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Sample records for clinical toxicology devices

  1. Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System. Final order.

    Science.gov (United States)

    2017-10-18

    The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

  2. 21 CFR 862.3200 - Clinical toxicology calibrator.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Clinical toxicology calibrator. 862.3200 Section... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Toxicology Test Systems § 862.3200 Clinical toxicology calibrator. (a) Identification. A clinical toxicology calibrator is...

  3. Toxicodynetics: A new discipline in clinical toxicology.

    Science.gov (United States)

    Baud, F J; Houzé, P; Villa, A; Borron, S W; Carli, P

    2016-05-01

    Regarding the different disciplines that encompass the pharmacology and the toxicology, none is specifically dedicated to the description and analysis of the time-course of relevant toxic effects both in experimental and clinical studies. The lack of a discipline devoted to this major field in toxicology results in misconception and even in errors by clinicians. Review of the basic different disciplines that encompass pharmacology toxicology and comparing with the description of the time-course of effects in conditions in which toxicological analysis was not performed or with limited analytical evidence. Review of the literature clearly shows how misleading is the current extrapolation of toxicokinetic data to the description of the time-course of toxic effects. A new discipline entitled toxicodynetics should be developed aiming at a more systematic description of the time-course of effects in acute human and experimental poisonings. Toxicodynetics might help emergency physicians in risk assessment when facing a poisoning and contribute to a better assessment of quality control of data collected by poison control centres. Toxicodynetics would also allow a quantitative approach to the clinical effects resulting from drug-drug interaction. Copyright © 2016. Published by Elsevier Masson SAS.

  4. The clinical toxicology of metamfetamine.

    Science.gov (United States)

    Schep, Leo J; Slaughter, Robin J; Beasley, D Michael G

    2010-08-01

    Metamfetamine is a highly addictive amfetamine analog that acts primarily as a central nervous system (CNS) stimulant. The escalating abuse of this drug in recent years has lead to an increasing burden upon health care providers. An understanding of the drug's toxic effects and their medical treatment is therefore essential for the successful management of patients suffering this form of intoxication. The aim of this review is to summarize all main aspects of metamfetamine poisoning including epidemiology, mechanisms of toxicity, toxicokinetics, clinical features, diagnosis, and management. A summary of the literature on metamfetamine was compiled by systematically searching OVID MEDLINE and ISI Web of Science. Further information was obtained from book chapters, relevant news reports, and web material. Epidemiology. Following its use in the Second World War, metamfetamine gained popularity as an illicit drug in Japan and later the United States. Its manufacture and use has now spread to include East and South-East Asia, North America, Mexico, and Australasia, and its world-wide usage, when combined with amfetamine, exceeds that of all other drugs of abuse except cannabis. Mechanisms of toxicity. Metamfetamine acts principally by stimulating the enhanced release of catecholamines from sympathetic nerve terminals, particularly of dopamine in the mesolimbic, mesocortical, and nigrostriatal pathways. The consequent elevation of intra-synaptic monoamines results in an increased activation of central and peripheral α±- and β-adrenergic postsynaptic receptors. This can cause detrimental neuropsychological, cardiovascular, and other systemic effects, and, following long-term abuse, neuronal apoptosis and nerve terminal degeneration. Toxicokinetics. Metamfetamine is rapidly absorbed and well distributed throughout the body, with extensive distribution across high lipid content tissues such as the blood-brain barrier. In humans the major metabolic pathways are aromatic

  5. [Clinical toxicology of the Academy: yesterday, today and tomorrow].

    Science.gov (United States)

    Sofronov, G A; Khalimov, Iu Sh; Matveev, S Iu; Kuz'mich, V G; Fomichev, A V

    2013-12-01

    National toxicology school of the Kirov Military Medical Academy, demonstrates the unity of clinical and experimental approaches related to one purpose throughout its history--saving human life and health from exposure to toxic substances of chemical nature. For more than three centuries the russian science of toxicology has been steadily developing, often ahead of the world science. It helped to create the means of protection and develop methods of treatment for chemical lesions. Currently, toxicology departments of military field therapy and military toxicology and medical protection are actively involved in the current study of military medicine, restructuring policy to provide toxicological aid in the Armed Forces, the development and introduction of Innovative methods of diagnosis and treatment of victims of toxicological etiology.

  6. Clinical toxicology of newer recreational drugs.

    Science.gov (United States)

    Hill, Simon L; Thomas, Simon H L

    2011-10-01

    Novel synthetic 'designer' drugs with stimulant, ecstasy-like (entactogenic) and/or hallucinogenic properties have become increasingly popular among recreational drug users in recent years. The substances used change frequently in response to market trends and legislative controls and it is an important challenge for poisons centres and clinical toxicologists to remain updated on the pharmacological and toxicological effects of these emerging agents. To review the available information on newer synthetic stimulant, entactogenic and hallucinogenic drugs, provide a framework for classification of these drugs based on chemical structure and describe their pharmacology and clinical toxicology. A comprehensive review of the published literature was performed using PUBMED and Medline databases, together with additional non-peer reviewed information sources, including books, media reports, government publications and internet resources, including drug user web forums. Novel synthetic stimulant, entactogenic or hallucinogenic designer drugs are increasingly available to users as demonstrated by user surveys, poisons centre calls, activity on internet drug forums, hospital attendance data and mortality data. Some population sub groups such as younger adults who attend dance music clubs are more likely to use these substances. The internet plays an important role in determining the awareness of and availability of these newer drugs of abuse. Most novel synthetic stimulant, entactogenic or hallucinogenic drugs of abuse can be classified according to chemical structure as piperazines (e.g. benzylpiperazine (BZP), trifluoromethylphenylpiperazine), phenethylamines (e.g. 2C or D-series of ring-substituted amfetamines, benzodifurans, cathinones, aminoindans), tryptamines (e.g. dimethyltryptamine, alpha-methyltryptamine, ethyltryptamine, 5-methoxy-alphamethyltryptamine) or piperidines and related substances (e.g. desoxypipradrol, diphenylprolinol). Alternatively classification may

  7. Drug screening in clinical or forensic toxicology: are there differences?

    Science.gov (United States)

    Gerostamoulos, Dimitri; Beyer, Jochen

    2010-09-01

    Legal and medical practitioners need to remember that, with respect to drug analysis, there are two distinct disciplines in analytical toxicology concerned with human biological matrices, namely clinical and forensic toxicology. Both fields use similar analytical techniques designed to detect and quantify drugs, chemicals and poisons in fluids or tissues. In clinical toxicology, analytical results help to specify the appropriate treatment of a poisoned or intoxicated patient. In forensic toxicology, the results often play a vital role in determining the possible impairment or behavioural changes in an individual, or the contribution of drugs or poisons to death in a medico-legal investigation. This column provides an overview of the similarities and differences inherent in clinical and forensic toxicology.

  8. Tetrahydrocannabinols in clinical and forensic toxicology.

    Science.gov (United States)

    Kochanowski, Maciej; Kała, Maria

    2005-01-01

    Cannabinoids are the natural constituents of marihuana (cannabis). The main of them are delta9-tetrahydrocannabinol (9THC)--psychoactive agent, cannabinol (CBN) and cannabidiol (CBD). Cannabis is administered either by smoking or orally. 9THC potency and duration of action as well as its and two of its major metabolites concentrations in organism highly depend on the route of administration. A single active dose of 9THC is estimated on 520 mg. 9THC is rapidly metabolised. It is hydroxylated to an active metabolite, I1 -hydroxy-delta9-tetrahydro-cannabinol (11-OH-THC), then oxidised to an inactive 11-nor-9-carboxy-delta9-tetrahydrocannabinol (THCCOOH), which is conjugated with glucuronic acid and predominantly excreted in the urine. The maximum psychological effect persists for 4-6 h after administration despite of very low 9THC blood concentrations. 9THC plasma concentration declined to values of 2-3 ng/ml during 3-4 h after smoking. Such a low concentration of the active compound in human organism create a demand for use of sensitive analytical methods for detection and determination of 9THC and its metabolites. The most effective techniques for 9THC and related compounds determination in biological material are chromatographic ones (gas and liquid) with mass spectrometric detection and different ionization modes. 9THC and its two metabolites (11-OH-THC and THCCOOH) are present in blood and hair, 9THC in saliva, and THCCOOH in urine. 9THC and related compounds are determined in autopsy material, although deaths by overdose of cannabis are exceptionally rare. Fatalities happen most often after intravenous injection of hashish oil. 9THC and its metabolites determination in different biological materials gives the basis for a wide interpretation of analytical results for clinical and forensic toxicology purposes.

  9. LC-MS (/MS) in clinical toxicology screening methods.

    Science.gov (United States)

    Viette, Véronique; Hochstrasser, Denis; Fathi, Marc

    2012-01-01

    Toxicological screening is the analysis of biological samples to detect and identify unknown compounds. The high selectivity and sensitivity of liquid chromatography (LC) coupled to mass spectrometry (MS) or tandem mass spectrometry (MS/MS) technology provide an attractive alternative to the current methods (LC-UV, GC/MS, etc.). For these reasons, an increasing number of applications are being published. This paper is a brief overview of LC-MS(/MS) screening methods developed for clinical toxicology in recent years. Various sample treatments, chromatographic separations and detection by mass spectrometry can be combined to obtain screening methods adapted to the constraints and needs of clinical toxicology laboratories. Currently the techniques are in the hands of specialists, mainly in academic institutions. However, the evolution in technology should allow application of these techniques as a tool in toxicology laboratories, thus allowing a more widespread exploitation of their potential.

  10. Current role of ICP-MS in clinical toxicology and forensic toxicology: a metallic profile.

    Science.gov (United States)

    Goullé, Jean-Pierre; Saussereau, Elodie; Mahieu, Loïc; Guerbet, Michel

    2014-08-01

    As metal/metalloid exposure is inevitable owing to its omnipresence, it may exert toxicity in humans. Recent advances in metal/metalloid analysis have been made moving from flame atomic absorption spectrometry and electrothermal atomic absorption spectrometry to the multi-elemental inductively coupled plasma (ICP) techniques as ICP atomic emission spectrometry and ICP-MS. ICP-MS has now emerged as a major technique in inorganic analytical chemistry owing to its flexibility, high sensitivity and good reproducibility. This in depth review explores the ICP-MS metallic profile in human toxicology. It is now routinely used and of great importance, in clinical toxicology and forensic toxicology to explore biological matrices, specifically whole blood, plasma, urine, hair, nail, biopsy samples and tissues.

  11. [The challenges of the ethics of personalism to clinical toxicology].

    Science.gov (United States)

    Brusiło, Jerzy

    2011-01-01

    The fields of philosophical anthropology and the ethics of personalism overlap in the area of many difficult personal situations involving clinical toxicology. These therapeutic situations need an integral, multidimensional, and personal approach for both the patient and the toxicologist. This means that man is treated not only as a physical (biological) being but also there is an appreciation for the mental sphere, which includes rational, emotional, and spiritual elements while not forgetting that the human person is also part of the human community. Studying such an individual's personal decision as suicide, we must realize that it's not just physiological or biochemical poisons but also includes the poisoning of the psyche, as well as poisoning relationships with loved ones (family), poisoning social relations (in school or the workplace) and poisoning the spirit, in other words, there is no meaning in life itself, nor the meaning of God's existence, nor the meaning of faith, hope and love. Not only is there a greater "variety of poisons" than before, they are much more extensive and deep. For example, we can name environmental pollution, industrial poisons, chemical waste, genetic modification, powerful medications, or even the toxic social environment of evil ideas, malicious manipulation of the human mind (destructive religious sects). In approaching the challenges of clinical toxicology, the doctor must not only be a specialist in chemistry, biochemistry and pharmacology. What then is of future of toxicology because of this human dimension (anthropological, ethical and spiritual) of this teaching? As today marks the occasion of the 45th anniversary of the Clinic of Toxicology CM UJ, should we shape the ethos of young doctors who want to deal with toxicology seriously?

  12. University Clinic of Toxicology--historical note and present work.

    Science.gov (United States)

    Bozinovska, C

    2013-01-01

    The University Clinic of Toxicology (UCT) in Skopje was founded as the Clinic for Toxicology and Emergency Internal Medicine on January 15th 1976. Today UCT has a modern building with office space of 1,300 m2 on 4 floors, 40 hospital beds and 72 employees including 18 doctors. UCT works in accordance with the public healthcare services in the Republic of Macedonia through the use of specialist/consultative and hospital healthcare for people over the age of 14 years. The Clinic also provides services in the field of emergency internal medicine, acute poisoning with medications, pesticides, corrosives, poisonous gases and mushrooms, heavy metals and other chemicals. The Clinic takes an active part in the detoxification programme for users of opiates and psychotropic substances, protocols for enteral and parenteral nutrition and guides for home treatment. Yearly there are more than 14,000 ambulance admissions, over 1,400 hospitalized patients, over 4,000 urgent EHO checks, more than 1,000 urgent upper endoscopies and over 700 other toxicological analyses and other interventions. The educational services and activities are realized through the chair for internal medicine. The Clinic offers undergraduate and graduate level education for medical students and dentists, for medical nurses, radiology technicians, speech therapists and physiotherapists. Over 300 papers and reports have been published to date by the medical staff at the UCT in the form of abstracts and integrated projects in the Republic of Macedonia and aboard. 8 doctorates have been successfully completed by employees from the Clinic as well as 4 master's theses and 1 in-depth project. UCT employees are the authors of some textbooks and monographs. UCT have undertaken some scientific projects. Employees from the Clinic of Toxicology are members taking an active part in many domestic and international associations.

  13. Toxicología clínica comunitaria Community Clinical Toxicology

    Directory of Open Access Journals (Sweden)

    María Elena Leal

    2011-08-01

    Full Text Available En algunos países de América Latina las intoxicaciones agudas se manejan de manera profesional por médicos especialistas en la mate-ria. Algo similar ocurre con las intoxicaciones crónicas de origen laboral en el sector formal. No obstante, una realidad diferente ocurre en cuanto a la evaluación de las intoxicaciones crónicas de origen ambiental, dado que éstas por su naturaleza, son más difíciles de diagnosticar. Para el tratamiento de las intoxicaciones agudas se han organizado Centros de Información y Atención Toxicológica, pero para las intoxicaciones crónicas ambientales no se ha generado organismos semejantes. Por consiguiente, en este trabajo sugerimos un modelo de atención de la intoxicaciones crónicas a través de grupos multidisciplinarios bajo el esquema de una nueva disciplina: la Toxicología Clínica Comunitaria, cuyo objetivo sería la atención simultánea de las intoxicaciones agudas que generalmente se atienden en un ámbito hospitalario y de las intoxicaciones ambientales que por lo normal se presentan a nivel comunitario. El objetivo final es aprovechar la experiencia que existe en la Región en cuanto a Toxicología Clínica para organizar el trabajo comunitario.In some Latin American countries acute intoxication is professionally managed by specialized physicians qualified in the area. Something similar occurs with work-related chronic intoxication in the formal sector. However, a different reality prevails for the assessment of chronic intoxication of environmental origin, since it is by definition more difficult to diagnose. For treatment of acute intoxication, Toxicological Information and Care Centers have been set up, though similar bodies have not been created for chronic environmental intoxication. Therefore, in this study a model of chronic intoxication care is proposed, using multidisciplinary teams adopting a new approach, namely Community Clinical Toxicology, the goal of which would be the

  14. Building bridges between clinical and forensic toxicology laboratories.

    Science.gov (United States)

    Martin, Bernardino Barcelo; Gomila, Isabel; Noce, Valeria

    2018-05-09

    Clinical and forensic toxicology can be defined as the two disciplines involved the detection, identification and measurement of xenobiotics in biological and non-biological specimens to help in the diagnosis, treatment, prognosis, prevention of poisonings and to disclose causes and contributory causes of fatal intoxications, respectively. This article explores the close connections between clinical and forensic toxicology in overlapping areas of interest. An update has been carried out of the following seven areas of interest in analytical toxicology: doping control, sudden cardiac death (SCD), brain death, sudden infant death syndrome (SIDS) and Munchausen syndrome by proxy (MSBP), prenatal exposure to drugs and fetal alcohol syndrome (FAS), drug-facilitated crimes (DFC) and intoxications by new psychoactive substances (NPS). While issues such as SCD, SIDS or doping control are investigated mainly in forensic laboratories, other as prenatal exposure to drugs or FAS are mainly treated in clinical laboratories. On the other hand, areas such MSBP, DFC or the intoxications by NPS are of interest in both laboratories. Some of these topics are initially treated in hospital emergency departments, involving clinical laboratories and sometimes lately derived to forensic laboratories. Conversely, cases with initial medical-legal implications and fatalities are directly handled by forensic toxicology, but may trigger further studies in the clinical setting. Many areas of common interest between clinical and forensic laboratories are building bridges between them. The increasing relationships are improving the growth, the reliability and the robustness of both kind of laboratories. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  15. Toxicology and clinical potential of nanoparticles

    Science.gov (United States)

    Yildirimer, Lara; Thanh, Nguyen T.K.; Loizidou, Marilena; Seifalian, Alexander M.

    2011-01-01

    Summary In recent years, nanoparticles (NPs) have increasingly found practical applications in technology, research and medicine. The small particle size coupled to their unique chemical and physical properties is thought to underlie their exploitable biomedical activities. Here, we review current toxicity studies of NPs with clinical potential. Mechanisms of cytotoxicity are discussed and the problem of extrapolating knowledge gained from cell-based studies into a human scenario is highlighted. The so-called ‘proof-of-principle’ approach, whereby ultra-high NP concentrations are used to ensure cytotoxicity, is evaluated on the basis of two considerations; firstly, from a scientific perspective, the concentrations used are in no way related to the actual doses required which, in many instances, discourages further vital investigations. Secondly, these inaccurate results cast doubt on the science of nanomedicine and thus, quite dangerously, encourage unnecessary alarm in the public. In this context, the discrepancies between in vitro and in vivo results are described along with the need for a unifying protocol for reliable and realistic toxicity reports. PMID:23293661

  16. Metabolism of psilocybin and psilocin: clinical and forensic toxicological relevance.

    Science.gov (United States)

    Dinis-Oliveira, Ricardo Jorge

    2017-02-01

    Psilocybin and psilocin are controlled substances in many countries. These are the two main hallucinogenic compounds of the "magic mushrooms" and both act as agonists or partial agonists at 5-hydroxytryptamine (5-HT) 2A subtype receptors. During the last few years, psilocybin and psilocin have gained therapeutic relevance but considerable physiological variability between individuals that can influence dose-response and toxicological profile has been reported. This review aims to discuss metabolism of psilocybin and psilocin, by presenting all major and minor psychoactive metabolites. Psilocybin is primarily a pro-drug that is dephosphorylated by alkaline phosphatase to active metabolite psilocin. This last is then further metabolized, psilocin-O-glucuronide being the main urinary metabolite with clinical and forensic relevance in diagnosis.

  17. Poisonings and clinical toxicology: a template for Ireland.

    LENUS (Irish Health Repository)

    Tormey, W P

    2013-03-01

    Poisons information is accessed around the clock in the British Isles from six centres of which two are in Ireland at Dublin and Belfast accompanied by consultant toxicologist advisory service. The numbers of calls in Ireland are down to about 40 per day due to easy access to online data bases. Access to Toxbase, the clinical toxicology database of the National Poisons Information Service is available to National Health Service (NHS) health professionals and to Emergency Departments and Intensive Care units in the Republic of Ireland. There are 59 Toxbase users in the Republic of Ireland and 99 % of activity originates in Emergency Departments. All United States Poison Control Centres primarily use Poisindex which is a commercial database from Thomson Reuters.

  18. 21 CFR 862.2270 - Thin-layer chromatography system for clinical use.

    Science.gov (United States)

    2010-04-01

    ... SERVICES (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... equilibrium occurs between the two phases. (b) Classification. Class I (general controls). The device is...

  19. The current role of on-line extraction approaches in clinical and forensic toxicology.

    Science.gov (United States)

    Mueller, Daniel M

    2014-08-01

    In today's clinical and forensic toxicological laboratories, automation is of interest because of its ability to optimize processes, to reduce manual workload and handling errors and to minimize exposition to potentially infectious samples. Extraction is usually the most time-consuming step; therefore, automation of this step is reasonable. Currently, from the field of clinical and forensic toxicology, methods using the following on-line extraction techniques have been published: on-line solid-phase extraction, turbulent flow chromatography, solid-phase microextraction, microextraction by packed sorbent, single-drop microextraction and on-line desorption of dried blood spots. Most of these published methods are either single-analyte or multicomponent procedures; methods intended for systematic toxicological analysis are relatively scarce. However, the use of on-line extraction will certainly increase in the near future.

  20. Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries.

    Science.gov (United States)

    Tomlinson, Lindsay; Boone, Laura I; Ramaiah, Lila; Penraat, Kelley A; von Beust, Barbara R; Ameri, Mehrdad; Poitout-Belissent, Florence M; Weingand, Kurt; Workman, Heather C; Aulbach, Adam D; Meyer, Dennis J; Brown, Diane E; MacNeill, Amy L; Bolliger, Anne Provencher; Bounous, Denise I

    2013-09-01

    The purpose of this paper by the Regulatory Affairs Committee (RAC) of the American Society for Veterinary Clinical Pathology (ASVCP) is to review the current regulatory guidances (eg, guidelines) and published recommendations for best practices in veterinary toxicologic clinical pathology, particularly in the pharmaceutical and biotechnology industries, and to utilize the combined experience of ASVCP RAC to provide updated recommendations. Discussion points include (1) instrumentation, validation, and sample collection, (2) routine laboratory variables, (3) cytologic laboratory variables, (4) data interpretation and reporting (including peer review, reference intervals and statistics), and (5) roles and responsibilities of clinical pathologists and laboratory personnel. Revision and improvement of current practices should be in alignment with evolving regulatory guidance documents, new technology, and expanding understanding and utility of clinical pathology. These recommendations provide a contemporary guide for the refinement of veterinary toxicologic clinical pathology best practices. © 2013 American Society for Veterinary Clinical Pathology.

  1. Mass Spectrometry for Research and Application in Therapeutic Drug Monitoring or Clinical and Forensic Toxicology.

    Science.gov (United States)

    Maurer, Hans H

    2018-04-30

    This paper reviews current applications of various hyphenated low- and high-resolution mass spectrometry techniques in the field of therapeutic drug monitoring and clinical/forensic toxicology in both research and practice. They cover gas chromatography, liquid chromatography, matrix-assisted laser desorption ionization, or paper spray ionization coupled to quadrupole, ion trap, time-of-flight, or Orbitrap mass analyzers.

  2. Current role of liquid chromatography coupled to mass spectrometry in clinical toxicology screening methods.

    Science.gov (United States)

    Viette, Véronique; Fathi, Marc; Rudaz, Serge; Hochstrasser, Denis; Veuthey, Jean-Luc

    2011-07-01

    Abstract Toxicological screening is the analysis of a biological specimen to detect and identify compounds in patients admitted to the hospital with acute intoxication of unknown origin. The screening of a wide range of toxicologically relevant compounds in biological samples is a serious challenge for clinical laboratories. The high selectivity and sensitivity of liquid chromatography coupled to mass spectrometry or tandem mass spectrometry technology provides an attractive alternative to the current methods. For these reasons, an increasing number of applications for multi-target screening or general screening of unknown compounds in biological matrices are being published. This paper is an overview of sample clean-up, chromatographic separation and mass spectrometry detection procedures which can be combined to obtain screening methods adapted to the constraints and needs of various laboratories, and none specifically in clinical toxicology. Currently the techniques are in the hands of specialists, principally in academic institutes. However, the evolution in technology should allow application of the techniques as a tool in toxicology laboratories and thus more widespread exploitation of their potential.

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

    Science.gov (United States)

    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.

  4. Importance of clinical toxicology teaching and its impact in improving knowledge: sharing experience from a workshop

    International Nuclear Information System (INIS)

    Khan, N.U.; Fayyaz, J.; Khan, U.R.; Feroze, A.

    2013-01-01

    Objective: To assess the impact of a one-day clinical toxicology workshop in improving knowledge. Methods: A one-day clinical toxicology workshop was conducted as a pre-conference workshop of the Annual Emergency Medicine Conference at the Aga Khan University Hospital, Karachi, in April 2012. The course was composed of poisoning-related common clinical scenarios. The pre-test and post-test understanding was used to assess the impact of the course in improving knowledge. The participants also evaluated the workshop as a whole thorough written evaluation forms. SPSS 19 was used for statistical analysis of the data. Result: There were 22 participants in the course. The pre-test mean score was 31.6+-15.1% (95% CI; 24-40; n=19) compared to the post-test the mean score of 56.0+-10.8% (95% CI; 47- 61; n=17). The positive difference was also statistically significant (p<0.001). The overall workshop was evaluated as excellent by 08 (47.46%) and very good by 10 (52.63%) participants. Conclusion: Short training in clinical toxicology improved knowledge of the participants. (author)

  5. Integration of clinical chemistry, expression, and metabolite data leads to better toxicological class separation

    DEFF Research Database (Denmark)

    Spicker, Jeppe; Brunak, Søren; Frederiksen, K.S.

    2008-01-01

    A large number of databases are currently being implemented within toxicology aiming to integrate diverse biological data, such as clinical chemistry, expression, and other types of data. However, for these endeavors to be successful, tools for integration, visualization, and interpretation...... are needed. This paper presents a method for data integration using a hierarchical model based on either principal component analysis or partial least squares discriminant analysis of clinical chemistry, expression, and nuclear magnetic resonance data using a toxicological study as case. The study includes...... the three toxicants alpha-naphthyl-isothiocyanate, dimethylnitrosamine, and N-methylformamide administered to rats. Improved predictive ability of the different classes is seen, suggesting that this approach is a suitable method for data integration and visualization of biological data. Furthermore...

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

    Science.gov (United States)

    Peters, Frank T

    2011-01-01

    Liquid chromatography (LC) coupled to mass spectrometry (MS) or tandem mass spectrometry (MS/MS) has become increasingly important in clinical and forensic toxicology as well as doping control and is now a robust and reliable technique for routine analysis in these fields. In recent years, methods for LC-MS(/MS)-based systematic toxicological analysis using triple quadrupole or ion trap instruments have been considerably improved and a new screening approach based on high-resolution MS analysis using benchtop time-of-flight MS instruments has been developed. Moreover, many applications for so-called multi-target screening and/or quantification of drugs, poisons, and or their metabolites in various biomatrices have been published. The present paper will provide an overview and discuss these recent developments focusing on the literature published after 2006. Copyright © 2010 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  7. Specific determination of clinical and toxicological important substances in biological samples by LC-MS

    International Nuclear Information System (INIS)

    Mitulovic, G.

    2001-02-01

    This thesis of this dissertation is the specific determination of clinical and toxicological important substances in biological samples by LC-MS. Nicotine was determined in serum after application of nicotine plaster and nicotine nasal spray with HPLC-ESI-MS. Cotinine was determined direct in urine with HPLC-ESI-MS. Short time anesthetics were determined in blood and cytostatics were determined in liquor with HPLC-ESI-MS. (botek)

  8. Green toxicology.

    Science.gov (United States)

    Maertens, Alexandra; Anastas, Nicholas; Spencer, Pamela J; Stephens, Martin; Goldberg, Alan; Hartung, Thomas

    2014-01-01

    Historically, early identification and characterization of adverse effects of industrial chemicals was difficult because conventional toxicological test methods did not meet R&D needs for rapid, relatively inexpensive methods amenable to small amounts of test material. The pharmaceutical industry now front-loads toxicity testing, using in silico, in vitro, and less demanding animal tests at earlier stages of product development to identify and anticipate undesirable toxicological effects and optimize product development. The Green Chemistry movement embraces similar ideas for development of less toxic products, safer processes, and less waste and exposure. Further, the concept of benign design suggests ways to consider possible toxicities before the actual synthesis and to apply some structure/activity rules (SAR) and in silico methods. This requires not only scientific development but also a change in corporate culture in which synthetic chemists work with toxicologists. An emerging discipline called Green Toxicology (Anastas, 2012) provides a framework for integrating the principles of toxicology into the enterprise of designing safer chemicals, thereby minimizing potential toxicity as early in production as possible. Green Toxicology`s novel utility lies in driving innovation by moving safety considerations to the earliest stage in a chemical`s lifecycle, i.e., to molecular design. In principle, this field is no different than other subdisciplines of toxicology that endeavor to focus on a specific area - for example, clinical, environmental or forensic toxicology. We use the same principles and tools to evaluate an existing substance or to design a new one. The unique emphasis is in using 21st century toxicology tools as a preventative strategy to "design out" undesired human health and environmental effects, thereby increasing the likelihood of launching a successful, sustainable product. Starting with the formation of a steering group and a series of workshops

  9. Forensic toxicology.

    Science.gov (United States)

    Davis, Gregory G

    2012-01-01

    Toxicologic analysis is an integral part of death investigation, and the use or abuse of an unsuspected substance belongs in the differential diagnosis of patients who have a sudden, unexpected change in their condition. History and physical findings may alter suspicion that intoxication played a role in a patient's decline or death, but suspicions cannot be confirmed and is performed, analysis unless toxicologic no toxicologic analysis is possible unless someone collects the proper specimens necessary for analysis. In a hospital autopsy the only specimens that can rightfully be collected are those within the restrictions stated in the autopsy permit. Autopsies performed by the medical examiner do not have these restrictions. Sometimes the importance of toxicologic testing in a case is not evident until days or weeks after the change in the patient's status, thus retaining the appropriate specimens until investigation of that case has ended is important. Proper interpretation of toxicologic findings requires integrating the clinical setting and findings with the toxicologic results in a way that makes medical sense. If called upon to testify concerning findings, answer the questions truthfully, politely, and in a way that is understandable to someone who has no special training in toxicology.

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

    Science.gov (United States)

    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.

  11. Orbital atherectomy: device evolution and clinical data.

    Science.gov (United States)

    Staniloae, Cezar S; Korabathina, Ravikiran

    2014-05-01

    A number of atherectomy devices were developed in the last few years. Among them, the DiamondBack 360° Peripheral Orbital Atherectomy System (Cardiovascular Systems, Inc) was specifically designed to work in severely calcified plaque. This article reviews the history, mechanism of action, evolution, clinical data, and future applications of this particular atherectomy device.

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

    Science.gov (United States)

    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.

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

    Science.gov (United States)

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

    2016-09-01

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

  14. Spine device clinical trials: design and sponsorship.

    Science.gov (United States)

    Cher, Daniel J; Capobianco, Robyn A

    2015-05-01

    Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Cross matching observations on toxicological and clinical data for the assessment of tolerability and safety of Ginkgo biloba leaf extract

    International Nuclear Information System (INIS)

    Heinonen, Tuula; Gaus, Wilhelm

    2015-01-01

    Highlights: • Cross-matching of toxicological, clinical and other data improves risk analysis. • Induction of drug metabolism is linked to increased cell proliferation. • Rodents and man have differences in metabolism of Ginkgo biloba. • Controlled clinical data did not reveal any serious or specific adverse drug reaction. • Cross-matching of various sources gives strong evidence that G. biloba is safe. - Abstract: Ginkgo biloba is one of the most widely used herbal remedies in Europe and the US. It may be purchased in different types of formulations, but most of the clinical studies have been performed with the controlled G. biloba extract EGb761 ® . Indications include Alzheimers disease, cardiovascular disease, dementia, memory loss, and cerebral ischemia. The pharmacological modes of action cover antioxidant effects, radical scavenging, inhibition of platelet activating factor, alterations in membrane fluidity (signal transduction), and inhibition of glucocorticoid synthesis. Due to the widespread and long-term use of G. biloba – about a million doses of EGb761 ® are sold per day – tolerability and safety are a crucial issue. Based on broad and long-term clinical use of G. biloba extracts, it is regarded as well tolerated in man. Cross matching, a tool we introduced, combines different fields of knowledge and types of data to a consolidated result. In this article, we combine toxicological and clinical data and utilize other sources of information to assess tolerability and safety of G. biloba. It is well known that because of biological differences between animals and man or even between animal species, animal experiments do not necessarily mimic the effects in humans. Therefore, for adequate risk assessment, the relevance of non-clinical toxicological findings should be correlated with human data. The cross matching of toxicological data and results from clinical studies is possible because many toxicological and clinical studies are available

  16. Synthetic cathinone “bath salts”: the mechanism of action, toxicological aspects, clinic, dependence development

    Directory of Open Access Journals (Sweden)

    Antsyborov A.V.

    2017-05-01

    Full Text Available according to the authors synthetic cathinone is a new class of designer drugs with psychoactive effect at the peak of intoxication which can cause hallucinatory disorders, acute paranoid disorders of psychotic level, the development of delirious disorders, affective disorders comparable to cocaine, methylenedioxymethamphetamine (MDMA and other drugs with amphetamine-like effect. The first reports of synthetic cathinone appeared in early 2009. On the black market, these substances were marketed as «bath salts». The legislation of the European countries have been carrying these substances to the drug since 2010, in the United States synthetic cathinone has been included in the list of narcotic substances since 2011, in the Russian Federation, these substances can be attributed to narcotic according to the Decree of the RF Government dated 31 December 2009 №1186 «About modification of some resolutions of the Government of the Russian Federation on issues related to trafficking in narcotic drugs». Recent clinical studies indicate dysregulation effect of synthetic cathinone’s on central monoamine system, which is one of the main mechanisms of synthetic cathinone’s action, and is the basis of behavioral disorders due to use. The review provides data about the chemical structure of synthetic cathinone’s, mechanisms of addiction, toxicology, clinical aspects of use.

  17. Risk assessment of medical devices: evaluation of microbiological and toxicological safety

    International Nuclear Information System (INIS)

    Dorpema, J.W.

    1995-01-01

    Safety assessment of medical devices includes sterilization and biological evaluation or biocompatability testing. Sterilization by ETO gas is criticised for their carcinogenic potency or even banned. Mutual acceptance of biological evaluation test results is promoted by a laboratory accreditation and qualification program. (Author)

  18. Clinical and anatomic pathology effects of serial blood sampling in rat toxicology studies, using conventional or microsampling methods.

    Science.gov (United States)

    Caron, Alexis; Lelong, Christine; Bartels, T; Dorchies, O; Gury, T; Chalier, Catherine; Benning, Véronique

    2015-08-01

    As a general practice in rodent toxicology studies, satellite animals are used for toxicokinetic determinations, because of the potential impact of serial blood sampling on toxicological endpoints. Besides toxicological and toxicokinetic determinations, blood samples obtained longitudinally from a same animal may be used for the assessment of additional parameters (e.g., metabolism, pharmacodynamics, safety biomarkers) to maximize information that can be deduced from rodents. We investigated whether removal of up to 6 × 200 μL of blood over 24h can be applied in GLP rat toxicology studies without affecting the scientific outcome. 8 week-old female rats (200-300 g) were dosed for up to 1 month with a standard vehicle and subjected or not (controls) to serial blood sampling for sham toxicokinetic/ancillary determinations, using miniaturized methods allowing collection of 6 × 50, 100 or 200 μL over 24h. In-life endpoints, clinical pathology parameters and histopathology of organs sensitive to blood volume reduction were evaluated at several time points after completion of sampling. In sampled rats, minimal and reversible changes in red blood cell mass (maximally 15%) and subtle variations in liver enzymes, fibrinogen and neutrophils were not associated with any organ/tissue macroscopic or microscopic correlate. Serial blood sampling (up to 6 × 200 μL over 24h) is compatible with the assessment of standard toxicity endpoints in adult rats. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

    Science.gov (United States)

    Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

    2015-01-01

    Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

  20. Current role of liquid chromatography-mass spectrometry in clinical and forensic toxicology.

    Science.gov (United States)

    Maurer, Hans H

    2007-08-01

    This paper reviews multi-analyte single-stage and tandem liquid chromatography-mass spectrometry (LC-MS) procedures using different mass analyzers (quadrupole, ion trap, time-of-flight) for screening, identification, and/or quantification of drugs, poisons, and/or their metabolites in blood, plasma, serum, or urine published after 2004. Basic information about the biosample assayed, work-up, LC column, mobile phase, ionization type, mass spectral detection mode, and validation data of each procedure is summarized in tables. The following analytes are covered: drugs of abuse, analgesics, opioids, sedative-hypnotics, benzodiazepines, antidepressants including selective-serotonin reuptake inhibitors (SSRIs), herbal phenalkylamines (ephedrines), oral antidiabetics, antiarrhythmics and other cardiovascular drugs, antiretroviral drugs, toxic alkaloids, quaternary ammonium drugs and herbicides, and dialkylphosphate pesticides. The pros and cons of the reviewed procedures are critically discussed, particularly, the need for studies on matrix effects, selectivity, analyte stability, and the use of stable-isotope labeled internal standards instead of unlabeled therapeutic drugs. In conclusion, LC-MS will probably become a gold standard for detection of very low concentrations particularly in alternative matrices and for quantification in clinical and forensic toxicology. However, some drawbacks still need to be addressed and finally overcome.

  1. Chiral drug analysis using mass spectrometric detection relevant to research and practice in clinical and forensic toxicology.

    Science.gov (United States)

    Schwaninger, Andrea E; Meyer, Markus R; Maurer, Hans H

    2012-12-21

    This paper reviews analytical approaches published in 2002-2012 for chiral drug analysis and their relevance in research and practice in the field of clinical and forensic toxicology. Separation systems such as gas chromatography, high performance liquid chromatography, capillary electromigration, and supercritical fluid chromatography, all coupled to mass spectrometry, are discussed. Typical applications are reviewed for relevant chiral analytes such as amphetamines and amphetamine-derived designer drugs, methadone, tramadol, psychotropic and other CNS acting drugs, anticoagulants, cardiovascular drugs, and some other drugs. Usefulness of chiral drug analysis in the interpretation of analytical results in clinical and forensic toxicology is discussed as well. Copyright © 2012 Elsevier B.V. All rights reserved.

  2. Clinical, cytogenetic and toxicological studies in rural workers exposed to pesticides in Botucatu, São Paulo, Brazil

    Directory of Open Access Journals (Sweden)

    Salete Marcia Bréga

    1998-01-01

    Full Text Available Pesticides can cause gene mutations and chromosomal aberrations in exposed individuals. We have investigated 24 workers exposed to pesticides. Clinical examinations and cytogenetic and toxicological tests were performed. Ten non-exposed individuals were used as controls. Toxicological dosages of copper, zinc and manganese (metals found in some pesticides, hepatic enzyme dosage (GOT, GPT, AR and acetylcholinesterase activity were performed in 16 workers and 8 controls. In the exposed workers, the most relevant clinical symptoms were poor digestion with fullness sensation after meals, irritated eyes, headache and fasciculations. The exposed group showed significantly lower manganese dosage and acetylcholinesterase activity, and significantly higher levels of alkaline phosphatase. Cytogenetic studies showed significantly higher chromosomal aberrations in the exposed group compared to the control group. Although the workers used protection against the pesticide's fog, the results revealed that the workers were contaminated with the pesticides. Therefore, the cytogenetic, toxicological studies with clinical examination are necessary for monitoring workers who are exposed to pesticides in any situation.

  3. DEONTOLOGICAL PROBLEMS OF CLINICAL TOXICOLOGY IN BULGARIA, CONNECTED TO COMMUNICATION DIFFICULTIES, DURING THE DECADE 2000-2010

    Directory of Open Access Journals (Sweden)

    Marieta Yovcheva

    2012-10-01

    Full Text Available The specificity of clinical toxicology has always raised many deontological, medico ethical and legal problems, mainly connected to communication barriers, leading to distortion or total disappearance of the ability of the intoxicated patient to perceive and process the received information about his state and necessity of treatment, to agree or refuse medical help, to permit announcing data about his case. During the decade 2000-2010 significant changes in Health law, minor decrees and Medical Ethic Codes have been done, solving partially some of these questions. The new conceptions and conditions aroused new problems, connected with the intoxicated patient’s autonomy, right to information, confidentiality, etc. The necessity of some adaptation of the official formulary of informed consent for clinical toxicology is discussed with accent on the dynamics of the process rather than on one-moment decision. A requirement of informed refusal by a whole sentence, free text, hand written by the patient, instead of simple signature is recommended. Current analysis and discussions of the deontological questions of toxicology are important.

  4. A metabonomic approach for mechanistic exploration of pre-clinical toxicology.

    Science.gov (United States)

    Coen, Muireann

    2010-12-30

    Metabonomics involves the application of advanced analytical tools to profile the diverse metabolic complement of a given biofluid or tissue. Subsequent statistical modelling of the complex multivariate spectral profiles enables discrimination between phenotypes of interest and identifies panels of discriminatory metabolites that represent candidate biomarkers. This review article presents an overview of recent developments in the field of metabonomics with a focus on application to pre-clinical toxicology studies. Recent research investigations carried out as part of the international COMET 2 consortium project on the hepatotoxic action of the aminosugar, galactosamine (galN) are presented. The application of advanced, high-field NMR spectroscopy is demonstrated, together with complementary application of a targeted mass spectrometry platform coupled with ultra-performance liquid chromatography. Much novel mechanistic information has been gleaned on both the mechanism of galN hepatotoxicity in multiple biofluids and tissues, and on the protection afforded by co-administration of glycine and uridine. The simultaneous identification of both the metabolic fate of galN and its associated endogenous consequences in spectral profiles is demonstrated. Furthermore, metabonomic assessment of inter-animal variability in response to galN presents enhanced mechanistic insight on variable response phentoypes and is relevant to understanding wider aspects of individual variability in drug response. This exemplar highlights the analytical and statistical tools commonly applied in metabonomic studies and notably, the approach is applicable to the study of any toxin/drug or intervention of interest. The metabonomic approach holds considerable promise and potential to significantly advance our understanding of the mechanistic bases for adverse drug reactions. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

  5. Pharmacokinetics of (synthetic) cannabinoids in pigs and their relevance for clinical and forensic toxicology.

    Science.gov (United States)

    Schaefer, Nadine; Wojtyniak, Jan-Georg; Kettner, Mattias; Schlote, Julia; Laschke, Matthias W; Ewald, Andreas H; Lehr, Thorsten; Menger, Michael D; Maurer, Hans H; Schmidt, Peter H

    2016-06-24

    Synthetic cannabinoids (SCs) are gaining increasing importance in clinical and forensic toxicology. They are consumed without any preclinical safety studies. Thus, controlled human pharmacokinetic (PK) studies are not allowed, although being relevant for interpretation of analytical results in cases of misuse or poisoning. As alternative, in a controlled animal experiment, six pigs per drug received a single intravenous dose of 200μg/kg BW each of Δ(9)-tetrahydrocannabinol (THC), 4-ethylnaphthalen-1-yl-(1-pentylindol-3-yl)methanone (JWH-210), or 2-(4-methoxyphenyl)-1-(1-pentyl-indol-3-yl)methanone (RCS-4). In addition, six pigs received a combination of the three drugs with the identical dose each. The drugs were determined in serum using LC-MS/MS. A population (pop) PK analysis revealed that a three-compartment model described best the PK data of all three cannabinoids. Central volumes of distribution were estimated at 0.29L/kg, 0.20L/kg, and 0.67L/kg for THC, JWH-210, and RCS-4, respectively. Clearances were 0.042L/min/kg, 0.048L/min/kg, and 0.093L/min/kg for THC, JWH-210, and RCS-4, respectively. The popPK THC pig model was upscaled to humans using allometric techniques. Comparison with published human data revealed that the concentration-time profiles could successfully be predicted. These findings indicate that pigs in conjunction with PK modeling technique may serve as a tool for prediction of human PK of SCs. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. Modafinil in Forensic and Clinical Toxicology-Case Reports, Analytics and Literature.

    Science.gov (United States)

    Radünz, Lars; Reuter, Hannah; Andresen-Streichert, Hilke

    2018-06-01

    Modafinil is used because of its wakefulness-promoting properties for treatment of diseases associated with extreme sleepiness (i.e., narcolepsy). Additionally, it is misused as a "cognitive enhancer" to increase alertness and to improve concentration. We present modafinil concentrations in serum samples in five cases of our routine work measured by high-performance liquid chromatography coupled with a photo diode array detector after solid-phase extraction. One sample was analyzed for clinical toxicology purposes. The other four were investigated for the police: three cases of driving under the influence of drugs and one case of bodily harm. Sample preparation consisted of solid-phase extraction using Bond Elut® C18 columns. Papaverine was used as internal standard. Chromatographic separation was carried out using a Polaris C18-A column in an isocratic run. Wavelengths used for UV-detection were 220 nm for modafinil and 239 nm for the internal standard, respectively. The method was validated with a reduced validation design for rare analytes. A six-point-calibration from 0.5 to 5.0 mg/L, covering the therapeutic range (0.9-3.3 mg/L), was used for quantification. Concentrations in serum were in the range of 1.3 to ~34 mg/L (median: 3.6 mg/L; mean: 9.0 mg/L). To our knowledge, there are only few publications concerning the serum concentrations of modafinil in cases of (suspected) misuse, forensic cases or intoxications. In our discussion, the serum concentrations we determined are compared with the levels described in the literature so far.

  7. Toxicology screen

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/article/003578.htm Toxicology screen To use the sharing features on this page, please enable JavaScript. A toxicology screen refers to various tests that determine the ...

  8. Toxicology elements

    International Nuclear Information System (INIS)

    Viala, A.

    1998-01-01

    This work studies the different aspects of the modern toxicology: toxico-kinetic, biological, medico legal, food, professional, pharmaceuticals, environmental, social and regulatory. It is divided in three parts that consider the principle problems of general toxicology and analytical toxicology. (N.C.)

  9. Multiple stage MS in analysis of plasma, serum, urine and in vitro samples relevant to clinical and forensic toxicology.

    Science.gov (United States)

    Meyer, Golo M; Maurer, Hans H; Meyer, Markus R

    2016-01-01

    This paper reviews MS approaches applied to metabolism studies, structure elucidation and qualitative or quantitative screening of drugs (of abuse) and/or their metabolites. Applications in clinical and forensic toxicology were included using blood plasma or serum, urine, in vitro samples, liquids, solids or plant material. Techniques covered are liquid chromatography coupled to low-resolution and high-resolution multiple stage mass analyzers. Only PubMed listed studies published in English between January 2008 and January 2015 were considered. Approaches are discussed focusing on sample preparation and mass spectral settings. Comments on advantages and limitations of these techniques complete the review.

  10. Current use of high-resolution mass spectrometry in drug screening relevant to clinical and forensic toxicology and doping control.

    Science.gov (United States)

    Ojanperä, Ilkka; Kolmonen, Marjo; Pelander, Anna

    2012-05-01

    Clinical and forensic toxicology and doping control deal with hundreds or thousands of drugs that may cause poisoning or are abused, are illicit, or are prohibited in sports. Rapid and reliable screening for all these compounds of different chemical and pharmaceutical nature, preferably in a single analytical method, is a substantial effort for analytical toxicologists. Combined chromatography-mass spectrometry techniques with standardised reference libraries have been most commonly used for the purpose. In the last ten years, the focus has shifted from gas chromatography-mass spectrometry to liquid chromatography-mass spectrometry, because of progress in instrument technology and partly because of the polarity and low volatility of many new relevant substances. High-resolution mass spectrometry (HRMS), which enables accurate mass measurement at high resolving power, has recently evolved to the stage that is rapidly causing a shift from unit-resolution, quadrupole-dominated instrumentation. The main HRMS techniques today are time-of-flight mass spectrometry and Orbitrap Fourier-transform mass spectrometry. Both techniques enable a range of different drug-screening strategies that essentially rely on measuring a compound's or a fragment's mass with sufficiently high accuracy that its elemental composition can be determined directly. Accurate mass and isotopic pattern acts as a filter for confirming the identity of a compound or even identification of an unknown. High mass resolution is essential for improving confidence in accurate mass results in the analysis of complex biological samples. This review discusses recent applications of HRMS in analytical toxicology.

  11. Regulatory issues in accreditation of toxicology laboratories.

    Science.gov (United States)

    Bissell, Michael G

    2012-09-01

    Clinical toxicology laboratories and forensic toxicology laboratories operate in a highly regulated environment. This article outlines major US legal/regulatory issues and requirements relevant to accreditation of toxicology laboratories (state and local regulations are not covered in any depth). The most fundamental regulatory distinction involves the purposes for which the laboratory operates: clinical versus nonclinical. The applicable regulations and the requirements and options for operations depend most basically on this consideration, with clinical toxicology laboratories being directly subject to federal law including mandated options for accreditation and forensic toxicology laboratories being subject to degrees of voluntary or state government–required accreditation.

  12. Current challenges for clinical trials of cardiovascular medical devices.

    Science.gov (United States)

    Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

    2014-07-15

    Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  13. Clinical, Toxicological, Biochemical, and Hematologic Parameters in Lead Exposed Workers of a Car Battery Industry

    OpenAIRE

    Kianoush, Sina; Balali-Mood, Mahdi; Mousavi, Seyed Reza; Shakeri, Mohammad Taghi; Dadpour, Bita; Moradi, Valiollah; Sadeghi, Mahmoud

    2013-01-01

    Background: Lead is a toxic element which causes acute, subacute or chronic poisoning through environmental and occupational exposure. The aim of this study was to investigate clinical and laboratory abnormalities of chronic lead poisoning among workers of a car battery industry. Methods: Questionnaires and forms were designed and used to record demographic data, past medical histories and clinical manifestations of lead poisoning. Blood samples were taken to determine biochemical (using Auto...

  14. MRI with cardiac pacing devices – Safety in clinical practice

    Energy Technology Data Exchange (ETDEWEB)

    Kaasalainen, Touko, E-mail: touko.kaasalainen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Physics, University of Helsinki (Finland); Pakarinen, Sami, E-mail: sami.pakarinen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Kivistö, Sari, E-mail: sari.kivisto@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Holmström, Miia, E-mail: miia.holmstrom@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Hänninen, Helena, E-mail: helena.hanninen@hus.fi [HUS Department of Cardiology, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Peltonen, Juha, E-mail: juha.peltonen@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Department of Biomedical Engineering and Computational Science, School of Science, Aalto University, Helsinki (Finland); Lauerma, Kirsi, E-mail: kirsi.lauerma@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland); Sipilä, Outi, E-mail: outi.sipila@hus.fi [HUS Medical Imaging Center, Helsinki University Central Hospital, POB 340 (Haartmaninkatu 4), 00290 Helsinki (Finland)

    2014-08-15

    Objectives: The aim of this study was to introduce a single centre “real life” experience of performing MRI examinations in clinical practice on patients with cardiac pacemaker systems. Additionally, we aimed to evaluate the safety of using a dedicated safety protocol for these patients. Materials and methods: We used a 1.5 T MRI scanner to conduct 68 MRI scans of different body regions in patients with pacing systems. Of the cardiac devices, 32% were MR-conditional, whereas the remaining 68% were MR-unsafe. We recorded the functional parameters of the devices prior, immediately after, and approximately one month after the MRI scanning, and compared the device parameters to the baseline values. Results: All MRI examinations were completed safely, and each device could be interrogated normally following the MRI. We observed no changes in the programmed parameters of the devices. For most of the participants, the distributions of the immediate and one-month changes in the device parameters were within 20% of the baseline values, although some changes approached clinically important thresholds. Furthermore, we observed no differences in the variable changes between MR-conditional and MR-unsafe pacing systems, or between scans of the thorax area and other scanned areas. Conclusion: MRI in patients with MR-conditional pacing systems and selected MR-unsafe systems could be performed safely under strict conditions in this study.

  15. The various aspects of genetic and epigenetic toxicology: testing methods and clinical applications.

    Science.gov (United States)

    Ren, Ning; Atyah, Manar; Chen, Wan-Yong; Zhou, Chen-Hao

    2017-05-22

    Genotoxicity refers to the ability of harmful substances to damage genetic information in cells. Being exposed to chemical and biological agents can result in genomic instabilities and/or epigenetic alterations, which translate into a variety of diseases, cancer included. This concise review discusses, from both a genetic and epigenetic point of view, the current detection methods of different agents' genotoxicity, along with their basic and clinical relation to human cancer, chemotherapy, germ cells and stem cells.

  16. Clinical, Toxicological, Biochemical, and Hematologic Parameters in Lead Exposed Workers of a Car Battery Industry

    Directory of Open Access Journals (Sweden)

    Sina Kianoush

    2013-03-01

    Full Text Available Background: Lead is a toxic element which causes acute, subacute or chronic poisoning through environmental and occupational exposure. The aim of this study was to investigate clinical and laboratory abnormalities of chronic lead poisoning among workers of a car battery industry. Methods: Questionnaires and forms were designed and used to record demographic data, past medical histories and clinical manifestations of lead poisoning. Blood samples were taken to determine biochemical (using Auto Analyzer; Model BT3000 and hematologic (using Cell Counter Sysmex; Model KX21N parameters. An atomic absorption spectrometer (Perkin-Elmer, Model 3030, USA was used to determine lead concentration in blood and urine by heated graphite atomization technique. Results: A total of 112 men mean age 28.78±5.17 years, who worked in a car battery industry were recruited in the present study. The most common signs/symptoms of lead poisoning included increased excitability 41.9%, arthralgia 41.0%, fatigue 40.1%, dental grey discoloration 44.6%, lead line 24.1%, increased deep tendon reflexes (DTR 22.3%, and decreased DTR (18.7%. Blood lead concentration (BLC was 398.95 µg/L±177.40, which was significantly correlated with duration of work (P=0.044 but not with the clinical manifestations of lead poisoning. However, BLC was significantly correlated with urine lead concentration (83.67 µg/L±49.78; r2=0.711; P<0.001, mean corpuscular hemoglobin (r=-0.280; P=0.011, mean corpuscular hemoglobin concentration (r=-0.304; P=0.006 and fasting blood sugar or FBS (r=-0.258; P=0.010. Conclusion: Neuropsychiatric and skeletal findings were common manifestations of chronic occupational lead poisoning. BLC was significantly correlated with duration of work, urine lead concentration, two hemoglobin indices and FBS.

  17. Clinical, Toxicological, Biochemical, and Hematologic Parameters in Lead Exposed Workers of a Car Battery Industry

    Science.gov (United States)

    Kianoush, Sina; Balali-Mood, Mahdi; Mousavi, Seyed Reza; Shakeri, Mohammad Taghi; Dadpour, Bita; Moradi, Valiollah; Sadeghi, Mahmoud

    2013-01-01

    Background: Lead is a toxic element which causes acute, subacute or chronic poisoning through environmental and occupational exposure. The aim of this study was to investigate clinical and laboratory abnormalities of chronic lead poisoning among workers of a car battery industry. Methods: Questionnaires and forms were designed and used to record demographic data, past medical histories and clinical manifestations of lead poisoning. Blood samples were taken to determine biochemical (using Auto Analyzer; Model BT3000) and hematologic (using Cell Counter Sysmex; Model KX21N) parameters. An atomic absorption spectrometer (Perkin-Elmer, Model 3030, USA) was used to determine lead concentration in blood and urine by heated graphite atomization technique. Results: A total of 112 men mean age 28.78±5.17 years, who worked in a car battery industry were recruited in the present study. The most common signs/symptoms of lead poisoning included increased excitability 41.9%, arthralgia 41.0%, fatigue 40.1%, dental grey discoloration 44.6%, lead line 24.1%, increased deep tendon reflexes (DTR) 22.3%, and decreased DTR (18.7%). Blood lead concentration (BLC) was 398.95 µg/L±177.40, which was significantly correlated with duration of work (P=0.044) but not with the clinical manifestations of lead poisoning. However, BLC was significantly correlated with urine lead concentration (83.67 µg/L±49.78; r2=0.711; Psugar or FBS (r=-0.258; P=0.010). Conclusion: Neuropsychiatric and skeletal findings were common manifestations of chronic occupational lead poisoning. BLC was significantly correlated with duration of work, urine lead concentration, two hemoglobin indices and FBS. PMID:23645955

  18. Clinical, toxicological, biochemical, and hematologic parameters in lead exposed workers of a car battery industry.

    Science.gov (United States)

    Kianoush, Sina; Balali-Mood, Mahdi; Mousavi, Seyed Reza; Shakeri, Mohammad Taghi; Dadpour, Bita; Moradi, Valiollah; Sadeghi, Mahmoud

    2013-03-01

    Lead is a toxic element which causes acute, subacute or chronic poisoning through environmental and occupational exposure. The aim of this study was to investigate clinical and laboratory abnormalities of chronic lead poisoning among workers of a car battery industry. Questionnaires and forms were designed and used to record demographic data, past medical histories and clinical manifestations of lead poisoning. Blood samples were taken to determine biochemical (using Auto Analyzer; Model BT3000) and hematologic (using Cell Counter Sysmex; Model KX21N) parameters. An atomic absorption spectrometer (Perkin-Elmer, Model 3030, USA) was used to determine lead concentration in blood and urine by heated graphite atomization technique. A total of 112 men mean age 28.78±5.17 years, who worked in a car battery industry were recruited in the present study. The most common signs/symptoms of lead poisoning included increased excitability 41.9%, arthralgia 41.0%, fatigue 40.1%, dental grey discoloration 44.6%, lead line 24.1%, increased deep tendon reflexes (DTR) 22.3%, and decreased DTR (18.7%). Blood lead concentration (BLC) was 398.95 µg/L±177.40, which was significantly correlated with duration of work (P=0.044) but not with the clinical manifestations of lead poisoning. However, BLC was significantly correlated with urine lead concentration (83.67 µg/L±49.78; r(2)=0.711; Psugar or FBS (r=-0.258; P=0.010). Neuropsychiatric and skeletal findings were common manifestations of chronic occupational lead poisoning. BLC was significantly correlated with duration of work, urine lead concentration, two hemoglobin indices and FBS.

  19. Acute poisoning in children; changes over the years, data of pediatric clinic department of toxicology

    Directory of Open Access Journals (Sweden)

    Alije Keka

    2014-01-01

    Conclusion: In our study drugs and house cleaning products are the most frequent agents causing accidental poisoning in children less than 5 years-old, this age of children is the most susceptible in terms of morbidity. Compared with the previous studies in Pediatric Clinic of Pristina, drugs are still the most frequent cause of acute poisoning in children; the number of poisoning with pesticides has fallen but has increased the number of poisoning with cleaning products. All preventive measures against poisoning should be taken including preventive strategies of education at national level especially in drug and household product storage.

  20. HPLC MS/MS method for quantification of meprobamate in human plasma: application to 24/7 clinical toxicology.

    Science.gov (United States)

    Delavenne, Xavier; Gay-Montchamp, Jean Pierre; Basset, Thierry

    2011-01-15

    We described the development and full validation of rapid and accurate liquid chromatography method, coupled with tandem mass spectrometry detection, for quantification of meprobamate in human plasma with [(13)C-(2)H(3)]-meprobamate as internal standard. Plasma pretreatment involved a one-step protein precipitation with acetonitrile. Separation was performed by reversed-phase chromatography on a Luna MercuryMS C18 (20 mm×4 mm×3 μm) column using a gradient elution mode. The mobile phase was a mix of distilled water containing 0.1% formic acid and acetonitrile containing 0.1% formic acid. The selected reaction monitoring transitions, in electrospray positive ionization, used for quantification were 219.2→158.2 m/z and 223.1→161.1m/z for meprobamate and internal standard, respectively. Qualification transitions were 219.2→97.0 and 223.1→101.1 m/z for meprobamate and internal standard, respectively. The method was linear over the concentration range of 1-300 mg/L. The intra- and inter-day precision values were below 6.4% and accuracy was within 95.3% and 103.6% for all QC levels (5, 75 and 200 mg/L). The lower limit of quantification was 1 mg/L. Total analysis time was reduced to 6 min including sample preparation. The present method is successfully applied to 24/7 clinical toxicology and demonstrated its usefulness to detect meprobamate poisoning. Copyright © 2010 Elsevier B.V. All rights reserved.

  1. The clinical toxicology of γ-hydroxybutyrate, γ-butyrolactone and 1,4-butanediol.

    Science.gov (United States)

    Schep, Leo J; Knudsen, Kai; Slaughter, Robin J; Vale, J Allister; Mégarbane, Bruno

    2012-07-01

    Gamma-hydroxybutyrate (GHB) and its precursors, gamma-butyrolactone (GBL) and 1,4-butanediol (1,4-BD), are drugs of abuse which act primarily as central nervous system (CNS) depressants. In recent years, the rising recreational use of these drugs has led to an increasing burden upon health care providers. Understanding their toxicity is therefore essential for the successful management of intoxicated patients. We review the epidemiology, mechanisms of toxicity, toxicokinetics, clinical features, diagnosis, and management of poisoning due to GHB and its analogs and discuss the features and management of GHB withdrawal. OVID MEDLINE and ISI Web of Science databases were searched using the terms "GHB," "gamma-hydroxybutyrate," "gamma-hydroxybutyric acid," "4-hydroxybutanoic acid," "sodium oxybate," "gamma-butyrolactone," "GBL," "1,4-butanediol," and "1,4-BD" alone and in combination with the keywords "pharmacokinetics," "kinetics," "poisoning," "poison," "toxicity," "ingestion," "adverse effects," "overdose," and "intoxication." In addition, bibliographies of identified articles were screened for additional relevant studies including nonindexed reports. Non-peer-reviewed sources were also included: books, relevant newspaper reports, and applicable Internet resources. These searches produced 2059 nonduplicate citations of which 219 were considered relevant. There is limited information regarding statistical trends on world-wide use of GHB and its analogs. European data suggests that the use of GHB is generally low; however, there is some evidence of higher use among some sub-populations, settings, and geographical areas. In the United States of America, poison control center data have shown that enquiries regarding GHB have decreased between 2002 and 2010 suggesting a decline in use over this timeframe. GHB is an endogenous neurotransmitter synthesized from glutamate with a high affinity for GHB-receptors, present on both on pre- and postsynaptic neurons, thereby

  2. Phytochemical, toxicological and antimicrobial evaluation of Lawsonia inermis extracts against clinical isolates of pathogenic bacteria.

