The emergency department triage of community-acquired pneumonia project data and documentation systems: a model for multicenter clinical trials.

Multicenter clinical trials are complex undertakings that require significant resources to ensure efficient, high quality research. This paper describes the goals, design, and implementation of a multicenter clinical trial database management system to support this aim. A large number of study sites or patients, and the goal of automatically generating large portions of data management infrastructure from common metadata, motivated the development of the system. This paper also describes extensions for a generalized project documentation system, and discusses plans for further extensions and improvements based on observed strengths, limitations, and anticipated technological change.     

A periodontal probe with automated cemento--enamel junction detection-design and clinical trials.

An automated periodontal probe has been developed to measure pocket depth and attachment loss in a single measurement under controlled force conditions. A natural anatomic landmark, the cemento-enamel junction (CEJ), is used as a reference for attachment level measurements. The CEJ is detected automatically by immediate digital postprocessing of simultaneous measurements of probe tip acceleration and displacement during probing. Clinical trials in the beagle dog model for naturally occurring periodontitis have shown that the automated probe, when used with 35 g probing force, has a repeatability of 0.16 mm and a bias of 0.09 mm. These results indicate that the automated periodontal probe is capable of attachment level measurements with a high degree of repeatability and validity.     

Information mining over heterogeneous and high-dimensional time-series data in clinical trials databases.

An effective analysis of clinical trials data involves analyzing different types of data such as heterogeneous and high dimensional time series data. The current time series analysis methods generally assume that the series at hand have sufficient length to apply statistical techniques to them. Other ideal case assumptions are that data are collected in equal length intervals, and while comparing time series, the lengths are usually expected to be equal to each other. However, these assumptions are not valid for many real data sets, especially for the clinical trials data sets. An addition, the data sources are different from each other, the data are heterogeneous, and the sensitivity of the experiments varies by the source. Approaches for mining time series data need to be revisited, keeping the wide range of requirements in mind. In this paper, we propose a novel approach for information mining that involves two major steps: applying a data mining algorithm over homogeneous subsets of data, and identifying common or distinct patterns over the information gathered in the first step. Our approach is implemented specifically for heterogeneous and high dimensional time series clinical trials data. Using this framework, we propose a new way of utilizing frequent itemset mining, as well as clustering and declustering techniques with novel distance metrics for measuring similarity between time series data. By clustering the data, we find groups of analytes (substances in blood) that are most strongly correlated. Most of these relationships already known are verified by the clinical panels, and, in addition, we identify novel groups that need further biomedical analysis. A slight modification to our algorithm results an effective declustering of high dimensional time series data, which is then used for "feature selection." Using industry-sponsored clinical trials data sets, we are able to identify a small set of analytes that effectively models the state of normal health.     

CommLog/spl copy/: A communication log system for clinical trials

Thanks to the advent of information technologies, the emergence of commercial products for electronic clinical trials has improved many aspects of conducting clinical trials. While there are many new options available to facilitate the collection of patient data, little advancements have been made in the way in which information generated from the coordination of a clinical trial is managed. The coordination of a clinical trial has proven to have a significant impact on the quality and economy of clinical trials. The Vanderbilt Coordinating Center has designed and implemented a communication log system (CommLog/spl copy/) to streamline the coordination of clinical trials in order to improve the quality and economy of clinical trials. The CommLog/spl copy/ has been operational for several industry-sponsored phase II/III clinical trails and has provided a knowledge base for the studies and repository for useful study information.     

