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.

21 CFR 54.4 - Certification and disclosure requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS § 54.4 Certification and disclosure requirements. For purposes of this part, an applicant must submit a list of all clinical investigators who conducted covered clinical studies to determine whether the applicant's product meets FDA's marketing requirements...

Clinical application of near-infrared spectroscopy in patients with traumatic brain injury: a review of the progress of the field.

PubMed

Sen, Anish N; Gopinath, Shankar P; Robertson, Claudia S

2016-07-01

Near-infrared spectroscopy (NIRS) is a technique by which the interaction between light in the near-infrared spectrum and matter can be quantitatively measured to provide information about the particular chromophore. Study into the clinical application of NIRS for traumatic brain injury (TBI) began in the 1990s with early reports of the ability to detect intracranial hematomas using NIRS. We highlight the advances in clinical applications of NIRS over the past two decades as they relate to TBI. We discuss recent studies evaluating NIRS techniques for intracranial hematoma detection, followed by the clinical application of NIRS in intracranial pressure and brain oxygenation measurement, and conclude with a summary of potential future uses of NIRS in TBI patient management.

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

Method of App Selection for Healthcare Providers Based on Consumer Needs.

PubMed

Lee, Jisan; Kim, Jeongeun

2018-01-01

Mobile device applications can be used to manage health. However, healthcare providers hesitate to use them because selection methods that consider the needs of health consumers and identify the most appropriate application are rare. This study aimed to create an effective method of identifying applications that address user needs. Women experiencing dysmenorrhea and premenstrual syndrome were the targeted users. First, we searched for related applications from two major sources of mobile applications. Brainstorming, mind mapping, and persona and scenario techniques were used to create a checklist of relevant criteria, which was used to rate the applications. Of the 2784 applications found, 369 were analyzed quantitatively. Of those, five of the top candidates were evaluated by three groups: application experts, clinical experts, and potential users. All three groups ranked one application the highest; however, the remaining rankings differed. The results of this study suggest that the method created is useful because it considers not only the needs of various users but also the knowledge of application and clinical experts. This study proposes a method for finding and using the best among existing applications and highlights the need for nurses who can understand and combine opinions of users and application and clinical experts.

Factors associated with reporting results for pulmonary clinical trials in ClinicalTrials.gov.

PubMed

Riley, Isaretta L; Boulware, L Ebony; Sun, Jie-Lena; Chiswell, Karen; Que, Loretta G; Kraft, Monica; Todd, Jamie L; Palmer, Scott M; Anderson, Monique L

2018-02-01

Background/aims The Food and Drug Administration Amendments Act mandates that applicable clinical trials report basic summary results to the ClinicalTrials.gov database within 1 year of trial completion or termination. We aimed to determine the proportion of pulmonary trials reporting basic summary results to ClinicalTrials.gov and assess factors associated with reporting. Methods We identified pulmonary clinical trials subject to the Food and Drug Administration Amendments Act (called highly likely applicable clinical trials) that were completed or terminated between 2008 and 2012 and reported results by September 2013. We estimated the cumulative percentage of applicable clinical trials reporting results by pulmonary disease category. Multivariable Cox regression modeling identified characteristics independently associated with results reporting. Results Of 1450 pulmonary highly likely applicable clinical trials, 380 (26%) examined respiratory neoplasms, 238 (16%) asthma, 175 (12%) chronic obstructive pulmonary disease, and 657 (45%) other respiratory diseases. Most (75%) were pharmaceutical highly likely applicable clinical trials and 71% were industry-funded. Approximately 15% of highly likely applicable clinical trials reported results within 1 year of trial completion, while 55% reported results over the 5-year study period. Earlier phase highly likely applicable clinical trials were less likely to report results compared to phase 4 highly likely applicable clinical trials (phases 1/2 and 2 (adjusted hazard ratio 0.41 (95% confidence interval: 0.31-0.54)), phases 2/3 and 3 (adjusted hazard ratio 0.55 (95% confidence interval: 0.42-0.72)) and phase not applicable (adjusted hazard ratio 0.43 (95% confidence interval: 0.29-0.63)). Pulmonary highly likely applicable clinical trials without Food and Drug Administration oversight were less likely to report results compared with those with oversight (adjusted hazard ratio 0.65 (95% confidence interval: 0.51-0.83)). Conclusion A total of 15% of pulmonary clinical highly likely applicable clinical trials report basic summary results to ClinicalTrials.gov within 1 year of trial completion. Strategies to improve reporting are needed within the pulmonary community.

The clinical application of teaching people about pain.

PubMed

Louw, Adriaan; Zimney, Kory; O'Hotto, Christine; Hilton, Sandra

2016-07-01

Teaching people about the neurobiology and neurophysiology of their pain experience has a therapeutic effect and has been referred to as pain neuroscience education (PNE). Various high-quality randomized controlled trials and systematic reviews have shown increasing efficacy of PNE decreasing pain, disability, pain catastrophization, movement restrictions, and healthcare utilization. Research studies, however, by virtue of their design, are very controlled environments and, therefore, in contrast to the ever-increasing evidence for PNE, little is known about the clinical application of this emerging therapy. In contrast, case studies, case series, and expert opinion and perspectives by authorities in the world of pain science provide clinicians with a glimpse into potential "real" clinical application of PNE in the face of the ever-increasing chronic pain epidemic. By taking the material from the randomized controlled trials, systematic reviews, case series, case studies, and expert opinion, this article aims to provide a proposed layout of the clinical application of PNE. The article systematically discusses key elements of PNE including examination, educational content, and delivery methods, merging of PNE with movement, goal setting, and progression. This perspectives article concludes with a call for research into the clinical application of PNE.

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…

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…

Evaluation systems for clinical governance development: a comparative study.

PubMed

Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

2014-01-01

Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

Telerehabilitation store and forward applications: a review of applications and privacy considerations in physical and occupational therapy practice.

PubMed

Peterson, Christopher; Watzlaf, Valerie

2014-01-01

An overview of store and forward applications commonly used in physical and occupational therapy practice is reviewed with respect to regulation, privacy, security, and clinical applications. A privacy and security checklist provides a clear reference of pertinent regulatory issues regarding these software applications. A case study format is used to highlight clinical applications of store and forward software features. Important considerations of successful implementation of store and forward applications are also identified and discussed.

Monitoring healthy and disturbed sleep through smartphone applications: a review of experimental evidence.

PubMed

Fino, Edita; Mazzetti, Michela

2018-04-23

Smartphone applications are considered as the prime candidate for the purposes of large-scale, low-cost and long-term sleep monitoring. How reliable and scientifically grounded is smartphone-based assessment of healthy and disturbed sleep remains a key issue in this direction. Here we offer a review of validation studies of sleep applications to the aim of providing some guidance in terms of their reliability to assess sleep in healthy and clinical populations, and stimulating further examination of their potential for clinical use and improved sleep hygiene. Electronic literature review was conducted on Pubmed. Eleven validation studies published since 2012 were identified, evaluating smartphone applications' performance compared to standard methods of sleep assessment in healthy and clinical samples. Studies with healthy populations show that most sleep applications meet or exceed accuracy levels of wrist-based actigraphy in sleep-wake cycle discrimination, whereas performance levels drop in individuals with low sleep efficiency (SE) and in clinical populations, mirroring actigraphy results. Poor correlation with polysomnography (PSG) sleep sub-stages is reported by most accelerometer-based apps. However, multiple parameter-based applications (i.e., EarlySense, SleepAp) showed good capability in detection of sleep-wake stages and sleep-related breathing disorders (SRBD) like obstructive sleep apnea (OSA) respectively with values similar to PSG. While the reviewed evidence suggests a potential role of smartphone sleep applications in pre-screening of SRBD, more experimental studies are warranted to assess their reliability in sleep-wake detection particularly. Apps' utility in post treatment follow-up at home or as an adjunct to the sleep diary in clinical setting is also stressed.

Balancing the Need for Clinical Photography With Patient Privacy Issues: The Search for a Secure SmartPhone Application to Take and Store Clinical Photographs.

PubMed

Dumestre, Danielle O; Fraulin, Frankie O G

2017-11-01

Physicians are increasingly using smartphones to take clinical photographs. This study evaluates a smartphone application for clinical photography that prioritizes and facilitates patient security. Ethics approval was obtained to trial a smartphone clinical photography application, PicSafe Medi. Calgary plastic surgeons and residents used the application to obtain informed consent and photograph patients. Surveys gauging the application's usability, consent process, and photograph storage/sharing were then sent to surgeons and patients. Over a 6-month trial period, 15 plastic surgeons and residents used the application to photograph 86 patients. Over half of the patients (57%) completed the survey. The majority of patients (96%) were satisfied with the application's consent process, and all felt their photographs were secure. The majority (93%) of surgeons/residents completed the survey. The application was felt to overcome issues with current photography practices: inadequate consent and storage of photographs (100%), risk to patient confidentiality (92%), and unsecure photograph sharing (93%). Barriers to regular use of the application included need for cellphone service/Internet (54%), sanitary concerns due to the need for patients to sign directly on the phone (46%), inability to obtain proactive/retroactive consent (85%), and difficulty viewing photographs (80%). The majority of surgeons (85%) believe a smartphone application would be suitable for clinical patient photography, but due to its limitations, only 23% would use the trialed application. A smartphone clinical photography application addresses the patient confidentiality risks of current photography methods; however, limitations of the trialed application prevent its broad implementation.

Perspective on Clinical Application of Biomarkers in AKI

PubMed Central

Mansour, Sherry G.

2017-01-01

Several biomarkers of renal injury have been identified but the utility of these biomarkers is largely confined to research studies, whereas widespread clinical applicability is limited. This is partly because the use of serum creatinine as the comparator has several limitations and restricts the full interpretation of biomarker performance. To highlight the potential for clinical application of biomarkers, the most pertinent biomarker data are summarized here, using clinically relevant scenarios in which biomarkers could assist with diagnostic and management dilemmas. The paradigms proposed in this review aim to enhance the clinical diagnosis, management, and prognosis of AKI through the combined use of available clinical markers and novel inflammatory, injury, and repair biomarkers. PMID:28220028

Evaluation Criteria for Nursing Student Application of Evidence-Based Practice: A Delphi Study.

PubMed

Bostwick, Lina; Linden, Lois

2016-06-01

Core clinical evaluation criteria do not exist for measuring prelicensure baccalaureate nursing students' application of evidence-based practice (EBP) during direct care assignments. The study objective was to achieve consensus among EBP nursing experts to create clinical criteria for faculty to use in evaluating students' application of EBP principles. A three-round Delphi method was used. Experts were invited to participate in Web-based surveys. Data were analyzed using qualitative coding and categorizing. Quantitative analyses were descriptive calculations for rating and ranking. Expert consensus occurred in the Delphi rounds. The study provides a set of 10 core clinical evaluation criteria for faculty evaluating students' progression toward competency in their application of EBP. A baccalaureate program curriculum requiring the use of Bostwick's EBP Core Clinical Evaluation Criteria will provide a clear definition for understanding basic core EBP competence as expected for the assessment of student learning. [J Nurs Educ. 2016;55(5):336-341.]. Copyright 2016, SLACK Incorporated.

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.

Characteriation of clinical data packages using foreign data in new drug applications in Japan.

PubMed

Tanaka, M; Nagata, T

2008-09-01

The objective of this research was to characterize clinical data packages (CDPs) of new drug applications (NDAs) using foreign data based on the International Conference on Harmonization (ICH) E5 guideline. Official review reports of NDAs approved in Japan between January 1999 and April 2005 were examined. Those NDAs considered by the official reviewers to be approved based on the ICH E5 guideline (E5-NDAs) were identified and classified into six categories of approval requirements in Japan. The details of pivotal clinical efficacy studies in the CDPs were examined. Forty-one NDAs were identified as E5-NDAs. Pivotal clinical studies conducted in Japan were required by the E5-NDAs, except for nine of those in which the foreign clinical studies reduced Japanese clinical studies in the CDPs. Given the differences in approval requirements among regions, the acceptability of foreign clinical data to Japanese approval is limited.

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.

Pilot Clinical Application of an Adaptive Robotic System for Young Children with Autism

ERIC Educational Resources Information Center

Bekele, Esubalew; Crittendon, Julie A.; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E.

2014-01-01

It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small…

The Use of Mesenchymal Stem Cells for the Treatment of Autoimmunity: From Animals Models to Human Disease.

PubMed

Fierabracci, Alessandra; Del Fattore, Andrea; Muraca, Marta; Delfino, Domenico Vittorio; Muraca, Maurizio

2016-01-01

Mesenchymal stem cells are multipotent progenitors able to differentiate into osteoblasts, chondrocytes and adipocytes. These cells also exhibit remarkable immune regulatory properties, which stimulated both in vitro and in vivo experimental studies to unravel the underlying mechanisms as well as extensive clinical applications. Here, we describe the effects of MSCs on immune cells and their application in animal models as well as in clinical trials of autoimmune diseases. It should be pointed out that, while the number of clinical applications is increasing steadily, results should be interpreted with caution, in order to avoid rising false expectations. Major issues conditioning clinical application are the heterogeneity of MSCs and their unpredictable behavior following therapeutic administration. However, increasing knowledge on the interaction between exogenous cell and host tissue, as well as some encouraging clinical observations suggest that the therapeutic applications of MSCs will be further expanded on firmer grounds in the near future.

The STARD statement for reporting diagnostic accuracy studies: application to the history and physical examination.

PubMed

Simel, David L; Rennie, Drummond; Bossuyt, Patrick M M

2008-06-01

The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Nonsystematic review of the STARD statement. Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient's history and physical examination.

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

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 laboratory studies of disinfection with Sporicidin.

PubMed Central

Isenberg, H D

1985-01-01

The clinical microbiology laboratory evaluation of disinfectants can serve as a guide for their application to reduce hospital-acquired infections. The use of Sporicidin, a glutaraldehyde-phenol formulation, was evaluated by the application of modified MIC and MBC determinations for standard organisms. In addition, the effect of this formulation on bacteria that may proliferate in water at ambient temperatures was studied. This investigation indicated that such studies can help the clinical microbiologist to guide the use of disinfectants and sterilants for the maintenance of a safe hospital environment. PMID:3932457

The application of disease management to clinical trial designs.

PubMed

Puterman, Jared; Alter, David A

2009-08-01

The utilization of disease management (DM) as a minimum standard of care is believed to facilitate pronounced benefits in overall patient outcome and cost management. Randomized clinical trials remain the gold standard evaluative tool in clinical medicine. However, the extent to which contemporary cardiovascular clinical trials incorporate DM components into their treatment or control arms is unknown. Our study is the first to evaluate the extent to which clinical trials incorporate DM as a minimum standard of care for both the intervention and control groups. In total, 386 clinical trials published in 3 leading medical journals between 2003 and 2006 were evaluated. For each study, elements related to DM care, as defined using the American Heart Association Taxonomy, were abstracted and characterized. Our results demonstrate that while the application of DM has increased over time, only 3.4% of the clinical trials examined incorporated all 8 DM elements (and only 11% of such trials incorporated 4 DM elements). A significant association was found between study year and the inclusion of more than 3 elements of DM (chi(2) = 10.10 (3); p = 0.018). In addition, associations were found between study objective and DM criteria, as well as between cohort type and domains described. Our study serves as a baseline reference for the tracking of DM within, and its application to, randomized clinical trials. Moreover, our results underscore the need for broader implementation and evaluation of DM as a minimum care standard within clinical trial research.

Experimental application of Business Process Management technology to manage clinical pathways: a pediatric kidney transplantation follow up case.

PubMed

Andellini, Martina; Fernandez Riesgo, Sandra; Morolli, Federica; Ritrovato, Matteo; Cosoli, Piero; Petruzzellis, Silverio; Rosso, Nicola

2017-11-03

To test the application of Business Process Management technology to manage clinical pathways, using a pediatric kidney transplantation as case study, and to identify the benefits obtained from using this technology. Using a Business Process Management platform, we implemented a specific application to manage the clinical pathway of pediatric patients, and monitored the activities of the coordinator in charge of the case management during a 6-month period (from June 2015 to November 2015) using two methodologies: the traditional procedure and the one under study. The application helped physicians and nurses to optimize the amount of time and resources devoted to management purposes. In particular, time reduction was close to 60%. In addition, the reduction of data duplication, the integrated event management and the efficient data collection improved the quality of the service. The use of Business Process Management technology, usually related to well-defined processes with high management costs, is an established procedure in multiple environments; its use in healthcare, however, is innovative. The use of already accepted clinical pathways is known to improve outcomes. The combination of these two techniques, well established in their respective areas of application, could represent a revolution in clinical pathway management. The study has demonstrated that the use of this technology in a clinical environment, using a proper architecture and identifying a well-defined process, leads to real benefits in terms of resources optimization and quality improvement.

Laboratory and clinical trials of cocamide diethanolamine lotion against head lice

PubMed Central

Brunton, Elizabeth R.; Brown, Christine M.

2015-01-01

Context. During the late 1990s, insecticide resistance had rendered a number of treatment products ineffective; some companies saw this as an opportunity to develop alternative types of treatment. We investigated the possibility that a surfactant-based lotion containing 10% cocamide diethanolamine (cocamide DEA) was effective to eliminate head louse infestation. Settings and Design. Initial in vitro testing of the lotion formulation versus laboratory reared body/clothing lice, followed by two randomised, controlled, community-based, assessor blinded, clinical studies. Materials and Methods. Preliminary laboratory tests were performed by exposing lice or louse eggs to the product using a method that mimicked the intended use. Clinical Study 1: Children and adults with confirmed head louse infestation were treated by investigators using a single application of aqueous 10% cocamide DEA lotion applied for 60 min followed by shampooing or a single 1% permethrin creme rinse treatment applied to pre-washed hair for 10 min. Clinical Study 2: Compared two treatment regimens using 10% cocamide DEA lotion that was concentrated by hair drying. A single application left on for 8 h/overnight was compared with two applications 7 days apart of 2 h duration, followed by a shampoo wash. Results. The initial laboratory tests showed a pediculicidal effect for a 60 min application but limited ovicidal effect. A longer application time of 8 h or overnight was found capable of killing all eggs but this differed between batches of test material. Clinical Study 1: Both treatments performed badly with only 3/23 (13%) successful treatments using cocamide DEA and 5/25 (23.8%) using permethrin. Clinical Study 2: The single overnight application of cocamide DEA concentrated by hair drying gave 10/56 (17.9%) successes compared with 19/56 (33.9%) for the 2 h application regimen repeated after 1 week. Intention to treat analysis showed no significant difference (p = 0.0523) between the treatments. Over the two studies, there were 18 adverse events possibly or probably associated with treatment, most of which were increased pruritus after treatment. Conclusions. Cocamide DEA 10% lotion, even when concentrated by hair drying, showed limited activity to eliminate head louse infestation. PMID:26557439

Application development environment for advanced digital workstations

NASA Astrophysics Data System (ADS)

Valentino, Daniel J.; Harreld, Michael R.; Liu, Brent J.; Brown, Matthew S.; Huang, Lu J.

1998-06-01

One remaining barrier to the clinical acceptance of electronic imaging and information systems is the difficulty in providing intuitive access to the information needed for a specific clinical task (such as reaching a diagnosis or tracking clinical progress). The purpose of this research was to create a development environment that enables the design and implementation of advanced digital imaging workstations. We used formal data and process modeling to identify the diagnostic and quantitative data that radiologists use and the tasks that they typically perform to make clinical decisions. We studied a diverse range of radiology applications, including diagnostic neuroradiology in an academic medical center, pediatric radiology in a children's hospital, screening mammography in a breast cancer center, and thoracic radiology consultation for an oncology clinic. We used object- oriented analysis to develop software toolkits that enable a programmer to rapidly implement applications that closely match clinical tasks. The toolkits support browsing patient information, integrating patient images and reports, manipulating images, and making quantitative measurements on images. Collectively, we refer to these toolkits as the UCLA Digital ViewBox toolkit (ViewBox/Tk). We used the ViewBox/Tk to rapidly prototype and develop a number of diverse medical imaging applications. Our task-based toolkit approach enabled rapid and iterative prototyping of workstations that matched clinical tasks. The toolkit functionality and performance provided a 'hands-on' feeling for manipulating images, and for accessing textual information and reports. The toolkits directly support a new concept for protocol based-reading of diagnostic studies. The design supports the implementation of network-based application services (e.g., prefetching, workflow management, and post-processing) that will facilitate the development of future clinical applications.

Ginkgo biloba Extract in Vascular Protection: Molecular Mechanisms and Clinical Applications.

PubMed

Tian, Jinfan; Liu, Yue; Chen, Keji

2017-01-01

Leaves of Ginkgo biloba, a "living fossil," have been used as traditional herbal medicine for hundreds of years in China. Currently, its application in vascular protection is garnering much attention. In this manuscript, preclinical studies were reviewed to discuss various mechanisms underlying the vascular protection by Ginkgo biloba extract (GBE). Additionally, we reviewed clinical studies to present the application of GBE in the ischaemic disease. GBE, a commonly used dietary supplement, has been shown to act as an antioxidant and freeradical scavenger, a membrane stabilizer, an inhibitor of the platelet-activating factor, a vasodilator, and a regulator of metabolism. Currently, there exist a growing number of clinical studies about GBE in the application of cardiovascular disease, peripheral vascular disease (PVD) and diabetic vascular complications. GBE, a promising therapeutic agent for cardiovascular and ischaemic diseases, exerts vascular- protection function by a comprehensive mechanisms. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

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.

[Evaluation of Web-based software applications for administrating and organising an ophthalmological clinical trial site].

PubMed

Kortüm, K; Reznicek, L; Leicht, S; Ulbig, M; Wolf, A

2013-07-01

The importance and complexity of clinical trials is continuously increasing, especially in innovative specialties like ophthalmology. Therefore an efficient clinical trial site organisational structure is essential. In modern internet times, this can be accomplished by web-based applications. In total, 3 software applications (Vibe on Prem, Sharepoint and open source software) were evaluated in a clinical trial site in ophthalmology. Assessment criteria were set; they were: reliability, easiness of administration, usability, scheduling, task list, knowledge management, operating costs and worldwide availability. Vibe on Prem customised by the local university met the assessment criteria best. Other applications were not as strong. By introducing a web-based application for administrating and organising an ophthalmological trial site, studies can be conducted in a more efficient and reliable manner. Georg Thieme Verlag KG Stuttgart · New York.

76 FR 70152 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications AGENCY: Food and... feasibility study investigational device exemption (IDE) applications. The pilot program will conform to the... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Under the pilot...

The STARD Statement for Reporting Diagnostic Accuracy Studies: Application to the History and Physical Examination

PubMed Central

Rennie, Drummond; Bossuyt, Patrick M. M.

2008-01-01

Summary Objective The Standards for Reporting of Diagnostic Accuracy (STARD) statement provided guidelines for investigators conducting diagnostic accuracy studies. We reviewed each item in the statement for its applicability to clinical examination diagnostic accuracy research, viewing each discrete aspect of the history and physical examination as a diagnostic test. Setting Nonsystematic review of the STARD statement. Interventions Two former STARD Group participants and 1 editor of a journal series on clinical examination research reviewed each STARD item. Suggested interpretations and comments were shared to develop consensus. Measurements and Main Results The STARD Statement applies generally well to clinical examination diagnostic accuracy studies. Three items are the most important for clinical examination diagnostic accuracy studies, and investigators should pay particular attention to their requirements: describe carefully the patient recruitment process, describe participant sampling and address if patients were from a consecutive series, and describe whether the clinicians were masked to the reference standard tests and whether the interpretation of the reference standard test was masked to the clinical examination components or overall clinical impression. The consideration of these and the other STARD items in clinical examination diagnostic research studies would improve the quality of investigations and strengthen conclusions reached by practicing clinicians. Conclusions The STARD statement provides a very useful framework for diagnostic accuracy studies. The group correctly anticipated that there would be nuances applicable to studies of the clinical examination. We offer guidance that should enhance their usefulness to investigators embarking on original studies of a patient’s history and physical examination. PMID:18347878

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.

Clinical Epidemiology Unit - overview of research areas

Cancer.gov

Clinical Epidemiology Unit (CEU) conducts etiologic research with potential clinical and public health applications, and leads studies evaluating population-based early detection and cancer prevention strategies

Concise Review: Endothelial Progenitor Cells in Regenerative Medicine: Applications and Challenges

PubMed Central

Chong, Mark Seow Khoon; Ng, Wei Kai

2016-01-01

Endothelial progenitor cells (EPCs) are currently being studied as candidate cell sources for revascularization strategies. Significant advances have been made in understanding the biology of EPCs, and preclinical studies have demonstrated the vasculogenic, angiogenic, and beneficial paracrine effects of transplanted EPCs in the treatment of ischemic diseases. Despite these promising results, widespread clinical acceptance of EPCs for clinical therapies remains hampered by several challenges. The present study provides a concise summary of the different EPC populations being studied for ischemic therapies and their known roles in the healing of ischemic tissues. The challenges and issues surrounding the use of EPCs and the current strategies being developed to improve the harvest efficiency and functionality of EPCs for application in regenerative medicine are discussed. Significance Endothelial progenitor cells (EPCs) have immense clinical value for cardiovascular therapies. The present study provides a concise description of the EPC subpopulations being evaluated for clinical applications. The current major lines of investigation involving preclinical and clinical evaluations of EPCs are discussed, and significant gaps limiting the translation of EPCs are highlighted. The present report could be useful for clinicians and clinical researchers with interests in ischemic therapy and for basic scientists working in the related fields of tissue engineering and regenerative medicine. PMID:26956207

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

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.

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.

Comparing ECT data of two different inpatient clinics: propofol or thiopental?

PubMed

Yazici, Esra; Bosgelmez, Sukriye; Tas, Halil Ibrahim; Karabulut, Umit; Yazici, Ahmet Bulent; Yildiz, Mustafa; Kirpinar, Ismet

2013-10-01

This study compares the data of (modified) electroconvulsive theraphy (ECT) applications from two different inpatient clinics in Turkey: Kocaeli Derince Training and Research Hospital (Clinic-I) and Kocaeli University (Clinic-II). Recorded files of patients from the two clinics were compared in terms of ECT indications, number and duration of seizures, and anesthetic agents used (propofol vs. thiopental). ECT applications occurring between January 2011 and January 2013 were included in the study. A total of 86 patients (9.5% of the inpatients) received ECT in Clinic-I and 103 patients (21.1% of the inpatients) in Clinic-II during the period studied. The yearly ECT rate (treated person rate per 10,000 per year) was 0.59/10,000 for Kocaeli (Turkey) as a whole. The overall number of ECT applications was 539 in Clinic-I and 999 in Clinic-II, and the average number of ECT sessions for each patient was 6.4 ± 2.33 in Clinic-I and 9.69 ± 4.66 in Clinic-II. The majority of indications were depressive disorders and insufficient response to medicine. Patients in the clinic which utilized thiopental as the anesthetic agent experienced more cardiovascular and respiratory side effects than the one which used propofol. The number of ECT sessions required was greater for patients with schizoaffective disorder than for others. The administration of ECT was considered to be a reliable method of treatment in these clinics. With respect to specific anesthetic agents, propofol was found to have less hemodynamic side effects and shorter seizure durations than thiopental.

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 application of ozone in dentistry: a systematic review of literature.

PubMed

Azarpazhooh, Amir; Limeback, Hardy

2008-02-01

(1) To systematically review the clinical application and remineralization potentials of ozone in dentistry; (2) To summarize the available in vitro applications of ozone in dentistry. Ovid MEDLINE, CINAHL, etc. (up to April 2007). In vitro or in vivo English language publications, original studies, and reviews were included. Conference papers, abstracts, and posters were excluded. In vitro: Good evidence of ozone biocompatibility with human oral epithelial cells, gingival fibroblast, and periodontal cells; Conflicting evidence of antimicrobial efficacy of ozone but some evidence that ozone is effective in removing the microorganisms from dental unit water lines, the oral cavity, and dentures; Conflicting evidence for the application of ozone in endodontics; Insufficient evidence for the application of ozone in oral surgery and implantology; Good evidence of the prophylactic application of ozone in restorative dentistry prior to etching and the placement of dental sealants and restorations. In vivo: Despite the promising in vitro evidence, the clinical application of ozone in dentistry (so far in management of dental and root caries) has not achieved a strong level of efficacy and cost-effectiveness. While laboratory studies suggest a promising potential of ozone in dentistry, this has not been fully realised in clinical studies to date. More well designed and conducted double-blind randomised clinical trials with adequate sample size, limited or no loss to follow up, and carefully standardised methods of measurement and analyses are needed to evaluate the possible use of ozone as a treatment modality in dentistry.

The use of exer-learning games for rehabilitation in spa clinics at home.

PubMed

Lucht, Martina; Krausser, Kati; Joerg, Daniel; Schwandt, Tobias

2012-01-01

This paper examines benefits of the exer-learning concept HOPSCOTCH for rehabilitation in spa clinics and at home. It describes a specific application to motivate obese patients in spa clinics for exercise. Furthermore results of an empirical study are reported where HOPSCOTCH was implemented in two spa clinics for a period of four weeks. The results of the study have shown that the concept is very convincing, but mainly depends on the content of the application; however the idea of HOPSCOTCH appeared to have a high potential to be used as a therapeutic agent in terms of motivation for exercise.

Safety and Feasibility of Topical Application of Limonene as a Massage Oil to the Breast.

PubMed

Miller, Jessica A; Thompson, Patricia A; Hakim, Iman A; Lopez, Ana Maria; Thomson, Cynthia A; Chew, Wade; Hsu, Chiu-Hsieh; Chow, H-H Sherry

2012-10-01

Limonene, a major component in citrus oil, has demonstrated anti-cancer effects in preclinical mammary cancer models. However, the effective oral dose translates to a human dose that may not be feasible for chronic dosing. We proposed to evaluate topical application of limonene to the breast as an alternative dosing strategy. We conducted a mouse disposition study to determine whether limonene would be bio available in the mammary tissue after topical application. SKH-1 mice received topical or oral administration of limonene in the form of orange oil every day for 4 weeks. Plasma and mammary pads were collected 4 hrs after the final dosing. We also conducted an exploratory clinical study to evaluate the safety and feasibility of topically applied limonene in the form of orange oil to the breast. Healthy women were recruited to apply orange oil containing massage oil to their breasts daily for four weeks. Safety and feasibility were assessed by reported adverse events, clinical labs, and usage compliance. Pre and post-intervention nipple aspirate fluid (NAF) and plasma were collected for limonene concentration determination. The mouse disposition study showed that topical and oral orange oil administration resulted in similar mammary tissue disposition of limonene with no clinical signs of toxicity. In the clinical study, the topical application of limonene containing massage oil to the breast was found to be safe with high levels of usage compliance for daily application, although NAF and plasma limonene concentrations were not significantly changed after the massage oil application. Our studies showed that limonene is bio available in mammary tissue after topical orange oil application in mice and this novel route of administration to the breast is safe and feasible in healthy women.

Safety and Feasibility of Topical Application of Limonene as a Massage Oil to the Breast

PubMed Central

Miller, Jessica A.; Thompson, Patricia A.; Hakim, Iman A.; Lopez, Ana Maria; Thomson, Cynthia A.; Chew, Wade; Hsu, Chiu-Hsieh; Chow, H.-H. Sherry

2013-01-01

Background Limonene, a major component in citrus oil, has demonstrated anti-cancer effects in preclinical mammary cancer models. However, the effective oral dose translates to a human dose that may not be feasible for chronic dosing. We proposed to evaluate topical application of limonene to the breast as an alternative dosing strategy. Materials and Methods We conducted a mouse disposition study to determine whether limonene would be bio available in the mammary tissue after topical application. SKH-1 mice received topical or oral administration of limonene in the form of orange oil every day for 4 weeks. Plasma and mammary pads were collected 4 hrs after the final dosing. We also conducted an exploratory clinical study to evaluate the safety and feasibility of topically applied limonene in the form of orange oil to the breast. Healthy women were recruited to apply orange oil containing massage oil to their breasts daily for four weeks. Safety and feasibility were assessed by reported adverse events, clinical labs, and usage compliance. Pre and post-intervention nipple aspirate fluid (NAF) and plasma were collected for limonene concentration determination. Results The mouse disposition study showed that topical and oral orange oil administration resulted in similar mammary tissue disposition of limonene with no clinical signs of toxicity. In the clinical study, the topical application of limonene containing massage oil to the breast was found to be safe with high levels of usage compliance for daily application, although NAF and plasma limonene concentrations were not significantly changed after the massage oil application. Conclusions Our studies showed that limonene is bio available in mammary tissue after topical orange oil application in mice and this novel route of administration to the breast is safe and feasible in healthy women. PMID:24236248

Inter-professional delirium education and care: a qualitative feasibility study of implementing a delirium Smartphone application.

PubMed

Zhang, Melvyn; Bingham, Kathleen; Kantarovich, Karin; Laidlaw, Jennifer; Urbach, David; Sockalingam, Sanjeev; Ho, Roger

2016-04-30

Delirium is a common medical condition with a high prevalence in hospital settings. Effective delirium management requires a multi-component intervention, including the use of Interprofessional teams and evidence-based interventions at the point of care. One vehicle for increasing access of delirium practice tools at the point of care is E-health. There has been a paucity of studies describing the implementation of delirium related clinical application. The purpose of this current study is to acquire users' perceptions of the utility, feasibility and effectiveness of a smartphone application for delirium care in a general surgery unit. In addition, the authors aimed to elucidate the potential challenges with implementing this application. This quantitative study was conducted between January 2015 and June 2015 at the University Health Network, Toronto General Hospital site. Participants met inclusion criteria if they were clinical staff on the General Surgery Unit at the Toronto General Hospital site and had experience caring for patients with delirium. At the conclusion of the 4 weeks after the implementation of the intervention, participants were invited by email to participate in a focus group to discuss their perspectives related to using the delirium application Our findings identified several themes related to the implementation and use of this smartphone application in an acute care clinical setting. These themes will provide clinicians preparing to use a smartphone application to support delirium care with an implementation framework. This study is one of the first to demonstrate the potential utility of a smartphone application for delirium inter-professional education. While this technology does appeal to healthcare professionals, it is important to note potential implementation challenges. Our findings provide insights into these potential barriers and can be used to assist healthcare professionals considering the development and use of an inter-professional clinical care application in their setting.

Evaluation of the clinical process in a critical care information system using the Lean method: a case study

PubMed Central

2012-01-01

Background There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy. PMID:23259846

Evaluation of the clinical process in a critical care information system using the Lean method: a case study.

PubMed

Yusof, Maryati Mohd; Khodambashi, Soudabeh; Mokhtar, Ariffin Marzuki

2012-12-21

There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

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.

Nursing Students' Opinion on the Use of Smartphone Applications (Apps) in Clinical Education and Training: A Study Protocol.

PubMed

O'Connor, Siobhan; Andrews, Tom

2016-01-01

Nurse educators are exploring different mobile technologies to provide additional support to nursing students in clinical practice. However, the view of nursing students on the use of smartphone applications (apps) to enhance clinical education has not been explored. This proposed study will use a self-reported questionnaire to examine the opinions of nursing students on the current and potential use of smartphone apps when training in clinical settings. Descriptive and inferential statistics will be performed on the quantitative data. Qualitative data from open ended questions will be thematically analysed using the framework approach. This will be the first study to examine the use of smartphone apps as a support in clinical teaching from a students' perspective. Their opinion is vital if the right mobile technology is to be designed and implemented.

From bench to bedside and to health policies: ethics in translational research.

PubMed

Petrini, C

2011-01-01

Translation of biomedical research knowledge to effective clinical treatment is essential to the public good. The first level of translation ("from bench to bedside") corresponds to efficacy studies under controlled conditions with careful attention to internal validity (clinical research). The second level is the translation of results from clinical studies into everyday clinical practice and health decision making. The article summarises the ethical issues involved in the translation of biomedical research advances to clinical applications and to clinical practice. In particular, the article synthesizes theory from clinical ethics, operational design, and philosophy to examine the unique bioethical issues raised by the recent focus on translational research. In this framework safety of study participants and balancing of risk due to treatment with the potential benefits of the research are crucial: in clinical research there is a danger that the emphasis on advancements in scientific knowledge might prevail over the protection of the people who participate in research. These issues involve basic scientists, clinicians and bioethicists because of their application to comparative effectiveness research, clinical trials and evidence-based medicine, as well basic biomedical research.

Chimeric Antigen Receptor-Modified T Cells for Solid Tumors: Challenges and Prospects

PubMed Central

Guo, Yelei; Wang, Yao; Han, Weidong

2016-01-01

Recent studies have highlighted the successes of chimeric antigen receptor-modified T- (CART-) cell-based therapy for B-cell malignancies, and early phase clinical trials have been launched in recent years. The few published clinical studies of CART cells in solid tumors have addressed safety and feasibility, but the clinical outcome data are limited. Although antitumor effects were confirmed in vitro and in animal models, CART-cell-based therapy still faces several challenges when directed towards solid tumors, and it has been difficult to achieve the desired outcomes in clinical practice. Many studies have struggled to improve the clinical responses to and benefits of CART-cell treatment of solid tumors. In this review, the status quo of CART cells and their clinical applications for solid tumors will be summarized first. Importantly, we will suggest improvements that could increase the therapeutic effectiveness of CART cells for solid tumors and their future clinical applications. These interventions will make treatment with CART cells an effective and routine therapy for solid tumors. PMID:26998495

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.

Using athletic training clinical education standards in radiography.

PubMed

Giordano, Shelley; Harris, Katherine

2012-01-01

The selection of clinical education sites for radiography students is based on availability, access to radiographic examinations, and appropriate student-to-technologist ratio. Radiography program directors are not required to evaluate sites based on their educational validity (eg, the clinical instructor's knowledge of basic teaching and learning principles, how well the site communicates with the program, or the clinical instructor's involvement in professional organizations). The purpose of this study was to determine if a set of 12 clinical education standards used in athletic training would be applicable and beneficial to radiography program directors when selecting clinical sites for students. A survey concerning the applicability of the athletic training standards to radiography site selection was completed by 270 directors of radiography programs accredited by the Joint Review Committee on Education in Radiologic Technology. The survey results indicated the athletic training clinical education standards were considered applicable to the selection of clinical sites for radiography students and would be beneficial to radiography program directors when selecting sites.

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

Practical Considerations for Clinical PET/MR Imaging.

PubMed

Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

2018-01-01

Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2017 Elsevier Inc. All rights reserved.

Practical Considerations for Clinical PET/MR Imaging.

PubMed

Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

2017-05-01

Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2016 Elsevier Inc. All rights reserved.

Advances of human bone marrow-derived mesenchymal stem cells in the treatment of cartilage defects: a systematic review.

PubMed

Gopal, Kaliappan; Amirhamed, Haji Alizadeh; Kamarul, Tunku

2014-06-01

Mesenchymal stem cell (MSC)-based therapies represent a new option for treating damaged cartilage. However, the outcomes following its clinical application have seldom been previously compared. The present paper presents the systematic review of current literatures on MSC-based therapy for cartilage repair in clinical applications. Ovid, Scopus, PubMed, ISI Web of Knowledge and Google Scholar online databases were searched using several keywords, which include "cartilage" and "stem cells". Only studies using bone marrow-derived MSC (BM-MSC) to treat cartilage defects clinically were included in this review. The clinical outcomes were compared, and the quality of the tissue repair was analysed where possible. Of the 996 articles, only six (n = 6) clinical studies have described the use of BM-MSC in clinical applications. Two studies were cohort observational trials, three were case series, and one was a case report. In the two comparative trials, BM-MSCs produced superior repair to cartilage treatment without cells and have comparable outcomes to autologous chondrocyte implantation. The case series and case-control studies have demonstrated that use of BM-MSCs resulted in better short- to long-term clinical outcomes with minimal complications. In addition, histological analyses in two studies have resulted in good repair tissue formation at the damaged site, composed mainly of hyaline-like cartilage. Although results of the respective studies are highly indicative that BM-MSC-based therapy is superior, due to the differences in methods and selection criteria used, it was not possible to make direct comparison between the studies. In conclusion, published studies do suggest that BM-MSCs could provide superior cartilage repair. However, due to limited number of reports, more robust studies might be required before a definitive conclusion can be drawn.

The sweet and sour of serological glycoprotein tumor biomarker quantification

PubMed Central

2013-01-01

Aberrant and dysregulated protein glycosylation is a well-established event in the process of oncogenesis and cancer progression. Years of study on the glycobiology of cancer have been focused on the development of clinically viable diagnostic applications of this knowledge. However, for a number of reasons, there has been only sparse and varied success. The causes of this range from technical to biological issues that arise when studying protein glycosylation and attempting to apply it to practical applications. This review focuses on the pitfalls, advances, and future directions to be taken in the development of clinically applicable quantitative assays using glycan moieties from serum-based proteins as analytes. Topics covered include the development and progress of applications of lectins, mass spectrometry, and other technologies towards this purpose. Slowly but surely, novel applications of established and development of new technologies will eventually provide us with the tools to reach the ultimate goal of quantification of the full scope of heterogeneity associated with the glycosylation of biomarker candidate glycoproteins in a clinically applicable fashion. PMID:23390961

Pharmacogenetic studies of antidepressant response: how far from the clinic?

PubMed

Perlis, Roy H

2007-03-01

Because the US FDA has begun to focus on disclosure of pharmacogenetic testing results in applications for new drug approval and review of existing drugs (see, eg, http://www.fda.gov/OHRMS/DOCKETS/AC/05/slides/2005-4194S1_Slide-Index.htm), the application of such testing in a clinical setting is likely to increase substantially. Instead of small cohorts of patients, potentially nearly every participant in the large pivotal trials required for drug approval could help inform the future application of that drug. Psychiatry as a whole, and antidepressant prescribing ni particular, stands to benefit in the near term from the identification of newer treatment targets that may overcome some of the limitations of current therapeutics. On the other hand, despite the excitement about the rapid pace of development in psychiatric pharmacogenetics, a number of key issues remain to be addressed before these discoveries are applied in a clinical setting. Close coordination will be required between those who study treatment efficacy and effectiveness and those who study genetic variation in populations to ensure that studies yield results that have scientific importance and clinical importance as well.

Healthcare Applications of Smart Watches

PubMed Central

Lu, Tsung-Chien; Fu, Chia-Ming; Ma, Matthew Huei-Ming; Fang, Cheng-Chung

2016-01-01

Summary Objective The aim of this systematic review is to synthesize research studies involving the use of smart watch devices for healthcare. Materials and Methods The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was chosen as the systematic review methodology. We searched PubMed, CINAHL Plus, EMBASE, ACM, and IEEE Xplore. In order to include ongoing clinical trials, we also searched ClinicalTrials.gov. Two investigators evaluated the retrieved articles for inclusion. Discrepancies between investigators regarding article inclusion and extracted data were resolved through team discussion. Results 356 articles were screened and 24 were selected for review. The most common publication venue was in conference proceedings (13, 54%). The majority of studies were published or presented in 2015 (19, 79%). We identified two registered clinical trials underway. A large proportion of the identified studies focused on applications involving health monitoring for the elderly (6, 25%). Five studies focused on patients with Parkinson’s disease and one on cardiac arrest. There were no studies which reported use of usability testing before implementation. Discussion Most of the reviewed studies focused on the chronically ill elderly. There was a lack of detailed description of user-centered design or usability testing before implementation. Based on our review, the most commonly used platform in healthcare research was that of the Android Wear. The clinical application of smart watches as assistive devices deserves further attention. Conclusion Smart watches are unobtrusive and easy to wear. While smart watch technology supplied with biosensors has potential to be useful in a variety of healthcare applications, rigorous research with their use in clinical settings is needed. PMID:27623763

Healthcare Applications of Smart Watches. A Systematic Review.

PubMed

Lu, Tsung-Chien; Fu, Chia-Ming; Ma, Matthew Huei-Ming; Fang, Cheng-Chung; Turner, Anne M

2016-09-14

The aim of this systematic review is to synthesize research studies involving the use of smart watch devices for healthcare. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was chosen as the systematic review methodology. We searched PubMed, CINAHL Plus, EMBASE, ACM, and IEEE Xplore. In order to include ongoing clinical trials, we also searched ClinicalTrials.gov. Two investigators evaluated the retrieved articles for inclusion. Discrepancies between investigators regarding article inclusion and extracted data were resolved through team discussion. 356 articles were screened and 24 were selected for review. The most common publication venue was in conference proceedings (13, 54%). The majority of studies were published or presented in 2015 (19, 79%). We identified two registered clinical trials underway. A large proportion of the identified studies focused on applications involving health monitoring for the elderly (6, 25%). Five studies focused on patients with Parkinson's disease and one on cardiac arrest. There were no studies which reported use of usability testing before implementation. Most of the reviewed studies focused on the chronically ill elderly. There was a lack of detailed description of user-centered design or usability testing before implementation. Based on our review, the most commonly used platform in healthcare research was that of the Android Wear. The clinical application of smart watches as assistive devices deserves further attention. Smart watches are unobtrusive and easy to wear. While smart watch technology supplied with biosensors has potential to be useful in a variety of healthcare applications, rigorous research with their use in clinical settings is needed.

ODM Data Analysis-A tool for the automatic validation, monitoring and generation of generic descriptive statistics of patient data.

PubMed

Brix, Tobias Johannes; Bruland, Philipp; Sarfraz, Saad; Ernsting, Jan; Neuhaus, Philipp; Storck, Michael; Doods, Justin; Ständer, Sonja; Dugas, Martin

2018-01-01

A required step for presenting results of clinical studies is the declaration of participants demographic and baseline characteristics as claimed by the FDAAA 801. The common workflow to accomplish this task is to export the clinical data from the used electronic data capture system and import it into statistical software like SAS software or IBM SPSS. This software requires trained users, who have to implement the analysis individually for each item. These expenditures may become an obstacle for small studies. Objective of this work is to design, implement and evaluate an open source application, called ODM Data Analysis, for the semi-automatic analysis of clinical study data. The system requires clinical data in the CDISC Operational Data Model format. After uploading the file, its syntax and data type conformity of the collected data is validated. The completeness of the study data is determined and basic statistics, including illustrative charts for each item, are generated. Datasets from four clinical studies have been used to evaluate the application's performance and functionality. The system is implemented as an open source web application (available at https://odmanalysis.uni-muenster.de) and also provided as Docker image which enables an easy distribution and installation on local systems. Study data is only stored in the application as long as the calculations are performed which is compliant with data protection endeavors. Analysis times are below half an hour, even for larger studies with over 6000 subjects. Medical experts have ensured the usefulness of this application to grant an overview of their collected study data for monitoring purposes and to generate descriptive statistics without further user interaction. The semi-automatic analysis has its limitations and cannot replace the complex analysis of statisticians, but it can be used as a starting point for their examination and reporting.

The SALOME study: recruitment experiences in a clinical trial offering injectable diacetylmorphine and hydromorphone for opioid dependency.

PubMed

Oviedo-Joekes, Eugenia; Marchand, Kirsten; Lock, Kurt; MacDonald, Scott; Guh, Daphne; Schechter, Martin T

2015-01-26

The Study to Assess Long-term Opioid Medication Effectiveness (SALOME) is a two-stage phase III, single site (Vancouver, Canada), randomized, double blind controlled trial designed to test if hydromorphone is as effective as diacetylmorphine for the treatment of long-term illicit opioid injection. Recruiting participants for clinical trials continues to be a challenge in medical and addiction research, with many studies not being able to reach the planned sample size in a timely manner. The aim of this study is to describe the recruitment strategies in SALOME, which offered appealing treatments but had limited clinic capacity and no guaranteed post-trial continuation of the treatments. SALOME included chronic opioid-dependent, current illicit injection opioid users who had at least one previous episode of opioid maintenance treatment. Regulatory approvals were received in June 2011 and recruitment strategies were implemented over the next 5 months. Recruitment strategies included ongoing open communication with the community, a consistent and accessible team and participant-centered screening. All applicants completed a pre-screening checklist to assess prerequisites. Applicants meeting these prerequisites were later contacted to commence the screening process. A total of 598 applications were received over the two-year recruitment period; 130 were received on the first day of recruitment. Of these applicants, 485 met prerequisites; however, many could not be found or were not reached before recruitment ended. For the 253 candidates who initiated the screening process, the average time lapse between application and screening date was 8.3 months (standard deviation [SD] = 4.44) and for the 202 randomized to the study, the average processing time from initial screen to randomization was 25.9 days (SD = 37.48; Median = 15.0). As in prior trials offering injectable diacetylmorphine within a supervised model, recruiting participants for this study took longer than planned. The recruitment challenges overcome in SALOME were due to the high number of applicants compared with the limited number that could be randomized and treated. Our study emphasizes the value of integrating these strategies into clinical addiction research to overcome study-specific barriers. ClinicalTrials.gov: NCT01447212.

The application of proteomics in different aspects of hepatocellular carcinoma research.

PubMed

Xing, Xiaohua; Liang, Dong; Huang, Yao; Zeng, Yongyi; Han, Xiao; Liu, Xiaolong; Liu, Jingfeng

2016-08-11

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors, which is causing the second leading cancer-related death worldwide. With the significant advances of high-throughput protein analysis techniques, the proteomics offered an extremely useful and versatile analytical platform for biomedical researches. In recent years, different proteomic strategies have been widely applied in the various aspects of HCC studies, ranging from screening the early diagnostic and prognostic biomarkers to in-depth investigating the underlying molecular mechanisms. In this review, we would like to systematically summarize the current applications of proteomics in hepatocellular carcinoma study, and discuss the challenges of applying proteomics in study clinical samples, as well as discuss the possible application of proteomics in precision medicine. In this review, we have systematically summarized the current applications of proteomics in hepatocellular carcinoma study, ranging from screening biomarkers to in-depth investigating the underlying molecular mechanisms. In addition, we have discussed the challenges of applying proteomics in study clinical samples, as well as the possible applications of proteomics in precision medicine. We believe that this review would help readers to be better familiar with the recent progresses of clinical proteomics, especially in the field of hepatocellular carcinoma research. Copyright © 2016 Elsevier B.V. All rights reserved.

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.

Melaleuca alternifolia and its application against dental plaque and periodontal diseases: A systematic review.

PubMed

Casarin, Maísa; Pazinatto, Josiele; Santos, Roberto Christ Vianna; Zanatta, Fabricio Batistin

2018-02-01

This is a systematic review of clinical and laboratory studies evaluating the effect of Melaleuca alternifolia on periodontopathogens, dental plaque, gingivitis, periodontitis, and inflammatory responses. The PubMed, Cochrane, Web of science, Bireme, Lilacs, Prospero, Open Grey, and Clinical Trials databases were searched to identify potentially eligible studies through October 2016. Of 1,654 potentially eligible studies, 25 were included in the systematic review. Their methodology was evaluated through the Cochrane Handbook for clinical studies and the GRADE system for in vivo/in vitro studies. Although clinical studies must be interpreted with caution due to methodological limitations, laboratory studies have found promising results. In vitro evidences showed that M. alternifolia has bactericidal and bacteriostatic effects against the most prevalent periodontopathogens. Clinical studies found comparable effects to chlorhexidine 0.12% in reducing gingival inflammation, although the antiplaque effect was lower. M. alternifolia also showed antioxidant properties, which are beneficial to the host, allied to the reduction on immune-inflammatory responses to pathogens. This systematic review suggests that the M. alternifolia has potential anti-inflammatory and antimicrobial properties, which can be easily applied to the periodontal tissues. However, further clinical trials are needed to elucidate the clinical relevance of its application. Copyright © 2017 John Wiley & Sons, Ltd.

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.

Future role of MR elastography in tissue engineering and regenerative medicine.

PubMed

Othman, Shadi F; Xu, Huihui; Mao, Jeremy J

2015-05-01

Tissue engineering (TE) has been introduced for more than 25 years without a boom in clinical trials. More than 70 TE-related start-up companies spent more than $600 million/year, with only two FDA-approved tissue-engineered products. Given the modest performance in clinically approved organs, TE is a tenaciously promising field. The TE community is advocating the application of clinically driven methodologies in large animal models enabling clinical translation. This challenge is hindered by the scarcity of tissue biopsies and the absence of standardized evaluation tools, but can be negated through non-invasive assessment of growth and integration, with reduced sample size and low cost. Solving this issue will speed the transition to cost-efficient clinical studies. In this paper we: (a) introduce magnetic resonance elastography to the tissue-engineering and regenerative medicine (TERM) community; (b) review recent MRE applications in TERM; and (c) discuss future directions of MRE in TERM. We have used MRE to study engineered tissues both in vitro and in vivo, where the mechanical properties of mesenchymally derived constructs were progressively monitored before and after tissues were implanted in mouse models. This study represents a stepping stone toward the applications of MRE in directing clinical trials with low cost and likely expediting the translation to more relevantly large animal models and clinical trials. Copyright © 2013 John Wiley & Sons, Ltd.

