The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.
Clinical Trials as Topic ; standards ; Data Accuracy ; Reproducibility of Results

AIM: To study the effects of Sodium Hyaluronate (HA) and Bion Tears on corneal thickness in adult myopic patients.METHODS: A total of 38 cases (76 eyes) were involved in this study. Three consecutive corneal measurements (the thinnest point of the cornea,THN) were evaluated before and half an hour after the instillation of one drop of HA in one eye and Bion Tears in the other at random with the Orbscan Corneal Topography System II (Orbscan,Inc,Salt Lake City,UT,USA,Version 3.00E).RESULTS: There were no significant between-group differences in baseline variable (t=0.264). Thirty minutes after the instillation of HA and Bion tears,THN were significantly increased by 5.57±7.00μm (t=4.906,P<0.01) and 7.89±7.64μm (t=6.369,P<0.01) respectively. However,there were no between-group differences in THN changes(t=1.381,P>0.05).Increase in the corneal thickness were found in 32 eyes (84%) and 33 eyes (87%) for the HA and Bion tears group,respectively.CONCLUSION: Artificial tears including HA and Bion Tears can significantly increase the corneal thickness in a short period of time. Corneal thickness can be used as one of the objective indices for evaluating the quality and therapeutic role of artificial tears.

OBJECTIVESThe mutations of growth hormone receptor (GHR) gene results in growth hormone insensitivity (Laron syndrome) or partial growth hormone insensitivity. This study aimed to understand the relation between mutations of GHR gene and short stature with non-growth-hormone deficiency, and the clinical feature of the patients with the GHR gene mutations.

METHODS(1) Forty-seven patients with non-growth-hormone deficiency and short stature were enrolled in this study, 33 were male and 14 female. The age of the patients were at a range of 2 - 16 years. (2) The mutations of GHR gene were identified by PCR-SSCP and DNA sequencing. (3) The characteristics of the GHR mutation was assumed by screening for the same mutations in patients' family members and the control samples.

RESULTS(1) Four GHR mutations were identified in 5 patients with non-growth-hormone deficiency: H56R, G148E, IVS6-30, -31CA > TG and IVS8 + 10G > C. These mutations were located within the extracellular domain of GHR and not reported before. Five patients were the heterozygous of H56R, G148E, IVS6-30, -31CA > TG and IVS8 + 10G > C. The detection rate of mutant heterozygous individual accounted for 10.6% (5/47). The mutations were considered non-polymorphism by the GHR gene analysis in patients' family members and control samples. (2) Comparison of the amino acid sequence of different species and the position of the mutations H56R and G148E in the GHR protein structure suggested impact of the mutations on the protein function. (3) A polymorphism site was identified in exon 6 of GHR gene: G168G (GGA > GGG). The allelic frequency of G168G had no difference between the patients with non-growth-hormone deficiency and control samples but had significant difference between Chinese and Caucasian. It seems that the G168G was a polymorphism and has no relationship with the height stature. However, there was the allele diversity in different races.

CONCLUSIONThe mutations of GHR gene were detected in the patients with non-growth-hormone deficiency. Special attention should be paid clinically to its potential pathogenesis for short stature.

Adolescent ; Asian Continental Ancestry Group ; genetics ; Base Sequence ; Case-Control Studies ; Child ; Child, Preschool ; DNA Mutational Analysis ; European Continental Ancestry Group ; genetics ; Female ; Growth Disorders ; genetics ; Humans ; Male ; Molecular Sequence Data ; Mutation ; Polymorphism, Genetic ; Receptors, Somatotropin ; genetics

