XML, Ontologies, and Their Clinical Applications.

PubMed

Yu, Chunjiang; Shen, Bairong

2016-01-01

The development of information technology has resulted in its penetration into every area of clinical research. Various clinical systems have been developed, which produce increasing volumes of clinical data. However, saving, exchanging, querying, and exploiting these data are challenging issues. The development of Extensible Markup Language (XML) has allowed the generation of flexible information formats to facilitate the electronic sharing of structured data via networks, and it has been used widely for clinical data processing. In particular, XML is very useful in the fields of data standardization, data exchange, and data integration. Moreover, ontologies have been attracting increased attention in various clinical fields in recent years. An ontology is the basic level of a knowledge representation scheme, and various ontology repositories have been developed, such as Gene Ontology and BioPortal. The creation of these standardized repositories greatly facilitates clinical research in related fields. In this chapter, we discuss the basic concepts of XML and ontologies, as well as their clinical applications.

[Latest development in mass spectrometry for clinical application].

PubMed

Takino, Masahiko

2013-09-01

Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has seen enormous growth in special clinical chemistry laboratories. It significantly increases the analytic potential in clinical chemistry, especially in the field of low molecular weight biomarker analysis. This review summarizes the state of the art in mass spectrometry and related techniques for clinical application with a main focus on recent developments in LC-MS. Current trends in ionization techniques, automated online sample preparation techniques coupled with LC-MS, and ion mobility spectrometry are discussed. Emerging mass spectrometric approaches complementary to LC-MS are discussed as well.

Clinical Application Projects (CAPs) for Health Science Students in Introductory Microbiology.

ERIC Educational Resources Information Center

Halyard, Rebecca A.

Clinical Application Projects (CAPs) have been developed that allow dental hygiene and nursing students to apply introductory microbiology principles and skills learned in lecture and laboratory to a problem in an appropriate clinical situation. CAPs therefore substitute for the traditional study of "unknowns". Principles and processes emphasized…

Spinal cord injury: promising interventions and realistic goals.

PubMed

McDonald, John W; Becker, Daniel

2003-10-01

Long regarded as impossible, spinal cord repair is approaching the realm of reality as efforts to bridge the gap between bench and bedside point to novel approaches to treatment. It is important to recognize that the research playing field is rapidly changing and that new mechanisms of resource development are required to effectively make the transition from basic science discoveries to effective clinical treatments. This article reviews recent laboratory studies and phase 1 clinical trials in neural and nonneural cell transplantation, stressing that the transition from basic science to clinical applications requires a parallel rather than serial approach, with continuous, two-way feedback to most efficiently translate basic science findings, through evaluation and optimization, to clinical treatments. An example of mobilizing endogenous stem cells for repair is reviewed, with emphasis on the rapid application of basic science to clinical therapy. Successful and efficient transition from basic science to clinical applications requires (1) a parallel rather than a serial approach; (2) development of centers that integrate three spheres of science, translational, transitional, and clinical trials; and (3) development of novel resources to fund the most critically limited step of transitional to clinical trials.

Clinical Application of Ambient Ionization Mass Spectrometry

PubMed Central

Li, Li-Hua; Hsieh, Hua-Yi; Hsu, Cheng-Chih

2017-01-01

Ambient ionization allows mass spectrometry analysis directly on the sample surface under atmospheric pressure with almost zero sample pretreatment. Since the development of desorption electrospray ionization (DESI) in 2004, many other ambient ionization techniques were developed. Due to their simplicity and low operation cost, rapid and on-site clinical mass spectrometry analysis becomes real. In this review, we will highlight some of the most widely used ambient ionization mass spectrometry approaches and their applications in clinical study. PMID:28337399

Calculating Clinically Significant Change: Applications of the Clinical Global Impressions (CGI) Scale to Evaluate Client Outcomes in Private Practice

ERIC Educational Resources Information Center

Kelly, Peter James

2010-01-01

The Clinical Global Impressions (CGI) scale is a therapist-rated measure of client outcome that has been widely used within the research literature. The current study aimed to develop reliable and clinically significant change indices for the CGI, and to demonstrate its application in private psychological practice. Following the guidelines…

KAT: A Flexible XML-based Knowledge Authoring Environment

PubMed Central

Hulse, Nathan C.; Rocha, Roberto A.; Del Fiol, Guilherme; Bradshaw, Richard L.; Hanna, Timothy P.; Roemer, Lorrie K.

2005-01-01

As part of an enterprise effort to develop new clinical information systems at Intermountain Health Care, the authors have built a knowledge authoring tool that facilitates the development and refinement of medical knowledge content. At present, users of the application can compose order sets and an assortment of other structured clinical knowledge documents based on XML schemas. The flexible nature of the application allows the immediate authoring of new types of documents once an appropriate XML schema and accompanying Web form have been developed and stored in a shared repository. The need for a knowledge acquisition tool stems largely from the desire for medical practitioners to be able to write their own content for use within clinical applications. We hypothesize that medical knowledge content for clinical use can be successfully created and maintained through XML-based document frameworks containing structured and coded knowledge. PMID:15802477

Distributed user interfaces for clinical ubiquitous computing applications.

PubMed

Bång, Magnus; Larsson, Anders; Berglund, Erik; Eriksson, Henrik

2005-08-01

Ubiquitous computing with multiple interaction devices requires new interface models that support user-specific modifications to applications and facilitate the fast development of active workspaces. We have developed NOSTOS, a computer-augmented work environment for clinical personnel to explore new user interface paradigms for ubiquitous computing. NOSTOS uses several devices such as digital pens, an active desk, and walk-up displays that allow the system to track documents and activities in the workplace. We present the distributed user interface (DUI) model that allows standalone applications to distribute their user interface components to several devices dynamically at run-time. This mechanism permit clinicians to develop their own user interfaces and forms to clinical information systems to match their specific needs. We discuss the underlying technical concepts of DUIs and show how service discovery, component distribution, events and layout management are dealt with in the NOSTOS system. Our results suggest that DUIs--and similar network-based user interfaces--will be a prerequisite of future mobile user interfaces and essential to develop clinical multi-device environments.

Current advances in research and clinical applications of PLGA-based nanotechnology

PubMed Central

Lü, Jian-Ming; Wang, Xinwen; Marin-Muller, Christian; Wang, Hao; Lin, Peter H; Yao, Qizhi; Chen, Changyi

2009-01-01

Co-polymer poly(lactic-co-glycolic acid) (PLGA) nanotechnology has been developed for many years and has been approved by the US FDA for the use of drug delivery, diagnostics and other applications of clinical and basic science research, including cardiovascular disease, cancer, vaccine and tissue engineering. This article presents the more recent successes of applying PLGA-based nanotechnologies and tools in these medicine-related applications. It focuses on the possible mechanisms, diagnosis and treatment effects of PLGA preparations and devices. This updated information will benefit to both new and established research scientists and clinical physicians who are interested in the development and application of PLGA nanotechnology as new therapeutic and diagnostic strategies for many diseases. PMID:19435455

Applied breath analysis: an overview of the challenges and opportunities in developing and testing sensor technology for human health monitoring in aerospace and clinical applications

PubMed Central

Hunter, Gary W; Dweik, Raed A

2010-01-01

The aerospace industry requires the development of a range of chemical sensor technologies for such applications as leak detection, emission monitoring, fuel leak detection, environmental monitoring, and fire detection. A family of chemical sensors are being developed based on micromachining and microfabrication technology to fabricate microsensors with minimal size, weight, and power consumption, and the use of nanomaterials and structures to develop sensors with improved stability combined with higher sensitivity. However, individual sensors are limited in the amount of information that they can provide in environments that contain multiple chemical species. Thus, sensor arrays are being developed to address detection needs in such multi-species environments. These technologies and technical approaches have direct relevance to breath monitoring for clinical applications. This paper gives an overview of developing cutting-edge sensor technology and possible barriers to new technology implementation. This includes lessons learned from previous microsensor development, recent work in development of a breath monitoring system, and future directions in the implementation of cutting edge sensor technology. Clinical applications and the potential impact to the biomedical field of miniaturized smart gas sensor technology are discussed. PMID:20622933

Tissue fluid pressures - From basic research tools to clinical applications

NASA Technical Reports Server (NTRS)

Hargens, Alan R.; Akeson, Wayne H.; Mubarak, Scott J.; Owen, Charles A.; Gershuni, David H.

1989-01-01

This paper describes clinical applications of two basic research tools developed and refined in the past 20 years: the wick catheter (for measuring tissue fluid pressure) and the colloid osmometer (for measuring osmotic pressure). Applications of the osmometer include estimations of the reduced osmotic pressure of sickle-cell hemoglobin with deoxygenation, and of reduced swelling pressure of human nucleus pulposus with hydration or upon action of certain enzymes. Clinical uses of the wick-catheter technique include an improvement of diagnosis and treatment of acute and chronic compartment syndromes, the elucidation of the tissue pressure thresholds for neuromuscular dysfunction, and the development of a better tourniquet for orthopedics.

The Johns Hopkins model of psychological first aid (RAPID-PFA): curriculum development and content validation.

PubMed

Everly, George S; Barnett, Daniel J; Links, Jonathan M

2012-01-01

There appears to be virtual universal endorsement of the need for and value of acute "psychological first aid" (PFA) in the wake of trauma and disasters. In this paper, we describe the development of the curriculum for The Johns Hopkins RAPID-PFA model of psychological first aid. We employed an adaptation of the basic framework for the development of a clinical science as recommended by Millon which entailed: historical review, theoretical development, and content validation. The process of content validation of the RAPID-PFA curriculum entailed the assessment of attitudes (confidence in the application of PFA interventions, preparedness in the application of PFA); knowledge related to the application of immediate mental health interventions; and behavior (the ability to recognize clinical markers in the field as assessed via a videotape recognition exercise). Results of the content validation phase suggest the six-hour RAPID-PFA curriculum, initially based upon structural modeling analysis, can improve confidence in the application of PFA interventions, preparedness in the application of PFA, knowledge related to the application of immediate mental health interventions, and the ability to recognize clinical markers in the field as assessed via a videotape recognition exercise.

[Clinical applications of molecular imaging methods for patients with ischemic stroke].

PubMed

Yamauchi, Hiroshi; Fukuyama, Hidenao

2007-02-01

Several molecular imaging methods have been developed to visualize pathophysiology of cerebral ischemia in humans in vivo. PET and SPECT with specific ligands have been mainly used as diagnostic tools for the clinical usage of molecular imaging in patients with ischemic stroke. Recently, cellular MR imaging with specific contrast agents has been developed to visualize targeted cells in human stroke patients. This article reviews the current status in the clinical applications of those molecular imaging methods for patients with ischemic stroke.

Computer algorithms and applications used to assist the evaluation and treatment of adolescent idiopathic scoliosis: a review of published articles 2000-2009.

PubMed

Phan, Philippe; Mezghani, Neila; Aubin, Carl-Éric; de Guise, Jacques A; Labelle, Hubert

2011-07-01

Adolescent idiopathic scoliosis (AIS) is a complex spinal deformity whose assessment and treatment present many challenges. Computer applications have been developed to assist clinicians. A literature review on computer applications used in AIS evaluation and treatment has been undertaken. The algorithms used, their accuracy and clinical usability were analyzed. Computer applications have been used to create new classifications for AIS based on 2D and 3D features, assess scoliosis severity or risk of progression and assist bracing and surgical treatment. It was found that classification accuracy could be improved using computer algorithms that AIS patient follow-up and screening could be done using surface topography thereby limiting radiation and that bracing and surgical treatment could be optimized using simulations. Yet few computer applications are routinely used in clinics. With the development of 3D imaging and databases, huge amounts of clinical and geometrical data need to be taken into consideration when researching and managing AIS. Computer applications based on advanced algorithms will be able to handle tasks that could otherwise not be done which can possibly improve AIS patients' management. Clinically oriented applications and evidence that they can improve current care will be required for their integration in the clinical setting.

Aspiring to Unintended Consequences of Natural Language Processing: A Review of Recent Developments in Clinical and Consumer-Generated Text Processing.

PubMed

Demner-Fushman, D; Elhadad, N

2016-11-10

This paper reviews work over the past two years in Natural Language Processing (NLP) applied to clinical and consumer-generated texts. We included any application or methodological publication that leverages text to facilitate healthcare and address the health-related needs of consumers and populations. Many important developments in clinical text processing, both foundational and task-oriented, were addressed in community- wide evaluations and discussed in corresponding special issues that are referenced in this review. These focused issues and in-depth reviews of several other active research areas, such as pharmacovigilance and summarization, allowed us to discuss in greater depth disease modeling and predictive analytics using clinical texts, and text analysis in social media for healthcare quality assessment, trends towards online interventions based on rapid analysis of health-related posts, and consumer health question answering, among other issues. Our analysis shows that although clinical NLP continues to advance towards practical applications and more NLP methods are used in large-scale live health information applications, more needs to be done to make NLP use in clinical applications a routine widespread reality. Progress in clinical NLP is mirrored by developments in social media text analysis: the research is moving from capturing trends to addressing individual health-related posts, thus showing potential to become a tool for precision medicine and a valuable addition to the standard healthcare quality evaluation tools.

Implementation of a scalable, web-based, automated clinical decision support risk-prediction tool for chronic kidney disease using C-CDA and application programming interfaces.

PubMed

Samal, Lipika; D'Amore, John D; Bates, David W; Wright, Adam

2017-11-01

Clinical decision support tools for risk prediction are readily available, but typically require workflow interruptions and manual data entry so are rarely used. Due to new data interoperability standards for electronic health records (EHRs), other options are available. As a clinical case study, we sought to build a scalable, web-based system that would automate calculation of kidney failure risk and display clinical decision support to users in primary care practices. We developed a single-page application, web server, database, and application programming interface to calculate and display kidney failure risk. Data were extracted from the EHR using the Consolidated Clinical Document Architecture interoperability standard for Continuity of Care Documents (CCDs). EHR users were presented with a noninterruptive alert on the patient's summary screen and a hyperlink to details and recommendations provided through a web application. Clinic schedules and CCDs were retrieved using existing application programming interfaces to the EHR, and we provided a clinical decision support hyperlink to the EHR as a service. We debugged a series of terminology and technical issues. The application was validated with data from 255 patients and subsequently deployed to 10 primary care clinics where, over the course of 1 year, 569 533 CCD documents were processed. We validated the use of interoperable documents and open-source components to develop a low-cost tool for automated clinical decision support. Since Consolidated Clinical Document Architecture-based data extraction extends to any certified EHR, this demonstrates a successful modular approach to clinical decision support. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Implications of pharmacogenomics for drug development and clinical practice.

PubMed

Ginsburg, Geoffrey S; Konstance, Richard P; Allsbrook, Jennifer S; Schulman, Kevin A

2005-11-14

Pharmacogenomics is likely to be among the first clinical applications of the Human Genome Project and is certain to have an enormous impact on the clinical practice of medicine. Herein, we discuss the potential implications of pharmacogenomics on the drug development process, including drug safety, productivity, market segmentation, market expansion, differentiation, and personalized health care. We also review 3 challenges facing the translation of pharmacogenomics into clinical practice: dependence on information technology, limited health care financing, and the scientific uncertainty surrounding validation of specific applications of the technology. To our knowledge, there is currently no formal agenda to promote and cultivate innovation, to develop progressive information technology, or to obtain the financing that would be required to advance the use of pharmacogenomic technologies in patient care. Although the potential of these technologies is driving change in the development of clinical sciences, it remains to be seen which health care systems level needs will be addressed.

Technological choices for mobile clinical applications.

PubMed

Ehrler, Frederic; Issom, David; Lovis, Christian

2011-01-01

The rise of cheaper and more powerful mobile devices make them a new and attractive platform for clinical applications. The interaction paradigm and portability of the device facilitates bedside human-machine interactions. The better accessibility to information and decision-support anywhere in the hospital improves the efficiency and the safety of care processes. In this study, we attempt to find out what are the most appropriate Operating System (OS) and Software Development Kit (SDK) to support the development of clinical applications on mobile devices. The Android platform is a Linux-based, open source platform that has many advantages. Two main SDKs are available on this platform: the native Android and the Adobe Flex SDK. Both of them have interesting features, but the latter has been preferred due its portability at comparable performance and ease of development.

Development and application of neuropsychology in Hong Kong: implications of its value and future advancement.

PubMed

Chan, Agnes S; Sze, Sophia L; Cheung, Mei-Chun; Han, Yvonne M Y

2016-11-01

To review the development, application, and value of neuropsychology, and the standard education and training pathway for neuropsychologists or clinical neuropsychologists in Hong Kong. The information provided here was gathered via a literature review of the status of neuropsychology and the validity of commonly adopted neuropsychological tests in Hong Kong. Additional details were acquired via the internet about local tertiary education curricula and the related requirements, the availability of professional associations for licensure or board certification, and relevant statistics/surveys conducted by the government. Some information about the clinical practice of neuropsychology was collected through personal communication with local clinical psychologists. The development of neuropsychology in Hong Kong over the past 20 years is rapid and productive, given the increasing application of advanced neuroimaging techniques, neuropsychological tests, and opportunities for exchanging up-to-date neuropsychological knowledge and professional training through international conferences, workshops, and seminars. Given that neuropsychology services are often provided by clinical psychologists who are master's degree graduates in clinical psychology, the relatively limited training in neuropsychological knowledge and skills and the lack of division for membership or mandatory registration as a neuropsychologist/clinical neuropsychologist may have an impact on the quality of clinical neuropsychological services and the development of this specialty. These findings signify a need for further improvement or refinement of educational and training pathways for neuropsychologist or clinical neuropsychologist along with the recognition of its value in clinical practice through registration of different disciplines of psychology in Hong Kong.

Spiral microstrip hyperthermia applicators: technical design and clinical performance.

PubMed

Samulski, T V; Fessenden, P; Lee, E R; Kapp, D S; Tanabe, E; McEuen, A

1990-01-01

Spiral microstrip microwave (MW) antennas have been developed and adapted for use as clinical hyperthermia applicators. The design has been configured in a variety of forms including single fixed antenna applicators, multi-element arrays, and mechanically scanned single or paired antennas. The latter three configurations have been used to allow an expansion of the effective heating area. Specific absorption rate (SAR) distributions measured in phantom have been used to estimate the depth and volume of effective heating. The estimates are made using the bioheat equation assuming uniformly perfused tissue. In excess of 500 treatments of patients with advanced or recurrent localized superficial tumors have been performed using this applicator technology. Data from clinical treatments have been analyzed to quantify the heating performance and verify the suitability of these applicators for clinical use. Good microwave coupling efficiency together with the compact applicator size have proved to be valuable clinical assets.

Developments in laser Doppler blood perfusion monitoring

NASA Astrophysics Data System (ADS)

Leahy, Martin J.; de Mul, Frits F. M.; Nilsson, Gert E.; Maniewski, Roman; Liebert, Adam

2003-03-01

This paper reviews the development and use of laser Doppler perfusion monitors and imagers. Despite their great success and almost universal applicability in microcirculation research, they have had great difficulty in converting to widespread clinical application. The enormous interest in microvascular blood perfusion coupled with the 'ease of use' of the technique has led to 2000+ publications citing its use. However, useful results can only be achieved with an understanding of the basic principles of the instrumentation and its application in the various clinical disciplines. The basic technical background is explored and definitions of blood perfusion and laser Doppler perfusion are established. The calibration method is then described together with potential routes to standardisation. A guide to the limitations in application of the technique gives the user a clear indication of what can be achieved in new studies as well as possible inadequacy in some published investigations. Finally some clinical applications have found acceptability and these will be explored.

Clinical uses of liver stem cells.

PubMed

Dan, Yock Young

2012-01-01

Liver transplantation offers a definitive cure for many liver and metabolic diseases. However, the complex invasive procedure and paucity of donor liver graft organs limit its clinical applicability. Liver stem cells provide a potentially limitless source of cells that would be useful for a variety of clinical applications. These stem cells or hepatocytes generated from them can be used in cellular transplantation, bioartificial liver devices and drug testing in the development of new drugs. In this chapter, we review the technical aspects of clinical applications of liver stem cells and the progress made to date in the clinical setting. The difficulties and challenges of realizing the potential of these cells are discussed.

Trends in the Design and Development of Specific Aptamers Against Peptides and Proteins.

PubMed

Tabarzad, Maryam; Jafari, Marzieh

2016-04-01

Aptamers are single stranded oligonucleotides, comparable to monoclonal antibodies (mAbs) in selectivity and affinity and have significant strategic properties in design, development and applications more than mAbs. Ease of design and development, simple chemical modification and the attachment of functional groups, easily handling and more adaptability with analytical methods, small size and adaptation with nanostructures are the valuable characteristics of aptamers in comparison to large protein based ligands. Among a broad range of targets that their specific aptamers developed, proteins and peptides have significant position according to the number of related studies performed so far. Since proteins control many of important physiological and pathological incidents in the living organisms, particularly human beings and because of the benefits of aptamers in clinical and analytical applications, aptamer related technologies in the field of proteins and peptides are under progress, exclusively. Currently, there is only one FDA approved therapeutic aptamer in the pharmaceutical market, which is specific to vascular endothelial growth factor and is prescribed for age related macular degenerative disease. Additionally, there are several aptamers in the different phases of clinical trials. Almost all of these aptamers are specific to clinically important peptide or protein targets. In addition, the application of protein specific aptamers in the design and development of targeted drug delivery systems and diagnostic biosensors is another interesting field of aptamer technology. In this review, significant efforts related to development and applications of aptamer technologies in proteins and peptides sciences were considered to emphasis on the importance of aptamers in medicinal and clinical applications.

Development and Evaluation of Polyvinyl Alcohol-Hydrogels as an Artificial Atrticular Cartilage for Orthopedic Implants

PubMed Central

Kobayashi, Masanori; Hyu, Hyon Suong

2010-01-01

Due to its excellent biocompatibility and mechanical properties, various different applications of polyvinyl alcohol-hydrogels (PVA-H) has been attempted in many fields. In the field of orthopedic surgery, we have been engaged for long time in research on the clinical applications of PVA-H as a artificial cartilage, and have performed many basic experiments on the mechanical properties, synthesis of PVA-H, and developed orthopedic implants using PVA-H. From these studies, many applications of artificial articular cartilage, intervertbral disc and artificial meniscus etc. have been developed. This review will present the overview of the applications and recent advances of PVA-H cartilages, and discuss clinical potential of PVA-H for orthopedics implant.

Mobile Clinical Decision Support System for Acid-base Balance Diagnosis and Treatment Recommendation.

PubMed

Mandzuka, Mensur; Begic, Edin; Boskovic, Dusanka; Begic, Zijo; Masic, Izet

2017-06-01

This paper presents mobile application implementing a decision support system for acid-base disorder diagnosis and treatment recommendation. The application was developed using the official integrated development environment for the Android platform (to maximize availability and minimize investments in specialized hardware) called Android Studio. The application identifies disorder, based on the blood gas analysis, evaluates whether the disorder has been compensated, and based on additional input related to electrolyte imbalance, provides recommendations for treatment. The application is a tool in the hands of the user, which provides assistance during acid-base disorders treatment. The application will assist the physician in clinical practice and is focused on the treatment in intensive care.

Aspiring to Unintended Consequences of Natural Language Processing: A Review of Recent Developments in Clinical and Consumer-Generated Text Processing

PubMed Central

Elhadad, N.

2016-01-01

Summary Objectives This paper reviews work over the past two years in Natural Language Processing (NLP) applied to clinical and consumer-generated texts. Methods We included any application or methodological publication that leverages text to facilitate healthcare and address the health-related needs of consumers and populations. Results Many important developments in clinical text processing, both foundational and task-oriented, were addressed in community-wide evaluations and discussed in corresponding special issues that are referenced in this review. These focused issues and in-depth reviews of several other active research areas, such as pharmacovigilance and summarization, allowed us to discuss in greater depth disease modeling and predictive analytics using clinical texts, and text analysis in social media for healthcare quality assessment, trends towards online interventions based on rapid analysis of health-related posts, and consumer health question answering, among other issues. Conclusions Our analysis shows that although clinical NLP continues to advance towards practical applications and more NLP methods are used in large-scale live health information applications, more needs to be done to make NLP use in clinical applications a routine widespread reality. Progress in clinical NLP is mirrored by developments in social media text analysis: the research is moving from capturing trends to addressing individual health-related posts, thus showing potential to become a tool for precision medicine and a valuable addition to the standard healthcare quality evaluation tools. PMID:27830255

Does medical students' clinical performance affect their actual performance during medical internship?

PubMed

Han, Eui-Ryoung; Chung, Eun-Kyung

2016-02-01

This study examines the relationship between the clinical performance of medical students and their performance as doctors during their internships. This retrospective study involved 63 applicants to a residency programme conducted at the Chonnam National University Hospital, South Korea, in November 2012. We compared the performance of the applicants during their internship with the clinical performance of the applicants during their fourth year of medical school. The performance of the applicants as interns was periodically evaluated by the faculty of each department, while the clinical performance of the applicants as fourth year medical students was assessed using the Clinical Performance Examination (CPX) and the Objective Structured Clinical Examination (OSCE). The performance of the applicants as interns was positively correlated with their clinical performance as fourth year medical students, as measured by CPX and OSCE. The performance of the applicants as interns was moderately correlated with the patient-physician interactions items addressing communication and interpersonal skills in the CPX. The clinical performance of medical students during their fourth year in medical school was related to their performance as medical interns. Medical students should be trained to develop good clinical skills, through actual encounters with patients or simulated encounters using manikins, so that they are able to become competent doctors. Copyright © Singapore Medical Association.

Transforming medical imaging applications into collaborative PACS-based telemedical systems

NASA Astrophysics Data System (ADS)

Maani, Rouzbeh; Camorlinga, Sergio; Arnason, Neil

2011-03-01

Telemedical systems are not practical for use in a clinical workflow unless they are able to communicate with the Picture Archiving and Communications System (PACS). On the other hand, there are many medical imaging applications that are not developed as telemedical systems. Some medical imaging applications do not support collaboration and some do not communicate with the PACS and therefore limit their usability in clinical workflows. This paper presents a general architecture based on a three-tier architecture model. The architecture and the components developed within it, transform medical imaging applications into collaborative PACS-based telemedical systems. As a result, current medical imaging applications that are not telemedical, not supporting collaboration, and not communicating with PACS, can be enhanced to support collaboration among a group of physicians, be accessed remotely, and be clinically useful. The main advantage of the proposed architecture is that it does not impose any modification to the current medical imaging applications and does not make any assumptions about the underlying architecture or operating system.

Optical Tecnology Developments in Biomedicine: History, Current and Future

PubMed Central

Nioka, Shoko; Chen, Yu

2011-01-01

Biomedical optics is a rapidly emerging field for medical imaging and diagnostics. This paper reviews several biomedical optical technologies that have been developed and translated for either clinical or pre-clinical applications. Specifically, we focus on the following technologies: 1) near-infrared spectroscopy and tomography, 2) optical coherence tomography, 3) fluorescence spectroscopy and imaging, and 4) optical molecular imaging. There representative biomedical applications are also discussed here. PMID:23905030

Clinical Nurse Specialists Guide Staff Nurses to Promote Practice Accountability Through Peer Review.

PubMed

Semper, Julie; Halvorson, Betty; Hersh, Mary; Torres, Clare; Lillington, Linda

2016-01-01

The aim of the study was to describe the clinical nurse specialist role in developing and implementing a staff nurse education program to promote practice accountability using peer review principles. Peer review is essential for professional nursing practice demanding a significant culture change. Clinical nurse specialists in a Magnet-designated community hospital were charged with developing a staff nurse peer review education program. Peer review is a recognized mechanism of professional self-regulation to ensure delivery of quality care. The American Nurses Association strongly urges incorporating peer review in professional nursing practice models. Clinical nurse specialists play a critical role in educating staff nurses about practice accountability. Clinical nurse specialists developed an education program guided by the American Nurses Association's principles of peer review. A baseline needs assessment identified potential barriers and learning needs. Content incorporated tools and strategies to build communication skills, collaboration, practice change, and peer accountability. The education program resulted in increased staff nurse knowledge about peer review and application of peer review principles in practice. Clinical nurse specialists played a critical role in helping staff nurses understand peer review and its application to practice. The clinical nurse specialist role will continue to be important in sustaining the application of peer review principles in practice.

Clinical Applications of Personalized Medicine: A New Paradigm and Challenge.

PubMed

Di Sanzo, Mariantonia; Cipolloni, Luigi; Borro, Marina; La Russa, Raffaele; Santurro, Alessandro; Scopetti, Matteo; Simmaco, Maurizio; Frati, Paola

2017-01-01

The personalized medicine is an emergent and rapidly developing method of clinical practice that uses new technologies to provide decisions in regard to the prediction, prevention, diagnosis and treatment of disease. A continuous evolution of technology and the developments in molecular diagnostics and genomic analysis increased the possibility of an even more understanding and interpretation of the human genome and exome, allowing a "personalized" approach to clinical care, so that the concepts of "Systems Medicine" and "System Biology" are actually increasing. The purpose of this study is to evaluate the personalized medicine about its indications and benefits, actual clinical applications and future perspectives as well as its issues and health care implications. A careful review of the scientific literature on this field that highlighted the applicability and usefulness of this new medical approach as well as the fact that personalized medicine strategy is even more increasing in numerous fields of applications. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Diffusion Tensor Imaging: Application to the Study of the Developing Brain

ERIC Educational Resources Information Center

Cascio, Carissa J.; Gerig, Guido; Piven, Joseph

2007-01-01

Objective: To provide an overview of diffusion tensor imaging (DTI) and its application to the study of white matter in the developing brain in both healthy and clinical samples. Method: The development of DTI and its application to brain imaging of white matter tracts is discussed. Forty-eight studies using DTI to examine diffusion properties of…

A Study of Clinically Related Open Source Software Projects

PubMed Central

Hogarth, Michael A.; Turner, Stuart

2005-01-01

Open source software development has recently gained significant interest due to several successful mainstream open source projects. This methodology has been proposed as being similarly viable and beneficial in the clinical application domain as well. However, the clinical software development venue differs significantly from the mainstream software venue. Existing clinical open source projects have not been well characterized nor formally studied so the ‘fit’ of open source in this domain is largely unknown. In order to better understand the open source movement in the clinical application domain, we undertook a study of existing open source clinical projects. In this study we sought to characterize and classify existing clinical open source projects and to determine metrics for their viability. This study revealed several findings which we believe could guide the healthcare community in its quest for successful open source clinical software projects. PMID:16779056

Executable medical guidelines with Arden Syntax-Applications in dermatology and obstetrics.

PubMed

Seitinger, Alexander; Rappelsberger, Andrea; Leitich, Harald; Binder, Michael; Adlassnig, Klaus-Peter

2016-08-12

Clinical decision support systems (CDSSs) are being developed to assist physicians in processing extensive data and new knowledge based on recent scientific advances. Structured medical knowledge in the form of clinical alerts or reminder rules, decision trees or tables, clinical protocols or practice guidelines, score algorithms, and others, constitute the core of CDSSs. Several medical knowledge representation and guideline languages have been developed for the formal computerized definition of such knowledge. One of these languages is Arden Syntax for Medical Logic Systems, an International Health Level Seven (HL7) standard whose development started in 1989. Its latest version is 2.10, which was presented in 2014. In the present report we discuss Arden Syntax as a modern medical knowledge representation and processing language, and show that this language is not only well suited to define clinical alerts, reminders, and recommendations, but can also be used to implement and process computerized medical practice guidelines. This section describes how contemporary software such as Java, server software, web-services, XML, is used to implement CDSSs based on Arden Syntax. Special emphasis is given to clinical decision support (CDS) that employs practice guidelines as its clinical knowledge base. Two guideline-based applications using Arden Syntax for medical knowledge representation and processing were developed. The first is a software platform for implementing practice guidelines from dermatology. This application employs fuzzy set theory and logic to represent linguistic and propositional uncertainty in medical data, knowledge, and conclusions. The second application implements a reminder system based on clinically published standard operating procedures in obstetrics to prevent deviations from state-of-the-art care. A to-do list with necessary actions specifically tailored to the gestational week/labor/delivery is generated. Today, with the latest versions of Arden Syntax and the application of contemporary software development methods, Arden Syntax has become a powerful and versatile medical knowledge representation and processing language, well suited to implement a large range of CDSSs, including clinical-practice-guideline-based CDSSs. Moreover, such CDS is provided and can be shared as a service by different medical institutions, redefining the sharing of medical knowledge. Arden Syntax is also highly flexible and provides developers the freedom to use up-to-date software design and programming patterns for external patient data access. Copyright © 2016. Published by Elsevier B.V.

DEVELOPING AN IPAD® APPLICATION FOR DATA COLLECTION IN A RHEUMATOLOGY RESEARCH CLINIC.

PubMed

Kaka, Hussam; Ayearst, Renise; Tran, Maithy; Touma, Zahi; Bagovich, Maria; Vinik, Ophir; Somaily, Mansour; Haddad, Amir; Gladman, Dafna D; Chandran, Vinod

2015-01-01

Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system. We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured. A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry. Entering data using the iPad® application makes the patient encounter slightly longer, but reduces "missing fields." It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

[Development of Diagrammatic Recording System for Choledochoscope and Its Clinical Application].

PubMed

Xue, Zhao; Hu, Liangshuo; Tang, Bo; Zhang, Xiaogang; Lyu, Yi

2017-11-30

To develop a diagrammatic recording system for choledochoscopy and evaluate the system with clinical application. To match the real-time image and procedure illustration during choledochoscopy examination, we combined video-image capture and speech recognition technology to quickly generate personalized choledochoscopy images and texts records. The new system could be used in sharing territorial electronic medical records, telecommuting, scientific research and education, et al. In the clinical application of 32 patients, the choledochoscopy diagrammatic recording system could significantly improve the surgeons' working efficiency and patients' satisfaction. It could also meet the design requirement of remote information interaction. The choledochoscopy diagrammatic recording system which is recommended could elevate the quality of medical service and promote academic exchange and training.

Ultrasonography in gastroenterology.

PubMed

Ødegaard, Svein; Nesje, Lars B; Hausken, Trygve; Gilja, Odd Helge

2015-06-01

Ultrasonography (US) is a safe and available real-time, high-resolution imaging method, which during the last decades has been increasingly integrated as a clinical tool in gastroenterology. New US applications have emerged with enforced data software and new technical solutions, including strain evaluation, three-dimensional imaging and use of ultrasound contrast agents. Specific gastroenterologic applications have been developed by combining US with other diagnostic or therapeutic methods, such as endoscopy, manometry, puncture needles, diathermy and stents. US provides detailed structural information about visceral organs without hazard to the patients and can play an important clinical role by reducing the need for invasive procedures. This paper presents different aspects of US in gastroenterology, with a special emphasis on the contribution from Nordic scientists in developing clinical applications.

SU-F-T-100: Development and Implementation of a Treatment Planning Tracking System Into the Radiation Oncology Clinic

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kabat, C; Cline, K; Li, Y

Purpose: With increasing numbers of cancer patients being diagnosed and the complexity of radiotherapy treatments rising it’s paramount that patient plan development continues to stay fluid within the clinic. In order to maintain a high standard of care and clinical efficiency the establishment of a tracking system for patient plan development allows healthcare providers to view real time plan progression and drive clinical workflow. In addition, it provides statistical datasets which can further identify inefficiencies within the clinic. Methods: An application was developed utilizing Microsoft’s ODBC SQL database engine to track patient plan status throughout the treatment planning process whilemore » also managing key factors pertaining to the patient’s treatment. Pertinent information is accessible to staff in many locations, including tracking monitors within dosimetry, the clinic network for both computers and handheld devices, and through email notifications. Plans are initiated with a CT and continually tracked through planning stages until final approval by staff. Patient’s status is dynamically updated by the physicians, dosimetrists, and medical physicists based on the stage of the patient’s plan. Results: Our application has been running over a six month period with all patients being processed through the system. Modifications have been made to allow for new features to be implemented along with additional tracking parameters. Based on in-house feedback, the application has been supportive in streamlining patient plans through the treatment planning process and data has been accumulating to further improve procedures within the clinic. Conclusion: Over time the clinic will continue to track data with this application. As data accumulates the clinic will be able to highlight inefficiencies within the workflow and adapt accordingly. We will add in new features to help support the treatment planning process in the future.« less

Comprehensive, powerful, efficient, intuitive: a new software framework for clinical imaging applications

NASA Astrophysics Data System (ADS)

Augustine, Kurt E.; Holmes, David R., III; Hanson, Dennis P.; Robb, Richard A.

2006-03-01

One of the greatest challenges for a software engineer is to create a complex application that is comprehensive enough to be useful to a diverse set of users, yet focused enough for individual tasks to be carried out efficiently with minimal training. This "powerful yet simple" paradox is particularly prevalent in advanced medical imaging applications. Recent research in the Biomedical Imaging Resource (BIR) at Mayo Clinic has been directed toward development of an imaging application framework that provides powerful image visualization/analysis tools in an intuitive, easy-to-use interface. It is based on two concepts very familiar to physicians - Cases and Workflows. Each case is associated with a unique patient and a specific set of routine clinical tasks, or a workflow. Each workflow is comprised of an ordered set of general-purpose modules which can be re-used for each unique workflow. Clinicians help describe and design the workflows, and then are provided with an intuitive interface to both patient data and analysis tools. Since most of the individual steps are common to many different workflows, the use of general-purpose modules reduces development time and results in applications that are consistent, stable, and robust. While the development of individual modules may reflect years of research by imaging scientists, new customized workflows based on the new modules can be developed extremely fast. If a powerful, comprehensive application is difficult to learn and complicated to use, it will be unacceptable to most clinicians. Clinical image analysis tools must be intuitive and effective or they simply will not be used.

Mobile clinical decision support systems and applications: a literature and commercial review.

PubMed

Martínez-Pérez, Borja; de la Torre-Díez, Isabel; López-Coronado, Miguel; Sainz-de-Abajo, Beatriz; Robles, Montserrat; García-Gómez, Juan Miguel

2014-01-01

The latest advances in eHealth and mHealth have propitiated the rapidly creation and expansion of mobile applications for health care. One of these types of applications are the clinical decision support systems, which nowadays are being implemented in mobile apps to facilitate the access to health care professionals in their daily clinical decisions. The aim of this paper is twofold. Firstly, to make a review of the current systems available in the literature and in commercial stores. Secondly, to analyze a sample of applications in order to obtain some conclusions and recommendations. Two reviews have been done: a literature review on Scopus, IEEE Xplore, Web of Knowledge and PubMed and a commercial review on Google play and the App Store. Five applications from each review have been selected to develop an in-depth analysis and to obtain more information about the mobile clinical decision support systems. Ninety-two relevant papers and 192 commercial apps were found. Forty-four papers were focused only on mobile clinical decision support systems. One hundred seventy-one apps were available on Google play and 21 on the App Store. The apps are designed for general medicine and 37 different specialties, with some features common in all of them despite of the different medical fields objective. The number of mobile clinical decision support applications and their inclusion in clinical practices has risen in the last years. However, developers must be careful with their interface or the easiness of use, which can impoverish the experience of the users.

Translating airway biomarker information into practice: from theoretical science to applied medicine.

PubMed

Ameredes, Bill T

2011-04-01

Biomarkers ranging from simple to sophisticated have been used by man for many years of his existence. The main use for biomarkers over that time has been to assess relative states health and well-being, including the presence of functional limitations that presage debilitation and even death. In recent years, there has been intense interest in the development of non-invasive biomarkers to accurately predict disease state and progression, as well as potential drug therapy to assist in early mitigation of morbidity and possibly, forestall premature mortality. The development of biomarkers of airway status has followed a similar pattern, and in recent years, several biomarkers have followed the progression from basic and pre-clinical development, to clinical/translational application, and finally to potential clinical therapeutic application. Inherent in this progression is the refinement of technology that has allowed measurement of these biomarkers in a fast, convenient, and reliable fashion, such that they can be obtainable within a clinical practice setting, to allow the physician to make treatment decisions for diseases such as asthma and COPD. While the clinical therapeutic application of airway biomarkers such as exhaled nitric oxide and β(2)-adrenoreceptor Arg-16 polymorphism are still in their infancy, they have followed this common pathway of development, and now will require some years of application to demonstrate their true utility as predictive biomarkers of airway status and treatment response. Copyright © 2010 Elsevier Ltd. All rights reserved.

Application and Exploration of Big Data Mining in Clinical Medicine.

PubMed

Zhang, Yue; Guo, Shu-Li; Han, Li-Na; Li, Tie-Ling

2016-03-20

To review theories and technologies of big data mining and their application in clinical medicine. Literatures published in English or Chinese regarding theories and technologies of big data mining and the concrete applications of data mining technology in clinical medicine were obtained from PubMed and Chinese Hospital Knowledge Database from 1975 to 2015. Original articles regarding big data mining theory/technology and big data mining's application in the medical field were selected. This review characterized the basic theories and technologies of big data mining including fuzzy theory, rough set theory, cloud theory, Dempster-Shafer theory, artificial neural network, genetic algorithm, inductive learning theory, Bayesian network, decision tree, pattern recognition, high-performance computing, and statistical analysis. The application of big data mining in clinical medicine was analyzed in the fields of disease risk assessment, clinical decision support, prediction of disease development, guidance of rational use of drugs, medical management, and evidence-based medicine. Big data mining has the potential to play an important role in clinical medicine.

Mobile Clinical Decision Support System for Acid-base Balance Diagnosis and Treatment Recommendation

PubMed Central

Mandzuka, Mensur; Begic, Edin; Boskovic, Dusanka; Begic, Zijo; Masic, Izet

2017-01-01

Introduction: This paper presents mobile application implementing a decision support system for acid-base disorder diagnosis and treatment recommendation. Material and methods: The application was developed using the official integrated development environment for the Android platform (to maximize availability and minimize investments in specialized hardware) called Android Studio. Results: The application identifies disorder, based on the blood gas analysis, evaluates whether the disorder has been compensated, and based on additional input related to electrolyte imbalance, provides recommendations for treatment. Conclusion: The application is a tool in the hands of the user, which provides assistance during acid-base disorders treatment. The application will assist the physician in clinical practice and is focused on the treatment in intensive care. PMID:28883678

Critical thinking in clinical nurse education: application of Paul's model of critical thinking.

PubMed

Andrea Sullivan, E

2012-11-01

Nurse educators recognize that many nursing students have difficulty in making decisions in clinical practice. The ability to make effective, informed decisions in clinical practice requires that nursing students know and apply the processes of critical thinking. Critical thinking is a skill that develops over time and requires the conscious application of this process. There are a number of models in the nursing literature to assist students in the critical thinking process; however, these models tend to focus solely on decision making in hospital settings and are often complex to actualize. In this paper, Paul's Model of Critical Thinking is examined for its application to nursing education. I will demonstrate how the model can be used by clinical nurse educators to assist students to develop critical thinking skills in all health care settings in a way that makes critical thinking skills accessible to students. Copyright © 2012 Elsevier Ltd. All rights reserved.

[Discussion of the Application of Micro-lecture in the Clinical Training 
of Thoracic Surgery].

PubMed

Li, Xiaofei; Lei, Jie

2018-04-20

Today, with the rapid development of network information technology, the micro-lecture plays a role in the teaching activities is becoming more and more important. The short and efficient teaching content of micro-lecture can be downloaded rapidly, expediently, and repeatedly, which improve the learning efficiency and independent learning capability. The clinical training of thoracic surgery elementarily remains at the scrabble stage. We require continuous reform and introduce new modes of teaching, which compatible with the development of society and the study habits of novice, to enhance the effectiveness of clinical training. In this paper, the concept, characteristic and advantage of micro-lecture was discussed, and the feasibility of application of micro-lecture in thoracic surgery teaching was also discussed. Our aim was to promote the application of micro-lecture in the clinical training of thoracic surgery reasonable and extensive.
.

Early developments and clinical applications of total parenteral nutrition.

PubMed

Dudrick, Stanley J

2003-01-01

This article recounts the conditions and status of surgical nutrition support in the 1960s and the antecedent basic and clinical investigational work leading to the development of a practical and efficacious method of adequate nourishment entirely by vein in Beagle puppies; describes the subsequent clinical application of the knowledge, techniques, and technology to the first successful long-term total parenteral nutrition (TPN) support of critically ill pediatric and adult patients; and admonishes nutritionists of all backgrounds that some need for parenteral nutrition will likely always exist and that it is incumbent upon everyone to continue endeavors to advance the germinal methodology to perfection. The relevant indications, limitations, hindrances, motivational factors, and studies regarding the development of TPN are reviewed, and the fundamental investigational work culminating in the first successful growth and development of Beagle puppies and a human infant fed entirely by vein are described firsthand. The details of the orderly and logical scientific development of the principles and components of the techniques in animals, infants, and adults are related. Knowledge, techniques, and technologic constituents of the first successful long-term TPN system were developed in the basic biochemical and animal laboratories initially in 6 puppies and subsequently adapted clinically for the efficacious long-term i.v. support of 6 critically ill surgical adult patients and a newborn infant before its widespread clinical application. Long-term TPN was inaugurated successfully as a safe and effective i.v. feeding technique nearly 4 decades ago. However, basic and clinical investigations must continue to be encouraged, supported, and carried out in the quest to perfect the current rudimentary technology, methodology, and outcomes.

[Forensic assessments from the Netherlands Institute of Forensic Psychiatry and Psychology in retrospect; applications of genetics and neuroscience, in 2000 and 2009].

PubMed

Ter Harmsel, J F; Molendijk, T; van El, C G; M'charek, A; Kempes, M; Rinne, T; Pieters, T

2016-01-01

Developments in neurosciences and genetics are relevant for forensic psychiatry. To find out whether and how genetic and neuroscientific applications are being used in forensic psychiatric assessments, and, if they are, to estimate to what extent new applications will fit in with these uses. We analysed 60 forensic psychiatric assessments from the Netherlands Institute of Forensic Psychiatry and Psychology, Pieter Baan Center, and 30 non-clinical assessments from 2000 and 2009. We found that (behavioral) genetic, neurological and neuropsychological applications played only a modest role in forensic psychiatric assessment and they represent different phases of the implementation process. Neuropsychological assessment already occupied a position of some importance, but needed to be better integrated. Applications from neurology were still being developed. Clinical genetic assessment was being used occasionally in order to diagnose a genetic syndrome with behavioral consequences. If further validated information becomes available in the future, it should be possible to integrate new research methods more fully into current clinical practice.

Expanding Role of Data Science and Bioinformatics in Drug Discovery and Development.

PubMed

Fingert, Howard J

2018-01-01

Numerous barriers have been identified which detract from successful applications of clinical trial data and platforms. Despite the challenges, opportunities are growing to advance compliance, quality, and practical applications through top-down establishment of guiding principles, coupled with bottom-up approaches to promote data science competencies among data producers. Recent examples of successful applications include modern treatments for hematologic malignancies, developed with support from public-private partnerships, guiding principles for data-sharing, standards for protocol designs and data management, digital technologies, and quality analytics. © 2017 American Society for Clinical Pharmacology and Therapeutics.

[Progress in methodological characteristics of clinical practice guideline for osteoarthritis].

PubMed

Xing, D; Wang, B; Lin, J H

2017-06-01

At present, several clinical practice guidelines for the treatment of osteoarthritis have been developed by institutes or societies. The ultimate purpose of developing clinical practice guidelines is to formulate the process in the treatment of osteoarthritis effectively. However, the methodologies used in developing clinical practice guidelines may place an influence on the transformation and application of that in treating osteoarthritis. The present study summarized the methodological features of individual clinical practice guideline and presented the tools for quality evaluation of clinical practice guideline. The limitations of current osteoarthritis guidelines of China are also indicated. The review article might help relevant institutions improve the quality in developing guide and clinical transformation.

Clinical translation of handheld optical coherence tomography: practical considerations and recent advancements

NASA Astrophysics Data System (ADS)

Monroy, Guillermo L.; Won, Jungeun; Spillman, Darold R.; Dsouza, Roshan; Boppart, Stephen A.

2017-12-01

Since the inception of optical coherence tomography (OCT), advancements in imaging system design and handheld probes have allowed for numerous advancements in disease diagnostics and characterization of the structural and optical properties of tissue. OCT system developers continue to reduce form factor and cost, while improving imaging performance (speed, resolution, etc.) and flexibility for applicability in a broad range of fields, and nearly every clinical specialty. An extensive array of components to construct customized systems has also become available, with a range of commercial entities that produce high-quality products, from single components to full systems, for clinical and research use. Many advancements in the development of these miniaturized and portable systems can be linked back to a specific challenge in academic research, or a clinical need in medicine or surgery. Handheld OCT systems are discussed and explored for various applications. Handheld systems are discussed in terms of their relative level of portability and form factor, with mention of the supporting technologies and surrounding ecosystem that bolstered their development. Additional insight from our efforts to implement systems in several clinical environments is provided. The trend toward well-designed, efficient, and compact handheld systems paves the way for more widespread adoption of OCT into point-of-care or point-of-procedure applications in both clinical and commercial settings.

Development of a high precision dosimetry system for the measurement of surface dose rate distribution for eye applicators.

PubMed

Eichmann, Marion; Flühs, Dirk; Spaan, Bernhard

2009-10-01

The therapeutic outcome of the therapy with ophthalmic applicators is highly dependent on the application of a sufficient dose to the tumor, whereas the dose applied to the surrounding tissue needs to be minimized. The goal for the newly developed apparatus described in this work is the determination of the individual applicator surface dose rate distribution with a high spatial resolution and a high precision in dose rate with respect to time and budget constraints especially important for clinical procedures. Inhomogeneities of the dose rate distribution can be detected and taken into consideration for the treatment planning. In order to achieve this, a dose rate profile as well as a surface profile of the applicator are measured and correlated with each other. An instrumental setup has been developed consisting of a plastic scintillator detector system and a newly designed apparatus for guiding the detector across the applicator surface at a constant small distance. It performs an angular movement of detector and applicator with high precision. The measurements of surface dose rate distributions discussed in this work demonstrate the successful operation of the measuring setup. Measuring the surface dose rate distribution with a small distance between applicator and detector and with a high density of measuring points results in a complete and gapless coverage of the applicator surface, being capable of distinguishing small sized spots with high activities. The dosimetrical accuracy of the measurements and its analysis is sufficient (uncertainty in the dose rate in terms of absorbed dose to water is <7%), especially when taking the surgical techniques in positioning of the applicator on the eyeball into account. The method developed so far allows a fully automated quality assurance of eye applicators even under clinical conditions. These measurements provide the basis for future calculation of a full 3D dose rate distribution, which then can be used as input for a refined clinical treatment planning system. The improved dose rate measurements will facilitate a clinical study, which could correlate the therapeutic outcome of a brachytherapy treatment with an applicator and its individual dose rate distribution.

Development of a high precision dosimetry system for the measurement of surface dose rate distribution for eye applicators

DOE Office of Scientific and Technical Information (OSTI.GOV)

Eichmann, Marion; Fluehs, Dirk; Spaan, Bernhard

2009-10-15

Purpose: The therapeutic outcome of the therapy with ophthalmic applicators is highly dependent on the application of a sufficient dose to the tumor, whereas the dose applied to the surrounding tissue needs to be minimized. The goal for the newly developed apparatus described in this work is the determination of the individual applicator surface dose rate distribution with a high spatial resolution and a high precision in dose rate with respect to time and budget constraints especially important for clinical procedures. Inhomogeneities of the dose rate distribution can be detected and taken into consideration for the treatment planning. Methods: Inmore » order to achieve this, a dose rate profile as well as a surface profile of the applicator are measured and correlated with each other. An instrumental setup has been developed consisting of a plastic scintillator detector system and a newly designed apparatus for guiding the detector across the applicator surface at a constant small distance. It performs an angular movement of detector and applicator with high precision. Results: The measurements of surface dose rate distributions discussed in this work demonstrate the successful operation of the measuring setup. Measuring the surface dose rate distribution with a small distance between applicator and detector and with a high density of measuring points results in a complete and gapless coverage of the applicator surface, being capable of distinguishing small sized spots with high activities. The dosimetrical accuracy of the measurements and its analysis is sufficient (uncertainty in the dose rate in terms of absorbed dose to water is <7%), especially when taking the surgical techniques in positioning of the applicator on the eyeball into account. Conclusions: The method developed so far allows a fully automated quality assurance of eye applicators even under clinical conditions. These measurements provide the basis for future calculation of a full 3D dose rate distribution, which then can be used as input for a refined clinical treatment planning system. The improved dose rate measurements will facilitate a clinical study, which could correlate the therapeutic outcome of a brachytherapy treatment with an applicator and its individual dose rate distribution.« less

Development of a Web-Based Clinical Decision Support System for Drug Prescription: Non-Interventional Naturalistic Description of the Antipsychotic Prescription Patterns in 4345 Outpatients and Future Applications.

PubMed

Berrouiguet, Sofian; Barrigón, Maria Luisa; Brandt, Sara A; Ovejero-García, Santiago; Álvarez-García, Raquel; Carballo, Juan Jose; Lenca, Philippe; Courtet, Philippe; Baca-García, Enrique

2016-01-01

The emergence of electronic prescribing devices with clinical decision support systems (CDSS) is able to significantly improve management pharmacological treatments. We developed a web application available on smartphones in order to help clinicians monitor prescription and further propose CDSS. A web application (www.MEmind.net) was developed to assess patients and collect data regarding gender, age, diagnosis and treatment. We analyzed antipsychotic prescriptions in 4345 patients attended in five Psychiatric Community Mental Health Centers from June 2014 to October 2014. The web-application reported average daily dose prescribed for antipsychotics, prescribed daily dose (PDD), and the PDD to defined daily dose (DDD) ratio. The MEmind web-application reported that antipsychotics were used in 1116 patients out of the total sample, mostly in 486 (44%) patients with schizophrenia related disorders but also in other diagnoses. Second generation antipsychotics (quetiapine, aripiprazole and long-acting paliperidone) were preferably employed. Low doses were more frequently used than high doses. Long acting paliperidone and ziprasidone however, were the only two antipsychotics used at excessive dosing. Antipsychotic polypharmacy was used in 287 (26%) patients with classic depot drugs, clotiapine, amisulpride and clozapine. In this study we describe the first step of the development of a web application that is able to make polypharmacy, high dose usage and off label usage of antipsychotics visible to clinicians. Current development of the MEmind web application may help to improve prescription security via momentary feedback of prescription and clinical decision support system.

Development of a Web-Based Clinical Decision Support System for Drug Prescription: Non-Interventional Naturalistic Description of the Antipsychotic Prescription Patterns in 4345 Outpatients and Future Applications

PubMed Central

Berrouiguet, Sofian; Barrigón, Maria Luisa; Brandt, Sara A.; Ovejero-García, Santiago; Álvarez-García, Raquel; Carballo, Juan Jose; Lenca, Philippe; Courtet, Philippe; Baca-García, Enrique

2016-01-01

Purpose The emergence of electronic prescribing devices with clinical decision support systems (CDSS) is able to significantly improve management pharmacological treatments. We developed a web application available on smartphones in order to help clinicians monitor prescription and further propose CDSS. Method A web application (www.MEmind.net) was developed to assess patients and collect data regarding gender, age, diagnosis and treatment. We analyzed antipsychotic prescriptions in 4345 patients attended in five Psychiatric Community Mental Health Centers from June 2014 to October 2014. The web-application reported average daily dose prescribed for antipsychotics, prescribed daily dose (PDD), and the PDD to defined daily dose (DDD) ratio. Results The MEmind web-application reported that antipsychotics were used in 1116 patients out of the total sample, mostly in 486 (44%) patients with schizophrenia related disorders but also in other diagnoses. Second generation antipsychotics (quetiapine, aripiprazole and long-acting paliperidone) were preferably employed. Low doses were more frequently used than high doses. Long acting paliperidone and ziprasidone however, were the only two antipsychotics used at excessive dosing. Antipsychotic polypharmacy was used in 287 (26%) patients with classic depot drugs, clotiapine, amisulpride and clozapine. Conclusions In this study we describe the first step of the development of a web application that is able to make polypharmacy, high dose usage and off label usage of antipsychotics visible to clinicians. Current development of the MEmind web application may help to improve prescription security via momentary feedback of prescription and clinical decision support system. PMID:27764107

A multimedia perioperative record keeper for clinical research.

PubMed

Perrino, A C; Luther, M A; Phillips, D B; Levin, F L

1996-05-01

To develop a multimedia perioperative recordkeeper that provides: 1. synchronous, real-time acquisition of multimedia data, 2. on-line access to the patient's chart data, and 3. advanced data analysis capabilities through integrated, multimedia database and analysis applications. To minimize cost and development time, the system design utilized industry standard hardware components and graphical. software development tools. The system was configured to use a Pentium PC complemented with a variety of hardware interfaces to external data sources. These sources included physiologic monitors with data in digital, analog, video, and audio as well as paper-based formats. The development process was guided by trials in over 80 clinical cases and by the critiques from numerous users. As a result of this process, a suite of custom software applications were created to meet the design goals. The Perioperative Data Acquisition application manages data collection from a variety of physiological monitors. The Charter application provides for rapid creation of an electronic medical record from the patient's paper-based chart and investigator's notes. The Multimedia Medical Database application provides a relational database for the organization and management of multimedia data. The Triscreen application provides an integrated data analysis environment with simultaneous, full-motion data display. With recent technological advances in PC power, data acquisition hardware, and software development tools, the clinical researcher now has the ability to collect and examine a more complete perioperative record. It is hoped that the description of the MPR and its development process will assist and encourage others to advance these tools for perioperative research.

7T: Physics, safety, and potential clinical applications.

PubMed

Kraff, Oliver; Quick, Harald H

2017-12-01

With more than 60 installed magnetic resonance imaging (MRI) systems worldwide operating at a magnetic field strength of 7T or higher, ultrahigh-field (UHF) MRI has been established as a platform for clinically oriented research in recent years. Profound technical and methodological developments have helped overcome the inherent physical challenges of UHF radiofrequency (RF) signal homogenization in the human body. The ongoing development of dedicated RF coil arrays was pivotal in realizing UHF body MRI, beyond mere brain imaging applications. Another precondition to clinical application of 7T MRI is the safety testing of implants and the establishment of safety concepts. Against this backdrop, 7T MRI and MR spectroscopy (MRS) recently have demonstrated capabilities and potentials for clinical diagnostics in a variety of studies. This article provides an overview of the immanent physical challenges of 7T UHF MRI and discusses recent technical solutions and safety concepts. Furthermore, recent clinically oriented studies are highlighted that span a broad application spectrum from 7T UHF brain to body MRI. 4 Technical Efficacy: Stage 1 J. Magn. Reson. Imaging 2017;46:1573-1589. © 2017 International Society for Magnetic Resonance in Medicine.

Development of a smartphone application for eating disorder self-monitoring.

PubMed

Tregarthen, Jenna P; Lock, James; Darcy, Alison M

2015-11-01

This case report aims to (1) describe the development and refinement of a smartphone application for eating disorder self-monitoring; (2) characterize its users in terms of demographic and clinical characteristics; and (3) explore its feasibility and utilization as a self-monitoring tool. We developed a mobile phone application through which people with eating disorders can self-monitor meals, emotions, behaviors, and thoughts. The application also included positive reinforcement, coping skill suggestions, social support, and feedback components. The app was made available on two Internet app stores. Data include number of downloads and subsequent usage statistics, consumer ratings on app-stores are used as indicators of satisfaction, anonymous aggregate demographic data and Eating Disorder Examination Questionnaire scores from 57,940 individuals collected over a two-year period. The app demonstrated population-level utilization with over 100,000 users over a two-year period. Almost 50% percent of users stated that they are not currently receiving clinical treatment and 33% reported they had not told anyone about their eating disorder. A surprising number of people with severe problems are using the app. Smartphone apps have the capacity to reach and engage traditionally underserved individuals with eating disorders at a large scale. Additional work is indicated for the evaluation of the clinical effectiveness of applications for specific user groups and in clinical treatment contexts. © 2015 Wiley Periodicals, Inc.

Design and Development of a Sharable Clinical Decision Support System Based on a Semantic Web Service Framework.

PubMed

Zhang, Yi-Fan; Gou, Ling; Tian, Yu; Li, Tian-Chang; Zhang, Mao; Li, Jing-Song

2016-05-01

Clinical decision support (CDS) systems provide clinicians and other health care stakeholders with patient-specific assessments or recommendations to aid in the clinical decision-making process. Despite their demonstrated potential for improving health care quality, the widespread availability of CDS systems has been limited mainly by the difficulty and cost of sharing CDS knowledge among heterogeneous healthcare information systems. The purpose of this study was to design and develop a sharable clinical decision support (S-CDS) system that meets this challenge. The fundamental knowledge base consists of independent and reusable knowledge modules (KMs) to meet core CDS needs, wherein each KM is semantically well defined based on the standard information model, terminologies, and representation formalisms. A semantic web service framework was developed to identify, access, and leverage these KMs across diverse CDS applications and care settings. The S-CDS system has been validated in two distinct client CDS applications. Model-level evaluation results confirmed coherent knowledge representation. Application-level evaluation results reached an overall accuracy of 98.66 % and a completeness of 96.98 %. The evaluation results demonstrated the technical feasibility and application prospect of our approach. Compared with other CDS engineering efforts, our approach facilitates system development and implementation and improves system maintainability, scalability and efficiency, which contribute to the widespread adoption of effective CDS within the healthcare domain.

Clinical perspectives of hybrid proton-fluorine magnetic resonance imaging and spectroscopy.

PubMed

Wolters, Martijn; Mohades, Seyede G; Hackeng, Tilman M; Post, Mark J; Kooi, Marianne E; Backes, Walter H

2013-05-01

The number of applications of fluorine 19 (19F) magnetic resonance (MR) imaging and spectroscopy in biomedical and clinical research is steadily growing. The 100% natural abundance of fluorine and its relatively high sensitivity for MR (83% to that of protons) make it an interesting nucleus for a wide range of MR applications. Fluorinated contrast media have a number of advantages over the conventionally used gadolinium-based or iron-based contrast agents. The absence of an endogenous fluorine background intensity in the human body facilitates reliable quantification of fluorinated contrast medium or drugs. Anatomy can be visualized separately with proton MR imaging, creating the application of hybrid hydrogen 1 (1H)/19F MR imaging. The availability of 2 channels (ie, the 1H and 19F channels) enables dual-targeted molecular imaging. Recently, novel developments have emerged on fluorine-based contrast media in preclinical studies and imaging techniques. The developments in fluorine MR seem promising for clinical applications, with contributions in therapy monitoring, assessment of lung function, angiography, and molecular imaging. This review outlines the translation from recent advances in preclinical MR imaging and spectroscopy to future perspectives of clinical hybrid 1H/19/F MR imaging applications.