[Bone morphogenetic proteins (BMP): clinical application for reconstruction of bone defects].

PubMed

Sierra-García, Gerardo Daniel; Castro-Ríos, Rocío; Gónzalez-Horta, Azucena; Lara-Arias, Jorge; Chávez-Montes, Abelardo

2016-01-01

Since the introduction of bone morphogenetic proteins, their use has become an invaluable ally for the treatment of bone defects. These proteins are potent growth factors, related to angiogenic and osteogenic activity. The osteoinductive capacity of recombinant bone morphogenetic protein (rhBMP) in the formation of bone and cartilage has been confirmed in in vitro studies and evaluated in clinical trials. To obtain a therapeutic effect, administration is systemic, by injection over the physiological dose. Among the disadvantages, ectopic bone formation or high morbidity in cases of spinal fusion is observed. In this review, the roles of bone morphogenetic proteins in bone repair and clinical applications are analyzed. These findings represent advances in the study of bone regeneration and application of growth factors for more predictable results.

Procuring interoperability at the expense of usability: a case study of UK National Programme for IT assurance process.

PubMed

Krause, Paul; de Lusignan, Simon

2010-01-01

The allure of interoperable systems is that they should improve patient safety and make health services more efficient. The UK's National Programme for IT has made great strides in achieving interoperability; through linkage to a national electronic spine. However, there has been criticism of the usability of the applications in the clinical environment. Analysis of the procurement and assurance process to explore whether they predetermine usability. Processes separate developers from users, and test products against theoretical assurance models of use rather than simulate or pilot in a clinical environment. The current process appears to be effective for back office systems and high risk applications, but too inflexible for developing applications for the clinical setting. For clinical applications agile techniques are more appropriate. Usability testing should become an integrated part of the contractual process and be introduced earlier in the development process.

Molecular classification and molecular forecasting of breast cancer: ready for clinical application?

PubMed

Brenton, James D; Carey, Lisa A; Ahmed, Ahmed Ashour; Caldas, Carlos

2005-10-10

Profiling breast cancer with expression arrays has become common, and it has been suggested that the results from early studies will lead to understanding of the molecular differences between clinical cases and allow individualization of care. We critically review two main applications of expression profiling; studies unraveling novel breast cancer classifications and those that aim to identify novel markers for prediction of clinical outcome. Breast cancer may now be subclassified into luminal, basal, and HER2 subtypes with distinct differences in prognosis and response to therapy. However, profiling studies to identify predictive markers have suffered from methodologic problems that prevent general application of their results. Future work will need to reanalyze existing microarray data sets to identify more representative sets of candidate genes for use as prognostic signatures and will need to take into account the new knowledge of molecular subtypes of breast cancer when assessing predictive effects.

[Up-to-date research for clinical application in breast cancer].

PubMed

Koyama, Hiroki

2006-03-01

Breast cancer is still increasing in number of patients affected annually, with a peak incidence between 40-50 years of age. Various researches to control the disease have been attracting much attention scientifically and socially. Clinical application of trastuzumab (Herceptin), sentinel node biopsy to avoid unnecessary axillary dissection and individualized use of chemo-endocrine therapy as indicated by large scale clinical trials are among the recent successful results by pre-clinical and early clinical studies. In this context, the present special edition deals with articles on recent progress in breast cancer researches by leading scientists in this field. Hoping readers to understand, digest, and also to be stimulated by the updates for daily clinical practice.

Potential consequences of clinical application of artificial gametes: a systematic review of stakeholder views.

PubMed

Hendriks, Saskia; Dondorp, Wybo; de Wert, Guido; Hamer, Geert; Repping, Sjoerd; Dancet, Eline A F

2015-01-01

Recent progress in the formation of artificial gametes, i.e. gametes generated from progenitors or somatic cells, has led to scientific and societal discussion about their use in medically assisted reproduction. In animals, live births have already been achieved using artificial gametes of varying (cell type) sources and biological research seems to be progressing steadily toward clinical application in humans. Artificial gametes could potentially help not only infertile heterosexual couples of reproductive age of which one or both partners lacks functional gametes, but also post-menopausal women and same-sex couples, to conceive a child who will be genetically related to them. But as clinical application of these new technologies may have wider societal consequences, a proactive consideration of the possible impact seems timely and important. This review aims to contribute to this by providing a systematic overview of the potential consequences of clinical application of artificial gametes anticipated by different stakeholders. The electronic database 'Medline/Pubmed' was systematically searched with medical subject heading terms (MesH) for articles published in English between January 1970 and December 2013. Articles were selected based on eligibility and reference lists of eligible studies were hand searched. The reported potential consequences of clinical application of artificial gametes were extracted from the articles and were grouped into categories by content analysis. Per category, we noted which stakeholders referred to which potential consequences, based on author affiliations and, if applicable, study participants. The systematic search yielded 2424 articles, and 84 studies were included after screening. Nine positive consequences, 21 specific consequences requiring consideration and 22 recommendations referring to clinical application of artificial gametes were documented. All positive consequences, consequences requiring consideration and recommendations could be categorized under the following eight objectives to be safeguarded during clinical application of artificial gametes: (i) timing the implementation of new treatments correctly, (ii) meeting 'plausible demands of patients', (iii) improving and safeguarding public health, (iv) promoting the progress of medical science in the interest of future patients, (v) providing treatments that are morally acceptable for the general public, (vi) controlling medical practice, (vii) offering treatments that allow acquisition of informed consent and (viii) funding treatments fairly. Professionals specialized in biomedical science, science journalists and professionals specialized in ethics all addressed these eight objectives on artificial gametes, whereas professionals specialized in law or political science addressed seven objectives. Although one study reported on the perspective of parents of under-aged patients on three objectives, the perspectives of patients themselves were not reported by the reviewed literature. Of course, clinical introduction of artificial gametes should only be considered on the basis of reassuring outcomes of appropriate preclinical effectiveness and safety studies. In addition, potential users' views on the desirability and acceptability of artificial gametes should be studied before clinical introduction. A societal debate including all stakeholders is needed to determine the relative importance of all arguments in favor of and against the introduction of artificial gametes into clinical practice. More broadly, establishing pre-implementation processes for new medical techniques is relevant for all fields of medicine. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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

Review of functional near-infrared spectroscopy in neurorehabilitation

PubMed Central

Mihara, Masahito; Miyai, Ichiro

2016-01-01

Abstract. We provide a brief overview of the research and clinical applications of near-infrared spectroscopy (NIRS) in the neurorehabilitation field. NIRS has several potential advantages and shortcomings as a neuroimaging tool and is suitable for research application in the rehabilitation field. As one of the main applications of NIRS, we discuss its application as a monitoring tool, including investigating the neural mechanism of functional recovery after brain damage and investigating the neural mechanisms for controlling bipedal locomotion and postural balance in humans. In addition to being a monitoring tool, advances in signal processing techniques allow us to use NIRS as a therapeutic tool in this field. With a brief summary of recent studies investigating the clinical application of NIRS using motor imagery task, we discuss the possible clinical usage of NIRS in brain–computer interface and neurofeedback. PMID:27429995

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.

[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.

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.

Magnetic resonance imaging with hyperpolarized agents: methods and applications

NASA Astrophysics Data System (ADS)

Adamson, Erin B.; Ludwig, Kai D.; Mummy, David G.; Fain, Sean B.

2017-07-01

In the past decade, hyperpolarized (HP) contrast agents have been under active development for MRI applications to address the twin challenges of functional and quantitative imaging. Both HP helium (3He) and xenon (129Xe) gases have reached the stage where they are under study in clinical research. HP 129Xe, in particular, is poised for larger scale clinical research to investigate asthma, chronic obstructive pulmonary disease, and fibrotic lung diseases. With advances in polarizer technology and unique capabilities for imaging of 129Xe gas exchange into lung tissue and blood, HP 129Xe MRI is attracting new attention. In parallel, HP 13C and 15N MRI methods have steadily advanced in a wide range of pre-clinical research applications for imaging metabolism in various cancers and cardiac disease. The HP [1-13C] pyruvate MRI technique, in particular, has undergone phase I trials in prostate cancer and is poised for investigational new drug trials at multiple institutions in cancer and cardiac applications. This review treats the methodology behind both HP gases and HP 13C and 15N liquid state agents. Gas and liquid phase HP agents share similar technologies for achieving non-equilibrium polarization outside the field of the MRI scanner, strategies for image data acquisition, and translational challenges in moving from pre-clinical to clinical research. To cover the wide array of methods and applications, this review is organized by numerical section into (1) a brief introduction, (2) the physical and biological properties of the most common polarized agents with a brief summary of applications and methods of polarization, (3) methods for image acquisition and reconstruction specific to improving data acquisition efficiency for HP MRI, (4) the main physical properties that enable unique measures of physiology or metabolic pathways, followed by a more detailed review of the literature describing the use of HP agents to study: (5) metabolic pathways in cancer and cardiac disease and (6) lung function in both pre-clinical and clinical research studies, concluding with (7) some future directions and challenges, and (8) an overall summary.

VARK Learning Preferences and Mobile Anatomy Software Application Use in Pre-Clinical Chiropractic Students

ERIC Educational Resources Information Center

Meyer, Amanda J.; Stomski, Norman J.; Innes, Stanley I.; Armson, Anthony J.

2016-01-01

Ubiquitous smartphone ownership and reduced face-to-face teaching time may lead to students making greater use of mobile technologies in their learning. This is the first study to report on the prevalence of mobile gross anatomy software applications (apps) usage in pre-clinical chiropractic students and to ascertain if a relationship exists…

[Research progress in mechanisms and clinical application for blonanserin and lurasidone in improving cognitive function of schizophrenia].

PubMed

Zheng, Qi; Liu, Bangshan; Xu, Shuyin; Liao, Mei; Zhang, Yan; Li, Lingjiang

2017-04-28

Cognition deficit is one of the most common symptoms of schizophrenia, including abstract thinking and memory, and attention deficits. Previous studies have suggested that the improvement of cognition is very important for the recovery of disease and social function for the patients. Recent studies indicated that two new atypical antipsychotics, blonanserin and lurasidone, are expected to improve the cognitive impairment in patients with schizophrenia. This review introduces pathogenesis of cognitive impairment in schizophrenia, mechanisms of blonanserin and lurasidone in the improvement of cognitive impairment and progress in their clinical application for schizophrenia. We hope that this review could guide clinical use of antipsychotics and provide new directions for future studies.

High usability of a smartphone application for reporting symptoms in adults with cystic fibrosis.

PubMed

Wood, Jamie; Jenkins, Sue; Putrino, David; Mulrennan, Siobhain; Morey, Sue; Cecins, Nola; Hill, Kylie

2017-01-01

Introduction In cystic fibrosis, exacerbations impair lung function and health-related quality of life, increase healthcare costs and reduce survival. Delayed reporting of worsening symptoms can result in more severe exacerbations and worse clinical outcomes; therefore there is a need for a novel approach to facilitate the early identification and treatment of exacerbations in this population. This study investigated the usability of a smartphone application to report symptoms in adults with cystic fibrosis, and the observer agreement in clinical decision-making between senior clinicians interpreting smartphone application responses. Methods Adults with cystic fibrosis used the smartphone application weekly for four weeks. The application comprised 10 yes/no questions regarding respiratory symptoms and two regarding emotional well-being. Usability was measured with the System Usability Scale; Observer agreement was tested by providing a cystic fibrosis physician and a nurse practitioner with 45 clinical scenarios. For each scenario the clinicians, who were blinded to each other's responses, were asked to indicate whether or not they would: (i) initiate telephone contact, and/or (ii) request a clinic visit for the individual. Results Ten participants (five female), aged mean (SD) 33 (11) years, FEV1 49 (27)% predicted completed the study. The mean (SD) System Usability Scale score was 94 (6). There was perfect agreement between clinicians for initiating contact with the participant ( κ = 1.0, p < 0.001), and near-perfect for requesting a clinic visit ( κ = 0.86, p < 0.001). Discussion The use of a smartphone application for reporting symptoms in adults with cystic fibrosis has excellent usability and near-perfect agreement between senior clinicians when interpreting the application responses.

Comparative Clinical Efficacy between Electrodesiccation with Curettage and Application of 80% Phenol Solution in Treatment of Common Warts

PubMed Central

Dalimunthe, Dina Arwina; Siregar, Remenda; Tanjung, Chairiyah

2018-01-01

BACKGROUND: Common warts are skin diseases caused by human papillomavirus. Several treatment modalities available for common warts, two of them are electrodesiccation with curettage and application of 80% phenol solution. AIM: This study aims to compare clinical efficacy between these two modalities. MATERIAL AND METHODS: Open clinical trial was conducted at Dr Pirngadi General Hospital Medan and H. Adam Malik General Hospital Medan from February to June 2013 on 17 patients with multiple common warts. Both treatments began and applied simultaneously on the same day on each patient. RESULTS: Cure rate was higher in electrodesiccation with curettage (76.5%, 100%) compared to the application of 80% phenol solution (11.8%, 64.7%) on three weeks and six weeks of follow up. Statistical analysis showed a significant difference of common warts cure rate between electrodesiccation with curettage and application of 80% phenol solution after three weeks (p < 0.001) and six weeks (p = 0.018) of treatment. CONCLUSION: As a conclusion, electrodesiccation with curettage has higher cure rate than the application of 80% phenol solution on the treatment of common warts. Further study is needed to find out the best concentration and time interval for application of phenol solution to improve its clinical efficacy as an alternative treatment of choice for common warts. PMID:29531597

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

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.

Generalizing the Arden Syntax to a Common Clinical Application Language.

PubMed

Kraus, Stefan

2018-01-01

The Arden Syntax for Medical Logic Systems is a standard for encoding and sharing knowledge in the form of Medical Logic Modules (MLMs). Although the Arden Syntax has been designed to meet the requirements of data-driven clinical event monitoring, multiple studies suggest that its language constructs may be suitable for use outside the intended application area and even as a common clinical application language. Such a broader context, however, requires to reconsider some language features. The purpose of this paper is to outline the related modifications on the basis of a generalized Arden Syntax version. The implemented prototype provides multiple adjustments to the standard, such as an option to use programming language constructs without the frame-like MLM structure, a JSON compliant data type system, a means to use MLMs as user-defined functions, and native support of restful web services with integrated data mapping. This study does not aim to promote an actually new language, but a more generic version of the proven Arden Syntax standard. Such an easy-to-understand domain-specific language for common clinical applications might cover multiple additional medical subdomains and serve as a lingua franca for arbitrary clinical algorithms, therefore avoiding a patchwork of multiple all-purpose languages between, and even within, institutions.

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

Factors Influencing the Application of a Biopsychosocial Perspective in Clinical Judgement of Chronic Pain: Interactive Management with Medical Students.

PubMed

Dwyer, Christopher P; McKenna-Plumley, Phoebe E; Durand, Hannah; Gormley, Emer M; Slattery, Brian W; Harney, Owen M; MacNeela, Padraig; McGuire, Brian E

2017-09-01

Though there is wide support for the application of biopsychosocial perspectives in clinical judgement of chronic pain cases, such perspectives are often overlooked due to either inadequate training or attitudes favoring a biomedical approach. Recent research has indicated that despite such explanations, both established general practitioners (GP) and medical students account for some psychosocial factors when making clinical judgements regarding chronic pain cases, but report not being likely to apply these in real-world, clinical settings due to numerous factors, including available time with patients. Thus, it is evident that a greater understanding of clinical judgement-making processes and the factors that affect application of these processes is required, particularly regarding chronic pain. The aims of the current study were to investigate medical students' conceptualizations of the factors that influence application of a biopsychosocial approach to clinical judgement-making in cases of chronic pain using interactive management (IM), model the relationships among these factors, and make recommendations to chronic pain treatment policy in light of the findings. The current study used IM to identify and model factors that influence the application of a biopsychosocial approach to clinical judgement-making in cases of chronic pain, based on medical students' conceptualizations of these factors. Two university classrooms. IM is a systems thinking and action mapping strategy used to aid groups in developing outcomes regarding complex issues, through integrating contributions from individuals with diverse views, backgrounds, and perspectives. IM commonly utilizes the nominal group technique and interpretive structural modeling, which in this context were employed to help medical students identify, clarify, and model influences on the application of biopsychosocial perspectives in treating chronic pain patients. Results of IM group work revealed 7 core biopsychosocial approach application categories: GP attitudes, cost, GP knowledge, time, patient-doctor relationship, biomedical factors. and patient perception. GP attitudes was the most critical driver of all other competencies in the system, with cost and GP knowledge revealed as secondary drivers. Potential differences in level of prior biopsychosocial perspective knowledge across participants and a potentially small sample size (though consistent with past research and appropriate for an exploratory study of this nature - for purposes of achieving the depth and richness of the deliberation and qualitative insights revealed by participants using the IM methodology). Results from this study may be used to both recommend further research on the identified factors influencing application of biopsychosocial perspectives in treatment of chronic pain and support amendment to extant health care policy, particularly with respect to cost, GP attitudes, and knowledge. Though this research claims neither that the influences identified are the only influences on biopsychosocial application, nor the order of their importance, the research does contribute to an on-going effort to better understand the factors that influence doctors in their treatment of chronic pain.Key words: Chronic pain, biopsychosocial, medical education, clinical judgement, interactive management, pain management.

Applications of mid-infrared spectroscopy in the clinical laboratory setting.

PubMed

De Bruyne, Sander; Speeckaert, Marijn M; Delanghe, Joris R

2018-01-01

Fourier transform mid-infrared (MIR-FTIR) spectroscopy is a nondestructive, label-free, highly sensitive and specific technique that provides complete information on the chemical composition of biological samples. The technique both can offer fundamental structural information and serve as a quantitative analysis tool. Therefore, it has many potential applications in different fields of clinical laboratory science. Although considerable technological progress has been made to promote biomedical applications of this powerful analytical technique, most clinical laboratory analyses are based on spectroscopic measurements in the visible or ultraviolet (UV) spectrum and the potential role of FTIR spectroscopy still remains unexplored. In this review, we present some general principles of FTIR spectroscopy as a useful method to study molecules in specimens by MIR radiation together with a short overview of methods to interpret spectral data. We aim at illustrating the wide range of potential applications of the proposed technique in the clinical laboratory setting with a focus on its advantages and limitations and discussing the future directions. The reviewed applications of MIR spectroscopy include (1) quantification of clinical parameters in body fluids, (2) diagnosis and monitoring of cancer and other diseases by analysis of body fluids, cells, and tissues, (3) classification of clinically relevant microorganisms, and (4) analysis of kidney stones, nails, and faecal fat.

Embodied Conversational Agents in Clinical Psychology: A Scoping Review.

PubMed

Provoost, Simon; Lau, Ho Ming; Ruwaard, Jeroen; Riper, Heleen

2017-05-09

Embodied conversational agents (ECAs) are computer-generated characters that simulate key properties of human face-to-face conversation, such as verbal and nonverbal behavior. In Internet-based eHealth interventions, ECAs may be used for the delivery of automated human support factors. We aim to provide an overview of the technological and clinical possibilities, as well as the evidence base for ECA applications in clinical psychology, to inform health professionals about the activity in this field of research. Given the large variety of applied methodologies, types of applications, and scientific disciplines involved in ECA research, we conducted a systematic scoping review. Scoping reviews aim to map key concepts and types of evidence underlying an area of research, and answer less-specific questions than traditional systematic reviews. Systematic searches for ECA applications in the treatment of mood, anxiety, psychotic, autism spectrum, and substance use disorders were conducted in databases in the fields of psychology and computer science, as well as in interdisciplinary databases. Studies were included if they conveyed primary research findings on an ECA application that targeted one of the disorders. We mapped each study's background information, how the different disorders were addressed, how ECAs and users could interact with one another, methodological aspects, and the study's aims and outcomes. This study included N=54 publications (N=49 studies). More than half of the studies (n=26) focused on autism treatment, and ECAs were used most often for social skills training (n=23). Applications ranged from simple reinforcement of social behaviors through emotional expressions to sophisticated multimodal conversational systems. Most applications (n=43) were still in the development and piloting phase, that is, not yet ready for routine practice evaluation or application. Few studies conducted controlled research into clinical effects of ECAs, such as a reduction in symptom severity. ECAs for mental disorders are emerging. State-of-the-art techniques, involving, for example, communication through natural language or nonverbal behavior, are increasingly being considered and adopted for psychotherapeutic interventions in ECA research with promising results. However, evidence on their clinical application remains scarce. At present, their value to clinical practice lies mostly in the experimental determination of critical human support factors. In the context of using ECAs as an adjunct to existing interventions with the aim of supporting users, important questions remain with regard to the personalization of ECAs' interaction with users, and the optimal timing and manner of providing support. To increase the evidence base with regard to Internet interventions, we propose an additional focus on low-tech ECA solutions that can be rapidly developed, tested, and applied in routine practice. ©Simon Provoost, Ho Ming Lau, Jeroen Ruwaard, Heleen Riper. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 09.05.2017.

Computational models of the pulmonary circulation: Insights and the move towards clinically directed studies

PubMed Central

Tawhai, Merryn H.; Clark, Alys R.; Burrowes, Kelly S.

2011-01-01

Biophysically-based computational models provide a tool for integrating and explaining experimental data, observations, and hypotheses. Computational models of the pulmonary circulation have evolved from minimal and efficient constructs that have been used to study individual mechanisms that contribute to lung perfusion, to sophisticated multi-scale and -physics structure-based models that predict integrated structure-function relationships within a heterogeneous organ. This review considers the utility of computational models in providing new insights into the function of the pulmonary circulation, and their application in clinically motivated studies. We review mathematical and computational models of the pulmonary circulation based on their application; we begin with models that seek to answer questions in basic science and physiology and progress to models that aim to have clinical application. In looking forward, we discuss the relative merits and clinical relevance of computational models: what important features are still lacking; and how these models may ultimately be applied to further increasing our understanding of the mechanisms occurring in disease of the pulmonary circulation. PMID:22034608

Approaches using molecular imaging technology - use of PET in clinical microdose studies§

PubMed Central

Wagner, Claudia C; Langer, Oliver

2013-01-01

Positron emission tomography (PET) imaging uses minute amounts of radiolabeled drug tracers and thereby meets the criteria for clinical microdose studies. The advantage of PET, when compared to other analytical methods used in microdose studies, is that the pharmacokinetics (PK) of a drug can be determined in the tissue targeted for drug treatment. PET microdosing already offers interesting applications in clinical oncology and in the development of central nervous system pharmaceuticals and is extending its range of application to many other fields of pharmaceutical medicine. Although requirements for preclinical safety testing for microdose studies have been cut down by regulatory authorities, radiopharmaceuticals increasingly need to be produced under good manufacturing practice (GMP) conditions, which increases the costs of PET microdosing studies. Further challenges in PET microdosing include combining PET with other ultrasensitive analytical methods, such as accelerator mass spectrometry (AMS), to gain plasma PK data of drugs, beyond the short PET examination periods. Finally, conducting clinical PET studies with radiolabeled drugs both at micro- and therapeutic doses is encouraged to answer the question of dose linearity in clinical microdosing. PMID:20887762

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…

Biosimilars approval process.

PubMed

Zuñiga, Leyre; Calvo, Begoña

2010-04-01

For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier. Copyright 2009 Elsevier Inc. All rights reserved.

Finite element strategies to satisfy clinical and engineering requirements in the field of percutaneous valves.

PubMed

Capelli, Claudio; Biglino, Giovanni; Petrini, Lorenza; Migliavacca, Francesco; Cosentino, Daria; Bonhoeffer, Philipp; Taylor, Andrew M; Schievano, Silvia

2012-12-01

Finite element (FE) modelling can be a very resourceful tool in the field of cardiovascular devices. To ensure result reliability, FE models must be validated experimentally against physical data. Their clinical application (e.g., patients' suitability, morphological evaluation) also requires fast simulation process and access to results, while engineering applications need highly accurate results. This study shows how FE models with different mesh discretisations can suit clinical and engineering requirements for studying a novel device designed for percutaneous valve implantation. Following sensitivity analysis and experimental characterisation of the materials, the stent-graft was first studied in a simplified geometry (i.e., compliant cylinder) and validated against in vitro data, and then in a patient-specific implantation site (i.e., distensible right ventricular outflow tract). Different meshing strategies using solid, beam and shell elements were tested. Results showed excellent agreement between computational and experimental data in the simplified implantation site. Beam elements were found to be convenient for clinical applications, providing reliable results in less than one hour in a patient-specific anatomical model. Solid elements remain the FE choice for engineering applications, albeit more computationally expensive (>100 times). This work also showed how information on device mechanical behaviour differs when acquired in a simplified model as opposed to a patient-specific model.

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study

PubMed Central

Lee, Jie-Eun; Lee, Dong Hwa; Oh, Tae Jung; Kim, Kyoung Min; Choi, Sung Hee; Lim, Soo; Park, Young Joo; Park, Do Joon; Jang, Hak Chul

2018-01-01

Background Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis. Objective The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment. Methods Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded. Results Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017. Conclusions This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis. Trial Registration ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2) PMID:29467121

Advances of high intensity focused ultrasound (HIFU) for pancreatic cancer.

PubMed

Xiaoping, Li; Leizhen, Zheng

2013-11-01

High intensity focused ultrasound (HIFU) is a novel therapeutic modality. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumours, including pancreatic cancer. Preliminary studies suggest that HIFU may be useful for the palliative therapy of cancer-related pain in patients with unresectable pancreatic cancer. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges.

DigitalVHI--a freeware open-source software application to capture the Voice Handicap Index and other questionnaire data in various languages.

PubMed

Herbst, Christian T; Oh, Jinook; Vydrová, Jitka; Švec, Jan G

2015-07-01

In this short report we introduce DigitalVHI, a free open-source software application for obtaining Voice Handicap Index (VHI) and other questionnaire data, which can be put on a computer in clinics and used in clinical practice. The software can simplify performing clinical studies since it makes the VHI scores directly available for analysis in a digital form. It can be downloaded from http://www.christian-herbst.org/DigitalVHI/.

A Study on Fitts' Law Based Gait Symmetric Evaluation and It's Clinic Application.

PubMed

Rencheng, Wang; Meiqin, Zhang; Xiaonan, Deng; Dewen, Jin; Maobin, Wang; Guangqing, Li

2005-01-01

Symmetry, one of the prominent characters of normal human gait, could be destroyed by some special or abnormal factors such as barrier spanning, walking impediment, etc. Therefore, it becomes an important factor used to evaluate qualities and functions of walking. In this paper, the fitts' law based symmetry index calculation is introduced and its application in clinic test is also reported. The results show that the fitts' law based index is effective in clinic evaluation.

The evolution of spinal/epidural neostigmine in clinical application: Thoughts after two decades

PubMed Central

Lauretti, Gabriela Rocha

2015-01-01

Since the first clinical application of analgesia following spinal anticholinesterase by 1940's, several clinical double-blind studies have been conducted to date, where intrathecal doses of neostigmine in humans ranged from 750 to 1 μg, due to side-effects. Conversely, epidural neostigmine has been evaluated in proportionally higher doses and represents an alternative, but still deserves more investigation concerning both acute and chronic pain, as it seems devoid of important side-effects. PMID:25558203

Clinical Application of Diode Laser (980 nm) in Maxillofacial Surgical Procedures.

PubMed

Aldelaimi, Tahrir N; Khalil, Afrah A

2015-06-01

For many procedures, lasers are now becoming the treatment of choice by both clinicians and patients, and in some cases, the standard of care. This clinical study was carried out at Department of Maxillofacial Surgery, Ramadi Teaching Hospital, Rashid Private Hospital and Razi Private Hospital, Anbar Health Directorate, Anbar Province, Iraq. A total of 32 patients including 22 (≈ 70%) male and 10 (≈ 30%) female with age range from 5 months to 34 years old. Chirolas 20 W diode laser emitting at 980 nm was used. Our preliminary clinical findings include sufficient hemostasis, coagulation properties, precise incision margin, lack of swelling, bleeding, pain, scar tissue formation and overall satisfaction were observed in the clinical application. The clinical application of the diode (980 nm) laser in maxillofacial surgery proved to be of beneficial effect for daily practice and considered practical, effective, easy to used, offers a safe, acceptable, and impressive alternative for conventional surgical techniques.

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…

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.

The Ottawa knee rules - a useful clinical decision tool.

PubMed

Yao, Kaihan; Haque, Tasneem

2012-04-01

Acute knee injuries are a common presentation in the primary care setting. The Ottawa knee rules provide guidance on how to identify which cases of knee injury require radiographic investigation. This article describes the Ottawa knee rules and outlines their sensitivity, reproducibility and application in the clinical setting. The Ottawa knee rules are a valuable tool for clinicians in the routine management of acute knee injuries. Studies show that they are highly sensitive at identifying patients with fractures of the knee and have a high degree of interobserver agreement and reproducible results. Application of the Ottawa knee rules in appropriate clinical scenarios may reduce the number of unnecessary radiographs ordered, streamlining patient throughput and allowing for significant cost savings. Although designed for use in adults, some studies have suggested that the Ottawa knee rules may also be applicable to the paediatric population.

Early clinical applications for imaging at microscopic detail: microfocus computed tomography (micro-CT).

PubMed

Hutchinson, J Ciaran; Shelmerdine, Susan C; Simcock, Ian C; Sebire, Neil J; Arthurs, Owen J

2017-07-01

Microfocus CT (micro-CT) has traditionally been used in industry and preclinical studies, although it may find new applicability in the routine clinical setting. It can provide high-resolution three-dimensional digital imaging data sets to the same level of detail as microscopic examination without the need for tissue dissection. Micro-CT is already enabling non-invasive detailed internal assessment of various tissue specimens, particularly in breast imaging and early gestational fetal autopsy, not previously possible from more conventional modalities such as MRI or CT. In this review, we discuss the technical aspects behind micro-CT image acquisition, how early work with small animal studies have informed our knowledge of human disease and the imaging performed so far on human tissue specimens. We conclude with potential future clinical applications of this novel and emerging technique.

21 CFR 54.1 - Purpose.

Code of Federal Regulations, 2010 CFR

2010-04-01

... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...

21 CFR 54.1 - Purpose.

Code of Federal Regulations, 2011 CFR

2011-04-01

... steps have not been taken in the design, conduct, reporting, and analysis of the studies to minimize... INVESTIGATORS § 54.1 Purpose. (a) The Food and Drug Administration (FDA) evaluates clinical studies submitted in... clinical studies to determine whether the applications are approvable under the statutory requirements. FDA...

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.

[Effect of naphthalan and therapeutic mud applications on clinical and roentgenological characteristics in patients with protracted pneumonia].

PubMed

Rassulova, M A; Siziakova, L A; Aĭrapetova, N S

2009-01-01

The influence of application of naftalan and therapeutic muds on clinical and roentgenological parameters, external respiration function, biochemical and immunological characteristics of the inflammatory process was studied in 82 patients presenting with protracted pneumonia and compared with the outcome of therapy using no physical factors. The application of naftalan and therapeutic muds was shown to reduce activity of inflammatory processes, improve airway patency and the state ofbronchial mucosa. Naftalan produced better therapeutic effect than muds.

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.

PubMed

Berendt, Louise; Håkansson, Cecilia; Bach, Karin Friis; Dalhoff, Kim; Andreasen, Per Buch; Petersen, Lene Grejs; Andersen, Elin; Poulsen, Henrik Enghusen

2008-01-05

To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark. Retrospective review of applications for drug trials to the Danish Medicines Agency, 1993-2006. Applications for drug trials for alternate years were classified as academic or commercial trials. A random subset of academic trials was reviewed for number of participants in and intended monitoring of the trials. Academic and commercial drug trials showed an identical steady decline from 1993 to 2006 and no noticeable change after 2004 when good clinical practice became mandatory for academic trials. The Clinical Trials Directive introduced in May 2004 to ensure good clinical practice for academic drug trials was not associated with a decline in research activity in Denmark; presumably because good clinical practice units had already been in place in Danish universities since 1999. With such an infrastructure academic researchers can do drug trials under the same regulations as drug companies.

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.

The effectiveness of telemental health applications: a review.

PubMed

Hailey, David; Roine, Risto; Ohinmaa, Arto

2008-11-01

To review the evidence of benefit from use of telemental health (TMH) in studies that reported clinical or administrative outcomes. Relevant publications were identified through computerized literature searches using several electronic databases. Included for review were scientifically valid articles that described controlled studies, comparing TMH with a non-TMH alternative, and uncontrolled studies that had no fewer than 20 participants. Quality of the evidence was assessed with an approach that considers both study performance and study design. Judgments were made on whether further data were needed to establish each TMH application as suitable for routine clinical use. Included in the review were 72 papers that described 65 clinical studies; 32 (49%) studies were of high or good quality. Quality of evidence was higher for Internet- and telephone-based interventions than for video conferencing approaches. There was evidence of success with TMH in the areas of child psychiatry, depression, dementia, schizophrenia, suicide prevention, posttraumatic stress, panic disorders, substance abuse, eating disorders, and smoking prevention. Evidence of success for general TMH programs and in the management of obsessive-compulsive disorder were less convincing. Further study was judged to be necessary or desirable in 53 (82%) of the studies. Evidence of benefit from TMH applications is encouraging, though still limited. There is a need for more good-quality studies on the use of TMH in routine care. The emerging use of Internet-based applications is an important development that deserves further evaluation.

Application of Standard Project Management Tools to Research--A Case Study from a Multi-National Clinical Trial

ERIC Educational Resources Information Center

Gist, Peter; Langley, David

2007-01-01

PRINCE2, which stands for Projects in Controlled Environments, is a project management method covering the organisation, management, and control of projects and is widely used in both government and commercial IT and building projects in the UK. This paper describes the application of PRINCE2 to the management of large clinical trials…

Silk Fibroin Biomaterial Shows Safe and Effective Wound Healing in Animal Models and a Randomized Controlled Clinical Trial.

PubMed

Zhang, Wei; Chen, Longkun; Chen, Jialin; Wang, Lingshuang; Gui, Xuexian; Ran, Jisheng; Xu, Guowei; Zhao, Hongshi; Zeng, Mengfeng; Ji, Junfeng; Qian, Li; Zhou, Jianda; Ouyang, Hongwei; Zou, Xiaohui

2017-05-01

Due to its excellent biological and mechanical properties, silk fibroin has been intensively explored for tissue engineering and regenerative medicine applications. However, lack of translational evidence has hampered its clinical application for tissue repair. Here a silk fibroin film is developed and its translational potential is investigated for skin repair by performing comprehensive preclinical and clinical studies to fully evaluate its safety and effectiveness. The silk fibroin film fabricated using all green chemistry approaches demonstrates remarkable characteristics, including transmittance, fluid handling capacity, moisture vapor permeability, waterproofness, bacterial barrier properties, and biocompatibility. In vivo rabbit full-thickness skin defect study shows that the silk fibroin film effectively reduces the average wound healing time with better skin regeneration compared with the commercial wound dressings. Subsequent assessment in porcine model confirms its long-term safety and effectiveness for full-thickness skin defects. Finally, a randomized single-blind parallel controlled clinical trial with 71 patients shows that the silk fibroin film significantly reduces the time to wound healing and incidence of adverse events compared to commercial dressing. Therefore, the study provides systematic preclinical and clinical evidence that the silk fibroin film promotes wound healing thereby establishing a foundation towards its application for skin repair and regeneration in the clinic. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[Basics and clinical application of human mesenchymal stromal/stem cells].

PubMed

Miura, Yasuo

2015-10-01

Human mesenchymal stromal/stem cells (MSCs) show a variety of biological characteristics. The clinical trials database provided by the National Institutes of Health, USA, contains about 400 clinical trials of MSCs for a wide range of therapeutic applications internationally (http://www.clinicaltrials.gov, key words "mesenchymal stem cells", as of April, 2015). Encouraging results from these clinical trials include evidence of efficacy against graft versus host disease (GVHD) in hematopoietic stem cell transplantation. Treatment for and/or prevention of engraftment failure and insufficient hematopoietic recovery have also been explored. Herein, we will address the basic principles of MSCs and the current status of clinical studies using MSCs. Future prospects for MSC-based therapy will also be discussed.

[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.

Effectiveness of a mobile cooperation intervention during the clinical practicum of nursing students: a parallel group randomized controlled trial protocol.

PubMed

Strandell-Laine, Camilla; Saarikoski, Mikko; Löyttyniemi, Eliisa; Salminen, Leena; Suomi, Reima; Leino-Kilpi, Helena

2017-06-01

The aim of this study was to describe a study protocol for a study evaluating the effectiveness of a mobile cooperation intervention to improve students' competence level, self-efficacy in clinical performance and satisfaction with the clinical learning environment. Nursing student-nurse teacher cooperation during the clinical practicum has a vital role in promoting the learning of students. Despite an increasing interest in using mobile technologies to improve the clinical practicum of students, there is limited robust evidence regarding their effectiveness. A multicentre, parallel group, randomized, controlled, pragmatic, superiority trial. Second-year pre-registration nursing students who are beginning a clinical practicum will be recruited from one university of applied sciences. Eligible students will be randomly allocated to either a control group (engaging in standard cooperation) or an intervention group (engaging in mobile cooperation) for the 5-week the clinical practicum. The complex mobile cooperation intervention comprises of a mobile application-assisted, nursing student-nurse teacher cooperation and a training in the functions of the mobile application. The primary outcome is competence. The secondary outcomes include self-efficacy in clinical performance and satisfaction with the clinical learning environment. Moreover, a process evaluation will be undertaken. The ethical approval for this study was obtained in December 2014 and the study received funding in 2015. The results of this study will provide robust evidence on mobile cooperation during the clinical practicum, a research topic that has not been consistently studied to date. © 2016 John Wiley & Sons Ltd.

Review and classification of variability analysis techniques with clinical applications.

PubMed

Bravi, Andrea; Longtin, André; Seely, Andrew J E

2011-10-10

Analysis of patterns of variation of time-series, termed variability analysis, represents a rapidly evolving discipline with increasing applications in different fields of science. In medicine and in particular critical care, efforts have focussed on evaluating the clinical utility of variability. However, the growth and complexity of techniques applicable to this field have made interpretation and understanding of variability more challenging. Our objective is to provide an updated review of variability analysis techniques suitable for clinical applications. We review more than 70 variability techniques, providing for each technique a brief description of the underlying theory and assumptions, together with a summary of clinical applications. We propose a revised classification for the domains of variability techniques, which include statistical, geometric, energetic, informational, and invariant. We discuss the process of calculation, often necessitating a mathematical transform of the time-series. Our aims are to summarize a broad literature, promote a shared vocabulary that would improve the exchange of ideas, and the analyses of the results between different studies. We conclude with challenges for the evolving science of variability analysis.

Review and classification of variability analysis techniques with clinical applications

PubMed Central

2011-01-01

Analysis of patterns of variation of time-series, termed variability analysis, represents a rapidly evolving discipline with increasing applications in different fields of science. In medicine and in particular critical care, efforts have focussed on evaluating the clinical utility of variability. However, the growth and complexity of techniques applicable to this field have made interpretation and understanding of variability more challenging. Our objective is to provide an updated review of variability analysis techniques suitable for clinical applications. We review more than 70 variability techniques, providing for each technique a brief description of the underlying theory and assumptions, together with a summary of clinical applications. We propose a revised classification for the domains of variability techniques, which include statistical, geometric, energetic, informational, and invariant. We discuss the process of calculation, often necessitating a mathematical transform of the time-series. Our aims are to summarize a broad literature, promote a shared vocabulary that would improve the exchange of ideas, and the analyses of the results between different studies. We conclude with challenges for the evolving science of variability analysis. PMID:21985357

WE-B-BRD-01: Innovation in Radiation Therapy Planning II: Cloud Computing in RT

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

Moore, K; Kagadis, G; Xing, L

As defined by the National Institute of Standards and Technology, cloud computing is “a model for enabling ubiquitous, convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” Despite the omnipresent role of computers in radiotherapy, cloud computing has yet to achieve widespread adoption in clinical or research applications, though the transition to such “on-demand” access is underway. As this transition proceeds, new opportunities for aggregate studies and efficient use of computational resources are set againstmore » new challenges in patient privacy protection, data integrity, and management of clinical informatics systems. In this Session, current and future applications of cloud computing and distributed computational resources will be discussed in the context of medical imaging, radiotherapy research, and clinical radiation oncology applications. Learning Objectives: Understand basic concepts of cloud computing. Understand how cloud computing could be used for medical imaging applications. Understand how cloud computing could be employed for radiotherapy research.4. Understand how clinical radiotherapy software applications would function in the cloud.« less

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.

Latest status of the clinical and industrial applications of cell sheet engineering and regenerative medicine.

PubMed

Egami, Mime; Haraguchi, Yuji; Shimizu, Tatsuya; Yamato, Masayuki; Okano, Teruo

2014-01-01

Cell sheet engineering, which allows tissue engineering to be realized without the use of biodegradable scaffolds as an original approach, using a temperature-responsive intelligent surface, has been applied in regenerative medicine for various tissues, and a number of clinical studies have been already performed for life-threatening diseases. By using the results and findings obtained from the initial clinical studies, additional investigative clinical studies in several tissues with cell sheet engineering are currently in preparation stage. For treating many patients effectively by cell sheet engineering, an automated system integrating cell culture, cell-sheet fabrication, and layering is essential, and the system should include an advanced three-dimensional suspension cell culture system and an in vitro bioreactor system to scale up the production of cultured cells and fabricate thicker vascularized tissues. In this paper, cell sheet engineering, its clinical application, and further the authors' challenge to develop innovative cell culture systems under newly legislated regulatory platform in Japan are summarized and discussed.

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

From Theory to Application: A Study of Knowledge Transfer in Dental Education

ERIC Educational Resources Information Center

Peltz, Ivy D.

2014-01-01

Traditionally, dental education is divided into two phases: pre-clinical and clinical education. The pre-clinical phase of dental education includes the assimilation of theoretical topical knowledge in addition to the completion of simulated exercises. Upon completion of and demonstration of competency in their pre-clinical courses, students begin…

5 CFR 5502.107 - Supplemental disclosure of financial interests in substantially affected organizations applicable...

Code of Federal Regulations, 2010 CFR

2010-01-01

... clinical study involving human subjects under a clinical research protocol approved by an institutional review board. (2) Clinical research has the meaning set forth in 42 U.S.C. 284d(b). (3) Institutional... review a clinical research protocol and approve the initiation of biomedical research involving human...

Dental student attitudes towards communication skills instruction and clinical application.

PubMed

McKenzie, Carly T

2014-10-01

This study investigated dental students' attitudes towards communication skills instruction and clinical application and explored the impact of a one-semester course and year in school on students' attitudes, measured by the Communication Skills Attitude Scale. Demographic characteristics and self-assessment of communication skills were also analyzed. The study employed a pretest-posttest survey design combined with cross-sectional data. Participants were first- and fourth-year students at a U.S. dental school. Out of a possible 120 students, 106 (fifty-seven D1 and forty-nine D4) participated in the pretest, an 88 percent response rate; out of a possible 121 students, 115 (fifty-seven D1 and fifty-eight D4) participated in the posttest, a 95 percent response rate. In the results, D4 students consistently demonstrated less positive attitudes towards communication skills instruction and more negative attitudes regarding the importance of interpersonal skills in clinical encounters than did their D1 counterparts. A single communications course had no discernible effect on attitudes or self-assessments for either cohort. Females reported more positive attitudes towards clinical application of interpersonal skills than did males. Gender significantly interacted with two demographic variables: primary language and parent as health care professional. Female children of health care professionals reported poorer attitudes towards clinical communication skills training and application than did their male counterparts. Generally, parental occupation in health care moderated the decrease in positive attitudes over time towards clinical usefulness of communication skills. The D4 students rated their communication skills higher than did the D1 students. Students who demonstrated more positive attitudes towards communication skills training and application were more likely to say their own skills needed improvement.

The Role of Platelet Rich Plasma (PRP) and Other Biologics for Rotator Cuff Repair.

PubMed

Greenspoon, Joshua A; Moulton, Samuel G; Millett, Peter J; Petri, Maximilian

2016-01-01

Surgical treatment of rotator cuff tears has consistently demonstrated good clinical and functional outcomes. However, in some cases, the rotator cuff fails to heal. While improvements in rotator cuff constructs and biomechanics have been made, the role of biologics to aid healing is currently being investigated. A selective literature search was performed and personal surgical experiences are reported. Biologic augmentation of rotator cuff repairs can for example be performed wtableith platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs). Clinical results on PRP application have been controversial. Application of MSCs has shown promise in animal studies, but clinical data on its effectiveness is presently lacking. The role of Matrix Metalloproteinase (MMP) inhibitors is another interesting field for potential targeted drug therapy after rotator cuff repair. Large randomized clinical studies need to confirm the benefit of these approaches, in order to eventually lower retear rates and improve clinical outcomes after rotator cuff repair.

Polyamidoamine Dendrimers for Enhanced Solubility of Small Molecules and Other Desirable Properties for Site Specific Delivery: Insights from Experimental and Computational Studies.

PubMed

Shadrack, Daniel M; Swai, Hulda S; Munissi, Joan J E; Mubofu, Egid B; Nyandoro, Stephen S

2018-06-12

Clinical applications of many small molecules are limited due to poor solubility and lack of controlled release besides lack of other desirable properties. Experimental and computational studies have reported on the therapeutic potential of polyamidoamine (PAMAM) dendrimers as solubility enhancers in pre-clinical and clinical settings. Besides formulation strategies, factors such as pH, PAMAM dendrimer generation, PAMAM dendrimer concentration, nature of the PAMAM core, special ligand and surface modifications of PAMAM dendrimer have an influence on drug solubility and other recommendable pharmacological properties. This review, therefore, compiles the recently reported applications of PAMAM dendrimers in pre-clinical and clinical uses as enhancers of solubility and other desirable properties such as sustained and controlled release, bioavailability, bio-distribution, toxicity reduction or enhancement, and targeted delivery of small molecules with emphasis on cancer treatment.

Applications of Chondrocyte-Based Cartilage Engineering: An Overview

PubMed Central

Eo, Seong-Hui; Abbas, Qamar; Ahmed, Madiha

2016-01-01

Chondrocytes are the exclusive cells residing in cartilage and maintain the functionality of cartilage tissue. Series of biocomponents such as different growth factors, cytokines, and transcriptional factors regulate the mesenchymal stem cells (MSCs) differentiation to chondrocytes. The number of chondrocytes and dedifferentiation are the key limitations in subsequent clinical application of the chondrocytes. Different culture methods are being developed to overcome such issues. Using tissue engineering and cell based approaches, chondrocytes offer prominent therapeutic option specifically in orthopedics for cartilage repair and to treat ailments such as tracheal defects, facial reconstruction, and urinary incontinence. Matrix-assisted autologous chondrocyte transplantation/implantation is an improved version of traditional autologous chondrocyte transplantation (ACT) method. An increasing number of studies show the clinical significance of this technique for the chondral lesions treatment. Literature survey was carried out to address clinical and functional findings by using various ACT procedures. The current study was conducted to study the pharmacological significance and biomedical application of chondrocytes. Furthermore, it is inferred from the present study that long term follow-up studies are required to evaluate the potential of these methods and specific positive outcomes. PMID:27631002

Clinical Utilization of Repeated Open Application Test Among American Contact Dermatitis Society Members.

PubMed

Brown, Gabrielle E; Botto, Nina; Butler, Daniel C; Murase, Jenny E

2015-01-01

The repeated open application test (ROAT) provides useful information regarding allergens in suspected cases of allergic contact dermatitis; however, standardized methodology has not been established. The aim of this study was to assess how ROAT is used in clinical and research settings. We distributed a survey regarding ROAT practice to the American Contact Dermatitis Society and conducted a literature review of ROAT utilization in research. A total of 67 American Contact Dermatitis Society members participated in the survey. Respondents most frequently recommend application of leave-on products twice daily (46.0%) and rinse-off products once daily (43.5%). The most commonly used anatomical sites include the forearm (38.7%) and antecubital fossa (32.3%). Most respondents continue ROAT for 1 (49.2%) or 2 weeks (31.7%). Literature review of 32 studies (26 leave-on, 6 rinse-off) revealed that application frequency is most common at twice daily for both leave-on (96.2%) and rinse-off (50.0%) products. The most common anatomical site is the forearm (62.5%), with an overall study duration of 3 to 4 weeks (65.6%). When comparing ROAT clinical and research practice, the majority trend was consistent for leave-on product application frequency and anatomical site, but not for rinse-off product application frequency, or overall duration. Further research is needed to determine best practice recommendations.

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 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.

Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair

PubMed Central

Mithoefer, Kai; Saris, Daniel B.F.; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J.; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

2011-01-01

Objective: To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. Design: A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Results: Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. Conclusions: High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project. PMID:26069574

Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility.

PubMed

da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

2015-01-01

to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context.

An Ontology-based Architecture for Integration of Clinical Trials Management Applications

PubMed Central

Shankar, Ravi D.; Martins, Susana B.; O’Connor, Martin; Parrish, David B.; Das, Amar K.

2007-01-01

Management of complex clinical trials involves coordinated-use of a myriad of software applications by trial personnel. The applications typically use distinct knowledge representations and generate enormous amount of information during the course of a trial. It becomes vital that the applications exchange trial semantics in order for efficient management of the trials and subsequent analysis of clinical trial data. Existing model-based frameworks do not address the requirements of semantic integration of heterogeneous applications. We have built an ontology-based architecture to support interoperation of clinical trial software applications. Central to our approach is a suite of clinical trial ontologies, which we call Epoch, that define the vocabulary and semantics necessary to represent information on clinical trials. We are continuing to demonstrate and validate our approach with different clinical trials management applications and with growing number of clinical trials. PMID:18693919

Photodynamic therapy for infections: clinical applications.

PubMed

Kharkwal, Gitika B; Sharma, Sulbha K; Huang, Ying-Ying; Dai, Tianhong; Hamblin, Michael R

2011-09-01

Photodynamic therapy (PDT) was discovered over 100 years ago by its ability to kill various microorganisms when the appropriate dye and light were combined in the presence of oxygen. However it is only in relatively recent times that PDT has been studied as a treatment for various types of localized infections. This resurgence of interest has been partly motivated by the alarming increase in drug resistance amongst bacteria and other pathogens. This review will focus on the clinical applications of antimicrobial PDT. The published peer-reviewed literature was reviewed between 1960 and 2011. The basics of antimicrobial PDT are discussed. Clinical applications of antimicrobial PDT to localized viral infections caused by herpes and papilloma viruses, and nonviral dermatological infections such as acne and other yeast, fungal and bacterial skin infections are covered. PDT has been used to treat bacterial infections in brain abscesses and non-healing ulcers. PDT for dental infections including periodontitis and endodontics has been well studied. PDT has also been used for cutaneous Leishmaniasis. Clinical trials of PDT and blue light alone therapy for gastric Helicobacter pylori infection are also covered. As yet clinical PDT for infections has been mainly in the field of dermatology using 5-aminolevulanic acid and in dentistry using phenothiazinium dyes. We expect more to see applications of PDT to more challenging infections using advanced antimicrobial photosensitizers targeted to microbial cells in the years to come. Copyright © 2011 Wiley-Liss, Inc.

Does teaching method affect students' perceptions regarding communication patterns in pediatric dentistry? A comparison of lecture and video methods.

