Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.

Aim To investigate the effect of Sonic Hedgehog on normal hearts and hypoxic-ischemic myo-cardial cells. Methods A method for left anterior de-scending artery ( LAD ) ligation was employed to con-struct the myocardial infarction model, and ultrasonic cardiogram was used for identification. Western blot and immunofluorescence staining were used to detect expressions of Shh, Ptch-1, Smo and Gli-1 in H9C2 cells and H2 O2-induced H9C2 cells, and that in 12 ca-ses of myocardial infarction tissues and 9 cases of nor-mal myocardium, respectively. Agonist and antagonist of Shh pathway were adminstered in the hypoxic-ische-mic myocardial H2 O2-induced H9C2 cell model, and once again expressions and strength of Shh, Ptch-1, Smo, Gli-1 were detected. Results Shh and Gli-1 were not expressed in normal hearts, but expressed in hearts with myocardial infarction;Ptch-1 and Smo were expressed in both normal hearts and hearts with myo-cardial infarction. Under the action of agonist, expres-sions of Shh and Gli-1 increased in the hypoxic-ische-mic H9C2 cell model. Similarly, Shh and Gli-1 were not expressed in normal H9C2 cells, but in H2 O2-in-duced H9C2 cells, and Ptch-1 and Smo were expressed in both normal H9C2 and in H2 O2-induced H9C2 cells. Conclusion Shh signaling pathway can be acti-vated in the condition of ischemia and oxidative stress, and then it promotes the repairing of myocardial cell damage.

Objective:To evaluate the diagnostic value of rifampin resistance real-time fluorescent quantitative nucleic acid amplification technology (GeneXpert) combined with T cell spot test of tuberculosis infection (T-SPOT.TB) in tuberculous meningitis (TBM).Methods:The clinical data of 70 TBM patients (TBM group) and 30 non-TBM patients (non-TBM group) in Shenyang Chest Hospital from March 2017 to December 2019 were retrospectively analyzed. All patients were detected by GeneXpert and T-SPOT.TB. The results of MGIT960 liquid culture of cerebrospinal fluid were used as the gold standard to evaluate the diagnosis of TBM by GeneXpert and T-SPOT.TB.Results:The positive rates of GeneXpert and T-SPOT.TB in parallel and in series in TBM group were significantly higher than those in non-TBM group: 27.14% (19/70) vs. 0, 72.86% (51/70) vs. 46.67% (14/30), 78.57% (55/70) vs. 46.67% (14/30) and 21.43% (15/70) vs. 0, and there were statistical differences ( P<0.01 or <0.05). The sensitivity and accuracy of two methods in parallel in TBM diagnosis were 78.57% and 71.00% respectively. The specificity and misdiagnosis rate of two methods in series in TBM diagnosis were 100.00% and 0 respectively. Conclusions:The sensitivity of GeneXpert and T-SPOT.TB in parallel is the highest in TBM diagnosis. The specificity of the two methods in series and GeneXpert alone is as high as 100.00%. The two methods can reduce the misdiagnosis rate of TBM in series and reduce the rate of missed diagnosis in parallel.

Blind review is one of the most important milestones in clinical trials, which connects data management process to statistical analysis. During blind review, data quality should be reviewed and assessed on both data management and statistical aspects. The primary work of data managers in blind review is to ensure the accuracy of data before it is handed over to biostatistics group. Database auditing, listing data reviewing and reconciliation should become a good clinical data management practice. Statisticians, on the other hand, will focus on quality findings related to protocol deviations or protocol violations. To investigate the protocol deviations and/or violations and relevant impacts on data outcomes, it is important to provide the essential basis of data quality through the blind review, and to assess the reliability of study outcomes.
Biostatistics ; Clinical Trials as Topic ; Data Accuracy ; Databases, Factual ; Reproducibility of Results

Mother-to-child transmission (MTCT)is an important way of hepatitis B virus (HBV)transmission.Blocking the HBV MTCT has a great significance for the prevention and treatment of hepatitis B.This article reviews the current blocking strategies implemented in the antepar-tum,peripartum,and postpartum stages,and summarizes the controversies existing in the blocking strategies in different stages.The significance of HBV occult infection and germ cell transmission in the HBV MTCT is analyzed.The results indicate that the current strategies for the prevention of hepatitis B MTCT need further improvement.Attentions should be focused on HBV occult infection and germ cell transmission.

Animals ; Hepatocytes ; transplantation ; Humans ; Liver Diseases ; genetics ; surgery ; therapy ; Liver Failure ; surgery

CD4 Antigens ; immunology ; Humans ; Interleukin-2 Receptor alpha Subunit ; immunology ; T-Lymphocyte Subsets ; immunology ; physiology ; T-Lymphocytes, Regulatory ; physiology

Adolescent ; Atherosclerosis ; drug therapy ; etiology ; prevention & control ; therapy ; Child ; Humans ; Hyperlipidemias ; complications ; prevention & control ; therapy ; Hypolipidemic Agents ; therapeutic use ; Life Style ; Obesity ; complications ; prevention & control ; Primary Prevention ; Risk Factors

0.05).Conclusion Intracoronary transplantation of ABMMNCs may not improve the heart function of DCM with abnormal Q wave.

To evaluate the effect of delayed treatment with monoclonal antibody to tumor necrosis factor-alpha (TNF-? MAb) on systemic hemodynamics and multiple organ dysfunction following prolonged hemorrhagic shock and resuscitation. Method: Adult male Sprague-Dawley rats were subjected to prolonged hemorrhagic shock (MAP of 4.00-4.66 kPa for 180 rain)followed by resuscitation over 50 min. The animals were treated intravenously with either TNF-? MAb (20.0 mg/kg) or the control protein(albumin,20.0 mg/kg)15 rain after the end of resuscitation(65 min after shock). Result: Compared to the albumin controls, delayed treatment with TNF-? MAh significantly reduced the total peripheral resistance index (P