The epigenetics of prostate cancer diagnosis and prognosis: update on clinical applications.

PubMed

Blute, Michael L; Damaschke, Nathan A; Jarrard, David F

2015-01-01

There is a major deficit in our ability to detect and predict the clinical behavior of prostate cancer (PCa). Epigenetic changes are associated with PCa development and progression. This review will focus on recent results in the clinical application of diagnostic and prognostic epigenetic markers. The development of high throughput technology has seen an enormous increase in the discovery of new markers that encompass epigenetic changes including those in DNA methylation and histone modifications. Application of these findings to urine and other biofluids, but also cancer and noncancerous prostate tissue, has resulted in new biomarkers. There has been a recent commercial development of a DNA methylation-based assay for identifying PCa risk from normal biopsy tissue. Other biomarkers are currently in the validation phase and encompass combinations of multiple genes. Epigenetic changes improve the specificity and sensitivity of PCa diagnosis and have the potential to help determine clinical prognosis. Additional studies will not only provide new and better biomarker candidates, but also have the potential to inform new therapeutic strategies given the reversibility of these processes.

A "building block" approach to application development for education and decision support in radiology: implications for integrated clinical information systems environments.

PubMed

Greenes, R A

1991-11-01

Education and decision-support resources useful to radiologists are proliferating for the personal computer/workstation user or are potentially accessible via high-speed networks. These resources are typically made available through a set of application programs that tend to be developed in isolation and operate independently. Nonetheless, there is a growing need for an integrated environment for access to these resources in the context of professional work, during clinical problem-solving and decision-making activities, and for use in conjunction with other information resources. New application development environments are required to provide these capabilities. One such architecture for applications, which we have implemented in a prototype environment called DeSyGNER, is based on separately delineating the component information resources required for an application, termed entities, and the user interface and organizational paradigms, or composition methods, by which the entities are used to provide particular kinds of capability. Examples include composition methods to support query, book browsing, hyperlinking, tutorials, simulations, or question/answer testing. Future steps must address true integration of such applications with existing clinical information systems. We believe that the most viable approach for evolving this capability is based on the use of new software engineering methodologies, open systems, client-server communication, and delineation of standard message protocols.

[The clinical application of three dimention printing technology].

PubMed

Zhong, S Z; Fang, C H

2016-09-01

In recent years, the three-dimentional(3D)printing technology is gradually applied in medicine.Now, the 3D printing has already play an important role in medical education, surgical device development, prosthesis implantation and so on.There are still many challenges and difficulties in the clinical overall application of 3D printing for some time, but it also contains a huge application prospect.Once with appropriate applications of this technology, it will be a major breakthrough in iatrical history once more.

An update on the clinical evidence that supports biosimilar approvals in Europe.

PubMed

Mielke, Johanna; Jilma, Bernd; Jones, Byron; Koenig, Franz

2018-03-25

Sponsors and regulators have more than 10 years of experience with the development of biosimilars in Europe. However, the regulatory pathway is still evolving. The present article provides an update on biosimilar development in practice by reviewing the clinical development programmes of recently approved biosimilars in Europe. We used the European public assessment reports (EPARs) which are published by the European Medicines Agency (EMA) for a comparison of the clinical development programmes of the 37 approved biosimilars in Europe. Here, we present novel strategies in the development of biosimilars by focusing specifically on the 17 biosimilars that have gained approval in the last year, but we also compare additional key characteristics for all approved biosimilars. The high variability of the clinical development strategies that we found previously was confirmed in the present analysis. Compared with earlier biosimilar applications, more nonstandard development strategies have been used recently. This includes, for example, applications without any studies in patients, and more complex study designs. During this study, we found that the EPARs for biosimilars seem to be improving; however, we identified important details which were still often missing. We provide a proposal for a checklist of the minimum information that should be included in biosimilar EPARs for giving the general public insights into the rationale for the approval of biosimilars. European regulators still seem to be open to consider approaches that differ from the guidelines or previous applications, as long as justification is provided. © 2018 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

Development and promotion in translational medicine: perspectives from 2012 sino-american symposium on clinical and translational medicine

PubMed Central

2012-01-01

Background Clinical translational medicine (CTM) is an emerging area comprising multidisciplinary research from basic science to medical applications and entails a close collaboration among hospital, academia and industry. Findings This Session focused discussing on new models for project development and promotion in translational medicine. The conference stimulated the scientific and commercial communication of project development between academies and companies, shared the advanced knowledge and expertise of clinical applications, and created the environment for collaborations. Conclusions Although strategic collaborations between corporate and academic institutions have resulted in a state of resurgence in the market, new cooperation models still need time to tell whether they will improve the translational medicine process. PMID:23369198

Report on the development and application of PET/CT in mainland China.

PubMed

Chen, Yumei; Chen, Ruohua; Zhou, Xiang; Liu, Jianjun; Huang, Gang

2017-09-08

To examine the development and application of systems combining positron emission and x-ray-computed tomography systems (PET/CTs) in mainland China. Using a questionnaire, we surveyed Chinese medical institutions on a variety topics relating to their PET/CT systems and its use. The respondents had PET/CTs installed and in clinical use before 31 December 2015. We examined the clinical scenarios to which Chinese PET/CTs were applied by reviewing the related Chinese and international literature from the start of 1995 to the end of 2013; these papers were found by searching the Wanfang and PubMed databases, respectively. The data were then classified and analyzed statistically. At the end of 2015, there were 240 PET/CTs and 101 medical cyclotrons in mainland China. The total number of PET studies performed in 2015 was 469,364. The main clinical applications of PET were found to be diagnostic fludeoxyglucose ( 18 F-FDG) imaging and oncological imaging. A minority of PET/CT studies were performed using 11 C-choline and other imaging agents. The number of papers relating to clinical use of PET/CT in mainland China increased each year over the period of study, in both the Chinese and international literature. Despite this progress, important problems were also apparent, including unbalanced regional development and the limited quality of the research. This study provides detailed information for understanding the development PET/CT technology in mainland China, along with its geographical distribution and clinical application. It may thus prove a useful reference for all those involved in planning the future of PET/CT in China.

MYPLAN - A Mobile Phone Application for Supporting People at Risk of Suicide.

PubMed

Skovgaard Larsen, Jette L; Frandsen, Hanne; Erlangsen, Annette

2016-05-01

Safety plans have been suggested as an intervention for people at risk of suicide. Given the impulsive character of suicidal ideation, a safety plan in the format of a mobile phone application is likely to be more available and useful than traditional paper versions. The study describes MYPLAN, a mobile phone application designed to support people at risk of suicide by letting them create a safety plan. MYPLAN was developed in collaboration with clinical psychiatric staff at Danish suicide preventive clinics. The mobile application lets the user create an individualized safety plan by filling in templates with strategies, actions, and direct links to contact persons. MYPLAN was developed in 2013 and is freely available in Denmark and Norway. It is designed for iPhone and android platforms. As of December 2015, the application has been downloaded almost 8,000 times. Users at risk of suicide as well as clinical staff have provided positive feedback on the mobile application. Support via mobile phone applications might be particularly useful for younger age groups at risk of suicide as well as in areas or countries where support options are lacking. Yet, it is important to examine the effectiveness of this type of intervention.

Development of a Clinical Framework for Mirror Therapy in Patients with Phantom Limb Pain: An Evidence-based Practice Approach.

PubMed

Rothgangel, Andreas; Braun, Susy; de Witte, Luc; Beurskens, Anna; Smeets, Rob

2016-04-01

To describe the development and content of a clinical framework for mirror therapy (MT) in patients with phantom limb pain (PLP) following amputation. Based on an a priori formulated theoretical model, 3 sources of data collection were used to develop the clinical framework. First, a review of the literature took place on important clinical aspects and the evidence on the effectiveness of MT in patients with phantom limb pain. In addition, questionnaires and semi-structured interviews were used to analyze clinical experiences and preferences of physical and occupational therapists and patients suffering from PLP regarding the application of MT. All data were finally clustered into main and subcategories and were used to complement and refine the theoretical model. For every main category of the a priori formulated theoretical model, several subcategories emerged from the literature search, patient, and therapist interviews. Based on these categories, we developed a clinical flowchart that incorporates the main and subcategories in a logical way according to the phases in methodical intervention defined by the Royal Dutch Society for Physical Therapy. In addition, we developed a comprehensive booklet that illustrates the individual steps of the clinical flowchart. In this study, a structured clinical framework for the application of MT in patients with PLP was developed. This framework is currently being tested for its effectiveness in a multicenter randomized controlled trial. © 2015 World Institute of Pain.

The development of a clinical outcomes survey research application: Assessment Center.

PubMed

Gershon, Richard; Rothrock, Nan E; Hanrahan, Rachel T; Jansky, Liz J; Harniss, Mark; Riley, William

2010-06-01

The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment Center) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer "scrum" sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed.

Clinical application of three-dimensional printing technology in craniofacial plastic surgery.

PubMed

Choi, Jong Woo; Kim, Namkug

2015-05-01

Three-dimensional (3D) printing has been particularly widely adopted in medical fields. Application of the 3D printing technique has even been extended to bio-cell printing for 3D tissue/organ development, the creation of scaffolds for tissue engineering, and actual clinical application for various medical parts. Of various medical fields, craniofacial plastic surgery is one of areas that pioneered the use of the 3D printing concept. Rapid prototype technology was introduced in the 1990s to medicine via computer-aided design, computer-aided manufacturing. To investigate the current status of 3D printing technology and its clinical application, a systematic review of the literature was conducted. In addition, the benefits and possibilities of the clinical application of 3D printing in craniofacial surgery are reviewed, based on personal experiences with more than 500 craniofacial cases conducted using 3D printing tactile prototype models.

Clinical Application of Three-Dimensional Printing Technology in Craniofacial Plastic Surgery

PubMed Central

Kim, Namkug

2015-01-01

Three-dimensional (3D) printing has been particularly widely adopted in medical fields. Application of the 3D printing technique has even been extended to bio-cell printing for 3D tissue/organ development, the creation of scaffolds for tissue engineering, and actual clinical application for various medical parts. Of various medical fields, craniofacial plastic surgery is one of areas that pioneered the use of the 3D printing concept. Rapid prototype technology was introduced in the 1990s to medicine via computer-aided design, computer-aided manufacturing. To investigate the current status of 3D printing technology and its clinical application, a systematic review of the literature was conducted. In addition, the benefits and possibilities of the clinical application of 3D printing in craniofacial surgery are reviewed, based on personal experiences with more than 500 craniofacial cases conducted using 3D printing tactile prototype models. PMID:26015880

Application and Exploration of Big Data Mining in Clinical Medicine

PubMed Central

Zhang, Yue; Guo, Shu-Li; Han, Li-Na; Li, Tie-Ling

2016-01-01

Objective: To review theories and technologies of big data mining and their application in clinical medicine. Data Sources: Literatures published in English or Chinese regarding theories and technologies of big data mining and the concrete applications of data mining technology in clinical medicine were obtained from PubMed and Chinese Hospital Knowledge Database from 1975 to 2015. Study Selection: Original articles regarding big data mining theory/technology and big data mining's application in the medical field were selected. Results: This review characterized the basic theories and technologies of big data mining including fuzzy theory, rough set theory, cloud theory, Dempster–Shafer theory, artificial neural network, genetic algorithm, inductive learning theory, Bayesian network, decision tree, pattern recognition, high-performance computing, and statistical analysis. The application of big data mining in clinical medicine was analyzed in the fields of disease risk assessment, clinical decision support, prediction of disease development, guidance of rational use of drugs, medical management, and evidence-based medicine. Conclusion: Big data mining has the potential to play an important role in clinical medicine. PMID:26960378

Update on Research and Application of Problem-Based Learning in Medical Science Education

ERIC Educational Resources Information Center

Fan, Chuifeng; Jiang, Biying; Shi, Xiuying; Wang, Enhua; Li, Qingchang

2018-01-01

Problem-based learning (PBL) is a unique form of pedagogy dedicated to developing students' self-learning and clinical practice skills. After several decades of development, although applications vary, PBL has been recognized all over the world and implemented by many medical schools. This review summarizes and updates the application and study of…

Does medical students’ clinical performance affect their actual performance during medical internship?

PubMed Central

Han, Eui-Ryoung; Chung, Eun-Kyung

2016-01-01

INTRODUCTION This study examines the relationship between the clinical performance of medical students and their performance as doctors during their internships. METHODS This retrospective study involved 63 applicants of a residency programme conducted at Chonnam National University Hospital, South Korea, in November 2012. We compared the performance of the applicants during their internship with their clinical performance during their fourth year of medical school. The performance of the applicants as interns was periodically evaluated by the faculty of each department, while their clinical performance as fourth-year medical students was assessed using the Clinical Performance Examination (CPX) and the Objective Structured Clinical Examination (OSCE). RESULTS The performance of the applicants as interns was positively correlated with their clinical performance as fourth-year medical students, as measured by the CPX and OSCE. The performance of the applicants as interns was moderately correlated with the patient-physician interaction items addressing communication and interpersonal skills in the CPX. CONCLUSION The clinical performance of medical students during their fourth year in medical school was related to their performance as medical interns. Medical students should be trained to develop good clinical skills through actual encounters with patients or simulated encounters using manikins, to enable them to become more competent doctors. PMID:26768172

Pathway mapping and development of disease-specific biomarkers: protein-based network biomarkers

PubMed Central

Chen, Hao; Zhu, Zhitu; Zhu, Yichun; Wang, Jian; Mei, Yunqing; Cheng, Yunfeng

2015-01-01

It is known that a disease is rarely a consequence of an abnormality of a single gene, but reflects the interactions of various processes in a complex network. Annotated molecular networks offer new opportunities to understand diseases within a systems biology framework and provide an excellent substrate for network-based identification of biomarkers. The network biomarkers and dynamic network biomarkers (DNBs) represent new types of biomarkers with protein–protein or gene–gene interactions that can be monitored and evaluated at different stages and time-points during development of disease. Clinical bioinformatics as a new way to combine clinical measurements and signs with human tissue-generated bioinformatics is crucial to translate biomarkers into clinical application, validate the disease specificity, and understand the role of biomarkers in clinical settings. In this article, the recent advances and developments on network biomarkers and DNBs are comprehensively reviewed. How network biomarkers help a better understanding of molecular mechanism of diseases, the advantages and constraints of network biomarkers for clinical application, clinical bioinformatics as a bridge to the development of diseases-specific, stage-specific, severity-specific and therapy predictive biomarkers, and the potentials of network biomarkers are also discussed. PMID:25560835

Mentoring in the Clinical Setting to Improve Student Decision-Making Competence

ERIC Educational Resources Information Center

Stick-Mueller, Misty; Boesch, Ron; Silverman, Steven; Carpenter, Scott; Illingworth, Robert; Countryman, James

2010-01-01

Introduction: The physician-intern relationship can be difficult to develop. A new chiropractic intern in a teaching clinic undergoes a major transition from classroom to clinical practice and must learn to turn classroom knowledge into clinical application. The ability to start formulating clinical techniques and apply them on a patient is…

Endoscopic optical coherence tomography: technologies and clinical applications [Invited

PubMed Central

Gora, Michalina J.; Suter, Melissa J.; Tearney, Guillermo J.; Li, Xingde

2017-01-01

In this paper, we review the current state of technology development and clinical applications of endoscopic optical coherence tomography (OCT). Key design and engineering considerations are discussed for most OCT endoscopes, including side-viewing and forward-viewing probes, along with different scanning mechanisms (proximal-scanning versus distal-scanning). Multi-modal endoscopes that integrate OCT with other imaging modalities are also discussed. The review of clinical applications of endoscopic OCT focuses heavily on diagnosis of diseases and guidance of interventions. Representative applications in several organ systems are presented, such as in the cardiovascular, digestive, respiratory, and reproductive systems. A brief outlook of the field of endoscopic OCT is also discussed. PMID:28663882

Bedside to Bench: Integrating Quantitative Clinical Pharmacology and Reverse Translation to Optimize Drug Development.

PubMed

Gibbs, John P; Menon, Rajeev; Kasichayanula, Sreeneeranj

2018-02-01

With so much emphasis on reducing attrition and becoming more efficient in the delivery of healthcare, there are many opportunities to leverage existing clinical data in drug development and to foster the practice of reverse translation. The application of quantitative approaches to convert clinical trial and real-world data to knowledge will continue to drive innovation. Herein we discuss recent examples of reverse translation and consider future opportunities to capture critical clinical knowledge to inform decision-making in drug development. © 2017 The Authors. Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

[Biodegradable synthetic implant materials : clinical applications and immunological aspects].

PubMed

Witte, F; Calliess, T; Windhagen, H

2008-02-01

In the last decade biodegradable synthetic implant materials have been established for various clinical applications. Ceramic materials such as calcium phosphate, bioglass and polymers are now routinely used as degradable implants in the clinical practice. Additionally these materials are now also used as coating materials or as microspheres for controlled drug release and belong to a series of examples for applications as scaffolds for tissue engineering. Because immense local concentrations of degradation products are produced during biodegradation, this review deals with the question whether allergic immune reactions, which have been reported for classical metallic and organic implant materials, also play a role in the clinical routine for synthetic biodegradable materials. Furthermore, possible explanatory theories will be developed to clarify the lack of clinical reports on allergy or sensitization to biodegradable synthetic materials.

Review of Virtual Reality Treatment in Psychiatry: Evidence Versus Current Diffusion and Use.

PubMed

Mishkind, Matthew C; Norr, Aaron M; Katz, Andrea C; Reger, Greg M

2017-09-18

This review provides an overview of the current evidence base for and clinical applications of the use of virtual reality (VR) in psychiatric practice, in context of recent technological developments. The use of VR in psychiatric practice shows promise with much of the research demonstrating clinical effectiveness for conditions including post-traumatic stress disorder, anxiety and phobias, chronic pain, rehabilitation, and addictions. However, more research is needed before the use of VR is considered a clinical standard of practice in some areas. The recent release of first generation consumer VR products signals a change in the viability of further developing VR systems and applications. As applications increase so will the need for good quality research to best understand what makes VR effective, and when VR is not appropriate for clinical services. As the field progresses, it is hopeful that the flexibility afforded by this technology will yield superior outcomes and a better understanding of the underlying mechanisms impacting those outcomes.

A component-based, distributed object services architecture for a clinical workstation.

PubMed

Chueh, H C; Raila, W F; Pappas, J J; Ford, M; Zatsman, P; Tu, J; Barnett, G O

1996-01-01

Attention to an architectural framework in the development of clinical applications can promote reusability of both legacy systems as well as newly designed software. We describe one approach to an architecture for a clinical workstation application which is based on a critical middle tier of distributed object-oriented services. This tier of network-based services provides flexibility in the creation of both the user interface and the database tiers. We developed a clinical workstation for ambulatory care using this architecture, defining a number of core services including those for vocabulary, patient index, documents, charting, security, and encounter management. These services can be implemented through proprietary or more standard distributed object interfaces such as CORBA and OLE. Services are accessed over the network by a collection of user interface components which can be mixed and matched to form a variety of interface styles. These services have also been reused with several applications based on World Wide Web browser interfaces.

A component-based, distributed object services architecture for a clinical workstation.

PubMed Central

Chueh, H. C.; Raila, W. F.; Pappas, J. J.; Ford, M.; Zatsman, P.; Tu, J.; Barnett, G. O.

1996-01-01

Attention to an architectural framework in the development of clinical applications can promote reusability of both legacy systems as well as newly designed software. We describe one approach to an architecture for a clinical workstation application which is based on a critical middle tier of distributed object-oriented services. This tier of network-based services provides flexibility in the creation of both the user interface and the database tiers. We developed a clinical workstation for ambulatory care using this architecture, defining a number of core services including those for vocabulary, patient index, documents, charting, security, and encounter management. These services can be implemented through proprietary or more standard distributed object interfaces such as CORBA and OLE. Services are accessed over the network by a collection of user interface components which can be mixed and matched to form a variety of interface styles. These services have also been reused with several applications based on World Wide Web browser interfaces. PMID:8947744

The clinical applications of genome editing in HIV.

PubMed

Wang, Cathy X; Cannon, Paula M

2016-05-26

HIV/AIDS has long been at the forefront of the development of gene- and cell-based therapies. Although conventional gene therapy approaches typically involve the addition of anti-HIV genes to cells using semirandomly integrating viral vectors, newer genome editing technologies based on engineered nucleases are now allowing more precise genetic manipulations. The possible outcomes of genome editing include gene disruption, which has been most notably applied to the CCR5 coreceptor gene, or the introduction of small mutations or larger whole gene cassette insertions at a targeted locus. Disruption of CCR5 using zinc finger nucleases was the first-in-human application of genome editing and remains the most clinically advanced platform, with 7 completed or ongoing clinical trials in T cells and hematopoietic stem/progenitor cells (HSPCs). Here we review the laboratory and clinical findings of CCR5 editing in T cells and HSPCs for HIV therapy and summarize other promising genome editing approaches for future clinical development. In particular, recent advances in the delivery of genome editing reagents and the demonstration of highly efficient homology-directed editing in both T cells and HSPCs are expected to spur the development of even more sophisticated applications of this technology for HIV therapy. © 2016 by The American Society of Hematology.

From impedance theory to needle electrode guidance in tissue

NASA Astrophysics Data System (ADS)

Kalvøy, Håvard; Høyum, Per; Grimnes, Sverre; Martinsen, Ørjan G.

2010-04-01

Fast access to blood vessels or other tissues/organs can be crucial in clinical or acute medical treatment. We have developed a method for needle guidance for use in different types of applications. The feasibility of an automatic application for fast access to blood vessels during acute cardiac arrest, based on this method, has been evaluated. Suited electrode setups were found by development of needle electrode models used in simulation and sensitivity analyses. In vitro measurements were done both to determine the fundamental properties of the electrodes for use in the models and to confirm the simulation results. Development of algorithms for tissue characterization and differentiation was based on in vivo impedance measurement in porcine models and confirmed in human tissue in vivo. Feasibility was proven by application prototyping and impedance data presented as invasive Electrical Impedance Tomography (iEIT). Our conclusion is that this method can be utilized in a wide range of clinical applications.

Recent development of mass spectrometry and proteomics applications in identification and typing of bacteria.

PubMed

Cheng, Keding; Chui, Huixia; Domish, Larissa; Hernandez, Drexler; Wang, Gehua

2016-04-01

Identification and typing of bacteria occupy a large fraction of time and work in clinical microbiology laboratories. With the certification of some MS platforms in recent years, more applications and tests of MS-based diagnosis methods for bacteria identification and typing have been created, not only on well-accepted MALDI-TOF-MS-based fingerprint matches, but also on solving the insufficiencies of MALDI-TOF-MS-based platforms and advancing the technology to areas such as targeted MS identification and typing of bacteria, bacterial toxin identification, antibiotics susceptibility/resistance tests, and MS-based diagnostic method development on unique bacteria such as Clostridium and Mycobacteria. This review summarizes the recent development in MS platforms and applications in bacteria identification and typing of common pathogenic bacteria. © 2016 The Authors. PROTEOMICS - Clinical Applications Published by WILEY-VCH Verlag GmbH & Co. KGaA.

Enhancing value of clinical pharmacodynamics in oncology drug development: An alliance between quantitative pharmacology and translational science.

PubMed

Venkatakrishnan, K; Ecsedy, J A

2017-01-01

Clinical pharmacodynamic evaluation is a key component of the "pharmacologic audit trail" in oncology drug development. We posit that its value can and should be greatly enhanced via application of a robust quantitative pharmacology framework informed by biologically mechanistic considerations. Herein, we illustrate examples of intersectional blindspots across the disciplines of quantitative pharmacology and translational science and offer a roadmap aimed at enhancing the caliber of clinical pharmacodynamic research in the development of oncology therapeutics. © 2016 American Society for Clinical Pharmacology and Therapeutics.

Information Model for Reusability in Clinical Trial Documentation

ERIC Educational Resources Information Center

Bahl, Bhanu

2013-01-01

In clinical research, New Drug Application (NDA) to health agencies requires generation of a large number of documents throughout the clinical development life cycle, many of which are also submitted to public databases and external partners. Current processes to assemble the information, author, review and approve the clinical research documents,…

Biomedical Knowledge and Clinical Expertise.

ERIC Educational Resources Information Center

Boshuizen, Henny P. A.; Schmidt, Henk G.

A study examined the application and availability of clinical and biomedical knowledge in the clinical reasoning of physicians as well as possible mechanisms responsible for changes in the organization of clinical and biomedical knowledge in the development from novice to expert. Subjects were 28 students (10 second year, 8 fourth year, and 10…

[Application of virtual reality in the motor aspects of neurorehabilitation].

PubMed

Peñasco-Martín, Benito; de los Reyes-Guzmán, Ana; Gil-Agudo, Ángel; Bernal-Sahún, Alberto; Pérez-Aguilar, Beatriz; de la Peña-González, Ana Isabel

2010-10-16

Virtual reality allows the user to interact with elements within a simulated scene. In recent times we have been witness to the introduction of virtual reality-based devices as one of the most significant novelties in neurorehabilitation. To review the clinical applications of the developments based on virtual reality for the neurorehabilitation treatment of the motor aspects of the most frequent disabling processes with a neurological origin. A review was carried out of the Medline, Physiotherapy Evidence Database, Ovid and Cochrane Library databases up until April 2009. This was completed with a web search using Google. No clinical trial conducted on its effectiveness has been found to date. The information that was collected is based on the description of the various prototypes produced by the different groups involved in their development. In most cases they are clinical trials conducted with a small number of patients, which have focused more on testing the validity of the device and checking whether it works correctly than on attempting to prove its clinical effectiveness. Although most of the clinical applications refer to patients with stroke, there were also several applications for patients with spinal cord injuries, multiple sclerosis, Parkinson's disease or balance disorders. Virtual reality is a novel tool with a promising future in neurorehabilitation. Further studies are needed to demonstrate its clinical effectiveness as compared to the traditional techniques.

Smartphone Applications for the Clinical Oncologist in UK Practice.

PubMed

Rozati, Hamoun; Shah, Sonya Pratik; Shah, Neha

2015-06-01

A number of medical smartphone applications have been developed to assist clinical oncology specialists. Concerns have arisen that the information provided may not be under sufficient scrutiny. This study aims to analyse the current applications available for clinical oncologists in the UK. Applications aimed specifically at physician clinical oncologists were searched for on the major smartphone operating systems: Apple iOS; Google Android; Microsoft Windows OS; and Blackberry OS. All applications were installed and analysed. The applications were scrutinised to assess the following information: cost; whether the information included was referenced; when the information was last updated; and whether they made any reference to UK guidelines. A novel rating score based on these criteria was applied to each application. Fifty applications were identified: 24 for Apple's iOS; 23 for Google's Android; 2 for Blackberry OS; and 1 for Windows OS. The categories of applications available were: drug reference; journal reference; learning; clinical calculators; decision support; guidelines; and dictionaries. Journal reference and guideline applications scored highly on our rating system. Drug reference application costs were prohibitive. Learning tools were poorly referenced and not up-to-date. Smartphones provide easy access to information. There are numerous applications devoted to oncology physicians, many of which are free and contain referenced, up-to-date data. The cost and quality of drug reference and learning applications have significant scope for improvement. A regulatory body is needed to ensure the presence of peer-reviewed, validated applications to ensure their reliability.

Applications of stable isotopes in clinical pharmacology

PubMed Central

Schellekens, Reinout C A; Stellaard, Frans; Woerdenbag, Herman J; Frijlink, Henderik W; Kosterink, Jos G W

2011-01-01

This review aims to present an overview of the application of stable isotope technology in clinical pharmacology. Three main categories of stable isotope technology can be distinguished in clinical pharmacology. Firstly, it is applied in the assessment of drug pharmacology to determine the pharmacokinetic profile or mode of action of a drug substance. Secondly, stable isotopes may be used for the assessment of drug products or drug delivery systems by determination of parameters such as the bioavailability or the release profile. Thirdly, patients may be assessed in relation to patient-specific drug treatment; this concept is often called personalized medicine. In this article, the application of stable isotope technology in the aforementioned three areas is reviewed, with emphasis on developments over the past 25 years. The applications are illustrated with examples from clinical studies in humans. PMID:21801197

Wireless remote control clinical image workflow: utilizing a PDA for offsite distribution

NASA Astrophysics Data System (ADS)

Liu, Brent J.; Documet, Luis; Documet, Jorge; Huang, H. K.; Muldoon, Jean

2004-04-01

Last year we presented in RSNA an application to perform wireless remote control of PACS image distribution utilizing a handheld device such as a Personal Digital Assistant (PDA). This paper describes the clinical experiences including workflow scenarios of implementing the PDA application to route exams from the clinical PACS archive server to various locations for offsite distribution of clinical PACS exams. By utilizing this remote control application, radiologists can manage image workflow distribution with a single wireless handheld device without impacting their clinical workflow on diagnostic PACS workstations. A PDA application was designed and developed to perform DICOM Query and C-Move requests by a physician from a clinical PACS Archive to a CD-burning device for automatic burning of PACS data for the distribution to offsite. In addition, it was also used for convenient routing of historical PACS exams to the local web server, local workstations, and teleradiology systems. The application was evaluated by radiologists as well as other clinical staff who need to distribute PACS exams to offsite referring physician"s offices and offsite radiologists. An application for image workflow management utilizing wireless technology was implemented in a clinical environment and evaluated. A PDA application was successfully utilized to perform DICOM Query and C-Move requests from the clinical PACS archive to various offsite exam distribution devices. Clinical staff can utilize the PDA to manage image workflow and PACS exam distribution conveniently for offsite consultations by referring physicians and radiologists. This solution allows the radiologist to expand their effectiveness in health care delivery both within the radiology department as well as offisite by improving their clinical workflow.

Biomagnetic instrumentation and measurement

NASA Technical Reports Server (NTRS)

Iufer, E. J.

1978-01-01

The instruments and techniques of biomagnetic measurement have progressed greatly in the past 15 years and are now of a quality appropriate to clinical applications. The paper reports on recent developments in the design and application of SQUID (Superconducting Quantum Interference Device) magnetometers to biomagnetic measurement. The discussion covers biomagnetic field levels, magnetocardiography, magnetic susceptibility plethysmography, ambient noise and sensor types, principles of operation of a SQUID magnetometer, and laboratory techniques. Of the many promising applications of noninvasive biomagnetic measurement, magnetocardiography is the most advanced and the most likely to find clinical application in the near future.

Considerations in the development of circulating tumor cell technology for clinical use

PubMed Central

2012-01-01

This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC) technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development–analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA) and the US National Cancer Institute (NCI). PMID:22747748

Centralized Research Recruitment—Evolving a Local Clinical Research Recruitment Web Application to Better Meet User Needs

PubMed Central

Dwyer‐White, Molly; Doshi, Aalap; Hill, Mary; Pienta, Kenneth J.

2011-01-01

Abstract  Recruiting volunteers into clinical research remains a significant challenge for many clinical research study teams, thus the Michigan Institute for Clinical and Health Research (MICHR) at the University of Michigan developed UMClinicalStudies (http://www.UMClinicalStudies.org)—a Web application that links the community to a single gateway for clinical research. UMClinicalStudies (formerly named “Engage”) is an integral piece of MICHR’s efforts to increase clinical research participation in order to advance medical discoveries. Despite the initial success of the application, barriers to research participation remain, including the applications accessibility for potential research volunteers and study team members. In response, new initiatives were instigated to identify user needs, in order to broaden the ability to simultaneously assist researchers in recruitment activities, while also aiding potential volunteers in the exploration of and participation in clinical research opportunities. To do this, improvements to the interface and functionality were identified and implemented for both the public and the research audiences through extensive system analysis, and through the application of human computer interactivity processes, resulting in significant improvements in usability and ultimately research volunteerism, indicating that utilizing such technology is pivotal in reaching broader audiences for clinical trial participation. Clin Trans Sci 2011; Volume 4: 363–368 PMID:22029810

Department of Defense Acquisition of Vaccine Production. Volume 1

DTIC Science & Technology

2000-12-01

and by Science Applications International Corporation (SAIC) under a contract with the Office of the Director, Defense Research and Engineering...development clinical trials, manufacturing, and development; requires application of state-of- testing the-art research capability to problem solving...trials, vaccine recommending usage manufacturing scale, and logistics bodies (e.g., AFEB, ACIP) License application Prepare and submit -100 volume

[R-ALERGO. Allergy-healthy routes in Valencia].

PubMed

Temes Cordovez, Rafael R; Moya Fuero, Alfonso; Martí Garrido, Jaume; Perales Chordá, Carolina; Díaz Palacios, Miguel; Hernández Fernández de Rojas, Dolores

2016-01-01

R-ALERGO is a project developed by researchers from the Universitat Politècnica de València and the Hospital Universitario La Fe (Valencia, Spain). The main objective of the project is to create a mobile application identifying, within the city of Valencia, the most favorable routes for allergic individuals. The application is developed using nine environmental variables with a potential effect on the development of clinical manifestations in allergic individuals. The application combines the use of spatial analysis based on network technology and implemented with a geographic information system software. The first 01 version is under evaluation for a Healthy app hallmark. The next step in this project is to design a clinical validation process to test its usefulness in allergic individuals. Copyright © 2015 SESPAS. Published by Elsevier Espana. All rights reserved.

What techniques might be used to harness placebo effects in non-malignant pain? A literature review and survey to develop a taxonomy.

PubMed

Bishop, Felicity L; Coghlan, Beverly; Geraghty, Adam Wa; Everitt, Hazel; Little, Paul; Holmes, Michelle M; Seretis, Dionysis; Lewith, George

2017-06-30

Placebo effects can be clinically meaningful but are seldom fully exploited in clinical practice. This review aimed to facilitate translational research by producing a taxonomy of techniques that could augment placebo analgesia in clinical practice. Literature review and survey. We systematically analysed methods which could plausibly be used to elicit placebo effects in 169 clinical and laboratory-based studies involving non-malignant pain, drawn from seven systematic reviews. In a validation exercise, we surveyed 33 leading placebo researchers (mean 12 years’ research experience, SD 9.8), who were asked to comment on and add to the draft taxonomy derived from the literature. The final taxonomy defines 30 procedures that may contribute to placebo effects in clinical and experimental research, proposes 60 possible clinical applications and classifies procedures into five domains: the patient’s characteristics and belief (5 procedures and 11 clinical applications), the practitioner’s characteristics and beliefs (2 procedures and 4 clinical applications), the healthcare setting (8 procedures and 13 clinical applications), treatment characteristics (8 procedures and 14 clinical applications) and the patientâ€"practitioner interaction (7 procedures and 18 clinical applications). The taxonomy provides a preliminary and novel tool with potential to guide translational research aiming to harness placebo effects for patient benefit in practice. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Pulmonary Testing Laboratory Computer Application

PubMed Central

Johnson, Martin E.

1980-01-01

An interactive computer application reporting patient pulmonary function data has been developed by Washington, D.C. VA Medical Center staff. A permanent on-line data base of patient demographics, lung capacity, flows, diffusion, arterial blood gases and physician interpretation is maintained by a minicomputer at the hospital. A user oriented application program resulted from development in concert with the clinical users. Rapid program development resulted from employing a newly developed time saving technique that has found wide application at other VA Medical Centers. Careful attention to user interaction has resulted in an application program requiring little training and which has been satisfactorily used by a number of clinicians.

Photodynamic therapy (PDT) and photodiagnosis (PD) using endogenous photosensitization induced by 5-aminolevulinic acid (ALA): current clinical and development status

NASA Astrophysics Data System (ADS)

Marcus, Stuart L.; Sobel, Russel S.; Golub, Allyn L.; Carroll, Ronald L.; Lundahl, Scott L.; Shulman, D. Geoffrey

1996-04-01

Exogenous provision of ALA to many tissues results in the accumulation of sufficient quantities of the endogenous photosensitizer protoporphyrin IX, (PpIX), to produce a photodynamic effect. Therefore, ALA may be considered the only current PDT agent in clinical development which is a biochemical precursor of a photosensitizer. Topical ALA application, followed by exposure to activating light (ALA PDT), has been reported effective for the treatment of a variety of dermatologic diseases including cutaneous T-cell lymphoma, superficial basal cell carcinoma, Bowen's disease, and actinic (solar) keratoses, and is also being examined for treatment of acne and hirsutism. PpIX induced by ALA application also may serve as a fluorescence detection marker for photodiagnosis (PD) of malignant and pre- malignant conditions of the urinary bladder and other organs. Local internal application of ALA has also been used for selective endometrial ablation in animal model systems and is beginning to be examined in human clinical studies. Systemic, oral administration of ALA has been used for ALA PDT of superficial head and neck cancer, various gastrointestinal cancers, and the condition known as Barrett's esophagus. This brief paper reviews the current clinical and development status of ALA PDT.

Report on the development and application of PET/CT in mainland China

PubMed Central

Zhou, Xiang; Liu, Jianjun; Huang, Gang

2017-01-01

Purpose To examine the development and application of systems combining positron emission and x-ray-computed tomography systems (PET/CTs) in mainland China. Methods Using a questionnaire, we surveyed Chinese medical institutions on a variety topics relating to their PET/CT systems and its use. The respondents had PET/CTs installed and in clinical use before 31 December 2015. We examined the clinical scenarios to which Chinese PET/CTs were applied by reviewing the related Chinese and international literature from the start of 1995 to the end of 2013; these papers were found by searching the Wanfang and PubMed databases, respectively. The data were then classified and analyzed statistically. Results At the end of 2015, there were 240 PET/CTs and 101 medical cyclotrons in mainland China. The total number of PET studies performed in 2015 was 469,364. The main clinical applications of PET were found to be diagnostic fludeoxyglucose (18F-FDG) imaging and oncological imaging. A minority of PET/CT studies were performed using 11C-choline and other imaging agents. The number of papers relating to clinical use of PET/CT in mainland China increased each year over the period of study, in both the Chinese and international literature. Despite this progress, important problems were also apparent, including unbalanced regional development and the limited quality of the research. Conclusions This study provides detailed information for understanding the development PET/CT technology in mainland China, along with its geographical distribution and clinical application. It may thus prove a useful reference for all those involved in planning the future of PET/CT in China. PMID:28969081

Toxicogenomics and clinical toxicology: an example of the connection between basic and applied sciences.

PubMed

Ferrer-Dufol, Ana; Menao-Guillen, Sebastian

2009-04-10

The relationship between basic research and its potential clinical applications is often a difficult subject. Clinical toxicology has always been very dependent on experimental research whose usefulness has been impaired by the existence of huge differences in the toxicity expression of different substances, inter- and intra-species which make it difficult to predict clinical effects in humans. The new methods in molecular biology developed in the last decades are furnishing very useful tools to study some of the more relevant molecules implied in toxicokinetic and toxicodynamic processes. We aim to show some meaningful examples of how recent research developments with genes and proteins have clear applications to understand significant clinical matters, such as inter-individual variations in susceptibility to chemicals, and other phenomena related to the way some substances act to induce variations in the expression and functionality of these targets.

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

The value of item response theory in clinical assessment: a review.

PubMed

Thomas, Michael L

2011-09-01

Item response theory (IRT) and related latent variable models represent modern psychometric theory, the successor to classical test theory in psychological assessment. Although IRT has become prevalent in the measurement of ability and achievement, its contributions to clinical domains have been less extensive. Applications of IRT to clinical assessment are reviewed to appraise its current and potential value. Benefits of IRT include comprehensive analyses and reduction of measurement error, creation of computer adaptive tests, meaningful scaling of latent variables, objective calibration and equating, evaluation of test and item bias, greater accuracy in the assessment of change due to therapeutic intervention, and evaluation of model and person fit. The theory may soon reinvent the manner in which tests are selected, developed, and scored. Although challenges remain to the widespread implementation of IRT, its application to clinical assessment holds great promise. Recommendations for research, test development, and clinical practice are provided.

[Artificial Intelligence in Drug Discovery].

PubMed

Fujiwara, Takeshi; Kamada, Mayumi; Okuno, Yasushi

2018-04-01

According to the increase of data generated from analytical instruments, application of artificial intelligence(AI)technology in medical field is indispensable. In particular, practical application of AI technology is strongly required in "genomic medicine" and "genomic drug discovery" that conduct medical practice and novel drug development based on individual genomic information. In our laboratory, we have been developing a database to integrate genome data and clinical information obtained by clinical genome analysis and a computational support system for clinical interpretation of variants using AI. In addition, with the aim of creating new therapeutic targets in genomic drug discovery, we have been also working on the development of a binding affinity prediction system for mutated proteins and drugs by molecular dynamics simulation using supercomputer "Kei". We also have tackled for problems in a drug virtual screening. Our developed AI technology has successfully generated virtual compound library, and deep learning method has enabled us to predict interaction between compound and target protein.

Pharmacogenomics in early-phase clinical development

PubMed Central

Burt, Tal; Dhillon, Savita

2015-01-01

Pharmacogenomics (PGx) offers the promise of utilizing genetic fingerprints to predict individual responses to drugs in terms of safety, efficacy and pharmacokinetics. Early-phase clinical trial PGx applications can identify human genome variations that are meaningful to study design, selection of participants, allocation of resources and clinical research ethics. Results can inform later-phase study design and pipeline developmental decisions. Nevertheless, our review of the clinicaltrials.gov database demonstrates that PGx is rarely used by drug developers. Of the total 323 trials that included PGx as an outcome, 80% have been conducted by academic institutions after initial regulatory approval. Barriers for the application of PGx are discussed. We propose a framework for the role of PGx in early-phase drug development and recommend PGx be universally considered in study design, result interpretation and hypothesis generation for later-phase studies, but PGx results from underpowered studies should not be used by themselves to terminate drug-development programs. PMID:23837482

Hermeneutic application research - finding a common understanding and consensus on care and caring.

PubMed

Koskinen, Camilla; Nyström, Lisbet

2017-03-01

To clinically and contextually implement the theoretical and factual knowledge of care and caring that has been developed in the last 30 years is seen as a great challenge in caring science research. Emphasis has been put on problem-solving research methodologies and action research in hopes of narrowing the divide between caring theory and clinical practice. Thus, the intention is now to further action research towards a hermeneutic approach and to put emphasis on hermeneutic application where theory and praxis become one through human dialogue. This article highlights hermeneutic application research as an alternative methodology within participatory-oriented research which presents a new opportunity to unite clinical practice and caring theory. The aim is to contribute to the development of the hermeneutical application research design in its epistemological, ontological and ethical perspective, by articulating and clarifying the central foundations in the application. On the basis of Gadamer's hermeneutical thinking and Levinas ethical thinking, the central foundations in the application research are ethics, creation of a hermeneutical room, dialogue and common understanding and appropriation and action. When theoretical understanding turns into praxis, knowledge also becomes activity and theory and practice become one. Application thus realises the basic idea that praxis and theory are one, and thus, theory of caring can only become evident and implemented in a clinical practice through moments when the participants find a common understanding and consensus on the knowledge of care and caring. © 2015 Nordic College of Caring Science.

77 FR 10758 - Submission for OMB Review; Comment Request; Application for Collaboration With the NIH Center for...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-23

... programs delivering assay development, screening, hit to lead chemistry, lead optimization, chemical biology studies, drug development capabilities, expertise, and clinical/regulatory resources in a collaborative environment with the goal of moving promising therapeutics into human clinical trials. NCTT uses...

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

PubMed

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

A platform for exploration into chaining of web services for clinical data transformation and reasoning.

PubMed

Maldonado, José Alberto; Marcos, Mar; Fernández-Breis, Jesualdo Tomás; Parcero, Estíbaliz; Boscá, Diego; Legaz-García, María Del Carmen; Martínez-Salvador, Begoña; Robles, Montserrat

2016-01-01

The heterogeneity of clinical data is a key problem in the sharing and reuse of Electronic Health Record (EHR) data. We approach this problem through the combined use of EHR standards and semantic web technologies, concretely by means of clinical data transformation applications that convert EHR data in proprietary format, first into clinical information models based on archetypes, and then into RDF/OWL extracts which can be used for automated reasoning. In this paper we describe a proof-of-concept platform to facilitate the (re)configuration of such clinical data transformation applications. The platform is built upon a number of web services dealing with transformations at different levels (such as normalization or abstraction), and relies on a collection of reusable mappings designed to solve specific transformation steps in a particular clinical domain. The platform has been used in the development of two different data transformation applications in the area of colorectal cancer.

[Review of the initiation and development of the conception of clinical pathway].

PubMed

Wang, Zhen-E; Shangguan, Qing-Miao; Wu, Ping

2010-11-01

Dupont, an American company, used the concept of "pathway" in industry to improve the quality of their products in 1957. In the 1970s, under the pressure of a rise in medical costs, some people realized the concept of the "key pathway" could be used in medicine too. In 1985, the Boston New England Medical Center Hospital (NEMC) succeeded in using the concept of the clinical pathway in medical practice, and afterwards the concept gradually found worldwide application. In 1996, the Fourth Military Medical University in China reported the application of clinical pathway in America. The West China Hospital began to try out the clinical pathway in 1998 and the concept gradually found application in China.

Information warehouse - a comprehensive informatics platform for business, clinical, and research applications.

PubMed

Kamal, Jyoti; Liu, Jianhua; Ostrander, Michael; Santangelo, Jennifer; Dyta, Ravi; Rogers, Patrick; Mekhjian, Hagop S

2010-11-13

Since its inception in 1997, the IW (Information Warehouse) at the Ohio State University Medical Center (OSUMC) has gradually transformed itself from a single purpose business decision support system to a comprehensive informatics platform supporting basic, clinical, and translational research. The IW today is the combination of four integrated components: a clinical data repository containing over a million patients; a research data repository housing various research specific data; an application development platform for building business and research enabling applications; a business intelligence environment assisting in reporting in all function areas. The IW is structured and encoded using standard terminologies such as SNOMED-CT, ICD, and CPT. The IW is an important component of OSUMC's Clinical and Translational Science Award (CTSA) informatics program.

A Brief Review of OPT101 Sensor Application in Near-Infrared Spectroscopy Instrumentation for Intensive Care Unit Clinics

PubMed Central

Li, Ting; Zhong, Fulin; Pan, Boan; Li, Zebin; Huang, Chong; Deng, Zishan

2017-01-01

The optoelectronic sensor OPT101 have merits in advanced optoelectronic response characteristics at wavelength range for medical near-infrared spectroscopy and small-size chip design with build-in trans-impedance amplifier. Our lab is devoted to developing a series of portable near-infrared spectroscopy (NIRS) devices embedded with OPT101 for applications in intensive care unit clinics, based on NIRS principle. Here we review the characteristics and advantages of OPT101 relative to clinical NIRS instrumentation, and the most recent achievements, including early-diagnosis and therapeutic effect evaluation of thrombus, noninvasive monitoring of patients' shock severity, and fatigue evaluation. The future prospect on OPT101 improvements in noninvasive clinical applications is also discussed. PMID:28757564

[Application of three compartment model and response surface model to clinical anesthesia using Microsoft Excel].

PubMed

Abe, Eiji; Abe, Mari

2011-08-01

With the spread of total intravenous anesthesia, clinical pharmacology has become more important. We report Microsoft Excel file applying three compartment model and response surface model to clinical anesthesia. On the Microsoft Excel sheet, propofol, remifentanil and fentanyl effect-site concentrations are predicted (three compartment model), and probabilities of no response to prodding, shaking, surrogates of painful stimuli and laryngoscopy are calculated using predicted effect-site drug concentration. Time-dependent changes in these calculated values are shown graphically. Recent development in anesthetic drug interaction studies are remarkable, and its application to clinical anesthesia with this Excel file is simple and helpful for clinical anesthesia.

Communication challenges in system development: involvement of system developers in small-scale IT projects.

PubMed

Petersen, Lone Stub; Bjoernes, Charlotte D; Bertelsen, Pernille

2010-01-01

A well-known challenge in system development is the aspect of user participation. In this paper we shift perspective from how to involve users in system development to how project managers with a clinical background, but without technical system knowledge, can involve system developers in IT projects. Using data from the development of an online patient book (an ICT application for clinical practice), we analyze challenges using the concept of language-games. We conclude that further research and development of participatory and communicative methods to involve system developers in IT projects, based in a clinical context, is needed.

The Application of Web-based Computer-assisted Instruction Courseware within Health Assessment

NASA Astrophysics Data System (ADS)

Xiuyan, Guo

Health assessment is a clinical nursing course and places emphasis on clinical skills. The application of computer-assisted instruction in the field of nursing teaching solved the problems in the traditional lecture class. This article stated teaching experience of web-based computer-assisted instruction, based upon a two-year study of computer-assisted instruction courseware use within the course health assessment. The computer-assisted instruction courseware could develop teaching structure, simulate clinical situations, create teaching situations and facilitate students study.

The eClinical Care Pathway Framework: a novel structure for creation of online complex clinical care pathways and its application in the management of sexually transmitted infections.

PubMed

Gibbs, Jo; Sutcliffe, Lorna J; Gkatzidou, Voula; Hone, Kate; Ashcroft, Richard E; Harding-Esch, Emma M; Lowndes, Catherine M; Sadiq, S Tariq; Sonnenberg, Pam; Estcourt, Claudia S

2016-07-22

Despite considerable international eHealth impetus, there is no guidance on the development of online clinical care pathways. Advances in diagnostics now enable self-testing with home diagnosis, to which comprehensive online clinical care could be linked, facilitating completely self-directed, remote care. We describe a new framework for developing complex online clinical care pathways and its application to clinical management of people with genital chlamydia infection, the commonest sexually transmitted infection (STI) in England. Using the existing evidence-base, guidelines and examples from contemporary clinical practice, we developed the eClinical Care Pathway Framework, a nine-step iterative process. Step 1: define the aims of the online pathway; Step 2: define the functional units; Step 3: draft the clinical consultation; Step 4: expert review; Step 5: cognitive testing; Step 6: user-centred interface testing; Step 7: specification development; Step 8: software testing, usability testing and further comprehension testing; Step 9: piloting. We then applied the Framework to create a chlamydia online clinical care pathway (Online Chlamydia Pathway). Use of the Framework elucidated content and structure of the care pathway and identified the need for significant changes in sequences of care (Traditional: history, diagnosis, information versus Online: diagnosis, information, history) and prescribing safety assessment. The Framework met the needs of complex STI management and enabled development of a multi-faceted, fully-automated consultation. The Framework provides a comprehensive structure on which complex online care pathways such as those needed for STI management, which involve clinical services, public health surveillance functions and third party (sexual partner) management, can be developed to meet national clinical and public health standards. The Online Chlamydia Pathway's standardised method of collecting data on demographics and sexual behaviour, with potential for interoperability with surveillance systems, could be a powerful tool for public health and clinical management.

Analysis of the Chemical, Pharmacological and Clinical Applications of Polygonum Cuspidatum

NASA Astrophysics Data System (ADS)

Guo, Chenyang; Bai, Ming; Miao, Mingsan; Miao, Yanyan

2018-01-01

Traditional Chinese medicine Polygonum cuspidatum widely used, the larger production, and in the clinical application of more, but the role played by the role of different roles are also different. By reviewing the relevant literatures in recent years, the chemical constituents and pharmacological effects of Polygonum cuspidatum were sorted and summarized, and the role of Polygonum cuspidatum was analyzed, and the function of Polygonum cuspidatum was explored to find out the role of Polygonum cuspidatum in compatibility. Application law. Which can not only study the medicinal mechanism of Polygonum cuspidatum, but also provide the theoretical basis for the medicinal development, clinical treatment and comprehensive utilization of Polygonum cuspidatum.

Home monitoring of patients with Parkinson's disease via wearable technology and a web-based application.

PubMed

Patel, Shyamal; Chen, Bor-Rong; Buckley, Thomas; Rednic, Ramona; McClure, Doug; Tarsy, Daniel; Shih, Ludy; Dy, Jennifer; Welsh, Matt; Bonato, Paolo

2010-01-01

Objective long-term health monitoring can improve the clinical management of several medical conditions ranging from cardiopulmonary diseases to motor disorders. In this paper, we present our work toward the development of a home-monitoring system. The system is currently used to monitor patients with Parkinson's disease who experience severe motor fluctuations. Monitoring is achieved using wireless wearable sensors whose data are relayed to a remote clinical site via a web-based application. The work herein presented shows that wearable sensors combined with a web-based application provide reliable quantitative information that can be used for clinical decision making.

Moral sensitivity relating to the application of the code of ethics.

PubMed

Kim, Yong-Soon; Kang, Se-Won; Ahn, Jeong-Ah

2013-06-01

This study investigated the clinical application of the 2006 Third Revised Korean Nurses' Code of Ethics and the moral sensitivity of nurses. A total of 303 clinical nurses in South Korea participated in the survey in May and June 2011. As instruments of this study, we used the 15 statements of the Korean Nurses' Code of Ethics and Korean Moral Sensitivity Questionnaire. The mean score for application was 3.77 ± 0.59 (out of 5), and the mean score for moral sensitivity was 5.14 ± 0.55 (out of 7). The correlation coefficient (r) of the application and moral sensitivity was 0.336 (p < 0.001). Nurses who scored high on moral sensitivity also scored high on application (t = -5.018, p < 0.001). In clinical settings, educational programmes to develop the moral sensitivity of nurses are necessary for improving the application of the code of ethics.

The development of a clinical outcomes survey research application: Assessment CenterSM

PubMed Central

Rothrock, Nan E.; Hanrahan, Rachel T.; Jansky, Liz J.; Harniss, Mark; Riley, William

2013-01-01

Introduction The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Purpose Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment CenterSM) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Methods Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer “scrum” sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Results Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. Conclusions This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed. PMID:20306332

Concise Review: The Clinical Application of Mesenchymal Stem Cells for Musculoskeletal Regeneration: Current Status and Perspectives

PubMed Central

Steinert, Andre F.; Rackwitz, Lars; Gilbert, Fabian; Nöth, Ulrich

2012-01-01

Regenerative therapies in the musculoskeletal system are based on the suitable application of cells, biomaterials, and/or factors. For an effective approach, numerous aspects have to be taken into consideration, including age, disease, target tissue, and several environmental factors. Significant research efforts have been undertaken in the last decade to develop specific cell-based therapies, and in particular adult multipotent mesenchymal stem cells hold great promise for such regenerative strategies. Clinical translation of such therapies, however, remains a work in progress. In the clinical arena, autologous cells have been harvested, processed, and readministered according to protocols distinct for the target application. As outlined in this review, such applications range from simple single-step approaches, such as direct injection of unprocessed or concentrated blood or bone marrow aspirates, to fabrication of engineered constructs by seeding of natural or synthetic scaffolds with cells, which were released from autologous tissues and propagated under good manufacturing practice conditions (for example, autologous chondrocyte implantation). However, only relatively few of these cell-based approaches have entered the clinic, and none of these treatments has become a “standard of care” treatment for an orthopaedic disease to date. The multifaceted reasons for the current status from the medical, research, and regulatory perspectives are discussed here. In summary, this review presents the scientific background, current state, and implications of clinical mesenchymal stem cell application in the musculoskeletal system and provides perspectives for future developments. PMID:23197783

Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee.

PubMed

Rossini, P M; Burke, D; Chen, R; Cohen, L G; Daskalakis, Z; Di Iorio, R; Di Lazzaro, V; Ferreri, F; Fitzgerald, P B; George, M S; Hallett, M; Lefaucheur, J P; Langguth, B; Matsumoto, H; Miniussi, C; Nitsche, M A; Pascual-Leone, A; Paulus, W; Rossi, S; Rothwell, J C; Siebner, H R; Ugawa, Y; Walsh, V; Ziemann, U

2015-06-01

These guidelines provide an up-date of previous IFCN report on "Non-invasive electrical and magnetic stimulation of the brain, spinal cord and roots: basic principles and procedures for routine clinical application" (Rossini et al., 1994). A new Committee, composed of international experts, some of whom were in the panel of the 1994 "Report", was selected to produce a current state-of-the-art review of non-invasive stimulation both for clinical application and research in neuroscience. Since 1994, the international scientific community has seen a rapid increase in non-invasive brain stimulation in studying cognition, brain-behavior relationship and pathophysiology of various neurologic and psychiatric disorders. New paradigms of stimulation and new techniques have been developed. Furthermore, a large number of studies and clinical trials have demonstrated potential therapeutic applications of non-invasive brain stimulation, especially for TMS. Recent guidelines can be found in the literature covering specific aspects of non-invasive brain stimulation, such as safety (Rossi et al., 2009), methodology (Groppa et al., 2012) and therapeutic applications (Lefaucheur et al., 2014). This up-dated review covers theoretical, physiological and practical aspects of non-invasive stimulation of brain, spinal cord, nerve roots and peripheral nerves in the light of more updated knowledge, and include some recent extensions and developments. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Using a Context-aware Medical Application to Address Information Needs for Extubation Decisions

PubMed Central

Zhu, Xinxin; Lord, William

2005-01-01

Information overload has been one of the causes of preventable medical errors [1] and escalating costs [2]. A context-aware application with embedded clinical knowledge is proposed to provide practitioners with the appropriate amount of information and content. We developed a prototype of a context-aware medical application to address clinicians’ information needs that arise in a data-intensive unit, the Cardio-Thoracic Intensive Care Unit (CTICU). A major clinical decision supported by the prototype, the extubation decision, is illustrated. PMID:16779455

Bioimpedance imaging: an overview of potential clinical applications.

PubMed

Bayford, Richard; Tizzard, Andrew

2012-10-21

Electrical Impedance Tomography (EIT) is an imaging technique based on multiple bio impedance measurements to produce a map (image) of impedance or changes in impedance across a region. Its origins lay in geophysics where it is still used to today. This review highlights potential clinical applications of EIT. Beginning with a brief overview of the underlying principles behind the modality, it describes the background research leading towards the development of the application of EIT for monitoring pulmonary function, detecting and localising tumours and monitoring brain function.

NCI Consumers Guide to Peer Review

Cancer.gov

To define the role consumer advocate in the peer review of applications that support extramural clinical and population-based research and clinical career development and training by various grant and cooperative agreement mechanisms.

Translational Radiomics: Defining the Strategy Pipeline and Considerations for Application-Part 2: From Clinical Implementation to Enterprise.

PubMed

Shaikh, Faiq; Franc, Benjamin; Allen, Erastus; Sala, Evis; Awan, Omer; Hendrata, Kenneth; Halabi, Safwan; Mohiuddin, Sohaib; Malik, Sana; Hadley, Dexter; Shrestha, Rasu

2018-03-01

Enterprise imaging has channeled various technological innovations to the field of clinical radiology, ranging from advanced imaging equipment and postacquisition iterative reconstruction tools to image analysis and computer-aided detection tools. More recently, the advancement in the field of quantitative image analysis coupled with machine learning-based data analytics, classification, and integration has ushered in the era of radiomics, a paradigm shift that holds tremendous potential in clinical decision support as well as drug discovery. However, there are important issues to consider to incorporate radiomics into a clinically applicable system and a commercially viable solution. In this two-part series, we offer insights into the development of the translational pipeline for radiomics from methodology to clinical implementation (Part 1) and from that point to enterprise development (Part 2). In Part 2 of this two-part series, we study the components of the strategy pipeline, from clinical implementation to building enterprise solutions. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

An open architecture for medical image workstation

NASA Astrophysics Data System (ADS)

Liang, Liang; Hu, Zhiqiang; Wang, Xiangyun

2005-04-01

Dealing with the difficulties of integrating various medical image viewing and processing technologies with a variety of clinical and departmental information systems and, in the meantime, overcoming the performance constraints in transferring and processing large-scale and ever-increasing image data in healthcare enterprise, we design and implement a flexible, usable and high-performance architecture for medical image workstations. This architecture is not developed for radiology only, but for any workstations in any application environments that may need medical image retrieving, viewing, and post-processing. This architecture contains an infrastructure named Memory PACS and different kinds of image applications built on it. The Memory PACS is in charge of image data caching, pre-fetching and management. It provides image applications with a high speed image data access and a very reliable DICOM network I/O. In dealing with the image applications, we use dynamic component technology to separate the performance-constrained modules from the flexibility-constrained modules so that different image viewing or processing technologies can be developed and maintained independently. We also develop a weakly coupled collaboration service, through which these image applications can communicate with each other or with third party applications. We applied this architecture in developing our product line and it works well. In our clinical sites, this architecture is applied not only in Radiology Department, but also in Ultrasonic, Surgery, Clinics, and Consultation Center. Giving that each concerned department has its particular requirements and business routines along with the facts that they all have different image processing technologies and image display devices, our workstations are still able to maintain high performance and high usability.

A prototype mobile application for triaging dental emergencies.

PubMed

Stein, Corey D; Xiao, Xiang; Levine, Steven; Schleyer, Titus K L; Hochheiser, Harry; Thyvalikakath, Thankam P

2016-10-01

Evidence suggests that dental emergencies are likely to occur when preferred care is less accessible. Communication barriers often exist that cause patients to receive suboptimal treatment or experience discomfort for extended lengths of time. Furthermore, limitations in the conventional approach for managing dental emergencies prevent dentists from receiving critical information before patient visits. The authors developed a mobile application to mediate the uncertainty of dental emergencies. The development and study consisted of a needs analysis and quality assessment of intraoral images captured by smartphones, prototype development, refining the prototype through usability inspection methods, and formative evaluation through usability testing with prospective users. The developed application successfully guided all users through a series of questions designed to capture clinically meaningful data by using familiar smartphone functions. All participants were able to complete a report within 4 minutes, and all clinical information was comprehended by the users. Patient-provided information accompanied by high-resolution images may help dentists substantially in predicting urgency or preparing necessary treatment resources. The results illustrate the feasibility of patients using smartphone applications to report dental emergencies. This technology allows dentists to assess care remotely when direct patient contact is less practical. This study's results demonstrate that patients can use mobile applications to transmit clinical data to their dentists and suggest the possibility of expanding the use of mobile applications to enhance access to routine and emergency dental care. The authors addressed how to enable patients to communicate emergency needs directly to a dentist while obviating patient emergency department visits. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

A Systematic Review of Smartphone Applications for Plastic Surgery Providers: Target Audience, Uses, and Cost.