PubMed

Kalwitzki, Matthias; Meller, Christina; Beyer, Christine

2011-08-01

The purpose of this study was to determine whether dental students' perceptions regarding six communication patterns for use in pediatric dentistry differed depending on whether they were taught by lecturing or by video-based teaching. Prior to the introduction of interpersonal skills in a clinical course in pediatric dentistry, four consecutive cohorts of students (n=107) in a German dental school were divided equally into two groups. Group one (n=57) was taught by video sequences and group two (n=50) by conventional lecture. Six communication patterns were presented: involvement of the child's toy(s), speaking in positive phrases, mentioning a personal aspect, recalling positive behavior of the patient, addressing fear verbally, and complimenting the patient. Immediately after the presentation, students were asked by means of a questionnaire about their assessment of and intentions regarding the clinical application of the communication patterns presented. After completion of the course, they were asked about the communication patterns that had been used. There were significant differences for three communication patterns in favor of video-based teaching (p<0.05); there were no significant differences regarding the intention for clinical application and the actual clinical application. In this study, students perceived differences between video-based teaching and lecturing regarding ease of use, but they did not seem to benefit from one method over the other regarding clinical application.

The practical application of adaptive study design in early phase clinical trials: a retrospective analysis of time savings.

PubMed

Lorch, U; Berelowitz, K; Ozen, C; Naseem, A; Akuffo, E; Taubel, J

2012-05-01

The interest in adaptive study design is evident from the growing amount of clinical research employing this model in the mid to later stages of medicines development. Little has been published on the practical application and merits of adaptive study design in early phase clinical research. This paper describes a retrospective analysis performed on a sample of 29 industry lead adaptive early phase studies commencing between 1 January 2006 and 31 December 2010 in a clinical trials unit in London, England. All studies containing at least one adaptive feature in the original protocol were included in the analysis. The scope of the analysis was to assess whether the use of adaptive study designs provided tangible benefits over the use of conventional study designs using time savings as the main measure. We conclude that the use of adaptive study design saves time in early phase research programs. This is achieved by abolishing the need for substantial amendments or by mitigating their impact on timelines and by using adaptive scheduling efficiencies.

Current and Future Clinical Applications of High-Intensity Focused Ultrasound (HIFU) for Pancreatic Cancer.

PubMed

Jang, Hyun Joo; Lee, Jae-Young; Lee, Don-Haeng; Kim, Won-Hong; Hwang, Joo Ha

2010-09-01

High-intensity focused ultrasound (HIFU) is a novel therapeutic modality that permits noninvasive treatment of various benign and malignant solid tumors, including prostatic cancer, uterine fibroids, hepatic tumors, renal tumors, breast cancers, and pancreatic cancers. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumors, including pancreatic cancer. The results of nonrandomized studies of HIFU therapy in patients with pancreatic cancer have suggested that HIFU treatment can effectively alleviate cancer-related pain without any significant complications. This noninvasive method of delivering ultrasound energy into the body has recently been evolving from a method for purely thermal ablation to harnessing the mechanical effects of HIFU to induce a systemic immune response and to enhance targeted drug delivery. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges.

Current and Future Clinical Applications of High-Intensity Focused Ultrasound (HIFU) for Pancreatic Cancer

PubMed Central

Jang, Hyun Joo; Lee, Jae-Young; Lee, Don-Haeng; Kim, Won-Hong

2010-01-01

High-intensity focused ultrasound (HIFU) is a novel therapeutic modality that permits noninvasive treatment of various benign and malignant solid tumors, including prostatic cancer, uterine fibroids, hepatic tumors, renal tumors, breast cancers, and pancreatic cancers. Several preclinical and clinical studies have investigated the safety and efficacy of HIFU for treating solid tumors, including pancreatic cancer. The results of nonrandomized studies of HIFU therapy in patients with pancreatic cancer have suggested that HIFU treatment can effectively alleviate cancer-related pain without any significant complications. This noninvasive method of delivering ultrasound energy into the body has recently been evolving from a method for purely thermal ablation to harnessing the mechanical effects of HIFU to induce a systemic immune response and to enhance targeted drug delivery. This review provides a brief overview of HIFU, describes current clinical applications of HIFU for pancreatic cancer, and discusses future applications and challenges. PMID:21103296

Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

PubMed

Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

2018-06-01

There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

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 software development for the Web: lessons learned from the BOADICEA project

PubMed Central

2012-01-01

Background In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. Results We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web Application version 1 was released for general use in November 2007. By May 2010, we had > 1200 registered users based in the UK, USA, Canada, South America, Europe, Africa, Middle East, SE Asia, Australia and New Zealand. Conclusions We found that an evolutionary software process was effective when we developed the BOADICEA Web Application. The key clinical software development issues identified during the BOADICEA Web Application project were: software reliability, Web security, clinical data protection and user feedback. PMID:22490389

Clinical software development for the Web: lessons learned from the BOADICEA project.

PubMed

Cunningham, Alex P; Antoniou, Antonis C; Easton, Douglas F

2012-04-10

In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web Application version 1 was released for general use in November 2007. By May 2010, we had > 1200 registered users based in the UK, USA, Canada, South America, Europe, Africa, Middle East, SE Asia, Australia and New Zealand. We found that an evolutionary software process was effective when we developed the BOADICEA Web Application. The key clinical software development issues identified during the BOADICEA Web Application project were: software reliability, Web security, clinical data protection and user feedback.

Embodied Conversational Agents in Clinical Psychology: A Scoping Review

PubMed Central

Lau, Ho Ming; Ruwaard, Jeroen; Riper, Heleen

2017-01-01

Background Embodied conversational agents (ECAs) are computer-generated characters that simulate key properties of human face-to-face conversation, such as verbal and nonverbal behavior. In Internet-based eHealth interventions, ECAs may be used for the delivery of automated human support factors. Objective We aim to provide an overview of the technological and clinical possibilities, as well as the evidence base for ECA applications in clinical psychology, to inform health professionals about the activity in this field of research. Methods Given the large variety of applied methodologies, types of applications, and scientific disciplines involved in ECA research, we conducted a systematic scoping review. Scoping reviews aim to map key concepts and types of evidence underlying an area of research, and answer less-specific questions than traditional systematic reviews. Systematic searches for ECA applications in the treatment of mood, anxiety, psychotic, autism spectrum, and substance use disorders were conducted in databases in the fields of psychology and computer science, as well as in interdisciplinary databases. Studies were included if they conveyed primary research findings on an ECA application that targeted one of the disorders. We mapped each study’s background information, how the different disorders were addressed, how ECAs and users could interact with one another, methodological aspects, and the study’s aims and outcomes. Results This study included N=54 publications (N=49 studies). More than half of the studies (n=26) focused on autism treatment, and ECAs were used most often for social skills training (n=23). Applications ranged from simple reinforcement of social behaviors through emotional expressions to sophisticated multimodal conversational systems. Most applications (n=43) were still in the development and piloting phase, that is, not yet ready for routine practice evaluation or application. Few studies conducted controlled research into clinical effects of ECAs, such as a reduction in symptom severity. Conclusions ECAs for mental disorders are emerging. State-of-the-art techniques, involving, for example, communication through natural language or nonverbal behavior, are increasingly being considered and adopted for psychotherapeutic interventions in ECA research with promising results. However, evidence on their clinical application remains scarce. At present, their value to clinical practice lies mostly in the experimental determination of critical human support factors. In the context of using ECAs as an adjunct to existing interventions with the aim of supporting users, important questions remain with regard to the personalization of ECAs’ interaction with users, and the optimal timing and manner of providing support. To increase the evidence base with regard to Internet interventions, we propose an additional focus on low-tech ECA solutions that can be rapidly developed, tested, and applied in routine practice. PMID:28487267

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.

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

Psychoeducation in bipolar disorder with a SIMPLe smartphone application: Feasibility, acceptability and satisfaction.

PubMed

Hidalgo-Mazzei, Diego; Mateu, Ainoa; Reinares, María; Murru, Andrea; Del Mar Bonnín, Caterina; Varo, Cristina; Valentí, Marc; Undurraga, Juan; Strejilevich, Sergio; Sánchez-Moreno, José; Vieta, Eduard; Colom, Francesc

2016-08-01

During the last fifteen years, the possibility of delivering psychoeducation programs through Internet-based platforms have been explored. Studies evaluating those programs have shown good to acceptable retention rates. In this context, we developed a smartphone application (SIMPLe) collecting information about mood symptoms and offering personalized psychoeducation messages. The main aims of this study were to evaluate the feasibility, acceptability and satisfaction of the smartphone application. The study was conducted from March to August 2015. Participation in the study was proposed to a consecutive sample of adult patients attending an outpatient mental health clinic. Sociodemographic data, clinical and functional assessments alongside smartphone ownership and uses were collected at baseline and at 3 months' follow-up. A 5 item Likert-scale satisfaction questionnaire was also employed. 51 participants were initially enrolled in the study, 36 (74%) remained actively using the application after 3 months. The whole sample interacted with the application a mean of 77 days (SD=26.2). During these days they completed 88% of the daily tests. Over 86% of the participants agreed that the experience using the application was satisfactory. The diversity of smartphones operating systems led to a moderate, although representative, sample number. Additionally, the subjective data reporting, narrow time frame of use and stability of the patients could have affected the results. The results confirm that this particular intervention is feasible and represent a satisfactory and acceptable instrument for the self-management of bipolar disorder as an add-on to the usual treatment but future clinical trials must still probe its efficacy. Copyright © 2016 Elsevier B.V. All rights reserved.

Success factors for telehealth--a case study.

PubMed

Moehr, J R; Schaafsma, J; Anglin, C; Pantazi, S V; Grimm, N A; Anglin, S

2006-01-01

To present the lessons learned from an evaluation of a comprehensive telehealth project regarding success factors and evaluation methodology for such projects. A recent experience with the evaluation of new telehealth services in BC, Canada, is summarized. Two domains of clinical applications, as well as educational and administrative uses, and the project environment were evaluated. In order to contribute to the success of the project, the evaluation included formative and summative approaches employing qualitative and quantitative methods with data collection from telehealth events, participants and existing databases. The evaluation had to be carried out under severe budgetary and time constraints. We therefore deliberately chose a broad ranging exploratory approach within a framework provided, and generated questions to be answered on the basis of initial observations and participant driven interviews with progressively more focused and detailed data gathering, including perusal of a variety of existing data sources. A unique feature was an economic evaluation using static simulation models. The evaluation yielded rich and detailed data, which were able to explain a number of unanticipated findings. One clinical application domain was cancelled after 6 months, the other continues. The factors contributing to success include: Focus on chronic conditions which require visual information for proper management. Involvement of established teams in regular scheduled visits or in sessions scheduled well in advance. Problems arose with: Ad hoc applications, in particular under emergency conditions. Applications that disregard established referral patterns. Applications that support only part of a unit's services. The latter leads to the service mismatch dilemma (SMMD) with the end result that even those e-health services provided are not used. The problems encountered were compounded by issues arising from the manner in which the telehealth services had been introduced, in particular the lack of time for preparation and establishment of routine use. Educational applications had significant clinical benefits. Administrative applications generated savings which exceeded the substantial capital investment and made educational and clinical applications available at variable cost. Evaluation under severe constraints can yield rich information. The identified success factors, including provision of an overarching architecture and infrastructure, strong program management, thorough needs analysis and detailing applications to match the identified needs should improve the sustainability of e-health projects. Insights gained: Existing assumptions before the study was conducted: Evaluation has to proceed from identified questions according to a rigorous experimental design. Emergency and trauma services in remote regions can and should be supported via telehealth based on video-conferencing. Educational applications of telehealth directed at providers are beneficial for recruitment and retention of providers in remote areas. Insights gained by the study: An exploratory approach to evaluation using a multiplicity of methods can yield rich and detailed information even under severe constraints. Ad hoc and emergency clinical applications of telehealth can present problems unless they are based on thorough, detailed analyses of environment and need, conform to established practice patterns and rely on established trusting collaborative relationships. Less difficult applications should be introduced before attempting to support use under emergency conditions. Educational applications are of interest beyond the provider community to patients, family and community members, and have clinical value. In large, sparsely populated areas with difficult travel conditions administrative applications by themselves generate savings that compensate for the substantial capital investment for telehealth required for clinical applications.

Criteria for evidence-based practice in Iranian traditional medicine.

PubMed

Soltani Arabshahi, SeyyedKamran; Mohammadi Kenari, Hoorieh; Kordafshari, Gholamreza; Shams-Ardakani, MohammadReza; Bigdeli, Shoaleh

2015-07-01

The major difference between Iranian traditional medicine and allopathic medicine is in the application  of  evidence  and  documents.  In  this  study,  criteria  for  evidence-based  practice  in  Iranian traditional medicine and its rules of practice were studied. The experts' views were investigated through in- depth, semi-structured interviews and the results were categorized into four main categories including Designing clinical questions/clinical question-based search, critical appraisal, resource search criteria and clinical prescription appraisal. Although the application of evidence in Iranian traditional medicine follows Evidence Based Medicine (EBM) principles but it benefits from its own rules, regulations, and criteria that are compatible with EBM.

Approaches using molecular imaging technology -- use of PET in clinical microdose studies.

PubMed

Wagner, Claudia C; Langer, Oliver

2011-06-19

Positron emission tomography (PET) imaging uses minute amounts of radiolabeled drug tracers and thereby meets the criteria for clinical microdose studies. The advantage of PET, when compared to other analytical methods used in microdose studies, is that the pharmacokinetics (PK) of a drug can be determined in the tissue targeted for drug treatment. PET microdosing already offers interesting applications in clinical oncology and in the development of central nervous system pharmaceuticals and is extending its range of application to many other fields of pharmaceutical medicine. Although requirements for preclinical safety testing for microdose studies have been cut down by regulatory authorities, radiopharmaceuticals increasingly need to be produced under good manufacturing practice (GMP) conditions, which increases the costs of PET microdosing studies. Further challenges in PET microdosing include combining PET with other ultrasensitive analytical methods, such as accelerator mass spectrometry (AMS), to gain plasma PK data of drugs, beyond the short PET examination periods. Finally, conducting clinical PET studies with radiolabeled drugs both at micro- and therapeutic doses is encouraged to answer the question of dose linearity in clinical microdosing. Copyright © 2010 Elsevier B.V. All rights reserved.

The ART of Social Networking: How SART member clinics are connecting with patients online

PubMed Central

OMURTAG, Kenan; JIMENEZ, Patricia T.; RATTS, Valerie; ODEM, Randall; COOPER, Amber R.

2013-01-01

Objective To study and describe the use of social networking websites among SART member clinics Design Cross-sectional study Setting University Based Practice Patients Not Applicable Interventions Not Applicable Main Outcome Measure Prevalence of social networking websites among SART member clinics and evaluation of content, volume and location (i.e mandated state, region) using multivariate regression analysis Results 384 SART registered clinics and 1,382 social networking posts were evaluated. Of the clinics, 96% have a website and 30% link to a social networking website. The majority of clinics (89%) with social networking websites were affiliated with non-academic centers. Social networking posts mostly provide information (31%) and/or advertise (28%), while the remaining offer support (19%) or are irrelevant (17%) to the target audience. Only 5% of posts involved patients requesting information. Clinic volume correlates with the presence of a clinic website and a social networking website (p<0.001). Conclusion Almost all SART member clinics have a website. Nearly one-third of these clinics host a social networking website like Facebook, Twitter and/or a Web-log (“blog”). Larger volume clinics commonly host social networking websites. These sites provide new ways to communicate with patients, but clinics should maintain policies on the incorporation of social networks into practice. PMID:22088209

Bioinformatics tools for the analysis of NMR metabolomics studies focused on the identification of clinically relevant biomarkers.

PubMed

Puchades-Carrasco, Leonor; Palomino-Schätzlein, Martina; Pérez-Rambla, Clara; Pineda-Lucena, Antonio

2016-05-01

Metabolomics, a systems biology approach focused on the global study of the metabolome, offers a tremendous potential in the analysis of clinical samples. Among other applications, metabolomics enables mapping of biochemical alterations involved in the pathogenesis of diseases, and offers the opportunity to noninvasively identify diagnostic, prognostic and predictive biomarkers that could translate into early therapeutic interventions. Particularly, metabolomics by Nuclear Magnetic Resonance (NMR) has the ability to simultaneously detect and structurally characterize an abundance of metabolic components, even when their identities are unknown. Analysis of the data generated using this experimental approach requires the application of statistical and bioinformatics tools for the correct interpretation of the results. This review focuses on the different steps involved in the metabolomics characterization of biofluids for clinical applications, ranging from the design of the study to the biological interpretation of the results. Particular emphasis is devoted to the specific procedures required for the processing and interpretation of NMR data with a focus on the identification of clinically relevant biomarkers. © The Author 2015. Published by Oxford University Press. For Permissions, please email: journals.permissions@oup.com.

Federating heterogeneous datasets to enhance data sharing and experiment reproducibility

NASA Astrophysics Data System (ADS)

Prieto, Juan C.; Paniagua, Beatriz; Yatabe, Marilia S.; Ruellas, Antonio C. O.; Fattori, Liana; Muniz, Luciana; Styner, Martin; Cevidanes, Lucia

2017-03-01

Recent studies have demonstrated the difficulties to replicate scientific findings and/or experiments published in past.1 The effects seen in the replicated experiments were smaller than previously reported. Some of the explanations for these findings include the complexity of the experimental design and the pressure on researches to report positive findings. The International Committee of Medical Journal Editors (ICMJE) suggests that every study considered for publication must submit a plan to share the de-identified patient data no later than 6 months after publication. There is a growing demand to enhance the management of clinical data, facilitate data sharing across institutions and also to keep track of the data from previous experiments. The ultimate goal is to assure the reproducibility of experiments in the future. This paper describes Shiny-tooth, a web based application created to improve clinical data acquisition during the clinical trial; data federation of such data as well as morphological data derived from medical images; Currently, this application is being used to store clinical data from an osteoarthritis (OA) study. This work is submitted to the SPIE Biomedical Applications in Molecular, Structural, and Functional Imaging conference.

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.

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

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.

Predictors of future success in otolaryngology residency applicants.

PubMed

Chole, Richard A; Ogden, M Allison

2012-08-01

To evaluate the information available about otolaryngology residency applicants for factors that may predict future success as an otolaryngologist. Retrospective review of residency applications; survey of resident graduates and otolaryngology clinical faculty. Otolaryngology residency program. Otolaryngology program graduates from 2001 to 2010 and current clinical faculty from Barnes-Jewish Hospital/Washington University School of Medicine. Overall ratings of the otolaryngology graduates by clinical faculty (on a 5-point scale) were compared with the resident application attributes that might predict success. The application factors studied are United States Medical Licensing Examination part 1 score, Alpha Omega Alpha Honor Medical Society election, medical school grades, letter of recommendation, rank of the medical school, extracurricular activities, residency interview, experience with acting intern, and extracurricular activities. Forty-six graduates were included in the study. The overall faculty rating of the residents showed good interrater reliability. The objective factors, letters of recommendation, experience as an acting intern, and musical excellence showed no correlation with higher faculty rating. Rank of the medical school and faculty interview weakly correlated with faculty rating. Having excelled in a team sport correlated with higher faculty rating. Many of the application factors typically used during otolaryngology residency candidate selection may not be predictive of future capabilities as a clinician. Prior excellence in a team sport may suggest continued success in the health care team.

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.

PET measurements of myocardial blood flow post myocardial infarction: Relationship to invasive and cardiac magnetic resonance studies and potential clinical applications.

PubMed

Gewirtz, Henry

2017-12-01

This review focuses on clinical studies concerning assessment of coronary microvascular and conduit vessel function primarily in the context of acute and sub acute myocardial infarction (MI). The ability of quantitative PET measurements of myocardial blood flow (MBF) to delineate underlying pathophysiology and assist in clinical decision making in this setting is discussed. Likewise, considered are physiological metrics fractional flow reserve, coronary flow reserve, index of microvascular resistance (FFR, CFR, IMR) obtained from invasive studies performed in the cardiac catheterization laboratory, typically at the time of PCI for MI. The role both of invasive studies and cardiac magnetic resonance (CMR) imaging in assessing microvascular function, a key determinant of prognosis, is reviewed. The interface between quantitative PET MBF measurements and underlying pathophysiology, as demonstrated both by invasive and CMR methodology, is discussed in the context of optimal interpretation of the quantitative PET MBF exam and its potential clinical applications.

Neurosurgical Virtual Reality Simulation for Brain Tumor Using High-definition Computer Graphics: A Review of the Literature.

PubMed

Kin, Taichi; Nakatomi, Hirofumi; Shono, Naoyuki; Nomura, Seiji; Saito, Toki; Oyama, Hiroshi; Saito, Nobuhito

2017-10-15

Simulation and planning of surgery using a virtual reality model is becoming common with advances in computer technology. In this study, we conducted a literature search to find trends in virtual simulation of surgery for brain tumors. A MEDLINE search for "neurosurgery AND (simulation OR virtual reality)" retrieved a total of 1,298 articles published in the past 10 years. After eliminating studies designed solely for education and training purposes, 28 articles about the clinical application remained. The finding that the vast majority of the articles were about education and training rather than clinical applications suggests that several issues need be addressed for clinical application of surgical simulation. In addition, 10 of the 28 articles were from Japanese groups. In general, the 28 articles demonstrated clinical benefits of virtual surgical simulation. Simulation was particularly useful in better understanding complicated spatial relations of anatomical landmarks and in examining surgical approaches. In some studies, Virtual reality models were used on either surgical navigation system or augmented reality technology, which projects virtual reality images onto the operating field. Reported problems were difficulties in standardized, objective evaluation of surgical simulation systems; inability to respond to tissue deformation caused by surgical maneuvers; absence of the system functionality to reflect features of tissue (e.g., hardness and adhesion); and many problems with image processing. The amount of description about image processing tended to be insufficient, indicating that the level of evidence, risk of bias, precision, and reproducibility need to be addressed for further advances and ultimately for full clinical application.

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol.

PubMed

Recio-Rodríguez, José I; Martín-Cantera, Carlos; González-Viejo, Natividad; Gómez-Arranz, Amparo; Arietaleanizbeascoa, Maria S; Schmolling-Guinovart, Yolanda; Maderuelo-Fernandez, Jose A; Pérez-Arechaederra, Diana; Rodriguez-Sanchez, Emiliano; Gómez-Marcos, Manuel A; García-Ortiz, Luis

2014-03-15

New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Clinical Trials.gov Identifier: NCT02016014.

A mixed methods pilot study to investigate the impact of a hospital-specific iPhone application (iTreat) within a British junior doctor cohort.

PubMed

Payne, Karl Fb; Weeks, Lucy; Dunning, Paul

2014-03-01

We present a pilot study to investigate the impact of introducing a hospital-specific smartphone application into a cohort of British junior doctors. We created the iPhone application 'iTreat' that contained disease management and antibiotic dosing guidelines specific to our hospital, together with a postgraduate education department really simple syndication feed, a contact number phonebook and a favourites section. This intervention was trialled in a group of 39 foundation grade junior doctors, in a UK hospital, for a time period of 4 months. Mixed methods data capture, utilising survey and semi-structured interviews, was used to evaluate application usage patterns and potential barriers to endorsement of smartphone technology in the hospital setting. Sixty eight per cent of participants felt the application saved them time during clinical activities, with a decrease in the frequency of participants not referring to hospital clinical guidelines. The findings from this pilot study point towards the internal hospital environment as having a major impact upon smartphone usage. Participants viewed smartphone use as unprofessional in the ward-based setting, with a perceived negative attitude from other healthcare staff. An understanding of how healthcare staff choose to utilise smartphones in the clinical environment is crucial to enable the successful assimilation of smartphone technology into the hospital setting. This pilot study provides experience and parameters for future substantive studies being carried out by this group.

Compliance with results reporting at ClinicalTrials.gov.

PubMed

Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert M

2015-03-12

The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).

Clinical proteomic biomarkers: relevant issues on study design & technical considerations in biomarker development

PubMed Central

2014-01-01

Biomarker research is continuously expanding in the field of clinical proteomics. A combination of different proteomic–based methodologies can be applied depending on the specific clinical context of use. Moreover, current advancements in proteomic analytical platforms are leading to an expansion of biomarker candidates that can be identified. Specifically, mass spectrometric techniques could provide highly valuable tools for biomarker research. Ideally, these advances could provide with biomarkers that are clinically applicable for disease diagnosis and/ or prognosis. Unfortunately, in general the biomarker candidates fail to be implemented in clinical decision making. To improve on this current situation, a well-defined study design has to be established driven by a clear clinical need, while several checkpoints between the different phases of discovery, verification and validation have to be passed in order to increase the probability of establishing valid biomarkers. In this review, we summarize the technical proteomic platforms that are available along the different stages in the biomarker discovery pipeline, exemplified by clinical applications in the field of bladder cancer biomarker research. PMID:24679154

Effects of using mobile device-based academic electronic medical records for clinical practicum by undergraduate nursing students: A quasi-experimental study.

PubMed

Choi, Mona; Lee, HyeongSuk; Park, Joon Ho

2018-02-01

The academic electronic medical record (AEMR) system is applied with the expectation that nursing students will be able to attain competence in healthcare decision-making and nursing informatics competencies. However, there is insufficient evidence regarding the advantage of applying mobile devices to clinical practicum. This study aimed to examine the effect of an experiment that introduced a mobile AEMR application for undergraduate nursing students in their practicum. A quasi-experimental design was used. The subjects were 75 third-year nursing students enrolled in clinical practicum and were divided into an experimental (practicum with AEMR) and a control (conventional practicum) group. Nursing informatics competencies, critical thinking disposition, and satisfaction with clinical practicum were measured before and after the clinical practicum for each group. The usability of the AEMR application was also examined for the experimental group after the experiment. After the experiment, the experimental group showed a significant increase in the informatics knowledge domain of nursing informatics competencies in the post-test. The difference in critical thinking between the experimental and control groups was not statistically significant. Regarding satisfaction with the clinical practicum, the experimental group exhibited a significantly higher level of satisfaction in "preparation of a diagnostic test or laboratory test and understanding of the results" and "nursing intervention and documentation" than the control group. Students who participated in the practicum using the AEMR application considered it useful. The AEMR application was an effective educational method for practicing the immediate documentation of students' observations and interventions and was available at the patients' bedsides. To improve critical thinking, it is necessary to apply a variety of approaches when solving clinical problems. Copyright © 2017 Elsevier Ltd. All rights reserved.

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...

Clinical Application of Stem Cells in the Cardiovascular System

NASA Astrophysics Data System (ADS)

Stamm, Christof; Klose, Kristin; Choi, Yeong-Hoon

Regenerative medicine encompasses "tissue engineering" - the in vitro fabrication of tissues and/or organs using scaffold material and viable cells - and "cell therapy" - the transplantation or manipulation of cells in diseased tissue in vivo. In the cardiovascular system, tissue engineering strategies are being pursued for the development of viable replacement blood vessels, heart valves, patch material, cardiac pacemakers and contractile myocardium. Anecdotal clinical applications of such vessels, valves and patches have been described, but information on systematic studies of the performance of such implants is not available, yet. Cell therapy for cardiovascular regeneration, however, has been performed in large series of patients, and numerous clinical studies have produced sometimes conflicting results. The purpose of this chapter is to summarize the clinical experience with cell therapy for diseases of the cardiovascular system, and to analyse possible factors that may influence its outcome.

Spirulina in Clinical Practice: Evidence-Based Human Applications

PubMed Central

Karkos, P. D.; Leong, S. C.; Karkos, C. D.; Sivaji, N.; Assimakopoulos, D. A.

2011-01-01

Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and systematic reviews suggest that this alga may improve several symptoms and may even have an anticancer, antiviral and antiallergic effects. Current and potential clinical applications, issues of safety, indications, side-effects and levels of evidence are addressed in this review. Areas of ongoing and future research are also discussed. PMID:18955364

Rank-based estimation in the {ell}1-regularized partly linear model for censored outcomes with application to integrated analyses of clinical predictors and gene expression data.

PubMed

Johnson, Brent A

2009-10-01

We consider estimation and variable selection in the partial linear model for censored data. The partial linear model for censored data is a direct extension of the accelerated failure time model, the latter of which is a very important alternative model to the proportional hazards model. We extend rank-based lasso-type estimators to a model that may contain nonlinear effects. Variable selection in such partial linear model has direct application to high-dimensional survival analyses that attempt to adjust for clinical predictors. In the microarray setting, previous methods can adjust for other clinical predictors by assuming that clinical and gene expression data enter the model linearly in the same fashion. Here, we select important variables after adjusting for prognostic clinical variables but the clinical effects are assumed nonlinear. Our estimator is based on stratification and can be extended naturally to account for multiple nonlinear effects. We illustrate the utility of our method through simulation studies and application to the Wisconsin prognostic breast cancer data set.

Broad-range PCR: past, present, or future of bacteriology?

PubMed

Renvoisé, A; Brossier, F; Sougakoff, W; Jarlier, V; Aubry, A

2013-08-01

PCR targeting the gene encoding 16S ribosomal RNA (commonly named broad-range PCR or 16S PCR) has been used for 20 years as a polyvalent tool to study prokaryotes. Broad-range PCR was first used as a taxonomic tool, then in clinical microbiology. We will describe the use of broad-range PCR in clinical microbiology. The first application was identification of bacterial strains obtained by culture but whose phenotypic or proteomic identification remained difficult or impossible. This changed bacterial taxonomy and allowed discovering many new species. The second application of broad-range PCR in clinical microbiology is the detection of bacterial DNA from clinical samples; we will review the clinical settings in which the technique proved useful (such as endocarditis) and those in which it did not (such as characterization of bacteria in ascites, in cirrhotic patients). This technique allowed identifying the etiological agents for several diseases, such as Whipple disease. This review is a synthesis of data concerning the applications, assets, and drawbacks of broad-range PCR in clinical microbiology. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

The clinical application of research utilization: amphotericin B.

PubMed

Reedy, A M; Shivnan, J C; Hanson, J L; Haisfield, M E; Gregory, R E

1994-05-01

To describe the first application of the research utilization process by clinical nurses using the Stetler-Marram Model of Research Utilization to the practice of amphotericin B administration; to share the findings; and to discuss issues encountered in the process and their solutions. Published articles identified through computerized literature searches, published abstracts and books, personal communication with one author, and an informal survey of other cancer centers' amphotericin B infusion practices; research articles were selected for review if studies included settings and patient populations similar to those of the authors and if they used experimental designs. Studies were reviewed for scientific merit and clinical applicability according to the Stetler-Marram model; findings were used to develop a specific nursing protocol for infusion times of amphotericin B based on clinical criteria. The Stetler-Marram model helped staff nurses decide how to apply research findings to practice, although using it was difficult and required mentorship. A research base exists for amphotericin B administration time but not for test doses or premedications to prevent or minimize side effects. Staff nurses can use the Stetler-Marram model but need resources and support from individuals, committees, and administration. A specific protocol representing a practice change was implemented and may be applicable to other settings.

Reliability and Validity of the KIPPPI: An Early Detection Tool for Psychosocial Problems in Toddlers

PubMed Central

Kruizinga, Ingrid; Jansen, Wilma; de Haan, Carolien L.; Raat, Hein

2012-01-01

Background The KIPPPI (Brief Instrument Psychological and Pedagogical Problem Inventory) is a Dutch questionnaire that measures psychosocial and pedagogical problems in 2-year olds and consists of a KIPPPI Total score, Wellbeing scale, Competence scale, and Autonomy scale. This study examined the reliability, validity, screening accuracy and clinical application of the KIPPPI. Methods Parents of 5959 2-year-old children in the Rotterdam area, the Netherlands, were invited to participate in the study. Parents of 3164 children (53.1% of all invited parents) completed the questionnaire. The internal consistency was evaluated and in subsamples the test-retest reliability and concurrent validity with regard to the Child Behavioral Checklist (CBCL). Discriminative validity was evaluated by comparing scores of parents who worried about their child’s upbringing and parent’s that did not. Screening accuracy of the KIPPPI was evaluated against the CBCL by calculating the Receiver Operating Characteristic (ROC) curves. The clinical application was evaluated by the relation between KIPPPI scores and the clinical decision made by the child health professionals. Results Psychometric properties of the KIPPPI Total score, Wellbeing scale, Competence scale and Autonomy scale were respectively: Cronbach’s alphas: 0.88, 0.86, 0.83, 0.58. Test-retest correlations: 0.80, 0.76, 0.73, 0.60. Concurrent validity was as hypothesised. The KIPPPI was able to discriminate between parents that worried about their child and parents that did not. Screening accuracy was high (>0.90) for the KIPPPI Total score and for the Wellbeing scale. The KIPPPI scale scores and clinical decision of the child health professional were related (p<0.05), indicating a good clinical application. Conclusion The results in this large-scale study of a diverse general population sample support the reliability, validity and clinical application of the KIPPPI Total score, Wellbeing scale and Competence scale. Also, the screening accuracy of the KIPPPI Total score and Wellbeing scale were supported. The Autonomy scale needs further study. PMID:23185388

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study.

PubMed

Lee, Jie-Eun; Lee, Dong Hwa; Oh, Tae Jung; Kim, Kyoung Min; Choi, Sung Hee; Lim, Soo; Park, Young Joo; Park, Do Joon; Jang, Hak Chul; Moon, Jae Hoon

2018-02-21

Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis. The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment. Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded. Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017. This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis. ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2). ©Jie-Eun Lee, Dong Hwa Lee, Tae Jung Oh, Kyoung Min Kim, Sung Hee Choi, Soo Lim, Young Joo Park, Do Joon Park, Hak Chul Jang, Jae Hoon Moon. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.02.2018.

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

Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility 1

PubMed Central

da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

2015-01-01

AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility METHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context. PMID:25806631

[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.
.

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.

Clinical utility of resting-state functional connectivity magnetic resonance imaging for mood and cognitive disorders.

PubMed

Takamura, T; Hanakawa, T

2017-07-01

Although functional magnetic resonance imaging (fMRI) has long been used to assess task-related brain activity in neuropsychiatric disorders, it has not yet become a widely available clinical tool. Resting-state fMRI (rs-fMRI) has been the subject of recent attention in the fields of basic and clinical neuroimaging research. This method enables investigation of the functional organization of the brain and alterations of resting-state networks (RSNs) in patients with neuropsychiatric disorders. Rs-fMRI does not require participants to perform a demanding task, in contrast to task fMRI, which often requires participants to follow complex instructions. Rs-fMRI has a number of advantages over task fMRI for application with neuropsychiatric patients, for example, although applications of task fMR to participants for healthy are easy. However, it is difficult to apply these applications to patients with psychiatric and neurological disorders, because they may have difficulty in performing demanding cognitive task. Here, we review the basic methodology and analysis techniques relevant to clinical studies, and the clinical applications of the technique for examining neuropsychiatric disorders, focusing on mood disorders (major depressive disorder and bipolar disorder) and dementia (Alzheimer's disease and mild cognitive impairment).

42 CFR 51b.405 - What information is required in the application?

Code of Federal Regulations, 2010 CFR

2010-10-01

... appropriate allied health personnel) venereal disease education, training, and clinical skills improvement...) At the option of the applicant, special studies or demonstrations to evaluate or test venereal...

Clinical use of three-dimensional video measurements of eye movements

NASA Technical Reports Server (NTRS)

Merfeld, D. M.; Black, F. O.; Wade, S.; Paloski, W. H. (Principal Investigator)

1998-01-01

Noninvasive measurements of three-dimensional eye position can be accurately achieved with video methods. A case study showing the potential clinical benefit of these enhanced measurements is presented along with some thoughts about technological advances, essential for clinical application, that are likely to occur in the next several years.

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.

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.

Development and evaluation of a web-based application for digital findings and documentation in physiotherapy education.

PubMed

Spieler, Bernadette; Burgsteiner, Harald; Messer-Misak, Karin; Gödl-Purrer, Barbara; Salchinger, Beate

2015-01-01

Findings in physiotherapy have standardized approaches in treatment, but there is also a significant margin of differences in how to implement these standards. Clinical decisions require experience and continuous learning processes to consolidate personal values and opinions and studies suggest that lecturers can influence students positively. Recently, the study course of Physiotherapy at the University of Applied Science in Graz has offered a paper based finding document. This document supported decisions through the adaption of the clinical reasoning process. The document was the starting point for our learning application called "EasyAssess", a Java based web-application for a digital findings documentation. A central point of our work was to ensure efficiency, effectiveness and usability of the web-application through usability tests utilized by both students and lecturers. Results show that our application fulfills the previously defined requirements and can be efficiently used in daily routine largely because of its simple user interface and its modest design. Due to the close cooperation with the study course Physiotherapy, the application has incorporated the various needs of the target audiences and confirmed the usefulness of our application.

Lectins and their application to clinical microbiology.

PubMed Central

Slifkin, M; Doyle, R J

1990-01-01

Lectins are generally associated with plant or animal components, selectively bind carbohydrates, and interact with procaryotic and eucaryotic cells. Lectins have various specificities that are associated with their ability to interact with acetylaminocarbohydrates, aminocarbohydrates, sialic acids, hexoses, pentoses, and as other carbohydrates. Microbial surfaces generally contain many of the sugar residues that react with lectins. Lectins are presently used in the clinical laboratory to type blood cells and are used in a wide spectrum of applications, including, in part, as carriers of chemotherapeutic agents, as mitogens, for fractionation of animal cells, and for investigations of cellular surfaces. Numerous studies have shown that lectins can be used to identify rapidly certain microorganisms isolated from a clinical specimen or directly in a clinical specimen. Lectins have been demonstrated to be important diagnostic reagents in the major realms of clinical microbiology. Thus, they have been applied in bacteriology, mycology, mycobacteriology, and virology for the identification and/or differentiation of various microorganisms. Lectins have been used successfully as epidemiologic as well as taxonomic markers of specific microorganisms. Lectins provide the clinical microbiologist with cost-effective and potential diagnostic reagents. This review describes the applications of lectins in clinical microbiology. Images PMID:2200603

76 FR 47148 - Application(s) for Duty-Free Entry of Scientific Instruments

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-04

... work in microbiology and pathology, to study biological materials in order to identify bacterial or viral pathogens with clinical significance in veterinary medicine. Justification for Duty-Free Entry: No...

The biophysical basis and clinical applications of rheoencephalography.

DOT National Transportation Integrated Search

1967-05-01

A method for screening large populations for asymptomatic but potentially incapacitating cerebrovascular disease has obvious application in aviation medicine. Rheoencephalography (REG), a simple, rapid and innocuous method of studying the cranial cir...

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.

Clinical Computer Applications in Mental Health

PubMed Central

Greist, John H.; Klein, Marjorie H.; Erdman, Harold P.; Jefferson, James W.

1982-01-01

Direct patient-computer interviews were among the earliest applications of computing in medicine. Yet patient interviewing and other clinical applications have lagged behind fiscal/administrative uses. Several reasons for delays in the development and implementation of clinical computing programs and their resolution are discussed. Patient interviewing, clinician consultation and other applications of clinical computing in mental health are reviewed.

Application of Quality Assurance Strategies in Diagnostics and Clinical Support Services in Iranian Hospitals

PubMed Central

Aghaei Hashjin, Asgar; Kringos, Dionne; Ravaghi, Hamid; Manoochehri, Jila; Gorji, Hassan Abolghasem; Klazinga, Niek S.

2015-01-01

Background: Iran has a widespread diagnostics and clinical support services (DCSS) network that plays a crucial role in providing diagnostic and clinical support services to both inpatient and outpatient care. However, very little is known on the application of quality assurance (QA) policies in DCSS units. This study explores the extent of application of eleven QA strategies in DCSS units within Iranian hospitals and its association with hospital characteristics. Methods: A descriptive cross-sectional study was conducted in 2009/2010. Data were collected from 554 DCSS units among 84 hospitals. Results: The average reported application rate for the QA strategies ranged from 57%-94% in the DCSS units. Most frequently reported were checking drugs expiration dates (94%), pharmacopoeia availability (92%), equipment calibration (87%) and identifying responsibilities (86%). Least reported was external auditing of the DCSS (57%). The clinical chemistry and microbiology laboratories (84%), pharmacies, blood bank services (83%) reported highest average application rates across all questioned QA strategies. Lowest application rates were reported in human tissue banks (50%). There was no significant difference between the reported application rates in DCSS in the general/specialized, teaching/research, nonteaching/research hospitals with the exception of pharmacies and radiology departments. They reported availability of a written QA plan significantly more often in research hospitals. Nearly all QA strategies were reported to be applied significantly more often in the DCSS of Social Security Organization (SSO) and private-for-profit hospitals than in governmental hospitals. Conclusion: There is still room for strengthening the managerial cycle of QA systems and accountability in the DCSS in Iranian hospitals. Getting feedback, change and learning through application of specific QA strategies (eg, external/internal audits) can be improved. Both the effectiveness of QA strategies in practice, and the application of these strategies in outpatient DCSS units require further policy attention. PMID:26673175

Application of Quality Assurance Strategies in Diagnostics and Clinical Support Services in Iranian Hospitals.

PubMed

Aghaei Hashjin, Asgar; Kringos, Dionne; Ravaghi, Hamid; Manoochehri, Jila; Gorji, Hassan Abolghasem; Klazinga, Niek S

2015-05-20

Iran has a widespread diagnostics and clinical support services (DCSS) network that plays a crucial role in providing diagnostic and clinical support services to both inpatient and outpatient care. However, very little is known on the application of quality assurance (QA) policies in DCSS units. This study explores the extent of application of eleven QA strategies in DCSS units within Iranian hospitals and its association with hospital characteristics. A descriptive cross-sectional study was conducted in 2009/2010. Data were collected from 554 DCSS units among 84 hospitals. The average reported application rate for the QA strategies ranged from 57%-94% in the DCSS units. Most frequently reported were checking drugs expiration dates (94%), pharmacopoeia availability (92%), equipment calibration (87%) and identifying responsibilities (86%). Least reported was external auditing of the DCSS (57%). The clinical chemistry and microbiology laboratories (84%), pharmacies, blood bank services (83%) reported highest average application rates across all questioned QA strategies. Lowest application rates were reported in human tissue banks (50%). There was no significant difference between the reported application rates in DCSS in the general/specialized, teaching/research, nonteaching/research hospitals with the exception of pharmacies and radiology departments. They reported availability of a written QA plan significantly more often in research hospitals. Nearly all QA strategies were reported to be applied significantly more often in the DCSS of Social Security Organization (SSO) and private-for-profit hospitals than in governmental hospitals. There is still room for strengthening the managerial cycle of QA systems and accountability in the DCSS in Iranian hospitals. Getting feedback, change and learning through application of specific QA strategies (eg, external/internal audits) can be improved. Both the effectiveness of QA strategies in practice, and the application of these strategies in outpatient DCSS units require further policy attention. © 2015 by Kerman University of Medical Sciences.

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.

Clinical applications at ultrahigh field (7  T). Where does it make the difference?

PubMed

Trattnig, Siegfried; Bogner, Wolfgang; Gruber, Stephan; Szomolanyi, Pavol; Juras, Vladimir; Robinson, Simon; Zbýň, Štefan; Haneder, Stefan

2016-09-01

Presently, three major MR vendors provide commercial 7-T units for clinical research under ethical permission, with the number of operating 7-T systems having increased to over 50. This rapid increase indicates the growing interest in ultrahigh-field MRI because of improved clinical results with regard to morphological as well as functional and metabolic capabilities. As the signal-to-noise ratio scales linearly with the field strength (B0 ) of the scanner, the most obvious application at 7 T is to obtain higher spatial resolution in the brain, musculoskeletal system and breast. Of specific clinical interest for neuro-applications is the cerebral cortex at 7 T, for the detection of changes in cortical structure as a sign of early dementia, as well as for the visualization of cortical microinfarcts and cortical plaques in multiple sclerosis. In the imaging of the hippocampus, even subfields of the internal hippocampal anatomy and pathology can be visualized with excellent resolution. The dynamic and static blood oxygenation level-dependent contrast increases linearly with the field strength, which significantly improves the pre-surgical evaluation of eloquent areas before tumor removal. Using susceptibility-weighted imaging, the plaque-vessel relationship and iron accumulation in multiple sclerosis can be visualized for the first time. Multi-nuclear clinical applications, such as sodium imaging for the evaluation of repair tissue quality after cartilage transplantation and (31) P spectroscopy for the differentiation between non-alcoholic benign liver disease and potentially progressive steatohepatitis, are only possible at ultrahigh fields. Although neuro- and musculoskeletal imaging have already demonstrated the clinical superiority of ultrahigh fields, whole-body clinical applications at 7 T are still limited, mainly because of the lack of suitable coils. The purpose of this article was therefore to review the clinical studies that have been performed thus far at 7 T, compared with 3 T, as well as those studies performed at 7 T that cannot be routinely performed at 3 T. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

Applicable or non-applicable: investigations of clinical heterogeneity in systematic reviews.

PubMed

Chess, Laura E; Gagnier, Joel J

2016-02-17

Clinical heterogeneity can be defined as differences in participant characteristics, types or timing of outcome measurements and intervention characteristics. Clinical heterogeneity in systematic reviews has the possibility to significantly affect statistical heterogeneity leading to inaccurate conclusions and misled decision making. The aim of this study is to identify to what extent investigators are assessing clinical heterogeneity in both Cochrane and non-Cochrane systematic reviews. The most recent 100 systematic reviews from the top five journals in medicine-JAMA, Archives of Internal Medicine, British Medical Journal, The Lancet, and PLOS Medicine-and the 100 most recently published and/or updated systematic reviews from Cochrane were collected. Various defined items of clinical heterogeneity were extracted from the included reviews. Investigators used chi-squared tests, logarithmic modeling and linear regressions to determine if the presence of such items served as a predictor for clinical heterogeneity when comparing Cochrane to non-Cochrane reviews. Extracted variables include number of studies, number of participants, presence of quantitative synthesis, exploration of clinical heterogeneity, heterogeneous characteristics explored, basis and methods used for investigating clinical heterogeneity, plotting/visual aids, author contact, inferences from clinical heterogeneity investigation, reporting assessment, and the presence of a priori or post-hoc analysis. A total of 317 systematic reviews were considered, of which 199 were in the final analysis. A total of 81% of Cochrane reviews and 90% of non-Cochrane reviews explored characteristics that are considered aspects of clinical heterogeneity and also described the methods they planned to use to investigate the influence of those characteristics. Only 1% of non-Cochrane reviews and 8% of Cochrane reviews explored the clinical characteristics they initially chose as potential for clinical heterogeneity. Very few studies mentioned clinician training, compliance, brand, co-interventions, dose route, ethnicity, prognostic markers and psychosocial variables as covariates to investigate as potentially clinically heterogeneous. Addressing aspects of clinical heterogeneity was not different between Cochrane and non-Cochrane reviews. The ability to quantify and compare the clinical differences of trials within a meta-analysis is crucial to determining its applicability and use in clinical practice. Despite Cochrane Collaboration emphasis on methodology, the proportion of reviews that assess clinical heterogeneity is less than those of non-Cochrane reviews. Our assessment reveals that there is room for improvement in assessing clinical heterogeneity in both Cochrane and non-Cochrane reviews.

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.

Implementing a low-cost web-based clinical trial management system for community studies: a case study.

PubMed

Geyer, John; Myers, Kathleen; Vander Stoep, Ann; McCarty, Carolyn; Palmer, Nancy; DeSalvo, Amy

2011-10-01

Clinical trials with multiple intervention locations and a single research coordinating center can be logistically difficult to implement. Increasingly, web-based systems are used to provide clinical trial support with many commercial, open source, and proprietary systems in use. New web-based tools are available which can be customized without programming expertise to deliver web-based clinical trial management and data collection functions. To demonstrate the feasibility of utilizing low-cost configurable applications to create a customized web-based data collection and study management system for a five intervention site randomized clinical trial establishing the efficacy of providing evidence-based treatment via teleconferencing to children with attention-deficit hyperactivity disorder. The sites are small communities that would not usually be included in traditional randomized trials. A major goal was to develop database that participants could access from computers in their home communities for direct data entry. Discussed is the selection process leading to the identification and utilization of a cost-effective and user-friendly set of tools capable of customization for data collection and study management tasks. An online assessment collection application, template-based web portal creation application, and web-accessible Access 2007 database were selected and customized to provide the following features: schedule appointments, administer and monitor online secure assessments, issue subject incentives, and securely transmit electronic documents between sites. Each tool was configured by users with limited programming expertise. As of June 2011, the system has successfully been used with 125 participants in 5 communities, who have completed 536 sets of assessment questionnaires, 8 community therapists, and 11 research staff at the research coordinating center. Total automation of processes is not possible with the current set of tools as each is loosely affiliated, creating some inefficiency. This system is best suited to investigations with a single data source e.g., psychosocial questionnaires. New web-based applications can be used by investigators with limited programming experience to implement user-friendly, efficient, and cost-effective tools for multi-site clinical trials with small distant communities. Such systems allow the inclusion in research of populations that are not usually involved in clinical trials.

Application of virtual reality technology in clinical medicine

PubMed Central

Li, Lan; Yu, Fei; Shi, Dongquan; Shi, Jianping; Tian, Zongjun; Yang, Jiquan; Wang, Xingsong; Jiang, Qing

2017-01-01

The present review discusses the application of virtual reality (VR) technology in clinical medicine, especially in surgical training, pain management and therapeutic treatment of mental illness. We introduce the common types of VR simulators and their operational principles in aforementioned fields. The clinical effects are also discussed. In almost every study that dealt with VR simulators, researchers have arrived at the same conclusion that both doctors and patients could benefit from this novel technology. Moreover, advantages and disadvantages of the utilization of VR technology in each field were discussed, and the future research directions were proposed. PMID:28979666

Application of virtual reality technology in clinical medicine.

PubMed

Li, Lan; Yu, Fei; Shi, Dongquan; Shi, Jianping; Tian, Zongjun; Yang, Jiquan; Wang, Xingsong; Jiang, Qing

2017-01-01

The present review discusses the application of virtual reality (VR) technology in clinical medicine, especially in surgical training, pain management and therapeutic treatment of mental illness. We introduce the common types of VR simulators and their operational principles in aforementioned fields. The clinical effects are also discussed. In almost every study that dealt with VR simulators, researchers have arrived at the same conclusion that both doctors and patients could benefit from this novel technology. Moreover, advantages and disadvantages of the utilization of VR technology in each field were discussed, and the future research directions were proposed.

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

[Technical specification for clinical application of critical ultrasonography].

PubMed

Yin, M G; Wang, X T; Liu, D W; Chao, Y G; Guan, X D; Kang, Y; Yan, J; Ma, X C; Tang, Y Q; Hu, Z J; Yu, K J; Chen, D C; Ai, Y H; Zhang, L N; Zhang, H M; Wu, J; Liu, L X; Zhu, R; He, W; Zhang, Q; Ding, X; Li, L; Li, Y; Liu, H T; Zeng, Q B; Si, X; Chen, H; Zhang, J W; Xu, Q H; Chen, W J; Chen, X K; Huang, D Z; Cai, S H; Shang, X L; Guan, J; Du, J; Zhao, L; Wang, M J; Cui, S; Wang, X M; Zhou, R; Zeng, X Y; Wang, Y P; Lyu, L W; Zhu, W H; Zhu, Y; Duan, J; Yang, J; Yang, H

2018-06-01

Critical ultrasonography(CUS) is different from the traditional diagnostic ultrasound, the examiner and interpreter of the image are critical care medicine physicians. The core content of CUS is to evaluate the pathophysiological changes of organs and systems and etiology changes. With the idea of critical care medicine as the soul, it can integrate the above information and clinical information, bedside real-time diagnosis and titration treatment, and evaluate the therapeutic effect so as to improve the outcome. CUS is a traditional technique which is applied as a new application method. The consensus of experts on critical ultrasonography in China released in 2016 put forward consensus suggestions on the concept, implementation and application of CUS. It should be further emphasized that the accurate and objective assessment and implementation of CUS requires the standardization of ultrasound image acquisition and the need to establish a CUS procedure. At the same time, the standardized training for CUS accepted by critical care medicine physicians requires the application of technical specifications, and the establishment of technical specifications is the basis for the quality control and continuous improvement of CUS. Chinese Critical Ultrasound Study Group and Critical Hemodynamic Therapy Collabration Group, based on the rich experience of clinical practice in critical care and research, combined with the essence of CUS, to learn the traditional ultrasonic essence, established the clinical application technical specifications of CUS, including in five parts: basic view and relevant indicators to obtain in CUS; basic norms for viscera organ assessment and special assessment; standardized processes and systematic inspection programs; examples of CUS applications; CUS training and the application of qualification certification. The establishment of applied technology standard is helpful for standardized training and clinical correct implementation. It is helpful for clinical evaluation and correct guidance treatment, and is also helpful for quality control and continuous improvement of CUS application.

