A CDASH-based CRF annotation plays an important role in database setup and data verification. The STDM-based CRF annotation is also one of the essential documents when the package of clinical trial data is submitted to the regulatory authority. This paper describes the contents, procedures and related stipulations used in the CDISC-based CRF annotation.

There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.

Objective:To investigate the possibility for human papillomavirus (HPV)infection to be a predictable signal for the carcinogenesis of oral mucosa by comparing the prevalences of HPV in each stage of oral mucosal carcinogenesis and to compare the sensitivity differences of the two methods in de-tecting HPV infection in oral cavity.Methods:The hybrid capture (HC-Ⅱ)was used to detect infection of HPV in 255 samples taken from 1 2 cases of healthy oral mucosa,21 1 cases of patients with pathologi-cal diagnosis and 32 cases of patients with clinical diagnosis.The diagnosed cases included 8 cases of be-nign lesions of the oral mucosa,precancerous lesions [74 cases of oral leukoplakia (OLK)with hyper-plasia and 42 cases of OLK with oral epithelial dysplasia (OED)],91 cases of precancerous condition
[oral lichen planus (OLP)]and 28 cases of oral squamous cell carcinoma (OSCC).And in situ hybri-dization (ISH)was used to detect infection of HPV in 33 cases of OSCC and 76 cases of OLK,including 30 cases of hyperplasia,1 5 cases of mild OED,1 5 cases of moderate OED and 1 6 cases of severe OED. Results:The prevalence of HPV in OLP samples was higher (1 2.1 2%,8/66 )than that of OLK (2.59%,3/1 1 6)(χ2 =4.666,P=0.031 )and OSCC(7.1 4%,2/28,χ2 =0.51 3,P=0.474).The prevalence of HPV in OSCC (7.1 4%,2/28)was higher than that of OLK (2.59%,3/1 1 6),and no significant difference was found.There was only one case of smoke spot and statistical analysis was not carried out.ISH was used to detect type 1 6/1 8 and type 31 /33 HPV DNA in 1 09 cases of oral mucosal lesions in paraffin sections and only one case of OSCC was HPV positive.Thirty-seven cases were detec-ted by HC-Ⅱ and ISH methods at the same time.The same negative results by the two methods were found in 94.6% samples (35/37).In the other two samples,one was OSCC with early infiltration and the other was OLK with hyperplasia,The HC-Ⅱ results were positive while the ISH results were nega-tive.The patients with OLP and HPV testing results were followed up and the average follow-up period was (36.2 ±1 0.5)months.It was found that three of them had a malignant transformation,and the ma-lignant transformation rate of HPV positive patients was 1 2.50% (1 /8),which was higher than that of HPV negative patients (3.45%,2/58),and the difference was not statistically significant,P=0.249. Conclusion:HC-Ⅱ assay was more sensitive in detecting HPV infection of oral mucosal lesions than ISH.The results of this study showed that there was insufficient evidence for taking HPV infection as a predictor of OLK carcinogenesis.Patients suffering from OLP were in a precancerous condition.The pre-valence of HPV in OLP patients of this study was higher than that in OLK and OSCC patients,suggesting that for some reason,OLP patients were susceptible to HPV.HPV testing can be considered as routine in patients with OLP,and HC-Ⅱassay was recommended.And patients with OLP and HPV positive should be followed up regularly.

With the deployment of electronic medical records systems, more and more routine clinical data are recorded electronically, which become a potential data source for new drug clinical trials. In this paper, we summarized the opportunities, challenges, obstacles and the latest development in this field.

Background and purpose:hTERT is indistinct in the effect of neo-adjuvant chemotherapy. Our aim was to detect both expression of hTERT mRNA and protein in breast cancer tissue and their changes after neoadjuvant chemotherapy. Methods:From Feb 2004 to Jun 2007, 53 cases with untreated advanced breast cancer were enrolled. All patients received CEF chemotherapy three cycles. The breast cancer tissue was collected before and after chemotherapy. hTERT mRNA and protein expression were detected by RT-PCR and immunohistochemistry techniques. Results:The positive hTERT mRNA and protein expression in breast cancer tissue before chemotherapy were 77.4% and 73.6% respectively, and after neo-adjuvant chemotherapy were 28.3%,22.6% respectively.The effective rate of the neo-adjuvant chemotherapy of the patients with positive of hTERT expression was higher than those with negative hTERT expression. Conclusion:The chemo-agents altered hTERT gene expression, improved negative rate of hTERT expression. Detecting expression of hTERT gene in breast cancer tissue would be an important index for predicting the effects of neo-adjuvant chemotherapy.