PubMed

Reusche, Ryan; Buchanan, Patrick J; Kozlow, Jeffrey H; Vercler, Christian J

2016-01-01

The growth and acceptance of smartphones among clinicians has been remarkable over the last decade. Over 87% of doctors use a smartphone or tablet capable of running third-party software known as applications (apps). In the field of plastic surgery, apps have been designed for personal practice development, education, clinical tools and guidelines, and entertainment. This study reviews the literature on apps related to plastic surgery and determines the number and types of apps available. A systematic review of the literature was performed to find articles written about plastic surgery applications. Queries were run in the Apple iPhone iOS App store and Google Play using the term "plastic surgery." Apps were reviewed for ratings, downloads, and cost. In addition, apps were categorized based on purpose. Categories include practice development, media/literature, clinical tool and guideline apps, or recreation. The literature search yielded 8 articles for review, 2 articles focused on categorizing apps and 6 articles focused on describing useful apps. Searching Apple's iTunes (iOS) store identified 273 and Google Play identified 250 apps related to plastic surgery; since 2013, a 62%, and 580% increase, respectively. The iOS store included practice development (46%), recreation (26%), media/literature (14%), and clinical tool and guideline (11%). Google Play store included recreation apps (44%), practice development (24%), clinical tools and guidelines (11%), and media and literature (9%). Apps related to the field of plastic surgery are increasing in prevalence. The content of these apps are variable, and the majority are intended for marketing and development of private practices. Apps linking to literature, texts, study materials, and clinical tools and guidelines are developed for both practicing plastic surgeons and surgical trainees. Finding "useful" apps takes time because searches are often complicated by a variety of apps.

[Correspondence between advances of dental composites and adhesives and clinical guidelines for direct restorations].

PubMed

Wang, X Y; Yue, L

2018-06-09

The longevity of direct adhesive restoration is related to the restorative materials, the patient and the professional. On one hand, dental composites/adhesives have been modified and developed to fulfill the criteria for clinical application. On the other hand, the clinical guidelines for adhesive restorations have been released and updated accordingly, which would prolong the longevity of restorations. In this commentary, the removal of carious tissues, interface preparation for bonding and application of adhesives are emphasized. The administrative measures for registration and clinical evaluation criteria for adhesive restorative material are also introduced.

Laparoscopic sterilization with the spring clip: instrumentation development and current clinical experience.

PubMed

Hulka, J F; Omran, K; Lieberman, B A; Gordon, A G

1979-12-15

Since the original spring clip sterilization studies were reported, a number of clinically important modifications to the spring clip and applicator have been developed. The spring-loaded clip, manufactured by Richard Wolf Medical Instruments Corporation of Chicago, Illinois, and Rocket of London, Inc., London, England, and New York, New York can be applied with either a one- or two-incision applicator and the clips and applicators currently available incorporate improvements to the original prototypes in design, manufacture, and quality control. The two-incision applicator is associated with significantly fewer misapplications and the high pregnancy rates reported with the original clip and applicator have not occurred with the current designs. Comparative studies between the clip and band have revealed less operative bleeding and pain associated with the clip. The method is appropriate to all women requesting sterilization but especially to those in the younger age group who may subsequently request reversal because of divorce and remarriage.

77 FR 64598 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

.... Neurobiology-A November 16, 2012...... *VA Central Office. Cellular and Molecular Medicine...... November 19... December 11, 2012...... Sheraton Crystal City Hotel. Clinical Application of Genetics..... December 12...

78 FR 22622 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-16

... City. Cardiovascular Studies June 3, 2013 Ritz-Carlton, Pentagon City. Cellular and Molecular Medicine..., 2013........ VA Central Office.* Clinical Application of Genetics..... June 18, 2013 Ritz-Carlton...

A Prototype Mobile Application for Triaging Dental Emergencies

PubMed Central

Stein, Corey D.; Xiao, Xiang; Levine, Steven; Schleyer, Titus K. L.; Hochheiser, Harry; Thyvalikakath, Thankam P

2016-01-01

Evidence suggests that dental emergencies are likely to occur when preferred care is less accessible. Communicative barriers often exist that cause patients to receive sub-optimal treatment or remain in discomfort for extended lengths of time. Furthermore, limitations in the conventional approach for managing dental emergencies prevent dentists from receiving critical information prior to patient visits. We developed a mobile application to mediate the uncertainty of dental emergencies. Patient-provided information accompanied by high-resolution images may significantly help dentists predict urgency or prepare necessary treatment resources. The development and study consisted of a needs analysis and quality assessment of intraoral images captured by smartphones; prototype development; refining the prototype through usability inspection methods; and formative evaluation through usability testing with prospective users. The developed application successfully guided all users through a series of questions designed to capture clinically meaningful data using familiar smartphone functions. All participants were able to complete a report within 4 minutes and all clinical information was comprehendible by the users. Our results illustrate the feasibility of patients utilizing smartphone applications to report dental emergencies. This technology allows dentists to remotely assess care when direct patient contact is less practical. This study demonstrates that patients can use mobile applications to transmit clinical data to their dentists and suggests the possibility of expanding its use to enhance access to routine and emergency dental care. Here, we address how we can enable patients to directly communicate emergent needs to a dentist while relieving them of enduring emergency room visits. PMID:27206728

Drug-device combination products in the twenty-first century: epinephrine auto-injector development using human factors engineering.

PubMed

Edwards, Eric S; Edwards, Evan T; Simons, F Estelle R; North, Robert

2015-05-01

The systematic application of human factors engineering (HFE) principles to the development of drug-device combination products, including epinephrine auto-injectors (EAIs), has the potential to improve the effectiveness and safety of drug administration. A PubMed search was performed to assess the role of HFE in the development of drug-device combination products. The following keywords were used in different combinations: 'human factors engineering,' 'human factors,' 'medical products,' 'epinephrine/adrenaline auto-injector,' 'healthcare' and 'patient safety.' This review provides a summary of HFE principles and their application to the development of drug-device combination products as advised by the US FDA. It also describes the HFE process that was applied to the development of Auvi-Q, a novel EAI, highlighting specific steps that occurred during the product-development program. For drug-device combination products, device labeling and usability are critical and have the potential to impact clinical outcomes. Application of HFE principles to the development of drug-delivery devices has the potential to improve product quality and reliability, reduce risk and improve patient safety when applied early in the development process. Additional clinical and real-world studies will confirm whether the application of HFE has helped to develop an EAI that better meets the needs of patients at risk of anaphylaxis.

Closing the gap between knowledge and clinical application: challenges for genomic translation.

PubMed

Burke, Wylie; Korngiebel, Diane M

2015-01-01

Despite early predictions and rapid progress in research, the introduction of personal genomics into clinical practice has been slow. Several factors contribute to this translational gap between knowledge and clinical application. The evidence available to support genetic test use is often limited, and implementation of new testing programs can be challenging. In addition, the heterogeneity of genomic risk information points to the need for strategies to select and deliver the information most appropriate for particular clinical needs. Accomplishing these tasks also requires recognition that some expectations for personal genomics are unrealistic, notably expectations concerning the clinical utility of genomic risk assessment for common complex diseases. Efforts are needed to improve the body of evidence addressing clinical outcomes for genomics, apply implementation science to personal genomics, and develop realistic goals for genomic risk assessment. In addition, translational research should emphasize the broader benefits of genomic knowledge, including applications of genomic research that provide clinical benefit outside the context of personal genomic risk.

Developing a clinical information system: the role of the chief information officer.

PubMed

Glaser, J

1994-11-01

Chief information officers (CIOs) must play a pivotal role in the formation and implementation of a clinical information system, the subset of an organizational information system that deals specifically with support of clinical care activities. Major elements include the applications software, technology and data architecture, databases, and analysis. The organizational structures and processes that manage the development of improvement activities, including the clinical information system itself, are just as vital to the design of an information system as the hardware and software. To develop, sustain, and advance an information infrastructure, the CIO must help establish certain organizational precursors, such as medical staff involvement, experience with quality improvement, and ability to meet data needs. The CIO must then work with the senior administrative and medical leadership in developing a vision for the information system. The CIO must also create new roles and knowledge for information system and medical staff members. Interaction between information services and medical staff is vitally important to the success of a clinical information system. Organizational committees and structures that Brigham and Women's Hospital in Boston put in place to formalize the relationship between information systems and medical staff include the Clinical Initiative Development Program and the Center for Applied Medical Information Systems Research. Improving the clinical management of care and the efficacy of care processes involves complex changes in organizational culture and processes, medical practice and information system applications, technologies, staff, and data.

Transforming practice into clinical scholarship.

PubMed

Limoges, Jacqueline; Acorn, Sonia

2016-04-01

The aims of this paper were to explicate clinical scholarship as synonymous with the scholarship of application and to explore the evolution of scholarly practice to clinical scholarship. Boyer contributed an expanded view of scholarship that recognized various approaches to knowledge production beyond pure research (discovery) to include the scholarship of integration, application and teaching. There is growing interest in using Boyer's framework to advance knowledge production in nursing but the discussion of clinical scholarship in relation to Boyer's framework is sparse. Discussion paper. Literature from 1983-2015 and Boyer's framework. When clinical scholarship is viewed as a synonym for Boyer's scholarship of application, it can be aligned to this well established framework to support knowledge generated in clinical practice. For instance, applying the three criteria for scholarship (documentation, peer review and dissemination) can ensure that the knowledge produced is rigorous, available for critique and used by others to advance nursing practice and patient care. Understanding the differences between scholarly practice and clinical scholarship can promote the development of clinical scholarship. Supporting clinical leaders to identify issues confronting nursing practice can enable scholarly practice to be transformed into clinical scholarship. Expanding the understanding of clinical scholarship and linking it to Boyer's scholarship of application can assist nurses to generate knowledge that addresses clinical concerns. Further dialogue about how clinical scholarship can address the theory-practice gap and how publication of clinical scholarship could be expanded given the goals of clinical scholarship is warranted. © 2016 John Wiley & Sons Ltd.

Clinical Investigator Development Program | Center for Cancer Research

Cancer.gov

The Center for Cancer Research (CCR), a division of the National Cancer Institute (NCI), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), is pleased to announce its annual call for applications for the Clinical Investigator Development Program (CIDP). This is an exciting training opportunity intended for physicians interested in dedicating

Automated information systems provide health information management support to veterans' healthcare.

PubMed

Lloyd, S S

1992-06-01

The Veterans Health Administration has implemented a comprehsnsive DHCP which supports the VA healthcare system at both local and national levels. Numerous clinical and management modules have been developed; an overview was given of selected applications impacting health information managers. Continuing development includes an automated clinical record and expanded electronic data exchange.

Data-driven decision support for radiologists: re-using the National Lung Screening Trial dataset for pulmonary nodule management.

PubMed

Morrison, James J; Hostetter, Jason; Wang, Kenneth; Siegel, Eliot L

2015-02-01

Real-time mining of large research trial datasets enables development of case-based clinical decision support tools. Several applicable research datasets exist including the National Lung Screening Trial (NLST), a dataset unparalleled in size and scope for studying population-based lung cancer screening. Using these data, a clinical decision support tool was developed which matches patient demographics and lung nodule characteristics to a cohort of similar patients. The NLST dataset was converted into Structured Query Language (SQL) tables hosted on a web server, and a web-based JavaScript application was developed which performs real-time queries. JavaScript is used for both the server-side and client-side language, allowing for rapid development of a robust client interface and server-side data layer. Real-time data mining of user-specified patient cohorts achieved a rapid return of cohort cancer statistics and lung nodule distribution information. This system demonstrates the potential of individualized real-time data mining using large high-quality clinical trial datasets to drive evidence-based clinical decision-making.

[Discussion on efficacy evaluation thought and method for innovation medicine of Chinese herbal compound formula based on clinical application characteristics].

PubMed

Sun, Jian-Ning; Sun, Wen-Yan; Dong, Shi-Fen

2017-03-01

The Chinese herbal compound formula preparation was made based on theory of Chinese medicine, which was confirmed by long period clinical application, and with multi-compound and multi-target characteristics. During the exploitation process of innovation medicine of Chinese herbal compound formula, selecting and speeding up the research development of drugs with clinical value shall be paid more attention, and as request of rules involved in new drug research and development, the whole process management should be carried out, including project evaluation, manufacturing process determination, establishment of quality control standards, evaluation for pharmacological and toxic effect, as well as new drug application process. This reviews was aimed to give some proposals for pharmacodynamics research methods involved in exploration of Chinese herbal compound formula preparation, including： ①the endpoint criteria should meet the clinical attribution of new drugs; ②the pre-clinical pharmacodynamics evaluation should be carried on appropriate animal models according to the characteristics of diagnosis and therapy of Chinese medicine and observation indexes; ③during the innovation of drug for infants and children, information on drug action conforming to physiological characteristics of infants and children should be supplied, and the pharmacodynamics and toxicology research shall be conducted in immature rats according to the body weight of children. In a summary, the clinical application characteristics are the important criteria for evaluation of pharmacological effect of innovation medicine of Chinese herbal compound formula. Copyright© by the Chinese Pharmaceutical Association.

Clinical genomics information management software linking cancer genome sequence and clinical decisions.

PubMed

Watt, Stuart; Jiao, Wei; Brown, Andrew M K; Petrocelli, Teresa; Tran, Ben; Zhang, Tong; McPherson, John D; Kamel-Reid, Suzanne; Bedard, Philippe L; Onetto, Nicole; Hudson, Thomas J; Dancey, Janet; Siu, Lillian L; Stein, Lincoln; Ferretti, Vincent

2013-09-01

Using sequencing information to guide clinical decision-making requires coordination of a diverse set of people and activities. In clinical genomics, the process typically includes sample acquisition, template preparation, genome data generation, analysis to identify and confirm variant alleles, interpretation of clinical significance, and reporting to clinicians. We describe a software application developed within a clinical genomics study, to support this entire process. The software application tracks patients, samples, genomic results, decisions and reports across the cohort, monitors progress and sends reminders, and works alongside an electronic data capture system for the trial's clinical and genomic data. It incorporates systems to read, store, analyze and consolidate sequencing results from multiple technologies, and provides a curated knowledge base of tumor mutation frequency (from the COSMIC database) annotated with clinical significance and drug sensitivity to generate reports for clinicians. By supporting the entire process, the application provides deep support for clinical decision making, enabling the generation of relevant guidance in reports for verification by an expert panel prior to forwarding to the treating physician. Copyright © 2013 Elsevier Inc. All rights reserved.

A knowledge authoring tool for clinical decision support.

PubMed

Dunsmuir, Dustin; Daniels, Jeremy; Brouse, Christopher; Ford, Simon; Ansermino, J Mark

2008-06-01

Anesthesiologists in the operating room are unable to constantly monitor all data generated by physiological monitors. They are further distracted by clinical and educational tasks. An expert system would ideally provide assistance to the anesthesiologist in this data-rich environment. Clinical monitoring expert systems have not been widely adopted, as traditional methods of knowledge encoding require both expert medical and programming skills, making knowledge acquisition difficult. A software application was developed for use as a knowledge authoring tool for physiological monitoring. This application enables clinicians to create knowledge rules without the need of a knowledge engineer or programmer. These rules are designed to provide clinical diagnosis, explanations and treatment advice for optimal patient care to the clinician in real time. By intelligently combining data from physiological monitors and demographical data sources the expert system can use these rules to assist in monitoring the patient. The knowledge authoring process is simplified by limiting connective relationships between rules. The application is designed to allow open collaboration between communities of clinicians to build a library of rules for clinical use. This design provides clinicians with a system for parameter surveillance and expert advice with a transparent pathway of reasoning. A usability evaluation demonstrated that anesthesiologists can rapidly develop useful rules for use in a predefined clinical scenario.

Challenges in the Implementation of a Mobile Application in Clinical Practice: Case Study in the Context of an Application that Manages the Daily Interventions of Nurses

PubMed Central

Wipfli, Rolf; Teodoro, Douglas; Sarrey, Everlyne; Walesa, Magali; Lovis, Christian

2013-01-01

Background Working in a clinical environment requires unfettered mobility. This is especially true for nurses who are always on the move providing patients’ care in different locations. Since the introduction of clinical information systems in hospitals, this mobility has often been considered hampered by interactions with computers. The popularity of personal mobile assistants such as smartphones makes it possible to gain easy access to clinical data anywhere. Objective To identify the challenges involved in the deployment of clinical applications on handheld devices and to share our solutions to these problems. Methods A team of experts underwent an iterative development process of a mobile application prototype that aimed to improve the mobility of nurses during their daily clinical activities. Through the process, challenges inherent to mobile platforms have emerged. These issues have been classified, focusing on factors related to ensuring information safety and quality, as well as pleasant and efficient user experiences. Results The team identified five main challenges related to the deployment of clinical mobile applications and presents solutions to overcome each of them: (1) Financial: Equipping every care giver with a new mobile device requires substantial investment that can be lowered if users use their personal device instead, (2) Hardware: The constraints inherent to the clinical environment made us choose the mobile device with the best tradeoff between size and portability, (3) Communication: the connection of the mobile application with any existing clinical information systems (CIS) is insured by a bridge formatting the information appropriately, (4) Security: In order to guarantee the confidentiality and safety of the data, the amount of data stored on the device is minimized, and (5) User interface: The design of our user interface relied on homogeneity, hierarchy, and indexicality principles to prevent an increase in data acquisition errors. Conclusions The introduction of nomadic computing often raises enthusiastic reactions from users, but several challenges due to specific constraints of mobile platforms must be overcome. The ease of development of mobile applications and their rapid spread should not overshadow the real challenges of clinical applications and the potential threats for patient safety and the liability of people and organizations using them. For example, careful attention must be given to the overall architecture of the system and to user interfaces. If these precautions are not taken, it can easily lead to unexpected failures such as an increased number of input errors, loss of data, or decreased efficiency. PMID:25100680

Challenges in the Implementation of a Mobile Application in Clinical Practice: Case Study in the Context of an Application that Manages the Daily Interventions of Nurses.

PubMed

Ehrler, Frederic; Wipfli, Rolf; Teodoro, Douglas; Sarrey, Everlyne; Walesa, Magali; Lovis, Christian

2013-06-12

Working in a clinical environment requires unfettered mobility. This is especially true for nurses who are always on the move providing patients' care in different locations. Since the introduction of clinical information systems in hospitals, this mobility has often been considered hampered by interactions with computers. The popularity of personal mobile assistants such as smartphones makes it possible to gain easy access to clinical data anywhere. To identify the challenges involved in the deployment of clinical applications on handheld devices and to share our solutions to these problems. A team of experts underwent an iterative development process of a mobile application prototype that aimed to improve the mobility of nurses during their daily clinical activities. Through the process, challenges inherent to mobile platforms have emerged. These issues have been classified, focusing on factors related to ensuring information safety and quality, as well as pleasant and efficient user experiences. The team identified five main challenges related to the deployment of clinical mobile applications and presents solutions to overcome each of them: (1) Financial: Equipping every care giver with a new mobile device requires substantial investment that can be lowered if users use their personal device instead, (2) Hardware: The constraints inherent to the clinical environment made us choose the mobile device with the best tradeoff between size and portability, (3) Communication: the connection of the mobile application with any existing clinical information systems (CIS) is insured by a bridge formatting the information appropriately, (4) Security: In order to guarantee the confidentiality and safety of the data, the amount of data stored on the device is minimized, and (5) User interface: The design of our user interface relied on homogeneity, hierarchy, and indexicality principles to prevent an increase in data acquisition errors. The introduction of nomadic computing often raises enthusiastic reactions from users, but several challenges due to specific constraints of mobile platforms must be overcome. The ease of development of mobile applications and their rapid spread should not overshadow the real challenges of clinical applications and the potential threats for patient safety and the liability of people and organizations using them. For example, careful attention must be given to the overall architecture of the system and to user interfaces. If these precautions are not taken, it can easily lead to unexpected failures such as an increased number of input errors, loss of data, or decreased efficiency.

Therapeutic clinical applications of reactor-produced radioisotopes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Knapp, F.F. Jr.

1997-12-01

One of the most rapidly growing areas of clinical nuclear medicine is the therapeutic use of radioisotopes for applications in oncology, rheumatology and, more recently, interventional cardiology. With the rapidly increasing development and evaluation of new agents, their introduction into clinical use, and commercialization, the availability of high levels of therapeutic reactor-produced neutron-rich radioisotopes is of increasing importance. The goals of this paper are to discuss the issues associated with optimization of the production and processing of reactor-produced radioisotopes for therapy, with special emphasis on {sup 188}W, and the optimization of the use of the {sup 188}W/{sup 188}Re generator. Inmore » addition, other key examples of therapeutic radioisotopes of current interest and their specific clinical applications are discussed.« less

Information Warehouse – A Comprehensive Informatics Platform for Business, Clinical, and Research Applications

PubMed Central

Kamal, Jyoti; Liu, Jianhua; Ostrander, Michael; Santangelo, Jennifer; Dyta, Ravi; Rogers, Patrick; Mekhjian, Hagop S.

2010-01-01

Since its inception in 1997, the IW (Information Warehouse) at the Ohio State University Medical Center (OSUMC) has gradually transformed itself from a single purpose business decision support system to a comprehensive informatics platform supporting basic, clinical, and translational research. The IW today is the combination of four integrated components: a clinical data repository containing over a million patients; a research data repository housing various research specific data; an application development platform for building business and research enabling applications; a business intelligence environment assisting in reporting in all function areas. The IW is structured and encoded using standard terminologies such as SNOMED-CT, ICD, and CPT. The IW is an important component of OSUMC’s Clinical and Translational Science Award (CTSA) informatics program. PMID:21347019

Lightweight application for generating clinical research information systems: MAGIC.

PubMed

Leskošek, Brane; Pajntar, Marjan

2015-12-01

Our purpose was to build and test a lightweight solution for generating clinical research information systems (CRIS) that would allow non-IT professionals with basic knowledge of computer usage to quickly define and build a ready-to-use, safe and secure web-based clinical research system for data management. We use the acronym MAGIC (Medical Application Generator InteraCtive) for the system. The generated CRIS should be very easy to build and use, so a common LAMP (Linux Apache MySQL Perl) platform was used, which also enables short development cycles. The application was built and tested using eXtreme Programming (XP) principles by a small development team consisting of one informatics specialist, one physician and one graphical designer/programmer. The parameter and graphical user interface (GUI) definitions for the CRIS can be made by non-IT professionals using an intuitive English-language-like formalism called application definition language (ADL). From these definitions, the MAGIC builds an end-user CRIS that can be used on a wide variety of platforms (from standard workstations to hand-held devices). A working example of a national health-care-quality assessment program is presented to illustrate this process. The lightweight application for generating CRIS (MAGIC) has proven to be useful for both clinical and analytical users in real working environment. To achieve better performance and interoperability, we are planning to recompile the application using XML schemas (XSD) in HL7 CDA or openEHR archetypes formats used for parameters definition and for data interchange between different information systems.

Implementation of a Mobile Clinical Decision Support Application to Augment Local Antimicrobial Stewardship.

PubMed

Hoff, Brian M; Ford, Diana C; Ince, Dilek; Ernst, Erika J; Livorsi, Daniel J; Heintz, Brett H; Masse, Vincent; Brownlee, Michael J; Ford, Bradley A

2018-01-01

Medical applications for mobile devices allow clinicians to leverage microbiological data and standardized guidelines to treat patients with infectious diseases. We report the implementation of a mobile clinical decision support (CDS) application to augment local antimicrobial stewardship. We detail the implementation of our mobile CDS application over 20 months. Application utilization data were collected and evaluated using descriptive statistics to quantify the impact of our implementation. Project initiation focused on engaging key stakeholders, developing a business case, and selecting a mobile platform. The preimplementation phase included content development, creation of a pathway for content approval within the hospital committee structure, engaging clinical leaders, and formatting the first version of the guide. Implementation involved a media campaign, staff education, and integration within the electronic medical record and hospital mobile devices. The postimplementation phase required ongoing quality improvement, revision of outdated content, and repeated staff education. The evaluation phase included a guide utilization analysis, reporting to hospital leadership, and sustainability and innovation planning. The mobile application was downloaded 3056 times and accessed 9259 times during the study period. The companion web viewer was accessed 8214 times. Successful implementation of a customizable mobile CDS tool enabled our team to expand beyond microbiological data to clinical diagnosis, treatment, and antimicrobial stewardship, broadening our influence on antimicrobial prescribing and incorporating utilization data to inspire new quality and safety initiatives. Further studies are needed to assess the impact on antimicrobial utilization, infection control measures, and patient care outcomes.

Clinical ladder program implementation: a project guide.

PubMed

Ko, Yu Kyung; Yu, Soyoung

2014-11-01

This article describes the development of a clinical ladder program (CLP) implementation linked to a promotion system for nurses. The CLP task force developed criteria for each level of performance and a performance evaluation tool reflecting the self-motivation of the applicant for professional development. One year after implementation, the number of nurses taking graduate courses increased, and 7 nurses were promoted to nurse manager positions.

Neuroimaging-based biomarkers in psychiatry: clinical opportunities of a paradigm shift.

PubMed

Fu, Cynthia H Y; Costafreda, Sergi G

2013-09-01

Neuroimaging research has substantiated the functional and structural abnormalities underlying psychiatric disorders but has, thus far, failed to have a significant impact on clinical practice. Recently, neuroimaging-based diagnoses and clinical predictions derived from machine learning analysis have shown significant potential for clinical translation. This review introduces the key concepts of this approach, including how the multivariate integration of patterns of brain abnormalities is a crucial component. We survey recent findings that have potential application for diagnosis, in particular early and differential diagnoses in Alzheimer disease and schizophrenia, and the prediction of clinical response to treatment in depression. We discuss the specific clinical opportunities and the challenges for developing biomarkers for psychiatry in the absence of a diagnostic gold standard. We propose that longitudinal outcomes, such as early diagnosis and prediction of treatment response, offer definite opportunities for progress. We propose that efforts should be directed toward clinically challenging predictions in which neuroimaging may have added value, compared with the existing standard assessment. We conclude that diagnostic and prognostic biomarkers will be developed through the joint application of expert psychiatric knowledge in addition to advanced methods of analysis.

Positron Emission Tomography: Principles, Technology, and Recent Developments

NASA Astrophysics Data System (ADS)

Ziegler, Sibylle I.

2005-04-01

Positron emission tomography (PET) is a nuclear medical imaging technique for quantitative measurement of physiologic parameters in vivo (an overview of principles and applications can be found in [P.E. Valk, et al., eds. Positron Emission Tomography. Basic Science and Clinical Practice. 2003, Springer: Heidelberg]), based on the detection of small amounts of posi-tron-emitter-labelled biologic molecules. Various radiotracers are available for neuro-logical, cardiological, and oncological applications in the clinic and in research proto-cols. This overview describes the basic principles, technology, and recent develop-ments in PET, followed by a section on the development of a tomograph with ava-lanche photodiodes dedicated for small animal imaging as an example of efforts in the domain of high resolution tomographs.

Just tell me what you want!: the promise and perils of rapid prototyping with the World Wide Web.

PubMed

Cimino, J J; Socratous, S A

1996-01-01

Construction of applications using the World Wide Web architecture and Hypertext Markup Language (HTML) documents is relatively simple. We are exploring this approach with an application, called PolyMed now in use by surgical residents for one year. We monitored use and obtained user feedback to develop new features and eliminate undesirable ones. The system has been used to keep track of over 4,200 patients. We predicted, several advantages and disadvantages to this approach to prototyping clinical applications. Our experience confirms some advantages (ease of development and customization, ability to exploit non-Web system components, and simplified user interface design) and disadvantages (lack of database management services). Some predicted disadvantages failed to materialize (difficulty modeling a clinical application with hypertext and inconveniences associated with the "connectionless" nature of the Web). We were disappointed to find that while integration of external Web applications (such as Medline) into our application was easy, our users did not find it useful.

Just tell me what you want!: the promise and perils of rapid prototyping with the World Wide Web.

PubMed Central

Cimino, J. J.; Socratous, S. A.

1996-01-01

Construction of applications using the World Wide Web architecture and Hypertext Markup Language (HTML) documents is relatively simple. We are exploring this approach with an application, called PolyMed now in use by surgical residents for one year. We monitored use and obtained user feedback to develop new features and eliminate undesirable ones. The system has been used to keep track of over 4,200 patients. We predicted, several advantages and disadvantages to this approach to prototyping clinical applications. Our experience confirms some advantages (ease of development and customization, ability to exploit non-Web system components, and simplified user interface design) and disadvantages (lack of database management services). Some predicted disadvantages failed to materialize (difficulty modeling a clinical application with hypertext and inconveniences associated with the "connectionless" nature of the Web). We were disappointed to find that while integration of external Web applications (such as Medline) into our application was easy, our users did not find it useful. PMID:8947759

Designing Health Information Technology Tools to Prevent Gaps in Public Health Insurance.

PubMed

Hall, Jennifer D; Harding, Rose L; DeVoe, Jennifer E; Gold, Rachel; Angier, Heather; Sumic, Aleksandra; Nelson, Christine A; Likumahuwa-Ackman, Sonja; Cohen, Deborah J

2017-06-23

Changes in health insurance policies have increased coverage opportunities, but enrollees are required to annually reapply for benefits which, if not managed appropriately, can lead to insurance gaps. Electronic health records (EHRs) can automate processes for assisting patients with health insurance enrollment and re-enrollment. We describe community health centers' (CHC) workflow, documentation, and tracking needs for assisting families with insurance application processes, and the health information technology (IT) tool components that were developed to meet those needs. We conducted a qualitative study using semi-structured interviews and observation of clinic operations and insurance application assistance processes. Data were analyzed using a grounded theory approach. We diagramed workflows and shared information with a team of developers who built the EHR-based tools. Four steps to the insurance assistance workflow were common among CHCs: 1) Identifying patients for public health insurance application assistance; 2) Completing and submitting the public health insurance application when clinic staff met with patients to collect requisite information and helped them apply for benefits; 3) Tracking public health insurance approval to monitor for decisions; and 4) assisting with annual health insurance reapplication. We developed EHR-based tools to support clinical staff with each of these steps. CHCs are uniquely positioned to help patients and families with public health insurance applications. CHCs have invested in staff to assist patients with insurance applications and help prevent coverage gaps. To best assist patients and to foster efficiency, EHR based insurance tools need comprehensive, timely, and accurate health insurance information.

Decision support and disease management: a logic engineering approach.

PubMed

Fox, J; Thomson, R

1998-12-01

This paper describes the development and application of PROforma, a unified technology for clinical decision support and disease management. Work leading to the implementation of PROforma has been carried out in a series of projects funded by European agencies over the past 13 years. The work has been based on logic engineering, a distinct design and development methodology that combines concepts from knowledge engineering, logic programming, and software engineering. Several of the projects have used the approach to demonstrate a wide range of applications in primary and specialist care and clinical research. Concurrent academic research projects have provided a sound theoretical basis for the safety-critical elements of the methodology. The principal technical results of the work are the PROforma logic language for defining clinical processes and an associated suite of software tools for delivering applications, such as decision support and disease management procedures. The language supports four standard objects (decisions, plans, actions, and enquiries), each of which has an intuitive meaning with well-understood logical semantics. The development toolset includes a powerful visual programming environment for composing applications from these standard components, for verifying consistency and completeness of the resulting specification and for delivering stand-alone or embeddable applications. Tools and applications that have resulted from the work are described and illustrated, with examples from specialist cancer care and primary care. The results of a number of evaluation activities are included to illustrate the utility of the technology.

Clinical Hypnosis with Children and Adolescents—What? Why? How?: Origins, Applications, and Efficacy

PubMed Central

Kohen, Daniel P.; Kaiser, Pamela

2014-01-01

This review article addresses the process, intention, and therapeutic value of clinical hypnosis with children and adolescents. A brief historical perspective is followed by a digest of the published laboratory and clinical research that has accelerated substantially over the past two decades. This review lends appropriate credence to the benefits and integration to clinical practice of this powerful tool for teaching young people self-regulation skills. The breadth of application is described, and several clinical vignettes are provided as examples of what is possible. In addition to the provision of the most relevant citations in the pediatric, psychological, and neuroscience literature, this synopsis concludes with information regarding availability of skill development training in pediatric clinical hypnosis. PMID:27417468

DICOM for quantitative imaging biomarker development: a standards based approach to sharing clinical data and structured PET/CT analysis results in head and neck cancer research.

PubMed

Fedorov, Andriy; Clunie, David; Ulrich, Ethan; Bauer, Christian; Wahle, Andreas; Brown, Bartley; Onken, Michael; Riesmeier, Jörg; Pieper, Steve; Kikinis, Ron; Buatti, John; Beichel, Reinhard R

2016-01-01

Background. Imaging biomarkers hold tremendous promise for precision medicine clinical applications. Development of such biomarkers relies heavily on image post-processing tools for automated image quantitation. Their deployment in the context of clinical research necessitates interoperability with the clinical systems. Comparison with the established outcomes and evaluation tasks motivate integration of the clinical and imaging data, and the use of standardized approaches to support annotation and sharing of the analysis results and semantics. We developed the methodology and tools to support these tasks in Positron Emission Tomography and Computed Tomography (PET/CT) quantitative imaging (QI) biomarker development applied to head and neck cancer (HNC) treatment response assessment, using the Digital Imaging and Communications in Medicine (DICOM(®)) international standard and free open-source software. Methods. Quantitative analysis of PET/CT imaging data collected on patients undergoing treatment for HNC was conducted. Processing steps included Standardized Uptake Value (SUV) normalization of the images, segmentation of the tumor using manual and semi-automatic approaches, automatic segmentation of the reference regions, and extraction of the volumetric segmentation-based measurements. Suitable components of the DICOM standard were identified to model the various types of data produced by the analysis. A developer toolkit of conversion routines and an Application Programming Interface (API) were contributed and applied to create a standards-based representation of the data. Results. DICOM Real World Value Mapping, Segmentation and Structured Reporting objects were utilized for standards-compliant representation of the PET/CT QI analysis results and relevant clinical data. A number of correction proposals to the standard were developed. The open-source DICOM toolkit (DCMTK) was improved to simplify the task of DICOM encoding by introducing new API abstractions. Conversion and visualization tools utilizing this toolkit were developed. The encoded objects were validated for consistency and interoperability. The resulting dataset was deposited in the QIN-HEADNECK collection of The Cancer Imaging Archive (TCIA). Supporting tools for data analysis and DICOM conversion were made available as free open-source software. Discussion. We presented a detailed investigation of the development and application of the DICOM model, as well as the supporting open-source tools and toolkits, to accommodate representation of the research data in QI biomarker development. We demonstrated that the DICOM standard can be used to represent the types of data relevant in HNC QI biomarker development, and encode their complex relationships. The resulting annotated objects are amenable to data mining applications, and are interoperable with a variety of systems that support the DICOM standard.

Tissue Engineered Constructs: Perspectives on Clinical Translation

PubMed Central

Lu, Lichun; Arbit, Harvey M.; Herrick, James L.; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J.

2015-01-01

In this article, a “bedside to bench and back” approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the US Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or New Drug Application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented. PMID:25711151

Tissue engineered constructs: perspectives on clinical translation.

PubMed

Lu, Lichun; Arbit, Harvey M; Herrick, James L; Segovis, Suzanne Glass; Maran, Avudaiappan; Yaszemski, Michael J

2015-03-01

In this article, a "bedside to bench and back" approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the U.S. Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or new drug application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented.

EVOLUTION OF ENVIRONMENTAL IMMUNOCHEMISTRY

EPA Science Inventory

Enzyme-linked immunosorbent assays (ELISAs), initially developed for clinical applications, have made a tremendous impact as clinical diagnostic indicators. Pesticide chemists became attracted to the potential of these sensitive and selective methods in the 1970s. Thus, beg...

78 FR 66992 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-07

... Sheraton Crystal City Hotel. Cellular and Molecular Medicine........ November 25, 2013 *VA Central Office... Hotel. Oncology-A December 5-6, 2013 Sheraton Crystal City Hotel. Clinical Application of Genetics...

Model driven development of clinical information sytems using openEHR.

PubMed

Atalag, Koray; Yang, Hong Yul; Tempero, Ewan; Warren, Jim

2011-01-01

openEHR and the recent international standard (ISO 13606) defined a model driven software development methodology for health information systems. However there is little evidence in the literature describing implementation; especially for desktop clinical applications. This paper presents an implementation pathway using .Net/C# technology for Microsoft Windows desktop platforms. An endoscopy reporting application driven by openEHR Archetypes and Templates has been developed. A set of novel GUI directives has been defined and presented which guides the automatic graphical user interface generator to render widgets properly. We also reveal the development steps and important design decisions; from modelling to the final software product. This might provide guidance for other developers and form evidence required for the adoption of these standards for vendors and national programs alike.

Ultrasound elastography: principles, techniques, and clinical applications.

PubMed

Dewall, Ryan J

2013-01-01

Ultrasound elastography is an emerging set of imaging modalities used to image tissue elasticity and are often referred to as virtual palpation. These techniques have proven effective in detecting and assessing many different pathologies, because tissue mechanical changes often correlate with tissue pathological changes. This article reviews the principles of ultrasound elastography, many of the ultrasound-based techniques, and popular clinical applications. Originally, elastography was a technique that imaged tissue strain by comparing pre- and postcompression ultrasound images. However, new techniques have been developed that use different excitation methods such as external vibration or acoustic radiation force. Some techniques track transient phenomena such as shear waves to quantitatively measure tissue elasticity. Clinical use of elastography is increasing, with applications including lesion detection and classification, fibrosis staging, treatment monitoring, vascular imaging, and musculoskeletal applications.

Prevention of in-hospital falls: development of criteria for the conduct of a multi-site audit.

PubMed

Giles, Kristy; Stephenson, Matthew; McArthur, Alexa; Aromataris, Edoardo

2015-06-01

Patient falls are a significant issue for hospitals due to the high rates of morbidity and mortality associated with these events, as well as the financial costs for the healthcare system. To establish what constitutes best practice in terms of fall prevention in acute care facilities and use this to inform the development of best practice audit criteria. Criteria for clinical audit were developed from evidence derived from systematic reviews and guidelines. While these were drawn from the best available evidence, they were also developed in conjunction with clinicians undertaking a fall-prevention clinical audit and key stakeholders from the clinical settings to ensure their relevance and applicability to the acute care setting. Current literature recommends a comprehensive and multifactorial approach to fall prevention. Eight audit criteria were derived from the best available evidence including the domains of physical environment, hospital culture and care processes, use of technology and targeted interventions. Existing research evidence and consultation with stakeholders has allowed the development of applicable, evidence-based audit criteria for fall prevention in acute care settings. This model can promote engagement, impact clinical practice and lead to improved outcomes.

Clinical Supervision Strategies for School Counselors Working with Twice-Exceptional Students

ERIC Educational Resources Information Center

Goldsmith, SaDohl K.

2012-01-01

Clinical supervision is a way for counselors in training to develop needed skills (Bernard & Goodyear, 1998). Best practices indicate that counselors trained in the application of supervision theory should provide clinical supervision. However, many school counselors receive administrative supervision by non-counseling professionals who may…

Nano/microfluidics for diagnosis of infectious diseases in developing countries

PubMed Central

Lee, Won Gu; Kim, Yun-Gon; Chung, Bong Geun; Demirci, Utkan; Khademhosseini, Ali

2010-01-01

Nano/microfluidic technologies are emerging as powerful enabling tools for diagnosis and monitoring of infectious diseases in both developed and developing countries. Miniaturized nano/microfluidic platforms that precisely manipulate small fluid volumes can be used to enable medical diagnosis in a more rapid and accurate manner. In particular, these nano/microfluidic diagnostic technologies are potentially applicable to global health applications, because they are disposable, inexpensive, portable, and easy-to-use for detection of infectious diseases. In this paper, we review recent developments in nano/microfluidic technologies for clinical point-of-care applications at resource-limited settings in developing countries. PMID:19954755

Recent Advances in Clinical Natural Language Processing in Support of Semantic Analysis.

PubMed

Velupillai, S; Mowery, D; South, B R; Kvist, M; Dalianis, H

2015-08-13

We present a review of recent advances in clinical Natural Language Processing (NLP), with a focus on semantic analysis and key subtasks that support such analysis. We conducted a literature review of clinical NLP research from 2008 to 2014, emphasizing recent publications (2012-2014), based on PubMed and ACL proceedings as well as relevant referenced publications from the included papers. Significant articles published within this time-span were included and are discussed from the perspective of semantic analysis. Three key clinical NLP subtasks that enable such analysis were identified: 1) developing more efficient methods for corpus creation (annotation and de-identification), 2) generating building blocks for extracting meaning (morphological, syntactic, and semantic subtasks), and 3) leveraging NLP for clinical utility (NLP applications and infrastructure for clinical use cases). Finally, we provide a reflection upon most recent developments and potential areas of future NLP development and applications. There has been an increase of advances within key NLP subtasks that support semantic analysis. Performance of NLP semantic analysis is, in many cases, close to that of agreement between humans. The creation and release of corpora annotated with complex semantic information models has greatly supported the development of new tools and approaches. Research on non-English languages is continuously growing. NLP methods have sometimes been successfully employed in real-world clinical tasks. However, there is still a gap between the development of advanced resources and their utilization in clinical settings. A plethora of new clinical use cases are emerging due to established health care initiatives and additional patient-generated sources through the extensive use of social media and other devices.

Recent Advances in Clinical Natural Language Processing in Support of Semantic Analysis

PubMed Central

Mowery, D.; South, B. R.; Kvist, M.; Dalianis, H.

2015-01-01

Summary Objectives We present a review of recent advances in clinical Natural Language Processing (NLP), with a focus on semantic analysis and key subtasks that support such analysis. Methods We conducted a literature review of clinical NLP research from 2008 to 2014, emphasizing recent publications (2012-2014), based on PubMed and ACL proceedings as well as relevant referenced publications from the included papers. Results Significant articles published within this time-span were included and are discussed from the perspective of semantic analysis. Three key clinical NLP subtasks that enable such analysis were identified: 1) developing more efficient methods for corpus creation (annotation and de-identification), 2) generating building blocks for extracting meaning (morphological, syntactic, and semantic subtasks), and 3) leveraging NLP for clinical utility (NLP applications and infrastructure for clinical use cases). Finally, we provide a reflection upon most recent developments and potential areas of future NLP development and applications. Conclusions There has been an increase of advances within key NLP subtasks that support semantic analysis. Performance of NLP semantic analysis is, in many cases, close to that of agreement between humans. The creation and release of corpora annotated with complex semantic information models has greatly supported the development of new tools and approaches. Research on non-English languages is continuously growing. NLP methods have sometimes been successfully employed in real-world clinical tasks. However, there is still a gap between the development of advanced resources and their utilization in clinical settings. A plethora of new clinical use cases are emerging due to established health care initiatives and additional patient-generated sources through the extensive use of social media and other devices. PMID:26293867

A web access script language to support clinical application development.

PubMed

O'Kane, K C; McColligan, E E

1998-02-01

This paper describes the development of a script language to support the implementation of decentralized, clinical information applications on the World Wide Web (Web). The goal of this work is to facilitate construction of low overhead, fully functional clinical information systems that can be accessed anywhere by low cost Web browsers to search, retrieve and analyze stored patient data. The Web provides a model of network access to data bases on a global scale. Although it was originally conceived as a means to exchange scientific documents, Web browsers and servers currently support access to a wide variety of audio, video, graphical and text based data to a rapidly growing community. Access to these services is via inexpensive client software browsers that connect to servers by means of the open architecture of the Internet. In this paper, the design and implementation of a script language that supports the development of low cost, Web-based, distributed clinical information systems for both Inter- and Intra-Net use is presented. The language is based on the Mumps language and, consequently, supports many legacy applications with few modifications. Several enhancements, however, have been made to support modern programming practices and the Web interface. The interpreter for the language also supports standalone program execution on Unix, MS-Windows, OS/2 and other operating systems.

[Clinical application of "categorization by analogy" in acupuncture for pain syndromes].

PubMed

Chen, Xiaojun

2018-03-12

The"categorization by analogy"is one of the most primitive thinking methods for ancient people to explore the world, which has exerted far-reaching impact on the origin and development of TCM. With examples of Sanjian (LI 3) for neck pain, Chize (LU 5) for low back pain and Chengshan (BL 57) for dysmenorrhea, the clinical application of"categorization by analogy"in acupuncture for pain syndromes was discussed, hoping more acupuncturists will pay attention to the guiding role of"categorization by analogy"in acupuncture clinical treatment.

Genomic Sequence Variation Markup Language (GSVML).

PubMed

Nakaya, Jun; Kimura, Michio; Hiroi, Kaei; Ido, Keisuke; Yang, Woosung; Tanaka, Hiroshi

2010-02-01

With the aim of making good use of internationally accumulated genomic sequence variation data, which is increasing rapidly due to the explosive amount of genomic research at present, the development of an interoperable data exchange format and its international standardization are necessary. Genomic Sequence Variation Markup Language (GSVML) will focus on genomic sequence variation data and human health applications, such as gene based medicine or pharmacogenomics. We developed GSVML through eight steps, based on case analysis and domain investigations. By focusing on the design scope to human health applications and genomic sequence variation, we attempted to eliminate ambiguity and to ensure practicability. We intended to satisfy the requirements derived from the use case analysis of human-based clinical genomic applications. Based on database investigations, we attempted to minimize the redundancy of the data format, while maximizing the data covering range. We also attempted to ensure communication and interface ability with other Markup Languages, for exchange of omics data among various omics researchers or facilities. The interface ability with developing clinical standards, such as the Health Level Seven Genotype Information model, was analyzed. We developed the human health-oriented GSVML comprising variation data, direct annotation, and indirect annotation categories; the variation data category is required, while the direct and indirect annotation categories are optional. The annotation categories contain omics and clinical information, and have internal relationships. For designing, we examined 6 cases for three criteria as human health application and 15 data elements for three criteria as data formats for genomic sequence variation data exchange. The data format of five international SNP databases and six Markup Languages and the interface ability to the Health Level Seven Genotype Model in terms of 317 items were investigated. GSVML was developed as a potential data exchanging format for genomic sequence variation data exchange focusing on human health applications. The international standardization of GSVML is necessary, and is currently underway. GSVML can be applied to enhance the utilization of genomic sequence variation data worldwide by providing a communicable platform between clinical and research applications. Copyright 2009 Elsevier Ireland Ltd. All rights reserved.

Application of grounded theory to content definition: a case study.

PubMed

Audiss, D; Roth, T

1999-02-01

Successful implementation of a clinical information system requires clinician involvement throughout the process of content definition and system development to ensure acceptance of the automated care process. In these times of downsizing, however, clinicians are not always able to participate fully in the dontent definition phase of system development and often become frustrated with their inability to obtain the patient information they need from the system. The qualitative research principles of grounded theory afford clinicians the opportunity to participate in content definition for information systems. This article presents a case study of the application of grounded theory to develop systematically the content definition for a clinical information system in preparation for implementation on four medical-surgical units.

Customized vaginal vault brachytherapy with computed tomography imaging-derived applicator prototyping.

PubMed

Wiebe, Ericka; Easton, Harry; Thomas, Gillian; Barbera, Lisa; D'Alimonte, Laura; Ravi, Ananth

2015-01-01

A novel customized vaginal brachytherapy mould technique has been developed for clinical use. This image-guided technique provides a brachytherapy applicator solution for irregular vaginal vault configuration and/or a wide vaginal apex relative to the vaginal introitus that would be sub-optimally treated with standard cylinders. The customized vaginal applicator is generated by the following process: CT images are obtained with contrast-soaked vaginal packing in situ to highlight unique anatomical detail. A 3-dimensional digital model is developed from the images and subsequently converted into a custom applicator with the use of stereolithography, which is an additive manufacturing technique whereby layers 50-100 μm thick of resin are deposited and polymerized using a laser to create intricate 3-dimensional objects. The density of the applicator and the dose delivered using the custom applicator were both measured to ensure accurate dosimetry. The CT-based densities of a clinical vaginal cylinder and the cylinder generated using stereolithography were 1.29 ± 0.06 g/cm(3) vs 1.28 ± 0.01 g/cm(3), respectively. The mean measured dose from a representative stereolithographed applicator normalized to dose measured for a single plastic catheter was 99.8 ± 4.2%. In patient dosimetric results indicate improved coverage of the lateral aspect of vaginal vault with the custom cylinder relative to the standard cylinder; 700 cGy vs 328 cGy, respectively, at a representative lateral vaginal dose point, while simultaneously achieving relatively narrow dose distribution in the anterior/posterior direction. Stereolithographic applicator production was available within a clinically acceptable timeframe, and its clinical feasibility and utility has been demonstrated. Copyright © 2015 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Technology needs for the development of the accommodative intraocular lens

NASA Astrophysics Data System (ADS)

Nishi, Okihiro

2010-02-01

Refilling the lens capsule while preserving capsular integrity offers the potential to restore ocular accommodation. There are two persisting problems in capsular bag refilling for possible clinical application: Leakage of the injectable material through the capsular opening and capsular opacification. Numerous attempts for solving these cardinal problems have not been proven to be clinically applicable. Recently, we developed a novel capsular bag refilling procedure using a novel accommodative intraocular lens that serves as an optic as well as a plug for sealing the capsular opening. The procedure and the results of monkey experiments will be presented.

Writing a technical note.

PubMed

Ng, K H; Peh, W C G

2010-02-01

A technical note is a short article giving a brief description of a specific development, technique or procedure, or it may describe a modification of an existing technique, procedure or device applicable to medicine. The technique, procedure or device described should have practical value and should contribute to clinical diagnosis or management. It could also present a software tool, or an experimental or computational method. Technical notes are variously referred to as technical innovations or technical developments. The main criteria for publication will be the novelty of concepts involved, the validity of the technique and its potential for clinical applications.

Delays in new drug applications in Japan and industrial R&D strategies.

PubMed

Hirai, Y; Kinoshita, H; Kusama, M; Yasuda, K; Sugiyama, Y; Ono, S

2010-02-01

The gap between Japan and both the United States (US) and the European Union (EU) with regard to access to new drugs is becoming a major issue in Japan. We analyzed the time lags involved in new drug application (NDA) and biological license application submissions in Japan, the US, and the EU in order to identify the causes of delayed access. The time lag related to submission of applications ("submission lag") was longer for in-licensed products and for non-Japanese companies. Factors related to costs of clinical studies and potential volumes of sales were not associated with the submission lag. A bridging strategy (extrapolative use of foreign clinical data in the clinical data package based on International Conference on Harmonisation guideline E5) seemed to reduce submission lag, but the association between the two diminished when the cause-and-effect relationship was specifically investigated. These results suggest that multinational companies are likely to place more emphasis on the choice of development strategies that successfully lead to their goal rather than on direct costs and expected sales when deciding to introduce their pharmaceutical products in Japan. Our findings indicate that the clinical development guidances that helps pharmaceutical companies decide on investment and strategies are also the key to narrowing the gap in access to new drugs.

Clinical Transition Framework: Integrating Coaching Plans, Sampling, and Accountability in Clinical Practice Development.

PubMed

Boyer, Susan A; Mann-Salinas, Elizabeth A; Valdez-Delgado, Krystal K

The clinical transition framework (CTF) is a competency-based practice development system used by nursing professional development practitioners to support nurses' initial orientation or transition to a new specialty. The CTF is applicable for both new graduate and proficient nurses. The current framework and tools evolved from 18 years of performance improvement and research projects engaged in both acute and community care environments in urban and rural settings. This article shares core CTF concepts, a description of coaching plans, and a professional accountability statement as experienced within the framework.

Non-clinical studies in the process of new drug development - Part II: Good laboratory practice, metabolism, pharmacokinetics, safety and dose translation to clinical studies.

PubMed

Andrade, E L; Bento, A F; Cavalli, J; Oliveira, S K; Schwanke, R C; Siqueira, J M; Freitas, C S; Marcon, R; Calixto, J B

2016-12-12

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical development process, also known as Go/No-Go decision, a drug candidate needs to pass through several steps, such as determination of drug availability (studies on pharmacokinetics), absorption, distribution, metabolism and elimination (ADME) and preliminary studies that aim to investigate the candidate safety including genotoxicity, mutagenicity, safety pharmacology and general toxicology. These preliminary studies generally do not need to comply with GLP regulations. These studies aim at investigating the drug safety to obtain the first information about its tolerability in different systems that are relevant for further decisions. There are, however, other studies that should be performed according to GLP standards and are mandatory for the safe exposure to humans, such as repeated dose toxicity, genotoxicity and safety pharmacology. These studies must be conducted before the Investigational New Drug (IND) application. The package of non-clinical studies should cover all information needed for the safe transposition of drugs from animals to humans, generally based on the non-observed adverse effect level (NOAEL) obtained from general toxicity studies. After IND approval, other GLP experiments for the evaluation of chronic toxicity, reproductive and developmental toxicity, carcinogenicity and genotoxicity, are carried out during the clinical phase of development. However, the necessity of performing such studies depends on the new drug clinical application purpose.

PTT Advisor: A CDC-supported initiative to develop a mobile clinical laboratory decision support application for the iOS platform

PubMed Central

Savel, Thomas G.; Lee, Brian A.; Ledbetter, Greg; Brown, Sara; LaValley, Dale; Taylor, Julie; Thompson, Pam

2013-01-01

Objectives: This manuscript describes the development of PTT (Partial Thromboplastin Time) Advisor, one of the first of a handful of iOS-based mobile applications to be released by the US Centers for Disease Control and Prevention (CDC). PTT Advisor has been a collaboration between two groups at CDC (Informatics R&D and Laboratory Science), and one partner team (Clinical Laboratory Integration into Healthcare Collaborative - CLIHC). The application offers clinicians a resource to quickly select the appropriate follow-up tests to evaluate patients with a prolonged PTT and a normal Prothrombin Time (PT) laboratory result. Methods: The application was designed leveraging an agile methodology, and best practices in user experience (UX) design and mobile application development. Results: As it is an open-source project, the code to PTT Advisor was made available to the public under the Apache Software License. On July 6, 2012, the free app was approved by Apple, and was published to their App Store. Conclusions: Regardless of the complexity of the mobile application, the level of effort required in the development process should not be underestimated. There are several issues that make designing the UI for a mobile phone challenging (not just small screen size): the touchscreen, users' mobile mindset (tasks need to be quick and focused), and the fact that mobile UI conventions/expectations are still being defined and refined (due to the maturity level of the field of mobile application development). PMID:23923100

PTT Advisor: A CDC-supported initiative to develop a mobile clinical laboratory decision support application for the iOS platform.

PubMed

Savel, Thomas G; Lee, Brian A; Ledbetter, Greg; Brown, Sara; Lavalley, Dale; Taylor, Julie; Thompson, Pam

2013-01-01

This manuscript describes the development of PTT (Partial Thromboplastin Time) Advisor, one of the first of a handful of iOS-based mobile applications to be released by the US Centers for Disease Control and Prevention (CDC). PTT Advisor has been a collaboration between two groups at CDC (Informatics R&D and Laboratory Science), and one partner team (Clinical Laboratory Integration into Healthcare Collaborative - CLIHC). The application offers clinicians a resource to quickly select the appropriate follow-up tests to evaluate patients with a prolonged PTT and a normal Prothrombin Time (PT) laboratory result. The application was designed leveraging an agile methodology, and best practices in user experience (UX) design and mobile application development. As it is an open-source project, the code to PTT Advisor was made available to the public under the Apache Software License. On July 6, 2012, the free app was approved by Apple, and was published to their App Store. Regardless of the complexity of the mobile application, the level of effort required in the development process should not be underestimated. There are several issues that make designing the UI for a mobile phone challenging (not just small screen size): the touchscreen, users' mobile mindset (tasks need to be quick and focused), and the fact that mobile UI conventions/expectations are still being defined and refined (due to the maturity level of the field of mobile application development).

Biomarkers of PTSD: military applications and considerations.

PubMed

Lehrner, Amy; Yehuda, Rachel

2014-01-01

Although there are no established biomarkers for posttraumatic stress disorder (PTSD) as yet, biological investigations of PTSD have made progress identifying the pathophysiology of PTSD. Given the biological and clinical complexity of PTSD, it is increasingly unlikely that a single biomarker of disease will be identified. Rather, investigations will more likely identify different biomarkers that indicate the presence of clinically significant PTSD symptoms, associate with risk for PTSD following trauma exposure, and predict or identify recovery. While there has been much interest in PTSD biomarkers, there has been less discussion of their potential clinical applications, and of the social, legal, and ethical implications of such biomarkers. This article will discuss possible applications of PTSD biomarkers, including the social, legal, and ethical implications of such biomarkers, with an emphasis on military applications. Literature on applications of PTSD biomarkers and on potential ethical and legal implications will be reviewed. Biologically informed research findings hold promise for prevention, assessment, treatment planning, and the development of prophylactic and treatment interventions. As with any biological indicator of disorder, there are potentially positive and negative clinical, social, legal, and ethical consequences of using such biomarkers. Potential clinical applications of PTSD biomarkers hold promise for clinicians, patients, and employers. The search for biomarkers of PTSD should occur in tandem with an interdisciplinary discussion regarding the potential implications of applying biological findings in clinical and employment settings.

Thymoquinone, as an anticancer molecule: from basic research to clinical investigation

PubMed Central

Asaduzzaman Khan, Md.; Tania, Mousumi; Fu, Shangyi; Fu, Junjiang

2017-01-01

Thymoquinone is an anticancer phytochemical commonly found in black cumin. In this review, we discuss the potential of thymoquinone as anticancer molecule, its mechanism of action and future usage in clinical applications. Thymoquinone exhibits anticancer activity via numerous mechanisms of action, specifically by showing selective antioxidant and oxidant activity, interfering with DNA structure, affecting carcinogenic signaling molecules/pathways and immunomodulation. In vitro activity of thymoquinone has been further implicated in animal models of cancer; however, no clinical application has been proven yet. This is the optimum time to focus on clinical trials for developing thymoquinone as a future drug in cancer therapeutics. PMID:28881699

Thymoquinone, as an anticancer molecule: from basic research to clinical investigation.

PubMed

Asaduzzaman Khan, Md; Tania, Mousumi; Fu, Shangyi; Fu, Junjiang

2017-08-01

Thymoquinone is an anticancer phytochemical commonly found in black cumin. In this review, we discuss the potential of thymoquinone as anticancer molecule, its mechanism of action and future usage in clinical applications. Thymoquinone exhibits anticancer activity via numerous mechanisms of action, specifically by showing selective antioxidant and oxidant activity, interfering with DNA structure, affecting carcinogenic signaling molecules/pathways and immunomodulation. In vitro activity of thymoquinone has been further implicated in animal models of cancer; however, no clinical application has been proven yet. This is the optimum time to focus on clinical trials for developing thymoquinone as a future drug in cancer therapeutics.

On mixed reality environments for minimally invasive therapy guidance: Systems architecture, successes and challenges in their implementation from laboratory to clinic

PubMed Central

Linte, Cristian A.; Davenport, Katherine P.; Cleary, Kevin; Peters, Craig; Vosburgh, Kirby G.; Navab, Nassir; Edwards, Philip “Eddie”; Jannin, Pierre; Peters, Terry M.; Holmes, David R.; Robb, Richard A.

2013-01-01

Mixed reality environments for medical applications have been explored and developed over the past three decades in an effort to enhance the clinician’s view of anatomy and facilitate the performance of minimally invasive procedures. These environments must faithfully represent the real surgical field and require seamless integration of pre- and intra-operative imaging, surgical instrument tracking, and display technology into a common framework centered around and registered to the patient. However, in spite of their reported benefits, few mixed reality environments have been successfully translated into clinical use. Several challenges that contribute to the difficulty in integrating such environments into clinical practice are presented here and discussed in terms of both technical and clinical limitations. This article should raise awareness among both developers and end-users toward facilitating a greater application of such environments in the surgical practice of the future. PMID:23632059

A semi-automated, field-portable microscopy platform for clinical diagnostic applications

NASA Astrophysics Data System (ADS)

Jagannadh, Veerendra Kalyan; Srinivasan, Rajesh; Gorthi, Sai Siva

2015-08-01

Clinical microscopy is a versatile diagnostic platform used for diagnosis of a multitude of diseases. In the recent past, many microfluidics based point-of-care diagnostic devices have been developed, which serve as alternatives to microscopy. However, these point-of-care devices are not as multi-functional and versatile as clinical microscopy. With the use of custom designed optics and microfluidics, we have developed a versatile microscopy-based cellular diagnostic platform, which can be used at the point of care. The microscopy platform presented here is capable of detecting infections of very low parasitemia level (in a very small quantity of sample), without the use of any additional computational hardware. Such a cost-effective and portable diagnostic device, would greatly impact the quality of health care available to people living in rural locations of the world. Apart from clinical diagnostics, it's applicability to field research in environmental microbiology has also been outlined.

Development and application of a biorelevant dissolution method using USP apparatus 4 in early phase formulation development.

PubMed

Fang, Jiang B; Robertson, Vivian K; Rawat, Archana; Flick, Tawnya; Tang, Zhe J; Cauchon, Nina S; McElvain, James S

2010-10-04

Dissolution testing is frequently used to determine the rate and extent at which a drug is released from a dosage form, and it plays many important roles throughout drug product development. However, the traditional dissolution approach often emphasizes its application in quality control testing and usually strives to obtain 100% drug release. As a result, dissolution methods are not necessarily biorelevant and meaningful application of traditional dissolution methods in the early phases of drug product development can be very limited. This article will describe the development of a biorelevant in vitro dissolution method using USP apparatus 4, biorelevant media, and real-time online UV analysis. Several case studies in the areas of formulation selection, lot-to-lot variability, and food effect will be presented to demonstrate the application of this method in early phase formulation development. This biorelevant dissolution method using USP apparatus 4 provides a valuable tool to predict certain aspects of the in vivo drug release. It can be used to facilitate the formulation development/selection for pharmacokinetic (PK) and clinical studies. It may also potentially be used to minimize the number of PK studies, and to aid in the design of more efficient PK and clinical studies.

A platform for exploration into chaining of web services for clinical data transformation and reasoning

PubMed Central

Maldonado, José Alberto; Marcos, Mar; Fernández-Breis, Jesualdo Tomás; Parcero, Estíbaliz; Boscá, Diego; Legaz-García, María del Carmen; Martínez-Salvador, Begoña; Robles, Montserrat

2016-01-01

The heterogeneity of clinical data is a key problem in the sharing and reuse of Electronic Health Record (EHR) data. We approach this problem through the combined use of EHR standards and semantic web technologies, concretely by means of clinical data transformation applications that convert EHR data in proprietary format, first into clinical information models based on archetypes, and then into RDF/OWL extracts which can be used for automated reasoning. In this paper we describe a proof-of-concept platform to facilitate the (re)configuration of such clinical data transformation applications. The platform is built upon a number of web services dealing with transformations at different levels (such as normalization or abstraction), and relies on a collection of reusable mappings designed to solve specific transformation steps in a particular clinical domain. The platform has been used in the development of two different data transformation applications in the area of colorectal cancer. PMID:28269882

Engineered pharmabiotics with improved therapeutic potential.