Integrating HL7 RIM and ontology for unified knowledge and data representation in clinical decision support systems.

PubMed

Zhang, Yi-Fan; Tian, Yu; Zhou, Tian-Shu; Araki, Kenji; Li, Jing-Song

2016-01-01

The broad adoption of clinical decision support systems within clinical practice has been hampered mainly by the difficulty in expressing domain knowledge and patient data in a unified formalism. This paper presents a semantic-based approach to the unified representation of healthcare domain knowledge and patient data for practical clinical decision making applications. A four-phase knowledge engineering cycle is implemented to develop a semantic healthcare knowledge base based on an HL7 reference information model, including an ontology to model domain knowledge and patient data and an expression repository to encode clinical decision making rules and queries. A semantic clinical decision support system is designed to provide patient-specific healthcare recommendations based on the knowledge base and patient data. The proposed solution is evaluated in the case study of type 2 diabetes mellitus inpatient management. The knowledge base is successfully instantiated with relevant domain knowledge and testing patient data. Ontology-level evaluation confirms model validity. Application-level evaluation of diagnostic accuracy reaches a sensitivity of 97.5%, a specificity of 100%, and a precision of 98%; an acceptance rate of 97.3% is given by domain experts for the recommended care plan orders. The proposed solution has been successfully validated in the case study as providing clinical decision support at a high accuracy and acceptance rate. The evaluation results demonstrate the technical feasibility and application prospect of our approach. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Magnetic resonance imaging criteria for thrombolysis in hyperacute cerebral infarction.

PubMed

Ahmetgjekaj, Ilir; Kabashi-Muçaj, Serbeze; Lascu, Luana Corina; Kabashi, Antigona; Bondari, A; Bondari, Simona; Dedushi-Hoti, Kreshnike; Biçaku, Ardian; Shatri, Jeton

2014-01-01

Selection of patients with cerebral infarction for MRI that is suitable for thrombolytic therapy as an emerging application. Although the efficiency of the therapy with i.v. tissue plasminogen activator (tPA) within 3 hours after onset of symptoms has been proven in selected patients with CT, now these criteria are determined by MRI, as the data we gather are fast and accurate in the first hours. MRI screening in patients with acute cerebral infarction before application of thrombolytic therapy was done in a UCC Mannheim in Germany. Unlike trials with CT, MRI studies demonstrated the benefits of therapy up to 6 hours after the onset of symptoms. We studied 21 patients hospitalized in Clinic of Neuroradiology at University Clinical Centre in Mannheim-Germany. They all undergo brain MRI evaluation for stroke. This article reviews literature that has followed application of thrombolysis in patients with cerebral infarction based on MRI. We have analyzed the MRI criteria for i.v. application of tPA at this University Centre. Alongside the personal viewpoints of clinicians, survey reveals a variety of clinical aspects and MRI features that are opened for further more exploration: therapeutic effects, the use of the MRI angiography, dynamics, and other. MRI is a tested imaging method for rapid evaluation of patients with hyperacute cerebral infarction, replacing the use of CT imaging and clinical features. MRI criteria for thrombolytic therapy are being applied in some cerebral vascular centres. In Kosovo, the application of thrombolytic therapy has not started yet.

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.

Bioeffect of lipohemia rabbits irradiated in oral mucosa with 650-nm diode-laser-accompanied oxygen inspiration and clinical application

NASA Astrophysics Data System (ADS)

Yang, Fu-Shou; Tang, Jin-Xian; Liu, Cheng; Yang, Xi-Cheng; Pang, Hi-Xiu

1998-11-01

The study on irradiating in oral mucosa of rabbits with 650 nm diode laser and clinical application has been reported in this paper. The result of animal experiment showed: the obvious decrease of cholesterin and triglyceride has been found among those highly lipohemia rabbits in the experiments of 650nm diode laser irradiating accompanying with oxygen, as well as the parameters of hemorheology obviously being improved, as compared with highly lipohemia rabbits un-irradiating, the statistical analysis showing P < 0.01. In the meantime, the observation of histopathology shows, the lipide decreasing in aorta wall, intramyocardinal membranous layer,and renal interstitial in the group of rabbits which are irradiated with laser and accompanying with oxygen inspiration, and even the perfectly recovered tissue in some rabbits has been seen. This experimental result is significantly for clinical application. The results of clinic application showed, that the patients employed this method which treatment cerebral infarction, lipohemia, the total effective ratio achieved 91.7 percent, perfect effect 30.6 percent.

Progression of Inflammatory Bowel Disease to Cancer: Is the Patient Better Off without Lymphatic Vessels or Nodes (or Angiopoietin 2)?

DTIC Science & Technology

2013-12-01

carcinoma (CRC) in IBD patients and experimental models. Nonetheless, the pathogenic link, interrelationship, and practical clinical application of these...and are continuing final data analysis and latest imaging studies. This project has potentially high impact because of the substantial incidence of...pathogenic link, interrelationship, and practical clinical application of these various theories of progression have remained elusive. We proposed that

An exploration into study design for biomarker identification: issues and recommendations.

PubMed

Hall, Jacqueline A; Brown, Robert; Paul, Jim

2007-01-01

Genomic profiling produces large amounts of data and a challenge remains in identifying relevant biological processes associated with clinical outcome. Many candidate biomarkers have been identified but few have been successfully validated and make an impact clinically. This review focuses on some of the study design issues encountered in data mining for biomarker identification with illustrations of how study design may influence the final results. This includes issues of clinical endpoint use and selection, power, statistical, biological and clinical significance. We give particular attention to study design for the application of supervised clustering methods for identification of gene networks associated with clinical outcome and provide recommendations for future work to increase the success of identification of clinically relevant biomarkers.

The effect of a corticosteroid cream and a barrier-strengthening moisturizer in hand eczema. A double-blind, randomized, prospective, parallel group clinical trial.

PubMed

Lodén, M; Wirén, K; Smerud, K T; Meland, N; Hønnås, H; Mørk, G; Lützow-Holm, C; Funk, J; Meding, B

2012-05-01

Hand eczema is a common and persistent disease with a relapsing course. Clinical data suggest that once daily treatment with corticosteroids is just as effective as twice daily treatment. The aim of this study was to compare once and twice daily applications of a strong corticosteroid cream in addition to maintenance therapy with a moisturizer in patients with a recent relapse of hand eczema. The study was a parallel, double-blind, randomized, clinical trial on 44 patients. Twice daily application of a strong corticosteroid cream (betamethasone valerate 0.1%) was compared with once daily application, where a urea-containing moisturizer was substituted for the corticosteroid cream in the morning. The investigator scored the presence of eczema and the patients judged the health-related quality of life (HRQoL) using the Dermatology Life Quality Index (DLQI), which measures how much the patient's skin problem has affected his/her life over the past week. The patients also judged the severity of their eczema daily on a visual analogue scale. Both groups improved in terms of eczema and DLQI. However, the clinical scoring demonstrated that once daily application of corticosteroid was superior to twice daily application in diminishing eczema, especially in the group of patients with lower eczema scores at inclusion. Twice daily use of corticosteroids was not superior to once daily use in treating eczema. On the contrary, the clinical assessment showed a larger benefit from once daily treatment compared with twice daily, especially in the group of patients with a moderate eczema at inclusion. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

WhatsApp: a telemedicine platform for facilitating remote oral medicine consultation and improving clinical examinations.

PubMed

Petruzzi, Massimo; De Benedittis, Michele

2016-03-01

Increased use of smartphone and related software applications has created a new era in clinical data exchange among patients and clinicians. This study describes use of the smartphone-based application WhatsApp to share clinical oral medicine information. Clinical images and related questions were submitted by general dentists, physicians, dental hygienists, and patients to the authors via WhatsApp. For each submission, a clinical impression was made and categorized as traumatic, infective, neoplastic, autoimmune, or unclassified. Submissions were summarized by sender type, number of photographs per sender, and category of question. Patients were invited to undergo a clinical examination with biopsy, when indicated. The telemedicine impression was compared to the clinicopathologic diagnosis. Three hundred and thirty-nine images were received for 96 patients; 92 (95.8%) patients underwent clinicopathologic examination, and 45 (49%) received a biopsy. General dentists (62%) and dental hygienists (26%) were the most frequent senders. The most common question was related to diagnosis (56%). The telemedicine impression agreed with the clinicopathologic assessment for 82% of cases. Telemedicine applications, such as WhatsApp, can support communication about oral conditions among clinicians and patients. Telemedicine consultation reduced geographic barriers to initial clinical consultation and encouraged the significant majority of patients to pursue expert clinical examination. Copyright © 2016 Elsevier Inc. All rights reserved.

The ART of social networking: how SART member clinics are connecting with patients online.

PubMed

Omurtag, Kenan; Jimenez, Patricia T; Ratts, Valerie; Odem, Randall; Cooper, Amber R

2012-01-01

To study and describe the use of social networking websites among Society for Assisted Reproductive Technology (SART) member clinics. Cross-sectional study. University-based practice. Not applicable. Not applicable. Prevalence of social networking websites among SART member clinics and evaluation of content, volume, and location (i.e., mandated state, region) using multivariate regression analysis. A total of 384 SART-registered clinics and 1,382 social networking posts were evaluated. Of the clinics, 96% had a website and 30% linked to a social networking website. The majority of clinics (89%) with social networking websites were affiliated with nonacademic centers. Social networking posts mostly provided information (31%) and/or advertising (28%), and the remaining offered support (19%) or were irrelevant (17%) to the target audience. Only 5% of posts involved patients requesting information. Clinic volume correlated with the presence of a clinic website and a social networking website. Almost all SART member clinics have a website. Nearly one-third of these clinics host a social networking website such as Facebook, Twitter, and/or a blog. Large-volume clinics commonly host social networking websites. These sites provide new ways to communicate with patients, but clinics should maintain policies on the incorporation of social networks into practice. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

[Vaccinations in psychiatry].

PubMed

Dols, A; van den Brink, W; Eikelenboom, P

2009-01-01

Vaccination is a well-known strategy for preventing and treating infections. The purpose of vaccinations is to render antigens harmless by the production of antibodies. In psychiatry there are also situations where antigens that have been introduced from outside or that have developed during an illness constitute a threat to the patient's health. To explore the possible applications of vaccination in psychiatry. In this article we discuss the applications of vaccination in psychiatry on the basis of two examples. In addiction research, trials are being conducted with antibodies against substances such as cocaine and nicotine in order to prevent such addictive substances from crossing the blood-brain barrier and thereby initiating their rewarding effect. The first clinical results are very promising, but vaccines have not yet been applied clinically. With regard to Alzheimer's disease it has been shown by means of animal models that specific antibodies can prevent AlphaBeta aggregation and dissolve existing aggregates. On the basis of these findings various large-scale clinical trials have begun in order to study immunotherapy for Alzheimer's disease. The first clinical results showed little neurocognitive effects. A wellknown study had to be terminated because of side-effects of the therapy, in the form of neuro-encephalitis. Our tentative conclusion is that the clinical application of immunotherapy in psychiatry still has its limitations, but is indeed promising.

[Related issues in clinical translational application of adipose-derived stem cells].

PubMed

Liu, Hongwei; Cheng, Biao; Fu, Xiaobing

2012-10-01

To introduce the related issues in the clinical translational application of adipose-derived stem cells (ASCs). The latest papers were extensively reviewed, concerning the issues of ASCs production, management, transportation, use, and safety during clinical application. ASCs, as a new member of adult stem cells family, bring to wide application prospect in the field of regenerative medicine. Over 40 clinical trials using ASCs conducted in 15 countries have been registered on the website (http://www.clinicaltrials.gov) of the National Institutes of Health (NIH), suggesting that ASCs represents a promising approach to future cell-based therapies. In the clinical translational application, the related issues included the quality control standard that management and production should follow, the prevention measures of pathogenic microorganism pollution, the requirements of enzymes and related reagent in separation process, possible effect of donor site, age, and sex in sampling, low temperature storage, product transportation, and safety. ASCs have the advantage of clinical translational application, much attention should be paid to these issues in clinical application to accelerate the clinical translation process.

There's an App for That? Highlighting the Difficulty in Finding Clinically Relevant Smartphone Applications.

PubMed

Wiechmann, Warren; Kwan, Daniel; Bokarius, Andrew; Toohey, Shannon L

2016-03-01

The use of personal mobile devices in the medical field has grown quickly, and a large proportion of physicians use their mobile devices as an immediate resource for clinical decision-making, prescription information and other medical information. The iTunes App Store (Apple, Inc.) contains approximately 20,000 apps in its "Medical" category, providing a robust repository of resources for clinicians; however, this represents only 2% of the entire App Store. The App Store does not have strict criteria for identifying content specific to practicing physicians, making the identification of clinically relevant content difficult. The objective of this study is to quantify the characteristics of existing medical applications in the iTunes App Store that could be used by emergency physicians, residents, or medical students. We found applications related to emergency medicine (EM) by searching the iTunes App Store for 21 terms representing core content areas of EM, such as "emergency medicine," "critical care," "orthopedics," and "procedures." Two physicians independently reviewed descriptions of these applications in the App Store and categorized each as the following: Clinically Relevant, Book/Published Source, Non-English, Study Tools, or Not Relevant. A third physician reviewer resolved disagreements about categorization. Descriptive statistics were calculated. We found a total of 7,699 apps from the 21 search terms, of which 17.8% were clinical, 9.6% were based on a book or published source, 1.6% were non-English, 0.7% were clinically relevant patient education resources, and 4.8% were study tools. Most significantly, 64.9% were considered not relevant to medical professionals. Clinically relevant apps make up approximately 6.9% of the App Store's "Medical" Category and 0.1% of the overall App Store. Clinically relevant apps represent only a small percentage (6.9%) of the total App volume within the Medical section of the App Store. Without a structured search-and-evaluation strategy, it may be difficult for the casual user to identify this potentially useful content. Given the increasing adoption of devices in healthcare, national EM associations should consider curating these resources for their members.

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.

The clinical use of Skype--For which patients, with which problems and in which settings? A snapshot review of the literature.

PubMed

Armfield, Nigel R; Bradford, Madeleine; Bradford, Natalie K

2015-10-01

Low-cost and no-cost software-based video tools may be a feasible and effective way to provide some telemedicine services, particularly in low-resource settings. One of the most popular tools is Skype; it is freely available, may be installed on many types of devices, and is easy to use by clinicians and patients. While a previous review found no evidence in favor of, or against the clinical use of Skype, anecdotally it is believed to be widely used in healthcare for providing clinical services. However, the range of clinical applications in which Skype has been used has not been described. We aimed to identify and summarize the clinical applications of Skype. We reviewed the literature to identify studies that reported the use of Skype in clinical care or clinical education. We searched three electronic databases using the single search term "Skype". We found 239 unique articles. Twenty seven of the articles met our criteria for further review. The use of Skype was most prevalent in the management of chronic diseases such as cardiovascular diseases and diabetes, followed by educational and speech and language pathology applications. Most reported uses were in developed countries. In all but one case, Skype was reported by the authors to be feasible and to have benefit. However, while Skype may be a pragmatic approach to providing telemedicine services, in the absence of formal studies, the clinical and economic benefits remain unclear. Copyright © 2015. Published by Elsevier Ireland Ltd.

RPMIS: The Roswell Park Management Information System

PubMed Central

Priore, R.L.; Lane, W.W.; Edgerton, F.T.; Naeher, C.H.; Reese, P.A.

1978-01-01

This paper presents a generalized approach to data entry and editing utilizing formatted video computer terminals. The purpose of the system developed is to facilitate the creation of many small data bases, with a minimum of implementation time, while maintaining extensive editing capability and preserving ease of use by data entry personnel. RPMIS has demonstrated its utility in shortening the time between research activities and clinical application of results. The system allows entry and retrieval of overlapping subsets of the patient's record in an order and format most appropriate to the individual application. It is used for production of synoptic presentations of information from the labs, the ward and the clinic. RPMIS was designed for the clinical trials setting and has been well received and implemented for numerous such studies. Additional uses have included several registries, screening clinics, retrospective studies, and epidemiologic investigations. The system has found fortuitous use in maintaining curriculum vitae, publications lists and continuing medical education credits.

Management and Analysis of Biological and Clinical Data: How Computer Science May Support Biomedical and Clinical Research

NASA Astrophysics Data System (ADS)

Veltri, Pierangelo

The use of computer based solutions for data management in biology and clinical science has contributed to improve life-quality and also to gather research results in shorter time. Indeed, new algorithms and high performance computation have been using in proteomics and genomics studies for curing chronic diseases (e.g., drug designing) as well as supporting clinicians both in diagnosis (e.g., images-based diagnosis) and patient curing (e.g., computer based information analysis on information gathered from patient). In this paper we survey on examples of computer based techniques applied in both biology and clinical contexts. The reported applications are also results of experiences in real case applications at University Medical School of Catanzaro and also part of experiences of the National project Staywell SH 2.0 involving many research centers and companies aiming to study and improve citizen wellness.

[The effectiveness of fenspiride in the treatment of patients with chronic obstructive pulmonary disease].

PubMed

Butorov, S I; Muntianu, V I

2007-01-01

The purpose of the study was to assess the effectiveness and safety of long-term application of fenspiride, an anti-inflammatory drug, in patients with chronic obstructive pulmonary disease (COPD) under outpatient conditions. The drug was studied on 24 COPD patients. Fenspiride application resulted in improvement in bronchoobstructive syndrome and external respiration parameters, as well as a significant increase in exercise tolerance. In patients with stable stage I COPD, the use of fenspiride as a part of therapeutic regimen leads to better clinical results than in stage II patients. Long-term application of fenspiride in medium therapeutic doses under outpatient conditions is associated with positive clinical effects and leads to significant improvement in quality of life.

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.

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.

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.

76 FR 1620 - Trials to Verify and Describe Clinical Benefit of Midodrine Hydrochloride; Establishment of...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-11

... a surrogate endpoint that is reasonably likely to predict clinical benefit or based on a clinical endpoint other than survival or irreversible morbidity. Approval of PROAMATINE was based on trials... surrogate endpoints are ``subject to the requirement that the applicant study the drug further to verify and...

[Bibliometrics study on indications of acupuncture therapy based on foreign acupuncture clinical trials].

PubMed

He, Wei; Tong, Yuan-Yuan; Zhao, Ying-Kai; Rong, Pei-Jing; Wang, Hong-Cai

2012-10-01

In the present paper, the authors make a bibliometrics study on clinical indications of acupuncture therapy based on the published foreign articles about acupuncture clinical trials collected from PubMed database and Excerpta Medica database (EMbase). In 1996, 64 acupuncture indications were declared by WHO in Milan conference. But in recent 15 years, clinical trials have been conducted extensively in the foreign countries. Till now, 77 new indications for acupuncture therapy have been found in the foreign journals. The authors recommended that 29 indications (knee osteoarthritis, critique age problems, muscular fasciae ache, anxiety, etc.) should be added to the first class, 4 indications (irritable bowel syndrome, malposition, backache, simple obesity) should be upgraded from the second class to the first class, and the other 3 indications (childbirth pain, male and female barren) should be upgraded from the third class to the first class due to their application frequency in clinical trials. Increase of clinical indications reflects extensive application of acupuncture therapy and may help providing a better service for people's health.

Laser Surgery of Soft Tissue in Orthodontics: Review of the Clinical Trials.

PubMed

Seifi, Massoud; Matini, Negin-Sadat

2017-01-01

Introduction: Recently, a wide variety of procedures have been done by laser application in orthodontics. Apart from the mentioned range of various treatments, laser has become a tool for many soft tissue surgeries as an alternative to conventional scalpel-based technique during orthodontic treatments in the management of soft tissue. Due to scarce information in the latter subject, this study was designed in order to include clinical trials that included soft tissue ablation by laser in orthodontics. Methods: Literature was searched based on PubMed and Google Scholar databases in 5 years (2010-2015) with English language restriction and clinical trial design. Studies that performed soft tissue application of laser during orthodontic treatment were extracted by the authors. Results: Only eight studies met the inclusion criteria. No significant difference was found between laser ablation and conventional scalpel technique in the matter of treatment outcome. However, few issues remained to clarify the differences in the mentioned procedures. Conclusion: Laser performance can be recommended in case of preceding less bleeding and discomfort during surgical procedure. There are still quandaries among clinical application of scalpel-based surgery in aesthetic region with bracket-bonded teeth. Precaution and knowledge regarding the characteristics of laser beam such as wavelength, frequency, power and timing is extremely needed.

Laser Surgery of Soft Tissue in Orthodontics: Review of the Clinical Trials

PubMed Central

Seifi, Massoud; Matini, Negin-Sadat

2017-01-01

Introduction: Recently, a wide variety of procedures have been done by laser application in orthodontics. Apart from the mentioned range of various treatments, laser has become a tool for many soft tissue surgeries as an alternative to conventional scalpel-based technique during orthodontic treatments in the management of soft tissue. Due to scarce information in the latter subject, this study was designed in order to include clinical trials that included soft tissue ablation by laser in orthodontics. Methods: Literature was searched based on PubMed and Google Scholar databases in 5 years (2010-2015) with English language restriction and clinical trial design. Studies that performed soft tissue application of laser during orthodontic treatment were extracted by the authors. Results: Only eight studies met the inclusion criteria. No significant difference was found between laser ablation and conventional scalpel technique in the matter of treatment outcome. However, few issues remained to clarify the differences in the mentioned procedures. Conclusion: Laser performance can be recommended in case of preceding less bleeding and discomfort during surgical procedure. There are still quandaries among clinical application of scalpel-based surgery in aesthetic region with bracket-bonded teeth. Precaution and knowledge regarding the characteristics of laser beam such as wavelength, frequency, power and timing is extremely needed. PMID:29263776

Biological effects of electrolyzed water in hemodialysis.

PubMed

Nakayama, Masaaki; Kabayama, Shigeru; Nakano, Hirofumi; Zhu, Wan-Jun; Terawaki, Hiroyuki; Nakayama, Keisuke; Katoh, Kiyoshi; Satoh, Toshinobu; Ito, Sadayoshi

2009-01-01

The application of electrolyzed water (EW) at the cathode side to manufacture reverse osmosis (RO) water and hemodialysis (HD) solution can actually lead to less oxidative capacity in chemical terms. The present study examined the biological actions of this water on human polymorphonuclear leukocytes (PMNs), and the clinical feasibility of applying this technology to HD treatment. RO water using EW (e-RO) exhibited less chemiluminescence in luminol-hydrogen peroxide and higher dissolved hydrogen levels (-99.0 ppb) compared with control RO water. The effects of e-RO on PMN viability were tested. HD using e-RO was performed for 12 consecutive sessions in 8 patients for the feasibility test. Basal cellular viability and function to generate superoxide radicals of PMNs were better preserved by e-RO application. In the clinical trial, reductions of blood pressure were noted, but no adverse events were observed. There were no changes in the blood dialysis parameters, although methylguanidine levels were significantly decreased at the end of study. The present study demonstrated the capacity of e-RO to preserve the viability of PMNs, and the clinical feasibility of applying this water for HD treatment. The clinical application of this technology may improve the bio-compatibility of HD treatment. Copyright 2009 S. Karger AG, Basel.

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.

A Study of the Influence of Academic Achievement on the Resident Selection Process.

ERIC Educational Resources Information Center

Goller, William L.

1980-01-01

Discusses a study, which indicated a significant difference between residency applicants considered finalists after their interview was completed, and those considered nonfinalists (among applicants representing differing levels of academic achievement as measured by National Board of Podiatry Examiners examination scores and clinical evaluation…

A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children.

PubMed

Eichenfield, Lawrence F; Funk, Ann; Fallon-Friedlander, Sheila; Cunningham, Bari B

2002-06-01

A double-randomized, blinded crossover trial was performed to assess the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics (EMLA) for pain relief during pediatric venipuncture procedures. Safety was assessed by evaluation for topical or systemic effects and measurement of serum lidocaine concentrations. A total of 120 children who were scheduled for repeat venipuncture for non-study-related reasons at 2 sites participated in the study. Patients were doubly randomized to treatment regimen (study medication application time of either 30 or 60 minutes) and to the order of application of the topical anesthetics for each venipuncture. The primary outcome measures were the child's rating of pain immediately after the venipuncture procedures using a 100-mm visual analog scale (VAS) tool and the parent's and blinded research observer's Observed Behavioral Distress scores. Both ELA-Max and EMLA seemed to alleviate venipuncture pain. There was no clinically or statistically significant difference in the patient VAS scores within the 30-minute or 60-minute treatment groups, and there was no clinical or statistical difference in VAS scores between the 30-minute ELA-Max treatment without occlusion and the 60-minute EMLA treatment with occlusion. There were no clinically or statistically significant differences between treatment with ELA-Max and EMLA in parental or blinded researcher Observed Behavioral Distress scores, the most frequent response at any observation time being "no distress." This study demonstrates that a 30-minute application of ELA-Max without occlusion is as safe and as effective for ameliorating pain associated with venipuncture as a 60-minute application of the prescription product EMLA requiring occlusion.

Cancer Bioinformatics for Updating Anticancer Drug Developments and Personalized Therapeutics.

PubMed

Lu, Da-Yong; Qu, Rong-Xin; Lu, Ting-Ren; Wu, Hong-Ying

2017-01-01

Last two to three decades, this world witnesses a rapid progress of biomarkers and bioinformatics technologies. Cancer bioinformatics is one of such important omics branches for experimental/clinical studies and applications. Same as other biological techniques or systems, bioinformatics techniques will be widely used. But they are presently not omni-potent. Despite great popularity and improvements, cancer bioinformatics has its own limitations and shortcomings at this stage of technical advancements. This article will offer a panorama of bioinformatics in cancer researches and clinical therapeutic applications-possible advantages and limitations relating to cancer therapeutics. A lot of beneficial capabilities and outcomes have been described. As a result, a successful new era for cancer bioinformatics is waiting for us if we can adhere on scientific studies of cancer bioinformatics in malignant- origin mining, medical verifications and clinical diagnostic applications. Cancer bioinformatics gave a great significance in disease diagnosis and therapeutic predictions. Many creative ideas and future perspectives are highlighted. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Therapeutic Applications of Herbal Medicines for Cancer Patients

PubMed Central

Yin, Shu-Yi; Wei, Wen-Chi; Jian, Feng-Yin; Yang, Ning-Sun

2013-01-01

Medicinal herbs and their derivative phytocompounds are being increasingly recognized as useful complementary treatments for cancer. A large volume of clinical studies have reported the beneficial effects of herbal medicines on the survival, immune modulation, and quality of life (QOL) of cancer patients, when these herbal medicines are used in combination with conventional therapeutics. Here, we briefly review some examples of clinical studies that investigated the use of herbal medicines for various cancers and the development of randomized controlled trials (RCTs) in this emerging research area. In addition, we also report recent studies on the biochemical and cellular mechanisms of herbal medicines in specific tumor microenvironments and the potential application of specific phytochemicals in cell-based cancer vaccine systems. This review should provide useful technological support for evidence-based application of herbal medicines in cancer therapy. PMID:23956768

I-Maculaweb: A Tool to Support Data Reuse in Ophthalmology

PubMed Central

Bonetto, Monica; Nicolò, Massimo; Gazzarata, Roberta; Fraccaro, Paolo; Rosa, Raffaella; Musetti, Donatella; Musolino, Maria; Traverso, Carlo E.

2016-01-01

This paper intends to present a Web-based application to collect and manage clinical data and clinical trials together in a unique tool. I-maculaweb is a user-friendly Web-application designed to manage, share, and analyze clinical data from patients affected by degenerative and vascular diseases of the macula. The unique and innovative scientific and technological elements of this project are the integration with individual and population data, relevant for degenerative and vascular diseases of the macula. Clinical records can also be extracted for statistical purposes and used for clinical decision support systems. I-maculaweb is based on an existing multilevel and multiscale data management model, which includes general principles that are suitable for several different clinical domains. The database structure has been specifically built to respect laterality, a key aspect in ophthalmology. Users can add and manage patient records, follow-up visits, treatment, diagnoses, and clinical history. There are two different modalities to extract records: one for the patient’s own center, in which personal details are shown and the other for statistical purposes, where all center’s anonymized data are visible. The Web-platform allows effective management, sharing, and reuse of information within primary care and clinical research. Clear and precise clinical data will improve understanding of real-life management of degenerative and vascular diseases of the macula as well as increasing precise epidemiologic and statistical data. Furthermore, this Web-based application can be easily employed as an electronic clinical research file in clinical studies. PMID:27170913

[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.

An assessment of the current treatment landscape for rheumatology patients in Qatar: Recognising unmet needs and moving towards solutions.

PubMed

Emadi, Samar Al; Hammoudeh, Mohammed; Mounir, Mohamed; Mueller, Ruediger B; Wells, Alvin F; Sarakbi, Housam Aldeen

2017-04-01

Objective This study assessed the mode of application (oral, intravenous or subcutaneous (SC)) currently employed in the treatment of rheumatoid arthritis (RA) in patients from Qatar in comparison with patients' individual preferences for the mode of application of their treatment. Methods This study included 294 RA patients visiting three clinics at the main referral hospital in Qatar who were interviewed using a standard questionnaire to determine their preference of mode of application for their disease-modifying antirheumatic drug (DMARD) treatment in relation to their currently employed mode of application. Results The majority of patients were female (76%), and 93% of male patients and 61% of female patients in the study clinics were of a nationality other than Qatari. The highest patient preference recorded was for an oral therapy (69%), compared with injection (23%) and intravenous (8%) therapy. In total, 85% of patients expressed a preference to remain on oral therapy compared with 63% and 58% of intravenous and SC injection patients indicating a preference to remain on their current method of administration. Conclusions This high preference for oral therapies highlights the considerable need for incorporation of new oral targeted synthetic DMARD therapies into clinical practice within the region.

An assessment of the current treatment landscape for rheumatology patients in Qatar: Recognising unmet needs and moving towards solutions

PubMed Central

Hammoudeh, Mohammed; Mounir, Mohamed; Mueller, Ruediger B.; Wells, Alvin F.; Sarakbi, Housam Aldeen

2017-01-01

Objective This study assessed the mode of application (oral, intravenous or subcutaneous (SC)) currently employed in the treatment of rheumatoid arthritis (RA) in patients from Qatar in comparison with patients’ individual preferences for the mode of application of their treatment. Methods This study included 294 RA patients visiting three clinics at the main referral hospital in Qatar who were interviewed using a standard questionnaire to determine their preference of mode of application for their disease-modifying antirheumatic drug (DMARD) treatment in relation to their currently employed mode of application. Results The majority of patients were female (76%), and 93% of male patients and 61% of female patients in the study clinics were of a nationality other than Qatari. The highest patient preference recorded was for an oral therapy (69%), compared with injection (23%) and intravenous (8%) therapy. In total, 85% of patients expressed a preference to remain on oral therapy compared with 63% and 58% of intravenous and SC injection patients indicating a preference to remain on their current method of administration. Conclusions This high preference for oral therapies highlights the considerable need for incorporation of new oral targeted synthetic DMARD therapies into clinical practice within the region. PMID:28415924

Honey and contemporary wound care: an overview.

PubMed

Cutting, Keith F

2007-11-01

A growing body of research and empirical evidence have supported the re-discovery of medicinal grade honey as a wound management agent. Pre-clinical study results suggest that honey has therapeutic benefit; clinical study results have shown that honey effectively addresses exudate, inflammation, devitalized tissue, and infection. Honey-containing dressings and gels have been developed to facilitate the application of medicinal-grade honey to the wound. Clinical studies to compare the safety and effectiveness of these products to other moisture-retentive dressings and treatment modalities are warranted.

[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.

Repurposing historical control clinical trial data to provide safety context.

PubMed

Bhuyan, Prakash; Desai, Jigar; Louis, Matthew St; Carlsson, Martin; Bowen, Edward; Danielson, Mark; Cantor, Michael N

2016-02-01

Billions of dollars spent, millions of subject-hours of clinical trial experience and an abundance of archived study-level data, yet why are historical data underutilized? We propose that historical data can be aggregated to provide safety, background incidence rate and context to improve the evaluation of new medicinal products. Here, we describe the development and application of the eControls database, which is derived from the control arms of studies of licensed products, and discuss the challenges and potential solutions to the proper application of historical data to help interpret product safety. Copyright © 2015 Elsevier Ltd. All rights reserved.

Preliminary Discussion On The Three Dimensional Space Quantitative Analysis Of Erythrocytes By SEMP And Some Applications On The Clinic And Research Of Blood Disease.

NASA Astrophysics Data System (ADS)

Lian-Huang, Lu; Wen-Meng, Tong; Zhi-Jun, Zhang; Gui-Huan, He; Su-Hui, Huan

1989-04-01

The abnormity of the quality and quantity for erythrocytes is one of the important changes of blood disease. It shows the abnormal blood-making function of human body. Therefore, the study of the change of shape of erythrocytes is the indispensible and important basis of reference in the clinic, diagnose and research of blood disease. In this paper, a preliminary discussion is made on the acquisition of scanning stereographs for erythrocytes, the application of the theory of photographic measurement on the three dimensional space quantitative analysis of erythrocytes, drawings of isoline map and section map of various erythrocytes for normal persons, paroxysmal nocturanal hemoglobinuria (PNH) patients and aplastic anemia patients, study of the shape characteristics of normal erythrocytes and various abnormal erytnrocytes and the applications in clinic, diagnose and research. This research is a combination of microphotogrammetry and erythrocyte morphology. It is polssible to push fotward the study of erythrocyte morphology from LM, SEM to a higher stage of scanning electron micrographic photogrammetry(SEMP) for stereograpic observationand three diamensional quantitative analysis to explore a new path for the further study of the shape of erthrocytes.

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

Roadblocks en route to the clinical application of induced pluripotent stem cells.

PubMed

Lowry, William E; Quan, William L

2010-03-01

Since the first studies of human embryonic stem cells (hESCs) and, more recently, human induced pluripotent stem cells (hiPSCs), the stem-cell field has been abuzz with the promise that these pluripotent populations will one day be a powerful therapeutic tool. Although it has been proposed that hiPSCs will supersede hESCs with respect to their research and/or clinical potential because of the ease of their derivation and the ability to create immunologically matched iPSCs for each individual patient, recent evidence suggests that iPSCs in fact have several underappreciated characteristics that might mean they are less suitable for clinical application. Continuing research is revealing the similarities, differences and deficiencies of various pluripotent stem-cell populations, and suggests that many years will pass before the clinical utility of hESCs and hiPSCs is realized. There are a plethora of ethical, logistical and technical roadblocks on the route to the clinical application of pluripotent stem cells, particularly of iPSCs. In this Essay, we discuss what we believe are important issues that should be considered when attempting to bring hiPSC-based technology to the clinic.

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.

The application of telemedicine in orthopedic surgery in singapore: a pilot study on a secure, mobile telehealth application and messaging platform.

PubMed

Daruwalla, Zubin Jimmy; Wong, Keng Lin; Thambiah, Joseph

2014-06-05

The application of telemedicine has been described for its use in medical training and education, management of stroke patients, urologic surgeries, pediatric laparoscopic surgeries, clinical outreach, and the field of orthopedics. However, the usefulness of a secure, mobile telehealth application, and messaging platform has not been well described. A pilot study was conducted to implement a health insurance portability and accountability act (HIPAA) compliant form of communication between doctors in an orthopedic clinical setting and determine their reactions to MyDoc, a secure, mobile telehealth application, and messaging platform. By replacing current methods of communication through various mobile applications and text messaging services with MyDoc over a six week period, we gained feedback and determined user satisfaction with this innovative system from questionnaires handed to the program director, program coordinator, one trauma consultant, all orthopedic residents, and six non-orthopedic residents at the National University Hospital in Singapore. Almost everyone who completed the questionnaire strongly agreed that MyDoc should replace current systems of peer to peer communication in the hospital. The majority also felt that the quality of images, videos, and sound were excellent. Almost everyone agreed that they could communicate easily with each other and would feel comfortable doing so routinely. The majority felt that virtual consults through MyDoc should be made available to inpatients as well as outpatients to potentially lessen clinic loads and provide a secure manner in which patients can communicate with their primary teams any time convenient to both. It was also agreed by most that the potential of telerounding had advantages, especially on weekends as a supplement to normal rounds. Potential uses of MyDoc in an orthopedic clinical setting include HIPAA-compliant peer to peer communication, clinical outreach in the setting of trauma, supervision in the operating room or watching procedures being performed remotely, providing both patient and parent reassurance in pediatric orthopedic patients, and finally in the setting of outpatient clinics. With our pilot study having excellent results in terms of acceptance and satisfaction, the integration of a secure, mobile telehealth application, and messaging platform, not only in the orthopedic department but also the hospital in general, has an exciting and limitless potential. More so in this era where downsizing hospital costs is beneficial, doing so may also be mandatory in order to comply with the soon to be introduced personal data protection act.

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

PubMed

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

2017-09-01

This study is to assess the Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine in clinical application and provide evidence for further guideline revision. The assessment was divided into applicability assessment and practicability assessment. The applicability assessment based on questionnaire survey and the traditional Chinese medicine (TCM) practitioners were asked to independently fill the Questionnaire for Applicability Assessment on the Guidelines for Diagnosis and Treatment in Traditional Chinese Medicine. The practicability assessment was based on prospective case investigation and analysis method and the TCM practitioners-in-charge filled the Case Investigation Questionnaire for Practicability Assessment on the Guidelines for Diagnosis and Treatment in Traditional Chinese Medicine. The data were analyzed in descriptive statistics. 151 questionnaires were investigated for applicability assessment and 1 016 patients were included for practicability assessment. The results showed that 88.74% of them were familiar with the guidelines and 45.70% used them. The guidelines quality and related items were similar in applicability assessment and practicability assessment, and scored highly as more than 85.00% except the "recuperating and prevention". The results suggested that the quality of Guidelines for Diagnosis and Treatment of Common Diseases of Otolaryngology in Traditional Chinese Medicine was high and could better guide the clinical practice. The "recuperating and prevention" part should be improved and the evidence data should be included in future guideline revision, so that the clinical utilization rate could be increased. Copyright© by the Chinese Pharmaceutical Association.

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.

Application of Science and Medicine to Sport.

ERIC Educational Resources Information Center

Taylor, Albert W., Ed.

Great progress has been made in recent years in the scientific study of exercise and application to sport. This book provides an analysis of the state of physiological and clinical knowledge related to exercise and sports. The three sections--medicine and physical activity, science and exercise, and practical application to sport--cover a variety…

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.

Lasers in the in-vitro fertilization laboratory

NASA Astrophysics Data System (ADS)

Tadir, Yona; Neev, Joseph; Berns, Michael W.

1993-05-01

Laser beams are routinely used in the clinical practice of assisted reproduction. The main applications are in laparoscopic and hysteroscopic surgery. The potential applications of laser microbeams as a tool for gamete manipulations are studied and basic concepts are discussed.

Digital applications: the future in psychiatry?

PubMed

Thibaut, Florence

2016-06-01

Digital applications and new mobile technologies can change the nature of the psychiatrist-patient relationship and future clinical practice in terms of diagnosis, follow-up, and treatment, but need to be further studied. This issue explores these new approaches in psychiatry.

Clinical applications of gas chromatograph/mass spectrometer/computer systems.

PubMed

Horning, M G; Nowlin, J; Butler, C M; Lertratanangkoon, K; Sommer, K; Hill, R M

1975-08-01

Gas chromatograph/mass spectrometer/computer systems can be used to quantify a wide variety of compounds of clinical interest. A quadrupole instrument operated in the chemical ionization (Cl) mode was used in these studies. Because of the sensitivity and specificity of selective ion detection, it is possible to make measurements routinely in the nanogram to picogram range, with 0.1-1.0 ml samples of plasma and 1-5 ml samples or urine. Internal standards, preferably stable-isotope-labeled compounds, were added to the biological samples before isolation was begun. We describe clinical applications of these procedures to problems in toxicology, pharmacokinetics, and perinatal pharmacology.

A novel hydrogel electrolyte extender for rapid application of EEG sensors and extended recordings.

PubMed

Kleffner-Canucci, Killian; Luu, Phan; Naleway, John; Tucker, Don M

2012-04-30

Dense-array EEG recordings are now commonplace in research and gaining acceptance in clinical settings. Application of many sensors with traditional electrolytes is time consuming. Saline electrolytes can be used to minimize application time but recording duration is limited due to evaporation. In the present study, we evaluate a NIPAm (N-isopropyl acrylamide:acrylic acid) base electrolyte extender for use with saline electrolytes. Sensor-scalp impedances and EEG data quality acquired with the electrolyte extender are compared with those obtained for saline and an EEG electrolyte commonly used in clinical exams (Elefix). The results show that when used in conjunction with saline, electrode-scalp impedances and data across the EEG spectrum are comparable with those obtained using Elefix EEG paste. When used in conjunction with saline, the electrolyte extender permits rapid application of dense-sensor arrays and stable, high-quality EEG data to be obtained for at least 4.5 h. This is an enabling technology that will make benefits of dense-array EEG recordings practical for clinical applications. Copyright © 2011 Elsevier B.V. All rights reserved.

Fundamentals of Clinical Pharmacology With Application for Pregnant Women.

PubMed

Patil, Avinash S; Sheng, Jessica; Dotters-Katz, Sarah K; Schmoll, Maria S; Onslow, Mitchell; Pierson, Rebecca C

2017-05-01

Medication use is common in pregnancy, yet for most medications the optimal formulation and dosage have not been described specifically for pregnant women. Often, adverse effects are only discovered anecdotally or after extensive off-label use occurs. Since pharmacologic research that includes pregnant women is sparse and animal studies are often not applicable to the human fetus, providers must use knowledge of drug behavior and normal physiologic changes of pregnancy to personalize treatment for pregnant women. In this review, we present an overview of the basic concepts of clinical pharmacology: pharmacokinetics, pharmacodynamics, and pharmacogenomics. The normal physiologic changes of pregnancy are presented as a framework to understand alterations in drug behavior. A clinical vignette that addresses 4 pregnancy scenarios involving medications-preterm birth, vaccination, herpes simplex virus infection, and codeine toxicity-is provided to illustrate application of core clinical pharmacologic concepts. Discussion of relevant literature illustrates the challenges of offering individualized pharmacologic therapy in pregnancy. © 2017 by the American College of Nurse-Midwives.

[Controlled weight bearing after osteosynthesis].

PubMed

Perren, T; Matter, P

1993-01-01

Patient compliance with postoperative partial weight bearing can be a difficult management problem. The problem may be intentional or unintentional. There is no objective way to assess the amount of weight placed on the lower extremity by the patient. It is our clinical suspicion that patients place more weight than is desirable on the effected limb. There are few reports in the literature on this topic. One study has confirmed our suspicion of poor patient compliance with postoperative weight bearing. Our goal is to develop a system to accurately assess weight bearing and to improve this aspect of postoperative fracture care. Through an active feedback device we hope to improve patient education and understanding. We plan to study the clinical applications of using a pressure sensitive shoe insert device. Our ultimate goal is to improve upon the present device and to study the clinical application of there use.

Clinical Metabolomics in Neonatology: From Metabolites to Diseases.

PubMed

Fanos, Vassilios; Pintus, Roberta; Dessì, Angelica

2018-01-01

Today, disorders that affect the newborn remain a challenge for physicians because of the enigmatic pathophysiology and difficulties in treating such delicate patients. Metabolomics, the "omics" science that studies the metabolome, namely the metabolites present in biological fluids, such as saliva, blood, sweat, and breast milk in a given time or condition, can be useful in helping neonatologists to prevent, diagnose, and treat diseases affecting the neonate, especially those with higher mortality rates. Since it is a relatively new technology, studies of its application in neonatology are limited. The aims of this review are to present metabolomics data on relevant neonatal disorders and to identify and discuss the most important 5 metabolites and their clinical significance rather than focusing on each disorder. The preliminary data are promising but further studies on metab-olomics in neonatology are needed together with the standardization of results before their application in clinical practice. © 2018 S. Karger AG, Basel.

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.

42 CFR 447.321 - Outpatient hospital and clinic services: Application of upper payment limits.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 4 2010-10-01 2010-10-01 false Outpatient hospital and clinic services: Application of upper payment limits. 447.321 Section 447.321 Public Health CENTERS FOR MEDICARE & MEDICAID... Clinic Services § 447.321 Outpatient hospital and clinic services: Application of upper payment limits...

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.

Flow cytometric chemosensitivity assay using JC‑1, a sensor of mitochondrial transmembrane potential, in acute leukemia.

PubMed

Yokosuka, Tomoko; Goto, Hiroaki; Fujii, Hisaki; Naruto, Takuya; Takeuchi, Masanobu; Tanoshima, Reo; Kato, Hiromi; Yanagimachi, Masakatsu; Kajiwara, Ryosuke; Yokota, Shumpei

2013-12-01

The purpose of the study is to establish a simple and relatively inexpensive flow cytometric chemosensitivity assay (FCCA) for leukemia to distinguish leukemic blasts from normal leukocytes in clinical samples. We first examined whether the FCCA with the mitochondrial membrane depolarization sensor, 5, 50, 6, 60-tetrachloro-1, 10, 3, 30 tetraethyl benzimidazolo carbocyanine iodide (JC-1), could detect drug-induced apoptosis as the conventional FCCA by annexin V/7-AAD detection did and whether it was applicable in the clinical samples. Second, we compared the results of the FCCA for prednisolone (PSL) with clinical PSL response in 18 acute lymphoblastic leukemia (ALL) patients to evaluate the reliability of the JC-1 FCCA. Finally, we performed the JC-1 FCCA for bortezomib (Bor) in 25 ALL or 11 acute myeloid leukemia (AML) samples as the example of the clinical application of the FCCA. In ALL cells, the results of the JC-1 FCCA for nine anticancer drugs were well correlated with those of the conventional FCCA using anti-annexin V antibody (P < 0.001). In the clinical samples from 18 children with ALL, the results of the JC-1 FCCA for PSL were significantly correlated with the clinical PSL response (P = 0.005). In ALL samples, the sensitivity for Bor was found to be significantly correlated with the sensitivity for PSL (P = 0.005). In AML samples, the Bor sensitivity was strongly correlated with the cytarabine sensitivity (P = 0.0003). This study showed the reliability of a relatively simple and the FCCA using JC-1, and the possibility for the further clinical application.

Establishing pan-European clinical trials: regulatory compliance and other practical considerations.

PubMed

Grienenberger, Aurelie

2004-01-01

There are currently many concerns in the pharmaceutical and scientific community working in or around clinical research on the EU Directive 2001/20/EC or Clinical Trials Directive. The Directive introduces regulatory requirements for all phases of study in human subjects, drawing no distinction between commercially funded drug trials and non-commercial/academic research. The Directive makes Good Clinical Practice (GCP) a legal requirement in Europe and all clinical research will be subjected to the same rigorous standards including GCP and Good Manufacturing Practice (GMP) application even at the early clinical phases as well as exhaustive pharmacovigilance and protection of trial subjects. Some of these requirements may be seen as additional burden and a brake to clinical research in Europe. However, the application of the directive should provide a single and highly regulated market of 25 European countries for investigational medicinal products. This article reviews the main aspects and areas of concern of the Directive and provide US sponsor with useful references.

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.

CER Hub: An informatics platform for conducting comparative effectiveness research using multi-institutional, heterogeneous, electronic clinical data.

PubMed

Hazlehurst, Brian L; Kurtz, Stephen E; Masica, Andrew; Stevens, Victor J; McBurnie, Mary Ann; Puro, Jon E; Vijayadeva, Vinutha; Au, David H; Brannon, Elissa D; Sittig, Dean F

2015-10-01

Comparative effectiveness research (CER) requires the capture and analysis of data from disparate sources, often from a variety of institutions with diverse electronic health record (EHR) implementations. In this paper we describe the CER Hub, a web-based informatics platform for developing and conducting research studies that combine comprehensive electronic clinical data from multiple health care organizations. The CER Hub platform implements a data processing pipeline that employs informatics standards for data representation and web-based tools for developing study-specific data processing applications, providing standardized access to the patient-centric electronic health record (EHR) across organizations. The CER Hub is being used to conduct two CER studies utilizing data from six geographically distributed and demographically diverse health systems. These foundational studies address the effectiveness of medications for controlling asthma and the effectiveness of smoking cessation services delivered in primary care. The CER Hub includes four key capabilities: the ability to process and analyze both free-text and coded clinical data in the EHR; a data processing environment supported by distributed data and study governance processes; a clinical data-interchange format for facilitating standardized extraction of clinical data from EHRs; and a library of shareable clinical data processing applications. CER requires coordinated and scalable methods for extracting, aggregating, and analyzing complex, multi-institutional clinical data. By offering a range of informatics tools integrated into a framework for conducting studies using EHR data, the CER Hub provides a solution to the challenges of multi-institutional research using electronic medical record data. Copyright © 2015. Published by Elsevier Ireland Ltd.

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

Biomagnetism using SQUIDs: status and perspectives

NASA Astrophysics Data System (ADS)

Sternickel, Karsten; Braginski, Alex I.

2006-03-01

Biomagnetism involves the measurement and analysis of very weak local magnetic fields of living organisms and various organs in humans. Such fields can be of physiological origin or due to magnetic impurities or markers. This paper reviews existing and prospective applications of biomagnetism in clinical research and medical diagnostics. Currently, such applications require sensitive magnetic SQUID sensors and amplifiers. The practicality of biomagnetic methods depends especially on techniques for suppressing the dominant environmental electromagnetic noise, and on suitable nearly real-time data processing and interpretation methods. Of the many biomagnetic methods and applications, only the functional studies of the human brain (magnetoencephalography) and liver susceptometry are in clinical use, while functional diagnostics of the human heart (magnetocardiography) approaches the threshold of clinical acceptance. Particularly promising for the future is the ongoing research into low-field magnetic resonance anatomical imaging using SQUIDs.

[The applicability of results].

PubMed

Marín-León, I

2015-11-01

The ultimate aim of the critical reading of medical literature is to use the scientific advances in clinical practice or for innovation. This requires an evaluation of the applicability of the results of the studies that have been published, which begins with a clear understanding of these results. When the studies do not provide sufficient guarantees of rigor in design and analysis, the conditions necessary for the applicability of the results are not met; however, the fact that the results are reliable is not enough to make it worth trying to use their conclusions. This article explains how carrying out studies in experimental or artificial conditions often moves them away from the real conditions in which they claim to apply their conclusions. To evaluate this applicability, the article proposes evaluating a set of items that will enable the reader to determine the likelihood that the benefits and risks reported in the studies will yield the least uncertainty in the clinical arena where they aim to be applied. Copyright © 2015 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency.

PubMed

Driscoll, Andrea; Currey, Judy; Worrall-Carter, Linda; Stewart, Simon

2008-08-01

To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects. The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC. Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study. Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services. The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.

Magnetic Resonance Imaging Criteria for Thrombolysis in Hyperacute Cerebral Infarction

PubMed Central

AHMETGJEKAJ, ILIR; KABASHI-MUÇAJ, SERBEZE; LASCU, LUANA CORINA; KABASHI, ANTIGONA; BONDARI, A.; BONDARI, SIMONA; DEDUSHI-HOTI, KRESHNIKE; BIÇAKU, ARDIAN; SHATRI, JETON

2014-01-01

Purpose: Selection of patients with cerebral infarction for MRI that is suitable for thrombolytic therapy as an emerging application. Although the efficiency of the therapy with i.v. tissue plasminogen activator (tPA) within 3 hours after onset of symptoms has been proven in selected patients with CT, now these criteria are determined by MRI, as the data we gather are fast and accurate in the first hours. Material and methods: MRI screening in patients with acute cerebral infarction before application of thrombolytic therapy was done in a UCC Mannheim in Germany. Unlike trials with CT, MRI studies demonstrated the benefits of therapy up to 6 hours after the onset of symptoms. We studied 21 patients hospitalized in Clinic of Neuroradiology at University Clinical Centre in Mannheim-Germany. They all undergo brain MRI evaluation for stroke. This article reviews literature that has followed application of thrombolysis in patients with cerebral infarction based on MRI. Results: We have analyzed the MRI criteria for i.v. application of tPA at this University Centre. Alongside the personal viewpoints of clinicians, survey reveals a variety of clinical aspects and MRI features that are opened for further more exploration: therapeutic effects, the use of the MRI angiography, dynamics, and other. Conclusions: MRI is a tested imaging method for rapid evaluation of patients with hyperacute cerebral infarction, replacing the use of CT imaging and clinical features. MRI criteria for thrombolytic therapy are being applied in some cerebral vascular centres. In Kosovo, the application of thrombolytic therapy has not started yet. PMID:25729591

Mobile task management tool that improves workflow of an acute general surgical service.