Objective To determine the potential sources of food safety risk and food safety related awareness of employees in the farmer markets in Yangpu District of Shanghai, and to provide evidence for food safety management. Methods The investigation on food safety and food-borne disease knowledge were conducted in 13 farmer markets in Yangpu District, and to assess the impact of employees′ behavior on food safety. Results A total of 368 employees in the 13 farmer markets were included in the study.Employees with high school education and above had better knowledge of food safety (P < 0.001).There was significant difference in the physical examination and habit of smoking in public places among the employees with different education levels.In addition, the employees in various positions in the markets differed significantly in the knowledge of food safety and behavior, such as taking physical examination, washing hands before meal and continuing working when feeling sick. Conclusion Food safety related risk in the farmer markets in Yangpu District mainly originates from the inadequate knowledge of the employees with low education levels, which further affects their behavior.Market management should strengthen the training of food safety related knowledge in the employees and advocate healthy behavior, such as taking physical examination and stop smoking, which contributes to creating a healthy work and shopping environment.

Intracranial germinomas are malignant neoplasms of gonadal origin, which have some features in terms of age, sex, and clinical manifestations. They mainly occur in children and adolescents. Patients with intracranial germinomas mainly manifest with hypothalamic pituitary axis dysfunction and/or compression syndromes. Visual disturbance is one of the most significant clinical presentations, which is mainly caused by tumor cell infiltration into the optic pathway. In this article, we present three cases of patient with intracranial germinoma to analyze the ocular manifestations. All the three patients presented with endocrine symptoms in the early stage and with visual disturbances (including decreased visual acuity and visual field defects) later. In general, germinoma is diagnosed by its characteristic radiological appearance, supported by tumor markers and/or stereotactic biopsy. However, decisive diagnoses were established when ocular manifestations were presented. A suspicion for germinoma should be considered, when young patients manifest visual disturbances accompanied by endocrine symptoms.
Adolescent ; Adult ; Brain Neoplasms ; diagnosis ; physiopathology ; Female ; Germinoma ; diagnosis ; physiopathology ; Humans ; Male ; Middle Aged ; Vision Disorders ; physiopathology ; Young Adult

Adolescent ; Adult ; Aged ; Antithyroid Agents ; therapeutic use ; Female ; Graves Disease ; blood ; drug therapy ; Humans ; Iodides ; urine ; Iodine ; administration & dosage ; Male ; Middle Aged ; Propylthiouracil ; therapeutic use ; Prospective Studies ; Sodium Chloride, Dietary ; administration & dosage ; Thyroid Hormones ; blood

Objective To learn the status of human resources of vaccination clinics in Zhejiang province and to give suggestions for optimizing the allocation.Methods Investigation and the focus group interview were conducted in Zhejiang Province to learn the configuration standards in vaccination clinics.Results The mean number who attended the immunization work every vaccination day in those clinics was five.The number of staff in each clinic differed from county to county but all reached 0.9 persons serving for 10,000 residents.There should not be less than four persons in each vaccination clinic theoretically.It should be necessary to increase one vaccination staff in every 50 injection doses of vaccine workload.Conclusion The staff of vaccination clinics is inadequate and unbalanced in Zhejiang Province.We should increase staff numbers according to workload and served population.

Objective To evaluate the correlation between lesions of dorsal artery of foot and type 2 diabetes on CDFI. Methods Dorsal artery of foot was examinated in 97 cases with type 2 diabetes and 46 cases without diabetes mellitus. Results There were variable changes in intima-media of dorsal artery of foot in type 2 diabetes patients.And the patients with hyperlipidemia and hypertension showed serious lesions in the dorsal artery of foot and bifurcation of the blood vessel .Simple arteriosclerosis showed not only lesions in intima-media of dorsal artery of foot but also relative mild lesions in bifurcation of the blood vessel. Blood vessel lesion incidence in type 2 diabetes was significantly higher than that of the control group (P<0.01). Conclusions There was a significant correlation between lesions of dorsal artery of foot and type 2 diabetes patient's condition. CDFI is an effective method in evaluating patient's condition, degree and prognosis of type 2 diabetes, and has an important clinical value in early diagnosis, prognosis and treatment.Simple arteriosclerosis showed focal lesions in bifurcation of the blood vessel while dorsal artery of foot showed relatively mild lesions .