PubMed

Sleator, Roy D; Hill, Colin

2008-01-01

Although described for over a century, scientists and clinicians alike are only now beginning to realize the significant medical applications of probiotic cultures. Given the increasing commercial and clinical relevance of probiotics, improving their stress tolerance profile and ability to overcome the physiochemical defences of the host is an important biological goal. Patho-biotechnology describes the application of pathogen derived (ex vivo and in vivo) stress survival strategies for the design of more technologically robust and effective probiotic cultures with improved biotechnological and clinical applications as well as the development of novel vaccine and drug delivery platforms.

[Prospects for applications in human health of nanopore-based sequencing].

PubMed

Audebert, Christophe; Hot, David; Caboche, Ségolène

2018-04-01

High throughput sequencing has opened up new clinical opportunities moving towards a medicine of precision. Oncology, infectious diseases or human genomics, many applications have been developed in recent years. The introduction of a third generation of nanopore-based sequencing technology, addressing some of the weaknesses of the previous generation, heralds a new revolution. Portability, real time, long reads and marginal investment costs, these promising new technologies point to a new shift of paradigm. What are the perspectives opened up by nanopores for clinical applications? © 2018 médecine/sciences – Inserm.

Developing clinical leadership capability.

PubMed

Pintar, Kristi A; Capuano, Terry A; Rosser, Gwendolyn D

2007-01-01

Nursing facilities must be committed to ongoing leadership development and to developing and retaining their staff in the increasingly competitive healthcare market. In this article, the authors share the processes involved in creating a focused small group approach to developing clinical leaders. Programmatic approaches to development, clarity of needs of those targeted for development, individual development plans, external expertise partnerships, and small group session dynamics are discussed. Applications of the process and lessons learned from the program will benefit others in their efforts to enhance organization succession planning, leadership development, group learning, and program administration.

A Vision for Better Health: Mass Spectrometry Imaging for Clinical Diagnostics

PubMed Central

Ye, Hui; Gemperline, Erin; Li, Lingjun

2012-01-01

Background Mass spectrometry imaging (MSI) is a powerful tool that grants the ability to investigate a broad mass range of molecules from small molecules to large proteins by creating detailed distribution maps of selected compounds. Its usefulness in biomarker discovery towards clinical applications has obtained success by correlating the molecular expression of tissues acquired from MSI with well-established histology. Results To date, MSI has demonstrated its versatility in clinical applications, such as biomarker diagnostics of different diseases, prognostics of disease severities and metabolic response to drug treatment, etc. These studies have provided significant insight in clinical studies over the years and current technical advances are further facilitating the improvement of this field. Although the underlying concept is simple, factors such as choice of ionization method, sample preparation, instrumentation and data analysis must be taken into account for successful applications of MSI. Herein, we briefly reviewed these key elements yet focused on the clinical applications of MSI that cannot be addressed by other means. Conclusions Challenges and future perspectives in this field are also discussed to conclude that the ever-growing applications with continuous development of this powerful analytical tool will lead to a better understanding of the biology of diseases and improvements in clinical diagnostics. PMID:23078851

Reliability Stress-Strength Models for Dependent Observations with Applications in Clinical Trials

NASA Technical Reports Server (NTRS)

Kushary, Debashis; Kulkarni, Pandurang M.

1995-01-01

We consider the applications of stress-strength models in studies involving clinical trials. When studying the effects and side effects of certain procedures (treatments), it is often the case that observations are correlated due to subject effect, repeated measurements and observing many characteristics simultaneously. We develop maximum likelihood estimator (MLE) and uniform minimum variance unbiased estimator (UMVUE) of the reliability which in clinical trial studies could be considered as the chances of increased side effects due to a particular procedure compared to another. The results developed apply to both univariate and multivariate situations. Also, for the univariate situations we develop simple to use lower confidence bounds for the reliability. Further, we consider the cases when both stress and strength constitute time dependent processes. We define the future reliability and obtain methods of constructing lower confidence bounds for this reliability. Finally, we conduct simulation studies to evaluate all the procedures developed and also to compare the MLE and the UMVUE.

PalmCIS: A Wireless Handheld Application for Satisfying Clinician Information Needs

PubMed Central

Chen, Elizabeth S.; Mendonça, Eneida A.; McKnight, Lawrence K.; Stetson, Peter D.; Lei, Jianbo; Cimino, James J.

2004-01-01

Wireless handheld technology provides new ways to deliver and present information. As with any technology, its unique features must be taken into consideration and its applications designed accordingly. In the clinical setting, availability of needed information can be crucial during the decision-making process. Preliminary studies performed at New York Presbyterian Hospital (NYPH) determined that there are inadequate access to information and ineffective communication among clinicians (potential proximal causes of medical errors). In response to these findings, the authors have been developing extensions to their Web-based clinical information system including PalmCIS, an application that provides access to needed patient information via a wireless personal digital assistant (PDA). The focus was on achieving end-to-end security and developing a highly usable system. This report discusses the motivation behind PalmCIS, design and development of the system, and future directions. PMID:14527976

Concise Review: Process Development Considerations for Cell Therapy

PubMed Central

Brieva, Thomas; Raviv, Lior; Rowley, Jon; Niss, Knut; Brandwein, Harvey; Oh, Steve; Karnieli, Ohad

2015-01-01

The development of robust and well-characterized methods of production of cell therapies has become increasingly important as therapies advance through clinical trials toward approval. A successful cell therapy will be a consistent, safe, and effective cell product, regardless of the cell type or application. Process development strategies can be developed to gain efficiency while maintaining or improving safety and quality profiles. This review presents an introduction to the process development challenges of cell therapies and describes some of the tools available to address production issues. This article will provide a summary of what should be considered to efficiently advance a cellular therapy from the research stage through clinical trials and finally toward commercialization. The identification of the basic questions that affect process development is summarized in the target product profile, and considerations for process optimization are discussed. The goal is to identify potential manufacturing concerns early in the process so they may be addressed effectively and thus increase the probability that a therapy will be successful. Significance The present study contributes to the field of cell therapy by providing a resource for those transitioning a potential therapy from the research stage to clinical and commercial applications. It provides the necessary steps that, when followed, can result in successful therapies from both a clinical and commercial perspective. PMID:26315572

Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective.

PubMed

McBlane, James W; Phul, Parvinder; Sharpe, Michaela

2018-06-25

This article describes preclinical development of cell-based medicinal products for European markets and discusses European regulatory mechanisms open to developers to aid successful product development. Cell-based medicinal products are diverse, including cells that are autologous or allogeneic, have been genetically modified, or not, or expanded ex vivo, and applied systemically or to an anatomical site different to that of their origin; comments applicable to one product may not be applicable to others, so bespoke development is needed, for all elements - quality, preclinical and clinical. After establishing how the product is produced, proof of potential for therapeutic efficacy, and then safety, of the product need to be determined. This includes understanding biodistribution, persistence and toxicity, including potential for malignant transformation. These elements need to be considered in the context of the intended clinical development. This article describes regulatory mechanisms available to developers to support product development that aim to resolve scientific issues prior to marketing authorization application, to enable patients to have faster access to the product than would otherwise be the case. Developers are encouraged to be aware of both the scientific issues and regulatory mechanisms to ensure patients can be supplied with these products.

Investigation of the medical applications of the unique biocarbons developed by NASA. [compatibility of percutaneous prosthetic carbon devices

NASA Technical Reports Server (NTRS)

Mooney, V.

1973-01-01

The biocompatibility of percutaneous endoskeletal fixation devices made from carbon compounds, and their applications are considered. The clinical application of these carbons to solve human problems is demonstrated and the nature of myoelectric simulation by carbon implants is studied.

Development and validation of a clinically applicable score to classify cachexia stages in advanced cancer patients

PubMed Central

Zhou, Ting; Wang, Bangyan; Liu, Huiquan; Yang, Kaixiang; Thapa, Sudip; Zhang, Haowen; Li, Lu

2018-01-01

Abstract Background Cachexia is a multifactorial syndrome that is highly prevalent in advanced cancer patients and leads to progressive functional impairments. The classification of cachexia stages is essential for diagnosing and treating cachexia. However, there is a lack of simple tools with good discrimination for classifying cachexia stages. Therefore, our study aimed to develop a clinically applicable cachexia staging score (CSS) and validate its discrimination of clinical outcomes for different cachexia stages. Methods Advanced cancer patients were enrolled in our study. A CSS comprising the following five components was developed: weight loss, a simple questionnaire of sarcopenia (SARC‐F), Eastern Cooperative Oncology Group, appetite loss, and abnormal biochemistry. According to the CSS, patients were classified into non‐cachexia, pre‐cachexia, cachexia, and refractory cachexia stages, and clinical outcomes were compared among the four groups. Results Of the 297 participating patients, data from 259 patients were ultimately included. Based on the CSS, patients were classified into non‐cachexia (n = 69), pre‐cachexia (n = 68), cachexia (n = 103), and refractory cachexia (n = 19) stages. Patients with more severe cachexia stages had lower skeletal muscle indexes (P = 0.002 and P = 0.004 in male and female patients, respectively), higher prevalence of sarcopenia (P = 0.017 and P = 0.027 in male and female patients, respectively), more severe symptom burden (P < 0.001), poorer quality of life (P < 0.001 for all subscales except social well‐being), and shorter survival times (P < 0.001). Conclusions The CSS is a simple and clinically applicable tool with excellent discrimination for classifying cachexia stages. This score is extremely useful for the clinical treatment and prognosis of cachexia and for designing clinical trials. PMID:29372594

Development and feasibility of smartphone application for cognitive-behavioural case management of individuals with early psychosis.

PubMed

Kim, Sung-Wan; Lee, Ga-Young; Yu, Hye-Young; Jung, Eun-I; Lee, Ju-Yeon; Kim, Seon-Young; Kim, Jae-Min; Shin, Il-Seon; Yoon, Jin-Sang

2017-05-18

This article describes the development of the smartphone application for cognitive-behavioural case management of young individuals with early psychosis and examines the acceptance and potential clinical benefits of this application through a pilot survey. Gwangju Bukgu-Community Mental Health Center developed and launched a smartphone application (Heal Your Mind [HYM]) for cognitive-behavioural case management and symptom monitoring. The HYM application for clients includes 6 main modules including thought record, symptom record, daily life record, official notices, communication and scales. The key module is the "thought record" for self-directed cognitive-behavioural treatment. When the client writes and sends the self-cognitive-behavioural therapy sheet to the case manager, the latter receives a notification and can provide feedback in real time. We conducted a survey to investigate the acceptance and feasibility of this approach among young clients with early psychosis. A total of 24 clients with early psychosis participated in this survey. More than 80% of participants reported that it was easy to learn to use this application, and no one described this application as very complicated or reported that they needed a long time to learn how to use it. About 80% of participants were satisfied with this application, and 70% reported that they received help as a result of using this application. This study suggests that this smartphone application is useful for young individuals with early psychosis and that it may contribute to the development of both young customer- and case manager-friendly systems for this clinical population. © 2017 John Wiley & Sons Australia, Ltd.

Clinical Natural Language Processing in languages other than English: opportunities and challenges.

PubMed

Névéol, Aurélie; Dalianis, Hercules; Velupillai, Sumithra; Savova, Guergana; Zweigenbaum, Pierre

2018-03-30

Natural language processing applied to clinical text or aimed at a clinical outcome has been thriving in recent years. This paper offers the first broad overview of clinical Natural Language Processing (NLP) for languages other than English. Recent studies are summarized to offer insights and outline opportunities in this area. We envision three groups of intended readers: (1) NLP researchers leveraging experience gained in other languages, (2) NLP researchers faced with establishing clinical text processing in a language other than English, and (3) clinical informatics researchers and practitioners looking for resources in their languages in order to apply NLP techniques and tools to clinical practice and/or investigation. We review work in clinical NLP in languages other than English. We classify these studies into three groups: (i) studies describing the development of new NLP systems or components de novo, (ii) studies describing the adaptation of NLP architectures developed for English to another language, and (iii) studies focusing on a particular clinical application. We show the advantages and drawbacks of each method, and highlight the appropriate application context. Finally, we identify major challenges and opportunities that will affect the impact of NLP on clinical practice and public health studies in a context that encompasses English as well as other languages.

[The historical background and present development of evidence-based healthcare and clinical nursing].

PubMed

Tsai, Jung-Mei

2014-12-01

Evidence-based healthcare (EBHC) emphasizes the integration of the best research evidence with patient values, specialist suggestions, and clinical circumstances during the process of clinical decision-making. EBHC is a recognized core competency in modern healthcare. Nursing is a professional discipline of empirical science that thrives in an environment marked by advances in knowledge and technology in medicine as well as in nursing. Clinical nurses must elevate their skills and professional qualifications, provide efficient and quality health services, and promote their proficiency in EBHC. The Institute of Medicine in the United States indicates that evidence-based research results often fail to disseminate efficiently to clinical decision makers. This problem highlights the importance of better promoting the evidence-based healthcare fundamentals and competencies to frontline clinical nurses. This article describes the historical background and present development of evidence-based healthcare from the perspective of modern clinical nursing in light of the importance of evidence-based healthcare in clinical nursing; describes the factors associated with evidence-based healthcare promotion; and suggests strategies and policies that may improve the promotion and application of EBHC in clinical settings. The authors hope that this paper provides a reference for efforts to improve clinical nursing in the realms of EBHC training, promotion, and application.

[The use of systematic review to develop a self-management program for CKD].

PubMed

Lee, Yu-Chin; Wu, Shu-Fang Vivienne; Lee, Mei-Chen; Chen, Fu-An; Yao, Yen-Hong; Wang, Chin-Ling

2014-12-01

Chronic kidney disease (CKD) has become a public health issue of international concern due to its high prevalence. The concept of self-management has been comprehensively applied in education programs that address chronic diseases. In recent years, many studies have used self-management programs in CKD interventions and have investigated the pre- and post-intervention physiological and psychological effectiveness of this approach. However, a complete clinical application program in the self-management model has yet to be developed for use in clinical renal care settings. A systematic review is used to develop a self-management program for CKD. Three implementation steps were used in this study. These steps include: (1) A systematic literature search and review using databases including CEPS (Chinese Electronic Periodical Services) of Airiti, National Digital Library of Theses and Dissertations in Taiwan, CINAHL, Pubmed, Medline, Cochrane Library, and Joanna Briggs Institute. A total of 22 studies were identified as valid and submitted to rigorous analysis. Of these, 4 were systematic literature reviews, 10 were randomized experimental studies, and 8 were non-randomized experimental studies. (2) Empirical evidence then was used to draft relevant guidelines on clinical application. (3) Finally, expert panels tested the validity of the draft to ensure the final version was valid for application in practice. This study designed a self-management program for CKD based on the findings of empirical studies. The content of this program included: design principles, categories, elements, and the intervention measures used in the self-management program. This program and then was assessed using the content validity index (CVI) and a four-point Liker's scale. The content validity score was .98. The guideline of self-management program to CKD was thus developed. This study developed a self-management program applicable to local care of CKD. It is hoped that the guidelines developed in this study offer a reference for clinical caregivers to improve their healthcare practices.

Smartphone applications: A contemporary resource for dermatopathology

PubMed Central

Hanna, Matthew G.; Parwani, Anil V.; Pantanowitz, Liron; Punjabi, Vinod; Singh, Rajendra

2015-01-01

Introduction: Smartphone applications in medicine are becoming increasingly prevalent. Given that most pathologists and pathology trainees today use smartphones, an obvious modality for pathology education is through smartphone applications. “MyDermPath” is a novel smartphone application that was developed as an interactive reference tool for dermatology and dermatopathology, available for iOS and Android. Materials and Methods: “MyDermPath” was developed using Apple Xcode and Google Android SDK. Dermatology images (static and virtual slides) were annotated and configured into an algorithmic format. Each image comprised educational data (diagnosis, clinical information, histopathology, special stains, differential diagnosis, clinical management, linked PubMed references). Added functionality included personal note taking, pop quiz, and image upload capabilities. A website was created (http://mydermpath.com) to mirror the app. Results: The application was released in August 2011 and updated in November 2013. More than 1,100 reference diagnoses, with over 2,000 images are available via the application and website. The application has been downloaded approximately 14,000 times. The application is available for use on iOS and Android platforms. Conclusions: Smartphone applications have tremendous potential for advancing pathology education. “MyDermPath” represents an interactive reference tool for dermatology and dermatopathologists. PMID:26284155

Smartphone applications: A contemporary resource for dermatopathology.

PubMed

Hanna, Matthew G; Parwani, Anil V; Pantanowitz, Liron; Punjabi, Vinod; Singh, Rajendra

2015-01-01

Smartphone applications in medicine are becoming increasingly prevalent. Given that most pathologists and pathology trainees today use smartphones, an obvious modality for pathology education is through smartphone applications. "MyDermPath" is a novel smartphone application that was developed as an interactive reference tool for dermatology and dermatopathology, available for iOS and Android. "MyDermPath" was developed using Apple Xcode and Google Android SDK. Dermatology images (static and virtual slides) were annotated and configured into an algorithmic format. Each image comprised educational data (diagnosis, clinical information, histopathology, special stains, differential diagnosis, clinical management, linked PubMed references). Added functionality included personal note taking, pop quiz, and image upload capabilities. A website was created (http://mydermpath.com) to mirror the app. The application was released in August 2011 and updated in November 2013. More than 1,100 reference diagnoses, with over 2,000 images are available via the application and website. The application has been downloaded approximately 14,000 times. The application is available for use on iOS and Android platforms. Smartphone applications have tremendous potential for advancing pathology education. "MyDermPath" represents an interactive reference tool for dermatology and dermatopathologists.

Use of dyes in cariology.

PubMed

van de Rijke, J W

1991-04-01

The property of dyes to enhance contrast by their colour can be used in clinical dentistry and in investigations in vitro or in vivo. They have been used for indication of affected dental tissues, improvement of diagnostic methods, enhancement of patient awareness and information about specific processes. The development of particular dye systems, aimed at clinical application, is often laborious because of toxic effects, lack of specificity, irreversible staining or difficulties with removal of the dye. Clinically used dyes are often visually observed, which means a qualitative assessment of the staining, while quantification of the staining, if performed at all, is confined mostly to laboratory experiments. In this paper the application of dyes, arranged according to their specific purpose in cariology, is discussed, and a brief historical overview is given of the development of two particular dye applications for which commercial dye systems are now available. If certain requirements are met, dyes can be of great help in detection and quantification when used with several diagnostic methods.

Development of Standardized Clinical Training Cases for Diagnosis of Sexual Abuse using a Secure Telehealth Application

ERIC Educational Resources Information Center

Frasier, Lori D.; Thraen, Ioana; Kaplan, Rich; Goede, Patricia

2012-01-01

Objectives: The training of physicians, nurse examiners, social workers and other health professional on the evidentiary findings of sexual abuse in children is challenging. Our objective was to develop peer reviewed training cases for medical examiners of child sexual abuse, using a secure web based telehealth application (TeleCAM). Methods:…

The Development of Clinical Reasoning Skills: A Major Objective of the Anatomy Course

ERIC Educational Resources Information Center

Elizondo-Omana, Rodrigo E.; Lopez, Santos Guzman

2008-01-01

Traditional medical school curricula have made a clear demarcation between the basic biomedical sciences and the clinical years. It is our view that a comprehensive medical education necessarily involves an increased correlation between basic science knowledge and its clinical applications. A basic anatomy course should have two main objectives:…

Cell and tissue engineering and clinical applications: an overview.

PubMed

Stoltz, J F; Bensoussan, D; Decot, V; Ciree, A; Netter, P; Gillet, P

2006-01-01

Most human tissues do not regenerate spontaneously; this is why cell therapies and tissue engineering are promising alternatives. The principle is simple: cells are collected in a patient and introduced in the damaged tissue or in a tridimentional porous support and harvested in a bioreactor in which the physico-chemical and mechanical parameters are controlled. Once the tissues (or the cells) are mature they may be implanted. In parallel, the development of biotherapies with stem cells is a field of research in turmoil given the hopes for clinical applications that it brings up. Embryonic stem cells are potentially more interesting since they are totipotent, but they can only be obtained at the very early stages of the embryo. The potential of adult stem cells is limited but isolating them induces no ethical problem and it has been known for more than 40 years that bone marrow does possess the regenerating functions of blood cells. Finally, the properties of foetal stem cells (blood cells from the umbilical cord) are forerunners of the haematopoietic system but the ability of these cells to participate to the formation of other tissues is more problematic. Another field for therapeutic research is that of dendritic cells, antigen presenting cells. Their efficiency in cell therapy relies on the initiation of specific immune responses. They represent a promising tool in the development of a protective immune response against antigens which the host is usually unable to generate an efficient response (melanomas, breast against cancer, prostate cancer, ..). Finally, gene therapy, has been nourishing high hopes but few clinical applications can be envisaged in the short term, although potential applications are multiple (haemophilia, myopathies, ..). A large number of clinical areas stand as candidates for clinical applications: leukaemia and cancers, cardiac insufficiency and vascular diseases, cartilage and bone repair, ligaments and tendons, liver diseases, ophthalmology, diabetes, neurological diseases (Parkinson, Huntington disease, ..), .. Various aspects of this new regenerative therapeutic medicine are developed in this work.

v3NLP Framework: Tools to Build Applications for Extracting Concepts from Clinical Text

PubMed Central

Divita, Guy; Carter, Marjorie E.; Tran, Le-Thuy; Redd, Doug; Zeng, Qing T; Duvall, Scott; Samore, Matthew H.; Gundlapalli, Adi V.

2016-01-01

Introduction: Substantial amounts of clinically significant information are contained only within the narrative of the clinical notes in electronic medical records. The v3NLP Framework is a set of “best-of-breed” functionalities developed to transform this information into structured data for use in quality improvement, research, population health surveillance, and decision support. Background: MetaMap, cTAKES and similar well-known natural language processing (NLP) tools do not have sufficient scalability out of the box. The v3NLP Framework evolved out of the necessity to scale-up these tools up and provide a framework to customize and tune techniques that fit a variety of tasks, including document classification, tuned concept extraction for specific conditions, patient classification, and information retrieval. Innovation: Beyond scalability, several v3NLP Framework-developed projects have been efficacy tested and benchmarked. While v3NLP Framework includes annotators, pipelines and applications, its functionalities enable developers to create novel annotators and to place annotators into pipelines and scaled applications. Discussion: The v3NLP Framework has been successfully utilized in many projects including general concept extraction, risk factors for homelessness among veterans, and identification of mentions of the presence of an indwelling urinary catheter. Projects as diverse as predicting colonization with methicillin-resistant Staphylococcus aureus and extracting references to military sexual trauma are being built using v3NLP Framework components. Conclusion: The v3NLP Framework is a set of functionalities and components that provide Java developers with the ability to create novel annotators and to place those annotators into pipelines and applications to extract concepts from clinical text. There are scale-up and scale-out functionalities to process large numbers of records. PMID:27683667

[NEW PROGRESS OF ACELLULAR FISH SKIN AS NOVEL TISSUE ENGINEERED SCAFFOLD].

PubMed

Wei, Xiaojuan; Wang, Nanping; He, Lan; Guo, Xiuyu; Gu, Qisheng

2016-11-08

To review the recent research progress of acellular fish skin as a tissue engineered scaffold, and to analyze the feasibility and risk management in clinical application. The research and development, application status of acellular fish skin as a tissue engineered scaffold were comprehensively analyzed, and then several key points were put forward. Acellular fish skin has a huge potential in clinical practice as novel acellular extracellular matrix, but there have been no related research reports up to now in China. As an emerging point of translational medicine, investigation of acellular fish skin is mainly focused on artificial skin, surgical patch, and wound dressings. Development of acellular fish skin-based new products is concerned to be clinical feasible and necessary, but a lot of applied basic researches should be carried out.

Clinical applications of preimplantation genetic testing.

PubMed

Brezina, Paul R; Kutteh, William H

2015-02-19

Genetic diagnostic technologies are rapidly changing the way medicine is practiced. Preimplantation genetic testing is a well established application of genetic testing within the context of in vitro fertilization cycles. It involves obtaining a cell(s) from a developing embryo in culture, which is then subjected to genetic diagnostic analysis; the resulting information is used to guide which embryos are transferred into the uterus. The potential applications and use of this technology have increased in recent years. Experts agree that preimplantation genetic diagnosis is clinically appropriate for many known genetic disorders. However, some applications of such testing, such as preimplantation genetic screening for aneuploidy, remain controversial. Clinical data suggest that preimplantation genetic screening may be useful, but further studies are needed to quantify the size of the effect and who would benefit most. © BMJ Publishing Group Ltd 2015.

Clinical application of antidepressant pharmacogenetics: considerations for the design of future studies.

PubMed

Fabbri, Chiara; Serretti, Alessandro

2018-06-12

A frustrating inertia has affected the development of clinical applications of antidepressant pharmacogenetics and personalized treatments of depression are still lacking 20 years after the first findings. Candidate gene studies provided replicated findings for some polymorphisms, but each of them shows at best a small effect on antidepressant efficacy and the cumulative effect of different polymorphisms is unclear. Further, no candidate was immune by at least some negative studies. These considerations give rise to some concerns about the clinical benefits of currently available pharmacogenetic tests since they are based on the results of candidate gene studies. Clinical guidelines in fact suggest that only polymorphisms that alter cytochrome 2D6 or 2C19 enzymatic activity probably provide useful clinical indications, while variants in genes involved in antidepressant pharmacodynamics have no recommended clinical applications. The present review discusses possible strategies to facilitate the identification of genetic biomarkers with clinical usefulness in guiding antidepressant treatments. These include analysis methods for the study of the polygenic/omnigenic nature of antidepressant response, the prioritization of polymorphisms on the basis of functional considerations, the incorporation of clinical-demographic predictors in pharmacogenetic studies (e.g. mixed polygenic and clinical risk scores), the application of methodological improvements to the design of future studies in order to maximize the comparability of results and improve power. Copyright © 2018. Published by Elsevier B.V.

Integrating pharmacogenomics into pharmacy practice via medication therapy management.

PubMed

Reiss, Susan M

2011-01-01

To explore the application and integration of pharmacogenomics in pharmacy clinical practice via medication therapy management (MTM) to improve patient care. Department of Health & Human Services (HHS) Personalized Health Care Initiative, Food and Drug Administration (FDA) pharmacogenomics activity, and findings from the Utilizing E-Prescribing Technologies to Integrate Pharmacogenomics into Prescribing and Dispensing Practices Stakeholder Workshop, convened by the American Pharmacists Association (APhA) on March 5, 2009. Participants at the Stakeholder Workshop included diverse representatives from pharmacy, medicine, pathology, health information technology (HIT), standards, science, academia, government, and others with a key interest in the clinical application of pharmacogenomics. In 2006, HHS initiated the Personalized Health Care Initiative with the goal of building the foundation for the delivery of gene-based care, which may prove to be more effective for large patient subpopulations. In the years since the initiative was launched, drug manufacturers and FDA have begun to incorporate pharmacogenomic data and applications of this information into the drug development, labeling, and approval processes. New applications and processes for using this emerging pharmacogenomics data are needed to effectively integrate this information into clinical practice. Building from the findings of a stakeholder workshop convened by APhA and the advancement of the pharmacist's collaborative role in patient care through MTM, emerging roles for pharmacists using pharmacogenomic information to improve patient care are taking hold. Realizing the potential role of the pharmacist in pharmacogenomics through MTM will require connectivity of pharmacists into the electronic health record infrastructure to permit the exchange of pertinent health information among all members of a patient's health care team. Addressing current barriers, concerns, and system limitations and developing an effective infrastructure will be necessary for pharmacogenomics to achieve its true potential. To achieve integration of pharmacogenomics into clinical practice via MTM, the pharmacy profession must define a process for the application of pharmacogenomic data into pharmacy clinical practice that is aligned with MTM service delivery, develop a viable business model for these practices, and encourage and direct the development of HIT solutions that support the pharmacist's role in this emerging field.

Advances in mass spectrometry-based cancer research and analysis: from cancer proteomics to clinical diagnostics.

PubMed

Timms, John F; Hale, Oliver J; Cramer, Rainer

2016-06-01

The last 20 years have seen significant improvements in the analytical capabilities of biological mass spectrometry (MS). Studies using advanced MS have resulted in new insights into cell biology and the etiology of diseases as well as its use in clinical applications. This review discusses recent developments in MS-based technologies and their cancer-related applications with a focus on proteomics. It also discusses the issues around translating the research findings to the clinic and provides an outline of where the field is moving. Expert commentary: Proteomics has been problematic to adapt for the clinical setting. However, MS-based techniques continue to demonstrate potential in novel clinical uses beyond classical cancer proteomics.

Software for MR image overlay guided needle insertions: the clinical translation process

NASA Astrophysics Data System (ADS)

Ungi, Tamas; U-Thainual, Paweena; Fritz, Jan; Iordachita, Iulian I.; Flammang, Aaron J.; Carrino, John A.; Fichtinger, Gabor

2013-03-01

PURPOSE: Needle guidance software using augmented reality image overlay was translated from the experimental phase to support preclinical and clinical studies. Major functional and structural changes were needed to meet clinical requirements. We present the process applied to fulfill these requirements, and selected features that may be applied in the translational phase of other image-guided surgical navigation systems. METHODS: We used an agile software development process for rapid adaptation to unforeseen clinical requests. The process is based on iterations of operating room test sessions, feedback discussions, and software development sprints. The open-source application framework of 3D Slicer and the NA-MIC kit provided sufficient flexibility and stable software foundations for this work. RESULTS: All requirements were addressed in a process with 19 operating room test iterations. Most features developed in this phase were related to workflow simplification and operator feedback. CONCLUSION: Efficient and affordable modifications were facilitated by an open source application framework and frequent clinical feedback sessions. Results of cadaver experiments show that software requirements were successfully solved after a limited number of operating room tests.

Improving Medical Students' Application of Knowledge and Clinical Decision-Making Through a Porcine-Based Integrated Cardiac Basic Science Program.

PubMed

Stott, Martyn Charles; Gooseman, Michael Richard; Briffa, Norman Paul

2016-01-01

Despite the concerted effort of modern undergraduate curriculum designers, the ability to integrate basic sciences in clinical rotations is an ongoing problem in medical education. Students and newly qualified doctors themselves report worry about the effect this has on their clinical performance. There are examples in the literature to support development of attempts at integrating such aspects, but this "vertical integration" has proven to be difficult. We designed an expert-led integrated program using dissection of porcine hearts to improve the use of cardiac basic sciences in clinical medical students' decision-making processes. To our knowledge, this is the first time in the United Kingdom that an animal model has been used to teach undergraduate clinical anatomy to medical students to direct wider application of knowledge. Action research methodology was used to evaluate the local curriculum and assess learners needs, and the agreed teaching outcomes, methods, and delivery outline were established. A total of 18 students in the clinical years of their degree program attended, completing precourse and postcourse multichoice questions examinations and questionnaires to assess learners' development. Student's knowledge scores improved by 17.5% (p = 0.01; students t-test). Students also felt more confident at applying underlying knowledge to decision-making and diagnosis in clinical medicine. An expert teacher (consultant surgeon) was seen as beneficial to students' understanding and appreciation. This study outlines how the development of a teaching intervention using porcine-based methods successfully improved both student's knowledge and application of cardiac basic sciences. We recommend that clinicians fully engage with integrating previously learnt underlying sciences to aid students in developing decision-making and diagnostic skills as well as a deeper approach to learning. Copyright © 2016 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Applications of Doppler ultrasound in clinical vascular disease

NASA Technical Reports Server (NTRS)

Barnes, R. W.; Hokanson, D. E.; Sumner, D. S.; Strandness, D. E., Jr.

1975-01-01

Doppler ultrasound has become the most useful and versatile noninvasive technique for objective evaluation of clinical vascular disease. Commercially available continuous-wave instruments provide qualitative and quantitative assessment of venous and arterial disease. Pulsed Doppler ultrasound was developed to provide longitudinal and transverse cross-sectional images of the arterial lumen with a resolution approaching that of conventional X-ray techniques. Application of Doppler ultrasound in venous, peripheral arterial, and cerebrovascular diseases is reviewed.

An initial assessment of the cost and utilization of the Integrated Academic Information System (IAIMS) at Columbia Presbyterian Medical Center.

PubMed Central

Clayton, P. D.; Anderson, R. K.; Hill, C.; McCormack, M.

1991-01-01

The concept of "one stop information shopping" is becoming a reality at Columbia Presbyterian Medical Center (CPMC). The goal of our effort is to provide access to university and hospital administrative systems as well as clinical and library applications from a single workstation, which also provides utility functions such as word processing and mail. Since June 1987, CPMC has invested the equivalent of $23 million dollars to install a digital communications network that encompasses 18 buildings at seven geographically separate sites and to develop clinical and library applications that are integrated with the existing hospital and university administrative and research computing facilities. During June 1991, 2425 different individuals used the clinical information system, 425 different individuals used the library applications, and 900 different individuals used the hospital administrative applications via network access. If we were to freeze the system in its current state, amortize the development and network installation costs, and add projected maintenance costs for the clinical and library applications, our integrated information system would cost $2.8 million on an annual basis. This cost is 0.3% of the medical center's annual budget. These expenditures could be justified by very small improvements in time savings for personnel and/or decreased length of hospital stay and/or more efficient use of resources. In addition to the direct benefits which we detail, a major benefit is the ease with which additional computer-based applications can be added incrementally at an extremely modest cost. PMID:1666966

MNE Scan: Software for real-time processing of electrophysiological data.

PubMed

Esch, Lorenz; Sun, Limin; Klüber, Viktor; Lew, Seok; Baumgarten, Daniel; Grant, P Ellen; Okada, Yoshio; Haueisen, Jens; Hämäläinen, Matti S; Dinh, Christoph

2018-06-01

Magnetoencephalography (MEG) and Electroencephalography (EEG) are noninvasive techniques to study the electrophysiological activity of the human brain. Thus, they are well suited for real-time monitoring and analysis of neuronal activity. Real-time MEG/EEG data processing allows adjustment of the stimuli to the subject's responses for optimizing the acquired information especially by providing dynamically changing displays to enable neurofeedback. We introduce MNE Scan, an acquisition and real-time analysis software based on the multipurpose software library MNE-CPP. MNE Scan allows the development and application of acquisition and novel real-time processing methods in both research and clinical studies. The MNE Scan development follows a strict software engineering process to enable approvals required for clinical software. We tested the performance of MNE Scan in several device-independent use cases, including, a clinical epilepsy study, real-time source estimation, and Brain Computer Interface (BCI) application. Compared to existing tools we propose a modular software considering clinical software requirements expected by certification authorities. At the same time the software is extendable and freely accessible. We conclude that MNE Scan is the first step in creating a device-independent open-source software to facilitate the transition from basic neuroscience research to both applied sciences and clinical applications. Copyright © 2018 Elsevier B.V. All rights reserved.

Measuring Workload Demand of Informatics Systems with the Clinical Case Demand Index

PubMed Central

Iyengar, M. Sriram; Rogith, Deevakar; Florez-Arango, Jose F

2017-01-01

Introduction: The increasing use of Health Information Technology (HIT) can add substantially to workload on clinical providers. Current methods for assessing workload do not take into account the nature of clinical cases and the use of HIT tools while solving them. Methods: The Clinical Case Demand Index (CCDI), consisting of a summary score and visual representation, was developed to meet this need. Consistency with current perceived workload measures was evaluated in a Randomized Control Trial of a mobile health system. Results: CCDI is significantly correlated with existing workload measures and inversely related to provider performance. Discussion: CCDI combines subjective and objective characteristics of clinical cases along with cognitive and clinical dimensions. Applications include evaluation of HIT tools, clinician scheduling, medical education. Conclusion: CCDI supports comparative effectiveness research of HIT tools. In addition, CCDI could have numerous applications including training, clinical trials, design of clinical workflows, and others. PMID:29854166

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines

PubMed Central

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-01-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association’s governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research;Improving patient care provided by members by providing focus on quality and evidence;Creating legislative environments that favour effective clinical practice;Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; andIdentifying areas that require further information or research to improve clinical care.The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement. PMID:25314352

Canadian Association of Gastroenterology policy on the application for, and implementation of, clinical practice guidelines.

PubMed

Singh, Harminder; Leontiadis, Grigorios I; Hookey, Lawrence; Enns, Robert; Bistritz, Lana; Rioux, Louis-Charles; Hope, Louise; Sinclair, Paul

2014-10-01

An important mandate of the Canadian Association of Gastroenterology (CAG), as documented in the Association's governance policies, is to optimize the care of patients with digestive disorders. Clinical practice guidelines are one means of achieving this goal. The benefits of timely, high-quality and evidenced-based recommendations include: Enhancing the professional development of clinical members through education and dissemination of synthesized clinical research; Improving patient care provided by members by providing focus on quality and evidence; Creating legislative environments that favour effective clinical practice; Enhancing the clinical care provided to patients with digestive disease by nongastroenterologists; and Identifying areas that require further information or research to improve clinical care. The present document provides the foundation required to ensure that clinical practice guidelines produced by the CAG are necessary, appropriate, credible and applicable. These recommendations should be adhered to as closely as possible to obtain CAG endorsement.

Computational and mathematical methods in brain atlasing.

PubMed

Nowinski, Wieslaw L

2017-12-01

Brain atlases have a wide range of use from education to research to clinical applications. Mathematical methods as well as computational methods and tools play a major role in the process of brain atlas building and developing atlas-based applications. Computational methods and tools cover three areas: dedicated editors for brain model creation, brain navigators supporting multiple platforms, and atlas-assisted specific applications. Mathematical methods in atlas building and developing atlas-aided applications deal with problems in image segmentation, geometric body modelling, physical modelling, atlas-to-scan registration, visualisation, interaction and virtual reality. Here I overview computational and mathematical methods in atlas building and developing atlas-assisted applications, and share my contribution to and experience in this field.

The clinical application of genome-wide sequencing for monogenic diseases in Canada: Position Statement of the Canadian College of Medical Geneticists

PubMed Central

Boycott, Kym; Hartley, Taila; Adam, Shelin; Bernier, Francois; Chong, Karen; Fernandez, Bridget A; Friedman, Jan M; Geraghty, Michael T; Hume, Stacey; Knoppers, Bartha M; Laberge, Anne-Marie; Majewski, Jacek; Mendoza-Londono, Roberto; Meyn, M Stephen; Michaud, Jacques L; Nelson, Tanya N; Richer, Julie; Sadikovic, Bekim; Skidmore, David L; Stockley, Tracy; Taylor, Sherry; van Karnebeek, Clara; Zawati, Ma'n H; Lauzon, Julie; Armour, Christine M

2015-01-01

Purpose and scope The aim of this Position Statement is to provide recommendations for Canadian medical geneticists, clinical laboratory geneticists, genetic counsellors and other physicians regarding the use of genome-wide sequencing of germline DNA in the context of clinical genetic diagnosis. This statement has been developed to facilitate the clinical translation and development of best practices for clinical genome-wide sequencing for genetic diagnosis of monogenic diseases in Canada; it does not address the clinical application of this technology in other fields such as molecular investigation of cancer or for population screening of healthy individuals. Methods of statement development Two multidisciplinary groups consisting of medical geneticists, clinical laboratory geneticists, genetic counsellors, ethicists, lawyers and genetic researchers were assembled to review existing literature and guidelines on genome-wide sequencing for clinical genetic diagnosis in the context of monogenic diseases, and to make recommendations relevant to the Canadian context. The statement was circulated for comment to the Canadian College of Medical Geneticists (CCMG) membership-at-large and, following incorporation of feedback, approved by the CCMG Board of Directors. The CCMG is a Canadian organisation responsible for certifying medical geneticists and clinical laboratory geneticists, and for establishing professional and ethical standards for clinical genetics services in Canada. Results and conclusions Recommendations include (1) clinical genome-wide sequencing is an appropriate approach in the diagnostic assessment of a patient for whom there is suspicion of a significant monogenic disease that is associated with a high degree of genetic heterogeneity, or where specific genetic tests have failed to provide a diagnosis; (2) until the benefits of reporting incidental findings are established, we do not endorse the intentional clinical analysis of disease-associated genes other than those linked to the primary indication; and (3) clinicians should provide genetic counselling and obtain informed consent prior to undertaking clinical genome-wide sequencing. Counselling should include discussion of the limitations of testing, likelihood and implications of diagnosis and incidental findings, and the potential need for further analysis to facilitate clinical interpretation, including studies performed in a research setting. These recommendations will be routinely re-evaluated as knowledge of diagnostic and clinical utility of clinical genome-wide sequencing improves. While the document was developed to direct practice in Canada, the applicability of the statement is broader and will be of interest to clinicians and health jurisdictions internationally. PMID:25951830

Medical application and clinical validation for reliable and trustworthy physiological monitoring using functional textiles: experience from the HeartCycle and MyHeart project.

PubMed

Reiter, Harald; Muehlsteff, Jens; Sipilä, Auli

2011-01-01

Functional textiles are seen as promising technology to enable healthcare services and medical care outside hospitals due to their ability to integrate textile-based sensing and monitoring technologies into the daily life. In the past much effort has been spent onto basic functional textile research already showing that reliable monitoring solutions can be realized. The challenge remains to find and develop suited medical application and to fulfil the boundary conditions for medical endorsement and exploitation. The HeartCycle vest described in this abstract will serve as an example for a functional textile carefully developed according to the requirements of a specific medical application, its clinical validation, the related certification aspects and the next improvement steps towards exploitation.

Research Output from CPTC highlighted in recent articles | Office of Cancer Clinical Proteomics Research

Cancer.gov

In the special December issue of Proteomics Clinical Applications , two articles focus directly on scientific outputs from CPTC. A Viewpoint article, authored by Participants of a Wellcome Trust/EBI meeting and retreat (Patterson et al.), advocate the leveraging of the mock 510 (k) documents developed by CPTC for further development in order to better understand regulatory need.

Development and Application of a Computer Simulation Program to Enhance the Clinical Problem-Solving Skills of Students.

ERIC Educational Resources Information Center

Boh, Larry E.; And Others

1987-01-01

A project to (1) develop and apply a microcomputer simulation program to enhance clinical medication problem solving in preclerkship and clerkship students and (2) perform an initial formative evaluation of the simulation is described. A systematic instructional design approach was used in applying the simulation to the disease state of rheumatoid…

[Microdose clinical trial--impact of PET molecular imaging].

PubMed

Yano, Tsuneo; Watanabe, Yasuyoshi

2010-10-01

Microdose (MD) clinical trial and exploratory IND study including sub-therapeutic dose and therapeutic dose which are higher than microdoses are expected to bring about innovations in drug development. The outlines of guidances for microdose clinical trial and ICH-M3 (R2) issued by the MHLW in June, 2008, and February, 2010, are first explained, respectively, and some examples of their application to clinical developments of therapeutic drugs in the infection and cancer fields are introduced. Especially, thanks to the progress of molecular imaging research, a new field of drug development is explored by using imaging biomarkers for efficacy or safety evaluation which visualize biomarkers by PET imaging agents. Finally, the roadmap for drug development in infection and cancer fields utilizing PET molecular imaging is discussed.

Next-Generation Sequencing in Oncology: Genetic Diagnosis, Risk Prediction and Cancer Classification

PubMed Central

Kamps, Rick; Brandão, Rita D.; van den Bosch, Bianca J.; Paulussen, Aimee D. C.; Xanthoulea, Sofia; Blok, Marinus J.; Romano, Andrea

2017-01-01

Next-generation sequencing (NGS) technology has expanded in the last decades with significant improvements in the reliability, sequencing chemistry, pipeline analyses, data interpretation and costs. Such advances make the use of NGS feasible in clinical practice today. This review describes the recent technological developments in NGS applied to the field of oncology. A number of clinical applications are reviewed, i.e., mutation detection in inherited cancer syndromes based on DNA-sequencing, detection of spliceogenic variants based on RNA-sequencing, DNA-sequencing to identify risk modifiers and application for pre-implantation genetic diagnosis, cancer somatic mutation analysis, pharmacogenetics and liquid biopsy. Conclusive remarks, clinical limitations, implications and ethical considerations that relate to the different applications are provided. PMID:28146134

Behavioral economics and empirical public policy.

PubMed

Hursh, Steven R; Roma, Peter G

2013-01-01

The application of economics principles to the analysis of behavior has yielded novel insights on value and choice across contexts ranging from laboratory animal research to clinical populations to national trends of global impact. Recent innovations in demand curve methods provide a credible means of quantitatively comparing qualitatively different reinforcers as well as quantifying the choice relations between concurrently available reinforcers. The potential of the behavioral economic approach to inform public policy is illustrated with examples from basic research, pre-clinical behavioral pharmacology, and clinical drug abuse research as well as emerging applications to public transportation and social behavior. Behavioral Economics can serve as a broadly applicable conceptual, methodological, and analytical framework for the development and evaluation of empirical public policy. © Society for the Experimental Analysis of Behavior.

Soft tissue fillers for adipose tissue regeneration: From hydrogel development toward clinical applications.

PubMed

Van Nieuwenhove, I; Tytgat, L; Ryx, M; Blondeel, P; Stillaert, F; Thienpont, H; Ottevaere, H; Dubruel, P; Van Vlierberghe, S

2017-11-01

There is a clear and urgent clinical need to develop soft tissue fillers that outperform the materials currently used for adipose tissue reconstruction. Recently, extensive research has been performed within this field of adipose tissue engineering as the commercially available products and the currently existing techniques are concomitant with several disadvantages. Commercial products are highly expensive and associated with an imposing need for repeated injections. Lipofilling or free fat transfer has an unpredictable outcome with respect to cell survival and potential resorption of the fat grafts. Therefore, researchers are predominantly investigating two challenging adipose tissue engineering strategies: in situ injectable materials and porous 3D printed scaffolds. The present work provides an overview of current research encompassing synthetic, biopolymer-based and extracellular matrix-derived materials with a clear focus on emerging fabrication technologies and developments realized throughout the last decade. Moreover, clinical relevance of the most promising materials will be discussed, together with potential concerns associated with their application in the clinic. Copyright © 2017 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

Benefits of object-oriented models and ModeliChart: modern tools and methods for the interdisciplinary research on smart biomedical technology.

PubMed

Gesenhues, Jonas; Hein, Marc; Ketelhut, Maike; Habigt, Moriz; Rüschen, Daniel; Mechelinck, Mare; Albin, Thivaharan; Leonhardt, Steffen; Schmitz-Rode, Thomas; Rossaint, Rolf; Autschbach, Rüdiger; Abel, Dirk

2017-04-01

Computational models of biophysical systems generally constitute an essential component in the realization of smart biomedical technological applications. Typically, the development process of such models is characterized by a great extent of collaboration between different interdisciplinary parties. Furthermore, due to the fact that many underlying mechanisms and the necessary degree of abstraction of biophysical system models are unknown beforehand, the steps of the development process of the application are iteratively repeated when the model is refined. This paper presents some methods and tools to facilitate the development process. First, the principle of object-oriented (OO) modeling is presented and the advantages over classical signal-oriented modeling are emphasized. Second, our self-developed simulation tool ModeliChart is presented. ModeliChart was designed specifically for clinical users and allows independently performing in silico studies in real time including intuitive interaction with the model. Furthermore, ModeliChart is capable of interacting with hardware such as sensors and actuators. Finally, it is presented how optimal control methods in combination with OO models can be used to realize clinically motivated control applications. All methods presented are illustrated on an exemplary clinically oriented use case of the artificial perfusion of the systemic circulation.

Information management to enable personalized medicine: stakeholder roles in building clinical decision support.

PubMed

Downing, Gregory J; Boyle, Scott N; Brinner, Kristin M; Osheroff, Jerome A

2009-10-08

Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized decision-making, a comparison of current and future applications of clinical decision support to enable individualized medical treatment plans is presented. If clinical decision support tools are to impact outcomes in a clear and positive manner, their development and deployment must therefore consider the needs of the providers, including specific practice needs, information workflow, and practice environment.

Information management to enable personalized medicine: stakeholder roles in building clinical decision support

PubMed Central

2009-01-01

Background Advances in technology and the scientific understanding of disease processes are presenting new opportunities to improve health through individualized approaches to patient management referred to as personalized medicine. Future health care strategies that deploy genomic technologies and molecular therapies will bring opportunities to prevent, predict, and pre-empt disease processes but will be dependent on knowledge management capabilities for health care providers that are not currently available. A key cornerstone to the potential application of this knowledge will be effective use of electronic health records. In particular, appropriate clinical use of genomic test results and molecularly-targeted therapies present important challenges in patient management that can be effectively addressed using electronic clinical decision support technologies. Discussion Approaches to shaping future health information needs for personalized medicine were undertaken by a work group of the American Health Information Community. A needs assessment for clinical decision support in electronic health record systems to support personalized medical practices was conducted to guide health future development activities. Further, a suggested action plan was developed for government, researchers and research institutions, developers of electronic information tools (including clinical guidelines, and quality measures), and standards development organizations to meet the needs for personalized approaches to medical practice. In this article, we focus these activities on stakeholder organizations as an operational framework to help identify and coordinate needs and opportunities for clinical decision support tools to enable personalized medicine. Summary This perspective addresses conceptual approaches that can be undertaken to develop and apply clinical decision support in electronic health record systems to achieve personalized medical care. In addition, to represent meaningful benefits to personalized decision-making, a comparison of current and future applications of clinical decision support to enable individualized medical treatment plans is presented. If clinical decision support tools are to impact outcomes in a clear and positive manner, their development and deployment must therefore consider the needs of the providers, including specific practice needs, information workflow, and practice environment. PMID:19814826

Building Bridges: Leveraging Interdisciplinary Collaborations in the Development of Biomaterials to Meet Clinical Needs

PubMed Central

Fong, Eliza L.S.; Watson, Brendan M.; Kasper, F. Kurtis

2013-01-01

Our laboratory at Rice University has forged numerous collaborations with clinicians and basic scientists over the years to advance the development of novel biomaterials and modification of existing materials to meet clinical needs. This review highlights collaborative advances in biomaterials research from our laboratory in the areas of scaffold development, drug delivery and gene therapy, especially as related to applications in bone and cartilage tissue engineering. PMID:22821772

Alternative Methods by Which Basic Science Pharmacy Faculty Can Relate to Clinical Practice, Executive Summary and Final Report, October 1, 1978 - March 15, 1980.

ERIC Educational Resources Information Center

Kabat, Hugh F.; And Others

The areas of basic science pharmacy instruction and clinical pharmacy practice and their interrelationships were identified in order to help develop didactic and clinical experience alternatives. A 10-member advisory committee ranked basic pharmaceutical science topical areas in terms of their applicability to clinical practice utilizing a Delphi…

A Flexible Method for Multi-Material Decomposition of Dual-Energy CT Images.

PubMed

Mendonca, Paulo R S; Lamb, Peter; Sahani, Dushyant V

2014-01-01

The ability of dual-energy computed-tomographic (CT) systems to determine the concentration of constituent materials in a mixture, known as material decomposition, is the basis for many of dual-energy CT's clinical applications. However, the complex composition of tissues and organs in the human body poses a challenge for many material decomposition methods, which assume the presence of only two, or at most three, materials in the mixture. We developed a flexible, model-based method that extends dual-energy CT's core material decomposition capability to handle more complex situations, in which it is necessary to disambiguate among and quantify the concentration of a larger number of materials. The proposed method, named multi-material decomposition (MMD), was used to develop two image analysis algorithms. The first was virtual unenhancement (VUE), which digitally removes the effect of contrast agents from contrast-enhanced dual-energy CT exams. VUE has the ability to reduce patient dose and improve clinical workflow, and can be used in a number of clinical applications such as CT urography and CT angiography. The second algorithm developed was liver-fat quantification (LFQ), which accurately quantifies the fat concentration in the liver from dual-energy CT exams. LFQ can form the basis of a clinical application targeting the diagnosis and treatment of fatty liver disease. Using image data collected from a cohort consisting of 50 patients and from phantoms, the application of MMD to VUE and LFQ yielded quantitatively accurate results when compared against gold standards. Furthermore, consistent results were obtained across all phases of imaging (contrast-free and contrast-enhanced). This is of particular importance since most clinical protocols for abdominal imaging with CT call for multi-phase imaging. We conclude that MMD can successfully form the basis of a number of dual-energy CT image analysis algorithms, and has the potential to improve the clinical utility of dual-energy CT in disease management.

Fast liquid chromatography combined with mass spectrometry for the analysis of metabolites and proteins in human body fluids.

PubMed

Kortz, Linda; Helmschrodt, Christin; Ceglarek, Uta

2011-03-01

In the last decade various analytical strategies have been established to enhance separation speed and efficiency in high performance liquid chromatography applications. Chromatographic supports based on monolithic material, small porous particles, and porous layer beads have been developed and commercialized to improve throughput and separation efficiency. This paper provides an overview of current developments in fast chromatography combined with mass spectrometry for the analysis of metabolites and proteins in clinical applications. Advances and limitations of fast chromatography for the combination with mass spectrometry are discussed. Practical aspects of, recent developments in, and the present status of high-throughput analysis of human body fluids for therapeutic drug monitoring, toxicology, clinical metabolomics, and proteomics are presented.

Drugs, money and society (Part II).

PubMed

Walley, Tom

2010-09-01

Pharmacoeconomics started as marketing but has developed into a valuable tool in the fuller assessment of drug therapies. Its principles are now widely accepted, and many countries have government-funded agencies with responsibility for its application, most notably the National Institute for Health and Clinical Excellence in England. Many clinical pharmacologists are active in this area, and the discipline itself is part of the clinical pharmacology trainees' curriculum. Further developments will include value-based pricing and its use in cost sharing arrangements between health service and manufacturers.

An update on the clinical use of drug-coated balloons in percutaneous coronary interventions.

PubMed

Cheng, Yanping; Leon, Martin B; Granada, Juan F

2016-06-01

Drug-coated balloons (DCB) promise to deliver anti-proliferative drugs and prevent restenosis leaving nothing behind. Although, randomized clinical trials have demonstrated their efficacy for the treatment of in-stent restenosis, clinical evidence supporting their use in other coronary applications is still lacking. This review summarizes the development status of clinically available DCB technologies and provides an update on the current data for their coronary use. Current generation DCB prevent restenosis by delivering paclitaxel particles on the surface of the vessel wall. Although clinically available technologies share a common mechanism of action, important differences in pharmacokinetic behavior and safety profiles do exist. Future technological improvements include the development of coatings displaying: high transfer efficiency; low particle embolization potential; and alternative drug formulations. Optimized balloon-based delivery systems and drug encapsulation technologies also promise to improve the technical limitations of current generation DCB. Although proving clinical superiority against DES may prove to be difficult in mainstream applications (i.e., de novo), new generation DCB technologies have the potential to achieve a strong position in the interventional field in clinical settings in which the efficacy of DES use is not proven or justified (i.e., bifurcations).

[Current status of gene test market].

PubMed

Ohtani, Shinichi

2002-12-01

The technological innovation of the gene analysis makes the adaptation range of the gene test in clinical diagnosis expand. Then, gene test has popularized increasingly around the infection disease for clinical inspection. Also in the field of clinical inspection, the increase of the importance of clinical application and the inspection item new year by year have appeared with the functional analysis of a gene. Moreover, the new test method and automation analysis equipment tend to be developed by progress of gene-analysis technology, and it is going to be introduced. The spread of gene test and development of a gene test market have an important possibility of activating the present clinical inspection field.

Clinical Applications of Gastrointestinal Manometry in Children

PubMed Central

2014-01-01

Manometry is a noninvasive diagnostic tool for identifying motility dysfunction of the gastrointestinal tract. Despite the great technical advances in monitoring motility, performance of the study in pediatric patients has several limitations that should be considered during the procedure and interpretation of the test results. This article reviews the clinical applications of conventional esophageal and anorectal manometries in children by describing a technique for performing the test. This review will develop the uniformity required for the methods of performance, the parameters for measurement, and interpretation of test results that could be applied in pediatric clinical practice. PMID:24749084

Nanoinformatics: developing new computing applications for nanomedicine

PubMed Central

Maojo, V.; Fritts, M.; Martin-Sanchez, F.; De la Iglesia, D.; Cachau, R.E.; Garcia-Remesal, M.; Crespo, J.; Mitchell, J.A.; Anguita, A.; Baker, N.; Barreiro, J.M.; Benitez, S. E.; De la Calle, G.; Facelli, J. C.; Ghazal, P.; Geissbuhler, A.; Gonzalez-Nilo, F.; Graf, N.; Grangeat, P.; Hermosilla, I.; Hussein, R.; Kern, J.; Koch, S.; Legre, Y.; Lopez-Alonso, V.; Lopez-Campos, G.; Milanesi, L.; Moustakis, V.; Munteanu, C.; Otero, P.; Pazos, A.; Perez-Rey, D.; Potamias, G.; Sanz, F.; Kulikowski, C.

2012-01-01

Nanoinformatics has recently emerged to address the need of computing applications at the nano level. In this regard, the authors have participated in various initiatives to identify its concepts, foundations and challenges. While nanomaterials open up the possibility for developing new devices in many industrial and scientific areas, they also offer breakthrough perspectives for the prevention, diagnosis and treatment of diseases. In this paper, we analyze the different aspects of nanoinformatics and suggest five research topics to help catalyze new research and development in the area, particularly focused on nanomedicine. We also encompass the use of informatics to further the biological and clinical applications of basic research in nanoscience and nanotechnology, and the related concept of an extended “nanotype” to coalesce information related to nanoparticles. We suggest how nanoinformatics could accelerate developments in nanomedicine, similarly to what happened with the Human Genome and other –omics projects, on issues like exchanging modeling and simulation methods and tools, linking toxicity information to clinical and personal databases or developing new approaches for scientific ontologies, among many others. PMID:22942787

General guidelines for biomedical software development

PubMed Central

Silva, Luis Bastiao; Jimenez, Rafael C.; Blomberg, Niklas; Luis Oliveira, José

2017-01-01

Most bioinformatics tools available today were not written by professional software developers, but by people that wanted to solve their own problems, using computational solutions and spending the minimum time and effort possible, since these were just the means to an end. Consequently, a vast number of software applications are currently available, hindering the task of identifying the utility and quality of each. At the same time, this situation has hindered regular adoption of these tools in clinical practice. Typically, they are not sufficiently developed to be used by most clinical researchers and practitioners. To address these issues, it is necessary to re-think how biomedical applications are built and adopt new strategies that ensure quality, efficiency, robustness, correctness and reusability of software components. We also need to engage end-users during the development process to ensure that applications fit their needs. In this review, we present a set of guidelines to support biomedical software development, with an explanation of how they can be implemented and what kind of open-source tools can be used for each specific topic. PMID:28443186

Point-of-care testing: applications of 3D printing.

PubMed

Chan, Ho Nam; Tan, Ming Jun Andrew; Wu, Hongkai

2017-08-08

Point-of-care testing (POCT) devices fulfil a critical need in the modern healthcare ecosystem, enabling the decentralized delivery of imperative clinical strategies in both developed and developing worlds. To achieve diagnostic utility and clinical impact, POCT technologies are immensely dependent on effective translation from academic laboratories out to real-world deployment. However, the current research and development pipeline is highly bottlenecked owing to multiple restraints in material, cost, and complexity of conventionally available fabrication techniques. Recently, 3D printing technology has emerged as a revolutionary, industry-compatible method enabling cost-effective, facile, and rapid manufacturing of objects. This has allowed iterative design-build-test cycles of various things, from microfluidic chips to smartphone interfaces, that are geared towards point-of-care applications. In this review, we focus on highlighting recent works that exploit 3D printing in developing POCT devices, underscoring its utility in all analytical steps. Moreover, we also discuss key advantages of adopting 3D printing in the device development pipeline and identify promising opportunities in 3D printing technology that can benefit global health applications.

An update on Lab Rover: A hospital material transporter

NASA Technical Reports Server (NTRS)

Mattaboni, Paul

1994-01-01

The development of a hospital material transporter, 'Lab Rover', is described. Conventional material transport now utilizes people power, push carts, pneumatic tubes and tracked vehicles. Hospitals are faced with enormous pressure to reduce operating costs. Cyberotics, Inc. developed an Autonomous Intelligent Vehicle (AIV). This battery operated service robot was designed specifically for health care institutions. Applications for the AIV include distribution of clinical lab samples, pharmacy drugs, administrative records, x-ray distribution, meal tray delivery, and certain emergency room applications. The first AIV was installed at Lahey Clinic in Burlington, Mass. Lab Rover was beta tested for one year and has been 'on line' for an additional 2 years.

Laser therapy in the treatment of urological diseases

NASA Astrophysics Data System (ADS)

Nelius, T.; de Riese, W. T.; Reiher, F.; Filleur, S.; Allhoff, E. P.

2006-02-01

Applications of lasers (light amplification by stimulated emission of radiation) in various disciplines of medicine including Urology are well developed. Urology is among the medical specialties that apply many different types of laser systems to treat a broad spectrum of clinical conditions ranging from genital, bladder and urethral tumors to the treatment of benign prostate hyperplasia (BPH), urethral strictures, and stones. The specific application of various laser systems depends on the characteristics of the laser itself, delivery media for the beams, laser-tissue interaction and the desired effect. These complex conditions require an intensive and continuous exchange of information between non-medical researchers and physicians to verify "what is currently technically possible and what is medically needed". Only this exchange can lead to the development of new laser systems. While lasers have become the treatment of choice in some conditions, they could not, despite excellent clinical results, replace conventional therapy options in others. Nonetheless, the use and the introduction of lasers of different wavelengths forces urologists to keep step with the fast developing laser technology. This paper reviews current indications for clinical laser applications relevant to urology and the advantages and disadvantages of using lasers for the management of various urological lesions.

A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM.

PubMed

Yamamoto, Keiichi; Ota, Keiko; Akiya, Ippei; Shintani, Ayumi

2017-06-01

The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug application studies but also to all types of research, including observational and public health studies. Our method is also adaptable to clinical data collected with CDASH at the beginning of a study in non-standard format. We believe that this tool will reduce the workload of new drug application studies and will support data sharing and reuse of clinical research data in academia. Copyright © 2017 Elsevier Inc. All rights reserved.