    Science.gov (United States)

    Gull, Iram; Sohail, Maria; Aslam, Muhammad Shahbaz; Amin Athar, Muhammad

    2013-12-01

    The emerging resistance of pathogen against the currently available antimicrobial agents demands the search of new antimicrobial agents. The use of medicinal plants as natural substitute is the paramount area of research to overwhelm the drug resistance of infectious agents. Scientists have not made enough effort on the evaluation of safety of medicinal plant yet. In the present study antimicrobial activity of Lawsonia inermis is investigated against clinical isolates of seven bacteria including four Gram negative (Escherichia coli, Salmonella typhi, Klebsiella spp., Shigella sonnei) and three Gram positive (Bacillus subtilis, Staphylococcus aureus, Staphylococcus epidermidis) using disc diffusion method. Four types of Lawsonia inermis extracts were prepared using methanol, chloroform, acetone and water as extraction solvents, while DMSO (Dimethyl sulfoxide) and water as dissolution solvents. The rate and extent of bacterial killing was estimated by time-kill kinetic assay at 1× MIC of each bacterial isolate. The overall safety of Lawsonia inermis extracts was assessed in mice. Lawsonia inermis displayed noteworthy antimicrobial activity against both gram positive and gram negative bacterial strains used in the study. The minimum value of MIC for different bacterial strains ranged from 2.31 mg/ml to 9.27 mg/ml. At 1x MIC of each bacterial isolate, 3log10 decrease in CFU was recorded after 6 hours of drug exposure and no growth was observed in almost all tested bacteria after 24 hours of exposure. No sign of toxidrome were observed during in vivo toxicity evaluation in mice at 300 mg/kg concentration. In conclusion, the present study provides the scientific rational for medicinal use of Lawsonia inermis. The use of Lawsonia inermis extracts is of great significance as substitute antimicrobial agent in therapeutics.

  3. Biocarbon ureterostomy device for urinary diversion. Multicenter clinical trial.

    Science.gov (United States)

    Chancellor, M; Grossman, H B; Konnak, J; Diokno, A C; Gonzalez, J; Pontes, J E; Huben, R P; King, G W

    1989-07-01

    The bioCarbon ureterostomy device is a stomal prosthesis for upper tract urinary diversion that has had preliminary successes in animal and human trials in Europe and Peru. Implantation of a pure carbon stomal prosthesis offers the potential advantages of high biocompatibility, lack of encrustation, and elimination of stomal stenosis which is frequently associated with cutaneous ureterostomy. Nine bioCarbon ureterostomy devices were implanted from August, 1984 through July, 1985. Although successful implantation was achieved in 2 patients, the complication rate was high. The bioCarbon ureterostomy device has potential as an alternative form of urinary diversion. However, significant problems need to be remedied before it can be recommended for routine clinical application.

  4. Integrating Personalized Technology in Toxicology: Sensors, Smart Glass, and Social Media Applications in Toxicology Research.

    Science.gov (United States)

    Carreiro, Stephanie; Chai, Peter R; Carey, Jennifer; Chapman, Brittany; Boyer, Edward W

    2017-06-01

    Rapid proliferation of mobile technologies in social and healthcare spaces create an opportunity for advancement in research and clinical practice. The application of mobile, personalized technology in healthcare, referred to as mHealth, has not yet become routine in toxicology. However, key features of our practice environment, such as frequent need for remote evaluation, unreliable historical data from patients, and sensitive subject matter, make mHealth tools appealing solutions in comparison to traditional methods that collect retrospective or indirect data. This manuscript describes the features, uses, and costs associated with several of common sectors of mHealth research including wearable biosensors, ingestible biosensors, head-mounted devices, and social media applications. The benefits and novel challenges associated with the study and use of these applications are then discussed. Finally, opportunities for further research and integration are explored with a particular focus on toxicology-based applications.

  5. Mass Spectrometry Applications for Toxicology.

    Science.gov (United States)

    Mbughuni, Michael M; Jannetto, Paul J; Langman, Loralie J

    2016-12-01

    Toxicology is a multidisciplinary study of poisons, aimed to correlate the quantitative and qualitative relationships between poisons and their physiological and behavioural effects in living systems. Other key aspects of toxicology focus on elucidation of the mechanisms of action of poisons and development of remedies and treatment plans for associated toxic effects. In these endeavours, Mass spectrometry (MS) has become a powerful analytical technique with a wide range of application used in the Toxicological analysis of drugs, poisons, and metabolites of both. To date, MS applications have permeated all fields of toxicology which include; environmental, clinical, and forensic toxicology. While many different analytical applications are used in these fields, MS and its hyphenated applications such as; gas chromatography MS (GC-MS), liquid chromatography MS (LC-MS), inductively coupled plasma ionization MS (ICP-MS), tandem mass spectrometry (MS/MS and MS n ) have emerged as powerful tools used in toxicology laboratories. This review will focus on these hyphenated MS technologies and their applications for toxicology.

  6. Mass Spectrometry Applications for Toxicology

    Science.gov (United States)

    Mbughuni, Michael M.; Jannetto, Paul J.

    2016-01-01

    Toxicology is a multidisciplinary study of poisons, aimed to correlate the quantitative and qualitative relationships between poisons and their physiological and behavioural effects in living systems. Other key aspects of toxicology focus on elucidation of the mechanisms of action of poisons and development of remedies and treatment plans for associated toxic effects. In these endeavours, Mass spectrometry (MS) has become a powerful analytical technique with a wide range of application used in the Toxicological analysis of drugs, poisons, and metabolites of both. To date, MS applications have permeated all fields of toxicology which include; environmental, clinical, and forensic toxicology. While many different analytical applications are used in these fields, MS and its hyphenated applications such as; gas chromatography MS (GC-MS), liquid chromatography MS (LC-MS), inductively coupled plasma ionization MS (ICP-MS), tandem mass spectrometry (MS/MS and MSn) have emerged as powerful tools used in toxicology laboratories. This review will focus on these hyphenated MS technologies and their applications for toxicology. PMID:28149262

  7. IRIS Toxicological Review of Thallium and Compounds ...

    Science.gov (United States)

    Thallium compounds are used in the semiconductor industry, the manufacture of optic lenses and low-melting glass, low-temperature thermometers, alloys, electronic devices, mercury lamps, fireworks, and imitation germs, and clinically as an imaging agent in the diagnosis of certain tumors. EPA's assessment of noncancer health effects and carcinogenic potential of thallium compounds was last prepared and added to the IRIS database between 1988 and 1990. The IRIS program is preparing an assessment that will incorporate current health effects information available for thallium and compounds, and current risk assessment methods. The IRIS assessment for thallium compounds will consist of a Toxicological Review and IRIS Summary. The Toxicological Review is a critical review of the physiochemical and toxicokinetic properties of a chemical, and its toxicity in humans and experimental systems. The assessment will present reference values for the noncancer effects of thallium compounds (RfD and Rfc), and a cancer assessment. The Toxicological Review and IRIS Summary have been subject to Agency review, Interagency review, and external scientific peer review. The final product will reflect the Agency opinion on the overall toxicity of thallium and compounds. EPA is undertaking an Integrated Risk Information System (IRIS) health assessment for thallium and compounds. IRIS is an EPA database containing Agency scientific positions on potential adverse human health effec

  8. TOXNET: Toxicology Data Network

    Science.gov (United States)

    ... to TOXNET Your resource for searching databases on toxicology, hazardous chemicals, environmental health, and toxic releases SEARCH ... over 3,000 chemicals (1991-1998) Environmental Health & Toxicology Resources on environmental health and toxicology Visit Site ...

  9. [New medical device hospital assessment: what kind of clinical data?].

    Science.gov (United States)

    Beaussier, H; Junot, H; Lancrenon, S; Faure, P

    2012-01-01

    Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD. All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology). One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period. The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation. Copyright © 2011 Elsevier Masson SAS. All rights reserved.

  10. Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays. Final order.

    Science.gov (United States)

    2017-07-27

    The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.

  11. Space Toxicology

    Science.gov (United States)

    James, John T.

    2011-01-01

    Safe breathing air for space faring crews is essential whether they are inside an Extravehicular Mobility Suit (EMU), a small capsule such as Soyuz, or the expansive International Space Station (ISS). Sources of air pollution can include entry of propellants, excess offgassing from polymeric materials, leakage of systems compounds, escape of payload compounds, over-use of utility compounds, microbial metabolism, and human metabolism. The toxicological risk posed by a compound is comprised of the probability of escaping to cause air pollution and the magnitude of adverse effects on human health if escape occurs. The risk from highly toxic compounds is controlled by requiring multiple levels of containment to greatly reduce the probability of escape; whereas compounds that are virtually non-toxic may require little or no containment. The potential for toxicity is determined by the inherent toxicity of the compound and the amount that could potentially escape into the breathing air.

  12. Animal toxicology

    Energy Technology Data Exchange (ETDEWEB)

    Amdur, M.

    1996-12-31

    The chapter evaluates results of toxicological studies on experimental animals to investigate health effects of air pollutants and examines the animal data have predicted the response to human subject. Data are presented on the comparative toxicity of sulfur dioxide and sulfuric acid. The animal data obtained by measurement of airway resistance in guinea pigs and of bronchial clearance of particles in donkeys predicted clearly that sulfuric acid was more irritant than sulfur dioxide. Data obtained on human subjects confirmed this prediction. These acute studies also correctly predicted the comparative toxicity of the two compounds in two year studies of monkeys. Such chronic studies are not possible in human subjects but it is a reasonable to assume that sulfuric acid would be more toxic than sulfur dioxide. Current findings in epidemiological studies certainly support this assumption.

  13. Forensic Toxicology: An Introduction.

    Science.gov (United States)

    Smith, Michael P; Bluth, Martin H

    2016-12-01

    This article presents an overview of forensic toxicology. The authors describe the three components that make up forensic toxicology: workplace drug testing, postmortem toxicology, and human performance toxicology. Also discussed are the specimens that are tested, the methods used, and how the results are interpreted in this particular discipline. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Clinical assessment of the accuracy of blood glucose measurement devices.

    Science.gov (United States)

    Pfützner, Andreas; Mitri, Michael; Musholt, Petra B; Sachsenheimer, Daniela; Borchert, Marcus; Yap, Andrew; Forst, Thomas

    2012-04-01

    Blood glucose meters for patient self-measurement need to comply with the accuracy standards of the ISO 15197 guideline. We investigated the accuracy of the two new blood glucose meters BG*Star and iBG*Star (Sanofi-Aventis) in comparison to four other competitive devices (Accu-Chek Aviva, Roche Diagnostics; FreeStyle Freedom Lite, Abbott Medisense; Contour, Bayer; OneTouch Ultra 2, Lifescan) at different blood glucose ranges in a clinical setting with healthy subjects and patients with type 1 and type 2 diabetes. BGStar and iBGStar are employ dynamic electrochemistry, which is supposed to result in highly accurate results. The study was performed on 106 participants (53 female, 53 male, age (mean ± SD): 46 ± 16 years, type 1: 32 patients, type 2: 34 patients, and 40 healthy subjects). Two devices from each type and strips from two different production lots were used for glucose assessment (∼200 readings/meter). Spontaneous glucose assessments and glucose or insulin interventions under medical supervision were applied to perform measurements in the different glucose ranges in accordance with the ISO 15197 requirements. Sample values 400 mg/dL were prepared by laboratory manipulations. The YSI glucose analyzer (glucose oxidase method) served as the standard reference method which may be considered to be a limitation in light of glucose hexokinase-based meters. For all devices, there was a very close correlation between the glucose results compared to the YSI reference method results. The correlation coefficients were r = 0.995 for BGStar and r = 0.992 for iBGStar (Aviva: 0.995, Freedom Lite: 0.990, Contour: 0.993, Ultra 2: 0.990). Error-grid analysis according to Parkes and Clarke revealed both 100% of the readings to be within the clinically acceptable areas (Clarke: A + B with BG*Star (100 + 0), Aviva (97 + 3), and Contour (97 + 3); and 99.5% with iBG*Star (97.5 + 2), Freedom Lite (98 + 1.5), and Ultra 2 (97.5 + 2

  15. Prospective clinical evaluation of an electronic portal imaging device

    International Nuclear Information System (INIS)

    Michalski, Jeff M.; Graham, Mary V.; Bosch, Walter R.; Wong, John; Gerber, Russell L.; Cheng, Abel; Tinger, Alfred; Valicenti, Richard K.

    1996-01-01

    Purpose: To determine whether the clinical implementation of an electronic portal imaging device can improve the precision of daily external beam radiotherapy. Methods and Materials: In 1991, an electronic portal imaging device was installed on a dual energy linear accelerator in our clinic. After training the radiotherapy technologists in the acquisition and evaluation of portal images, we performed a randomized study to determine whether online observation, interruption, and intervention would result in more precise daily setup. The patients were randomized to one of two groups: those whose treatments were actively monitored by the radiotherapy technologists and those that were imaged but not monitored. The treating technologists were instructed to correct the following treatment errors: (a) field placement error (FPE) > 1 cm; (b) incorrect block; (c) incorrect collimator setting; (d) absent customized block. Time of treatment delivery was recorded by our patient tracking and billing computers and compared to a matched set of patients not participating in the study. After the patients radiation therapy course was completed, an offline analysis of the patient setup error was planned. Results: Thirty-two patients were treated to 34 anatomical sites in this study. In 893 treatment sessions, 1,873 fields were treated (1,089 fields monitored and 794 fields unmonitored). Ninety percent of the treated fields had at least one image stored for offline analysis. Eighty-seven percent of these images were analyzed offline. Of the 1,011 fields imaged in the monitored arm, only 14 (1.4%) had an intervention recorded by the technologist. Despite infrequent online intervention, offline analysis demonstrated that the incidence of FPE > 10 mm in the monitored and unmonitored groups was 56 out of 881 (6.1%) and 95 out of 595 (11.2%), respectively; p 10 mm was confined to the pelvic fields. The time to treat patients in this study was 10.78 min (monitored) and 10.10 min (unmonitored

  16. 77 FR 66848 - Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and...

    Science.gov (United States)

    2012-11-07

    ...] Minimum Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation... Clinically Important Difference: An Outcome Metric in Orthopaedic Device Science and Regulation.'' FDA is co... (MCID) for patient-reported outcome (PRO) instruments used in orthopaedic extremity device-related...

  17. Cornerstones of Toxicology.

    Science.gov (United States)

    Hayes, A Wallace; Dixon, Darlene

    2017-01-01

    The 35th Annual Society of Toxicologic Pathology Symposium, held in June 2016 in San Diego, California, focused on "The Basis and Relevance of Variation in Toxicologic Responses." In order to review the basic tenants of toxicology, a "broad brush" interactive talk that gave an overview of the Cornerstones of Toxicology was presented. The presentation focused on the historical milestones and perspectives of toxicology and through many scientific graphs, data, and real-life examples covered the three basic principles of toxicology that can be summarized, as dose matters (as does timing), people differ, and things change (related to metabolism and biotransformation).

  18. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    2013-11-07

    .... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...

  19. 76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-04-01

    ...] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting... comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel... Clinical Genetics Panel of the Medical Devices Advisory Committee, and the opening of a public docket to...

  20. National Toxicology Program

    Science.gov (United States)

    ... NTP? NTP develops and applies tools of modern toxicology and molecular biology to identify substances in the ... depend on for decisions that matter. The National Toxicology Program provides the scientific basis for programs, activities, ...

  1. Toxicology Education Foundation

    Science.gov (United States)

    ... bodies and our world. Welcome to the Toxicology Education Foundation! Our mission is to enhance public understanding ... In with us, follow our Tweets, choose Toxicology Education Foundation as your preferred charity through Smile.Amazon. ...

  2. Environmental Toxicology Research Facility

    Data.gov (United States)

    Federal Laboratory Consortium — Fully-equipped facilities for environmental toxicology researchThe Environmental Toxicology Research Facility (ETRF) located in Vicksburg, MS provides over 8,200 ft...

  3. Handbook of systems toxicology

    National Research Council Canada - National Science Library

    Casciano, Daniel A; Sahu, Saura C

    2011-01-01

    "In the first handbook to comprehensively cover the emerging area of systems toxicology, the Handbook of Systems Toxicology provides an authoritative compilation of up-to-date developments presented...

  4. Green Toxicology – Application of predictive toxicology

    DEFF Research Database (Denmark)

    Vinggaard, Anne Marie; Wedebye, Eva Bay; Taxvig, Camilla

    2014-01-01

    safer chemicals and to identify problematic compounds already in use such as industrial compounds, drugs, pesticides and cosmetics, is required. Green toxicology is the application of predictive toxicology to the production of chemicals with the specific intent of improving their design for hazard...

  5. Clinical evaluation of a new intracranial pressure monitoring device.

    Science.gov (United States)

    Stendel, R; Heidenreich, J; Schilling, A; Akhavan-Sigari, R; Kurth, R; Picht, T; Pietilä, T; Suess, O; Kern, C; Meisel, J; Brock, M

    2003-03-01

    Continuous monitoring of intracranial pressure (ICP) still plays a key role in the management of patients at risk from intracranial hypertension. Numerous ICP-measuring devices are available. The aim of the present study was to investigate the clinical characteristics and the magnetic resonance imaging (MRI) compatibility of the recently developed Neurovent-P(REHAU AG+CO, REHAU, Germany) ICP monitoring device. In a prospective two-center study, a total of 98 patients with severe head injury, subarachnoid haemorrhage, intracerebral haemorrhage, and non-traumatic brain edema underwent intraparenchymal monitoring of ICP using the Neurovent-P. A control group comprising 50 patients underwent implantation of the Camino-OLM-110-4B ICP monitor. The zero drift of the probes was determined before and after the ICP recording period. Technical and medical complications were documented. The MRI compatibility of the Neurovent-P ICP probe was investigated by evaluating artifacts caused by the probe, probe function and temperature changes during MRI, and probe movement caused by the magnetic field. The mean zero drift was 0.2+/-0.41 mmHg (maximum 3 mmHg) for the Neurovent-P ICP probes and 0.4+/-0.57 mmHg (maximum 12 mmHg) for the Camino-OLM-110-4B ICP probes. No significant correlation was identified between the extent of zero drift following the removal of the probes and the length of monitoring. Intraparenchymal haemorrhage spatially related to the probe occurred in 1 out of 50 (2%) patients with a Camino-OLM-110-4B probe and in 1 out of 98 (1%) with a Neurovent-P. Damage of the probe due to kinking or overextension of the cable or glass fiber occurred in 4 of the 50 (8%) Camino-OLM-110-4B ICP probes and in 5 of the 98 (5%) Neurovent-P probes. On T2-weighted MR images, the Neurovent-P ICP probe induced only small artifacts with very good discrimination of the surrounding tissue. On T1-weighted MR images, there was a good imaging quality but artifact-related local disturbances

  6. Evaluation of commercial self-monitoring devices for clinical purposes

    DEFF Research Database (Denmark)

    Leth, Søren; Hansen, John; Nielsen, Olav Wendelboe

    2017-01-01

    Commercial self-monitoring devices are becoming increasingly popular, and over the last decade, the use of self-monitoring technology has spread widely in both consumer and medical markets. The purpose of this study was to evaluate five commercially available self-monitoring devices for further...

  7. 78 FR 11207 - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation...

    Science.gov (United States)

    2013-02-15

    ...] Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation; Guidance for... devices intended for the treatment of atrial fibrillation. DATES: Submit either electronic or written... Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation'' to the Division of...

  8. Pilot for the Australian Breast Device Registry (ABDR): a national opt-out clinical quality registry for breast device surgery.

    Science.gov (United States)

    Hopper, Ingrid; Best, Renee L; McNeil, John J; Mulvany, Catherine M; Moore, Colin C M; Elder, Elisabeth; Pase, Marie; Cooter, Rodney D; Evans, Sue M

    2017-12-28

    To establish a pilot clinical quality registry (CQR) to monitor the quality of care and device performance for breast device surgery in Australia. All patients having breast device surgery from contributing hospitals in Australia. A literature review was performed which identified quality indicators for breast device surgery. A pilot CQR was established in 2011 to capture prospective data on breast device surgery. An interim Steering Committee and Management Committee were established to provide clinical governance, and guide quality indicator selection. The registry's minimum dataset was formulated in consultation with stakeholder groups; potential quality indicators were assessed in terms of (1) importance and relevance, (2) usability, (3) feasibility to collect and (4) scientific validity. Data collection was by a two-sided paper-based form with manual data entry. Seven sites were recruited, including one public hospital, four private hospitals and two day surgeries. Patients were recruited and opt-out consent used. The pilot breast device registry provides high-quality population-based data. It provides a model for developing a national CQR for breast devices; its minimum dataset and quality indicators reflect the opinions of the broad range of stakeholders. It is easily scalable, and has formed the basis for other international surgical groups establishing similar registries. © 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.

  9. [Ethic review on clinical experiments of medical devices in medical institutions].

    Science.gov (United States)

    Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

    2011-07-01

    Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

  10. Evaluating clinical accuracy of continuous glucose monitoring devices: other methods

    NARCIS (Netherlands)

    Wentholt, Iris M. E.; Hart, August A.; Hoekstra, Joost B. L.; DeVries, J. Hans

    2008-01-01

    With more and more continuous glucose monitoring devices entering the market, the importance of adequate accuracy assessment grows. This review discusses pros and cons of Regression Analysis and Correlation Coefficient, Relative Difference measures, Bland Altman plot, ISO criteria, combined curve

  11. The clinical use of the device for flowing blood irradiation

    International Nuclear Information System (INIS)

    Arutyunov, A.S.; Karasev, A.B.; Kovalev, O.I.; Pisarevskij, A.A.; Skobennikov, A.K.; Trofimov, V.I.; Khaskel'berg, N.G.

    1988-01-01

    The indications and possibilities of using the device for flowing extracorporeal ultraviolet radiation of blood are considered. The uniformity of the radiation of blood in the proposed device provides an annular gap of the quartz dish with the partition in the shape of a spiral. It makes it possible to expose a larger part of the blood content of an organism simultaneously making use of various perfused methods of its detoxication

  12. Development and validation of an EI-GC-MS method for the determination of benzodiazepine drugs and their metabolites in blood: applications in clinical and forensic toxicology.

    Science.gov (United States)

    Papoutsis, Ioannis I; Athanaselis, Sotirios A; Nikolaou, Panagiota D; Pistos, Constantinos M; Spiliopoulou, Chara A; Maravelias, Constantinos P

    2010-08-01

    Benzodiazepines are used widely in daily clinical practice, due to their multiple pharmacological actions. The frequent problems associated with the wide use of benzodiazepines, as well as the multiple incidents of poisonings, led to the necessity for the development of a precise, sensitive and rapid method for the simultaneous determination of the 23 most commonly used benzodiazepines (diazepam, nordiazepam, oxazepam, bromazepam, alprazolam, lorazepam, medazepam, flurazepam, fludiazepam, tetrazepam, chlordiazepoxide, clobazam, midazolam, flunitrazepam, 7-amino-flunitrazepam, triazolam, prazepam, nimetazepam, nitrazepam, temazepam, lormetazepam, clonazepam, camazepam) in blood. A gas chromatographic method combined with mass spectrometric detection was developed, optimized and validated for the determination of the above substances. This method includes liquid-liquid extraction with chloroform at pH 9 and two stages of derivatization using tetramethylammonium hydroxide and propyliodide (propylation), as well as a mixture of triethylamine:propionic anhydride (propionylation). The recoveries were higher than 74% for all the benzodiazepines. The calibration curves were linear within the dynamic range of each benzodiazepine with a correlation coefficient higher than 0.9981. The limits of detection and quantification for each analyte were statistically calculated from the relative calibration curves. Accuracy and precision were also calculated and were found to be less than 8.5% and 11.1%, respectively. The developed method was successfully applied for the investigation of both forensic and clinical toxicological cases of accidental and suicidal poisoning. Copyright (c) 2010 Elsevier B.V. All rights reserved.

  13. Doctors' use of mobile devices in the clinical setting: a mixed methods study.

    Science.gov (United States)

    Nerminathan, Arany; Harrison, Amanda; Phelps, Megan; Alexander, Shirley; Scott, Karen M

    2017-03-01

    Mobile device use has become almost ubiquitous in daily life and therefore includes use by doctors in clinical settings. There has been little study as to the patterns of use and impact this has on doctors in the workplace and how negatively or positively it impacts at the point of care. To explore how doctors use mobile devices in the clinical setting and understand drivers for use. A mixed methods study was used with doctors in a paediatric and adult teaching hospital in 2013. A paper-based survey examined mobile device usage data by doctors in the clinical setting. Focus groups explored doctors' reasons for using or refraining from using mobile devices in the clinical setting, and their attitudes about others' use. The survey, completed by 109 doctors, showed that 91% owned a smartphone and 88% used their mobile devices frequently in the clinical setting. Trainees were more likely than consultants to use their mobile devices for learning and accessing information related to patient care, as well as for personal communication unrelated to work. Focus group data highlighted a range of factors that influenced doctors to use personal mobile devices in the clinical setting, including convenience for medical photography, and factors that limited use. Distraction in the clinical setting due to use of mobile devices was a key issue. Personal experience and confidence in using mobile devices affected their use, and was guided by role modelling and expectations within a medical team. Doctors use mobile devices to enhance efficiency in the workplace. In the current environment, doctors are making their own decisions based on balancing the risks and benefits of using mobile devices in the clinical setting. There is a need for guidelines around acceptable and ethical use that is patient-centred and that respects patient privacy. © 2016 Royal Australasian College of Physicians.

  14. Evaluation of Commercial Self-Monitoring Devices for Clinical Purposes

    DEFF Research Database (Denmark)

    Leth, Soren; Hansen, John; Nielsen, Olav W

    2017-01-01

    Commercial self-monitoring devices are becoming increasingly popular, and over the last decade, the use of self-monitoring technology has spread widely in both consumer and medical markets. The purpose of this study was to evaluate five commercially available self-monitoring devices for further...... activity trackers and compared to gyroscope readings. Two trackers were also tested on nine subjects by comparing pulse readings to Holter monitoring. RESULTS: The lowest average systematic error in the walking tests was -0.2%, recorded on the Garmin Vivofit 2 at 3.5 km/h; the highest error was the Fitbit...... the current functionality and limitations of the five self-tracking devices, and point towards a need for future research in this area....

  15. Bridging the gap between heart failure and the device clinic.

    Science.gov (United States)

    Rickard, John; Wilkoff, Bruce L

    2017-08-01

    While cardiac resynchronization therapy (CRT) is a mainstay in the management of selected patients with chronic systolic dysfunction, many patients are noted to experience less than expected or no benefit at all from the therapy. Multidisciplinary care has been shown to provide benefit in follow up for patients receiving CRT devices. Areas covered: This review will focus on the apparent reasons behind less than optimal outcomes following CRT as well as multidisciplinary approaches to treating patients with CRT devices. The literature review focused mainly on the data behind multidisciplinary care of CRT patients. Expert commentary: A multidisciplinary approach incorporating input from various cardiology backgrounds is an important strategy in ensuring optimal outcomes in patients receiving CRT devices. Breaking down the 'silo' effect amongst cardiac subspecialties is vital in achieving high level multidisciplinary care.

  16. A clinical comparison of disposable airway devices | Strydom ...

    African Journals Online (AJOL)

    Cuff pressures were significantly higher in the Ambu™ and LMA Unique™ (p = 0.001). Maximum airway pressure attainable after 5 minutes was significantly higher in the Ambu™ (p = 0.036). Airway trauma as graded by visible blood on the device was low, and similar between groups (p = 0.237). Secretions were negligible ...

  17. Reproductive and developmental toxicology

    National Research Council Canada - National Science Library

    Gupta, Ramesh C

    2011-01-01

    .... Reproductive and Developmental Toxicology is a comprehensive and authoritative resource providing the latest literature enriched with relevant references describing every aspect of this area of science...

  18. Information resources in toxicology--Italy

    International Nuclear Information System (INIS)

    Preziosi, Paolo; Dracos, Adriana; Marcello, Ida

    2003-01-01

    The purpose of the present paper is to provide an overview of current resources in the field of toxicology in Italy. The discussion will begin with a brief history of toxicology in this country, which includes the study of the toxicity of plants and other natural substances, and the birth of industrial and forensic toxicology. We will also provide information on research, education, and hazard control in the field of toxicology. Within this context we will examine the public bodies responsible for surveillance and regulatory activities, state-owned and private structures involved in toxicological research, and the educational programs and research activities of universities. Particular emphasis will be placed on the activities of the National Health Service, which plays an important role in areas such as clinical toxicology, food safety, and animal health, as well as those of national and regional agencies dedicated to the protection of the environment. The presentation will be organized as follows: - A Brief History of Toxicology in Italy; - Professional Societies; - National Health Service; - National Bodies; - Resources for the Environment; - Biomedical Websites; - Recent Publications; - Research Structures; - Graduate and Postgraduate Programs; - Legislation

  19. A primer on systematic reviews in toxicology.

    Science.gov (United States)

    Hoffmann, Sebastian; de Vries, Rob B M; Stephens, Martin L; Beck, Nancy B; Dirven, Hubert A A M; Fowle, John R; Goodman, Julie E; Hartung, Thomas; Kimber, Ian; Lalu, Manoj M; Thayer, Kristina; Whaley, Paul; Wikoff, Daniele; Tsaioun, Katya

    2017-07-01

    Systematic reviews, pioneered in the clinical field, provide a transparent, methodologically rigorous and reproducible means of summarizing the available evidence on a precisely framed research question. Having matured to a well-established approach in many research fields, systematic reviews are receiving increasing attention as a potential tool for answering toxicological questions. In the larger framework of evidence-based toxicology, the advantages and obstacles of, as well as the approaches for, adapting and adopting systematic reviews to toxicology are still being explored. To provide the toxicology community with a starting point for conducting or understanding systematic reviews, we herein summarized available guidance documents from various fields of application. We have elaborated on the systematic review process by breaking it down into ten steps, starting with planning the project, framing the question, and writing and publishing the protocol, and concluding with interpretation and reporting. In addition, we have identified the specific methodological challenges of toxicological questions and have summarized how these can be addressed. Ultimately, this primer is intended to stimulate scientific discussions of the identified issues to fuel the development of toxicology-specific methodology and to encourage the application of systematic review methodology to toxicological issues.

  20. Enabling Medical Device Interoperability for the Integrated Clinical Environment

    Science.gov (United States)

    2016-12-01

    context. For instance, part of the data logger demo at NIH included a scenario in which the patient received an overdose from a PCA pump . The device...data shows the patient’s physiologic response, the log from a PCA pump would show that the dose request button was pressed, but only the video could...databases including Microsoft Access  vcd (IEEE-1364) – Value Change Dump – a waveform storage format defined by the Institute of Electrical and

  1. Recommendations for blood pressure measuring devices for office/clinic use in low resource settings

    NARCIS (Netherlands)

    Parati, G.; Mendis, S.; Abegunde, D.; Asmar, R.; Mieke, S.; Murray, A.; Shengelia, B.; Steenvoorden, G.; Montfrans, G. van; O'Brien, E.

    2005-01-01

    This paper, which summarizes the conclusions of a WHO Expert meeting, is aimed at proposing indications to develop technical specifications for an accurate and affordable blood pressure measuring device for office/ clinic use in low resource settings. Blood pressure measuring devices to be used in

  2. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Science.gov (United States)

    2011-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0457] Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices Indicated... other electrical continence devices; protective garment for incontinence; surgical mesh; electrosurgical...

  3. Fossil fuel toxicology

    International Nuclear Information System (INIS)

    Anon.

    1976-01-01

    A program is described for the investigation of the toxicology of coal-derived effluents that will utilize a battery of cellular and mammalian test systems and end points to evaluate the toxicological effects of acute, sub-acute, and long-term, low-level exposure to gaseous and particulate effluents from combustion of coal, with special emphasis on fluidized bed combustion

  4. Toxicology ontology perspectives.

    Science.gov (United States)

    Hardy, Barry; Apic, Gordana; Carthew, Philip; Clark, Dominic; Cook, David; Dix, Ian; Escher, Sylvia; Hastings, Janna; Heard, David J; Jeliazkova, Nina; Judson, Philip; Matis-Mitchell, Sherri; Mitic, Dragana; Myatt, Glenn; Shah, Imran; Spjuth, Ola; Tcheremenskaia, Olga; Toldo, Luca; Watson, David; White, Andrew; Yang, Chihae

    2012-01-01

    The field of predictive toxicology requires the development of open, public, computable, standardized toxicology vocabularies and ontologies to support the applications required by in silico, in vitro, and in vivo toxicology methods and related analysis and reporting activities. In this article we review ontology developments based on a set of perspectives showing how ontologies are being used in predictive toxicology initiatives and applications. Perspectives on resources and initiatives reviewed include OpenTox, eTOX, Pistoia Alliance, ToxWiz, Virtual Liver, EU-ADR, BEL, ToxML, and Bioclipse. We also review existing ontology developments in neighboring fields that can contribute to establishing an ontological framework for predictive toxicology. A significant set of resources is already available to provide a foundation for an ontological framework for 21st century mechanistic-based toxicology research. Ontologies such as ToxWiz provide a basis for application to toxicology investigations, whereas other ontologies under development in the biological, chemical, and biomedical communities could be incorporated in an extended future framework. OpenTox has provided a semantic web framework for the implementation of such ontologies into software applications and linked data resources. Bioclipse developers have shown the benefit of interoperability obtained through ontology by being able to link their workbench application with remote OpenTox web services. Although these developments are promising, an increased international coordination of efforts is greatly needed to develop a more unified, standardized, and open toxicology ontology framework.

  5. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    Science.gov (United States)

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  6. Evidence-Based Toxicology.

    Science.gov (United States)

    Hoffmann, Sebastian; Hartung, Thomas; Stephens, Martin

    Evidence-based toxicology (EBT) was introduced independently by two groups in 2005, in the context of toxicological risk assessment and causation as well as based on parallels between the evaluation of test methods in toxicology and evidence-based assessment of diagnostics tests in medicine. The role model of evidence-based medicine (EBM) motivated both proposals and guided the evolution of EBT, whereas especially systematic reviews and evidence quality assessment attract considerable attention in toxicology.Regarding test assessment, in the search of solutions for various problems related to validation, such as the imperfectness of the reference standard or the challenge to comprehensively evaluate tests, the field of Diagnostic Test Assessment (DTA) was identified as a potential resource. DTA being an EBM discipline, test method assessment/validation therefore became one of the main drivers spurring the development of EBT.In the context of pathway-based toxicology, EBT approaches, given their objectivity, transparency and consistency, have been proposed to be used for carrying out a (retrospective) mechanistic validation.In summary, implementation of more evidence-based approaches may provide the tools necessary to adapt the assessment/validation of toxicological test methods and testing strategies to face the challenges of toxicology in the twenty first century.

  7. Digital device in postextraction implantology : a clinical case presentation

    OpenAIRE

    Borgonovo, A..E.; Rigaldo, F.; Battaglia, D.; Re, D.; Giannì, A.B.

    2014-01-01

    Aim. The aim of this work is to describe a case of immediate implant placement after extraction of the upper right first premolar, with the use of CAD/CAM technology, which allows an early digital impression of the implant site with an intraoral scanner (MHT 3D Progress, Verona, Italy). Case Report. A 46-year-old female was referred with a disorder caused by continuous debonding of the prosthetic crown on the upper right first premolar. Clinically, there were no signs, and the evaluation of t...

  8. Agenda of behavioral toxicology

    Energy Technology Data Exchange (ETDEWEB)

    Weiss, B

    1978-01-01

    The author describes behavioral toxicology as a new discipline and contrasts it to the fields of physics and pharmacology. Several questions are raised and discussed concerning the field of behavioral toxicology. Some of these questions are: (1) how is an adverse behavioral effect recognized; (2) how can the non-specific be specified; (3) are standardized test batteries feasible. The problem of chronic intake is discussed as well as drawing information from other related disciplines such as neurochemistry, neuropathology and neurophysiology. The author concludes with several statements concerning new directions in the discipline of behavioral toxicology.

  9. Pre-market clinical evaluations of innovative high-risk medical devices in Europe.

    Science.gov (United States)

    Hulstaert, Frank; Neyt, Mattias; Vinck, Imgard; Stordeur, Sabine; Huić, Mirjana; Sauerland, Stefan; Kuijpers, Marja R; Abrishami, Payam; Vondeling, Hindrik; Flamion, Bruno; Garattini, Silvio; Pavlovic, Mira; van Brabandt, Hans

    2012-07-01

    High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information. In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.

  10. Safety and effectiveness considerations for clinical studies of visual prosthetic devices

    Science.gov (United States)

    Cohen, Ethan D.

    2007-03-01

    With the advent of new designs of visual prostheses for the blind, FDA is faced with developing guidance for evaluating their engineering, safety and patient performance. Visual prostheses are considered significant risk medical devices, and their use in human clinical trials must be approved by FDA under an investigation device exemption (IDE). This paper contains a series of test topics and design issues that sponsors should consider in order to assess the safety and efficacy of their device. The IDE application includes a series of pre-clinical and clinical data sections. The pre-clinical section documents laboratory, animal and bench top performance tests of visual prostheses safety and reliability to support a human clinical trial. The materials used in constructing the implant should be biocompatible, sterile, corrosion resistant, and able to withstand any forces exerted on it during normal patient use. The clinical data section is composed of items related to patient-related evaluation of device performance. This section documents the implantation procedure, trial design, statistical analysis and how visual performance is assessed. Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness.

  11. Metabonomics and toxicology.

    Science.gov (United States)

    Zhao, Liang; Hartung, Thomas

    2015-01-01

    Being an emerging field of "omics" research, metabonomics has been increasingly used in toxicological studies mostly because this technology has the ability to provide more detailed information to elucidate mechanism of toxicity. As an interdisciplinary field of science, metabonomics combines analytical chemistry, bioinformatics, statistics, and biochemistry. When applied to toxicology, metabonomics also includes aspects of patho-biochemistry, systems biology, and molecular diagnostics. During a toxicological study, the metabolic changes over time and dose after chemical treatment can be monitored. Therefore, the most important use of this emerging technology is the identification of signatures of toxicity-patterns of metabolic changes predictive of a hazard manifestation. This chapter summarizes the current state of metabonomics technology and its applications in various areas of toxicological studies.

  12. Downloadable Computational Toxicology Data

    Science.gov (United States)

    EPA’s computational toxicology research generates data that investigates the potential harm, or hazard of a chemical, the degree of exposure to chemicals as well as the unique chemical characteristics. This data is publicly available here.

  13. Occupational medicine and toxicology

    Directory of Open Access Journals (Sweden)

    Fischer Axel

    2006-02-01

    Full Text Available Abstract This editorial is to announce the Journal of Occupational Medicine and Toxicology, a new Open Access, peer-reviewed, online journal published by BioMed Central. Occupational medicine and toxicology belong to the most wide ranging disciplines of all medical specialties. The field is devoted to the diagnosis, prevention, management and scientific analysis of diseases from the fields of occupational and environmental medicine and toxicology. It also covers the promotion of occupational and environmental health. The complexity of modern industrial processes has dramatically changed over the past years and today's areas include effects of atmospheric pollution, carcinogenesis, biological monitoring, ergonomics, epidemiology, product safety and health promotion. We hope that the launch of the Journal of Occupational Medicine and Toxicology will aid in the advance of these important areas of research bringing together multi-disciplinary research findings.

  14. Ethanol Forensic Toxicology.

    Science.gov (United States)

    Perry, Paul J; Doroudgar, Shadi; Van Dyke, Priscilla

    2017-12-01

    Ethanol abuse can lead to negative consequences that oftentimes result in criminal charges and civil lawsuits. When an individual is suspected of driving under the influence, law enforcement agents can determine the extent of intoxication by measuring the blood alcohol concentration (BAC) and performing a standardized field sobriety test. The BAC is dependent on rates of absorption, distribution, and elimination, which are influenced mostly by the dose of ethanol ingested and rate of consumption. Other factors contributing to BAC are gender, body mass and composition, food effects, type of alcohol, and chronic alcohol exposure. Because of individual variability in ethanol pharmacology and toxicology, careful extrapolation and interpretation of the BAC is needed, to justify an arrest and assignment of criminal liability. This review provides a summary of the pharmacokinetic properties of ethanol and the clinical effects of acute intoxication as they relate to common forensic questions. Concerns regarding the extrapolation of BAC and the implications of impaired memory caused by alcohol-induced blackouts are discussed. © 2017 American Academy of Psychiatry and the Law.

  15. Using an Elastic Band Device After a Severe Obstetric Pubic Symphyseal Separation: Clinical and Imaging Evaluation.

    Science.gov (United States)

    Lasbleiz, Jeremy; Sevestre, François-Xavier; Moquet, Pierre-Yves

    2017-09-01

    Severe separation of the pubic symphysis is a rare delivery complication. Facing this pathology, we decided to study a new elastic band device. To evaluate the elastic band device, clinical (pain-rated) and imaging (magnetic resonance imaging and radiography) evaluations with and without the device were performed. The elastic band device is a European Conformity-certified medical device, which is made of neoprene straps, that reduces the mobility of the pelvis and the use of the internal rotator muscles. Once the elastic band device was in place, on postpartum day 1, radiography showed a decrease of the pubic width from 41 to 12 mm. Furthermore, pain decreased from 10 of 10 to 2 of 10 in 2 days, allowing the patient to ambulate and avoid surgery. After 1 month, the pubic width (6 mm) and anatomy were recovered but minor pain was still present with hip rotatory movements. The elastic band device was worn 24 hours a day from postpartum days 1-90 and 12 hours a day from postpartum days 90 to 150; afterward, the patient returned to normal life without the elastic band device. Use of an elastic band device was associated with a reduction of the pubic width and pain associated after obstetric pubic symphysis separation.

  16. Digital Device in Postextraction Implantology: A Clinical Case Presentation

    Directory of Open Access Journals (Sweden)

    A. E. Borgonovo

    2014-01-01

    Full Text Available Aim. The aim of this work is to describe a case of immediate implant placement after extraction of the upper right first premolar, with the use of CAD/CAM technology, which allows an early digital impression of the implant site with an intraoral scanner (MHT 3D Progress, Verona, Italy. Case Report. A 46-year-old female was referred with a disorder caused by continuous debonding of the prosthetic crown on the upper right first premolar. Clinically, there were no signs, and the evaluation of the periapical radiograph showed a fracture of the root, with a mesial well-defined lesion of the hard tissue of the upper right first premolar, as the radiolucent area affected the root surface of the tooth. It was decided, in accordance with the patient, that the tooth would be extracted and the implant (Primer, Edierre implant system, Genoa, Italy with diameter of 4.2 mm and length of 13 mm would be inserted. After the insertion of the implant, it was screwed to the scan abutment, and a scan was taken using an intraoral scanner (MHT 3D Progress, Verona, Italy. The scanned images were processed with CAD/CAM software (Exocad DentalCAD, Darmstadt, Germany and the temporary crown was digitally drawn (Dental Knowledge, Milan, Italy and then sent to the milling machine for production with a composite monoblock. After 4 months, when the implant was osteointegrated, it was not necessary to take another dental impression, and the definitive crown could be screwed in. Conclusion. The CAD/CAM technology is especially helpful in postextraction implant for aesthetic rehabilitation, as it is possible to immediately fix a provisional crown with an anatomic shape that allows an optimal healing process of the tissues. Moreover, the removal of healing abutments, and the use of impression copings, impression materials, and dental stone became unnecessary, enabling the reduction of the chair time, component cost, and patient’s discomfort. However, it is still necessary

  17. Progress in computational toxicology.

    Science.gov (United States)

    Ekins, Sean

    2014-01-01

    Computational methods have been widely applied to toxicology across pharmaceutical, consumer product and environmental fields over the past decade. Progress in computational toxicology is now reviewed. A literature review was performed on computational models for hepatotoxicity (e.g. for drug-induced liver injury (DILI)), cardiotoxicity, renal toxicity and genotoxicity. In addition various publications have been highlighted that use machine learning methods. Several computational toxicology model datasets from past publications were used to compare Bayesian and Support Vector Machine (SVM) learning methods. The increasing amounts of data for defined toxicology endpoints have enabled machine learning models that have been increasingly used for predictions. It is shown that across many different models Bayesian and SVM perform similarly based on cross validation data. Considerable progress has been made in computational toxicology in a decade in both model development and availability of larger scale or 'big data' models. The future efforts in toxicology data generation will likely provide us with hundreds of thousands of compounds that are readily accessible for machine learning models. These models will cover relevant chemistry space for pharmaceutical, consumer product and environmental applications. Copyright © 2013 Elsevier Inc. All rights reserved.

  18. In silico toxicology protocols.

    Science.gov (United States)

    Myatt, Glenn J; Ahlberg, Ernst; Akahori, Yumi; Allen, David; Amberg, Alexander; Anger, Lennart T; Aptula, Aynur; Auerbach, Scott; Beilke, Lisa; Bellion, Phillip; Benigni, Romualdo; Bercu, Joel; Booth, Ewan D; Bower, Dave; Brigo, Alessandro; Burden, Natalie; Cammerer, Zoryana; Cronin, Mark T D; Cross, Kevin P; Custer, Laura; Dettwiler, Magdalena; Dobo, Krista; Ford, Kevin A; Fortin, Marie C; Gad-McDonald, Samantha E; Gellatly, Nichola; Gervais, Véronique; Glover, Kyle P; Glowienke, Susanne; Van Gompel, Jacky; Gutsell, Steve; Hardy, Barry; Harvey, James S; Hillegass, Jedd; Honma, Masamitsu; Hsieh, Jui-Hua; Hsu, Chia-Wen; Hughes, Kathy; Johnson, Candice; Jolly, Robert; Jones, David; Kemper, Ray; Kenyon, Michelle O; Kim, Marlene T; Kruhlak, Naomi L; Kulkarni, Sunil A; Kümmerer, Klaus; Leavitt, Penny; Majer, Bernhard; Masten, Scott; Miller, Scott; Moser, Janet; Mumtaz, Moiz; Muster, Wolfgang; Neilson, Louise; Oprea, Tudor I; Patlewicz, Grace; Paulino, Alexandre; Lo Piparo, Elena; Powley, Mark; Quigley, Donald P; Reddy, M Vijayaraj; Richarz, Andrea-Nicole; Ruiz, Patricia; Schilter, Benoit; Serafimova, Rositsa; Simpson, Wendy; Stavitskaya, Lidiya; Stidl, Reinhard; Suarez-Rodriguez, Diana; Szabo, David T; Teasdale, Andrew; Trejo-Martin, Alejandra; Valentin, Jean-Pierre; Vuorinen, Anna; Wall, Brian A; Watts, Pete; White, Angela T; Wichard, Joerg; Witt, Kristine L; Woolley, Adam; Woolley, David; Zwickl, Craig; Hasselgren, Catrin

    2018-04-17

    The present publication surveys several applications of in silico (i.e., computational) toxicology approaches across different industries and institutions. It highlights the need to develop standardized protocols when conducting toxicity-related predictions. This contribution articulates the information needed for protocols to support in silico predictions for major toxicological endpoints of concern (e.g., genetic toxicity, carcinogenicity, acute toxicity, reproductive toxicity, developmental toxicity) across several industries and regulatory bodies. Such novel in silico toxicology (IST) protocols, when fully developed and implemented, will ensure in silico toxicological assessments are performed and evaluated in a consistent, reproducible, and well-documented manner across industries and regulatory bodies to support wider uptake and acceptance of the approaches. The development of IST protocols is an initiative developed through a collaboration among an international consortium to reflect the state-of-the-art in in silico toxicology for hazard identification and characterization. A general outline for describing the development of such protocols is included and it is based on in silico predictions and/or available experimental data for a defined series of relevant toxicological effects or mechanisms. The publication presents a novel approach for determining the reliability of in silico predictions alongside experimental data. In addition, we discuss how to determine the level of confidence in the assessment based on the relevance and reliability of the information. Copyright © 2018. Published by Elsevier Inc.

  19. The Global Educational Toxicology Uniting Project (GETUP): an Analysis of the First Year of a Novel Toxicology Education Project.

    Science.gov (United States)

    Wong, Anselm; Vohra, Rais; Ruha, Anne-Michelle; Koutsogiannis, Zeff; Graeme, Kimberlie; Dargan, Paul I; Wood, David M; Greene, Shaun L

    2015-09-01

    The international boundaries to medical education are becoming less marked as new technologies such as multiuser videoconferencing are developed and become more accessible to help bridge the communication gaps. The Global Educational Toxicology Uniting Project (GETUP) is aimed at connecting clinicians in countries with established clinical toxicology services to clinicians in countries without clinical toxicologists around the globe. Centers that manage or consult on toxicology cases were registered through the American College of Medical Toxicology website via Survey Monkey®. Data was analyzed retrospectively from February 2014 to January 2015. Google hangouts® was used as the main conferencing software, but some sites preferred the use of Skype®. Registration data included contact details and toxicology background and qualifications. Thirty sites in 19 different countries in Australasia, Europe, Africa, and America were registered. Twenty-eight (93 %) sites were located in a major urban center, one (3.5 %) site in a major rural center and one (3.5 %) a private practice. Expectations of GETUP included sharing toxicology cases and education (30, 100 % of sites), assistance with toxicology management guidelines (2, 7 %), assistance with providing a toxicology teaching curriculum in languages other than English (2, 7 %), and managing toxicology presentations in resource-poor settings, international collaboration, and toxicovigilance (2 sites, 7 %). Twenty-two conferences were performed during the first 12 months with a mean of 3 cases per conference. GETUP has connected countries and clinical units with and without toxicology services and will provide a platform to improve international collaboration in clinical toxicology.

  20. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    Directory of Open Access Journals (Sweden)

    Ross JS

    2015-05-01

    Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

  1. Polymer coating embolism from intravascular medical devices - a clinical literature review.

    Science.gov (United States)

    Chopra, Amitabh M; Mehta, Monik; Bismuth, Jean; Shapiro, Maksim; Fishbein, Michael C; Bridges, Alina G; Vinters, Harry V

    Over the past three decades, lubricious (hydrophobic and/or hydrophilic) polymer-coated devices have been increasingly adopted by interventional physicians and vascular surgeons to access and treat a wider range of clinical presentations. Recent clinical literature highlights the presence of polymer coating emboli within the anatomy - a result of coating separation from an intravascular device - and associates it with a range of adverse clinical sequelae. The 2015 U.S. Food and Drug Administration safety communication titled "Lubricious Coating Separation from Intravascular Medical Devices" acknowledges these concerns and concludes that it will work with stakeholders to develop nonclinical test methodologies, establish performance criteria, and identify gaps in current national and international device standards for coating integrity performance. Despite this communication and multiple case reports from interventional physicians, pathologists, dermatologists and other involved physician specialties, polymer coating embolism remains clinically underrecognized. This article consolidates the available literature on polymer coating embolism (1986-2016) and highlights the following relevant information for the physician: (a) the history and elusive nature of polymer coating embolism; (b) potential incidence rates of this phenomenon; (c) reported histologic findings and clinical effects of polymer emboli in the anatomy; (d) the importance of the collaborative clinician-pathologist partnership to report polymer embolism findings; and (e) the importance to study particulate release from intravascular devices so as to further understand and potentially evolve coated interventional technologies. Preliminary research on coatings highlights the potential of using iterations of coatings on medical devices that attain the desired therapeutic result and mitigate or eliminate particulates altogether. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  2. Wireless Synchronization of a Multi-Pinhole Small Animal SPECT Collimation Device With a Clinical Scanner

    Science.gov (United States)

    DiFilippo, Frank P.; Patel, Sagar

    2009-06-01

    A multi-pinhole collimation device for small animal single photon emission computed tomography (SPECT) uses the gamma camera detectors of a standard clinical SPECT scanner. The collimator and animal bed move independently of the detectors, and therefore their motions must be synchronized. One approach is manual triggering of the SPECT acquisition simultaneously with a programmed motion sequence for the device. However, some data blurring and loss of image quality result, and true electronic synchronization is preferred. An off-the-shelf digital gyroscope with integrated Bluetooth interface provides a wireless solution to device synchronization. The sensor attaches to the SPECT gantry and reports its rotational speed to a notebook computer controlling the device. Software processes the rotation data in real-time, averaging the signal and issuing triggers while compensating for baseline drift. Motion commands are sent to the collimation device with minimal delay, within approximately 0.5 second of the start of SPECT gantry rotation. Test scans of a point source demonstrate an increase in true counts and a reduction in background counts compared to manual synchronization. The wireless rotation sensor provides robust synchronization of the collimation device with the clinical SPECT scanner and enhances image quality.

  3. Impact of a "No Mobile Device" Policy on Developmental Surveillance in a Pediatric Clinic.

    Science.gov (United States)

    Regan, Paul A; Fogel, Benjamin S; Hicks, Steven D

    2018-04-01

    Children commonly use mobile devices at pediatric office visits. This practice may affect patient-provider interaction and undermine accuracy of developmental surveillance. A randomized, provider-blinded, controlled trial examined whether a policy prohibiting mobile device use in a pediatric clinic improved accuracy of pediatricians' developmental surveillance. Children, aged 18 to 36 months, were randomized to device-prohibited (intervention; n = 58) or device-allowed (control; n = 54) groups. After a 30-minute well-visit, development was evaluated as "normal," "borderline," or "delayed" in 5 categories using the Ages and Stages Questionnaire (ASQ-3). ASQ-3 results were compared with providers' clinical assessment in each category. Provider-ASQ discrepancies were more common for intervention participants ( P = .025). Providers "missed" more ASQ-3 "delayed" scores ( P = .005) in the intervention group, particularly in the fine motor domain ( P = .018). Prohibiting mobile device use at well-visits did not improve accuracy of providers' developmental surveillance. Mobile devices may entertain children at well-visits, allowing opportunities for parent-provider discussion, or observation of fine motor skills.

  4. Aerospace Toxicology and Microbiology

    Science.gov (United States)

    James, John T.; Parmet, A. J.; Pierson, Duane L.

    2007-01-01

    Toxicology dates to the very earliest history of humanity with various poisons and venom being recognized as a method of hunting or waging war with the earliest documentation in the Evers papyrus (circa 1500 BCE). The Greeks identified specific poisons such as hemlock, a method of state execution, and the Greek word toxos (arrow) became the root of our modern science. The first scientific approach to the understanding of poisons and toxicology was the work during the late middle ages of Paracelsus. He formulated what were then revolutionary views that a specific toxic agent or "toxicon" caused specific dose-related effects. His principles have established the basis of modern pharmacology and toxicology. In 1700, Bernardo Ramazzini published the book De Morbis Artificum Diatriba (The Diseases of Workers) describing specific illnesses associated with certain labor, particularly metal workers exposed to mercury, lead, arsenic, and rock dust. Modern toxicology dates from development of the modern industrial chemical processes, the earliest involving an analytical method for arsenic by Marsh in 1836. Industrial organic chemicals were synthesized in the late 1800 s along with anesthetics and disinfectants. In 1908, Hamilton began the long study of occupational toxicology issues, and by WW I the scientific use of toxicants saw Haber creating war gases and defining time-dosage relationships that are used even today.

  5. New clinical and toxicological scenario of gammaglutamyltranspeptidase Nueva singladura clínica y toxicológica de la gammaglutamiltranspeptidasa

    Directory of Open Access Journals (Sweden)

    Ramón Bataller-Sifre

    2011-11-01

    Full Text Available After the discovery of gammaglutamyltranspeptidase in 1950 by Hanes, the significance of its increased levels in clinical practice has mainly been focused on ethanol toxicity, and also some neoplasms and biliary tract obstruction. More recently, attention has swift to the metabolic functions of this enzyme, as a neutralizer of oxygen free radicals and as a glutathione donor to the cell. High serum levels of gamma-glutamyltranspeptidase is known to occur when oxidative stress is increased, or associated with several vascular risk factors and the insulin resistance syndrome, as an early marker of diabetes. There are also a number of drugs that induce the expression of the tissue enzyme (microsomes with the result of high serum levels without structural damage to the liver. Because it is a ubiquitous enzyme, a very high number of causes can be involved, that may be difficult to recognize. Finally, because glutathione is necessary to conjugate a number of chemical compounds, from an epidemiological and toxicological perspective, the enzyme might be useful as a biomarker of several ambient toxins. In this review we want to emphasize the increasing clinical and diagnostic significance of this enzyme discovered half a century ago.Desde su descubrimiento en 1950 por Hanes, la enzima gammaglutamiltranspeptidasa, al menos en medicina clínica, se ha vinculado casi en exclusiva, al valor de su aumento en la toxicidad por etanol y, en menor medida, de la existencia de ciertas neoplasias y de bloqueo de la vía biliar. Más recientemente, menudean trabajos acerca de su papel metabólico, mediando la neutralización de radicales libres de oxígeno y aprovisionando de glutatión a las células. El nivel sérico de gammaglutamiltranspeptidasa es expresivo de estrés oxidativo aumentado y se ha asociado a diversos factores de riesgo cardiovascular y a componentes del síndrome de resistencia a la insulina, de modo que sería un biomarcador precoz para el

  6. A Novel Electronic Device for Measuring Urine Flow Rate: A Clinical Investigation

    OpenAIRE

    Aliza Goldman; Hagar Azran; Tal Stern; Mor Grinstein; Dafna Wilner

    2017-01-01

    Objective: Currently, most vital signs in the intensive care unit (ICU) are electronically monitored. However, clinical practice for urine output (UO) measurement, an important vital sign, usually requires manual recording of data that is subject to human errors. In this study, we assessed the ability of a novel electronic UO monitoring device to measure real-time hourly UO versus current clinical practice. Design: Patients were connected to the RenalSense Clarity RMS Sensor Kit with a sensor...

  7. Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

    Science.gov (United States)

    Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria

    2018-01-01

    This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.

  8. Virtual reality for mobility devices: training applications and clinical research: a review

    NARCIS (Netherlands)

    Erren-Wolters, Cathelijne V.; van Dijk, Henk; de Kort, Alexander C.; IJzerman, Maarten Joost; Jannink, M.J.A.

    2007-01-01

    Virtual reality technology is an emerging technology that possibly can address the problems encountered in training (elderly) people to handle a mobility device. The objective of this review was to study different virtual reality training applications as well as their clinical implication for

  9. Optimizing clinical performance and geometrical robustness of a new electrode device for intracranial tumor electroporation

    DEFF Research Database (Denmark)

    Mahmood, Faisal; Gehl, Julie

    2011-01-01

    and genes to intracranial tumors in humans, and demonstrate a method to optimize the design (i.e. geometry) of the electrode device prototype to improve both clinical performance and geometrical tolerance (robustness). We have employed a semiempirical objective function based on constraints similar to those...... sensitive to random geometrical deviations. The method is readily applicable to other electrode configurations....

  10. Do we have to Include HCI Issues in Clinical Trials of Medical Devices?

    DEFF Research Database (Denmark)

    Nielsen, Lene; Christensen, Lars Rune; Sabers, Anne

    2017-01-01

    Digital devices play an important role in medical treatment and will in the future play a larger role in connection to cures of health-related issues. Traditionally medicine has been tested by clinical double blind, randomized trials to document the efficacy and safety profile. When it comes to t...

  11. Animal-free toxicology

    DEFF Research Database (Denmark)

    Knudsen, Lisbeth E

    2013-01-01

    Human data on exposure and adverse effects are the most appropriate for human risk assessment, and modern toxicology focuses on human pathway analysis and the development of human biomarkers. Human biomonitoring and human placental transport studies provide necessary information for human risk...... assessment, in accordance with the legislation on chemical, medicine and food safety. Toxicology studies based on human mechanistic and exposure information can replace animal studies. These animal-free approaches can be further supplemented by new in silico methods and chemical structure......-activity relationships. The inclusion of replacement expertise in the international Three Rs centres, the ongoing exploration of alternatives to animal research, and the improvement of conditions for research animals, all imply the beginning of a paradigm shift in toxicology research toward the use of human data....

  12. Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

    Science.gov (United States)

    Jokstad, Asbjørn; Winnett, Brenton; Fava, Joseph; Powell, David; Somogyi-Ganss, Eszter

    New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery. Study participants with up to four missing teeth were recruited from the pool of patients referred to the University of Toronto Graduate Prosthodontics clinic. The first 10 participants were allocated to either a conventional or a prototype device study arm in a randomized trial. The next 10 participants received implants using the prototype device. All study participants were restored with fixed dental prostheses after 3 (mandible) or 6 (maxilla) months healing, and monitored over 12 months. The primary outcome was the incidence of any surgical, biologic, or prosthetic adverse events or device-related complications. Secondary outcomes were the incidence of positioning of implants not considered suitable for straightforward prosthetic restoration (yes/no); the perception of the ease of use of the prototype device by the two oral surgeons, recorded by use of a Likert-type questionnaire; and the clinical performance of the implant and superstructure after 1 year in function. Positioning of the implants was appraised on periapical radiographs and clinical photographs by four independent blinded examiners. Peri-implant bone loss was measured on periapical radiographs by a blinded examiner. No adverse events occurred related to placing any implants. Four device-related complications led to a switch from using the prototype device to the conventional method. All implants placed by use of the prototype device were in a position considered suitable for straightforward prosthetic restoration (n = 21). The qualitative evaluation by the surgeons was generally positive, although ergonomic challenges were identified

  13. Shuttle Lesson Learned - Toxicology

    Science.gov (United States)

    James, John T.

    2010-01-01

    This is a script for a video about toxicology and the space shuttle. The first segment is deals with dust in the space vehicle. The next segment will be about archival samples. Then we'll look at real time on-board analyzers that give us a lot of capability in terms of monitoring for combustion products and the ability to monitor volatile organics on the station. Finally we will look at other issues that are about setting limits and dealing with ground based lessons that pertain to toxicology.

  14. MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2016-06-15

    Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of

  15. MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

    International Nuclear Information System (INIS)

    2016-01-01

    Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of

  16. Portable (handheld) clinical device for quantitative spectroscopy of skin, utilizing spatial frequency domain reflectance techniques

    Science.gov (United States)

    Saager, Rolf B.; Dang, An N.; Huang, Samantha S.; Kelly, Kristen M.; Durkin, Anthony J.

