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.

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plaque for-ming unit(PFU) RSV to construct RSV-induced nephropathy in rat model.Rats were anesthetized and blood was withdrawn from cardiac on day 4,14,30,60 after inoculation.The normal ones without intervention were set as control group.The renal histology was observed by light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.

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.

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

Objective To investigate the association between chronic kidney dysfunction and the complexity of coronary artery disease in elderly patients.Methods A prospective study was conducted on 1380 consecutive patients underwent coronary angiography for the first time in our hospital and with angiographically diagnosed coronary artery disease from January 2011 to June 2012.The complexity of coronary artery disease were classified according to the American College of Cardiology/American Heart Association (ACC/AHA) grading system as types A,B1,B2,and C.Estimated glomerular filtration rate (eGFR) was calculated by the simplified Modification of Diet in Renal Disease(MDRD)equation.Patients were classified into 3 stages according to eGFR as follows:normal renalfunction(n=234,eGFR≥90 ml· min-1 · 1.73 m-2),mild renaldysfunction(n=881,60≤eGFR＜90 ml · min-1 · 1.73 m-2,and moderate or severe renaldysfunction(n=265,eGFR＜60ml · min-1 · 1.73 m-2).Ordinal logistic regression was used to analyze the association between chronic kidney dysfunction and the complexity of coronary artery disease.Results Patients with mild,moderate or severe renal dysfunction were older (F=56.82,P＜0.001),more predominantly female (x2 =66.29,P＜ 0.001) and more likely to have history of hypertension (x2 =17.57,P ＜ 0.001),diabetes (x2=20.97,P＜0.001) and hyperlipidemia (x2=10.48,P 0.005) than those with normal renal function.The percentage of lesions of types B2 or C in moderate or severe renal dysfunction group was higher than that in normal renal function group (x2=175.03,P＜0.001).The ordinal logistic regression showed that age,male,hypertension,diabetes,C-reactive protein and eGFR were independent risk factors for the ACC/AHA lesion classification.Conclusions Age,male,hypertension,diabetes,C-reactive protein and eGFR are independent risk factors for the complexity of coronary artery disease.

Objective To investigate the effect of hyperacute intensive antihypertensive treatment on the prognosis of intracerebral hemorrhage in basal ganglia region. Methods From January 2013 to December 2015,100 patients with intracerebral hematoma in basal ganglia region (onset ≤3 h)at the Neurological Intensive Care Unit,the First Affiliated Hospital of Dalian Medical University were enrolled prospectively. They all randomly received the intensive antihypertensive or standard antihypertensive treatment voluntarily. They were divided into either an intensive antihypertensive group or a standard antihypertensive group according to the random number table (n = 50 in each group). Within 1 h after beginning to treatment,the target systolic blood pressure was controlled in 130 -140 mmHg in the intensive antihypertensive group,the target systolic blood pressure was controlled in 160 -180 mmHg in the standard antihypertensive group,and the target systolic blood pressure was maintained respectively in the following 7 d. Head CT was performed gain at 24 h after treatment. The intracranial hematoma expansion was evaluated. The National Institutes of Health Stroke Scale (NIHSS)and the modified Rankin scale (mRS)were used to
evaluate their prognoses. The differences of the cumulative mortality in both groups were compared at the same time. Results The incidences of hematoma expansion of the intensive antihypertensive group and the standard antihypertensive group were 12. 0% (6/ 50)and 30. 0% (15/ 50)respectively. There was significant difference between the 2 groups (χ2 = 4. 882,P = 0. 027). There were no significant differences in NIHSS scores within or between both groups at each time points (all P > 0. 05). They were followed up for 90 d,no adverse events occurred in both groups. The favorable prognosis rates of the neurological function were 36. 0% (18 / 50)and 18. 0% (9 / 50)respectively in the intensive antihypertensive group and the standard antihypertensive group. There was significant difference between the 2 groups (χ2 = 0. 411,P =0. 043). Kaplan-Meier curves showed that the cumulative mortality at 24 h,within 7 d and 90 d in the intensive antihypertensive group and the standard antihypertensive group were 4. 0% (2 / 50),6. 0%(3 / 50),and 10. 0% (5 / 50),respectively,those of the standard antihypertensive group were 10. 0%(5 / 50),24. 0%(12 / 50),and 30. 0%(15 / 50),respectively. The results of Log-rank test found that there was significant difference in cumulative mortality between the 2 groups (χ2 =6.280,P =0.012). Conclusions The intensive antihypertensive treatment in the hyperacute cerebral hemorrhage is safe and feasible in basal ganglia region. It contributes to improve prognosis of neurological function,and reduce the incidence of hematoma expansion and the 90 d cumulative mortality.

Objective Despite regular treatment,antineutrophil eytoplasmie antibodies(ANCA)asso- ciated systemic vasculitis(AASV),in which the role of Fc?Rs has been established,are still associated with significant long-term mortality and remain an important cause of end-stage renal failure.ANCA plays an im- portant role in the pathogenisis of primary systemic small vessel vasculitis(PSV)by their potential to activate neutrophils.Because the interaction between ANCA and its receptors on the Fc portion of immunoglobulins (Fc?R)on neutrophils is essential in the activation process,we investigate the inhibitory,effect of tg19320 on ANCA induced activation of neutrophils,which is a tetrameric tripeptide that interferes with IgG/Fe?Rs in- teraction.Methods We prepared tg19320 by solid-phase peptide syntbesis.The binding between tg19320 and human IgG was assessed by enzyme-linked immunosorbent assay.The biological activity of tg19320 to intefere with FcF?receptor recognition was identified by rosette formation assay.ANCA IgG was prepared from the sera of active Wegener's granulomatosis(WG)and microscopic polyangiitis(MPA)patients.Neu- trophils isolated from the blood of healthy volunteers were primed with TNF-?(2 ng/ml)and then incubated with ANCA IgG(200?g/ml),or pretreated with tg19320(2.5 mg/ml)and then added with ANCA IgG.Su- peroxide burst of neutrophils was determined by Ferri-cytochrome reduction assay.Results We found that tg19320 bound tightly to human IgG in a dose dependent manner and the inhibition of the rosette formation between SRBC-IgG and U937 cells was statistically significant(20.3% vs 53.2%,P

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.

Objective To assess the diagnostic value of mediastinal lymph node in non-small cell lung cancer using PET-CT by Meta-analysis. Methods Publications on mediastinal lymph node staging of non-small cell lung cancer by PET-CT published from January 2002 to January 2016 were filtered and assessed according to criteria from the PubMed, EMBASE, Cochrane library database. The number of true positive, false positive, false negative and true negative were extracted, meta-analysis was performed using STATA software, and receiver operating characteristic curve was applied, then area under the curve(AUC) was calculated. At last, heterogeneous sources were discussed and subgroup analyses were performed. Results Twenty-three relevant literatures(2 959 patients) were enrolled, the diagnostic sensitivity and specificity based on the patients were 0.66(0.55—0.75) and 0.84(0.79—0.89), AUC was 0.84 (0.80—0.87). The results of subgroup analysis suggested that pulmonary tuberculosis was one important factor that influenced the PET-CT diagnosis of mediastinal lymph node metastasis in NSCLC patients(P=0.01). Conclusions PET-CT has a high accuracy for the mediastinal lymph node staging in non-small cell lung cancer, and it is the recommendedexamination method in these patients. Patients who had suffered from pulmonary tuberculosis should be treated with caution.