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

Angiofibroma ; metabolism ; pathology ; surgery ; Angiomyoma ; metabolism ; pathology ; Antigens, CD34 ; metabolism ; Diagnosis, Differential ; Female ; Fibroma ; metabolism ; pathology ; Follow-Up Studies ; Humans ; Leiomyoma ; metabolism ; pathology ; Middle Aged ; Mucin-1 ; metabolism ; Myxoma ; metabolism ; pathology ; Vimentin ; metabolism ; Vulvar Neoplasms ; metabolism ; pathology ; surgery

ObjectiveTo investigate the clinical significance of determination of 20S proteasomal activities changes in circulating white blood cells (WBC) in patients with advanced gastric carcinoma.MethodsThe 20S proteasomal activities in circulating WBC separated from 80 patients with advanced gastric carcinoma were determined by 20S proteasome assay kit; the concentrations of interleukin-6(IL-6) in plasma were determined by radioimmunoassay method.The result was compared with that of 11 healthy volunteers.ResultsThe proteasomal activities in circulating WBC[(38.26 ±9.23),(101.85 ±27.63)pmol AMC/ ( s *mg pro) ] and concentrations of IL-6 [ (23.89 ± 6.76),(72.52 ± 20.71 ) ng/L ] of healthy volunteers and the patients with advanced gastric carcinoma had statistical significance (P ＜ 0.01 ).The proteasomal activities and the concentration of IL-6 were correlated with age,pathological type,weight changes,Karnofsky score and disease severe degree(P ＜ 0.01 );while they had no relationship with sex(P ＞ 0.05).Cox's proportional hazard regression model demonstrated that pathological type,Karnofsky score and proteasomal activities were the independent risk factors affecting the survival of patients with advanced gastric carcinoma (P ＜0.01 or ＜0.05).20S proteasomal activities and the concentration of IL-6 had positive correlation (r =0.691,P =0.000).ConclusionsThe proteasomal activites in circulating WBC and the concentration of IL-6 in plasma increase and are correlated with age,pathological type,weight changes,Karnofsky score and disease severe degree.Proteasomal activities in circulating WBC can be used as the prognostic reference factor of advanced gastric carcinoma.20S proteasomal activities and the concentration of IL-6 have positive correlation.

Objective To explore cardioprotective effect of matrine on myocardial ischemia in hypercholesterolemia rats. Methods Myocardial infarction was induced by subcutaneous injection of isopreterenol (ISO, 85 mg/kg) once daily for two consecutive days in rats feeding cholesterol-rich diet for 4 weeks. Content of serum lipid, myocardial injury marker enzymes, lipid peroxidatase and activities of antioxidative enzymes in serum and/or heart tissues were measured, and cardiac function was evaluated. Results Administration of matrine (50, 100, and 200 mg/kg, respectively) decreased serum level of TC and TG, improved left ventricle (LV) contractile function (increased LVSP and +dp/dtmax) and LV diastolic function (decreased LVEDP and increased -dp/dtmax), depressed the levels of myocardial injury marker enzymes of lactic dehydrogenase (LDH) and creatine kinase (CK), promoted the activities of antioxidative enzymes of superoxide dismutase (SOD), catalyst (CAT), and glutathione peroxidase (GHS-PX), as well as decreased the content of lipid peroxidation product of malondialdehyde (MDA) in plasma and/or myocardial tissues in hypercholesterolemia rats with myocardial infarction. Histopathology examination demonstrated that matrine could attenuate ISO-induced myocardial infarction morphologically in hypercholesterolemia rats. Conclusion Our results suggest that cardioprotective effect of matrine on myocardial infarction in hypercholesterolemia rats is attributed to its ability to decrease the TC and TG content of serum, enhance the activities of antioxidative enzymes, and maintain the stability of myocardial cellular membranes.

Objective To explore the effect of pain intervention on limb function exercises in patients with peripheric fractures of knee joint.Methods 60 patients with peripheric fractures of knee joint were randomized in equal number into the observation group and control group.Both groups took functional exercises for affected limbs.Besides,the former and latter groups were administered with celecoxib at a dosage of 200mg twice a day from pre-operation to discharge and after operation,respectively.The two groups were compared in terms of pain degree at different time points as well as the functional recovery of affected limbs.Results The observation group was lower in pain scores than the control group at hours 6,8,12,24,36 and 48.The active and passive motions of the affected limbs in the observation group were significantly better than those in the control at days 1,2,3,4 and 5(all P<0.001).Conclusion Pain intervention with celecoxib before operation may help patients to take functional exercises as early as possible,promoting the rehabilitation of functions of affected limbs.

