Nuclear Pedigree Criteria for the Identification of Individuals Suspected to Be at Risk of an Inherited Predisposition to Gastric Cancer

Gastric cancer is the second most frequently diagnosed malignancy worldwide and therefore represents a significant healthcare burden. Environmental and genetic factors are involved in the development of gastric cancer. To date only one clear genetic predisposition has been identified involving mutations in the E-cadherin gene. The disease phenotype in patients harbouring E-cadherin mutations appears to be specifically related to diffuse gastric cancer. Little is known genetically about the other forms of gastric cancer. Since there is a growing awareness about the necessity of early intervention criteria have been developed that aid the identification of hereditary forms of gastric cancer. The aim of the current study was to identify minimal inclusion criteria so that nuclear pedigree families can be provided with risk assessment and/or genetic testing.The results reveal that inclusion features described herein such as (a) gastric cancer diagnosed before 46 years of age; (b) two gastric cancers among first degree relatives diagnosed over the age of 50 are useful in identifying suspected hereditary gastric cancer patients.     

毛脉酸模药材质量标准研究

目的制定毛脉酸模药材质量标准,为该药用植物资源的开发利用提供科学依据。方法生药学研究,浸出物测定法,灰分测定法,水分测定法,薄层色谱法及HPLC色谱法。结果对毛脉酸模的性状、显微特征进行了描述;对14个不同产地毛脉酸模的浸出物、总灰分、酸不溶性灰分和水分进行了测定;同时进行了薄层定性鉴别和HPLC色谱的定量研究。结论通过研究制定了毛脉酸模的质量控制标准。     

栀芩清热软胶囊质量标准的研究

【目的】建立栀芩清热软胶囊的质量标准。【方法】采用TCL法对方中栀子、甘草、黄芩进行定性鉴别；采用HPLC法测定黄芩苷的含量。【结果】黄芩苷的线性范围为0．2675～1．07μg（R=0．9999），平均回收率为90．4％。【结论】方法可行，重复性好，可作为该产品质量控制的方法。     

基于伪F统计量的模糊聚类方法在医疗质量综合评价中的应用

目的探讨一种新的基于伪F统计量的最佳聚类分析方法,该方法不需要预先选择类的数目作为先验值.并有效地应用于医疗质量的综合评价.方法首先,应用FCM模糊聚类法(Fuzzy Clustering Method)进行聚类,然后应用PFS(Pseudo F-statistics)统计量作为一个判别函数来确定最佳类数目.结果将该方法应用于某院2002年度各科室医疗质量综合评价,得到了一种合理的综合评价结果.结论该方法基于没有聚类数据的任何先验知识和组成成分信息的前提下,考虑如何确定数据的分类结构.根据应用的情况,发现该方法是医疗质量综合评价的有力工具.     

Natural Course of Silicosis in Dust-exposed Workers

Silica-containing dust and silicosis have beenattracting more and more attention with numerousresearches worldwide[1 ,2], especially in China .However ,few studies have been conducted con-cerning the criteria of the period and content ofmedical examination of health surveillance for dust-exposed workers[3]. Since 1986 an epidemiologicalstudy onthe relation of silica dust exposure ,silico-sis and lung cancer was jointly made by TongjiMedical College , US National Cancer Institute andthe US …     

Overview Of Stability Study Designs

Stability requirements for the worldwide registration of pharmaceutical products have changed dramatically in the past few years. A series of guidelines on the design, conduct, and data analysis of stability studies of pharmaceuticals have been published by the International Conference on Harmonization (ICH); however, the statistical discussion on study design is limited. In this paper, stability designs including full, bracketing, and matrixing designs will be exemplified. The statistical aspects of these stability designs will be discussed in relation to the recent ICH guidelines. The statistical and regulatory considerations on the selection of stability design will also be presented. The stability study should be well designed so the shelf life of the drug product can be estimated with a high degree of accuracy and precision. Several commonly used criteria for design comparison will be presented. Finally, a case study is presented to illustrate the potential problems of an overreduced design from the statistical and regulatory perspectives.

     

A new concept for the non-invasive treatment of Adolescent Idiopathic Scoliosis: The Corrective Movement© principle integrated in the SpineCor System

Purpose. To evaluate the change in spinal curvature and posture of Idiopathic Scoliosis patients when a curve specific ‘Corrective Movement^© Principle’ (CMP) is applied.

Methods. This prospective interventional study was carried out on a group of 639 patients (92.3% females) having idiopathic scoliosis treated with the SpineCor brace. All girls were premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness followed the SRS outcome criteria for bracing. The clinical, radiological and postural evaluations assisted to define the patient classification, which guided the unique application of the CMP to each type of curvature.

Results. A total of 583 patients met the outcome criteria. Overall, 349 patients have a definitive outcome. Successful treatment was achieved in 259 (74.2%) of the 349 patients from the fitting to the weaning of the brace. Some 51 immature patients (14.6%) required surgical fusion while receiving treatment. Eight mature patients out of 298 (2.7%) required surgery within 2 years of follow-up beyond skeletal maturity.

Conclusion. The SpineCor brace is effective for the treatment of adolescent idiopathic scoliosis. Moreover, positive outcomes are maintained after 2 years because 151 (93.2%) of 162 patients stabilized or corrected their end of bracing Cobb angle up to 2 years after bracing.     

Processus,procédures et critères d’évaluation conduisant à la mise sur la liste d’aptitude aux fonctions de Maître de conférences des universités – praticien hospitalier (MCU-PH) et de professeur des universités – praticien hospitalier (PU-PH) en anesthésie-réanimation

Since several decades, anesthesia care and intensive care, as well, are engaged in the way of excellence in clinical care and research. This requirement is also applied for the selection of professor and academic workers. The goals of this article are twice: first to diffuse this knowledge at the medical community and second to describe in details the long process leading to the final appointment.     

Towards clinical data-driven eligibility criteria optimization for interventional COVID-19 clinical trials

ObjectiveThis research aims to evaluate the impact of eligibility criteria on recruitment and observable clinical outcomes of COVID-19 clinical trials using electronic health record (EHR) data.Materials and MethodsOn June 18, 2020, we identified frequently used eligibility criteria from all the interventional COVID-19 trials in ClinicalTrials.gov (n = 288), including age, pregnancy, oxygen saturation, alanine/aspartate aminotransferase, platelets, and estimated glomerular filtration rate. We applied the frequently used criteria to the EHR data of COVID-19 patients in Columbia University Irving Medical Center (CUIMC) (March 2020–June 2020) and evaluated their impact on patient accrual and the occurrence of a composite endpoint of mechanical ventilation, tracheostomy, and in-hospital death.ResultsThere were 3251 patients diagnosed with COVID-19 from the CUIMC EHR included in the analysis. The median follow-up period was 10 days (interquartile range 4–28 days). The composite events occurred in 18.1% (n = 587) of the COVID-19 cohort during the follow-up. In a hypothetical trial with common eligibility criteria, 33.6% (690/2051) were eligible among patients with evaluable data and 22.2% (153/690) had the composite event.DiscussionBy adjusting the thresholds of common eligibility criteria based on the characteristics of COVID-19 patients, we could observe more composite events from fewer patients.ConclusionsThis research demonstrated the potential of using the EHR data of COVID-19 patients to inform the selection of eligibility criteria and their thresholds, supporting data-driven optimization of participant selection towards improved statistical power of COVID-19 trials.