    2017-09-01

    Spatial Frequency Domain Spectroscopy (SFDS) is a technique for quantifying in-vivo tissue optical properties. SFDS employs structured light patterns that are projected onto tissues using a spatial light modulator, such as a digital micromirror device. In combination with appropriate models of light propagation, this technique can be used to quantify tissue optical properties (absorption, μa, and scattering, μs', coefficients) and chromophore concentrations. Here we present a handheld implementation of an SFDS device that employs line (one dimensional) imaging. This instrument can measure 1088 spatial locations that span a 3 cm line as opposed to our original benchtop SFDS system that only collects a single 1 mm diameter spot. This imager, however, retains the spectral resolution (˜1 nm) and range (450-1000 nm) of our original benchtop SFDS device. In the context of homogeneous turbid media, we demonstrate that this new system matches the spectral response of our original system to within 1% across a typical range of spatial frequencies (0-0.35 mm-1). With the new form factor, the device has tremendously improved mobility and portability, allowing for greater ease of use in a clinical setting. A smaller size also enables access to different tissue locations, which increases the flexibility of the device. The design of this portable system not only enables SFDS to be used in clinical settings but also enables visualization of properties of layered tissues such as skin.

  17. Textbooks on tap: using electronic books housed in handheld devices in nursing clinical courses.

    Science.gov (United States)

    Williams, Margaret G; Dittmer, Arlis

    2009-01-01

    Changing technology is creating new ways to approach nursing education and practice. Beginning in 2003, using a quasi-experimental design, this project introduced personal digital assistants (PDAs) as a clinical tool to five experimental and control groups of students and faculty. The handheld device, or PDA, was loaded with e-books for clinical practice. Differences in learning styles and preferences emerged during the different phases of the study. Students were quickly able to master the technology and use the device effectively, reporting that they liked the concise nature of the information obtained. No students expressed dissatisfaction or regret at being in the experimental group. Results and implications for clinical practice, education, and library resources are discussed.

  18. Toxicología Vegetal

    OpenAIRE

    García Fernández, Antonio Juan

    2010-01-01

    Presentaciones de clase de los temas de Toxicología Vegetal de la licenciatura de Veterinaria de la Universidad de Murcia del curso 2011/12. Presentaciones de Toxicología Vegetal de la asignatura de Toxicología de la Licenciatura de Veterinaria del curso 2011/12

  19. Clinical implementation of a new HDR brachytherapy device for partial breast irradiation

    International Nuclear Information System (INIS)

    Scanderbeg, Daniel J.; Yashar, Catheryn; Rice, Roger; Pawlicki, Todd

    2009-01-01

    Purpose: To present the clinical implementation of a new HDR device for partial breast irradiation, the Strut-Adjusted Volume Implant (SAVI), at the University of California, San Diego. Methods and materials: The SAVI device has multiple peripheral struts that can be differentially loaded with the HDR source. Planning criteria used for evaluation of the treatment plans included the following dose volume histogram (DVH) criteria: V90 >90%, V150 <50 cc and V200 <20 cc. Results: SAVI has been used on 20 patients to date at UC San Diego. In each case, the dose was modulated according to patient-specific anatomy to cover the tumor bed, while sparing normal tissues. The dosimetric data show that we can achieve greater than 90% coverage with respect to V90 (median of 95.3%) and also keep a low V150 and V200 dose at 24.5 and 11.2 cc, respectively. Complete treatment can be done within a 30-min time slot, which includes implant verification, setup, and irradiation time as well as wound dressing. Conclusion: SAVI has been implemented at UC San Diego for accelerated partial breast irradiation with excellent tumor bed conformance and minimal normal tissue exposure. Patient positioning is the key to identifying any inter-fraction device motion. Device asymmetry or tissue conformance has been shown to resolve itself 24 h after the device implantation. The device can be implemented into an existing HDR program with minimal effort

  20. PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

    DEFF Research Database (Denmark)

    Hulstaert, F.; Neyt, M.; Vinck, I.

    2012-01-01

    data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate. Methods: The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified...... of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials. Conclusions: For innovative high-risk devices, new EU legislation should...

  1. Toxicological aspects of water

    International Nuclear Information System (INIS)

    Garcia Puertas, P.

    1991-01-01

    Different toxicological aspects of water have been studied, remarking the activity of various chemical substances in the organism. These substances are divided in: trace metals (Sb, As, Cd, Zn, Cu, Cr, Fe, Mn, Hg, Ni, Pb, Se), other contaminants (CN-, polycyclic aromatic hydrocarbons, phenols, pesticides, detergents) and radioactivity. Finally, some considerations on this subject are made [es

  2. 76 FR 6623 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0066] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Molecular and Clinical Genetics Panel of the Medical Devices Advisory...

  3. Clinical and histopathological study of the TriPollar home-use device for body treatments.

    Science.gov (United States)

    Boisnic, Sylvie; Branchet, Marie-Christine; Birnstiel, Oliver; Beilin, Ghislaine

    2010-01-01

    Professional non invasive treatments for body contouring based on radiofrequency (RF) became popular in aesthetic clinics due to proven efficacy and safety. A new home-use RF device for body treatments has been developed based on TriPollar technology. Our objective was to evaluate the TriPollar home-use device for circumference reduction, cellulite improvement and skin tightening using objective and subjective methods. An ex-vivo human skin model was used for histological and biochemical evaluations of the TriPollar clinical effect. Additionally, twenty four subjects used the new device on the abdomen and thigh areas and the circumference reduction was measured. Ex-vivo models indicated a significant increase of 82% in hypodermal glycerol release. Histology revealed a 34% alteration in adipocyte appearance. Collagen synthesis increased by 31% following TriPollar treatment. A significant average reduction of 2.4 cm was measured on the treated thighs. On the control thighs a lesser, non-significant reduction was found. Average abdominal laxity was reduced from 1.4 at baseline to 0.8 following treatments. A certain reduction was measured in the abdomen circumferences, although it was not significant. The reported results demonstrate the safety and efficacy of the new TriPollar home-use device for body contouring and skin tightening. Treatment may lead to discrete circumference reduction and moderate laxity improvement.

  4. Psychiatrists' Comfort Using Computers and Other Electronic Devices in Clinical Practice.

    Science.gov (United States)

    Duffy, Farifteh F; Fochtmann, Laura J; Clarke, Diana E; Barber, Keila; Hong, Seung-Hee; Yager, Joel; Mościcki, Eve K; Plovnick, Robert M

    2016-09-01

    This report highlights findings from the Study of Psychiatrists' Use of Informational Resources in Clinical Practice, a cross-sectional Web- and paper-based survey that examined psychiatrists' comfort using computers and other electronic devices in clinical practice. One-thousand psychiatrists were randomly selected from the American Medical Association Physician Masterfile and asked to complete the survey between May and August, 2012. A total of 152 eligible psychiatrists completed the questionnaire (response rate 22.2 %). The majority of psychiatrists reported comfort using computers for educational and personal purposes. However, 26 % of psychiatrists reported not using or not being comfortable using computers for clinical functions. Psychiatrists under age 50 were more likely to report comfort using computers for all purposes than their older counterparts. Clinical tasks for which computers were reportedly used comfortably, specifically by psychiatrists younger than 50, included documenting clinical encounters, prescribing, ordering laboratory tests, accessing read-only patient information (e.g., test results), conducting internet searches for general clinical information, accessing online patient educational materials, and communicating with patients or other clinicians. Psychiatrists generally reported comfort using computers for personal and educational purposes. However, use of computers in clinical care was less common, particularly among psychiatrists 50 and older. Information and educational resources need to be available in a variety of accessible, user-friendly, computer and non-computer-based formats, to support use across all ages. Moreover, ongoing training and technical assistance with use of electronic and mobile device technologies in clinical practice is needed. Research on barriers to clinical use of computers is warranted.

  5. Psychiatrists’ Comfort Using Computers and Other Electronic Devices in Clinical Practice

    Science.gov (United States)

    Fochtmann, Laura J.; Clarke, Diana E.; Barber, Keila; Hong, Seung-Hee; Yager, Joel; Mościcki, Eve K.; Plovnick, Robert M.

    2015-01-01

    This report highlights findings from the Study of Psychiatrists’ Use of Informational Resources in Clinical Practice, a cross-sectional Web- and paper-based survey that examined psychiatrists’ comfort using computers and other electronic devices in clinical practice. One-thousand psychiatrists were randomly selected from the American Medical Association Physician Masterfile and asked to complete the survey between May and August, 2012. A total of 152 eligible psychiatrists completed the questionnaire (response rate 22.2 %). The majority of psychiatrists reported comfort using computers for educational and personal purposes. However, 26 % of psychiatrists reported not using or not being comfortable using computers for clinical functions. Psychiatrists under age 50 were more likely to report comfort using computers for all purposes than their older counterparts. Clinical tasks for which computers were reportedly used comfortably, specifically by psychiatrists younger than 50, included documenting clinical encounters, prescribing, ordering laboratory tests, accessing read-only patient information (e.g., test results), conducting internet searches for general clinical information, accessing online patient educational materials, and communicating with patients or other clinicians. Psychiatrists generally reported comfort using computers for personal and educational purposes. However, use of computers in clinical care was less common, particularly among psychiatrists 50 and older. Information and educational resources need to be available in a variety of accessible, user-friendly, computer and non-computer-based formats, to support use across all ages. Moreover, ongoing training and technical assistance with use of electronic and mobile device technologies in clinical practice is needed. Research on barriers to clinical use of computers is warranted. PMID:26667248

  6. Pain control in orthodontics using a micropulse vibration device: A randomized clinical trial.

    Science.gov (United States)

    Lobre, Wendy D; Callegari, Brent J; Gardner, Gary; Marsh, Curtis M; Bush, Anneke C; Dunn, William J

    2016-07-01

    To investigate the relationship between a micropulse vibration device and pain perception during orthodontic treatment. This study was a parallel group, randomized clinical trial. A total of 58 patients meeting eligibility criteria were assigned using block allocation to one of two groups: an experimental group using the vibration device or a control group (n  =  29 for each group). Patients used the device for 20 minutes daily. Patients rated pain intensity on a visual analog scale at appropriate intervals during the weeks after the separator or archwire appointment. Data were analyzed using repeated measures analysis of variance at α  =  .05. During the 4-month test period, significant differences between the micropulse vibration device group and the control group for overall pain (P  =  .002) and biting pain (P  =  .003) were identified. The authors observed that perceived pain was highest at the beginning of the month, following archwire adjustment. The micropulse vibration device significantly lowered the pain scores for overall pain and biting pain during the 4-month study period.

  7. The clinical trial of TOMOTRON - a new electronic device - and eight months' clinical experience

    International Nuclear Information System (INIS)

    Kroepelin, T.; Billmann, P.; Wenz, W.; Baumann, H.

    1985-01-01

    We have been using digital tomography (TOMOTRON) clinically for eight months. Its advantages include savings in both time and dose, good image quality throug increased contrast, and improved magnification and image postprocessing compared with conventional tomography. However, lower image resolution and small image sections are the disadvantages of digital tomography. Weighing these advantages and disadvantages by our experience, the diagnostic accuracy of digital tomography is higher than conventional tomography, particularly in skeletal studies. (author)

  8. Classroom to Clinic: Merging Education and Research to Efficiently Prototype Medical Devices.

    Science.gov (United States)

    Hanumara, Nevan C; Begg, Nikolai D; Walsh, Conor; Custer, David; Gupta, Rajiv; Osborn, Lynn R; Slocum, Alexander H

    2013-01-01

    Innovation in patient care requires both clinical and technical skills, and this paper presents the methods and outcomes of a nine-year, clinical-academic collaboration to develop and evaluate new medical device technologies, while teaching mechanical engineering. Together, over the course of a single semester, seniors, graduate students, and clinicians conceive, design, build, and test proof-of-concept prototypes. Projects initiated in the course have generated intellectual property and peer-reviewed publications, stimulated further research, furthered student and clinician careers, and resulted in technology licenses and start-up ventures.

  9. Assessment of three frequently used blood glucose monitoring devices in clinical routine.

    Science.gov (United States)

    Zueger, Thomas; Schuler, Vanessa; Stettler, Christoph; Diem, Peter; Christ, Emanuel R

    2012-07-12

    Self-monitoring of blood glucose plays an important role in the management of diabetes and has been shown to improve metabolic control. The use of blood glucose meters in clinical practice requires sufficient reliability to allow adequate treatment. Direct comparison of different blood glucose meters in clinical practice, independent of the manufactures is scarce. We, therefore, aimed to evaluate three frequently used blood glucose meters in daily clinical practice. Capillary blood glucose was measured simultaneous using the following glucose meters: Contour® (Bayer Diabetes Care, Zürich, Switzerland), Accu-Chek® aviva (Roche Diagnostics, Rotkreuz, Switzerland), Free-Style® lite (Abbott Diabetes Care, Baar, Switzerland). The reference method consisted of the HemoCue® Glucose 201+ System (HemoCue® AB, Ängelholm, Sweden) with plasma conversion. The devices were assessed by comparison of the Mean Absolute Relative Differences (MARD), the Clarke Error Grid Analysis (EGA) and the compliance with the International Organization of Standardization criteria (ISO 15197:2003). Capillary blood samples were obtained from 150 patients. MARD was 10.1 ± 0.65%, 7.0 ± 0.62% and 7.8 ± 0.48% for Contour®, Accu-Chek® and Free-Style®, respectively. EGA showed 99.3% (Contour®), 98.7% (Accu-Chek®) and 100% (Free-Style®) of all measurements in zone A and B (clinically acceptable). The ISO criteria were fulfilled by Accu-Chek® (95.3%) and Free-Style® (96%), but not by Contour® (92%). In the present study the three glucose meters provided good agreement with the reference and reliable results in daily clinical routine. Overall, the Free-Style® and Accu-Chek® device slightly outperformed the Contour® device.

  10. Veterinary Forensic Toxicology.

    Science.gov (United States)

    Gwaltney-Brant, S M

    2016-09-01

    Veterinary pathologists working in diagnostic laboratories are sometimes presented with cases involving animal poisonings that become the object of criminal or civil litigation. Forensic veterinary toxicology cases can include cases involving animal cruelty (malicious poisoning), regulatory issues (eg, contamination of the food supply), insurance litigation, or poisoning of wildlife. An understanding of the appropriate approach to these types of cases, including proper sample collection, handling, and transport, is essential so that chain of custody rules are followed and proper samples are obtained for toxicological analysis. Consultation with veterinary toxicologists at the diagnostic laboratory that will be processing the samples before, during, and after the forensic necropsy can help to ensure that the analytical tests performed are appropriate for the circumstances and findings surrounding the individual case. © The Author(s) 2016.

  11. Application of Model Animals in the Study of Drug Toxicology

    Science.gov (United States)

    Song, Yagang; Miao, Mingsan

    2018-01-01

    Drug safety is a key factor in drug research and development, Drug toxicology test is the main method to evaluate the safety of drugs, The body condition of an animal has important implications for the results of the study, Previous toxicological studies of drugs were carried out in normal animals in the past, There is a great deviation from the clinical practice.The purpose of this study is to investigate the necessity of model animals as a substitute for normal animals for toxicological studies, It is expected to provide exact guidance for future drug safety evaluation.

  12. Toxicology of inorganic tin

    International Nuclear Information System (INIS)

    Burba, J.V.

    1982-01-01

    Tin(II) or stannous ion as a reducing agent is important in nuclear medicine because it is an essential component and common denominator for many in vivo radiodiagnostic agents, commonly called kits for the preparation of radiopharmaceuticals. This report is intended to alert nuclear medicine community regarding the wide range of biological effects that the stannous ion is capable of producing, and is a review of a large number of selected publications on the toxicological potential of tin(II)

  13. Operational Toxicology Research

    Science.gov (United States)

    2006-08-01

    techniques for perchlorate in water, groundwater, soil and biological matrices such as blood, urine, milk . thyroid and other tissues required for...toxicity when they are inhaled or ingested and they are irritating to the skin and mucus membranes (Committee on Toxicology, 1996). When compared to...the data collected. Develop analytical techniques for perchlorate in water, groundwater, soil, and biological matrices such as blood, urine, milk

  14. Collection of biological samples in forensic toxicology.

    Science.gov (United States)

    Dinis-Oliveira, R J; Carvalho, F; Duarte, J A; Remião, F; Marques, A; Santos, A; Magalhães, T

    2010-09-01

    Forensic toxicology is the study and practice of the application of toxicology to the purposes of the law. The relevance of any finding is determined, in the first instance, by the nature and integrity of the specimen(s) submitted for analysis. This means that there are several specific challenges to select and collect specimens for ante-mortem and post-mortem toxicology investigation. Post-mortem specimens may be numerous and can endow some special difficulties compared to clinical specimens, namely those resulting from autolytic and putrefactive changes. Storage stability is also an important issue to be considered during the pre-analytic phase, since its consideration should facilitate the assessment of sample quality and the analytical result obtained from that sample. The knowledge on degradation mechanisms and methods to increase storage stability may enable the forensic toxicologist to circumvent possible difficulties. Therefore, advantages and limitations of specimen preservation procedures are thoroughfully discussed in this review. Presently, harmonized protocols for sampling in suspected intoxications would have obvious utility. In the present article an overview is given on sampling procedures for routinely collected specimens as well as on alternative specimens that may provide additional information on the route and timing of exposure to a specific xenobiotic. Last, but not least, a discussion on possible bias that can influence the interpretation of toxicological results is provided. This comprehensive review article is intented as a significant help for forensic toxicologists to accomplish their frequently overwhelming mission.

  15. A review of performance of near-infrared fluorescence imaging devices used in clinical studies

    Science.gov (United States)

    Zhu, B

    2015-01-01

    Near-infrared fluorescence (NIRF) molecular imaging holds great promise as a new “point-of-care” medical imaging modality that can potentially provide the sensitivity of nuclear medicine techniques, but without the radioactivity that can otherwise place limitations of usage. Recently, NIRF imaging devices of a variety of designs have emerged in the market and in investigational clinical studies using indocyanine green (ICG) as a non-targeting NIRF contrast agent to demark the blood and lymphatic vasculatures both non-invasively and intraoperatively. Approved in the USA since 1956 for intravenous administration, ICG has been more recently used off label in intradermal or subcutaneous administrations for fluorescence imaging of the lymphatic vasculature and lymph nodes. Herein, we summarize the devices of a variety of designs, summarize their performance in lymphatic imaging in a tabular format and comment on necessary efforts to develop standards for device performance to compare and use these emerging devices in future, NIRF molecular imaging studies. PMID:25410320

  16. Progress of artificial pancreas devices towards clinical use: the first outpatient studies.

    Science.gov (United States)

    Russell, Steven J

    2015-04-01

    This article describes recent progress in the automated control of glycemia in type 1 diabetes with artificial pancreas devices that combine continuous glucose monitoring with automated decision-making and insulin delivery. After a gestation period of closely supervised feasibility studies in research centers, the last 2 years have seen publication of studies testing these devices in outpatient environments, and many more such studies are ongoing. The most basic form of automation, suspension of insulin delivery for actual or predicted hypoglycemia, has been shown to be effective and well tolerated, and a first-generation device has actually reached the market. Artificial pancreas devices that actively dose insulin fall into two categories, those that dose insulin alone and those that also use glucagon to prevent and treat hypoglycemia (bihormonal artificial pancreas). Initial outpatient clinical trials have shown that both strategies can improve glycemic management in comparison with patient-controlled insulin pump therapy, but only the bihormonal strategy has been tested without restrictions on exercise. Artificial pancreas technology has the potential to reduce acute and chronic complications of diabetes and mitigate the burden of diabetes self-management. Successful outpatient studies bring these technologies one step closer to availability for patients.

  17. A balancing act: a phenomenological exploration of medical students' experiences of using mobile devices in the clinical setting.

    Science.gov (United States)

    Rashid-Doubell, F; Mohamed, S; Elmusharaf, K; O'Neill, C S

    2016-05-03

    The aims of this study were to describe the experiences of senior students using mobile devices in a clinical setting while learning and interacting with clinical teachers, patients and each other, and to identify challenges that facilitated or impeded the use of such devices in the hospital. Interpretative phenomenology was chosen to guide our enquiry. Semi-structured interviews were conducted to examine the experiences of five senior medical students using mobile devices in the clinical setting. Senior medical students at an international medical school in the Middle East. Three main themes emerged from the data analysis: learning; professional identity and transitioning from student to doctor. The findings showed that using mobile devices in the clinical area as a learning tool was not a formalised process. Rather, it was opportunistic learning at the bedside and on occasion a source of distraction from clinical teaching. Students needed to negotiate relationships between themselves, the clinical teacher and patients in order to ensure that they maintained an acceptable professional image. Participants experienced and negotiated the change from student to doctor making them mindful of using their devices at the bedside. Mobile devices are part of daily life for a medical student and there is a need to adapt medical education in the clinical setting, to allow the students to use their devices in a sensitive manner. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  18. Toxicological Benchmarks for Wildlife

    Energy Technology Data Exchange (ETDEWEB)

    Sample, B.E. Opresko, D.M. Suter, G.W.

    1993-01-01

    Ecological risks of environmental contaminants are evaluated by using a two-tiered process. In the first tier, a screening assessment is performed where concentrations of contaminants in the environment are compared to no observed adverse effects level (NOAEL)-based toxicological benchmarks. These benchmarks represent concentrations of chemicals (i.e., concentrations presumed to be nonhazardous to the biota) in environmental media (water, sediment, soil, food, etc.). While exceedance of these benchmarks does not indicate any particular level or type of risk, concentrations below the benchmarks should not result in significant effects. In practice, when contaminant concentrations in food or water resources are less than these toxicological benchmarks, the contaminants may be excluded from further consideration. However, if the concentration of a contaminant exceeds a benchmark, that contaminant should be retained as a contaminant of potential concern (COPC) and investigated further. The second tier in ecological risk assessment, the baseline ecological risk assessment, may use toxicological benchmarks as part of a weight-of-evidence approach (Suter 1993). Under this approach, based toxicological benchmarks are one of several lines of evidence used to support or refute the presence of ecological effects. Other sources of evidence include media toxicity tests, surveys of biota (abundance and diversity), measures of contaminant body burdens, and biomarkers. This report presents NOAEL- and lowest observed adverse effects level (LOAEL)-based toxicological benchmarks for assessment of effects of 85 chemicals on 9 representative mammalian wildlife species (short-tailed shrew, little brown bat, meadow vole, white-footed mouse, cottontail rabbit, mink, red fox, and whitetail deer) or 11 avian wildlife species (American robin, rough-winged swallow, American woodcock, wild turkey, belted kingfisher, great blue heron, barred owl, barn owl, Cooper's hawk, and red

  19. A time-gated near-infrared spectroscopic imaging device for clinical applications.

    Science.gov (United States)

    Poulet, Patrick; Uhring, Wilfried; Hanselmann, Walter; Glazenborg, René; Nouizi, Farouk; Zint, Virginie; Hirschi, Werner

    2013-03-01

    A time-resolved, spectroscopic, diffuse optical tomography device was assembled for clinical applications like brain functional imaging. The entire instrument lies in a unique setup that includes a light source, an ultrafast time-gated intensified camera and all the electronic control units. The light source is composed of four near infrared laser diodes driven by a nanosecond electrical pulse generator working in a sequential mode at a repetition rate of 100 MHz. The light pulses are less than 80 ps FWHM. They are injected in a four-furcated optical fiber ended with a frontal light distributor to obtain a uniform illumination spot directed towards the head of the patient. Photons back-scattered by the subject are detected by the intensified CCD camera. There are resolved according to their time of flight inside the head. The photocathode is powered by an ultrafast generator producing 50 V pulses, at 100 MHz and a width corresponding to a 200 ps FWHM gate. The intensifier has been specially designed for this application. The whole instrument is controlled by an FPGA based module. All the acquisition parameters are configurable via software through an USB plug and the image data are transferred to a PC via an Ethernet link. The compactness of the device makes it a perfect device for bedside clinical applications. The instrument will be described and characterized. Preliminary data recorded on test samples will be presented.

  20. Traceable working standards with SI units of radiance for characterizing the measurement performance of investigational clinical NIRF imaging devices

    Science.gov (United States)

    Zhu, Banghe; Rasmussen, John C.; Litorja, Maritoni; Sevick-Muraca, Eva M.

    2017-03-01

    All medical devices for Food and Drug market approval require specifications of performance based upon International System of Units (SI) or units derived from SI for reasons of traceability. Recently, near-infrared fluorescence (NIRF) imaging devices of a variety of designs have emerged on the market and in investigational clinical studies. Yet the design of devices used in the clinical studies vary widely, suggesting variable device performance. Device performance depends upon optimal excitation of NIRF imaging agents, rejection of backscattered excitation and ambient light, and selective collection of fluorescence emanating from the fluorophore. There remains no traceable working standards with SI units of radiance to enable prediction that a given molecular imaging agent can be detected in humans by a given NIRF imaging device. Furthermore, as technologies evolve and as NIRF imaging device components change, there remains no standardized means to track device improvements over time and establish clinical performance without involving clinical trials, often costly. In this study, we deployed a methodology to calibrate luminescent radiance of a stable, solid phantom in SI units of mW/cm2/sr for characterizing the measurement performance of ICCD and IsCMOS camera based NIRF imaging devices, such as signal-to-noise ratio (SNR) and contrast. The methodology allowed determination of superior SNR of the ICCD over the IsCMOS system; comparable contrast of ICCD and IsCMOS depending upon binning strategies.

  1. Summary introduction to environmental toxicology

    International Nuclear Information System (INIS)

    Heinzow, B.; Jessen, H.; Wendorff, D.

    1986-01-01

    The increasing environmental consciousness and the increasing public interest in environmental medicine and toxicology is much appreciated by the Research Institute for Environmental Toxicology. This information brochure gives the reader some insight into the importance of environmental toxicology and into the waste of the Research Institute. In response to the current situation, the authors have included an appendix on radiation protection. (orig./PW) [de

  2. Mobile applications for handheld devices to screen and randomize acute stroke patients in clinical trials.

    Science.gov (United States)

    Qureshi, Ai; Connelly, B; Abbott, Ei; Maland, E; Kim, J; Blake, J

    2012-08-01

    The availability of internet connectivity and mobile application software used by low-power handheld devices makes smart phones of unique value in time-sensitive clinical trials. Trial-specific applications can be downloaded by investigators from various mobile software distribution platforms or web applications delivered over HTTP. The Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH) II investigators in collaboration with MentorMate released the ATACH-II Patient Recruitment mobile application available on iPhone, Android, and Blackberry in 2011. The mobile application provides tools for pre-screening, assessment of eligibility, and randomization of patients. Since the release of ATACH-II mobile application, the CLEAR-IVH (Clot Lysis Evaluating Accelerated Resolution of Intraventricular Hemorrhage) trial investigators have also adopted such a mobile application. The video-conferencing capabilities of the most recent mobile devices open up additional opportunities to involve central coordinating centers in the recruitment process in real time.

  3. High Throughput Transcriptomics @ USEPA (Toxicology ...

    Science.gov (United States)

    The ideal chemical testing approach will provide complete coverage of all relevant toxicological responses. It should be sensitive and specific It should identify the mechanism/mode-of-action (with dose-dependence). It should identify responses relevant to the species of interest. Responses should ideally be translated into tissue-, organ-, and organism-level effects. It must be economical and scalable. Using a High Throughput Transcriptomics platform within US EPA provides broader coverage of biological activity space and toxicological MOAs and helps fill the toxicological data gap. Slide presentation at the 2016 ToxForum on using High Throughput Transcriptomics at US EPA for broader coverage biological activity space and toxicological MOAs.

  4. Designing a placebo device: involving service users in clinical trial design.

    Science.gov (United States)

    Gooberman-Hill, Rachael; Jinks, Clare; Bouças, Sofia Barbosa; Hislop, Kelly; Dziedzic, Krysia S; Rhodes, Carol; Burston, Amanda; Adams, Jo

    2013-12-01

    Service users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported. To enhance the design of a future clinical trial of hand splints for thumb-base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process. Two fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb-base OA were approached about involvement by Occupational Therapy (OT) practitioners. A total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group ('arm') was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint. This is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability. © 2013 John Wiley & Sons Ltd.

  5. ACToR-AGGREGATED COMPUTATIONAL TOXICOLOGY ...

    Science.gov (United States)

    One goal of the field of computational toxicology is to predict chemical toxicity by combining computer models with biological and toxicological data. predict chemical toxicity by combining computer models with biological and toxicological data

  6. Postmortem Biochemistry and Toxicology

    Directory of Open Access Journals (Sweden)

    Robert Flanagan

    2017-04-01

    Full Text Available The aim of postmortem biochemistry and toxicology is either to help establish the cause of death, or to gain information on events immediately before death. If self-poisoning is suspected, the diagnosis may be straightforward and all that could be required is confirmation of the agents involved. However, if the cause of death is not immediately obvious then suspicion of possible poisoning or of conditions such as alcoholic ketoacidosis is of course crucial. On the other hand, it may be important to investigate adherence to prescribed therapy, for example with anticonvulsants or antipsychotics, hence sensitive methods are required. Blood sampling (needle aspiration, peripheral vein, for example femoral, ideally after proximal ligation before opening the body minimizes the risk of sample contamination with, for example, gut contents or urine. Other specimens (stomach contents, urine, liver, vitreous humor may also be valuable and may be needed to corroborate unexpected or unusual findings in the absence of other evidence. The site of sampling should always be recorded. The availability of antemortem specimens should not necessarily preclude postmortem sampling. Appropriate sample preservation, transport, and storage are mandatory. Interpretation of analytical toxicology results must take into account what is known of the pharmacokinetics and toxicology of the agent(s in question, the circumstances under which death occurred including the mechanism of exposure, and other factors such as the stability of the analyte(s and the analytical methods used. It is important to realise that changes may occur in the composition of body fluids, even peripheral blood, after death. Such changes are likely to be greater after attempted resuscitation, and with centrally-acting drugs with large volumes of distribution given chronically, and may perhaps be minimised by prompt refrigeration of the body and performing the autopsy quickly.

  7. Toxicology of freshwater cyanobacteria.

    Science.gov (United States)

    Liyanage, H M; Arachchi, D N Magana; Abeysekara, T; Guneratne, L

    2016-07-02

    Many chemical contaminants in drinking water have been shown to cause adverse health effects in humans after prolonged exposure. Cyanobacteria are one of the most potent and diverse groups of photosynthetic prokaryotes. One key component of cyanobacterial success in the environment is the production of potent toxins as secondary metabolites, which have been responsible for numerous adverse health impacts in humans. Anthropogenic activities have led to the increase of eutrophication in freshwater bodies' worldwide, causing cyanobacterial blooms to become more frequent. The present article will discuss about harmful cyanobacteria and their toxicology with special references to microcystin, nodularin, and cylindrospermopsin.

  8. Pharmacogenetics and forensic toxicology.

    Science.gov (United States)

    Musshoff, Frank; Stamer, Ulrike M; Madea, Burkhard

    2010-12-15

    Large inter-individual variability in drug response and toxicity, as well as in drug concentrations after application of the same dosage, can be of genetic, physiological, pathophysiological, or environmental origin. Absorption, distribution and metabolism of a drug and interactions with its target often are determined by genetic differences. Pharmacokinetic and pharmacodynamic variations can appear at the level of drug metabolizing enzymes (e.g., the cytochrome P450 system), drug transporters, drug targets or other biomarker genes. Pharmacogenetics or toxicogenetics can therefore be relevant in forensic toxicology. This review presents relevant aspects together with some examples from daily routines. Copyright © 2010. Published by Elsevier Ireland Ltd.

  9. Translational toxicology: a developmental focus for integrated research strategies.

    Science.gov (United States)

    Hughes, Claude; Waters, Michael; Allen, David; Obasanjo, Iyabo

    2013-09-30

    Given that toxicology studies the potential adverse effects of environmental exposures on various forms of life and that clinical toxicology typically focuses on human health effects, what can and should the relatively new term of "translational toxicology" be taken to mean? Our assertion is that the core concept of translational toxicology must incorporate existing principles of toxicology and epidemiology, but be driven by the aim of developing safe and effective interventions beyond simple reduction or avoidance of exposure to prevent, mitigate or reverse adverse human health effects of exposures.The field of toxicology has now reached a point where advances in multiple areas of biomedical research and information technologies empower us to make fundamental transitions in directly impacting human health. Translational toxicology must encompass four action elements as follows: 1) Assessing human exposures in critical windows across the lifespan; 2) Defining modes of action and relevance of data from animal models; 3) Use of mathematical models to develop plausible predictions as the basis for: 4) Protective and restorative human health interventions. The discussion focuses on the critical window of in-utero development. Exposure assessment, basic toxicology and development of certain categories of mathematical models are not new areas of research; however overtly integrating these in order to conceive, assess and validate effective interventions to mitigate or reverse adverse effects of environmental exposures is our novel opportunity. This is what we should do in translational toxicology so that we have a portfolio of interventional options to improve human health that include both minimizing exposures and specific preventative/restorative/mitigative therapeutics.

  10. Virtual reality for mobility devices: training applications and clinical results: a review.

    Science.gov (United States)

    Erren-Wolters, Catelijne Victorien; van Dijk, Henk; de Kort, Alexander C; Ijzerman, Maarten J; Jannink, Michiel J

    2007-06-01

    Virtual reality technology is an emerging technology that possibly can address the problems encountered in training (elderly) people to handle a mobility device. The objective of this review was to study different virtual reality training applications as well as their clinical implication for patients with mobility problems. Computerized literature searches were performed using the MEDLINE, Cochrane, CIRRIE and REHABDATA databases. This resulted in eight peer reviewed journal articles. The included studies could be divided into three categories, on the basis of their study objective. Five studies were related to training driving skills, two to physical exercise training and one to leisure activity. This review suggests that virtual reality is a potentially useful means to improve the use of a mobility device, in training one's driving skills, for keeping up the physical condition and also in a way of leisure time activity. Although this field of research appears to be in its early stages, the included studies pointed out a promising transfer of training in a virtual environment to the real-life use of mobility devices.

  11. Mechanisms and clinical applications of the vacuum-assisted closure (VAC) Device: a review.

    Science.gov (United States)

    Venturi, Mark L; Attinger, Christopher E; Mesbahi, Ali N; Hess, Christopher L; Graw, Katherine S

    2005-01-01

    The use of sub-atmospheric pressure dressings, available commercially as the vacuum-assisted closure (VAC) device, has been shown to be an effective way to accelerate healing of various wounds. The optimal sub-atmospheric pressure for wound healing appears to be approximately 125 mm Hg utilizing an alternating pressure cycle of 5 minutes of suction followed by 2 minutes off suction. Animal studies have demonstrated that this technique optimizes blood flow, decreases local tissue edema, and removes excessive fluid from the wound bed. These physiologic changes facilitate the removal of bacteria from the wound. Additionally, the cyclical application of sub-atmospheric pressure alters the cytoskeleton of the cells in the wound bed, triggering a cascade of intracellular signals that increases the rate of cell division and subsequent formation of granulation tissue. The combination of these mechanisms makes the VAC device an extremely versatile tool in the armamentarium of wound healing. This is evident in the VAC device's wide range of clinical applications, including treatment of infected surgical wounds, traumatic wounds, pressure ulcers, wounds with exposed bone and hardware, diabetic foot ulcers, and venous stasis ulcers. VAC has also proven useful in reconstruction of wounds by allowing elective planning of the definitive reconstructive surgery without jeopardizing the wound or outcome. Furthermore, VAC has significantly increased the skin graft success rate when used as a bolster over the freshly skin-grafted wound. VAC is generally well tolerated and, with few contraindications or complications, is fast becoming a mainstay of current wound care.

  12. Home-use TriPollar RF device for facial skin tightening: Clinical study results.

    Science.gov (United States)

    Beilin, Ghislaine

    2011-04-01

    Professional, non-invasive, anti-aging treatments based on radio-frequency (RF) technologies are popular for skin tightening and improvement of wrinkles. A new home-use RF device for facial treatments has recently been developed based on TriPollar™ technology. To evaluate the STOP™ home-use device for facial skin tightening using objective and subjective methods. Twenty-three female subjects used the STOP at home for a period of 6 weeks followed by a maintenance period of 6 weeks. Facial skin characteristics were objectively evaluated at baseline and at the end of the treatment and maintenance periods using a three-dimensional imaging system. Additionally, facial wrinkles were classified and subjects scored their satisfaction and sensations. Following STOP treatment, a statistically significant reduction of perioral and periorbital wrinkles was achieved in 90% and 95% of the patients, respectively, with an average periorbital wrinkle reduction of 41%. This objective result correlated well with the periorbital wrinkle classification result of 40%. All patients were satisfied to extremely satisfied with the treatments and all reported moderate to excellent visible results. The clinical study demonstrated the safety and efficacy of the STOP home-use device for facial skin tightening. Treatment can maintain a tighter and suppler skin with improvement of fine lines and wrinkles.

  13. Endoscopic removal of over-the-scope clips: Clinical experience with a bipolar cutting device

    Science.gov (United States)

    Meier, Benjamin; Caca, Karel; Schmidt, Arthur

    2016-01-01

    Background Over-the-scope clips (OTSCs) are increasingly used for the closure of perforations/fistulae, hemostasis and endoscopic full-thickness resection (FTRD system). When OTSC-associated complications occur or re-therapy at the OTSC site is needed, OTSC removal may be indicated. An experimental study in an animal model and a case series have shown good results for OTSC removal with a bipolar cutting device. We present a larger clinical study using this device. Methods Data of all consecutive patients with indication for OTSC removal were collected and analyzed retrospectively. OTSCs were cut at two opposing sites using a bipolar grasping device to apply short direct current impulses. OTSC fragments were extracted with a standard forceps and a cap at the tip of the endoscope to avoid tissue damage. Results Between December 2012 and February 2016 a total of 42 OTSC removals in the upper (n = 25) and lower (n = 17) gastrointestinal tract have been performed at our department. Overall technical success, defined as cutting the OTSC at two opposing sites and extraction of both fragments, was achieved in 92.9% (39/42) of all cases. Successful fragmentation of the OTSC was achieved in 97.6% (41/42). Minor bleedings were rare and could be managed endoscopically in all cases. There were no perforations and no major or delayed bleedings. Conclusion Endoscopic OTSC removal with a bipolar cutting device is feasible, effective and safe. This technique can be applied in the upper and lower gastrointestinal tract. PMID:28588877

  14. Clinical characteristic and intraoperative findings of uterine perforation patients in using of intrauterine devices (IUDs).

    Science.gov (United States)

    Sun, Xin; Xue, Min; Deng, Xinliang; Lin, Yun; Tan, Ying; Wei, Xueli

    2018-01-01

    Intrauterine devices (IUDs) are the most popular form of contraception used worldwide; however, IUD is not risk-free. IUD migrations, especially uterine perforations, were frequently occurred in patients. The aim of this study was to investigate the clinical characteristics and intraoperative findings in patients with migrated IUDs. 29 cases of uterine perforation associated with migrated IUDs and 69 control patients were followed between January 2008 to March 2015. Patients who used IUDs within first 6 months from the last delivery experienced a characteristically high rate of the perforation of the uterine wall. A significantly larger number of IUD insertion associated with uterine perforation were performed in rural hospitals or operated at a lower level health care system. There was no clear difference in the age and presented symptoms in patients between two groups. Majority of contraceptive intrauterine devices was the copper-releasing IUDs. Furthermore, patients who used V-shaped IUD showed significantly higher incidence of pelvic adhesions when compared with the users of O-shaped IUDs. Unique clinical characteristics of IUD migration were identified in patients with uterine perforation. Hysteroscopy and/or laparoscopy were the effective approaches to remove the migrated IUDs. Improving operating skills is required at the lower level of health care system.

  15. A Novel Electronic Device for Measuring Urine Flow Rate: A Clinical Investigation

    Directory of Open Access Journals (Sweden)

    Aliza Goldman

    2017-09-01

    Full Text Available Objective: Currently, most vital signs in the intensive care unit (ICU are electronically monitored. However, clinical practice for urine output (UO measurement, an important vital sign, usually requires manual recording of data that is subject to human errors. In this study, we assessed the ability of a novel electronic UO monitoring device to measure real-time hourly UO versus current clinical practice. Design: Patients were connected to the RenalSense Clarity RMS Sensor Kit with a sensor integrated within a standard sterile urinary catheter drainage tube to monitor urine flow in real time. The Clarity RMS Sensor Kit was modified to incorporate a standard urinometer (Unomedical for the nursing staff to record UO as per their standard practice. The drainage bag was placed in a container on a scientific scale (Precisa BJ to be used as the gold standard. Interventions: Nursing records for hourly UO were collected and compared with the electronically recorded UO. Sensor measurements and nursing staff manual records of UO were compared with the scale data. Setting: The study setting was the ICU of Hadassah Hospital, Jerusalem. Patients: Data from 23 patients with a urinary catheter were observed in this study. Measurements and main results: A total of 1046 hours of UO were recorded from 23 subjects. Compared with the scale data, the measurements of hourly urine flow measured with the RenalSense system were closer, had a better correlation, and narrower limits of agreement to gravimetrically determined values than the measurements obtained by the nurses. In addition, continuous monitoring of UO provided graphical display of response to repeated diuretic administration. Conclusions: An electronic device for recording UO has been shown to provide more reliable information of UO records and patient fluid status than current practice. Future applications of this device will provide valuable information to help set protocol goals such as decisions for

  16. Preliminary clinical application of SilverHawk directional atherectomy device in arteriosclerosis obliterans of lower extremity

    International Nuclear Information System (INIS)

    Qian Jun; Jiang Hong; Xu Gang; Yang Xiaohong

    2011-01-01

    Objective: To evaluate the clinical efficiency and security of SilverHawk directional atherectomy device in treating arteriosclerosis obliterans of lower extremity. Methods: Seven patients with lower extremity ischemia were treated with SilverHawk directional atherectomy. The lesions length varied from 1.8 to 14.5 cm. Clinical symptoms (Fontaine classification) included 4 cases of grade Ⅱ b, I case of grade Ⅲ, 2 cases of grade Ⅳ. The ABI varied from 0.28 to 0.65. Patency was evaluated with color duplex sonography or CTA besides clinical examination during follow-up. Results: Seven occlusive lesions were recanalizated successfully. The technical success (residual stenosis < 30%) rate was 100%. Clinical symptoms were obviously improved or disappeared. The ABI varied from 0.82 to 1.18 (P=0.002), and Fontaine classification included 6 cases of Ⅰ; 1 case of Ⅱ a. Patency rate was 100% and the ABI varied from 0.75 to 1.14 (P=0.938). Fontaine classifications keep consistent 1-6 months after operation. Conclusion: SilverHawk directional atherectomy was a safe and effective way for treatment of lower arteriosclerosis obliteran. (authors)

  17. Nails in Forensic Toxicology: An Update.

    Science.gov (United States)

    Solimini, Renata; Minutillo, Adele; Kyriakou, Chrystalla; Pichini, Simona; Pacifici, Roberta; Busardo, Francesco Paolo

    2017-01-01

    The analysis of nails as a keratinized matrix to detect drugs or illicit substances has been increasingly used in forensic and clinical toxicology as a complementary test, especially for the specific characteristics of stably accumulating substances for long periods of time. This allows a retrospective investigation of chronic drug abuse, monitoring continuous drug or pharmaceutical use, reveal in utero drug exposure or environmental exposures. We herein review the recent literature investigating drug incorporation mechanisms and drug detection in nails for forensic toxicological purposes. Mechanisms of drug incorporation have not yet been fully elucidated. However, some research has lately contributed to a better understanding of how substances are incorporated into nails, suggesting three potential mechanisms of drug incorporation: contamination from sweat, incorporation from nail bed and incorporation from germinal matrix. In addition, numerous methods dealing with the determination of drugs of abuse, medications and alcohol biomarkers in nails have been reported in studies over the years. The latter methods could find application in clinical and forensic toxicology. The studies herein reviewed point out how important it is to standardize and harmonize the methodologies (either pre-analytical or analytical) for nails analysis and the optimization of sampling as well as the development of proficiency testing programs and the determination of cut-off values. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  18. [Interest of toxicological analysis for poisonings].

    Science.gov (United States)

    Mégarbane, Bruno; Baud, Frédéric J

    2008-04-30

    The clinical approach of the poisoned patients is mainly based on the analysis of the circumstances of intoxication and the search for toxidromes. Toxicological analysis aims to detect the toxicants or measure their concentrations, in order to confirm the hypothesis of poisoning, to evaluate its severity and to help the follow-up regarding the treatment efficiency. Emergent toxicological analysis appears only useful if the method is specific and the results rapidly obtained. Therefore, systematic screening using immunochesmistry-based tests is not recommended in the situation of emergency. Measurement of blood concentrations of the toxicants is only indicated if it may influence the patient management. However, in the perspective of research, the study of toxicokinetic/toxicodynamic relationships, i.e. the relationships between the toxicant effects and its blood concentrations, may be helpful to understand the inter-individual variability of the response to a toxicant.

  19. Augmenting retention and stability of an occlusal device for a partially dentate patient using existing extracoronal attachments: a clinical report.

    Science.gov (United States)

    Al-Rowaieh, Saleh A

    2011-04-01

    Occlusal devices are a valid treatment modality in certain clinical situations. For an occlusal device to be effective, sufficient retention and stability should be derived from coverage of the occlusal and incisal surfaces of the teeth. In the absence of most or all of the posterior teeth, the effectiveness of the device could become compromised as the incisal portions of the anterior teeth are typically not conducive to adequately retaining and stabilizing the device. This clinical report describes an approach to improving the retention and stability of an occlusal device for a patient with shortened dental arches by use of the patient's existing extracoronal attachments. Copyright © 2011 The Editorial Council of the Journal of Prosthetic Dentistry. Published by Mosby, Inc. All rights reserved.

  20. Clinical effectiveness of the Respimat® inhaler device in managing chronic obstructive pulmonary disease: evidence when compared with other handheld inhaler devices

    Directory of Open Access Journals (Sweden)

    et al

    2011-02-01

    Full Text Available Felix SF Ram1, Celso R Carvallho2, John White31School of Health and Social Services, Massey University, Auckland, New Zealand; 2Department of Physical Therapy, School of Medicine, University of São Paulo, Brazil; 3York Hospitals NHS Foundation Trust, York Hospital, York, UKObjectives: Medication for the management of chronic obstructive pulmonary disease (COPD may be delivered by a number of different inhaler devices. This study was undertaken to determine the clinical effectiveness of the Respimat® handheld inhaler device compared with other handheld inhaler devices for the delivery of medication in stable COPD.Methodology: A systematic review of high-quality randomized controlled clinical trials comparing Respimat with other inhaler devices using the same medication was performed. Studies were searched for in the Cochrane Central Register of Controlled Trials as well as other relevant electronic databases. Manufacturers of inhaled COPD medication were also contacted for potential trials.Results: Seven studies of high methodological quality with 3813 participants were included in the review. Three trials used Handihaler® as the comparator inhaler, three used a chlorofluorocarbon metered-dose inhaler (CFC-MDI, and one trial used a hydroflouroalkane (HFA-MDI. When Respimat was compared with Handihaler, the following reported outcomes were not significantly different: trough forced expiratory volume in 1 second (FEV1 (weighted mean difference [WMD] 0.01 L; P = 0.14, trough forced vital capacity (FVC (WMD 0.001 L: P = 0.88, peak FEV1 (WMD 0.01 L: P = 0.08, peak FVC (WMD 0.01 L: P = 0.55, morning peak expiratory flow rate (PEFR (WMD 5.06 L/min: P = 0.08, and evening PEFR (WMD 4.39 L/min: P = 0.15. Furthermore, there were no differences when Respimat was compared with Handihaler for risk of exacerbations (relative risk [RR] 0.94: P = 0.81, dry mouth (RR 1.57: P = 0.34, or nasopharyngitis (RR 1.42: P = 0.22. For Respimat compared with CFC-MDI, the

  1. Use of mobile devices in nursing student-nurse teacher cooperation during the clinical practicum: an integrative review.

    Science.gov (United States)

    Strandell-Laine, Camilla; Stolt, Minna; Leino-Kilpi, Helena; Saarikoski, Mikko

    2015-03-01

    To identify and appraise study findings on the use of mobile devices, in particular for what purposes and how, in nursing student-nurse teacher cooperation during the clinical practicum. A systematic literature search was conducted using the PubMed/Medline, CINAHL, PsycINFO and ERIC for primary empirical studies published in English. An integrative literature review was undertaken. Quality appraisal of the included studies was conducted using design-specific standardized checklists. Studies were thematically analyzed. Based on the inclusion and exclusion criteria, eleven studies were included in the review. Weaknesses in designs, samples, questionnaires and results, compromised comparison and/or generalization of the findings of the studies. Three main themes were identified: (1) features of mobile devices (2) utility of mobile devices and (3) barriers to the use of mobile devices. Problems of connectivity were the main challenges reported in the use of mobile devices. Participants used mobile devices primarily as reference tools, but less frequently as tools for reflection, assessment or cooperation during the clinical practicum. Interest in mobile device use during the clinical practicum was reported, but training and ongoing support are needed. As only a small number of eligible primary empirical studies were found, it is not possible to draw firm conclusions on the results. In the future, rigorous primary empirical studies are needed to explore the potential of mobile devices in providing a supplementary pedagogical method in nursing student-nurse teacher cooperation during the clinical practicum. Robust study designs, including experimental ones, are clearly needed to assess the effectiveness of mobile devices in nursing student-nurse teacher cooperation during the clinical practicum. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Pediatric supraglottic airway devices in clinical practice: A prospective observational study.

    Science.gov (United States)

    Kleine-Brueggeney, Maren; Gottfried, Anne; Nabecker, Sabine; Greif, Robert; Book, Malte; Theiler, Lorenz

    2017-09-02

    Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™. This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH 2 O ± 10%. None of the SGA showed a mean airway leak pressure of 20 cmH 2 O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH 2 O, Air-Q® 15.9 (3.2) cmH 2 O, Ambu® Aura-i™ 17.3 (3.7) cmH 2 O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™,

  3. [Toxicological evaluation in the childhood].

    Science.gov (United States)

    Arroyo, Amparo; Rodrigo, Carlos; Marrón, M Teresa

    2014-03-01

    Intoxications in infancy require urgent medical treatment within national health systems. In our country they represent 0.3% of paediatric urgencies. Most of them are accidental intoxications but is not infrequent to find some related to child abuse or to suicidal intentions, especially in adolescence. The objectives of the study are to evaluate both clinical health care and medical legal aspects in intoxications in infancy. Medical assistance is described and it includes clinical diagnosis, typology of the more common toxics, percentages and referral to social work and emergency care equipment units of the Ministry of Social Welfare and the Department of Health or, where appropriate, directly to prosecutors and courts for their intervention. In cases of detection of alcohol, drugs or medication in infants, the importance of the correct interpretation of the results of toxicological findings is discussed. Several studies for the interpretation of results concerning the detection of these toxics are reported. Both legal aspects and the forensic medical opinion are assessed. The findings will be analysed by the judicial authority in order to circumscribe responsibilities or to take appropriate decisions concerning the protection of infants' interests. In conclusion intoxication in infancy can lead to legal proceedings requiring specific actions for their protection. Both physicians and hospitals must comply with the legal requirement of the submission to the court of judicial parties. On the other hand, this information is an interesting step toward reinforcing public health surveillance. Copyright © 2014 Elsevier España, S.L. All rights reserved.

  4. Single incision device (TVT Secur) versus retropubic tension-free vaginal tape device (TVT) for the management of stress urinary incontinence in women: a randomized clinical trial.

    Science.gov (United States)

    Ross, Sue; Tang, Selphee; Schulz, Jane; Murphy, Magnus; Goncalves, Jose; Kaye, Stephen; Dederer, Lorel; Robert, Magali

    2014-12-22

    In 2006, Ethicon Inc. introduced a new minimally invasive single incision sling device for the surgical treatment of stress urinary incontinence, the Gynecare TVT Secur®. For device licensing, no new evidence of TVT Secur efficacy and safety was needed: rather evidence was provided of the long-term follow-up of patients who had a procedure using a predecate retropubic tension-free vaginal tape device. Before adopting TVT Secur into our routine clinical practice, we decided to evaluate it. The objective of our Canadian multi-centre pragmatic randomized controlled trial was to compare the effectiveness of the new single-incision device, TVT Secur, to the established TVT device, in terms of objective cure of stress urinary incontinence (SUI) at 12 months postoperatively. Other outcomes included: complications, symptoms, and incontinence-related quality of life. The sample size estimate for our trial was 300, but the trial stopped early because of poor recruitment. 74 women participated (40 allocated to TVT Secur, 34 to TVT). At 12 months postoperatively, 27/33(82%) of TVT Secur group were cured, compared with 25/28(89%) of the TVT group (relative risk 0.92, 95% confidence interval 0.75 to 1.13, p=0.49). Most women reported little or no SUI symptoms (35/37(95%) vs 29/30(97%), >0.999). Quality of life improved significantly from baseline for both groups (IIQ-7 mean change -25 for both groups) but did not differ between groups (p=0.880). Our small randomized trial did not find statistically significant differences in outcomes between women allocated to the TVT Secur device versus those allocated to the TVT device for stress urinary incontinence. Despite the discontinuation of TVT Secur in March 2013 for commercial reasons, the importance of our study lies in making evidence available for the many women who had a TVT Secur device implanted and their physicians who may be considering alternative treatments. Our experience illustrates the difficulty of undertaking research

  5. Nuclear toxicology at CEA

    International Nuclear Information System (INIS)

    Giustranti, C.

    2001-01-01

    CEA (French commission of atomic energy) has launched a new program dedicated to the study of the transfer of heavy metals and some radionuclides from environment to living beings. The substances that will be studied, are those that are involved in research, medical activities, and in nuclear industry. It means iodine, technetium, trans-uranides (uranium and plutonium), fission products (iodine, cesium), carbon, cobalt, boron and beryllium. This program is composed of 2 axis: the first one concerns the bio-geo-chemical cycles that are involved in transfer and the second axis deals with the detoxication processes that appear in animal and man cells. This program will rely on the strong competencies of CEA in chemistry, radiochemistry, biology, physiology and toxicology. (A.C.)

  6. Emerging approaches in predictive toxicology.

    Science.gov (United States)

    Zhang, Luoping; McHale, Cliona M; Greene, Nigel; Snyder, Ronald D; Rich, Ivan N; Aardema, Marilyn J; Roy, Shambhu; Pfuhler, Stefan; Venkatactahalam, Sundaresan

    2014-12-01

    Predictive toxicology plays an important role in the assessment of toxicity of chemicals and the drug development process. While there are several well-established in vitro and in vivo assays that are suitable for predictive toxicology, recent advances in high-throughput analytical technologies and model systems are expected to have a major impact on the field of predictive toxicology. This commentary provides an overview of the state of the current science and a brief discussion on future perspectives for the field of predictive toxicology for human toxicity. Computational models for predictive toxicology, needs for further refinement and obstacles to expand computational models to include additional classes of chemical compounds are highlighted. Functional and comparative genomics approaches in predictive toxicology are discussed with an emphasis on successful utilization of recently developed model systems for high-throughput analysis. The advantages of three-dimensional model systems and stem cells and their use in predictive toxicology testing are also described. © 2014 Wiley Periodicals, Inc.

  7. Biodegradable device applied in flatfoot surgery: Comparative studies between clinical and technological aspects of removed screws

    International Nuclear Information System (INIS)

    Ruozi, Barbara; Belletti, Daniela; Manfredini, Giuseppe; Tonelli, Massimo; Sena, Paola; Vandelli, Maria Angela; Forni, Flavio; Tosi, Giovanni

    2013-01-01

    Poly-L-lactide (PLLA) is one of the most used polymers for biomedical application; its use in sutures and other implants has been widely investigated. Although the knowledge of PLLA biodegradation and biocompatibility features is deep, PLLA screws used to correct the flat foot deformity have deserved attention since they are not degraded in most of cases after a long period of years (3–7) from the implantation. In this article, a clinical and radiological evaluation (NMR, histological and clinical outcomes) on patients was correlated with physico-chemical characterization (by SEM, DSC, GPC and XRD analysis at different temperatures) on both native and patient-recovered screws together with the theoretical degradation processes of PLLA-based implants. The data demonstrated the need for crossing the biodegradation and bioabsorption of the polymer with the characteristics of both the device (geometry, structure and fabrication process) and the implantation site. Highlights: ► Resorbable PLLA screws were proposed for arthroereisis in pediatric flatfoot. ► Satisfactory clinical results were obtained almost in the totality of patients. ► The bioabsorption period is slightly longer than what is expected. ► Patient-recovered screws were analyzed to evaluate the biodegradation stage. ► Degradability/structural integrity during implantation should be ameliorated

  8. Guidelines for clinical studies with compression devices in patients with venous disorders of the lower limb.

    Science.gov (United States)

    Rabe, E; Partsch, H; Jünger, M; Abel, M; Achhammer, I; Becker, F; Cornu-Thenard, A; Flour, M; Hutchinson, J; Issberner, K; Moffatt, Ch; Pannier, F

    2008-04-01

    The scientific quality of published clinical trials is generally poor in studies where compression devices have been assessed in the management of venous disease. The authors' aim was to establish a set of guidelines which could be used in the design of future clinical trials of compression treatments for venous diseases. Consensus conference leading to a consensus statement. The authors form a expert consensus group known as the International Compression Club (ICC). This group obtained published medical literature in the field of compression treatment in venous disease by searching medical literature databases. The literature was studied by the group which attended a consensus meeting. A draft document was circulated to ICC members and revised until agreement between contributors was reached. The authors have prepared a set of guidelines which should be given consideration when conducting studies to assess the efficacy of compression in venous disease. The form of compression therapy including the comparators used in the clinical study must be clearly characterised. In future studies the characteristics of the material provided by the manufacturer should be described including in vivo data on pressure and stiffness of the final compression system. The pressure exerted on the distal lower leg should be stated in mmHg and the method of pressure determination must be quoted.

  9. Biodegradable device applied in flatfoot surgery: Comparative studies between clinical and technological aspects of removed screws

    Energy Technology Data Exchange (ETDEWEB)

    Ruozi, Barbara, E-mail: barbara.ruozi@unimore.it [Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 183, 41100 Modena, MO (Italy); Belletti, Daniela, E-mail: daniela.belletti@unimore.it [Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 183, 41100 Modena, MO (Italy); Manfredini, Giuseppe, E-mail: giuseppe626@virgilio.it [Orthopaedic and Traumatologic Clinic, University Hospital of Modena and Reggio Emilia, Modena Italy, Director Prof. F. Catani, Via del Pozzo 71, Policlinico, 41100 Modena, MO (Italy); Tonelli, Massimo, E-mail: massimo.tonelli@unimore.it [CIGS, University of Modena and Reggio Emilia, Via Campi 213/A, 41100 Modena, MO (Italy); Sena, Paola, E-mail: paola.sena@unimore.it [Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Via del Pozzo 71, Policlinico, 41100 Modena, MO (Italy); Vandelli, Maria Angela, E-mail: mariaangela.vandelli@unimore.it [Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 183, 41100 Modena, MO (Italy); Forni, Flavio, E-mail: flavio.forni@unimore.it [Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 183, 41100 Modena, MO (Italy); Tosi, Giovanni, E-mail: giovanni.tosi@unimore.it [Department of Life Sciences, University of Modena and Reggio Emilia, Via Campi 183, 41100 Modena, MO (Italy)

    2013-04-01

    Poly-L-lactide (PLLA) is one of the most used polymers for biomedical application; its use in sutures and other implants has been widely investigated. Although the knowledge of PLLA biodegradation and biocompatibility features is deep, PLLA screws used to correct the flat foot deformity have deserved attention since they are not degraded in most of cases after a long period of years (3–7) from the implantation. In this article, a clinical and radiological evaluation (NMR, histological and clinical outcomes) on patients was correlated with physico-chemical characterization (by SEM, DSC, GPC and XRD analysis at different temperatures) on both native and patient-recovered screws together with the theoretical degradation processes of PLLA-based implants. The data demonstrated the need for crossing the biodegradation and bioabsorption of the polymer with the characteristics of both the device (geometry, structure and fabrication process) and the implantation site. Highlights: ► Resorbable PLLA screws were proposed for arthroereisis in pediatric flatfoot. ► Satisfactory clinical results were obtained almost in the totality of patients. ► The bioabsorption period is slightly longer than what is expected. ► Patient-recovered screws were analyzed to evaluate the biodegradation stage. ► Degradability/structural integrity during implantation should be ameliorated.

  10. Clinical Evaluation of Measuring the ACT during Elective Cardiac Surgery with Two Different Devices.

    Science.gov (United States)

    Falter, Florian; Razzaq, Nabeel; John, Martin; Fassl, Jens; Maurer, Markus; Ewing, Sean; Hofmeyr, Ross

    2018-03-01

    Unfractionated heparin is the mainstay of anticoagulation during cardiac surgery on cardiopulmonary bypass (CPB) due to its low cost, quick onset, and ease of reversal. Since over 30 years, the activated clotting time (ACT) has been used to assess the level of heparin activity both before and after CPB. We compared two different methods of measuring the ACT: i-STAT, which uses amperometric detection of thrombin cleavage, and Hemochron Jr, which is based on detecting viscoelastic changes in blood. We included 402 patients from three institutions (Papworth Hospital, Cambridge, UK; Groote Schuur, Cape Town, South Africa; University Hospital Basel, Basel, Switzerland) undergoing elective cardiac surgery on CPB in our study. We analyzed duplicate samples on both devices at all standard measuring points during the procedure. The correlation coefficient between two Hemochron and two i-STAT devices was .9165 and .9857, respectively. The within-subject coefficient of variation (WSCV) ranged from 8.2 to 13.6% for the Hemochron and from 4.1 to 9.1% for the i-STAT. We found that the number of occasions where one of the duplicate readings was >1,000 seconds while the other was below or close to the clinically significant threshold of 400 seconds were higher for the Hemochron. We found the i-STAT to systematically return higher measurements. We conclude that the i-STAT provides a more reliable test for heparin activity and assesses safe anticoagulation during cardiac surgery on pump. The fact the that the i-STAT reads higher than the Hemochron leads to the recommendation to validate the methods against each other before changing devices.

