Pediatric Trials Run in India: An Analysis of Clinical Trials.gov 2006-2015.

OBJECTIVE: To present a snapshot of 10 y of pediatric research, with a focus on trials with at least one enrolling site in India. METHODS: The study included all interventional trials registered at ClinicalTrials.gov from January 2006 through December 2015, enrolling patients aged 0 to 18 y. The database for Aggregate Analysis of ClinicalTrials.gov (AACT) was the data source used. RESULTS: Nine thousand, six hundred forty-eight pediatric clinical studies were identified. Of these, 193 had at least one enrolling site in India. The primary purpose for most of these trials was treatment (n = 92) and prevention (n = 65) coupled with an efficacy and/or safety endpoint (n = 158). Infant and toddlers were eligible for enrollment in the majority of trials (97%) while neonates only in 22% of trials. The rate of early termination or withdrawal was 5%. The most commonly studied conditions were bacterial infections, viruses, digestive and mental diseases. Overall, communicable diseases (n = 75) and major non-communicable diseases (n = 72) were equally investigated. CONCLUSIONS: The most commonly studied therapeutic areas in trials enrolling from India and registered in ClinicalTrials.gov were appropriate for India public health needs and patients were not enrolled into studies inappropriately from this perspective.

A history of pharmacoepidemiology.

Pharmacoepidemiology, in the sense of the study of the reciprocal interactions between drugs and populations, was probably conceived far before being named so. However, the modern era started in 1985 with the birth of the International society of pharmacoepidemiology and the development of specific methodological approaches and large databases. This advent of pharmacoepidemiology resulted from a long period where the actual target of medicines, i.e., patients in real-life settings, was not considered, the truth being provided solely by pre-approval or peri-approval clinical trials. The methodological advances made during the last three decades are unprecedented. The challenge is now to avoid focusing excessively on the method to the detriment of pharmacological and public health objectives.

Current status of cardiovascular surgery in Japan, 2013 and 2014: A report based on the Japan Cardiovascular Surgery Database (JCVSD). 1: Mission and history of JCVSD.

The Japan Cardiovascular Surgery Database (JCVSD) was created in 2000 with the support of the Society of Thoracic Surgeons (STS). The STS database content was translated to Japanese using the same disease criteria and in 2001, data entry for adult cardiac surgeries was initiated online using the University Hospital Medical Information Network (UMIN). In 2008, data entry for congenital heart surgeries was initiated in the congenital section of JCVSD and preoperative expected mortality (JapanSCORE) in adult cardiovascular surgeries was first calculated using the risk model of JCVSD. The Japan Surgical Board system merged with JCVSD in 2011, and all cardiovascular surgical data were registered in the JCVSD from 2012 onward. The reports resulting from the data analyses of the JCVSD will encourage further improvements in the quality of cardiovascular surgeries, patient safety, and medical care in Japan.

Including historical data in the analysis of clinical trials: Is it worth the effort?

Data of previous trials with a similar setting are often available in the analysis of clinical trials. Several Bayesian methods have been proposed for including historical data as prior information in the analysis of the current trial, such as the (modified) power prior, the (robust) meta-analytic-predictive prior, the commensurate prior and methods proposed by Pocock and Murray et al. We compared these methods and illustrated their use in a practical setting, including an assessment of the comparability of the current and the historical data. The motivating data set consists of randomised controlled trials for acute myeloid leukaemia. A simulation study was used to compare the methods in terms of bias, precision, power and type I error rate. Methods that estimate parameters for the between-trial heterogeneity generally offer the best trade-off of power, precision and type I error, with the meta-analytic-predictive prior being the most promising method. The results show that it can be feasible to include historical data in the analysis of clinical trials, if an appropriate method is used to estimate the heterogeneity between trials, and the historical data satisfy criteria for comparability.

From ecological records to big data: the invention of global biodiversity.

This paper is a critical assessment of the epistemological impact of the systematic quantification of nature with the accumulation of big datasets on the practice and orientation of ecological science. We examine the contents of big databases and argue that it is not just accumulated information; records are translated into digital data in a process that changes their meanings. In order to better understand what is at stake in the 'datafication' process, we explore the context for the emergence and quantification of biodiversity in the 1980s, along with the concept of the global environment. In tracing the origin and development of the global biodiversity information facility (GBIF) we describe big data biodiversity projects as a techno-political construction dedicated to monitoring a new object: the global diversity. We argue that, biodiversity big data became a powerful driver behind the invention of the concept of the global environment, and a way to embed ecological science in the political agenda.

Progress in Biomedical Knowledge Discovery: A 25-year Retrospective.