A periodontal probe with automated cemento-enamel detection-designand clinical trials

An automated periodontal probe has been developed to measure pocket depth and attachment loss in a single measurement under controlled force conditions. A natural anatomic landmark, the cemento-enamel junction (CEJ), is used as a reference for attachment-level measurements. The CEJ is detected automatically by immediate digital postprocessing of simultaneous measurements of probe-tip acceleration and displacement during probing. Clinical trials in the beagle dog model for naturally occurring periodontitis have shown that the automated probe, when used with 35-g probing force, has a repeatability of 0.13 mm and a bias of 0.09 mm, indicating that the automated periodontal probe is capable of attachment-level measurements with a high degree of repeatability and validity     

Ⅰ期药物临床试验智能手机客户端APP的开发与应用

文章旨在使用安卓手机APP客户端完成Ⅰ期药物临床试验数据的录入和后期处理,根据需求使用SDK安卓开发工具包,基于Eclipse开发智能手机应用程序,通过实验,在智能手机客户端即能完成对Ⅰ期药物临床试验数据的管理和操作,总结出APP手机客户端方便易携、不用打开电脑即可实现各项功能的特点。     

Automatic "pipeline" analysis of 3-D MRI data for clinical trials: application to multiple sclerosis

The quantitative analysis of magnetic resonance imaging (MRI) data has become increasingly important in both research and clinical studies aiming at human brain development, function, and pathology. Inevitably, the role of quantitative image analysis in the evaluation of drug therapy will increase, driven in part by requirements imposed by regulatory agencies. However, the prohibitive length of time involved and the significant intraand inter-rater variability of the measurements obtained from manual analysis of large MRI databases represent major obstacles to the wider application of quantitative MRI analysis. We have developed a fully automatic "pipeline" image analysis framework and have successfully applied it to a number of large-scale, multicenter studies (more than 1,000 MRI scans). This pipeline system is based on robust image processing algorithms, executed in a parallel, distributed fashion. This paper describes the application of this system to the automatic quantification of multiple sclerosis lesion load in MRI, in the context of a phase III clinical trial. The pipeline results were evaluated through an extensive validation study, revealing that the obtained lesion measurements are statistically indistinguishable from those obtained by trained human observers. Given that intra- and inter-rater measurement variability is eliminated by automatic analysis, this system enhances the ability to detect small treatment effects not readily detectable through conventional analysis techniques. While useful for clinical trial analysis in multiple sclerosis, this system holds widespread potential for applications in other neurological disorders, as well as for the study of neurobiology in general.     

A novel measurement technique to assess the effects of coronary brachytherapy in clinical trials

This paper presents a novel measurement technique to assess the effects of coronary brachytherapy. This new technique is based upon the conventional quantitative coronary analysis (QCA) technique, which is accepted worldwide as an accurate and reliable analysis tool for clinical trials. This paper provides the definitions and main issues important for correct brachytherapy analysis. Based on these definitions, this novel technique is implemented as an extension of conventional QCA software, as a multisegmental analysis tool. It allows to follow the influence of radiation on restenosis, and the mutual relation between intervention devices. A pilot interobserver study was performed to assess the reliability and reproducibility of the brachytherapy analysis tool, using 15 patient cases. The validation results show that the segment lengths, minimum lumen diameter, and reference diameters of the user-defined and derived (sub)segments can be assessed reproducible. However, these good results can only be obtained, when strict and extensive image acquisition and image analysis protocols are followed. From this pilot validation study presented in this paper and only based on a small number of patients, we may conclude that the software can be applied to clinical trials.     

A semantic grid infrastructure enabling integrated access and analysis of multilevel biomedical data in support of postgenomic clinical trials on cancer.

This paper reports on original results of the Advancing Clinico-Genomic Trials on Cancer integrated project focusing on the design and development of a European biomedical grid infrastructure in support of multicentric, postgenomic clinical trials (CTs) on cancer. Postgenomic CTs use multilevel clinical and genomic data and advanced computational analysis and visualization tools to test hypothesis in trying to identify the molecular reasons for a disease and the stratification of patients in terms of treatment. This paper provides a presentation of the needs of users involved in postgenomic CTs, and presents such needs in the form of scenarios, which drive the requirements engineering phase of the project. Subsequently, the initial architecture specified by the project is presented, and its services are classified and discussed. A key set of such services are those used for wrapping heterogeneous clinical trial management systems and other public biological databases. Also, the main technological challenge, i.e. the design and development of semantically rich grid services is discussed. In achieving such an objective, extensive use of ontologies and metadata are required. The Master Ontology on Cancer, developed by the project, is presented, and our approach to develop the required metadata registries, which provide semantically rich information about available data and computational services, is provided. Finally, a short discussion of the work lying ahead is included.     

