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

Cochlear Implantation ; Cochlear Implants ; Humans

Objective To assess the efficacy and safety of ketogenic diet(KD) on refractory epilepsy in children.Methods KD treatment was designed to observe the effects for 12 weeks.Totally 22 children with 16 boys and 6 girls were enrolled in the study.The epileptic syndromes included infantile spasms(13 cases),Lennox-Gastaut syndrome(4 cases),Dravet syndrome(2 cases),and the unclassified(3 cases).The KD was prepared according to the modified Johns Hopkins regimen.Urinary ketones were measured every day to ensure that ketosis state and parents′ diaries were kept to find out when it started to work and the change of seizure frequency.Effects of KD was evaluated by Engel standard.Blood chemistry was done at baseline,4 weeks and 12 weeks to analyze the effects of KD on metabolism.Side effects were monitored and treated.Results All cases completed the KD regimen for at least 2 weeks,19 cases for at least 4 weeks,and 10 cases for at least 12 weeks.Sixteen out of 22 children experienced the seizure reduction within 3 weeks(1-15 d),especially in the first week,and seizure free appeared within 5 weeks(1-32 d) in 8 cases.Overall,the diet achieved the seizure-free in 36.4%(8/22 cases) and an over 90% of seizure frequency reduction in 22.7%(5/22 cases).The efficacy of KD seemed not correlated with the sex,age,etiopathogenisis,and syndromes and so on.Blood chemistry suggested a normal range of glucose level at 4 weeks,though higher than that at the baseline.The blood triglyceride and total cholesterol level at 12 weeks increased strikingly,even beyond the normal range compared with the baseline.The side effects mainly including transient gastrointestinal symptoms and metabolic disturbances were mostly tolerable.Conclusions KD is probably a feasible therapy on refractory epilepsy in children,with quick and high efficacy and few side effects.

OBJECTIVETo observe the inhibitory effect of gefitineb on the proliferation and its inducing effect on the apoptosis of mouse I-10 Leydig testicular cancer cells in vitro.

METHODSWe treated I-10 Leydig testicular cancer cells of mice with gefitineb at 0, 1.25, 2.5, 5, 10, 20, and 40 µmol/L. Then we determined the inhibitory effect of gefitineb on the growth of the cells by MTT, detected their early and late apoptosis by Annexin V-FITC/propidium iodide double staining and Hoechst 33258 nuclear staining, respectively, and observed the expressions of apoptosis-related proteins Bcl-2, Bax and caspase 3/9 by Western blot.

RESULTSCompared with the blank control group, gefitineb significantly inhibited the proliferation of the I-10 cells at 10 and 20 µmol/L (P < 0.05). The survival rate of the cells was (32.4 ± 2.8)% (P < 0.01) and their early and late apoptosis rates were (26.7 ± 4.2)% and (59.33 ± 10.2)% in the 40 µmol/L group, significantly different from those in the control (P < 0.05 and P <0.01). In comparison with the blank control group, gefitineb at 10, 20, and 40 µmol/L increased the expression of pro-apoptotic protein Bax by (41.9 ± 7.1), (60.1 ± 9.8), and (69.0 ± 11.3)% (all P < 0.05), decreased that of apoptosis-inhibitory protein Bcl-2 by (50.3 ± 8.9), (63.9 ± 6.9), and (88.7 ± 13.9)% (all P < 0.05), and elevated that of the cleft proteins caspase-3 by (69.0 ± 6.9)% (P < 0.05), (71.5 ± 8.1)% (P < 0.05), and (110.9 ± 14.2)% (P < 0.01) and caspase-9 by (51.8 ± 4.9), (54.7 ± 6.7), and (43.8 ± 11.8)% (all P < 0.05).

CONCLUSIONGefitineb can increase the cytotoxicity of I-10 Leydig testicular cancer cells of mice and induce their apoptosis via the mitochondria-mediated apoptosis signaling pathway.

Animals ; Antineoplastic Agents ; pharmacology ; Apoptosis ; drug effects ; Apoptosis Regulatory Proteins ; metabolism ; Caspase 3 ; metabolism ; Caspase 9 ; metabolism ; Cell Proliferation ; drug effects ; Cell Survival ; Leydig Cell Tumor ; drug therapy ; metabolism ; pathology ; Male ; Mice ; Neoplasm Proteins ; metabolism ; Neoplasms, Germ Cell and Embryonal ; drug therapy ; metabolism ; pathology ; Quinazolines ; pharmacology ; Testicular Neoplasms ; drug therapy ; metabolism ; pathology ; bcl-2-Associated X Protein ; metabolism

