Data is the basis and soul of clinical trials. To obtain accurate data, strict and standard data management is essential, which can be effectively supported by quality control in statistical analysis. In this paper, we briefly introduce the concept of the quality control in clinical trials, and describe its contents and methods. We hope that this work will be helpful to the application of statistical quality control in data management of clinical trials.
Clinical Trials as Topic ; standards ; Data Collection ; standards ; Quality Control ; Statistics as Topic

Neural cell adhesion molecule (NCAM) is a glycoprotein expressing on the surface of neurons, glial cells, bone cells and natural killer cells. NCAM plays an important role in the process of cell - cell adhesion and cell migration, and is also a model protein to study polysialic acid. In this paper, NCAM gene from mouse mammary gland cells (NMuMG) was cloned into eukaryotic expression vectors pcDNA3.1(+) and transfected into mutant Chinese hamster ovary cells ldlD-14. The stable transfection over-expressing NCAM was obtained through the G418 selection and confirmed by Western blotting. Due to unique characters of ldlD-14 cells, carbohydrate chain of NCAM molecule can be easily manipulated with or without adding galactose in the serum free medium, and this modification can provide the basis for further studies on the effect of glycosylation on NCAM molecular function.
Animals ; CHO Cells ; Cloning, Molecular ; Cricetinae ; Cricetulus ; Female ; Galactose ; Glycosylation ; Mammary Glands, Animal ; cytology ; Mice ; Neural Cell Adhesion Molecules ; biosynthesis ; Polysaccharides ; chemistry ; Sialic Acids ; chemistry ; Transfection

Objective: To learn the characteristics of adolescent pregnancy in Wenzhou from 2015 to 2019, so as to provide basis for protecting adolescent physical and mental health. Methods: Data of demographic characteristics, pregnancy and delivery outcomes of the women aged under 19 years ( adolescent pregnant ) and 20 to 34 years ( right-age pregnant ) who delivered in Wenzhou from 2015 to 2019 were collected from Wenzhou Maternal and Child Health Information Management System. The incidence of pregnancy complication, comorbidity and adverse delivery outcomes of adolescent pregnant women was compared with that of right-age pregnant women. Results: Among 536 753 parturients reported in Wenzhou from 2015 to 2019, there were 22 419 ( 4.18% ) of adolescent pregnancy and 430 163 ( 80.14% ) of right-age pregnancy. The average age of adolescent pregnant women was (18.11±0.82) years ( range, 10-19 years ). The majority of adolescent pregnant women were migrant population (19 437 cases, 86.70%), had an education level of junior high school and below ( 18 594 cases, 82.94% ), and had no occupation (19 192 cases, 85.61%). The incidence rates of anemia, gestational diabetes, postpartum hemorrhage, perineal laceration and premature delivery in adolescent pregnant women increased from 2015 to 2019 ( all P<0.05 ). The incidence rates of gestational diabetes, anemia, gestational hypertension, placental abruption, postpartum hemorrhage, perineal laceration, premature delivery, low birth weight, fetal death and stillbirth were 1.65%, 11.76%, 0.19%, 0.26%, 3.19%, 24.52%, 6.03%, 5.53%, 0.50% and 0.04% in adolescent pregnant women, which were significant different from 5.49%, 8.94%, 0.13%, 0.01%, 0.17%, 23.46%, 4.66%, 3.08%, 0.26% and 0.01% in the right-age pregnant women, respectively ( all P<0.05 ). Conclusions The adolescent pregnant population in Wenzhou are mainly migrant population with lower education level and no occupation. The incidence rates of pregnancy complication, comorbidity and adverse birth outcomes in adolescent pregnant population are higher than those in right-age pregnant population, and are increasing year by year.