Field trials for fiber access in the EC

The European Economic Community's (EC) RACE program (Research and Development in Advanced Communications Technologies in Europe) started with a definition phase in 1986. The main effort of the first phase was aimed at customer access connections (CACs) and customer premises networks (CPNs), as well as identification of services that will use these high-speed networks. In the second phase, which began in 1992, RACE projects are focused on managing the high data rates generated by these networks and the need for high-capacity transport networks. The greater functionality required and the large number of multiuser applications operating simultaneously within and between organizations generates data rates, both intra- and intersite, on the order of tens of Gb/s. Such high data rates will spur the market for gigabit networks. At the start of the RACE program, some projects were devoted to integrating interactive and distributive services into one ATM-based electrical user network interface. The main motivation was the use of the same fiber for different services to the subscriber. The RACE projects demonstrate fiber-based broadband infrastructures for local access     

Versatile clinical information system design for emergency departments.

Compared to other hospital units, the emergency department presents some distinguishing characteristics of its own. Emergency health-care delivery is a collaborative process involving the contribution of several individuals who accomplish their tasks while working autonomously under pressure and sometimes with limited resources. Effective computerization of the emergency department information system presents a real challenge due to the complexity of the scenario. Current computerized support suffers from several problems, including inadequate data models, clumsy user interfaces, and poor integration with other clinical information systems. To tackle such complexity, we propose an approach combining three points of view, namely the transactions (in and out of the department), the (mono and multi) user interfaces and data management. Unlike current systems, we pay particular attention to the user-friendliness and versatility of our system. This means that intuitive user interfaces have been conceived and specific software modeling methodologies have been applied to provide our system with the flexibility and adaptability necessary for the individual and group coordinated tasks. Our approach has been implemented by prototyping a web-based, multiplatform, multiuser, and versatile clinical information system built upon multitier software architecture, using the Java programming language.     

Online classification of single EEG trials during finger movements.

Many offline studies have explored the feasibility of EEG potentials related to single limb movements for a brain-computer interface (BCI) control signal. However, only few functional online single-trial BCI systems have been reported. We investigated whether inexperienced subjects could control a BCI accurately by means of visually-cued left versus right index finger movements, performed every 2 s, after only a 20-min training period. Ten subjects tried to move a circle from the center to a target location at the left or right side of the computer screen by moving their left or right index finger. The classifier was updated after each trial using the correct class labels, enabling up-to-date feedback to the subjects throughout the training. Therefore, a separate data collection session for optimizing the classification algorithm was not needed. When the performance of the BCI was tested, the classifier was not updated. Seven of the ten subjects were able to control the BCI well. They could choose the correct target in 84%-100% of the cases, 3.5-7.7 times a minute. Their mean single trial classification rate was 80% and bit rate 10 bits/min. These results encourage the development of BCIs for paralyzed persons based on detection of single-trial movement attempts.     

AMUSE: advanced broadband services trials for residential users

The AMUSE project in the framework of the ACTS program sponsored by the European Union, has answered various questions related to the implementation and provisioning of new multimedia services. The means to pursue such objectives has been the setup and operation of small-scale trials in various European countries, involving real residential users. The article first presents the project as a whole. Then the focus is moved to evaluation of the different technologies experimented with in the field. AMUSE services have been supplied in the context of trial islands characterized by different access network typologies. Validation of the different access technologies and results coming from their installation, integration, and operation have represented a major objective of the project. Although it is very difficult to highlight particular outcomes from the technical experiments, with so many technologies put in place, some general indications emerging from the deployment of some of these technologies are supplied. Emphasis is then put on the facts and findings resulting from the activities performed in the Italian trial island, where interactive services, including fast Internet access from PCs or STBs, Internet TV style, and switched video broadcasting services have been offered. The article concludes with a summary of the major lessons learned from the trials and the identification of a number of key factors of success for interactive multimedia     

Enhancing IHE XDS for federated clinical affinity domain support.