This study was to investigate the relationship between Clostridium difficile associated diarrhea (CDAD) and intestinal microecosystem in patients received allogeneic hematopoietic stem cell transplantation (allo-HSCT) and to clarify clinical characteristics of intestinal microecosystem disorder. Clostridium difficile (CD) was isolated and identified by enzyme-linked-immunosorbent assay using clostridium difficile Premier toxins A&B Kit and anaerobic culture in 44 cases with diarrhea. Fecal flora (bifidobacteria, lactobacillus, bacteroides, peptostreptococcus, Clostridium perfringens, enterobacteriaceae, enterococcus, and yeasts) of patients were quantitatively and qualitatively analyzed by Mitsuoka's methods. The results showed that CDAD occurred after using antibiotic or chemotherapy. Clostridium difficile was detected in 12 patients with diarrhea (positive rate was 27.27%). There was marked changes of intestinal microecosystem when patients suffered from CDAD. The number of lactobacillus, bifidobacteria, bacteroides, enterobacteriaceae and so on decreased significantly. It was effective to treat CDAD with vancomycin, metronidazole and probiotic, but the recurrence rate was 16.67%. In conclusion, CDAD complicated by allo-HSCT is related to change of intestinal microecosystem. While treating CDAD with the sensitive antibiotic, the intestinal flora of patients should be supported actively. This treatment contributes to improving disease status and reducing diarrhea recurrence.
Adolescent ; Adult ; Anti-Bacterial Agents ; adverse effects ; therapeutic use ; Child ; Clostridium Infections ; microbiology ; Clostridium difficile ; growth & development ; Diarrhea ; microbiology ; Female ; Hematologic Neoplasms ; therapy ; Hematopoietic Stem Cell Transplantation ; adverse effects ; Humans ; Male ; Middle Aged ; Young Adult

In December 2019, an outbreak of viral pneumonia began in Wuhan, Hubei Province, which caused the spread of infectious pneumonia to a certain extent in China and neighboring countries and regions, and triggered the epidemic crisis. The coronavirus disease 2019(COVID-19) is an acute respiratory infectious disease listed as a B infectious disease, which is managed according to standards for A infectious disease. Traditional Chinese medicine and integrated traditional Chinese and Western medicine have played an active role in the prevention and control of this epidemic. China's ethnomedicine has recognized infectious diseases since ancient times, and formed a medical system including theory, therapies, formula and herbal medicines for such diseases. Since the outbreak of the COVID-19 epidemic, Tibet Autonomous Region, Qinghai Province, Inner Mongolia Autonomous Region, Xinjiang Uygur Autonomous Region and Chuxiong Autonomous Prefecture of Yunnan, Qiandongnan Autonomous Prefecture of Guizhou have issued the prevention and control programs for COVID-19 using Tibetan, Mongolian, Uygur, Yi and Miao medicines. These programs reflect the wisdom of ethnomedicine in preventing and treating diseases, which have successfully extracted prescriptions and preventive measures for the outbreak of the epidemic from their own medical theories and traditional experiences. In this paper, we summarized and explained the prescriptions and medicinal materials of ethnomedicine in these programs, and the origin of Tibetan medicine prescriptions and Mongolian medicine prescriptions in ancient books were studied. These become the common characteristics of medical prevention and treatment programs for ethnomedicine to formulate therapeutic programs under the guidance of traditional medicine theories, recommend prescriptions and prevention and treatment methods with characteristics of ethnomedicine, and focus on the conve-nience and standardization. However, strengthening the support of science and technology and the popularization to the public, and improving the participation of ethnomedicine in national public health services and the capacity-building to deal with sudden and critical diseases are key contents in the development of ethnomedicine in the future.
Betacoronavirus ; China ; Coronavirus Infections ; drug therapy ; Humans ; Medicine, Traditional ; Pandemics ; Pneumonia, Viral ; drug therapy ; Tibet