  11. Assessment of biofilm formation in device-associated clinical bacterial isolates in a tertiary level hospital

    Directory of Open Access Journals (Sweden)

    Summaiya A Mulla

    2011-01-01

    Full Text Available Background: Biofilm formation is a developmental process with intercellular signals that regulate growth. Biofilms contaminate catheters, ventilators, and medical implants; they act as a source of disease for humans, animals, and plants. Aim: In this study we have done quantitative assessment of biofilm formation in device-associated clinical bacterial isolates in response to various concentrations of glucose in tryptic soya broth and with different incubation time. Materials and Methods: The study was carried out on 100 positive bacteriological cultures of medical devices, which were inserted in hospitalized patients. The bacterial isolates were processed as per microtitre plate method with tryptic soya broth alone and with varying concentrations of glucose and were observed in response to time. Results: Majority of catheter cultures were positive. Out of the total 100 bacterial isolates tested, 88 of them were biofilm formers. Incubation period of 16-20 h was found to be optimum for biofilm development. Conclusions: Availability of nutrition in the form of glucose enhances the biofilm formation by bacteria. Biofilm formation depends on adherence of bacteria to various surfaces. Time and availability of glucose are important factors for assessment of biofilm progress.

  12. COMPUTATIONAL TOXICOLOGY-WHERE IS THE DATA? ...

    Science.gov (United States)

    This talk will briefly describe the state of the data world for computational toxicology and one approach to improve the situation, called ACToR (Aggregated Computational Toxicology Resource). This talk will briefly describe the state of the data world for computational toxicology and one approach to improve the situation, called ACToR (Aggregated Computational Toxicology Resource).

  13. The magazine picture collage: its clinical use and validity as an assessment device.

    Science.gov (United States)

    Lerner, C J

    1979-08-01

    To contribute to an understanding of the magazine picture collage as a clinical assessment device, experienced psychiatric staff from various disciplines were asked to distinguish the collages of hospitalized psychiatric patients from those of paired controls, to note whatever descriptive and dynamic features about the individual that could be inferred from the collage, and to document what specific aspects of the collage were used in drawing the inferences. The raters, on the basis of the collage, were not able to distinguish the patients from the controls but were able to derive highly accurate inferences. The results were taken to indicate that, while the collage is best used as a means of assessing psychological processes as contrasted with assigning a diagnosis or predicting behavior, more rigorous research is needed to relate collage factors to personality factors.

  14. Phrenic paralysis during cardiac electronic device implantation: incidence, causes and clinical course.

    Science.gov (United States)

    López-Gil, María; Fontenla, Adolfo; Juliá, Justo; Parra, Juan José; Arribas, Fernando

    2016-10-01

    Phrenic paralysis is a known complication of central venous catheterization, but it is not listed as a complication related to cardiac implantable electronic device (CIED) implants. The aim of this study is to describe the incidence, causes, clinical picture, and management of phrenic paralysis occurring in this scenario. We retrospectively analysed data from our CIED implantation database and identified those patients who suffered phrenic paralysis during the implantation procedure. Four of 891 patients (subclavian puncture in 626) developed phrenic paralysis during pacemaker or defibrillator implant procedures. Severe respiratory failure needing ventilatory support occurred in two, being the phrenic paralysis transient in all of the cases. Transient phrenic paralysis may occur during CIED implantation probably related to the infiltration of local anaesthesia in the subclavian area. Mechanism, prevention, and management are discussed. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

  15. Ninth Triennial Toxicology Salary Survey.

    Science.gov (United States)

    Gad, Shayne Cox; Sullivan, Dexter Wayne

    2016-01-01

    This survey serves as the ninth in a series of toxicology salary surveys conducted at 3-year intervals and beginning in 1988. An electronic survey instrument was distributed to 5919 individuals including members of the Society of Toxicology, American College of Toxicology, and 23 additional professional organizations. Question items inquired about gender, age, degree, years of experience, certifications held, areas of specialization, society membership, employment and income. Overall, 1293 responses were received (response rate 21.8%). The results of the 2014 survey provide insight into the job market and career path for current and future toxicologists. © The Author(s) 2016.

  16. Exploration of the affordances of mobile devices in integrating theory and clinical practice in an undergraduate nursing programme.

    Science.gov (United States)

    Willemse, Juliana J; Bozalek, Vivienne

    2015-01-01

    Promoting the quality and effectiveness of nursing education is an important factor, given the increased demand for nursing professionals. It is important to establish learning environments that provide personalised guidance and feedback to students about their practical skills and application of their theoretical knowledge. To explore and describe the knowledge and points of view of students and educators about introduction of new technologies into an undergraduate nursing programme. The qualitative design used Tesch's (1990) steps of descriptive data analysis to complete thematic analysis of the data collected in focus group discussions (FGDs) and individual interviews to identify themes. Themes identified from the students’ FGDs and individual interviews included: mobile devices as a communication tool; email, WhatsApp and Facebook as methods of communication; WhatsApp as a method of communication; nurses as role-models in the clinical setting; setting personal boundaries; and impact of mobile devices in clinical practice on professionalism. Themes identified from the FGD, individual interviews and a discussion session held with educators included: peer learning via mobile devices; email, WhatsApp and Facebook as methods of communication; the mobile device as a positive learning method; students need practical guidance; and ethical concerns in clinical facilities about Internet access and use of mobile devices. The research project established an understanding of the knowledge and points of view of students and educators regarding introduction of new technologies into an undergraduate nursing programme with the aim of enhancing integration of theory and clinical practice through use of mobile devices.

  17. Establishment of virtual three-dimensional model for intravascular interventional devices and its clinical value

    International Nuclear Information System (INIS)

    Wei Xin; Zhong Liming; Xie Xiaodong; Wang Chaohua; You Jian; Hu Hong; Hu Kongqiong; Zhao Xiaowei

    2012-01-01

    Objective: To explore virtual three-dimensional (3D) model for intravascular interventional devices,the method of preoperative simulation and its value in clinical work. Methods: The virtual models including catheter, guide wire, stent and coil were established by using the 3D moulding software of 3D Studio MAX R3. The interventional preoperative simulation was performed on personal computer including 21 patients of cerebral aneurysm embolization (anterior communicating artery 5, posterior communicating artery 10,middle cerebral artery 3, internal carotid artery 2, and vertebral artery 1), during interventional procedures, the surgeon relied on the simulation results for plastic micro-guide wire, catheter and the release of micro-coils and stents. Results: (1) All the virtual instruments and real instruments had similar shape,the overall tine for constructing virtual model was about 20 hours. The preoperative simulation took 50 to 80 minutes. (2) The simulation result of catheter insertion in the 18 cases had relevant value to guide micro-catheter, molding micro-guide wire tip, and shortened the operating time. For embolization, the simulation results of filling coil and releasing stent were similar to surgical results in 76% of the patients (16/21). (3)For teaching and training, 93% (38/41) of doctors in training believed that preoperative simulation facilitated the understanding of surgery. Conclusions: The method of virtual model of intravascular interventional devices was reliable. The preoperative simulation results could be used to guide practical clinical operation with relatively high degree of similarity, and could play a role in promoting researches on interventional virtual operations. (authors)

  18. High-resolution mass spectrometry in toxicology: current status and future perspectives.

    Science.gov (United States)

    Maurer, H H; Meyer, Markus R

    2016-09-01

    This paper reviews high-resolution mass spectrometry (HRMS) approaches using time-of-flight or Orbitrap techniques for research and application in various toxicology fields, particularly in clinical toxicology and forensic toxicology published since 2013 and referenced in PubMed. In the introduction, an overview on applications of HRMS in various toxicology fields is given with reference to current review articles. Papers concerning HRMS in metabolism, screening, and quantification of pharmaceuticals, drugs of abuse, and toxins in human body samples are critically reviewed. Finally, a discussion on advantages as well as limitations and future perspectives of these methods is included.

  19. American College of Medical Toxicology

    Science.gov (United States)

    ... Publications Journal of Medical Toxicology About ACMT About Us History of ACMT ACMT Fact Sheet Strategic Plan ACMT ... Policies IJMT JMT Editorial Board About ACMT About Us History of ACMT ACMT Fact Sheet Strategic Plan ACMT ...

  20. Aggregated Computational Toxicology Resource (ACTOR)

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Aggregated Computational Toxicology Resource (ACTOR) is a database on environmental chemicals that is searchable by chemical name and other identifiers, and by...

  1. Predictive toxicology in drug safety

    National Research Council Canada - National Science Library

    Xu, Jinghai J; Urban, Laszlo

    2011-01-01

    .... It provides information on the present knowledge of drug side effects and their mitigation strategy during drug discovery, gives guidance for risk assessment, and promotes evidence-based toxicology...

  2. Aggregated Computational Toxicology Online Resource

    Data.gov (United States)

    U.S. Environmental Protection Agency — Aggregated Computational Toxicology Online Resource (AcTOR) is EPA's online aggregator of all the public sources of chemical toxicity data. ACToR aggregates data...

  3. Toxicology of Biodiesel Combustion products

    Science.gov (United States)

    1. Introduction The toxicology of combusted biodiesel is an emerging field. Much of the current knowledge about biological responses and health effects stems from studies of exposures to other fuel sources (typically petroleum diesel, gasoline, and wood) incompletely combusted. ...

  4. Clinical decision support systems in hospital care using ubiquitous devices: Current issues and challenges.

    Science.gov (United States)

    Baig, Mirza Mansoor; GholamHosseini, Hamid; Moqeem, Aasia A; Mirza, Farhaan; Lindén, Maria

    2017-11-01

    Supporting clinicians in decision making using advanced technologies has been an active research area in biomedical engineering during the past years. Among a wide range of ubiquitous systems, smartphone applications have been increasingly developed in healthcare settings to help clinicians as well as patients. Today, many smartphone applications, from basic data analysis to advanced patient monitoring, are available to clinicians and patients. Such applications are now increasingly integrating into healthcare for clinical decision support, and therefore, concerns around accuracy, stability, and dependency of these applications are rising. In addition, lack of attention to the clinicians' acceptability, as well as the low impact on the medical professionals' decision making, are posing more serious issues on the acceptability of smartphone applications. This article reviews smartphone-based decision support applications, focusing on hospital care settings and their overall impact of these applications on the wider clinical workflow. Additionally, key challenges and barriers of the current ubiquitous device-based healthcare applications are identified. Finally, this article addresses current challenges, future directions, and the adoption of mobile healthcare applications.

  5. Development of a computer-based automated pure tone hearing screening device: a preliminary clinical trial.

    Science.gov (United States)

    Gan, Kok Beng; Azeez, Dhifaf; Umat, Cila; Ali, Mohd Alauddin Mohd; Wahab, Noor Alaudin Abdul; Mukari, Siti Zamratol Mai-Sarah

    2012-10-01

    Hearing screening is important for the early detection of hearing loss. The requirements of specialized equipment, skilled personnel, and quiet environments for valid screening results limit its application in schools and health clinics. This study aimed to develop an automated hearing screening kit (auto-kit) with the capability of realtime noise level monitoring to ensure that the screening is performed in an environment that conforms to the standard. The auto-kit consists of a laptop, a 24-bit resolution sound card, headphones, a microphone, and a graphical user interface, which is calibrated according to the American National Standards Institute S3.6-2004 standard. The auto-kit can present four test tones (500, 1000, 2000, and 4000 Hz) at 25 or 40 dB HL screening cut-off level. The clinical results at 40 dB HL screening cut-off level showed that the auto-kit has a sensitivity of 92.5% and a specificity of 75.0%. Because the 500 Hz test tone is not included in the standard hearing screening procedure, it can be excluded from the auto-kit test procedure. The exclusion of 500 Hz test tone improved the specificity of the auto-kit from 75.0% to 92.3%, which suggests that the auto-kit could be a valid hearing screening device. In conclusion, the auto-kit may be a valuable hearing screening tool, especially in countries where resources are limited.

  6. Implementation of clinical research trials using web-based and mobile devices: challenges and solutions

    Directory of Open Access Journals (Sweden)

    Roy Eagleson

    2017-03-01

    Full Text Available Abstract Background With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature. Results The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy. Conclusion We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.

  7. Toxicologia do praguicida aldicarb ("chumbinho": aspectos gerais, clínicos e terapêuticos em cães e gatos Aldicarb toxicology: general, clinic and therapeutic features in dogs and cats

    Directory of Open Access Journals (Sweden)

    Fabiana Galtarossa Xavier

    2007-08-01

    Full Text Available O aldicarb (Temik®, um agente anticolinesterásico carbamato vulgarmente conhecido como "chumbinho", é considerado um dos praguicidas mais tóxicos disponíveis comercialmente. No Brasil, embora seja registrado para uso agrícola exclusivo, tem sido freqüentemente apontado como o responsável por diversos casos de intoxicação em seres humanos e em animais. Desta forma, o presente estudo faz uma abordagem da toxicologia deste agente, enfocando as propriedades químicas, a toxicocinética, a toxicodinâmica, o diagnóstico e os aspectos clínicos e terapêuticos da intoxicação em cães e gatos.Aldicarb (Temik®, an anticholinesterase inhibitor of the carbamate group known as ‘chumbinho’, is one of the most toxic of registered pesticides, and has its use restricted to agriculture in Brazil. In spite of it, aldicarb is being very often involved in severe intoxication in humans and animals. It is largely and illegally sold as rodenticide and often used in baits for intentional poisoning of companion animals. Because of this the aldicarb toxicology was reviewed empathizing its chemical properties, toxicokinetic, toxicodynamic, diagnostic and the clinical and therapeutics aspects in dogs and cats.

  8. Mass Spectrometry Applications for Toxicology

    OpenAIRE

    Mbughuni, Michael M.; Jannetto, Paul J.; Langman, Loralie J.

    2016-01-01

    Toxicology is a multidisciplinary study of poisons, aimed to correlate the quantitative and qualitative relationships between poisons and their physiological and behavioural effects in living systems. Other key aspects of toxicology focus on elucidation of the mechanisms of action of poisons and development of remedies and treatment plans for associated toxic effects. In these endeavours, Mass spectrometry (MS) has become a powerful analytical technique with a wide range of application used i...

  9. Behavioral assays in environmental toxicology

    Energy Technology Data Exchange (ETDEWEB)

    Weiss, B.

    1979-01-01

    Environmental toxicology is too permeated by questions about how the whole organism functions to abandon intact animals as test systems. Behavior does not participate as a single entity or discipline. It ranges across the total spectrum of functional toxicity, from tenuous subjective complaints to subtle sensory and motor disturbances demanding advanced instrumentation for their evaluation. Three facets of behavioral toxicology that illustrate its breadth of interests and potential contributions are discussed.

  10. A practice analysis of toxicology.

    Science.gov (United States)

    Wood, Carol S; Weis, Christopher P; Caro, Carla M; Roe, Amy

    2016-12-01

    In 2015, the American Board of Toxicology (ABT), with collaboration from the Society of Toxicology (SOT), in consultation with Professional Examination Service, performed a practice analysis study of the knowledge required for general toxicology. The purpose of this study is to help assure that the examination and requirements for attainment of Diplomate status are relevant to modern toxicology and based upon an empirical foundation of knowledge. A profile of the domains and tasks used in toxicology practice was developed by subject-matter experts representing a broad range of experiences and perspectives. An on-line survey of toxicologists, including Diplomates of the ABT and SOT members, confirmed the delineation. Results of the study can be used to improve understanding of toxicology practice, to better serve all toxicologists, and to present the role of toxicologists to those outside the profession. Survey results may also be used by the ABT Board of Directors to develop test specifications for the certifying examination and will be useful for evaluating and updating the content of professional preparation, development, and continuing education programs. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  11. Clinical manifestations and management of left ventricular assist device-associated infections.

    Science.gov (United States)

    Nienaber, Juhsien Jodi C; Kusne, Shimon; Riaz, Talha; Walker, Randall C; Baddour, Larry M; Wright, Alan J; Park, Soon J; Vikram, Holenarasipur R; Keating, Michael R; Arabia, Francisco A; Lahr, Brian D; Sohail, M Rizwan

    2013-11-01

    Infection is a serious complication of left ventricular assist device (LVAD) therapy. Published data regarding LVAD-associated infections (LVADIs) are limited by single-center experiences and use of nonstandardized definitions. We retrospectively reviewed 247 patients who underwent continuous-flow LVAD implantation from January 2005 to December 2011 at Mayo Clinic campuses in Minnesota, Arizona, and Florida. LVADIs were defined using the International Society for Heart and Lung Transplantation criteria. We identified 101 episodes of LVADI in 78 patients (32%) from this cohort. Mean age (± standard deviation [SD]) was 57±15 years. The majority (94%) underwent Heartmate II implantation, with 62% LVADs placed as destination therapy. The most common type of LVADIs were driveline infections (47%), followed by bloodstream infections (24% VAD related, and 22% non-VAD related). The most common causative pathogens included gram-positive cocci (45%), predominantly staphylococci, and nosocomial gram-negative bacilli (27%). Almost half (42%) of the patients were managed by chronic suppressive antimicrobial therapy. While 14% of the patients had intraoperative debridement, only 3 underwent complete LVAD removal. The average duration (±SD) of LVAD support was 1.5±1.0 years. At year 2 of follow-up, the cumulative incidence of all-cause mortality was estimated to be 43%. Clinical manifestations of LVADI vary on the basis of the type of infection and the causative pathogen. Mortality remained high despite combined medical and surgical intervention and chronic suppressive antimicrobial therapy. Based on clinical experiences, a management algorithm for LVADI is proposed to assist in the decision-making process.

  12. The SPOTS System: An Ocular Scoring System Optimized for Use in Modern Preclinical Drug Development and Toxicology.

    Science.gov (United States)

    Eaton, Joshua Seth; Miller, Paul E; Bentley, Ellison; Thomasy, Sara M; Murphy, Christopher J

    2017-12-01

    To present a semiquantitative ocular scoring system comprising elements and criteria that address many of the limitations associated with systems commonly used in preclinical studies, providing enhanced cross-species applicability and predictive value in modern ocular drug and device development. Revisions to the ocular scoring systems of McDonald-Shadduck and Hackett-McDonald were conducted by board-certified veterinary ophthalmologists at Ocular Services On Demand (OSOD) over the execution of hundreds of in vivo preclinical ocular drug and device development studies and general toxicological investigations. This semiquantitative preclinical ocular toxicology scoring (SPOTS) system was driven by limitations of previously published systems identified by our group's recent review of slit lamp-based scoring systems in clinical ophthalmology, toxicology, and vision science. The SPOTS system provides scoring criteria for the anterior segment, posterior segment, and characterization of intravitreal test articles. Key elements include: standardized slit lamp settings; expansion of criteria to enhance applicability to nonrabbit species; refinement and disambiguation of scoring criteria for corneal opacity, fluorescein staining severity, and aqueous flare; introduction of novel criteria for scoring of aqueous and anterior vitreous cell; and introduction of criteria for findings observed with drugs/devices targeting the posterior segment. A modified Standardization of Uveitis Nomenclature (SUN) system is also introduced to facilitate accurate use of SUN's criteria in laboratory species. The SPOTS systems provide criteria that stand to enhance the applicability of semiquantitative scoring criteria to the full range of laboratory species, in the context of modern approaches to ocular therapeutics and drug delivery and drug and device development.

  13. Practicability of Hygienic Wrapping of Touchscreen Operated Mobile Devices in a Clinical Setting

    Science.gov (United States)

    Hammon, Matthias; Kunz, Bernd; Dinzl, Veronika; Kammerer, Ferdinand J.; Schwab, Siegfried A.; Bogdan, Christian; Uder, Michael; Schlechtweg, Philipp M.

    2014-01-01

    Background To prove effectiveness of wrapping tablet computers in order to reduce microbiological contamination and to evaluate whether a plastic bag-covered tablet leads to impaired user satisfaction or touchscreen functionality. Materials and Methods Within a period of 11 days 115 patients were provided with a tablet computer while waiting for their magnetic resonance imaging examination. Every day the contamination of the surface of the tablet was determined before the first and after the final use. Before the device was handed over to a patient, it was enclosed in a customized single-use plastic bag, which was analyzed for bacterial contamination after each use. A questionnaire was applied to determine whether the plastic bag impairs the user satisfaction and the functionality of the touchscreen. Results Following the use by patients the outside of the plastic bags was found to be contaminated with various bacteria (657.5 ± 368.5 colony forming units/day); some of them were potentially pathogenic. In contrast, the plastic bag covered surface of the tablet was significantly less contaminated (1.7 ± 1.9 colony forming units/day). Likewise, unused plastic bags did not show any contamination. 11% of the patients reported problems with the functionality of the touchscreen. These patients admitted that they had never used a tablet or a smartphone before. Conclusions Tablets get severely contaminated during usage in a clinical setting. Wrapping with a customized single-use plastic bag significantly reduces microbiological contamination of the device, protects patients from the acquisition of potentially pathogenic bacteria and hardly impairs the user satisfaction and the functionality of the touchscreen. PMID:25180580

  14. Practicability of hygienic wrapping of touchscreen operated mobile devices in a clinical setting.

    Directory of Open Access Journals (Sweden)

    Matthias Hammon

    Full Text Available BACKGROUND: To prove effectiveness of wrapping tablet computers in order to reduce microbiological contamination and to evaluate whether a plastic bag-covered tablet leads to impaired user satisfaction or touchscreen functionality. MATERIALS AND METHODS: Within a period of 11 days 115 patients were provided with a tablet computer while waiting for their magnetic resonance imaging examination. Every day the contamination of the surface of the tablet was determined before the first and after the final use. Before the device was handed over to a patient, it was enclosed in a customized single-use plastic bag, which was analyzed for bacterial contamination after each use. A questionnaire was applied to determine whether the plastic bag impairs the user satisfaction and the functionality of the touchscreen. RESULTS: Following the use by patients the outside of the plastic bags was found to be contaminated with various bacteria (657.5 ± 368.5 colony forming units/day; some of them were potentially pathogenic. In contrast, the plastic bag covered surface of the tablet was significantly less contaminated (1.7 ± 1.9 colony forming units/day. Likewise, unused plastic bags did not show any contamination. 11% of the patients reported problems with the functionality of the touchscreen. These patients admitted that they had never used a tablet or a smartphone before. CONCLUSIONS: Tablets get severely contaminated during usage in a clinical setting. Wrapping with a customized single-use plastic bag significantly reduces microbiological contamination of the device, protects patients from the acquisition of potentially pathogenic bacteria and hardly impairs the user satisfaction and the functionality of the touchscreen.

  15. Practicability of hygienic wrapping of touchscreen operated mobile devices in a clinical setting.

    Science.gov (United States)

    Hammon, Matthias; Kunz, Bernd; Dinzl, Veronika; Kammerer, Ferdinand J; Schwab, Siegfried A; Bogdan, Christian; Uder, Michael; Schlechtweg, Philipp M

    2014-01-01

    To prove effectiveness of wrapping tablet computers in order to reduce microbiological contamination and to evaluate whether a plastic bag-covered tablet leads to impaired user satisfaction or touchscreen functionality. Within a period of 11 days 115 patients were provided with a tablet computer while waiting for their magnetic resonance imaging examination. Every day the contamination of the surface of the tablet was determined before the first and after the final use. Before the device was handed over to a patient, it was enclosed in a customized single-use plastic bag, which was analyzed for bacterial contamination after each use. A questionnaire was applied to determine whether the plastic bag impairs the user satisfaction and the functionality of the touchscreen. Following the use by patients the outside of the plastic bags was found to be contaminated with various bacteria (657.5 ± 368.5 colony forming units/day); some of them were potentially pathogenic. In contrast, the plastic bag covered surface of the tablet was significantly less contaminated (1.7 ± 1.9 colony forming units/day). Likewise, unused plastic bags did not show any contamination. 11% of the patients reported problems with the functionality of the touchscreen. These patients admitted that they had never used a tablet or a smartphone before. Tablets get severely contaminated during usage in a clinical setting. Wrapping with a customized single-use plastic bag significantly reduces microbiological contamination of the device, protects patients from the acquisition of potentially pathogenic bacteria and hardly impairs the user satisfaction and the functionality of the touchscreen.

  16. A novel telemonitoring device for improving diabetes control: protocol and results from a randomized clinical trial.

    Science.gov (United States)

    Pressman, Alice R; Kinoshita, Linda; Kirk, Susan; Barbosa, Gina Monraz; Chou, Cathy; Minkoff, Jerome

    2014-02-01

    Telemedicine is one approach to managing patients with chronic illness. Several telephone-based monitoring studies of diabetes patients have shown improved glycosylated hemoglobin (HbA1c), blood pressure (BP), and low-density lipoprotein (LDL) levels. The purpose of this study was to evaluate an investigational in-home telemetry device for improving glucose and BP control over 6 months for patients with type 2 diabetes. The device was used to transmit weekly blood glucose, weight, and BP readings to a diabetes care manager. We conducted a two-arm, parallel-comparison, single-blind, randomized controlled trial among Kaiser Permanente Northern California members 18-75 years old with type 2 diabetes mellitus and entry HbA1c levels between 7.5% and 10.0%. Participants were randomly assigned to either the telemonitoring arm or the usual care arm. We observed very small, nonsignificant changes in fructosamine (telemonitoring, -54.9 μmol; usual care, -59.4 μmol) and systolic BP (telemonitoring, -6.3 mm Hg; usual care, -3.2 mm Hg) from baseline to 6 weeks in both groups. At 6 months, we observed no significant intergroup differences in change from baseline for HbA1c, fructosamine, or self-efficacy. However, LDL cholesterol in the telemonitoring arm decreased more than in the usual care arm (-17.1 mg/dL versus -5.4 mg/dL; P=0.045). Although HbA1c improved significantly over 6 months in both groups, the difference in improvement between the groups was not significant. This lack of significance may be due to the relatively healthy status of the volunteers in our study and to the high level of care provided by the care managers in the Santa Rosa, CA clinic. Further study in subgroups of less healthy diabetes patients is recommended.

  17. [Toxicologic blood emergency screening].

    Science.gov (United States)

    Cohen, Sabine; Manat, Aurélie; Dumont, Benoit; Bévalot, Fabien; Manchon, Monique; Berny, Claudette

    2010-01-01

    In order to overcome the stop marketing by Biorad company of automated high performance liquid chromatograph with UV detection (Remedi), we developed a gas chromatography-mass spectrometry (GC-MS) to detect and to give an approximation of the overdose of molecules frequently encountered in drug intoxications. Therefore two hundred eighty seventeen blood samples were collected over a period of one year and allowed us to evaluate and compare the performance of these two techniques. As identification, GC-MS does not identify all molecules detected by Remedi in 24.2% of cases; there is a lack of sensitivity for opiates and the systematic absence of certain molecules such as betablockers. However, in 75.8% of cases the GC-MS detects all molecules found by Remedi and other molecules such as meprobamate, paracetamol, benzodiazepines and phenobarbital. The concentrations obtained are interpreted in terms of overdose showed 15.7% of discrepancy and 84.3% of concordance between the two techniques. The GC-MS technique described here is robust, fast and relatively simple to implement; the identification is facilitated by macro commands and the semi quantification remains manual. Despite a sequence of cleaning the column after each sample, carryover of a sample to the next remains possible. This technique can be used for toxicologic screening in acute intoxications. Nevertheless it must be supplemented by a HPLC with UV detection if molecules such as betablockers are suspected.

  18. Toxicology of plutonium

    International Nuclear Information System (INIS)

    Bair, W.J.

    1974-01-01

    Data are reviewed from studies on the toxicity of Pu in experimental animals. Of the several plutonium isotopes, only 238 Pu and 239 Pu have been studied well. Sufficient results have been obtained to show that the behavior of 238 Pu in biological systems and the resulting biological effects cannot be precisely predicted from studies of 239 Pu. This probably applies also to other radiologically important plutonium isotopes which have half-lives ranging from 45 days to 10 7 years and decay by β-emission, electron capture, and spontaneous fission, as well as by emission of α-particles. All the biological effects of plutonium described in this review are attributed to alpha-particle radiation emitted by the plutonium. However, since plutonium is a chemically active heavy metal, one cannot ignore the possibility of chemical toxicity of the low-specific-activity isotopes, 239 Pu, 242 Pu, and 244 Pu. The preponderance of our knowledge of plutonium toxicology has come from short-term studies of relatively high dosage levels in several animal species. The consequences of high-level internal exposures can be predicted with confidence in experimental animals and probably also in man. However, considering the care with which plutonium is handled in the nuclear industry, a high-level contamination event is unlikely. Considerably less is known about the long-term effects of low levels of contamination. (250 references) (U.S.)

  19. Non-clinical immuno-toxicological evaluation of HER1 cancer vaccine in non-human primates: a 12-month study.

    Science.gov (United States)

    Barro, Ana M Bada; Rivero, Arianna Iglesias; Goñi, Avelina León; Navarro, Bárbara O González; Angarica, Meilis Mesa; Ramírez, Belinda Sánchez; Bedoya, Darel Martínez; Triana, Consuelo González; Rodríguez, Axel Mancebo; Parada, Ángel Casacó

    2012-12-17

    Human epidermal growth factor receptor (HER1) constitutes a tumor associated antigen. Its overexpression in many epithelial tumors has been associated with bad prognosis and poor survival. Cancer vaccine based on the extracellular domain (ECD) of HER1 and adjuvated in very small sized proteoliposomes (VSSP) and Montanide ISA 51-VG is a new and complementary approach for the treatment of epithelial tumors. The present study deals with the immunogenicity of this vaccine in Macaca fascicularis monkeys and evaluation of its toxicity during 12 months. Twelve monkeys were randomized into two groups of 3 animals per sex: control and vaccinated. Treated monkeys received 9 doses of vaccination and were daily inspected for clinical signs. Body weight, rectal temperature, cardiac and respiratory rates were measured during the study. Humoral immune response, clinical pathology parameters and delayed type hypensensitivity were analyzed. Skin biopsy was performed at the end of the study in all animals. Animal's survival in the study was 100% (n=12). Local reactions were observed at the administration site of four treated animals (n=6), with two showing slight inflammatory cutaneous damage. Clinical pathology parameters were not affected. HER1 vaccine induced high IgG antibodies titers in the treated animals even when DTH was not observed. The induced antibodies recognized HER1+ tumor cell lines, decreased HER1 phosphorylation and showed anti-proliferative and pro-apoptotic effects in H125 cells. In general the present study showed that HER1 vaccine induced specific immune response in M. fascicularis monkeys and was well tolerated, suggesting it could be safely used in clinical studies in epithelial cancer patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

  20. Mobile Devices, Learning and Clinical Workplaces: Medical Student Use of Smartphones in Parisian Hospitals

    Science.gov (United States)

    Phelps, Megan; Scott, Karen M.; Chauffeté-Manillier, Martine; Lenne, Frédéric; Le Jeunne, Claire

    2017-01-01

    Mobile devices are ubiquitous worldwide, including in hospitals. "Just in time" learning provided by these devices is important for students. We investigated current use of, and learning with, smartphones and other mobile devices by medical students in Parisian hospitals. A survey with quantitative and qualitative items previously used…

  1. In silico toxicology for the pharmaceutical sciences

    International Nuclear Information System (INIS)

    Valerio, Luis G.

    2009-01-01

    The applied use of in silico technologies (a.k.a. computational toxicology, in silico toxicology, computer-assisted tox, e-tox, i-drug discovery, predictive ADME, etc.) for predicting preclinical toxicological endpoints, clinical adverse effects, and metabolism of pharmaceutical substances has become of high interest to the scientific community and the public. The increased accessibility of these technologies for scientists and recent regulations permitting their use for chemical risk assessment supports this notion. The scientific community is interested in the appropriate use of such technologies as a tool to enhance product development and safety of pharmaceuticals and other xenobiotics, while ensuring the reliability and accuracy of in silico approaches for the toxicological and pharmacological sciences. For pharmaceutical substances, this means active and impurity chemicals in the drug product may be screened using specialized software and databases designed to cover these substances through a chemical structure-based screening process and algorithm specific to a given software program. A major goal for use of these software programs is to enable industry scientists not only to enhance the discovery process but also to ensure the judicious use of in silico tools to support risk assessments of drug-induced toxicities and in safety evaluations. However, a great amount of applied research is still needed, and there are many limitations with these approaches which are described in this review. Currently, there is a wide range of endpoints available from predictive quantitative structure-activity relationship models driven by many different computational software programs and data sources, and this is only expected to grow. For example, there are models based on non-proprietary and/or proprietary information specific to assessing potential rodent carcinogenicity, in silico screens for ICH genetic toxicity assays, reproductive and developmental toxicity, theoretical

  2. Right heart failure and "failure to thrive" after left ventricular assist device: clinical predictors and outcomes.

    Science.gov (United States)

    Baumwol, Jay; Macdonald, Peter S; Keogh, Anne M; Kotlyar, Eugene; Spratt, Phillip; Jansz, Paul; Hayward, Christopher S

    2011-08-01

    This study determined predictors of early post-operative right heart failure (RHF) and its consequences, as well as predictors of those who clinically thrive longer term after insertion of a continuous-flow left ventricular assist device (LVAD). Pre-operative and latest follow-up data were analyzed for 40 consecutive patients who received third-generation centrifugal-flow LVADs. RHF was defined using previously described criteria, including post-operative inotropes, pulmonary vasodilator use, or right-sided mechanical support. Patients were also categorized according to clinical outcomes after LVAD insertion. LVADs were implanted as a bridge to transplantation (BTT) in 33 patients and as destination therapy in 7. Before LVAD implant, 22 patients were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1, and 17 were at level 2. Temporary mechanical assistance was present in 50% of the cohort at LVAD implantation. The 6-month survival/progression to transplant was 92.5%. Average LVAD support time was 385 days (range, 21-1,011 days). RHF developed postoperatively in 13 of 40 patients (32.5%). RHF patients had more severe pre-operative tricuspid incompetence than non-RHF patients. The BTT patients with evidence of RHF had poorer survival to transplant (6 of 11 [54.5%]) than those without RHF (20 of 22 [90.9%]), p = 0.027). There were no other hemodynamic or echocardiographic predictors of short-term RHF. After LVAD, 22 of the 40 patients (55%) thrived clinically. For BTT patients, 20 of 21 (95%) of those who thrived progressed to transplant or were alive at latest follow-up vs 6 of 12 (50%) of those who failed to thrive (FTT; p thrived. Early post-operative RHF results in poorer survival/progression to transplantation for BTT patients and is predicted by greater pre-operative tricuspid incompetence. The most important predictor for those who will clinically thrive longer-term after LVAD insertion is younger age. Crown Copyright © 2011

  3. Clinical utility of scintimammography: From the Anger-camera to new dedicated devices

    Energy Technology Data Exchange (ETDEWEB)

    Schillaci, Orazio [Department of Biopathology and Diagnostic Imaging, University ' Tor Vergata' , Viale G. Mazzini 121, 00195 Rome (Italy)]. E-mail: oschil@tiscali.it; Danieli, Roberta [Department of Biopathology and Diagnostic Imaging, University ' Tor Vergata' , Viale G. Mazzini 121, 00195 Rome (Italy); Romano, Pasquale [Department of Biopathology and Diagnostic Imaging, University ' Tor Vergata' , Viale G. Mazzini 121, 00195 Rome (Italy); Cossu, Elsa [Department of Biopathology and Diagnostic Imaging, University ' Tor Vergata' , Viale G. Mazzini 121, 00195 Rome (Italy); Simonetti, Giovanni [Department of Biopathology and Diagnostic Imaging, University ' Tor Vergata' , Viale G. Mazzini 121, 00195 Rome (Italy)

    2006-12-20

    Scintimammography is a functional imaging technique which uses a radiation detection camera to detect radionuclide tracers in the patient's breasts. Tracers are designed to accumulate in tumours more than in healthy tissue: the most used are Tc-99 m sestamibi and Tc-99 m tetrofosmin. Scintimammography is useful in some clinical indications as an adjunct to mammography: it is recommended for those lesions where additional information is required to reach a definitive diagnosis. Patients with dubious mammograms may benefit from this test, as well as women with dense breasts or with implants. Scintimammography is a valuable diagnostic tool also in patients with locally advanced breast cancer for monitoring and predicting response to neoadjuvant chemotherapy. Nevertheless, using an Anger-camera this technique shows a high sensitivity only for cancers >1 cm. Since other modalities are increasingly employed for the early identification of small abnormalities, the issue of detecting small cancers is critical for the future development and clinical utility of breast imaging with radiopharmaceuticals. The use of high-resolution cameras dedicated for breast imaging is the best option to improve the detection of small cancers: they allow higher flexibility in patient positioning, and the availability of mammography-like projections. Moreover, the detector can be placed directly in contact with the breast allowing a mild compression with reduction of the breast's thickness, thus increasing the target-to-background ratio and the sensitivity. These new devices have the potential of increasing the total number of breast scintigraphies performed thereby enhancing the role of nuclear medicine in breast cancer imaging.

  4. Copper intrauterine device for emergency contraception: clinical practice among contraceptive providers.

    Science.gov (United States)

    Harper, Cynthia C; Speidel, J Joseph; Drey, Eleanor A; Trussell, James; Blum, Maya; Darney, Philip D

    2012-02-01

    The copper intrauterine device (IUD) is the most effective emergency contraceptive available but is largely ignored in clinical practice. We examined clinicians' recommendations of the copper IUD for emergency contraception in a setting with few cost obstacles. We conducted a survey among clinicians (n=1,246; response rate 65%) in a California State family planning program, where U.S. Food and Drug Administration-approved contraceptives are available at no cost to low-income women. We used multivariable logistic regression to measure the association of intrauterine contraceptive training and evidence-based knowledge with having recommended the copper IUD for emergency contraception. The large majority of clinicians (85%) never recommended the copper IUD for emergency contraception, and most (93%) required two or more visits for an IUD insertion. Multivariable analyses showed insertion skills were associated with having recommended the copper IUD for emergency contraception, but the most significant factor was evidence-based knowledge of patient selection for IUD use. Clinicians who viewed a wide range of patients as IUD candidates were twice as likely to have recommended the copper IUD for emergency contraception. Although more than 93% of obstetrician-gynecologists were skilled in inserting the copper IUD, they were no more likely to have recommended it for emergency contraception than other physicians or advance practice clinicians. Recommendation of the copper IUD for emergency contraception is rare, despite its high efficacy and long-lasting contraceptive benefits. Recommendation would require clinic flow and scheduling adjustments to allow same-day IUD insertions. Patient-centered and high-quality care for emergency contraception should include a discussion of the most effective method. III.

  5. Clinical features and changes in epidemiology of infective endocarditis on pacemaker devices over a 27-year period (1987-2013).

    Science.gov (United States)

    Carrasco, Francisco; Anguita, Manuel; Ruiz, Martín; Castillo, Juan Carlos; Delgado, Mónica; Mesa, Dolores; Romo, Elias; Pan, Manuel; Suárez de Lezo, Jose

    2016-06-01

    Use of cardiac pacing devices has grown in recent years. Our aim was to evaluate changes in epidemiology and clinical features of infective endocarditis (IE) involving pacemaker devices in a large series of IE over the last 27 years (1987-2013). From 1987 to December 2013, 413 consecutive IE cases were diagnosed in our hospital. During this period, 7424 pacemaker devices were implanted (6917 pacemakers, 239 implantable cardiac defibrillators, 158 resynchronization devices, and 110 resynchronization/defibrillator devices). All consecutive cases of IE on pacemaker devices were included and analysed. Infective endocarditis on pacemaker devices represented 6.1% of all endocarditis cases (25 patients), affecting 3.6/1000 of all implanted pacemakers. Its proportion increased from 1.25% of all endocarditis in 1987-1993 to 4.08% in 1994-2000, 7.69% in 2001-2007 and 9.32% in 2008-2013 (P pacemaker implants in the period of 1987-1993 to 2.5/1000 in 1994-2000, 3.3/1000 in 2001-2007 and 4.5/1000 implanted devices in 2008-2013 (P pacemaker devices has shown an increasing incidence during the past decades, representing almost 10% of all IE in the last 6 years. This is a severe disease, with a high rate of severe complications and requiring removal of device in most cases. In spite of therapy, early mortality is high. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  6. Analytical performance of centrifuge-based device for clinical chemistry testing.

    Science.gov (United States)

    Suk-Anake, Jamikorn; Promptmas, Chamras

    2012-01-01

    A centrifuge-based device has been introduced to the Samsung Blood Analyzer (SBA). The verification of this analyzer is essential to meet the ISO15189 standard. Analytical performance was evaluated according to the NCCLS EP05-A method. The results of plasma samples were compared between the SBA and a Hitachi 917 analyzer according to the NCCLS EP09-A2-IR method. Percent recovery was determined via analysis of original control serum and spiked serum. Within-run precision was found to be 0.00 - 6.61% and 0.96 - 5.99% in normal- and abnormal-level assays, respectively, while between-run precision was 1.31 - 9.09% and 0.89 - 6.92%, respectively. The correlation coefficients (r) were > 0.990. The SBA presented analytical accuracy at 96.64 +/- 3.39% to 102.82 +/- 2.75% and 98.31 +/- 4.04% to 103.61 +/- 8.28% recovery, respectively. The results obtained verify that all of the 13 tests performed using the SBA demonstrates good and reliable precision suitable for use in qualified clinical chemistry laboratory service.

  7. Veal calves’ clinical/health status in large groups fed with automatic feeding devices

    Directory of Open Access Journals (Sweden)

    Giulio Cozzi

    2010-01-01

    Full Text Available Aim of the current study was to evaluate the clinical/health status of veal calves in 3 farms that adopt large group housing and automatic feeding stations in Italy. Visits were scheduled in three phases of the rearing cycle (early, middle, and end. Results showed a high incidence of coughing, skin infection and bloated rumen particularly in the middle phase while cross-sucking signs were present at the early stage when calves’ nibbling proclivity is still high. Throughout the rearing cycle, the frequency of bursitis increased reaching 53% of calves at the end. The percentage of calves with a poorer body condition than the mid-range of the batch raised gradually as well, likely due to the non-proportioned teat/calves ratio that increases competition for feed and reduces milk intake of the low ranking animals. The remarked growth differences among pen-mates and the mortality rate close to 7% showed by the use of automatic feeding devices for milk delivery seem not compensating the lower labour demand, therefore its sustainability at the present status is doubtful both for the veal calves’ welfare and the farm incomes.

  8. A clinical comparison of safety and efficacy in phacoemulsification with versus without ophthalmic viscoelastic device.

    Science.gov (United States)

    Kugu, Suleyman; Erdogan, Gurkan; Sahin Sevim, M; Ozerturk, Yusuf

    2015-03-01

    To evaluate in a comparative manner the safety and efficacy of 1.0% sodium-Hyaluronate used during capsulorhexis and intraocular lens (IOL) implantation in phacoemulsification surgery. 1.0% sodium-Hyaluronate, which is commonly used as one of the ophthalmic viscoelastic devices, was compared to intraocular irrigating solution, which can bring up these effects. In addition, the effect of both methods on occurring corneal endothelial cell (CEC) loss was investigated. Each group comprised 19 eyes. The mean preoperative CEC density was 2525.68 ± 181.85 in Group H and 2514.16 ± 174.59 in Group V; no statistically significant difference was found between the groups (p > 0.05). Preoperative and postoperative first and twelfth week CEC densities were 2438.21 ± 198.12 (p  0.05). Although it was found that there was no statistically difference in terms of preventing CEC loss between 1.0% sodium-Hyaluronate and the irrigation method during phacoemulsification, it was observed clinically that 1.0% sodium-hyaluronate can make the procedure easy, safer, very helpful, especially for understanding phacoemulsification.

  9. Heart resynchronization therapy: experience, clinical Follow-up and optimization of the device with echocardiography

    International Nuclear Information System (INIS)

    Munera, Ana G; Restrepo, Gustavo; Duque, Mauricio; Cubides, Carlos; Uribe, William; Medina, Eduardo; Marin, Jorge; Gil, Efrain; Aristizabal, Dagnovar

    2007-01-01

    In patients with advanced heart failure, functional class lll-IV, mortality reaches 50% at one year and 80% at two years. Some remain asymptomatic and have a poor functional state, regardless of the pharmacologic treatment. Heart resynchronization therapy is a therapeutic alternative that improves hemodynamic and symptoms in these patients. The objective is to analyze the experience in the management of heart failure with heart resynchronization therapy devices with or without cardio defibrillator. Methodological design: an intervention study without aleatory patients assignment, with evaluation before and after the intervention. Results: the cohort was constituted by 82 patients. 73% were men. Mean age was 65.4+/- 11.9 years. The etiology was non-ischemic in 50 patients and ischemic in 32. Mean initial ejection fraction was 19.4% +/- 11.7%. Initial functional class was class lll - IV in 85% of cases and all patients received optimal medical treatment. During the follow-up, it was observed improvement of functional class, diastolic function, diastolic diameter of left ventricle, ejection fraction, mitral insufficiency, left atrial area, systolic lung pressure, synchrony parameters and myocardial function index with statistical significant difference in relation to the initial value (p<0.05). Survival at 44 months was 72%. Conclusion: the experience with heart resynchronization therapy and clinical and echocardiographic follow-up of the studied patients is similar to that found in other studies described in the literature

  10. Cancer and Toxicology Section

    International Nuclear Information System (INIS)

    Anon.

    1980-01-01

    The Cancer and Toxicology Section is concerned with the investigation of the mechanisms by which chemicals, radiation, and viruses cause the changes broadly identified as cancer. In addition, the study of mechanisms has been extended to include the nontumorigenic effects of various agents associated with fossil energy and fuels. Research in molecular genetics of carcinogenesis focuses largely on the transposon properties of the genomes of retroviruses. The transposon structure of the DNA genomes of endogenous murine N-tropic and B-tropic type C retroviruses is being elucidated, and their chromosomal location mapped in hamster-mouse cell hybrids. A model of the mechanism of retrovirus induction by radiation and chemicals is being developed, and experiments have established that compounds such as hydroxyurea act as inducer. There is the possibility that transposition of sequences of this endogenous virus may be linked to leukemogenesis. Research in regulation of gene expression aims at defining in molecular terms the mechanisms determining expression of specific genes, how these are regulated by hormones, and the events responsible for dysfunction of gene expression in cancer. In corollary work, a library of cloned cDNAs specific for products of genes of special interest to regulation is being developed. Improvement of reversed-phase chromatography as a means of isolating bacterial plasmids and restriction fragments of DNA is underway. Newly developed techniques permit the isolation of supercoiled plasmid DNA directly from bacterial extracts. The technology has been developed recently for the photosynthetic growth of the chemo-autotrophic organism Rhodospirillum rubrum and the enzyme ribulosebisphosphate carboxylase has been produced in quantity

  11. Arthroscopic treatment of acute acromioclavicular dislocations using a double button device: Clinical and MRI results.

    Science.gov (United States)

    Loriaut, P; Casabianca, L; Alkhaili, J; Dallaudière, B; Desportes, E; Rousseau, R; Massin, P; Boyer, P

    2015-12-01

    Arthroscopic treatment of acute grade 3 and 4 acromioclavicular dislocation is controversial, due to the risk of recurrence and of postoperative reduction defect. The purpose of the present study was to investigate whether the healing of the acromioclavicular (AC) and coracoclavicular (CC) ligaments and the accurate 3D positioning parameters of the AC joint using MRI were correlated with satisfactory functional outcome. Thirty-nine patients were enrolled from 2009 to 2011 and managed arthroscopically by CC lacing using a double-button device. Clinical assessment included the Shoulder and Hand (QuickDash) score, Constant-Murley score and visual analog scale (VAS) for residual pain. Time and rate to return to work and return to sport were assessed according to type of sport and work. Postoperative complications were recorded. Radiological examination consisted of anteroposterior clavicle and lateral axillary radiographs. AC ligament healing and 3D joint congruency were assessed on MRI and correlated to the clinical results. Mean patient age was 35.7 years (range, 20-55). Mean follow-up was 42.3±10.6 months (range, 24-60). At final follow-up, mean QuickDash score, Constant score and VAS were respectively 1.7±4 (range, 0-11), 94.7±7.3 (range, 82-100) and 0.5±1.4 (range, 0-2). Thirty-five (90%) patients were able to resume work, including heavy manual labor, and sport. Radiology found accurate 3D joint congruency in 34 patients (87%) and CC and AC ligament healing in 36 (93%). Complications included reduction loss at 6 weeks in 3 patients, requiring surgical stabilization. Satisfactory functional results were associated with accurate AC joint congruency in the coronal and axial planes (P<0.05) and good AC and CC ligament healing (P<0.04). An initial 25% reduction defect in the coronal plane was not associated with poor functional results (P=0.07). Arthroscopic treatment by CC lacing satisfactorily restored ligament and joint anatomy in the present series. These

  12. Exploration of the affordances of mobile devices in integrating theory and clinical practice in an undergraduate nursing programme

    Directory of Open Access Journals (Sweden)

    Juliana J. Willemse

    2015-09-01

    Full Text Available Background: Promoting the quality and effectiveness of nursing education is an important factor, given the increased demand for nursing professionals. It is important to establish learning environments that provide personalised guidance and feedback to students about their practical skills and application of their theoretical knowledge. Objective: To explore and describe the knowledge and points of view of students and educators about introduction of new technologies into an undergraduate nursing programme. Method: The qualitative design used Tesch’s (1990 steps of descriptive data analysis to complete thematic analysis of the data collected in focus group discussions (FGDs andindividual interviews to identify themes. Results: Themes identified from the students’ FGDs and individual interviews included:mobile devices as a communication tool; email, WhatsApp and Facebook as methods of communication; WhatsApp as a method of communication; nurses as role-models in the clinical setting; setting personal boundaries; and impact of mobile devices in clinical practiceon professionalism. Themes identified from the FGD, individual interviews and a discussion session held with educators included: peer learning via mobile devices; email, WhatsApp and Facebook as methods of communication; the mobile device as a positive learning method; students need practical guidance; and ethical concerns in clinical facilities about Internet access and use of mobile devices. Conclusion: The research project established an understanding of the knowledge and points of view of students and educators regarding introduction of new technologies into an undergraduate nursing programme with the aim of enhancing integration of theory and clinical practice through use of mobile devices.

  13. Opportunity for Collaboration Between Radiation Injury Treatment Network Centers and Medical Toxicology Specialists.

    Science.gov (United States)

    Davlantes, Elizabeth; Shartar, Samuel; Venero, Jennifer; Steck, Alaina; Langston, Amelia; Kazzi, Ziad N

    2017-08-01

    The Radiation Injury Treatment Network (RITN) comprises >50 centers across the United States that are poised to care for victims of a radiation emergency. The network is organized around bone marrow transplant centers because these facilities excel in both radiation medicine and the care of patients with severe bone marrow depression. A radiation emergency may cause not only irradiation from an external source but also internal contamination with radioactive material. Because medical toxicologists are trained in radiation injury management and have expertise in the management of internal contamination, RITN centers may benefit from partnerships with medical toxicology resources, which may be located at academic medical centers, hospital inpatient clinical services, outpatient clinics, or poison control centers. We determined the locations of existing RITN centers and assessed their proximity to various medical toxicology resources, including medical toxicology fellowship programs, inpatient toxicology services, outpatient toxicology clinics, and poison control centers. Data were derived from publicly available Internet sources in March 2015. The majority of RITN centers do not have a medical toxicology fellowship, an inpatient toxicology service, or an outpatient toxicology clinic within the same institution. Fifty-seven percent of RITN centers have at least one of these resources located in the same city, however, and 73% of centers have at least one of these resources or a poison control center within the same city. Ninety-five percent of RITN centers have at least one medical toxicology resource within the state. Most RITN centers are located in the same city as at least one medical toxicology resource. Establishing relationships between RITN centers and medical toxicologists needs to be explored further.

  14. Analysis of implantable defibrillator longevity under clinical circumstances: implications for device selection.

    Science.gov (United States)

    Knops, Paul; Theuns, Dominic A M J; Res, Jan C J; Jordaens, Luc

    2009-10-01

    Information about implantable cardioverter-defibrillator (ICD) longevity is mostly calculated from measurements under ideal laboratory conditions. However, little information about longevity under clinical circumstances is available. This survey gives an overview on ICD service times and generator replacements in a cohort of consecutive ICD patients. Indications for replacement were classified as a normal end-of-service (EOS), premature EOS, system malfunction, infection and device advisory, or recall actions. From the premature and normal EOS group, longevity from single-chamber (SC), dual-chamber (DC), and cardiac resynchronization therapy defibrillator (CRT-D), rate-responsive (RR) settings, high output (HO) stimulation, and indication for ICD therapy was compared. Differences between brands were compared as well. In a total of 854 patients, 203 ICD replacements (165 patients) were recorded. Premature and normal EOS replacements consisted of 32 SC, 98 DC and 24 CRT-D systems. Longevity was significantly longer in SC systems compared to DC and CRT-D systems (54 +/- 19 vs. 40 +/- 17 and 42 +/- 15 months; P = 0.008). Longevity between non-RR (n = 143) and RR (n = 11) settings was not significantly different (43 +/- 18 vs. 45 +/- 13 months) as it also was not for HO versus non-HO stimulation (43 +/- 19 vs. 46 +/- 17 months). Longevity of ICDs was not significantly different between primary and secondary prevention (42 +/- 19 vs. 44 +/- 18 months). The average longevity on account of a device-based EOS message was 43 +/- 18 months. Average longevity for Biotronik (BIO, n = 72) was 33 +/- 10 months, for ELA Medical (ELA, n = 12) 44 +/- 17 months, for Guidant (GDT, n = 36) 49 +/- 12 months, for Medtronic (MDT, n = 29) 62 +/- 22 months, and for St. Jude Medical (SJM, n = 5) 31 +/- 9 months (P generators had a longer service time compared to DC and CRT-D systems. No influence of indication for ICD therapy and HO stimulation on generator longevity was observed in this

  15. Pharmacy Students’ Preference for Using Mobile Devices in a Clinical Setting for Practice-Related Tasks

    Science.gov (United States)

    Hastings, Justine F.; Bryant, Jennifer E.

    2015-01-01

    Objective. To examine pharmacy students’ ownership of, use of, and preference for using a mobile device in a practice setting. Methods. Eighty-one pharmacy students were recruited and completed a pretest that collected information about their demographics and mobile devices and also had them rank the iPhone, iPad mini, and iPad for preferred use in a pharmacy practice setting. Students used the 3 devices to perform pharmacy practice-related tasks and then completed a posttest to again rank the devices for preferred use in a pharmacy practice setting. Results. The iPhone was the most commonly owned mobile device (59.3% of students), and the iPad mini was the least commonly owned (18.5%). About 70% of the students used their mobile devices at least once a week in a pharmacy practice setting. The iPhone was the most commonly used device in a practice setting (46.9% of students), and the iPod Touch was the least commonly used device (1.2%). The iPad mini was the most preferred device for use in a pharmacy practice setting prior to performing pharmacy practice-related tasks (49.4% of students), and was preferred by significantly more students after performing the tasks (70.4%). Conclusion. Pharmacy students commonly use their mobile devices in pharmacy practice settings and most selected the iPad mini as the preferred device for use in a practice setting even though it was the device owned by the fewest students. PMID:25861103

  16. Pharmacy students' preference for using mobile devices in a clinical setting for practice-related tasks.

    Science.gov (United States)

    Richard, Craig A H; Hastings, Justine F; Bryant, Jennifer E

    2015-03-25

    To examine pharmacy students' ownership of, use of, and preference for using a mobile device in a practice setting. Eighty-one pharmacy students were recruited and completed a pretest that collected information about their demographics and mobile devices and also had them rank the iPhone, iPad mini, and iPad for preferred use in a pharmacy practice setting. Students used the 3 devices to perform pharmacy practice-related tasks and then completed a posttest to again rank the devices for preferred use in a pharmacy practice setting. The iPhone was the most commonly owned mobile device (59.3% of students), and the iPad mini was the least commonly owned (18.5%). About 70% of the students used their mobile devices at least once a week in a pharmacy practice setting. The iPhone was the most commonly used device in a practice setting (46.9% of students), and the iPod Touch was the least commonly used device (1.2%). The iPad mini was the most preferred device for use in a pharmacy practice setting prior to performing pharmacy practice-related tasks (49.4% of students), and was preferred by significantly more students after performing the tasks (70.4%). Pharmacy students commonly use their mobile devices in pharmacy practice settings and most selected the iPad mini as the preferred device for use in a practice setting even though it was the device owned by the fewest students.

  17. Development and validation of a simple GC-MS method for the simultaneous determination of 11 anticholinesterase pesticides in blood--clinical and forensic toxicology applications.

    Science.gov (United States)

    Papoutsis, Ioannis; Mendonis, Marcela; Nikolaou, Panagiota; Athanaselis, Sotirios; Pistos, Constantinos; Maravelias, Constantinos; Spiliopoulou, Chara

    2012-05-01

    Anticholinesterase pesticides are widely used, and as a result they are involved in numerous acute and even fatal poisonings. The aim of this study was the development, optimization, and validation of a simple, rapid, specific, and sensitive gas chromatography-mass spectrometry method for the determination of 11 anticholinesterase pesticides (aldicarb, azinphos methyl, carbofuran, chlorpyrifos, dialifos, diazinon, malathion, methamidophos, methidathion, methomyl, and terbufos) in blood. Only 500 μL of blood was used, and the recoveries after liquid-liquid extraction (toluene/chloroform, 4:1, v/v) were more than 65.6%. The calibration curves were linear (R(2) ≥ 0.996). Limit of detections and limit of quantifications were found to be between 1.00-10.0 and 3.00-30.0 μg/L, respectively. Accuracy expressed as the %E(r) was found to be between -11.0 and 7.8%. Precision expressed as the percent relative standard deviation was found to be forensic and clinical cases of accidental or suicidal poisoning with these pesticides. © 2011 American Academy of Forensic Sciences.

  18. Development of a three-microneedle device for hypodermic drug delivery and clinical application.

    Science.gov (United States)

    Fukamizu, Hidekazu; Fujiwara, Masao; Kim, Taishi; Matsushita, Yuki; Tokura, Yoshiki

    2012-08-01

    There is a potential use for intradermic or hypodermic drug delivery in skin surgery or aesthetic surgery. Hypodermic delivery with the use of a noninvasive device can be a more useful, reliable, and effective administration route to obtain higher compliance. The authors developed a microneedle device composed of three fine needles (three-microneedle device). The tip of each needle was fabricated with a bevel angle to release a drug broadly into the tissue in a horizontal fashion. In this study, the authors investigated the usefulness of this newly developed three-microneedle device for hypodermic liquid injection, focusing on the optimum insertion depth and the diffusion of injected materials to the tissue. The authors also assessed the efficacy of and patient satisfaction with three-microneedle device injections of botulinum toxin type A for wrinkle reduction in patients with glabellar rhytides. The three-microneedle device yielded consistent results in hypodermal diffusion. On India ink diffusion test and ultrasonographic imaging, three-microneedle device injection showed a broad diffusion in horizontal extension, as compared with usual 31-gauge needle injection. The efficiency and satisfaction of the patients receiving botulinum toxin type A with the three-microneedle device were highly rated. Three-microneedle device delivery enables accurate and broad diffusion of injected substances, thus reducing the total dose and/or injection number of drugs. Therapeutic, IV.

  19. Zebrafish neurotransmitter systems as potential pharmacological and toxicological targets.

    Science.gov (United States)

    Rico, E P; Rosemberg, D B; Seibt, K J; Capiotti, K M; Da Silva, R S; Bonan, C D

    2011-01-01

    Recent advances in neurobiology have emphasized the study of brain structure and function and its association with numerous pathological and toxicological events. Neurotransmitters are substances that relay, amplify, and modulate electrical signals between neurons and other cells. Neurotransmitter signaling mediates rapid intercellular communication by interacting with cell surface receptors, activating second messenger systems and regulating the activity of ion channels. Changes in the functional balance of neurotransmitters have been implicated in the failure of central nervous system function. In addition, abnormalities in neurotransmitter production or functioning can be induced by several toxicological compounds, many of which are found in the environment. The zebrafish has been increasingly used as an animal model for biomedical research, primarily due to its genetic tractability and ease of maintenance. These features make this species a versatile tool for pre-clinical drug discovery and toxicological investigations. Here, we present a review regarding the role of different excitatory and inhibitory neurotransmitter systems in zebrafish, such as dopaminergic, serotoninergic, cholinergic, purinergic, histaminergic, nitrergic, glutamatergic, glycinergic, and GABAergic systems, and emphasizing their features as pharmacological and toxicological targets. The increase in the global knowledge of neurotransmitter systems in zebrafish and the elucidation of their pharmacological and toxicological aspects may lead to new strategies and appropriate research priorities to offer insights for biomedical and environmental research. Copyright © 2011 Elsevier Inc. All rights reserved.

  20. Toxicological aspects of energy production

    International Nuclear Information System (INIS)

    Sanders, C.L.

    1986-01-01

    Part I reviews the principles of toxicology, describes the biological fate of chemicals in the body, discusses basic pathobiology, and reviews short-term toxicity tests. Part II describes the toxicology and pathology of pollutants in several important organ systems. The greatest emphasis is placed on the respiratory tract because of its high probability as a route of exposure to pollutants from energy technologies and its high sensitivity to pollutant related tissue damage. Part III describes the toxicological aspects of specific chemical classes associated with fossil fuels; these include polycyclic hydrocarbons, gases and metals. Part IV describes the biomedical effects associated with each energy technology, including coal and oil, fossil fuel and biomass conversions, solar and geothermal and radiological health aspects associated with uranium mining, nuclear fission and fusion, and with nonionising radiations and electromagnetic fields

  1. 2007 TOXICOLOGY AND RISK ASSESSMENT ...