Clinical image processing engine

NASA Astrophysics Data System (ADS)

Han, Wei; Yao, Jianhua; Chen, Jeremy; Summers, Ronald

2009-02-01

Our group provides clinical image processing services to various institutes at NIH. We develop or adapt image processing programs for a variety of applications. However, each program requires a human operator to select a specific set of images and execute the program, as well as store the results appropriately for later use. To improve efficiency, we design a parallelized clinical image processing engine (CIPE) to streamline and parallelize our service. The engine takes DICOM images from a PACS server, sorts and distributes the images to different applications, multithreads the execution of applications, and collects results from the applications. The engine consists of four modules: a listener, a router, a job manager and a data manager. A template filter in XML format is defined to specify the image specification for each application. A MySQL database is created to store and manage the incoming DICOM images and application results. The engine achieves two important goals: reduce the amount of time and manpower required to process medical images, and reduce the turnaround time for responding. We tested our engine on three different applications with 12 datasets and demonstrated that the engine improved the efficiency dramatically.

[Theory analysis and clinical application of spirit-regulating and pain-relieving acupuncture method].

PubMed

Chen, Liang; Tang, Lewei; Du, Huaibin; Zheng, Hui; Liang, Fanrong

2015-04-01

The theoretical foundation and scientific connotation of spirit-regulating and pain-relieving acupuncture method as well as its clinical application for pain are discussed. During spirit regulation, attention should be paid on regulating heart and brain, while acupoints should be selected mainly from the Heart Meridian, Pericardium Meridian and Governor Vessel. It has significant efficacy for refractory pain in clinical treatment. Spirit-regulating and pain-relieving acupuncture method is development of acupuncture treating spirit, and it is an important method for pain in clinic. Improvement on sensitization of pain center and brain function is considered as one of the mechanisms in spirit-regulating and pain-relieving acupuncture method.

Clinical applications of magnetic nanoparticles for hyperthermia.

PubMed

Thiesen, Burghard; Jordan, Andreas

2008-09-01

Magnetic fluids are increasingly used for clinical applications such as drug delivery, magnetic resonance imaging and magnetic fluid hyperthermia. The latter technique that has been developed as a cancer treatment for several decades comprises the injection of magnetic nanoparticles into tumors and their subsequent heating in an alternating magnetic field. Depending on the applied temperature and the duration of heating this treatment either results in direct tumor cell killing or makes the cells more susceptible to concomitant radio- or chemotherapy. Numerous groups are working in this field worldwide, but only one approach has been tested in clinical trials so far. Here, we summarize the clinical data gained in these studies on magnetic fluid induced hyperthermia.

Frontiers of monoclonal antibodies: Applications in medical practices.

PubMed

Ghagane, Shridhar C; Puranik, Sridevi I; Gan, Siew Hua; Hiremath, Murigendra B; Nerli, R B; Ravishankar, M V

2017-01-01

With the flourishing of innovation in drug discovery into a new era of personalized therapy, the use of monoclonal antibodies (mAbs) in the treatment of various ailments lies at the forefront. Major improvements in genetic sequencing and biomedical techniques as well as research into mAbs emphasize on determining new targets for advanced therapy while maximizing efficacy for clinical application. However, a balance has to be achieved concerning developing a target with low toxicity combined with high specificity and versatility, to allow a specific antibody to facilitate several biotic effects, ranging from neutralization of virus mechanisms to modulation of immune response and maintaining low global economic cost. Presently, there are approximately 30 mAbs' permitted for therapeutic use with many more being tested in clinical trials. Nevertheless, the heavy cost of mAbs' production, stowage and management as well as the subsequent hindrances to their development are outweighed by mAbs' clinical advantages. Compared to conventional drugs, since mAbs use as pharmacologic iotas have specific physical features and modes of action, they should be considered as a discrete therapeutic category. In this review, the history of mAb generation and the innovative technological applications of mAbs that has advanced in clinical practices is reviewed.

Clinical staff nurse leadership: Identifying gaps in competency development.

PubMed

Franks-Meeks, Sherron

2018-01-01

To date, there has been no development of a complete, applicable inventory of clinical staff nurse (CSN) leadership role competencies through a valid and reliable methodology. Further, the CSN has not been invited to engage in the identification, definition, or development of their own leadership competencies. Compare existing leadership competencies to identify and highlight gaps in clinical staff nurse leadership role competency development and validation. Literature review. The CSN has not participated in the development of CSN leadership role competencies, nor have the currently identified CSN leadership role competencies been scientifically validated through research. Finally, CSN leadership role competencies are incomplete and do not reflect the CSN perspective. © 2017 Wiley Periodicals, Inc.

PREFACE: 2nd International Conference and Young Scientist School ''Magnetic resonance imaging in biomedical research''

NASA Astrophysics Data System (ADS)

Naumova, A. V.; Khodanovich, M. Y.; Yarnykh, V. L.

2016-02-01

The Second International Conference and Young Scientist School ''Magnetic resonance imaging in biomedical research'' was held on the campus of the National Research Tomsk State University (Tomsk, Russia) on September 7-9, 2015. The conference was focused on magnetic resonance imaging (MRI) applications for biomedical research. The main goal was to bring together basic scientists, clinical researchers and developers of new MRI techniques to bridge the gap between clinical/research needs and advanced technological solutions. The conference fostered research and development in basic and clinical MR science and its application to health care. It also had an educational purpose to promote understanding of cutting-edge MR developments. The conference provided an opportunity for researchers and clinicians to present their recent theoretical developments, practical applications, and to discuss unsolved problems. The program of the conference was divided into three main topics. First day of the conference was devoted to educational lectures on the fundamentals of MRI physics and image acquisition/reconstruction techniques, including recent developments in quantitative MRI. The second day was focused on developments and applications of new contrast agents. Multinuclear and spectroscopic acquisitions as well as functional MRI were presented during the third day of the conference. We would like to highlight the main developments presented at the conference and introduce the prominent speakers. The keynote speaker of the conference Dr. Vasily Yarnykh (University of Washington, Seattle, USA) presented a recently developed MRI method, macromolecular proton fraction (MPF) mapping, as a unique tool for modifying image contrast and a unique tool for quantification of the myelin content in neural tissues. Professor Yury Pirogov (Lomonosov Moscow State University) described development of new fluorocarbon compounds and applications for biomedicine. Drs. Julia Velikina and Alexey Samsonov (University of Wisconsin-Madison, USA) demonstrated new image reconstruction methods for accelerated quantitative parameter mapping and magnetic resonance angiography. Finally, we would like to thank the scientific committee, the local organizing committee and the National Research Tomsk State University for giving an opportunity to share scientific ideas and new developments at the conference and the Russian Science Foundation (project № 14-45-00040) for financial support.

Physical basics of endovenous laser treatment and potential of innovative developments

NASA Astrophysics Data System (ADS)

Sroka, R.; Esipova, A.; Schmedt, C. G.

2017-04-01

During the last decade, endoluminal laser treatment (ELT) has been rapidly developing. Protocols using radially emitting ELT fibres in combination with infrared laser light show clinical advantages over the bare-fibre technique and near infrared irradiation. Although the clinical response rate is high several side effects occurred. Innovative light application systems and feedback systems are therefore being under development to potentially improve the clinical situation. The irradiation patterns of bare fibres and radially emitting 1-ring and 2-ring fibres were measured using the goniometer technique. The device robustness, device handling and tissue effects were investigated using the established ox-foot-model. Furthermore, temperature measurements were performed either intraluminal within the irradiation field using a tiny temperature sensor and on the outer surface of the vessel wall by means of a thermocamera. All fibres showed sufficient mechanical and thermal robustness. The destruction threshold is far beyond the light powers employed during clinical application. The 1-ring fibre showed very high peak temperatures for a short time, while the 2-ring-fibre hold its somewhat lower maximum temperature for a longer time. Both forms of energy application resulted in the desired shrinkage and destruction effect. In this regard, the handling of the 2-ring fibre appears subjectively more convenient with reduced sticking-related problems. Acute tissue effects could be investigated to improve the understanding especially of the interaction between handling, maneuvers and tissue effects. The 2-ring radially emitting fibre in combination with IR laser light and specific application parameters showed improved handling and safety features.

DICOM for quantitative imaging biomarker development: a standards based approach to sharing clinical data and structured PET/CT analysis results in head and neck cancer research

PubMed Central

Clunie, David; Ulrich, Ethan; Bauer, Christian; Wahle, Andreas; Brown, Bartley; Onken, Michael; Riesmeier, Jörg; Pieper, Steve; Kikinis, Ron; Buatti, John; Beichel, Reinhard R.

2016-01-01

Background. Imaging biomarkers hold tremendous promise for precision medicine clinical applications. Development of such biomarkers relies heavily on image post-processing tools for automated image quantitation. Their deployment in the context of clinical research necessitates interoperability with the clinical systems. Comparison with the established outcomes and evaluation tasks motivate integration of the clinical and imaging data, and the use of standardized approaches to support annotation and sharing of the analysis results and semantics. We developed the methodology and tools to support these tasks in Positron Emission Tomography and Computed Tomography (PET/CT) quantitative imaging (QI) biomarker development applied to head and neck cancer (HNC) treatment response assessment, using the Digital Imaging and Communications in Medicine (DICOM®) international standard and free open-source software. Methods. Quantitative analysis of PET/CT imaging data collected on patients undergoing treatment for HNC was conducted. Processing steps included Standardized Uptake Value (SUV) normalization of the images, segmentation of the tumor using manual and semi-automatic approaches, automatic segmentation of the reference regions, and extraction of the volumetric segmentation-based measurements. Suitable components of the DICOM standard were identified to model the various types of data produced by the analysis. A developer toolkit of conversion routines and an Application Programming Interface (API) were contributed and applied to create a standards-based representation of the data. Results. DICOM Real World Value Mapping, Segmentation and Structured Reporting objects were utilized for standards-compliant representation of the PET/CT QI analysis results and relevant clinical data. A number of correction proposals to the standard were developed. The open-source DICOM toolkit (DCMTK) was improved to simplify the task of DICOM encoding by introducing new API abstractions. Conversion and visualization tools utilizing this toolkit were developed. The encoded objects were validated for consistency and interoperability. The resulting dataset was deposited in the QIN-HEADNECK collection of The Cancer Imaging Archive (TCIA). Supporting tools for data analysis and DICOM conversion were made available as free open-source software. Discussion. We presented a detailed investigation of the development and application of the DICOM model, as well as the supporting open-source tools and toolkits, to accommodate representation of the research data in QI biomarker development. We demonstrated that the DICOM standard can be used to represent the types of data relevant in HNC QI biomarker development, and encode their complex relationships. The resulting annotated objects are amenable to data mining applications, and are interoperable with a variety of systems that support the DICOM standard. PMID:27257542

F30. SMARTPHONE APPLICATION “ROBIN”: FEASIBILITY, ENGAGEMENT AND SATISFACTION OF A SMARTPHONE APPLICATION APPROACH TO SUPPORT TREATMENT OF (ATTENUATED) PSYCHOTIC SYMPTOMS IN ADOLESCENTS

PubMed Central

Traber-Walker, Nina; Metzler, Sibylle; Gerstenberg, Miriam; Walitza, Susanne; Franscini, Maurizia

2018-01-01

Abstract Background There is increasing interest in using mobile technologies such as smartphones application in mental health care. First research results from the use of smartphone applications in the treatment of psychotic disorders are promising. Current analysis showed, that especially young people would be interested in smartphone applications within treatment settings. However, there is a lack of investigations in this population. There is also little known about mobile technologies in the work with attenuated psychotic symptoms. To address these gaps, we developed “Robin”, a specific smartphone application to support the therapy of adolescents with attenuated or full-blown psychotic symptoms. The smartphone application targets medication adherence, real-time symptom assessment and provides help coping with symptoms and stressful situations in daily life. Methods Based on existing literature and our clinical expertise within a specialized outpatient care for adolescents with (attenuated) psychotic symptoms, a first modular version of the app was developed and adapted after first pilot investigations with patients (N=7, Age 14–18) and therapists (N=10). Participants of the pilot investigation completed a questionnaire regarding usability and acceptance of the application. Furthermore, we investigated how the patients used the application in their daily life by analyzing the user data from the application. In September 2017, the development of the smartphone application has been finalized and we have started with a systematic clinical evaluation study for testing the efficiency of the app. The application is only used in combination with psychotherapy in our university hospital for child and adolescent psychiatry. Results The data from our pilot investigation showed, that “Robin” was accepted by clinicians and patients. All clinicians said they would like to use the application to enrich their therapeutic approaches. All patients in the pilot project used the application in their daily life. Especially modules with information about symptoms and coping strategies were frequently used. Since September 2017, first patients have been included to the systematic evaluation study. In Florence 2018, we will present first data from this study about feasibility, engagement and subjectively perceived benefit of the smartphone application. Discussion The first feedbacks from the pilot investigation were encouraging. The findings were used to improve and adapt the application. Since September 2017, the application is used in psychotherapy and an evaluation study has started. This is one of the first clinical trials to test the efficacy of a specific application developed for adolescents with psychotic and with attenuated psychotic symptoms.

Developing and delivering clinical pharmacology in pharmaceutical companies.

PubMed

Richards, Duncan

2012-06-01

The challenges of developing new medicines are well known. Effective application of clinical pharmacology expertise is vital to the successful evaluation of potential new medicines. In drug development, this depends on effective integration of diverse skills. Many of these are currently in short supply, but through innovative partnerships between industry and academia there is an opportunity to reinvigorate the discipline by nurturing these key skills to the benefit of both partners. Specific areas of focus should be experimental medicine, modelling and simulation, and translational skills. © 2012 The Author. British Journal of Clinical Pharmacology © 2012 The British Pharmacological Society.

Optimizing oncology therapeutics through quantitative translational and clinical pharmacology: challenges and opportunities.

PubMed

Venkatakrishnan, K; Friberg, L E; Ouellet, D; Mettetal, J T; Stein, A; Trocóniz, I F; Bruno, R; Mehrotra, N; Gobburu, J; Mould, D R

2015-01-01

Despite advances in biomedical research that have deepened our understanding of cancer hallmarks, resulting in the discovery and development of targeted therapies, the success rates of oncology drug development remain low. Opportunities remain for objective dose selection informed by exposure-response understanding to optimize the benefit-risk balance of novel therapies for cancer patients. This review article discusses the principles and applications of modeling and simulation approaches across the lifecycle of development of oncology therapeutics. Illustrative examples are used to convey the value gained from integration of quantitative clinical pharmacology strategies from the preclinical-translational phase through confirmatory clinical evaluation of efficacy and safety. © 2014 American Society for Clinical Pharmacology and Therapeutics.

Development and application of social learning theory.

PubMed

Price, V; Archbold, J

This article traces the development of social learning theory over the last 30 years, relating the developments to clinical nursing practice. Particular attention is focused on the contribution of Albert Bandura, the American psychologist, and his work on modelling.

Development and validation of an automated delirium risk assessment system (Auto-DelRAS) implemented in the electronic health record system.

PubMed

Moon, Kyoung-Ja; Jin, Yinji; Jin, Taixian; Lee, Sun-Mi

2018-01-01

A key component of the delirium management is prevention and early detection. To develop an automated delirium risk assessment system (Auto-DelRAS) that automatically alerts health care providers of an intensive care unit (ICU) patient's delirium risk based only on data collected in an electronic health record (EHR) system, and to evaluate the clinical validity of this system. Cohort and system development designs were used. Medical and surgical ICUs in two university hospitals in Seoul, Korea. A total of 3284 patients for the development of Auto-DelRAS, 325 for external validation, 694 for validation after clinical applications. The 4211 data items were extracted from the EHR system and delirium was measured using CAM-ICU (Confusion Assessment Method for Intensive Care Unit). The potential predictors were selected and a logistic regression model was established to create a delirium risk scoring algorithm to construct the Auto-DelRAS. The Auto-DelRAS was evaluated at three months and one year after its application to clinical practice to establish the predictive validity of the system. Eleven predictors were finally included in the logistic regression model. The results of the Auto-DelRAS risk assessment were shown as high/moderate/low risk on a Kardex screen. The predictive validity, analyzed after the clinical application of Auto-DelRAS after one year, showed a sensitivity of 0.88, specificity of 0.72, positive predictive value of 0.53, negative predictive value of 0.94, and a Youden index of 0.59. A relatively high level of predictive validity was maintained with the Auto-DelRAS system, even one year after it was applied to clinical practice. Copyright © 2017. Published by Elsevier Ltd.

The detection of oral cancer using differential pathlength spectroscopy

NASA Astrophysics Data System (ADS)

Sterenborg, H. J. C. M.; Kanick, S.; de Visscher, S.; Witjes, M.; Amelink, A.

2010-02-01

The development of optical techniques for non-invasive diagnosis of cancer is an ongoing challenge to biomedical optics. For head and neck cancer we see two main fields of potential application 1) Screening for second primaries in patients with a history of oral cancer. This requires imaging techniques or an approach where a larger area can be scanned quickly. 2) Distinguishing potentially malignant visible primary lesions from benign ones. Here fiberoptic point measurements can be used as the location of the lesion is known. This presentation will focus on point measurement techniques. Various techniques for point measurements have been developed and investigated clinically for different applications. Differential Pathlength Spectroscopy is a recently developed fiberoptic point measurement technique that measures scattered light in a broad spectrum. Due to the specific fiberoptic geometry we measure only scattered photons that have travelled a predetermined pathlength. This allows us to analyse the spectrum mathematically and translate the measured curve into a set of parameters that are related to the microvasculature and to the intracellular morphology. DPS has been extensively evaluated on optical phantoms and tested clinically in various clinical applications. The first measurements in biopsy proven squamous cell carcinoma showed significant changes in both vascular and morphological parameters. Measurements on thick keratinized lesions however failed to generate any vascular signatures. This is related to the sampling depth of the standard optical fibers used. Recently we developed a fiberoptic probe with a ~1 mm sampling depth. Measurements on several leukoplakias showed that with this new probe we sample just below the keratin layer and can obtain vascular signatures. The results of a first set of clinical measurements will be presented and the significance for clinical diagnostics will be discussed.

Application description and policy model in collaborative environment for sharing of information on epidemiological and clinical research data sets.

PubMed

de Carvalho, Elias César Araujo; Batilana, Adelia Portero; Simkins, Julie; Martins, Henrique; Shah, Jatin; Rajgor, Dimple; Shah, Anand; Rockart, Scott; Pietrobon, Ricardo

2010-02-19

Sharing of epidemiological and clinical data sets among researchers is poor at best, in detriment of science and community at large. The purpose of this paper is therefore to (1) describe a novel Web application designed to share information on study data sets focusing on epidemiological clinical research in a collaborative environment and (2) create a policy model placing this collaborative environment into the current scientific social context. The Database of Databases application was developed based on feedback from epidemiologists and clinical researchers requiring a Web-based platform that would allow for sharing of information about epidemiological and clinical study data sets in a collaborative environment. This platform should ensure that researchers can modify the information. A Model-based predictions of number of publications and funding resulting from combinations of different policy implementation strategies (for metadata and data sharing) were generated using System Dynamics modeling. The application allows researchers to easily upload information about clinical study data sets, which is searchable and modifiable by other users in a wiki environment. All modifications are filtered by the database principal investigator in order to maintain quality control. The application has been extensively tested and currently contains 130 clinical study data sets from the United States, Australia, China and Singapore. Model results indicated that any policy implementation would be better than the current strategy, that metadata sharing is better than data-sharing, and that combined policies achieve the best results in terms of publications. Based on our empirical observations and resulting model, the social network environment surrounding the application can assist epidemiologists and clinical researchers contribute and search for metadata in a collaborative environment, thus potentially facilitating collaboration efforts among research communities distributed around the globe.

Quantitative imaging biomarkers: the application of advanced image processing and analysis to clinical and preclinical decision making.

PubMed

Prescott, Jeffrey William

2013-02-01

The importance of medical imaging for clinical decision making has been steadily increasing over the last four decades. Recently, there has also been an emphasis on medical imaging for preclinical decision making, i.e., for use in pharamaceutical and medical device development. There is also a drive towards quantification of imaging findings by using quantitative imaging biomarkers, which can improve sensitivity, specificity, accuracy and reproducibility of imaged characteristics used for diagnostic and therapeutic decisions. An important component of the discovery, characterization, validation and application of quantitative imaging biomarkers is the extraction of information and meaning from images through image processing and subsequent analysis. However, many advanced image processing and analysis methods are not applied directly to questions of clinical interest, i.e., for diagnostic and therapeutic decision making, which is a consideration that should be closely linked to the development of such algorithms. This article is meant to address these concerns. First, quantitative imaging biomarkers are introduced by providing definitions and concepts. Then, potential applications of advanced image processing and analysis to areas of quantitative imaging biomarker research are described; specifically, research into osteoarthritis (OA), Alzheimer's disease (AD) and cancer is presented. Then, challenges in quantitative imaging biomarker research are discussed. Finally, a conceptual framework for integrating clinical and preclinical considerations into the development of quantitative imaging biomarkers and their computer-assisted methods of extraction is presented.

Robotic Arm-Assisted Sonography: Review of Technical Developments and Potential Clinical Applications.

PubMed

Swerdlow, Daniel R; Cleary, Kevin; Wilson, Emmanuel; Azizi-Koutenaei, Bamshad; Monfaredi, Reza

2017-04-01

Ultrasound imaging requires trained personnel. Advances in robotics and data transmission create the possibility of telesonography. This review introduces clinicians to current technical work in and potential applications of this developing capability. Telesonography offers advantages in hazardous or remote environments. Robotically assisted ultrasound can reduce stress injuries in sonographers and has potential utility during robotic surgery and interventional procedures.

Evaluation of software maintain ability with open EHR - a comparison of architectures.

PubMed

Atalag, Koray; Yang, Hong Yul; Tempero, Ewan; Warren, James R

2014-11-01

To assess whether it is easier to maintain a clinical information system developed using open EHR model driven development versus mainstream methods. A new open source application (GastrOS) has been developed following open EHR's multi-level modelling approach using .Net/C# based on the same requirements of an existing clinically used application developed using Microsoft Visual Basic and Access database. Almost all the domain knowledge was embedded into the software code and data model in the latter. The same domain knowledge has been expressed as a set of open EHR Archetypes in GastrOS. We then introduced eight real-world change requests that had accumulated during live clinical usage, and implemented these in both systems while measuring time for various development tasks and change in software size for each change request. Overall it took half the time to implement changes in GastrOS. However it was the more difficult application to modify for one change request, suggesting the nature of change is also important. It was not possible to implement changes by modelling only. Comparison of relative measures of time and software size change within each application highlights how architectural differences affected maintain ability across change requests. The use of open EHR model driven development can result in better software maintain ability. The degree to which open EHR affects software maintain ability depends on the extent and nature of domain knowledge involved in changes. Although we used relative measures for time and software size, confounding factors could not be totally excluded as a controlled study design was not feasible. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Translating Basic Behavioral and Social Science Research to Clinical Application: The EVOLVE Mixed Methods Approach

ERIC Educational Resources Information Center

Peterson, Janey C.; Czajkowski, Susan; Charlson, Mary E.; Link, Alissa R.; Wells, Martin T.; Isen, Alice M.; Mancuso, Carol A.; Allegrante, John P.; Boutin-Foster, Carla; Ogedegbe, Gbenga; Jobe, Jared B.

2013-01-01

Objective: To describe a mixed-methods approach to develop and test a basic behavioral science-informed intervention to motivate behavior change in 3 high-risk clinical populations. Our theoretically derived intervention comprised a combination of positive affect and self-affirmation (PA/SA), which we applied to 3 clinical chronic disease…

Development of Bioethics and Clinical Ethics in Bulgaria.

PubMed

Aleksandrova-Yankulovska, Silviya S

2017-03-01

Bioethics and clinical ethics emerged from the classical medical ethics in the 1970s of the 20th century. Both fields are new for the Bulgarian academic tradition. The aims of this paper were to demarcate the subject fields of medical ethics, bioethics, and clinical ethics, to present the developments in the field of medical ethics in Bulgaria, to delineate the obstacles to effective ethics education of medical professionals, and to present the results of the application of an adapted bottom-up methodology for clinical ethics consultation in several clinical units in Bulgaria. Extended literature review and application of an adapted METAP methodology for clinical ethics consultation in six clinical units in the Northern Bulgaria between May 2013 and December 2014. Teaching of medical ethics in Bulgaria was introduced in the 1990s and still stands mainly as theoretical expertise without sufficient dilemma training in clinical settings. Earlier studies revealed need of clinical ethics consultation services in our country. METAP methodology was applied in 69 ethics meetings. In 31.9% of them non-medical considerations affected the choice of treatment and 34.8% resulted in reaching consensus between the team and the patient. Participants' opinion about the meetings was highly positive with 87.7% overall satisfaction. Development of bioethics in Bulgaria follows recent worldwide trends. Several ideas could be applied towards increasing the effectiveness of ethics education. Results of the ethics meetings lead to the conclusion that it is a successful and well accepted approach for clinical ethics consultation with a potential for wider introduction in our medical practice.

Functionalized Nanostructures with Application in Regenerative Medicine

PubMed Central

Perán, Macarena; García, María A.; López-Ruiz, Elena; Bustamante, Milán; Jiménez, Gema; Madeddu, Roberto; Marchal, Juan A.

2012-01-01

In the last decade, both regenerative medicine and nanotechnology have been broadly developed leading important advances in biomedical research as well as in clinical practice. The manipulation on the molecular level and the use of several functionalized nanoscaled materials has application in various fields of regenerative medicine including tissue engineering, cell therapy, diagnosis and drug and gene delivery. The themes covered in this review include nanoparticle systems for tracking transplanted stem cells, self-assembling peptides, nanoparticles for gene delivery into stem cells and biomimetic scaffolds useful for 2D and 3D tissue cell cultures, transplantation and clinical application. PMID:22489186

Emerging Non-Cancer Applications of Therapeutic Ultrasound

PubMed Central

O’Reilly, Meaghan A.; Hynynen, Kullervo

2015-01-01

Ultrasound therapy has been investigated for over half a century. Ultrasound can act on tissue through a variety of mechanisms, including thermal, shockwave and cavitation mechanisms, and through these can elicit different responses. Ultrasound therapy can provide a non-invasive or minimally invasive treatment option, and ultrasound technology has advanced to the point where devices can be developed to investigate a wide range of applications. This review focuses on non-cancer, clinical applications of therapeutic ultrasound, with an emphasis on treatments that have recently reached clinical investigations, and preclinical research programs that have great potential to impact patient care. PMID:25792225

Do smartphone applications in healthcare require a governance and legal framework? It depends on the application!

PubMed

Charani, Esmita; Castro-Sánchez, Enrique; Moore, Luke S P; Holmes, Alison

2014-02-14

The fast pace of technological improvement and the rapid development and adoption of healthcare applications present crucial challenges for clinicians, users and policy makers. Some of the most pressing dilemmas include the need to ensure the safety of applications and establish their cost-effectiveness while engaging patients and users to optimize their integration into health decision-making. Healthcare organizations need to consider the risk of fragmenting clinical practice within the organization as a result of too many apps being developed or used, as well as mechanisms for app integration into the wider electronic health records through development of governance framework for their use. The impact of app use on the interactions between clinicians and patients needs to be explored, together with the skills required for both groups to benefit from the use of apps. Although healthcare and academic institutions should support the improvements offered by technological advances, they must strive to do so within robust governance frameworks, after sound evaluation of clinical outcomes and examination of potential unintended consequences.

[Clinical use of interventional MR imaging].

PubMed

Kahn, Thomas; Schulz, Thomas; Moche, Michael; Prothmann, Sascha; Schneider, Jens-Peter

2003-01-01

The integration of diagnostic and therapeutic procedures by MRI is based on the combination of excellent morphologic and functional imaging. The spectrum of MR-guided interventions includes biopsies, thermal ablation procedures, vascular applications, and intraoperative MRI. In all these applications, different scientific groups have obtained convincing results in basic developments as well as in clinical use. Interventional MRI (iMRI) is expected to attain an important role in interventional radiology, minimal invasive therapy, and monitoring of surgical procedures.

Analysis of Biological Interactions by Affinity Chromatography: Clinical and Pharmaceutical Applications

PubMed Central

Hage, David S.

2017-01-01

BACKGROUND The interactions between biochemical and chemical agents in the body are important in many clinical processes. Affinity chromatography and high-performance affinity chromatography (HPAC), in which a column contains an immobilized biologically-related binding agent, are two methods that can be used to study these interactions. CONTENT This review looks at various approaches that can be used in affinity chromatography and HPAC to characterize the strength or rate of a biological interaction, the number and types of sites that are involved in this process, and the interactions between multiple solutes for the same binding agent. A number of applications for these methods are examined, with an emphasis on recent developments and high-performance affinity methods. These applications include the use of these techniques for fundamental studies of biological interactions, high-throughput screening of drugs, work with modified proteins, tools for personalized medicine, and studies of drug-drug competition for a common binding agent. SUMMARY The wide range of formats and detection methods that can be used with affinity chromatography and HPAC for examining biological interactions makes these tools attractive for various clinical and pharmaceutical applications. Future directions in the development of small-scale columns and the coupling of these methods with other techniques, such as mass spectrometry or other separation methods, should continue to increase the flexibility and ease with which these approaches can be used in work involving clinical or pharmaceutical samples. PMID:28396561

A Domain Analysis Model for eIRB Systems: Addressing the Weak Link in Clinical Research Informatics

PubMed Central

He, Shan; Narus, Scott P.; Facelli, Julio C.; Lau, Lee Min; Botkin, Jefferey R.; Hurdle, John F.

2014-01-01

Institutional Review Boards (IRBs) are a critical component of clinical research and can become a significant bottleneck due to the dramatic increase, in both volume and complexity of clinical research. Despite the interest in developing clinical research informatics (CRI) systems and supporting data standards to increase clinical research efficiency and interoperability, informatics research in the IRB domain has not attracted much attention in the scientific community. The lack of standardized and structured application forms across different IRBs causes inefficient and inconsistent proposal reviews and cumbersome workflows. These issues are even more prominent in multi-institutional clinical research that is rapidly becoming the norm. This paper proposes and evaluates a domain analysis model for electronic IRB (eIRB) systems, paving the way for streamlined clinical research workflow via integration with other CRI systems and improved IRB application throughput via computer-assisted decision support. PMID:24929181

A generative tool for building health applications driven by ISO 13606 archetypes.

PubMed

Menárguez-Tortosa, Marcos; Martínez-Costa, Catalina; Fernández-Breis, Jesualdo Tomás

2012-10-01

The use of Electronic Healthcare Records (EHR) standards in the development of healthcare applications is crucial for achieving the semantic interoperability of clinical information. Advanced EHR standards make use of the dual model architecture, which provides a solution for clinical interoperability based on the separation of the information and knowledge. However, the impact of such standards is biased by the limited availability of tools that facilitate their usage and practical implementation. In this paper, we present an approach for the automatic generation of clinical applications for the ISO 13606 EHR standard, which is based on the dual model architecture. This generator has been generically designed, so it can be easily adapted to other dual model standards and can generate applications for multiple technological platforms. Such good properties are based on the combination of standards for the representation of generic user interfaces and model-driven engineering techniques.

Psychiatric diagnoses in a group of astronaut applicants

NASA Technical Reports Server (NTRS)

Santy, Patricia A.; Faulk, Dean M.; Holland, Al W.

1991-01-01

Between 1959 and 1987, the psychiatric evaluation of astronaut candidates evolved from a 30-h intensive examination evaluating applicants for psychopathology, and studying their performance under stress, to a 2-h clinical interview whose structure and contents were determined by the individual examiner. Evaluations done during these years applied both psychiatric (or, 'select-out') criteria and psychological (or, 'select-in') criteria. In an attempt to more rigorously define the psychiatric, 'select-out' component, a standardized, semistructured clinical interview was developed to identify the presence or history of psychiatric disorders listed in the Diagnostic and Statistical Manual of Mental Disorders, 3rd Ed. ('DSM-III'). A total of 117 astronaut applicants underwent this clinical interview as part of a comprehensive medical evaluation during a recent astronaut selection. Of the 117 applicants, 9 (7.7 percent) met DSM-III criteria for a variety of Axis I and Axis II diagnoses, including V-code diagnoses.

A Review of Current Clinical Applications of Three-Dimensional Printing in Spine Surgery

PubMed Central

Job, Alan Varkey; Chen, Jing; Baek, Jung Hwan

2018-01-01

Three-dimensional (3D) printing is a transformative technology with a potentially wide range of applications in the field of orthopaedic spine surgery. This article aims to review the current applications, limitations, and future developments of 3D printing technology in orthopaedic spine surgery. Current preoperative applications of 3D printing include construction of complex 3D anatomic models for improved visual understanding, preoperative surgical planning, and surgical simulations for resident education. Intraoperatively, 3D printers have been successfully used in surgical guidance systems and in the creation of patient specific implantable devices. Furthermore, 3D printing is revolutionizing the field of regenerative medicine and tissue engineering, allowing construction of biocompatible scaffolds suitable for cell growth and vasculature. Advances in printing technology and evidence of positive clinical outcomes are needed before there is an expansion of 3D printing applied to the clinical setting. PMID:29503698

A Review of Current Clinical Applications of Three-Dimensional Printing in Spine Surgery.

PubMed

Cho, Woojin; Job, Alan Varkey; Chen, Jing; Baek, Jung Hwan

2018-02-01

Three-dimensional (3D) printing is a transformative technology with a potentially wide range of applications in the field of orthopaedic spine surgery. This article aims to review the current applications, limitations, and future developments of 3D printing technology in orthopaedic spine surgery. Current preoperative applications of 3D printing include construction of complex 3D anatomic models for improved visual understanding, preoperative surgical planning, and surgical simulations for resident education. Intraoperatively, 3D printers have been successfully used in surgical guidance systems and in the creation of patient specific implantable devices. Furthermore, 3D printing is revolutionizing the field of regenerative medicine and tissue engineering, allowing construction of biocompatible scaffolds suitable for cell growth and vasculature. Advances in printing technology and evidence of positive clinical outcomes are needed before there is an expansion of 3D printing applied to the clinical setting.

Proteases as therapeutics

PubMed Central

Craik, Charles S.; Page, Michael J.; Madison, Edwin L.

2015-01-01

Proteases are an expanding class of drugs that hold great promise. The U.S. FDA (Food and Drug Administration) has approved 12 protease therapies, and a number of next generation or completely new proteases are in clinical development. Although they are a well-recognized class of targets for inhibitors, proteases themselves have not typically been considered as a drug class despite their application in the clinic over the last several decades; initially as plasma fractions and later as purified products. Although the predominant use of proteases has been in treating cardiovascular disease, they are also emerging as useful agents in the treatment of sepsis, digestive disorders, inflammation, cystic fibrosis, retinal disorders, psoriasis and other diseases. In the present review, we outline the history of proteases as therapeutics, provide an overview of their current clinical application, and describe several approaches to improve and expand their clinical application. Undoubtedly, our ability to harness proteolysis for disease treatment will increase with our understanding of protease biology and the molecular mechanisms responsible. New technologies for rationally engineering proteases, as well as improved delivery options, will expand greatly the potential applications of these enzymes. The recognition that proteases are, in fact, an established class of safe and efficacious drugs will stimulate investigation of additional therapeutic applications for these enzymes. Proteases therefore have a bright future as a distinct therapeutic class with diverse clinical applications. PMID:21406063

Social leverage of intellectual property: road to the development of better therapy for tuberculosis.

PubMed

Thangaraj, Harry; Reljic, Rajko

2009-06-01

Current TB drug development is beset with many problems. There is a perceived lack of commercial return on investment, as the vast majority of TB patients come from impoverished areas of the world. Clinical trials for new TB drugs are complex, protracted and very expensive. Therefore, the development of new anti-tuberculosis drugs requires simultaneous forward planning of the design of the trials that will be required for licensing purposes. In this article we briefly review the current state of new TB drug development and discuss issues related to intellectual property (IP), with a special emphasis on how IP can facilitate rather than hinder the development of better TB drugs. We also list and discuss the major patent applications that underpin TB drugs that have entered prominent clinical trials and additional applications that were filed over the last five years for drugs resulting from basic upstream research.

Clinical Application of High-intensity Focused Ultrasound in Cancer Therapy

PubMed Central

Hsiao, Yi-Hsuan; Kuo, Shou-Jen; Tsai, Horng-Der; Chou, Ming-Chih; Yeh, Guang-Perng

2016-01-01

The treatment of cancer is an important issue in both developing and developed countries. Clinical use of ultrasound in cancer is not only for the diagnosis but also for the treatment. Focused ultrasound surgery (FUS) is a noninvasive technique. By using the combination of high-intensity focused ultrasound (HIFU) and imaging method, FUS has the potential to ablate tumor lesions precisely. The main mechanisms of HIFU ablation involve mechanical and thermal effects. Recent advances in HIFU have increased its popularity. Some promising results were achieved in managing various malignancies, including pancreas, prostate, liver, kidney, breast and bone. Other applications include brain tumor ablation and disruption of the blood-brain barrier. We aim at briefly outlining the clinical utility of FUS as a noninvasive technique for a variety of types of cancer treatment. PMID:26918034

MicroPET imaging and transgenic models: a blueprint for Alzheimer's disease clinical research.

PubMed

Zimmer, Eduardo R; Parent, Maxime J; Cuello, A Claudio; Gauthier, Serge; Rosa-Neto, Pedro

2014-11-01

Over the past decades, developments in neuroimaging have significantly contributed to the understanding of Alzheimer's disease (AD) pathophysiology. Specifically, positron emission tomography (PET) imaging agents targeting amyloid deposition have provided unprecedented opportunities for refining in vivo diagnosis, monitoring disease propagation, and advancing AD clinical trials. Furthermore, the use of a miniaturized version of PET (microPET) in transgenic (Tg) animals has been a successful strategy for accelerating the development of novel radiopharmaceuticals. However, advanced applications of microPET focusing on the longitudinal propagation of AD pathophysiology or therapeutic strategies remain in their infancy. This review highlights what we have learned from microPET imaging in Tg models displaying amyloid and tau pathology, and anticipates cutting-edge applications with high translational value to clinical research. Copyright © 2014 Elsevier Ltd. All rights reserved.

Microfluidics for Drug Discovery and Development: From Target Selection to Product Lifecycle Management

PubMed Central

Kang, Lifeng; Chung, Bong Geun; Langer, Robert; Khademhosseini, Ali

2009-01-01

Microfluidic technologies’ ability to miniaturize assays and increase experimental throughput have generated significant interest in the drug discovery and development domain. These characteristics make microfluidic systems a potentially valuable tool for many drug discovery and development applications. Here, we review the recent advances of microfluidic devices for drug discovery and development and highlight their applications in different stages of the process, including target selection, lead identification, preclinical tests, clinical trials, chemical synthesis, formulations studies, and product management. PMID:18190858

Evolution in Clinical Knowledge Management Strategy at Intermountain Healthcare

PubMed Central

Hulse, Nathan C.; Galland, Joel; Borsato, Emerson P.

2012-01-01

In this manuscript, we present an overview of the clinical knowledge management strategy at Intermountain Healthcare in support of our electronic medical record systems. Intermountain first initiated efforts in developing a centralized enterprise knowledge repository in 2001. Applications developed, areas of emphasis served, and key areas of focus are presented. We also detail historical and current areas of emphasis, in response to business needs. PMID:23304309

Harvest: a web-based biomedical data discovery and reporting application development platform.

PubMed

Italia, Michael J; Pennington, Jeffrey W; Ruth, Byron; Wrazien, Stacey; Loutrel, Jennifer G; Crenshaw, E Bryan; Miller, Jeffrey; White, Peter S

2013-01-01

Biomedical researchers share a common challenge of making complex data understandable and accessible. This need is increasingly acute as investigators seek opportunities for discovery amidst an exponential growth in the volume and complexity of laboratory and clinical data. To address this need, we developed Harvest, an open source framework that provides a set of modular components to aid the rapid development and deployment of custom data discovery software applications. Harvest incorporates visual representations of multidimensional data types in an intuitive, web-based interface that promotes a real-time, iterative approach to exploring complex clinical and experimental data. The Harvest architecture capitalizes on standards-based, open source technologies to address multiple functional needs critical to a research and development environment, including domain-specific data modeling, abstraction of complex data models, and a customizable web client.

Comprehensive Psychopathological Assessment Based on the Association for Methodology and Documentation in Psychiatry (AMDP) System: Development, Methodological Foundation, Application in Clinical Routine, and Research.

PubMed

Stieglitz, Rolf-Dieter; Haug, Achim; Fähndrich, Erdmann; Rösler, Michael; Trabert, Wolfgang

2017-01-01

The documentation of psychopathology is core to the clinical practice of the psychiatrist and clinical psychologist. However, both in initial as well as further training and specialization in their fields, this particular aspect of their work receives scanty attention only. Yet, for the past 50 years, the Association for Methodology and Documentation in Psychiatry (AMDP) System has been in existence and available as a tool to serve precisely the purpose of offering a systematic introduction to the terminology and documentation of psychopathology. The motivation for its development was based on the need for an assessment procedure for the reliable documentation of the effectiveness of newly developed psychopharmacological substances. Subsequently, the AMDP-System began to be applied in the context of investigations into a number of methodological issues in psychiatry (e.g., the frequency and specificity of particular symptoms, the comparison of rating scales). The System then became increasingly important also in clinical practice and, today, represents the most used instrument for the documentation of psychopathology in the German-speaking countries of Europe. This paper intends to offer an overview of the AMDP-System, its origins, design, and functionality. After an initial account of the history and development of the AMDP-System, the discussion will in turn focus on the System's underlying methodological principles, the transfer of clinical skills and competencies in its practical application, and its use in research and clinical practice. Finally, potential future areas of development in relation to the AMDP-System are explored.

Comprehensive Psychopathological Assessment Based on the Association for Methodology and Documentation in Psychiatry (AMDP) System: Development, Methodological Foundation, Application in Clinical Routine, and Research

PubMed Central

Stieglitz, Rolf-Dieter; Haug, Achim; Fähndrich, Erdmann; Rösler, Michael; Trabert, Wolfgang

2017-01-01

The documentation of psychopathology is core to the clinical practice of the psychiatrist and clinical psychologist. However, both in initial as well as further training and specialization in their fields, this particular aspect of their work receives scanty attention only. Yet, for the past 50 years, the Association for Methodology and Documentation in Psychiatry (AMDP) System has been in existence and available as a tool to serve precisely the purpose of offering a systematic introduction to the terminology and documentation of psychopathology. The motivation for its development was based on the need for an assessment procedure for the reliable documentation of the effectiveness of newly developed psychopharmacological substances. Subsequently, the AMDP-System began to be applied in the context of investigations into a number of methodological issues in psychiatry (e.g., the frequency and specificity of particular symptoms, the comparison of rating scales). The System then became increasingly important also in clinical practice and, today, represents the most used instrument for the documentation of psychopathology in the German-speaking countries of Europe. This paper intends to offer an overview of the AMDP-System, its origins, design, and functionality. After an initial account of the history and development of the AMDP-System, the discussion will in turn focus on the System’s underlying methodological principles, the transfer of clinical skills and competencies in its practical application, and its use in research and clinical practice. Finally, potential future areas of development in relation to the AMDP-System are explored. PMID:28439242

Web Tools for Distributed Clinical Case Conferencing

PubMed Central

Lober, WB; Li, H; Trigg, LJ; Stewart, BK; Chou, D

2001-01-01

We have developed an information system to support distributed clinical case conferences held via video conferencing. The system has been designed by studying physicians of several specialties presenting hematology-oncology patients at Tumor Board. However, the principles of clinical case presentation are similar across many medical specialties, and we believe our approach has general applicability for presenting image and other clinical information, and organizing it for subsequent re-use in teaching files.

Clinical applications of the functional connectome

PubMed Central

Castellanos, F. Xavier; Di Martino, Adriana; Craddock, R. Cameron; Mehta, Ashesh D.; Milham, Michael P.

2013-01-01

Central to the development of clinical applications of functional connectomics for neurology and psychiatry is the discovery and validation of biomarkers. Resting state fMRI (R-fMRI) is emerging as a mainstream approach for imaging-based biomarker identification, detecting variations in the functional connectome that can be attributed to clinical variables (e.g., diagnostic status). Despite growing enthusiasm, many challenges remain. Here, we assess evidence of the readiness of R-fMRI based functional connectomics to lead to clinically meaningful biomarker identification through the lens of the criteria used to evaluate clinical tests (i.e., validity, reliability, sensitivity, specificity, and applicability). We focus on current R-fMRI-based prediction efforts, and survey R-fMRI used for neurosurgical planning. We identify gaps and needs for R-fMRI-based biomarker identification, highlighting the potential of emerging conceptual, analytical and cultural innovations (e.g., the Research Domain Criteria Project (RDoC), open science initiatives, and Big Data) to address them. Additionally, we note the need to expand future efforts beyond identification of biomarkers for disease status alone to include clinical variables related to risk, expected treatment response and prognosis. PMID:23631991

Why Physics in Medicine?

PubMed

Samei, Ehsan; Grist, Thomas M

2018-05-18

Despite its crucial role in the development of new medical imaging technologies, in clinical practice, physics has primarily been involved in the technical evaluation of technologies. However, this narrow role is no longer adequate. New trajectories in medicine call for a stronger role for physics in the clinic. The movement toward evidence-based, quantitative, and value-based medicine requires physicists to play a more integral role in delivering innovative precision care through the intentional clinical application of physical sciences. There are three aspects of this clinical role: technology assessment based on metrics as they relate to expected clinical performance, optimized use of technologies for patient-centered clinical outcomes, and retrospective analysis of imaging operations to ensure attainment of expectations in terms of quality and variability. These tasks fuel the drive toward high-quality, consistent practice of medical imaging that is patient centered, evidence based, and safe. While this particular article focuses on imaging, this trajectory and paradigm is equally applicable to the multitudes of the applications of physics in medicine. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

PhotoExam: adoption of an iOS-based clinical image capture application at Mayo Clinic.

PubMed

Wyatt, Kirk D; Willaert, Brian N; Pallagi, Peter J; Uribe, Richard A; Yiannias, James A; Hellmich, Thomas R

2017-12-01

Mayo Clinic developed an internal iOS-based, point-of-care clinical image capture application for clinicians. We aimed to assess the adoption and utilization of the application at Mayo Clinic. Metadata of 22,784 photos of 6417 patients taken by 606 users over 8040 clinical encounters between 3/1/2015 and 10/31/2015 were analyzed. A random sample of photos from 100 clinical encounters was assessed for quality using a five-item rubric. Use of traditional medical photography services before and after application launch were compared. The largest group of users was residents/fellows, accounting for 31% of users but only 18% of all photos. Attending physicians accounted for 29% of users and 30% of photos. Nurses accounted for 14% of users and 28% of photos. Surgical specialties had the most users (36% of users), followed by dermatology (14% of users); however, dermatology accounted for 54% of all photos, and surgery accounted for 26% of photos. Images received an average of 91% of possible points on the quality scoring rubric. Most frequent reasons for missing points were the location on the body not clearly being demonstrated (19% of encounters) and the perspective/scale not being clearly demonstrated (12% of encounters). There was no discernible pre-post effect of the application's launch on use of traditional medical photography services. Point-of-care clinical photography is a growing phenomenon with potential to become the new standard of care. Patient and provider attitudes and the impact on patient outcomes remain unclear. © 2017 The International Society of Dermatology.

An interview study of how clinical teachers develop skills to attend to different level learners.

PubMed

Chen, H Carrie; Fogh, Shannon; Kobashi, Brent; Teherani, Arianne; Ten Cate, Olle; O'Sullivan, Patricia

2016-06-01

One clinical teaching challenge is the engagement of learners at different levels. Faculty development offerings mostly address general strategies applicable to all learners. This study examined how clinical faculty members develop the skills to work with different level learners. We conducted semi-structured interviews with medical school faculty members identified as excellent clinical teachers teaching multiple levels of learners. They discussed how they developed their approach to teaching different level learners and how their teaching evolved over time. We performed thematic analysis of the interview transcripts using open and axial coding. We interviewed 19 faculty members and identified three themes related to development of teaching practices: teacher agency and work-based learning of teaching strategies, developmental trajectory of clinical teachers, and interplay between clinical confidence and teaching skills. Faculty members were proactive in using on-the-job experiences to develop their teaching practices. Their teaching practices followed a developmental trajectory towards learner centeredness, and this evolution was associated with the development of clinical skills and confidence. Learning skills to teach multi-level learners requires workplace learning. Faculty development should include workplace learning opportunities and use a developmental approach that accounts for the trajectory of teaching as well as clinical skills attainment.

[Development and application of a medical device maintenance information platform based on BS architecture].

PubMed

Liu, Shenglin; Zhang, Xutian; Wang, Guohong; Zhang, Qiang

2012-03-01

Based on specified demands on medical devices maintenance for clinical engineers and Browser/Server architecture technology, a medical device maintenance information platform was developed, which implemented the following modules such as repair, preventive maintenance, accessories management, training, document, system management and regional cooperation. The characteristics of this system were summarized and application in increase of repair efficiency, improvement of preventive maintenance and cost control was introduced. The application of this platform increases medical device maintenance service level.

Cellular Therapies Clinical Research Roadmap: Lessons learned on how to move a cellular therapy into a clinical trial

PubMed Central

Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M.

2014-01-01

A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, via and Investigational New Drug (IND) application, into early phase clinical trials. The roadmap describes four key areas; basic and preclinical research, resource development, translational research and good manufacturing practice (GMP), and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value using a model of the relevant disease. During resource development the appropriate specialists and the required expertise to bring this product into the clinic are identified (e.g., researchers, regulatory specialists, GMP manufacturing staff, clinicians, and clinical trials staff, etc.). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase the plan to translate the research product into a clinical grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States this is done by filing an IND application with the Food and Drug Administration. The NHLBI-funded Production Assistance for Cellular Therapies (PACT) program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five PACT facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly, and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. PMID:25484311

Application of nutrient intake values (NIVs).

PubMed

Vorster, Hester H; Murphy, Suzanne P; Allen, Lindsay H; King, Janet C

2007-03-01

The process of applying nutrient intake values (NIVs) for dietary assessment, planning, and implementing programs is discussed in this paper. In addition to assessing, monitoring, and evaluating nutritional situations, applications include planning food policies, strategies, and programs for promotion of optimal nutrition and preventing and treating malnutrition (both over- and undernutrition). Other applications include nutrition education, food and nutrient legislation, marketing and labeling, research, product development, food procurement and trade (import and export), food aid, and therapeutic (clinical) nutrition. Specific examples of how NIVs are used to develop food labels, fortification policies, and food-based dietary guidelines are described. Applications in both developed and developing countries are also described. In summary, NIVs are the scientific backbone of all aspects of nutrition policy in countries and regions worldwide.

Applications for detection of acute kidney injury using electronic medical records and clinical information systems: workgroup statements from the 15(th) ADQI Consensus Conference.

PubMed

James, Matthew T; Hobson, Charles E; Darmon, Michael; Mohan, Sumit; Hudson, Darren; Goldstein, Stuart L; Ronco, Claudio; Kellum, John A; Bagshaw, Sean M

2016-01-01

Electronic medical records and clinical information systems are increasingly used in hospitals and can be leveraged to improve recognition and care for acute kidney injury. This Acute Dialysis Quality Initiative (ADQI) workgroup was convened to develop consensus around principles for the design of automated AKI detection systems to produce real-time AKI alerts using electronic systems. AKI alerts were recognized by the workgroup as an opportunity to prompt earlier clinical evaluation, further testing and ultimately intervention, rather than as a diagnostic label. Workgroup members agreed with designing AKI alert systems to align with the existing KDIGO classification system, but recommended future work to further refine the appropriateness of AKI alerts and to link these alerts to actionable recommendations for AKI care. The consensus statements developed in this review can be used as a roadmap for development of future electronic applications for automated detection and reporting of AKI.

Composite prognostic models across the non-alcoholic fatty liver disease spectrum: Clinical application in developing countries

PubMed Central

Lückhoff, Hilmar K; Kruger, Frederik C; Kotze, Maritha J

2015-01-01

Heterogeneity in clinical presentation, histological severity, prognosis and therapeutic outcomes characteristic of non-alcoholic fatty liver disease (NAFLD) necessitates the development of scientifically sound classification schemes to assist clinicians in stratifying patients into meaningful prognostic subgroups. The need for replacement of invasive liver biopsies as the standard method whereby NAFLD is diagnosed, graded and staged with biomarkers of histological severity injury led to the development of composite prognostic models as potentially viable surrogate alternatives. In the present article, we review existing scoring systems used to (1) confirm the presence of undiagnosed hepatosteatosis; (2) distinguish between simple steatosis and NASH; and (3) predict advanced hepatic fibrosis, with particular emphasis on the role of NAFLD as an independent cardio-metabolic risk factor. In addition, the incorporation of functional genomic markers and application of emerging imaging technologies are discussed as a means to improve the diagnostic accuracy and predictive performance of promising composite models found to be most appropriate for widespread clinical adoption. PMID:26019735

Recent advances of liquid chromatography-(tandem) mass spectrometry in clinical and forensic toxicology - An update.

PubMed

Remane, Daniela; Wissenbach, Dirk K; Peters, Frank T

2016-09-01

Liquid chromatography (LC) coupled to mass spectrometry (MS) or tandem mass spectrometry (MS/MS) is a well-established and widely used technique in clinical and forensic toxicology as well as doping control especially for quantitative analysis. In recent years, many applications for so-called multi-target screening and/or quantification of drugs, poisons, and or their metabolites in biological matrices have been developed. Such methods have proven particularly useful for analysis of so-called new psychoactive substances that have appeared on recreational drug markets throughout the world. Moreover, the evolvement of high resolution MS techniques and the development of data-independent detection modes have opened new possibilities for applications of LC-(MS/MS) in systematic toxicological screening analysis in the so called general unknown setting. The present paper will provide an overview and discuss these recent developments focusing on the literature published after 2010. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Study on traditional Chinese medicine theory of lung being connected with large intestine.

PubMed

Liu, Ping; Wang, Ping; Tian, Daizhi; Liu, Junfeng; Chen, Gang; Liu, Songlin

2012-09-01

The theory of lung being connected with large intestine, which is a major topic in Traditional Chinese Medicine (TCM), has guided clinical practice for thousands of years in China. In this study, we analyzed the history, main contents, clinical application, and material basis of the theory, to attempt to improve the potential clinical significance of "lung being connected with large intestine" in China. The lung being connected with large intestine was first described in "Huang Di Nei Jing", and formed one of the basic theories of TCM. For thousands of years, the majority of TCM practitioners explored this theory continuously, leading to its development and use as an important theory in the guidance of TCM clinics In the last decade, researchers in the field of integrated TCM and Western medicine have studied clinical applications and biomedical mechanisms with experimental methods to explore the implications of the theory. With the further development of science and technology, research concerning the theory of lung being connected with large intestine will be greatly stimulated and contribute to the modernization of TCM.

Application of evidence-based dentistry: from research to clinical periodontal practice.

PubMed

Kwok, Vivien; Caton, Jack G; Polson, Alan M; Hunter, Paul G

2012-06-01

Dentists need to make daily decisions regarding patient care, and these decisions should essentially be scientifically sound. Evidence-based dentistry is meant to empower clinicians to provide the most contemporary treatment. The benefits of applying the evidence-based method in clinical practice include application of the most updated treatment and stronger reasoning to justify the treatment. A vast amount of information is readily accessible with today's digital technology, and a standardized search protocol can be developed to ensure that a literature search is valid, specific and repeatable. It involves developing a preset question (population, intervention, comparison and outcome; PICO) and search protocol. It is usually used academically to perform commissioned reviews, but it can also be applied to answer simple clinical queries. The scientific evidence thus obtained can then be considered along with patient preferences and values, clinical patient circumstances and the practitioner's experience and judgment in order to make the treatment decision. This paper describes how clinicians can incorporate evidence-based methods into patient care and presents a clinical example to illustrate the process. © 2012 John Wiley & Sons A/S.

MR-guided focused ultrasound surgery, present and future

PubMed Central

Schlesinger, David; Benedict, Stanley; Diederich, Chris; Gedroyc, Wladyslaw; Klibanov, Alexander; Larner, James

2013-01-01

MR-guided focused ultrasound surgery (MRgFUS) is a quickly developing technology with potential applications across a spectrum of indications traditionally within the domain of radiation oncology. Especially for applications where focal treatment is the preferred technique (for example, radiosurgery), MRgFUS has the potential to be a disruptive technology that could shift traditional patterns of care. While currently cleared in the United States for the noninvasive treatment of uterine fibroids and bone metastases, a wide range of clinical trials are currently underway, and the number of publications describing advances in MRgFUS is increasing. However, for MRgFUS to make the transition from a research curiosity to a clinical standard of care, a variety of challenges, technical, financial, clinical, and practical, must be overcome. This installment of the Vision 20/20 series examines the current status of MRgFUS, focusing on the hurdles the technology faces before it can cross over from a research technique to a standard fixture in the clinic. It then reviews current and near-term technical developments which may overcome these hurdles and allow MRgFUS to break through into clinical practice. PMID:23927296

RNAi therapeutics and applications of microRNAs in cancer treatment.

PubMed

Uchino, Keita; Ochiya, Takahiro; Takeshita, Fumitaka

2013-06-01

RNA interference-based therapies are proving to be powerful tools for combating various diseases, including cancer. Scientists are researching the development of safe and efficient systems for the delivery of small RNA molecules, which are extremely fragile in serum, to target organs and cells in the human body. A dozen pre-clinical and clinical trials have been under way over the past few years involving biodegradable nanoparticles, lipids, chemical modification and conjugation. On the other hand, microRNAs, which control the balance of cellular biological processes, have been studied as attractive therapeutic targets in cancer treatment. In this review, we provide an overview of RNA interference-based therapeutics in clinical trials and discuss the latest technology for the systemic delivery of nucleic acid drugs. Furthermore, we focus on dysregulated microRNAs in human cancer, which have progressed in pre-clinical trials as therapeutic targets, and describe a wide range of strategies to control the expression levels of endogenous microRNAs. Further development of RNA interference technologies and progression of clinical trials will contribute to the achievement of practical applications of nucleic acid drugs.

Automated array-based genomic profiling in chronic lymphocytic leukemia: Development of a clinical tool and discovery of recurrent genomic alterations

PubMed Central

Schwaenen, Carsten; Nessling, Michelle; Wessendorf, Swen; Salvi, Tatjana; Wrobel, Gunnar; Radlwimmer, Bernhard; Kestler, Hans A.; Haslinger, Christian; Stilgenbauer, Stephan; Döhner, Hartmut; Bentz, Martin; Lichter, Peter

2004-01-01

B cell chronic lymphocytic leukemia (B-CLL) is characterized by a highly variable clinical course. Recurrent chromosomal imbalances provide significant prognostic markers. Risk-adapted therapy based on genomic alterations has become an option that is currently being tested in clinical trials. To supply a robust tool for such large scale studies, we developed a comprehensive DNA microarray dedicated to the automated analysis of recurrent genomic imbalances in B-CLL by array-based comparative genomic hybridization (matrix–CGH). Validation of this chip in a series of 106 B-CLL cases revealed a high specificity and sensitivity that fulfils the criteria for application in clinical oncology. This chip is immediately applicable within clinical B-CLL treatment trials that evaluate whether B-CLL cases with distinct chromosomal abnormalities should be treated with chemotherapy of different intensities and/or stem cell transplantation. Through the control set of DNA fragments equally distributed over the genome, recurrent genomic imbalances were discovered: trisomy of chromosome 19 and gain of the MYCN oncogene correlating with an elevation of MYCN mRNA expression. PMID:14730057

Kinetic chains: a review of the concept and its clinical applications.

PubMed

Karandikar, Ninad; Vargas, Oscar O Ortiz

2011-08-01

During the past decade, our understanding of biomechanics and its importance in rehabilitation has advanced significantly. The kinetic chain, a concept borrowed from engineering, has helped us better understand the underlying physiology of human movement. This understanding, in turn, has facilitated the development of new and more rational rehabilitation strategies. The kinetic chain concept has application in a wide spectrum of clinical conditions, including musculoskeletal medicine, sports medicine, and neurorehabilitation, as well as prosthetics and orthotics. The purpose of this review is to provide insights into the biomechanics related to the concept of kinetic chains, with a specific focus on closed kinetic chains and its clinical applications in rehabilitation. Copyright © 2011 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Complement inhibition in pre-clinical models of periodontitis and prospects for clinical application.

PubMed

Hajishengallis, George; Hajishengallis, Evlambia; Kajikawa, Tetsuhiro; Wang, Baomei; Yancopoulou, Despina; Ricklin, Daniel; Lambris, John D

2016-06-01

Periodontitis is a dysbiotic inflammatory disease leading to the destruction of the tooth-supporting tissues. Current therapies are not always effective and this prevalent oral disease continues to be a significant health and economic burden. Early clinical studies have associated periodontitis with elevated complement activity. Consistently, subsequent genetic and pharmacological studies in rodents have implicated the central complement component C3 and downstream signaling pathways in periodontal host-microbe interactions that promote dysbiosis and inflammatory bone loss. This review discusses these mechanistic advances and moreover focuses on the compstatin family of C3 inhibitors as a novel approach to treat periodontitis. In this regard, local application of the current lead analog Cp40 was recently shown to block both inducible and naturally occurring periodontitis in non-human primates. These promising results from non-human primate studies and the parallel development of Cp40 for clinical use highlight the feasibility for developing an adjunctive, C3-targeted therapy for human periodontitis. Copyright © 2016 Elsevier Ltd. All rights reserved.

On mixed reality environments for minimally invasive therapy guidance: systems architecture, successes and challenges in their implementation from laboratory to clinic.

PubMed

Linte, Cristian A; Davenport, Katherine P; Cleary, Kevin; Peters, Craig; Vosburgh, Kirby G; Navab, Nassir; Edwards, Philip Eddie; Jannin, Pierre; Peters, Terry M; Holmes, David R; Robb, Richard A

2013-03-01

Mixed reality environments for medical applications have been explored and developed over the past three decades in an effort to enhance the clinician's view of anatomy and facilitate the performance of minimally invasive procedures. These environments must faithfully represent the real surgical field and require seamless integration of pre- and intra-operative imaging, surgical instrument tracking, and display technology into a common framework centered around and registered to the patient. However, in spite of their reported benefits, few mixed reality environments have been successfully translated into clinical use. Several challenges that contribute to the difficulty in integrating such environments into clinical practice are presented here and discussed in terms of both technical and clinical limitations. This article should raise awareness among both developers and end-users toward facilitating a greater application of such environments in the surgical practice of the future. Copyright © 2013 Elsevier Ltd. All rights reserved.

Mobile Tablet Use among Academic Physicians and Trainees

PubMed Central

Sclafani, Joseph; Tirrell, Timothy F.