Objective To study the effect of local mild hypothermia on the expression of matrix metallopro- teinases-2/9 (MMP-2/9) and brain edema in experimental intracerebral hemorrhage (ICH) in rat. Methods One hundred and forty-five Wistar rats were randomly divided into a normothermia sham-operation (NSO) group ( n = 15 ), a normothermia intracerebral hemorrhage (NICH) group (n = 75 ) and a mild hypotbermia intracerebral hemor- rhage (MHICH) group (n = 75). Autologous arterial blood was stereotaxically injected into the right caudate nucleus of the rats of the NICH and MHICH groups to make intracerebral hemorrhage model. The rats in the MHICH group were then subjected to 4 hours of local mild hypothermia, while those in the NICH group were under the room temper- ature. The brain water content, permeability of brain-blood barrier (BBB) and expressions of MMP-2/9 were meas- ured by immunohistochemistry method at 6 h, 24 h, 72 h, 5 d and 7 d after operation. Results In NICH group, the brain water content, permeability of BBB and expression of MMP-9 all began to increase at 6 h and peaked at 3 d after injection of blood and still higher than the NSO group at 7 d. The expression of MMP-2 only began to increase little at 24 h and peaked at 5 d after operation and remained highly expressed at 7 d. In the MHICH group, the chan- ges of brain water content, permeability of BBB and expression of MMP-9 were similar to those of the NICH group, but the extent of changes was significantly lower at the every time point. In NICH group and MHICH group, MMP-9 expression was positively correlated with both the brain water content and the permeability of BBB, but MMP-2 ex- pression was not correlated with them. Conclusion Mild hypothermia might protect BBB against injury caused by ICH and relieve brain edema and inflammation reaction through inhibiting the expression of MMP-2/9.

Background Granulocyte colony-stimulating factor(G-CSF)has been reported to have beneficial effect on cardiac dysfunction in post infarction and doxorubicin-induced cardiomyopathy.Objective To investigate the effects of G-CSF on cardiac remodeling in cardiac hypertrophy induced by angiotensin Ⅱ(Ang Ⅱ).Methods Thirty-six male wild type mice(WT)were allocated randomly to receive subcutaneously G-CSF(10 ?g/kg per day, n=9),or Ang Ⅱ(2.88 mg/kg per day,n=9),or Ang Ⅱ plus G-CSF(Ang Ⅱ 2.88 mg/kg+G-CSF 10 ?g/kg,n =9)for 4 weeks with untreated WT(n=9)as controls.Blood pressure and cardiac function were measured. Heart weight/body weight ratio,myocyte cross-sectional area and fibrosis area were determined.The mRNA ex- pression of osteopontin(OPN)in myocardium was detected by RT-PCR.The expressions of angiotensin converting enzyme(ACE),ACE2 and phosph-p70S6 kinase protein in myocardium were assessed by Western-Blot.Results Ang Ⅱ significantly elevated blood pressure(SBP,Ang Ⅱ:139.7?1.6 vs WT:108.7?2.3 mmHg,P0.05),but significantly attenuated the myocyte cross-sectional area(Ang Ⅱ+G-CSF:181.06?0.11 vs Ang Ⅱ:202.02?0.16 ?m~2,P

Objective To discuss the strategy and intervention measures of the iodine deficiency disorders (IDD)control in coastal salt.producing areas so as to shoot the problem of non-iodized salt causing IDD.Methods Accordinng to different areas,periods and crowds,eomplicatd measures and strategies were taken such as supply of iodized salt to peopie in special need while universalizaion of iodized salt,health promotion,private salt factory censu8 and close.iodized salt quality monitoring and promotion of technology of iodized salt producion in Xiamen, where the probiem of non-iodized salt Was serious since 1995.Results Iodized salt manufactured Was qualified in a increased rate from 89.50% in 1995 to 96.17% in 1997,stablized at 99.00%since 2000.Qualified iodized salt sold in the shops waft increased from 87.33%in 1996 to 96.33%in 1998.Popularization covered by iodized salt in urban areas increaased from 0.92%in 1 995 to 100.00%in 2000,and it Was increased from 0 to 99.00%in suburban area8 and increased from 0 to 89.00%in rural areas.Since 2001 iodized salt covered up 93.00%of the people.The rate of child goitre in urban,suburban and rural areas respectively Wag 16.44%(228/1387), 20.57%(266/1293) and 24.93%(651/2611).Moreover,beginning from 1996,it reduced tO below of 5.00%respectively in 1999,2001 and 2005.The median of urinary iodine of children in urban,suburban and rural areas respectively was 137.50, 102.12,94.66 μg/L in 1995,since 1997 it reached 100.00μg/L and kept at 120.00μg/L In 2007 the median of urinarv iedine of children respectively was 271.10,240.40,198.10μg/L in urban,suburban and rural areas.The pereentage of awareness of IDD knowledge was 74.00%(444/600)in students in 1997 and reached 95.00% since 2000.Conclusion The paRern of eliminating iodine deficiency dis ease in Xiamen has successful established,which works efficiently and sets an example for iodized salt supplement in non-iodized salt areas and continually eliminating the iodine deficiency disease.