    Science.gov (United States)

    EPA has announced The 2007 Toxicology and Risk Assessment Conference Cincinnati Marriott North, West Chester (Cincinnati), OHApril 23- 26, 2007 - Click to register!The Annual Toxicology and Risk Assessment Conference is a unique meeting where several Government Agencies come together to discuss toxicology and risk assessment issues that are not only of concern to the government, but also to a broader audience including academia and industry. The theme of this year's conference is Emerging Issues and Challenges in Risk Assessment and the preliminary agenda includes: Plenary Sessions and prominent speakers (tentative) include: Issues of Emerging Chemical ContaminantsUncertainty and Variability in Risk Assessment Use of Mechanistic data in IARC evaluationsParallel Sessions:Uncertainty and Variability in Dose-Response Assessment Recent Advances in Toxicity and Risk Assessment of RDX The Use of Epidemiologic Data for Risk Assessment Applications Cumulative Health Risk Assessment:

  2. Juvenile Toxicology: Relevance and Challenges for Toxicologists and Pathologists

    Science.gov (United States)

    Remick, Amera K.; Catlin, Natasha R.; Quist, Erin M.; Steinbach, Thomas J.; Dixon, Darlene

    2015-01-01

    The Society of Toxicologic Pathology (STP) Education Committee and the STP Reproductive Special Interest Group held a North Carolina regional meeting entitled, “Juvenile Toxicology: Relevance and Challenges for Toxicologists and Pathologists” on March 13, 2015, at the National Institute of Environmental Health Sciences/National Toxicology Program in Research Triangle Park, North Carolina. The purpose of this regional meeting was to familiarize attendees with the topic of juvenile toxicity testing and discuss its relevance to clinical pediatric medicine, regulatory perspectives, challenges of appropriate study design confronted by toxicologists, and challenges of histopathologic examination and interpretation of juvenile tissues faced by pathologists. The 1-day meeting was a success with over 60 attendees representing industry, government, research organizations, and academia. PMID:26220944

  3. Clinical Evaluation of a Novel Intrarectal Device for Management of Fecal Incontinence in Bedridden Patients.

    Science.gov (United States)

    Singh, Sandeep; Bhargava, Balram; Vasantha, Padma; Bhatia, Rohit; Sharma, Hanish; Pal, Sujoy; Sahni, Peush; Makharia, Govind K

    The primary objective of the study was to evaluate the safety and efficacy of a stool management kit (SMK) for containment of fecal incontinence in hospitalized bedridden patients. A single-group quasi-experimental study. Twenty bedridden adults who had at least 1 episode of fecal incontinence in the prior 24 hours participated in the study. The study setting was the neurological unit of the All India Institute of Medical Sciences in New Delhi, India. The study was carried out in 2 phases. The device was placed in situ for up to 24 hours in 10 patients during phase I of the study and up to 120 hours in an additional 10 patients during phase II. Participants were assessed for anorectal injury and peripheral device leakage on a 4- to 6-hourly basis. Sigmoidoscopy was performed to evaluate for any mucosal trauma or alteration of anorectal pathology after retrieval of the device. The device was successfully placed in all patients following the first attempt to place the device; 80% of patients retained the device until planned removal. The SMK diverted fecal matter without anal leakage in 174 (93.5%) out of 186 assessment points in a group of 20 patients. The devices remained in situ for 21 ± 0.2 and 84.5 ± 38.9 hours during phase I and phase II, respectively. None experienced anorectal bleeding, sphincter injury, or mucosal ulceration with device usage. Post-device sigmoidoscopy revealed erythema at the site of diverter placement in 2 participants. Study findings suggest that the SMK successfully diverted liquid to semiformed fecal exudate without peripheral device leakage in 93.5% of bedridden patients. No serious adverse events occurred. Additional research is needed to compare its effectiveness with that of currently available intrarectal balloon devices.

  4. Developmental and Reproductive Toxicology Database (DART)

    Data.gov (United States)

    U.S. Department of Health & Human Services — A bibliographic database on the National Library of Medicine's (NLM) Toxicology Data Network (TOXNET) with references to developmental and reproductive toxicology...

  5. IRIS Toxicological Review of Acrolein (2003 Final)

    Science.gov (United States)

    EPA announced the release of the final report, Toxicological Review of Acrolein: in support of the Integrated Risk Information System (IRIS). The updated Summary for Acrolein and accompanying toxicological review have been added to the IRIS Database.

  6. Initial Clinical Experience Performing Patient Treatment Verification With an Electronic Portal Imaging Device Transit Dosimeter

    Energy Technology Data Exchange (ETDEWEB)

    Berry, Sean L., E-mail: BerryS@MSKCC.org [Department of Applied Physics and Applied Mathematics, Columbia University, New York, New York (United States); Department of Medical Physics, Memorial Sloan-Kettering Cancer Center, New York, New York (United States); Polvorosa, Cynthia; Cheng, Simon; Deutsch, Israel; Chao, K. S. Clifford; Wuu, Cheng-Shie [Department of Radiation Oncology, Columbia University, New York, New York (United States)

    2014-01-01

    Purpose: To prospectively evaluate a 2-dimensional transit dosimetry algorithm's performance on a patient population and to analyze the issues that would arise in a widespread clinical adoption of transit electronic portal imaging device (EPID) dosimetry. Methods and Materials: Eleven patients were enrolled on the protocol; 9 completed and were analyzed. Pretreatment intensity modulated radiation therapy (IMRT) patient-specific quality assurance was performed using a stringent local 3%, 3-mm γ criterion to verify that the planned fluence had been appropriately transferred to and delivered by the linear accelerator. Transit dosimetric EPID images were then acquired during treatment and compared offline with predicted transit images using a global 5%, 3-mm γ criterion. Results: There were 288 transit images analyzed. The overall γ pass rate was 89.1% ± 9.8% (average ± 1 SD). For the subset of images for which the linear accelerator couch did not interfere with the measurement, the γ pass rate was 95.7% ± 2.4%. A case study is presented in which the transit dosimetry algorithm was able to identify that a lung patient's bilateral pleural effusion had resolved in the time between the planning CT scan and the treatment. Conclusions: The EPID transit dosimetry algorithm under consideration, previously described and verified in a phantom study, is feasible for use in treatment delivery verification for real patients. Two-dimensional EPID transit dosimetry can play an important role in indicating when a treatment delivery is inconsistent with the original plan.

  7. A Randomized Trial of Pocket-Echocardiography Integrated Mobile Health Device Assessments in Modern Structural Heart Disease Clinics.

    Science.gov (United States)

    Bhavnani, Sanjeev P; Sola, Srikanth; Adams, David; Venkateshvaran, Ashwin; Dash, P K; Sengupta, Partho P

    2018-04-01

    This study sought to determine whether mobile health (mHealth) device assessments used as clinical decision support tools at the point-of-care can reduce the time to treatment and improve long-term outcomes among patients with rheumatic and structural heart diseases (SHD). Newly developed smartphone-connected mHealth devices represent promising methods to diagnose common diseases in resource-limited areas; however, the impact of technology-based care on long-term outcomes has not been rigorously evaluated. A total of 253 patients with SHD were randomized to an initial diagnostic assessment with wireless devices in mHealth clinics (n = 139) or to standard-care (n = 114) in India. mHealth clinics were equipped with point-of-care devices including pocket-echocardiography, smartphone-connected-electrocardiogram blood pressure and oxygen measurements, activity monitoring, and portable brain natriuretic peptide laboratory testing. All individuals underwent comprehensive transthoracic echocardiography to assess the severity of SHD. The primary endpoint was the time to referral for therapy with percutaneous valvuloplasty or surgical valve replacement. Secondary endpoints included the probability of a cardiovascular hospitalization and/or death over 1 year. An initial mHealth assessment was associated with a shorter time to referral for valvuloplasty and/or valve replacement (83 ± 79 days vs. 180 ± 101 days; p Mobile Health Device Assessments in Modern Structural Heart Disease Clinics; NCT02881398). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  8. 42 CFR 493.937 - Toxicology.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Toxicology. 493.937 Section 493.937 Public Health... Proficiency Testing Programs by Specialty and Subspecialty § 493.937 Toxicology. (a) Program content and frequency of challenge. To be approved for proficiency testing for toxicology, the annual program must...

  9. 42 CFR 493.1213 - Condition: Toxicology.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Condition: Toxicology. 493.1213 Section 493.1213 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES....1213 Condition: Toxicology. If the laboratory provides services in the subspecialty of Toxicology, the...

  10. A reanalysis of the Cu-7 intrauterine contraceptive device clinical trial and the incidence of pelvic inflammatory disease: a paradigm for assessing intrauterine contraceptive device safety.

    Science.gov (United States)

    Roy, S; Azen, C

    1994-06-01

    We calculated and compared the incidence of pelvic inflammatory disease in a 10% random sample of the Cu-7 intrauterine contraceptive device (G.D. Searle & Co., Skokie, Ill.) clinical trial with the rates reported to the Food and Drug Administration and those in subsequent trials published in the world literature. A 10% random sample of the Cu-7 clinical trial was examined because calculations had demonstrated this random sample to be sufficient in size (n = 1614) to detect a difference in rates of pelvic inflammatory disease from those reported to the Food and Drug Administration. An audit of a subset of the patient files, compared with the original files in Skokie, Illinois, confirmed that the files available for analysis were complete. Standard definitions were used to identify cases of pelvic inflammatory disease and to calculate rates of pelvic inflammatory disease. The world literature on Cu-7 clinical trials was reviewed. The calculated crude and Pearl index rates of pelvic inflammatory disease were consistent with those rates previously reported to the Food and Drug Administration and published in the medical literature. Life-table pelvic inflammatory disease rates were not different between nulliparous and parous women and pelvic inflammatory disease did not differ from basal annual rates in fecund women. On the basis of the analysis of this 10% sample, the pelvic inflammatory disease patient rates reported to the Food and Drug Administration for the entire Cu-7 clinical trial are accurate and are similar to those published in the world literature.

  11. Pulmonary toxicology of respirable particles

    International Nuclear Information System (INIS)

    Sanders, C.L.; Cross, F.T.; Dagle, G.E.; Mahaffey, J.A.

    1980-09-01

    Separate abstracts were prepared for the 44 papers presented in these proceedings that deal will radioactive particles. The last paper (Stannard) in the proceedings is an historical review of the field of inhalation toxicology and is not included in the analytics

  12. Surprises and omissions in toxicology

    Czech Academy of Sciences Publication Activity Database

    Rašková, H.; Zídek, Zdeněk

    2004-01-01

    Roč. 12, - (2004), S94-S96 ISSN 1210-7778. [Inderdisciplinary Czech-Slovak Toxicological Conference /8./. Praha, 03.09.2004-05.09.2004] Institutional research plan: CEZ:AV0Z5008914 Keywords : bacterial toxins Subject RIV: FR - Pharmacology ; Medidal Chemistry

  13. 75 FR 47819 - Workshop on Optimizing Clinical Trial Design for the Development of Pediatric Cardiovascular Devices

    Science.gov (United States)

    2010-08-09

    ... unmet need. The marketing approval of more cardiovascular devices specifically designed and/or labeled... particular patient population. After each section there will be an audience question and answer session and...

  14. Development of patient support devices for execution of clinical radiotherapy for cancer patients: A preliminary report

    Directory of Open Access Journals (Sweden)

    Babu N

    2006-01-01

    Full Text Available The present paper illustrates our attempt to design and test the reproducibility of low-cost patient positioning devices prepared in-house in our radiotherapy department. Rigid thermocole boards with angulations, scales and support were designed as breast, pelvis and head positioning devices. Reproducibility and accuracy were tested by serial electronic portal imaging detector imaging. The positioning devices (with or without superimposed moulds showed variations within 2-3 mm on serial treatment days which were within acceptable limits. It is therefore concluded that low-cost patient positioning devices for head, breast and pelvis (the common sites of treatments in radiotherapy can be fabricated from available materials in-house. These have been shown to be resulting in accurate immobilization, can be customized for particular techniques and are considerably cheaper than commercially available solutions.

  15. Point-of-care coagulation monitoring: first clinical experience using a paper-based lateral flow diagnostic device.

    Science.gov (United States)

    Hegener, Michael A; Li, Hua; Han, Daewoo; Steckl, Andrew J; Pauletti, Giovanni M

    2017-09-01

    Vitamin K antagonists such as warfarin are the most widely used class of oral anticoagulants. Due to a narrow therapeutic window, patients on warfarin require regular monitoring. Self-testing using point-of-care (POC) diagnostic devices is available, but cost makes this monitoring method beyond reach for many. The main objective of this research was to assess the clinical utility of a low-cost, paper-based lateral flow POC diagnostic device developed for anticoagulation monitoring without the need for a separate electronic reader. Custom-fabricated lateral flow assay (LFA) test strips comprised of a glass fiber sample pad, a nitrocellulose analytical membrane, a cellulose wicking pad, and a plastic backing card were assembled in a plastic cassette. Healthy volunteers and patients on warfarin therapy were recruited for this prospective study. For each participant, a whole blood sample was collected via fingerstick to determine: (1) international normalized ratio (INR) using the CoaguChek® XS coagulometer, (2) hematocrit by centrifugation, and (3) red blood cell (RBC) travel distance on the experimental LFA device after 240 s using digital image analysis. RBC travel distance measured on the LFA device using blood samples obtained from warfarin patients positively correlated with increasing INR value and the LFA device had the capability to statistically distinguish between healthy volunteer INR values and those for patients groups with INR ≥ 2.6. From these data, it is predicted that this low-cost, paper-based LFA device can have clinical utility for identifying anticoagulated patients taking vitamin K antagonists who are outside of the desired therapeutic efficacy window.

  16. Characteristics of Clinical Studies Used for US Food and Drug Administration Approval of High-Risk Medical Device Supplements.

    Science.gov (United States)

    Zheng, Sarah Y; Dhruva, Sanket S; Redberg, Rita F

    2017-08-15

    High-risk medical devices often undergo modifications, which are approved by the US Food and Drug Administration (FDA) through various kinds of premarket approval (PMA) supplements. There have been multiple high-profile recalls of devices approved as PMA supplements. To characterize the quality of the clinical studies and data (strength of evidence) used to support FDA approval of panel-track supplements (a type of PMA supplement pathway that is used for significant changes in a device or indication for use and always requires clinical data). Descriptive study of clinical studies supporting panel-track supplements approved by the FDA between April 19, 2006, and October 9, 2015. Panel-track supplement approval. Methodological quality of studies including randomization, blinding, type of controls, clinical vs surrogate primary end points, use of post hoc analyses, and reporting of age and sex. Eighty-three clinical studies supported the approval of 78 panel-track supplements, with 71 panel-track supplements (91%) supported by a single study. Of the 83 studies, 37 (45%) were randomized clinical trials and 25 (30%) were blinded. The median number of patients per study was 185 (interquartile range, 75-305), and the median follow-up duration was 180 days (interquartile range, 84-270 days). There were a total of 150 primary end points (mean [SD], 1.8 [1.2] per study), and 57 primary end points (38%) were compared with controls. Of primary end points with controls, 6 (11%) were retrospective controls and 51 (89%) were active controls. One hundred twenty-one primary end points (81%) were surrogate end points. Thirty-three studies (40%) did not report age and 25 (30%) did not report sex for all enrolled patients. The FDA required postapproval studies for 29 of 78 (37%) panel-track supplements. Among clinical studies used to support FDA approval of high-risk medical device modifications, fewer than half were randomized, blinded, or controlled, and most primary outcomes were

  17. Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

    Science.gov (United States)

    Motte, Anne-France; Diallo, Stéphanie; van den Brink, Hélène; Châteauvieux, Constance; Serrano, Carole; Naud, Carole; Steelandt, Julie; Alsac, Jean-Marc; Aubry, Pierre; Cour, Florence; Pellerin, Olivier; Pineau, Judith; Prognon, Patrice; Borget, Isabelle; Bonan, Brigitte; Martelli, Nicolas

    2017-11-01

    The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Towards a workflow driven design for mHealth devices within temporary eye clinics in low-income settings.

    Science.gov (United States)

    Bolster, Nigel M; Bastawrous, Andrew; Giardini, Mario E

    2015-01-01

    Only a small minority of mobile healthcare technologies that have been successful in pilot studies have subsequently been integrated into healthcare systems. Understanding the reasons behind this discrepancy is crucial if such technologies are to be adopted. We believe that the mismatch is due to a breakdown in the relation between technical soundness of the original mobile health (mHealth) device design, and integration into healthcare provision workflows. Quantitative workflow modelling provides an opportunity to test this hypothesis. In this paper we present our current progress in developing a clinical workflow model for mobile eye assessment in low-income settings. We test the model for determining the appropriateness of design parameters of a mHealth device within this workflow, by assessing their impact on the entire clinical workflow performance.

  19. First clinical experience with Celt ACD(®) : a femoral arterial puncture closure device.

    LENUS (Irish Health Repository)

    Jan, Aftab

    2013-08-01

    This prospective nonrandomized study compared the safety and efficacy of a novel arterial closure device (ACD) in common femoral artery procedures to that of the FDA submitted historical manual pressure control group, who underwent either a diagnostic angiogram (DA) or a percutaneous coronary intervention (PCI) procedure.

  20. Testing devices or experimental systems? Cancer clinical trials take the genomic turn.

    Science.gov (United States)

    Nelson, Nicole C; Keating, Peter; Cambrosio, Alberto; Aguilar-Mahecha, Adriana; Basik, Mark

    2014-06-01

    Clinical trials are often described as machine-like systems for generating specific information concerning drug safety and efficacy, and are understood as a component of the industrial drug development processes. This paper argues that contemporary clinical trials in oncology are not reducible to mere drug testing. Drawing on ethnographic fieldwork and interviews with researchers in the field of oncology from 2010 to 2013, we introduce a conceptual contrast between trials as testing machines and trials as clinical experimental systems to draw attention to the ways trials are increasingly being used to ask open-ended scientific questions. When viewed as testing machines, clinical trials are seen as a means to produce answers to straightforward questions and deviations from the protocol are seen as bugs in the system; but practitioners can also treat trials as clinical experimental systems to investigate as yet undefined problems and where heterogeneity becomes a means to produce novel biological or clinical insights. The rise of "biomarker-driven" clinical trials in oncology, which link measurable biological characteristics such as genetic mutations to clinical features such as a patient's response to a particular drug, exemplifies a trend towards more experimental styles of clinical work. These transformations are congruent with changes in the institutional structure of clinical research in oncology, including a movement towards more flexible, networked research arrangements, and towards using individual patients as model systems for asking biological questions. Copyright © 2014 Elsevier Ltd. All rights reserved.

  1. Electronic cigarettes in the USA: a summary of available toxicology data and suggestions for the future.

    Science.gov (United States)

    Orr, Michael S

    2014-05-01

    To review the available evidence evaluating the toxicological profiles of electronic cigarettes (e-cigarettes) in order to understand the potential impact of e-cigarettes on individual users and the public health. Systematic literature searches were conducted between October 2012 and October 2013 using five electronic databases. Search terms such as 'e-cigarettes' and 'electronic delivery devices' were used to identify the toxicology information for e-cigarettes. As of October 2013, the scientific literature contains very limited information regarding the toxicity of e-cigarettes commercially available in the USA. While some preliminary toxicology data suggests that e-cigarette users are exposed to lower levels of toxicants relative to cigarette smokers, the data available is extremely limited at this time. At present, there is insufficient toxicological data available to perform thorough risk assessment analyses for e-cigarettes; few toxicology studies evaluating e-cigarettes have been conducted to date, and standard toxicological testing paradigms have not been developed for comparing disparate types of tobacco products such as e-cigarettes and traditional cigarettes. Overall, the limited toxicology data on e-cigarettes in the public domain is insufficient to allow a thorough toxicological evaluation of this new type of tobacco product. In the future, the acquisition of scientific datasets that are derived from scientifically robust standard testing paradigms, include comprehensive chemical characterisation of the aerosol, provide information on users' toxicant exposure levels, and from studies replicated by independent researchers will improve the scientific community's ability to perform robust toxicological evaluations of e-cigarettes.

  2. Safety and Toxicology of Cannabinoids

    OpenAIRE

    Sachs, Jane; McGlade, Erin; Yurgelun-Todd, Deborah

    2015-01-01

    There is extensive research on the safety, toxicology, potency, and therapeutic potential of cannabis. However, uncertainty remains facilitating continued debate on medical and recreational cannabis policies at the state and federal levels. This review will include a brief description of cannabinoids and the endocannabinoid system; a summary of the acute and long-term effects of cannabis; and a discussion of the therapeutic potential of cannabis. The conclusions about safety and efficacy will...

  3. Handbook of toxicology of chemical warfare agents

    CERN Document Server

    2010-01-01

    This groundbreaking book covers every aspect of deadly toxic chemicals used as weapons of mass destruction and employed in conflicts, warfare and terrorism. Including findings from experimental as well as clinical studies, this one-of-a-kind handbook is prepared in a very user- friendly format that can easily be followed by students, teachers and researchers, as well as lay people. Stand-alone chapters on individual chemicals and major topics allow the reader to easily access required information without searching through the entire book. This is the first book that offers in-depth coverage of individual toxicants, target organ toxicity, major incidents, toxic effects in humans, animals and wildlife, biosensors, biomarkers, on-site and laboratory analytical methods, decontamination and detoxification procedures, prophylactic, therapeutic and countermeasures, and the role of homeland security. Presents a comprehensive look at all aspects of chemical warfare toxicology in one reference work. This saves research...

  4. Development and Clinical Application of a Precise Temperature-Control Device as an Alternate for Conventional Moxibustion Therapy

    Directory of Open Access Journals (Sweden)

    Shin Takayama

    2012-01-01

    Full Text Available Moxibustion therapy has been used in East Asian medicine for more than a thousand years. However, there are some problems associated with this therapy in clinical practice. These problems include lack of control over the treatment temperature, emission of smoke, and uneven temperature distribution over the treatment region. In order to resolve these problems, we developed a precise temperature-control device for use as an alternate for conventional moxibustion therapy. In this paper, we describe the treatment of a single patient with paralytic ileus that was treated with moxibustion. We also describe an evaluation of temperature distribution on the skin surface after moxibustion therapy, the development of a heat-transfer control device (HTCD, an evaluation of the HTCD, and the clinical effects of treatment using the HTCD. The HTCD we developed can heat the skin of the treatment region uniformly, and its effect may be equivalent to conventional moxibustion, without the emission of smoke and smell. This device can be used to treat ileus, abdominal pain, and coldness of abdomen in place of conventional moxibustion in modern hospitals.

  5. Assessment of knee laxity using a robotic testing device: a comparison to the manual clinical knee examination.

    Science.gov (United States)

    Branch, T P; Stinton, S K; Siebold, R; Freedberg, H I; Jacobs, C A; Hutton, W C

    2017-08-01

    The purpose of this study was to collect knee laxity data using a robotic testing device. The data collected were then compared to the results obtained from manual clinical examination. Two human cadavers were studied. A medial collateral ligament (MCL) tear was simulated in the left knee of cadaver 1, and a posterolateral corner (PLC) injury was simulated in the right knee of cadaver 2. Contralateral knees were left intact. Five blinded examiners carried out manual clinical examination on the knees. Laxity grades and a diagnosis were recorded. Using a robotic knee device which can measure knee laxity in three planes of motion: anterior-posterior, internal-external tibia rotation, and varus-valgus, quantitative data were obtained to document tibial motion relative to the femur. One of the five examiners correctly diagnosed the MCL injury. Robotic testing showed a 1.7° larger valgus angle, 3° greater tibial internal rotation, and lower endpoint stiffness (11.1 vs. 24.6 Nm/°) in the MCL-injured knee during varus-valgus testing when compared to the intact knee and 4.9 mm greater medial tibial translation during rotational testing. Two of the five examiners correctly diagnosed the PLC injury, while the other examiners diagnosed an MCL tear. The PLC-injured knee demonstrated 4.1 mm more lateral tibial translation and 2.2 mm more posterior tibial translation during varus-valgus testing when compared to the intact knee. The robotic testing device was able to provide objective numerical data that reflected differences between the injured knees and the uninjured knees in both cadavers. The examiners that performed the manual clinical examination on the cadaver knees proved to be poor at diagnosing the injuries. Robotic testing could act as an adjunct to the manual clinical examination by supplying numbers that could improve diagnosis of knee injury. Level II.

  6. Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices

    NARCIS (Netherlands)

    Mahmoud, Karim D.; Lennon, Ryan J.; Holmes, David R.

    2015-01-01

    Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the

  7. An Application for Mobile Devices Focused on Clinical Decision Support: Diabetes Mellitus Case

    NARCIS (Netherlands)

    Klein, Lucas Felipe; Rigo, Sandro José; Cazella, Silvio César; Ben, Angela Jornada

    2016-01-01

    Clinical decision-making is performed by health professionals and it is currently connected to the need for manual query for these professionals for clinical guidelines, which are generally formed by large text files, which makes this process very slow and laborious. The development of

  8. Resource Guide to Careers in Toxicology, 3rd Edition.

    Science.gov (United States)

    Society of Toxicology, Reston, VA.

    This resource guide was prepared by the Tox 90's Educational Issues Task Force of the Society of Toxicology. The introduction provides information on the Society of Toxicology and financial support for graduate students in toxicology. Other sections include career opportunities in toxicology, academic and postdoctoral programs in toxicology, and…

  9. [Clinical study of liver resection with bipolar radiofrequency device: Habib 4X].

    Science.gov (United States)

    Chen, Jian; Dong, Xin; Tang, Zhe; Gao, Shun-liang; Wu, Yu-lian; Fang, He-qing

    2013-08-27

    To assess the application value of a new radiofrequency device Habib 4X in liver resection. A retrospective study was performed during March 2010 to July 2011.Forty-four patients underwent liver resection with radiofrequency device Habib 4X and another 54 patients traditional liver resection.Intraoperative blood loss, blood transfusion, Pringle's maneuver requirement, liver parenchyma transaction time, liver function recovery, complications, mortality and recurrence were recorded. The mean resection time was (67 ± 22) min for Habib 4X group versus (93 ± 23) min for traditional group (P = 0.000). Pringle's maneuver was required in 10 patients (22.7%) for Habib 4X group and 31 (57.4%) for traditional group (P = 0.001). The mean blocking time was (7 ± 2) vs (18 ± 6) min (P = 0.001), mean blood loss volume (243 ± 132) vs (500 ± 421) ml (P = 0.002). Postoperative recovery of liver function was better in Habib 4X group than traditional group. None developed mortality in Habib 4X group. And no resection margin recurred during a 18-month follow-up. Bipolar radiofrequency device Habib 4X is recommended for pre-coagulation in hepatectomy. And the advantages of minimized blood loss and reduced resection time result in its lower rates of morbidity and mortality.

  10. Postmortem aviation forensic toxicology: an overview.

    Science.gov (United States)

    Chaturvedi, Arvind K

    2010-05-01

    An overview of the subtopic aviation combustion toxicology of the field of aerospace toxicology has been published. In a continuation of the overview, the findings associated with postmortem aviation forensic toxicology are being summarized in the present overview. A literature search for the period of 1960-2007 was performed. The important findings related to postmortem toxicology were evaluated. In addition to a brief introduction, this overview is divided into the sections of analytical methods; carboxyhemoglobin and blood cyanide ion; ethanol; drugs; result interpretation; glucose and hemoglobin A(1c); and references. Specific details of the subject matter were discussed. It is anticipated that this overview will be an outline source for aviation forensic toxicology within the field of aerospace toxicology.

  11. Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics.

    Science.gov (United States)

    Li, Zhaoyang; Easton, Rachael

    2018-01-01

    The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field.

  12. Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics

    Science.gov (United States)

    Easton, Rachael

    2018-01-01

    ABSTRACT The development of an injectable drug-device combination (DDC) product for biologics is an intricate and evolving process that requires substantial investments of time and money. Consequently, the commercial dosage form(s) or presentation(s) are often not ready when pivotal trials commence, and it is common to have drug product changes (manufacturing process or presentation) during clinical development. A scientifically sound and robust bridging strategy is required in order to introduce these changes into the clinic safely. There is currently no single developmental paradigm, but a risk-based hierarchical approach has been well accepted. The rigor required of a bridging package depends on the level of risk associated with the changes. Clinical pharmacokinetic/pharmacodynamic comparability or outcome studies are only required when important changes occur at a late stage. Moreover, an injectable DDC needs to be user-centric, and usability assessment in real-world clinical settings may be required to support the approval of a DDC. In this review, we discuss the common issues during the manufacturing process and presentation development of an injectable DDC and practical considerations in establishing a clinical strategy to address these issues, including key elements of clinical studies. We also analyze the current practice in the industry and review relevant and status of regulatory guidance in the DDC field. PMID:29035675

  13. Clinical Usefulness of a Mobile Application for the Appropriate Selection of the Antiarrhythmic Device in Heart Failure.

    Science.gov (United States)

    Curcio, Antonio; DE Rosa, Salvatore; Sabatino, Jolanda; DE Luca, Simona; Bochicchio, Angela; Polimeni, Alberto; Santarpia, Giuseppe; Ricci, Pietrantonio; Indolfi, Ciro

    2016-07-01

    Appropriate selection of implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device can be challenging in patients with left ventricular (LV) dysfunction. In this setting, limited information exists about the role of medical applications in helping physicians to choose the most useful device. We developed a medical application that provides guidelines-based algorithms for helping doctors in decision process using the Apache Cordova application programming interface. e-CRTD App was tested in 36 consecutive patients (age 66.4 ± 8.5 years, 31 males) with diagnosis of heart failure (HF) addressed to electrophysiology laboratory for evaluation of ICD (N = 18) or CRT with defibrillator device (CRT-D; N = 18) implantation. Two separate teams evaluated each patient independently: expert electrophysiologists (Group A); cardiologists in training using the App (Group B). The outcomes of the clinical evaluation performed by Groups A and B were similar in 100% of patients in terms of classes of recommendations to device (Class I in eight cases, Class IIa in seven cases, Class III in the remaining 21). Surprisingly, the majority of indications from the general practitioners to cardiac device were inappropriate (N = 17 ICD, and N = 4 CRT-D, Class III); nevertheless, e-CRTD App helped Group B (nonexpert cardiologists) in excluding all these cases. This study describes and validates a mobile application realized to help the decision-making process in HF patients candidate to ICD/CRT-D. This application supports physicians to assess the eligibility for ICD or CRT-D according to current guidelines in patients with LV dysfunction. © 2016 Wiley Periodicals, Inc.

  14. Objective Assessment of Joint Stiffness: A Clinically Oriented Hardware and Software Device with an Application to the Shoulder Joint.

    Science.gov (United States)

    McQuade, Kevin; Price, Robert; Liu, Nelson; Ciol, Marcia A

    2012-08-30

    Examination of articular joints is largely based on subjective assessment of the "end-feel" of the joint in response to manually applied forces at different joint orientations. This technical report aims to describe the development of an objective method to examine joints in general, with specific application to the shoulder, and suitable for clinical use. We adapted existing hardware and developed laptop-based software to objectively record the force/displacement behavior of the glenohumeral joint during three common manual joint examination tests with the arm in six positions. An electromagnetic tracking system recorded three-dimensional positions of sensors attached to a clinician examiner and a patient. A hand-held force transducer recorded manually applied translational forces. The force and joint displacement were time-synchronized and the joint stiffness was calculated as a quantitative representation of the joint "end-feel." A methodology and specific system checks were developed to enhance clinical testing reproducibility and precision. The device and testing protocol were tested on 31 subjects (15 with healthy shoulders, and 16 with a variety of shoulder impairments). Results describe the stiffness responses, and demonstrate the feasibility of using the device and methods in clinical settings.

  15. Clinical protocol levels are required in laboratory animal surgery when using medical devices: experiences with ureteral replacement surgery in goats.

    Science.gov (United States)

    de Jonge, Paul K J D; Sloff, Marije; Janke, Heinz P; Kortmann, Barbara B M; de Gier, Robert P E; Geutjes, Paul J; Oosterwijk, Egbert; Feitz, Wout F J

    2017-10-01

    It is common to test medical devices in large animal studies that are or could also be used in humans. In this short report we describe the use of a ureteral J-stent for the evaluation of biodegradable tubular constructs for tissue reconstruction, and the regeneration of ureters in Saanen goats. Similarly to a previous study in pigs, the ureteral J-stent was blindly inserted until some resistance was met. During evaluation of the goats after three months, perforation of the renal cortex by the stent was observed in four out of seven animals. These results indicated that blind stent placement was not possible in goats. In four new goats, clinical protocols were followed using X-ray and iodinated contrast fluids to visualize the kidney and stent during stent placement. With this adaptation the stents were successfully placed in the kidneys of these four new goats with minimal additional effort. It is likely that other groups in other fields ran into similar problems that could have been avoided by following clinical protocols. Therefore, we would like to stress the importance of following clinical protocols when using medical devices in animals to prevent unnecessary suffering and to reduce the number of animals needed.

  16. MO-C-BRB-05: Translating NIH funding to a [potential] clinical device in breast cancer radiation therapy

    International Nuclear Information System (INIS)

    Yu, C.

    2015-01-01

    Diagnostic radiology and radiation oncology are arguably two of the most technologically advanced specialties in medicine. The imaging and radiation medicine technologies in clinical use today have been continuously improved through new advances made in the commercial and academic research arenas. This symposium explores the translational path from research through clinical implementation. Dr. Pettigrew will start this discussion by sharing his perspectives as director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The NIBIB has focused on promoting research that is technological in nature and has high clinical impact. We are in the age of precision medicine, and the technological innovations and quantitative tools developed by engineers and physicists working with physicians are providing innovative tools that increase precision and improve outcomes in health care. NIBIB funded grants lead to a very high patenting rate (per grant dollar), and these patents have higher citation rates by other patents, suggesting greater clinical impact, as well. Two examples of clinical translation resulting from NIH-funded research will be presented, in radiation therapy and diagnostic imaging. Dr. Yu will describe a stereotactic radiotherapy device developed in his laboratory that is designed for treating breast cancer with the patient in the prone position. It uses 36 rotating Cobalt-60 sources positioned in an annular geometry to focus the radiation beam at the system’s isocenter. The radiation dose is delivered throughout the target volume in the breast by constantly moving the patient in a planned trajectory relative to the fixed isocenter. With this technique, the focal spot dynamically paints the dose distribution throughout the target volume in three dimensions. Dr. Jackson will conclude this symposium by describing the RSNA Quantitative Imaging Biomarkers Alliance (QIBA), which is funded in part by NIBIB and is a synergistic collaboration

  17. MO-C-BRB-05: Translating NIH funding to a [potential] clinical device in breast cancer radiation therapy

    Energy Technology Data Exchange (ETDEWEB)

    Yu, C. [Univ Maryland School of Medicine (United States)

    2015-06-15

    Diagnostic radiology and radiation oncology are arguably two of the most technologically advanced specialties in medicine. The imaging and radiation medicine technologies in clinical use today have been continuously improved through new advances made in the commercial and academic research arenas. This symposium explores the translational path from research through clinical implementation. Dr. Pettigrew will start this discussion by sharing his perspectives as director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB). The NIBIB has focused on promoting research that is technological in nature and has high clinical impact. We are in the age of precision medicine, and the technological innovations and quantitative tools developed by engineers and physicists working with physicians are providing innovative tools that increase precision and improve outcomes in health care. NIBIB funded grants lead to a very high patenting rate (per grant dollar), and these patents have higher citation rates by other patents, suggesting greater clinical impact, as well. Two examples of clinical translation resulting from NIH-funded research will be presented, in radiation therapy and diagnostic imaging. Dr. Yu will describe a stereotactic radiotherapy device developed in his laboratory that is designed for treating breast cancer with the patient in the prone position. It uses 36 rotating Cobalt-60 sources positioned in an annular geometry to focus the radiation beam at the system’s isocenter. The radiation dose is delivered throughout the target volume in the breast by constantly moving the patient in a planned trajectory relative to the fixed isocenter. With this technique, the focal spot dynamically paints the dose distribution throughout the target volume in three dimensions. Dr. Jackson will conclude this symposium by describing the RSNA Quantitative Imaging Biomarkers Alliance (QIBA), which is funded in part by NIBIB and is a synergistic collaboration

  18. History of Japanese Society of Toxicology.

    Science.gov (United States)

    Satoh, Tetsuo

    2016-01-01

    Founded in 1981, the Japanese Society of Toxicology (JSOT) has grown into an organization of nearly 3,000 members working together to advance the nation's scientific knowledge and understanding of toxicology through the implementation of planning that ensures a systematic and efficient expenditure of energies and resources, and is closely aligned with a strategy for accomplishing the Society's long-range plans. To promote public education in toxicology, the Society organizes public lectures during each year's annual meeting. Other activities include hosting scientific conferences, promoting continuing education, and facilitating international collaboration. Internally, the JSOT operates five standing committees: General Affairs, Educational, Editorial, Finance, and Science and Publicity to handle its necessary relationships. To bestow official recognition, the Society established its Toxicologist Certification Program in 1997, and has certified 536 members as Diplomat Toxicologists (DJSOT) as of May 1, 2016. Furthermore, on the same date, 43 JSOT members were certified as Emeritus Diplomats of the JSOT (EDJSOT). The Society has launched two official journals, the "Journal of Toxicological Sciences (JTS)" in 1981 and "Fundamental Toxicological Sciences (Fundam. Toxicol. Sci.)" in 2014. As for participation in the international organizations, the JSOT (then known as the Toxicological Research Group) joined the International Union of Toxicology as a charter member in 1980, and became a founding member of the Asian Society of Toxicology at its inauguration in 1994. Into the future, the JSOT will continue working diligently to advance knowledge and understanding of toxicology and secure its place among the interdisciplinary fields of science, humane studies, and ethics.

  19. The subject-fixated coaxially sighted corneal light reflex: a clinical marker for centration of refractive treatments and devices.

    Science.gov (United States)

    Chang, Daniel H; Waring, George O

    2014-11-01

    To describe the inconsistencies in definition, application, and usage of the ocular reference axes (optical axis, visual axis, line of sight, pupillary axis, and topographic axis) and angles (angle kappa, lambda, and alpha) and to propose a precise, reproducible, clinically defined reference marker and axis for centration of refractive treatments and devices. Perspective. Literature review of papers dealing with ocular reference axes, angles, and centration. The inconsistent definitions and usage of the current ocular axes, as derived from eye models, limit their clinical utility. With a clear understanding of Purkinje images and a defined alignment of the observer, light source/fixation target, and subject eye, the subject-fixated coaxially sighted corneal light reflex can be a clinically useful reference marker. The axis formed by connecting the subject-fixated coaxially sighted corneal light reflex and the fixation point, the subject-fixated coaxially sighted corneal light reflex axis, is independent of pupillary dilation and phakic status of the eye. The relationship of the subject-fixated coaxially sighted corneal light reflex axis to a refined definition of the visual axis without reference to nodal points, the foveal-fixation axis, is discussed. The displacement between the subject-fixated coaxially sighted corneal light reflex and pupil center is described not by an angle, but by a chord, here termed chord mu. The application of the subject-fixated coaxially sighted corneal light reflex to the surgical centration of refractive treatments and devices is discussed. As a clinically defined reference marker, the subject-fixated coaxially sighted corneal light reflex avoids the shortcomings of current ocular axes for clinical application and may contribute to better consensus in the literature and improved patient outcomes. Copyright © 2014 Elsevier Inc. All rights reserved.

  20. Guiding Device for Precision Grafting of Peripheral Nerves in Complete Thoracic Spinal Cord Injury: Design and Sizing for Clinical Trial

    Directory of Open Access Journals (Sweden)

    Arvid Frostell

    2018-05-01

    Full Text Available BackgroundIn an effort to translate preclinical success in achieving spinal cord regeneration through peripheral nerve grafts, this study details the design and sizing of a guiding device for precision grafting of peripheral nerves for use in a clinical trial in complete (AIS-A thoracic spinal cord injury (SCI. The device’s design and sizing are compared to a simulation of human spinal cord sizes based on the best available data.MethodsSpinal cord segmental sizes were generated by computer simulation based on data from a meta-analysis recently published by our group. Thoracic segments T2–T12 were plotted, and seven elliptical shapes were positioned across the center of the distribution of sizes. Geometrical measures of error-of-fit were calculated. CAD modeling was used to create cranial and caudal interfaces for the human spinal cord, aiming to guide descending white matter tracts to gray matter at the caudal end of the device and ascending white matter tracts to gray matter at the cranial end of the device. The interfaces were compared qualitatively to the simulated spinal cord sizes and gray-to-white matter delineations.ResultsThe mean error-of-fit comparing simulated spinal cord segments T2–T12 to the best elliptical shape was 0.41 and 0.36 mm, and the 95th percentile was found at 1.3 and 0.98 mm for transverse and anteroposterior diameter, respectively. A guiding device design was reached for capturing the majority of corticospinal axons at the cranial end of the device and guiding them obliquely to gray matter at the caudal end of the device. Based on qualitative comparison, the vast majority of spinal cord sizes generated indicate an excellent fit to the device’s interfaces.ConclusionA set of SCI guiding devices of seven sizes can cover the variability of human thoracic spinal cord segments T2–T12 with an acceptable error-of-fit for the elliptical shape as well as guiding channels. The computational framework developed can

  1. The usefulness of a mobile device-based system for patient-reported outcomes in a spine outpatient clinic.

    Science.gov (United States)

    Kim, Chi Heon; Chung, Chun Kee; Choi, Yunhee; Shin, HyunJeong; Woo, Ji Won; Kim, Sung-Mi; Lee, Hyuk-Joon

    2016-07-01

    Patient-reported outcomes (PROs) are typically collected using a paper form, but this format is cumbersome to incorporate into outpatient clinic visits as well as in research. Therefore, we developed a mobile device-based system (mobile system) for spinal PRO. We hypothesized that this system may improve the quality of care in an outpatient clinic. This study aimed to analyze the patient-reported efficacy of a mobile system through a survey of patients' responses compared with a paper system. A prospective observational study was carried out. Surveys were conducted for 103 patients who had experience using both the paper and electronic systems in the outpatient clinic. Patient-reported positive response score (PRS) was the outcome measure. The survey included the characteristics of the patients (sex, age, use of smartphone, familiarity with smartphone applications, proficiency of typing with mobile device, site of pain, and education level) and eight questions in four domains: (1) efficacy in the waiting room, (2) efficacy during the clinic visit, (3) overall satisfaction, and (4) opinion about the use of this system. The response to each question was scored from 1 to 5 (1, negative; 5, positive response). The patient-reported PRS was calculated by adding the scores of the 8 questions and converting the total range to 0-100 (60, neutral). The mean PRS of the 8 questions was 79.8 (95% CI, 76.7-83.9). The mean PRS was 78.9 (75.6-82.2) at the waiting room and was 80.5 (77.1-83.9) during the clinic. The PRS for overall satisfaction and use of this system were 83.3 (79.6-87.0) and 77.1 (71.9-82.3), respectively. The use of smartphones and the proficiency of typing were independently significant predictors of PRS with an R(2) value of 0.325. The mobile device-based system improved the patient-reported efficacy in spine outpatient clinics. However, various factors such as the use of smartphones need to be considered when developing and applying mobile systems. Copyright

  2. 78 FR 45253 - National Toxicology Program Scientific Advisory Committee on Alternative Toxicological Methods...

    Science.gov (United States)

    2013-07-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program... Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of... Director, National Toxicology Program. [FR Doc. 2013-17919 Filed 7-25-13; 8:45 am] BILLING CODE 4140-01-P ...

  3. Postmortem diagnosis and toxicological validation of illicit substance use

    OpenAIRE

    Lehrmann, E; Afanador, ZR; Deep-Soboslay, A; Gallegos, G; Darwin, WD; Lowe, RH; Barnes, AJ; Huestis, MA; Cadet, JL; Herman, MM; Hyde, TM; Kleinman, JE; Freed, WJ

    2008-01-01

    The present study examines the diagnostic challenges of identifying ante-mortem illicit substance use in human postmortem cases. Substance use, assessed by clinical case history reviews, structured next-of-kin interviews, by general toxicology of blood, urine, and/or brain, and by scalp hair testing, identified 33 cocaine, 29 cannabis, 10 phencyclidine and 9 opioid cases. Case history identified 42% cocaine, 76% cannabis, 10% phencyclidine, and 33% opioid cases. Next-of-kin interviews identif...

  4. The evaluation of family functioning by the family assessment device: a systematic review of studies in adult clinical populations.

    Science.gov (United States)

    Staccini, Laura; Tomba, Elena; Grandi, Silvana; Keitner, Gabor I

    2015-03-01

    A large body of research, documenting the impact of a family's functioning on health outcomes, highlights the importance of introducing the evaluation of patients' family dynamics into clinical judgment. The Family Assessment Device (FAD) is a self-report questionnaire designed to assess specific dimensions of family functioning. This qualitative systematic review, which follows PRISMA guidelines, aimed to identify the FAD's clinimetric properties and to report the incremental utility of its inclusion in clinical settings. A thorough literature search was performed, using both computerized and manual searches, yielding a total of 148 studies that were included in this review. The FAD has been extensively used in a variety of research contexts. In the majority of studies it was able to discriminate between clinical populations and controls and among groups of patients with different illnesses. The FAD also showed good test-retest and concurrent reliability, and modest sensitivity to change after treatment. FAD-dysfunctional family functioning was related to several patient clinical outcomes, including lower recovery rates and adherence to treatment, longer recovery time, poorer quality of life, and increased risk of relapse and drop-out. The present review demonstrates that the FAD is a suitable instrument for the evaluation of family functioning both in clinical and research settings. © 2014 Family Process Institute.

  5. Trichomonas vaginalis clinical isolates: cytoadherence and adherence to polystyrene, intrauterine device, and vaginal ring.

    Science.gov (United States)

    Dos Santos, Odelta; Rigo, Graziela Vargas; Macedo, Alexandre José; Tasca, Tiana

    2017-12-01

    The parasitism by Trichomonas vaginalis is complex and in part is mediated by cytoadherence accomplished via five surface proteins named adhesins and a glycoconjugate called lipophosphoglycan (TvLPG). In this study, we evaluated the ability of T. vaginalis isolates to adhere to cells, plastic (polystyrene microplates), intrauterine device (IUD), and vaginal ring. Of 32 T. vaginalis isolates, 4 (12.5%) were strong adherent. The T. vaginalis isolates TV-LACM6 and TV-LACM14 (strong polystyrene-adherent) were also able to adhere to IUD and vaginal ring. Following chemical treatments, results demonstrated that the T. vaginalis components, lipophosphoglycan, cytoskeletal proteins, and surface molecules, were involved in both adherence to polystyrene and cytoadherence. The gene expression level from four adhesion proteins was highest in trophozoites adhered to cells than trophozoites adhered to the abiotic surface (polystyrene microplate). Our data indicate the major involvement of TvLPG in adherence to polystyrene, and that adhesins are important for cytoadherence. Furthermore, to our knowledge, this is the first report showing the T. vaginalis adherence to contraceptive devices, reaffirming its importance as pathogen among women in reproductive age.

  6. Multicenter clinical perspectives on a broadband infrared light device for skin tightening.

    Science.gov (United States)

    Taub, Amy Forman; Battle, Eliot F; Nikolaidis, Gregory

    2006-09-01

    Modalities for skin tightening include radiofrequency (RF) energy, lasers, and combination RF and diode lasers. A new broadband infrared light device (BILD) (Titan, Cutera, Inc, Brisbane, CA) targets water to achieve dermal heating and collagen remodeling for skin tightening. Although thousands of procedures have been performed worldwide with this device, only one article (to the author's knowledge) describing its performance in skin tightening has been published. Three US dermatologists report their experience with and provide their perspective on facial skin tightening with the BILD system. As early adopters, they each have 12 to 18 months experience with this system. One author (A.F.T.) treated 42 patients twice at 1-month intervals over 18 months. The mean improvement score was 1.83 (scale 0 to 4, with 4 denoting maximum improvement) with an average follow-up time of 3.7 months. More than 90% of treated patients showed visible improvement. No complications were observed and patient satisfaction was high. This paper presents the general consensus of the authors on patient selection and treatment protocol, their modifications of the manufacturer's treatment protocol, and the outcomes of 42 patients treated by one author (A.F.T.). The observations were gathered separately and turned out to be very similar. The recommendations are presented to help practitioners achieve consistently good results and avoid complications with the BILD procedure.

  7. Implications of medical devices quality assurance for implementation of experimental clinical trials

    International Nuclear Information System (INIS)

    Tirindelli Danesi, D.; Altavista, P.; Marino, C.; Benassi, M.

    1992-01-01

    The basis for all controlled clinical trials is the comparison of a new treatment with the standard treatment. The effect of the experimental procedure on the natural history of the disease is the result observed; but the interpretation of the results in cancer clinical experimentation is often difficult due to the variability of the clinical course of individual cancers in a given category. It has been possible to categorize cancers by means of prognostic factors and evaluate the results of therapy within each prognostic category, but there is still much variability within each category. The only way to determine whether or not a new treatment can be used for a particular form of cancer is to try it out on patients in clinical trials. The cooperative practice was originally induced by the realistic need for large sample sizes, but the variability in the interpretation of the results increased due to difficulties in comparing data. This is one of the main problems in cancer literature. These problems originate from inconsistent or incomplete reporting of the patient population under study, the treatment administered, the statistical methods employed to assess treatment efficacy and from differences in the definition of response criteria. This paper tries to outline the impact on the results evaluation of the lack of standardized prognostic factors and standardized therapeutic modalities in the selection and treatment of patients included in clinical trials

  8. Microfluidic paper-based analytical devices for potential use in quantitative and direct detection of disease biomarkers in clinical analysis.

    Science.gov (United States)

    Lim, Wei Yin; Goh, Boon Tong; Khor, Sook Mei

    2017-08-15

    Clinicians, working in the health-care diagnostic systems of developing countries, currently face the challenges of rising costs, increased number of patient visits, and limited resources. A significant trend is using low-cost substrates to develop microfluidic devices for diagnostic purposes. Various fabrication techniques, materials, and detection methods have been explored to develop these devices. Microfluidic paper-based analytical devices (μPADs) have gained attention for sensing multiplex analytes, confirming diagnostic test results, rapid sample analysis, and reducing the volume of samples and analytical reagents. μPADs, which can provide accurate and reliable direct measurement without sample pretreatment, can reduce patient medical burden and yield rapid test results, aiding physicians in choosing appropriate treatment. The objectives of this review are to provide an overview of the strategies used for developing paper-based sensors with enhanced analytical performances and to discuss the current challenges, limitations, advantages, disadvantages, and future prospects of paper-based microfluidic platforms in clinical diagnostics. μPADs, with validated and justified analytical performances, can potentially improve the quality of life by providing inexpensive, rapid, portable, biodegradable, and reliable diagnostics. Copyright © 2017 Elsevier B.V. All rights reserved.

  9. Safety and Toxicology of Cannabinoids.

    Science.gov (United States)

    Sachs, Jane; McGlade, Erin; Yurgelun-Todd, Deborah

    2015-10-01

    There is extensive research on the safety, toxicology, potency, and therapeutic potential of cannabis. However, uncertainty remains facilitating continued debate on medical and recreational cannabis policies at the state and federal levels. This review will include a brief description of cannabinoids and the endocannabinoid system; a summary of the acute and long-term effects of cannabis; and a discussion of the therapeutic potential of cannabis. The conclusions about safety and efficacy will then be compared with the current social and political climate to suggest future policy directions and general guidelines.

  10. From Paper to PDA: Design and Evaluation of a Clinical Ward Instruction on a Mobile Device

    Science.gov (United States)

    Kanstrup, Anne Marie; Stage, Jan

    Mobile devices with small screens and minimal facilities for interaction are increasingly being used in complex human activities for accessing and processing information, while the user is moving. This paper presents a case study of the design and evaluation of a mobile system, which involved transformation of complex text and tables to digital format on a PDA. The application domain was an emergency medical ward, and the user group was junior registrars. We designed a PDA-based system for accessing information, focusing on the ward instruction, implemented a prototype and evaluated it for usability and utility. The evaluation results indicate significant problems in the interaction with the system as well as the extent to which the system is useful for junior registrars in their daily work.

  11. Research and development of metals for medical devices based on clinical needs

    Directory of Open Access Journals (Sweden)

    Takao Hanawa

    2012-01-01

    Full Text Available The current research and development of metallic materials used for medicine and dentistry is reviewed. First, the general properties required of metals used in medical devices are summarized, followed by the needs for the development of α + β type Ti alloys with large elongation and β type Ti alloys with a low Young's modulus. In addition, nickel-free Ni–Ti alloys and austenitic stainless steels are described. As new topics, we review metals that are bioabsorbable and compatible with magnetic resonance imaging. Surface treatment and modification techniques to improve biofunctions and biocompatibility are categorized, and the related problems are presented at the end of this review. The metal surface may be biofunctionalized by various techniques, such as dry and wet processes. These techniques make it possible to apply metals to scaffolds in tissue engineering.

  12. [Clinical Experience of Beating Heart Atrial Septostomy Using a Device for Coronary Artery Anastomosis Site Creator].

    Science.gov (United States)

    Takahashi, Goro; Sai, Sadahiro; Konishi, Akinobu

    2015-09-01

    Intra-atrial communication was mandatory for several congenital cardiac diseases, such as pulmonary atresia with intact ventricular septum (PA/IVS), and either sided aortoventricular valve atresia. We assessed whether the new methods of atrial septal defect(ASD)creation was effective. We experienced 4 cases of the surgical atrial septostomy performed under on-pump beating. We used a new device, a circular punch out defect creator. All cases were alive. The mean ASD diameter was enlarged from 4.37 mm to 5.55 mm and the mean ASD shunt flow was significantly decreased from 1.47 m/s to 1.11 m/s. We performed the surgical atrial septostomy using an aortic puncher under beating heart effectively and safely.

  13. Specific barriers to the conduct of randomised clinical trials on medical devices

    DEFF Research Database (Denmark)

    Neugebauer, Edmund A M; Rath, Ana; Antoine, Sunya-Lee

    2017-01-01

    Clinical Research Infrastructure Network (ECRIN) communications taking place during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project. RESULTS: In addition to the barriers that exist for all trials, we identified three...

  14. A decision support system for medical mobile devices based on clinical guidelines for tuberculosis

    NARCIS (Netherlands)

    Cazella, Silvio César; Feyh, Rafael; Ben, Angela Jornada

    2014-01-01

    The decision making process conducted by health professionals is strongly linked to the consultations of clinical guidelines, generally available in large text files, making the access to the information very laborious and time consuming. The health area is very fertile for the emergence of

  15. An externally head-mounted wireless neural recording device for laboratory animal research and possible human clinical use.

    Science.gov (United States)

    Yin, Ming; Li, Hao; Bull, Christopher; Borton, David A; Aceros, Juan; Larson, Lawrence; Nurmikko, Arto V

    2013-01-01

    In this paper we present a new type of head-mounted wireless neural recording device in a highly compact package, dedicated for untethered laboratory animal research and designed for future mobile human clinical use. The device, which takes its input from an array of intracortical microelectrode arrays (MEA) has ninety-seven broadband parallel neural recording channels and was integrated on to two custom designed printed circuit boards. These house several low power, custom integrated circuits, including a preamplifier ASIC, a controller ASIC, plus two SAR ADCs, a 3-axis accelerometer, a 48MHz clock source, and a Manchester encoder. Another ultralow power RF chip supports an OOK transmitter with the center frequency tunable from 3GHz to 4GHz, mounted on a separate low loss dielectric board together with a 3V LDO, with output fed to a UWB chip antenna. The IC boards were interconnected and packaged in a polyether ether ketone (PEEK) enclosure which is compatible with both animal and human use (e.g. sterilizable). The entire system consumes 17mA from a 1.2Ahr 3.6V Li-SOCl2 1/2AA battery, which operates the device for more than 2 days. The overall system includes a custom RF receiver electronics which are designed to directly interface with any number of commercial (or custom) neural signal processors for multi-channel broadband neural recording. Bench-top measurements and in vivo testing of the device in rhesus macaques are presented to demonstrate the performance of the wireless neural interface.

  16. Clinical implementation of a low energy x-ray therapy device in the treatment of breast cancer

    International Nuclear Information System (INIS)

    Haworth, A.; University of Western Australia, WA; Joseph, D.; Lanzon, P.; Caswell, N.; Ebert, M.; University of Western Asutralia, WA

    2001-01-01

    Full text: A low energy device producing x-rays of maximum operating potential of 50kV is used to treat primary breast tumours intraoperatively. In pathologically favourable cases, the treatment replaces conventional external beam irradiation. For patients at greater risk of local recurrence, the treatment replaces conventional 'boost' therapy. The dosimetry of the device will be described in a companion paper. QA tests prior to irradiation include: output calibration/verification; isotropy verification and external radiation monitor (the secondary beam termination device) functionality. The internal radiation monitor count (similar to setting monitor units on a linac) for a prescribed dose is calculated from tables of measured depth dose and applicator factors. The spherical applicator which best suits the size of the excised tumour is lightly sutured into position maintaining as much distance between the skin surface as possible to minimise skin erythema. Radiation protection is achieved with the use of portable lead shields and tungsten impregnated silicon drapes. Patients entered into a TROG randomised clinical trial comparing intraoperative with conventional postoperative radiotherapy after conservative breast surgery for women with early stage breast cancer will be studied in collaboration with the CRC/University College London, Cancer Trials Centre (UK) to record the effects of local tumour control, cosmesis, patient satisfaction and health economics. QA tests take approximately 15 minutes to perform and a treatment prescription of 5Gy at 1cm depth with a 5cm applicator would take approximately 30 minutes. A low energy x-ray device may be used intraoperatively in selected cases to replace conventional radiotherapy minimising the inconvenience for patients and reducing waiting lists on treatment machines. Copyright (2001) Australasian College of Physical Scientists and Engineers in Medicine

  17. Rapid Globalization of Medical Device Clinical Development Programs in Japan - The Case of Drug-Eluting Stents.

    Science.gov (United States)

    Murakami, Madoka; Suzuki, Yuka; Tominaga, Toshiyoshi

    2018-02-23

    Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.

  18. Computerized Neuropsychological Assessment Devices: Joint Position Paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology†

    Science.gov (United States)

    Bauer, Russell M.; Iverson, Grant L.; Cernich, Alison N.; Binder, Laurence M.; Ruff, Ronald M.; Naugle, Richard I.

    2012-01-01

    This joint position paper of the American Academy of Clinical Neuropsychology and the National Academy of Neuropsychology sets forth our position on appropriate standards and conventions for computerized neuropsychological assessment devices (CNADs). In this paper, we first define CNADs and distinguish them from examiner-administered neuropsychological instruments. We then set forth position statements on eight key issues relevant to the development and use of CNADs in the healthcare setting. These statements address (a) device marketing and performance claims made by developers of CNADs; (b) issues involved in appropriate end-users for administration and interpretation of CNADs; (c) technical (hardware/software/firmware) issues; (d) privacy, data security, identity verification, and testing environment; (e) psychometric development issues, especially reliability, and validity; (f) cultural, experiential, and disability factors affecting examinee interaction with CNADs; (g) use of computerized testing and reporting services; and (h) the need for checks on response validity and effort in the CNAD environment. This paper is intended to provide guidance for test developers and users of CNADs that will promote accurate and appropriate use of computerized tests in a way that maximizes clinical utility and minimizes risks of misuse. The positions taken in this paper are put forth with an eye toward balancing the need to make validated CNADs accessible to otherwise underserved patients with the need to ensure that such tests are developed and utilized competently, appropriately, and with due concern for patient welfare and quality of care. PMID:22382386

  19. Success rates and factors associated with failure of temporary anchorage devices: A prospective clinical trial.

    Science.gov (United States)

    Aly, Shehab A; Alyan, Doha; Fayed, Mona S; Alhammadi, Maged S; Mostafa, Yehya A

    2018-03-06

    The objective of the present study was to investigate success rates and associated factors affecting temporary anchorage device (TAD) failure in different biomechanical applications. A total of 180 TADs were used as a part of 82 patients' treatment plan (24 males and 58 females); their mean age was 21.41 years. Three types of TADs were used: 50 (3M ESPE, Neuss, Germany), 56 (Bone screw; Jeil Medical, Seoul, Korea), and 74 (Morelli, Sorocaba, Brazil). Eight maxillary and four mandibular sites were selected for insertion. Three different lengths (6, 8, and 10 mm) and three different diameters (1.5, 1.6, and 1.8 mm) were used. The force levels were set at 50, 100, 150, 200, and 250 g. Patient-, implant-, and operator-dependent factors were evaluated throughout the 266 days of function. Qualitative variables were described by proportions and percentages and analyzed using χ 2 test. The overall success rate was 82.2%. The higher age group showed a significantly higher success rate. Oral hygiene showed a statistically-significant (P ˂ .05) difference between both success and failure groups. All other patient-related factors showed no significant differences. Regarding force levels used, the highest success rate was in 250 g and the lowest was in 100 g. There were no significant differences between both groups regarding other implant- and operator-related factors. Temporary anchorage devices have a good success rate and are beneficial to be integrated in orthodontic treatment planning. Patient age, oral hygiene, and force level are the most significant factors affecting TAD success. © 2018 John Wiley & Sons Australia, Ltd.

  20. Covalent immobilisation of antibodies in Teflon-FEP microfluidic devices for the sensitive quantification of clinically relevant protein biomarkers.