2014-01-01

The rapid adoption rate and integration of mobile technology (tablet computing devices and smartphones) by physicians is reshaping the current clinical landscape. These devices have sparked an evolution in a variety of arenas, including educational media dissemination, remote patient data access and point of care applications. Quantifying usage patterns of clinical applications of mobile technology is of interest to understand how these technologies are shaping current clinical care. A digital survey examining mobile tablet and associated application usage was administered via email to all ACGME training programs. Data regarding respondent specialty, level of training, and habits of tablet usage were collected and analyzed. 40 % of respondents used a tablet, of which the iPad was the most popular. Nearly half of the tablet owners reported using the tablet in clinical settings; the most commonly used application types were point of care and electronic medical record access. Increased level of training was associated with decreased support for mobile computing improving physician capabilities and patient interactions. There was strong and consistent desire for institutional support of mobile computing and integration of mobile computing technology into medical education. While many physicians are currently purchasing mobile devices, often without institutional support, successful integration of these devices into the clinical setting is still developing. Potential reasons behind the low adoption rate may include interference of technology in doctor-patient interactions or the lack of appropriate applications available for download. However, the results convincingly demonstrate that physicians recognize a potential utility in mobile computing, indicated by their desire for institutional support and integration of mobile technology into medical education. It is likely that the use of tablet computers in clinical practice will expand in the future. Thus, we believe medical institutions, providers, educators, and developers should collaborate in ways that enhance the efficacy, reliability, and safety of integrating these devices into daily medical practice. PMID:23321961

[Clinical application evaluation of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine].

PubMed

Wang, Yue-Xi; Liu, Meng-Yu; Wang, Li-Ying; Shi, Nan-Nan; Zhao, Xue-Yao; Liu, Yu-Qi; Wang, Yan-Ping; Han, Xue-Jie

2017-09-01

To assess the quality and application effect of Guidelines for Diagnosis and Treatment of Common Diseases of Dermatology in Traditional Chinese Medicine(Guidelines) through the applicability and applicability evaluation respectively. The questionnaire survey was adopted to evaluate the applicability of the Guidelines, including the utilization, quality, and clinical application conditions. The results showed that the familiarity rate and utilization rate of the Guidelines were 85.37%, 48.78%, respectively. The data showed that the familiarity and the utilization rates were different in the working staff with different professional titles. The evaluation level was the lowest given by the staff with junior professional title (70.97%, 29.03%) in comparison. The assessment showed the overall quality of the Guideline was good and slightly low level for the rationality scores of the other therapeutic methods as well as for the recuperation and prevention (80.49%, 85.37%), which was in line with the clinical compliance of the Guideline. The perspective observation of clinical cases was used for the applicability evaluation, including clinical compliance of the Guideline, effect evaluation, and comprehensive assessment, et al. The results showed that the safety score was the highest, followed by the economic issue and efficacy. For the comprehensive evaluation of the applicability, complete applicability accounted for 29.27%, and the general applicability accounted for 87.80%. It was showed in the three index scores of the applicability evaluation that the accumulative score 7-9 scores were 75.65%, 73.89%, 71.12%. Through the applicability and applicability evaluation, the Guideline was satisfactory in the overall quality, high in the safety of clinical application and good in efficacy and economic issues. There are some limits on the development method and technical issues in the Guideline, which is required to be supplemented in the revision. Additionally, the strategy study on the promotion of the Guideline should be enhanced so as to expedite the recognition and utilization of the Guideline. Copyright© by the Chinese Pharmaceutical Association.

Normalization and standardization of electronic health records for high-throughput phenotyping: the SHARPn consortium

PubMed Central

Pathak, Jyotishman; Bailey, Kent R; Beebe, Calvin E; Bethard, Steven; Carrell, David S; Chen, Pei J; Dligach, Dmitriy; Endle, Cory M; Hart, Lacey A; Haug, Peter J; Huff, Stanley M; Kaggal, Vinod C; Li, Dingcheng; Liu, Hongfang; Marchant, Kyle; Masanz, James; Miller, Timothy; Oniki, Thomas A; Palmer, Martha; Peterson, Kevin J; Rea, Susan; Savova, Guergana K; Stancl, Craig R; Sohn, Sunghwan; Solbrig, Harold R; Suesse, Dale B; Tao, Cui; Taylor, David P; Westberg, Les; Wu, Stephen; Zhuo, Ning; Chute, Christopher G

2013-01-01

Research objective To develop scalable informatics infrastructure for normalization of both structured and unstructured electronic health record (EHR) data into a unified, concept-based model for high-throughput phenotype extraction. Materials and methods Software tools and applications were developed to extract information from EHRs. Representative and convenience samples of both structured and unstructured data from two EHR systems—Mayo Clinic and Intermountain Healthcare—were used for development and validation. Extracted information was standardized and normalized to meaningful use (MU) conformant terminology and value set standards using Clinical Element Models (CEMs). These resources were used to demonstrate semi-automatic execution of MU clinical-quality measures modeled using the Quality Data Model (QDM) and an open-source rules engine. Results Using CEMs and open-source natural language processing and terminology services engines—namely, Apache clinical Text Analysis and Knowledge Extraction System (cTAKES) and Common Terminology Services (CTS2)—we developed a data-normalization platform that ensures data security, end-to-end connectivity, and reliable data flow within and across institutions. We demonstrated the applicability of this platform by executing a QDM-based MU quality measure that determines the percentage of patients between 18 and 75 years with diabetes whose most recent low-density lipoprotein cholesterol test result during the measurement year was <100 mg/dL on a randomly selected cohort of 273 Mayo Clinic patients. The platform identified 21 and 18 patients for the denominator and numerator of the quality measure, respectively. Validation results indicate that all identified patients meet the QDM-based criteria. Conclusions End-to-end automated systems for extracting clinical information from diverse EHR systems require extensive use of standardized vocabularies and terminologies, as well as robust information models for storing, discovering, and processing that information. This study demonstrates the application of modular and open-source resources for enabling secondary use of EHR data through normalization into standards-based, comparable, and consistent format for high-throughput phenotyping to identify patient cohorts. PMID:24190931

Systematic review of the methodological quality of clinical guideline development for the management of chronic disease in Europe.

PubMed

Knai, Cécile; Brusamento, Serena; Legido-Quigley, Helena; Saliba, Vanessa; Panteli, Dimitra; Turk, Eva; Car, Josip; McKee, Martin; Busse, Reinhard

2012-10-01

The use of evidence-based clinical guidelines is an essential component of chronic disease management. However, there is well-documented concern about variability in the quality of clinical guidelines, with evidence of persisting methodological shortcomings. The most widely accepted approach to assessing the quality of guidelines is the Appraisal of Guidelines for Research and Evaluation (AGREE) instrument. We have conducted a systematic review of the methodological quality (as assessed by AGREE) of clinical guidelines developed in Europe for the management of chronic diseases published since 2000. The systematic review was undertaken in accordance with the Cochrane methodology. The inclusion criteria were that studies should have appraised European clinical guidelines for certain selected chronic disorders using the AGREE instrument. We searched five databases (Cab Abstracts, EMBASE, MEDLINE, Trip and EPPI). Nine studies reported in 10 papers, analysing a total of 28 European guidelines from eight countries as well as pan-European, were included. There was considerable variation in the quality of clinical guidelines across the AGREE domains. The least well addressed domains were 'editorial independence' (with a mean domain score of 41%), 'applicability' (44%), 'stakeholder involvement' (55%), and 'rigour of development' (64%), while 'clarity of presentation' (80%) and 'scope and purpose' (84%) were less problematic. This review indicates that there is considerable scope for improvement in the methods used to develop clinical guidelines for the prevention, management and treatment of chronic diseases in Europe. Given the importance of decision support strategies such as clinical guidelines in chronic disease management, improvement measures should include the explicit and transparent involvement of key stakeholders (especially scientific experts, guideline users and methodological specialists) and consideration of the implications for guideline implementation and applicability early on in the process. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Application Instructions | Division of Cancer Prevention

Cancer.gov

This is NOT a grant application - if successful, funds will not be transferred to your institution to support your project. Rather, this is an application to access the scientific capabilities and resources of the NCI with the goal of moving promising cancer chemopreventive agents into clinical testing. If successful, you will partner with the NCI in developing a drug

Complexity theory in the management of communicable diseases.

PubMed

Simmons, Mike

2003-06-01

In nature, apparently complex behavioural patterns are the result of repetitive simple rules. Complexity science studies the application of these rules and looks for applications in society. Complexity management opportunities have developed from this science and are providing a revolutionary approach in the constantly changing workplace. This article discusses how complexity management techniques have already been applied to communicable disease management in Wales and suggests further developments. A similar approach is recommended to others in the field, while complexity management probably has wider applications in the NHS, not least in relation to the developing managed clinical networks.

The Bobath concept - a model to illustrate clinical practice.

PubMed

Michielsen, Marc; Vaughan-Graham, Julie; Holland, Ann; Magri, Alba; Suzuki, Mitsuo

2017-12-17

The model of Bobath clinical practice provides a framework identifying the unique aspects of the Bobath concept in terms of contemporary neurological rehabilitation. The utilisation of a framework to illustrate the clinical application of the Bobath concept provides the basis for a common understanding with respect to Bobath clinical practice, education, and research. The development process culminating in the model of Bobath clinical practice is described. The use of the model in clinical practice is illustrated using two cases: a client with a chronic incomplete spinal cord injury and a client with a stroke. This article describes the clinical application of the Bobath concept in terms of the integration of posture and movement with respect to the quality of task performance, applying the Model of Bobath Clinical Practice. Facilitation, a key aspect of Bobath clinical practice, was utilised to positively affect motor control and perception in two clients with impairment-related movement problems due to neurological pathology and associated activity limitations and participation restrictions - the outcome measures used to reflect the individual clinical presentation. Implications for Rehabilitation The model of Bobath clinical practice provides a framework identifying the unique aspects of the Bobath-concept. The model of Bobath clinical practice provides the basis for a common understanding with respect to Bobath clinical practice, education, and research. The clinical application of the Bobath-concept highlights the integration of posture and movement with respect to the quality of task performance. Facilitation, a key aspect of Bobath clinical practice, positively affects motor control, and perception.

Development of inexpensive blood imaging systems: where are we now?

PubMed

Chu, Kaiqin; Smith, Zachary J; Wachsmann-Hogiu, Sebastian

2015-01-01

Clinical applications in the developing world, such as malaria and anemia diagnosis, demand a change in the medical paradigm of expensive care given in central locations by highly trained professionals. There has been a recent explosion in optical technologies entering the consumer market through the widespread adoption of smartphones and LEDs. This technology commoditization has enabled the development of small, portable optical imaging systems at an unprecedentedly low cost. Here, we review the state-of-the-field of the application of these systems for low-cost blood imaging with an emphasis on cellular imaging systems. In addition to some promising results addressing specific clinical issues, an overview of the technology landscape is provided. We also discuss several key issues that need to be addressed before these technologies can be commercialized.

Cryopreservation and Revival of Human Mesenchymal Stromal Cells.

PubMed

Haack-Sørensen, Mandana; Ekblond, Annette; Kastrup, Jens

2016-01-01

Cell-based therapy is a promising and innovative new treatment for different degenerative and autoimmune diseases, and mesenchymal stromal cells (MSCs) from the bone marrow have demonstrated great therapeutic potential due to their immunosuppressive and regenerative capacities.The establishment of methods for large-scale expansion of clinical-grade MSCs in vitro has paved the way for their therapeutic use in clinical trials. However, the clinical application of MSCs also requires cryopreservation and banking of the cell products. To preserve autologous or allogeneic MSCs for future clinical applications, a reliable and effective cryopreservation method is required.Developing a successful cryopreservation protocol for clinical stem cell products, cryopreservation media, cryoprotectant agents (CPAs), the freezing container, the freezing temperature, and the cooling and warming rate are all aspects which should be considered.A major challenge is the selection of a suitable cryoprotectant which is able to penetrate the cells and yet has low toxicity.This chapter focuses on recent technological developments relevant for the cryopreservation of MSCs using the most commonly used cryopreservation medium containing DMSO and animal serum or human-derived products for research use and the animal protein-free cryopreservation media CryoStor (BioLife Solutions) for clinical use.

Developments in x-ray tomography I - IX

NASA Astrophysics Data System (ADS)

Stock, S. R.

2016-10-01

Nine Developments in X-ray Tomography conferences have been held previously, and this paper summarizes data from these conference proceedings. The Developments conference provides snapshots of the x-ray tomography field which spans clinical and biological applications, engineering and industrial studies and physical sciences.

A Roadmap for the Development of Applied Computational Psychiatry.

PubMed

Paulus, Martin P; Huys, Quentin J M; Maia, Tiago V

2016-09-01

Computational psychiatry is a burgeoning field that utilizes mathematical approaches to investigate psychiatric disorders, derive quantitative predictions, and integrate data across multiple levels of description. Computational psychiatry has already led to many new insights into the neurobehavioral mechanisms that underlie several psychiatric disorders, but its usefulness from a clinical standpoint is only now starting to be considered. Examples of computational psychiatry are highlighted, and a phase-based pipeline for the development of clinical computational-psychiatry applications is proposed, similar to the phase-based pipeline used in drug development. It is proposed that each phase has unique endpoints and deliverables, which will be important milestones to move tasks, procedures, computational models, and algorithms from the laboratory to clinical practice. Application of computational approaches should be tested on healthy volunteers in Phase I, transitioned to target populations in Phase IB and Phase IIA, and thoroughly evaluated using randomized clinical trials in Phase IIB and Phase III. Successful completion of these phases should be the basis of determining whether computational models are useful tools for prognosis, diagnosis, or treatment of psychiatric patients. A new type of infrastructure will be necessary to implement the proposed pipeline. This infrastructure should consist of groups of investigators with diverse backgrounds collaborating to make computational psychiatry relevant for the clinic.

Functional brain imaging in neuropsychology over the past 25 years.

PubMed

Roalf, David R; Gur, Ruben C

2017-11-01

Outline effects of functional neuroimaging on neuropsychology over the past 25 years. Functional neuroimaging methods and studies will be described that provide a historical context, offer examples of the utility of neuroimaging in specific domains, and discuss the limitations and future directions of neuroimaging in neuropsychology. Tracking the history of publications on functional neuroimaging related to neuropsychology indicates early involvement of neuropsychologists in the development of these methodologies. Initial progress in neuropsychological application of functional neuroimaging has been hampered by costs and the exposure to ionizing radiation. With rapid evolution of functional methods-in particular functional MRI (fMRI)-neuroimaging has profoundly transformed our knowledge of the brain. Its current applications span the spectrum of normative development to clinical applications. The field is moving toward applying sophisticated statistical approaches that will help elucidate distinct neural activation networks associated with specific behavioral domains. The impact of functional neuroimaging on clinical neuropsychology is more circumscribed, but the prospects remain enticing. The theoretical insights and empirical findings of functional neuroimaging have been led by many neuropsychologists and have transformed the field of behavioral neuroscience. Thus far they have had limited effects on the clinical practices of neuropsychologists. Perhaps it is time to add training in functional neuroimaging to the clinical neuropsychologist's toolkit and from there to the clinic or bedside. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Clinical applications of PET in oncology.

PubMed

Rohren, Eric M; Turkington, Timothy G; Coleman, R Edward

2004-05-01

Positron emission tomography (PET) provides metabolic information that has been documented to be useful in patient care. The properties of positron decay permit accurate imaging of the distribution of positron-emitting radiopharmaceuticals. The wide array of positron-emitting radiopharmaceuticals has been used to characterize multiple physiologic and pathologic states. PET is used for characterizing brain disorders such as Alzheimer disease and epilepsy and cardiac disorders such as coronary artery disease and myocardial viability. The neurologic and cardiac applications of PET are not covered in this review. The major utilization of PET clinically is in oncology and consists of imaging the distribution of fluorine 18 fluorodeoxyglucose (FDG). FDG, an analogue of glucose, accumulates in most tumors in a greater amount than it does in normal tissue. FDG PET is being used in diagnosis and follow-up of several malignancies, and the list of articles supporting its use continues to grow. In this review, the physics and instrumentation aspects of PET are described. Many of the clinical applications in oncology are mature and readily covered by third-party payers. Other applications are being used clinically but have not been as carefully evaluated in the literature, and these applications may not be covered by third-party payers. The developing applications of PET are included in this review.

Supercontinuum ultra-high resolution line-field OCT; experimental spectrograph comparison and comparison with current clinical OCT systems by the imaging of a human cornea

NASA Astrophysics Data System (ADS)

Lawman, Samuel; Romano, Vito; Madden, Peter W.; Mason, Sharon; Williams, Bryan M.; Zheng, Yalin; Shen, Yao-Chun

2018-03-01

Ultra high axial resolution (UHR) was demonstrated early in the development of optical coherence tomography (OCT), but has not yet reached clinical practice. We present the combination of supercontinuum light source and line field (LF-) OCT as a technical and economical route to get UHR-OCT into clinic and other OCT application areas. We directly compare images of a human donor cornea taken with low and high resolution current generation clinical OCT systems with UHR-LF-OCT. These images highlight the massive information increase of UHR-OCT. Application to pharmaceutical pellets, and the functionality and imaging performance of different imaging spectrograph choices for LF- OCT are also demonstrated.

Innovation in pediatric clinical education: application of the essential competencies.

PubMed

Kenyon, Lisa K; Birkmeier, Marisa; Anderson, Deborah K; Martin, Kathy

2015-01-01

At the Section on Pediatrics Education Summit in July 2012, consensus was achieved on 5 essential core competencies (ECCs) that represent a knowledge base essential to all graduates of professional physical therapist education programs. This article offers suggestions for how clinical instructors (CIs) might use the ECCs to identify student needs and guide student learning during a pediatric clinical education experience. Pediatric CIs potentially might choose to use the ECCs as a reference tool in clinical education to help (1) organize and develop general, clinic-specific clinical education objectives, (2) develop and plan individualized student learning experiences, (3) identify student needs, and (4) show progression of student learning from beginner to intermediate to entry level. The ECCs may offer CIs insights into the role of pediatric clinical education in professional physical therapist education.

Neural prostheses in clinical applications--trends from precision mechanics towards biomedical microsystems in neurological rehabilitation.

PubMed

Stieglitz, T; Schuettler, M; Koch, K P

2004-04-01

Neural prostheses partially restore body functions by technical nerve excitation after trauma or neurological diseases. External devices and implants have been developed since the early 1960s for many applications. Several systems have reached nowadays clinical practice: Cochlea implants help the deaf to hear, micturition is induced by bladder stimulators in paralyzed persons and deep brain stimulation helps patients with Parkinson's disease to participate in daily life again. So far, clinical neural prostheses are fabricated with means of precision mechanics. Since microsystem technology opens the opportunity to design and develop complex systems with a high number of electrodes to interface with the nervous systems, the opportunity for selective stimulation and complex implant scenarios seems to be feasible in the near future. The potentials and limitations with regard to biomedical microdevices are introduced and discussed in this paper. Target specifications are derived from existing implants and are discussed on selected applications that has been investigated in experimental research: a micromachined implant to interface a nerve stump with a sieve electrode, cuff electrodes with integrated electronics, and an epiretinal vision prosthesis.

Ultrasound Elastography: Review of Techniques and Clinical Applications

PubMed Central

Sigrist, Rosa M.S.; Liau, Joy; Kaffas, Ahmed El; Chammas, Maria Cristina; Willmann, Juergen K.

2017-01-01

Elastography-based imaging techniques have received substantial attention in recent years for non-invasive assessment of tissue mechanical properties. These techniques take advantage of changed soft tissue elasticity in various pathologies to yield qualitative and quantitative information that can be used for diagnostic purposes. Measurements are acquired in specialized imaging modes that can detect tissue stiffness in response to an applied mechanical force (compression or shear wave). Ultrasound-based methods are of particular interest due to its many inherent advantages, such as wide availability including at the bedside and relatively low cost. Several ultrasound elastography techniques using different excitation methods have been developed. In general, these can be classified into strain imaging methods that use internal or external compression stimuli, and shear wave imaging that use ultrasound-generated traveling shear wave stimuli. While ultrasound elastography has shown promising results for non-invasive assessment of liver fibrosis, new applications in breast, thyroid, prostate, kidney and lymph node imaging are emerging. Here, we review the basic principles, foundation physics, and limitations of ultrasound elastography and summarize its current clinical use and ongoing developments in various clinical applications. PMID:28435467

microRNAs as cancer therapeutics: A step closer to clinical application.

PubMed

Catela Ivkovic, Tina; Voss, Gjendine; Cornella, Helena; Ceder, Yvonne

2017-10-28

During the last decades, basic and translational research has enabled great improvements in the clinical management of cancer. However, scarcity of complete remission and many drug-induced toxicities are still a major problem in the clinics. Recently, microRNAs (miRNAs) have emerged as promising therapeutic targets due to their involvement in cancer development and progression. Their extraordinary regulatory potential, which enables regulation of entire signalling networks within the cells, makes them an interesting tool for the development of cancer therapeutics. In this review we will focus on miRNAs with experimentally proven therapeutic potential, and discuss recent advances in the technical development and clinical evaluation of miRNA-based therapeutic agents. Copyright © 2017 Elsevier B.V. All rights reserved.

Platelet-rich fibrin application in dentistry: a literature review.

PubMed

Borie, Eduardo; Oliví, Daniel García; Orsi, Iara Augusta; Garlet, Katia; Weber, Benjamín; Beltrán, Víctor; Fuentes, Ramón

2015-01-01

The development of bioactive surgical additives to regulate the inflammation and increase the speed of healing process is one of the great challenges in clinical research. In this sense, platelet rich fibrin (PRF) appears as a natural and satisfactory alternative with favorable results and low risks. The following review attempts to summarize the relevant literature regarding the technique of using PRF, focusing on its preparation, advantages, and disadvantages of using it in clinical applications. PRF alone or in combination with other biomaterials seems to have several advantages and indications both for medicine and dentistry, due it is a minimally invasive technique with low risks and satisfactory clinical results.

Genomic data into everyday work of a medical practitioner - digital tools for decision-making.

PubMed

Jokiranta, Sakari; Hotakainen, Kristina; Salonen, Iiris; Pöllänen, Pasi; Hänninen, Kai-Petri; Forsström, Jari; Kunnamo, Ilkka

Recent technological development has enabled fast and cost-effective simultaneous analyses of several gene variants or sequence of even the whole genome. For medical practitioners this has created challenges although genomic information may be clinically useful in new applications such as finding out individual risk for diseases influenced by as many as 50,000 variable DNA regions or in detecting pharmacogenetic risks prior to prescribing a medicine. New digital tools have paved the way for utilization of genomic data via easy access and clear clinical interpretation for both doctor and patient. In this review we describe some of these tools and applications for clinical use.

A comprehensive clinical assessment tool to inform policy and practice: applications of the minimum data set.

PubMed

Mor, Vincent

2004-04-01

The Minimum Data Set (MDS) for nursing home (NH) resident assessment, designed to assess elders functional status and care needs, exemplifies how the information needs of clinical practice are congruent with those of research. Building on a review of the published literature, this article describes the development of the MDS, its reliability and validity testing, as well as the variety of different policy and research uses to which it has been applied. Interrater reliability of items and internal consistency of MDS summary scales is generally good to excellent. Validation studies reveal good correspondence to research quality instruments for cognition, activities of daily living, and diagnoses with more variable results for vision, pain, mood, and behavior scales. To date, no consistent evidence suggests that applications of MDS data for case-mix reimbursement and quality indicator monitoring systematically bias the data. Although facility variation in data quality could compromise some applications, creation of the MDS as a clinical tool for care planning provides an example of how assessment tools with clinical use can be used in administrative databases for research and policy applications.

[Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

PubMed

Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

2014-09-01

Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

Engineering growth factors for regenerative medicine applications.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mitchell, Aaron C.; Briquez, Priscilla S.; Hubbell, Jeffrey A.

Growth factors are important morphogenetic proteins that instruct cell behavior and guide tissue repair and renewal. Although their therapeutic potential holds great promise in regenerative medicine applications, translation of growth factors into clinical treatments has been hindered by limitations including poor protein stability, low recombinant expression yield, and suboptimal efficacy. This review highlights current tools, technologies, and approaches to design integrated and effective growth factor-based therapies for regenerative medicine applications. The first section describes rational and combinatorial protein engineering approaches that have been utilized to improve growth factor stability, expression yield, biodistribution, and serum half-life, or alter their cell traffickingmore » behavior or receptor binding affinity. The second section highlights elegant biomaterial-based systems, inspired by the natural extracellular matrix milieu, that have been developed for effective spatial and temporal delivery of growth factors to cell surface receptors. Although appearing distinct, these two approaches are highly complementary and involve principles of molecular design and engineering to be considered in parallel when developing optimal materials for clinical applications.« less

ERPs and Psychopathology. I. Behavioral process issues.

PubMed

Roth, W T; Tecce, J J; Pfefferbaum, A; Rosenbloom, M; Callaway, E

1984-01-01

The clinical study of ERPs has an inherent defect--a self-selection of clinical populations that hampers equating of clinically defined groups on factors extraneous to the independent variables. Such ex post facto studies increase the likelihood of confounding variables in the interpretation of findings. Hence, the development of lawful relationships between clinical variables and ERPs is impeded and the fulfillment of description, explanation, prediction, and control in brain science is thwarted. Proper methodologies and theory development can increase the likelihood of establishing these lawful relationships. One methodology of potential value in the clinical application of ERPs, particularly in studies of aging, is that of divided attention. Two promising theoretical developments in the understanding of brain functioning and aging are the distraction-arousal hypothesis and the controlled-automatic attention model. The evaluation of ERPs in the study of brain-behavior relations in clinical populations might be facilitated by the differentiation of concurrent, predictive, content, and construct validities.

The VEPSY UPDATED Project: clinical rationale and technical approach.

PubMed

Riva, G; Alcãniz, M; Anolli, L; Bacchetta, M; Baños, R; Buselli, C; Beltrame, F; Botella, C; Castelnuovo, G; Cesa, G; Conti, S; Galimberti, C; Gamberini, L; Gaggioli, A; Klinger, E; Legeron, P; Mantovani, F; Mantovani, G; Molinari, E; Optale, G; Ricciardiello, L; Perpiñá, C; Roy, S; Spagnolli, A; Troiani, R; Weddle, C

2003-08-01

More than 10 years ago, Tart (1990) described virtual reality (VR) as a technological model of consciousness offering intriguing possibilities for developing diagnostic, inductive, psychotherapeutic, and training techniques that can extend and supplement current ones. To exploit and understand this potential is the overall goal of the "Telemedicine and Portable Virtual Environment in Clinical Psychology"--VEPSY UPDATED--a European Community-funded research project (IST-2000-25323, www.cybertherapy.info). Particularly, its specific goal is the development of different PC-based virtual reality modules to be used in clinical assessment and treatment of social phobia, panic disorders, male sexual disorders, obesity, and eating disorders. The paper describes the clinical and technical rationale behind the clinical applications developed by the project. Moreover, the paper focuses its analysis on the possible role of VR in clinical psychology and how it can be used for therapeutic change.

Drug safety assurance through clinical genotyping: near-term considerations for a system-wide implementation of personalized medicine.

PubMed

Kane, Michael D; Springer, John A; Sprague, Jon E

2008-07-01

The rationale and overall system-wide behavior of a clinical genotyping information system (both DNA analysis and data management) requires a near-term, scalable approach, which is emerging in the focused implementation of pharmacogenomics and drug safety assurance. The challenges to implementing a successful clinical genotyping system are described, as are how the benefits of a focused, near-term system for drug safety assessment and assurance overcome the logistical and operational challenges that perpetually hinder the development of a societal-scale clinical genotyping system. This rationale is based on the premise that a focused application domain for clinical genotyping, specifically drug safety assurance, provides a transition paradigm for both professionals and consumers of healthcare, thereby facilitating the movement of genotyping from bench to bedside and paving the way for the adoption of prognostic and diagnostic applications in clinical genomics.

Clinical dental application of Er:YAG laser for Class V cavity preparation.

PubMed

Matsumoto, K; Nakamura, Y; Mazeki, K; Kimura, Y

1996-06-01

Following the development of the ruby laser by Maiman in 1960, the Nd:YAG laser, the CO2 laser, the semiconductor laser, the He-Ne laser, excimer lasers, the argon laser, and finally the Er:YAG laser capable of cutting hard tissue easily were developed and have come to be applied clinically. In the present study, the Er:YAG laser emitting at a wavelength of 2.94 microns developed by Luxar was used for the clinical preparation of class V cavities. Parameters of 8 Hz and approx. 250 mJ/pulse maximum output were used for irradiation. Sixty teeth of 40 patients were used in this clinical study. The Er:YAG laser used in this study was found to be a system suitable for clinical application. No adverse reaction was observed in any of the cases. Class V cavity preparation was performed without inducing any pain in 48/60 cases (80%). All of the 12 cases that complained of mild or severe intraoperative pain had previously complained of cervical dentin hypersensibility during the preoperative examination. Cavity preparation was completed with this laser system in 58/60 cases (91.7%). No treatment-related clinical problems were observed during the follow-up period of approx. 30 days after cavity preparation and resin filling. Cavity preparation took between approx. 10 sec and 3 min and was related more or less to cavity size and depth. Overall clinical evaluation showed no safety problem with very good rating in 49 cases (81.7%).

Remote magnetic actuation using a clinical scale system

PubMed Central

Stehning, Christian; Gleich, Bernhard

2018-01-01

Remote magnetic manipulation is a powerful technique for controlling devices inside the human body. It enables actuation and locomotion of tethered and untethered objects without the need for a local power supply. In clinical applications, it is used for active steering of catheters in medical interventions such as cardiac ablation for arrhythmia treatment and for steering of camera pills in the gastro-intestinal tract for diagnostic video acquisition. For these applications, specialized clinical-scale field applicators have been developed, which are rather limited in terms of field strength and flexibility of field application. For a general-purpose field applicator, flexible field generation is required at high field strengths as well as high field gradients to enable the generation of both torques and forces on magnetic devices. To date, this requirement has only been met by small-scale experimental systems. We have built a highly versatile clinical-scale field applicator that enables the generation of strong magnetic fields as well as strong field gradients over a large workspace. We demonstrate the capabilities of this coil-based system by remote steering of magnetic drills through gel and tissue samples with high torques on well-defined curved trajectories. We also give initial proof that, when equipped with high frequency transmit-receive coils, the machine is capable of real-time magnetic particle imaging while retaining a clinical-scale bore size. Our findings open the door for image-guided radiation-free remote magnetic control of devices at the clinical scale, which may be useful in minimally invasive diagnostic and therapeutic medical interventions. PMID:29494647

Motor Rehabilitation Using Kinect: A Systematic Review.

PubMed

Da Gama, Alana; Fallavollita, Pascal; Teichrieb, Veronica; Navab, Nassir

2015-04-01

Interactive systems are being developed with the intention to help in the engagement of patients on various therapies. Amid the recent technological advances, Kinect™ from Microsoft (Redmond, WA) has helped pave the way on how user interaction technology facilitates and complements many clinical applications. In order to examine the actual status of Kinect developments for rehabilitation, this article presents a systematic review of articles that involve interactive, evaluative, and technical advances related to motor rehabilitation. Systematic research was performed in the IEEE Xplore and PubMed databases using the key word combination "Kinect AND rehabilitation" with the following inclusion criteria: (1) English language, (2) page number >4, (3) Kinect system for assistive interaction or clinical evaluation, or (4) Kinect system for improvement or evaluation of the sensor tracking or movement recognition. Quality assessment was performed by QualSyst standards. In total, 109 articles were found in the database research, from which 31 were included in the review: 13 were focused on the development of assistive systems for rehabilitation, 3 in evaluation, 3 in the applicability category, 7 on validation of Kinect anatomic and clinical evaluation, and 5 on improvement techniques. Quality analysis of all included articles is also presented with their respective QualSyst checklist scores. Research and development possibilities and future works with the Kinect for rehabilitation application are extensive. Methodological improvements when performing studies on this area need to be further investigated.

A hospital-wide clinical findings dictionary based on an extension of the International Classification of Diseases (ICD).

PubMed

Bréant, C; Borst, F; Campi, D; Griesser, V; Momjian, S

1999-01-01

The use of a controlled vocabulary set in a hospital-wide clinical information system is of crucial importance for many departmental database systems to communicate and exchange information. In the absence of an internationally recognized clinical controlled vocabulary set, a new extension of the International statistical Classification of Diseases (ICD) is proposed. It expands the scope of the standard ICD beyond diagnosis and procedures to clinical terminology. In addition, the common Clinical Findings Dictionary (CFD) further records the definition of clinical entities. The construction of the vocabulary set and the CFD is incremental and manual. Tools have been implemented to facilitate the tasks of defining/maintaining/publishing dictionary versions. The design of database applications in the integrated clinical information system is driven by the CFD which is part of the Medical Questionnaire Designer tool. Several integrated clinical database applications in the field of diabetes and neuro-surgery have been developed at the HUG.

A hospital-wide clinical findings dictionary based on an extension of the International Classification of Diseases (ICD).

PubMed Central

Bréant, C.; Borst, F.; Campi, D.; Griesser, V.; Momjian, S.

1999-01-01

The use of a controlled vocabulary set in a hospital-wide clinical information system is of crucial importance for many departmental database systems to communicate and exchange information. In the absence of an internationally recognized clinical controlled vocabulary set, a new extension of the International statistical Classification of Diseases (ICD) is proposed. It expands the scope of the standard ICD beyond diagnosis and procedures to clinical terminology. In addition, the common Clinical Findings Dictionary (CFD) further records the definition of clinical entities. The construction of the vocabulary set and the CFD is incremental and manual. Tools have been implemented to facilitate the tasks of defining/maintaining/publishing dictionary versions. The design of database applications in the integrated clinical information system is driven by the CFD which is part of the Medical Questionnaire Designer tool. Several integrated clinical database applications in the field of diabetes and neuro-surgery have been developed at the HUG. Images Figure 1 PMID:10566451

Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project.

PubMed

Thangaratinam, Shakila; Barnfield, Gemma; Weinbrenner, Susanne; Meyerrose, Berit; Arvanitis, Theodoros N; Horvath, Andrea R; Zanrei, Gianni; Kunz, Regina; Suter, Katja; Walczak, Jacek; Kaleta, Anna; Oude Rengerink, Katrien; Gee, Harry; Mol, Ben W J; Khan, Khalid S

2009-09-10

Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education.

Teaching trainers to incorporate evidence-based medicine (EBM) teaching in clinical practice: the EU-EBM project

PubMed Central

Thangaratinam, Shakila; Barnfield, Gemma; Weinbrenner, Susanne; Meyerrose, Berit; Arvanitis, Theodoros N; Horvath, Andrea R; Zanrei, Gianni; Kunz, Regina; Suter, Katja; Walczak, Jacek; Kaleta, Anna; Rengerink, Katrien Oude; Gee, Harry; Mol, Ben WJ; Khan, Khalid S

2009-01-01

Background Evidence based medicine (EBM) is considered an integral part of medical training, but integration of teaching various EBM steps in everyday clinical practice is uncommon. Currently EBM is predominantly taught through theoretical courses, workshops and e-learning. However, clinical teachers lack confidence in teaching EBM in workplace and are often unsure of the existing opportunities for teaching EBM in the clinical setting. There is a need for continuing professional development (CPD) courses that train clinical trainers to teach EBM through on-the-job training by demonstration of applied EBM real time in clinical practice. We developed such a course to encourage clinically relevant teaching of EBM in post-graduate education in various clinical environments. Methods We devised an e-learning course targeting trainers with EBM knowledge to impart educational methods needed to teach application of EBM teaching in commonly used clinical settings. The curriculum development group comprised experienced EBM teachers, clinical epidemiologists, clinicians and educationalists from institutions in seven European countries. The e-learning sessions were designed to allow participants (teachers) to undertake the course in the workplace during short breaks within clinical activities. An independent European steering committee provided input into the process. Results The curriculum defined specific learning objectives for teaching EBM by exploiting educational opportunities in six different clinical settings. The e-modules incorporated video clips that demonstrate practical and effective methods of EBM teaching in everyday clinical practice. The course encouraged focussed teaching activities embedded within a trainer's personal learning plan and documentation in a CPD portfolio for reflection. Conclusion This curriculum will help senior clinicians to identify and make the best use of available opportunities in everyday practice in clinical situations to teach various steps of EBM and demonstrate their applicability to clinical practice. Once fully implemented, the ultimate outcome of this pilot project will be a European qualification in teaching EBM, which will be used by doctors, hospitals, professional bodies responsible for postgraduate qualifications and continuing medical education. PMID:19744327

Lost in translation: neuropsychiatric drug development.

PubMed

Becker, Robert E; Greig, Nigel H

2010-12-08

Recent studies have identified troubling method and practice lapses in neuropsychiatric drug developments. These problems have resulted in errors that are of sufficient magnitude to invalidate clinical trial data and interpretations. We identify two potential sources for these difficulties: investigators selectively choosing scientific practices for demonstrations of efficacy in human-testing phases of drug development and investigators failing to anticipate the needs of practitioners who must optimize treatment for the individual patient. When clinical investigators neglect to use clinical trials as opportunities to test hypotheses of disease mechanisms in humans, the neuropsychiatric knowledge base loses both credibility and scope. When clinical investigators do not anticipate the need to translate discoveries into applications, the practitioner cannot provide optimal care for the patient. We conclude from this evidence that clinical trials, and other aspects of neuropsychiatric drug development, must adopt more practices from basic science and show greater responsiveness to conditions of clinical practice. We feel that these changes are necessary to overcome current threats to the validity and utility of studies of neurological and psychiatric drugs.

Multi-scale Modeling of the Cardiovascular System: Disease Development, Progression, and Clinical Intervention.

PubMed

Zhang, Yanhang; Barocas, Victor H; Berceli, Scott A; Clancy, Colleen E; Eckmann, David M; Garbey, Marc; Kassab, Ghassan S; Lochner, Donna R; McCulloch, Andrew D; Tran-Son-Tay, Roger; Trayanova, Natalia A

2016-09-01

Cardiovascular diseases (CVDs) are the leading cause of death in the western world. With the current development of clinical diagnostics to more accurately measure the extent and specifics of CVDs, a laudable goal is a better understanding of the structure-function relation in the cardiovascular system. Much of this fundamental understanding comes from the development and study of models that integrate biology, medicine, imaging, and biomechanics. Information from these models provides guidance for developing diagnostics, and implementation of these diagnostics to the clinical setting, in turn, provides data for refining the models. In this review, we introduce multi-scale and multi-physical models for understanding disease development, progression, and designing clinical interventions. We begin with multi-scale models of cardiac electrophysiology and mechanics for diagnosis, clinical decision support, personalized and precision medicine in cardiology with examples in arrhythmia and heart failure. We then introduce computational models of vasculature mechanics and associated mechanical forces for understanding vascular disease progression, designing clinical interventions, and elucidating mechanisms that underlie diverse vascular conditions. We conclude with a discussion of barriers that must be overcome to provide enhanced insights, predictions, and decisions in pre-clinical and clinical applications.

Development and validation of an instrument to measure nurse educator perceived confidence in clinical teaching.

PubMed

Nguyen, Van N B; Forbes, Helen; Mohebbi, Mohammadreza; Duke, Maxine

2017-12-01

Teaching nursing in clinical environments is considered complex and multi-faceted. Little is known about the role of the clinical nurse educator, specifically the challenges related to transition from clinician, or in some cases, from newly-graduated nurse to that of clinical nurse educator, as occurs in developing countries. Confidence in the clinical educator role has been associated with successful transition and the development of role competence. There is currently no valid and reliable instrument to measure clinical nurse educator confidence. This study was conducted to develop and psychometrically test an instrument to measure perceived confidence among clinical nurse educators. A multi-phase, multi-setting survey design was used. A total of 468 surveys were distributed, and 363 were returned. Data were analyzed using exploratory and confirmatory factor analyses. The instrument was successfully tested and modified in phase 1, and factorial validity was subsequently confirmed in phase 2. There was strong evidence of internal consistency, reliability, content, and convergent validity of the Clinical Nurse Educator Skill Acquisition Assessment instrument. The resulting instrument is applicable in similar contexts due to its rigorous development and validation process. © 2017 The Authors. Nursing & Health Sciences published by John Wiley & Sons Australia, Ltd.

Multi-scale Modeling of the Cardiovascular System: Disease Development, Progression, and Clinical Intervention

PubMed Central

Zhang, Yanhang; Barocas, Victor H.; Berceli, Scott A.; Clancy, Colleen E.; Eckmann, David M.; Garbey, Marc; Kassab, Ghassan S.; Lochner, Donna R.; McCulloch, Andrew D.; Tran-Son-Tay, Roger; Trayanova, Natalia A.

2016-01-01

Cardiovascular diseases (CVDs) are the leading cause of death in the western world. With the current development of clinical diagnostics to more accurately measure the extent and specifics of CVDs, a laudable goal is a better understanding of the structure-function relation in the cardiovascular system. Much of this fundamental understanding comes from the development and study of models that integrate biology, medicine, imaging, and biomechanics. Information from these models provides guidance for developing diagnostics, and implementation of these diagnostics to the clinical setting, in turn, provides data for refining the models. In this review, we introduce multi-scale and multi-physical models for understanding disease development, progression, and designing clinical interventions. We begin with multi-scale models of cardiac electrophysiology and mechanics for diagnosis, clinical decision support, personalized and precision medicine in cardiology with examples in arrhythmia and heart failure. We then introduce computational models of vasculature mechanics and associated mechanical forces for understanding vascular disease progression, designing clinical interventions, and elucidating mechanisms that underlie diverse vascular conditions. We conclude with a discussion of barriers that must be overcome to provide enhanced insights, predictions, and decisions in pre-clinical and clinical applications. PMID:27138523

[Research Progress of CircRNA and Its Application Prospect in Forensic Medicine].

PubMed

Tu, C Y; Jin, K D; Shao, C C; Liu, B N; Zhang, Y Q; Xie, J H; Shen, Y W

2018-02-01

Circular RNA （circRNA） is a type of noncoding RNA with tissue specificity and high stability, which forms a closed continuous loop and is abundantly expressed in tissue cells. According to recent research, the regulatory function of circRNA elucidating in the occurrence and development of disease shows a potential for diagnosing clinical disease and revealing disease mechanism. This paper reviews the biological characteristics, analysis methods of circRNA and its research progress in clinical application as biomarker, and outlooks its application in the field of forensic medicine. Copyright© by the Editorial Department of Journal of Forensic Medicine.

From POEM to POET: Applications and perspectives for submucosal tunnel endoscopy.

PubMed

Chiu, Philip W Y; Inoue, Haruhiro; Rösch, Thomas

2016-12-01

Recent advances in submucosal endoscopy have unlocked a new horizon for potential development in diagnostic and therapeutic endoscopy. Increasing evidence has demonstrated that peroral endoscopic myotomy (POEM) is not only clinically feasible and safe, but also has excellent results in symptomatic relief of achalasia. The success of submucosal endoscopy in performance of tumor resection has confirmed the potential of this new area in diagnostic and therapeutic endoscopy. This article reviews the current applications and evidence, from POEM to peroral endoscopic tunnel resection (POET), while exploring the possible future clinical applications in this field. © Georg Thieme Verlag KG Stuttgart · New York.

Advances in dental veneers: materials, applications, and techniques

PubMed Central

Pini, Núbia Pavesi; Aguiar, Flávio Henrique Baggio; Lima, Débora Alves Nunes Leite; Lovadino, José Roberto; Terada, Raquel Sano Suga; Pascotto, Renata Corrêa

2012-01-01

Laminate veneers are a conservative treatment of unaesthetic anterior teeth. The continued development of dental ceramics offers clinicians many options for creating highly aesthetic and functional porcelain veneers. This evolution of materials, ceramics, and adhesive systems permits improvement of the aesthetic of the smile and the self-esteem of the patient. Clinicians should understand the latest ceramic materials in order to be able to recommend them and their applications and techniques, and to ensure the success of the clinical case. The current literature was reviewed to search for the most important parameters determining the long-term success, correct application, and clinical limitations of porcelain veneers. PMID:23674920

Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

PubMed

Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

2010-01-01

The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

Objective Assessment of Joint Stiffness: A Clinically Oriented Hardware and Software Device with an Application to the Shoulder Joint.

PubMed

McQuade, Kevin; Price, Robert; Liu, Nelson; Ciol, Marcia A

2012-08-30

Examination of articular joints is largely based on subjective assessment of the "end-feel" of the joint in response to manually applied forces at different joint orientations. This technical report aims to describe the development of an objective method to examine joints in general, with specific application to the shoulder, and suitable for clinical use. We adapted existing hardware and developed laptop-based software to objectively record the force/displacement behavior of the glenohumeral joint during three common manual joint examination tests with the arm in six positions. An electromagnetic tracking system recorded three-dimensional positions of sensors attached to a clinician examiner and a patient. A hand-held force transducer recorded manually applied translational forces. The force and joint displacement were time-synchronized and the joint stiffness was calculated as a quantitative representation of the joint "end-feel." A methodology and specific system checks were developed to enhance clinical testing reproducibility and precision. The device and testing protocol were tested on 31 subjects (15 with healthy shoulders, and 16 with a variety of shoulder impairments). Results describe the stiffness responses, and demonstrate the feasibility of using the device and methods in clinical settings.

An evidence-based guide to clinical instruction in audiology.

PubMed

Mormer, Elaine; Palmer, Catherine; Messick, Cheryl; Jorgensen, Lindsey

2013-05-01

A significant portion of the AuD curriculum occurs in clinical settings outside the classroom. Expert clinicians, employed within and outside of the university, are called upon to provide this clinical education. Most have had little or no formal training in clinical teaching yet face pedagogical and logistical challenges when simultaneously providing clinical service and teaching. Training to provide optimal methods and approaches to clinical instruction should be based on research evidence; however, there is a paucity of research in this area within the audiology discipline. This article provides a review of literature supplying evidence for important concepts, elements, and approaches to the clinical instruction process. Additionally, we provide readers with some practical tools with which to facilitate application of optimal clinical teaching principles. We conducted a systematic review of literature on clinical education in audiology and across a wide array of health professions. Through the use of content analysis we identified four elements of the clinical teaching process most critical in examining optimal practices. The elements identified as critical to positive clinical learning outcomes include the establishment of mutual expectations and goals; structured content and delivery of feedback; establishment of a positive instructor/student relationship; and questioning strategies that lead to the development of critical thinking skills. Many disciplines outside of audiology demonstrate robust research activity related to understanding and optimizing the clinical education process. The application of a number of evidence-based clinical teaching principles should allow us to improve student outcomes in audiology. Researchers in our field might consider if and how we should develop our own research literature in clinical education. American Academy of Audiology.

Recent Developments in Cellular Immunotherapy for HSCT-Associated Complications

PubMed Central

Reis, Monica; Ogonek, Justyna; Qesari, Marsela; Borges, Nuno M.; Nicholson, Lindsay; Preußner, Liane; Dickinson, Anne Mary; Wang, Xiao-nong; Weissinger, Eva M.; Richter, Anne

2016-01-01

Allogeneic hematopoietic stem cell transplantation is associated with serious complications, and improvement of the overall clinical outcome of patients with hematological malignancies is necessary. During the last decades, posttransplant donor-derived adoptive cellular immunotherapeutic strategies have been progressively developed for the treatment of graft-versus-host disease (GvHD), infectious complications, and tumor relapses. To date, the common challenge of all these cell-based approaches is their implementation for clinical application. Establishing an appropriate manufacturing process, to guarantee safe and effective therapeutics with simultaneous consideration of economic requirements is one of the most critical hurdles. In this review, we will discuss the recent scientific findings, clinical experiences, and technological advances for cell processing toward the application of mesenchymal stromal cells as a therapy for treatment of severe GvHD, virus-specific T cells for targeting life-threating infections, and of chimeric antigen receptors-engineered T cells to treat relapsed leukemia. PMID:27895644

Antimicrobial Peptides: An Emerging Category of Therapeutic Agents.

PubMed

Mahlapuu, Margit; Håkansson, Joakim; Ringstad, Lovisa; Björn, Camilla

2016-01-01

Antimicrobial peptides (AMPs), also known as host defense peptides, are short and generally positively charged peptides found in a wide variety of life forms from microorganisms to humans. Most AMPs have the ability to kill microbial pathogens directly, whereas others act indirectly by modulating the host defense systems. Against a background of rapidly increasing resistance development to conventional antibiotics all over the world, efforts to bring AMPs into clinical use are accelerating. Several AMPs are currently being evaluated in clinical trials as novel anti-infectives, but also as new pharmacological agents to modulate the immune response, promote wound healing, and prevent post-surgical adhesions. In this review, we provide an overview of the biological role, classification, and mode of action of AMPs, discuss the opportunities and challenges to develop these peptides for clinical applications, and review the innovative formulation strategies for application of AMPs.

A CMOS camera-based system for clinical photoplethysmographic applications

NASA Astrophysics Data System (ADS)

Humphreys, Kenneth; Markham, Charles; Ward, Tomas E.

2005-06-01

In this work an image-based photoplethysmography (PPG) system is developed and tested against a conventional finger-based system as commonly used in clinical practise. A PPG is essentially an optical instrument consisting of a near infrared (NIR) source and detector that is capable of tracking blood flow changes in body tissue. When used with a number of wavelengths in the NIR band blood oxygenation changes as well as other blood chemical signatures can be ascertained yielding a very useful device in the clinical realm. Conventionally such a device requires direct contact with the tissue under investigation which eliminates the possibility of its use for applications like wound management where the tissue oxygenation measurement could be extremely useful. To circumnavigate this shortcoming we have developed a CMOS camera-based system, which can successfully extract the PPG signal without contact with the tissue under investigation. A comparison of our results with conventional techniques has yielded excellent results.

Stereoroentgenographic System With Portable Calibration Cage For Use In Clinical Medicine

NASA Astrophysics Data System (ADS)

Moffitt, Francis; Baumrind, Sheldon; Chafetz, Neil; Curry, Sean

1983-07-01

For the past five years, we have been accumulating information on the performance of a stereoroentgenographic system developed for use in clinical medicine and first reported at the NATO Symposium on the Application of Human Biostereometrics. This system represents an adaptation of normal case coplanar stereometry and involves the use of a single emitter which is displaced in a controlled fashion between exposures. The system has been used primarily for the detection of applicance loosening and settling following the placement of total hip protheses and also for the detection of pseudorthosis following lumbo-sacral fusion. One major goal has been the development of a data acquisition and analysis system suitable for general hospital use which can be operated by technicians without specialized photogrammetric training. This report will focus on system design and on the delineation of technical problems encountered during routine clinical use of the system.

Inflection Points in Magnetic Resonance Imaging Technology-35 Years of Collaborative Research and Development.

PubMed

Wood, Michael L; Griswold, Mark A; Henkelman, Mark; Hennig, Jürgen

2015-09-01

The technology for clinical magnetic resonance imaging (MRI) has advanced with remarkable speed and in such a manner reflecting the influence of 3 forces-collaboration between disciplines, collaboration between academia and industry, and the enabling of software applications by hardware. The forces are evident in the key developments from the past and emerging trends for the future highlighted in this review article. These developments are associated with MRI system attributes, such as wider, shorter, and stronger magnets; specialty magnets and hybrid devices; k space; and the notion that magnetic field gradients perform a Fourier transform on the spatial distribution of magnetization, phased-array coils and parallel imaging, the user interface, the wide range of contrast possible, and applications that exploit motion-induced phase shifts. An attempt is made to show connections between these developments and how the 3 forces mentioned previously will continue to shape the technology used so productively in clinical MRI.

Joint Models of Longitudinal and Time-to-Event Data with More Than One Event Time Outcome: A Review.

PubMed

Hickey, Graeme L; Philipson, Pete; Jorgensen, Andrea; Kolamunnage-Dona, Ruwanthi

2018-01-31

Methodological development and clinical application of joint models of longitudinal and time-to-event outcomes have grown substantially over the past two decades. However, much of this research has concentrated on a single longitudinal outcome and a single event time outcome. In clinical and public health research, patients who are followed up over time may often experience multiple, recurrent, or a succession of clinical events. Models that utilise such multivariate event time outcomes are quite valuable in clinical decision-making. We comprehensively review the literature for implementation of joint models involving more than a single event time per subject. We consider the distributional and modelling assumptions, including the association structure, estimation approaches, software implementations, and clinical applications. Research into this area is proving highly promising, but to-date remains in its infancy.

STOPP/START version 2-development of software applications: easier said than done?

PubMed

Anrys, Pauline; Boland, Benoît; Degryse, Jean-Marie; De Lepeleire, Jan; Petrovic, Mirko; Marien, Sophie; Dalleur, Olivia; Strauven, Goedele; Foulon, Veerle; Spinewine, Anne

2016-09-01

Explicit criteria, such as the STOPP/START criteria, are increasingly used both in clinical practice and in research to identify potentially inappropriate prescribing in older people. In an article on the STOPP/START criteria version 2, O'Mahony et al have pointed out the advantages of developing computerised criteria. Both clinical decision support systems to support healthcare professionals and software applications to automatically detect inappropriate prescribing in research studies can be developed. In the process of developing such tools, difficulties may occur. In the context of a research study, we have developed an algorithm to automatically apply STOPP/START criteria version 2 to our research database. We comment in this paper on different kinds of difficulties encountered and make suggestions that could be taken into account when developing the next version of the criteria. © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

New technology continues to invade healthcare. What are the strategic implications/outcomes?

PubMed

Smith, Coy

2004-01-01

Healthcare technology continues to advance and be implemented in healthcare organizations. Nurse executives must strategically evaluate the effectiveness of each proposed system or device using a strategic planning process. Clinical information systems, computer-chip-based clinical monitoring devices, advanced Web-based applications with remote, wireless communication devices, clinical decision support software--all compete for capital and registered nurse salary dollars. The concept of clinical transformation is developed with new models of care delivery being supported by technology rather than driving care delivery. Senior nursing leadership's role in clinical transformation and healthcare technology implementation is developed. Proposed standards, expert group action, business and consumer groups, and legislation are reviewed as strategic drivers in the development of an electronic health record and healthcare technology. A matrix of advancing technology and strategic decision-making parameters are outlined.

BLOODR: blood donor and requester mobile application

PubMed Central

Tatikonda, Vamsi Krishna

2017-01-01

Background With rapid increase in the usage of social networks sites across the world, there is also a steady increase in blood donation requests as being noticed in the number of posts on these sites such as Facebook and twitter seeking blood donors. Finding blood donor is a challenging issue in almost every country. There are some blood donor finder applications in the market such as Blood app by Red Cross and Blood Donor Finder application by Neologix. However, more reliable applications that meet the needs of users are prompted. Methods Several software technologies including languages and framework are used to develop our blood-donor web application known as BLOODR application. These technologies comprise Ruby programming language (simply known as Ruby) along with JavaScript and PostgreSQL for database are used. Ruby on Rails (simply known as Rails) is an open source Web framework that makes it possible to quickly and easily create data-based web applications. Results We show screenshots for the BLOODR application for different types of users including requester, donor, and administrator. Various features of the application are described and their needs of use are analyzed. If a patient needs a blood at a clinic, blood donors in vicinity can be contacted through using a clinic management service provided in this application. Registered donors will get notification for the blood requests only if their blood group is compatible with the requested blood type and in the same city/region. Then matching blood donors can go to the requesting clinic and donate. Conclusions BLOODR application provides a reliable platform to connect local blood donors with patients. BLOODR creates a communication channel through authenticated clinics whenever a patient needs blood donation. It is a useful tool to find compatible blood donors who can receive blood request posts in their local area. Clinics can use this web application to maintain the blood donation activity. Future improvement of the BLOODR is explained. PMID:29184892

BLOODR: blood donor and requester mobile application.

PubMed

Tatikonda, Vamsi Krishna; El-Ocla, Hosam

2017-01-01

With rapid increase in the usage of social networks sites across the world, there is also a steady increase in blood donation requests as being noticed in the number of posts on these sites such as Facebook and twitter seeking blood donors. Finding blood donor is a challenging issue in almost every country. There are some blood donor finder applications in the market such as Blood app by Red Cross and Blood Donor Finder application by Neologix. However, more reliable applications that meet the needs of users are prompted. Several software technologies including languages and framework are used to develop our blood-donor web application known as BLOODR application. These technologies comprise Ruby programming language (simply known as Ruby) along with JavaScript and PostgreSQL for database are used. Ruby on Rails (simply known as Rails) is an open source Web framework that makes it possible to quickly and easily create data-based web applications. We show screenshots for the BLOODR application for different types of users including requester, donor, and administrator. Various features of the application are described and their needs of use are analyzed. If a patient needs a blood at a clinic, blood donors in vicinity can be contacted through using a clinic management service provided in this application. Registered donors will get notification for the blood requests only if their blood group is compatible with the requested blood type and in the same city/region. Then matching blood donors can go to the requesting clinic and donate. BLOODR application provides a reliable platform to connect local blood donors with patients. BLOODR creates a communication channel through authenticated clinics whenever a patient needs blood donation. It is a useful tool to find compatible blood donors who can receive blood request posts in their local area. Clinics can use this web application to maintain the blood donation activity. Future improvement of the BLOODR is explained.

Developing a clinically viable angle-resolved low coherence interferometry optical biopsy system

NASA Astrophysics Data System (ADS)

Pyhtila, John W.

2007-12-01

Non-invasive optical biopsy techniques, which interrogate tissue in situ, offer a potential method to improve the detection of dysplasia, a pre-cancerous tissue state. Specifically, monitoring of Barrett's esophagus (BE) patients for dysplasia, currently done through systematic biopsy, can be improved by increasing the proportion of at-risk tissue examined. Angle-resolved low coherence interferometry (a/LCI) is an optical spectroscopic technique which measures the depth resolved nuclear morphology of tissue, a key biomarker for identifying dysplasia. Using an animal carcinogenesis model, it was shown that a/LCI can detect dysplasia with great sensitivity and specificity. However, for the clinical application of a/LCI, numerous hurdles must be overcome. This dissertation presents the development of three new a/LCI systems which incrementally address the three main obstacles preventing the clinical application of a/LCI. First, data acquisition time is reduced by implementing a frequency-domain detection scheme using an imaging spectrograph that collects the complete depth resolved angular scattering distribution in parallel. This advance reduces data collection time to a clinically acceptable 40 ms. Second, a fiber probe is developed to enable the endoscopic application of a/LCI. The probe incorporates a single fiber for delivering light and a coherent fiber bundle for collecting the angular distribution of scattered light. Third, a portable device is created through miniaturization of the optical design, and a flexible fiber probe is created using polarization maintaining fiber to deliver the light. These advances allow for the clinical application of the system to ex vivo human tissue samples. The performance of each described system is evaluated through a number of validation studies, including the sizing of polystyrene microspheres, a typical model used in light scattering studies, and the measurement of in vitro cell nuclear diameters, accomplished with sub-wavelength precision and accuracy. The culmination of this work is the first human study using a/LCI in which it is demonstrated that a/LCI depth resolved nuclear morphology measurements provide an excellent means to identify dysplasia in BE patients. The described results demonstrate the great potential for the in vivo application of a/LCI as a targeting mechanism for the detection of dysplasia in Barrett's esophagus patients.

Myocardial T2* Mapping at Ultrahigh Field: Physics and Frontier Applications

NASA Astrophysics Data System (ADS)

Huelnhagen, Till; Paul, Katharina; Ku, Min-Chi; Serradas Duarte, Teresa; Niendorf, Thoralf

2017-06-01

Cardiovascular magnetic resonance imaging (CMR) has become an indispensable clinical tool for the assessment of morphology, function and structure of the heart muscle. By exploiting quantification of the effective transverse relaxation time (T2*) CMR also affords myocardial tissue characterization and probing of cardiac physiology, both being in the focus of ongoing research. These developments are fueled by the move to ultrahigh magnetic field strengths, which permits enhanced sensitivity and spatial resolution that help to overcome limitations of current clinical MR systems with the goal to contribute to a better understanding of myocardial (patho)physiology in vivo. In this context, the aim of this report is to introduce myocardial T2* mapping at ultrahigh magnetic fields as a promising technique to non-invasively assess myocardial (patho)physiology. For this purpose the basic principles of T2* assessment, the biophysical mechanisms determining T2* and (pre)clinical applications of myocardial T2* mapping are presented. Technological challenges and solutions for T2* sensitized CMR at ultrahigh magnetic field strengths are discussed followed by a review of acquisition techniques and post processing approaches. Preliminary results derived from myocardial T2* mapping in healthy subjects and cardiac patients at 7.0 Tesla are presented. A concluding section discusses remaining questions and challenges and provides an outlook on future developments and potential clinical applications.

Selected options supporting use of the group embedded figures test in modeling achievement in clinical laboratory science programs.

PubMed

Powell, M E

1995-01-01

To identify, in light of predicted future shortages of allied-health personnel, student and curricular characteristics of clinical laboratory science (CLS) programs relevant to recruitment and retention at the baccalaureate level. Not applicable. Not applicable. Options for modeling achievement in CLS programs are developed, and designs and procedures for clarifying procedural questions are considered in a context of delivery of instruction for specialized curricula and skill development. Considerable attention is given to the potential for using the Group Embedded Figures Test (GEFT) in modeling, advising, designing curricula, and monitoring quality improvement of programs and graduates. Not applicable. Supporting evidence is supplied from the literature for options in developing an appropriate model for examining those salient variables known to have linkages to achievement. An argument is presented for better understanding of antecedent variables affecting achievement and retention of CLS students. In addition, a case is made for development of an appropriate model examining variables identified in the literature as being linked to achievement. Dynamic models based on these considerations should be developed chronologically from entry through graduation with emphasis on growth at year-end milestones.

APPLICATION OF A SIMPLE CIRCULATING MARKER OF OXIDATIVE STRESS FOR CLINICAL AND EPIDEMIOLOGICAL STUDIES

EPA Science Inventory

Biomarker development has improved our ability to detect early changes at the molecular, cellular and pre-clinical level that are often predictive of adverse cancer and non cancer related health outcomes. The role of reactive oxygen species (ROS) is implicated in many disease pr...