OBJECTIVES: We sought to explore, via a systematic review of the literature, the state of the art of knowledge discovery in biomedical databases as it existed in 1992, and then now, 25 years later, mainly focused on supervised learning. METHODS: We performed a rigorous systematic search of PubMed and latent Dirichlet allocation to identify themes in the literature and trends in the science of knowledge discovery in and between time periods and compare these trends. We restricted the result set using a bracket of five years previous, such that the 1992 result set was restricted to articles published between 1987 and 1992, and the 2015 set between 2011 and 2015. This was to reflect the current literature available at the time to researchers and others at the target dates of 1992 and 2015. The search term was framed as: Knowledge Discovery OR Data Mining OR Pattern Discovery OR Pattern Recognition, Automated. RESULTS: A total 538 and 18,172 documents were retrieved for 1992 and 2015, respectively. The number and type of data sources increased dramatically over the observation period, primarily due to the advent of electronic clinical systems. The period 1992- 2015 saw the emergence of new areas of research in knowledge discovery, and the refinement and application of machine learning approaches that were nascent or unknown in 1992. CONCLUSIONS: Over the 25 years of the observation period, we identified numerous developments that impacted the science of knowledge discovery, including the availability of new forms of data, new machine learning algorithms, and new application domains. Through a bibliometric analysis we examine the striking changes in the availability of highly heterogeneous data resources, the evolution of new algorithmic approaches to knowledge discovery, and we consider from legal, social, and political perspectives possible explanations of the growth of the field. Finally, we reflect on the achievements of the past 25 years to consider what the next 25 years will bring with regard to the availability of even more complex data and to the methods that could be, and are being now developed for the discovery of new knowledge in biomedical data.

[Rules of acupoints combination of ancient acupuncture for Xiaoke based on data mining technology].

The rules of acupoints combination of ancient acupuncture for Xiaoke are mainly explored. By retrieval on ancient literature, the database of acupuncture and moxibustion for Xiaoke is established; based on the database, association analysis between acupoints and symptoms is performed. According to the association analysis in 5 databases of Xiaoke database, Xiaoke database of kidney deficiency, Xiaoke-database of dry mnouth and thirst, Xiaoke database of difficult urination, Xiaoke database of drinking addiction, the results are mainly characterized with symptom differentiation combination, distal-local combination, local combination and front-back combination, which can nourish yin and clear heat. It is believed that establishment of TCM ancient literature database and exploration of data mining technology is a potential research orientation.

Microscopic Image Photography Techniques of the Past, Present, and Future.

CONTEXT: The field of pathology is driven by microscopic images. Educational activities for trainees and practicing pathologists alike are conducted through exposure to images of a variety of pathologic entities in textbooks, publications, online tutorials, national and international conferences, and interdepartmental conferences. During the past century and a half, photographic technology has progressed from primitive and bulky, glass-lantern projector slides to static and/or whole slide digital-image formats that can now be transferred around the world in a matter of moments via the Internet. OBJECTIVE: To provide a historic and technologic overview of the evolution of microscopic-image photographic tools and techniques. DATA SOURCES: Primary historic methods of microscopic image capture were delineated through interviews conducted with senior staff members in the Emory University Department of Pathology. Searches for the historic image-capturing methods were conducted using the Google search engine. Google Scholar and PubMed databases were used to research methods of digital photography, whole slide scanning, and smart phone cameras for microscopic image capture in a pathology practice setting. CONCLUSIONS: Although film-based cameras dominated for much of the time, the rise of digital cameras outside of pathology generated a shift toward digital-image capturing methods, including mounted digital cameras and whole slide digital-slide scanning. Digital image capture techniques have ushered in new applications for slide sharing and second-opinion consultations of unusual or difficult cases in pathology. With their recent surge in popularity, we suspect that smart phone cameras are poised to become a widespread, cost-effective method for pathology image acquisition.

[National Cancer Registry. Significance of a reliable database in the implementation of the required structural changes of cancer care in Hungary]. / Nemzeti Rákregiszter. A hiteles adatok gyujtésének jelentosége a hazai onkológiai ellátás szükségszeru szerkezetváltásában.

The authors summarize the basic objectives and scope of the Hungarian Cancer Registry. They review more than 100-year history of the national cancer database and its effects on current cancer data collection activities, which is outstanding in Europe. The compilation deals with the development of information technology, covers points of principle and practical issues such as parallel display and evaluation of mortality and morbidity statistics and their national and international importance concerning public health. The authors underline that reliable data collection and services of the National Cancer Registry are important for the society because they are public health issues with a critical importance for a better understanding of risk factors, prevention and patient care. Restructuring and European harmonization of the Hungarian cancer system are inevitable using a reliable information exchange and service, taking into account national specificities and international requirements.

The National Library of Medicine's (NLM) Hazardous Substances Data Bank (HSDB): background, recent enhancements and future plans.

The National Library of Medicine's (NLM) Division of Specialized Information Services (SIS) Toxicology and Environmental Health Information Program is responsible for the management of the online Hazardous Substances Data Bank (HSDB). HSDB, a part of NLM's Toxicology Data Network (TOXNET(®)), is a file of chemical/substance information with one record for each specific chemical or substance, or for a category of chemicals or substances. Like the rest of TOXNET's databases and other resources, HSDB is available online at no cost to global users. HSDB has approximately 5600 chemicals and substances, with a focus on toxicology information and also on human exposure, industrial hygiene, emergency handling procedures, environmental fate, regulatory requirements, and related areas of likely interest to HSDB users. All data are from a core set of books, government documents, technical reports, selected primary journal literature, and other online sources of information, with a goal of linking the HSDB content to as much publicly available information as possible. HSDB's content is peer-reviewed by the Scientific Review Panel, a group of experts in the areas covering the scope of HSDB content. Recent enhancements include the addition of chemical structures to HSDB records, the addition of new subfields such as age groups for human data, more occupational exposure standards, and the addition of information on numerous nanomaterials. Examples of future plans include providing more exposure-related information, e.g., uses of a chemical or substance in consumer products; the addition of information summaries aimed towards consumers and other members of the public wanting to learn about a chemical or substance; more visual content such as diagrams (images) of the pathways of metabolism of a substance; and enhanced search features and navigation.