Objective:To study whether sacral lymph nodes should be included in the target volume delineation for those patients with early (stageⅠB-ⅡA) uterus cervix cancer during postoperative radiotherapy. Methods:Forty-six patients with early uterus cervix cancer were given postoperative three dimensional conformal radiation therapy (3D-CRT) in our department for one month after radical resection. The patients were randomly divided into two groups. The sacral lymph nodes were not included in the target volume delineation in the treatment group. But they were delineated in control group. All the patents had no radiotherapy-related contraindications and signed the consent agreement. The patients were followed up. The local controlling rate and the incidence and degree of radioactive proctitis were compared between the two groups. Results:The local controlling rate of the two groups had no significant difference(t=0.000, P=1.000). The doses received by the 5% and 95% volume of the rectum(V_5, V_95), the average dose, and the minimum dose had significant difference between the two groups(t_(V5)=2.169, P_(V5)=0.041; t_(V95)=4.036, P_(V95)=0.001;t_(mean)=2.236, P_(mean)=0.036; t_(min)=2.265, P_(min=0.034), but the maximum dose received by the rectum had no obvious difference (t_(max)=0.518, P_(max)=0.610). The incidence of radioactive proctitis had significant difference between the two groups(t=2.174, P=0.190). Conclusion:For the early uterus cervix cancer patients who have recurrent risk after radical surgery, sacral lymph nodes should not be included in the delineation of target volume during 3D-CRT in order to decrease the incidence of radioactive proctitis.

AIM To investigate the changes of biochemical index of osteoporosis in rats induced by given total flavonoids of herba epimedii (HEF) . METHODS The rat osteoporosis was induced by given retinoic acid intragastrically, the biochemical index in serum (T, E 2, ALP, PTH, BGP, Osteocalcin ) and in urine (Ca, P, DPD and Cr) were determined after the rats were given HEF by low, middle and high dosages respectively, and were compared with the model group. The normal control and the positive control. RESULTS The E 2, T and BGP level in all three dosage groups were obviously higher than that of the model group. The Ca/Cr, DPD and PTH level were obviously lower than the model group. The content of Ca and P and the bone density in femur were similar with the normal control, and there was significant difference compared with the model group. CONCLUSION HEF prevents the rats treated by retinoic acid from becoming osteoporosis. The changes of biochemical index were consistent with the variation of bone density, indicating the great significance of biochemical index in diagnosis and treatment of osteoporosis.

Objective To explore the value of the spectral CT iodine-based material decomposition technique in differential diagnosis of central pulmonary carcinoma from obstructive pneumonia and atelectasis.Methods 25 cases with central pulmonary carcinoma complicating with obstructive pneumonia and atelectasis underwent CT plain scan and spectral contrast scan including pulmonary-arterial-phase (PAP) and bronchial-arterial-phase(BAP).Conventional CT images and iodine base images were generated in each phase by GSI viewer.The 4 groups of images differences between the tumor and the obstructive pneumonia and atelectasis were analyzed.Results The margin of the tumor was ill-defined in plain scan.The cases that showed difference between the tumor and the obstructive pneumonia and atelectasis in 4 groups of images were respectively as follows,10 in conventional CT images of PAP,1 6 in conventional CT images of BAP,1 9 in iodine base images of PAP,and 23 in iodine base images of BAP.The difference of the 4 groups was significant (χ2 =16.54,P<0.05).There was the highest accuracy in iodine base images of BAP in defining the tumor margin (χ2 = 12.83,χ2 = 4.20,χ2 =1.34,P <0.05). The accuracy between conventional CT images of BAP and iodine base images of PAP had no significant differences (χ2 =0.86,P >0.05),but were better than that of the conventional CT images of PAP(χ2 =6.65,P <0.05).Conclusion Spectral CT iodine-based material decomposition technique is helpful to improve subjective diagnosis of central pulmonary carcinoma complicating with obstructive pneumonia and atelectasis,especially in iodine base images of BAP,it can provide accurate information for clinical stage and treatment.

Objective To characterize the changes in the dimensions during systolic and diastolic periods in the aorta with ECG-gated multi-detector CTA scans.Methods The CT angiograms of 115 patients (78 males,mean age 55.2 ± 9.4 years;37 females,mean age 60.1 ± 8.5 years) both in systolic and diastolic periods were obtained on a 64-slice ECG-gated multi-detector CT scanner.The diameters were measured at four anatomic levels of the aorta.(Level A:1 mm proximal to the innominate artery;Level B:1 mm distal to the left common carotid artery;Level C:1 mm distal to the left subclavian artery;Level D:10cm distal to the left subclavian artery).On each level,the maximal and the minimal diameters were measured both in systolic and diastolic periods.Results The paired sample t test results showed a significant difference between the systolic and diastolic diameters in all individual subjects on every level (P ＜0.001).The mean maximum diameter changes were 1.95％ (range-2.0％ to 7.0％),2.12％ (range-3.0％ to 6.0％),1.88％(range-1.0％ to 8.0％)and2.47％(range-3.0％ to 10.0％)at level A,B,C and D,respectively.The mean minimum diameter changes were 1.43％ (range-3.0％ to 5.0％),2.67％ (range-2.0％ to 11.0％),1.75％ (range-14.0％ to 9.0％)and 2.99％ (range -2.0％ to 11.0％) at level A,B,C and D,respectively.Conclusions The differences of the aortic diameters between systolic and diastolic periods are significant.The pulsatility of aorta in Chinese population may be different from published Western literature.