PubMed

Foo, Elizabeth; McDonald, Rod; Savage, Earle; Floyd, Richard; Butler, Anthony; Rumball-Smith, Alistair; Connor, Saxon

2015-10-01

Understanding and being able to measure constraints within a health system is crucial if outcomes are to be improved. Current systems lack the ability to capture decision making with regard to tasks performed within a patient journey. The aim of this study was to assess the impact of a mobile task management tool on clinical workflow within an acute general surgical service by analysing data capture and usability of the application tool. The Cortex iOS application was developed to digitize patient flow and provide real-time visibility over clinical decision making and task performance. Study outcomes measured were workflow data capture for patient and staff events. Usability was assessed using an electronic survey. There were 449 unique patient journeys tracked with a total of 3072 patient events recorded. The results repository was accessed 7792 times. The participants reported that the application sped up decision making, reduced redundancy of work and improved team communication. The mode of the estimated time the application saved participants was 5-9 min/h of work. Of the 14 respondents, nine discarded their analogue methods of tracking tasks by the end of the study period. The introduction of a mobile task management system improved the working efficiency of junior clinical staff. The application allowed capture of data not previously available to hospital systems. In the future, such data will contribute to the accurate mapping of patient journeys through the health system. © 2015 Royal Australasian College of Surgeons.

Therapeutic hypothermia: applications in pediatric cardiac arrest.

PubMed

Kochanek, Patrick M; Fink, Ericka L; Bell, Michael J; Bayir, Hülya; Clark, Robert S B

2009-03-01

There is a rich history for the use of therapeutic hypothermia after cardiac arrest in neonatology and pediatrics. Laboratory reports date back to 1824 in experimental perinatal asphyxia. Similarly, clinical reports in pediatric cold water drowning victims represented key initiating work in the field. The application of therapeutic hypothermia in pediatric drowning victims represented some of the seminal clinical use of this modality in modern neurointensive care. Uncontrolled application (too deep and too long) and unique facets of asphyxial cardiac arrest in children (a very difficult insult to affect any benefit) likely combined to result in abandonment of therapeutic hypothermia in the mid to late 1980s. Important studies in perinatal medicine have built upon the landmark clinical trials in adults, and are once again bringing therapeutic hypothermia into standard care for pediatrics. Although more work is needed, particularly in the use of mild therapeutic hypothermia in children, there is a strong possibility that this important therapy will ultimately have broad applications after cardiac arrest and central nervous system (CNS) insults in the pediatric arena.

Parameters for measurement of oxidative stress in diabetes mellitus: applicability of enzyme-linked immunosorbent assay for clinical evaluation.

PubMed

Noiri, Eisei; Tsukahara, Hirokazu

2005-05-01

Investigations of the mechanisms involved in the onset and progression of diabetes have recently confronted the role of reactive oxygen species (ROS) and oxidative stress. Prolonged exposure to hyperglycemic conditions induces nonenzymatic glycation of protein via the so-called Maillard reaction, resulting in Schiff-base products and Amadori products that engender ROS production. These processes initiate and exacerbate micro- and macrovascular complications in diabetes. Increased oxidative stress is induced by excessive ROS production and inadequate antioxidant defenses. Recently, oxidative stress status markers have been associated directly with the severity and prognosis of diabetes. To examine oxidative stress, reliable and high-throughput methods are needed to examine large numbers of clinical samples. The emerging availability of enzyme-linked immunosorbent assay (ELISA) for oxidative stress status markers allows its application to assessment of various pathophysiologic conditions, including diabetes. This review outlines the recent achievements of ELISA application for clinical studies elucidating oxidative stress. It introduces the potential applicability of ELISA for investigating oxidative stress in diabetes.

Vertical integration of basic science in final year of medical education.

PubMed

Rajan, Sudha Jasmine; Jacob, Tripti Meriel; Sathyendra, Sowmya

2016-01-01

Development of health professionals with ability to integrate, synthesize, and apply knowledge gained through medical college is greatly hampered by the system of delivery that is compartmentalized and piecemeal. There is a need to integrate basic sciences with clinical teaching to enable application in clinical care. To study the benefit and acceptance of vertical integration of basic science in final year MBBS undergraduate curriculum. After Institutional Ethics Clearance, neuroanatomy refresher classes with clinical application to neurological diseases were held as part of the final year posting in two medical units. Feedback was collected. Pre- and post-tests which tested application and synthesis were conducted. Summative assessment was compared with the control group of students who had standard teaching in other two medical units. In-depth interview was conducted on 2 willing participants and 2 teachers who did neurology bedside teaching. Majority (>80%) found the classes useful and interesting. There was statistically significant improvement in the post-test scores. There was a statistically significant difference between the intervention and control groups' scores during summative assessment (76.2 vs. 61.8 P < 0.01). Students felt that it reinforced, motivated self-directed learning, enabled correlations, improved understanding, put things in perspective, gave confidence, aided application, and enabled them to follow discussions during clinical teaching. Vertical integration of basic science in final year was beneficial and resulted in knowledge gain and improved summative scores. The classes were found to be useful, interesting and thought to help in clinical care and application by majority of students.

Effectiveness of a smartphone application for improving healthy lifestyles, a randomized clinical trial (EVIDENT II): study protocol

PubMed Central

2014-01-01

Background New technologies could facilitate changes in lifestyle and improve public health. However, no large randomized, controlled studies providing scientific evidence of the benefits of their use have been made. The aims of this study are to develop and validate a smartphone application, and to evaluate the effect of adding this tool to a standardized intervention designed to improve adherence to the Mediterranean diet and to physical activity. An evaluation is also made of the effect of modifying habits upon vascular structure and function, and therefore on arterial aging. Methods/Design A randomized, double-blind, multicenter, parallel group clinical trial will be carried out. A total of 1215 subjects under 70 years of age from the EVIDENT trial will be included. Counseling common to both groups (control and intervention) will be provided on adaptation to the Mediterranean diet and on physical activity. The intervention group moreover will receive training on the use of a smartphone application designed to promote a healthy diet and increased physical activity, and will use the application for three months. The main study endpoints will be the changes in physical activity, assessed by accelerometer and the 7-day Physical Activity Recall (PAR) interview, and adaptation to the Mediterranean diet, as evaluated by an adherence questionnaire and a food frequency questionnaire (FFQ). Evaluation also will be made of vascular structure and function based on central arterial pressure, the radial augmentation index, pulse velocity, the cardio-ankle vascular index, and carotid intima-media thickness. Discussion Confirmation that the new technologies are useful for promoting healthier lifestyles and that their effects are beneficial in terms of arterial aging will have important clinical implications, and may contribute to generalize their application in favor of improved population health. Trial registration Clinical Trials.gov Identifier: NCT02016014 PMID:24628961

A systematic review on pharmacogenetics in cardiovascular disease: is it ready for clinical application?

PubMed

Verschuren, Jeffrey J W; Trompet, Stella; Wessels, Judith A M; Guchelaar, Henk-Jan; de Maat, Moniek P M; Simoons, Maarten L; Jukema, J Wouter

2012-01-01

Pharmacogenetics is the search for heritable genetic polymorphisms that influence responses to drug therapy. The most important application of pharmacogenetics is to guide choosing agents with the greatest potential of efficacy and smallest risk of adverse drug reactions. Many studies focusing on drug-gene interactions have been published in recent years, some of which led to adaptation of FDA recommendations, indicating that we are on the verge of the clinical application of genetic information in drug therapy. This systematic review provides a comprehensive overview of the current knowledge on pharmacogenetics of all major drug classes currently used in the treatment of cardiovascular diseases.

Clinical pharmacokinetics: perceptions of hospital pharmacists in Qatar about how it was taught and how it is applied.

PubMed

Kheir, Nadir; Awaisu, Ahmed; Gad, Hoda; Elazzazy, Shereen; Jibril, Farah; Gajam, Mawadda

2015-12-01

The application of clinical pharmacokinetics (PK) is essential when providing pharmaceutical care. Appropriate application of PK monitoring results in improved patient outcomes including decreased mortality, length of treatment, length of hospital stay, and adverse effects of drug therapy. Despite the well-documented evidence of benefits of clinical PK services, many pharmacists find it challenging to apply PK in clinical practice. To evaluate pharmacists' training backgrounds, attitude, practices, and perceived barriers pertaining to the application of PK in clinical practice in Qatar. All hospitals under Hamad Medical Corporation, the main healthcare provider in Qatar. This was a cross-sectional, descriptive study that was conducted between October 2012 and January 2013, using a self-administered web-based survey. Pharmacists were eligible to participate if they: (1) were working as full-time hospital pharmacists and; (2) have been in practice for at least 1 year. PK contents learned in undergraduate curriculum; perception towards the PK contents and instructions received in the undergraduate curriculum and; application of PK in current clinical practice. A total of 112 pharmacists responded to the questionnaire. The majority of the respondents (n = 91; 81.3 %) reported that they had received PK course(s) in their undergraduate curriculum. Similarly, the majority (70-80 %) of them agreed that the undergraduate PK courses or contents they received were important and relevant to their current practice. The pharmacists identified spending more time on dispensing and inventory issues rather than clinical practice, scarce resources, and manual rather than computerized PK calculations as some of the barriers they encountered in learning about PK and its application. The characteristics of the surveyed pharmacists such as gender, age, highest academic degree, and country of graduation did not influence the pharmacists' perception and attitudes towards PK teaching and application (p > 0.05). PK course contents were perceived to lack depth and relevance to practice, and pharmacist had no experiential training that included aspects of PK. These, and other issues, result in poor application of PK in practice.

Effect of concentrated growth factors on beagle periodontal ligament stem cells in vitro.

PubMed

Yu, Bohan; Wang, Zuolin

2014-01-01

Identifying a reliable and effective cytokine or growth factor group has been the focus of stem cell osteogenic induction studies. Concentrated growth factors (CGFs) as the novel generation of platelet concentrate products, appear to exhibit a superior clinical and biotechnological application potential, however, there are few studies that have demonstrated this effect. This study investigated the proliferation and differentiation of periodontal ligament stem cells (PDLSCs) co‑cultured with CGFs. The rate of proliferation was analyzed by cell counting and an MTT assay. Mineralization nodule counts, alkaline phosphatase activity detection, qPCR, western blot analysis and immunohistochemistry were used to analyze mineralization effects. The results showed that CGF significantly promoted the proliferation of PDLSCs, and exhibited a dose‑dependent effect on the activation and differentiation of the stem cells. The application of CGF on PDLSC proliferation and osteoinduction may offer numerous clinical and biotechnological application strategies.

Clinical applications of the human brainstem responses to auditory stimuli

NASA Technical Reports Server (NTRS)

Galambos, R.; Hecox, K.

1975-01-01

A technique utilizing the frequency following response (FFR) (obtained by auditory stimulation, whereby the stimulus frequency and duration are mirror-imaged in the resulting brainwaves) as a clinical tool for hearing disorders in humans of all ages is presented. Various medical studies are discussed to support the clinical value of the technique. The discovery and origin of the FFR and another significant brainstem auditory response involved in studying the eighth nerve is also discussed.

Translating research and into everyday clinical practice: Lessons learned from a USA national dental practice-based research network

PubMed Central

Gordan, Valeria V.

2012-01-01

Clinical studies are of paramount importance for testing and translation of the research findings to the community. Despite the existence of clinical studies, a significant delay exists between the generation of new knowledge and its application into the medical/dental community and their patients. One example is the repair of defective dental restorations. About 75% of practitioners in general dental practices do not consider the repair of dental restorations as a viable alternative to the replacement of defective restorations. Engaging and partnering with health practitioners in the field on studies addressing everyday clinical research questions may offer a solution to speed up the translation of the research findings. Practice-based research (PBR) offers a unique opportunity for practitioners to be involved in the research process, formulating clinical research questions. Additionally, PBR generates evidence-based knowledge with a broader spectrum that can be more readily generalized to the public. With PBR, clinicians are involved in the entire research process from its inception to its dissemination. Early practitioner interaction in the research process may result in ideas being more readily incorporated into practice. This paper discusses PBR as a mean to speed up the translation of research findings to clinical practice. It also reviews repair versus replacement of defective restorations as one example of the delay in the application of research findings to clinical practice. PMID:22889478

Acoustic Droplet Vaporization in Biology and Medicine

PubMed Central

Pitt, William G.

2013-01-01

This paper reviews the literature regarding the use of acoustic droplet vaporization (ADV) in clinical applications of imaging, embolic therapy, and therapeutic delivery. ADV is a physical process in which the pressure waves of ultrasound induce a phase transition that causes superheated liquid nanodroplets to form gas bubbles. The bubbles provide ultrasonic imaging contrast and other functions. ADV of perfluoropentane was used extensively in imaging for preclinical trials in the 1990s, but its use declined rapidly with the advent of other imaging agents. In the last decade, ADV was proposed and explored for embolic occlusion therapy, drug delivery, aberration correction, and high intensity focused ultrasound (HIFU) sensitization. Vessel occlusion via ADV has been explored in rodents and dogs and may be approaching clinical use. ADV for drug delivery is still in preclinical stages with initial applications to treat tumors in mice. Other techniques are still in preclinical studies but have potential for clinical use in specialty applications. Overall, ADV has a bright future in clinical application because the small size of nanodroplets greatly reduces the rate of clearance compared to larger contrast agent bubbles and yet provides the advantages of ultrasonographic contrast, acoustic cavitation, and nontoxicity of conventional perfluorocarbon contrast agent bubbles. PMID:24350267

[Progress of midfacial fat compartments and related clinical applications].

PubMed

Wen, Lihong; Wang, Jinhuang; Li, Yang; Liu, Dalie

2018-02-01

To review the research progress of midfacial fat compartments, and to thoroughly understand its current state of the anatomy and the aging morphologic characters of midfacial fat compartments, as well as the current status of clinical applications. The recent literature concerning the midfacial fat compartments and related clinical applications were extensively reviewed and analyzed. Midfacial fat layer has been considered as a fusion and a continuous layer, experiencing a global atrophy when aging. As more anatomical researches have done, recent studies have shown that midfacial fat layer is broadly divided into superficial and deep layers, which are both divided into different fat compartments by fascia, ligaments, or muscles. Midfacial fat compartments tend to atrophy with age, specifically in the deep fat compartments while hypertrophy in the superficial fat compartments. Clinical applications show that fat volumetric restoration with deep medial cheek fat and Ristow's space can restore the appearance of midface effectively. In recent years, the researches of midfacial fat compartments have achieved obvious progress, which will provide new ideas and basis for fat volumetric restoration. Corresponding treatments are selected based on different sites and different layers with different aging changes, reshaping a more youthful midface.

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.

Preventing pressure sores of the nasal ala after nasotracheal tube intubation: from animal model to clinical application.

PubMed

Huang, Tze-Ta; Tseng, Chih-En; Lee, Tsan-Mu; Yeh, Jen-Ying; Lai, Yu-Yung

2009-03-01

Nasal-ala pressure sores induced by nasotracheal intubation are common complications of oral and maxillofacial surgery, but are easily ignored. To determine whether such sores could be prevented, we studied the effects of a combination of cushioning material in an animal model, and then analyzed the efficacy of this combination clinically. Four pigs received nasotracheal intubation. Each pig received intubation for 4, 8, 12, or 16 hours. Outcomes from pigs undergoing 500-gram-weight compression on each nostril were compared: one nostril received an application of cushioning materials, and the contralateral nostril did not. After the required study period, clinical assessment and further evaluation were performed by measuring pressure-sore dimensions and performing incisional biopsies. Clinical applications of this protective technique were then undertaken. Eight patients who underwent intubation without Soft Liner (GC Co, Tokyo, Japan) and DuoDERM CGF (ConvaTec, Inc, Princeton, NJ) protection, and 10 patients with Soft Liner and DuoDERM protection, were evaluated. The protective efficacy of the cushioning materials was significant in the animal model as well as in clinical practice. Pressure sores were avoided on the protected side, with severe tissue necrosis documented on the control side. We found that the combined use of Soft Liner and DuoDERM reduced the size and severity of nasal-ala pressure sores attributable to nasotracheal intubation during oral and maxillofacial surgery.

Tandem Repeated Irritation Test (TRIT) Studies and Clinical Relevance: Post 2006.

PubMed

Reddy, Rasika; Maibach, Howard

2018-06-11

Single or multiple applications of irritants can lead to occupational contact dermatitis, and most commonly irritant contact dermatitis (ICD). Tandem irritation, the sequential application of two irritants to a target skin area, has been studied using the Tandem Repeated Irritation Test (TRIT) to provide a more accurate representation of skin irritation. Here we present an update to Kartono's review on tandem irritation studies since 2006 [1]. We surveyed the literature available on PubMed, Embase, Google Scholar, and the UCSF Dermatology library databases since 2006. The studies included discuss the tandem effects of common chemical irritants, organic solvents, occlusion as well as clinical relevance - and enlarge our ability to discern whether multiple chemical exposures are more or less likely to enhance irritation.

Brief Analysis of Application of Objective Structured Clinical Examination (OSCE) in Graduation Exams of Clinical Medical Students

ERIC Educational Resources Information Center

Du, Yihua; Yu, Ke; Li, Xiaohong; Wang, Feng; Wang, Tingting

2011-01-01

This article gives a brief introduction to the Objective Structured Clinical Examination (OSCE) and analyzes developmental progress of OSCE at both home and abroad and standardized patients' application in OSCE. Also, this article expounds application of OSCE in graduation exam of clinical medical students. Finally, this article summarizes…

Clinical utility of measures of breathlessness.

PubMed

Cullen, Deborah L; Rodak, Bernadette

2002-09-01

The clinical utility of measures of dyspnea has been debated in the health care community. Although breathlessness can be evaluated with various instruments, the most effective dyspnea measurement tool for patients with chronic lung disease or for measuring treatment effectiveness remains uncertain. Understanding the evidence for the validity and reliability of these instruments may provide a basis for appropriate clinical application. Evaluate instruments designed to measure breathlessness, either as single-symptom or multidimensional instruments, based on psychometrics foundations such as validity, reliability, and discriminative and evaluative properties. Classification of each dyspnea measurement instrument will recommend clinical application in terms of exercise, benchmarking patients, activities of daily living, patient outcomes, clinical trials, and responsiveness to treatment. Eleven dyspnea measurement instruments were selected. Each instrument was assessed as discriminative or evaluative and then analyzed as to its psychometric properties and purpose of design. Descriptive data from all studies were described according to their primary patient application (ie, chronic obstructive pulmonary disease, asthma, or other patient populations). The Borg Scale and the Visual Analogue Scale are applicable to exertion and thus can be applied to any cardiopulmonary patient to determine dyspnea. All other measures were determined appropriate for chronic obstructive pulmonary disease, whereas the Shortness of Breath Questionnaire can be applied to cystic fibrosis and lung transplant patients. The most appropriate utility for all instruments was measuring the effects on activities of daily living and for benchmarking patient progress. Instruments that quantify function and health-related quality of life have great utility for documenting outcomes but may be limited as to documenting treatment responsiveness in terms of clinically important changes. The dyspnea measurement instruments we studied meet important standards of validity and reliability. Discriminative measures have limited clinical utility and, when used for populations or conditions for which they are not designed or validated, the data collected may not be clinically relevant. Evaluative measures have greater clinical utility and can be applied for outcome purposes. Measures should be applied to the populations and conditions for which they were designed. The relationship between clinical therapies and the measurement of dyspnea as an outcome can develop as respiratory therapists become more comfortable with implementing dyspnea measurement instruments and use the data to improve patient treatment. Dyspnea evaluation should be considered for all clinical practice guidelines and care pathways.

SU-G-201-04: Can the Dynamic Library of Flap Applicators Replace Treatment Planning in Surface Brachytherapy?

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

Buzurovic, I; Devlin, P; Hansen, J

Purpose: Contemporary brachytherapy treatment planning systems-(TPS) include the applicator model libraries to improve digitization; however, the library of surface-flap-applicators-(SFA) is not incorporated into the commercial TPS. We propose the dynamic library-(DL) for SFA and investigate if such library can eliminate applicator reconstruction, source activation and dose normalization. Methods: DL was generated for the SFA using the C++class libraries of the Visualization Toolkit-(VTK) and Qt-application framework for complete abstraction of the graphical interface. DL was designed such that the user can initially choose the size of the applicator that corresponds to the one clinically placed to the patient. The virtual applicator-(VA)more » has an elastic property so that it can be registered to the clinical CT images with a real applicator-(RA) on it. The VA and RA matching is performed by adjusting the position and curvature of the VA. The VA does not elongate or change its size so each catheter could always be at a distance of 5mm from the skin and 10mm apart from the closest catheter maintaining the physical accuracy of the clinical setup. Upon the applicator placement, the dwell positions were automatically activated, and the dose is normalized to the prescription depth. The accuracy of source positioning was evaluated using various applicator sizes. Results: The accuracy of the applicator placement was in the sub-millimeter range. The time-study reveals that up to 50% of the planning time can be saved depending on the complexity of the clinical setup. Unlike in the classic approach, the planning time was not highly dependent on the applicator size. Conclusion: The practical benefits of the DL of the SFA were demonstrated. The time demanding planning processes can be partially automated. Consequently, the planner can dedicate effort to fine tuning, which can result in the improvement of the quality of treatment plans in surface brachytherapy.« less

A Smartphone Application for Customized Frequency Table Selection in Cochlear Implants.

PubMed

Jethanamest, Daniel; Azadpour, Mahan; Zeman, Annette M; Sagi, Elad; Svirsky, Mario A

2017-09-01

A novel smartphone-based software application can facilitate self-selection of frequency allocation tables (FAT) in postlingually deaf cochlear implant (CI) users. CIs use FATs to represent the tonotopic organization of a normal cochlea. Current CI fitting methods typically use a standard FAT for all patients regardless of individual differences in cochlear size and electrode location. In postlingually deaf patients, different amounts of mismatch can result between the frequency-place function they experienced when they had normal hearing and the frequency-place function that results from the standard FAT. For some CI users, an alternative FAT may enhance sound quality or speech perception. Currently, no widely available tools exist to aid real-time selection of different FATs. This study aims to develop a new smartphone tool for this purpose and to evaluate speech perception and sound quality measures in a pilot study of CI subjects using this application. A smartphone application for a widely available mobile platform (iOS) was developed to serve as a preprocessor of auditory input to a clinical CI speech processor and enable interactive real-time selection of FATs. The application's output was validated by measuring electrodograms for various inputs. A pilot study was conducted in six CI subjects. Speech perception was evaluated using word recognition tests. All subjects successfully used the portable application with their clinical speech processors to experience different FATs while listening to running speech. The users were all able to select one table that they judged provided the best sound quality. All subjects chose a FAT different from the standard FAT in their everyday clinical processor. Using the smartphone application, the mean consonant-nucleus-consonant score with the default FAT selection was 28.5% (SD 16.8) and 29.5% (SD 16.4) when using a self-selected FAT. A portable smartphone application enables CI users to self-select frequency allocation tables in real time. Even though the self-selected FATs that were deemed to have better sound quality were only tested acutely (i.e., without long-term experience with them), speech perception scores were not inferior to those obtained with the clinical FATs. This software application may be a valuable tool for improving future methods of CI fitting.

Bayesian methodology for the design and interpretation of clinical trials in critical care medicine: a primer for clinicians.

PubMed

Kalil, Andre C; Sun, Junfeng

2014-10-01

To review Bayesian methodology and its utility to clinical decision making and research in the critical care field. Clinical, epidemiological, and biostatistical studies on Bayesian methods in PubMed and Embase from their inception to December 2013. Bayesian methods have been extensively used by a wide range of scientific fields, including astronomy, engineering, chemistry, genetics, physics, geology, paleontology, climatology, cryptography, linguistics, ecology, and computational sciences. The application of medical knowledge in clinical research is analogous to the application of medical knowledge in clinical practice. Bedside physicians have to make most diagnostic and treatment decisions on critically ill patients every day without clear-cut evidence-based medicine (more subjective than objective evidence). Similarly, clinical researchers have to make most decisions about trial design with limited available data. Bayesian methodology allows both subjective and objective aspects of knowledge to be formally measured and transparently incorporated into the design, execution, and interpretation of clinical trials. In addition, various degrees of knowledge and several hypotheses can be tested at the same time in a single clinical trial without the risk of multiplicity. Notably, the Bayesian technology is naturally suited for the interpretation of clinical trial findings for the individualized care of critically ill patients and for the optimization of public health policies. We propose that the application of the versatile Bayesian methodology in conjunction with the conventional statistical methods is not only ripe for actual use in critical care clinical research but it is also a necessary step to maximize the performance of clinical trials and its translation to the practice of critical care medicine.

Clinical application of plasma thermograms. Utility, practical approaches and considerations.

PubMed

Garbett, Nichola C; Mekmaysy, Chongkham S; DeLeeuw, Lynn; Chaires, Jonathan B

2015-04-01

Differential scanning calorimetry (DSC) studies of blood plasma are part of an emerging area of the clinical application of DSC to biofluid analysis. DSC analysis of plasma from healthy individuals and patients with various diseases has revealed changes in the thermal profiles of the major plasma proteins associated with the clinical status of the patient. The sensitivity of DSC to the concentration of proteins, their interactions with other proteins or ligands, or their covalent modification underlies the potential utility of DSC analysis. A growing body of literature has demonstrated the versatility and performance of clinical DSC analysis across a range of biofluids and in a number of disease settings. The principles, practice and challenges of DSC analysis of plasma are described in this article. Copyright © 2014 Elsevier Inc. All rights reserved.

Clinical application of plasma thermograms. Utility, practical approaches and considerations

PubMed Central

Garbett, Nichola C.; Mekmaysy, Chongkham S.; DeLeeuw, Lynn; Chaires, Jonathan B.

2014-01-01

Differential scanning calorimetry (DSC) studies of blood plasma are part of an emerging area of the clinical application of DSC to biofluid analysis. DSC analysis of plasma from healthy individuals and patients with various diseases has revealed changes in the thermal profiles of the major plasma proteins associated with the clinical status of the patient. The sensitivity of DSC to the concentration of proteins, their interactions with other proteins or ligands, or their covalent modifications underlies the potential utility of DSC analysis. A growing body of literature has demonstrated the versatility and performance of clinical DSC analysis across a range of biofluids and in a number of disease settings. The principles, practice and challenges of DSC analysis of plasma are described in this article. PMID:25448297

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…

[Application of magnetic therapy in acute paraproctitis].

PubMed

Kondratenko, P G; Elin, F E; Avraimov, S L; Sobolev, D V

2003-09-01

There were studied the possibilities and perspectives of application of the magnetically liquefied layer as an instrument for better purulent and putrefactive wounds clearance after intervention for an acute paraproctitis. Together with clinical signs the results of bacteriological investigation were controlled as well. There was established high efficacy of the method proposed and expedience of its application.

Breast Cancer Diagnosis Using Ultrasound and Diffusive Light

DTIC Science & Technology

2004-08-01

been widely used in clinical studies. The fundamental problem remains the intense light scattering in tissue, which makes the lesion localization...Our 3 unique approach may have significant clinical applications on 1) breast cancer diagnosis; and 2) assessing treatment response and estimating...the response of cancers to presurgical chemotherapy are not completely understood [20]. Although recent trials reported clinical response rates >70

75 FR 29772 - Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-05-27

... (c)(6). Grant applications for the Recovery Act 2009 Limited Competition: Prospect Studies--Building... on: Recovery Act 2009 Limited Competition: Prospect Studies--Building New Clinical Infrastructure for...

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.

Clinical practice guidelines in hypertension: a review.

PubMed

Álvarez-Vargas, Mayita Lizbeth; Galvez-Olortegui, José Kelvin; Galvez-Olortegui, Tomas Vladimir; Sosa-Rosado, José Manuel; Camacho-Saavedra, Luis Arturo

2015-10-23

The aim of this study is the methodological evaluation of Clinical Practice Guidelines (CPG) in hypertension. This is the first in a series of review articles, analysis, assessment in methodology and content of clinical practice guidelines in Cardiology. Of all clinical practice guidelines, three were selected and the Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument was used to assess each guide. The guidelines obtained the lowest score in the domain of applicability (mean 43.8%); while the highest score was for clarity of presentation (mean 81.5%). The lowest percentage was found in the applicability domain (European guideline) and the highest of all scores was found in two domains: scope and purpose, and clarity of presentation (Canadian guideline). Assessing the quality of the clinical practice guidelines analyzed, the Canadian is one with the best scores obtained by applying the AGREE II instrument, and it is advised to be used without modifications.

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.

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

Family-based treatment of a 17-year-old twin presenting with emerging anorexia nervosa: a case study using the "Maudsley method".

PubMed

Loeb, Katharine L; Hirsch, Alicia M; Greif, Rebecca; Hildebrandt, Thomas B

2009-01-01

This article describes the successful application of family-based treatment (FBT) for a 17-year-old identical twin presenting with a 4-month history of clinically significant symptoms of anorexia nervosa (AN). FBT is a manualized treatment that has been studied in randomized controlled trials for adolescents with AN. This case study illustrates the administration of this evidence-based intervention in a clinical setting, highlighting how the best available research was used to make clinical decisions at each stage of treatment delivery.

[Study on biocompatibility of hydroxyapatite/high density polyethylene (HA/HDPE) nano-composites artificial ossicle].

PubMed

Wang, Guohui; Zhu, Shaihong; Tan, Guolin; Zhou, Kechao; Huang, Suping; Zhao, Yanzhong; Li, Zhiyou; Huang, Boyun

2008-06-01

This study was aimed to evaluate the biocompatibility of Hydroxyapatite/High density polyethylene (HA/ HDPE) nano-composites artificial ossicle. The percentage of S-period cells were detected by flow cytometry after L929 cells being incubated with extraction of the HA/HDPE nano-composites; the titanium materials for clinical application served as the contrast. In addition, both materials were implanted in animals and the histopathological evaluations were conducted. There were no statistically significant differences between the two groups (P >0.05). The results demonstrated that the HA/HDPE nano-composite artificial ossicle made by our laboratory is of a good biocompatibility and clinical application outlook.

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.

A NEW APPROACH TO THE STUDY OF MUCOADHESIVENESS OF POLYMERIC MEMBRANES USING SILICONE DISCS.

PubMed

Nowak, Karolina Maria; Szterk, Arkadiusz; Fiedor, Piotr; Bodek, Kazimiera Henryka

2016-01-01

The introduction of new test methods and the modification of existing ones are crucial for obtaining reliable results, which contributes to the development of innovative materials that may have clinical applications. Today, silicone is commonly used in medicine and the diversity of its applications are continually growing. The aim of this study is to evaluate the mucoadhesiveness of polymeric membranes by a method that modifies the existing test methods through the introduction of silicone discs. The matrices were designed for clinical application in the management of diseases within the oral cavity. The use of silicone discs allows reliable and reproducible results to be obtained, which allows us to make various tensometric measurements. In this study, different types of polymeric matrices were examined, as well as their crosslinking and the presence for the active pharmaceutical ingredient were compared to the pure dosage form. The lidocaine hydrochloride (Lid(HCl)) was used as a model active substance, due to its use in dentistry and clinical safety. The results were characterized by a high repeatability (RSD < 10.6%). The advantage of silicone material due to its mechanical strength, chemical and physical resistance, allowed a new test method using a texture analyzer to be proposed.

EVIDENT 3 Study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application

PubMed Central

Recio-Rodriguez, José I.; Gómez-Marcos, Manuel A.; Agudo-Conde, Cristina; Ramirez, Ignasi; Gonzalez-Viejo, Natividad; Gomez-Arranz, Amparo; Salcedo-Aguilar, Fernando; Rodriguez-Sanchez, Emiliano; Alonso-Domínguez, Rosario; Sánchez-Aguadero, Natalia; Gonzalez-Sanchez, Jesus; Garcia-Ortiz, Luis

2018-01-01

Abstract Introduction: Mobile technology, when included within multicomponent interventions, could contribute to more effective weight loss. The objective of this project is to assess the impact of adding the use of the EVIDENT 3 application, designed to promote healthy living habits, to traditional modification strategies employed for weight loss. Other targeted behaviors (walking, caloric-intake, sitting time) and outcomes (quality of life, inflammatory markers, measurements of arterial aging) will also be evaluated. Methods: Randomized, multicentre clinical trial with 2 parallel groups. The study will be conducted in the primary care setting and will include 700 subjects 20 to 65 years, with a body mass index (27.5–40 kg/m2), who are clinically classified as sedentary. The primary outcome will be weight loss. Secondary outcomes will include change in walking (steps/d), sitting time (min/wk), caloric intake (kcal/d), quality of life, arterial aging (augmentation index), and pro-inflammatory marker levels. Outcomes will be measured at baseline, after 3 months, and after 1 year. Participants will be randomly assigned to either the intervention group (IG) or the control group (CG). Both groups will receive the traditional primary care lifestyle counseling prior to randomization. The subjects in the IG will be lent a smartphone and a smartband for a 3-month period, corresponding to the length of the intervention. The EVIDENT 3 application integrates the information collected by the smartband on physical activity and the self-reported information by participants on daily food intake. Using this information, the application generates recommendations and personalized goals for weight loss. Discussion: There is a great diversity in the applications used obtaining different results on lifestyle improvement and weight loss. The populations studied are not homogeneous and generate different results. The results of this study will help our understanding of the efficacy of new technologies, combined with traditional counseling, towards reducing obesity and enabling healthier lifestyles. Ethics and dissemination: The study was approved by the Clinical Research Ethics Committee of the Health Area of Salamanca (“CREC of Health Area of Salamanca”) on April 2016. A SPIRIT checklist is available for this protocol. The trial was registered in ClinicalTrials.gov provided by the US National Library of Medicine-number NCT03175614. PMID:29480874

Quantifying exploratory low dose compounds in humans with AMS

PubMed Central

Dueker, Stephen R.; Vuong, Le T.; Lohstroh, Peter N.; Giacomo, Jason A.; Vogel, John S.

2010-01-01

Accelerator Mass Spectrometry is an established technology whose essentiality extends beyond simply a better detector for radiolabeled molecules. Attomole sensitivity reduces radioisotope exposures in clinical subjects to the point that no population need be excluded from clinical study. Insights in human physiochemistry are enabled by the quantitative recovery of simplified AMS processes that provide biological concentrations of all labeled metabolites and total compound related material at non-saturating levels. In this paper, we review some of the exploratory applications of AMS 14C in toxicological, nutritional, and pharmacological research. This body of research addresses the human physiochemistry of important compounds in their own right, but also serves as examples of the analytical methods and clinical practices that are available for studying low dose physiochemistry of candidate therapeutic compounds, helping to broaden the knowledge base of AMS application in pharmaceutical research. PMID:21047543

Application of dermoscopy image analysis technique in diagnosing urethral condylomata acuminata.

PubMed

Zhang, Yunjie; Jiang, Shuang; Lin, Hui; Guo, Xiaojuan; Zou, Xianbiao

2018-01-01

In this study, cases with suspected urethral condylomata acuminata were examined by dermoscopy, in order to explore an effective method for clinical. To study the application of dermoscopy image analysis technique in clinical diagnosis of urethral condylomata acuminata. A total of 220 suspected urethral condylomata acuminata were clinically diagnosed first with the naked eyes, and then by using dermoscopy image analysis technique. Afterwards, a comparative analysis was made for the two diagnostic methods. Among the 220 suspected urethral condylomata acuminata, there was a higher positive rate by dermoscopy examination than visual observation. Dermoscopy examination technique is still restricted by its inapplicability in deep urethral orifice and skin wrinkles, and concordance between different clinicians may also vary. Dermoscopy image analysis technique features a high sensitivity, quick and accurate diagnosis and is non-invasive, and we recommend its use.

Experimental and clinical experience with iodine 123-labeled iodophenylpentadecanoic acid in cardiology.

PubMed

Reske, S N

1994-01-01

Iodine 123-labeled iodophenylpentadecanoic acid (IPPA) has been synthesized for investigating myocardial free fatty acid (FFA) metabolism. The diagnostic application of labeled FFA in heart disease may be important, because FFA is the preferred substrate of cardiac energy metabolism at rest in the fasting state. In addition, regional myocardial FFA uptake and regional myocardial blood flow are tightly coupled in normal myocardium with beta-oxidation, which is extremely sensitive to oxygen deprivation. This article outlines basic physiologic pathways of cardiac IPPA metabolism in normal, acutely ischemic, and reperfused viable myocardium and summarizes the results of experimental studies in animals, validating the application of IPPA as an 123I-labeled fatty acid analog. In addition, the most important clinical studies indicating the clinical use of IPPA for diagnosis of coronary heart disease and myocardial viability are presented.

Nuclear Magnetic Resonance Technology for Medical Studies.

ERIC Educational Resources Information Center

Budinger, Thomas F.; Lauterbur, Paul C.

1984-01-01

Reports on the status of nuclear magnetic resonance (NMR) from theoretical and clinical perspectives, reviewing NMR theory and relaxation parameters relevant to NMR imaging. Also reviews literature related to modern imaging strategies, signal-to-noise ratio, contrast agents, in vivo spectroscopy, spectroscopic imaging, clinical applications, and…

Clinical relevance of liquid chromatography tandem mass spectrometry as an analytical method in microdose clinical studies.

PubMed

Yamane, Naoe; Tozuka, Zenzaburo; Kusama, Makiko; Maeda, Kazuya; Ikeda, Toshihiko; Sugiyama, Yuichi

2011-08-01

To investigate the potency of LC-MS/MS by means of sensitivity and the applicability for cassette dosing in microdose clinical trials. Thirty one top-selling 31 drugs were spiked to human plasma, extracted, and analyzed by LC-MS/MS. The lower limits of quantification for each drug varied from 0.08 to 50 pg/mL, and were lower than one eighth of the assumed maximum plasma concentration at microdose in all drugs except for losartan, indicating the high performance in acquisition of full pharmacokinetic profiles at microdose. We also succeeded in simultaneous analysis of multiple compounds, assuming a situation of cassette dosing in which multiple drug candidates would be administrated simultaneously. Together with the features of LC-MS/MS, such as immediate verification, the utilization of non-radiolabeled drugs and no special facilities, we suppose that LC-MS/MS analysis would be widely applicable in conducting microdose clinical studies.

The combination of ultrasound with antibiotics released from bone cement decreases the viability of planktonic and biofilm bacteria: an in vitro study with clinical strains.

PubMed

Ensing, Geert T; Neut, Daniëlle; van Horn, Jim R; van der Mei, Henny C; Busscher, Henk J

2006-12-01

Antibiotic-loaded bone cements are used for the permanent fixation of joint prostheses. Antibiotic-loaded cements significantly decrease the incidence of infection. The objective of this study was to investigate whether the viability of bacteria derived from patients with a prosthesis-related infection could be further decreased when antibiotic release from bone cements was combined with application of pulsed ultrasound. Escherichia coli ATCC 10798, Staphylococcus aureus 7323, coagulase-negative staphylococci (CoNS 7368 and CoNS 7391) and Pseudomonas aeruginosa 5148 were grown planktonically in suspension and as a biofilm on three different bone cements: Palacos R without gentamicin as control, gentamicin-loaded Palacos R-G and gentamicin/clindamycin-loaded Copal. The viability of planktonic and biofilm bacteria was measured in the absence and presence of pulsed ultrasound for 40 h. Ultrasound itself did not affect bacterial viability. However, application of pulsed ultrasound in combination with antibiotic release by antibiotic-loaded bone cements yielded a reduction of both planktonic and biofilm bacterial viability compared with antibiotic release without application of ultrasound. This study shows that antibiotic release in combination with ultrasound increases the antimicrobial efficacy further than antibiotic release alone against a variety of clinical isolates. Application of ultrasound in combination with antibiotic release in clinical practice could therefore lead to better prevention or treatment of prosthesis-related infections.

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

PubMed

Liu, Meng-Yu; Yang, Wei; Wang, Li-Ying; Zhao, Xue-Yao; Wang, Yue-Xi; Liu, Yu-Qi; Han, Xue-Jie; Lv, Ai-Ping

2017-09-01

Clinical application evaluation research of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine intends to evaluate the quality level and clinical application of the guideline. A questionnaire and prospective case survey methods were used to evaluate the applicability evaluation based on the clinician questionnaire and the application evaluation based on clinical case observation. The applicability evaluation, familiarity and utilization rate of doctors' guidelines were 85.06%, 62.76%; Sort by technical grade, intermediate grade doctors have a higher familiarity rate and utilization rate, while the junior grade doctor's is lower; Guide quality level of applicability evaluation, other items' rational percentage are better than 96% except the items of health preserving and prevention and other treatment is relatively low; Items' applicable percentage of applicability evaluation are more than 91% except the item of guide simplicity. Comprehensive applicability evaluation, The percentage of the guideline applicable to clinical practice accounted for 94.94%. The consistency rate of syndrome differentiation and clinical application is more than 96% in addition to prescription medication, other treatments and health preserving and prevention of the guidelines apply consistency of application evaluation. The percentage of good treatment effect accounted for 92.96% of application effect evaluation. The safety percentage is 99.89% and economy is 97.45%. The research shows that of Guidelines for the Diagnosis and Treatment of Common Diseases of Pediatrics in Traditional Chinese Medicine quality level is good and is basically applicable to pediatric clinical practice which can be used as a standardized recommendation of pediatric common diseases' treatment specification. A small part of the guidelines are not applicable and need to be further consummated. Health preserving and prevention and other treatment of the guideline need to be revised. Copyright© by the Chinese Pharmaceutical Association.

Radiographic applications of spatial frequency multiplexing

NASA Technical Reports Server (NTRS)

Macovski, A.

1981-01-01

The application of spacial frequency encoding techniques which allow different regions of the X-ray spectrum to be encoded on conventional radiographs was studied. Clinical considerations were reviewed, as were experimental studies involving the encoding and decoding of X-ray images at different energies and the subsequent processing of the data to produce images of specific materials in the body.

Clinical applications of image-based airway computational fluid dynamics: assessment of inhalation medication and endobronchial devices

NASA Astrophysics Data System (ADS)

De Backer, Jan W.; Vos, Wim G.; Germonpré, Paul; Salgado, Rodrigo; Parizel, Paul M.; De Backer, Wilfried

2009-02-01

Computational fluid dynamics (CFD) is a technique that is used increasingly in the biomedical field. Solving the flow equations numerically provides a convenient way to assess the efficiency of therapies and devices, ranging from cardiovascular stents and heart valves to hemodialysis workflows. Also in the respiratory field CFD has gained increasing interest, especially through the combination of three dimensional image reconstruction which results in highend patient-specific models. This paper provides an overview of clinical applications of CFD through image based modeling, resulting from recent studies performed in our center. We focused on two applications: assessment of the efficiency of inhalation medication and analysis of endobronchial valve placement. In the first application we assessed the mode of action of a novel bronchodilator in 10 treated patients and 4 controls. We assessed the local volume increase and resistance change based on the combination of imaging and CFD. We found a good correlation between the changes in volume and resistance coming from the CFD results and the clinical tests. In the second application we assessed the placement and effect of one way endobronchial valves on respiratory function in 6 patients. We found a strong patientspecific result of the therapy where in some patients the therapy resulted in complete atelectasis of the target lobe while in others the lobe remained inflated. We concluded from these applications that CFD can provide a better insight into clinically relevant therapies.

Clinical trials for stem cell transplantation: when are they needed?

PubMed

Van Pham, Phuc

2016-04-27

In recent years, both stem cell research and the clinical application of these promising cells have increased rapidly. About 1000 clinical trials using stem cells have to date been performed globally. More importantly, more than 10 stem cell-based products have been approved in some countries. With the rapid growth of stem cell applications, some countries have used clinical trials as a tool to diminish the rate of clinical stem cell applications. However, the point at which stem cell clinical trials are essential remains unclear. This commentary discusses when stem cell clinical trials are essential for stem cell transplantation therapies.

Mobile application to induce lifestyle modifications in type 2 diabetic patients: prototype based on international guidelines

NASA Astrophysics Data System (ADS)

García-Jaramillo, M.; Delgado, J. S.; León-Vargas, F.

2015-12-01

This paper describes a prototype app to induce lifestyle modifications in newly diagnosed type 2 diabetic patients. The app design is based on International Diabetes Federation guidelines and recommendations from clinical studies related to diabetes health-care. Two main approaches, lifestyle modification and self-management education are used owing to significant benefits reported. The method used is based on setting goals under medical support related to physical activity, nutritional habits and weight loss, in addition to educational messages. This is specially implemented to address the main challenges that have limited the success of similar mobile applications already validated on diabetic patients. A traffic light is used to show the overall state of the goals compliance. This state could be understood as excellent (green), there are aspects to improve (yellow), or some individual goals are not carrying out (red). An example of how works this method is presented in results. Furthermore, the app provides recommendations to the user in case the overall state was in yellow or red. The recommendations pretend to induce the user to make changes in their eating habits and physical activity. According to international guidelines and clinical studies, a prototype of mobile application to induce a lifestyle modification in order to prevent adverse risk factors related to diabetes was presented. The resulting application is apparently consistent with clinical judgments, but a formal clinical validation is required. The effectiveness of this app is currently under consideration for the Colombian population with type 2 diabetes.

Reducing motion artifacts for long-term clinical NIRS monitoring using collodion-fixed prism-based optical fibers

PubMed Central

Yücel, Meryem A.; Selb, Juliette; Boas, David A.; Cash, Sydney S.; Cooper, Robert J.

2013-01-01

As the applications of near-infrared spectroscopy (NIRS) continue to broaden and long-term clinical monitoring becomes more common, minimizing signal artifacts due to patient movement becomes more pressing. This is particularly true in applications where clinically and physiologically interesting events are intrinsically linked to patient movement, as is the case in the study of epileptic seizures. In this study, we apply an approach common in the application of EEG electrodes to the application of specialized NIRS optical fibers. The method provides improved optode-scalp coupling through the use of miniaturized optical fiber tips fixed to the scalp using collodion, a clinical adhesive. We investigate and quantify the performance of this new method in minimizing motion artifacts in healthy subjects, and apply the technique to allow continuous NIRS monitoring throughout epileptic seizures in two epileptic in-patients. Using collodion-fixed fibers reduces the percent signal change of motion artifacts by 90 % and increases the SNR by 6 and 3 fold at 690 and 830 nm wavelengths respectively when compared to a standard Velcro-based array of optical fibers. The change in both HbO and HbR during motion artifacts is found to be statistically lower for the collodion-fixed fiber probe. The collodion-fixed optical fiber approach has also allowed us to obtain good quality NIRS recording of three epileptic seizures in two patients despite excessive motion in each case. PMID:23796546

Histotripsy Methods in Mechanical Disintegration of Tissue: Toward Clinical Applications

PubMed Central

Khokhlova, VA; Fowlkes, JB; Roberts, WW; Schade, GR; Xu, Z; Khokhlova, TD; Hall, TL; Maxwell, AD; Wang, YN; Cain, CA

2015-01-01

Purpose In high intensity focused ultrasound (HIFU) therapy, an ultrasound beam is focused within the body to locally affect the targeted site without damaging intervening tissues. The most common HIFU regime is thermal ablation. Recently, there has been increasing interest in generating purely mechanical lesions in tissue (histotripsy). This paper provides an overview of several studies on the development of histotripsy methods toward clinical applications. Material and Methods Two histotripsy approaches and examples of their applications are presented. In one approach, sequences of high-amplitude, short (microsecond-long), focused ultrasound pulses periodically produce dense, energetic bubble clouds that mechanically disintegrate tissue. In an alternative approach, longer (millisecond-long) pulses with shock fronts generate boiling bubbles and the interaction of shock fronts with the resulting vapor cavity causes tissue disintegration. Results Recent pre-clinical studies on histotripsy are reviewed for treating benign prostatic hyperplasia (BPH), liver and kidney tumors, kidney stone fragmentation, enhancing antitumor immune response, and tissue decellularization for regenerative medicine applications. Potential clinical advantages of the histotripsy methods are discussed. Conclusions Histotripsy methods can be used to mechanically ablate a wide variety of tissues, whilst selectivity sparing structures such as large vessels. Both ultrasound and MR imaging can be used for targeting and monitoring the treatment in real time. Although the two approaches utilize different mechanisms for tissue disintegration, both have many of the same advantages and offer a promising alternative method of noninvasive surgery. PMID:25707817

[Mechanisms and applications of transcutaneous electrical nerve stimulation in analgesia].

PubMed

Tang, Zheng-Yu; Wang, Hui-Quan; Xia, Xiao-Lei; Tang, Yi; Peng, Wei-Wei; Hu, Li

2017-06-25

Transcutaneous electrical nerve stimulation (TENS), as a non-pharmacological and non-invasive analgesic therapy with low-cost, has been widely used to relieve pain in various clinical applications, by delivering current pulses to the skin area to activate the peripheral nerve fibers. Nevertheless, analgesia induced by TENS varied in the clinical practice, which could be caused by the fact that TENS with different stimulus parameters has different biological mechanisms in relieving pain. Therefore, to advance our understanding of TENS in various basic and clinical studies, we discussed (1) neurophysiological and biochemical mechanisms of TENS-induced analgesia; (2) relevant factors that may influence analgesic effects of TENS from the perspectives of stimulus parameters, including stimulated position, pulse parameters (current intensity, frequency, and pulse width), stimulus duration and used times in each day; and (3) applications of TENS in relieving clinical pain, including post-operative pain, chronic low back pain and labor pain. Finally, we propose that TENS may involve multiple and complex psychological neurophysiological mechanisms, and suggest that different analgesic effects of TENS with different stimulus parameters should be taken into consideration in clinical applications. In addition, to optimize analgesic effect, we recommend that individual-based TENS stimulation parameters should be designed by considering individual differences among patients, e.g., adaptively adjusting the stimulation parameters based on the dynamic ratings of patients' pain.

Clinical Application of Earlobe Augmentation with Hyaluronic Acid Filler in the Chinese Population.

PubMed

Qian, Wei; Zhang, Yan-Kun; Cao, Qian; Hou, Ying; Lv, Wei; Fan, Ju-Feng

2017-02-01

Larger earlobes, which are a symbol of "richness" in traditional Chinese culture, are favored by Chinese patients. The objective of this paper is to investigate the application of earlobe augmentation with hyaluronic acid (HA) filler injection and its clinical effects in the Chinese population. A total of 19 patients (38 ears) who received earlobe augmentation with HA filler injections between March 2013 and March 2015 were included. The clinical effects, duration, and complications of these cases were investigated. All patients who received earlobe HA injections showed immediate postoperative effects with obvious morphological improvement of their earlobes. The volume of HA filler injected into each ear was 0.3-0.5 ml. The duration of the effect was 6-9 months. Two of the 19 cases (3 ears) demonstrated mild bruising at the injection site, but the bruising completely disappeared within 7 days after the injection. No vascular embolism, infection, nodule, or granuloma complications were observed in the studied group. The application of earlobe augmentation with HA filler injection is a safe, effective, simple procedure for earlobe shaping. It has an easy clinical application with good clinical prospects. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Adipose Tissue as a Strategic Source of Mesenchymal Stem Cells in Bone Regeneration: A Topical Review on the Most Promising Craniomaxillofacial Applications

PubMed Central

Marrelli, Massimo; Amantea, Massimiliano; Rengo, Carlo; Rengo, Sandro; Goldberg, Michel; Spagnuolo, Gianrico

2017-01-01

Bone regeneration in craniomaxillofacial surgery represents an issue that involves both surgical and aesthetic aspects. The most recent studies on bone tissue engineering involving adipose-derived stromal/stem cells (ASCs) have clearly demonstrated that such cells can play a crucial role in the treatment of craniomaxillofacial defects, given their strong commitment towards the osteogenic phenotype. A deeper knowledge of the molecular mechanisms underlying ASCs is crucial for a correct understanding of the potentialities of ASCs-based therapies in the most complex maxillofacial applications. In this topical review, we analyzed the molecular mechanisms of ASCs related to their support toward angiogenesis and osteogenesis, during bone regeneration. Moreover, we analyzed both case reports and clinical trials reporting the most promising clinical applications of ASCs in the treatment of craniomaxillofacial defects. Our study aimed to report the main molecular and clinical features shown by ASCs, used as a therapeutic support in bone engineering, as compared to the use of conventional autologous and allogeneic bone grafts. PMID:29027958

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

GGEMS-Brachy: GPU GEant4-based Monte Carlo simulation for brachytherapy applications

NASA Astrophysics Data System (ADS)

Lemaréchal, Yannick; Bert, Julien; Falconnet, Claire; Després, Philippe; Valeri, Antoine; Schick, Ulrike; Pradier, Olivier; Garcia, Marie-Paule; Boussion, Nicolas; Visvikis, Dimitris

2015-07-01

In brachytherapy, plans are routinely calculated using the AAPM TG43 formalism which considers the patient as a simple water object. An accurate modeling of the physical processes considering patient heterogeneity using Monte Carlo simulation (MCS) methods is currently too time-consuming and computationally demanding to be routinely used. In this work we implemented and evaluated an accurate and fast MCS on Graphics Processing Units (GPU) for brachytherapy low dose rate (LDR) applications. A previously proposed Geant4 based MCS framework implemented on GPU (GGEMS) was extended to include a hybrid GPU navigator, allowing navigation within voxelized patient specific images and analytically modeled 125I seeds used in LDR brachytherapy. In addition, dose scoring based on track length estimator including uncertainty calculations was incorporated. The implemented GGEMS-brachy platform was validated using a comparison with Geant4 simulations and reference datasets. Finally, a comparative dosimetry study based on the current clinical standard (TG43) and the proposed platform was performed on twelve prostate cancer patients undergoing LDR brachytherapy. Considering patient 3D CT volumes of 400  × 250  × 65 voxels and an average of 58 implanted seeds, the mean patient dosimetry study run time for a 2% dose uncertainty was 9.35 s (≈500 ms 10-6 simulated particles) and 2.5 s when using one and four GPUs, respectively. The performance of the proposed GGEMS-brachy platform allows envisaging the use of Monte Carlo simulation based dosimetry studies in brachytherapy compatible with clinical practice. Although the proposed platform was evaluated for prostate cancer, it is equally applicable to other LDR brachytherapy clinical applications. Future extensions will allow its application in high dose rate brachytherapy applications.