    Science.gov (United States)

    Pivetal, Jeremy; Pereira, Filipa M; Barbosa, Ana I; Castanheira, Ana P; Reis, Nuno M; Edwards, Alexander D

    2017-03-13

    This study reports for the first time the sensitive colorimetric and fluorescence detection of clinically relevant protein biomarkers by sandwich immunoassays using the covalent immobilisation of antibodies onto the fluoropolymer surface inside Teflon®-FEP microfluidic devices. Teflon®-FEP has outstanding optical transparency ideal for high-sensitivity colorimetric and fluorescence bioassays, however this thermoplastic is regarded as chemically inert and very hydrophobic. Covalent immobilisation can offer benefits over passive adsorption to plastic surfaces by allowing better control over antibody density, orientation and analyte binding capacity, and so we tested a range of different and novel covalent immobilisation strategies. We first functionalised the inner surface of a 10-bore, 200 μm internal diameter FEP microcapillary film with high-molecular weight polyvinyl alcohol (PVOH) without changing the outstanding optical transparency of the device delivered by the matched refractive index of FEP and water. Glutaraldehyde immobilisation was compared with the use of photoactivated linkers and NHS-ester crosslinkers for covalently immobilising capture antibodies onto PVOH. Three clinically relevant sandwich ELISAs were tested against the cytokine IL-1β, the myocardial infarct marker cardiac troponin I (cTnI), and the chronic heart failure marker brain natriuretic peptide (BNP). Overall, glutaraldehyde immobilisation was effective for BNP assays, but yielded unacceptable background for IL-1β and cTnI assays caused by direct binding of the biotinylated detection antibody to the modified PVOH surface. We found NHS-ester groups reacted with APTES-treated PVOH coated fluoropolymers. This facilitated a novel method for capture antibody immobilisation onto fluoropolymer devices using a bifunctional NHS-maleimide crosslinker. The density of covalently immobilised capture antibodies achieved using PVOH/APTES/NHS/maleimide approached levels seen with passive adsorption

  1. The Toxicology Education Summit: building the future of toxicology through education.

    Science.gov (United States)

    Barchowsky, Aaron; Buckley, Lorrene A; Carlson, Gary P; Fitsanakis, Vanessa A; Ford, Sue M; Genter, Mary Beth; Germolec, Dori R; Leavens, Teresa L; Lehman-McKeeman, Lois D; Safe, Stephen H; Sulentic, Courtney E W; Eidemiller, Betty J

    2012-06-01

    Toxicology and careers in toxicology, as well as many other scientific disciplines, are undergoing rapid and dramatic changes as new discoveries, technologies, and hazards advance at a blinding rate. There are new and ever increasing demands on toxicologists to keep pace with expanding global economies, highly fluid policy debates, and increasingly complex global threats to public health. These demands must be met with new paradigms for multidisciplinary, technologically complex, and collaborative approaches that require advanced and continuing education in toxicology and associated disciplines. This requires paradigm shifts in educational programs that support recruitment, development, and training of the modern toxicologist, as well as continued education and retraining of the midcareer professional to keep pace and sustain careers in industry, government, and academia. The Society of Toxicology convened the Toxicology Educational Summit to discuss the state of toxicology education and to strategically address educational needs and the sustained advancement of toxicology as a profession. The Summit focused on core issues of: building for the future of toxicology through educational programs; defining education and training needs; developing the "Total Toxicologist"; continued training and retraining toxicologists to sustain their careers; and, finally, supporting toxicology education and professional development. This report summarizes the outcomes of the Summit, presents examples of successful programs that advance toxicology education, and concludes with strategies that will insure the future of toxicology through advanced educational initiatives.

  2. The Emergence of Systematic Review in Toxicology.

    Science.gov (United States)

    Stephens, Martin L; Betts, Kellyn; Beck, Nancy B; Cogliano, Vincent; Dickersin, Kay; Fitzpatrick, Suzanne; Freeman, James; Gray, George; Hartung, Thomas; McPartland, Jennifer; Rooney, Andrew A; Scherer, Roberta W; Verloo, Didier; Hoffmann, Sebastian

    2016-07-01

    The Evidence-based Toxicology Collaboration hosted a workshop on "The Emergence of Systematic Review and Related Evidence-based Approaches in Toxicology," on November 21, 2014 in Baltimore, Maryland. The workshop featured speakers from agencies and organizations applying systematic review approaches to questions in toxicology, speakers with experience in conducting systematic reviews in medicine and healthcare, and stakeholders in industry, government, academia, and non-governmental organizations. Based on the workshop presentations and discussion, here we address the state of systematic review methods in toxicology, historical antecedents in both medicine and toxicology, challenges to the translation of systematic review from medicine to toxicology, and thoughts on the way forward. We conclude with a recommendation that as various agencies and organizations adapt systematic review methods, they continue to work together to ensure that there is a harmonized process for how the basic elements of systematic review methods are applied in toxicology. © The Author 2016. Published by Oxford University Press on behalf of the Society of Toxicology.

  3. 42 CFR 493.845 - Standard; Toxicology.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard; Toxicology. 493.845 Section 493.845 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES... These Tests § 493.845 Standard; Toxicology. (a) Failure to attain a score of at least 80 percent of...

  4. Why OR.NET? Requirements and perspectives from a medical user's, clinical operator's and device manufacturer's points of view.

    Science.gov (United States)

    Czaplik, Michael; Voigt, Verena; Kenngott, Hannes; Clusmann, Hans; Hoffmann, Rüdiger; Will, Armin

    2018-02-23

    In the past decades, modern medicine has been undergoing a change in the direction of digitalisation and automation. Not only the integration of new digital technologies, but also the interconnection of all components can simplify clinical processes and allow progress and development of new innovations. The integration and interconnection of medical devices with each other and with information technology (IT) systems was addressed within the framework of the Federal Ministry of Education and Research (BMBF)-funded lighthouse project OR.NET ("Secure dynamic networking in the operating room and clinic".) (OR.net-Forschungskonsortium (OR.net Research Syndicate.) OR.net - Sichere dynamische Vernetzung in Operationssaal und Klinik [Online]. Available: www.ornet.org. [last accessed 22 March 2017]). In this project the standards and concepts for interdisciplinary networking in the operating room (OR) were developed. In this paper, the diverse advantages of the OR.NET concept are presented and explained by the OR.NET "Medical Board". This board represents the forum of clinical users and includes clinicians and experts from various specialties. Furthermore, the opinion from the viewpoint of operators is presented. In a concluding comment of the "Operator Board", clinical user needs are aligned with technical requirements.

  5. Use of Portable Digital Devices to Analyze Autonomic Stress Response in Psychology Objective Structured Clinical Examination.

    Science.gov (United States)

    Beltrán-Velasco, Ana Isabel; Bellido-Esteban, Alberto; Ruisoto-Palomera, Pablo; Clemente-Suárez, Vicente Javier

    2018-01-12

    The aim of the present study was to explore changes in the autonomic stress response of Psychology students in a Psychology Objective Structured Clinical Examination (OSCE) and their relationship with OSCE performance. Variables of autonomic modulation by the analysis of heart rate variability in temporal, frequency and non-linear domains, subjective perception of distress strait and academic performance were measured before and after the two different evaluations that composed the OSCE. A psychology objective structured clinical examination composed by two different evaluation scenarios produced a large anxiety anticipatory response, a habituation response in the first of the evaluation scenarios and a in the entire evaluation, and a no habituation response in the second evaluation scenario. Autonomic modulation parameters do not correlate with academic performance of students.

  6. Blood transcriptomics: applications in toxicology

    Science.gov (United States)

    Joseph, Pius; Umbright, Christina; Sellamuthu, Rajendran

    2015-01-01

    The number of new chemicals that are being synthesized each year has been steadily increasing. While chemicals are of immense benefit to mankind, many of them have a significant negative impact, primarily owing to their inherent chemistry and toxicity, on the environment as well as human health. In addition to chemical exposures, human exposures to numerous non-chemical toxic agents take place in the environment and workplace. Given that human exposure to toxic agents is often unavoidable and many of these agents are found to have detrimental human health effects, it is important to develop strategies to prevent the adverse health effects associated with toxic exposures. Early detection of adverse health effects as well as a clear understanding of the mechanisms, especially at the molecular level, underlying these effects are key elements in preventing the adverse health effects associated with human exposure to toxic agents. Recent developments in genomics, especially transcriptomics, have prompted investigations into this important area of toxicology. Previous studies conducted in our laboratory and elsewhere have demonstrated the potential application of blood gene expression profiling as a sensitive, mechanistically relevant and practical surrogate approach for the early detection of adverse health effects associated with exposure to toxic agents. The advantages of blood gene expression profiling as a surrogate approach to detect early target organ toxicity and the molecular mechanisms underlying the toxicity are illustrated and discussed using recent studies on hepatotoxicity and pulmonary toxicity. Furthermore, the important challenges this emerging field in toxicology faces are presented in this review article. PMID:23456664

  7. Evolution of toxicology information systems

    Energy Technology Data Exchange (ETDEWEB)

    Wassom, J.S.; Lu, P.Y. [Oak Ridge National Laboratory, TN (United States)

    1990-12-31

    Society today is faced with new health risk situations that have been brought about by recent scientific and technical advances. Federal and state governments are required to assess the many potential health risks to exposed populations from the products (chemicals) and by-products (pollutants) of these advances. Because a sound analysis of any potential health risk should be based on the use of relevant information, it behooves those individuals responsible for making the risk assessments to know where to obtain needed information. This paper reviews the origins of toxicology information systems and explores the specialized information center concept that was proposed in 1963 as a means of providing ready access to scientific and technical information. As a means of illustrating this concept, the operation of one specialized information center (the Environmental Mutagen Information Center at Oak Ridge National Laboratory) will be discussed. Insights into how toxicological information resources came into being, their design and makeup, will be of value to those seeking to acquire information for risk assessment purposes. 7 refs., 1 fig., 4 tabs.

  8. Toxicological profile for thorium. Draft report (Final)

    International Nuclear Information System (INIS)

    1990-10-01

    The ATSDR Toxicological Profile for Thorium is intended to characterize succinctly the toxicological and health effects information for the substance. It identifies and reviews the key literature that describes the substance's toxicological properties. Other literature is presented but described in less detail. The profile is not intended to be an exhaustive document; however, more comprehensive sources of specialty information are referenced. The profile begins with a public health statement, which describes in nontechnical language the substance's relevant toxicological properties. Following the statement is material that presents levels of significant human exposure and, where known, significant health effects. The adequacy of information to determine the substance's health effects is described. Research gaps in nontoxic and health effects information are described. Research gaps that are of significance to the protection of public health will be identified in a separate effort. The focus of the document is on health and toxicological information

  9. Toxicological profile for uranium. Final report

    International Nuclear Information System (INIS)

    1990-12-01

    The ATSDR Toxicological Profile for Uranium is intended to characterize succinctly the toxicological and health effects information for the substance. It identifies and reviews the key literature that describes the substances's toxicological properties. Other literature is presented but described in less detail. The profile is not intended to be an exhaustive document; however, more comprehensive sources of specialty information are referenced. The profile begins with a public health statement, which describes in nontechnical language the substance's relevant toxicological properties. Following the statement is material that presents levels of significant human exposure and, where known, significant health effects. The adequacy of information to determine the substance's health effects is described. Research gaps in nontoxic and health effects information are described. Research gaps that are of significance to the protection of public health will be identified in a separate effort. The focus of the document is on health and toxicological information

  10. Toxicological profile for radon. Final report

    International Nuclear Information System (INIS)

    1990-12-01

    The ATSDR Toxicological Profile for Radon is intended to characterize succinctly the toxicological and health effects information for the substance. It identifies and reviews the key literature that describes the substance's toxicological properties. Other literature is presented but described in less detail. The profile is not intended to be an exhaustive document; however, more comprehensive sources of specialty information are referenced. The profile begins with a public health statement, which describes in nontechnical language the substance's relevant toxicological properties. Following the statement is material that presents levels of significant human exposure and, where known, significant health effects. The adequacy of information to determine the substance's health effects is described. Research gaps in nontoxic and health effects information are described. Research gaps that are of significance to the protection of public health will be identified in a separate effort. The focus of the document is on health and toxicological information

  11. Toxicological profile for plutonium. Final report

    International Nuclear Information System (INIS)

    1990-12-01

    The ATSDR Toxicological Profile for Plutonium is intended to characterize succinctly the toxicological and health effects information for the substance. It identifies and reviews the key literature that describes the substance's toxicological properties. Other literature is presented but described in less detail. The profile is not intended to be an exhaustive document; however, more comprehensive sources of specialty information are referenced. The profile begins with a public health statement, which describes in nontechnical language the substance's relevant toxicological properties. Following the statement is material that presents levels of significant human exposure and, where known, significant health effects. The adequacy of information to determine the substance's health effects is described. Research gaps in nontoxic and health effects information are described. Research gaps that are of significance to the protection of public health will be identified in a separate effort. The focus of the document is on health and toxicological information

  12. Toxicological profile for radium. Final report

    International Nuclear Information System (INIS)

    1990-12-01

    The ATSDR Toxicological Profile for Radium is intended to characterize succinctly the toxicological and health effects information for the substance. It identifies and reviews the key literature that describes the substances' toxicological properties. Other literature is presented but described in less detail. The profile is not intended to be an exhaustive document; however, more comprehensive sources of specialty information are referenced. The profile begins with a public health statement, which describes in nontechnical language the substance's relevant toxicological properties. Following the statement is material that presents levels of significant human exposure and, where known, significant health effects. The adequacy of information to determine the substance's health effects is described. Research gaps in nontoxic and health effects information are described. Research gaps that are of significance to the protection of public health will be identified in a separate effort. The focus of the document is on health and toxicological information

  13. Toxicology

    Science.gov (United States)

    Macewen, J. W.

    1973-01-01

    Oxygen toxicity is examined, including the effects of oxygen partial pressure variations on toxicity and oxygen effects on ozone and nitrogen dioxide toxicity. Toxicity of fuels and oxidizers, such as hydrazines, are reported. Carbon monoxide, spacecraft threshold limit values, emergency exposure limits, spacecraft contaminants, and water quality standards for space missions are briefly summarized.

  14. Preliminary clinical evaluation of a noninvasive device for the measurement of coagulability in the elderly.

    Science.gov (United States)

    Lerman, Yaffa; Werber, Moshe M; Fine, Ilya; Kemelman, Polina

    2011-01-01

    The feasibility of the noninvasive assessment of blood 'coagulability' (the tendency to coagulate) has been tested by using a novel device, the Thrombo-Monitor. It monitors, by using the principles of near infra-red (NIR) dynamic light scattering, the tendency of blood to create clots. The Thrombo-Monitor observes the very initial changes of blood viscosity, which occurs due to the temporarily induced stasis of capillary blood of the finger. One hundred and fifteen patients aged >65 years (matched by age and sex) participated in the study. Patients were initially divided into four groups based on the patient's medical therapy. The study groups were: warfarin, enoxaparin, aspirin and/or clopidogrel, and a control group. The medications were given according to the patient's comorbidities (eg, atrial fibrillation [AF], status post pulmonary embolism [S/p PE], status post cerebrovascular accident [S/p CVA]). The Thrombo-Monitor Index (TMI) is a noninvasive index, derived on the basis of laboratory test results of international normalized ratio (INR) and prothrombin time (PT) values. For the group of patients who were treated only with warfarin, TMI was adjusted by using the jackknife statistical approach to create maximum correlation and linearity with INR and PT values that ranged from 1.1 to 5.0. For all warfarin patients (N = 35) the TMI was found to have a good correlation with INR and PT values (R(2) = 0.64, P index is significantly correlated with INR and PT values.

  15. Extracorporeal liver assist device to exchange albumin and remove endotoxin in acute liver failure: Results of a pivotal pre-clinical study.

    Science.gov (United States)

    Lee, Karla C L; Baker, Luisa A; Stanzani, Giacomo; Alibhai, Hatim; Chang, Yu Mei; Jimenez Palacios, Carolina; Leckie, Pamela J; Giordano, Paola; Priestnall, Simon L; Antoine, Daniel J; Jenkins, Rosalind E; Goldring, Christopher E; Park, B Kevin; Andreola, Fausto; Agarwal, Banwari; Mookerjee, Rajeshwar P; Davies, Nathan A; Jalan, Rajiv

    2015-09-01

    In acute liver failure, severity of liver injury and clinical progression of disease are in part consequent upon activation of the innate immune system. Endotoxaemia contributes to innate immune system activation and the detoxifying function of albumin, critical to recovery from liver injury, is irreversibly destroyed in acute liver failure. University College London-Liver Dialysis Device is a novel artificial extracorporeal liver assist device, which is used with albumin infusion, to achieve removal and replacement of dysfunctional albumin and reduction in endotoxaemia. We aimed to test the effect of this device on survival in a pig model of acetaminophen-induced acute liver failure. Pigs were randomised to three groups: Acetaminophen plus University College London-Liver Dialysis Device (n=9); Acetaminophen plus Control Device (n=7); and Control plus Control Device (n=4). Device treatment was initiated two h after onset of irreversible acute liver failure. The Liver Dialysis Device resulted in 67% reduced risk of death in acetaminophen-induced acute liver failure compared to Control Device (hazard ratio=0.33, p=0.0439). This was associated with 27% decrease in circulating irreversibly oxidised human non-mercaptalbumin-2 throughout treatment (p=0.046); 54% reduction in overall severity of endotoxaemia (p=0.024); delay in development of vasoplegia and acute lung injury; and delay in systemic activation of the TLR4 signalling pathway. Liver Dialysis Device-associated adverse clinical effects were not seen. The survival benefit and lack of adverse effects would support clinical trials of University College London-Liver Dialysis Device in acute liver failure patients. Copyright © 2015 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

  16. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

    Science.gov (United States)

    Fraser, Alan G; Daubert, Jean-Claude; Van de Werf, Frans; Estes, N A Mark; Smith, Sidney C; Krucoff, Mitchell W; Vardas, Panos E; Komajda, Michel

    2011-07-01

    The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

  17. Hair: a complementary source of bioanalytical information in forensic toxicology.

    Science.gov (United States)

    Barroso, Mário; Gallardo, Eugenia; Vieira, Duarte Nuno; López-Rivadulla, Manuel; Queiroz, João António

    2011-01-01

    Hair has been used for years in the assessment and documentation of human exposure to drugs, as it presents characteristics that make it extremely valuable for this purpose, namely the fact that sample collection is performed in a noninvasive manner, under close supervision, the possibility of collecting a specimen reflecting a similar timeline in the case of claims or suspicion of a leak in the chain of custody, and the increased window of detection for the drugs. For these reasons, testing for drugs in hair provides unique and useful information in several fields of toxicology, from which the most prominent is the possibility of studying individual drug use histories by means of segmental analysis. This paper will review the unique role of hair as a complementary sample in documenting human exposure to drugs in the fields of clinical and forensic toxicology and workplace drug testing.

  18. Use of piezosurgery device in management of oral surgery complications: clincal case and clinical experience report.

    Science.gov (United States)

    Sammartino, G; Riccitiello, F; Trosino, O; Marenzi, G; Cioffi, A; Mortellaro, C

    2012-05-01

    The root displacement into the maxillary sinus could be a complication of oral surgery in the upper jaw. In these cases, the root removal is needed in order to avoid the occurrence of sinus pathologies. Piezosurgery techniques could assure a safer management of such complications, because of the clear surgical visibility and the selective ability of cut. The aim of this article is to present a case of oral surgery complication (root displacement in the right maxillary sinus), in which piezosurgery technique helped for a correct and safe clinical management, allowing to reduce the soft tissue damage.

  19. Interoperability of medical device information and the clinical applications: an HL7 RMIM based on the ISO/IEEE 11073 DIM.

    Science.gov (United States)

    Yuksel, Mustafa; Dogac, Asuman

    2011-07-01

    Medical devices are essential to the practice of modern healthcare services. Their benefits will increase if clinical software applications can seamlessly acquire the medical device data. The need to represent medical device observations in a format that can be consumable by clinical applications has already been recognized by the industry. Yet, the solutions proposed involve bilateral mappings from the ISO/IEEE 11073 Domain Information Model (DIM) to specific message or document standards. Considering that there are many different types of clinical applications such as the electronic health record and the personal health record systems, the clinical workflows, and the clinical decision support systems each conforming to different standard interfaces, detailing a mapping mechanism for every one of them introduces significant work and, thus, limits the potential health benefits of medical devices. In this paper, to facilitate the interoperability of clinical applications and the medical device data, we use the ISO/IEEE 11073 DIM to derive an HL7 v3 Refined Message Information Model (RMIM) of the medical device domain from the HL7 v3 Reference Information Mode (RIM). This makes it possible to trace the medical device data back to a standard common denominator, that is, HL7 v3 RIM from which all the other medical domains under HL7 v3 are derived. Hence, once the medical device data are obtained in the RMIM format, it can easily be transformed into HL7-based standard interfaces through XML transformations because these interfaces all have their building blocks from the same RIM. To demonstrate this, we provide the mappings from the developed RMIM to some of the widely used HL7 v3-based standard interfaces.

  20. Mobile devices for the remote acquisition of physiological and behavioral biomarkers in psychiatric clinical research.

    Science.gov (United States)

    W Adams, Zachary; McClure, Erin A; Gray, Kevin M; Danielson, Carla Kmett; Treiber, Frank A; Ruggiero, Kenneth J

    2017-02-01

    Psychiatric disorders are linked to a variety of biological, psychological, and contextual causes and consequences. Laboratory studies have elucidated the importance of several key physiological and behavioral biomarkers in the study of psychiatric disorders, but much less is known about the role of these biomarkers in naturalistic settings. These gaps are largely driven by methodological barriers to assessing biomarker data rapidly, reliably, and frequently outside the clinic or laboratory. Mobile health (mHealth) tools offer new opportunities to study relevant biomarkers in concert with other types of data (e.g., self-reports, global positioning system data). This review provides an overview on the state of this emerging field and describes examples from the literature where mHealth tools have been used to measure a wide array of biomarkers in the context of psychiatric functioning (e.g., psychological stress, anxiety, autism, substance use). We also outline advantages and special considerations for incorporating mHealth tools for remote biomarker measurement into studies of psychiatric illness and treatment and identify several specific opportunities for expanding this promising methodology. Integrating mHealth tools into this area may dramatically improve psychiatric science and facilitate highly personalized clinical care of psychiatric disorders. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Clinical results with the Trabectome, a novel surgical device for treatment of open-angle glaucoma.

    Science.gov (United States)

    Minckler, Don; Baerveldt, George; Ramirez, Marina Alfaro; Mosaed, Sameh; Wilson, Richard; Shaarawy, Tarek; Zack, Barend; Dustin, Laurie; Francis, Brian

    2006-01-01

    To describe treatment outcomes after Trabectome surgery in an initial series of 101 patients with open-angle glaucoma. A 19-gauge microelectrosurgical device enabled ab interno removal of a strip of trabecular meshwork and inner wall of Schlemm's canal under gonioscopic control with continual infusion and foot-pedal control of aspiration and electrosurgery. A smooth, pointed ceramic-coated insulating footplate was inserted into Schlemm's canal to act as a guide within the canal and to protect adjacent structures from mechanical or heat injury during ablation of a 30- to 90-degree arc of angle tissue. Mean preoperative intraocular pressure (IOP) in the initial 101 patients was 27.6 +/- 7.2 mm Hg. Thirty months postoperatively, mean IOP was 16.3 +/- 3.3 mm Hg (n = 11). The mean percentage drop over the whole course of follow-up was 40%. At all times postoperatively, the absolute and percent decrease in IOP from preoperative levels were statistically significant (paired t test, P < .0001). Overall success (IOP

  2. The Toxicology Investigators Consortium Case Registry--the 2014 Experience.

    Science.gov (United States)

    Rhyee, Sean H; Farrugia, Lynn; Campleman, Sharan L; Wax, Paul M; Brent, Jeffrey

    2015-12-01

    The Toxicology Investigators Consortium (ToxIC) Case Registry was established in 2010 by the American College of Medical Toxicology. The Registry includes all medical toxicology consultations performed at participating sites. The Registry was queried for all cases entered between January 1 and December 31, 2014. Specific data reviewed for analysis included demographics (age, gender, ethnicity), source of consultation, reasons for consultation, agents involved in toxicological exposures, signs, symptoms, clinical findings, fatalities, and treatment. In 2014, 9172 cases were entered in the Registry across 47 active member sites. Females accounted for 51.1 % of cases. The majority (65.1 %) of cases were adults between the ages of 19 and 65. Caucasians made up the largest identified ethnic group (48.9 %). Most Registry cases originated from the inpatient setting (93.5 %), with a large majority of these consultations coming from the emergency department or inpatient admission services. Intentional and unintentional pharmaceutical exposures continued to be the most frequent reasons for consultation, accounting for 61.7 % of cases. Among cases of intentional pharmaceutical exposure, 62.4 % were associated with a self-harm attempt. Non-pharmaceutical exposures accounted for 14.1 % of Registry cases. Similar to the past years, non-opioid analgesics, sedative-hypnotics, and opioids were the most commonly encountered agents. Clinical signs or symptoms were noted in 81.9 % of cases. There were 89 recorded fatalities (0.97 %). Medical treatment (e.g., antidotes, antivenom, chelators, supportive care) was rendered in 62.3 % of cases. Patient demographics and exposure characteristics in 2014 Registry cases remain similar to prior years. The majority of consultations arose in the acute care setting (emergency department or inpatient) and involved exposures to pharmaceutical products. Among exposures, non-opioid analgesics, sedative/hypnotics, and opioids were the most frequently

  3. Preliminary clinical evaluation of a noninvasive device for the measurement of coagulability in the elderly

    Directory of Open Access Journals (Sweden)

    Lerman Y

    2011-08-01

    Full Text Available Yaffa Lerman1, Moshe M Werber2, Ilya Fine2, Polina Kemelman11Department of Geriatrics, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; 2Elfi-Tech Ltd, Rehovot, IsraelAbstract: The feasibility of the noninvasive assessment of blood ‘coagulability’ (the tendency to coagulate has been tested by using a novel device, the Thrombo-Monitor. It monitors, by using the principles of near infra-red (NIR dynamic light scattering, the tendency of blood to create clots. The Thrombo-Monitor observes the very initial changes of blood viscosity, which occurs due to the temporarily induced stasis of capillary blood of the finger. One hundred and fifteen patients aged >65 years (matched by age and sex participated in the study. Patients were initially divided into four groups based on the patient’s medical therapy. The study groups were: warfarin, enoxaparin, aspirin and/or clopidogrel, and a control group. The medications were given according to the patient’s comorbidities (eg, atrial fibrillation [AF], status post pulmonary embolism [S/p PE], status post cerebrovascular accident [S/p CVA]. The Thrombo-Monitor Index (TMI is a noninvasive index, derived on the basis of laboratory test results of international normalized ratio (INR and prothrombin time (PT values. For the group of patients who were treated only with warfarin, TMI was adjusted by using the jackknife statistical approach to create maximum correlation and linearity with INR and PT values that ranged from 1.1 to 5.0. For all warfarin patients (N = 35 the TMI was found to have a good correlation with INR and PT values (R2 = 0.64, P < 0.00001; mean TMI = 1.86 (SD = 0.91; mean INR and PT = 2.3 (SD = 0.91. The calibration curve thus generated was used to calculate the TMI for all other groups: aspirin group, mean TMI = 1.3 (SD = 0.14, N = 23, corresponding approximately to INR and PT values of 1.036; enoxaparin group (N = 24, mean TMI = 1.34 (SD

  4. Clinical evaluation of a novel microneedle device for intradermal delivery of an influenza vaccine: are all delivery methods the same?

    Science.gov (United States)

    Levin, Yotam; Kochba, Efrat; Kenney, Richard

    2014-07-23

    The skin provides the largest immune barrier to infection and is a readily accessible site for vaccination, although intradermal (ID) injection can be challenging. The MicronJet™ microneedle is a novel device that consistently injects antigens very close to the skin's dendritic cells. A dose-sparing ID injection study was conducted in 280 healthy adult volunteers using trivalent virosomal adjuvanted influenza vaccine. ID injection of 3 μg using the MicronJet™ was well tolerated and showed a statistically higher geometric mean fold rise than the same dose ID using a conventional needle (Mantoux technique) for the H1N1 and B strains or a 15 μg intramuscular (IM) injection for the H3N2 strain. Thus, the immune response appears to partially depend on the delivery device and route of injection. The MicronJet™ may allow dose-sparing, yet give a superior response in influenza vaccination and warrants further clinical evaluation. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Development of transfer standard devices for ensuring the accurate calibration of ultrasonic physical therapy machines in clinical use

    International Nuclear Information System (INIS)

    Hekkenberg, R T; Richards, A; Beissner, K; Zeqiri, B; Prout, G; Cantrall, Ch; Bezemer, R A; Koch, Ch; Hodnett, M

    2004-01-01

    Physical therapy ultrasound is widely applied to patients. However, many devices do not comply with the relevant standard stating that the actual power output shall be within ±20% of the device indication. Extreme cases have been reported: from delivering effectively no ultrasound or operating at maximum power at all powers indicated. This can potentially lead to patient injury as well as mistreatment. The present European (EC) project is an ongoing attempt to improve the quality of the treatment of patients being treated with ultrasonic physical-therapy. A Portable ultrasound Power Standard (PPS) is being developed and accurately calibrated. The PPS includes: Ultrasound transducers (including one exhibiting an unusual output) and a driver for the ultrasound transducers that has calibration and proficiency test functions. Also included with the PPS is a Cavitation Detector to determine the onset of cavitation occurring within the propagation medium. The PPS will be suitable for conducting in-the-field accreditation (proficiency testing and calibration). In order to be accredited it will be important to be able to show traceability of the calibration, the calibration process and qualification of testing staff. The clinical user will benefit from traceability because treatments will be performed more reliably

  6. Method Development in Forensic Toxicology.

    Science.gov (United States)

    Peters, Frank T; Wissenbach, Dirk K; Busardo, Francesco Paolo; Marchei, Emilia; Pichini, Simona

    2017-01-01

    In the field of forensic toxicology, the quality of analytical methods is of great importance to ensure the reliability of results and to avoid unjustified legal consequences. A key to high quality analytical methods is a thorough method development. The presented article will provide an overview on the process of developing methods for forensic applications. This includes the definition of the method's purpose (e.g. qualitative vs quantitative) and the analytes to be included, choosing an appropriate sample matrix, setting up separation and detection systems as well as establishing a versatile sample preparation. Method development is concluded by an optimization process after which the new method is subject to method validation. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  7. Testing of Binders Toxicological Effects

    Science.gov (United States)

    Strokova, V.; Nelyubova, V.; Rykunova, M.

    2017-11-01

    The article presents the results of a study of the toxicological effect of binders with different compositions on the vital activity of plant and animal test-objects. The analysis of the effect on plant cultures was made on the basis of the phytotesting data. The study of the effect of binders on objects of animal origin was carried out using the method of short-term testing. Based on the data obtained, binders are ranked according to the degree of increase in the toxic effect: Gypsum → Portland cement → Slag Portland cement. Regardless of the test-object type, the influence of binders is due to the release of various elements (calcium ions or heavy metals) into the solution. In case of plant cultures, the saturation of the solution with elements has a positive effect (there is no inhibitory effect), and in case of animal specimens - an increase in the toxic effect.

  8. Predictive toxicology: the paths of the future

    International Nuclear Information System (INIS)

    Detilleux, Ph.; Vallier, L.; Legallais, C.; Leclerc, E.; Prot, J.M.; Choucha, L.; Baudoin, R.; Dufresne, M.; Gautier, A.; Carpentier, B.; Mansuy, D.; Pery, A.; Brochot, C.; Manivet, Ph.; Rabilloud, Th.; Spire, C.; Coumoul, X.; Junot, Ch.; Laprevote, O.; Le pape, A.; Le Guevel, R.; Tourneur, E.; Ben Mkaddem, S.; Chassin, C.; Aloulou, M.; Goujon, J.M.; Hertif, A.; Ouali, N.; Vimont, S.; Monteiro, R.; Rondeau, E.; Elbim, C.; Werts, C.; Vandewalle, A.; Ben Mkaddem, S.; Pedruzzi, E.; Coant, N.; Bens, M.; Cluzeaud, F.; Ogier-Denis, E.; Pongnimitprasert, N.; Babin-Chevaye, C.; Fay, M.; Bernard, M.; Dupuy, C.; Ei Benna, J.; Gougerot-Pocidale, M.A.; Braut-Boucher, F.; Pinton, Ph.; Lucioli, J.; Tsybulskyy, D.; Joly, B.; Laffitte, J.; Bourges-Abella, N.; Oswald, I.P.; Kolf-Clauw, M.; Pierre, St.; Bats, A.S.; Chevallier, A.; Bui, L.Ch.; Ambolet-Camoit, A.; Garlatti, M.; Aggerbeck, M.; Barouki, R.; Al Khansa, I.; Blanck, O.; Guillouzo, A.; Bars, R.; Rouas, C.; Bensoussan, H.; Suhard, D.; Tessier, C.; Grandcolas, L.; Pallardy, M.; Gueguen, Y.; Sparfel, L.; Pinel-Marie, M.L.; Boize, M.; Koscielny, S.; Desmots, S.; Pery, A.; Fardel, O.; Alvergnas, M.; Rouleau, A.; Lucchi, G.; Mantion, G.; Heyd, B.; Richert, L.; Ducoroy, P.; Martin, H.; Val, St.; Martinon, L.; Cachier, H.; Yahyaoui, A.; Marfaing, H.; Baeza-Squiban, A.; Martin-Chouly, C.; Bonvallet, M.; Morzadec, C.; Fardel, O.; Vernhet, L.; Baverel, G.; El Hage, M.; Nazaret, R.; Conjard-Duplany, A.; Ferrier, B.; Martin, G.; Legendre, A.; Desmots, S.; Lecomte, A.; Froment, P.; Habert, R.; Lemazurier, E.; Robinel, F.; Dupont, O.; Sanfins, E.; Dairou, J.; Chaffotte, A.F.; Busi, F.; Rodrigues Lima, F.; Dupret, J.M.; Mayati, A.; Le Ferrec, E.; Levoin, N.; Paris, H.; Uriac, Ph.; N'Diaye, M.; Lagadic-Gossmann, D.; Fardel, O.; Assemat, E.; Boublil, L.; Borot, M.C.; Marano, F.; Baeza-Squiban, A.; Martiny, V.Y.; Moroy, G.; Badel, A.; Miteva, M.A.; Hussain, S.; Ferecatu, I.; Borot, C.; Andreau, K.; Baeza-Squiban, A.; Marano, F.; Boland, S.; Leroux, M.; Zucchini-Pascal, N.; Peyre, L.; Rahmani, R.; Buron, N.; Porcedou, M.; Fromenty, B.; Borgne-Sanchez, A.; Rogue, A.; Spire, C.; Claude, N.; Guillouzo, A.

    2010-01-01

    Prevention of possible noxious effects in relation with the exposure to one or several chemical, physical or biological agents present in our domestic or professional environment is one of today's big public health stakes. Another stake is the better assessment of the risks linked with the use of health-care products. The efficacy and predictiveness of toxicology studies are directly related to the combination of alternate complementary methods and animal experiments (obtaining data from different species and with different models: in vitro, ex vivo and in vivo). Despite important efforts, the toxicological evaluation remains perfectible. The proceedings of this 2010 congress of the French Society of cell pharmaco-toxicology deal with recent advances, both scientific and technological, in 'predictive toxicology'. Four main topics are approached: cell and organ models, 'omics', in silico modeling, and new technologies (imaging, cell ships, high-speed processing). Among the different presentations, 3 abstracts present some recent advances in imaging techniques applied to toxicology studies. These are: 1 - first uses in toxicology of TOF-SIMS mass spectroscopy imaging (O. Laprevote, Paris-Descartes Univ. (FR)); 2 - Small animal imaging, a tool for predictive toxicology (A. Le Pape, CNRS Orleans (FR)); 3 - uranium localization at cell level using SIMS imaging technique (C. Rouas et al., IRSN Fontenay-aux-Roses (FR)). (J.S.)

  9. Historical perspectives on cadmium toxicology

    International Nuclear Information System (INIS)

    Nordberg, Gunnar F.

    2009-01-01

    The first health effects of cadmium (Cd) were reported already in 1858. Respiratory and gastrointestinal symptoms occurred among persons using Cd-containing polishing agent. The first experimental toxicological studies are from 1919. Bone effects and proteinuria in humans were reported in the 1940's. After World War II, a bone disease with fractures and severe pain, the itai-itai disease, a form of Cd-induced renal osteomalacia, was identified in Japan. Subsequently, the toxicokinetics and toxicodynamics of Cd were described including its binding to the protein metallothionein. International warnings of health risks from Cd-pollution were issued in the 1970's. Reproductive and carcinogenic effects were studied at an early stage, but a quantitative assessment of these effects in humans is still subject to considerable uncertainty. The World Health Organization in its International Program on Chemical Safety, WHO/IPCS (1992) (Cadmium. Environmental Health Criteria Document 134, IPCS. WHO, Geneva, 1-280.) identified renal dysfunction as the critical effect and a crude quantitative evaluation was presented. In the 1990's and 2000 several epidemiological studies have reported adverse health effects, sometimes at low environmental exposures to Cd, in population groups in Japan, China, Europe and USA (reviewed in other contributions to the present volume). The early identification of an important role of metallothionein in cadmium toxicology formed the basis for recent studies using biomarkers of susceptibility to development of Cd-related renal dysfunction such as gene expression of metallothionein in peripheral lymphocytes and autoantibodies against metallothionein in blood plasma. Findings in these studies indicate that very low exposure levels to cadmium may give rise to renal dysfunction among sensitive subgroups of human populations such as persons with diabetes.

  10. Clinical research device for ovarian cancer detection by optical spectroscopy in the ultraviolet C-visible

    Science.gov (United States)

    George, Ronie; Chandrasekaran, Archana; Brewer, Molly A.; Hatch, Kenneth D.; Utzinger, Urs

    2010-09-01

    Early detection of ovarian cancer could greatly increase the likelihood of successful treatment. However, present detection techniques are not very effective, and symptoms are more commonly seen in later stage disease. Amino acids, structural proteins, and enzymatic cofactors have endogenous optical properties influenced by precancerous changes and tumor growth. We present the technical details of an optical spectroscopy system used to quantify these properties. A fiber optic probe excites the surface epithelium (origin of 90% of cases) over 270 to 580 nm and collects fluorescence and reflectance at 300 to 800 nm with four or greater orders of magnitude instrument to background suppression. Up to four sites per ovary are investigated on patients giving consent to oophorectomy and the system's in vivo optical evaluation. Data acquisition is completed within 20 s per site. We illustrate design, selection, and development of the components used in the system. Concerns relating to clinical use, performance, calibration, and quality control are addressed. In the future, spectroscopic data will be compared with histological biopsies from the corresponding tissue sites. If proven effective, this technique can be useful in screening women at high risk of developing ovarian cancer to determine whether oophorectomy is necessary.

  11. Respiratory rates measured by a standardised clinical approach, ward staff, and a wireless device

    DEFF Research Database (Denmark)

    Granholm, A; Pedersen, N E; Lippert, A.

    2016-01-01

    in a medical ward. Respiratory rate was measured by three methods: a standardised approach over 60 s while patients lay still and refrained from talking, by ward staff and by a wireless electronic patch (SensiumVitals). The Bland-Altman method was used to compare measurements and three breaths per minute (BPM......) was considered a clinically relevant difference. RESULTS: We included 50 patients. The mean difference between the standardised approach and the electronic measurement was 0.3 (95% CI: -1.4 to 2.0) BPM; 95% limits of agreement were -11.5 (95% CI: -14.5 to -8.6) and 12.1 (95% CI: 9.2 to 15.1) BPM. Removal...... of three outliers with huge differences lead to a mean difference of -0.1 (95% CI: -0.7 to 0.5) BPM and 95% limits of agreement of -4.2 (95% CI: -5.3 to -3.2) BPM and 4.0 (95% CI: 2.9 to 5.0) BPM. The mean difference between staff and electronic measurements was 1.7 (95% CI: -0.5 to 3.9) BPM; 95% limits...

  12. Validation of a new strength measurement device for amyotrophic lateral sclerosis clinical trials.

    Science.gov (United States)

    Andres, Patricia L; Skerry, Linda M; Munsat, Theodore L; Thornell, Brenda J; Szymonifka, Jackie; Schoenfeld, David A; Cudkowicz, Merit E

    2012-01-01

    Strength measures with reduced variability and higher sensitivity could improve efficiency in clinical trials of amyotrophic lateral sclerosis (ALS). The Accurate Test of Limb Isometric Strength (ATLIS) was developed to precisely and conveniently measure force in 12 muscle groups. In this study we evaluate the reliability and validity of the ATLIS testing protocol. Twenty healthy adults and 10 patients with ALS were tested twice by the same or by different evaluators to determine test-retest and interrater reliability. Twenty healthy adults were examined using ATLIS and a well-validated strength testing protocol (TQNE) to assess criterion-based validity. Mean absolute variation between tests was 8.6%, and intraclass correlation coefficients for each muscle group were high (range 0.82-0.99). The Pearson correlation coefficient of mean ATLIS and TQNE scores was 0.90. A subject survey demonstrated high user acceptance of ATLIS. ATLIS is convenient for patients and evaluators, produces precise strength measurements, and is easily moved between examining rooms. Copyright © 2011 Wiley Periodicals, Inc.

  13. Predictive Toxicology: Current Status and Future Outlook (EBI ...

    Science.gov (United States)

    Slide presentation at the EBI-EMBL Industry Programme Workshop on Predictive Toxicology and the currently status of Computational Toxicology activities at the US EPA. Slide presentation at the EBI-EMBL Industry Programme Workshop on Predictive Toxicology and the currently status of Computational Toxicology activities at the US EPA.

  14. Effect of a Scalp Cooling Device on Alopecia in Women Undergoing Chemotherapy for Breast Cancer: The SCALP Randomized Clinical Trial.

    Science.gov (United States)

    Nangia, Julie; Wang, Tao; Osborne, Cynthia; Niravath, Polly; Otte, Kristen; Papish, Steven; Holmes, Frankie; Abraham, Jame; Lacouture, Mario; Courtright, Jay; Paxman, Richard; Rude, Mari; Hilsenbeck, Susan; Osborne, C Kent; Rimawi, Mothaffar

    2017-02-14

    Chemotherapy may induce alopecia. Although scalp cooling devices have been used to prevent this alopecia, efficacy has not been assessed in a randomized clinical trial. To assess whether a scalp cooling device is effective at reducing chemotherapy-induced alopecia and to assess adverse treatment effects. Multicenter randomized clinical trial of women with breast cancer undergoing chemotherapy. Patients were enrolled from December 9, 2013, to September 30, 2016. One interim analysis was planned to allow the study to stop early for efficacy. Data reported are from the interim analysis. This study was conducted at 7 sites in the United States, and 182 women with breast cancer requiring chemotherapy were enrolled and randomized. Participants were randomized to scalp cooling (n = 119) or control (n = 63). Scalp cooling was done using a scalp cooling device. The primary efficacy end points were successful hair preservation assessed using the Common Terminology Criteria for Adverse Events version 4.0 scale (grade 0 [no hair loss] or grade 1 [Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, Hospital Anxiety and Depression Scale, and a summary scale of the Body Image Scale. At the time of the interim analysis, 142 participants were evaluable. The mean (SD) age of the patients was 52.6 (10.1) years; 36% (n = 51) received anthracycline-based chemotherapy and 64% (n = 91) received taxane-based chemotherapy. Successful hair preservation was found in 48 of 95 women with cooling (50.5%; 95% CI, 40.7%-60.4%) compared with 0 of 47 women in the control group (0%; 95% CI, 0%-7.6%) (success rate difference, 50.5%; 95% CI, 40.5%-60.6%). Because the 1-tailed P value from the Fisher exact test was women with stage I to II breast cancer receiving chemotherapy with a taxane, anthracycline, or both, those who underwent scalp cooling were significantly more likely to have less than 50% hair loss after the fourth chemotherapy cycle

  15. Principles and procedures in forensic toxicology.

    Science.gov (United States)

    Wyman, John F

    2012-09-01

    The principles and procedures employed in a modern forensic toxicology lab are detailed in this review. Aspects of Behavioral and Postmortem toxicology, including certification of analysts and accreditation of labs, chain of custody requirements, typical testing services provided, rationale for specimen selection, and principles of quality assurance are discussed. Interpretation of toxicology results in postmortem specimens requires the toxicologist and pathologist to be cognizant of drug-drug interactions, drug polymorphisms and pharmacogenomics, the gross signs of toxic pathology, postmortem redistribution, confirmation of systemic toxicity in suspected overdoses, the possibility of developed tolerance, and the effects of decomposition on drug concentration.

  16. Immunological and toxicological risk assessment of e-cigarettes

    Directory of Open Access Journals (Sweden)

    Gagandeep Kaur

    2018-02-01

    Full Text Available Knowledge of the long-term toxicological and immunological effects of e-cigarette (e-cig aerosols remains elusive due to the relatively short existence of vaping. Therefore, we performed a systematic search of articles published in public databases and analysed the research evidence in order to provide critical information regarding e-cig safety. Electronic nicotine delivery systems (or e-cigs are an alternative to traditional cigarettes for the delivery of nicotine and are typically filled with glycerol or propylene glycol-based solutions known as e-liquids. Though present in lower quantities, e-cig aerosols are known to contain many of the harmful chemicals found in tobacco smoke. However, due to the paucity of experimental data and contradictory evidence, it is difficult to draw conclusive outcomes regarding toxicological, immunological and clinical impacts of e-cig aerosols. Excessive vaping has been reported to induce inflammatory responses including mitogen-activated protein kinase, Janus tyrosine kinase/signal transducer and activator of transcription and nuclear factor-κB signalling, similar to that induced by tobacco smoke. Based on recent evidence, prolonged exposure to some constituents of e-cig aerosols might result in respiratory complications such as asthma, chronic obstructive pulmonary disease and inflammation. Future studies are warranted that focus on establishing correlations between e-cig types, generations and e-liquid flavours and immunological and toxicological profiles to broaden our understanding about the effects of vaping.

  17. Immunological and toxicological risk assessment of e-cigarettes.

    Science.gov (United States)

    Kaur, Gagandeep; Pinkston, Rakeysha; Mclemore, Benathel; Dorsey, Waneene C; Batra, Sanjay

    2018-03-31

    Knowledge of the long-term toxicological and immunological effects of e-cigarette (e-cig) aerosols remains elusive due to the relatively short existence of vaping. Therefore, we performed a systematic search of articles published in public databases and analysed the research evidence in order to provide critical information regarding e-cig safety. Electronic nicotine delivery systems (or e-cigs) are an alternative to traditional cigarettes for the delivery of nicotine and are typically filled with glycerol or propylene glycol-based solutions known as e-liquids. Though present in lower quantities, e-cig aerosols are known to contain many of the harmful chemicals found in tobacco smoke. However, due to the paucity of experimental data and contradictory evidence, it is difficult to draw conclusive outcomes regarding toxicological, immunological and clinical impacts of e-cig aerosols. Excessive vaping has been reported to induce inflammatory responses including mitogen-activated protein kinase, Janus tyrosine kinase/signal transducer and activator of transcription and nuclear factor-κB signalling, similar to that induced by tobacco smoke. Based on recent evidence, prolonged exposure to some constituents of e-cig aerosols might result in respiratory complications such as asthma, chronic obstructive pulmonary disease and inflammation. Future studies are warranted that focus on establishing correlations between e-cig types, generations and e-liquid flavours and immunological and toxicological profiles to broaden our understanding about the effects of vaping. Copyright ©ERS 2018.

  18. Genetic toxicology in the 21st century: Reflections and future ...

    Science.gov (United States)

    A symposium at the 40th anniversary of the Environmental Mutagen Society, held from October 24–28, 2009 in St. Louis, MO, surveyed the current status and future directions of genetic toxicology. This article summarizes the presentations and provides a perspective on the future. An abbreviated history is presented, highlighting the current standard battery of genotoxicity assays and persistent challenges. Application of computational toxicology to safety testing within a regulatory setting is discussed as a means for reducing the need for animal testing and human clinical trials, and current approaches and applications of in silico genotoxicity screening approaches across the pharmaceutical industry were surveyed and are reported here. The expanded use of toxicogenomics to illuminate mechanisms and bridge genotoxicity and carcinogenicity, and new public efforts to use high-throughput screening technologies to address lack of toxicity evaluation for the backlog of thousands of industrial chemicals in the environment are detailed. The Tox21 project involves coordinated efforts of four U.S. Government regulatory/research entities to use new and innovative assays to characterize key steps in toxicity pathways, including genotoxic and nongenotoxic mechanisms for carcinogenesis. Progress to date, highlighting preliminary test results from the National Toxicology Program is summarized. Finally, an overview is presented of ToxCast™, a related research program of the

  19. MicroRNAs and toxicology: A love marriage

    Directory of Open Access Journals (Sweden)

    Elisabeth Schraml

    Full Text Available With the dawn of personalized medicine, secreted microRNAs (miRNAs have come into the very focus of biomarker development for various diseases. MiRNAs fulfil key requirements of diagnostic tools such as i non or minimally invasive accessibility, ii robust, standardized and non-expensive quantitative analysis, iii rapid turnaround of the test result and iv most importantly because they provide a comprehensive snapshot of the ongoing physiologic processes in cells and tissues that package and release miRNAs into cell-free space. These characteristics have also established circulating miRNAs as promising biomarker candidates for toxicological studies, where they are used as biomarkers of drug-, or chemical-induced tissue injury for safety assessment. The tissue-specificity and early release of circulating miRNAs upon tissue injury, when damage is still reversible, are main factors for their clinical utility in toxicology. Here we summarize in brief, current knowledge of this field. Keywords: microRNAs, Biomarker, Toxicology, Minimal-invasive, DILI

  20. Multiscale Toxicology- Building the Next Generation Tools for Toxicology

    Energy Technology Data Exchange (ETDEWEB)

    Retterer, S. T. [ORNL; Holsapple, M. P. [Battelle Memorial Institute

    2013-10-31

    A Cooperative Research and Development Agreement (CRADA) was established between Battelle Memorial Institute (BMI), Pacific Northwest National Laboratory (PNNL), Oak Ridge National Laboratory (ORNL), Brookhaven National Laboratory (BNL), Lawrence Livermore National Laboratory (LLNL) with the goal of combining the analytical and synthetic strengths of the National Laboratories with BMI's expertise in basic and translational medical research to develop a collaborative pipeline and suite of high throughput and imaging technologies that could be used to provide a more comprehensive understanding of material and drug toxicology in humans. The Multi-Scale Toxicity Initiative (MSTI), consisting of the team members above, was established to coordinate cellular scale, high-throughput in vitro testing, computational modeling and whole animal in vivo toxicology studies between MSTI team members. Development of a common, well-characterized set of materials for testing was identified as a crucial need for the initiative. Two research tracks were established by BMI during the course of the CRADA. The first research track focused on the development of tools and techniques for understanding the toxicity of nanomaterials, specifically inorganic nanoparticles (NPs). ORNL"s work focused primarily on the synthesis, functionalization and characterization of a common set of NPs for dissemination to the participating laboratories. These particles were synthesized to retain the same surface characteristics and size, but to allow visualization using the variety of imaging technologies present across the team. Characterization included the quantitative analysis of physical and chemical properties of the materials as well as the preliminary assessment of NP toxicity using commercially available toxicity screens and emerging optical imaging strategies. Additional efforts examined the development of high-throughput microfluidic and imaging assays for measuring NP uptake, localization, and

  1. Toxicological Evaluation of Lactase Derived from Recombinant Pichia pastoris

    Science.gov (United States)

    Liu, Yifei; Chen, Delong; Luo, Yunbo; Huang, Kunlun; Zhang, Wei; Xu, Wentao

    2014-01-01

    A recombinant lactase was expressed in Pichia pastoris, resulting in enzymatic activity of 3600 U/mL in a 5 L fermenter. The lactase product was subjected to a series of toxicological tests to determine its safety for use as an enzyme preparation in the dairy industry. This recombinant lactase had the highest activity of all recombinant strains reported thus far. Acute oral toxicity, mutagenicity, genotoxic, and subchronic toxicity tests performed in rats and mice showed no death in any groups. The lethal dose 50% (LD50) based on the acute oral toxicity study is greater than 30 mL/kg body weight, which is in accordance with the 1500 L milk consumption of a 50 kg human daily. The lactase showed no mutagenic activity in the Ames test or a mouse sperm abnormality test at levels of up to 5 mg/plate and 1250 mg/kg body weight, respectively. It also showed no genetic toxicology in a bone marrow cell micronucleus test at levels of up to 1250 mg/kg body weight. A 90-day subchronic repeated toxicity study via the diet with lactase levels up to 1646 mg/kg (1000-fold greater than the mean human exposure) did not show any treatment-related significant toxicological effects on body weight, food consumption, organ weights, hematological and clinical chemistry, or histopathology compared to the control groups. This toxicological evaluation system is comprehensive and can be used in the safety evaluation of other enzyme preparations. The lactase showed no acute, mutagenic, genetic, or subchronic toxicity under our evaluation system. PMID:25184300

  2. Toxicological evaluation of lactase derived from recombinant Pichia pastoris.

    Directory of Open Access Journals (Sweden)

    Shiying Zou

    Full Text Available A recombinant lactase was expressed in Pichia pastoris, resulting in enzymatic activity of 3600 U/mL in a 5 L fermenter. The lactase product was subjected to a series of toxicological tests to determine its safety for use as an enzyme preparation in the dairy industry. This recombinant lactase had the highest activity of all recombinant strains reported thus far. Acute oral toxicity, mutagenicity, genotoxic, and subchronic toxicity tests performed in rats and mice showed no death in any groups. The lethal dose 50% (LD50 based on the acute oral toxicity study is greater than 30 mL/kg body weight, which is in accordance with the 1500 L milk consumption of a 50 kg human daily. The lactase showed no mutagenic activity in the Ames test or a mouse sperm abnormality test at levels of up to 5 mg/plate and 1250 mg/kg body weight, respectively. It also showed no genetic toxicology in a bone marrow cell micronucleus test at levels of up to 1250 mg/kg body weight. A 90-day subchronic repeated toxicity study via the diet with lactase levels up to 1646 mg/kg (1000-fold greater than the mean human exposure did not show any treatment-related significant toxicological effects on body weight, food consumption, organ weights, hematological and clinical chemistry, or histopathology compared to the control groups. This toxicological evaluation system is comprehensive and can be used in the safety evaluation of other enzyme preparations. The lactase showed no acute, mutagenic, genetic, or subchronic toxicity under our evaluation system.

  3. Techniques for Investigating Molecular Toxicology of Nanomaterials.

    Science.gov (United States)

    Wang, Yanli; Li, Chenchen; Yao, Chenjie; Ding, Lin; Lei, Zhendong; Wu, Minghong

    2016-06-01

    Nanotechnology has been a rapidly developing field in the past few decades, resulting in the more and more exposure of nanomaterials to human. The increased applications of nanomaterials for industrial, commercial and life purposes, such as fillers, catalysts, semiconductors, paints, cosmetic additives and drug carriers, have caused both obvious and potential impacts on human health and environment. Nanotoxicology is used to study the safety of nanomaterials and has grown at the historic moment. Molecular toxicology is a new subdiscipline to study the interactions and impacts of materials at the molecular level. To better understand the relationship between the molecular toxicology and nanomaterials, this review summarizes the typical techniques and methods in molecular toxicology which are applied when investigating the toxicology of nanomaterials and include six categories: namely; genetic mutation detection, gene expression analysis, DNA damage detection, chromosomal aberration analysis, proteomics, and metabolomics. Each category involves several experimental techniques and methods.

  4. Space Toxicology: Human Health during Space Operations

    Science.gov (United States)

    Khan-Mayberry, Noreen; James, John T.; Tyl, ROchelle; Lam, Chiu-Wing

    2010-01-01

    Space Toxicology is a unique and targeted discipline for spaceflight, space habitation and occupation of celestial bodies including planets, moons and asteroids. Astronaut explorers face distinctive health challenges and limited resources for rescue and medical care during space operation. A central goal of space toxicology is to protect the health of the astronaut by assessing potential chemical exposures during spaceflight and setting safe limits that will protect the astronaut against chemical exposures, in a physiologically altered state. In order to maintain sustained occupation in space on the International Space Station (ISS), toxicological risks must be assessed and managed within the context of isolation continuous exposures, reuse of air and water, limited rescue options, and the need to use highly toxic compounds for propulsion. As we begin to explore other celestial bodies in situ toxicological risks, such as inhalation of reactive mineral dusts, must also be managed.

  5. Comparative BioInformatics and Computational Toxicology

    Science.gov (United States)

    Reflecting the numerous changes in the field since the publication of the previous edition, this third edition of Developmental Toxicology focuses on the mechanisms of developmental toxicity and incorporates current technologies for testing in the risk assessment process.

  6. Pulmonary toxicology of respirable particles. [Lead abstract

    Energy Technology Data Exchange (ETDEWEB)

    Sanders, C.L.; Cross, F.T.; Dagle, G.E.; Mahaffey, J.A. (eds.)

    1980-09-01

    Separate abstracts were prepared for the 44 papers presented in these proceedings. The last paper (Stannard) in the proceedings is an historical review of the field of inhalation toxicology and is not included in the analytics. (DS)

  7. Environmental chemistry and toxicology of mercury

    National Research Council Canada - National Science Library

    Liu, Guangliang; Cai, Yong; O'Driscoll, Nelson J

    2012-01-01

    ... employed in recent studies. The coverage discusses the environmental behavior and toxicological effects of mercury on organisms, including humans, and provides case studies at the end of each chapter...

  8. IRIS Toxicological Review of Chloroform (Final Report)

    Science.gov (United States)

    EPA is announcing the release of the final report, Toxicological Review of Chloroform: in support of the Integrated Risk Information System (IRIS). The updated Summary for Chloroform and accompanying Quickview have also been added to the IRIS Database.

  9. Multiscale Toxicology - Building the Next Generation Tools for Toxicology

    Energy Technology Data Exchange (ETDEWEB)

    Thrall, Brian D.; Minard, Kevin R.; Teeguarden, Justin G.; Waters, Katrina M.

    2012-09-01

    A Cooperative Research and Development Agreement (CRADA) was sponsored by Battelle Memorial Institute (Battelle, Columbus), to initiate a collaborative research program across multiple Department of Energy (DOE) National Laboratories aimed at developing a suite of new capabilities for predictive toxicology. Predicting the potential toxicity of emerging classes of engineered nanomaterials was chosen as one of two focusing problems for this program. PNNL’s focus toward this broader goal was to refine and apply experimental and computational tools needed to provide quantitative understanding of nanoparticle dosimetry for in vitro cell culture systems, which is necessary for comparative risk estimates for different nanomaterials or biological systems. Research conducted using lung epithelial and macrophage cell models successfully adapted magnetic particle detection and fluorescent microscopy technologies to quantify uptake of various forms of engineered nanoparticles, and provided experimental constraints and test datasets for benchmark comparison against results obtained using an in vitro computational dosimetry model, termed the ISSD model. The experimental and computational approaches developed were used to demonstrate how cell dosimetry is applied to aid in interpretation of genomic studies of nanoparticle-mediated biological responses in model cell culture systems. The combined experimental and theoretical approach provides a highly quantitative framework for evaluating relationships between biocompatibility of nanoparticles and their physical form in a controlled manner.

  10. Principals Of Radiation Toxicology: Important Aspects.

    Science.gov (United States)

    Popov, Dmitri; Maliev, Slava; Jones, Jeffrey

    “All things are poison, and nothing is without poison; only the dose permits something not to be poisonous.” Paracelsus Key Words: Radiation Toxins (RT), Radiation Toxicants (RTc), Radiation Poisons (RP), Radiation Exposure (RE), Radiation Toxicology is the science about radiation poisons. [D.Popov et al. 2012,J.Zhou et al. 2007,] Radiation Toxins is a specific proteins with high enzymatic activity produced by living irradiated mammals. [D.Popov et al. 2012,] Radiation Toxicants is a substances that produce radiomimetics effects, adverse biological effects which specific for radiation. [D.Popov et al. 2012,] Radiation Toxic agent is specific proteins that can produce pathological biological effects specific for physical form of radiation.[D.Popov et al. 1990,2012,V. Maliev 2007] Different Toxic Substances isolated from cells or from blood or lymph circulation. [Kudriashov I. et al. 1970, D.Popov et al. 1990,2012,V. Maliev et al. 2007,] Radiation Toxins may affects many organs or specific organ, tissue, specific group of cells. [Kudriashov I. et al. 1970, D.Popov et al. 1990,2012,V. Maliev et al. 2007] For example: Radiation Toxins could induce collective toxic clinical states to include: systemic inflammatory response syndrome (SIRS),toxic multiple organ injury (TMOI), toxic multiple organ dysfunction syndromes (TMODS),and finally, toxic multiple organ failure (TMOF). [T. Azizova et al. 2005, Konchalovsky et al., 2005, D. Popov et al 2012] However, Radiation Toxins could induce specific injury of organs or tissue and induce Acute Radiation Syndromes such as Acute Radiation Cerebrovascular Syndrome, Acute Radiation Cardiovascular Syndrome, Acute Radiation Hematopoietic Syndrome, Acute Radiation GastroIntestinal Syndrome. [ D.Popov et al. 1990, 2012, V. Maliev et al. 2007] Radiation Toxins correlates with Radiation Exposure and the dose-response relationship is a fundamental and essential concept in classic Toxicology and Radiation Toxicology.[ D.Popov et al

  11. Modern Instrumental Methods in Forensic Toxicology*

    Science.gov (United States)

    Smith, Michael L.; Vorce, Shawn P.; Holler, Justin M.; Shimomura, Eric; Magluilo, Joe; Jacobs, Aaron J.; Huestis, Marilyn A.