A Three-Question Framework to Facilitate Clinical Decision Making

ERIC Educational Resources Information Center

Sibold, Jeremy

2012-01-01

Context: Highly developed critical thinking and the ability to discriminate among many possible therapeutic interventions is a core behavior for the practicing athletic trainer. However, while athletic training students receive a great deal of clinically applicable information, many are not explicitly trained in efficient methods for channeling…

Mobile-Assisted Grammar Exercises: Effects on Self-Editing in L2 Writing

ERIC Educational Resources Information Center

Li, Zhi; Hegelheimer, Volker

2013-01-01

In this paper, we report on the development and implementation of a web-based mobile application, "Grammar Clinic," for an ESL writing class. Drawing on insights from the interactionist approach to Second Language Acquisition (SLA), the Noticing Hypothesis, and mobile-assisted language learning (MALL), "Grammar Clinic" was…

Building a Vita for the Clinical Practice.

ERIC Educational Resources Information Center

Tentoni, Stuart C.

Vita review is used by most prospective employers to determine which applicants will be interviewed for a particular position opening in clinical practice. Most graduate students have little knowledge and no training in this topic, which is vital for professional development. Specific examples of vitae construction are provided for one of the…

HARMONIZATION OF HUMAN AND ECOLOGICAL HEALTH ASSESSMENT: DEVELOPMENT OF BAYESIAN UPDATING TECHNIQUES TO INCORPORATE MECHANISTIC INFORMATION ACROSS SPECIES

EPA Science Inventory

Bayesian statistical techniques have proven useful in clinical and environmental epidemiological applications to evaluate and integrate available information, and in regulatory applications such as the National Ambient Air Quality Assessment for Nitrogen Oxides. A recent special...

The TREAT-NMD advisory committee for therapeutics (TACT): an innovative de-risking model to foster orphan drug development.

PubMed

Heslop, Emma; Csimma, Cristina; Straub, Volker; McCall, John; Nagaraju, Kanneboyina; Wagner, Kathryn R; Caizergues, Didier; Korinthenberg, Rudolf; Flanigan, Kevin M; Kaufmann, Petra; McNeil, Elizabeth; Mendell, Jerry; Hesterlee, Sharon; Wells, Dominic J; Bushby, Kate

2015-04-23

Despite multiple publications on potential therapies for neuromuscular diseases (NMD) in cell and animal models only a handful reach clinical trials. The ability to prioritise drug development according to objective criteria is particularly critical in rare diseases with large unmet needs and a limited numbers of patients who can be enrolled into clinical trials. TREAT-NMD Advisory Committee for Therapeutics (TACT) was established to provide independent and objective guidance on the preclinical and development pathway of potential therapies (whether novel or repurposed) for NMD.We present our experience in the establishment and operation of the TACT. TACT provides a unique resource of recognized experts from multiple disciplines. The goal of each TACT review is to help the sponsor to position the candidate compound along a realistic and well-informed plan to clinical trials, and eventual registration. The reviews and subsequent recommendations are focused on generating meaningful and rigorous data that can enable clear go/no-go decisions and facilitate longer term funding or partnering opportunities. The review process thereby acts to comment on viability, de-risking the process of proceeding on a development programme.To date TACT has held 10 review meeting and reviewed 29 program applications in several rare neuromuscular diseases: Of the 29 programs reviewed, 19 were from industry and 10 were from academia; 15 were for novel compounds and 14 were for repurposed drugs; 16 were small molecules and 13 were biologics; 14 were preclinical stage applications and 15 were clinical stage applications. 3 had received Orphan drug designation from European Medicines Agency and 3 from Food and Drug Administration. A number of recurrent themes emerged over the course of the reviews and we found that applicants frequently require advice and education on issues concerned with preclinical standard operating procedures, interactions with regulatory agencies, formulation, repurposing, clinical trial design, manufacturing and ethics.Over the 5 years since its establishment TACT has amassed a body of experience that can be extrapolated to other groups of rare diseases to improve the community's chances of successfully bringing new rare disease drugs to registration and ultimately to market.

Universal suprapubic approach for complete mesocolic excision and central vascular ligation using the da Vinci Xi® system: from cadaveric models to clinical cases.

PubMed

Yeo, Shen Ann; Noh, Gyoung Tae; Han, Jeong Hee; Cheong, Chinock; Stein, Hubert; Kerdok, Amy; Min, Byung Soh

2017-12-01

There has been little enthusiasm for performing robotic colectomy for colon cancer in recent years due to multiple factors, one being that the previous robotic systems such as the da Vinci Si ® (dVSi) were poorly designed for multi-quadrant surgery. The new da Vinci Xi ® (dVXi) system enables colectomy with central mesocolic excision to be performed easily in a single docking procedure. We developed a universal port placement strategy to allow right and left hemicolectomies to be performed via a suprapubic approach and a Pfannensteil extraction site. This proof of concept paper describes the development and subsequent clinical application of this setup. After extensive training on the dVXi system concepts in collaboration with clinical development engineers, we developed a port placement strategy which was tested and adapted after performing experimental surgery in three cadaveric models. Subsequently our port placement was used for two clinical cases of suprapubic right and left hemicolectomy. With some modifications of port placements after the initial cadaveric colectomies, we have developed a potentially universal suprapubic port placement strategy for robotic colectomy with complete mesocolic excision and central vascular ligation using the dVXi robotic system. This port placement strategy was applied successfully in our first two clinical cases. Based on our cadaveric laboratory as well as our initial clinical application, the suprapubic port placement strategy for the dVXi system with its improved features over the dVSi can feasibly perform right and left hemicolectomy with complete mesocolic excision and central vascular ligation. Further studies will be required to establish efficacy as well as safety profile of these procedures.

[The application of universal adhesives in dental bonding].

PubMed

Guo, Jingmei; Lei, Wenlong; Yang, Hongye; Huang, Cui

2016-03-01

The bonding restoration has become an important clinical technique for the development of dental bonding technology. Because of its easy operation and the maximum preservation of tooth tissues, bonding repair is widely used in dental restoration. The recent multi-mode universal adhesives have brought new progress in dental bonding restoration. In this article the universal adhesives were reviewed according to its definition, development, improvement, application features and possible problems.

Applying a soft-robotic glove as assistive device and training tool with games to support hand function after stroke: Preliminary results on feasibility and potential clinical impact.

PubMed

Prange-Lasonder, Gerdienke B; Radder, Bob; Kottink, Anke I R; Melendez-Calderon, Alejandro; Buurke, Jaap H; Rietman, Johan S

2017-07-01

Recent technological developments regarding wearable soft-robotic devices extend beyond the current application of rehabilitation robotics and enable unobtrusive support of the arms and hands during daily activities. In this light, the HandinMind (HiM) system was developed, comprising a soft-robotic, grip supporting glove with an added computer gaming environment. The present study aims to gain first insight into the feasibility of clinical application of the HiM system and its potential impact. In order to do so, both the direct influence of the HiM system on hand function as assistive device and its therapeutic potential, of either assistive or therapeutic use, were explored. A pilot randomized clinical trial was combined with a cross-sectional measurement (comparing performance with and without glove) at baseline in 5 chronic stroke patients, to investigate both the direct assistive and potential therapeutic effects of the HiM system. Extended use of the soft-robotic glove as assistive device at home or with dedicated gaming exercises in a clinical setting was applicable and feasible. A positive assistive effect of the soft-robotic glove was proposed for pinch strength and functional task performance 'lifting full cans' in most of the five participants. A potential therapeutic impact was suggested with predominantly improved hand strength in both participants with assistive use, and faster functional task performance in both participants with therapeutic application.

Artificial intelligence: contemporary applications and future compass.

PubMed

Khanna, Sunali

2010-08-01

The clinical use of information technology in the dental profession has increased substantially in the past 10 to 20 years. In most developing countries an insufficiency of medical and dental specialists has increased the mortality of patients suffering from various diseases. Employing technology, especially artificial intelligence technology, in medical and dental application could reduce cost, time, human expertise and medical error. This approach has the potential to revolutionise the dental public health scenario in developing countries. Clinical decision support systems (CDSS) are computer programs that are designed to provide expert support for health professionals. The applications in dental sciences vary from dental emergencies to differential diagnosis of orofacial pain, radiographic interpretations, analysis of facial growth in orthodontia to prosthetic dentistry. However, despite the recognised need for CDSS, the implementation of these systems has been limited and slow. This can be attributed to lack of formal evaluation of the systems, challenges in developing standard representations, cost and practitioner scepticism about the value and feasibility of CDSS. Increasing public awareness of safety and quality has accelerated the adoption of generic knowledge based CDSS. Information technology applications for dental practice continue to develop rapidly and will hopefully contribute to reduce the morbidity and mortality of oral and maxillofacial diseases and in turn impact patient care.

Advancing pig cloning technologies towards application in regenerative medicine.

PubMed

Nagashima, H; Matsunari, H; Nakano, K; Watanabe, M; Umeyama, K; Nagaya, M

2012-08-01

Regenerative medicine is expected to make a significant contribution by development of novel therapeutic treatments for intractable diseases and for improving the quality of life of patients. Many advances in regenerative medicine, including basic and translational research, have been developed and tested in experimental animals; pigs have played an important role in various aspects of this work. The value of pigs as a model species is being enhanced by the generation of specially designed animals through cloning and genetic modifications, enabling more sophisticated research to be performed and thus accelerating the clinical application of regenerative medicine. This article reviews the significant aspects of the creation and application of cloned and genetically modified pigs in regenerative medicine research and considers the possible future directions of the technology. We also discuss the importance of reproductive biology as an interface between basic science and clinical medicine. © 2012 Blackwell Verlag GmbH.

Genome-Editing Technologies in Adoptive T Cell Immunotherapy for Cancer.

PubMed

Singh, Nathan; Shi, Junwei; June, Carl H; Ruella, Marco

2017-12-01

In this review, we discuss the most recent developments in gene-editing technology and discuss their application to adoptive T cell immunotherapy. Engineered T cell therapies targeting cancer antigens have demonstrated significant efficacy in specific patient populations. Most impressively, CD19-directed chimeric antigen receptor T cells (CART19) have led to impressive responses in patients with B-cell leukemia and lymphoma. CTL019, or KYMRIAH™ (tisagenlecleucel), a CD19 CAR T cell product developed by Novartis and the University of Pennsylvania, was recently approved for clinical use by the Food and Drug Administration, representing a landmark in the application of adoptive T cell therapies. As CART19 enters routine clinical use, improving the efficacy of this exciting platform is the next step in broader application. Novel gene-editing technologies like CRISPR-Cas9 allow facile editing of specific genes within the genome, generating a powerful platform to further optimize the activity of engineered T cells.

The IND application.

PubMed

Ferkany, John W; Williams, Michael

2008-09-01

Translational biomedical research is often directed to the introduction of a new drug or biologic intended to treat unmet medical need in humans. This unit describes the timing and content of the investigational new drug (IND) application, the primary document required by the U.S. FDA for the initiation of clinical trials in humans with any new chemical entity (NCE) or biologic. The IND application contains all the information necessary for the FDA to make an assessment of the risks and benefits of the proposed clinical trials for the NCE/biologic, containing a detailed but succinct description of the biology, safety, toxicology, chemistry and manufacturing process, and the proposed clinical plan. This unit is geared for those with little or no experience with the IND process and is intended as a global introduction to this, the initial stage of the drug development process for drugs used in humans.

Gait Analysis Using Wearable Sensors

PubMed Central

Tao, Weijun; Liu, Tao; Zheng, Rencheng; Feng, Hutian

2012-01-01

Gait analysis using wearable sensors is an inexpensive, convenient, and efficient manner of providing useful information for multiple health-related applications. As a clinical tool applied in the rehabilitation and diagnosis of medical conditions and sport activities, gait analysis using wearable sensors shows great prospects. The current paper reviews available wearable sensors and ambulatory gait analysis methods based on the various wearable sensors. After an introduction of the gait phases, the principles and features of wearable sensors used in gait analysis are provided. The gait analysis methods based on wearable sensors is divided into gait kinematics, gait kinetics, and electromyography. Studies on the current methods are reviewed, and applications in sports, rehabilitation, and clinical diagnosis are summarized separately. With the development of sensor technology and the analysis method, gait analysis using wearable sensors is expected to play an increasingly important role in clinical applications. PMID:22438763

Mass spectrometry for the detection of bioterrorism agents: from environmental to clinical applications.

PubMed

Duriez, Elodie; Armengaud, Jean; Fenaille, François; Ezan, Eric

2016-03-01

In the current context of international conflicts and localized terrorist actions, there is unfortunately a permanent threat of attacks with unconventional warfare agents. Among these, biological agents such as toxins, microorganisms, and viruses deserve particular attention owing to their ease of production and dissemination. Mass spectrometry (MS)-based techniques for the detection and quantification of biological agents have a decisive role to play for countermeasures in a scenario of biological attacks. The application of MS to every field of both organic and macromolecular species has in recent years been revolutionized by the development of soft ionization techniques (MALDI and ESI), and by the continuous development of MS technologies (high resolution, accurate mass HR/AM instruments, novel analyzers, hybrid configurations). New possibilities have emerged for exquisite specific and sensitive detection of biological warfare agents. MS-based strategies for clinical application can now address a wide range of analytical questions mainly including issues related to the complexity of biological samples and their available volume. Multiplexed toxin detection, discovery of new markers through omics approaches, and identification of untargeted microbiological or of novel molecular targets are examples of applications. In this paper, we will present these technological advances along with the novel perspectives offered by omics approaches to clinical detection and follow-up. Copyright © 2016 John Wiley & Sons, Ltd.

The clinical application of genome-wide sequencing for monogenic diseases in Canada: Position Statement of the Canadian College of Medical Geneticists.

PubMed

Boycott, Kym; Hartley, Taila; Adam, Shelin; Bernier, Francois; Chong, Karen; Fernandez, Bridget A; Friedman, Jan M; Geraghty, Michael T; Hume, Stacey; Knoppers, Bartha M; Laberge, Anne-Marie; Majewski, Jacek; Mendoza-Londono, Roberto; Meyn, M Stephen; Michaud, Jacques L; Nelson, Tanya N; Richer, Julie; Sadikovic, Bekim; Skidmore, David L; Stockley, Tracy; Taylor, Sherry; van Karnebeek, Clara; Zawati, Ma'n H; Lauzon, Julie; Armour, Christine M

2015-07-01

The aim of this Position Statement is to provide recommendations for Canadian medical geneticists, clinical laboratory geneticists, genetic counsellors and other physicians regarding the use of genome-wide sequencing of germline DNA in the context of clinical genetic diagnosis. This statement has been developed to facilitate the clinical translation and development of best practices for clinical genome-wide sequencing for genetic diagnosis of monogenic diseases in Canada; it does not address the clinical application of this technology in other fields such as molecular investigation of cancer or for population screening of healthy individuals. Two multidisciplinary groups consisting of medical geneticists, clinical laboratory geneticists, genetic counsellors, ethicists, lawyers and genetic researchers were assembled to review existing literature and guidelines on genome-wide sequencing for clinical genetic diagnosis in the context of monogenic diseases, and to make recommendations relevant to the Canadian context. The statement was circulated for comment to the Canadian College of Medical Geneticists (CCMG) membership-at-large and, following incorporation of feedback, approved by the CCMG Board of Directors. The CCMG is a Canadian organisation responsible for certifying medical geneticists and clinical laboratory geneticists, and for establishing professional and ethical standards for clinical genetics services in Canada. Recommendations include (1) clinical genome-wide sequencing is an appropriate approach in the diagnostic assessment of a patient for whom there is suspicion of a significant monogenic disease that is associated with a high degree of genetic heterogeneity, or where specific genetic tests have failed to provide a diagnosis; (2) until the benefits of reporting incidental findings are established, we do not endorse the intentional clinical analysis of disease-associated genes other than those linked to the primary indication; and (3) clinicians should provide genetic counselling and obtain informed consent prior to undertaking clinical genome-wide sequencing. Counselling should include discussion of the limitations of testing, likelihood and implications of diagnosis and incidental findings, and the potential need for further analysis to facilitate clinical interpretation, including studies performed in a research setting. These recommendations will be routinely re-evaluated as knowledge of diagnostic and clinical utility of clinical genome-wide sequencing improves. While the document was developed to direct practice in Canada, the applicability of the statement is broader and will be of interest to clinicians and health jurisdictions internationally. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

White Paper: Interventional MRI: Current Status and Potential for Development Considering Economic Perspectives, Part 1: General Application.

PubMed

Barkhausen, Jörg; Kahn, Thomas; Krombach, Gabriele A; Kuhl, Christiane K; Lotz, Joachim; Maintz, David; Ricke, Jens; Schönberg, Stefan O; Vogl, Thomas J; Wacker, Frank K

2017-07-01

Background  MRI is attractive for the guiding and monitoring of interventional procedures due to its high intrinsic soft tissue contrast and the possibility to measure physiologic parameters like flow and cardiac function. Method  The current status of interventional MRI for the clinical routine was analyzed. Results  The effort needed for the development of MR-safe monitoring systems and instruments initially resulted in the application of interventional MRI only for procedures that could not be performed by other means. Accordingly, biopsy of lesions in the breast, which are not detectable by other modalities, has been performed under MRI guidance for decades. Currently, biopsies of the prostate under MRI guidance are established in a similar fashion. At many sites blind biopsy has already been replaced by MR-guided biopsy or at least by the fusion of MR images with ultrasound. Cardiovascular interventions are performed at several centers for ablation as a treatment for atrial fibrillation. Conclusion  Interventional MRI has been established in the clinical routine for a variety of indications. Broader application can be expected in the clinical routine in the future owing to the multiple advantages compared to other techniques. Key points   · Due to the significant technical effort, MR-guided interventions are only recommended in the long term for regions in which MRI either facilitates or greatly improves the intervention.. · Breast biopsy of otherwise undetectable target lesions has long been established in the clinical routine. Prostate biopsy is currently being introduced in the clinical routine for similar reasons. Other methods such as MR-guided focused ultrasound for the treatment of uterine fibroids or tumor ablation of metastases represent alternative methods and are offered in many places.. · Endovascular MR-guided interventions offer advantages for a number of indications and have already been clinically established for the treatment of children with congenital heart defects and for atrial ablation at individual centers. Greater application can be expected in the future.. Citation format · Barkhausen J, Kahn T, Krombach GA et al. White Paper: Interventional MRI: Current Status and Potential for Development Considering Economic Perspectives, Part 1: General Application. Fortschr Röntgenstr 2017; 189: 611 - 623. © Georg Thieme Verlag KG Stuttgart · New York.

Cellular Therapies Clinical Research Roadmap: lessons learned on how to move a cellular therapy into a clinical trial.

PubMed

Ouseph, Stacy; Tappitake, Darah; Armant, Myriam; Wesselschmidt, Robin; Derecho, Ivy; Draxler, Rebecca; Wood, Deborah; Centanni, John M

2015-04-01

A clinical research roadmap has been developed as a resource for researchers to identify critical areas and potential pitfalls when transitioning a cellular therapy product from the research laboratory, by means of an Investigational New Drug (IND) application, into early-phase clinical trials. The roadmap describes four key areas: basic and preclinical research, resource development, translational research and Good Manufacturing Practice (GMP) and IND assembly and submission. Basic and preclinical research identifies a new therapeutic concept and demonstrates its potential value with the use of a model of the relevant disease. During resource development, the appropriate specialists and the required expertise to bring this product into the clinic are identified (eg, researchers, regulatory specialists, GMP manufacturing staff, clinicians and clinical trials staff, etc). Additionally, the funds required to achieve this goal (or a plan to procure them) are identified. In the next phase, the plan to translate the research product into a clinical-grade therapeutic is developed. Finally regulatory approval to start the trial must be obtained. In the United States, this is done by filing an IND application with the Food and Drug Administration. The National Heart, Lung and Blood Institute-funded Production Assistance for Cellular Therapies program has facilitated the transition of a variety of cellular therapy products from the laboratory into Phase1/2 trials. The five Production Assistance for Cellular Therapies facilities have assisted investigators by performing translational studies and GMP manufacturing to ensure that cellular products met release specifications and were manufactured safely, reproducibly and at the appropriate scale. The roadmap resulting from this experience is the focus of this article. Copyright © 2015 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Research interface on a programmable ultrasound scanner.

PubMed

Shamdasani, Vijay; Bae, Unmin; Sikdar, Siddhartha; Yoo, Yang Mo; Karadayi, Kerem; Managuli, Ravi; Kim, Yongmin

2008-07-01

Commercial ultrasound machines in the past did not provide the ultrasound researchers access to raw ultrasound data. Lack of this ability has impeded evaluation and clinical testing of novel ultrasound algorithms and applications. Recently, we developed a flexible ultrasound back-end where all the processing for the conventional ultrasound modes, such as B, M, color flow and spectral Doppler, was performed in software. The back-end has been incorporated into a commercial ultrasound machine, the Hitachi HiVision 5500. The goal of this work is to develop an ultrasound research interface on the back-end for acquiring raw ultrasound data from the machine. The research interface has been designed as a software module on the ultrasound back-end. To increase the amount of raw ultrasound data that can be spooled in the limited memory available on the back-end, we have developed a method that can losslessly compress the ultrasound data in real time. The raw ultrasound data could be obtained in any conventional ultrasound mode, including duplex and triplex modes. Furthermore, use of the research interface does not decrease the frame rate or otherwise affect the clinical usability of the machine. The lossless compression of the ultrasound data in real time can increase the amount of data spooled by approximately 2.3 times, thus allowing more than 6s of raw ultrasound data to be acquired in all the modes. The interface has been used not only for early testing of new ideas with in vitro data from phantoms, but also for acquiring in vivo data for fine-tuning ultrasound applications and conducting clinical studies. We present several examples of how newer ultrasound applications, such as elastography, vibration imaging and 3D imaging, have benefited from this research interface. Since the research interface is entirely implemented in software, it can be deployed on existing HiVision 5500 ultrasound machines and may be easily upgraded in the future. The developed research interface can aid researchers in the rapid testing and clinical evaluation of new ultrasound algorithms and applications. Additionally, we believe that our approach would be applicable to designing research interfaces on other ultrasound machines.

Regenerative endodontics as a tissue engineering approach: past, current and future.

PubMed

Malhotra, Neeraj; Mala, Kundabala

2012-12-01

With the reported startling statistics of high incidence of tooth decay and tooth loss, the current interest is focused on the development of alternate dental tissue replacement therapies. This has led to the application of dental tissue engineering as a clinically relevant method for the regeneration of dental tissues and generation of bioengineered whole tooth. Although, tissue engineering approach requires the three main key elements of stem cells, scaffold and morphogens, a conductive environment (fourth element) is equally important for successful engineering of any tissue and/or organ. The applications of this science has evolved continuously in dentistry, beginning from the application of Ca(OH)(2) in vital pulp therapy to the development of a fully functional bioengineered tooth (mice). Thus, with advances in basic research, recent reports and studies have shown successful application of tissue engineering in the field of dentistry. However, certain practical obstacles are yet to be overcome before dental tissue regeneration can be applied as evidence-based approach in clinics. The article highlights on the past achievements, current developments and future prospects of tissue engineering and regenerative therapy in the field of endodontics and bioengineered teeth (bioteeth). © 2012 The Authors. Australian Endodontic Journal © 2012 Australian Society of Endodontology.

Promoting the self-regulation of clinical reasoning skills in nursing students.

PubMed

Kuiper, R; Pesut, D; Kautz, D

2009-10-02

The purpose of this paper is to describe the research surrounding the theories and models the authors united to describe the essential components of clinical reasoning in nursing practice education. The research was conducted with nursing students in health care settings through the application of teaching and learning strategies with the Self-Regulated Learning Model (SRL) and the Outcome-Present-State-Test (OPT) Model of Reflective Clinical Reasoning. Standardized nursing languages provided the content and clinical vocabulary for the clinical reasoning task. This descriptive study described the application of the OPT model of clinical reasoning, use of nursing language content, and reflective journals based on the SRL model with 66 undergraduate nursing students over an 8 month period of time. The study tested the idea that self-regulation of clinical reasoning skills can be developed using self-regulation theory and the OPT model. This research supports a framework for effective teaching and learning methods to promote and document learner progress in mastering clinical reasoning skills. Self-regulated Learning strategies coupled with the OPT model suggest benefits of self-observation and self-monitoring during clinical reasoning activities, and pinpoints where guidance is needed for the development of cognitive and metacognitive awareness. Thinking and reasoning about the complexities of patient care needs requires attention to the content, processes and outcomes that make a nursing care difference. These principles and concepts are valuable to clinical decision making for nurses globally as they deal with local, regional, national and international health care issues.

'Televaluation' of clinical information systems: an integrative approach to assessing Web-based systems.

PubMed

Kushniruk, A W; Patel, C; Patel, V L; Cimino, J J

2001-04-01

The World Wide Web provides an unprecedented opportunity for widespread access to health-care applications by both patients and providers. The development of new methods for assessing the effectiveness and usability of these systems is becoming a critical issue. This paper describes the distance evaluation (i.e. 'televaluation') of emerging Web-based information technologies. In health informatics evaluation, there is a need for application of new ideas and methods from the fields of cognitive science and usability engineering. A framework is presented for conducting evaluations of health-care information technologies that integrates a number of methods, ranging from deployment of on-line questionnaires (and Web-based forms) to remote video-based usability testing of user interactions with clinical information systems. Examples illustrating application of these techniques are presented for the assessment of a patient clinical information system (PatCIS), as well as an evaluation of use of Web-based clinical guidelines. Issues in designing, prototyping and iteratively refining evaluation components are discussed, along with description of a 'virtual' usability laboratory.

Shiny FHIR: An Integrated Framework Leveraging Shiny R and HL7 FHIR to Empower Standards-Based Clinical Data Applications.

PubMed

Hong, Na; Prodduturi, Naresh; Wang, Chen; Jiang, Guoqian

2017-01-01

In this study, we describe our efforts in building a clinical statistics and analysis application platform using an emerging clinical data standard, HL7 FHIR, and an open source web application framework, Shiny. We designed two primary workflows that integrate a series of R packages to enable both patient-centered and cohort-based interactive analyses. We leveraged Shiny with R to develop interactive interfaces on FHIR-based data and used ovarian cancer study datasets as a use case to implement a prototype. Specifically, we implemented patient index, patient-centered data report and analysis, and cohort analysis. The evaluation of our study was performed by testing the adaptability of the framework on two public FHIR servers. We identify common research requirements and current outstanding issues, and discuss future enhancement work of the current studies. Overall, our study demonstrated that it is feasible to use Shiny for implementing interactive analysis on FHIR-based standardized clinical data.

Clinical application of brain imaging for the diagnosis of mood disorders: the current state of play

PubMed Central

Savitz, J B; Rauch, S L; Drevets, W C

2013-01-01

In response to queries about whether brain imaging technology has reached the point where it is useful for making a clinical diagnosis and for helping to guide treatment selection, the American Psychiatric Association (APA) has recently written a position paper on the Clinical Application of Brain Imaging in Psychiatry. The following perspective piece is based on our contribution to this APA position paper, which specifically emphasized the application of neuroimaging in mood disorders. We present an introductory overview of the challenges faced by researchers in developing valid and reliable biomarkers for psychiatric disorders, followed by a synopsis of the extant neuroimaging findings in mood disorders, and an evidence-based review of the current research on brain imaging biomarkers in adult mood disorders. Although there are a number of promising results, by the standards proposed below, we argue that there are currently no brain imaging biomarkers that are clinically useful for establishing diagnosis or predicting treatment outcome in mood disorders. PMID:23546169

Clinical application of brain imaging for the diagnosis of mood disorders: the current state of play.

PubMed

Savitz, J B; Rauch, S L; Drevets, W C

2013-05-01

In response to queries about whether brain imaging technology has reached the point where it is useful for making a clinical diagnosis and for helping to guide treatment selection, the American Psychiatric Association (APA) has recently written a position paper on the Clinical Application of Brain Imaging in Psychiatry. The following perspective piece is based on our contribution to this APA position paper, which specifically emphasized the application of neuroimaging in mood disorders. We present an introductory overview of the challenges faced by researchers in developing valid and reliable biomarkers for psychiatric disorders, followed by a synopsis of the extant neuroimaging findings in mood disorders, and an evidence-based review of the current research on brain imaging biomarkers in adult mood disorders. Although there are a number of promising results, by the standards proposed below, we argue that there are currently no brain imaging biomarkers that are clinically useful for establishing diagnosis or predicting treatment outcome in mood disorders.

Advances in the manufacturing, types, and applications of biosensors

NASA Astrophysics Data System (ADS)

Ravindra, Nuggehalli M.; Prodan, Camelia; Fnu, Shanmugamurthy; Padronl, Ivan; Sikha, Sushil K.

2007-12-01

In recent years, there have been significant technological advancements in the manufacturing, types, and applications of biosensors. Applications include clinical and non-clinical diagnostics for home, bio-defense, bio-remediation, environment, agriculture, and the food industry. Biosensors have progressed beyond the detection of biological threats such as anthrax and are finding use in a number of non-biological applications. Emerging biosensor technologies such as lab-on-a-chip have revolutionized the integration approaches for a very flexible, innovative, and user-friendly platform. An overview of the fundamentals, types, applications, and manufacturers, as well as the market trends of biosensors is presented here. Two case studies are discussed: one focused on a characterization technique—patch clamping and dielectric spectroscopy as a biological sensor—and the other about lithium phthalocyanine, a material that is being developed for in-vivo oxymetry.

Clinical applications of bioactive milk components

PubMed Central

Newburg, David S.

2015-01-01

Milk represents a unique resource for translational medicine: It contains a rich pool of biologically active molecules with demonstrated clinical benefits. The ongoing characterization of the mechanistic process through which milk components promote development and immunity has revealed numerous milk-derived compounds with potential applications as clinical therapies in infectious and inflammatory disease, cancer, and other conditions. Lactoferrin is an effective antimicrobial and antiviral agent in high-risk patient populations and a potentially potent adjuvant to chemotherapy in lung cancer. Enteric nutrition formulas supplemented with transforming growth factor β, a milk cytokine, have been shown to promote remission in pediatric Crohn's disease. A number of milk glycans, including human milk oligosaccharides, show promise in preclinical studies as antimicrobial and anti-inflammatory agents. While active preclinical investigations of human milk may soon result in large-scale production of human milk molecules, bovine milk components in many instances represent a practical source of bioactive milk compounds for use in clinical trials. This review summarizes current efforts to translate the compounds derived from human and bovine milk into effective clinical therapies. These efforts suggest a common pathway for the translation of milk-derived compounds into clinical applications. PMID:26011900

Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications

PubMed Central

Vavken, Patrick; Ganal-Antonio, Anne Kathleen B.; Quidde, Julia; Shen, Francis H.; Chapman, Jens R.; Samartzis, Dino

2015-01-01

Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of “personalized spine care.” PMID:26225283

Clinical applications of bioactive milk components.

PubMed

Hill, David R; Newburg, David S

2015-07-01

Milk represents a unique resource for translational medicine: It contains a rich pool of biologically active molecules with demonstrated clinical benefits. The ongoing characterization of the mechanistic process through which milk components promote development and immunity has revealed numerous milk-derived compounds with potential applications as clinical therapies in infectious and inflammatory disease, cancer, and other conditions. Lactoferrin is an effective antimicrobial and antiviral agent in high-risk patient populations and a potentially potent adjuvant to chemotherapy in lung cancer. Enteric nutrition formulas supplemented with transforming growth factor β, a milk cytokine, have been shown to promote remission in pediatric Crohn's disease. A number of milk glycans, including human milk oligosaccharides, show promise in preclinical studies as antimicrobial and anti-inflammatory agents. While active preclinical investigations of human milk may soon result in large-scale production of human milk molecules, bovine milk components in many instances represent a practical source of bioactive milk compounds for use in clinical trials. This review summarizes current efforts to translate the compounds derived from human and bovine milk into effective clinical therapies. These efforts suggest a common pathway for the translation of milk-derived compounds into clinical applications.

Viral mHealth​

PubMed Central

Fölster, Stefan

2017-01-01

ABSTRACT Thousands of mHealth applications are developed every year, but few of these spread or ‘go viral’. Even clinical applications that provide health benefits and social value often linger after an initial pilot phase. An examination of common hindrances in low-income countries suggests that more subsidies and education of health care personnel are insufficient solutions. Instead we propose better a priori screening of mHealth applications based on four criteria that may largely determine whether an mHealth application will spread. Further, we illustrate how using these criteria forms a good basis for involving ‘impact investors’ in the development of mHealth applications. This can reduce risks for public health care providers and increase the likelihood of success. PMID:28838304

The Use of Genograms in Educational Psychology Practice

ERIC Educational Resources Information Center

Tobias, Adele

2018-01-01

This article explores the application of the genogram in educational psychology (EP) practice. It provides a brief overview of the historical and theoretical development of the genogram. It then reviews and critiques some of the current literature regarding clinical application of the genogram in casework with children and adolescents and their…

Electroplating targets for production of unique PET radionuclides

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bui, V.; Sheh, Y.; Finn, R.

1994-12-31

The past decade has witnessed the applications of Positron Emission Tomography (PET) evolving from a purely research endeavour to a procedure which has specific clinical applications in the areas of cardiology, neurology and oncology. The growth of PET has been facilitated by developments in medical instrumentation and radiopharmaceutical chemistry efforts. Included in this latter effort has been the low energy accelerator production and processing of unique PET radionuclides appropriate for the radiolabeling of biomolecules i.e. monoclonal antibodies and pepetides. The development and application of electroplated targets of antimony and copper for the production of iodine-124 and gallium-66 respectively, utilizing themore » Memorial Sloan-Kettering Cancer Center cyclotron are examples of target design and development applicable to many medical accelerators.« less

Electroplated targets for production of unique PET radionuclides

NASA Astrophysics Data System (ADS)

Bui, V.; Sheh, Y.; Finn, R.; Francesconi, L.; Cai, S.; Schlyer, D.; Wieland, B.

1995-12-01

The past decade has witnessed the applications of positron emission tomography (PET) evolving from a purely research endeavor to a procedure which has specific clinical applications in the areas of cardiology, neurology and oncology. The growth of PET has been facilitated by developments in both medical instrumentation and radiopharmaceutical chemistry efforts. Included in this latter effort has been the low energy accelerator production and processing of unique PET radionuclides appropriate for the radiolabeling of biomolecules, i.e. monoclonal antibodies and peptides. The development and application of electroplated targets of antimony and copper for the production of iodine-124 and gallium-66 respectively, utilizing the Memorial Sloan-Kettering Cancer Center (MSKCC) cyclotron are examples of target design and development applicable to many medical accelerators.

Polysaccharide‐Based Controlled Release Systems for Therapeutics Delivery and Tissue Engineering: From Bench to Bedside

PubMed Central

Miao, Tianxin; Wang, Junqing; Zeng, Yun; Chen, Xiaoyuan

2018-01-01

Abstract Polysaccharides or polymeric carbohydrate molecules are long chains of monosaccharides that are linked by glycosidic bonds. The naturally based structural materials are widely applied in biomedical applications. This article covers four different types of polysaccharides (i.e., alginate, chitosan, hyaluronic acid, and dextran) and emphasizes their chemical modification, preparation approaches, preclinical studies, and clinical translations. Different cargo fabrication techniques are also presented in the third section. Recent progresses in preclinical applications are then discussed, including tissue engineering and treatment of diseases in both therapeutic and monitoring aspects. Finally, clinical translational studies with ongoing clinical trials are summarized and reviewed. The promise of new development in nanotechnology and polysaccharide chemistry helps clinical translation of polysaccharide‐based drug delivery systems. PMID:29721408

DCE-MRI, DW-MRI, and MRS in Cancer: Challenges and Advantages of Implementing Qualitative and Quantitative Multi-parametric Imaging in the Clinic

PubMed Central

Winfield, Jessica M.; Payne, Geoffrey S.; Weller, Alex; deSouza, Nandita M.

2016-01-01

Abstract Multi-parametric magnetic resonance imaging (mpMRI) offers a unique insight into tumor biology by combining functional MRI techniques that inform on cellularity (diffusion-weighted MRI), vascular properties (dynamic contrast-enhanced MRI), and metabolites (magnetic resonance spectroscopy) and has scope to provide valuable information for prognostication and response assessment. Challenges in the application of mpMRI in the clinic include the technical considerations in acquiring good quality functional MRI data, development of robust techniques for analysis, and clinical interpretation of the results. This article summarizes the technical challenges in acquisition and analysis of multi-parametric MRI data before reviewing the key applications of multi-parametric MRI in clinical research and practice. PMID:27748710

Engineering the extracellular matrix for clinical applications: endoderm, mesoderm, and ectoderm.

PubMed

Williams, Miguel L; Bhatia, Sujata K

2014-03-01

Tissue engineering is rapidly progressing from a research-based discipline to clinical applications. Emerging technologies could be utilized to develop therapeutics for a wide range of diseases, but many are contingent on a cell scaffold that can produce proper tissue ultrastructure. The extracellular matrix, which a cell scaffold simulates, is not merely a foundation for tissue growth but a dynamic participant in cellular crosstalk and organ homeostasis. Cells change their growth rates, recruitment, and differentiation in response to the composition, modulus, and patterning of the substrate on which they reside. Cell scaffolds can regulate these factors through precision design, functionalization, and application. The ideal therapy would utilize highly specialized cell scaffolds to best mimic the tissue of interest. This paper discusses advantages and challenges of optimized cell scaffold design in the endoderm, mesoderm, and ectoderm for clinical applications in tracheal transplant, cardiac regeneration, and skin grafts, respectively. Copyright © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Combining transrectal ultrasound and CT for image-guided adaptive brachytherapy of cervical cancer: Proof of concept.

PubMed

Nesvacil, Nicole; Schmid, Maximilian P; Pötter, Richard; Kronreif, Gernot; Kirisits, Christian

To investigate the feasibility of a treatment planning workflow for three-dimensional image-guided cervix cancer brachytherapy, combining volumetric transrectal ultrasound (TRUS) for target definition with CT for dose optimization to organs at risk (OARs), for settings with no access to MRI. A workflow for TRUS/CT-based volumetric treatment planning was developed, based on a customized system including ultrasound probe, stepper unit, and software for image volume acquisition. A full TRUS/CT-based workflow was simulated in a clinical case and compared with MR- or CT-only delineation. High-risk clinical target volume was delineated on TRUS, and OARs were delineated on CT. Manually defined tandem/ring applicator positions on TRUS and CT were used as a reference for rigid registration of the image volumes. Treatment plan optimization for TRUS target and CT organ volumes was performed and compared to MRI and CT target contours. TRUS/CT-based contouring, applicator reconstruction, image fusion, and treatment planning were feasible, and the full workflow could be successfully demonstrated. The TRUS/CT plan fulfilled all clinical planning aims. Dose-volume histogram evaluation of the TRUS/CT-optimized plan (high-risk clinical target volume D 90 , OARs D 2cm³ for) on different image modalities showed good agreement between dose values reported for TRUS/CT and MRI-only reference contours and large deviations for CT-only target parameters. A TRUS/CT-based workflow for full three-dimensional image-guided cervix brachytherapy treatment planning seems feasible and may be clinically comparable to MRI-based treatment planning. Further development to solve challenges with applicator definition in the TRUS volume is required before systematic applicability of this workflow. Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Pharmacogenetics in Europe: barriers and opportunities.

PubMed

Gurwitz, D; Zika, E; Hopkins, M M; Gaisser, S; Ibarreta, D

2009-01-01

This paper reviews the current situation in the field of pharmacogenetics/pharmacogenomics (PGx) in Europe. High expectations surrounding the clinical application of PGx remain largely unmet, as only a limited number of such applications have actually reached the market and clinical practice. Thus, the potential impact of PGx-based diagnostics on healthcare and its socio-economic implications are still unclear. With the aim of shedding some light on these uncertainties, the Institute for Prospective Technological Studies (IPTS) of the European Commission's Joint Research Centre (JRC) has conducted a review of the 'state of the art' and a further analysis on the use of pharmacogenetics diagnostics for preventing toxic drug reactions and improving drug efficacy in Europe. The paper presents highlights from the JRC-IPTS studies and discusses possibilities for improving translation of PGx research in Europe by comparing some experiences in the USA. We also illustrate the related barriers for the clinical uptake of PGx in Europe with specific case-studies. Most of the barriers identified extend beyond the European context. This reflects the global problems of scarcity of data demonstrating proven clinical validity or utility and favorable cost-effectiveness studies to support the clinical application of PGx diagnostic tests in the clinical setting. Another key barrier is the lack of incentives for the private sector to invest in the development and licensing of PGx diagnostic tests for improving the safety and efficacy of out-of-patent drugs. It therefore seems that one key aspect where policy can affect the clinical uptake of PGx is via sustaining large-scale industry-academia collaborations for developing and proving the utility of PGx diagnostics. Copyright 2009 S. Karger AG, Basel.

A mobile and web-based clinical decision support and monitoring system for diabetes mellitus patients in primary care: a study protocol for a randomized controlled trial.

PubMed

Kart, Özge; Mevsim, Vildan; Kut, Alp; Yürek, İsmail; Altın, Ayşe Özge; Yılmaz, Oğuz

2017-11-29

Physicians' guideline use rates for diagnosis, treatment and monitoring of diabetes mellitus (DM) is very low. Time constraints, patient overpopulation, and complex guidelines require alternative solutions for real time patient monitoring. Rapidly evolving e-health technology combined with clinical decision support and monitoring systems (CDSMS) provides an effective solution to these problems. The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for the screening, diagnosis, treatment, and monitoring of DM diseases which is used by physicians and patients in primary care and to determine the effectiveness of the system. The CDSMS will be based on evidence-based guidelines for DM disease. A web and mobile-based application will be developed in which the physician will remotely monitor patient data through mobile applications in real time. The developed CDSMS will be tested in two stages. In the first stage, the usability, understandability, and adequacy of the application will be determined. Five primary care physicians will use the developed application for at least 16 DM patients. Necessary improvements will be made according to physician feedback. In the second phase, a parallel, single-blind, randomized controlled trial will be implemented. DM diagnosed patients will be recruited for the CDSMS trial by their primary care physicians. Ten physicians and their 439 patients will be involved in the study. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p < 0.05. In the intervention group, the system will make recommendations on patient monitoring, diagnosis, and treatment. These recommendations will be implemented at the physician's discretion. Patients in the control group will be treated by physicians according to current DM treatment standards. Patients in both groups will be monitored for 6 months. Patient data will be compared between 0th and 6th month of the study. . Clinical and laboratory outcomes will be assessed in person while others will be self-assessed online. The developed system will be the first of its kind to utilize evidence based guidelines to provide health services to DM patients. ClinicalTrials.gov NCT02917226 . 28 September 2016.

The application and value of information sources in clinical practice: an examination of the perspective of naturopaths.

PubMed

Steel, Amie; Adams, Jon

2011-06-01

The approach of evidence-based medicine (EBM), providing a paradigm to validate information sources and a process for critiquing their value, is an important platform for guiding practice. Researchers have explored the application and value of information sources in clinical practice with regard to a range of health professions; however, naturopathic practice has been overlooked. An exploratory study of naturopaths' perspectives of the application and value of information sources has been undertaken. Semi-structured interviews with 12 naturopaths in current clinical practice, concerning the information sources used in clinical practice and their perceptions of these sources. Thematic analysis identified differences in the application of the variety of information sources used, depending upon the perceived validity. Internet databases were viewed as highly valid. Textbooks, formal education and interpersonal interactions were judged based upon a variety of factors, whilst validation of general internet sites and manufacturers information was required prior to use. The findings of this study will provide preliminary aid to those responsible for supporting naturopaths' information use and access. In particular, it may assist publishers, medical librarians and professional associations in developing strategies to expand the clinically useful information sources available to naturopaths. © 2011 The authors. Health Information and Libraries Journal © 2011 Health Libraries Group.

An Intracranial Electroencephalography (iEEG) Brain Function Mapping Tool with an Application to Epilepsy Surgery Evaluation.

PubMed

Wang, Yinghua; Yan, Jiaqing; Wen, Jianbin; Yu, Tao; Li, Xiaoli

2016-01-01

Before epilepsy surgeries, intracranial electroencephalography (iEEG) is often employed in function mapping and epileptogenic foci localization. Although the implanted electrodes provide crucial information for epileptogenic zone resection, a convenient clinical tool for electrode position registration and Brain Function Mapping (BFM) visualization is still lacking. In this study, we developed a BFM Tool, which facilitates electrode position registration and BFM visualization, with an application to epilepsy surgeries. The BFM Tool mainly utilizes electrode location registration and function mapping based on pre-defined brain models from other software. In addition, the electrode node and mapping properties, such as the node size/color, edge color/thickness, mapping method, can be adjusted easily using the setting panel. Moreover, users may manually import/export location and connectivity data to generate figures for further application. The role of this software is demonstrated by a clinical study of language area localization. The BFM Tool helps clinical doctors and researchers visualize implanted electrodes and brain functions in an easy, quick and flexible manner. Our tool provides convenient electrode registration, easy brain function visualization, and has good performance. It is clinical-oriented and is easy to deploy and use. The BFM tool is suitable for epilepsy and other clinical iEEG applications.

An Intracranial Electroencephalography (iEEG) Brain Function Mapping Tool with an Application to Epilepsy Surgery Evaluation

PubMed Central

Wang, Yinghua; Yan, Jiaqing; Wen, Jianbin; Yu, Tao; Li, Xiaoli

2016-01-01

Objects: Before epilepsy surgeries, intracranial electroencephalography (iEEG) is often employed in function mapping and epileptogenic foci localization. Although the implanted electrodes provide crucial information for epileptogenic zone resection, a convenient clinical tool for electrode position registration and Brain Function Mapping (BFM) visualization is still lacking. In this study, we developed a BFM Tool, which facilitates electrode position registration and BFM visualization, with an application to epilepsy surgeries. Methods: The BFM Tool mainly utilizes electrode location registration and function mapping based on pre-defined brain models from other software. In addition, the electrode node and mapping properties, such as the node size/color, edge color/thickness, mapping method, can be adjusted easily using the setting panel. Moreover, users may manually import/export location and connectivity data to generate figures for further application. The role of this software is demonstrated by a clinical study of language area localization. Results: The BFM Tool helps clinical doctors and researchers visualize implanted electrodes and brain functions in an easy, quick and flexible manner. Conclusions: Our tool provides convenient electrode registration, easy brain function visualization, and has good performance. It is clinical-oriented and is easy to deploy and use. The BFM tool is suitable for epilepsy and other clinical iEEG applications. PMID:27199729

Participatory design methods for the development of a clinical telehealth service for neonatal homecare.

PubMed

Garne Holm, Kristina; Brødsgaard, Anne; Zachariassen, Gitte; Smith, Anthony C; Clemensen, Jane

2017-01-01

Neonatal homecare delivered during home visits by neonatal nurses is a common method for supporting families of preterm infants following discharge. Telehealth has been introduced for the provision of neonatal homecare, resulting in positive feedback from parents of preterm infants. While the benefits are beginning to be realised, widespread uptake of telehealth has been limited due to a range of logistical challenges. Understanding user requirements is important when planning and developing a clinical telehealth service. We therefore used participatory design to develop a clinical telehealth service for neonatal homecare. The study adopted a participatory design approach to engage users in the development and design of a new telehealth service. Participatory design embraces qualitative research methods. Creative and technical workshops were conducted as part of the study. Tests of the telehealth service were conducted in the neonatal unit. Participants in this study were former and current parents of preterm infants eligible for neonatal homecare, and clinical staff (medical and nursing) from the neonatal unit. Preterm infants accompanied their parents. Based on the results obtained during the workshops and subsequent testing, we developed an application (app), which was integrated into the medical record at the neonatal unit. The app was used to initiate videoconferences and chat messages between the family at home and the neonatal unit, and to share information regarding infant growth and well-being. Results obtained from the workshops and testing demonstrated the importance of involving users when developing new telehealth applications. The workshops helped identify the challenges associated with delivery of the service, and helped instruct the design of a new telehealth service for neonatal homecare based on the needs of parents and clinical staff.

Left ventricular fluid mechanics: the long way from theoretical models to clinical applications.

PubMed

Pedrizzetti, Gianni; Domenichini, Federico

2015-01-01

The flow inside the left ventricle is characterized by the formation of vortices that smoothly accompany blood from the mitral inlet to the aortic outlet. Computational fluid dynamics permitted to shed some light on the fundamental processes involved with vortex motion. More recently, patient-specific numerical simulations are becoming an increasingly feasible tool that can be integrated with the developing imaging technologies. The existing computational methods are reviewed in the perspective of their potential role as a novel aid for advanced clinical analysis. The current results obtained by simulation methods either alone or in combination with medical imaging are summarized. Open problems are highlighted and perspective clinical applications are discussed.

Stem cell roadmap - The industrial point of view.

PubMed

Elzaabi, Mazen; Thevenin, Agnès; Lirsac, Pierre-Noël

2017-01-01

CELLforCURE is a French Contract Development and Manufacturing Organization (CDMO) dedicated to industrialization and process development for routine manufacturing, GMP manufacturing for clinical and commercial batches and regulatory services and associated logistics. CELLforCURE is a subsidiary of LFB Group.Stem cells fields of application gather cell and gene therapy as well as tissue engineering. According to VisionGain survey, cell therapy medicinal products will remain predominant in the future.Clinical trials are sponsored either by universities or private companies. Most of clinical trials are performed in oncology (53%). More than 100 clinical trials are currently performed in France, involving 36 products in clinical phases II or II/III.Tomorrow's regenerative medicine will be organ reconstruction using scaffolds and bioprinting technologies. The expected applications in the near future could be skin, cornea, blood vessels, retina, urethra and trachea. There are still important issues to overcome: create the vasculature and neuron connection.Solutions are expected regarding I) fundamental biology, in particular better understanding of IPS behavior and metabolism, precursor differentiation conditions, sustainability of induced genetic changes, II) technical approaches which involves injectable preservation medium, high density cells and centrifugation system.

Development and production of good manufacturing practice grade human embryonic stem cell lines as source material for clinical application.

PubMed

De Sousa, P A; Downie, J M; Tye, B J; Bruce, K; Dand, P; Dhanjal, S; Serhal, P; Harper, J; Turner, M; Bateman, M

2016-09-01

From 2006 to 2011, Roslin Cells Ltd derived 17 human embryonic stem cells (hESC) while developing (RCM1, RC-2 to -8, -10) and implementing (RC-9, -11 to -17) quality assured standards of operation in a facility operating in compliance with European Union (EU) directives and United Kingdom (UK) licensure for procurement, processing and storage of human cells as source material for clinical application, and targeted to comply with an EU Good Manufacturing Practice specification. Here we describe the evolution and specification of the facility, its operation and outputs, complementing hESC resource details communicated in Stem Cell Research Lab Resources. Copyright © 2016. Published by Elsevier B.V.

Magnetic nanoparticles for precision oncology: theranostic magnetic iron oxide nanoparticles for image-guided and targeted cancer therapy

PubMed Central

Zhu, Lei; Zhou, Zhiyang; Mao, Hui; Yang, Lily

2017-01-01

Recent advances in the development of magnetic nanoparticles (MNPs) have shown promise in the development of new personalized therapeutic approaches for clinical management of cancer patients. The unique physicochemical properties of MNPs endow them with novel multifunctional capabilities for imaging, drug delivery and therapy, which are referred to as theranostics. To facilitate the translation of those theranostic MNPs into clinical applications, extensive efforts have been made on designing and improving biocompatibility, stability, safety, drug-loading ability, targeted delivery, imaging signal and thermal- or photodynamic response. In this review, we provide an overview of the physicochemical properties, toxicity and theranostic applications of MNPs with a focus on magnetic iron oxide nanoparticles. PMID:27876448

[Severe complications after non-intended usage of octenidine dihydrochloride. A case series with four dogs].

PubMed

Kaiser, S; Kramer, M; Thiel, C

2015-01-01

Case series of four dogs in which extensive bite wounds had been treated using octenidine dihydrochloride (Octenivet® or Octenisept®) flushing. The dogs subsequently developed severe local complications. Retrospective evaluation of clinical symptoms, diagnostics, therapy and course of the disease. In four dogs, severe necrosis and persistent edematous changes of the treated area developed after the application of octenidine dihydrochloride. The clinical course was comparable to complications described previously in human medicine. Therapy was protracted and complicated by secondary wound infection. Irrigation of deep wounds, particularly bite wounds, using octenidine dihydrochloride without drainage may lead to persistent edematous changes, inflammatory reactions and necrosis. The inappropriate application of octenidine dihydrochloride for wound irrigation should be avoided in veterinary medicine.

Submucosal Tunneling Endoscopic Resection (STER) and Other Novel Applications of Submucosal Tunneling in Humans.

PubMed

Liu, Bing-Rong; Song, Ji-Tao

2016-04-01

The submucosal tunneling technique was originally developed to provide safe access to the peritoneal cavity for natural orifice transluminal endoscopic surgery procedures. With this technique, the submucosal tunnel becomes the working space for partial myotomy and tumor resection. The submucosal space has come to represent the "third space" distinguished from gastrointestinal lumen (first space) and peritoneal cavity (second space). New applications continue to be developed and further clinical applications in the future are anticipated. This article summarizes the current applications of submucosal tunneling endoscopic resection for subepithelial tumors and describes other related uses of submucosal tunneling. Copyright © 2016 Elsevier Inc. All rights reserved.

Review of MR Elastography Applications and Recent Developments

PubMed Central

Glaser, Kevin J.; Manduca, Armando; Ehman, Richard L.

2012-01-01

The technique of MR elastography (MRE) has emerged as a useful modality for quantitatively imaging the mechanical properties of soft tissues in vivo. Recently, MRE has been introduced as a clinical tool for evaluating chronic liver disease, but many other potential applications are being explored. These applications include measuring tissue changes associated with diseases of the liver, breast, brain, heart, and skeletal muscle including both focal lesions (e.g., hepatic, breast, and brain tumors) and diffuse diseases (e.g., fibrosis and multiple sclerosis). The purpose of this review article is to summarize some of the recent developments of MRE and to highlight some emerging applications. PMID:22987755

'Bioengineered Bugs' - a patho-biotechnology approach to probiotic research and applications.

PubMed

Sleator, Roy D; Hill, Colin

2008-01-01

Given the increasing commercial and clinical relevance of probiotic cultures, improving their stress tolerance profile and ability to overcome the physiochemical defences of the host is an important biological goal. Pathogenic bacteria have evolved sophisticated strategies to overcome host defences, interact with the immune system and modulate essential host systems. The 'Patho-biotechnology' concept promotes the exploitation of these valuable traits for the design of more technologically robust and effective probiotic cultures with potentially improved biotechnological and clinical applications, as well as the development of novel vaccine and drug delivery platforms.

NanoString, a novel digital color-coded barcode technology: current and future applications in molecular diagnostics.

PubMed

Tsang, Hin-Fung; Xue, Vivian Weiwen; Koh, Su-Pin; Chiu, Ya-Ming; Ng, Lawrence Po-Wah; Wong, Sze-Chuen Cesar

2017-01-01

Formalin-fixed, paraffin-embedded (FFPE) tissue sample is a gold mine of resources for molecular diagnosis and retrospective clinical studies. Although molecular technologies have expanded the range of mutations identified in FFPE samples, the applications of existing technologies are limited by the low nucleic acids yield and poor extraction quality. As a result, the routine clinical applications of molecular diagnosis using FFPE samples has been associated with many practical challenges. NanoString technologies utilize a novel digital color-coded barcode technology based on direct multiplexed measurement of gene expression and offer high levels of precision and sensitivity. Each color-coded barcode is attached to a single target-specific probe corresponding to a single gene which can be individually counted without amplification. Therefore, NanoString is especially useful for measuring gene expression in degraded clinical specimens. Areas covered: This article describes the applications of NanoString technologies in molecular diagnostics and challenges associated with its applications and the future development. Expert commentary: Although NanoString technology is still in the early stages of clinical use, it is expected that NanoString-based cancer expression panels would play more important roles in the future in classifying cancer patients and in predicting the response to therapy for better personal therapeutic care.

Prospects and applications of nanobiotechnology: a medical perspective.

PubMed

Fakruddin, Md; Hossain, Zakir; Afroz, Hafsa

2012-07-20

Nanobiotechnology is the application of nanotechnology in biological fields. Nanotechnology is a multidisciplinary field that currently recruits approach, technology and facility available in conventional as well as advanced avenues of engineering, physics, chemistry and biology. A comprehensive review of the literature on the principles, limitations, challenges, improvements and applications of nanotechnology in medical science was performed. Nanobiotechnology has multitude of potentials for advancing medical science thereby improving health care practices around the world. Many novel nanoparticles and nanodevices are expected to be used, with an enormous positive impact on human health. While true clinical applications of nanotechnology are still practically inexistent, a significant number of promising medical projects are in an advanced experimental stage. Implementation of nanotechnology in medicine and physiology means that mechanisms and devices are so technically designed that they can interact with sub-cellular (i.e. molecular) levels of the body with a high degree of specificity. Thus therapeutic efficacy can be achieved to maximum with minimal side effects by means of the targeted cell or tissue-specific clinical intervention. More detailed research and careful clinical trials are still required to introduce diverse components of nanobiotechnology in random clinical applications with success. Ethical and moral concerns also need to be addressed in parallel with the new developments.

Prospects and applications of nanobiotechnology: a medical perspective

PubMed Central

2012-01-01

Background Nanobiotechnology is the application of nanotechnology in biological fields. Nanotechnology is a multidisciplinary field that currently recruits approach, technology and facility available in conventional as well as advanced avenues of engineering, physics, chemistry and biology. Method A comprehensive review of the literature on the principles, limitations, challenges, improvements and applications of nanotechnology in medical science was performed. Results Nanobiotechnology has multitude of potentials for advancing medical science thereby improving health care practices around the world. Many novel nanoparticles and nanodevices are expected to be used, with an enormous positive impact on human health. While true clinical applications of nanotechnology are still practically inexistent, a significant number of promising medical projects are in an advanced experimental stage. Implementation of nanotechnology in medicine and physiology means that mechanisms and devices are so technically designed that they can interact with sub-cellular (i.e. molecular) levels of the body with a high degree of specificity. Thus therapeutic efficacy can be achieved to maximum with minimal side effects by means of the targeted cell or tissue-specific clinical intervention. Conclusion More detailed research and careful clinical trials are still required to introduce diverse components of nanobiotechnology in random clinical applications with success. Ethical and moral concerns also need to be addressed in parallel with the new developments. PMID:22817658

Application of Intervention Mapping to the Development of a Complex Physical Therapist Intervention.

PubMed

Jones, Taryn M; Dear, Blake F; Hush, Julia M; Titov, Nickolai; Dean, Catherine M

2016-12-01

Physical therapist interventions, such as those designed to change physical activity behavior, are often complex and multifaceted. In order to facilitate rigorous evaluation and implementation of these complex interventions into clinical practice, the development process must be comprehensive, systematic, and transparent, with a sound theoretical basis. Intervention Mapping is designed to guide an iterative and problem-focused approach to the development of complex interventions. The purpose of this case report is to demonstrate the application of an Intervention Mapping approach to the development of a complex physical therapist intervention, a remote self-management program aimed at increasing physical activity after acquired brain injury. Intervention Mapping consists of 6 steps to guide the development of complex interventions: (1) needs assessment; (2) identification of outcomes, performance objectives, and change objectives; (3) selection of theory-based intervention methods and practical applications; (4) organization of methods and applications into an intervention program; (5) creation of an implementation plan; and (6) generation of an evaluation plan. The rationale and detailed description of this process are presented using an example of the development of a novel and complex physical therapist intervention, myMoves-a program designed to help individuals with an acquired brain injury to change their physical activity behavior. The Intervention Mapping framework may be useful in the development of complex physical therapist interventions, ensuring the development is comprehensive, systematic, and thorough, with a sound theoretical basis. This process facilitates translation into clinical practice and allows for greater confidence and transparency when the program efficacy is investigated. © 2016 American Physical Therapy Association.

Design, development and deployment of a Diabetes Research Registry to facilitate recruitment in clinical research.

PubMed

Tan, Meng H; Bernstein, Steven J; Gendler, Stephen; Hanauer, David; Herman, William H

2016-03-01

A major challenge in conducting clinical trials/studies is the timely recruitment of eligible subjects. Our aim is to develop a Diabetes Research Registry (DRR) to facilitate recruitment by matching potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their electronic health records (EHR). A committee with expertise in diabetes, quality improvement, information technology, and informatics designed and developed the DRR. Using a hybrid approach, we identified and consented patients interested in research, abstracted their EHRs to assess common eligibility criteria, and contacted them about their interest in participating in specific studies. Investigators submit their requests with study entry criteria to the DRR which then provides a list of potential subjects who may be directly contacted for their study. The DRR meets all local, regional and federal regulatory requirements. After 5 years, the DRR has over 5000 registrants. About 30% have type 1 diabetes and 70% have type 2 diabetes. There are almost equal proportions of men and women. During this period, 31 unique clinical studies from 19 unique investigators requested lists of potential subjects for their studies. Eleven grant applications from 10 unique investigators used aggregated counts of potentially eligible subjects in their applications. The DRR matches potential subjects interested in research with approved clinical studies using study entry criteria abstracted from their EHR. By providing large lists of potentially eligible study subjects quickly, the DRR facilitated recruitment in 31 clinical studies. Copyright © 2016 Elsevier Inc. All rights reserved.

Technological progress and challenges towards cGMP manufacturing of human pluripotent stem cells based therapeutic products for allogeneic and autologous cell therapies.

PubMed

Abbasalizadeh, Saeed; Baharvand, Hossein

2013-12-01

Recent technological advances in the generation, characterization, and bioprocessing of human pluripotent stem cells (hPSCs) have created new hope for their use as a source for production of cell-based therapeutic products. To date, a few clinical trials that have used therapeutic cells derived from hESCs have been approved by the Food and Drug Administration (FDA), but numerous new hPSC-based cell therapy products are under various stages of development in cell therapy-specialized companies and their future market is estimated to be very promising. However, the multitude of critical challenges regarding different aspects of hPSC-based therapeutic product manufacturing and their therapies have made progress for the introduction of new products and clinical applications very slow. These challenges include scientific, technological, clinical, policy, and financial aspects. The technological aspects of manufacturing hPSC-based therapeutic products for allogeneic and autologous cell therapies according to good manufacturing practice (cGMP) quality requirements is one of the most important challenging and emerging topics in the development of new hPSCs for clinical use. In this review, we describe main critical challenges and highlight a series of technological advances in all aspects of hPSC-based therapeutic product manufacturing including clinical grade cell line development, large-scale banking, upstream processing, downstream processing, and quality assessment of final cell therapeutic products that have brought hPSCs closer to clinical application and commercial cGMP manufacturing. © 2013.

Emergence of a scientific and commercial research and development infrastructure for human gene therapy.