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.

Evolving technologies drive the new roles of Biomedical Engineering.

PubMed

Frisch, P H; St Germain, J; Lui, W

2008-01-01

Rapidly changing technology coupled with the financial impact of organized health care, has required hospital Biomedical Engineering organizations to augment their traditional operational and business models to increase their role in developing enhanced clinical applications utilizing new and evolving technologies. The deployment of these technology based applications has required Biomedical Engineering organizations to re-organize to optimize the manner in which they provide and manage services. Memorial Sloan-Kettering Cancer Center has implemented a strategy to explore evolving technologies integrating them into enhanced clinical applications while optimally utilizing the expertise of the traditional Biomedical Engineering component (Clinical Engineering) to provide expanded support in technology / equipment management, device repair, preventive maintenance and integration with legacy clinical systems. Specifically, Biomedical Engineering is an integral component of the Medical Physics Department which provides comprehensive and integrated support to the Center in advanced physical, technical and engineering technology. This organizational structure emphasizes the integration and collaboration between a spectrum of technical expertise for clinical support and equipment management roles. The high cost of clinical equipment purchases coupled with the increasing cost of service has driven equipment management responsibilities to include significant business and financial aspects to provide a cost effective service model. This case study details the dynamics of these expanded roles, future initiatives and benefits for Biomedical Engineering and Memorial Sloan Kettering Cancer Center.

[Design requirements for clinical trials on re-evaluation of safety and efficacy of post-marketed Chinese herbs].

PubMed

Xie, Yanming; Wei, Xu

2011-10-01

Re-evaluation of post-marketed based on pharmacoepidemiology is to study and collect clinical medicine safety in large population under practical applications for a long time. It is necessary to conduct re-evaluation of clinical effectiveness because of particularity of traditional Chinese medicine (TCM). Right before carrying out clinical trials on re-evaluation of post-marketed TCM, we should determine the objective of the study and progress it in the assessment mode of combination of disease and syndrome. Specical population, involving children and seniors who were excluded in pre-marketed clinical trial, were brought into drug monitoring. Sample size needs to comply with statistical requirement. We commonly use cohort study, case-control study, nested case-control, pragmatic randomized controlled trials.

The new production theory for health care through clinical reengineering: a study of clinical guidelines--Part II.

PubMed

Sharp, J R

1995-01-01

In Part I of this two-part article, in the December 1994 issue of the journal, the author discussed the manufacturing theories of Peter Drucker in terms of their applicability for the health care field. He concluded that Drucker's four principles and practices of manufacturing--statistical quality control, manufacturing accounting, modular organization, and systems approach--do have application to the health care system. Clinical guidelines, a variation on the Drucker theory, are a specific example of the manufacturing process in health. The performance to date of some guidelines and their implications for the health care reform debate are discussed in Part II of the article.

OSCE-based Clinical Skill Education for Physical and Occupational Therapists

PubMed Central

Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Wada, Yosuke; Yamada, Masayuki; Tomita, Masao; Tanabe, Shigeo; Teranishi, Toshio; Tsujimura, Toru; Sawa, Syunji; Okanishi, Tetsuo

2014-01-01

[Purpose] The aim of this study was to examine the applicability of the Objective Structured Clinical Examination (OSCE) to postgraduate education systems for novice and mid-career therapists in workplaces. [Subjects] Physical and occupational therapists with 1 to 5 years of clinical experience took the OSCE to assess their learning, with a physical or occupational therapy faculty member and a clinical supervisor as examiners. Another clinical supervisor acted as a simulated patient. [Methods] A Wilcoxon signed-rank test was performed to compare skills between before and after OSCE-based learning, and a Mann-Whitney U test was used to compare them between therapists with 1 to 2 years (novice) and 3 to 5 years (mid-career) of clinical experience. [Results] While no experience-related differences were observed in behavioral aspects, mid-career therapists exhibited markedly higher scores compared with novices in technical aspects, such as skills to guide patients for standing up, transfer, and dressing. [Conclusion] The OSCE may be sufficiently applicable to postgraduate education systems in workplaces. PMID:25276021

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.

The Clinical Use of Robots for Individuals with Autism Spectrum Disorders: A Critical Review

ERIC Educational Resources Information Center

Diehl, Joshua J.; Schmitt, Lauren M.; Villano, Michael; Crowell, Charles R.

2012-01-01

We examined peer-reviewed studies in order to understand the current status of empirically based evidence on the clinical applications of robots in the diagnosis and treatment of Autism Spectrum Disorders (ASD). Studies are organized into four broad categories: (a) the response of individuals with ASD to robots or robot-like behavior in comparison…

Assessment of statistical significance and clinical relevance.

PubMed

Kieser, Meinhard; Friede, Tim; Gondan, Matthias

2013-05-10

In drug development, it is well accepted that a successful study will demonstrate not only a statistically significant result but also a clinically relevant effect size. Whereas standard hypothesis tests are used to demonstrate the former, it is less clear how the latter should be established. In the first part of this paper, we consider the responder analysis approach and study the performance of locally optimal rank tests when the outcome distribution is a mixture of responder and non-responder distributions. We find that these tests are quite sensitive to their planning assumptions and have therefore not really any advantage over standard tests such as the t-test and the Wilcoxon-Mann-Whitney test, which perform overall well and can be recommended for applications. In the second part, we present a new approach to the assessment of clinical relevance based on the so-called relative effect (or probabilistic index) and derive appropriate sample size formulae for the design of studies aiming at demonstrating both a statistically significant and clinically relevant effect. Referring to recent studies in multiple sclerosis, we discuss potential issues in the application of this approach. Copyright © 2012 John Wiley & Sons, Ltd.

Clinical application of microsampling versus conventional sampling techniques in the quantitative bioanalysis of antibiotics: a systematic review.

PubMed

Guerra Valero, Yarmarly C; Wallis, Steven C; Lipman, Jeffrey; Stove, Christophe; Roberts, Jason A; Parker, Suzanne L

2018-03-01

Conventional sampling techniques for clinical pharmacokinetic studies often require the removal of large blood volumes from patients. This can result in a physiological or emotional burden, particularly for neonates or pediatric patients. Antibiotic pharmacokinetic studies are typically performed on healthy adults or general ward patients. These may not account for alterations to a patient's pathophysiology and can lead to suboptimal treatment. Microsampling offers an important opportunity for clinical pharmacokinetic studies in vulnerable patient populations, where smaller sample volumes can be collected. This systematic review provides a description of currently available microsampling techniques and an overview of studies reporting the quantitation and validation of antibiotics using microsampling. A comparison of microsampling to conventional sampling in clinical studies is included.

Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications.

PubMed

Riboh, Jonathan C; Saltzman, Bryan M; Yanke, Adam B; Cole, Brian J

2016-09-01

Amniotic membrane (AM)-derived products have been successfully used in ophthalmology, plastic surgery, and wound care, but little is known about their potential applications in orthopaedic sports medicine. To provide an updated review of the basic science and preclinical and clinical data supporting the use of AM-derived products and to review their current applications in sports medicine. Systematic review. A systematic search of the literature was conducted using the Medline, EMBASE, and Cochrane databases. The search term amniotic membrane was used alone and in conjunction with stem cell, orthopaedic, tissue engineering, scaffold, and sports medicine. The search identified 6870 articles, 80 of which, after screening of the titles and abstracts, were considered relevant to this study. Fifty-five articles described the anatomy, basic science, and nonorthopaedic applications of AM-derived products. Twenty-five articles described preclinical and clinical trials of AM-derived products for orthopaedic sports medicine. Because the level of evidence obtained from this search was not adequate for systematic review or meta-analysis, a current concepts review on the anatomy, physiology, and clinical uses of AM-derived products is presented. Amniotic membranes have many promising applications in sports medicine. They are a source of pluripotent cells, highly organized collagen, antifibrotic and anti-inflammatory cytokines, immunomodulators, and matrix proteins. These properties may make it beneficial when applied as tissue engineering scaffolds, improving tissue organization in healing, and treatment of the arthritic joint. The current body of evidence in sports medicine is heavily biased toward in vitro and animal studies, with little to no human clinical data. Nonetheless, 14 companies or distributors offer commercial AM products. The preparation and formulation of these products alter their biological and mechanical properties, and a thorough understanding of these differences will help guide the use of AM-derived products in sports medicine research. © 2015 The Author(s).

Potential Applications of the National Institute of Mental Health's Research Domain Criteria (RDoC) to Clinical Psychiatric Practice: How RDoC Might Be Used in Assessment, Diagnostic Processes, Case Formulation, Treatment Planning, and Clinical Notes.

PubMed

Yager, Joel; Feinstein, Robert E

2017-04-01

Offering a new framework for understanding and studying basic dimensions of normal and abnormal human functioning and mental disorders, the National Institute of Mental Health (NIMH) has initiated the Research Domain Criteria (RDoC) project in which a series of higher order domains, representing major systems of emotion, cognition, motivation, and social behavior, and their constituent operationally defined constructs serve as organizing templates for further research and inquiry, eg, to discover validated biomarkers and endophenotypes. Cutting across traditional DSM diagnoses, the domains are defined as Negative Valence Systems, Positive Valence Systems, Cognitive Systems, Systems for Social Processes, and Arousal/Regulatory Systems. To inform educators, trainees, and practitioners about RDoC, alert them to potential practical applications, and encourage their broad exploration in clinical settings, this article reviews the RDoC domains and their subsystem constructs with regard to potential current clinical considerations and applications. We describe ways in which the RDoC domains and constructs offer transdiagnostic frameworks for complementing traditional practice; suggest clinical questions to help elucidate salient information; and, translating RDoC domains and constructs headings into clinically friendly language, offer a template for the psychiatric review of systems that can serve in clinical notes. © Copyright 2017 Physicians Postgraduate Press, Inc.

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.

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.

Integration of Web-based and PC-based clinical research databases.

PubMed

Brandt, C A; Sun, K; Charpentier, P; Nadkarni, P M

2004-01-01

We have created a Web-based repository or data library of information about measurement instruments used in studies of multi-factorial geriatric health conditions (the Geriatrics Research Instrument Library - GRIL) based upon existing features of two separate clinical study data management systems. GRIL allows browsing, searching, and selecting measurement instruments based upon criteria such as keywords and areas of applicability. Measurement instruments selected can be printed and/or included in an automatically generated standalone microcomputer database application, which can be downloaded by investigators for use in data collection and data management. Integration of database applications requires the creation of a common semantic model, and mapping from each system to this model. Various database schema conflicts at the table and attribute level must be identified and resolved prior to integration. Using a conflict taxonomy and a mapping schema facilitates this process. Critical conflicts at the table level that required resolution included name and relationship differences. A major benefit of integration efforts is the sharing of features and cross-fertilization of applications created for similar purposes in different operating environments. Integration of applications mandates some degree of metadata model unification.

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

Features of Mobile Diabetes Applications: Review of the Literature and Analysis of Current Applications Compared Against Evidence-Based Guidelines

PubMed Central

Fernandez-Luque, Luis; Årsand, Eirik; Hartvigsen, Gunnar

2011-01-01

Background Interest in mobile health (mHealth) applications for self-management of diabetes is growing. In July 2009, we found 60 diabetes applications on iTunes for iPhone; by February 2011 the number had increased by more than 400% to 260. Other mobile platforms reflect a similar trend. Despite the growth, research on both the design and the use of diabetes mHealth applications is scarce. Furthermore, the potential influence of social media on diabetes mHealth applications is largely unexplored. Objective Our objective was to study the salient features of mobile applications for diabetes care, in contrast to clinical guideline recommendations for diabetes self-management. These clinical guidelines are published by health authorities or associations such as the National Institute for Health and Clinical Excellence in the United Kingdom and the American Diabetes Association. Methods We searched online vendor markets (online stores for Apple iPhone, Google Android, BlackBerry, and Nokia Symbian), journal databases, and gray literature related to diabetes mobile applications. We included applications that featured a component for self-monitoring of blood glucose and excluded applications without English-language user interfaces, as well as those intended exclusively for health care professionals. We surveyed the following features: (1) self-monitoring: (1.1) blood glucose, (1.2) weight, (1.3) physical activity, (1.4) diet, (1.5) insulin and medication, and (1.6) blood pressure, (2) education, (3) disease-related alerts and reminders, (4) integration of social media functions, (5) disease-related data export and communication, and (6) synchronization with personal health record (PHR) systems or patient portals. We then contrasted the prevalence of these features with guideline recommendations. Results The search resulted in 973 matches, of which 137 met the selection criteria. The four most prevalent features of the applications available on the online markets (n = 101) were (1) insulin and medication recording, 63 (62%), (2) data export and communication, 61 (60%), (3) diet recording, 47 (47%), and (4) weight management, 43 (43%). From the literature search (n = 26), the most prevalent features were (1) PHR or Web server synchronization, 18 (69%), (2) insulin and medication recording, 17 (65%), (3) diet recording, 17 (65%), and (4) data export and communication, 16 (62%). Interestingly, although clinical guidelines widely refer to the importance of education, this is missing from the top functionalities in both cases. Conclusions While a wide selection of mobile applications seems to be available for people with diabetes, this study shows there are obvious gaps between the evidence-based recommendations and the functionality used in study interventions or found in online markets. Current results confirm personalized education as an underrepresented feature in diabetes mobile applications. We found no studies evaluating social media concepts in diabetes self-management on mobile devices, and its potential remains largely unexplored. PMID:21979293

[Phosphodiesterase inhibitors in clinical practice. The present and the future. Part II].

PubMed

Baksheev, B I; Kolomiets, N M

2007-01-01

Type Sphosphodiesterase inhibitors (FDEI-5) used to be applied as the main drugs for treatment of erectile dysfunction. At present, this pharmacological group is being studied intensively in various fields of clinical medicine, such as pulmonology, cardiology, gastroenterology, gynecology etc. Part II of this system literature review is dedicated to analysis of the results of such application. In many randomized and non-randomized controlled studies sildenafil decreased pulmonary arterial pressure (independently of etiology) and pulmonary vascular resistance; it could be successfully combined with nitric oxide, illoprost, or epoprostenolol. Clinical studies have also demonstrated an increase in physical load tolerance, optimization of PAH studies according to NYHA functional classes, and good tolerance to the drug. In the recent years, antiischaemic effects of FDEI-5 and their ability to inhibit apoptosis have been proved It is possible to draw the conclusion that nature created a universal phosphodiesterase mechanism for the interconnection of biochemical processes that provide the vital activity of the cell and organism. The fact that more than 15 controlled studies of clinical application of sildenafil not for treatment of erectile dysfunction have been planned and commenced confirms the importance of further studies of this mechanism. Further analysis of the results will show how universal this mechanism is.

Advanced devices for photoacoustic imaging to improve cancer and cerebrovascular medicine

NASA Astrophysics Data System (ADS)

Montilla Marien, Leonardo Gabriel

Recent clinical studies have demonstrated that photoacoustic imaging (PAI) provides important diagnostic information for breast cancer staging. Despite these promising studies, PAI remains an unfeasible option for clinics due to the cost to implement, the required large modification in user conduct and the inflexibility of the hardware to accommodate other applications for the incremental enhancement in diagnostic information. The research described in this dissertation addresses these issues by designing attachments to clinical ultrasound probes and incorporating custom detectors into commercial ultrasound scanners. The ultimate benefit of these handheld devices is to expand the capability of current ultrasound systems and facilitate the translation of PAI to enhance cancer diagnostics and neurosurgical outcomes. Photoacoustic enabling devices (PEDs) were designed as attachments to two clinical ultrasound probes optimized for breast cancer diagnostics. PAI uses pulsed laser excitation to create transient heating (<1°C) and thermoelastic expansion that is detected as an ultrasonic emission. These ultrasonic emissions are remotely sensed to construct noninvasive images with optical contrast at depths much greater than other optical modalities. The PEDs are feasible in terms of cost, user familiarity and flexibility for various applications. Another possible application for PAI is in assisting neurosurgeons treating aneurysms. Aneurysms are often treated by placing a clip to prevent blood flow into the aneurysm. However, this procedure has risks associated with damaging nearby vessels. One of the developed PEDs demonstrated the feasibility to three-dimensionally image tiny microvasculature (<0.3mm) beyond large blood occlusions (>2.4mm) in a phantom model. The capability to use this during surgery would suggest decreasing the risks associated with these treatments. However, clinical ultrasound arrays are not clinically feasible for microsurgical applications due to their bulky size and linear scanning requirements for 3D. Therefore, capacitive micromachined ultrasound transducer (CMUT) two-dimensional arrays compatible with standard ultrasound scanners were used to generate real-time 3D photoacoustic images. Future probes, designed incorporating CMUT arrays, would be relatively simple to fabricate and a convenient upgrade to existing clinical ultrasound equipment. Eventually, a handheld tool with the ability to visualize, in real-time 3D, the desired microvasculature, would assist surgical procedures. The potential implications of PAI devices compatible with standard ultrasound equipment would be a streamlined cost efficient solution for translating photoacoustics into clinical practice. The practitioner could then explore the benefits of the enhanced contrast adjunctive to current ultrasound applications. Clinical availability of PAI could enhance breast cancer diagnostics and cerebrovascular surgical outcomes.

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.

Moxifloxacin: Clinically compatible contrast agent for multiphoton imaging

NASA Astrophysics Data System (ADS)

Wang, Taejun; Jang, Won Hyuk; Lee, Seunghun; Yoon, Calvin J.; Lee, Jun Ho; Kim, Bumju; Hwang, Sekyu; Hong, Chun-Pyo; Yoon, Yeoreum; Lee, Gilgu; Le, Viet-Hoan; Bok, Seoyeon; Ahn, G.-One; Lee, Jaewook; Gho, Yong Song; Chung, Euiheon; Kim, Sungjee; Jang, Myoung Ho; Myung, Seung-Jae; Kim, Myoung Joon; So, Peter T. C.; Kim, Ki Hean

2016-06-01

Multiphoton microscopy (MPM) is a nonlinear fluorescence microscopic technique widely used for cellular imaging of thick tissues and live animals in biological studies. However, MPM application to human tissues is limited by weak endogenous fluorescence in tissue and cytotoxicity of exogenous probes. Herein, we describe the applications of moxifloxacin, an FDA-approved antibiotic, as a cell-labeling agent for MPM. Moxifloxacin has bright intrinsic multiphoton fluorescence, good tissue penetration and high intracellular concentration. MPM with moxifloxacin was demonstrated in various cell lines, and animal tissues of cornea, skin, small intestine and bladder. Clinical application is promising since imaging based on moxifloxacin labeling could be 10 times faster than imaging based on endogenous fluorescence.

3D hyperpolarized C-13 EPI with calibrationless parallel imaging

NASA Astrophysics Data System (ADS)

Gordon, Jeremy W.; Hansen, Rie B.; Shin, Peter J.; Feng, Yesu; Vigneron, Daniel B.; Larson, Peder E. Z.

2018-04-01

With the translation of metabolic MRI with hyperpolarized 13C agents into the clinic, imaging approaches will require large volumetric FOVs to support clinical applications. Parallel imaging techniques will be crucial to increasing volumetric scan coverage while minimizing RF requirements and temporal resolution. Calibrationless parallel imaging approaches are well-suited for this application because they eliminate the need to acquire coil profile maps or auto-calibration data. In this work, we explored the utility of a calibrationless parallel imaging method (SAKE) and corresponding sampling strategies to accelerate and undersample hyperpolarized 13C data using 3D blipped EPI acquisitions and multichannel receive coils, and demonstrated its application in a human study of [1-13C]pyruvate metabolism.

Vertical integration of basic science in final year of medical education

PubMed Central

Rajan, Sudha Jasmine; Jacob, Tripti Meriel; Sathyendra, Sowmya

2016-01-01

Background: Development of health professionals with ability to integrate, synthesize, and apply knowledge gained through medical college is greatly hampered by the system of delivery that is compartmentalized and piecemeal. There is a need to integrate basic sciences with clinical teaching to enable application in clinical care. Aim: To study the benefit and acceptance of vertical integration of basic science in final year MBBS undergraduate curriculum. Materials and Methods: After Institutional Ethics Clearance, neuroanatomy refresher classes with clinical application to neurological diseases were held as part of the final year posting in two medical units. Feedback was collected. Pre- and post-tests which tested application and synthesis were conducted. Summative assessment was compared with the control group of students who had standard teaching in other two medical units. In-depth interview was conducted on 2 willing participants and 2 teachers who did neurology bedside teaching. Results: Majority (>80%) found the classes useful and interesting. There was statistically significant improvement in the post-test scores. There was a statistically significant difference between the intervention and control groups' scores during summative assessment (76.2 vs. 61.8 P < 0.01). Students felt that it reinforced, motivated self-directed learning, enabled correlations, improved understanding, put things in perspective, gave confidence, aided application, and enabled them to follow discussions during clinical teaching. Conclusion: Vertical integration of basic science in final year was beneficial and resulted in knowledge gain and improved summative scores. The classes were found to be useful, interesting and thought to help in clinical care and application by majority of students. PMID:27563584

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.

Current evidence of percutaneous nucleoplasty for the cervical herniated disk: a systematic review.

PubMed

Wullems, Jorgen A; Halim, Willy; van der Weegen, Walter

2014-07-01

Although percutaneous cervical nucleoplasty (PCN) has been shown to be both safe and effective, its application is still debated. PCN applied in disk herniation has not been systematically reviewed before, resulting in a limited insight into its effectiveness and safety, and the quality of available evidence. Therefore, we systematically reviewed the evidence on the efficacy and safety of PCN in patients with a (contained) herniated disk. MEDLINE, EMBASE, and the Cochrane Library (Central Register of Controlled Trials) were searched for randomized controlled trials (RCTs) and nonrandomized studies using the following keywords: "Nucleoplasty," "Cervical," "Hernia," "Herniation," "Prolapse," "Protrusion," "Intervertebral disk," and "Percutaneous disk decompression." First, all articles were appraised for methodological quality, and then, RCTs were graded for the level of evidence according a best-evidence synthesis, because a meta-analysis was not possible. Finally, the RCTs' applicability and clinical relevance also was assessed. Of 75 identified abstracts, 10 full-text articles were included (3 RCTs and 7 nonrandomized studies). These studies represented a total of 1021 patients: 823 patients (≥ 892 disks) were treated by PCN. All studies showed low methodological quality, except for two. The level of evidence of the RCTs was graded as moderate, with low to moderate applicability and clinical relevance. All included studies showed PCN to be an effective and safe procedure in the treatment of (contained) herniated disks at short-, mid-, and long-term follow-up. However, the level of evidence is moderate and shows only low to moderate applicability and clinical relevance. © 2013 World Institute of Pain.

The Effect of Sequence of Instruction on Students' Cognitive Preferences and Recall in the Context of a Problem-Oriented Method of Teaching.

ERIC Educational Resources Information Center

Boreham, N. C.; And Others

1985-01-01

This study investigated the effects of two sequences of instruction--theory-to-application and application-to-theory--on medical students' cognitive preferences in preclinical science teaching. Results indicate that presenting an example of the clinical application of biochemical theory before presenting the theory itself increased students'…

Design and Usability Testing of an mHealth Application for Midwives in Rural Ghana

ERIC Educational Resources Information Center

Velez, Olivia

2011-01-01

Midwives in Ghana provide the majority of rural primary and maternal healthcare services, but have limited access to data for decision making and knowledge work. Few mobile health (mHealth) applications have been designed for midwives. The study purpose was to design and test an mHealth application (mClinic) that can improve data access and reduce…

Clinical application of radiolabelled platelets

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

Kessler, C.

1990-01-01

This book presents papers on the clinical applications of radiolabelled platelets. The papers are grouped into six sections on platelet labelling techniques, radiolabelled platelets in cardiology, monitoring of antiplatelet therapy, platelet scintigraphy in stroke patients, platelet scintigraphy in angiology, and platelet scintigraphy in hematology and other clinical applications, including renal transplant rejection.

Incorporating uncertainty regarding applicability of evidence from meta-analyses into clinical decision making.

PubMed

Kriston, Levente; Meister, Ramona

2014-03-01

Judging applicability (relevance) of meta-analytical findings to particular clinical decision-making situations remains challenging. We aimed to describe an evidence synthesis method that accounts for possible uncertainty regarding applicability of the evidence. We conceptualized uncertainty regarding applicability of the meta-analytical estimates to a decision-making situation as the result of uncertainty regarding applicability of the findings of the trials that were included in the meta-analysis. This trial-level applicability uncertainty can be directly assessed by the decision maker and allows for the definition of trial inclusion probabilities, which can be used to perform a probabilistic meta-analysis with unequal probability resampling of trials (adaptive meta-analysis). A case study with several fictitious decision-making scenarios was performed to demonstrate the method in practice. We present options to elicit trial inclusion probabilities and perform the calculations. The result of an adaptive meta-analysis is a frequency distribution of the estimated parameters from traditional meta-analysis that provides individually tailored information according to the specific needs and uncertainty of the decision maker. The proposed method offers a direct and formalized combination of research evidence with individual clinical expertise and may aid clinicians in specific decision-making situations. Copyright © 2014 Elsevier Inc. All rights reserved.

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.

Validity and reliability of the iPhone to measure rib hump in scoliosis.

PubMed

Balg, Frederic; Juteau, Mathieu; Theoret, Chantal; Svotelis, Amy; Grenier, Guillaume

2014-12-01

This was a prospective blinded validity and reliability analysis. The aim of this study was validation and reliability evaluation of the Scoligauge iPhone app. The scoliometer is used to clinically measure the rib hump in scoliosis as a means to evaluate the axial trunk rotation. The increasing availability of smartphone with built-in accelerometer led to the development of a vast number of applications to measure angles. Of these, the Scoligauge mimics a scoliometer. The aim of this study was to compare the validity of the Scoligauge iPhone application without an associated adapter with the traditional scoliometer and to test the reliability of the application in a clinical setting. Two observers measured the rib hump deformity on 34 consecutive patients with idiopathic scoliosis with an average Cobb angle of 24.2 ± 13.5 degrees (range, 4 to 65 degrees). Measurements were made with an iPhone without the adapter and with a scoliometer. The validity as well as the interobserver and intraobserver reliability were calculated using the intraclass coefficient (ICC) and the Bland-Altman test. The mean difference between the scoliometer and the Scoligauge application was 0.4 degrees [95% confidence interval (CI) of ± 3.1 degrees] with an ICC of 0.947 (P < 0.001). The intraobserver and interobserver ICC were 0.961 (P < 0.001) and 0.901 (P < 0.001), respectively. The mean intraobserver difference was 0.0 degrees (95% CI of ± 2.7 degrees) and the mean interobserver difference was 0.1 degrees (95% CI of ± 4.4 degrees). The intraobserver and interobserver reliability of the Scoligauge iPhone app, as well as its validity compared with the scoliometer, are excellent. The mean differences between measurements are small and clinically not significant. Thus, the Scoligauge application is valid for clinical evaluation even without special adapter. Level I (Diagnostic Study).

Macro- and microperfusion during application of a new compression system, designed for patients with leg ulcer and concomitant peripheral arterial occlusive disease.

PubMed

Jünger, Michael; Haase, Hermann; Schwenke, Linda; Bichel, Jens; Schuren, Jan; Ladwig, Andrea

2013-01-01

To investigate macro- and microperfusion during 14 days of treatment with a new 2-layer compression system (3M™ Coban™ 2 Lite), designed for patients with leg ulcer and concomitant peripheral arterial occlusive disease. A single-centre, open-label, prospective pilot study was performed with 15 subjects suffering from peripheral arterial occlusive disease with an ankle brachial pressure index (ABPI) of 0.5-0.8, who volunteered to have their 'study leg' bandaged with the new system. Coincident leg ulcer or chronic venous disease was not mandatory. All subjects received the new compression system, which stayed in place from 1 up to 4 days according to scheduled study visits. The system was reapplied by study personnel at each clinical visit (days 1, 2, 3, 4, 7, 10 and 14). The study participation stopped after 14 days. At each clinical visit safety assessments were performed: measurement of acral pulsation to capture macroperfusion; laser Doppler fluxmetry to capture microperfusion; clinical signs of pressure related skin damage, hypoxia-related pain and sub-bandage pressure measurement. In addition, the leg volume was measured and a comfort questionnaire was completed. An average sub-bandage pressure in standing position of approximately 30 mmHg was measured at the B1 location immediately after bandage application. Laser Doppler fluxmetry demonstrated positive effects on microcirculation regarding vasomotion and respiratory reflux. No change of the cardiac signal appeared. For acrale pulsations a high intraindividual variability was found with no clear interference to the bandage application. No pressure-related skin damage or hypoxia-related pain was detected. After application of the new compression system in subjects with moderate PAOD, laser Doppler fluxmetry indicated significant improvements of the microcirculation. High variability and lack of correlation to clinical symptoms was found for the acral pulsation. The new compression system revealed a high grade of tolerability and a good safety profile.

Dosimetry applications in GATE Monte Carlo toolkit.

PubMed

Papadimitroulas, Panagiotis

2017-09-01

Monte Carlo (MC) simulations are a well-established method for studying physical processes in medical physics. The purpose of this review is to present GATE dosimetry applications on diagnostic and therapeutic simulated protocols. There is a significant need for accurate quantification of the absorbed dose in several specific applications such as preclinical and pediatric studies. GATE is an open-source MC toolkit for simulating imaging, radiotherapy (RT) and dosimetry applications in a user-friendly environment, which is well validated and widely accepted by the scientific community. In RT applications, during treatment planning, it is essential to accurately assess the deposited energy and the absorbed dose per tissue/organ of interest, as well as the local statistical uncertainty. Several types of realistic dosimetric applications are described including: molecular imaging, radio-immunotherapy, radiotherapy and brachytherapy. GATE has been efficiently used in several applications, such as Dose Point Kernels, S-values, Brachytherapy parameters, and has been compared against various MC codes which are considered as standard tools for decades. Furthermore, the presented studies show reliable modeling of particle beams when comparing experimental with simulated data. Examples of different dosimetric protocols are reported for individualized dosimetry and simulations combining imaging and therapy dose monitoring, with the use of modern computational phantoms. Personalization of medical protocols can be achieved by combining GATE MC simulations with anthropomorphic computational models and clinical anatomical data. This is a review study, covering several dosimetric applications of GATE, and the different tools used for modeling realistic clinical acquisitions with accurate dose assessment. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Diagnostics and Therapy with Radioisotopes; DIAGNOSTICA E TERAPIA CON I RADIOISOTOPI

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

Bastai, P.; Antogenetti, I.; Dogliotti, G.C.

1962-01-01

A review of the principal studies done on diagnosis and therapy with radioisotopes is presented. The book is divided into four sections. The ftrst section deals with the theoretical and practical fundamentals for an understanding of the use of radiosiotopes in diagnosis and treatment. The basic ideas of radioisotopic measurement are reviewed in the second section. The third section presents the applications of radioisotopes to clinical diagnosis, and the fourth section their application to clinical therapy. Abstracts have been prepared of the 35 papers compiled. (J.S.R.)

Regulatory and scientific issues regarding use of foreign data in support of new drug applications in the United States: an FDA perspective.

PubMed

Khin, N A; Yang, P; Hung, H M J; Maung-U, K; Chen, Y-F; Meeker-O'Connell, A; Okwesili, P; Yasuda, S U; Ball, L K; Huang, S-M; O'Neill, R T; Temple, R

2013-08-01

Globalization of clinical research has led to an increase in clinical trials conducted outside of the United States that are submitted to the US Food and Drug Administration (FDA) in new drug applications. This article discusses the FDA's experience with these submissions in specific therapeutic areas, including the extent of this practice, differences between the effectiveness and safety outcomes of studies conducted inside and outside the United States, and the FDA's approach to acceptance of these trials.

Transforming community services through the use of a multidimensional model of clinical leadership.

PubMed

Leigh, Jacqueline Anne; Wild, Jill; Hynes, Celia; Wells, Stuart; Kurien, Anish; Rutherford, June; Rosen, Lyn; Ashcroft, Tim; Hartley, Victoria

2015-03-01

To evaluate the application of a Multidimensional Model of Clinical Leadership on the community healthcare leader and on transforming community services. Healthcare policy advocates clinical leadership as the vehicle to transform community and healthcare services. Few studies have identified the key components of an effective clinical leadership development model. The first two stages of Kirkpatrick's (Personnel Administrator 28, 1983, 62) Four/Five Levels of Evaluation were used to evaluate the application of the multidimensional model of clinical leadership. Eighty community healthcare leaders were exposed to this multidimensional clinical leadership development model through attendance of a community clinical leadership development programme. Twenty five leaders participated in focus group interviews. Data from the interviews were analysed utilising thematic content analysis. Three key themes emerged that influenced the development of best practice principles for clinical leadership development: 1. Personal leadership development 2. Organisational leadership 3. The importance of multiprofessional action learning/reflective groups Emergent best practice principles for clinical leadership development include adopting a multidimensional development approach. This approach encompasses: preparing the individual leader in the role and seeking organisational leadership development that promotes the vision and corporate values of the organisation and delivers on service improvement and innovation. Moreover, application of the Multidimensional Model of Clinical Leadership could offer the best platform for embedding the Six C's of Nursing (Compassion in Practice - Our Culture of Compassionate Care, Department of Health, Crown Copyright, 2012) within the culture of the healthcare organisation: care, compassion, courage, commitment, communication, and competency. This is achieved in part through the application of emotional intelligence to understand self and to develop the personal integrity of the healthcare leader and through supporting a culture of lifelong leadership learning. Embedding the best practice principles of clinical leadership development within a multidimensional model of clinical leadership provides a promising approach to: equipping the healthcare leader with those transferable leadership skills required to help them embark on a journey of lifelong leadership learning; and producing the healthcare leader who is caring, compassionate and can confidently and effectively transform community services. © 2014 John Wiley & Sons Ltd.

Application of microfluidic technologies to human assisted reproduction

PubMed Central

Takayama, Shuichi

2017-01-01

Abstract Microfluidics can be considered both a science and a technology. It is defined as the study of fluid behavior at a sub-microliter level and the investigation into its application to cell biology, chemistry, genetics, molecular biology and medicine. There are at least two characteristics of microfluidics, mechanical and biochemical, which can be influential in the field of mammalian gamete and preimplantation embryo biology. These microfluidic characteristics can assist in basic biological studies on sperm, oocyte and preimplantation embryo structure, function and environment. The mechanical and biochemical characteristics of microfluidics may also have practical and/or technical application(s) to assisted reproductive technologies (ART) in rodents, domestic species, endangered species and humans. This review will consider data in mammals, and when available humans, addressing the potential application(s) of microfluidics to assisted reproduction. There are numerous sequential steps in the clinical assisted reproductive laboratory process that work, yet could be improved. Cause and effect relations of procedural inefficiencies can be difficult to identify and/or remedy. Data will be presented that consider microfluidic applications to sperm isolation, oocyte cumulus complex isolation, oocyte denuding, oocyte mechanical manipulation, conventional insemination, intracytoplasmic sperm injection, embryo culture, embryo analysis and oocyte and embryo cryopreservation. While these studies have progressed in animal models, data with human gametes and embryos are significantly lacking. These data from clinical trials are requisite for making future evidence-based decisions regarding the application of microfluidics in human ART. PMID:28130394

From Diagnosis to Treatment: Clinical Applications of Nanotechnology in Thoracic Surgery

PubMed Central

Digesu, Christopher S.; Hofferberth, Sophie C.; Grinstaff, Mark W.; Colson, Yolonda L.

2016-01-01

Synopsis Nanotechnology is an emerging field of medicine with significant potential to become a powerful adjunct to cancer therapy, and in particular, thoracic surgery. Using the unique properties of several different nanometer-sized platforms, therapy can be delivered to tumors in a more targeted fashion, with less of the systemic toxicity associated with traditional chemotherapeutics. In addition to the packaged delivery of chemotherapeutic drugs, nanoparticles show potential to aid in the diagnosis, pre-operative characterization, and intraoperative localization of thoracic tumors and their lymphatics. With increasing interest in their clinical application, there is a rapid expansion of in vitro and in vivo studies being conducted that provide a better understanding of potential toxicities and hopes of broader clinical translation. Focused research into nanotechnology’s ability to deliver both diagnostics and therapeutics has led to the development of a field known as nanotheranostics which promises to improve the treatment of thoracic malignancies through enhanced tumor targeting, controlled drug delivery, and therapeutic monitoring. This article reviews the various types of nanoplatforms, their unique properties, and the potential for clinical application in thoracic surgery. PMID:27112260

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.

Topical Vitamin C and the Skin: Mechanisms of Action and Clinical Applications.

PubMed

Al-Niaimi, Firas; Chiang, Nicole Yi Zhen

2017-07-01

OBJECTIVE: This review article details the main mechanisms of action and clinical applications of topical vitamin C on the skin, including its antioxidative, photoprotective, antiaging, and antipigmentary effects. DESIGN: A PubMed search for the relevant articles on vitamin C and the skin was conducted using the following key words: "vitamin C," "ascorbic acid," "ascorbyl-6-palmitate,"and "magnesium ascorbyl phosphate." RESULTS: As one of the most powerful antioxidants in the skin, vitamin C has been shown to protect against photoaging, ultraviolet-induced immunosuppression, and photocarcinogenesis. It also has an antiaging effect by increasing collagen synthesis, stabilizing collagen fibers, and decreasing collagen degradation. It decreases melanin formation, thereby reducing pigmentation. Vitamin C is the primary replenisher of vitamin E and works synergistically with vitamin E in the protection against oxidative damage. CONCLUSION: Topical vitamin C has a wide range of clinical applications, from antiaging and antipigmentary to photoprotective. Currently, clinical studies on the efficacy of topical formulations of vitamin C remain limited, and the challenge lies in finding the most stable and permeable formulation in achieving the optimal results.

Low intensity laser therapy: the clinical approach

NASA Astrophysics Data System (ADS)

Kahn, Fred

2006-02-01

Recently, there has been significant improvement in the process of research and application of Low Intensity Laser Therapy (LILT). Despite this positive direction, a wide discrepancy between the research component and clinical understanding of the technology remains. In our efforts to achieve better clinical results and more fully comprehend the mechanisms of interaction between light and cells, further studies are required. The clinical results presented in this paper are extrapolated from a wide range of musculoskeletal problems including degenerative osteoarthritis, repetitive motion injuries, sports injuries, etc. The paper includes three separate clinical studies comprising 151, 286 and 576 consecutive patient discharges at our clinic. Each patient studied received a specific course of treatment that was designed for that individual and was modified on a continuing basis as the healing process advanced. On each visit, clinical status correlation with the duration, dosage and other parameters was carried out. The essentials of the treatment consisted of a three stage approach. This involved a photon stream emanating from a number of specified gallium-aluminum-arsenide diodes; stage one, red light array, stage two consisting of an array of infrared diodes and stage three consisting of the application of an infrared laser diode probe. On average, each of these groups required less than 10 treatments per patient and resulted in a significant improvement / cure rate greater than 90% in all conditions treated. This report clearly demonstrates the benefits of LILT, indicating that it should be more widely adapted in all medical therapeutic settings.

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%).

No Sting Barrier Film to Protect Skin in Adult Patients: Findings From a Scoping Review With Implications for Evidence-Based Practice.

PubMed

Micheli, Chiara; Palese, Alvisa; Canzan, Federica; Ambrosi, Elisa

2017-10-01

In the industrialized world, approximately 1-1.5% of the population has received treatments for skin lesions. In the 1990s, a polymeric barrier film called the No Sting Barrier Film (NSBF) was developed as an alternative to petrolatum-based ointments and zinc oxide formulas. To date, few studies have explored the effectiveness of NSBF in protecting skin integrity. To map the methods, fields and outcomes used to produce evidence on NSBF effectiveness. A scoping review was performed in 2015. A search strategy for identifying relevant studies was designed and performed. Systematic reviews, meta-analyses, randomized controlled trials, controlled clinical trials, and comparative studies for all types of interventions were included; research conducted in any clinical context was eligible for inclusion. Studies were selected by two reviewers; data extraction and analysis also was performed by two reviewers and disagreements were discussed. Six studies were included. NSBF's potential as a skin protector was investigated with respect to (a) chronic wounds (pressure ulcers or vascular leg ulcers); (b) urinary or fecal incontinence; and (c) post-mastectomy irradiation. The principal clinical outcomes investigated were, respectively: (a) wound healing, wound exudates and erythema control; (b) incidence of incontinence-associated dermatitis and skin reactions; and (c) intensity of pruritus and skin reactions. Pain and comfort were measured in all clinical applications. The main process outcomes investigated were: (a) ease of application, (b) application and removal time, and (c) costs. Zinc oxide and petroleum formulations were the most common comparison interventions in research on chronic ulcers and incontinence; sorbolene cream and topical corticosteroids were the most frequent comparisons in the context of post-mastectomy irradiation. NBSF may be used for peri-wound skin protection in patients with chronic wounds, with urinary or fecal incontinence and for women undergoing post-mastectomy irradiation. However, more robust experimental studies are needed in all clinical fields where NBSF is applied. © 2017 Sigma Theta Tau International.

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...

The Translation of Health Research in Kinesiology

ERIC Educational Resources Information Center

Ainsworth, Barbara E.

2009-01-01

The translation of health research is a process of transforming scientific discoveries arising from laboratory, clinical, or population studies into clinical or population-based applications to improve health by reducing disease incidence, morbidity, and mortality. Initiated by the National Institutes for Health Roadmap Initiative and the U.S.…

Families with burn injury: application in the clinically relevant continuum model.

PubMed

Lehna, Carlee

2011-06-01

This article incorporates the findings from a predominantly qualitative, mixed-method study examining sibling survivors' experiences of a major childhood burn injury into the clinically relevant continuum model as a means of promoting culturally competent and family-centered care. Copyright © 2011 Elsevier Inc. All rights reserved.

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...

Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.

PubMed

Sridhara, Rajeshwari; Johnson, John R; Justice, Robert; Keegan, Patricia; Chakravarty, Aloka; Pazdur, Richard

2010-02-24

The Office of Oncology Drug Products (OODP) in the Center for Drug Evaluation and Research at the US Food and Drug Administration began reviewing marketing applications for oncological and hematologic indications in July 2005. We conducted an overview of products that were reviewed by the OODP for marketing approval and the regulatory actions taken during July 2005 to December 2007. We identified all applications that were reviewed by the OODP from July 1, 2005, through December 31, 2007, and reviewed the actions that OODP took. We also sought the basis for the actions taken, including the clinical trial design, endpoints used, patient accrual in the trial(s) supporting approval, and the type of regulatory approval. During the study period, the OODP reviewed marketing applications for 60 new indications and took regulatory action on 58 indications. Regulatory action was based on a risk-benefit evaluation of the data submitted with each application. Products that demonstrated efficacy and had an acceptable risk-benefit ratio were granted either regular or accelerated marketing approval for use in the specific indication that was studied. Regular approval was based on endpoints that demonstrated that the drug provided clinical benefit as evidenced by a longer or better life or a favorable effect on an established surrogate for a longer or better life. Accelerated approval was based on a less well-established surrogate endpoint that was reasonably likely to predict a longer or better life. Of the 53 new indications that were approved during the study period, 39 received regular approval, nine received accelerated approval, and five were converted from accelerated to regular approval. Five applications were not approved, and two applications were withdrawn before any regulatory action was taken. Eighteen of the 53 indications that were approved were for new molecular entities. During the study period, regulatory action was taken on 58 of the 60 marketing applications. Fifty-three applications were approved. A variety of clinical trial endpoints were used in the approval trials.

Lower Body Negative Pressure: Historical Perspective, Research Findings, and Clinical Applications.

PubMed

Crystal, George J; Salem, M Ramez

2015-04-01

Lower body negative pressure (LBNP) is a technique that redistributes blood from the upper body to the dependent regions of the pelvis and legs, thus reducing central venous pressure and venous return. The subject is placed in a cylindrical air-tight metal tank, which is sealed at the level of the iliac crests, and subatmospheric pressure is produced using a vacuum pump. This article reviews the historical background, physiological effects, research findings, and clinical applications of LBNP. LBNP is found in both the basic science and clinical literature, encompassing its diverse investigational and clinical applications. The first references to LBNP were in 1952 describing its effectiveness in inducing hypotensive anesthesia. Major interest in LBNP began in the mid 1960s when it was used to characterize the cardiovascular responses to hemorrhage and orthostatic stress, especially that associated with the weightlessness of space flight; these studies have continued to the present day. Advantages of LBNP for such experimental studies include the following: (1) The degree of central hypovolemia is easily controlled and has a rapid onset and reversal. (2) The technique is repeatable, reproducible, and noninvasive. (3) No exogenous pharmacologic agent is required to produce venous pooling. (4) The findings are independent of gravity. In recent years, a few institutions have applied LBNP clinically to diagnose abnormalities in cardiovascular autonomic function and, when combined with echocardiography, to uncover changes in cardiac performance through analysis of Starling curves. Copyright © 2015 Anesthesia History Association. Published by Elsevier Inc. All rights reserved.

Regenerative medicine for the respiratory system: distant future or tomorrow's treatment?

PubMed

Brouwer, Katrien M; Hoogenkamp, Henk R; Daamen, Willeke F; van Kuppevelt, Toin H

2013-03-01

Regenerative medicine (RM) is a new field of biomedical science that focuses on the regeneration of tissues and organs and the restoration of organ function. Although regeneration of organ systems such as bone, cartilage, and heart has attracted intense scientific research over recent decades, RM research regarding the respiratory system, including the trachea, the lung proper, and the diaphragm, has lagged behind. However, the last 5 years have witnessed novel approaches and initial clinical applications of tissue-engineered constructs to restore organ structure and function. In this regard, this article briefly addresses the basics of RM and introduces the key elements necessary for tissue regeneration, including (stem) cells, biomaterials, and extracellular matrices. In addition, the current status of the (clinical) application of RM to the respiratory system is discussed, and bottlenecks and recent approaches are identified. For the trachea, several initial clinical studies have been reported and have used various combinations of cells and scaffolds. Although promising, the methods used in these studies require optimization and standardization. For the lung proper, only (stem) cell-based approaches have been probed clinically, but it is becoming apparent that combinations of cells and scaffolds are required to successfully restore the lung's architecture and function. In the case of the diaphragm, clinical applications have focused on the use of decellularized scaffolds, but novel scaffolds, with or without cells, are clearly needed for true regeneration of diaphragmatic tissue. We conclude that respiratory treatment with RM will not be realized tomorrow, but its future looks promising.

High-frequency oscillations (HFOs) in clinical epilepsy

PubMed Central

Jacobs, J.; Staba, R.; Asano, E.; Otsubo, H.; Wu, J.Y.; Zijlmans, M.; Mohamed, I.; Kahane, P.; Dubeau, F.; Navarro, V.; Gotman, J.

2013-01-01

Epilepsy is one of the most frequent neurological diseases. In focal medically refractory epilepsies, successful surgical treatment largely depends on the identification of epileptogenic zone. High-frequency oscillations (HFOs) between 80 and 500 Hz, which can be recorded with EEG, may be novel markers of the epileptogenic zone. This review discusses the clinical importance of HFOs as markers of epileptogenicity and their application in different types of epilepsies. HFOs are clearly linked to the seizure onset zone, and the surgical removal of regions generating them correlates with a seizure free post-surgical outcome. Moreover, HFOs reflect the seizure-generating capability of the underlying tissue, since they are more frequent after the reduction of antiepileptic drugs. They can be successfully used in pediatric epilepsies such as epileptic spasms and help to understand the generation of this specific type of seizures. While mostly recorded on intracranial EEGs, new studies suggest that identification of HFOs on scalp EEG or magnetoencephalography (MEG) is possible as well. Thus not only patients with refractory epilepsies and invasive recordings but all patients might profit from the analysis of HFOs. Despite these promising results, the analysis of HFOs is not a routine clinical procedure; most results are derived from relatively small cohorts of patients and many aspects are not yet fully understood. Thus the review concludes that even if HFOs are promising biomarkers of epileptic tissue, there are still uncertainties about mechanisms of generation, methods of analysis, and clinical applicability. Large multicenter prospective studies are needed prior to widespread clinical application. PMID:22480752

[Clinical applications of dosing algorithm in the predication of warfarin maintenance dose].

PubMed

Huang, Sheng-wen; Xiang, Dao-kang; An, Bang-quan; Li, Gui-fang; Huang, Ling; Wu, Hai-li

2011-12-27

To evaluate the feasibility of clinical application for genetic based dosing algorithm in the predication of warfarin maintenance dose in Chinese population. The clinical data were collected and blood samples harvested from a total of 126 patients undergoing heart valve replacement. The genotypes of VKORC1 and CYP2C9 were determined by melting curve analysis after PCR. They were divided randomly into the study and control groups. In the study group, the first three doses of warfarin were prescribed according to the predicted warfarin maintenance dose while warfarin was initiated at 2.5 mg/d in the control group. The warfarin doses were adjusted according to the measured international normalized ratio (INR) values. And all subjects were followed for 50 days after an initiation of warfarin therapy. At the end of a 50-day follow-up period, the proportions of the patients on a stable dose were 82.4% (42/51) and 62.5% (30/48) for the study and control groups respectively. The mean durations of reaching a stable dose of warfarin were (27.5 ± 1.8) and (34.7 ± 1.8) days and the median durations were (24.0 ± 1.7) and (33.0 ± 4.5) days in the study and control groups respectively. Significant differences existed in the durations of reaching a stable dose between the two groups (P = 0.012). Compared with the control group, the hazard ratio (HR) for the duration of reaching a stable dose was 1.786 in the study group (95%CI 1.088 - 2.875, P = 0.026). The predicted dosing algorithm incorporating genetic and non-genetic factors may shorten the duration of achieving efficiently a stable dose of warfarin. And the present study validates the feasibility of its clinical application.

Can Robotic Interaction Improve Joint Attention Skills?

ERIC Educational Resources Information Center

Warren, Zachary E.; Zheng, Zhi; Swanson, Amy R.; Bekele, Esubalew; Zhang, Lian; Crittendon, Julie A.; Weitlauf, Amy F.; Sarkar, Nilanjan

2015-01-01

Although it has often been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorder (ASD), relatively few investigations have indexed the impact of intervention and feedback approaches. This pilot study investigated the application of a novel robotic interaction…

LIMS and Clinical Data Management.