One of the key problems in healthcare informatics is the inability to share patient records across enterprises. To address this problem, an important industry initiative called "integrating the healthcare enterprise (IHE)" specified the "cross enterprise document sharing (XDS)" profile. In the IHE XDS, healthcare enterprises that agree to work together form a "clinical affinity domain" and store healthcare documents in an ebXML registry/repository architecture to facilitate their sharing. The affinity domains also agree on a common set of policies such as coding lists to be used to annotate clinical documents in the registry/repository and the common schemes for patient identification. However, since patients expect their records to follow them as they move from one clinical affinity domain to another, there is a need for affinity domains to be federated to enable information exchange. In this paper, we describe how IHE XDS can be enhanced to support federated clinical affinity domains. We demonstrate that federation of affinity domains are facilitated when ontologies, rather than coding term lists, are used to annotate clinical documents. Furthermore, we describe a patient identification protocol that eliminates the need to keep a master patient index file for the federation.     

走过历练--访中科网威信息技术有限公司

中科网威信息技术有限公司,一家专业并且 资深的信息安全企业,虽然自成立以来在业内已 经具有相当的影响力,但是因为公司宣传一直保 持着低调,所以外界一直都对它存有一种好奇。 当记者有幸走进这家企业时,由衷地感觉到 它那种无形的震撼力--无需也难以用言语表达, 却处处存在。     

Minimum ON requirements for DRM reception based on field trials

This paper presents field measurements results of minimum signal to noise ratio required to achieve a threshold BER based on the first medium wave Digital Radio Mondiale (DRM) measurement campaign in Spain. The main goal of these measurements has been to compare the laboratory simulated values recommended by the ITU with field measurements using real transmission and reception systems and real propagation and reception environments.     

Tailored reversible watermarking schemes for authentication of electronic clinical atlas.

It is accepted that digital watermarking is quite relevant in medical imaging. However, due to the special nature of clinical practice, it is often required that watermarking not introduce irreversible distortions to medical images. The electronic clinical atlas has such a need of "lossless" watermarking. We present two tailored reversible watermarking schemes for the clinical atlas by exploiting its inherent characteristics. We have implemented the schemes and our experimental results look very promising.     

Confident interpretation of Bayesian decision tree ensembles for clinical applications.

Bayesian averaging (BA) over ensembles of decision models allows evaluation of the uncertainty of decisions that is of crucial importance for safety-critical applications such as medical diagnostics. The interpretability of the ensemble can also give useful information for experts responsible for making reliable decisions. For this reason, decision trees (DTs) are attractive decision models for experts. However, BA over such models makes an ensemble of DTs uninterpretable. In this paper, we present a new approach to probabilistic interpretation of Bayesian DT ensembles. This approach is based on the quantitative evaluation of uncertainty of the DTs, and allows experts to find a DT that provides a high predictive accuracy and confident outcomes. To make the BA over DTs feasible in our experiments, we use a Markov Chain Monte Carlo technique with a reversible jump extension. The results obtained from clinical data show that in terms of predictive accuracy, the proposed method outperforms the maximum a posteriori (MAP) method that has been suggested for interpretation of DT ensembles.     

Meteor burst polarisation trials

Measurements over an 850 km path show that radio waves reflected by ionised meteor trails are typically received with the same polarisation as they were transmitted. Furthermore, a vertically polarised wave seems to suffer a 3?4 dB larger loss than a horizontally polarised one.