    2009-01-01

    This article reviews modern analytical instrumentation in forensic toxicology for identification and quantification of drugs and toxins in biological fluids and tissues. A brief description of the theory and inherent strengths and limitations of each methodology is included. The focus is on new technologies that address current analytical limitations. A goal of this review is to encourage innovations to improve our technological capabilities and to encourage use of these analytical techniques in forensic toxicology practice. PMID:17579968

  12. Integrative Systems Biology Applied to Toxicology

    DEFF Research Database (Denmark)

    Kongsbak, Kristine Grønning

    associated with combined exposure to multiple chemicals. Testing all possible combinations of the tens of thousands environmental chemicals is impractical. This PhD project was launched to apply existing computational systems biology methods to toxicological research. In this thesis, I present in three...... of a system thereby suggesting new ways of thinking specific toxicological endpoints. Furthermore, computational methods can serve as valuable input for the hypothesis generating phase of the preparations of a research project....

  13. Good Practices in Forensic Toxicology.

    Science.gov (United States)

    Drummer, Olaf H

    2017-01-01

    This manuscript provides an overview for analysts, medical and scientific investigators, and laboratory administrators, the range of factors that should be considered to implement best practice forensic toxicology. These include laboratory influence over the collection of specimens, their proper transport and chain-of-custody before arrival in the laboratory. In addition, the laboratory needs to ensure properly trained staff use suitably validated and documented analytical procedures that meet the intended purpose and type of case in an accredited or suitably quality oriented management system. To assist the investigating officers laboratory results require an interpretation over their possible significance when sufficient details are available over the circumstances of the case. This requires a thorough understanding of the various factors that influence concentrations of substances and ultimately their likely physiological effect. These include consideration of the route of ingestion, influence over chronicity of usage on tissue concentrations and tolerance, possible combined drug effects or likely adverse reactions and consideration of relevant genetic factors that may have influenced pharmacokinetic or pharmacodynamic response. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  14. Introduction: biomarkers in neurodevelopment toxicology

    Energy Technology Data Exchange (ETDEWEB)

    Needleman, H.L.

    1987-10-01

    The search for markers of toxicant exposure and effect upon the development of organisms presents a set of challenges that differ in many ways from those encountered in the study of markers in reproduction or pregnancy. These latter two fields specify a relatively narrow set of organs or biological systems. The term development, on the other hand, can apply to any organ system, or to any set of phenomena that changes in an ordered way over time. For this reason the papers presented in the session on development were chosen to narrow the focus to neurodevelopmental markers, as such markers may be altered by neurotoxic exposure. In attempting to meet this task, the authors have been able to select a group of investigators who work at the leading edges of their respective fields of developmental neuroanatomy, neurotoxicology, neuroendocrinology, neuropsychology, and infant development. The notion that toxicants could affect behavior certainly is not new. Recent knowledge that behavioral aberrations can occur at exposures below those which produce organic changes, and that behavioral aberrations can occur at exposures below those which produce organic changes, and that behavioral observation might provide early markers of effect has given rise to two new fields: behavioral toxicology and behavioral teratology.

  15. Data governance in predictive toxicology: A review.

    Science.gov (United States)

    Fu, Xin; Wojak, Anna; Neagu, Daniel; Ridley, Mick; Travis, Kim

    2011-07-13

    Due to recent advances in data storage and sharing for further data processing in predictive toxicology, there is an increasing need for flexible data representations, secure and consistent data curation and automated data quality checking. Toxicity prediction involves multidisciplinary data. There are hundreds of collections of chemical, biological and toxicological data that are widely dispersed, mostly in the open literature, professional research bodies and commercial companies. In order to better manage and make full use of such large amount of toxicity data, there is a trend to develop functionalities aiming towards data governance in predictive toxicology to formalise a set of processes to guarantee high data quality and better data management. In this paper, data quality mainly refers in a data storage sense (e.g. accuracy, completeness and integrity) and not in a toxicological sense (e.g. the quality of experimental results). This paper reviews seven widely used predictive toxicology data sources and applications, with a particular focus on their data governance aspects, including: data accuracy, data completeness, data integrity, metadata and its management, data availability and data authorisation. This review reveals the current problems (e.g. lack of systematic and standard measures of data quality) and desirable needs (e.g. better management and further use of captured metadata and the development of flexible multi-level user access authorisation schemas) of predictive toxicology data sources development. The analytical results will help to address a significant gap in toxicology data quality assessment and lead to the development of novel frameworks for predictive toxicology data and model governance. While the discussed public data sources are well developed, there nevertheless remain some gaps in the development of a data governance framework to support predictive toxicology. In this paper, data governance is identified as the new challenge in

  16. Data governance in predictive toxicology: A review

    Directory of Open Access Journals (Sweden)

    Fu Xin

    2011-07-01

    Full Text Available Abstract Background Due to recent advances in data storage and sharing for further data processing in predictive toxicology, there is an increasing need for flexible data representations, secure and consistent data curation and automated data quality checking. Toxicity prediction involves multidisciplinary data. There are hundreds of collections of chemical, biological and toxicological data that are widely dispersed, mostly in the open literature, professional research bodies and commercial companies. In order to better manage and make full use of such large amount of toxicity data, there is a trend to develop functionalities aiming towards data governance in predictive toxicology to formalise a set of processes to guarantee high data quality and better data management. In this paper, data quality mainly refers in a data storage sense (e.g. accuracy, completeness and integrity and not in a toxicological sense (e.g. the quality of experimental results. Results This paper reviews seven widely used predictive toxicology data sources and applications, with a particular focus on their data governance aspects, including: data accuracy, data completeness, data integrity, metadata and its management, data availability and data authorisation. This review reveals the current problems (e.g. lack of systematic and standard measures of data quality and desirable needs (e.g. better management and further use of captured metadata and the development of flexible multi-level user access authorisation schemas of predictive toxicology data sources development. The analytical results will help to address a significant gap in toxicology data quality assessment and lead to the development of novel frameworks for predictive toxicology data and model governance. Conclusions While the discussed public data sources are well developed, there nevertheless remain some gaps in the development of a data governance framework to support predictive toxicology. In this paper

  17. Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes.

    Science.gov (United States)

    Zimpfer, Daniel; Netuka, Ivan; Schmitto, Jan D; Pya, Yuriy; Garbade, Jens; Morshuis, Michiel; Beyersdorf, Friedhelm; Marasco, Silvana; Rao, Vivek; Damme, Laura; Sood, Poornima; Krabatsch, Thomas

    2016-09-01

    The objective of this study was to describe the operative experience and 30-day outcomes of patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS) during the Conformité Européenne (CE) Mark clinical trial. Adult patients met inclusion and exclusion criteria defining advanced-stage heart failure and included the indications of bridge to transplant and destination therapy. Operative parameters, outcomes, adverse events, physical status and quality-of-life parameters were assessed in the first 30 days after LVAS implant. Fifty patients were implanted with the HeartMate 3 at 10 centres in 6 countries. The 30-day survival rate was 98%. The median operative and cardiopulmonary bypass times were 200 (range: 95-585) min and 84 (range: 47-250) min, respectively. Patients required transfusion with packed red blood cells (3.6 ± 2.3 units), fresh frozen plasma (6.5 ± 5 units) and platelets (2 ± 1 units). Six patients (12%) required reoperation for postoperative bleeding and 10 patients (20%) did not require blood transfusion. The median intensive care time was 6 days (range: 1-112 days) and the total hospital stay was 28 days (range: 14-116 days). The most common adverse events were bleeding (15, 30%), arrhythmia (14, 28%) and infection (10, 20%). There were 2 (4%) strokes. The 30-day outcomes following implantation of the HeartMate 3 demonstrates excellent survival with low adverse event rates. The LVAD performed as intended with no haemolysis or device failure. NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark). © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

  18. Liquid chromatography, in combination with a quadrupole time-of-flight instrument (LC QTOF), with sequential window acquisition of all theoretical fragment-ion spectra (SWATH) acquisition: systematic studies on its use for screenings in clinical and forensic toxicology and comparison with information-dependent acquisition (IDA).

    Science.gov (United States)

    Roemmelt, Andreas T; Steuer, Andrea E; Poetzsch, Michael; Kraemer, Thomas

    2014-12-02

    Forensic and clinical toxicological screening procedures are employing liquid chromatography-tandem mass spectrometry (LC-MS/MS) techniques with information-dependent acquisition (IDA) approaches more and more often. It is known that the complexity of a sample and the IDA settings might prevent important compounds from being triggered. Therefore, data-independent acquisition (DIA) methods should be more suitable for systematic toxicological analysis (STA). The DIA method sequential window acquisition of all theoretical fragment-ion spectra (SWATH), which uses Q1 windows of 20-35 Da for data-independent fragmentation, was systematically investigated for its suitability for STA. Quality of SWATH-generated mass spectra were evaluated with regard to mass error, relative abundance of the fragments, and library hits. With the Q1 window set to 20-25 Da, several precursors pass Q1 at the same time and are fragmented, thus impairing the library search algorithms to a different extent: forward fit was less affected than reverse fit and purity fit. Mass error was not affected. The relative abundance of the fragments was concentration dependent for some analytes and was influenced by cofragmentation, especially of deuterated analogues. Also, the detection rate of IDA compared to SWATH was investigated in a forced coelution experiment (up to 20 analytes coeluting). Even using several different IDA settings, it was observed that IDA failed to trigger relevant compounds. Screening results of 382 authentic forensic cases revealed that SWATH's detection rate was superior to IDA, which failed to trigger ∼10% of the analytes.

  19. Comparison of clinical outcomes using a Piezosurgery device vs. a conventional osteotome for lateral osteotomy in rhinoplasty.

    Science.gov (United States)

    Koc, Bulent; Koc, Eltaf Ayca; Erbek, Selim

    2017-08-01

    Our aim for this study was to evaluate and compare the clinical outcomes in patients who underwent lateral osteotomy with a Piezosurgery device or a conventional osteotome in open-technique rhinoplasty. This cohort trial involved 65 patients (36 women and 29 men; average age: 23.6 ± 5.71 yr) who underwent surgery between May 2015 and January 2016. Piezosurgery was used for lateral osteotomy in 32 patients, whereas 33 patients underwent conventional external osteotomy. These 2 groups were compared for duration of surgery, perioperative bleeding, postoperative edema, ecchymosis, pain, and patient satisfaction on the first and seventh postoperative days. The Piezosurgery group revealed significantly more favorable outcomes in terms of edema, ecchymosis, and hemorrhage on the first day postoperatively (p Piezosurgery group. Hemorrhage was similar in both groups on the seventh postoperative day (p = 0.67). The Piezosurgery group not only experienced less pain on the first postoperative day (p Piezosurgery may be a promising, safe, and effective method for lateral osteotomy, a critical step in rhinoplasty. The time interval necessary for the learning curve is counteracted by the comfort and satisfaction of both patients and surgeons.

  20. A clinical protocol for predicting outcomes with an implantable prosthetic device (Baha) in patients with single-sided deafness.

    Science.gov (United States)

    Snapp, Hillary A; Fabry, David A; Telischi, Fred F; Arheart, Kristopher L; Angeli, Simon I

    2010-01-01

    The Baha implant is increasingly becoming a common form of treatment for individuals with single-sided deafness (SSD). However, evidence-based guidelines for determining candidacy in these patients are not yet established. The purpose of this study was to investigate the clinical utility of speech-in-noise testing as a part of the preoperative evaluation of the Baha device in patients with SSD. The study design was a prospective cohort of 24 English-speaking adults comparing preoperative results on speech-in-noise measures using the Baha Cordelle II headband stimulator to postoperative results using the patient's external Baha processor. Outcome measures included signal-to-noise ratio (SNR) loss as measured by the QuickSIN™ and scores of self-reported disability questionnaires. Wilcoxon signed-rank test resulted in no significant difference between the preoperative and postoperative methods for measuring benefit on listening in noise tasks. Passing Bablok regression analysis showed the preoperative and postoperative results to be statistically equivalent, which suggests that postoperative results can be predicted during preoperative testing. Wilcoxon signed-rank test showed significant improvements in self-reported disability postoperatively. The results support the use of speech-in-noise measures as an accurate predictor of overall benefit in patients with SSD prior to implantation. American Academy of Audiology.

  1. A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation

    Directory of Open Access Journals (Sweden)

    Grapow Martin TR

    2012-06-01

    Full Text Available Abstract Background Wire closure still remains the preferred technique despite reasonable disadvantages. Associated complications, such as infection and sternal instability, cause time- and cost-consuming therapies. We present a new tool for sternal closure with its first clinical experience and results. Methods The sternal ZipFixTM System is based on the cable-tie principle. It primarily consists of biocompatible Poly-Ether-Ether-Ketone implants and is predominantly used peristernally through the intercostal space. The system provides a large implant-to-bone contact for better force distribution and for avoiding bone cut through. Results 50 patients were closed with the ZipFixTM system. No sternal instability was observed at 30 days. Two patients developed a mediastinitis that necessitated the removal of the device; however, the ZipFixTM were intact and the sternum remained stable. Conclusions In our initial evaluation, the short-term results have shown that the sternal ZipFixTM can be used safely and effectively. It is fast, easy to use and serves as a potential alternative for traditional wire closure.

  2. Use of a mobile device in mental health rehabilitation: A clinical and comprehensive analysis of 11 cases.

    Science.gov (United States)

    Briand, Catherine; Sablier, Juliette; Therrien, Julie-Anne; Charbonneau, Karine; Pelletier, Jean-François; Weiss-Lambrou, Rhoda

    2018-07-01

    This study aimed to test the feasibility of using a mobile device (Apple technology: iPodTouch®, iPhone® or iPad®) among people with severe mental illness (SMI) in a rehabilitation and recovery process and to document the parameters to be taken into account and the issues involved in implementing this technology in living environments and mental health care settings. A qualitative multiple case study design and multiple data sources were used to understand each case in depth. A clinical and comprehensive analysis of 11 cases was conducted with exploratory and descriptive aims (and the beginnings of explanation building). The multiple-case analysis brought out four typical profiles to illustrate the extent of integration of a personal digital assistant (PDA) as a tool to support mental health rehabilitation and recovery. Each profile highlights four categories of variables identified as determining factors in this process: (1) state of health and related difficulties (cognitive or functional); (2) relationship between comfort level with technology, motivation and personal effort deployed; (3) relationship between support required and support received; and (4) the living environment and follow-up context. This study allowed us to consider the contexts and conditions to be put in place for the successful integration of mobile technology in a mental health rehabilitation and recovery process.

  3. Precision toxicology based on single cell sequencing: an evolving trend in toxicological evaluations and mechanism exploration.

    Science.gov (United States)

    Zhang, Boyang; Huang, Kunlun; Zhu, Liye; Luo, Yunbo; Xu, Wentao

    2017-07-01

    In this review, we introduce a new concept, precision toxicology: the mode of action of chemical- or drug-induced toxicity can be sensitively and specifically investigated by isolating a small group of cells or even a single cell with typical phenotype of interest followed by a single cell sequencing-based analysis. Precision toxicology can contribute to the better detection of subtle intracellular changes in response to exogenous substrates, and thus help researchers find solutions to control or relieve the toxicological effects that are serious threats to human health. We give examples for single cell isolation and recommend laser capture microdissection for in vivo studies and flow cytometric sorting for in vitro studies. In addition, we introduce the procedures for single cell sequencing and describe the expected application of these techniques to toxicological evaluations and mechanism exploration, which we believe will become a trend in toxicology.

  4. Systems Toxicology: Real World Applications and Opportunities

    Science.gov (United States)

    2017-01-01

    Systems Toxicology aims to change the basis of how adverse biological effects of xenobiotics are characterized from empirical end points to describing modes of action as adverse outcome pathways and perturbed networks. Toward this aim, Systems Toxicology entails the integration of in vitro and in vivo toxicity data with computational modeling. This evolving approach depends critically on data reliability and relevance, which in turn depends on the quality of experimental models and bioanalysis techniques used to generate toxicological data. Systems Toxicology involves the use of large-scale data streams (“big data”), such as those derived from omics measurements that require computational means for obtaining informative results. Thus, integrative analysis of multiple molecular measurements, particularly acquired by omics strategies, is a key approach in Systems Toxicology. In recent years, there have been significant advances centered on in vitro test systems and bioanalytical strategies, yet a frontier challenge concerns linking observed network perturbations to phenotypes, which will require understanding pathways and networks that give rise to adverse responses. This summary perspective from a 2016 Systems Toxicology meeting, an international conference held in the Alps of Switzerland, describes the limitations and opportunities of selected emerging applications in this rapidly advancing field. Systems Toxicology aims to change the basis of how adverse biological effects of xenobiotics are characterized, from empirical end points to pathways of toxicity. This requires the integration of in vitro and in vivo data with computational modeling. Test systems and bioanalytical technologies have made significant advances, but ensuring data reliability and relevance is an ongoing concern. The major challenge facing the new pathway approach is determining how to link observed network perturbations to phenotypic toxicity. PMID:28362102

  5. Non-precautionary aspects of toxicology

    International Nuclear Information System (INIS)

    Grandjean, Philippe

    2005-01-01

    Empirical studies in toxicology aim at deciphering complex causal relationships, especially in regard to human disease etiologies. Several scientific traditions limit the usefulness of documentation from current toxicological research, in regard to decision-making based on the precautionary principle. Among non-precautionary aspects of toxicology are the focus on simplified model systems and the effects of single hazards, one by one. Thus, less attention is paid to sources of variability and uncertainty, including individual susceptibility, impacts of mixed and variable exposures, susceptible life-stages, and vulnerable communities. In emphasizing the need for confirmatory evidence, toxicology tends to penalize false positives more than false negatives. An important source of uncertainty is measurement error that results in misclassification, especially in regard to exposure assessment. Standard statistical analysis assumes that the exposure is measured without error, and imprecisions will usually result in an underestimation of the dose-effect relationship. In testing whether an effect could be considered a possible result of natural variability, a 5% limit for 'statistical significance' is usually applied, even though it may rule out many findings of causal associations, simply because the study was too small (and thus lacked statistical power) or because some imprecision or limited sensitivity of the parameters precluded a more definitive observation. These limitations may be aggravated when toxicology is influenced by vested interests. Because current toxicology overlooks the important goal of achieving a better characterization of uncertainties and their implications, research approaches should be revised and strengthened to counteract the innate ideological biases, thereby supporting our confidence in using toxicology as a main source of documentation and in using the precautionary principle as a decision procedure in the public policy arena

  6. Systems Toxicology: Real World Applications and Opportunities.

    Science.gov (United States)

    Hartung, Thomas; FitzGerald, Rex E; Jennings, Paul; Mirams, Gary R; Peitsch, Manuel C; Rostami-Hodjegan, Amin; Shah, Imran; Wilks, Martin F; Sturla, Shana J

    2017-04-17

    Systems Toxicology aims to change the basis of how adverse biological effects of xenobiotics are characterized from empirical end points to describing modes of action as adverse outcome pathways and perturbed networks. Toward this aim, Systems Toxicology entails the integration of in vitro and in vivo toxicity data with computational modeling. This evolving approach depends critically on data reliability and relevance, which in turn depends on the quality of experimental models and bioanalysis techniques used to generate toxicological data. Systems Toxicology involves the use of large-scale data streams ("big data"), such as those derived from omics measurements that require computational means for obtaining informative results. Thus, integrative analysis of multiple molecular measurements, particularly acquired by omics strategies, is a key approach in Systems Toxicology. In recent years, there have been significant advances centered on in vitro test systems and bioanalytical strategies, yet a frontier challenge concerns linking observed network perturbations to phenotypes, which will require understanding pathways and networks that give rise to adverse responses. This summary perspective from a 2016 Systems Toxicology meeting, an international conference held in the Alps of Switzerland, describes the limitations and opportunities of selected emerging applications in this rapidly advancing field. Systems Toxicology aims to change the basis of how adverse biological effects of xenobiotics are characterized, from empirical end points to pathways of toxicity. This requires the integration of in vitro and in vivo data with computational modeling. Test systems and bioanalytical technologies have made significant advances, but ensuring data reliability and relevance is an ongoing concern. The major challenge facing the new pathway approach is determining how to link observed network perturbations to phenotypic toxicity.

  7. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

    NARCIS (Netherlands)

    de Jong, Leo; Lafuma, Antoine; Aguadé, Anne-Sophie; Berdeaux, Gilles

    2011-01-01

    This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS

  8. Community health workers' experiences of mobile device-enabled clinical decision support systems for maternal, newborn and child health in developing countries: a qualitative systematic review protocol.

    Science.gov (United States)

    Dzabeng, Francis; Enuameh, Yeetey; Adjei, George; Manu, Grace; Asante, Kwaku Poku; Owusu-Agyei, Seth

    2016-09-01

    The objective of this review is to synthesize evidence on the experiences of community health workers (CHWs) of mobile device-enabled clinical decision support systems (CDSSs) interventions designed to support maternal newborn and child health (MNCH) in low-and middle-income countries.Specific objectives.

  9. Diagnostic yield of hair and urine toxicology testing in potential child abuse cases.

    Science.gov (United States)

    Stauffer, Stephanie L; Wood, Stephanie M; Krasowski, Matthew D

    2015-07-01

    Detection of drugs in a child may be the first objective finding that can be reported in cases of suspected child abuse. Hair and urine toxicology testing, when performed as part of the initial clinical evaluation for suspected child abuse or maltreatment, may serve to facilitate the identification of at-risk children. Furthermore, significant environmental exposure to a drug (considered by law to constitute child abuse in some states) may be identified by toxicology testing of unwashed hair specimens. In order to determine the clinical utility of hair and urine toxicology testing in this population we performed a retrospective chart review on all children for whom hair toxicology testing was ordered at our academic medical center between January 2004 and April 2014. The medical records of 616 children aged 0-17.5 years were reviewed for injury history, previous medication and illicit drug use by caregiver(s), urine drug screen result (if performed), hair toxicology result, medication list, and outcome of any child abuse evaluation. Hair toxicology testing was positive for at least one compound in 106 cases (17.2%), with unexplained drugs in 82 cases (13.3%). Of these, there were 48 cases in which multiple compounds (including combination of parent drugs and/or metabolites within the same drug class) were identified in the sample of one patient. The compounds most frequently identified in the hair of our study population included cocaine, benzoylecgonine, native (unmetabolized) tetrahydrocannabinol, and methamphetamine. There were 68 instances in which a parent drug was identified in the hair without any of its potential metabolites, suggesting environmental exposure. Among the 82 cases in which hair toxicology testing was positive for unexplained drugs, a change in clinical outcome was noted in 71 cases (86.5%). Urine drug screens (UDS) were performed in 457 of the 616 reviewed cases. Of these, over 95% of positive UDS results could be explained by iatrogenic drug

  10. Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges.

    Science.gov (United States)

    Zhang, Jing; Sun, Lei; Liu, Yu; Wang, Hongyi; Sun, Ningling; Zhang, Puhong

    2017-03-08

    Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device-based electronic data capture (mEDC) system has not been well evaluated. The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). We developed an mEDC to support an RCT called "Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)" study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes. The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study. The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely

  11. IRIS TOXICOLOGICAL REVIEW AND SUMMARY ...

    Science.gov (United States)

    The Draft Toxicological Review was developed to evaluate both the cancer and non cancer human health risks from environmental exposure to vinyl chloride. A reference concentration (RfC), and a reference dose (RfD) were developed based upon induction of liver cell polymorphism in a chronic dietary study utilizing Wistar rats. An RfC of 1E-1 mg/m3 and an RfD of 5E-3 mg/kg-d are recommended. On the basis of sufficient evidence for carcinogenicity in human epidemiology studies vinyl chloride is reaffirmed to be a known human carcinogen. Cancer potencies were derived for oral and inhalation exposure. An oral slope factor of 1.3 per (mg/kg-day) for continuous exposure during adulthood and 2.5 per (mg/kg-day) for continuous lifetime exposure from birth, based upon a chronic dietary study in female Wistar rats is recommended; an inhalation unit risk of 4.3 E-6 per (55g/m3) for continuous exposure during adulthood and 8.7 E-6 per (55g/m3) for continuous lifetime exposure from birth is also recommended, based upon exposure of male and female Sprague Dawley rats and Swiss mice, via inhalation, for a lifetime. A PBPK model was used in the derivation of the RfC, RfD, and cancer potency estimates. Its use is based on the assumption that equal tissue concentrations of reactive metabolite, chlorethylene oxide or chloracetaldehyde, at the critical target site will result in equivalent toxicity between species.

  12. Clinical results and radiographic appearance of the Rashkind double umbrella device in patients with occlusion of the ductus arteriosus

    International Nuclear Information System (INIS)

    Galal, O.; Sinner, W. von; Azhari, N.; Al-Fadley, F.; De Moor, M.; Boecker, J.; Fawzy, M.E..; Al-Halees, Z.

    1997-01-01

    Background. The Rashkind double umbrella device for patent arterial duct occlusion has been used in many patients. Its radiographic appearance has not been sufficiently described. Objective. To present the varying radiographic appearances of the Rashkind double umbrella device on the chest X-ray. Materials and methods. The chest radiographs of 69 patients (median age 60 months; median weight 17 kg), who underwent closure of their patent arterial duct between March 1990 and August 1994, were reviewed. The following parameters were evaluated: (1) the size of the heart (cardio-thoracic ratio) and pulmonary vessels, (2) the position of the device in AP/PA and lateral projections. The results of occlusion of the patent arterial duct were also reviewed. Results. Sixty-two of 69 (90 %) pa- tients had complete occlusion after a follow-up between 2 months and 3 1 / 2 years. The cardio-thoracic ratio showed significant reduction at follow-up (P < 0.001). The two different size devices could be well differentiated in the AP and the lateral projection. In 14 patients (20 %) the device was in an asymmetrical position. There was no significant correlation between position of the device and success of occlusion in our material. Conclusion. Complete occlusion of the arterial duct using Rashkind double umbrella devices can be achieved in 90 % of our population. In 20 % the device will have an asymmetrical position. There is no correlation between asymmetrical position of the device in the chest radiograph and residual shunting. (orig.)

  13. Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: design and rationale of the ROADMAP clinical trial.

    Science.gov (United States)

    Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C

    2015-02-01

    Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Initiation of a medical toxicology consult service at a tertiary care children's hospital.

    Science.gov (United States)

    Wang, George Sam; Monte, Andrew; Hatten, Benjamin; Brent, Jeffrey; Buchanan, Jennie; Heard, Kennon J

    2015-05-01

    Currently, only 10% of board-certified medical toxicologists are pediatricians. Yet over half of poison center calls involve children toxicology consultation is not common at children's hospitals. In collaboration with executive staff from Department of Pediatrics and Emergency Medicine, regional poison center, and our toxicology fellowship, we established a toxicology consulting service at our tertiary-care children's hospital. There were 139 consultations, and the service generated 13 consultations in the first month; median of 11 consultations per month thereafter (range 8-16). The service increased pediatric cases seen by the fellowship program from 30 to 94. The transition to a consult service required a culture change. Historically, call center advice was the mainstay of consulting practice and the medical staff was not accustomed to the availability of bedside medical toxicology consultations. However, after promotion of the service and full attending and fellowship coverage, consultations increased. In collaboration with toxicologists from different departments, a consultation service can be rapidly established. The service filled a clinical need that was disproportionately utilized for high acuity patients, immediately utilized by the medical staff and provided a robust pediatric population for the toxicology fellowship.

  15. Novel devices for individualized controlled inhalation can optimize aerosol therapy in efficacy, patient care and power of clinical trials

    Directory of Open Access Journals (Sweden)

    Fischer A

    2009-12-01

    Full Text Available Abstract In the treatment of pulmonary diseases the inhalation of aerosols plays a key role - it is the preferred route of drug delivery in asthma, chronic obstructive pulmonary disease (COPD and cystic fibrosis. But, in contrast to oral and intravenous administration drug delivery to the lungs is controlled by additional parameters. Beside its pharmacology the active agent is furthermore determined by its aerosol characteristics as particle diameter, particle density, hygroscopicity and electrical charge. The patient related factors like age and stage of pulmonary disease will be additionally affected by the individual breathing pattern and morphometry of the lower airways. A number of these parameters with essential impact on the pulmonary drug deposition can be influenced by the performance of the inhalation system. Therefore, the optimization of nebulisation technology was a major part of aerosol science in the last decade. At this time the control of inspiration volume and air flow as well as the administration of a defined aerosol bolus was in the main focus. Up to date a more efficient and a more targeted pulmonary drug deposition - e.g., in the alveoli - will be provided by novel devices which also allow shorter treatment times and a better reproducibility of the administered lung doses. By such means of precise dosing and drug targeting the efficacy of inhalation therapy can be upgraded, e.g., the continuous inhalation of budesonide in asthma. From a patients' perspective an optimized inhalation manoeuvre means less side effects, e.g., in cystic fibrosis therapy the reduced oropharyngeal tobramycin exposure causes fewer bronchial irritations. Respecting to shorter treatment times also, this result in an improved quality of life and compliance. For clinical trials the scaling down of dose variability in combination with enhanced pulmonary deposition reduces the number of patients to be included and the requirement of pharmaceutical

  16. Percutaneous excisional biopsy of clinically benign breast lesions with vacuum-assisted system: comparison of three devices.

    Science.gov (United States)

    Wang, Zhi Li; Liu, Gang; Huang, Yan; Wan, Wen Bo; Li, Jun Lai

    2012-04-01

    The aim of this study was to compare three devices in percutaneous excisional biopsy of clinically benign breast lesions in terms of complete excision rate, duration of procedure and complications. In a retrospective study from March 2005 to May 2009, 983 lesions underwent ultrasound-guided excisional biopsy with three vacuum-assisted systems, respectively. The lesions were category 3 lesions as determined by ultrasound imaging according to Breast Imaging Reporting and Data System (BI-RADS) (n=951) or had been confirmed as benign by a previous core needle biopsy (n=32). The completely excision rate, duration of procedure and complications (hematoma, pain and ecchymosis) were recorded. 99.7% (980/983) lesions were demonstrated to be benign by pathology after percutaneous excisional biopsy. The overall complete excision rate was 94.8% (932/983). In lesions whose largest diameter equal to or larger than 1.5cm, the complete excision rates of EnCor(®) group (97.8%, 348/356) and Mammotome(®) group (97.2%, 139/143) were significantly higher than that of Vacora(®) group (91.9%, 445/484) (P<0.05). The EnCor(®) group (6.6±6.5min) had a significant less duration than Mammotome(®) (10.6±9.3min) and Vacora(®) group (25.6±23.3min) (P<0.05). Hematoma occurred more in EnCor(®) group and Mammotome(®) group than in Vacora(®) group (P<0.05). All these three vacuum-assisted systems are highly successful for excisional biopsy of benign breast lesions. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  17. A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization

    Directory of Open Access Journals (Sweden)

    Wen-Hong Lu

    2014-06-01

    Full Text Available Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV. IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487, IVD-B (n = 485 or NSV (n = 487 groups and underwent operation. Follow-up included visits at the 3 rd -6 th and 12 th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations and semen analysis. The subjects' partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV among the three groups (P > 0.05. The cumulative rates of complications at the 12 th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method.

  18. A randomized, controlled, multicenter contraceptive efficacy clinical trial of the intravas device, a nonocclusive surgical male sterilization

    Science.gov (United States)

    Lu, Wen-Hong; Liang, Xiao-Wei; Gu, Yi-Qun; Wu, Wei-Xiong; Bo, Li-Wei; Zheng, Tian-Gui; Chen, Zhen-Wen

    2014-01-01

    Because of unavoidable complications of vasectomy, this study was undertaken to assess the efficacy and safety of male sterilization with a nonobstructive intravas device (IVD) implanted into the vas lumen by a mini-surgical method compared with no-scalpel vasectomy (NSV). IVDs were categorized into two types: IVD-B has a tail used for fixing to the vas deferens (fixed wing) whereas IVD-A does not. A multicenter prospective randomized controlled clinical trial was conducted in China. The study was comprised of 1459 male volunteers seeking vasectomy who were randomly assigned to the IVD-A (n = 487), IVD-B (n = 485) or NSV (n = 487) groups and underwent operation. Follow-up included visits at the 3rd–6th and 12th postoperative months. The assessments of the subjects involved regular physical examinations (including general and andrological examinations) and semen analysis. The subjects’ partners also underwent monitoring for pregnancy by monthly interviews regarding menstruation and if necessary, urine tests. There were no significant differences in pregnancy rates (0.65% for IVD-A, 0 for IVD-B and 0.21% for NSV) among the three groups (P > 0.05). The cumulative rates of complications at the 12th postoperative month were zero, 0.9% and 1.7% in the three groups, respectively. In conclusion, IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV technique. IVD male sterilization is expected to be a novel contraceptive method. PMID:24589454

  19. ACToR - Aggregated Computational Toxicology Resource

    International Nuclear Information System (INIS)

    Judson, Richard; Richard, Ann; Dix, David; Houck, Keith; Elloumi, Fathi; Martin, Matthew; Cathey, Tommy; Transue, Thomas R.; Spencer, Richard; Wolf, Maritja

    2008-01-01

    ACToR (Aggregated Computational Toxicology Resource) is a database and set of software applications that bring into one central location many types and sources of data on environmental chemicals. Currently, the ACToR chemical database contains information on chemical structure, in vitro bioassays and in vivo toxicology assays derived from more than 150 sources including the U.S. Environmental Protection Agency (EPA), Centers for Disease Control (CDC), U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), state agencies, corresponding government agencies in Canada, Europe and Japan, universities, the World Health Organization (WHO) and non-governmental organizations (NGOs). At the EPA National Center for Computational Toxicology, ACToR helps manage large data sets being used in a high-throughput environmental chemical screening and prioritization program called ToxCast TM

  20. Toxicology research projects directory, 1978. Monthly repts

    International Nuclear Information System (INIS)

    1978-01-01

    The Toxicology Research Projects Directory is a monthly publication of ongoing research projects in toxicology and related fields selected from the files of the Smithsonian Science Information Exchange (SSIE). Each issue lists toxicology-related research projects reported to SSIE during the one-month period preceding that issue. Each of the summaries is categorized by scientific discipline and assigned a unique identification number for cross-referencing from the Directory Indexes--Subject, Investigator, Performing Organization, Supporting Agency, and Master Grant Number. The thirteenth issue consists of Cumulative Indexes for the entire volume with referencing to projects in all of the previous twelve issues. The emphasis of the Directory is on the manifestations of the exposure of man and animals to toxic substances. Projects are classified by toxic agents, research orientation, and areas of environmental concern

  1. Prospects for applying synthetic biology to toxicology

    DEFF Research Database (Denmark)

    Behrendorff, James Bruce Yarnton H; Gillam, Elizabeth M.J.

    2017-01-01

    The 30 years since the inception of Chemical Research in Toxicology, game-changing advances in chemical and molecular biology, the fundamental disciplines underpinning molecular toxicology, have been made. While these have led to important advances in the study of mechanisms by which chemicals...... damage cells and systems, there has been less focus on applying these advances to prediction, detection, and mitigation of toxicity. Over the last ∼15 years, synthetic biology, the repurposing of biological "parts" in systems engineered for useful ends, has been explored in other areas of the biomedical...... and life sciences, for such applications as detecting metabolites, drug discovery and delivery, investigating disease mechanisms, improving medical treatment, and producing useful chemicals. These examples provide models for the application of synthetic biology to toxicology, which, for the most part, has...

  2. "Seeing is believing": perspectives of applying imaging technology in discovery toxicology.

    Science.gov (United States)

    Xu, Jinghai James; Dunn, Margaret Condon; Smith, Arthur Russell

    2009-11-01

    Efficiency and accuracy in addressing drug safety issues proactively are critical in minimizing late-stage drug attritions. Discovery toxicology has become a specialty subdivision of toxicology seeking to effectively provide early predictions and safety assessment in the drug discovery process. Among the many technologies utilized to select safer compounds for further development, in vitro imaging technology is one of the best characterized and validated to provide translatable biomarkers towards clinically-relevant outcomes of drug safety. By carefully applying imaging technologies in genetic, hepatic, and cardiac toxicology, and integrating them with the rest of the drug discovery processes, it was possible to demonstrate significant impact of imaging technology on drug research and development and substantial returns on investment.

  3. Comparison of toxicological and radiological aspects of K basins sludge

    International Nuclear Information System (INIS)

    RITTMANN, P.D.

    1999-01-01

    The composition of various K Basins sludge is evaluated for its toxicological and radiological impacts downwind from accidents. It is shown that the radiological risk evaluation guidelines are always more limiting than the toxicological risk evaluation guidelines

  4. Control of OSA during automatic positive airway pressure titration in a clinical case series: predictors and accuracy of device download data.

    Science.gov (United States)

    Huang, Hsin-Chia Carol; Hillman, David R; McArdle, Nigel

    2012-09-01

    To investigate the factors associated with physiologic control of obstructive sleep apnea (OSA) during automatic positive airway pressure (APAP) titration in a clinical series. To also assess the usefulness of apnea-hypopnea index (AHI) data downloaded from the APAP device (Dev AHI). Retrospective review of a consecutive series of patients with OSA who underwent APAP titration (Autoset Spirit, ResMed, Bella Vista, New South Wales, Australia ) with simultaneous polysomnographic (PSG) monitoring in the sleep laboratory. Tertiary sleep clinic. There were 190 consecutive patients with OSA referred for APAP titration. There were 58% of patients who achieved optimal or good control of OSA (titration PSG AHI titration. The independent predictors of titration PSG AHI were a history of cardiac disease and elevated central apnea and arousal indices during the diagnostic study. Although the median and interquartile range (IQR) AHI from the device (7.0, 3.9-11.6 events/hr) was only slightly less than the PSG AHI (7.8, 3.9-14.4 events/hr, P = 0.04) during titration, case-by-case agreement between the two measures was poor (chi-square titration is often poor, and close clinical follow-up is particularly needed in patients with a history of cardiac disease or with high arousal or central apnea indices on the diagnostic study. Device AHI does not reliably assess control during APAP titration, and PSG assessment may be required if clinical response to treatment is poor. The findings relate to the ResMed AutoSet device and may not apply to other devices.

  5. Developmental toxicology: adequacy of current methods.

    Science.gov (United States)

    Peters, P W

    1998-01-01

    Toxicology embraces several disciplines such as carcinogenicity, mutagenicity and reproductive toxicity. Reproductive toxicology is concerned with possible effects of substances on the reproductive process, i.e. on sexual organs and their functions, endocrine regulation, fertilization, transport of the fertilized ovum, implantation, and embryonic, fetal and postnatal development, until the end-differentiation of the organs is achieved. Reproductive toxicology is divided into areas related to male and female fertility, and developmental toxicology. Developmental toxicology can be further broken down into prenatal and postnatal toxicology. Today, much new information is available about the origins of developmental disorders resulting from chemical exposure. While these findings seem to promise important new developments in methodology and research, there is a danger of losing sight of the precepts and principles established in the light of existing knowledge. There is also a danger that we may fail to correct shortcomings in our existing procedures and practice. The aim of this presentation is to emphasize the importance of testing substances for their impact in advance of their use and to underline that we must use the best existing tools for carrying out risk assessments. Moreover, it needs to be stressed that there are many substances that are never assessed with respect to reproductive and developmental toxicity. Similarly, our programmes for post-marketing surveillance with respect to developmental toxicology are grossly inadequate. Our ability to identify risks to normal development and reproduction would be much improved, first if a number of straightforward precepts were always followed and second, if we had a clearer understanding of what we mean by risk and acceptable levels of risk in the context of development. Other aims of this paper are: to stress the complexity of the different stages of normal prenatal development; to note the principles that are

  6. Toxicological benchmarks for wildlife: 1996 Revision

    International Nuclear Information System (INIS)

    Sample, B.E.; Opresko, D.M.; Suter, G.W., II.

    1996-06-01

    The purpose of this report is to present toxicological benchmarks for assessment of effects of certain chemicals on mammalian and avian wildlife species. Publication of this document meets a milestone for the Environmental Restoration (ER) Risk Assessment Program. This document provides the ER Program with toxicological benchmarks that may be used as comparative tools in screening assessments as well as lines of evidence to support or refute the presence of ecological effects in ecological risk assessments. The chemicals considered in this report are some that occur at US DOE waste sites, and the wildlife species evaluated herein were chosen because they represent a range of body sizes and diets

  7. IRIS Toxicological Review of Trichloroethylene (TCE) ...

    Science.gov (United States)

    EPA is conducting a peer review and public comment of the scientific basis supporting the human health hazard and dose-response assessment of Trichloroethylene (TCE) that when finalized will appear on the Integrated Risk Information System (IRIS) database. The purpose of this Toxicological Review is to provide scientific support and rationale for the hazard and dose-response assessment in IRIS pertaining to chronic exposure to trichloroethylene. It is not intended to be a comprehensive treatise on the chemical or toxicological nature of trichloroethylene.

  8. [Forensic toxicology, a growing scientific discipline].

    Science.gov (United States)

    Augsburger, Marc; Staub, Christian

    2008-07-02

    Forensic toxicology has to bring evidence of substances that could have been involved directly or indirectly in the cause of death or that could influence the behaviour of somebody. The increase of the consumption of illegal and legal drugs in modern societies during last decades gave a boost to forensic toxicology. Moreover, improvement with analytical technology gave tools with high degrees of sensitivity and specificity for the screening and quantification of a large amount of substances in various biological specimens, even with very low concentration resulting of a single dose of medication.

  9. Toxicological benchmarks for wildlife: 1996 Revision

    Energy Technology Data Exchange (ETDEWEB)

    Sample, B.E.; Opresko, D.M.; Suter, G.W., II

    1996-06-01

    The purpose of this report is to present toxicological benchmarks for assessment of effects of certain chemicals on mammalian and avian wildlife species. Publication of this document meets a milestone for the Environmental Restoration (ER) Risk Assessment Program. This document provides the ER Program with toxicological benchmarks that may be used as comparative tools in screening assessments as well as lines of evidence to support or refute the presence of ecological effects in ecological risk assessments. The chemicals considered in this report are some that occur at US DOE waste sites, and the wildlife species evaluated herein were chosen because they represent a range of body sizes and diets.

  10. Clinical results and radiographic appearance of the Rashkind double umbrella device in patients with occlusion of the ductus arteriosus

    Energy Technology Data Exchange (ETDEWEB)

    Galal, O [King Faisal Specialist Hospital and Research Centre, Riyadh (Saudi Arabia); [Department of Cardiovascular Diseases, MBC 16, King Faisal Specialist Hospital and Research Centre, PO Box 3354, Riyadh 11211 (Saudi Arabia); Sinner, W von; Azhari, N; Al-Fadley, F; De Moor, M; Boecker, J; Fawzy, M E; Al-Halees, Z [King Faisal Specialist Hospital and Research Centre, Riyadh (Saudi Arabia)

    1997-12-01

    Background. The Rashkind double umbrella device for patent arterial duct occlusion has been used in many patients. Its radiographic appearance has not been sufficiently described. Objective. To present the varying radiographic appearances of the Rashkind double umbrella device on the chest X-ray. Materials and methods. The chest radiographs of 69 patients (median age 60 months; median weight 17 kg), who underwent closure of their patent arterial duct between March 1990 and August 1994, were reviewed. The following parameters were evaluated: (1) the size of the heart (cardio-thoracic ratio) and pulmonary vessels, (2) the position of the device in AP/PA and lateral projections. The results of occlusion of the patent arterial duct were also reviewed. Results. Sixty-two of 69 (90 %) pa- tients had complete occlusion after a follow-up between 2 months and 3{sup 1}/{sub 2} years. The cardio-thoracic ratio showed significant reduction at follow-up (P < 0.001). The two different size devices could be well differentiated in the AP and the lateral projection. In 14 patients (20 %) the device was in an asymmetrical position. There was no significant correlation between position of the device and success of occlusion in our material. Conclusion. Complete occlusion of the arterial duct using Rashkind double umbrella devices can be achieved in 90 % of our population. In 20 % the device will have an asymmetrical position. There is no correlation between asymmetrical position of the device in the chest radiograph and residual shunting. (orig.) With 7 figs., 12 refs.

  11. In-vivo dosimetry in external radiotherapy with amorphous silicon Portal Imaging Devices: from method to clinical validation

    International Nuclear Information System (INIS)

    Boissard, Philippe

    2012-01-01

    In vivo dose verification is used to prevent major deviations between the prescribed dose and the dose really delivered to the patient. This quality control was, nationally and internationally, widely recommended by scientific organizations. In France, its implementation and its use are now regulated. To do this, small detectors are fixed on the patient skin at the beginning of the treatment. However, the treatment delay is increased and not all treatment techniques could be assessed, such as IMRT plans (Intensity Modulated Radiation Therapy). In this context, Transit dosimetry performed with Electronic Portal Imaging Devices (EPIDs) appears as an interesting alternative for in vivo dose verification. During the treatment session, a transit dose is measured with the EPID, in two dimensions, and the dose in the patient is estimated from back projection of the portal dose. This work presents a quick and simple alternative method for verification of dose delivered to the patient using photon beams. Verifications in cases of complexes patient shapes and Intensity Modulated Radiation Therapy (IMRT) have been improved by using a Clarkson-Cunningham's integration method. 46 phantom test cases were designed to assess the accuracy of the method for 4, 6, 10 and 20 MV photon beams. For some points of interest the dose reconstructed by the method is compared to the dose measured with an ionization chamber. An additional in vivo uncertainty due to day to day deviations is defined and investigated. In the same time, a clinical study was driven during three years. In vivo dosimetry was performed for 494 patients treated for various tumors sites. Most of the patients were treated for a prostate cancer using IMRT. The in vivo dose is here compared to the dose calculated by the Treatment Planning System, TPS. The results of these two ways of validations are within the accepted tolerance of classical in vivo dosimetry. From the phantom study, we have estimated that the standard

  12. 40 CFR 161.340 - Toxicology data requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 23 2010-07-01 2010-07-01 false Toxicology data requirements. 161.340... Toxicology data requirements. (a) Table. Sections 161.100 through 161.102 describe how to use this table to determine the toxicology data requirements and the substance to be tested. Kind of data required (b) Notes...

  13. Quantitative Analysis of Motor Status in Parkinson’s Disease Using Wearable Devices: From Methodological Considerations to Problems in Clinical Applications

    Directory of Open Access Journals (Sweden)

    Masahiko Suzuki

    2017-01-01

    Full Text Available Long-term and objective monitoring is necessary for full assessment of the condition of patients with Parkinson’s disease (PD. Recent advances in biotechnology have seen the development of various types of wearable (body-worn sensor systems. By using accelerometers and gyroscopes, these devices can quantify motor abnormalities, including decreased activity and gait disturbances, as well as nonmotor signs, such as sleep disturbances and autonomic dysfunctions in PD. This review discusses methodological problems inherent in wearable devices. Until now, analysis of the mean values of motion-induced signals on a particular day has been widely applied in the clinical management of PD patients. On the other hand, the reliability of these devices to detect various events, such as freezing of gait and dyskinesia, has been less than satisfactory. Quantification of disease-specific changes rather than nonspecific changes is necessary.

  14. The New 3D Printed Left Atrial Appendage Closure with a Novel Holdfast Device: A Pre-Clinical Feasibility Animal Study.

    Directory of Open Access Journals (Sweden)

    M Brzeziński

    pericarditis or macroscopic signs of inflammation at the site of the device were found. All pigs were in good condition with normal weight gain and no other clinical symptoms.This novel 3D printed left atrial appendage closure technique with a novel holdfast device was proven to be safe and feasible in all pigs. A benign healing process without inflammation and damage to the surrounding structures or evidence of new thrombi formation was observed. Moreover, the uncomplicated survival and full LAA exclusion in all animals demonstrate the efficacy of this novel and relatively cheap device. Further clinical evaluation and implementation studies should be performed to introduce this new technology into clinical practice.

  15. Investigation of the Microsoft Kinect v2 Sensor as a Multi-Purpose Device for a Radiation Oncology Clinic

    Science.gov (United States)

    Silverstein, Evan Asher

    For a radiation oncology clinic, the number of devices available to assist in the workflow for radiotherapy treatments are quite numerous. Processes such as patient verification, motion management, or respiratory motion tracking can all be improved upon by devices currently on the market. These three specific processes can directly impact patient safety and treatment efficacy and, as such, are important to track and quantify. Most products available will only provide a solution for one of these processes and may be outside the reach of a typical radiation oncology clinic due to difficult implementation and incorporation with already existing hardware. This manuscript investigates the use of the Microsoft Kinect v2 sensor to provide solutions for all three processes all while maintaining a relatively simple and easy to use implementation. To assist with patient verification, the Kinect system was programmed to create a facial recognition and recall process. The basis of the facial recognition algorithm was created by utilizing a facial mapping library distributed by Microsoft within the Software Developers Toolkit (SDK). Here, the system extracts 31 fiducial points representing various facial landmarks. 3D vectors are created between each of the 31 points and the magnitude of each vector is calculated by the system. This allows for a face to be defined as a collection of 465 specific vector magnitudes. The 465 vector magnitudes defining a face are then used in both the creation of a facial reference data set and subsequent evaluations of real-time sensor data in the matching algorithm. To test the algorithm, a database of 39 faces was created, each with 465 vectors derived from the fiducial points, and a one-to-one matching procedure was performed to obtain sensitivity and specificity data of the facial identification system. In total, 5299 trials were performed and threshold parameters were created for match determination. Optimization of said parameters in the

  16. Systems toxicology: applications of toxicogenomics, transcriptomics, proteomics and metabolomics in toxicology

    NARCIS (Netherlands)

    Heijne, W.H.M.; Kienhuis, A.S.; Ommen, van B.; Stierum, R.; Groten, J.P.

    2005-01-01

    Toxicogenomics can facilitate the identification and characterization of toxicity, as illustrated in this review. Toxicogenomics, the application of the functional genomics technologies (transcriptomics, proteomics and metabolomics) in toxicology enables the study of adverse effects of xenobiotic

  17. Toxicological aspects of fuel and exhaust gas

    International Nuclear Information System (INIS)

    Avella, F.

    1993-01-01

    Some aspects concerning fuels (gasoline) and gas exhaust vehicle emissions toxicology are briefly examined in light of the results reported in recent literature on this argument. Many experimental studies carried out on animals and men turn out incomplete and do not allow thorough evaluations, for every aspect, of the risk to which men and the environment are subjected

  18. Evolution of Computational Toxicology-from Primitive ...

    Science.gov (United States)

    Presentation at the Health Canada seminar in Ottawa, ON, Canada on Nov. 15. 2016 Presentation at the Health Canada seminar in Ottawa, ON, Canada on Nov. 15. 2016 on the Evolution of Computational Toxicology-from Primitive Beginnings to Sophisticated Application

  19. Good cell culture practices &in vitro toxicology.

    Science.gov (United States)

    Eskes, Chantra; Boström, Ann-Charlotte; Bowe, Gerhard; Coecke, Sandra; Hartung, Thomas; Hendriks, Giel; Pamies, David; Piton, Alain; Rovida, Costanza

    2017-12-01

    Good Cell Culture Practices (GCCP) is of high relevance to in vitro toxicology. The European Society of Toxicology In Vitro (ESTIV), the Center for Alternatives for Animal Testing (CAAT) and the In Vitro Toxicology Industrial Platform (IVTIP) joined forces to address by means of an ESTIV 2016 pre-congress session the different aspects and applications of GCCP. The covered aspects comprised the current status of the OECD guidance document on Good In Vitro Method Practices, the importance of quality assurance for new technological advances in in vitro toxicology including stem cells, and the optimized implementation of Good Manufacturing Practices and Good Laboratory Practices for regulatory testing purposes. General discussions raised the duality related to the difficulties in implementing GCCP in an academic innovative research framework on one hand, and on the other hand, the need for such GCCP principles in order to ensure reproducibility and robustness of in vitro test methods for toxicity testing. Indeed, if good cell culture principles are critical to take into consideration for all uses of in vitro test methods for toxicity testing, the level of application of such principles may depend on the stage of development of the test method as well as on the applications of the test methods, i.e., academic innovative research vs. regulatory standardized test method. Copyright © 2017 Elsevier Ltd. All rights reserved.

  20. Research Models in Developmental Behavioral Toxicology.

    Science.gov (United States)

    Dietrich, Kim N.; Pearson, Douglas T.

    Developmental models currently used by child behavioral toxicologists and teratologists are inadequate to address current issues in these fields. Both child behavioral teratology and toxicology scientifically study the impact of exposure to toxic agents on behavior development: teratology focuses on prenatal exposure and postnatal behavior…

  1. A medical-toxicological view of tattooing

    DEFF Research Database (Denmark)

    Laux, Peter; Tralau, Tewes; Tentschert, Jutta

    2016-01-01

    of infections. Meanwhile, the increasing popularity of tattooing has led to the development of many new colours, allowing tattoos to be more spectacular than ever before. However, little is known about the toxicological risks of the ingredients used. For risk assessment, safe intradermal application...

  2. Metabolomics in Toxicology and Preclinical Research

    Science.gov (United States)

    Ramirez, Tzutzuy; Daneshian, Mardas; Kamp, Hennicke; Bois, Frederic Y.; Clench, Malcolm R.; Coen, Muireann; Donley, Beth; Fischer, Steven M.; Ekman, Drew R.; Fabian, Eric; Guillou, Claude; Heuer, Joachim; Hogberg, Helena T.; Jungnickel, Harald; Keun, Hector C.; Krennrich, Gerhard; Krupp, Eckart; Luch, Andreas; Noor, Fozia; Peter, Erik; Riefke, Bjoern; Seymour, Mark; Skinner, Nigel; Smirnova, Lena; Verheij, Elwin; Wagner, Silvia; Hartung, Thomas; van Ravenzwaay, Bennard; Leist, Marcel

    2013-01-01

    Summary Metabolomics, the comprehensive analysis of metabolites in a biological system, provides detailed information about the biochemical/physiological status of a biological system, and about the changes caused by chemicals. Metabolomics analysis is used in many fields, ranging from the analysis of the physiological status of genetically modified organisms in safety science to the evaluation of human health conditions. In toxicology, metabolomics is the -omics discipline that is most closely related to classical knowledge of disturbed biochemical pathways. It allows rapid identification of the potential targets of a hazardous compound. It can give information on target organs and often can help to improve our understanding regarding the mode-of-action of a given compound. Such insights aid the discovery of biomarkers that either indicate pathophysiological conditions or help the monitoring of the efficacy of drug therapies. The first toxicological applications of metabolomics were for mechanistic research, but different ways to use the technology in a regulatory context are being explored. Ideally, further progress in that direction will position the metabolomics approach to address the challenges of toxicology of the 21st century. To address these issues, scientists from academia, industry, and regulatory bodies came together in a workshop to discuss the current status of applied metabolomics and its potential in the safety assessment of compounds. We report here on the conclusions of three working groups addressing questions regarding 1) metabolomics for in vitro studies 2) the appropriate use of metabolomics in systems toxicology, and 3) use of metabolomics in a regulatory context. PMID:23665807

  3. FISH PHYSIOLOGY, TOXICOLOGY, AND WATER QUALITY:

    Science.gov (United States)

    Twenty-one participants from Europe, North America and China convened in Chongqing, China, October 12-14, 2005, for the Eighth International Symposium in Fish Physiology, Toxicology and Water Quality. The subject of the meeting was "Hypoxia in vertebrates: Comparisons of terrestr...

  4. Toxicological requirements for risk assessment of shellfish ...

    African Journals Online (AJOL)

    There is increasing concern by consumers with regard to the health aspects and safety of foodstuffs. Most food additives and contaminants are controlled by regulatory authorities, with Acceptable Daily Intakes (ADIs) having been set on the basis of detailed acute short- and long-term toxicological studies. The situation with ...

  5. Phytochemical Screening, Antibacterial and Toxicological Activities ...

    African Journals Online (AJOL)

    The phytochemical screening, antibacterial and toxicological activities of extracts of the stem bark of Acacia senegal were investigated. The phytochemical analyses according to standard screening tests using conventional protocols revealed the presence of tannins, saponins and sterols in the stem bark of the plant.

  6. Toxicological perspectives of inhaled therapeutics and nanoparticles.

    Science.gov (United States)

    Hayes, Amanda J; Bakand, Shahnaz

    2014-07-01

    The human respiratory system is an important route for the entry of inhaled therapeutics into the body to treat diseases. Inhaled materials may consist of gases, vapours, aerosols and particulates. In all cases, assessing the toxicological effect of inhaled therapeutics has many challenges. This article provides an overview of in vivo and in vitro models for testing the toxicity of inhaled therapeutics and nanoparticles implemented in drug delivery. Traditionally, inhalation toxicity has been performed on test animals to identify the median lethal concentration of airborne materials. Later maximum tolerable concentration denoted by LC0 has been introduced as a more ethically acceptable end point. More recently, in vitro methods have been developed, allowing the direct exposure of airborne material to cultured human target cells on permeable porous membranes at the air-liquid interface. Modifications of current inhalation therapies, new pulmonary medications for respiratory diseases and implementation of the respiratory tract for systemic drug delivery are providing new challenges when conducting well-designed inhalation toxicology studies. In particular, the area of nanoparticles and nanocarriers is of critical toxicological concern. There is a need to develop toxicological test models, which characterise the toxic response and cellular interaction between inhaled particles and the respiratory system.

  7. FISH PHYSIOLOGY, TOXICOLOGY, AND WATER QUALITY

    Science.gov (United States)

    Scientists from ten countries presented papers at the Fifth International Symposium on Fish Physiology, Toxicology, and Water Quality, which was held on the campus of the city University of Hong Kong on November 10-13, 1998. These Proceedings include 23 papers presented in sessi...

  8. Phytochemical analysis and toxicological evaluation of the ...

    African Journals Online (AJOL)

    Phytochemical analysis revealed the presence of tannins, Flavonoid, Alkaloids, Anthraquinone, Saponin and Cardiac glycosides. This work thus justifies the ethnomedicinal use of the plant in the treatment of anaemia and its safety profile. Keywords: Toxicological, Ethno toxicity, Hematological and phytochemical ...

  9. The rat incisor in toxicologic pathology

    NARCIS (Netherlands)

    Kuijpers, M.H.M.; Kooij, A.J. van de; Slootweg, P.J.

    1996-01-01

    Microscopic examination of the incisors of rats and mice may reveal toxicologically significant changes. First, the incisor morphology reflects the nutritional status of the animal: fluctuations of mineral metabolism and vitamin availability are disclosed by the rodent incisors, because the incisors

  10. A prospective toxicology analysis in alcoholics

    DEFF Research Database (Denmark)

    Thomsen, Jørgen Lange; Simonsen, Kirsten Wiese; Felby, Søren

    1997-01-01

    A prospective and comprehensive investigation was done on 73 medico–legal autopsies in alcoholics. The results of the toxicology analyses are described. Alcohol intoxication was the cause of death in 8%, combined alcohol/drug intoxication in 15% and drugs alone in 19%. Alcoholic ketoacidosis...

  11. Toxicology research for precautionary decision-making and the role of Human & Experimental Toxicology.

    Science.gov (United States)

    Grandjean, P

    2015-12-01

    A key aim of toxicology is the prevention of adverse effects due to toxic hazards. Therefore, the dissemination of toxicology research findings must confront two important challenges: one being the lack of information on the vast majority of potentially toxic industrial chemicals and the other being the strict criteria for scientific proof usually required for decision-making in regard to prevention. The present study ascertains the coverage of environmental chemicals in four volumes of Human & Experimental Toxicology and the presentation and interpretation of research findings in published articles. Links in SciFinder showed that the 530 articles published in four selected volumes between 1984 and 2014 primarily dealt with metals (126 links) and other toxicants that have received substantial attention in the past. Thirteen compounds identified by US authorities in 2006 as high-priority substances, for which toxicology documentation is badly needed, were not covered in the journal issues at all. When reviewing published articles, reliance on p values was standard, and non-significant findings were often called 'negative.' This tradition may contribute to the perceived need to extend existing research on toxic hazards that have already been well characterized. Several sources of bias towards the null hypothesis can affect toxicology research, but are generally not considered, thus adding to the current inclination to avoid false positive findings. In this regard, toxicology is particularly prone to bias because of the known paucity of false positives and, in particular, the existence of a vast number of toxic hazards which by default are considered innocuous due to lack of documentation. The Precautionary Principle could inspire decision-making on the basis of incomplete documentation and should stimulate a change in toxicology traditions and in toxicology research publication. © The Author(s) 2015.

  12. The Toxicology Investigators Consortium Case Registry-the 2015 Experience.

    Science.gov (United States)

    Farrugia, Lynn A; Rhyee, Sean H; Campleman, Sharan L; Ruha, Anne-Michelle; Weigand, Timothy; Wax, Paul M; Brent, Jeffrey

    2016-09-01

    The American College of Medical Toxicology established the Toxicology Investigators Consortium (ToxIC) Case Registry in 2010. The Registry contains all medical toxicology consultations performed at participating sites. The Registry has continued to grow since its inception, and as of December 31, 2015, contains 43,099 cases. This is the sixth annual report of the ToxIC Registry, summarizing the additional 8115 cases entered in 2015. Cases were identified by a query of the Registry for all cases entered between January 1 and December 31, 2015. Specific data reviewed for analysis included demographics (age, race, gender), source of consultation, reason for consultation, agents and agent classes involved in exposures, signs, symptoms, clinical findings, fatalities, and treatment. By the end of 2015, there were 50 active sites, consisting of 101 separate health-care facilities; 51.2 % of cases involved females. Adults between the ages of 19 and 65 made up the majority (64.2 %) of Registry cases. Caucasian race was the most commonly reported (55.6 %); 9.6 % of cases were identified as Hispanic ethnicity. Inpatient and emergency department referrals were by far the most common referral sources (92.9 %). Intentional pharmaceutical exposures remained the most frequent reason for consultation, making up 52.3 % of cases. Of these intentional pharmaceutical exposures, 69 % represented an attempt at self-harm, and 85.6 % of these were a suicide attempt. Nonopioid analgesics, sedative-hypnotics, and antidepressant agents were the most commonly reported agent classes in 2015. Almost one-third of Registry cases involved a diagnosed toxidrome (32.8 %), with a sedative-hypnotic toxidrome being the most frequently described. Significant vital sign abnormalities were recorded in 25.3 % of cases. There were 98 fatalities reported in the Registry (1.2 %). Adverse drug reactions were reported in 4.3 % of cases. Toxicological treatment was given in 65.3 % of cases, with 33.0

  13. Distance learning in toxicology: Australia's RMIT program

    International Nuclear Information System (INIS)

    Ahokas, Jorma; Donohue, Diana; Rix, Colin; Wright, Paul

    2005-01-01

    RMIT University was the first to offer a comprehensive Masters of Toxicology in Australasia 19 years ago. In 2001 the program was transformed into two stages, leading to a Graduate Diploma and Master of Applied Science in Toxicology. Now, these programs are fully online and suitable for graduates living and working anywhere in the world. The modular distance-learning courses are specifically designed to equip students with essential skills for entering fields such as chemical and drug evaluation; risk assessment of chemicals in the workplace; environmental and food toxicology. RMIT's online course delivery system has made it possible to deliver the toxicology programs, both nationally and internationally. The learning material and interactive activities (tests and quizzes, discussion boards, chat sessions) use Blackboard and WebBoard, each with a different educational function. Students log in to a Learning Hub to access their courses. The Learning Hub enables students to extend their learning beyond the classroom to the home, workplace, library and any other location with Internet access. The teaching staff log in to the Learning Hub to maintain and administer the online programs and courses which they have developed and/or which they teach. The Learning Hub is also a communication tool for students and staff, providing access to email, a diary and announcements. The early experience of delivering a full toxicology program online is very positive. However this mode of teaching continues to present many interesting technical, educational and cultural challenges, including: the design and presentation of the material; copyright issues; internationalisation of content; interactive participation; and the assessment procedures

  14. Applying a soft-robotic glove as assistive device and training tool with games to support hand function after stroke: Preliminary results on feasibility and potential clinical impact.