Objective To semiquantify salivary gland damage after 131I treatment in patients post thyroidectomy using salivary gland scintigraphy. Methods Fifty-six patients underwent salivary gland scintigraphy 6 months after 131I ablation therapy following thyroidectomy, including 21 with both baseline (before 131I treatment) and follow-up (6 months after the 1st 131I treatment) imaging. Salivary gland function was quantified by uptake ratios at 4 minutes (UR4) and 15 minutes (UR15), and excretory index at maximum secretion (MS), time duration from stimulation to minimum count (Tmin ). Paired t test was used for the 21 patients with both baseline and follow-up imaging. All the studies were divided into four groups: before 131I therapy, after 1st therapy, after 2nd therapy, and after 3rd or more times of therapy. Group differences were evaluated by the one-way analysis of variance (ANOVA)/Kruskal-Wallis test. Spearman test was used to analyze the correlation between the parameters and times of therapy. Results After the 1st 131I therapy, UR15 for the left and right parotid glands were 16% and 14% lower than the baseline, respectively (t=2.188, 3.322, both P<0.05). All the other parameters were not significantly different from those of baseline (t: -0.952 to 2.039, all P>0.05). Among the four groups, significantly different parameters for both parotid glands were found: UR4, UR15, MS for the left parotid of the four groups were 1.76±0.29, 2.60±0.38, (72.8±24.2)%; 1.55±0.34, 2.15±0.51, (64.4±21.6)%; 1.55±0.40, 2.02±0.68, (57.2±34.2)%; 1.45±0.33, 1.69±0.46, (30.6±36.9)%; respectively (F values for UR4 and UR15 were 7.018, 3.112 and H value for MS was 12.240, all P<0.05). UR4, UR15, MS for the right parotid were 1.81±0.33, 2.57±0.51, (69.1±18.5)%; 1.61±0.38, 2.19±0.59, (64.2±25.0)%; 1.60±0.42, 2.00±0.62, (53.2±41.7)%; 1.48±0.38, 1.63±0.29, (26.1±45.9)%, respectively (F=13.393,10.194,H=26.569,all P<0.05). However, no statistical differences were P>0.05). According to pair-pair comparison, only the degree of reduction of UR15 for parotid glands was significantly different between the 1st and 2nd therapy (P<0.05). UR4, UR15, MS for bilateral parotid glands reduced significantly after 3 or more times of therapy (all P<0.05).The parametres UR4, UR15, MS were correlated with times of 131I therapy (r:-0.296 to -0.566, all P<0.05). Conclusions Salivary uptake function is impaired slightly after the 1st radioiodine therapy. After several times of therapy, both parotid uptake and excretion functions are impaired. Submandibular functions are not affected even after repeated 131I therapy.

Objective To measure the level of diamine oxidase (DAO), and observe the intestinal motor and mucosal barrier injury after acute spinal cord injury (SCI) in rats. Methods A total of 45 Sprague-Dawley rats were randomly divided into SCI group (group A, n=15), sham group (group B, n=15) and control group (group C, n=15). SCI model was established with Allen's strike mode (10 g × 25 mm) by striking T10 spinal segment in rats. One day, three days and seven days after SCI, hind limb motor function was assessed with Basso-Beat-tie-Bresnahan (BBB) Scale in each group, the myoelectric slow wave and ileum smooth muscle contractility were measured in rats, ileum tis-sues were tested with HE staining, and the DAO content of serum was tested with ELISA kit. Results One day, three days and seven days af-ter SCI, the BBB score was significantly lower in group A than in groups B and C (P<0.001). One day, three days after SCI, the frequency and amplitude of both slow wave and contractility were lower in group A than in groups B and C (P<0.05);seven days after SCI, there was no significant difference among three groups (P>0.05). Group A showed ileal mucosal edema, lodging, inflammatory cell infiltration, and submucosal gap increase. The Chiu's score of intestinal mucosal injury was higher in group A than in groups B and C (P<0.05), as well as the serum DAO content one day and three days after SCI (P<0.05), and no significant difference was found in the serum DAO content among three groups seven days after SCI (P>0.05). Conclusion Serum DAO content may respond to the intestinal motor function and mu-cosal injury after acute SCI in rats.