 35 mA scanning was still fairing,when the dose fell to less than 25 mA,the model surface became rough and the exact shape of the model could not be recognized.The same results of model surface were pro-duced after registration.Conclusion:The low-dose (35 mA)CT can be used to reconstruct 3D model of the maxillofacial hard and soft tissues.

Functional magnetic resonance imaging (fMRI), a newly developing technique, contains function, anatomy and image, which makes the real-time, dynamic and non-invasive measurement of the functional brain imaging availability. This paper summarized the characteristics of fMRI in health and stroke populations, introduced the advances of fMRI in neuroplasticity, rehabilitation assessment and prognosis in hand movement dysfunction in patients with stroke, and discussed the difficulty fMRI faced in rehabilitation assessment and the further researches.

Objective To observe the expression of phosphoinositide 3-kinase(PI3K) and protein kinase B1 (Akt1) in PI3K/Akt signaling pathway in rat bones with fluorosis, and to reveal the mechanisms of the skeletal fluorosis. Methods Thirty-six SD rats were randomly divided into 3 groups (control group, low-dose fluorosis group, high-dose fluorosis group) and 12 rats were in each group according to body weight. The rats were fed with different concentrations of fluoride (NaF) to establish fluorosis models. Controls were fed with tap water( < 0.5 mg/L), experimental animals in low- or high-dose groups were fed with water containing NaF 5.0,50.0 mg/L, respectively. Rats were sacrificed after 6 months of treating with fluoride and the serum was kept for testing the bone metabolic markers of none gla protein(BGP) and cathepsin K(Cath-K) by enzyme-linked immunosorbent assay(ELISA), the proteins and mRNA levels of PI3K and Akt1 in rat bones were detected by immunohistochemistry and real time PCR, respectively. Results Each group of serum BGP and Cath-k were compared, the difference was statistically significant(F = 73.45,39.36, all P < 0.05). The contents of BGP[(1.99 ± 0.62), (2.38 ± 0.16)μg/L] and Cath-K [(89.07 ± 19.66), (110.16 ± 9.81)pmol/L] in the low-and high-dose fluorosis groups were higher than those in the control group[(0.15 ± 0.03)μg/L,( 18.32 ± 2.27)pmol/L], and the high fluorosis group was obviously higher than the low fluorosis group (all P < 0.05). Each group of serum PI3K and Akt1 protein and mRNA were compared, the difference was statistically significant(F- 178.16,118.08,38.81,52.31, all P< 0.05). Compared to the control group (181.55 ± 4.24,188.46 ± 2.18,3.84 ± 1.69,4.33 ± 0.89), the protein and mRNA expressions of PI3K(171.66 ± 2.85,154.12 ± 4.15,11.31 ± 4.18,20.54 ± 6.68), Akt1(177.47 ± 3.16,156.42 ± 3.18,12.52 ± 3.13,19.43 ± 5.36) were higher in the low- and high-dose fluorosis groups (all P < 0.05), and the high fluorosis group was obviously higher than the low fluorosis group (all P < 0.05). Conclusions BGP and Cath-K contents could be used as bone metabolic indices in the endemic fluorosis disease. Fluoride can increase the expression of PI3K and Akt1 mRNA and protein in bone tissue of fluorosis rats, and PI3K/Akt1 signaling pathway may be involved in the pathogenesis of bone injury caused by fluoride.

Objective To analyze monitoring results of iodized salt and distribution characteristics of problem areas with non-iodized salt in Gansu province during 2001 - 2009 and to provide a basis to develop countermeasures to iodine deficiency disorders. Methods According to the criterion of "The National Scheme of Iodized Salt Surveillance", two levels of monitoring were carried out on production and wholesale-level(during 2001 -2007) and household-level(during 2001 - 2009). Salt iodine was determined by direct titration method (GB/T13025.7-1999), and Sichuan salt or special salt was determined with an arbitration method. Criteria for qualified iodized salt was (35 ± 15)mg/kg(20 - 50 mg/kg), and for non-iodized salt was ＜ 5 mg/kg. Results During 2001 - 2007, a total of 4900 salt samples at production and wholesale-levels were examined, with a qualification rate of 97.80% (4792/4900). Non-iodized salt rates were all below 5% in Gansu province, consumption rate of qualified iodized salt was higher than 90% after 2003. During 2001 - 2009, cities(states) with non-iodized salt problems appeared 23 times, with Linxia accounting for 39.1%(9/23), Wuwei accounting for 21.7%(5/23). During 2001 -2009, counties(districts) with non-iodized salt problem appeared 123 times, including 68 times of ethnic minorities and state poverty counties, accounting for 55.3%(68/123). During 2001 - 2005 and 2006 - 2009, ethnic minorities and state poverty counties were accounting for 49.4%(44/89) and 70.6%(24/34) in counties with non-iodized salt problem. Conclusions The quality of iodized-salt at production and wholesale level is satisfactory in Gansu province, household consumption rate of qualified iodized salt have reached national standard for eliminating iodine deficiency disorders. But ethnic minorities and state poverty counties are main regions with non-iodized salt problem,these areas will be the key areas of prevention of iodine deficiency disorders in Gansu province in the future.