PubMed

Chen, Yalan; Lin, Yuxin; Yuan, Xuye; Shen, Bairong

2016-01-01

In order to achieve more accurate disease prevention, diagnosis, and treatment, clinical and genetic data need extensive and systematically associated study. As one way to achieve precision medicine, a laboratory information management system (LIMS) can effectively associate clinical data in a macrocosmic aspect and genomic data in a microcosmic aspect. This chapter summarizes the application of the LIMS in a clinical data management and implementation mode. It also discusses the principles of a LIMS in clinical data management, as well as the opportunities and challenges in the context of medical informatics.

Linguistic analysis of discourse in aphasia: A review of the literature.

PubMed

Bryant, Lucy; Ferguson, Alison; Spencer, Elizabeth

This review examined previous research applications of linguistic discourse analysis to assess the language of adults with aphasia. A comprehensive literature search of seven databases identified 165 studies that applied linguistic measures to samples of discourse collected from people with aphasia. Analysis of methodological applications revealed an increase in published research using linguistic discourse analysis over the past 40 years, particularly to measure the generalisation of therapy outcomes to language in use. Narrative language samples were most frequently subject to analysis though all language genres were observed across included studies. A total of 536 different linguistic measures were applied to examine language behaviours. Growth in the research use of linguistic discourse analysis and suggestions that this growth may be reflected in clinical practice requires further investigation. Future research directions are discussed to investigate clinical use of discourse analysis and examine the differences that exist between research and clinical practice.

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 applications of dynamic infrared thermography in plastic surgery: a systematic review

PubMed Central

John, Hannah Eliza; Niumsawatt, Vachara; Whitaker, Iain S.

2016-01-01

Background Infrared thermography (IRT) has become an increasingly utilized adjunct to more expensive and/or invasive investigations in a range of surgical fields, no more so than in plastic surgery. The combination of functional assessment, flow characteristics and anatomical localization has led to increasing applications of this technology. This article aims to perform a systematic review of the clinical applications of IRT in plastic surgery. Methods A systematic literature search using the keywords ‘IRT’ and ‘dynamic infrared thermography (DIRT)’ has been accomplished. A total of 147 papers were extracted from various medical databases, of which 34 articles were subjected to a full read by two independent reviewers, to ensure the papers satisfied the inclusion and exclusion criteria. Studies focusing on the use of IRT in breast cancer diagnosis were excluded. Results A systematic review of 29 publications demonstrated the clinical applications of IRT in plastic surgery today. They include preoperative planning of perforators for free flaps, post operative monitoring of free flaps, use of IRT as an adjunct in burns depth analysis, in assessment of response to treatment in hemangioma and as a diagnostic test for cutaneous melanoma and carpal tunnel syndrome (CTS). Conclusions Modern infrared imaging technology with improved standardization protocols is now a credible, useful non-invasive tool in clinical practice. PMID:27047781

[MUC4 research progress in tumor molecular markers].

PubMed

Zhu, Hua; You, Jinhui

2014-02-01

Mucin antigen 4 (MUC4) is a molecular marker for some malignant tumors for early tumor diagnosis, prognosis and targeted therapy. It provides a new research direction in tumor diagnosis and treatment that will have a wide application prospect. In recent years, there has been a large number of research reports on the basic and clini-a wide application prospect. In recent years, there has been a large number of research reports on the basic and clinical studies about MUC4, but the molecular imaging study about MUC4 is seldom reported. In this paper the recentcal studies about MUC4, but the molecular imaging study about MUC4 is seldom reported. In this paper the recent research about MUC4 on basic and clinical studies is briefly reviewed, and it is expected to promote the development of tumor molecular imaging.

Mothering: an unacknowledged aspect of undergraduate clinical teachers' work in nursing.

PubMed

McKenna, Lisa; Wellard, Sally

2009-05-01

Clinical education is an important component of undergraduate nurse education, in which clinical teachers facilitate students' application of theoretical classroom knowledge into the clinical practice setting. Mothering as part of clinical teachers' work was a major finding from a larger study exploring clinical teaching work to identify what shaped their work and barriers to their work in clinical settings. The study used semi-structured interviews, informed by the work of Foucault. Maternal discourses emerged as a predominant one as participants presented their relationships with students describing examples of nurturing, protecting, supporting, guiding and providing discipline. The unexpected finding contradicted the dominant view of students as adult learners, and potentially positions them as dependent in their learning in clinical environments. Exploration of this discourse in the context of the study forms the basis of this paper. It is argued that the overall impact of maternal discourses on clinical teaching and learning is unclear but warrants more detailed investigation.

Clinical applications of plasma based electrosurgical systems

NASA Astrophysics Data System (ADS)

Woloszko, Jean; Endler, Ashley; Ryan, Thomas P.; Stalder, Kenneth R.

2013-02-01

Over the past 18 years, several electrosurgical systems generating a low temperature plasma in an aqueous conductive solution have been commercialized for various clinical applications and have been used in over 10 million patients to date. The most popular utilizations are in arthroscopic surgery, otorhinolaryngology surgery, spine and neurosurgery, urology and wound care. These devices can be configured to bring saline to the tip and to have concomitant aspiration to remove by-products and excess fluid. By tuning the electrode geometry, waveform and fluid dynamic at the tip of the devices, tissue resection and thermal effects can be adjusted individually. This allows one to design products that can operate as precise tissue dissectors for treatment of articular cartilage or debridement of chronic wounds, as well as global tissue debulking devices providing sufficient concomitant hemostasis for applications like tonsillectomies. Effects of these plasma based electrosurgical devices on cellular biology, healing response and nociceptive receptors has also been studied in various models. This talk will include a review of the clinical applications, with product descriptions, results and introductory review of some of the research on the biological effects of these devices.

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.

Nanotechnology applications in urology: a review.

PubMed

Maddox, Michael; Liu, James; Mandava, Sree Harsha; Callaghan, Cameron; John, Vijay; Lee, Benjamin R

2014-11-01

The objectives of this review are to discuss the current literature and summarise some of the promising areas with which nanotechnology may improve urological care. A Medline literature search was performed to elucidate all relevant studies of nanotechnology with specific attention to its application in urology. Urological applications of nanotechnology include its use in medical imaging, gene therapy, drug delivery, and photothermal ablation of tumours. In vitro and animal studies have shown initial encouraging results. Further study of nanotechnology for urological applications is warranted to bridge the gap between preclinical studies and translation into clinical practice, but nanomedicine has shown significant potential to improve urological patient care. © 2014 The Authors. BJU International © 2014 BJU International.

Predicting medical school and internship success: does the quality of the research and clinical experience matter?

PubMed

Paolino, Nathalie D; Artino, Anthony R; Saguil, Aaron; Dong, Ting; Durning, Steven J; DeZee, Kent J

2015-04-01

This article explores specific aspects of self-reported clinical and research experience and their relationship to performance in medical training. This is a retrospective cohort study conducted at the Uniformed Services University. The American Medical College Application Service application was used to discern students' self-reported clinical and research experience. Two authors applied a classification scheme for clinical and research experience to the self-reported experiences. Study outcomes included medical school grade point average (GPA), U.S. Medical Licensing Examination (USMLE) scores, and intern expertise and professionalism scores. A linear regression analysis was conducted for each outcome while controlling for prematriculation GPA. Data were retrieved on 1,020 matriculants. There were several statistically significant but small differences across outcomes when comparing the various categories of clinical experience with no clinical experience. The technician-level experience group had a decrease of 0.1 in cumulative GPA in comparison to students without self-reported clinical experience (p = 0.004). This group also performed 5 points lower on the USMLE Step 2 than students who did not report clinical experience (p = 0.013). The various levels of self-reported research experience were unrelated to success in medical school and graduate medical education. These findings indicate that self-reported technician-level clinical experience is related to a small reduction in typically reported outcomes in medical school. Reprint & Copyright © 2015 Association of Military Surgeons of the U.S.

Psychometric characteristics of the BRIEF scale for the assessment of executive functions in Spanish clinical population.

PubMed

García Fernández, Trinidad; González-Pienda, Julio Antonio; Rodríguez Pérez, Celestino; Álvarez García, David; Álvarez Pérez, Luis

2014-01-01

The Behavior Rating Inventory of Executive Functions (BRIEF) scale, completed by families, is widely known in the assessment of executive functions in children and adolescents. However, its application is limited to English-speaking population. This study analyzes the preliminary results from its application in a Spanish clinical sample, comprising 125 participants aged 5-18 years. Internal structure and reliability of the translated scale were analyzed, as well as its relationship with other behavioral measures through the analysis of their correlations with the Assessment of Attention Deficit Hyperactivity Disorder Scale (EDAH). The results were compared with those from the original validation study. The data revealed the presence of the same internal structure, as well as acceptable internal consistency and significant correlations with the Attention Deficit and Hyperactivity components of the EDAH scale. This study provides preliminary evidence of the utility of the BRIEF scale in cultural contexts different from the original, particularly in Spanish clinical population.

Mass Spectrometry in Clinical Laboratory: Applications in Therapeutic Drug Monitoring and Toxicology.

PubMed

Garg, Uttam; Zhang, Yan Victoria

2016-01-01

Mass spectrometry (MS) has been used in research and specialized clinical laboratories for decades as a very powerful technology to identify and quantify compounds. In recent years, application of MS in routine clinical laboratories has increased significantly. This is mainly due to the ability of MS to provide very specific identification, high sensitivity, and simultaneous analysis of multiple analytes (>100). The coupling of tandem mass spectrometry with gas chromatography (GC) or liquid chromatography (LC) has enabled the rapid expansion of this technology. While applications of MS are used in many clinical areas, therapeutic drug monitoring, drugs of abuse, and clinical toxicology are still the primary focuses of the field. It is not uncommon to see mass spectrometry being used in routine clinical practices for those applications.

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.

Hazard report. Don't use industrial-grade gases for clinical applications.

PubMed

2010-01-01

The use of industrial-grade gases instead of medical-grade gases for clinical applications increases the risk of introducing undesirable and even toxic contaminants into the clinical environment. Hospitals should have policies in place to ensure that gases of the appropriate type and grade are used for the intended application.

Modern psychometrics applied in rheumatology--a systematic review.

PubMed

Siemons, Liseth; Ten Klooster, Peter M; Taal, Erik; Glas, Cees Aw; Van de Laar, Mart Afj

2012-10-31

Although item response theory (IRT) appears to be increasingly used within health care research in general, a comprehensive overview of the frequency and characteristics of IRT analyses within the rheumatic field is lacking. An overview of the use and application of IRT in rheumatology to date may give insight into future research directions and highlight new possibilities for the improvement of outcome assessment in rheumatic conditions. Therefore, this study systematically reviewed the application of IRT to patient-reported and clinical outcome measures in rheumatology. Literature searches in PubMed, Scopus and Web of Science resulted in 99 original English-language articles which used some form of IRT-based analysis of patient-reported or clinical outcome data in patients with a rheumatic condition. Both general study information and IRT-specific information were assessed. Most studies used Rasch modeling for developing or evaluating new or existing patient-reported outcomes in rheumatoid arthritis or osteoarthritis patients. Outcomes of principle interest were physical functioning and quality of life. Since the last decade, IRT has also been applied to clinical measures more frequently. IRT was mostly used for evaluating model fit, unidimensionality and differential item functioning, the distribution of items and persons along the underlying scale, and reliability. Less frequently used IRT applications were the evaluation of local independence, the threshold ordering of items, and the measurement precision along the scale. IRT applications have markedly increased within rheumatology over the past decades. To date, IRT has primarily been applied to patient-reported outcomes, however, applications to clinical measures are gaining interest. Useful IRT applications not yet widely used within rheumatology include the cross-calibration of instrument scores and the development of computerized adaptive tests which may reduce the measurement burden for both the patient and the clinician. Also, the measurement precision of outcome measures along the scale was only evaluated occasionally. Performed IRT analyses should be adequately explained, justified, and reported. A global consensus about uniform guidelines should be reached concerning the minimum number of assumptions which should be met and best ways of testing these assumptions, in order to stimulate the quality appraisal of performed IRT analyses.

77 FR 24984 - Importer of Controlled Substances; Notice of Application; Clinical Supplies Management, Inc.

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-26

... Application; Clinical Supplies Management, Inc. Pursuant to 21 U.S.C. 958(i), the Attorney General shall... on November 13, 2011, Clinical Supplies Management, Inc., 342 42nd Street South, Fargo, North Dakota... distributing to customers which are qualified clinical sites conducting clinical trials under the auspices of...

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

Big Data Application in Biomedical Research and Health Care: A Literature Review.

PubMed

Luo, Jake; Wu, Min; Gopukumar, Deepika; Zhao, Yiqing

2016-01-01

Big data technologies are increasingly used for biomedical and health-care informatics research. Large amounts of biological and clinical data have been generated and collected at an unprecedented speed and scale. For example, the new generation of sequencing technologies enables the processing of billions of DNA sequence data per day, and the application of electronic health records (EHRs) is documenting large amounts of patient data. The cost of acquiring and analyzing biomedical data is expected to decrease dramatically with the help of technology upgrades, such as the emergence of new sequencing machines, the development of novel hardware and software for parallel computing, and the extensive expansion of EHRs. Big data applications present new opportunities to discover new knowledge and create novel methods to improve the quality of health care. The application of big data in health care is a fast-growing field, with many new discoveries and methodologies published in the last five years. In this paper, we review and discuss big data application in four major biomedical subdisciplines: (1) bioinformatics, (2) clinical informatics, (3) imaging informatics, and (4) public health informatics. Specifically, in bioinformatics, high-throughput experiments facilitate the research of new genome-wide association studies of diseases, and with clinical informatics, the clinical field benefits from the vast amount of collected patient data for making intelligent decisions. Imaging informatics is now more rapidly integrated with cloud platforms to share medical image data and workflows, and public health informatics leverages big data techniques for predicting and monitoring infectious disease outbreaks, such as Ebola. In this paper, we review the recent progress and breakthroughs of big data applications in these health-care domains and summarize the challenges, gaps, and opportunities to improve and advance big data applications in health care.

Big Data Application in Biomedical Research and Health Care: A Literature Review

PubMed Central

Luo, Jake; Wu, Min; Gopukumar, Deepika; Zhao, Yiqing

2016-01-01

Big data technologies are increasingly used for biomedical and health-care informatics research. Large amounts of biological and clinical data have been generated and collected at an unprecedented speed and scale. For example, the new generation of sequencing technologies enables the processing of billions of DNA sequence data per day, and the application of electronic health records (EHRs) is documenting large amounts of patient data. The cost of acquiring and analyzing biomedical data is expected to decrease dramatically with the help of technology upgrades, such as the emergence of new sequencing machines, the development of novel hardware and software for parallel computing, and the extensive expansion of EHRs. Big data applications present new opportunities to discover new knowledge and create novel methods to improve the quality of health care. The application of big data in health care is a fast-growing field, with many new discoveries and methodologies published in the last five years. In this paper, we review and discuss big data application in four major biomedical subdisciplines: (1) bioinformatics, (2) clinical informatics, (3) imaging informatics, and (4) public health informatics. Specifically, in bioinformatics, high-throughput experiments facilitate the research of new genome-wide association studies of diseases, and with clinical informatics, the clinical field benefits from the vast amount of collected patient data for making intelligent decisions. Imaging informatics is now more rapidly integrated with cloud platforms to share medical image data and workflows, and public health informatics leverages big data techniques for predicting and monitoring infectious disease outbreaks, such as Ebola. In this paper, we review the recent progress and breakthroughs of big data applications in these health-care domains and summarize the challenges, gaps, and opportunities to improve and advance big data applications in health care. PMID:26843812

Clinical use of cardiac PET/MRI: current state-of-the-art and potential future applications.

PubMed

Krumm, Patrick; Mangold, Stefanie; Gatidis, Sergios; Nikolaou, Konstantin; Nensa, Felix; Bamberg, Fabian; la Fougère, Christian

2018-05-01

Combined PET/MRI is a novel imaging method integrating the advances of functional and morphological MR imaging with PET applications that include assessment of myocardial viability, perfusion, metabolism of inflammatory tissue and tumors, as well as amyloid deposition imaging. As such, PET/MRI is a promising tool to detect and characterize ischemic and non-ischemic cardiomyopathies. To date, the greatest benefit may be expected for diagnostic evaluation of systemic diseases and cardiac masses that remain unclear in cardiac MRI, as well as for clinical and scientific studies in the setting of ischemic cardiomyopathies. Diagnosis and therapeutic monitoring of cardiac sarcoidosis has the potential of a possible 'killer-application' for combined cardiac PET/MRI. In this article, we review the current evidence and discuss current and potential future applications of cardiac PET/MRI.

[Critical thinking skills in the nursing diagnosis process].

PubMed

Bittencourt, Greicy Kelly Gouveia Dias; Crossetti, Maria da Graça Oliveira

2013-04-01

The aim of this study was to identify the critical thinking skills utilized in the nursing diagnosis process. This was an exploratory descriptive study conducted with seven nursing students on the application of a clinical case to identify critical thinking skills, as well as their justifications in the nursing diagnosis process. Content analysis was performed to evaluate descriptive data. Six participants reported that analysis, scientific and technical knowledge and logical reasoning skills are important in identifying priority nursing diagnoses; clinical experience was cited by five participants, knowledge about the patient and application of standards were mentioned by three participants; Furthermore, discernment and contextual perspective were skills noted by two participants. Based on these results, the use of critical thinking skills related to the steps of the nursing diagnosis process was observed. Therefore, that the application of this process may constitute a strategy that enables the development of critical thinking skills.

Health Knowledge Among the Millennial Generation

PubMed Central

Lloyd, Tom; Shaffer, Michele L.; Christy, Stetter; Widome, Mark D.; Repke, John; Weitekamp, Michael R.; Eslinger, Paul J.; Bargainnier, Sandra S.; Paul, Ian M.

2013-01-01

The Millennial Generation, also known as Generation Y, is the demographic cohort following Generation X, and is generally regarded to be composed of those individuals born between 1980 and 2000. They are the first to grow up in an environment where health-related information is widely available by internet, TV and other electronic media, yet we know very little about the scope of their health knowledge. This study was undertaken to quantify two domains of clinically relevant health knowledge: factual content and ability to solve health related questions (application) in nine clinically related medical areas. Study subjects correctly answered, on average, 75% of health application questions but only 54% of health content questions. Since students were better able to correctly answer questions dealing with applications compared to those on factual content contemporary US high school students may not use traditional hierarchical learning models in acquisition of their health knowledge. PMID:25170479

Health knowledge among the millennial generation.

PubMed

Lloyd, Tom; Shaffer, Michele L; Christy, Stetter; Widome, Mark D; Repke, John; Weitekamp, Michael R; Eslinger, Paul J; Bargainnier, Sandra S; Paul, Ian M

2013-04-28

The Millennial Generation, also known as Generation Y, is the demographic cohort following Generation X, and is generally regarded to be composed of those individuals born between 1980 and 2000. They are the first to grow up in an environment where health-related information is widely available by internet, TV and other electronic media, yet we know very little about the scope of their health knowledge. This study was undertaken to quantify two domains of clinically relevant health knowledge: factual content and ability to solve health related questions (application) in nine clinically related medical areas. Study subjects correctly answered, on average, 75% of health application questions but only 54% of health content questions. Since students were better able to correctly answer questions dealing with applications compared to those on factual content contemporary US high school students may not use traditional hierarchical learning models in acquisition of their health knowledge.

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

[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.

[Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

PubMed

Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

2015-06-01

The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

Cardiac mechanics: Physiological, clinical, and mathematical considerations

NASA Technical Reports Server (NTRS)

Mirsky, I. (Editor); Ghista, D. N.; Sandler, H.

1974-01-01

Recent studies concerning the basic physiological and biochemical principles underlying cardiac muscle contraction, methods for the assessment of cardiac function in the clinical situation, and mathematical approaches to cardiac mechanics are presented. Some of the topics covered include: cardiac ultrastructure and function in the normal and failing heart, myocardial energetics, clinical applications of angiocardiography, use of echocardiography for evaluating cardiac performance, systolic time intervals in the noninvasive assessment of left ventricular performance in man, evaluation of passive elastic stiffness for the left ventricle and isolated heart muscle, a conceptual model of myocardial infarction and cardiogenic shock, application of Huxley's sliding-filament theory to the mechanics of normal and hypertrophied cardiac muscle, and a rheological modeling of the intact left ventricle. Individual items are announced in this issue.

Proceedings of the AMEDD (Army Medical Department) Clinical Psychology Short Course: Military Applications of Neuropsychology and Health Psychology Held in Presidio of San Francisco, California on 9-13 March 1987. Volume 1

DTIC Science & Technology

1987-03-01

1 ,•i \\fLL c;R: MILITARY APPLICATIONS OF CLINICAL NEUROPSYCHOLOGY AND HEALTH PSYCHOLOGY 00 ;-"~~L’ -’L--, ’• - 9-13 March 1987 .4+; Volume I...Clinical Psychology Short Course: Military Applications of Neuropsychology and Health Psychology Held in Presido -of San Franciscoj, California on 9-ý13...tApproved for public releasoo, DTIC FORM LLr3 OPI: DTIC-TID PROCEEDINGS OF THE 1987 AMEDD CLINICAL PSYCHOLOGY SHORT COURSE MILITARY APPLICATIONS OF

[Application of Delphi method in traditional Chinese medicine clinical research].

PubMed

Bi, Ying-fei; Mao, Jing-yuan

2012-03-01

In recent years, Delphi method has been widely applied in traditional Chinese medicine (TCM) clinical research. This article analyzed the present application situation of Delphi method in TCM clinical research, and discussed some problems presented in the choice of evaluation method, classification of observation indexes and selection of survey items. On the basis of present application of Delphi method, the author analyzed the method on questionnaire making, selection of experts, evaluation of observation indexes and selection of survey items. Furthermore, the author summarized the steps of application of Delphi method in TCM clinical research.

Simultaneous dual-color fluorescence microscope: a characterization study.

PubMed

Li, Zheng; Chen, Xiaodong; Ren, Liqiang; Song, Jie; Li, Yuhua; Zheng, Bin; Liu, Hong

2013-01-01

High spatial resolution and geometric accuracy is crucial for chromosomal analysis of clinical cytogenetic applications. High resolution and rapid simultaneous acquisition of multiple fluorescent wavelengths can be achieved by utilizing concurrent imaging with multiple detectors. However, such class of microscopic systems functions differently from traditional fluorescence microscopes. To develop a practical characterization framework to assess and optimize the performance of a high resolution and dual-color fluorescence microscope designed for clinical chromosomal analysis. A dual-band microscopic imaging system utilizes a dichroic mirror, two sets of specially selected optical filters, and two detectors to simultaneously acquire two fluorescent wavelengths. The system's geometric distortion, linearity, the modulation transfer function, and the dual detectors' alignment were characterized. Experiment results show that the geometric distortion at lens periphery is less than 1%. Both fluorescent channels show linear signal responses, but there exists discrepancy between the two due to the detectors' non-uniform response ratio to different wavelengths. In terms of the spatial resolution, the two contrast transfer function curves trend agreeably with the spatial frequency. The alignment measurement allows quantitatively assessing the cameras' alignment. A result image of adjusted alignment is demonstrated to show the reduced discrepancy by using the alignment measurement method. In this paper, we present a system characterization study and its methods for a specially designed imaging system for clinical cytogenetic applications. The presented characterization methods are not only unique to this dual-color imaging system but also applicable to evaluation and optimization of other similar multi-color microscopic image systems for improving their clinical utilities for future cytogenetic applications.

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

The bleomycin animal model: a useful tool to investigate treatment options for idiopathic pulmonary fibrosis?

PubMed Central

Moeller, Antje; Ask, Kjetil; Warburton, David; Gauldie, Jack; Kolb, Martin

2008-01-01

Different animal models of pulmonary fibrosis have been developed to investigate potential therapies for idiopathic pulmonary fibrosis (IPF). The most common is the bleomycin model in rodents (mouse, rat and hamster). Over the years, numerous agents have been shown to inhibit fibrosis in this model. However, to date none of these compounds are used in the clinical management of IPF and none has shown a comparable antifibrotic effect in humans. We performed a systematic review of publications on drug efficacy studies in the bleomycin model to evaluate the value of this model regarding transferability to clinical use. Between 1980 and 2006 we identified 246 experimental studies describing beneficial antifibrotic compounds in the bleomycin model. In 221 of the studies we found enough details about the timing of drug application to allow inter-study comparison. 211 of those used a preventive regimen (drug given ≤ day 7 after last bleomycin application), only 10 were therapeutic trials (> 7 days after last bleomycin application). It is critical to distinguish between drugs interfering with the inflammatory and early fibrogenic response from those preventing progression of fibrosis, the latter likely much more meaningful for clinical application. All potential antifibrotic compounds should be evaluated in the phase of established fibrosis rather than in the early period of bleomycin-induced inflammation for assessment of its antifibrotic properties. Further care should be taken in extrapolation of drugs successfully tested in the bleomycin model due to partial reversibility of bleomycin induced fibrosis over time. The use of alternative and more robust animal models, which better reflect human IPF, is warranted. PMID:17936056

Co-Designing Mobile Apps to Assist in Clinical Nursing Education: A Study Protocol.

PubMed

O'Connor, Siobhan; Andrews, Tom

2016-01-01

Mobile applications (apps) to train health professionals is gaining momentum as the benefits of mobile learning (mLearning) are becoming apparent in complex clinical environments. However, most educational apps are generic, off-the-shelf pieces of software that do not take into consideration the unique needs of nursing students. The proposed study will apply a user-centred design process to create a tailored mobile app for nursing students to learn and apply clinical skills in practice. The app will be piloted and evaluated to understand how nursing students use mobile technology in clinical settings to support their learning and educational needs.

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.

Routine clinical application of virtual reality in abdominal surgery.

PubMed

Sampogna, Gianluca; Pugliese, Raffaele; Elli, Marco; Vanzulli, Angelo; Forgione, Antonello

2017-06-01

The advantages of 3D reconstruction, immersive virtual reality (VR) and 3D printing in abdominal surgery have been enunciated for many years, but still today their application in routine clinical practice is almost nil. We investigate their feasibility, user appreciation and clinical impact. Fifteen patients undergoing pancreatic, hepatic or renal surgery were studied realizing a 3D reconstruction of target anatomy. Then, an immersive VR environment was developed to import 3D models, and some details of the 3D scene were printed. All the phases of our workflow employed open-source software and low-cost hardware, easily implementable by other surgical services. A qualitative evaluation of the three approaches was performed by 20 surgeons, who filled in a specific questionnaire regarding a clinical case for each organ considered. Preoperative surgical planning and intraoperative guidance was feasible for all patients included in the study. The vast majority of surgeons interviewed scored their quality and usefulness as very good. Despite extra time, costs and efforts necessary to implement these systems, the benefits shown by the analysis of questionnaires recommend to invest more resources to train physicians to adopt these technologies routinely, even if further and larger studies are still mandatory.

An ontologically founded architecture for information systems in clinical and epidemiological research.

PubMed

Uciteli, Alexandr; Groß, Silvia; Kireyev, Sergej; Herre, Heinrich

2011-08-09

This paper presents an ontologically founded basic architecture for information systems, which are intended to capture, represent, and maintain metadata for various domains of clinical and epidemiological research. Clinical trials exhibit an important basis for clinical research, and the accurate specification of metadata and their documentation and application in clinical and epidemiological study projects represents a significant expense in the project preparation and has a relevant impact on the value and quality of these studies.An ontological foundation of an information system provides a semantic framework for the precise specification of those entities which are presented in this system. This semantic framework should be grounded, according to our approach, on a suitable top-level ontology. Such an ontological foundation leads to a deeper understanding of the entities of the domain under consideration, and provides a common unifying semantic basis, which supports the integration of data and the interoperability between different information systems.The intended information systems will be applied to the field of clinical and epidemiological research and will provide, depending on the application context, a variety of functionalities. In the present paper, we focus on a basic architecture which might be common to all such information systems. The research, set forth in this paper, is included in a broader framework of clinical research and continues the work of the IMISE on these topics.

A systematic review of the uses of fluoroscopy in dentistry.

PubMed

Uzbelger Feldman, Daniel; Yang, Jie; Susin, Cristiano

2010-01-01

To determine the quality of the evidence for the uses of fluoroscopy in dentistry. A systematic review using Ovid and MEDLINE was conducted to identify papers showing the uses of fluoroscopy in dentistry published between 1953 and September 2009. Human, animal and phantom/skull/mannequin studies on fluoroscopy with regard to its diagnostic value, research performance, and clinical and safety applications in dentistry were included in this analysis. Studies that were not in English, as well as those that employed fluoroscopy in dentistry without the use of image intensification, were excluded. Articles were evaluated, classified and graded by levels of evidence. Fifty-five out of 139 papers fulfilled the inclusion criteria. Amongst them, 19 were related to diagnosis, 15 to research, 12 to clinical and nine to safety applications. Fluoroscopy has contributed to nine different areas of dentistry. Also, it was used on 895 dental patients, 37 animals and 17 phantoms/skulls/mannequins. Two randomised controlled trials, two cohort studies, two case controls, 48 case reports and one expert opinion were found. Fluoroscopy with image intensification has been a useful, but not consistently used tool in dentistry for over 50 years. Several lines of evidence have shown fluoroscopy's diagnostic potential, research use, and clinical and safety applications in dentistry.

Quantification of Hand Motor Symptoms in Parkinson's Disease: A Proof-of-Principle Study Using Inertial and Force Sensors.

PubMed

van den Noort, Josien C; Verhagen, Rens; van Dijk, Kees J; Veltink, Peter H; Vos, Michelle C P M; de Bie, Rob M A; Bour, Lo J; Heida, Ciska T

2017-10-01

This proof-of-principle study describes the methodology and explores and demonstrates the applicability of a system, existing of miniature inertial sensors on the hand and a separate force sensor, to objectively quantify hand motor symptoms in patients with Parkinson's disease (PD) in a clinical setting (off- and on-medication condition). Four PD patients were measured in off- and on- dopaminergic medication condition. Finger tapping, rapid hand opening/closing, hand pro/supination, tremor during rest, mental task and kinetic task, and wrist rigidity movements were measured with the system (called the PowerGlove). To demonstrate applicability, various outcome parameters of measured hand motor symptoms of the patients in off- vs. on-medication condition are presented. The methodology described and results presented show applicability of the PowerGlove in a clinical research setting, to objectively quantify hand bradykinesia, tremor and rigidity in PD patients, using a single system. The PowerGlove measured a difference in off- vs. on-medication condition in all tasks in the presented patients with most of its outcome parameters. Further study into the validity and reliability of the outcome parameters is required in a larger cohort of patients, to arrive at an optimal set of parameters that can assist in clinical evaluation and decision-making.

Promoting the Self-Regulation of Clinical Reasoning Skills in Nursing Students

PubMed Central

Kuiper, R; Pesut, D; Kautz, D

2009-01-01

Aim: 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. Materials and Methods: 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. Results: 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. Recommendations and Conclusions: 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. PMID:19888432

The Ontology of Clinical Research (OCRe): An Informatics Foundation for the Science of Clinical Research

PubMed Central

Sim, Ida; Tu, Samson W.; Carini, Simona; Lehmann, Harold P.; Pollock, Brad H.; Peleg, Mor; Wittkowski, Knut M.

2013-01-01

To date, the scientific process for generating, interpreting, and applying knowledge has received less informatics attention than operational processes for conducting clinical studies. The activities of these scientific processes — the science of clinical research — are centered on the study protocol, which is the abstract representation of the scientific design of a clinical study. The Ontology of Clinical Research (OCRe) is an OWL 2 model of the entities and relationships of study design protocols for the purpose of computationally supporting the design and analysis of human studies. OCRe’s modeling is independent of any specific study design or clinical domain. It includes a study design typology and a specialized module called ERGO Annotation for capturing the meaning of eligibility criteria. In this paper, we describe the key informatics use cases of each phase of a study’s scientific lifecycle, present OCRe and the principles behind its modeling, and describe applications of OCRe and associated technologies to a range of clinical research use cases. OCRe captures the central semantics that underlies the scientific processes of clinical research and can serve as an informatics foundation for supporting the entire range of knowledge activities that constitute the science of clinical research. PMID:24239612

The James Blundell Award Lecture 2006: transfusion and the treatment of haemorrhage: past, present and future.

PubMed

Dzik, W H

2007-10-01

In the early years of the 19th century, James Blundell reported in the Lancet the first clinical application of blood transfusion for the treatment of haemorrhage. Although these initial experiments may appear to us to have burst upon the medical world, Blundell had in fact done a decade of pre clinical research using animal models to establish principles to be brought to the clinic. His pivotal pre clinical experiments and the insights he gained are described in detail. Today, blood transfusion remains the cornerstone of treatment for serious bleeding - not only to restore oxygen carrying capacity but also to improve haemostasis, arrest and prevent bleeding. However, the indications for the use of blood components to treat bleeding remain ill-defined. In particular, despite the enormous volumes of fresh frozen plasma (FFP) transfused worldwide, the evidence that commonly used coagulation tests are reliable guides to transfusion with FFP is scant. Recent laboratory and clinical studies provide insight into the weaknesses of current coagulation tests as a guide to blood management. In the future, the application of genomics to haemostasis will uncover genetic polymorphisms leading to improved diagnostics and more tailored medical therapeutics. Examples of the emerging use of clinical genomics are presented. Ultimately, the application of widescale genomics testing will refresh our understanding of human physiology and will reassert the importance of the individual in patient care.

Clinical application of adipose stem cells in plastic surgery.

PubMed

Kim, Yong-Jin; Jeong, Jae-Ho

2014-04-01

Adipose stem cells (ASCs) are a type of adult stem cells that share common characteristics with typical mesenchymal stem cells. In the last decade, ASCs have been shown to be a useful cell resource for tissue regeneration. The major role of regenerative medicine in this century is based on cell therapy in which ASCs hold a key position. Active research on this new type of adult stem cell has been ongoing and these cells now have several clinical applications, including fat grafting, overcoming wound healing difficulties, recovery from local tissue ischemia, and scar remodeling. The application of cultured cells will increase the efficiency of cell therapy. However, the use of cultured stem cells is strictly controlled by government regulation to ensure patient safety. Government regulation is a factor that can limit more versatile clinical application of ASCs. In this review, current clinical applications of ASCs in plastic surgery are introduced. Future stem cell applications in clinical field including culturing and banking of ASCs are also discussed in this review.

A systematic review of clinical audit in companion animal veterinary medicine.

PubMed

Rose, Nicole; Toews, Lorraine; Pang, Daniel S J

2016-02-26

Clinical audit is a quality improvement process with the goal of continuously improving quality of patient care as assessed by explicit criteria. In human medicine clinical audit has become an integral and required component of the standard of care. In contrast, in veterinary medicine there appear to have been a limited number of clinical audits published, indicating that while clinical audit is recognised, its adoption in veterinary medicine is still in its infancy. A systematic review was designed to report and evaluate the veterinary literature on clinical audit in companion animal species (dog, cat, horse). A systematic search of English and French articles using Proquest Dissertations and Theses database (February 6, 2014), CAB Abstracts (March 21, 2014 and April 4, 2014), Scopus (March 21, 2014), Web of Science Citation index (March 21, 2014) and OVID Medline (March 21, 2014) was performed. Included articles were those either discussing clinical audit (such as review articles and editorials) or reporting parts of, or complete, audit cycles. The majority of articles describing clinical audit were reviews. From 89 articles identified, twenty-one articles were included and available for review. Twelve articles were reviews of clinical audit in veterinary medicine, five articles included at least one veterinary clinical audit, one thesis was identified, one report was of a veterinary clinical audit website and two articles reported incomplete clinical audits. There was no indication of an increase in the number of published clinical audits since the first report in 1998. However, there was evidence of article misclassification, with studies fulfilling the criteria of clinical audit not appropriately recognised. Quality of study design and reporting of findings varied considerably, with information missing on key components, including duration of study, changes in practice implemented between audits, development of explicit criteria and appropriate statistical analyses. Available evidence suggests the application and reporting of clinical audit in veterinary medicine is sporadic despite the potential to improve patient care, though the true incidence of clinical audit reporting is likely to be underestimated due to incorrect indexing. Reporting standards of clinical audits are highly variable, limiting evaluation, application and repeatability of published work.

The effects of mobile applications in cardiopulmonary assessment education.

PubMed

Yoo, In-Young; Lee, Young-Mi

2015-02-01

Mobile applications can be used as effective simulations for nursing education. However, little is known regarding the effects of mobile application-mediated training on nursing. The aim of this study was to determine the effectiveness of mobile applications by comparing the effectiveness of a high-fidelity human patient simulator to that of a mobile application on student learning. Following lectures on the lungs and the heart, twenty-two students were separated into two groups to perform a simulation exercise. Then, the students' education effects were evaluated based on their knowledge of lung and heart assessments, their clinical assessment skill, and satisfaction with their education. After four weeks, the mobile application group maintained their knowledge, whereas the high-fidelity human patient simulator group exhibited significantly decreased knowledge of the lung assessment. Knowledge of the heart assessment was significantly increased in both groups. There was no significant difference in clinical assessment skill or educational satisfaction between the groups. We found that mobile applications provide educational tools similarly effective to a high-fidelity human patient simulator to maintain memory and to teach cardiopulmonary assessment skills. Copyright © 2014 Elsevier Ltd. All rights reserved.

Electrical Stimulation and Cutaneous Wound Healing: A Review of Clinical Evidence

PubMed Central

Ud-Din, Sara; Bayat, Ardeshir

2014-01-01

Electrical stimulation (ES) has been shown to have beneficial effects in wound healing. It is important to assess the effects of ES on cutaneous wound healing in order to ensure optimization for clinical practice. Several different applications as well as modalities of ES have been described, including direct current (DC), alternating current (AC), high-voltage pulsed current (HVPC), low-intensity direct current (LIDC) and electrobiofeedback ES. However, no one method has been advocated as the most optimal for the treatment of cutaneous wound healing. Therefore, this review aims to examine the level of evidence (LOE) for the application of different types of ES to enhance cutaneous wound healing in the skin. An extensive search was conducted to identify relevant clinical studies utilising ES for cutaneous wound healing since 1980 using PubMed, Medline and EMBASE. A total of 48 studies were evaluated and assigned LOE. All types of ES demonstrated positive effects on cutaneous wound healing in the majority of studies. However, the reported studies demonstrate contrasting differences in the parameters and types of ES application, leading to an inability to generate sufficient evidence to support any one standard therapeutic approach. Despite variations in the type of current, duration, and dosing of ES, the majority of studies showed a significant improvement in wound area reduction or accelerated wound healing compared to the standard of care or sham therapy as well as improved local perfusion. The limited number of LOE-1 trials for investigating the effects of ES in wound healing make critical evaluation and assessment somewhat difficult. Further, better-designed clinical trials are needed to improve our understanding of the optimal dosing, timing and type of ES to be used. PMID:27429287

A simple versatile solution for collecting multidimensional clinical data based on the CakePHP web application framework.

PubMed

Biermann, Martin

2014-04-01

Clinical trials aiming for regulatory approval of a therapeutic agent must be conducted according to Good Clinical Practice (GCP). Clinical Data Management Systems (CDMS) are specialized software solutions geared toward GCP-trials. They are however less suited for data management in small non-GCP research projects. For use in researcher-initiated non-GCP studies, we developed a client-server database application based on the public domain CakePHP framework. The underlying MySQL database uses a simple data model based on only five data tables. The graphical user interface can be run in any web browser inside the hospital network. Data are validated upon entry. Data contained in external database systems can be imported interactively. Data are automatically anonymized on import, and the key lists identifying the subjects being logged to a restricted part of the database. Data analysis is performed by separate statistics and analysis software connecting to the database via a generic Open Database Connectivity (ODBC) interface. Since its first pilot implementation in 2011, the solution has been applied to seven different clinical research projects covering different clinical problems in different organ systems such as cancer of the thyroid and the prostate glands. This paper shows how the adoption of a generic web application framework is a feasible, flexible, low-cost, and user-friendly way of managing multidimensional research data in researcher-initiated non-GCP clinical projects. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Evaluating and improving recruitment and retention in an mHealth clinical trial: an example of iterating methods during a trial.

PubMed

Pfammatter, Angela Fidler; Mitsos, Alexa; Wang, Shirlene; Hood, Susan Hammett; Spring, Bonnie

2017-01-01

Recruitment and retention strategy investigations in mHealth clinical trials are rare. Technology presents an opportunity to intensely and remotely evaluate recruitment, use of mobile apps, and retention, leading to new insights for continuous improvement of mHealth trials. The objective of this paper is to present a case study in which a trial evaluated and changed strategies during a clinical trial to improve recruitment, adherence to study protocols, and retention in the mHealth trial. In Fall 2015, the NUYou trial enrolled 150 college freshmen in an mHealth protocol. Three months after study initiation, NUYou struggled to meet recruitment goals and maintain anticipated usage levels of the study smartphone application. Two sets of data were collected to improve recruitment and retention: a survey about recruitment was sent to the target population and surveys regarding usability of the app was sent to the study sample. Survey results informed improvements in recruitment strategies, the study retention protocol, and the smartphone application. Survey results revealed several insights including misunderstanding components of the trial by potential participants, low perceived usefulness of the app, and little recall or impact of the incentive structure. After implementation of user-centered improvements, the second cohort of NUYou recruitment in the fall of 2016 produced an equal sample size in 4 weeks less time. Winter quarter of 2016 compared to 2017 demonstrated an improvement in retention via app use and completion of weekly in-app surveys. Recruitment and retention in clinical trials continues to be a critical challenge and mHealth trials may present both unique challenges and opportunities. To our knowledge, this is the first study to describe a systematic evaluation followed by changes and further evaluation to recruitment, use of the mHealth application, adherence to study protocol, and retention during an mHealth clinical trial. Future work should adopt and explicitly study these processes to optimize both enrollment and retention in these types of trials to preserve validity and reliability of research results.

Factors Influencing Dental Students' Interest in Advanced Periodontal Education: Perspectives of Department Chairs.

PubMed

Hearty, Luke; Demko, Catherine; Bissada, Nabil F; da Silva, Andre Paes B

2017-06-01

The number of graduates of U.S. dental schools enrolled in U.S. postdoctoral programs in periodontics has been decreasing. The aims of this study were to determine the perspectives of periodontics department chairs regarding 1) features of a school's predoctoral curriculum that promote student interest in advanced periodontal education and 2) characteristics of a periodontal residency program that make it more attractive to dental students over other specialty programs. In 2015, a 14-question survey was designed and sent to chairs of periodontics departments at all 65 U.S. dental schools at the time. Questions addressed number of instructional hours; specialty clinic rotations; elective courses; number of applicants to periodontal residency; existence of a residency program; length of the residency program; and externships, fellowships, and financial stipends offered. The survey response rate was 73.8%. The results showed that departments offering more than seven clinical credit hours in periodontics to predoctoral students had the greatest number of residency applicants. Most of the applicants were from institutions that offered specialty clinic rotations, elective courses, and residency programs in periodontics. The number of applicants did not change significantly if a stipend or fellowship was offered. However, the availability of an externship was significantly associated with a greater number of applicants (p=0.042). These results suggest that offering periodontal clinical rotations, elective courses, and especially externships in periodontics during predoctoral education may encourage more graduating students to pursue postdoctoral periodontal education.

MO-FG-207-03: Maximizing the Utility of Integrated PET/MRI in Clinical Applications

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

Behr, S.

2015-06-15

The use of integrated PET/MRI systems in clinical applications can best benefit from understanding their technological advances and limitations. The currently available clinical PET/MRI systems have their own characteristics. Thorough analyses of existing technical data and evaluation of necessary performance metrics for quality assurances could be conducted to optimize application-specific PET/MRI protocols. This Symposium will focus on technical advances and limitations of clinical PET/MRI systems, and how this exciting imaging modality can be utilized in applications that can benefit from both PET and MRI. Learning Objectives: To understand the technological advances of clinical PET/MRI systems To correctly identify clinical applicationsmore » that can benefit from PET/MRI To understand ongoing work to further improve the current PET/MRI technology Floris Jansen is a GE Healthcare employee.« less

Investigation of the Study Characteristics Affecting Clinical Trial Quality Using the Protocol Deviations Leading to Exclusion of Subjects From the Per Protocol Set Data in Studies for New Drug Application: A Retrospective Analysis.

PubMed

Kohara, Norihito; Kaneko, Masayuki; Narukawa, Mamoru

2018-01-01

The concept of the risk-based approach has been introduced as an effort to secure the quality of clinical trials. In the risk-based approach, identification and evaluation of risk in advance are considered important. For recently completed clinical trials, we investigated the relationship between study characteristics and protocol deviations leading to the exclusion of subjects from Per Protocol Set (PPS) efficacy analysis. New drugs approved in Japan in the fiscal year 2014-2015 were targeted in the research. The reasons for excluding subjects from the PPS efficacy analysis were described in 102 trials out of 492 in the summary of new drug application documents, which was publicly disclosed after the drug's regulatory approval. The author extracted these reasons along with the numbers of the cases and the study characteristics of each clinical trial. Then, the direct comparison, univariate regression analysis, and multivariate regression analysis was carried out based on the exclusion rate. The study characteristics for which exclusion of subjects from the PPS efficacy analysis were frequently observed was multiregional clinical trials in study region; inhalant and external use in administration route; Anti-infective for systemic use; Respiratory system, Dermatologicals, and Nervous system in therapeutic drug under the Anatomical Therapeutic Chemical Classification. In the multivariate regression analysis, the clinical trial variables of inhalant, Respiratory system, or Dermatologicals were selected as study characteristics leading to a higher exclusion rate. The characteristics of the clinical trial that is likely to cause protocol deviations that will affect efficacy analysis were suggested. These studies should be considered for specific attention and priority observation in the trial protocol or its monitoring plan and execution, such as a clear description of inclusion/exclusion criteria in the protocol, development of training materials to site staff, and/or trial subjects as specific risk-alleviating measures.

A technical guide to tDCS, and related non-invasive brain stimulation tools.

PubMed

Woods, A J; Antal, A; Bikson, M; Boggio, P S; Brunoni, A R; Celnik, P; Cohen, L G; Fregni, F; Herrmann, C S; Kappenman, E S; Knotkova, H; Liebetanz, D; Miniussi, C; Miranda, P C; Paulus, W; Priori, A; Reato, D; Stagg, C; Wenderoth, N; Nitsche, M A

2016-02-01

Transcranial electrical stimulation (tES), including transcranial direct and alternating current stimulation (tDCS, tACS) are non-invasive brain stimulation techniques increasingly used for modulation of central nervous system excitability in humans. Here we address methodological issues required for tES application. This review covers technical aspects of tES, as well as applications like exploration of brain physiology, modelling approaches, tES in cognitive neurosciences, and interventional approaches. It aims to help the reader to appropriately design and conduct studies involving these brain stimulation techniques, understand limitations and avoid shortcomings, which might hamper the scientific rigor and potential applications in the clinical domain. Copyright © 2015 International Federation of Clinical Neurophysiology. All rights reserved.

Explanatory Versus Pragmatic Trials: An Essential Concept in Study Design and Interpretation.

PubMed

Merali, Zamir; Wilson, Jefferson R

2017-11-01

Randomized clinical trials often represent the highest level of clinical evidence available to evaluate the efficacy of an intervention in clinical medicine. Although the process of randomization serves to maximize internal validity, the external validity, or generalizability, of such studies depends on several factors determined at the design phase of the trial including eligibility criteria, study setting, and outcomes of interest. In general, explanatory trials are optimized to demonstrate the efficacy of an intervention in a highly selected patient group; however, findings from these studies may not be generalizable to the larger clinical problem. In contrast, pragmatic trials attempt to understand the real-world benefit of an intervention by incorporating design elements that allow for greater generalizability and clinical applicability of study results. In this article we describe the explanatory-pragmatic continuum for clinical trials in greater detail. Further, a well-accepted tool for grading trials on this continuum is described, and applied, to 2 recently published trials pertaining to the surgical management of lumbar degenerative spondylolisthesis.

Laser Speckle Contrast Imaging of Cerebral Blood Flow

PubMed Central

Dunn, Andrew K.

2011-01-01

Laser speckle contrast imaging (LSCI) has emerged over the past decade as a powerful, yet simple, method for imaging of blood flow dynamics in real time. The rapid adoption of LSCI for physiological studies is due to the relative ease and low cost of building an instrument as well as the ability to quantify blood flow changes with excellent spatial and temporal resolution. Although measurements are limited to superficial tissues with no depth resolution, LSCI has been instrumental in pre-clinical studies of neurological disorders as well as clinical applications including dermatological, neurosurgical and endoscopic studies. Recently a number of technical advances have been developed to improve the quantitative accuracy and temporal resolution of speckle imaging. This article reviews some of these recent advances and describes several applications of speckle imaging. PMID:22109805

Jean Comandon Neuroscientist.

PubMed

Lorusso, Lorenzo; Lefebvre, Thierry; de Pastre, Béatrice

2016-01-01

The microbiologist Jean Comandon is famous for his studies on the movement of the syphilis bacteria as differentiated in various forms by ultramicroscope. He was also a pioneer on the technical application of the microcinematography in laboratory research. His collaboration with clinicians and surgeons in the study of various pathological disorders is little known. From 1918 to the 1920s, he collaborated with such neurologists as André Thomas, Jean Athanase Sicard, and others in the study of various neurological disorders by using cinematography as a scientific tool for understanding the clinical and pathological mechanisms of diseases. These collaborations allowed him to be involved in the beginnings of the French cinematography industry, especially with Charles Pathé who established a small film studio laboratory in Vincennes where a multidisciplinary group improved the application of cinematography in clinical medical practice.

Development of Multimedia Computer Applications for Clinical Pharmacy Training.

ERIC Educational Resources Information Center

Schlict, John R.; Livengood, Bruce; Shepherd, John

1997-01-01

Computer simulations in clinical pharmacy education help expose students to clinical patient management earlier and enable training of large numbers of students outside conventional clinical practice sites. Multimedia instruction and its application to pharmacy training are described, the general process for developing multimedia presentations is…

Applications of Data Mining Methods in the Integrative Medical Studies of Coronary Heart Disease: Progress and Prospect

PubMed Central

Wang, Yixin; Guo, Fang

2014-01-01

A large amount of studies show that real-world study has strong external validity than the traditional randomized controlled trials and can evaluate the effect of interventions in a real clinical setting, which open up a new path for researches of integrative medicine in coronary heart disease. However, clinical data of integrative medicine in coronary heart disease are large in amount and complex in data types, making exploring the appropriate methodology a hot topic. Data mining techniques are to analyze and dig out useful information and knowledge from the mass data to guide people's practices. The present review provides insights for the main features of data mining and their applications of integrative medical studies in coronary heart disease, aiming to analyze the progress and prospect in this field. PMID:25544853

Influence of hyaluronic acid on bacterial and fungal species, including clinically relevant opportunistic pathogens.

PubMed

Ardizzoni, Andrea; Neglia, Rachele G; Baschieri, Maria C; Cermelli, Claudio; Caratozzolo, Manuela; Righi, Elena; Palmieri, Beniamino; Blasi, Elisabetta

2011-10-01

Hyaluronic acid (HA) has several clinical applications (aesthetic surgery, dermatology, orthopaedics and ophtalmology). Following recent evidence, suggesting antimicrobial and antiviral properties for HA, we investigated its effects on 15 ATCC strains, representative of clinically relevant bacterial and fungal species. The in vitro system employed allowed to assess optical density of broth cultures as a measure of microbial load in a time-dependent manner. The results showed that different microbial species and, sometimes, different strains belonging to the same species, are differently affected by HA. In particular, staphylococci, enterococci, Streptococcus mutans, two Escherichia coli strains, Pseudomonas aeruginosa, Candida glabrata and C. parapsilosis displayed a HA dose-dependent growth inhibition; no HA effects were detected in E. coli ATCC 13768 and C. albicans; S. sanguinis was favoured by the highest HA dose. Therefore, the influence of HA on bacteria and fungi warrants further studies aimed at better establishing its relevance in clinical applications.

Micropulsed diode laser therapy: evolution and clinical applications.

