With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
Clinical Trials as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Outsourced Services ; Quality Control

With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

AIM: To study the expressions and clinical significance of PDCD4 and B7-H4 in optic gliomas in children.
METHODS:We used immunohistochemistry to evaluate the expressions of PDCD4 and B7-H4 in specimens from 52 optic gliomas in children cases, and analyzed the correlation of PDCD4 and B7 - H4 expression with clinicopathological factors children optic gliomas.
RESULTS: PDCD4 expression reduced in optic glioma tissue:PDCD4 expression rate in 52 cases of optic glioma tissues decreasing was correlated with tumor malignancy increase (P<0. 01); B7-H4 positive expression increased in optic glioma tissue: B7-H4 expression rate in 52 cases of optic glioma tissues increasing was correlated with tumor malignancy increase (P<0. 01); PDCD4 expression was negatively correlated with B7-H4 expression in optic gliomas (P<0. 01).
CONCLUSION: Expressions of PDCD4 and B7-H4 may be clinically relevant to tumor malignancy of optic gliomas in children and prevention of metastasis and prediction of prognosis.

Objective To investigate the clinical manifestations, endoscopic manifestations, histological characteristics, diagnosis and treatment of the primary gastrointestinal melanoma in China. Methods The gender, age, position, endoscopic manifestations, histological characteristics, treatment, prognosis of the primary gastrointestinal melanoma were gathered and analyzed by reviewing retrospectively the data of 2 cases seen at our hospital and 449 cases searched in CNKI from 1983 to 2015. Results The primary gastrointestinal melanoma was mostly seen in the rectum and anus, and secondly in the esophagus. A typical endoscopic finding was a protuberant or nodular tumor, with erosion or dirty surface on it. Most lesions were friable and easily hemorrhagic. The maximum diameters of most lesions, accounted for 83.3 %, were larger than 2.0 cm. The average value of the maximum diameters was (4.79 ± 2.67) cm. Most cases presented brown or black, followed by hoar. However, some lesions presented various colors, such as blue, red, even co-exited color or achromatic color. Preoperative misdiagnosed rate was 73.64 % and 1-year mortality was 54.19 %. Negative correlation was observed between survival time and lesion size, infiltration depth. Positive correlation was observed between lesion size and metastasis infiltration depth. Survival time had nothing to do with metastasis and age. Conclusion The primary gastrointestinal melanoma was highly aggressive, and usually found in the terminal age, usually together with extensive metastasis, misdiagnosed and poor prognosis. Knowing the clinical features, endoscopic manifestations, histological and immunohistochemical characteristics is the key to early diagnosis.

Objective:To provide reference for the sedation therapy and clinical monitoring for the patients with liver cirrhosis and alcohol withdrawal.Methods:Clinical pharmacist participated in the treatment process of emergency dyspnea in one patient with liver cirrhosis and alcohol withdrawal,and the thoughts and practice methods of clinical pharmacist participating in clinics were shared.Results:Based on the literatures,clinical pharmacist thought the emergency dyspnea was caused by overdose of sedatives.Therefore,medication monitoring and education on the drugs were provided for the patient,and pharmaceutical suggestions were put forward for the next treatment.Conclusion:Clinical pharmacists can help physicians analyze the causes of adverse reactions,and provide pharmaceutical care and medication education to ensure the safety and effectiveness of drug treatment.

laparoscopic technology has been widely used in the fields of surgery such as general surgery etc. It has several advantages,such as directly showing abdominal organs,demonstrating operation procedure and being easy to make and spread operation video material. Laparoscopic system should be used for intern teaching in general surgery department to improve their learning and performance.

OBJECTIVETo investigate the permance index ofof portable X-ray fluorescence spectrometer in the determination of lead on filter membrane and to provide data for the determination of lead in workplace air.

METHODSIrradiated with X-ray, the lead would emit specific X-ray fluorescence during the process from the excited state back to the ground state. Rapid determination of lead was completed using fluorescence energy and wave length for qualitative analysis and fluorescence intensity for quantitative measurement. Under set conditions, a series of customized calibration samples were measured to create a standard curve for quantitative analysis of lead on filter membrane.