PubMed

Crofts, Christine; Krimsky, Sheldon

2005-02-01

A research and clinical subfield known as "human gene therapy" has grown rapidly since 1990, when the first human trials were approved in the United States. Using quantitative data, this paper describes and analyzes the research and commercial infrastructure, including academic centers, publications, intellectual property, and biotechnology firms, that has developed around the goal of discovering clinical applications for the modification and transport of DNA to somatic cells. Despite setbacks and few documented successes, the subfield of human gene therapy continues to serve as an influential clinical paradigm for the treatment of inherited and noninherited diseases.

The Promise of Neurotechnology in Clinical Translational Science.

PubMed

White, Susan W; Richey, John A; Gracanin, Denis; Bell, Martha Ann; LaConte, Stephen; Coffman, Marika; Trubanova, Andrea; Kim, Inyoung

2015-09-01

Neurotechnology is broadly defined as a set of devices used to understand neural processes and applications that can potentially facilitate the brain's ability to repair itself. In the past decade, an increasingly explicit understanding of basic biological mechanisms of brain-related illnesses has produced applications that allow a direct yet noninvasive method to index and manipulate the functioning of the human nervous system. Clinical scientists are poised to apply this technology to assess, treat, and better understand complex socioemotional processes that underlie many forms of psychopathology. In this review, we describe the potential benefits and hurdles, both technical and methodological, of neurotechnology in the context of clinical dysfunction. We also offer a framework for developing and evaluating neurotechnologies that is intended to expedite progress at the nexus of clinical science and neural interface designs by providing a comprehensive vocabulary to describe the necessary features of neurotechnology in the clinic.

The Promise of Neurotechnology in Clinical Translational Science

PubMed Central

White, Susan W.; Richey, John A.; Gracanin, Denis; Bell, Martha Ann; LaConte, Stephen; Coffman, Marika; Trubanova, Andrea; Kim, Inyoung

2014-01-01

Neurotechnology is broadly defined as a set of devices used to understand neural processes and applications that can potentially facilitate the brain’s ability to repair itself. In the past decade, an increasingly explicit understanding of basic biological mechanisms of brain-related illnesses has produced applications that allow a direct yet noninvasive method to index and manipulate the functioning of the human nervous system. Clinical scientists are poised to apply this technology to assess, treat, and better understand complex socioemotional processes that underlie many forms of psychopathology. In this review, we describe the potential benefits and hurdles, both technical and methodological, of neurotechnology in the context of clinical dysfunction. We also offer a framework for developing and evaluating neurotechnologies that is intended to expedite progress at the nexus of clinical science and neural interface designs by providing a comprehensive vocabulary to describe the necessary features of neurotechnology in the clinic. PMID:26504676

Clinical recommendations of cardiac magnetic resonance, Part I: ischemic and valvular heart disease: a position paper of the working group 'Applicazioni della Risonanza Magnetica' of the Italian Society of Cardiology.

PubMed

Aquaro, Giovanni Donato; Di Bella, Gianluca; Castelletti, Silvia; Maestrini, Viviana; Festa, Pierluigi; Ait-Ali, Lamia; Masci, Pier Giorgio; Monti, Lorenzo; di Giovine, Gabriella; De Lazzari, Manuel; Cipriani, Alberto; Guaricci, Andrea I; Dellegrottaglie, Santo; Pepe, Alessia; Marra, Martina Perazzolo; Pontone, Gianluca

2017-04-01

Cardiac magnetic resonance (CMR) has emerged as a reliable and accurate diagnostic tool for the evaluation of patients with cardiac disease in several clinical settings and with proven additional diagnostic and prognostic value compared with other imaging modalities. This document has been developed by the working group on the 'application of CMR' of the Italian Society of Cardiology to provide a perspective on the current state of technical advances and clinical applications of CMR and to inform cardiologists on how to implement their clinical and diagnostic pathways with the inclusion of this technique in clinical practice. The writing committee consisted of members of the working group of the Italian Society of Cardiology and two external peer reviewers with acknowledged experience in the field of CMR.

Development of a digital clinical pathway for emergency medicine: Lessons from usability testing and implementation failure.

PubMed

Gutenstein, Marc; Pickering, John W; Than, Martin

2018-06-01

Clinical pathways are used to support the management of patients in emergency departments. An existing document-based clinical pathway was used as the foundation on which to design and build a digital clinical pathway for acute chest pain, with the aim of improving clinical calculations, clinician decision-making, documentation, and data collection. Established principles of decision support system design were used to build an application within the existing electronic health record, before testing with a multidisciplinary team of doctors using a think-aloud protocol. Technical authoring was successful, however, usability testing revealed that the user experience and the flexibility of workflow within the application were critical barriers to implementation. Emergency medicine and acute care decision support systems face particular challenges to existing models of linear workflow that should be deliberately addressed in digital pathway design. We make key recommendations regarding digital pathway design in emergency medicine.

Barriers to the clinical translation of orthopedic tissue engineering.

PubMed

Evans, Christopher H

2011-12-01

Tissue engineering and regenerative medicine have been the subject of increasingly intensive research for over 20 years, and there is concern in some quarters over the lack of clinically useful products despite the large sums of money invested. This review provides one perspective on orthopedic applications from a biologist working in academia. It is suggested that the delay in clinical application is not atypical of new, biologically based technologies. Some barriers to progress are acknowledged and discussed, but it is also noted that preclinical studies have identified several promising types of cells, scaffolds, and morphogenetic signals, which, although not optimal, are worth advancing toward human trials to establish a bridgehead in the clinic. Although this transitional technology will be replaced by more sophisticated, subsequent systems, it will perform valuable pioneering functions and facilitate the clinical development of the field. Some strategies for achieving this are suggested. © Mary Ann Liebert, Inc.

An Environment for Guideline-based Decision Support Systems for Outpatients Monitoring.

PubMed

Zini, Elisa M; Lanzola, Giordano; Bossi, Paolo; Quaglini, Silvana

2017-08-11

We propose an architecture for monitoring outpatients that relies on mobile technologies for acquiring data. The goal is to better control the onset of possible side effects between the scheduled visits at the clinic. We analyze the architectural components required to ensure a high level of abstraction from data. Clinical practice guidelines were formalized with Alium, an authoring tool based on the PROforma language, using SNOMED-CT as a terminology standard. The Alium engine is accessible through a set of APIs that may be leveraged for implementing an application based on standard web technologies to be used by doctors at the clinic. Data sent by patients using mobile devices need to be complemented with those already available in the Electronic Health Record to generate personalized recommendations. Thus a middleware pursuing data abstraction is required. To comply with current standards, we adopted the HL7 Virtual Medical Record for Clinical Decision Support Logical Model, Release 2. The developed architecture for monitoring outpatients includes: (1) a guideline-based Decision Support System accessible through a web application that helps the doctors with prevention, diagnosis and treatment of therapy side effects; (2) an application for mobile devices, which allows patients to regularly send data to the clinic. In order to tailor the monitoring procedures to the specific patient, the Decision Support System also helps physicians with the configuration of the mobile application, suggesting the data to be collected and the associated collection frequency that may change over time, according to the individual patient's conditions. A proof of concept has been developed with a system for monitoring the side effects of chemo-radiotherapy in head and neck cancer patients. Our environment introduces two main innovation elements with respect to similar works available in the literature. First, in order to meet the specific patients' needs, in our work the Decision Support System also helps the physicians in properly configuring the mobile application. Then the Decision Support System is also continuously fed by patient-reported outcomes.

Biological Gene Delivery Vehicles: Beyond Viral Vectors

PubMed Central

Seow, Yiqi; Wood, Matthew J

2009-01-01

Gene therapy covers a broad spectrum of applications, from gene replacement and knockdown for genetic or acquired diseases such as cancer, to vaccination, each with different requirements for gene delivery. Viral vectors and synthetic liposomes have emerged as the vehicles of choice for many applications today, but both have limitations and risks, including complexity of production, limited packaging capacity, and unfavorable immunological features, which restrict gene therapy applications and hold back the potential for preventive gene therapy. While continuing to improve these vectors, it is important to investigate other options, particularly nonviral biological agents which include bacteria, bacteriophage, virus-like particles (VLPs), erythrocyte ghosts, and exosomes. Exploiting the natural properties of these biological entities for specific gene delivery applications will expand the repertoire of gene therapy vectors available for clinical use. Here, we review the prospects for nonviral biological delivery vehicles as gene therapy agents with focus on their unique evolved biological properties and respective limitations and potential applications. The potential of these nonviral biological entities to act as clinical gene therapy delivery vehicles has already been shown in clinical trials using bacteria-mediated gene transfer and with sufficient development, these entities will complement the established delivery techniques for gene therapy applications. PMID:19277019

Biological gene delivery vehicles: beyond viral vectors.

PubMed

Seow, Yiqi; Wood, Matthew J

2009-05-01

Gene therapy covers a broad spectrum of applications, from gene replacement and knockdown for genetic or acquired diseases such as cancer, to vaccination, each with different requirements for gene delivery. Viral vectors and synthetic liposomes have emerged as the vehicles of choice for many applications today, but both have limitations and risks, including complexity of production, limited packaging capacity, and unfavorable immunological features, which restrict gene therapy applications and hold back the potential for preventive gene therapy. While continuing to improve these vectors, it is important to investigate other options, particularly nonviral biological agents which include bacteria, bacteriophage, virus-like particles (VLPs), erythrocyte ghosts, and exosomes. Exploiting the natural properties of these biological entities for specific gene delivery applications will expand the repertoire of gene therapy vectors available for clinical use. Here, we review the prospects for nonviral biological delivery vehicles as gene therapy agents with focus on their unique evolved biological properties and respective limitations and potential applications. The potential of these nonviral biological entities to act as clinical gene therapy delivery vehicles has already been shown in clinical trials using bacteria-mediated gene transfer and with sufficient development, these entities will complement the established delivery techniques for gene therapy applications.

A Review of Progress in Clinical Photodynamic Therapy

PubMed Central

Huang, Zheng

2005-01-01

Photodynamic therapy (PDT) has received increased attention since the regulatory approvals have been granted to several photosensitizing drugs and light applicators world-wide. Much progress has been seen in basic sciences and clinical photodynamics in recent years. This review will focus on new developments of clinical investigation and discuss the usefulness of various forms of PDT techniques for curative or palliative treatment of malignant and non-malignant diseases. PMID:15896084

[The development of a distribution system for medical lasers and its clinical application].

PubMed

Okae, S; Ishiguchi, T; Ishigaki, T; Sakuma, S

1991-02-25

We developed a new laser beam generator system which can deliver laser beam to multiple terminals in distant clinical therapy rooms. The system possesses the distribution equipment by which Nd-YAG laser power is distributed to 8 output terminals under the computer control. Distributed laser beam is delivered to each distant terminal with clinical informations through the optical fiber. In the fundamental studies, possibility of distant transportation of laser beam (30 m) only with 10% loss of energy and without dangerous heating at the connection parts was shown. There seems to be no disadvantage associated with distribution laser beam. In the clinical study, the system was applied to five patients with the symptoms including hemosputum, esophageal stenosis, hemorrhage, lip ulcer and pain. Clinical usefulness of the system was proved. The advantages of the system are as follows: 1. Benefit of cost reduction due to multiple use of single laser source. 2. No necessity of transport of the equipment. 3. No requirement of a wide space to install the equipment in the distant room. 4. Efficient management and maintenance of the system by centralization. Further improvements, e.g., simultaneous use at multiple terminals and elongation of transportation up to 340 m, make the system more useful for clinical application.

Therapeutic Ultrasound Research And Development From An Industrial And Commercial Perspective

NASA Astrophysics Data System (ADS)

Seip, Ralf

2009-04-01

The objective of this paper is to share the challenges and opportunities as viewed from an industrial and commercial perspective that one encounters when performing therapeutic ultrasound research, development, manufacturing, and sales activities. Research in therapeutic ultrasound has become an active field in the last decade, spurred by technological advances in the areas of transducer materials, control electronics, treatment monitoring techniques, an ever increasing number of clinical applications, and private and governmental funding opportunities. The development of devices and methods utilizing therapeutic ultrasound to cure or manage disease is being pursued by startup companies and large established companies alike, driven by the promise of profiting at many levels from this new and disruptive technology. Widespread penetration within the clinical community remains elusive, with current approaches focusing on very specific applications and niche markets. Challenges include difficulties in securing capital to develop the technology and undertake costly clinical trials, a regulatory landscape that varies from country to country, resistance from established practitioners, and difficulties in assembling a team with the right mix of technological savvy and business expertise. Success is possible and increasing, however, as evidenced by several companies, initiatives, and products with measurable benefits to the patient, clinician, and companies alike.

[Surface coils for magnetic-resonance images].

PubMed

Rodríguez-González, Alfredo Odón; Amador-Baheza, Ricardo; Rojas-Jasso, Rafael; Barrios-Alvarez, Fernando Alejandro

2005-01-01

Since the introduction of magnetic resonance imaging in Mexico, the development of this important medical imaging technology has been almost non-existing in our country. The very first surface coil prototypes for clinical applications in magnetic resonance imaging has been developed at the Center of Research in Medical Imaging and Instrumentation of the Universidad Autónoma Metropolitana Iztapalapa (Metropolitan Autonomous University, Campus Iztapalapa). Two surface coil prototypes were built: a) a circular-shaped coil and b) a square-shaped coil for multiple regions of the body, such as heart, brain, knee, hands, and ankles. These coils were tested on the 1.5T imager of the ABC Hospital-Tacubaya, located in Mexico City. Brain images of healthy volunteers were obtained in different orientations: sagittal, coronal, and axial. Since images showed a good-enough clinical quality for diagnosis, it is fair to say that these coil prototypes can be used in the clinical environment, and with small modifications, they can be made compatible with almost any commercial scanner. This type of development can offer new alternatives for further collaboration between the research centers and the radiology community, in the search of new applications and developments of this imaging technique.

Clinical applications of squamous cell carcinoma antigen-immunoglobulins M to monitor chronic hepatitis C

PubMed Central

Martini, Andrea; Gallotta, Andrea; Pontisso, Patrizia; Fassina, Giorgio

2015-01-01

Hepatitis C virus (HCV) is the main cause of chronic liver disease and cirrhosis in Western countries. Over time, the majority of cirrhotic patients develop hepatocellular carcinoma (HCC), one of the most common fatal cancers worldwide - fourth for incidence rate. A high public health priority need is the development of biomarkers to screen for liver disease progression and for early diagnosis of HCC development, particularly in the high risk population represented by HCV-positive patients with cirrhosis. Several studies have shown that serological determination of a novel biomarker, squamous cell carcinoma antigen-immunoglobulins M (SCCA-IgM), might be useful to identify patients with progressive liver disease. In the initial part of this review we summarize the main clinical studies that have investigated this new circulating biomarker on HCV-infected patients, providing evidence that in chronic hepatitis C SCCA-IgM may be used to monitor progression of liver disease, and also to assess the virological response to antiviral treatment. In the last part of this review we address other, not less important, clinical applications of this biomarker in hepatology. PMID:26689503

Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research.

PubMed

Julé, Amélie; Furtado, Tamzin; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

2017-01-01

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas-(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally.

Developing a globally applicable evidence-informed competency framework to support capacity strengthening in clinical research

PubMed Central

Julé, Amélie; Boggs, Liam; van Loggerenberg, Francois; Ewing, Victoria; Vahedi, Manhaz; Launois, Pascal; Lang, Trudie

2017-01-01

Capacity development for clinical research is held back by a lack of recognition for the skills acquired through involvement in clinical trials and in other varied types of global health research studies. Although some competency frameworks and associated recognised career pathways exist for different clinical research roles, they mostly apply to a single role or study setting. Our experience supports the need for an integrated approach, looking at the many roles in parallel and at all types of clinical research beyond trials. Here, we propose a single, flexible framework which is applicable to the full global health research team, and can be used for recognising staff by highlighting acquired skills and possible progression between various roles. It can also illuminate where capacity needs strengthening and contribute to raising research engagement. Through systematic analysis of existing competency frameworks and current job descriptions covering 11 distinct, broad clinical research roles, we identified and defined 50 key competencies required by the team as a whole and throughout the study life cycle. The competencies are relevant and adaptable to studies that differ in design, geographical location or disease, and fall in five main areas—(1) Ethics, Quality and Risk Management; (2) Study and Site Management; (3) Research Operations; (4) Scientific Thinking; and (5) Professional Skills. A pilot framework and implementation tools are now available online and in paper format. They have the potential to be a new mechanism for enabling research skills development and career progression for all staff engaged in clinical research globally. PMID:28589027

Orbital atherectomy: device evolution and clinical data.

PubMed

Staniloae, Cezar S; Korabathina, Ravikiran

2014-05-01

A number of atherectomy devices were developed in the last few years. Among them, the DiamondBack 360° Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc) was specifically designed to work in severely calcified plaque. This article reviews the history, mechanism of action, evolution, clinical data, and future applications of this particular atherectomy device.

Group Cognitive-Behavioral Therapy for Insomnia in a VA Mental Health Clinic

ERIC Educational Resources Information Center

Perlman, Lawrence M.; Arnedt, J. Todd; Earnheart, Kristie L.; Gorman, Ashley A.; Shirley, Katherine G.

2008-01-01

Effective cognitive-behavioral therapies for insomnia have been developed over the past 2 decades, but they have not been systematically evaluated in some clinical settings. While insomnia is common among veterans with mental health problems, the availability of effective treatments is limited. We report on the group application of a…

Application of the MALDI Biotyper to clinical microbiology: progress and potential.

PubMed

Kostrzewa, Markus

2018-03-01

The introduction of the MALDI Biotyper in laboratories substantially changed microbiology practice, this has been called a revolution. The system accelerated diagnostic while costs were reduced and accuracy was increased. In just a few years MALDI-TOF MS became the first-line identification tool for microorganisms. Ten years after its introduction, more than 2000 MALDI Biotyper systems are installed in laboratories which are performing routine diagnostic, and the number is still increasing. Areas covered: This article summarises changes in clinical microbiology introduced by the MALDI Biotyper and its effects, as it has been published in peer reviewed articles found in PubMed. Further, the potential of novel developments to increase the value of the system is described. Expert commentary: The MALDI Biotyper has significantly improved clinical microbiology in the area of microorganism identification. Now new developments and applications, e.g. for typing and resistance testing, might further increase its value in clinical microbiology. The systems might get the central diagnostic analyser which is getting integrated into the widely automated microbiology laboratories of the future.

Potential Diagnostic and Therapeutic Applications of Oligonucleotide Aptamers in Breast Cancer.

PubMed

Wu, Xiaoqiu; Shaikh, Atik Badshah; Yu, Yuanyuan; Li, Yongshu; Ni, Shuaijian; Lu, Aiping; Zhang, Ge

2017-08-25

Breast cancer is one of the most common causes of cancer related deaths in women. Currently, with the development of early detection, increased social awareness and kinds of treatment options, survival rate has improved in nearly every type of breast cancer patients. However, about one third patients still have increased chances of recurrence within five years and the five-year relative survival rate in patients with metastasis is less than 30%. Breast cancer contains multiple subtypes. Each subtype could cause distinct clinical outcomes and systemic interventions. Thereby, new targeted therapies are of particular importance to solve this major clinical problem. Aptamers, often termed "chemical antibodies", are functionally similar to antibodies and have demonstrated their superiority of recognizing target with high selectivity, affinity and stability. With these intrinsic properties, aptamers have been widely studied in cancer biology and some are in clinical trials. In this review, we will firstly discuss about the global impacts and mechanisms of breast cancer, then briefly highlight applications of aptamers that have been developed for breast cancer and finally summarize various challenges in clinical translation of aptamers.

Clinical applications of an ATM/Ethernet network in departments of neuroradiology and radiotherapy.

PubMed

Cimino, C; Pizzi, R; Fusca, M; Bruzzone, M G; Casolino, D; Sicurello, F

1997-01-01

An integrated system for the multimedia management of images and clinical information has been developed at the Isituto Nazionale Neurologico C. Besta in Milan. The Institute physicians have the daily need of consulting images coming from various modalities. The high volume of archived material and the need of retrieving and displaying new and past images and clinical information has motivated the development of a Picture Archiving and Communication System (PACS) for the automatic management of images and clinical data, related not only to the Radiology Department, but also to the Radiotherapy Department for 3D virtual simulation, to remote teleconsulting, and in the following to all the wards, ambulatories and labs.

Nanochannels preparation and application in biosensing.

PubMed

de la Escosura-Muñiz, Alfredo; Merkoçi, Arben

2012-09-25

Selective transport in nanochannels (protein-based ion channels) is already used in living systems for electrical signaling in nerves and muscles, and this natural behavior is being approached for the application of biomimetic nanochannels in biosensors. On the basis of this principle, single nanochannels and nanochannel arrays seem to bring new advantages for biosensor development and applications. The purpose of this review is to provide a general comprehensive and critical overview on the latest trends in the development of nanochannel-based biosensing systems. A detailed description and discussion of representative and recent works covering the main nanochannel fabrication techniques, nanoporous material characterizations, and especially their application in both electrochemical and optical sensing systems is given. The state-of-the-art of the developed technology may open the way to new advances in the integration of nanochannels with (bio)molecules and synthetic receptors for the development of novel biodetection systems that can be extended to many other applications with interest for clinical analysis, safety, and security as well as environmental and other industrial studies and applications.

Diverse Applications of Nanomedicine

PubMed Central

2017-01-01

The design and use of materials in the nanoscale size range for addressing medical and health-related issues continues to receive increasing interest. Research in nanomedicine spans a multitude of areas, including drug delivery, vaccine development, antibacterial, diagnosis and imaging tools, wearable devices, implants, high-throughput screening platforms, etc. using biological, nonbiological, biomimetic, or hybrid materials. Many of these developments are starting to be translated into viable clinical products. Here, we provide an overview of recent developments in nanomedicine and highlight the current challenges and upcoming opportunities for the field and translation to the clinic. PMID:28290206

The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications.

PubMed

de Graaf, Gimon; Postmus, Douwe; Westerink, Jan; Buskens, Erik

2018-01-01

Translating prognostic and diagnostic biomarker candidates into clinical applications takes time, is very costly, and many candidates fail. It is therefore crucial to be able to select those biomarker candidates that have the highest chance of successfully being adopted in the clinic. This requires an early estimate of the potential clinical impact and commercial value. In this paper, we aim to demonstratively evaluate a set of novel biomarkers in terms of clinical impact and commercial value, using occurrence of cardiovascular disease (CVD) in type-2 diabetes (DM2) patients as a case study. We defined a clinical application for the novel biomarkers, and subsequently used data from a large cohort study in The Netherlands in a modeling exercise to assess the potential clinical impact and headroom for the biomarkers. The most likely application of the biomarkers would be to identify DM2 patients with a low CVD risk and subsequently withhold statin treatment. As a result, one additional CVD event in every 75 patients may be expected. The expected downstream savings resulted in a headroom for a point-of-care device ranging from €119.09 at a willingness to accept of €0 for one additional CVD event, to €0 at a willingness to accept of €15,614 or more. It is feasible to evaluate novel biomarkers on outcomes directly relevant to technological development and clinical adoption. Importantly, this may be attained at the same point in time and using the same data as used for the evaluation of association with disease and predictive power.

AplusB: A Web Application for Investigating A + B Designs for Phase I Cancer Clinical Trials.

PubMed

Wheeler, Graham M; Sweeting, Michael J; Mander, Adrian P

2016-01-01

In phase I cancer clinical trials, the maximum tolerated dose of a new drug is often found by a dose-escalation method known as the A + B design. We have developed an interactive web application, AplusB, which computes and returns exact operating characteristics of A + B trial designs. The application has a graphical user interface (GUI), requires no programming knowledge and is free to access and use on any device that can open an internet browser. A customised report is available for download for each design that contains tabulated operating characteristics and informative plots, which can then be compared with other dose-escalation methods. We present a step-by-step guide on how to use this application and provide several illustrative examples of its capabilities.

Mobile Clinical Decision Support Systems in Our Hands - Great Potential but also a Concern.

PubMed

Masic, Izet; Begic, Edin

2016-01-01

Due to the powerful computer resources as well as the availability of today's mobile devices, a special field of mobile systems for clinical decision support in medicine has been developed. The benefits of these applications (systems) are: availability of necessary hardware (mobile phones, tablets and phablets are widespread, and can be purchased at a relatively affordable price), availability of mobile applications (free or for a "small" amount of money) and also mobile applications are tailored for easy use and save time of clinicians in their daily work. In these systems lies a huge potential, and certainly a great economic benefit, so this issue must be approached multidisciplinary.

Towards advanced OCT clinical applications

NASA Astrophysics Data System (ADS)

Kirillin, Mikhail; Panteleeva, Olga; Agrba, Pavel; Pasukhin, Mikhail; Sergeeva, Ekaterina; Plankina, Elena; Dudenkova, Varvara; Gubarkova, Ekaterina; Kiseleva, Elena; Gladkova, Natalia; Shakhova, Natalia; Vitkin, Alex

2015-07-01

In this paper we report on our recent achievement in application of conventional and cross-polarization OCT (CP OCT) modalities for in vivo clinical diagnostics in different medical areas including gynecology, dermatology, and stomatology. In gynecology, CP OCT was employed for diagnosing fallopian tubes and cervix; in dermatology OCT for monitoring of treatment of psoriasis, scleroderma and atopic dermatitis; and in stomatology for diagnosis of oral diseases. For all considered application, we propose and develop different image processing methods which enhance the diagnostic value of the technique. In particular, we use histogram analysis, Fourier analysis and neural networks, thus calculating different tissue characteristics as revealed by OCT's polarization evolution. These approaches enable improved OCT image quantification and increase its resultant diagnostic accuracy.

Tissue engineering, stem cells, and cloning for the regeneration of urologic organs.

PubMed

Atala, Anthony

2003-10-01

Tissue engineering efforts are currently being undertaken for every type of tissue and organ within the urinary system. Most of the effort expended to engineer genitourinary tissues has occurred within the last decade. Tissue engineering techniques require a cell culture facility designed for human application. Personnel who have mastered the techniques of cell harvest, culture, and expansion as well as polymer design are essential for the successful application of this technology. Various engineered genitourinary tissues are at different stages of development, with some already being used clinically, a few in preclinical trials, and some in the discovery stage. Recent progress suggests that engineered urologic tissues may have an expanded clinical applicability in the future.

Development of a Lifespan-Based Novel Composite Person-Reported Outcome Measure Using Data from the CINRG Duchenne Natural History Study

DTIC Science & Technology

2016-10-01

and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation. REPORT...Applicability: Well- designed CAT-PRO questionnaires can be used in both clinical trials and day-to-day clinical practice. For clinical trials, they provide...confirm that items are responsive to self-reported changes in milestone ability over a time period consistent with design of contemporary clinical

Exploring New Frontiers of Microsurgery: From Anatomy to Clinical Methods.

PubMed

Wang, Zeng Tao; Zheng, You Mao; Zhu, Lei; Hao, Li Wen; Zhang, Ya Bin; Chen, Chao; Xia, Li Feng; Liu, Lin Feng

2017-04-01

This article presents the authors' understanding and experience concerning anatomic studies and clinical methods in microsurgical hand reconstruction. The 4 parts of this article include anatomic study of the hand for developing new flaps; application of miniflaps from the hand, including clinical experience with 8 unique flaps in the hand; anatomic and clinical considerations concerning several flaps from other parts of the human body; And our experience with vascularized free toe joint transfer. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical Pharmacology & Therapeutics: Past, Present, and Future.

PubMed

Waldman, S A; Terzic, A

2017-03-01

Clinical Pharmacology & Therapeutics (CPT), the definitive and timely source for advances in human therapeutics, transcends the drug discovery, development, regulation, and utilization continuum to catalyze, evolve, and disseminate discipline-transformative knowledge. Prioritized themes and multidisciplinary content drive the science and practice of clinical pharmacology, offering a trusted point of reference. An authoritative herald across global communities, CPT is a timeless information vehicle at the vanguard of discovery, translation, and application ushering therapeutic innovation into modern healthcare. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Interoperability of medical device information and the clinical applications: an HL7 RMIM based on the ISO/IEEE 11073 DIM.

PubMed

Yuksel, Mustafa; Dogac, Asuman

2011-07-01

Medical devices are essential to the practice of modern healthcare services. Their benefits will increase if clinical software applications can seamlessly acquire the medical device data. The need to represent medical device observations in a format that can be consumable by clinical applications has already been recognized by the industry. Yet, the solutions proposed involve bilateral mappings from the ISO/IEEE 11073 Domain Information Model (DIM) to specific message or document standards. Considering that there are many different types of clinical applications such as the electronic health record and the personal health record systems, the clinical workflows, and the clinical decision support systems each conforming to different standard interfaces, detailing a mapping mechanism for every one of them introduces significant work and, thus, limits the potential health benefits of medical devices. In this paper, to facilitate the interoperability of clinical applications and the medical device data, we use the ISO/IEEE 11073 DIM to derive an HL7 v3 Refined Message Information Model (RMIM) of the medical device domain from the HL7 v3 Reference Information Mode (RIM). This makes it possible to trace the medical device data back to a standard common denominator, that is, HL7 v3 RIM from which all the other medical domains under HL7 v3 are derived. Hence, once the medical device data are obtained in the RMIM format, it can easily be transformed into HL7-based standard interfaces through XML transformations because these interfaces all have their building blocks from the same RIM. To demonstrate this, we provide the mappings from the developed RMIM to some of the widely used HL7 v3-based standard interfaces.

Congruent leadership: values in action.

PubMed

Stanley, David

2008-07-01

To discuss the significance of an appropriate leadership theory in order to develop an understanding of clinical leadership. Leadership theories developed from management and related paradigms, particularly transformational leadership, may be ineffective in supporting nurses to gain insights into clinical leadership or to develop and implement clinical leadership skills. Instead, congruent leadership theory, based on a match between the clinical leaders' actions and their values and beliefs about care and nursing, may offer a more firm theoretical foundation on which clinical nurses can build an understanding of and capacity to implement clinical leadership or become clinical leaders. Evaluation The information used is drawn from the contemporary literature and a study conducted by the author. Leadership can be better understood when an appropriate theoretical foundation is employed. With regard to clinical leadership, congruent leadership is proposed as the most appropriate theory. It is important to recognize that leadership theories based on a management paradigm may not be appropriate for all clinical applications. Education should be aimed specifically at clinical leaders, recognizing that clinical leaders are followed not for their vision or creativity (even if they demonstrate these), but because they translate their values and beliefs about care into action.

Translational research in genomics of Alzheimer's disease: a review of current practice and future perspectives.

PubMed

Mihaescu, Raluca; Detmar, Symone B; Cornel, Martina C; van der Flier, Wiesje M; Heutink, Peter; Hol, Elly M; Rikkert, Marcel G M Olde; van Duijn, Cornelia M; Janssens, A Cecile J W

2010-01-01

Alzheimer's disease (AD) is the most prevalent form of dementia and the number of cases is expected to increase exponentially worldwide. Three highly penetrant genes (AbetaPP, PSEN1, and PSEN2) explain only a small number of AD cases with a Mendelian transmission pattern. Many genes have been analyzed for association with non-Mendelian AD, but the only consistently replicated finding is APOE. At present, possibilities for prevention, early detection, and treatment of the disease are limited. Predictive and diagnostic genetic testing is available only in Mendelian forms of AD. Currently, APOE genotyping is not considered clinically useful for screening, presymptomatic testing, or clinical diagnosis of non-Mendelian AD. However, clinical management of the disease is expected to benefit from the rapid pace of discoveries in the genomics of AD. Following a recently developed framework for the continuum of translation research that is needed to move genetic discoveries to health applications, this paper reviews recent genetic discoveries as well as translational research on genomic applications in the prevention, early detection, and treatment of AD. The four phases of translation research include: 1) translation of basic genomics research into a potential health care application; 2) evaluation of the application for the development of evidence-based guidelines; 3) evaluation of the implementation and use of the application in health care practice; and 4) evaluation of the achieved population health impact. Most research on genome-based applications in AD is still in the first phase of the translational research framework, which means that further research is still needed before their implementation can be considered.

Practice of Regulatory Science (Development of Medical Devices).

PubMed

Niimi, Shingo

2017-01-01

Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

Physiotherapy in Rheumatoid Arthritis

PubMed Central

Kavuncu, Vural; Evcik, Deniz

2004-01-01

Rheumatoid arthritis (RA) is a chronic and painful clinical condition that leads to progressive joint damage, disability, deterioration in quality of life, and shortened life expectancy. Even mild inflammation may result in irreversible damage and permanent disability. The clinical course according to symptoms may be either intermittent or progressive in patients with RA. In most patients, the clinical course is progressive, and structural damage develops in the first 2 years. The aim of RA management is to achieve pain relief and prevent joint damage and functional loss. Physiotherapy and rehabilitation applications significantly augment medical therapy by improving the management of RA and reducing handicaps in daily living for patients with RA. In this review, the application of physiotherapy modalities is examined, including the use of cold/heat applications, electrical stimulation, and hydrotherapy. Rehabilitation treatment techniques for patients with RA such as joint protection strategies, massage, exercise, and patient education are also presented. PMID:15266230

Computer-aided design and manufacturing of surgical templates and their clinical applications: a review.

PubMed

Chen, Xiaojun; Xu, Lu; Wang, Wei; Li, Xing; Sun, Yi; Politis, Constantinus

2016-09-01

The surgical template is a guide aimed at directing the implant placement, tumor resection, osteotomy and bone repositioning. Using it, preoperative planning can be transferred to the actual surgical site, and the precision, safety and reliability of the surgery can be improved. However, the actual workflow of the surgical template design and manufacturing is quite complicated before the final clinical application. The major goal of the paper is to provide a comprehensive reference source of the current and future development of the template design and manufacturing for relevant researchers. Expert commentary: This paper aims to present a review of the necessary procedures in the template-guided surgery including the image processing, 3D visualization, preoperative planning, surgical guide design and manufacturing. In addition, the template-guided clinical applications for various kinds of surgeries are reviewed, and it demonstrated that the precision of the surgery has been improved compared with the non-guided operations.

Preclinical evaluation of injectable sirolimus formulated with polymeric nanoparticle for cancer therapy

PubMed Central

Woo, Ha Na; Chung, Hye Kyung; Ju, Eun Jin; Jung, Joohee; Kang, Hye-Won; Lee, Sa-Won; Seo, Min-Hyo; Lee, Jin Seong; Lee, Jung Shin; Park, Heon Joo; Song, Si Yeol; Jeong, Seong-Yun; Choi, Eun Kyung

2012-01-01

Nanoparticles are useful delivery vehicles for promising drug candidates that face obstacles for clinical applicability. Sirolimus, an inhibitor of mammalian target of rapamycin has gained attention for targeted anticancer therapy, but its clinical application has been limited by its poor solubility. This study was designed to enhance the feasibility of sirolimus for human cancer treatment. Polymeric nanoparticle (PNP)–sirolimus was developed as an injectable formulation and has been characterized by transmission electron microscopy and dynamic light scattering. Pharmacokinetic analysis revealed that PNP–sirolimus has prolonged circulation in the blood. In addition, PNP–sirolimus preserved the in vitro killing effect of free sirolimus against cancer cells, and intravenous administration displayed its potent in vivo anticancer efficacy in xenograft tumor mice. In addition, PNP–sirolimus enhanced the radiotherapeutic efficacy of sirolimus both in vitro and in vivo. Clinical application of PNP–sirolimus is a promising strategy for human cancer treatment. PMID:22619555

Application of Quality by Design Approach to Bioanalysis: Development of a Method for Elvitegravir Quantification in Human Plasma.

PubMed

Baldelli, Sara; Marrubini, Giorgio; Cattaneo, Dario; Clementi, Emilio; Cerea, Matteo

2017-10-01

The application of Quality by Design (QbD) principles in clinical laboratories can help to develop an analytical method through a systematic approach, providing a significant advance over the traditional heuristic and empirical methodology. In this work, we applied for the first time the QbD concept in the development of a method for drug quantification in human plasma using elvitegravir as the test molecule. The goal of the study was to develop a fast and inexpensive quantification method, with precision and accuracy as requested by the European Medicines Agency guidelines on bioanalytical method validation. The method was divided into operative units, and for each unit critical variables affecting the results were identified. A risk analysis was performed to select critical process parameters that should be introduced in the design of experiments (DoEs). Different DoEs were used depending on the phase of advancement of the study. Protein precipitation and high-performance liquid chromatography-tandem mass spectrometry were selected as the techniques to be investigated. For every operative unit (sample preparation, chromatographic conditions, and detector settings), a model based on factors affecting the responses was developed and optimized. The obtained method was validated and clinically applied with success. To the best of our knowledge, this is the first investigation thoroughly addressing the application of QbD to the analysis of a drug in a biological matrix applied in a clinical laboratory. The extensive optimization process generated a robust method compliant with its intended use. The performance of the method is continuously monitored using control charts.

Ten factors to consider when developing usability scenarios and tasks for health information technology.

PubMed

Russ, Alissa L; Saleem, Jason J

2018-02-01

The quality of usability testing is highly dependent upon the associated usability scenarios. To promote usability testing as part of electronic health record (EHR) certification, the Office of the National Coordinator (ONC) for Health Information Technology requires that vendors test specific capabilities of EHRs with clinical end-users and report their usability testing process - including the test scenarios used - along with the results. The ONC outlines basic expectations for usability testing, but there is little guidance in usability texts or scientific literature on how to develop usability scenarios for healthcare applications. The objective of this article is to outline key factors to consider when developing usability scenarios and tasks to evaluate computer-interface based health information technologies. To achieve this goal, we draw upon a decade of our experience conducting usability tests with a variety of healthcare applications and a wide range of end-users, to include healthcare professionals as well as patients. We discuss 10 key factors that influence scenario development: objectives of usability testing; roles of end-user(s); target performance goals; evaluation time constraints; clinical focus; fidelity; scenario-related bias and confounders; embedded probes; minimize risks to end-users; and healthcare related outcome measures. For each factor, we present an illustrative example. This article is intended to aid usability researchers and practitioners in their efforts to advance health information technologies. The article provides broad guidance on usability scenario development and can be applied to a wide range of clinical information systems and applications. Published by Elsevier Inc.

IV-VI semiconductor lasers for gas phase biomarker detection

NASA Astrophysics Data System (ADS)

McCann, Patrick; Namjou, Khosrow; Roller, Chad; McMillen, Gina; Kamat, Pratyuma

2007-09-01

A promising absorption spectroscopy application for mid-IR lasers is exhaled breath analysis where sensitive, selective, and speedy measurement of small gas phase biomarker molecules can be used to diagnose disease and monitor therapies. Many molecules such as nitric oxide, ethane, formaldehyde, acetaldehyde, acetone, carbonyl sulfide, and carbon disulfide have been connected to diseases or conditions such as asthma, oxidative stress, breast cancer, lung cancer, diabetes, organ transplant rejection, and schizophrenia. Measuring these and other, yet to be discovered, biomarker molecules in exhaled breath with mid-IR lasers offers great potential for improving health care since such tests are non-invasive, real-time, and do not require expensive consumables or chemical reagents. Motivated by these potential benefits, mid-IR laser spectrometers equipped with presently available cryogenically-cooled IV-VI lasers mounted in compact Stirling coolers have been developed for clinical research applications. This paper will begin with a description of the development of mid-IR laser instruments and their use in the largest known exhaled breath clinical study ever performed. It will then shift to a description of recent work on the development of new IV-VI semiconductor quantum well materials and laser fabrication methods that offer the promise of low power consumption (i.e. efficient) continuous wave emission at room temperature. Taken together, the demonstration of compelling clinical applications with large market opportunities and the clear identification of a viable pathway to develop low cost mid-IR laser instrumentation can create a renewed focus for future research and development efforts within the mid-IR materials and devices area.

[E-commerce of pharmaceuticals].

PubMed

Shani, Segev

2003-05-01

The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

Aptamers as inhibitors of target proteins.

PubMed

Missailidis, S; Hardy, A

2009-08-01

Aptamers as inhibitors of proteins in therapeutic applications offer great advantages over their antibody counterparts and the promise to be developed into the next generation therapeutic agents. However, the control of aptamer intellectual property (IP) by two major players has made aptamers an area difficult to operate and often off-putting for academic and commercial organisations. Yet, their great potential is keeping aptamers at the research forefront, with one aptamer in the clinic and various at different stages of clinical trials. To provide a comprehensive review of the aptamer IP landscape and the issues associated with aptamer therapeutics against protein targets. Extensive review of the scientific and patent literature. Following our experience in developing, patenting and commercialising our aptamers against MUC1 and an extensive review of the literature, we have identified a variety of issues pertaining to the development of aptamers against protein targets for therapeutic applications, their patenting and granting of patents, the original IP holders and their policy, as well as the current market and traits. Despite a slow start, aptamers have been developed against various therapeutic proteins and offer the promise of providing a novel generation of therapeutic entities with a variety of applications.

Clinical Correlations as a Tool in Basic Science Medical Education

PubMed Central

Klement, Brenda J.; Paulsen, Douglas F.; Wineski, Lawrence E.

2016-01-01

Clinical correlations are tools to assist students in associating basic science concepts with a medical application or disease. There are many forms of clinical correlations and many ways to use them in the classroom. Five types of clinical correlations that may be embedded within basic science courses have been identified and described. (1) Correlated examples consist of superficial clinical information or stories accompanying basic science concepts to make the information more interesting and relevant. (2) Interactive learning and demonstrations provide hands-on experiences or the demonstration of a clinical topic. (3) Specialized workshops have an application-based focus, are more specialized than typical laboratory sessions, and range in complexity from basic to advanced. (4) Small-group activities require groups of students, guided by faculty, to solve simple problems that relate basic science information to clinical topics. (5) Course-centered problem solving is a more advanced correlation activity than the others and focuses on recognition and treatment of clinical problems to promote clinical reasoning skills. Diverse teaching activities are used in basic science medical education, and those that include clinical relevance promote interest, communication, and collaboration, enhance knowledge retention, and help develop clinical reasoning skills. PMID:29349328

SeqReporter: automating next-generation sequencing result interpretation and reporting workflow in a clinical laboratory.

PubMed

Roy, Somak; Durso, Mary Beth; Wald, Abigail; Nikiforov, Yuri E; Nikiforova, Marina N

2014-01-01

A wide repertoire of bioinformatics applications exist for next-generation sequencing data analysis; however, certain requirements of the clinical molecular laboratory limit their use: i) comprehensive report generation, ii) compatibility with existing laboratory information systems and computer operating system, iii) knowledgebase development, iv) quality management, and v) data security. SeqReporter is a web-based application developed using ASP.NET framework version 4.0. The client-side was designed using HTML5, CSS3, and Javascript. The server-side processing (VB.NET) relied on interaction with a customized SQL server 2008 R2 database. Overall, 104 cases (1062 variant calls) were analyzed by SeqReporter. Each variant call was classified into one of five report levels: i) known clinical significance, ii) uncertain clinical significance, iii) pending pathologists' review, iv) synonymous and deep intronic, and v) platform and panel-specific sequence errors. SeqReporter correctly annotated and classified 99.9% (859 of 860) of sequence variants, including 68.7% synonymous single-nucleotide variants, 28.3% nonsynonymous single-nucleotide variants, 1.7% insertions, and 1.3% deletions. One variant of potential clinical significance was re-classified after pathologist review. Laboratory information system-compatible clinical reports were generated automatically. SeqReporter also facilitated quality management activities. SeqReporter is an example of a customized and well-designed informatics solution to optimize and automate the downstream analysis of clinical next-generation sequencing data. We propose it as a model that may envisage the development of a comprehensive clinical informatics solution. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

Current developments and clinical applications of bubble technology in Japan: a report from 85th Annual Scientific Meeting of The Japan Society of Ultrasonic in Medicine, Tokyo, 25-27 May, 2012.

PubMed

Achmad, Arifudin; Taketomi-Takahashi, Ayako; Tsushima, Yoshito

2013-06-01

The potentials of bubble technology in ultrasound has been investigated thoroughly in the last decade. Japan has entered as one of the leaders in bubble technology in ultrasound since Sonazoid (Daiichi Sankyo & GE Healthcare) was marketed in 2007. The 85th Annual Scientific Meeting of The Japan Society of Ultrasonics in Medicine held in Tokyo from May 25 to 27, 2012 is where researchers and clinicians from all over Japan presented recent advances and new developments in ultrasound in both the medical and the engineering aspects of this science. Even though bubble technology was originally developed simply to improve the conventional ultrasound imaging, recent discoveries have opened up powerful emerging applications. Bubble technology is the particular topic to be reviewed in this report, including its mechanical advances for molecular imaging, drug/gene delivery device and sonoporation up to its current clinical application for liver cancers and other liver, gastrointestinal, kidney and breast diseases.

Biomarkers in Prodromal Parkinson Disease: a Qualitative Review.

PubMed

Cooper, Christine A; Chahine, Lama M

2016-11-01

Over the past several years, the concept of prodromal Parkinson disease (PD) has been increasingly recognized. This term refers to individuals who do not fulfill motor diagnostic criteria for PD, but who have clinical, genetic, or biomarker characteristics suggesting risk of developing PD in the future. Clinical diagnosis of prodromal PD has low specificity, prompting the need for objective biomarkers with higher specificity. In this qualitative review, we discuss objectively defined putative biomarkers for PD and prodromal PD. We searched Pubmed and Embase for articles pertaining to objective biomarkers for PD and their application in prodromal cohorts. Articles were selected based on relevance and methodology. Objective biomarkers of demonstrated utility in prodromal PD include ligand-based imaging and transcranial sonography. Development of serum, cerebrospinal fluid, and tissue-based biomarkers is underway, but their application in prodromal PD has yet to meaningfully occur. Combining objective biomarkers with clinical or genetic prodromal features increases the sensitivity and specificity for identifying prodromal PD. Several objective biomarkers for prodromal PD show promise but require further study, including their application to and validation in prodromal cohorts followed longitudinally. Accurate identification of prodromal PD will likely require a multimodal approach. (JINS, 2016, 22, 956-967).

Structuring of Hydrogels across Multiple Length Scales for Biomedical Applications.

PubMed

Cooke, Megan E; Jones, Simon W; Ter Horst, Britt; Moiemen, Naiem; Snow, Martyn; Chouhan, Gurpreet; Hill, Lisa J; Esmaeli, Maryam; Moakes, Richard J A; Holton, James; Nandra, Rajpal; Williams, Richard L; Smith, Alan M; Grover, Liam M

2018-04-01

The development of new materials for clinical use is limited by an onerous regulatory framework, which means that taking a completely new material into the clinic can make translation economically unfeasible. One way to get around this issue is to structure materials that are already approved by the regulator, such that they exhibit very distinct physical properties and can be used in a broader range of clinical applications. Here, the focus is on the structuring of soft materials at multiple length scales by modifying processing conditions. By applying shear to newly forming materials, it is possible to trigger molecular reorganization of polymer chains, such that they aggregate to form particles and ribbon-like structures. These structures then weakly interact at zero shear forming a solid-like material. The resulting self-healing network is of particular use for a range of different biomedical applications. How these materials are used to allow the delivery of therapeutic entities (cells and proteins) and as a support for additive layer manufacturing of larger-scale tissue constructs is discussed. This technology enables the development of a range of novel materials and structures for tissue augmentation and regeneration. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[Exploration of Recent Mobile Technologies Applied in Nursing Education].

PubMed

Wu, Ting-Ting; Lu, Yi-Chen; Chang, Lei

2017-12-01

The development of science and technology has fundamentally changed people's lives and the way that medical systems function. Increasingly, mobile technologies are being introduced and integrated into classroom teaching and clinical applications, resulting in healthcare providers introducing innovative applications into health education. These applications enhance the clinical, education, and research expertise of medical staffs and nurses, while improving quality of care and providing new experiences for patients. In order to understand the current situation and trends in nursing education, the present study adopted literature analysis to explore the influence and effect of mobile technologies that have been introduced into nursing education from the school and clinical environments. The results found that students hold positive attitudes toward introducing these technologies into their curricula. Although these technologies may increase the work efficiency of nurses in the workplace, questions remain user perceptions and professional expression. Therefore, securing patient agreement and healthcare system approval were major turning points in the introduction of mobile technologies into nursing education. In the future, adapting mobile technologies for use in teaching materials and courses may be further developed. Moreover, empirical studies may be used in future research in order to facilitate the increasingly successful integration of relevant technologies into nursing education.

Clinical EPR: Unique Opportunities and Some Challenges

PubMed Central

Swartz, Harold M.; Williams, Benjamin B.; Zaki, Bassem I.; Hartford, Alan C.; Jarvis, Lesley A.; Chen, Eunice; Comi, Richard J.; Ernstoff, Marc S.; Hou, Huagang; Khan, Nadeem; Swarts, Steven G.; Flood, Ann B.; Kuppusamy, Periannan

2014-01-01

Electron paramagnetic resonance (EPR) spectroscopy has been well established as a viable technique for measurement of free radicals and oxygen in biological systems, from in vitro cellular systems to in vivo small animal models of disease. However, the use of EPR in human subjects in the clinical setting, although attractive for a variety of important applications such as oxygen measurement, is challenged with several factors including the need for instrumentation customized for human subjects, probe and regulatory constraints. This paper describes the rationale and development of the first clinical EPR systems for two important clinical applications, namely, measurement of tissue oxygen (oximetry), and radiation dose (dosimetry) in humans. The clinical spectrometers operate at 1.2 GHz frequency and use surface loop resonators capable of providing topical measurements up to 1 cm depth in tissues. Tissue pO2 measurements can be carried out noninvasively and repeatedly after placement of an oxygen-sensitive paramagnetic material (currently India ink) at the site of interest. Our EPR dosimetry system is capable of measuring radiation-induced free radicals in the tooth of irradiated human subjects to determine the exposure dose. These developments offer potential opportunities for clinical dosimetry and oximetry, which include guiding therapy for individual patients with tumors or vascular disease, by monitoring of tissue oxygenation. Further work is in progress to translate this unique technology to routine clinical practice. PMID:24439333

Ngi and Internet2: accelerating the creation of tomorrow's internet.

PubMed

Kratz, M; Ackerman, M; Hanss, T; Corbato, S

2001-01-01

Internet2 is a consortium of leading U.S. universities working in partnership with industry and the U.S. government's Next Generation Internet (NGI) initiative to develop a faster, more reliable Internet for research and education including enhanced, high-performance networking services and the advanced applications that are enabled by those services [1]. By facilitating and coordinating the development, deployment, operation, and technology transfer of advanced, network-based applications and network services, Internet2 and NGI are working together to fundamentally change the way scientists, engineers, clinicians, and others work together. [http://www.internet2.edu] The NGI Program has three tracks: research, network testbeds, and applications. The aim of the research track is to promote experimentation with the next generation of network technologies. The network testbed track aims to develop next generation network testbeds to connect universities and federal research institutions at speeds that are sufficient to demonstrate new technologies and support future research. The aim of the applications track is to demonstrate new applications, enabled by the NGI networks, to meet important national goals and missions [2]. [http://www.ngi.gov/] The Internet2/NGI backbone networks, Abilene and vBNS (very high performance Backbone Network Service), provide the basis of collaboration and development for a new breed of advanced medical applications. Academic medical centers leverage the resources available throughout the Internet2 high-performance networking community for high-capacity broadband and selectable quality of service to make effective use of national repositories. The Internet2 Health Sciences Initiative enables a new generation of emerging medical applications whose architecture and development have been restricted by or are beyond the constraints of traditional Internet environments. These initiatives facilitate a variety of activities to foster the development and deployment of emerging applications that meet the requirements of clinical practice, medical and related biological research, education, and medical awareness throughout the public sector. Medical applications that work with high performance networks and supercomputing capabilities offer exciting new solutions for the medical industry. Internet2 and NGI,strive to combine the expertise of their constituents to establish a distributed knowledge system for achieving innovation in research, teaching, learning, and clinical care.

Development of an open metadata schema for prospective clinical research (openPCR) in China.

PubMed

Xu, W; Guan, Z; Sun, J; Wang, Z; Geng, Y

2014-01-01

In China, deployment of electronic data capture (EDC) and clinical data management system (CDMS) for clinical research (CR) is in its very early stage, and about 90% of clinical studies collected and submitted clinical data manually. This work aims to build an open metadata schema for Prospective Clinical Research (openPCR) in China based on openEHR archetypes, in order to help Chinese researchers easily create specific data entry templates for registration, study design and clinical data collection. Singapore Framework for Dublin Core Application Profiles (DCAP) is used to develop openPCR and four steps such as defining the core functional requirements and deducing the core metadata items, developing archetype models, defining metadata terms and creating archetype records, and finally developing implementation syntax are followed. The core functional requirements are divided into three categories: requirements for research registration, requirements for trial design, and requirements for case report form (CRF). 74 metadata items are identified and their Chinese authority names are created. The minimum metadata set of openPCR includes 3 documents, 6 sections, 26 top level data groups, 32 lower data groups and 74 data elements. The top level container in openPCR is composed of public document, internal document and clinical document archetypes. A hierarchical structure of openPCR is established according to Data Structure of Electronic Health Record Architecture and Data Standard of China (Chinese EHR Standard). Metadata attributes are grouped into six parts: identification, definition, representation, relation, usage guides, and administration. OpenPCR is an open metadata schema based on research registration standards, standards of the Clinical Data Interchange Standards Consortium (CDISC) and Chinese healthcare related standards, and is to be publicly available throughout China. It considers future integration of EHR and CR by adopting data structure and data terms in Chinese EHR Standard. Archetypes in openPCR are modularity models and can be separated, recombined, and reused. The authors recommend that the method to develop openPCR can be referenced by other countries when designing metadata schema of clinical research. In the next steps, openPCR should be used in a number of CR projects to test its applicability and to continuously improve its coverage. Besides, metadata schema for research protocol can be developed to structurize and standardize protocol, and syntactical interoperability of openPCR with other related standards can be considered.

Personality: individual differences and clinical assessment.

PubMed

Butcher, J N; Rouse, S V

1996-01-01

Research in clinical personality assessment continues to be produced at a high rate. The MMPI/MMPI-2 remains the most popular instrument for both clinical application and psychopathology research. Two other clinical personality instruments, the Rorschach and TAT, continue to find a place in research and clinical assessment. Some new instruments have surfaced recently to deal with areas, such as personality disorders, that have been considered inadequately addressed. There is a growing recognition that the Five-Factor Model is too superficial for clinical assessment that requires more refined and broadened patient information. Clinical personality assessment has successfully survived a number of past challenges. The newest challenge stems from the health-care revolution, in which managed-care providers are reluctant to pay for assessment because of shrinking funds. Psychologists need to develop models for incorporating assessment information into the treatment process. The future is likely to see more extensive research and theoretical development in this endeavor.

The Use and Abuse of Diagnostic/Classification Criteria

PubMed Central

June, Rayford R.; Aggarwal, Rohit

2015-01-01

In rheumatic diseases, classification criteria have been developed to identify well-defined homogenous cohorts for clinical research. Although, they are commonly used in clinical practice, their use may not be appropriate for routine diagnostic clinical care. Classification criteria are being revised with improved methodology and further understanding of disease pathophysiology, but still may not encompass all unique clinical situations to be applied for diagnosis of heterogeneous, rare, evolving rheumatic diseases. Diagnostic criteria development is challenging primarily due to difficulty for universal application given significant differences in prevalence of rheumatic diseases based on geographical area and clinic settings. Despite these shortcomings, the clinician can still use classification criteria for understanding the disease as well as a guide for diagnosis with a few caveats. We present the limits of current classification criteria, describe their use and abuse in clinical practice, and how they should be used with caution when applied in clinics. PMID:26096094

A review of wearable sensors and systems with application in rehabilitation

PubMed Central

2012-01-01

The aim of this review paper is to summarize recent developments in the field of wearable sensors and systems that are relevant to the field of rehabilitation. The growing body of work focused on the application of wearable technology to monitor older adults and subjects with chronic conditions in the home and community settings justifies the emphasis of this review paper on summarizing clinical applications of wearable technology currently undergoing assessment rather than describing the development of new wearable sensors and systems. A short description of key enabling technologies (i.e. sensor technology, communication technology, and data analysis techniques) that have allowed researchers to implement wearable systems is followed by a detailed description of major areas of application of wearable technology. Applications described in this review paper include those that focus on health and wellness, safety, home rehabilitation, assessment of treatment efficacy, and early detection of disorders. The integration of wearable and ambient sensors is discussed in the context of achieving home monitoring of older adults and subjects with chronic conditions. Future work required to advance the field toward clinical deployment of wearable sensors and systems is discussed. PMID:22520559

Membrane transporters in drug development

PubMed Central

2011-01-01

Membrane transporters can be major determinants of the pharmacokinetic, safety and efficacy profiles of drugs. This presents several key questions for drug development, including which transporters are clinically important in drug absorption and disposition, and which in vitro methods are suitable for studying drug interactions with these transporters. In addition, what criteria should trigger follow-up clinical studies, and which clinical studies should be conducted if needed. In this article, we provide the recommendations of the International Transporter Consortium on these issues, and present decision trees that are intended to help guide clinical studies on the currently recognized most important drug transporter interactions. The recommendations are generally intended to support clinical development and filing of a new drug application. Overall, it is advised that the timing of transporter investigations should be driven by efficacy, safety and clinical trial enrolment questions (for example, exclusion and inclusion criteria), as well as a need for further understanding of the absorption, distribution, metabolism and excretion properties of the drug molecule, and information required for drug labeling. PMID:20190787

A quantitative benefit-risk assessment approach to improve decision making in drug development: Application of a multicriteria decision analysis model in the development of combination therapy for overactive bladder.

PubMed

de Greef-van der Sandt, I; Newgreen, D; Schaddelee, M; Dorrepaal, C; Martina, R; Ridder, A; van Maanen, R

2016-04-01

A multicriteria decision analysis (MCDA) approach was developed and used to estimate the benefit-risk of solifenacin and mirabegron and their combination in the treatment of overactive bladder (OAB). The objectives were 1) to develop an MCDA tool to compare drug effects in OAB quantitatively, 2) to establish transparency in the evaluation of the benefit-risk profile of various dose combinations, and 3) to quantify the added value of combination use compared to monotherapies. The MCDA model was developed using efficacy, safety, and tolerability attributes and the results of a phase II factorial design combination study were evaluated. Combinations of solifenacin 5 mg and mirabegron 25 mg and mirabegron 50 (5+25 and 5+50) scored the highest clinical utility and supported combination therapy development of solifenacin and mirabegron for phase III clinical development at these dose regimens. This case study underlines the benefit of using a quantitative approach in clinical drug development programs. © 2015 The American Society for Clinical Pharmacology and Therapeutics.

Use of an android phone application for automated text messages in international settings: A case study in an HIV clinical trial in St. Petersburg, Russia.

PubMed

Forman, Leah S; Patts, Gregory J; Coleman, Sharon M; Blokhina, Elena; Lu, John; Yaroslavtseva, Tatiana; Gnatienko, Natalia; Krupitsky, Evgeny; Samet, Jeffrey H; Chaisson, Christine E

2018-02-01

Reproducible outcomes in clinical trials depend on adherence to study protocol. Short message service (also known as text message) reminders have been shown to improve clinical trial adherence in the United States and elsewhere. However, due to systematic differences in mobile data plans, languages, and technology, these systems are not easily translated to international settings. To gauge technical capabilities for international projects, we developed SMSMessenger, an automated Android application that uses a US server to send medication reminders to participants in a clinical trial in St. Petersburg, Russia (Zinc for HIV disease among alcohol users-a randomized controlled trial in the Russia Alcohol Research Collaboration on HIV/AIDS cohort). The application is downloaded once onto an Android study phone. When it is time for the text message reminders to be sent, study personnel access the application on a local phone, which in turn accesses the existing clinical trial database hosted on a US web server. The application retrieves a list of participants with the following information: phone number, whether a message should be received at that time, and the appropriate text of the message. The application is capable of storing multiple outgoing messages. With a few clicks, text messages are sent to study participants who can reply directly to the message. Study staff can check the local phone for incoming messages. The SMSMessenger application uses an existing clinical trial database and is able to receive real-time updates. All communications between the application and server are encrypted, and phone numbers are stored in a secure database behind a firewall. No sensitive data are stored on the phone, as outgoing messages are sent through the application and not by messaging features on the phone itself. Messages are sent simultaneously to study participants, which reduces the burden on local study staff. Costs and setup are minimal. The only local requirements are an Android phone and data plan. The SMSMessenger technology could be modified to be applied anywhere in the world, in any language, script, or alphabet, and for many different purposes. The novel application of this existing low-cost technology can improve the usefulness of text messaging in advancing the goals of international clinical trials.

Technology assessment for an integrated PC-based platform for three telemedicine applications

NASA Astrophysics Data System (ADS)

Tohme, Walid G.; Hayes, Wendelin S.; Dai, Hailei L.; Komo, Darmadi; Pahira, John J.; Abernethy, Darrell R.; Rennert, Wolfgang; Kuehl, Karen S.; Hauser, Gabriel J.; Mun, Seong K.

1996-05-01

This paper investigates the design and technical efficacy of an integrated PC based platform for three different medical applications. The technical efficacy of such a telemedicine platform has not been evaluated in the literature and optimal technical requirements have not been developed. The first application, with the Department of Surgery, Division of Urology, tests the utility of a telemedicine platform including radiology images for a surgical stone disease consultation service from an off site location in West Virginia. The second application, with the Department of Internal Medicine, Division of Clinical Pharmacology, investigates the usefulness of telemedicine when used for a clinical pharmacology consultation service from an off-site location. The third application, with the Department of Pediatrics, will test telemedicine for trauma care triage service first within an off-site location in Virginia and then from there to Georgetown University Medical Center.

Application of stereo x-ray photogrammetry (SRM) in the determination of absorbed dose values during intracavitary radiation therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

van Kleffens, H.J.; Star, W.M.

1979-04-01

The method of stereo x-ray photogrammetry is described, using a stereo x-ray comparator, as well as some clinical applications. The x-ray equipment consists of two x-ray tubes and a pneumatically driven cassette changer, developed to reduce effects of patient or organ motion between stero radiographs. The accuracy of the set-up is demonstated with measurements on a geometrical model and on a gelatine phantom containing radium needles. The clinical use is reported in determining dose rates to points of the intestinal wall during intracavitary radiotherapy of gynecological cancer. In a number of cases the stereo measurements have resulted in a changemore » in the application time or in the charge or position of the applicator, possibly preventing later complications, as a result of a high dose. Future applications for implant dosimetry (/sup 192/Ir, /sup 125/I) are suggested.« less