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

Objective To study the mechanism of toxicity of hexane. Methods SD rats inhaled 15 g/ma n-hexane statically for 8 hours. Results The levels of GSH in whole blood of rats declined significantly (t-test,P＜0. 01). The levels of MDA in serum of rats revealed increasing trend but without statistical significance (t-test,P＞0. 05). The activities of SOD and GSH-Px in liver of rats decreased significantly (t-test,P＜0.01). Conclusion n-Hexane could induce or enhance the reaction of oxygen free radical in organism,and result in damages of lipid peroxidation,which might be one of the mechanisms of the toxicity of alkane.

Despite a combination of all available treatment, the mortality of liver failure is very high,especially in children patients. Artificial liver support methods have been tested for over 50 years. Standard techniques of blood purification like hemodialysis, adsorption, hemo or plasma filtration as well as bioreactorbased approaches using liver cells or tissues have been used. It' s believed that the damaged liver has the ability to return to normal. Artificial liver support systems are expected to be useful for temporary support of liver function. If the liver does not regenerate to normal functions, an artificial liver support system may be useful as a bridge to liver transplantation. In conclusion, artificial liver support method appears to be a reliable therapy for advanced liver diseases and has significantly decreased the mortality of liver failure. Artificial liver support system has been used in children patients as well, but it still needs more researches.

ObjectiveTo explore the effect of aerobic exercise on serum leptin,interleukin-18 (IL-18),soluble intercellular adhesion molecule-1 (sICAM-1),C reaction protein (CRP) concentration,and homeostasis model assessment insulin resistance (HOMA-IR) of patients with metabolic syndrome ( MS),and to explore its mechanism.MethodsForty sedentary patients with MS were randomly divided into exercise group and fenofibrate group.Patients in exercise group were trained at anaerobic threshold intensity (30 min/times) for 12 weeks (5 times/wk).Patients in fenofibrate group were treated with fenofibrate 200 mg every night.Serum leptin,IL-18,CRP,and sICAM-1 concentration were measured by enzyme linked immunosorbent assay (ELISA).Twenty healthy subjects were selected as the control group.ResultsSerum concentration of leptin [ ( 26.04 ± 9.07 ) ng/ml vs ( 8.32 ± 2.94 ) ng/ml,t =12.72,P ＜0.01 ],IL-18[ (308.27 ±50.39)pg/ml vs (230.60 ±29.15)pg/ml,t =6.41,P ＜0.01 ],CRP[ (2.65±0.57)ng/ml vs ( 1.26 ±0.23) ng/ml,t =9.69,P ＜0.01 ],sICAM-1 [ (331.89 ±60.08) ng/ml vs (246.43±39.32)ng/ml,t =5.98,P ＜0.01],and HOMA-IR(4.38 ±2.06 vs 2.12 ± 0.50,t =4.81,P ＜ 0.01 ) of patients with MS were significantly increased compared to the control.Serum concentration of leptin[(26.38±10.85)ng/ml vs (19.63 ±6.27)ng/ml,t =2.22,P ＜0.05],IL-18[(309.40 ±49.77)pg/ml vs (291.80 ±39.21)pg/ml,t =2.33,P ＜0.05],CRP[ (2.73 ±0.72)ng/ml vs (2.28 ±0.38)ng/ml,t =3.41,P ＜0.01 ],sICAM-1 [ (333.85 ±55.97) ng/ml vs (306.24 ±50.55) ng/ml,t =3.16,P ＜0.01],and HOMA-IR(4.53 ±2.39 vs 2.89 ±0.69,t =2.87,P ＜0.01 ) were significantly decreased after training for 12 weeks.ConclusionsAerobic exercise is one of the effective treatments of patients with MS.Its underlying mechanism may be associated with reduction of serum inflammatory adipokine concentration,and improvement of vascular endothelial function and insulin resistance.

Human cytomegalovirus (HCMV) has a higher prevalence in the population, and most normal individuals after primary infection can establish latent infections. Recent reports have suggested that cytomegalovirus infection associated with lipid metabolism, and play an important role in the pathogenesis of many diseases, such as hepatitis, atherosclerosis, isolated syndrome, metabolic syndrome, etc. This article summarized the relationship between cytomegalovirus infection and lipid metabolism, as well as its role in a variety of diseases progression.

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.

Triple-negative breast cancer (TNBC) is a special type of breast cancer, accounting for 15%-20% of all diagnosed breast cancer cases. Its estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor receptor-2 (HER-2) expression is negative, with unique biological characteristics, clinicopathological features and tumor heterogeneity. Its clinical features include high incidence of relapse, early metastasis and poor prognosis. Currently, it lacks effective treatment. This review described the clinicopathological features of TNBC, its molecular subtypes, several important pathways and targets, as well as presented the progress in clinical studies of targeted drugs in the hope of generating new ideas for the treatment of TNBC in the future.

Insulin resistance ,a key component of type 2 diabetes,is recognized as the pathological basis of the metabolic syndrome. H owever,its underlying mechanisms are still not fully understood.Recently,eleva ted levels of free fatty acids (FFA)have been observed in many insulin-resist ance states,which has gradually drawn attention.Not only do FFA interfere in se veral steps involved in glucose metabolism,but also play an important role in i nsulin signal transduction,resulting in decreased insulin-stimulated glucose t ransport. The thiazolidinediones,as insulin-sensitizing drugs,have entered th e market. A prominent effect of these agents is the lowering of circulating FFA levels and it is believed that targeting FFA metabolism may therefore offer wide r expectations in therapy for insulin resistance and type 2 diabetes.

Objective To evaluate the immunoprotective effect of Schistosoma japonicum (Chinese strain) recombinant signaling protein 14-3-3(rSj14-3-3), and to observe the synergism of rSj14-3-3 and rSjGST proteins as candidate vaccine and the effect of ??-T cells activated by Mtb against Schistosoma japonicum. Methods BALB/c mice immunized with rSj14-3-3 and rSjGST purified through SDS-PAGE, electroelution and dialysis were challenged by cercaria infection. Six weeks after challenging infection, the mice were killed and the worm and egg reduction rates were calculated. Results Worm reduction rate was found to be 32.20% in rSj14-3-3+Freund adjuvant group, 31.10% in rSj14-3-3+rSjGST+Freund adjuvant group, 27.96% in rSj14-3-3+Mtb group, 26.00% in rSj14-3-3+rSjGST+Mtb group, and 27.10 % in rSjGST+Mtb group, respectively, number of eggs in liver tissue was reduced by 50.40%, 53.30%, 51.10%, 58.60% and 51.30%, respectively. Conclusion rSj14-3-3 could induce partial immunity against Schistosoma japonicum in BALB/c mice, and might serve as a candidate vaccine; ??-T cell activated by Mtb played a role in anti-Schistosoma japonicum similar to the immune reactions induced by Freund adjuvant, but no synergistic effect combined with rSjGST was observed.