Aim To investigate the combined effect of mangiferin and ephedrine as well as explore its underlying mechanism in mouse model of allergic asthma.Methods The mouse model of asthma was sensitized and challenged with ovalbumin(OVA).The behaviors of mice during the challenging period were observed.Continuous autonomic activities of mice after 1 h of drug treatment were monitored with the autonomic activity recorder for 14 days.The total and differential cells in peripheral blood were counted.Histological study of lung sections on airway inflammation was carried out with haematoxylin and eosin(HE) staining.The levels of ovalbumin-specific immunoglobulin E(OVA-sIgE) and(Cyclic Adenosine monophosphate) cAMP in serum were detected by enzyme-linked immunosorbent assay(ELISA).The mRNA expression of cytokines mainly produced by Th1/Th2 lymphocytes such as IFN-γ and IL-4, IL-5 were semi-quantitatively analyzed with reverse transcription polymerase chain reaction(RT-PCR).Results Combination treatment and mangiferin could reduce the aberrantly autonomic activity caused by ephedrine in mice.Compared with the model group, asthmatic symptoms in all treatment groups could be significantly relieved, the pathological changes of lung tissue were improved and airway inflammation was reduced.The effect of combined treatment was better than that of mangiferin treatment alone.Compared with the model group, the total number of white blood cells(WBC) and the eosinophils(EOS) ratio in peripheral blood in all treatment groups decreased, the level of OVA-sIgE declined and the level of cAMP increased in serum.Combination treatment could lower mRNA expressions of IL-4 and IL-5 from Th2 lymphocytes and increase the mRNA expressions of IFN-γ released by Th1 lymphocytes.Conclusions The effect of combined therapy of mangiferin and ephedrine is better than that of mangiferin treated alone, meanwhile it can reduce the side effects caused by ephedrine.The underlying mechanism is mainly associated with attenuating Th1/Th2 cytokine imbalance and increasing the level of cAMP.

Objective:To explore the clinical effect of prostatil combined with diosmin on the elderly patients with chronic prostatitis (CP) and the macrophage inflammatory protein-2 (MIP-2) and macrophage inflammatory protein-lα (MIP-lα) in prostate fluid and serum.Methods:126 cases of elderly patients with CP in our hospital fiom January 2015 to September 2016 were selected and randomly divided into two groups.Prostatil combined with diosmin were provided to the patients in observation groups (63 cases) while the control group (63 cases) was treated by prostatil alone.The clinical effect,MIP-2,MIP-1α levels in the prostate fluid and serum before and after therapy as well as the incidence of adverse reactions were observed and compared between two groups.Results:At 12 weeks after treatment,the total effective rate of observation group was 93.7％,which was obviously higher than that of the control group (81.0％,P＜0.05).The MIP-2 and MIP-1α levels in prostate fluid and serum of both groups at 12 weeks after therapy were significantly lower than those before therapy (P＜0.01),which were significantly lower in the observation group than those of the control group at the same time (P＜0.01).There was no significant difference in the incidence of adverse reactions between the two groups (P＞0.05).Conclusion:Prostatil combined with diosmin could more safely and effectively improve the clinical efficacy in the treatment of elderly patients with CP/CPPS,which might be related to reduce the levels ofMIP-2,MIP-lα in serum and prostatic fluid.