Objective To probe the influence of electron beam radiotherapy in different manners using different tissue equivalent boluses on skin and lung.Methods Adult female cavia cobayas were randomly divided into four groups as control group,fuU-time with bolus group,half-time with bolus group and without bolus group.Acute-irradiation animal models were established using electron beam in different manners with or without 0.5 cm tissue equivalent bolus.Pathological changes in lung,hair vesicle and fibroblast cell count were analyzed 40 clays after irradiation.Results The radiation dermatitis in the group with bolus was slighter than that of the group without bolus,but the radiation pneumonia was reverse.With bolus,the radiation dermatitis of haft-time group was slighter than that of full-time group.The injury repair of half-time group was more active than full-time group.Conclusions The treatment of haft-time bolus could protect lung without serious skin complications.

The deubiquitinating enzyme ubiquitin specific peptidase 15 (USP15) is regarded as a regulator of TGFβ signaling pathway. This process depends on Smad7, the inhibitory factor of the TGFβ signal, and type I TGFβ receptor (TβR-I), one of the receptors of TGFβ. The expression level of USP15 seems to play vital roles in the pathogenesis of many neoplasms, but so far there has been no report about USP15 in psoriasis. In this study, immunohistochemical staining of USP15, TβR-I and Smad7 was performed in 30 paraffin-embedded psoriasis specimens and 10 normal specimens to investigate the expression of USP15, TβR-I and Smad7 in psoriasis and to explore the relevance among them. And USP15 small interfering RNA (USP15 siRNA) was used to transfect Hacat cells to detect the mRNA expression of TβR-I and Smad7. Of 30 cases of psoriasis in active stage, 28, 24 and 26 cases were positive for USP15, TβR-I and Smad7 staining, respectively. The positive rates of USP15 and Smad7 were significantly higher in psoriasis specimens than in normal skin specimens (44.1%±26.0% vs. 6.1%±6.6%, 47.2%±27.1% vs. 6.6%±7.1%), and positive rate of TβR-I (20.3%±22.2%) in psoriasis was lower than that in normal skin specimens (46.7%±18.2%). There was a significant positive correlation between USP15 and Smad7 expression, and significant negative correlations between USP15 and TβR-expression, an I d between TβR- and Smad7 expression I in psoriasis. After transfection of USP15 siRNA in Hacat cells, the expression of TβR-mRNA was up I -regulated and that of Smad7 was down-regulated. It is concluded that USP15 may play a role in the pathogenesis of psoriasis through regulating the TβR-I/Smad7 pathway and there may be other cell signaling pathways interacting with USP15 to take part in the development of psoriasis.

Abstract: Schistosomiasis is a serious major parasitic disease that threatens human life and health. A better understanding of the mechanism of host-schistosome interactions is the key to designing new prevention and control strategies. MicroRNAs (miRNAs) are endogenous small non-coding RNA molecules, which lead to the degradation of the target messenger RNA (mRNA) or inhibition of its translation in a sequence-specific manner. Both schistosome and its host produce miRNAs, which can be secreted by extracellular vesicles (EVs). There is accumulating evidence that miRNAs from schistosome can be taken up by host cells, and finely manipulate the phenotype of host cells for their survival or pathogenesis in a cross-species manner, even inhibiting the growth and metastases of hepatoma cells. It is still unknown whether host free miRNAs can be taken up by schistosome, but this phenomenon is highly probable. miRNA-mediated cross-species regulation has emerged as a novel mechanism for host-schistosome interactions, and this review summarizes the advances in this regard.