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.

Objective To investigate the application of intubation laryngeal mask in laparoscopic anesthesia for elderly patients with hypertension. Methods A total of 80 patients ( ASA Ⅱ -Ⅲ) over 70 years old undergoing laparoscopic gastrointestinal and gallbladder surgery from March 2014 to February 2015 were selected.They were randomly divided into the intubating laryngeal mask group ( ILMA group) or endotracheal tube group ( ET group) , with 40 patients in each group.After the intubation, the two groups were anesthetized with remifentanil by target-controlled infusion ( TCI ) and sevoflurane inhalation.The ILMA group was inserted matching laryngeal mask to control respiratory ventilation and deepened to the proper depth of anesthesia.An endotracheal tube were inserted through the mask 5 min later, and then the breath was controlled via transtracheal catheter to maintain anesthesia.The ET group was inserted tracheal intubation after induction, and then the breath was controlled until extubation after the recovery of the tracheal extubation after surgery.The heart rate (HR), blood pressure (SBP and DBP) and bispectral index (BIS) were recorded at time points of before induction (T0), laryngeal mask or endotracheal tube insertion (T1), after endotracheal tube insertion (T2), skin incision (T3), beginning tissue dissection or entry of laparoscope (T4), resection of organs or tissues (T5), and tracheal extubation ( T6 ) , respectively.In addition, the recovery time, the recovery of spontaneous breathing, complications during the recovery time, such as restlessness, nausea and vomiting, were observed and compared. Results There were significant differences in HR, SBP, DBP, BIS between the two groups and among different time points (P=0.000).At time points of before operation ( T0 -T2 ) and anesthesia maintaining stage ( T3 -T6 ) , the HR, SBP, DBP and BIS were stable in both groups.At the time points of after endotracheal intubation ( T2 ) and extubation ( T6 ) , the ET group had significantly increased HR, SBP, and DBP, which were higher than the ILMA group (P<0.05).At the time point of T6, the BIS values were significantly increased in the ET group than the ILMA group (P<0.05).On postoperative recovery quality, the time from anesthesia to spontaneous breathing recovery and from end of surgery to call to open eyes was significantly longer in the ET group than the LIMA group [(130.1 ±26.1) min vs. (96.4 ±24.5) min, t=5.94, P=0.000;(16.1 ±2.7) min vs.(5.5 ±2.2) min, t=19.07, P=0.000]. Conclusion For elderly patients with hypertension undergoing laparoscopic surgery, use of intubation laryngeal mask for anesthesia is more stable and has less adverse cardiovascular reactions, with good outcomes of anesthesia recovery.

Objective To observe the therapeutic effects of dietary,exercise intervention combined with Rou-ganjiangzhi capsule on non -alcoholic fatty liver disease.Methods A randomized,double -blinded and placebo drug parallel controlled method was used in this study.Sixty patients were enrolled into the study and randomly assigned into treatment group and control group.The patients of treatment group were taken with Rouganjiangzhi capsule combined behavior intervention.The patients of control group were taken with placebo drug combined behavior inter-vention.Each patient were accepted 12 weeks of the therapy.After treatment,the clinical symptoms,liver function, blood lipids,indicators of changes in imaging were detected,and the results of each group statistically were analyzed. Results After 12 weeks treatment,five patients were rejected,and the clinical symptoms,body mass index (BMI), waist -hip ratio were markedly improved in each group:[(1.02 ±1.08)points,(26.29 ±2.54),(0.92 ±0.04), (0.81 ±0.95),(26.58 ±3.11)and (0.91 ±0.04)]compared with[(3.62 ±0.96)points,(27.63 ±2.50),(0.94 ± 0.03),(3.60 ±0.95),(28.22 ±3.14),(0.95 ±0.03)(t =4.74,2.64,0.82,4.62,3.61,0.84,all P <0.05)]. After the treatment,the liver function (ALT,GGT)and cholesterol (TC)of treatment group decreased significantly than that before treatment:[(75.28 ±25.19)IU /L,(48.41 ±38.42)IU /L,(3.02 ±0.85)IU /L],compared with [(127.46 ±52.42)IU /L,(48.41 ±38.42)IU /L,(4.63 ±0.69)IU /L (t =2.54,2.18,2.42,all P <0.05)],while the liver function (ALT,AST,GGT)and blood lipids(TC,TG)of control group had no significantly decreased.The liver and spleen CT ratio raised apparently in treatment group than control group (0.86 ±0.24),(0.71 ±0.20)(t =0.83, P <0.05).Conclusion Rouganjiangzhi capsule achieve the good therapeutic effect on non -alcoholic fatty liver.

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 observe the effect of Chinese Medicines with the function of antioxidation on lupus nephritis(LN)pa- tients.Methods The 25 LN patients consisting of renal function normal group(15 cases)and renal failure group(10 cases)were treated with Huang Qi(Radix Hedysari)and Shu Dihuang(Radix Rehmanniae Praeparata)as main ingredients for 6 months in suc- cession.Changes of symptom,systemic lupus erythematosus disease activity index(SLEDAI),activity index(AI),lipid peroxide (LPO),superoxide dismutase(SOD),glutathione peroxide(GSH-Px),malondialchehyche(MDA),nitric oxide(NO),blood and urine routine examination,24-hour urine protein quantity,liver and kidney function,anti-double-stranded DNA(anti ds-DNA),complement 3(C_3)and complement 4(C_4),after treatment were observed.Results SLEDAI and AI scores were remarkably different from those before treatment(P

Reflex sympathetic dystrophy after stroke,also called shoulder-hand syndrome(SHS),is a common complication of stroke.It is presumed that SHS is consequence of many factors,including periphery injury,effect of sympathetic never system,neurogenic inflammation,and plasticity of central nervous system.

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.

[Summary] The genomic DNA was extracted from peripheral blood leukocyte of the patient with thyroid hormone resistance syndrome and 14 members of his family.The exons 1-10 of thyroid hormone receptor β (TRβ) gene were amplified by PCR.The products of PCR were sequenced directly to detect the gene mutation.The results showed that 3 members of this family were confirmed to have the C→T transition mutation at nucleotide 1 303 site within exon 10 of TRβ gene,and the missense mutation results in the substitution of histidine to tyrosine (H435Y).The heterozygous mutation may lead to the occurrence of thyroid hormone resistance syndrome.

Objective To investigate the value of ultrasound in diagnosis of fetal simple unilateral multicystic dysplastic kidney (MCDK) disease.Methods Pregnant women who underwent prenatal ultrasound screening and follow-up were analyzed retrospectively,and 29 fetues with MCDK were found.After exclusion of pregnancy syndrome,other structural abnormalities and chromosomal abnormalities,15 fetues willing to continue pregnancy and accepting the follow-up tracking observation were observed to postpartum.Ipsilateral renal ultrasonographic characteristics,contralateral renal morphology and size,growth and development of children and the renal function were analyzed.Results The minimum follow-up time of the 15 fetus was pregnancy to 7 months after birth,the maximum follow-up time was pregnancy to 5 years of age in children.Ultrasound showed that ipsilateral kidney volume became large in fetal period,reduced gradually in late pregnancy,and atrophy in 5 6 months after birth,even could not displayed with untrasound.The shape,size,and sonographic characteristics of the healthy kidney were similar to the normal gestational age kidney.Prenatal fetal growth indicators and amniotic fluid volume were normal.After birth,except for 1 child with overweight,other children's growth and development indicators were almost normal.Conclusion Fetus with simple unilateral MCDK has a good prognosis.Ultrasound has important value in the examination and follow-up.It can provide reliable basis for prenatal diagnosis and consultation.