BACKGROUND: Induced pluripotent stem cells (iPSCs) are a special type of cells with self-renewal and multi-differentiation potential, which can differentiate into intestinal organoids under certain conditions. OBJECTIVE: To explore whether iPSCs can differentiate into intestinal organoids under specific conditions in vitro.METHODS: iPSCs from B6J mice were recovered and cultured for 3 days until clone units covered about 80％ of the culture dish, and then the cells were cultured in the medium containing Activin A for 3 days until the deterministic endoderm formed. Further, the culture medium was replaced by the medium with fibroblast growth factor 4 and Wnt3A for 4 days to differentiate into the spheroids with CDX2+. After that, spheroids were collected and mixed with Matrigel,and then the mixture was dropped into the 4-well plate and cultured with Rspondin1, Noggin, epidermal growth factor, B27 and other growth factors to differentiate into intestinal organoids. Cell morphology was observed, FoxA2 and Sox17 expresson in the deterministic endoderm was detected, and CDX2, Sox9, CGA, MMP7 were measured.RESULTS AND CONCLUSION: iPSCs were cultured with Activin A for 3 days with higher cell fusion, initial differentiation and FoxA2/Sox17 expression (P < 0.05) than those of non-induced iPSCs. Spheroids began to appear at the 3rd day after culture with fibroblast growth factor 4 and WNT3A, and formed a lot at the 4th day. And CDX2 expression in spheroids was significantly increased compared with that in the deterministic endoderm (P < 0.05). Organoids gradually formed after 3 days culture, which contained all cell types of intestinal organoids, and expressions of specific markers, Sox9, CGA, MMP7, were significantly higher than those in spheroids (P < 0.05). To conclude, iPSCs can be induced to differentiate into intestinal organoids in three-dimensional niche in vitro.

Objective To observe the changes of immunological parameters and the effects of intravenous immunoglobulin (IVIG) in children with idiopathic thrombocytopenic purpura (ITP),schonlein-Henoch purpura(HSP) and mucocutaneoas lymph node syn-drome(kawasaki disease, KD).Methods T cell subsets and serum immunoglobulins and complements were measured with the flow cytometry and enhanced trubidimetric immunoassay. Routine therapy combined with IVIG. Results CD3+ CD4+ T cells were de-creased in children with ITP accompanied by increased serum IgG;Serum IgA and CD3+ T cells were increased in children with HSP; CD3+ CD8+ T cells were decreased in children with KD. Clinical features were markedly improved after treatment with IVIG. It was noted that the incidence of damage to coronary artery decreased after the use of IVIG. Conclusions T cell subsets, serum immunoglobulins should undergo the clinical routine examinations in ITP,HSP and KD. Early administration of IVIG might be important to improve disease prognosis and shorten its course of treatment in children with three kinds of immunology related diseases.

AlM:To observe the relationship between axial length and complications of phacoemulsification with intraocular lens ( lOL) implantation in high axial myopia eyes and normal axis eyes.
METHODS: A retrospective review of 843 consecutive patients ( 1 042 eyes ) of cataract extraction with phacoemulsification and lOL implantation in our hospital from February 2012 to February 2013 was performed. The patients were divided into two groups according to the axial length: 853 eyes were in normal axis group ( 21-24mm) and 189 eyes were in high axial myopia group (≥26mm). The two groups were compared regarding surgical complications, such as vitreous loss, posterior capsular rupture, nucleolus drop, and abnormal location of lOL.
RESULTS:Age was a risk factor in both groups. There was positive correlation between age and surgical complications, and between axial length and surgical complications, especially for complications with posterior capsular rupture and vitreous loss.
CONCLUSlON:As the results illustrate, in this survey, age and high axial lengthare statistically significant risk factors for incidence of complications of phacoemulsification. Anticipation of these complications and also preparation and prophylactic measures may decrease incidence of these complications.

The event-related potential (ERP) is considered as one of the most effective methods to study and analyze objectively human mental activity based on nerve electrophysiology. At present, ERP is not only used in the study of lie detection, but also in the clinical medicine for the cognitive assessment on patients with cerebrovascular disease, dementia or traumatic brain injury and auxiliary diagnosis of mental illness. With the further development of ERP detection technology, it would have a wider application prospect in the field of forensic medicine.
Evoked Potentials/physiology* ; Forensic Medicine/trends* ; Humans

Aim The effects of midazolam on the whole-cell sodium currents in rat sympathetic neurons were studied to explore the mechanisms where by midazolam mediates hypotension. Methods Whole-cell patch-clamp recordings were performed on enzymatically isolated rat superior cervical sympathetic neurons. Results Midazolam dose-dependently blocked the whole-cell sodium currents evoked by a voltage step to 0 mV from a holding potential of -80 mV with a mean drug concentration required to produce 50% current inhibition (IC50) values of 18.35 ?mol?L-1; Clinically relevant concentration of midazolam(0.3 ?mol?L-1) reduced sodium peak currents by 19.98%(P