Objective To analyze the efficacy and hemodynamic changes in patients with complex symptomatic middle cerebral artery stenosis after Solitaire AB stent implantation.Methods From June 2013 to June 2016,7 consecutive patients with complex symptomatic middle cerebral artery stenosis treated with Solitaire stents at the Department of Neurology,the Third People's Hospital of Hubei Province were enrolled retrospectively.The stenosis rate ≥70% was confirmed by digital subtraction angiography (DSA).Of the 7 patients,5 were male and 2 were female,with an average age of 70±8 years.The general data of the patients were documented,including clinical symptoms,modified Rankin scale(mRS)score,stenosis degree,vascular pathways LMA classification and Mori typing for stenosis,and postoperative residual stenosis or restenosis.The hemodynamic parameters at day 1,7,and 3 months before and after procedure were compared.Results All patients were successfully implanted with the Solitaire AB stents.(1) Of the 7 patients,the Mori type A of stenosis lesions was in 4 cases,B in 2 cases,and C in 1 case.The LMA typing of vascular approaches were Type Ⅲ in 3 cases,type Ⅱ in 4 cases.The preoperative stenosis rate was 80±7%,the residual stenosis rate was 24±13%,and there were no operation-related complications.No ischemic events occurred during the follow-up period.(2) Before stent implantation and at 1 d,7 d,and 3 months after procedure,the peak systolic velocity (PSV) were 297±41,144±34,145±27,and 143±40 cm/s,respectively,the end diastolic velocity (EDV) were 159±22,68±16,68±14,and 66±17 cm/s,respectively,and the pulse index (PI) were 0.67±0.06,0.80±0.08,0.80±0.07,and 0.82±0.06,respectively.PSV,EDV,and PI at 1 d,7 d,and 3 months were improved compared with before procedure (all P<0.05),There were no significant differences at all time points in the pairwise comparison PSV and EDV and PI at all time points after the procedure (all P>0.05).Conclusions Initial analysis showed that no procedure-related complications were observed in the treatment of vascular tortuosity and complex middle cerebral artery stenosis with the Solitaire stents.The short-term curative effect is exact;However,it still needs to be validated further.

ObjectiveTo study electrophysiological characteristics and catheter ablation left-sided accessory pathways of Mahaim fiber.MethodsTwenty-eight patients underwent catheter ablation for Mabaim fiber and 3 patients was left-sided accessory pathways.All of them were male with 34,20,38 years old.The tachycardia history was1-5years. Electrophysiological characteristics,target sitesand electrocardiogram(ECG,12 leads) were recorded through catheter from coronary sinus(CS),high right atrium(HRA),His bundle and ablation.ResultsOne patient's ECG showed little preexcitation,the other two were normal. Atrial stimulation could be easily induced tachycardia.Their ECG showed wide QRS waves (right bundle branch block or similar right bundle branch block).The characteristics of accessory pathways were slow and anterograde decremental conduction as well as blocked by adenosine triphosphate injection.Ventricular-atrial conduction was via atrioventricular node with centripetal decreasing transmission during ventricular pacing.During tachycardia,the His bundle electrogram resulted in a V-H-A pattern,the retrograde A in His bundle was pioneer.The atriofascicular pathways of 2 patients were completely ablated respectively in left posterior lateral and before the free wall of mitral valve ring.The nodoventricular pathway of 1 patient was successfully ablated in left middle posterior lateral of mitral valve ring.ConclusionsThe left-sided accessory pathways of Mahaim fiber is an uncommon accessory pathway,which has specific electrophysiological characteristics.It is effective and safe to ablate accessory pathway with radiofrequency.

Objective To investigate the electrophysiological characteristics of atrial tachycardia (AT) originating from the side of the bundle of His, and to analyze the efficacy and safety of transcatheter radiofrequency ablation via the right side of the bundle of His and left noncoronary sinus of aorta for the treatment of AT. Methods A total of 12 patients with AT originating from the side the bundle of His, which was confirmed by conventional electrophysiological study and atrial activation patterns, were included in this study. The patient’s age ranged from 12 to 64 years old with a mean of (47.4±14.6) years. The mapping was carried out at the right side of the bundle of His and radiofrequency ablation was performed. When the ablation procedure failed, or the junction zone rhythm or atrioventricular block occurred, ablation via the left noncoronary sinus of aorta was employed. Results Atrial stimulation could repeatedly induce and terminate AT in all the 12 patients, the average cycle length was (327±76) ms. TA was terminated within 10 seconds after the start of ablation in 10 patients during their AT attacks. Ablation was unsuccessful in 2 patients. Ablation via the right side of His bundle was successfully accomplished in 2 patients, and the ablation via the left noncoronary sinus of aorta was successfully carried out in 8 patients. The average follow-up time was 1-6 years, and no recurrence of AT was observed. Conclusion Atrial tachycardia originating from the side of the bundle of His has certain electrophysiological characteristics, and transcatheter radiofrequency ablation is safe and effective for its treatment. Ablation via the left noncoronary sinus of aorta should be considered as a strategy of priority.