PubMed

Sivaprasad, Sobha; Elagouz, Mohammed; McHugh, Dominic; Shona, Olajumoke; Dorin, Giorgio

2010-01-01

Many clinical trials have demonstrated the clinical efficacy of laser photocoagulation in the treatment of retinal vascular diseases, including diabetic retinopathy. There is, however, collateral iatrogenic retinal damage and functional loss after conventional laser treatment. Such side effects may occur even when the treatment is appropriately performed because of morphological damage caused by the visible endpoint, typically a whitening burn. The development of the diode laser with micropulsed emission has allowed subthreshold therapy without a visible burn endpoint. This greatly reduces the risk of structural and functional retinal damage, while retaining the therapeutic efficacy of conventional laser treatment. Studies using subthreshold micropulse laser protocols have reported successful outcomes for diabetic macular edema, central serous chorioretinopathy, macular edema secondary to retinal vein occlusion, and primary open angle glaucoma. The report includes the rationale and basic principles underlying micropulse diode laser therapy, together with a review of its current clinical applications. Copyright © 2010 Elsevier Inc. All rights reserved.

Computer-Based Intepretation of the Marital Satisfaction Inventory: Use in Treatment Planning.

ERIC Educational Resources Information Center

Snyder, Douglas K.; And Others

1988-01-01

Describes computer-based interpretive system for Marital Satisfaction Inventory (MSI) and application in initial phases of clinical assessment and treatment planning. Provides case study. Compares clinical findings at intake with MSI profiles for one couple obtained at termination and follow-up. Considers strengths and limitations of self-report…

Applying openEHR's Guideline Definition Language to the SITS international stroke treatment registry: a European retrospective observational study.

PubMed

Anani, Nadim; Mazya, Michael V; Chen, Rong; Prazeres Moreira, Tiago; Bill, Olivier; Ahmed, Niaz; Wahlgren, Nils; Koch, Sabine

2017-01-10

Interoperability standards intend to standardise health information, clinical practice guidelines intend to standardise care procedures, and patient data registries are vital for monitoring quality of care and for clinical research. This study combines all three: it uses interoperability specifications to model guideline knowledge and applies the result to registry data. We applied the openEHR Guideline Definition Language (GDL) to data from 18,400 European patients in the Safe Implementation of Treatments in Stroke (SITS) registry to retrospectively check their compliance with European recommendations for acute stroke treatment. Comparing compliance rates obtained with GDL to those obtained by conventional statistical data analysis yielded a complete match, suggesting that GDL technology is reliable for guideline compliance checking. The successful application of a standard guideline formalism to a large patient registry dataset is an important step toward widespread implementation of computer-interpretable guidelines in clinical practice and registry-based research. Application of the methodology gave important results on the evolution of stroke care in Europe, important both for quality of care monitoring and clinical research.

Recommended Implementation of Arterial Spin Labeled Perfusion MRI for Clinical Applications: A consensus of the ISMRM Perfusion Study Group and the European Consortium for ASL in Dementia

PubMed Central

Alsop, David C.; Detre, John A.; Golay, Xavier; Günther, Matthias; Hendrikse, Jeroen; Hernandez-Garcia, Luis; Lu, Hanzhang; MacIntosh, Bradley J.; Parkes, Laura M.; Smits, Marion; van Osch, Matthias J. P.; Wang, Danny JJ; Wong, Eric C.; Zaharchuk, Greg

2014-01-01

This article provides a summary statement of recommended implementations of arterial spin labeling (ASL) for clinical applications. It is a consensus of the ISMRM Perfusion Study Group and the European ‘ASL in Dementia’ consortium, both of whom met to reach this consensus in October 2012 in Amsterdam. Although ASL continues to undergo rapid technical development, we believe that current ASL methods are robust and ready to provide useful clinical information, and that a consensus statement on recommended implementations will help the clinical community to adopt a standardized approach. In this article we describe the major considerations and tradeoffs in implementing an ASL protocol, and provide specific recommendations for a standard approach. Our conclusions are that, as an optimal default implementation we recommend: pseudo-continuous labeling, background suppression, a segmented 3D readout without vascular crushing gradients, and calculation and presentation of both label/control difference images and cerebral blood flow in absolute units using a simplified model. PMID:24715426

The circle of security parenting and parental conflict: a single case study

PubMed Central

Pazzagli, Chiara; Laghezza, Loredana; Manaresi, Francesca; Mazzeschi, Claudia; Powell, Bert

2014-01-01

The Circle of Security Parenting (COS-P) is an early attachment based intervention that can be used with groups, dyads, and individuals. Created in the USA and now used in many countries, COS-P is a visually based approach that demonstrates its central principles through videos of parent/child interactions. The core purpose of the COS-P is to provide an opportunity for caregivers to reflect on their child's needs and on the challenges each parent faces in meeting those needs. Even though there is a wide range of clinical settings in which child/parent attachment is an important component of assessment there is limited empirical data on when and how attachment based interventions are appropriate for specific clinical profiles and contexts. The aim of this paper is to present a clinical application of COS-P in order to explore and reflect on some specific therapeutic tasks where it works and on some clinical indicators and contexts appropriate for its application. A single case study of a father, “M.” (43 years old) in conflict for the custody of his 5 years old daughter is reported. The Adult Attachment Projective Picture System (AAP), the Parenting Stress Index, the Strengths and Difficulties Questionnaire, and the Parental Alliance Measure, were administered pre- and post-intervention. The clinical significance analysis method revealed that numerous changes occurred in the father. The AAP showed improvements in the level of agency of self. M. made gains in his capacity to use internal resources and to increase his agency of self. M. was classified as recovered in his perception of the child's functioning and as improved in his parenting stress and parenting alliance with the mother. Considerations on specific contexts and clinical indicators for the application of COS-P are proposed. PMID:25161643

[MRI methods for pulmonary ventilation and perfusion imaging].

PubMed

Sommer, G; Bauman, G

2016-02-01

Separate assessment of respiratory mechanics, gas exchange and pulmonary circulation is essential for the diagnosis and therapy of pulmonary diseases. Due to the global character of the information obtained clinical lung function tests are often not sufficiently specific in the differential diagnosis or have a limited sensitivity in the detection of early pathological changes. The standard procedures of pulmonary imaging are computed tomography (CT) for depiction of the morphology as well as perfusion/ventilation scintigraphy and single photon emission computed tomography (SPECT) for functional assessment. Magnetic resonance imaging (MRI) with hyperpolarized gases, O2-enhanced MRI, MRI with fluorinated gases and Fourier decomposition MRI (FD-MRI) are available for assessment of pulmonary ventilation. For assessment of pulmonary perfusion dynamic contrast-enhanced MRI (DCE-MRI), arterial spin labeling (ASL) and FD-MRI can be used. Imaging provides a more precise insight into the pathophysiology of pulmonary function on a regional level. The advantages of MRI are a lack of ionizing radiation, which allows a protective acquisition of dynamic data as well as the high number of available contrasts and therefore accessible lung function parameters. Sufficient clinical data exist only for certain applications of DCE-MRI. For the other techniques, only feasibility studies and case series of different sizes are available. The clinical applicability of hyperpolarized gases is limited for technical reasons. The clinical application of the techniques described, except for DCE-MRI, should be restricted to scientific studies.

Ten years of iPSC: clinical potential and advances in vitro hematopoietic differentiation.

PubMed

Paes, Bárbara Cristina Martins Fernandes; Moço, Pablo Diego; Pereira, Cristiano Gonçalves; Porto, Geciane Silveira; de Sousa Russo, Elisa Maria; Reis, Luiza Cunha Junqueira; Covas, Dimas Tadeu; Picanço-Castro, Virginia

2017-06-01

Ten years have passed since the first publication announcing the generation of induced pluripotent stem cells (iPSCs). Issues related to ethics, immune rejection, and cell availability seemed to be solved following this breakthrough. The development of iPSC technology allows advances in in vitro cell differentiation for cell therapy purpose and other clinical applications. This review provides a perspective on the iPSC potential for cell therapies, particularly for hematological applications. We discuss the advances in in vitro hematopoietic differentiation, the possibilities to employ iPSC in hematology studies, and their potential clinical application in hematologic diseases. The generation of red blood cells and functional T cells and the genome editing technology applied to mutation correction are also covered. We highlight some of the requirements and obstacles to be overcome before translating these cells from research to the clinic, for instance, iPSC variability, genotoxicity, the differentiation process, and engraftment. Also, we evaluate the patent landscape and compile the clinical trials in the field of pluripotent stem cells. Currently, we know much more about iPSC than in 2006, but there are still challenges that must be solved. A greater understanding of molecular mechanisms underlying the generation of hematopoietic stem cells is necessary to produce suitable and transplantable hematopoietic stem progenitor cells from iPSC.

Aspects of matrix effects in applications of liquid chromatography-mass spectrometry to forensic and clinical toxicology--a review.

PubMed

Peters, Frank T; Remane, Daniela

2012-06-01

In the last decade, liquid chromatography coupled to (tandem) mass spectrometry (LC-MS(-MS)) has become a versatile technique with many routine applications in clinical and forensic toxicology. However, it is well-known that ionization in LC-MS(-MS) is prone to so-called matrix effects, i.e., alteration in response due to the presence of co-eluting compounds that may increase (ion enhancement) or reduce (ion suppression) ionization of the analyte. Since the first reports on such matrix effects, numerous papers have been published on this matter and the subject has been reviewed several times. However, none of the existing reviews has specifically addressed aspects of matrix effects of particular interest and relevance to clinical and forensic toxicology, for example matrix effects in methods for multi-analyte or systematic toxicological analysis or matrix effects in (alternative) matrices almost exclusively analyzed in clinical and forensic toxicology, for example meconium, hair, oral fluid, or decomposed samples in postmortem toxicology. This review article will therefore focus on these issues, critically discussing experiments and results of matrix effects in LC-MS(-MS) applications in clinical and forensic toxicology. Moreover, it provides guidance on performance of studies on matrix effects in LC-MS(-MS) procedures in systematic toxicological analysis and postmortem toxicology.

Stem Cells and Regenerative Medicine: Myth or Reality of the 21th Century

PubMed Central

Stoltz, J.-F.; de Isla, N.; Li, Y. P.; Bensoussan, D.; Zhang, L.; Huselstein, C.; Chen, Y.; Decot, V.; Magdalou, J.; Li, N.; Reppel, L.; He, Y.

2015-01-01

Since the 1960s and the therapeutic use of hematopoietic stem cells of bone marrow origin, there has been an increasing interest in the study of undifferentiated progenitors that have the ability to proliferate and differentiate into various tissues. Stem cells (SC) with different potency can be isolated and characterised. Despite the promise of embryonic stem cells, in many cases, adult or even fetal stem cells provide a more interesting approach for clinical applications. It is undeniable that mesenchymal stem cells (MSC) from bone marrow, adipose tissue, or Wharton's Jelly are of potential interest for clinical applications in regenerative medicine because they are easily available without ethical problems for their uses. During the last 10 years, these multipotent cells have generated considerable interest and have particularly been shown to escape to allogeneic immune response and be capable of immunomodulatory activity. These properties may be of a great interest for regenerative medicine. Different clinical applications are under study (cardiac insufficiency, atherosclerosis, stroke, bone and cartilage deterioration, diabetes, urology, liver, ophthalmology, and organ's reconstruction). This review focuses mainly on tissue and organ regeneration using SC and in particular MSC. PMID:26300923

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.

[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 oncologic applications of PET/MRI: a new horizon

PubMed Central

Partovi, Sasan; Kohan, Andres; Rubbert, Christian; Vercher-Conejero, Jose Luis; Gaeta, Chiara; Yuh, Roger; Zipp, Lisa; Herrmann, Karin A; Robbin, Mark R; Lee, Zhenghong; Muzic, Raymond F; Faulhaber, Peter; Ros, Pablo R

2014-01-01

Positron emission tomography/magnetic resonance imaging (PET/MRI) leverages the high soft-tissue contrast and the functional sequences of MR with the molecular information of PET in one single, hybrid imaging technology. This technology, which was recently introduced into the clinical arena in a few medical centers worldwide, provides information about tumor biology and microenvironment. Studies on indirect PET/MRI (use of positron emission tomography/computed tomography (PET/CT) images software fused with MRI images) have already generated interesting preliminary data to pave the ground for potential applications of PET/MRI. These initial data convey that PET/MRI is promising in neuro-oncology and head & neck cancer applications as well as neoplasms in the abdomen and pelvis. The pediatric and young adult oncology population requiring frequent follow-up studies as well as pregnant woman might benefit from PET/MRI due to its lower ionizing radiation dose. The indication and planning of therapeutic interventions and specifically radiation therapy in individual patients could be and to a certain extent are already facilitated by performing PET/MRI. The objective of this article is to discuss potential clinical oncology indications of PET/MRI. PMID:24753986

[Development and application of hospital customer service center platform].

PubMed

Chen, Minya; Zheng, Konglin; Xia, Yong

2012-01-01

This paper introduces the construction and application of the platform of client service center in the general hospital and discusses how to provide patients with an entire service including service before clinic, on clinic and after clinic. It can also provide references for a new service mode for clinic service.

Accelerated approval of oncology products: a decade of experience.

PubMed

Dagher, Ramzi; Johnson, John; Williams, Grant; Keegan, Patricia; Pazdur, Richard

2004-10-20

We review the regulatory history of the accelerated approval process and summarize the U.S. Food and Drug Administration experience with accelerated approvals in oncology. The accelerated approval regulations, promulgated in 1992, allow approval of drugs for serious or life-threatening diseases on the basis of a surrogate endpoint that is reasonably likely to predict clinical benefit, such as survival or symptom benefit, pending completion of studies designed to confirm clinical benefit, referred to as phase 4 commitments, which are required to be conducted with due diligence. From 1992 to 2004, 22 applications involving anticancer drugs or biologics were approved. Of these 22 applications, accelerated approval was granted to 15 on the basis of findings from studies without an active comparator (i.e., single-arm studies or studies comparing two dose levels) and to the remaining seven on the basis of one or more randomized studies. Of the 22 approved applications, six (i.e., applications for dexrazoxane, irinotecan, capecitabine, docetaxel, imatinib mesylate, and oxaliplatin) have had one or more indications converted to regular approval. This review reports information that was presented at an Oncologic Drugs Advisory Committee meeting held in March 2003; it also presents a discussion of accelerated approval study designs, the study populations evaluated in the accelerated approval and confirmatory settings, and the integration of accelerated approval into a comprehensive drug development plan.

Feasibility of using interstitial ultrasound for intradiscal thermal therapy: a study in human cadaver lumbar discs

NASA Astrophysics Data System (ADS)

Nau, William H.; Diederich, Chris J.; Shu, Richard

2005-06-01

Application of heat in the spine using resistive wire heating devices is currently being used clinically for minimally invasive treatment of discogenic low back pain. In this study, interstitial ultrasound was evaluated for the potential to heat intradiscal tissue more precisely by directing energy towards the posterior annular wall while avoiding vertebral bodies. Two single-element directional applicator design configurations were tested: a 1.5 mm OD direct-coupled (DC) applicator which can be implanted directly within the disc, and a catheter-cooled (CC) applicator which is inserted in a 2.4 mm OD catheter with integrated water cooling and implanted within the disc. The transducers were sectored to produce 90° spatial heating patterns for directional control. Both applicator configurations were evaluated in four human cadaver lumbar disc motion segments. Two heating protocols were employed in this study in which the temperature measured 5 mm away from the applicator was controlled to either T = 52 °C, or T > 70 °C for the treatment period. These temperatures (thermal doses) are representative of those required for thermal necrosis of in-growing nociceptor nerve fibres and disc cellularity alone, or with coagulation and restructuring of annular collagen in the high-temperature case. Steady-state temperature maps, and thermal doses (t43) were used to assess the thermal treatments. Results from these studies demonstrated the capability of controlling temperature distributions within selected regions of the disc and annular wall using interstitial ultrasound, with minimal vertebral end-plate heating. While directional heating was demonstrated with both applicator designs, the CC configuration had greater directional heating capabilities and offered better temperature control than the DC configuration, particularly during the high-temperature protocol. Further, ultrasound energy was capable of penetrating within the highly attenuating disc tissue to produce more extensive radial thermal penetration, lower maximum intradiscal temperature, and shorter treatment times than can be achieved with current clinical intradiscal heating technology. Thus, interstitial ultrasound offers potential as a more precise and faster heating modality for the clinical management of low back pain.

The effect of exercise on skeletal muscle fibre type distribution in obesity: From cellular levels to clinical application.

PubMed

Pattanakuhar, Sintip; Pongchaidecha, Anchalee; Chattipakorn, Nipon; Chattipakorn, Siriporn C

Skeletal muscles play important roles in metabolism, energy expenditure, physical strength, and locomotive activity. Skeletal muscle fibre types in the body are heterogeneous. They can be classified as oxidative types and glycolytic types with oxidative-type are fatigue-resistant and use oxidative metabolism, while fibres with glycolytic-type are fatigue-sensitive and prefer glycolytic metabolism. Several studies demonstrated that an obese condition with abnormal metabolic parameters has been negatively correlated with the distribution of oxidative-type skeletal muscle fibres, but positively associated with that of glycolytic-type muscle fibres. However, some studies demonstrated otherwise. In addition, several studies demonstrated that an exercise training programme caused the redistribution of oxidative-type skeletal muscle fibres in obesity. In contrast, some studies showed inconsistent findings. Therefore, the present review comprehensively summarizes and discusses those consistent and inconsistent findings from clinical studies, regarding the association among the distribution of skeletal muscle fibre types, obese condition, and exercise training programmes. Furthermore, the possible underlying mechanisms and clinical application of the alterations in muscle fibre type following obesity are presented and discussed. Copyright © 2016 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

Therapeutic applications of circadian rhythms for the cardiovascular system

PubMed Central

Tsimakouridze, Elena V.; Alibhai, Faisal J.; Martino, Tami A.

2015-01-01

The cardiovascular system exhibits dramatic time-of-day dependent rhythms, for example the diurnal variation of heart rate, blood pressure, and timing of onset of adverse cardiovascular events such as heart attack and sudden cardiac death. Over the past decade, the circadian clock mechanism has emerged as a crucial factor regulating these daily fluctuations. Most recently, these studies have led to a growing clinical appreciation that targeting circadian biology offers a novel therapeutic approach toward cardiovascular (and other) diseases. Here we describe leading-edge therapeutic applications of circadian biology including (1) timing of therapy to maximize efficacy in treating heart disease (chronotherapy); (2) novel biomarkers discovered by testing for genomic, proteomic, metabolomic, or other factors at different times of day and night (chronobiomarkers); and (3) novel pharmacologic compounds that target the circadian mechanism with potential clinical applications (new chronobiology drugs). Cardiovascular disease remains a leading cause of death worldwide and new approaches in the management and treatment of heart disease are clearly warranted and can benefit patients clinically. PMID:25941487

Functional optical coherence tomography: principles and progress

NASA Astrophysics Data System (ADS)

Kim, Jina; Brown, William; Maher, Jason R.; Levinson, Howard; Wax, Adam

2015-05-01

In the past decade, several functional extensions of optical coherence tomography (OCT) have emerged, and this review highlights key advances in instrumentation, theoretical analysis, signal processing and clinical application of these extensions. We review five principal extensions: Doppler OCT (DOCT), polarization-sensitive OCT (PS-OCT), optical coherence elastography (OCE), spectroscopic OCT (SOCT), and molecular imaging OCT. The former three have been further developed with studies in both ex vivo and in vivo human tissues. This review emphasizes the newer techniques of SOCT and molecular imaging OCT, which show excellent potential for clinical application but have yet to be well reviewed in the literature. SOCT elucidates tissue characteristics, such as oxygenation and carcinogenesis, by detecting wavelength-dependent absorption and scattering of light in tissues. While SOCT measures endogenous biochemical distributions, molecular imaging OCT detects exogenous molecular contrast agents. These newer advances in functional OCT broaden the potential clinical application of OCT by providing novel ways to understand tissue activity that cannot be accomplished by other current imaging methodologies.

Functional Optical Coherence Tomography: Principles and Progress

PubMed Central

Kim, Jina; Brown, William; Maher, Jason R.; Levinson, Howard; Wax, Adam

2015-01-01

In the past decade, several functional extensions of optical coherence tomography (OCT) have emerged, and this review highlights key advances in instrumentation, theoretical analysis, signal processing and clinical application of these extensions. We review five principal extensions: Doppler OCT (DOCT), polarization-sensitive OCT (PS-OCT), optical coherence elastography (OCE), spectroscopic OCT (SOCT), and molecular imaging OCT. The former three have been further developed with studies in both ex vivo and in vivo human tissues. This review emphasizes the newer techniques of SOCT and molecular imaging OCT, which show excellent potential for clinical application but have yet to be well reviewed in the literature. SOCT elucidates tissue characteristics, such as oxygenation and carcinogenesis, by detecting wavelength-dependent absorption and scattering of light in tissues. While SOCT measures endogenous biochemical distributions, molecular imaging OCT detects exogenous molecular contrast agents. These newer advances in functional OCT broaden the potential clinical application of OCT by providing novel ways to understand tissue activity that cannot be accomplished by other current imaging methodologies. PMID:25951836

Current laser applications in reconstructive microsurgery: A review of the literature.

PubMed

Leclère, Franck Marie; Vogt, Peter; Schoofs, Michel; Delattre, Maryline; Mordon, Serge

2016-06-01

Microvascular surgery has become an important method for reconstructing surgical defects following trauma, tumor resection, or burns. Laser-assisted microanastomoses (LAMA) were introduced by Jain in 1979 in order to help the microsurgeon reduce both operating time and complications. This article reviews the literature on clinical applications of LAMA. A Medline literature search was performed and cross-referenced. Articles between 1979 and 2014 were included. Keywords used were laser, laser microanastomoses, laser microanastomosis, LAMA, and microsurgery. Only seven clinical studies using three different wavelengths were found in the literature: 1,064 nm (Nd: YAG), 10,600 nm (CO2), 514 nm (Argon), and 1,950 nm (Diode). Clinical outcomes, type of procedures, laser wavelength and parameters, and possible wider applications in the operating room are discussed in each case. The success rate for reconstructive free flap surgery and hand surgery achieved with LAMA appears promising. In particular, use of the 1950-nm diode laser for microsurgery is likely to increase in the near future.

Fluorescence fluctuation spectroscopy for clinical applications

NASA Astrophysics Data System (ADS)

Olson, Eben

Fluorescence correlation spectroscopy (FCS) and the related techniques of brightness analysis have become standard tools in biological and biophysical research. By analyzing the statistics of fluorescence emitted from a restricted volume, a number of parameters including concentrations, diffusion coefficients and chemical reaction rates can be determined. The single-molecule sensitivity, spectral selectivity, small sample volume and non-perturbative measurement mechanism of FCS make it an excellent technique for the study of molecular interactions. However, its adoption outside of the research laboratory has been limited. Potential reasons for this include the cost and complexity of the required apparatus. In this work, the application of fluorescence fluctuation analysis to several clinical problems is considered. Optical designs for FCS instruments which reduce the cost and increase alignment tolerance are presented. Brightness analysis of heterogenous systems, with application to the characterization of protein aggregates and multimer distributions, is considered. Methods for FCS-based assays of two clinically relevant proteins, von Willebrand factor and haptoglobin, are presented as well.

Ultrasonic propulsion of kidney stones.

PubMed

May, Philip C; Bailey, Michael R; Harper, Jonathan D

2016-05-01

Ultrasonic propulsion is a novel technique that uses short bursts of focused ultrasonic pulses to reposition stones transcutaneously within the renal collecting system and ureter. The purpose of this review is to discuss the initial testing of effectiveness and safety, directions for refinement of technique and technology, and opinions on clinical application. Preclinical studies with a range of probes, interfaces, and outputs have demonstrated feasibility and consistent safety of ultrasonic propulsion with room for increased outputs and refinement toward specific applications. Ultrasonic propulsion was used painlessly and without adverse events to reposition stones in 14 of 15 human study participants without restrictions on patient size, stone size, or stone location. The initial feasibility study showed applicability in a range of clinically relevant situations, including facilitating passage of residual fragments following ureteroscopy or shock wave lithotripsy, moving a large stone at the ureteropelvic junction with relief of pain, and differentiating large stones from a collection of small fragments. Ultrasonic propulsion shows promise as an office-based system for transcutaneously repositioning kidney stones. Potential applications include facilitating expulsion of residual fragments following ureteroscopy or shock wave lithotripsy, repositioning stones prior to treatment, and repositioning obstructing ureteropelvic junction stones into the kidney to alleviate acute renal colic.

Ultrasonic propulsion of kidney stones

PubMed Central

May, Philip C.; Bailey, Michael R.; Harper, Jonathan D.

2016-01-01

Purpose of review Ultrasonic propulsion is a novel technique that uses short bursts of focused ultrasonic pulses to reposition stones transcutaneously within the renal collecting system and ureter. The purpose of this review is to discuss the initial testing of effectiveness and safety, directions for refinement of technique and technology, and opinions on clinical application. Recent findings Preclinical studies with a range of probes, interfaces, and outputs have demonstrated feasibility and consistent safety of ultrasonic propulsion with room for increased outputs and refinement toward specific applications. Ultrasonic propulsion was used painlessly and without adverse events to reposition stones in 14 of 15 human study participants without restrictions on patient size, stone size, or stone location. The initial feasibility study showed applicability in a range of clinically relevant situations, including facilitating passage of residual fragments following ureteroscopy or shock wave lithotripsy, moving a large stone at the UPJ with relief of pain, and differentiating large stones from a collection of small fragments. Summary Ultrasonic propulsion shows promise as an office-based system for transcutaneously repositioning kidney stones. Potential applications include facilitating expulsion of residual fragments following ureteroscopy or shock wave lithotripsy, repositioning stones prior to treatment, and repositioning obstructing UPJ stones into the kidney to alleviate acute renal colic. PMID:26845428

Translating self-persuasion into an adolescent HPV vaccine promotion intervention for parents attending safety-net clinics.

PubMed

Baldwin, Austin S; Denman, Deanna C; Sala, Margarita; Marks, Emily G; Shay, L Aubree; Fuller, Sobha; Persaud, Donna; Lee, Simon Craddock; Skinner, Celette Sugg; Wiebe, Deborah J; Tiro, Jasmin A

2017-04-01

Self-persuasion is an effective behavior change strategy, but has not been translated for low-income, less educated, uninsured populations attending safety-net clinics or to promote human papillomavirus (HPV) vaccination. We developed a tablet-based application (in English and Spanish) to elicit parental self-persuasion for adolescent HPV vaccination and evaluated its feasibility in a safety-net population. Parents (N=45) of age-eligible adolescents used the self-persuasion application. Then, during cognitive interviews, staff gathered quantitative and qualitative feedback on the self-persuasion tasks including parental decision stage. The self-persuasion tasks were rated as easy to complete and helpful. We identified six question prompts rated as uniformly helpful, not difficult to answer, and generated non-redundant responses from participants. Among the 33 parents with unvaccinated adolescents, 27 (81.8%) reported deciding to get their adolescent vaccinated after completing the self-persuasion tasks. The self-persuasion application was feasible and resulted in a change in parents' decision stage. Future studies can now test the efficacy of the tablet-based application on HPV vaccination. The self-persuasion application facilitates verbalization of reasons for HPV vaccination in low literacy, safety-net settings. This self-administered application has the potential to be more easily incorporated into clinical practice than other patient education approaches. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Application of microfluidic technologies to human assisted reproduction.

PubMed

Smith, Gary D; Takayama, Shuichi

2017-04-01

Microfluidics can be considered both a science and a technology. It is defined as the study of fluid behavior at a sub-microliter level and the investigation into its application to cell biology, chemistry, genetics, molecular biology and medicine. There are at least two characteristics of microfluidics, mechanical and biochemical, which can be influential in the field of mammalian gamete and preimplantation embryo biology. These microfluidic characteristics can assist in basic biological studies on sperm, oocyte and preimplantation embryo structure, function and environment. The mechanical and biochemical characteristics of microfluidics may also have practical and/or technical application(s) to assisted reproductive technologies (ART) in rodents, domestic species, endangered species and humans. This review will consider data in mammals, and when available humans, addressing the potential application(s) of microfluidics to assisted reproduction. There are numerous sequential steps in the clinical assisted reproductive laboratory process that work, yet could be improved. Cause and effect relations of procedural inefficiencies can be difficult to identify and/or remedy. Data will be presented that consider microfluidic applications to sperm isolation, oocyte cumulus complex isolation, oocyte denuding, oocyte mechanical manipulation, conventional insemination, intracytoplasmic sperm injection, embryo culture, embryo analysis and oocyte and embryo cryopreservation. While these studies have progressed in animal models, data with human gametes and embryos are significantly lacking. These data from clinical trials are requisite for making future evidence-based decisions regarding the application of microfluidics in human ART. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.For Permissions, please email: journals.permissions@oup.com.

Graduate admissions in clinical neuropsychology: the importance of undergraduate training.

PubMed

Karazsia, Bryan T; Stavnezer, Amy Jo; Reeves, Jonathan W

2013-11-01

Discussions of and recommendations for the training of clinical neuropsychologists exist at the doctoral, internship, and post-doctoral level. With few exceptions, the literature on undergraduate preparations in clinical neuropsychology is sparse and lacks empirical evidence. In the present study, graduate-level faculty and current trainees completed surveys about graduate school preparations. Faculty expectations of minimum and ideal undergraduate training were highest for research methods, statistics, and assessment. Preferences for "goodness of fit" also emerged as important admissions factors. These results offer evidence for desirable undergraduate preparations for advanced study in clinical neuropsychology. Although undergraduate training in psychology is intentionally broad, results from this study suggest that students who desire advanced study in clinical neuropsychology need to tailor their experiences to be competitive in the application process. The findings have implications for prospective graduate students, faculty who train and mentor undergraduates, and faculty who serve on admissions committees.

Integrating statistical and clinical research elements in intervention-related grant applications: summary from an NIMH workshop.

PubMed

Sherrill, Joel T; Sommers, David I; Nierenberg, Andrew A; Leon, Andrew C; Arndt, Stephan; Bandeen-Roche, Karen; Greenhouse, Joel; Guthrie, Donald; Normand, Sharon-Lise; Phillips, Katharine A; Shear, M Katherine; Woolson, Robert

2009-01-01

The authors summarize points for consideration generated in a National Institute of Mental Health (NIMH) workshop convened to provide an opportunity for reviewers from different disciplines-specifically clinical researchers and statisticians-to discuss how their differing and complementary expertise can be well integrated in the review of intervention-related grant applications. A 1-day workshop was convened in October, 2004. The workshop featured panel presentations on key topics followed by interactive discussion. This article summarizes the workshop and subsequent discussions, which centered on topics including weighting the statistics/data analysis elements of an application in the assessment of the application's overall merit; the level of statistical sophistication appropriate to different stages of research and for different funding mechanisms; some key considerations in the design and analysis portions of applications; appropriate statistical methods for addressing essential questions posed by an application; and the role of the statistician in the application's development, study conduct, and interpretation and dissemination of results. A number of key elements crucial to the construction and review of grant applications were identified. It was acknowledged that intervention-related studies unavoidably involve trade-offs. Reviewers are helped when applications acknowledge such trade-offs and provide good rationale for their choices. Clear linkage among the design, aims, hypotheses, and data analysis plan and avoidance of disconnections among these elements also strengthens applications. The authors identify multiple points to consider when constructing intervention-related grant applications. The points are presented here as questions and do not reflect institute policy or comprise a list of best practices, but rather represent points for consideration.

Reversible Nerve Conduction Block Using Kilohertz Frequency Alternating Current

PubMed Central

Kilgore, Kevin L.; Bhadra, Niloy

2013-01-01

Objectives The features and clinical applications of balanced-charge kilohertz frequency alternating currents (KHFAC) are reviewed. Preclinical studies of KHFAC block have demonstrated that it can produce an extremely rapid and reversible block of nerve conduction. Recent systematic analysis and experimentation utilizing KHFAC block has resulted in a significant increase in interest in KHFAC block, both scientifically and clinically. Materials and Methods We review the history and characteristics of KHFAC block, the methods used to investigate this type of block, the experimental evaluation of block, and the electrical parameters and electrode designs needed to achieve successful block. We then analyze the existing clinical applications of high frequency currents, comparing the early results with the known features of KHFAC block. Results Although many features of KHFAC block have been characterized, there is still much that is unknown regarding the response of neural structures to rapidly fluctuating electrical fields. The clinical reports to date do not provide sufficient information to properly evaluate the mechanisms that result in successful or unsuccessful treatment. Conclusions KHFAC nerve block has significant potential as a means of controlling nerve activity for the purpose of treating disease. However, early clinical studies in the use of high frequency currents for the treatment of pain have not been designed to elucidate mechanisms or allow direct comparisons to preclinical data. We strongly encourage the careful reporting of the parameters utilized in these clinical studies, as well as the development of outcome measures that could illuminate the mechanisms of this modality. PMID:23924075

RBE and related modeling in carbon-ion therapy

NASA Astrophysics Data System (ADS)

Karger, Christian P.; Peschke, Peter

2018-01-01

Carbon ion therapy is a promising evolving modality in radiotherapy to treat tumors that are radioresistant against photon treatments. As carbon ions are more effective in normal and tumor tissue, the relative biological effectiveness (RBE) has to be calculated by bio-mathematical models and has to be considered in the dose prescription. This review (i) introduces the concept of the RBE and its most important determinants, (ii) describes the physical and biological causes of the increased RBE for carbon ions, (iii) summarizes available RBE measurements in vitro and in vivo, and (iv) describes the concepts of the clinically applied RBE models (mixed beam model, local effect model, and microdosimetric-kinetic model), and (v) the way they are introduced into clinical application as well as (vi) their status of experimental and clinical validation, and finally (vii) summarizes the current status of the use of the RBE concept in carbon ion therapy and points out clinically relevant conclusions as well as open questions. The RBE concept has proven to be a valuable concept for dose prescription in carbon ion radiotherapy, however, different centers use different RBE models and therefore care has to be taken when transferring results from one center to another. Experimental studies significantly improve the understanding of the dependencies and limitations of RBE models in clinical application. For the future, further studies investigating quantitatively the differential effects between normal tissues and tumors are needed accompanied by clinical studies on effectiveness and toxicity.

Rater reliability and construct validity of a mobile application for posture analysis

PubMed Central

Szucs, Kimberly A.; Brown, Elena V. Donoso

2018-01-01

[Purpose] Measurement of posture is important for those with a clinical diagnosis as well as researchers aiming to understand the impact of faulty postures on the development of musculoskeletal disorders. A reliable, cost-effective and low tech posture measure may be beneficial for research and clinical applications. The purpose of this study was to determine rater reliability and construct validity of a posture screening mobile application in healthy young adults. [Subjects and Methods] Pictures of subjects were taken in three standing positions. Two raters independently digitized the static standing posture image twice. The app calculated posture variables, including sagittal and coronal plane translations and angulations. Intra- and inter-rater reliability were calculated using the appropriate ICC models for complete agreement. Construct validity was determined through comparison of known groups using repeated measures ANOVA. [Results] Intra-rater reliability ranged from 0.71 to 0.99. Inter-rater reliability was good to excellent for all translations. ICCs were stronger for translations versus angulations. The construct validity analysis found that the app was able to detect the change in the four variables selected. [Conclusion] The posture mobile application has demonstrated strong rater reliability and preliminary evidence of construct validity. This application may have utility in clinical and research settings. PMID:29410561

Rater reliability and construct validity of a mobile application for posture analysis.

PubMed

Szucs, Kimberly A; Brown, Elena V Donoso

2018-01-01

[Purpose] Measurement of posture is important for those with a clinical diagnosis as well as researchers aiming to understand the impact of faulty postures on the development of musculoskeletal disorders. A reliable, cost-effective and low tech posture measure may be beneficial for research and clinical applications. The purpose of this study was to determine rater reliability and construct validity of a posture screening mobile application in healthy young adults. [Subjects and Methods] Pictures of subjects were taken in three standing positions. Two raters independently digitized the static standing posture image twice. The app calculated posture variables, including sagittal and coronal plane translations and angulations. Intra- and inter-rater reliability were calculated using the appropriate ICC models for complete agreement. Construct validity was determined through comparison of known groups using repeated measures ANOVA. [Results] Intra-rater reliability ranged from 0.71 to 0.99. Inter-rater reliability was good to excellent for all translations. ICCs were stronger for translations versus angulations. The construct validity analysis found that the app was able to detect the change in the four variables selected. [Conclusion] The posture mobile application has demonstrated strong rater reliability and preliminary evidence of construct validity. This application may have utility in clinical and research settings.

A comparison of dehydration effects of V2-antagonist (OPC-31260) on the inner ear between systemic and round window applications.

PubMed

Takeda, Taizo; Takeda, Setsuko; Kakigi, Akinobu; Okada, Teruhiko; Nishioka, Rie; Taguchi, Daizo

2006-08-01

V2-antagonist (OPC-31260 (OPC)) application to the scala tympani reduced endolymphatic hydrops. In the present study, we investigated whether systemic administration or local infusion via the round window (RW application) of OPC would be more suitable for clinical use. In Experiment 1, the increase ratios of the cross-sectional area of the scala media of experimentally induced endolymphatic hydrops were quantitatively assessed among four groups of non-OPC application, RW application of xanthan gum, systemic application of OPC and RW application of OPC. In Experiment 2, the effects of systemic and RW applications of OPC on plasma vasopressin (p-VP) concentrations and plasma osmolality (p-OSM) were investigated. In Experiment 3, endocochlear DC potential (EP) was measured in guinea pigs with the RW application of OPC. Electron microscopic observations of the stria vascularis and the hair cells were also made. Both systemic and RW applications of OPC significantly reduced endolymphatic hydrops. However, systemic application resulted in the distension of the Reissner's membrane in the non-operated ear, which seemed to be caused by elevated p-VP levels resulting from the systemic application of OPC. In contrast, RW application of OPC produced no apparent toxic effects in the inner ear, as indicated electrophysiological or morphological changes. Thus, drug delivery via the round window is more useful for the clinical application of OPC for medical decompression.

Ethical and social implications of genetic testing for communication disorders.

PubMed

Arnos, Kathleen S

2008-01-01

Advances in genetics and genomics have quickly led to clinical applications to human health which have far-reaching consequences at the individual and societal levels. These new technologies have allowed a better understanding of the genetic factors involved in a wide range of disorders. During the past decade, incredible progress has been made in the identification of genes involved in the normal process of hearing. The resulting clinical applications have presented consumers with new information and choices. Many of the same gene identification techniques are increasingly being applied to the investigation of complex disorders of speech and language. In parallel with gene identification, studies of the legal, ethical and psychosocial impacts of the clinical application of these advances and their influence on specific behaviors of individuals with communication disorders are paramount, but often lag behind. These studies will help to ensure that new technologies are introduced into clinical practice in a responsible manner. As a result of this activity, the participant will be able to (1) explain the differences between Mendelian and complex forms of inheritance and why these differences complicate the ethical impact of genetic testing, (2) explain how publicly funded genome research through the Human Genome Project, the International HapMap Project and others have examined the ethical, legal and social implications of genome research, (3) list some of the ethical complexities of prenatal, newborn and predictive testing for various genetic disorders and (4) discuss the importance of evidence-based practice to the development of public policy for the introduction and clinical use of genetic tests.

Ethical and social implications of genetic testing for communication disorders

PubMed Central

Arnos, Kathleen S.

2013-01-01

Advances in genetics and genomics have quickly led to clinical applications to human health which have far-reaching consequences at the individual and societal levels. These new technologies have allowed a better understanding of the genetic factors involved in a wide range of disorders. During the past decade, incredible progress has been made in the identification of genes involved in the normal process of hearing. The resulting clinical applications have presented consumers with new information and choices. Many of the same gene identification techniques are increasingly being applied to the investigation of complex disorders of speech and language. In parallel with gene identification, studies of the legal, ethical and psychosocial impacts of the clinical application of these advances and their influence on specific behaviors of individuals with communication disorders are paramount, but often lag behind. These studies will help to ensure that new technologies are introduced into clinical practice in a responsible manner. Learning outcomes As a result of this activity, the participant will be able to (1) explain the differences between Mendelian and complex forms of inheritance and why these differences complicate the ethical impact of genetic testing, (2) explain how publicly funded genome research through the Human Genome Project, the International HapMap Project and others have examined the ethical, legal and social implications of genome research, (3) list some of the ethical complexities of prenatal, newborn and predictive testing for various genetic disorders and (4) discuss the importance of evidence-based practice to the development of public policy for the introduction and clinical use of genetic tests. PMID:18452941

Bone Tissue Engineering Under Xenogeneic-Free Conditions in a Large Animal Model as a Basis for Early Clinical Applicability.

PubMed

Weigand, Annika; Beier, Justus P; Schmid, Rafael; Knorr, Tobias; Kilian, David; Götzl, Rebekka; Gerber, Thomas; Horch, Raymund E; Boos, Anja M

2017-03-01

For decades, researchers have been developing a range of promising strategies in bone tissue engineering with the aim of producing a significant clinical benefit over existing therapies. However, a major problem concerns the traditional use of xenogeneic substances for the expansion of cells, which complicates direct clinical transfer. The study's aim was to establish a totally autologous sheep model as a basis for further preclinical studies and future clinical application. Ovine mesenchymal stromal cells (MSC) were cultivated in different concentrations (0%, 2%, 5%, 10%, and 25%) of either autologous serum (AS) or fetal calf serum (FCS). With an increase of serum concentration, enhanced metabolic activity and proliferation could be observed. There were minor differences between MSC cultivated in AS or FCS, comparing gene and protein expression of osteogenic and stem cell markers, morphology, and osteogenic differentiation. MSC implanted subcutaneously in the sheep model, together with a nanostructured bone substitute, either in stable block or moldable putty form, induced similar vascularization and remodeling of the bone substitute irrespective of cultivation of MSC in AS or FCS and osteogenic differentiation. The bone substitute in block form together with MSC proved particularly advantageous in the induction of ectopic bone formation compared to the cell-free control and putty form. It could be demonstrated that AS is suitable for replacement of FCS for cultivation of ovine MSC for bone tissue engineering purposes. Substantial progress has been made in the development of a strictly xenogeneic-free preclinical animal model to bring future clinical application of bone tissue engineering strategies within reach.

Leading Educational Change Using a Neuropsychological Response-to-Intervention Approach: Linking Our Past, Present, and Future

ERIC Educational Resources Information Center

Witsken, Deborah; Stoeckel, Amanda; D'Amato, Rik Carl

2008-01-01

Neuropsychology may be described as the study of brain-behavior relationships (National Academy of Neuropsychology [NAN], 2001). Clinical neuropsychology represents the application of knowledge of the intricacies of these relationships to individual cases. Several authors have advocated for the application of neuropsychology to the public schools,…

Capacity of dental equipment to interfere with cardiac implantable electrical devices.

PubMed

Lahor-Soler, Eduard; Miranda-Rius, Jaume; Brunet-Llobet, Lluís; Sabaté de la Cruz, Xavier

2015-06-01

Patients with cardiac implantable electrical devices should take precautions when exposed to electromagnetic fields. Possible interference as a result of proximity to electromagnets or electricity flow from electronic tools employed in clinical odontology remains controversial. The objective of this study was to examine in vitro the capacity of dental equipment to provoke electromagnetic interference in pacemakers and implantable cardioverter defibrillators. Six electronic dental instruments were tested on three implantable cardioverter defibrillators and three pacemakers from different manufacturers. A simulator model, submerged in physiological saline, with elements that reproduced life-size anatomic structures was used. The instruments were analyzed at differing distances and for different time periods of application. The dental instruments studied displayed significant differences in their capacity to trigger electromagnetic interference. Significant differences in the quantity of registered interference were observed with respect to the variables manufacturer, type of cardiac implant, and application distance but not with the variable time of application. The electronic dental equipment tested at a clinical application distance (20 cm) provoked only slight interference in the pacemakers and implantable cardioverter defibrillators employed, irrespective of manufacturer. © 2015 Eur J Oral Sci.

A machine learning based approach to identify protected health information in Chinese clinical text.

PubMed

Du, Liting; Xia, Chenxi; Deng, Zhaohua; Lu, Gary; Xia, Shuxu; Ma, Jingdong

2018-08-01

With the increasing application of electronic health records (EHRs) in the world, protecting private information in clinical text has drawn extensive attention from healthcare providers to researchers. De-identification, the process of identifying and removing protected health information (PHI) from clinical text, has been central to the discourse on medical privacy since 2006. While de-identification is becoming the global norm for handling medical records, there is a paucity of studies on its application on Chinese clinical text. Without efficient and effective privacy protection algorithms in place, the use of indispensable clinical information would be confined. We aimed to (i) describe the current process for PHI in China, (ii) propose a machine learning based approach to identify PHI in Chinese clinical text, and (iii) validate the effectiveness of the machine learning algorithm for de-identification in Chinese clinical text. Based on 14,719 discharge summaries from regional health centers in Ya'an City, Sichuan province, China, we built a conditional random fields (CRF) model to identify PHI in clinical text, and then used the regular expressions to optimize the recognition results of the PHI categories with fewer samples. We constructed a Chinese clinical text corpus with PHI tags through substantial manual annotation, wherein the descriptive statistics of PHI manifested its wide range and diverse categories. The evaluation showed with a high F-measure of 0.9878 that our CRF-based model had a good performance for identifying PHI in Chinese clinical text. The rapid adoption of EHR in the health sector has created an urgent need for tools that can parse patient specific information from Chinese clinical text. Our application of CRF algorithms for de-identification has shown the potential to meet this need by offering a highly accurate and flexible solution to analyzing Chinese clinical text. Copyright © 2018 Elsevier B.V. All rights reserved.

Impact of a Student-Driven, Virtual Patient Application on Objective Structured Clinical Examination Performance: Observational Study.

PubMed

Bergeron, David; Champagne, Jean-Nicolas; Qi, Wen; Dion, Maxime; Thériault, Julie; Renaud, Jean-Sébastien

2018-02-22

Peer-assisted learning (PAL) refers to a learning activity whereby students of similar academic level teach and learn from one another. Groupe de perfectionnement des habiletés cliniques (Clinical Skills Improvement Group), a student organization at Université Laval, Canada, propelled PAL into the digital era by creating a collaborative virtual patient platform. Medical interviews can be completed in pairs (a student-patient and a student-doctor) through an interactive Web-based application, which generates a score (weighted for key questions) and automated feedback. The aim of the study was to measure the pedagogical impact of the application on the score at medical interview stations at the summative preclerkship Objective Structured Clinical Examination (OSCE). We measured the use of the application (cases completed, mean score) in the 2 months preceding the OSCE. We also accessed the results of medical interview stations at the preclerkship summative OSCE. We analyzed whether using the application was associated with higher scores and/or better passing grades (≥60%) at the OSCE. Finally, we produced an online form where students could comment on their appreciation of the application. Of the 206 students completing the preclerkship summative OSCE, 170 (82.5%) were registered users on the application, completing a total of 3133 cases (18 by active user in average, 7 minutes by case in average). The appreciation questionnaire was answered online by 45 students who mentioned appreciating the intuitive, easy-to-use, and interactive design, the diversity of cases, and the automated feedback. Using the application was associated with reduced reported stress, improved scores (P=.04), and improved passing rates (P=.11) at the preclerkship summative OSCE. This study suggests that PAL can go far beyond small-group teaching, showing students' potential to create helpful pedagogical tools for their peers. ©David Bergeron, Jean-Nicolas Champagne, Wen Qi, Maxime Dion, Julie Thériault, Jean-Sébastien Renaud. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 22.02.2018.

[Evidence-based medicine and 'The Cochrane Collaboration'].

PubMed

Kawamura, T; Tamakoshi, A; Wakai, K; Ohno, Y

1999-06-01

In Evidence-Based Medicine (EBM), a clinical decision is based neither on pathophysiological theories nor personal experience but on the results derived from scientifically designed clinical epidemiological studies (i.e., evidence). EBM is used in various clinical applications, such as therapy, diagnosis, and prognosis prediction. The process includes (1) asking a clinical question consisting of the three elements of "patient", "exposure", and "outcome"; (2) searching for the best evidence using MEDLINE or Cochrane Library; (3) appraising critically the validity of the method and the magnitude and probability of the result; and finally (4) applying the evidence of the patient. In actual clinical practice, clinical expertise and patient preferences should be as much regarded as research evidence. 'The Cochrane Collaboration' supplies systematic reviews of clinical trials carried out all over the world to its consumers. Its fruit, 'The Cochrane Library (CD-ROM),' is a highly valuable resource. 'The Cochrane Collaboration' serves as the infrastructure for EBM. EBM, which was originally developed for the individual patient care, can also be applicable to community- or workplace-healthcare and policy making by governments. Thus, EBM is both a philosophy and a method to provide people with the most appropriate medical practice.

[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.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l=515) and the intervention group received lecture plus a simulation exercise (n l+s=1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

A brief simulation intervention increasing basic science and clinical knowledge.

PubMed

Sheakley, Maria L; Gilbert, Gregory E; Leighton, Kim; Hall, Maureen; Callender, Diana; Pederson, David

2016-01-01

Background The United States Medical Licensing Examination (USMLE) is increasing clinical content on the Step 1 exam; thus, inclusion of clinical applications within the basic science curriculum is crucial. Including simulation activities during basic science years bridges the knowledge gap between basic science content and clinical application. Purpose To evaluate the effects of a one-off, 1-hour cardiovascular simulation intervention on a summative assessment after adjusting for relevant demographic and academic predictors. Methods This study was a non-randomized study using historical controls to evaluate curricular change. The control group received lecture (n l =515) and the intervention group received lecture plus a simulation exercise (n l+s =1,066). Assessment included summative exam questions (n=4) that were scored as pass/fail (≥75%). USMLE-style assessment questions were identical for both cohorts. Descriptive statistics for variables are presented and odds of passage calculated using logistic regression. Results Undergraduate grade point ratio, MCAT-BS, MCAT-PS, age, attendance at an academic review program, and gender were significant predictors of summative exam passage. Students receiving the intervention were significantly more likely to pass the summative exam than students receiving lecture only (P=0.0003). Discussion Simulation plus lecture increases short-term understanding as tested by a written exam. A longitudinal study is needed to assess the effect of a brief simulation intervention on long-term retention of clinical concepts in a basic science curriculum.

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.

Evaluation of the efficacy of a topical sialogogue spray containing malic acid 1% in elderly people with xerostomia: a double-blind, randomized clinical trial.

PubMed

Gómez-Moreno, Gerardo; Cabrera-Ayala, Maribel; Aguilar-Salvatierra, Antonio; Guardia, Javier; Ramírez-Fernández, María Piedad; González-Jaranay, Maximino; Calvo-Guirado, José Luis

2014-12-01

The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid for elderly people affected by xerostomia. This research took the form of a double-blind, randomized clinical trial. Forty-one individuals (mean age: 78.7 years) with xerostomia were divided into two groups: for the first 'intervention group' (21 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second 'control group' (20 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The Xerostomia Inventory (XI) was used to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after spray application, were measured. XI scores decreased significantly (clinically meaningful) from 36.4 ± 7.3 points to 29.1 ± 7.1 (p < 0.05) with an XI difference of 7.2 ± 6.1, after the combination among 1% malic acid with xylitol and fluoride application. After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < 0.05). A topical sialogogue spray containing 1% malic acid improved xerostomia in an elderly population and increased unstimulated and stimulated salivary flows rates. © 2013 The Gerodontology Society and John Wiley & Sons A/S.

[Research Progress and Prospect of Applications of Finite Element Method in Lumbar Spine Biomechanics].

PubMed

Zhang, Zhenjun; Li, Yang; Liao, Zhenhua; Liu, Weiqiang

2016-12-01

Based on the application of finite element analysis in spine biomechanics,the research progress of finite element method applied in lumbar spine mechanics is reviewed and the prospect is forecasted.The related works,including lumbar ontology modeling,clinical application research,and occupational injury and protection,are summarized.The main research areas of finite element method are as follows:new accurate modeling process,the optimized simulation method,diversified clinical effect evaluation,and the clinical application of artificial lumbar disc.According to the recent research progress,the application prospects of finite element method,such as automation and individuation of modeling process,evaluation and analysis of new operation methods and simulation of mechanical damage and dynamic response,are discussed.The purpose of this paper is to provide the theoretical reference and practical guidance for the clinical lumbar problems by reviewing the application of finite element method in the field of the lumbar spine biomechanics.