RESULTSThe regression equation obtained using a portable X-ray fluorescence spectrometer to determine the lead on filter membrane was y=0.004x-0.182 (r2= 0.9999). The linear range was 0.00 -10.40 mg/m3, the minimum detectable concentration was 0.53 µg/m3, and the minimum quantifiable concentration was 1.76µg/m3. The relative standard deviation (RSD) of within-run precision of samples with different concentrations was 0.48%-6.22%, the RSD of between-run precision was 2.51%-5.09%, and the degree of accuracy was in the calibration range of standard samples.

CONCLUSIONPortable X-ray fluorescence spectrometry is a simple, rapid, repeatable, and accurate method for the determination of lead on filter membrane.

Female ; Humans ; Infant ; Mitochondrial Proton-Translocating ATPases ; deficiency ; genetics ; Mutation

To study the therapeutic effect and possible mechanism of icariin on myocardial ischemia-reperfusion injury ( MIRI) model in diabetes rats. The model of diabetic rats were induced by Streptozotocin (STZ), then the model of MIRI was established by ligating the reversible left anterior descending coronary artery for 30 min, and then reperfusing for 120 min. totally 40 male SD were randomly divided into five groups: the control group (NS), the ischemia reperfusion group (NIR), the diabetes control group (MS), the diabetic ischemia reperfusion group (MIR) and the diabetic ischemia reperfusion with icariin group (MIRI). The changes in blood glucose, body weight and living status were observed; the enzyme activity of serum CK-MB, LDH, GSH-Px and myocardium SOD and the content MDA and NO in myocardium were detected; the myocardial pathological changes were observed by HE staining; the myocardial Caspase-3, the Bcl-2, Bax protein expressions were detected by Western blot. The result showed that the diabetes model was successfully replicated; myocardial ischemia-reperfusion injury was more serious in diabetes rats; icariin can increase NO, SOD, GSH-Px, Bcl-2 protein expression, decrease MDA formation, CK-MB and LDH activities and Caspase-3 and Bcl-2 protein expressions and myocardial damage. The result suggested that icariin may play a protective role against ischemia reperfusion myocardial injury in diabetes rats by resisting oxidative stress and inhibiting cell apoptosis.
Animals ; Apoptosis ; drug effects ; Caspase 3 ; metabolism ; Creatine Kinase ; metabolism ; Diabetes Mellitus, Type 2 ; complications ; Drugs, Chinese Herbal ; administration & dosage ; Flavonoids ; administration & dosage ; Humans ; Ischemia ; drug therapy ; etiology ; physiopathology ; Male ; Malondialdehyde ; metabolism ; Myocardial Reperfusion Injury ; drug therapy ; etiology ; metabolism ; physiopathology ; Myocardium ; metabolism ; Proto-Oncogene Proteins c-bcl-2 ; metabolism ; Rats ; Rats, Sprague-Dawley ; Superoxide Dismutase ; metabolism ; bcl-2-Associated X Protein ; metabolism

Objective:To evaluate the sealing ability of the 3.0th generation of polyamidoamine dendrimer(3.0 PAMAM)on hu-man dentinal tubules.Methods:1 6 extracted premolars were cut into 2 mm thick dentin slices to establish sensitive dentin model in vitro.Then 2 samples without any treatment were selected randomly into demineralized dentin group,and the remain 1 4 dentine pills were divided into 2 groups by the random number table(n=7).Samples in the experimental group were treated with 3.0 PAMAM, those in the control group were treated with deionized water.After having immersed in the artificial saliva for 2 and 4 weeks respec-tively,the dentin slices were examined by scanning electron microscope(SEM)and X-ray energy dispersive spectroscopy(EDS). Results:SEM showed that the minerals on the surfaces of the dentine disks in experimental group were formed gradually with the time,the dentinal tubules were blocked 4 weeks after treatment.The minerals on the sample surface in control group were less and the dentinal tubules remained open.EDS results showed that Ca/P(1 .49 ±0.1 6)of mineral deposition in the experimental group was higher than that in the control group (1 .1 8 ±0.20)(P<0.05).Conclusion:The 3.0th generation of PAMAMhas the occlu-ding ability by inducing remineralization on the dentine surface and it may be used in the treatment of dentin hypersensitivity.