    Science.gov (United States)

    Prange-Lasonder, Gerdienke B; Radder, Bob; Kottink, Anke I R; Melendez-Calderon, Alejandro; Buurke, Jaap H; Rietman, Johan S

    2017-07-01

    Recent technological developments regarding wearable soft-robotic devices extend beyond the current application of rehabilitation robotics and enable unobtrusive support of the arms and hands during daily activities. In this light, the HandinMind (HiM) system was developed, comprising a soft-robotic, grip supporting glove with an added computer gaming environment. The present study aims to gain first insight into the feasibility of clinical application of the HiM system and its potential impact. In order to do so, both the direct influence of the HiM system on hand function as assistive device and its therapeutic potential, of either assistive or therapeutic use, were explored. A pilot randomized clinical trial was combined with a cross-sectional measurement (comparing performance with and without glove) at baseline in 5 chronic stroke patients, to investigate both the direct assistive and potential therapeutic effects of the HiM system. Extended use of the soft-robotic glove as assistive device at home or with dedicated gaming exercises in a clinical setting was applicable and feasible. A positive assistive effect of the soft-robotic glove was proposed for pinch strength and functional task performance 'lifting full cans' in most of the five participants. A potential therapeutic impact was suggested with predominantly improved hand strength in both participants with assistive use, and faster functional task performance in both participants with therapeutic application.

  15. [Psychoactive substances in biological samples--toxicological laboratory data].

    Science.gov (United States)

    Gomółka, Ewa; Wilimowska, Jolanta; Piekoszewski, Wojciech; Groszek, Barbara

    2004-01-01

    The subject of the research was the analysis of frequency and type of psychoactive substances used, basing on the determinations the blood and/or urine samples, performed in the toxicological laboratory of the Department of Clinical and Industrial Toxicology Jagiellonian University in Kraków in the period from December 2001 to November 2003. From 17,649 performed determinations--45.5% were positive. 50% of the positive determinations were psychoactive substances. The most often psychoactive substance determined was ethyl alcohol (52.86%), next benzodiazepines (17.41%), amphetamines (10.54%), opiates (8.05%), THC (6.87%), barbiturates (3.74%), and occasionally atropine and cocaine. There was observed a variety of mixed, simultaneously taking psychoactive substances, especially ethyl alcohol, opiates, amphetamine derivatives and cannabinoids. The analysis of the occurrence of psychoactive substances in biological samples from patients treated in different hospital departments, others hospitals and ordered by private persons also was performed. In the last two years 369 private patients ordered psychoactive substances determinations and 78 of them were positive.

  16. Toxicological and pathophysiological roles of reactive oxygen and nitrogen species

    International Nuclear Information System (INIS)

    Roberts, Ruth A.; Smith, Robert A.; Safe, Stephen; Szabo, Csaba; Tjalkens, Ronald B.; Robertson, Fredika M.

    2010-01-01

    'Oxidative and Nitrative Stress in Toxicology and Disease' was the subject of a symposium held at the EUROTOX meeting in Dresden 15th September 2009. Reactive oxygen (ROS) and reactive nitrogen species (RNS) produced during tissue pathogenesis and in response to viral or chemical toxicants, induce a complex series of downstream adaptive and reparative events driven by the associated oxidative and nitrative stress. As highlighted by all the speakers, ROS and RNS can promote diverse biological responses associated with a spectrum of disorders including neurodegenerative/neuropsychiatric and cardiovascular diseases. Similar pathways are implicated during the process of liver and skin carcinogenesis. Mechanistically, reactive oxygen and nitrogen species drive sustained cell proliferation, cell death including both apoptosis and necrosis, formation of nuclear and mitochondrial DNA mutations, and in some cases stimulation of a pro-angiogenic environment. Here we illustrate the pivotal role played by oxidative and nitrative stress in cell death, inflammation and pain and its consequences for toxicology and disease pathogenesis. Examples are presented from five different perspectives ranging from in vitro model systems through to in vivo animal model systems and clinical outcomes.

  17. Proceedings of the 2015 National Toxicology Program Satellite Symposium.

    Science.gov (United States)

    Elmore, Susan A; Farman, Cindy A; Hailey, James R; Kovi, Ramesh C; Malarkey, David E; Morrison, James P; Neel, Jennifer; Pesavento, Patricia A; Porter, Brian F; Szabo, Kathleen A; Teixeira, Leandro B C; Quist, Erin M

    2016-06-01

    The 2015 Annual National Toxicology Program Satellite Symposium, entitled "Pathology Potpourri" was held in Minneapolis, Minnesota, at the American College of Veterinary Pathologists/American Society for Veterinary Clinical Pathology/Society of Toxicologic Pathology combined meeting. The goal of this symposium is to present and discuss diagnostic pathology challenges or nomenclature issues. Because of the combined meeting, both laboratory and domestic animal cases were presented. This article presents summaries of the speakers' talks, including challenging diagnostic cases or nomenclature issues that were presented, along with select images that were used for audience voting and discussion. Some lesions and topics covered during the symposium included hepatocellular lesions, a proposed harmonized diagnostic approach to rat cardiomyopathy, crop milk in a bird, avian feeding accoutrement, heat exchanger in a tuna, metastasis of a tobacco carcinogen-induced pulmonary carcinoma, neurocytoma in a rat, pituicytoma in a rat, rodent mammary gland whole mounts, dog and rat alveolar macrophage ultrastructure, dog and rat pulmonary phospholipidosis, alveolar macrophage aggregation in a dog, degenerating yeast in a cat liver aspirate, myeloid leukemia in lymph node aspirates from a dog, Trypanosoma cruzi in a dog, solanum toxicity in a cow, bovine astrovirus, malignant microglial tumor, and nomenclature challenges from the Special Senses International Harmonization of Nomenclature and Diagnostic Criteria Organ Working Group. © The Author(s) 2016.

  18. A case-based toxicology elective course to enhance student learning in pharmacotherapy.

    Science.gov (United States)

    Brown, Stacy D; Pond, Brooks B; Creekmore, Kathryn A

    2011-08-10

    To assess the impact of a case-based toxicology elective course on student learning in related required courses and student performance on the Pharmacy Curriculum Outcomes Assessment (PCOA) examination. A case-based clinical toxicology elective course that contained topics from 2 required courses, Pharmacology III and Pharmacotherapy II, was offered in the spring 2009 to second- and third-year pharmacy students. Scores on the Toxicology subsection of the PCOA of students enrolled in the elective were higher than those of students not enrolled (91.3% ± 4.1 vs. 67.2% ± 5.7). Enrollment in the elective was related to increased examination scores among Pharmacotherapy II students (89.5% ± 2.0 vs. 83.9% ± 1.8). Students indicated on course survey instruments that they were satisfied with the new elective offering. A toxicology elective provided a clinically relevant, active-learning experience for pharmacy students that addressed a curricular need within the college and increased examination scores.

  19. On-line sources of toxicological information in Canada

    International Nuclear Information System (INIS)

    Racz, William J.; Ecobichon, Donald J.; Baril, Marc

    2003-01-01

    This paper will provide an overview of the on-line resources available in toxicology in Canada. It will describe a brief history of The Society of Toxicology of Canada, with reference to other societies and also provide information on education, research and other resources related to toxicology. Toxicology in Canada emerged as a distinct and vibrant discipline following the thalidomide tragedy of the 1960s. In the pharmaceutical industry and government, toxicology was readily established as an essential component of drug development and safety, and as the need for toxicologists expanded, training programs were established, usually in collaboration with departments of pharmacology. In the last two to three decades other disciplines, environmental biology, analytical chemistry and epidemiology joined the ranks of toxicology. The on-line sources of toxicology information are rapidly expanding. This article describes those sources considered by the authors to be important from a national and international perspective. The majority of these sources are professional organizations and government agencies

  20. Custom-made titanium devices as membranes for bone augmentation in implant treatment: Clinical application and the comparison with conventional titanium mesh.

    Science.gov (United States)

    Sumida, Tomoki; Otawa, Naruto; Kamata, Y U; Kamakura, Satoshi; Mtsushita, Tomiharu; Kitagaki, Hisashi; Mori, Shigeo; Sasaki, Kiyoyuki; Fujibayashi, Shunsuke; Takemoto, Mitsuru; Yamaguchi, Atsushi; Sohmura, Taiji; Nakamura, Takashi; Mori, Yoshihide

    2015-12-01

    Development of new custom-made devices to reconstruct alveolar bone for implantation, and comparison with conventional methods were the goals of this study. Using a computer-aided design technique, three-dimensional images were constructed. From these data, custom-made devices were produced by a selective laser melting method with pure titanium. Clinical trials also have been conducted with 26 participants who needed bone reconstruction before implantation; they were divided into 2 groups with 13 patients each. The first group uses custom-made devices; the other uses commercial titanium meshes that need to bend during operation. Some clinical aspects are evaluated after the trial. The custom-made devices can be produced closely by following the data precisely. Devices are fit for bone defect site. Moreover, the operation time of the custom-made group (75.4 ± 11.6 min) was significantly shorter than that of the conventional group (111.9 ± 17.8 min) (p < 0.01). Mucosal rupture occurs, without significant difference (p = 0.27), in a patient in the custom-made without severe infection (7.7%), and 3 in conventional (23.1%), respectively. The retaining screw is significantly fewer in the custom-made group than commercial mesh group (p < 0.01). These results indicate that our novel protocol could be simple and safe for providing powerful support for guided bone regeneration. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  1. Primary limited lumbar discectomy with an annulus closure device: one-year clinical and radiographic results from a prospective, multi-center study.

    Science.gov (United States)

    Lequin, Michiel B; Barth, Martin; Thomė, Claudius; Bouma, Gerrit J

    2012-12-01

    Discectomy as a treatment for herniated lumbar discs results in outcomes after surgery that are not uniformly positive. Surgeons face the dilemma between limited nucleus removal which is associated with a higher risk of recurrence, or more aggressive nucleus removal which may lead to disc height loss and persistent back-pain. annulus closure devices may allow for the benefits of limited nucleus removal without the increased risk of recurrence. This is an interim report of an ongoing 24-month post-marketing study of the Barricaid® annulus closure device, consisting of a flexible polymer mesh that blocks the defect, held in place by a titanium bone anchor. We prospectively enrolled 45 patients at four hospitals, and implanted the Barricaid® after a limited discectomy. annulus defect size and volume of removed nucleus were recorded. Reherniations were reported, pain and function were monitored and imaging was performed at regular intervals during 24 months of follow-up. At 12 months postsurgery, pain and function were significantly improved, comparing favorably to reported results from limited discectomy. Disc height has been well maintained. One reherniation has occurred (2.4%), which was associated with a misplaced device. No device fracture, subsidence or migration has been observed. The use of an annulus closure device may provide a reduction in reherniation rate for lumbar discectomy patients with large annulus defects who are at the greatest risk of recurrence. Using such a device should provide the surgeon increased confidence in minimizing nucleus removal, which, in turn, may preserve disc height and biomechanics, reducing degeneration and associated poor clinical outcomes in the long-term. A randomized multicenter study evaluating limited discectomy with and without the Barricaid® is currently underway, and will provide a higher level of evidence.

  2. Comparison of the WarmCloud and Bair Hugger Warming Devices for the Prevention of Intraoperative Hypothermia in Patients Undergoing Orthotopic Liver Transplantation: A Randomized Clinical Trial

    Science.gov (United States)

    Pearce, Brett; Mattheyse, Linda; Ellard, Louise; Desmond, Fiona; Pillai, Param; Weinberg, Laurence

    2018-01-01

    Background The avoidance of hypothermia is vital during prolonged and open surgery to improve patient outcomes. Hypothermia is particularly common during orthotopic liver transplantation (OLT) and associated with undesirable physiological effects that can adversely impact on perioperative morbidity. The KanMed WarmCloud (Bromma, Sweden) is a revolutionary, closed-loop, warm-air heating mattress developed to maintain normothermia and prevent pressure sores during major surgery. The clinical effectiveness of the WarmCloud device during OLT is unknown. Therefore, we conducted a randomized controlled trial to determine whether the WarmCloud device reduces hypothermia and prevents pressure injuries compared with the Bair Hugger underbody warming device. Methods Patients were randomly allocated to receive either the WarmCloud or Bair Hugger warming device. Both groups also received other routine standardized multimodal thermoregulatory strategies. Temperatures were recorded by nasopharyngeal temperature probe at set time points during surgery. The primary endpoint was nasopharyngeal temperature recorded 5 minutes before reperfusion. Secondary endpoints included changes in temperature over the predefined intraoperative time points, number of patients whose nadir temperature was below 35.5°C and the development of pressure injuries during surgery. Results Twenty-six patients were recruited with 13 patients randomized to each group. One patient from the WarmCloud group was excluded because of a protocol violation. Baseline characteristics were similar. The mean (standard deviation) temperature before reperfusion was 36.0°C (0.7) in the WarmCloud group versus 36.3°C (0.6) in the Bairhugger group (P = 0.25). There were no statistical differences between the groups for any of the secondary endpoints. Conclusions When combined with standardized multimodal thermoregulatory strategies, the WarmCloud device does not reduce hypothermia compared with the Bair Hugger device in

  3. Toxicology: a discipline in need of academic anchoring--the point of view of the German Society of Toxicology.

    Science.gov (United States)

    Gundert-Remy, U; Barth, H; Bürkle, A; Degen, G H; Landsiedel, R

    2015-10-01

    The paper describes the importance of toxicology as a discipline, its past achievements, current scientific challenges, and future development. Toxicological expertise is instrumental in the reduction of human health risks arising from chemicals and drugs. Toxicological assessment is needed to evaluate evidence and arguments, whether or not there is a scientific base for concern. The immense success already achieved by toxicological work is exemplified by reduced pollution of air, soil, water, and safer working places. Predominantly predictive toxicological testing is derived from the findings to assess risks to humans and the environment. Assessment of the adversity of molecular effects (including epigenetic effects), the effects of mixtures, and integration of exposure and biokinetics into in vitro testing are emerging challenges for toxicology. Toxicology is a translational science with its base in fundamental science. Academic institutions play an essential part by providing scientific innovation and education of young scientists.

  4. Impact of online toxicology training on health professionals: the Global Educational Toxicology Uniting Project (GETUP).

    Science.gov (United States)

    Wong, Anselm; Vohra, Rais; Dawson, Andrew H; Stolbach, Andrew

    2017-11-01

    The Global Educational Toxicology Uniting Project (GETUP), supported by the American College of Medical Toxicology, links countries with and without toxicology services via distance education with the aim to improve education. Due to the lack of toxicology services in some countries there is a knowledge gap in the management of poisonings. We describe our experience with the worldwide delivery of an online introductory toxicology curriculum to emergency doctors and other health professionals treating poisoned patients. We delivered a 15-module introductory Internet-based toxicology curriculum to emergency doctors and health professionals, conducted from August to December 2016. This Internet-based curriculum was adapted from one used to teach emergency residents toxicology in the United States. Modules covered themes such as pharmaceutical (n = 8), toxidromes (n = 2) and agrochemicals (n = 5) poisoning. Participants completed pre-test and post-test multiple choice questions (MCQs) before and after completing the online module, respectively, throughout the course. We collected information on participant demographics, education and training, and perception of relevance of the curriculum. Participants gave feedback on the course and how it affected their practice. One hundred and thirty-six health professionals from 33 countries participated in the course: 98 emergency doctors/medical officers, 25 physicians, eight pharmacists/poisons information specialists, two toxicologists, two medical students and one nurse. Median age of participants was 34 years. Median number of years postgraduate was seven. Ninety (65%) had access to either a poisons information centre over the phone or toxicologist and 48 (35%) did not. All participants expected the course to help improve their knowledge. Overall median pre-module MCQ scores were 56% (95%CI: 38, 75%) compared to post-module MCQ scores median 89% (95% CI: 67, 100%) (p education to health professionals treating

  5. Using Mobile Devices for Learning in Clinical Settings: A Mixed-Methods Study of Medical Student, Physician and Patient Perspectives

    Science.gov (United States)

    Scott, Karen M.; Nerminathan, Arany; Alexander, Shirley; Phelps, Megan; Harrison, Amanda

    2017-01-01

    This study was conducted with medical students, physicians, patients and carers in a paediatric and an adult hospital to determine use of mobile devices for learning, and beliefs and attitudes about others' use. Awareness of ethical, patient privacy and data security concerns was explored. The research was conducted using a mixed-methods…

  6. Clinical protocol levels are required in laboratory animal surgery when using medical devices: experiences with ureteral replacement surgery in goats

    NARCIS (Netherlands)

    Jonge, P.K.J.D. de; Sloff, M.; Janke, H.P.; Kortmann, B.B.M.; Gier, R.P.E. de; Geutjes, P.J.; Oosterwijk, E.; Feitz, W.F.J.

    2017-01-01

    It is common to test medical devices in large animal studies that are or could also be used in humans. In this short report we describe the use of a ureteral J-stent for the evaluation of biodegradable tubular constructs for tissue reconstruction, and the regeneration of ureters in Saanen goats.

  7. Transforming Clinical Imaging and 3D Data for Virtual Reality Learning Objects: HTML5 and Mobile Devices Implementation

    Science.gov (United States)

    Trelease, Robert B.; Nieder, Gary L.

    2013-01-01

    Web deployable anatomical simulations or "virtual reality learning objects" can easily be produced with QuickTime VR software, but their use for online and mobile learning is being limited by the declining support for web browser plug-ins for personal computers and unavailability on popular mobile devices like Apple iPad and Android…

  8. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rickard Claire M

    2010-09-01

    Full Text Available Abstract Background Peripheral intravenous device (IVD complications were traditionally thought to be reduced by limiting dwell time. Current recommendations are to resite IVDs by 96 hours with the exception of children and patients with poor veins. Recent evidence suggests routine resite is unnecessary, at least if devices are inserted by a specialised IV team. The aim of this study was to compare the impact of peripheral IVD 'routine resite' with 'removal on clinical indication' on IVD complications in a general hospital without an IV team. Methods A randomised, controlled trial was conducted in a regional teaching hospital. After ethics approval, 362 patients (603 IVDs were randomised to have IVDs replaced on clinical indication (185 patients or routine change every 3 days (177 patients. IVDs were inserted and managed by the general hospital medical and nursing staff; there was no IV team. The primary endpoint was a composite of IVD complications: phlebitis, infiltration, occlusion, accidental removal, local infection, and device-related bloodstream infection. Results IVD complication rates were 68 per 1,000 IVD days (clinically indicated and 66 per 1,000 IVD days (routine replacement (P = 0.86; HR 1.03; 95% CI, 0.74-1.43. Time to first complication per patient did not differ between groups (KM with log rank, P = 0.53. There were no local infections or IVD-related bloodstream infections in either group. IV therapy duration did not differ between groups (P = 0.22, but more (P = 0.004 IVDs were placed per patient in the routine replacement (mean, 1.8 than the clinical indication group (mean, 1.5, with significantly higher hospital costs per patient (P Conclusions Resite on clinical indication would allow one in two patients to have a single cannula per course of IV treatment, as opposed to one in five patients managed with routine resite; overall complication rates appear similar. Clinically indicated resite would achieve savings in equipment

  9. The attitudes of Australian radiography students towards the use of assistive transfer devices to reduce biomechanical stress in the clinical setting

    International Nuclear Information System (INIS)

    Ngo, Mark; Schneider-Kolsky, Michal; Baird, Marilyn

    2013-01-01

    The duties performed by radiographers, which includes transferring patients onto and off the examination table, can increase their risk of developing back and neck pain. This study used a survey to identify the assistive transfer devices Australian radiography undergraduate students are familiar with and have had practise using in the clinical setting. It also sought to determine whether students are being encouraged by other radiographers to use these devices during clinical training and if they would conform to practicing unsafe transfers if instructed to by senior staff. Results indicated that radiography students were familiar with the majority of the surveyed assistive devices such as the Patslide and X-ray cassette slider. Many of the students were unlikely to participate in unsafe work practices and were able to provide alternative methods of transferring patients. However, some of the respondents could be coerced into participating in unsafe patient transfers. Radiographers should therefore be vigilant in refraining from practicing unsafe transfer techniques as it could lead to students believing it is acceptable and emulating these practices in the work place

  10. Clinical Trials

    Medline Plus

    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

  11. Nano-technology and nano-toxicology.

    Science.gov (United States)

    Maynard, Robert L

    2012-01-01

    Rapid developments in nano-technology are likely to confer significant benefits on mankind. But, as with perhaps all new technologies, these benefits are likely to be accompanied by risks, perhaps by new risks. Nano-toxicology is developing in parallel with nano-technology and seeks to define the hazards and risks associated with nano-materials: only when risks have been identified they can be controlled. This article discusses the reasons for concern about the potential effects on health of exposure to nano-materials and relates these to the evidence of the effects on health of the ambient aerosol. A number of hypotheses are proposed and the dangers of adopting unsubstantiated hypotheses are stressed. Nano-toxicology presents many challenges and will need substantial financial support if it is to develop at a rate sufficient to cope with developments in nano-technology.

  12. Avian models in teratology and developmental toxicology.

    Science.gov (United States)

    Smith, Susan M; Flentke, George R; Garic, Ana

    2012-01-01

    The avian embryo is a long-standing model for developmental biology research. It also has proven utility for toxicology research both in ovo and in explant culture. Like mammals, avian embryos have an allantois and their developmental pathways are highly conserved with those of mammals, thus avian models have biomedical relevance. Fertile eggs are inexpensive and the embryo develops rapidly, allowing for high-throughput. The chick genome is sequenced and significant molecular resources are available for study, including the ability for genetic manipulation. The absence of a placenta permits the direct study of an agent's embryotoxic effects. Here, we present protocols for using avian embryos in toxicology research, including egg husbandry and hatch, toxicant delivery, and assessment of proliferation, apoptosis, and cardiac structure and function.

  13. Systems Toxicology: The Future of Risk Assessment.

    Science.gov (United States)

    Sauer, John Michael; Hartung, Thomas; Leist, Marcel; Knudsen, Thomas B; Hoeng, Julia; Hayes, A Wallace

    2015-01-01

    Risk assessment, in the context of public health, is the process of quantifying the probability of a harmful effect to individuals or populations from human activities. With increasing public health concern regarding the potential risks associated with chemical exposure, there is a need for more predictive and accurate approaches to risk assessment. Developing such an approach requires a mechanistic understanding of the process by which xenobiotic substances perturb biological systems and lead to toxicity. Supplementing the shortfalls of traditional risk assessment with mechanistic biological data has been widely discussed but not routinely implemented in the evaluation of chemical exposure. These mechanistic approaches to risk assessment have been generally referred to as systems toxicology. This Symposium Overview article summarizes 4 talks presented at the 35th Annual Meeting of the American College of Toxicology. © The Author(s) 2015.

  14. Regulated necrosis and its implications in toxicology.

    Science.gov (United States)

    Aki, Toshihiko; Funakoshi, Takeshi; Uemura, Koichi

    2015-07-03

    Recent research developments have revealed that caspase-dependent apoptosis is not the sole form of regulated cell death. Caspase-independent, but genetically regulated, forms of cell death include pyroptosis, necroptosis, parthanatos, and the recently discovered ferroptosis and autosis. Importantly, regulated necrosis can be modulated by small molecule inhibitors/activators, confirming the cell autonomous mechanism of these forms of cell death. The success of small molecule-mediated manipulation of regulated necrosis has produced great changes in the field of cell death research, and has also brought about significant changes in the fields of pharmacology as well as toxicology. In this review, we intend to summarize the modes of regulated cell death other than apoptosis, and discuss their implications in toxicology. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  15. Toxicology of Nanomaterials: Permanent interactive learning

    Directory of Open Access Journals (Sweden)

    Castranova Vince

    2009-10-01

    Full Text Available Abstract Particle and Fibre Toxicology wants to play a decisive role in a time where particle research is challenged and driven by the developments and applications of nanomaterials. This aim is not merely quantitative in publishing a given number of papers on nanomaterials, but also qualitatively since the field of nanotoxicology is rapidly emerging and benchmarks for good science are needed. Since then a number of things have happened that merit further analysis. The interactive learning issue is best shown by report and communications on the toxicology of multi-wall carbon nanotubes (CNT. A special workshop on the CNT has now been organized twice in Nagano (Japan and this editorial contains a summary of the most important outcomes. Finally, we take the opportunity discuss some recent reports from the nanotech literature, and more specifically a Chinese study that claims severe consequences of nanoparticle exposure.

  16. Pharmacological and toxicological evaluation of Urtica dioica.

    Science.gov (United States)

    Dar, Sabzar Ahmad; Ganai, Farooq Ahmad; Yousuf, Abdul Rehman; Balkhi, Masood-Ul-Hassan; Bhat, Towseef Mohsin; Sharma, Poonam

    2013-02-01

    Medicinal plants are a largely unexplored source of drug repository. Urtica dioica L. (Urticaceae) is used in traditional medicine to treat diverse conditions. The present study describes the antidiabetic, antiinflammatory, antibacterial activity, and toxicological studies of Urtica dioica. U. dioica leaves were subjected to solvent extraction with hexane, chloroform, ethyl acetate, methanol, and aqueous, respectively, and screened for antidiabetic (300 mg/kg bw by glucose tolerance test; GTT), antiinflammatory (200 mg/kg bw by rat paw edema assay) and antibacterial activities [by disc-diffusion and minimum inhibitory concentration (MIC) assays]. Toxicological studies were carried on Artemia salina and Wistar rats; phytochemical analyses were carried out, using chromatographic and spectroscopic techniques. The aqueous extract of U. dioica (AEUD) significantly (p 1000 μg/mL each on A. salina. Our results showed that the U. dioica leaves are an interesting source of bioactive compounds, justifying their use in folk medicine, to treat various diseases.

  17. Toxicology in Asia--Past, present, and future.

    Science.gov (United States)

    Satoh, T

    2015-12-01

    The Asian Society of Toxicology (ASIATOX), which consists of the seven national toxicology member societies of Japan, Korea, China, Taiwan, Thailand, Singapore, and Iran, now boasts of more than 3,000 members from a variety of industries, academia, and regulatory organizations. ASIATOX congresses are spaced three years apart and rotated among the member societies. In 1995, ASIATOX joined the International Union of Toxicology (IUTOX) as a regional society, and now serves as the scientific voice of toxicology in Asia under the IUTOX umbrella. Since its inauguration, the society has worked diligently to handle matters deemed essential to promoting the vision set fourth by its founders. Future perspectives of ASIATOX include the establishment of education and training programs, and the certification and accreditation of toxicologists. As the leading voice of toxicology in Asia, the society seeks to extend knowledge of toxicological issues to developing nations in Asia based on the following missions and goals: (1) to provide leadership as a worldwide scientific organization that objectively addresses global issues involving the toxicological sciences, (2) to broaden the geographical base of toxicology as a discipline and profession to all countries of the world, and (3) to pursue capacity building in toxicology, particularly in developing countries, while utilizing its global perspective and network to contribute to the enhancement of toxicology education and the career development of young toxicologists. © The Author(s) 2015.

  18. Advancing Toxicology Research Using In Vivo High Throughput Toxicology with Small Fish Models

    Science.gov (United States)

    Planchart, Antonio; Mattingly, Carolyn J.; Allen, David; Ceger, Patricia; Casey, Warren; Hinton, David; Kanungo, Jyotshna; Kullman, Seth W.; Tal, Tamara; Bondesson, Maria; Burgess, Shawn M.; Sullivan, Con; Kim, Carol; Behl, Mamta; Padilla, Stephanie; Reif, David M.; Tanguay, Robert L.; Hamm, Jon

    2017-01-01

    Summary Small freshwater fish models, especially zebrafish, offer advantages over traditional rodent models, including low maintenance and husbandry costs, high fecundity, genetic diversity, physiology similar to that of traditional biomedical models, and reduced animal welfare concerns. The Collaborative Workshop on Aquatic Models and 21st Century Toxicology was held at North Carolina State University on May 5-6, 2014, in Raleigh, North Carolina, USA. Participants discussed the ways in which small fish are being used as models to screen toxicants and understand mechanisms of toxicity. Workshop participants agreed that the lack of standardized protocols is an impediment to broader acceptance of these models, whereas development of standardized protocols, validation, and subsequent regulatory acceptance would facilitate greater usage. Given the advantages and increasing application of small fish models, there was widespread interest in follow-up workshops to review and discuss developments in their use. In this article, we summarize the recommendations formulated by workshop participants to enhance the utility of small fish species in toxicology studies, as well as many of the advances in the field of toxicology that resulted from using small fish species, including advances in developmental toxicology, cardiovascular toxicology, neurotoxicology, and immunotoxicology. We also review many emerging issues that will benefit from using small fish species, especially zebrafish, and new technologies that will enable using these organisms to yield results unprecedented in their information content to better understand how toxicants affect development and health. PMID:27328013

  19. Toxicological awakenings: the rebirth of hormesis as a central pillar of toxicology

    International Nuclear Information System (INIS)

    Calabrese, Edward J.

    2005-01-01

    This paper assesses historical reasons that may account for the marginalization of hormesis as a dose-response model in the biomedical sciences in general and toxicology in particular. The most significant and enduring explanatory factors are the early and close association of the concept of hormesis with the highly controversial medical practice of homeopathy and the difficulty in assessing hormesis with high-dose testing protocols which have dominated the discipline of toxicology, especially regulatory toxicology. The long-standing and intensely acrimonious conflict between homeopathy and 'traditional' medicine (allopathy) lead to the exclusion of the hormesis concept from a vast array of medical- and public health-related activities including research, teaching, grant funding, publishing, professional societal meetings, and regulatory initiatives of governmental agencies and their advisory bodies. Recent publications indicate that the hormetic dose-response is far more common and fundamental than the dose-response models [threshold/linear no threshold (LNT)] used in toxicology and risk assessment, and by governmental regulatory agencies in the establishment of exposure standards for workers and the general public. Acceptance of the possibility of hormesis has the potential to profoundly affect the practice of toxicology and risk assessment, especially with respect to carcinogen assessment

  20. Nano-technology and nano-toxicology

    OpenAIRE

    Maynard, Robert L.

    2012-01-01

    Rapid developments in nano-technology are likely to confer significant benefits on mankind. But, as with perhaps all new technologies, these benefits are likely to be accompanied by risks, perhaps by new risks. Nano-toxicology is developing in parallel with nano-technology and seeks to define the hazards and risks associated with nano-materials: only when risks have been identified they can be controlled. This article discusses the reasons for concern about the potential effects on health of ...

  1. The four cornerstones of Evolutionary Toxicology.

    Science.gov (United States)

    Bickham, John W

    2011-05-01

    Evolutionary Toxicology is the study of the effects of chemical pollutants on the genetics of natural populations. Research in Evolutionary Toxicology uses experimental designs familiar to the ecotoxicologist with matched reference and contaminated sites and the selection of sentinel species. It uses the methods of molecular genetics and population genetics, and is based on the theories and concepts of evolutionary biology and conservation genetics. Although it is a relatively young field, interest is rapidly growing among ecotoxicologists and more and more field studies and even controlled laboratory experiments are appearing in the literature. A number of population genetic impacts have been observed in organisms exposed to pollutants which I refer to here as the four cornerstones of Evolutionary Toxicology. These include (1) genome-wide changes in genetic diversity, (2) changes in allelic or genotypic frequencies caused by contaminant-induced selection acting at survivorship loci, (3) changes in dispersal patterns or gene flow which alter the genetic relationships among populations, and (4) changes in allelic or genotypic frequencies caused by increased mutation rates. It is concluded that population genetic impacts of pollution exposure are emergent effects that are not necessarily predictable from the mode of toxicity of the pollutant. Thus, to attribute an effect to a particular contaminant requires a careful experimental design which includes selection of appropriate reference sites, detailed chemistry analyses of environmental samples and tissues, and the use of appropriate biomarkers to establish exposure and effect. This paper describes the field of Evolutionary Toxicology and discusses relevant field studies and their findings. © Springer Science+Business Media, LLC 2011

  2. Aquatic toxicology: past, present, and prospects.

    OpenAIRE

    Pritchard, J B

    1993-01-01

    Aquatic organisms have played important roles as early warning and monitoring systems for pollutant burdens in our environment. However, they have significant potential to do even more, just as they have in basic biology where preparations like the squid axon have been essential tools in establishing physiological and biochemical mechanisms. This review provides a brief summary of the history of aquatic toxicology, focusing on the nature of aquatic contaminants, the levels of contamination in...

  3. IRIS Toxicological Review of Trichloroacetic Acid (TCA) ...

    Science.gov (United States)

    EPA is conducting a peer review and public comment of the scientific basis supporting the human health hazard and dose-response assessment of Trichloroacetic acid (TCA) that when finalized will appear on the Integrated Risk Information System (IRIS) database. The draft Toxicological Review of trichloroacetic acid provides scientific support and rationale for the hazard and dose-response assessment pertaining to chronic exposure to trichloroacetic acid.

  4. Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea-hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure.

    Science.gov (United States)

    Sharples, Linda; Glover, Matthew; Clutterbuck-James, Abigail; Bennett, Maxine; Jordan, Jake; Chadwick, Rebecca; Pittman, Marcus; East, Clare; Cameron, Malcolm; Davies, Mike; Oscroft, Nick; Smith, Ian; Morrell, Mary; Fox-Rushby, Julia; Quinnell, Timothy

    2014-01-01

    BACKGROUND Obstructive sleep apnoea-hypopnoea (OSAH) causes excessive daytime sleepiness (EDS), impairs quality of life (QoL) and increases cardiovascular disease and road traffic accident risks. Continuous positive airway pressure (CPAP) treatment is clinically effective but undermined by intolerance, and its cost-effectiveness is borderline in milder cases. Mandibular advancement devices (MADs) are another option, but evidence is lacking regarding their clinical effectiveness and cost-effectiveness in milder disease. OBJECTIVES (1) Conduct a randomised controlled trial (RCT) examining the clinical effectiveness and cost-effectiveness of MADs against no treatment in mild to moderate OSAH. (2) Update systematic reviews and an existing health economic decision model with data from the Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea-hypopnoea (TOMADO) and newly published results to better inform long-term clinical effectiveness and cost-effectiveness of MADs and CPAP in mild to moderate OSAH. TOMADO A crossover RCT comparing clinical effectiveness and cost-effectiveness of three MADs: self-moulded [SleepPro 1™ (SP1); Meditas Ltd, Winchester, UK]; semibespoke [SleepPro 2™ (SP2); Meditas Ltd, Winchester, UK]; and fully bespoke [bespoke MAD (bMAD); NHS Oral-Maxillofacial Laboratory, Addenbrooke's Hospital, Cambridge, UK] against no treatment, in 90 adults with mild to moderate OSAH. All devices improved primary outcome [apnoea-hypopnoea index (AHI)] compared with no treatment: relative risk 0.74 [95% confidence interval (CI) 0.62 to 0.89] for SP1; relative risk 0.67 (95% CI 0.59 to 0.76) for SP2; and relative risk 0.64 (95% CI 0.55 to 0.76) for bMAD (p < 0.001). Differences between MADs were not significant. Sleepiness [as measured by the Epworth Sleepiness Scale (ESS)] was scored 1.51 [95% CI 0.73 to 2.29 (SP1)] to 2.37 [95% CI 1.53 to 3.22 (bMAD)] lower than no treatment (p < 0.001), with SP2 and bMAD significantly better than SP1

  5. Rotatostereoradiography; a new radiodiagnostic method; Development of a new three-dimensional radiodiagnostic device and evaluation in neurosurgical clinics

    Energy Technology Data Exchange (ETDEWEB)

    Ottomo, Michinori [Aomori Rosai Hospital, Hachinohe (Japan); Basugi, Norihiko; Handa, Hajime; Taniguchi, Takashi; Iwabuchi, Takashi; Kosaka, Mitsuo

    1991-02-01

    The rotatostereoradiographic device uses an x-ray tube coupled with an image intensifier rotating through a 180deg arc in 2.25 seconds. The rapidly rotating x-ray tube allows 180deg -arc angiograms to be obtained with a single injection of contrast medium. Subtracted fluoroscopic angiograms can be viewed immediately after injection of the contrast medium with digital recording. These three-dimensional images are displayed on side-by-side monitors stereoscopically. The mortality and morbidity of subarachnoid hemorrhage can only be greatly reduced by surgical treatment of unruptured aneurysms and arteriovenous malformations detected by a wide survey of subarachnoid hemorrhage. Such a wide survey would be possible utilizing intra-arterial digital subtraction angiography via the ascending aorta and this new three-dimensional radiodiagnostic method. A fluoroscopic device must be used to allow easier manipulation of the catheter from the axillary or brachial artery. (author).

  6. Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.

    Science.gov (United States)

    Samuel, Gbeminiyi O; Hoffmann, Sebastian; Wright, Robert A; Lalu, Manoj Mathew; Patlewicz, Grace; Becker, Richard A; DeGeorge, George L; Fergusson, Dean; Hartung, Thomas; Lewis, R Jeffrey; Stephens, Martin L

    2016-01-01

    Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  7. ICPP radiological and toxicological sabotage analysis

    International Nuclear Information System (INIS)

    Kubiak, V.R.; Mortensen, F.G.

    1995-01-01

    In June of 1993, the Department of Energy (DOE) issued Notice 5630.3A, open-quotes Protection of Departmental Facilities Against Radiological and Toxicological Sabotage,close quotes which states that all significant radiological and toxicological hazards at Department facilities must be examined for potential sabotage. This analysis has been completed at the Idaho Chemical Processing Plant (ICPP). The ICPP radiological and toxicological hazards include spent government and commercial fuels, Special Nuclear Materials (SNM), high-level liquid wastes, high-level solid wastes, and process and decontamination chemicals. The analysis effort included identification and assessment of quantities of hazardous materials present at the facility; identification and ranking of hazardous material targets; development of worst case scenarios detailing possible sabotage actions and hazard releases; performance of vulnerability assessments using table top and computer methodologies on credible threat targets; evaluation of potential risks to the public, workers, and the environment; evaluation of sabotage risk reduction options; and selection of cost effective prevention and mitigation options

  8. Toxicological benchmarks for wildlife: 1994 Revision

    International Nuclear Information System (INIS)

    Opresko, D.M.; Sample, B.E.; Suter, G.W. II.

    1994-09-01

    The process by which ecological risks of environmental contaminants are evaluated is two-tiered. The first tier is a screening assessment where concentrations of contaminants in the environment are compared to toxicological benchmarks which represent concentrations of chemicals in environmental media (water, sediment, soil, food, etc.) that are presumed to be nonhazardous to the surrounding biota. The second tier is a baseline ecological risk assessment where toxicological benchmarks are one of several lines of evidence used to support or refute the presence of ecological effects. The report presents toxicological benchmarks for assessment of effects of 76 chemicals on 8 representative mammalian wildlife species and 31 chemicals on 9 avian wildlife species. The chemicals are some of those that occur at United States Department of Energy waste sites; the wildlife species were chosen because they are widely distributed and provide a representative range of body sizes and diets. Further descriptions of the chosen wildlife species and chemicals are provided in the report. The benchmarks presented in this report represent values believed to be nonhazardous for the listed wildlife species. These benchmarks only consider contaminant exposure through oral ingestion of contaminated media; exposure through inhalation or direct dermal exposure are not considered in this report

  9. Toxicological benchmarks for wildlife: 1994 Revision

    Energy Technology Data Exchange (ETDEWEB)

    Opresko, D.M.; Sample, B.E.; Suter, G.W. II

    1994-09-01

    The process by which ecological risks of environmental contaminants are evaluated is two-tiered. The first tier is a screening assessment where concentrations of contaminants in the environment are compared to toxicological benchmarks which represent concentrations of chemicals in environmental media (water, sediment, soil, food, etc.) that are presumed to be nonhazardous to the surrounding biota. The second tier is a baseline ecological risk assessment where toxicological benchmarks are one of several lines of evidence used to support or refute the presence of ecological effects. The report presents toxicological benchmarks for assessment of effects of 76 chemicals on 8 representative mammalian wildlife species and 31 chemicals on 9 avian wildlife species. The chemicals are some of those that occur at United States Department of Energy waste sites; the wildlife species were chosen because they are widely distributed and provide a representative range of body sizes and diets. Further descriptions of the chosen wildlife species and chemicals are provided in the report. The benchmarks presented in this report represent values believed to be nonhazardous for the listed wildlife species. These benchmarks only consider contaminant exposure through oral ingestion of contaminated media; exposure through inhalation or direct dermal exposure are not considered in this report.

  10. Bioprinted three dimensional human tissues for toxicology and disease modeling.

    Science.gov (United States)

    Nguyen, Deborah G; Pentoney, Stephen L

    2017-03-01

    The high rate of attrition among clinical-stage therapies, due largely to an inability to predict human toxicity and/or efficacy, underscores the need for in vitro models that better recapitulate in vivo human biology. In much the same way that additive manufacturing has revolutionized the production of solid objects, three-dimensional (3D) bioprinting is enabling the automated production of more architecturally and functionally accurate in vitro tissue culture models. Here, we provide an overview of the most commonly used bioprinting approaches and how they are being used to generate complex in vitro tissues for use in toxicology and disease modeling research. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Transforming clinical imaging and 3D data for virtual reality learning objects: HTML5 and mobile devices implementation.

    Science.gov (United States)

    Trelease, Robert B; Nieder, Gary L

    2013-01-01

    Web deployable anatomical simulations or "virtual reality learning objects" can easily be produced with QuickTime VR software, but their use for online and mobile learning is being limited by the declining support for web browser plug-ins for personal computers and unavailability on popular mobile devices like Apple iPad and Android tablets. This article describes complementary methods for creating comparable, multiplatform VR learning objects in the new HTML5 standard format, circumventing platform-specific limitations imposed by the QuickTime VR multimedia file format. Multiple types or "dimensions" of anatomical information can be embedded in such learning objects, supporting different kinds of online learning applications, including interactive atlases, examination questions, and complex, multi-structure presentations. Such HTML5 VR learning objects are usable on new mobile devices that do not support QuickTime VR, as well as on personal computers. Furthermore, HTML5 VR learning objects can be embedded in "ebook" document files, supporting the development of new types of electronic textbooks on mobile devices that are increasingly popular and self-adopted for mobile learning. © 2012 American Association of Anatomists.

  12. Pocket atlas of toxicology. Substances, effects, environment. 2. ed.; Taschenatlas der Toxikologie. Substanzen, Wirkungen, Umwelt

    Energy Technology Data Exchange (ETDEWEB)

    Reichl, F.X. (ed.)

    2002-07-01

    The revised and enhanced edition of this atlas explains and illustrates the effects of substances with ecological effects that may be harmful to vegetation, animals, and humans. The most recent findings in this respect are taken into account. Risk assessments in case of exposure are made by competent experts and in consideration of the most recent limiting values, enabling the interested lay public to assess environmental hazards on their own. What makes the book particularly valuable is the mention of most recent findings, e.g. newly discovered poisonous birds and mammals and their toxic effects. The former two-section structure of the book has been retained. The first part (general toxicology) contains updated fundamental information on toxicokinetics, toxicodynamics, test methods, aspects of clinical toxicology, and new findings of environmental medicine and environmental toxicology. In the second part (special toxicology), the various groups of noxious and toxic substances are presented, including the effects of radiation and noise. Current limiting values are presented for pollutants and environmental factors that facilitate risk assessment in case of exposure. (orig.)

  13. Levonorgestrel-releasing intrauterine device in the treatment of abnormal uterine bleeding: a 6- and 12-month morphological and clinical follow-up.

    Science.gov (United States)

    Palmara, Vittorio; Sturlese, Emanuele; Villari, Daniela; Giacobbe, Valentina; Retto, Annalisa; Santoro, Giuseppe

    2013-08-01

    Abnormal uterine bleeding is defined as any alteration in the pattern or volume of menstrual blood flow, and it is preferably treated using hysterectomy, endometrial destruction or the levonorgestrel-releasing intrauterine system (Mirena(®) ). Recently, it has been demonstrated that studies of Mirena(®) were generally small and consequently imprecise. Our study was aimed at assessing the effects of a slow-release levonorgestrel (20 μg/day) intrauterine device in fertile and postmenopausal women experiencing abnormal uterine bleeding that did not respond to traditional medical management. A total of 40 women, of whom 24 were of reproductive capacity and 16 were postmenopausal, were enrolled in the trial. Removal of the intrauterine device was required for only 2 of the 24 fertile women and for only 3 of the 16 postmenopausal women. After 6 and 12 months of treatment, the remaining women were clinically evaluated and underwent ultrasound and hysteroscopy using biopsy specimens as a control. The EuroQol Group EQ-5D questionnaire was used for evaluation of quality of life. The device showed good tolerability and efficacy. It resulted in a reduction in the endometrial mucosal thickness with a regression of bleeding and collateral effects, which were more evident after 12 months of treatment. A positive effect of the device on the woman's quality of life was demonstrated. The slow-release levonorgestrel intrauterine device may be a valid therapeutic tool for treating basic symptomatology and increasing quality of life in women with abnormal uterine bleeding. © 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  14. Gordon Research Conference on Genetic Toxicology

    Energy Technology Data Exchange (ETDEWEB)

    Project Director Penelope Jeggo

    2003-02-15

    Genetic toxicology represents a study of the genetic damage that a cell can incur, the agents that induce such damage, the damage response mechanisms available to cells and organisms, and the potential consequences of such damage. Genotoxic agents are abundant in the environment and are also induced endogenously. The consequences of such damage can include carcinogenesis and teratogenesis. An understanding of genetic toxicology is essential to carry out risk evaluations of the impact of genotoxic agents and to assess how individual genetic differences influence the response to genotoxic damage. In recent years, the importance of maintaining genomic stability has become increasingly recognized, in part by the realization that failure of the damage response mechanisms underlies many, if not all, cancer incidence. The importance of these mechanisms is also underscored by their remarkable conservation between species, allowing the study of simple organisms to provide significant input into our understanding of the underlying mechanisms. It has also become clear that the damage response mechanisms interface closely with other aspects of cellular metabolism including replication, transcription and cell cycle regulation. Moreover, defects in many of these mechanisms, as observed for example in ataxia telangiectasia patients, confer disorders with associated developmental abnormalities demonstrating their essential roles during growth and development. In short, while a decade ago, a study of the impact of DNA damage was seen as a compartmentalized area of cellular research, it is now appreciated to lie at the centre of an array of cellular responses of crucial importance to human health. Consequently, this has become a dynamic and rapidly advancing area of research. The Genetic Toxicology Gordon Research Conference is biannual with an evolving change in the emphasis of the meetings. From evaluating the nature of genotoxic chemicals, which lay at the centre of the early

  15. Clinical Trials

    Medline Plus

    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

  16. Post-mortem toxicology in young sudden cardiac death victims

    DEFF Research Database (Denmark)

    Bjune, Thea; Risgaard, Bjarke; Kruckow, Line

    2017-01-01

    Aims: Several drugs increase the risk of ventricular fibrillation and sudden cardiac death (SCD). We aimed to investigate in detail the toxicological findings of all young SCD throughout Denmark. Methods and results: Deaths in persons aged 1-49 years were included over a 10-year period. Death...... certificates and autopsy reports were retrieved and read to identify cases of sudden death and establish cause of death. All medico-legal autopsied SCD were included and toxicological reports collected. Positive toxicology was defined as the presence of any substance (licit and/or illicit). All toxicological...... findings had previously been evaluated not to have caused the death (i.e. lethal concentrations were excluded). We identified 620 medico-legal autopsied cases of SCD, of which 77% (n = 477) were toxicologically investigated post-mortem, and 57% (n = 270) had a positive toxicology profile. Sudden cardiac...

  17. Clinical protocol levels are required in laboratory animal surgery when using medical devices: experiences with ureteral replacement surgery in goats

    OpenAIRE

    de Jonge, Paul K. J. D.; Sloff, Marije; Janke, Heinz P.; Kortmann, Barbara B. M.; de Gier, Robert P. E.; Geutjes, Paul J.; Oosterwijk, Egbert; Feitz, Wout F. J.

    2017-01-01

    It is common to test medical devices in large animal studies that are or could also be used in humans. In this short report we describe the use of a ureteral J-stent for the evaluation of biodegradable tubular constructs for tissue reconstruction, and the regeneration of ureters in Saanen goats. Similarly to a previous study in pigs, the ureteral J-stent was blindly inserted until some resistance was met. During evaluation of the goats after three months, perforation of the renal cortex by th...

  18. Internal Mammary Arterial Injury from Lead Extraction: A Clinically Subtle yet Important Complication of Implantable Device Removal

    Directory of Open Access Journals (Sweden)

    Cesar Cruz

    2011-01-01

    Full Text Available Percutaneous implantable device extraction has increased in recent years and is associated with small but significant risk. Arteriovenous fistula formation is an uncommon complication of this procedure. We report two cases where lead extraction was complicated by an arteriovenous fistula between the left internal mammary artery and the left brachiocephalic vein. In both cases, the patients were asymptomatic and the presence of a continuous murmur in the left subclavicular region led to the appropriate diagnosis. These were successfully treated with coil embolization. Auscultation around prior extraction sites should be routinely done to aid in the diagnosis of this potentially harmful complication.

  19. Advancing Risk Assessment through the Application of Systems Toxicology

    Science.gov (United States)

    Sauer, John Michael; Kleensang, André; Peitsch, Manuel C.; Hayes, A. Wallace

    2016-01-01

    Risk assessment is the process of quantifying the probability of a harmful effect to individuals or populations from human activities. Mechanistic approaches to risk assessment have been generally referred to as systems toxicology. Systems toxicology makes use of advanced analytical and computational tools to integrate classical toxicology and quantitative analysis of large networks of molecular and functional changes occurring across multiple levels of biological organization. Three presentations including two case studies involving both in vitro and in vivo approaches described the current state of systems toxicology and the potential for its future application in chemical risk assessment. PMID:26977253

  20. New horizons in predictive toxicology: current status and application

    National Research Council Canada - National Science Library

    Wilson, A. G. E

    2012-01-01

    "In this comprehensive discussion of predictive toxicology and its applications, leading experts express their views on the technologies currently available and the potential for future developments...

  1. La toxicología en la Universidad de Sevilla

    OpenAIRE

    Puerto Rodríguez, María; Cameán Fernández, Ana María; Moreno Navarro, Isabel María; Pichardo Sánchez, Silvia; Prieto Ortega, Ana Isabel; Jos Gallego, Ángeles Mencía

    2010-01-01

    La docencia del Área de Toxicología en la Universidad de Sevilla se desarrolla en la actualidad en dos titulaciones, Farmacia y Bioquímica. En los planes de estudios actuales la carga lectiva del Área viene dada por las asignaturas de Toxicología (asignatura troncal), y Toxicología Alimentaria (asignatura optativa) en la Licenciatura de Farmacia, y de Toxicología Molecular (asignatura optativa) en la Licenciatura de Bioquímica. Una vez aprobados por la Agencia Nacional de la Evaluación de la ...

  2. Microfluidic Organ/Body-on-a-Chip Devices at the Convergence of Biology and Microengineering

    Directory of Open Access Journals (Sweden)

    Ana Rubina Perestrelo

    2015-12-01

    Full Text Available Recent advances in biomedical technologies are mostly related to the convergence of biology with microengineering. For instance, microfluidic devices are now commonly found in most research centers, clinics and hospitals, contributing to more accurate studies and therapies as powerful tools for drug delivery, monitoring of specific analytes, and medical diagnostics. Most remarkably, integration of cellularized constructs within microengineered platforms has enabled the recapitulation of the physiological and pathological conditions of complex tissues and organs. The so-called “organ-on-a-chip” technology, which represents a new avenue in the field of advanced in vitro models, with the potential to revolutionize current approaches to drug screening and toxicology studies. This review aims to highlight recent advances of microfluidic-based devices towards a body-on-a-chip concept, exploring their technology and broad applications in the biomedical field.

  3. Microfluidic Organ/Body-on-a-Chip Devices at the Convergence of Biology and Microengineering

    Science.gov (United States)

    Perestrelo, Ana Rubina; Águas, Ana C. P.; Rainer, Alberto; Forte, Giancarlo

    2015-01-01

    Recent advances in biomedical technologies are mostly related to the convergence of biology with microengineering. For instance, microfluidic devices are now commonly found in most research centers, clinics and hospitals, contributing to more accurate studies and therapies as powerful tools for drug delivery, monitoring of specific analytes, and medical diagnostics. Most remarkably, integration of cellularized constructs within microengineered platforms has enabled the recapitulation of the physiological and pathological conditions of complex tissues and organs. The so-called “organ-on-a-chip” technology, which represents a new avenue in the field of advanced in vitro models, with the potential to revolutionize current approaches to drug screening and toxicology studies. This review aims to highlight recent advances of microfluidic-based devices towards a body-on-a-chip concept, exploring their technology and broad applications in the biomedical field. PMID:26690442

  4. Plant Poisonings According to the Czech Toxicological Information Centre from 2005 to 2008

    Czech Academy of Sciences Publication Activity Database

    Říčařová, B.; Rakovcová, H.; Pelclová, D.; Navrátil, Tomáš

    2009-01-01

    Roč. 47, č. 5 (2009), s. 473-473 ISSN 1556-3650. [The International Congress of the European Association of Poison Centres and Clinical Toxicologists /29./. 12.05.2009-15.05.2009, Stockholm] R&D Projects: GA AV ČR IAA400400806 Institutional research plan: CEZ:AV0Z40400503 Keywords : Czech Toxicological Information Centre * plant poison ings according Subject RIV: CF - Physical ; Theoretical Chemistry

  5. First clinical tests using a liquid-filled electronic portal imaging device and a convolution model for the verification of the midplane dose

    International Nuclear Information System (INIS)

    Boellaard, R.; Herk, M. van; Uiterwaal, H.; Mijnheer, B.

    1998-01-01

    Background and purpose: Recently, algorithms have been developed to derive the patient dose from portal dose measurements using a liquid-filled electronic portal imaging device. These algorithms have already been validated for several phantom geometries irradiated under clinical conditions. It is the aim of the present study to investigate the applicability of a liquid-filled electronic portal imaging device in combination with these algorithms for two-dimensional midplane dose verification in clinical practice. Measurements and methods: Portal dose images were obtained during several patient treatments under routine clinical conditions. Measurements were performed to verify the midplane dose during radiotherapy of larynx cancer with 4 MV beams, breast and lung cancer with 8 MV beams and prostate cancer with both 8 and 18 MV beams. Midplane doses, determined from portal dose measurements and analyzed with our algorithms, were compared with midplane doses calculated with our three-dimensional (3D) treatment planning system (TPS). Results: For the larynx treatment the measured 2D midplane dose agreed within 2.0% with TPS calculations in most parts of the field. Larger differences were found in a small region below the skin due to the absence of electron equilibrium, which is not taken into account in our portal dose analysis. For breast irradiations the measured midplane dose showed a homogeneous distribution in the AP direction in the axial plane, while high dose regions were observed in the cranial and caudal part of the breast. Portal dose measurements and TPS calculations agreed within 2.5% for most of the prostate and lung irradiations. For a few of the prostate and lung treatments larger local differences were found due to differences between the actual patient anatomy and the planning CT data, e.g. as a result of variable gas filling in the rectum and anatomical changes in the lung. Conclusions: Portal dose measurements with a liquid-filled electronic portal

  6. Toxicological evaluation of liquids proposed for use in direct contact liquid--liquid heat exchangers for solar heated and cooled buildings

    Energy Technology Data Exchange (ETDEWEB)

    Buchan, R.M.; Majestic, J.R.; Billau, R.

    1976-09-01

    This report contains the results of the toxicological evaluation part of the project entitled, ''Direct Contact Liquid-Liquid Heat Exchangers for Solar Heated and Cooled Buildings.'' Obviously any liquid otherwise suitable for use in such a device should be subjected to a toxicological evaluation. 34 liquids (24 denser than water, 10 less dense) have physical and chemical properties that would make them suitable for use in such a device. In addition to the complexity involved in selecting the most promising liquids from the standpoint of their chemical and physical properties is added the additional difficulty of also considering their toxicological properties. Some of the physical and chemical properties of these liquids are listed. The liquids are listed in alphabetical order within groups, the denser than water liquids are listed first followed by those liquids less dense than water.

  7. Application of toxicogenomics in hepatic systems toxicology for risk assessment: Acetaminophen as a case study

    NARCIS (Netherlands)

    Kienhuis, A.S.; Bessems, J.G.M.; Pennings, J.L.A.; Driessen, M.; Luijten, M.; Delft, van J.H.M.; Ven, van der L.T.M.

    2011-01-01

    Hepatic systems toxicology is the integrative analysis of toxicogenomic technologies, e.g., transcriptomics, proteomics, and metabolomics, in combination with traditional toxicology measures to improve the understanding of mechanisms of hepatotoxic action. Hepatic toxicology studies that have

  8. 78 FR 24762 - National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for...

    Science.gov (United States)

    2013-04-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program... announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC... authorities knowledgeable in fields such as toxicology, pharmacology, pathology, biochemistry, epidemiology...

  9. 77 FR 60707 - National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for...

    Science.gov (United States)

    2012-10-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Toxicology Program... announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC... such as toxicology, pharmacology, pathology, biochemistry, epidemiology, risk assessment...

  10. 76 FR 23323 - Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)

    Science.gov (United States)

    2011-04-26

    ... the scientific validation and regulatory acceptance of toxicological and safety testing methods that... DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) AGENCY: National Toxicology Program (NTP), National Institute of...

  11. Opioids in the Frame of New Psychoactive Substances Network: A Complex Pharmacological and Toxicological Issue.

    Science.gov (United States)

    Ventura, Ludovic; Carvalho, Felix; Dinis-Oliveira, Ricardo Jorge

    2018-01-01

    New psychoactive substances (NPS), often referred to as "legal highs" or "designer drugs", are derivatives and analogues of existing psychoactive drugs that are introduced in the recreational market to circumvent existing legislation on drugs of abuse. This systematic review aims to gather the state of the art regarding chemical, molecular pharmacology and toxicological information of opioid class of NPS. Chemical, pharmacological, toxicological and clinical effects of opioid class of NPS were searched in books and in PubMed (U.S. National Library of Medicine) without a limiting period. Within this class, fentanyl analogues are among the most frequently abused and pose several clinical concerns and therefore will be thoroughly discussed. Other opioid sub-categories of NPS frequently misused include AH-7921, MT-45, U-47700, U-50488, desomorphine, mitragynine, tramadol, tapentadol, salvinorin A and its analogue herkinorin. Due to inefficient monitoring techniques, as well as limited knowledge regarding the acute and long-term effects of opioids NPS, further clinical and forensic toxicological studies are required. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  12. Pharmacological and Toxicological Profile of Harmane-β-Carboline Alkaloid: Friend or Foe.

    Science.gov (United States)

    Khan, Haroon; Patel, Seema; Kamal, Mohammad A

    2017-01-01

    The plant secondary metabolites have an outstanding therapeutic potential and success over the years. In fact, it is the foundation of numerous clinically used drugs. Similarly, these is a general perception that these products are inherent safety. However, such products might have toxic/unwanted lethal effects therefore, along with biological relevance, toxicological evaluation is equally important for clinical applications. Therefore, harmane- β-carboline alkaloid was investigated for both therapeutic and toxicological potential. The literature related to the therapeutic/toxicological effects of the alkaloid was searched using various scientific data bases including Google, ScienceDirect, PubMed, SpringerLink, ASC. The peer reviewed articles were only selected. The harmane-β-carboline alkaloid has shown several pharmacological activities such as antianxiety, antidepressant, antiplatelet, antidiabetic, acetylcholinesterase and myeloperoxidase inhibition, antioxidant, antiparasitic, hypotensive, morphine withdrawal syndrome alleviation, and antinociceptive effects. On the other hand, it exhibited tremorogenic effect, for a symptom of Parkinson's disease. Adverse effect of the alkaloid on learning and memory have also been observed. All together, it is, concluded in this review that harmane elicited marked pharmacological effects but simultaneously, it possessed some serious side effects that could be the primary hurdle in the way of its clinical testing. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  13. Two new dynamic devices / orthoses for training / assisting / rehabilitation of hand functionality in patients with stroke as a result of clinical experience

    Directory of Open Access Journals (Sweden)

    Catalin Moghioroiu

    2016-12-01

    Full Text Available Introduction - Observing stroke patients with hemiplegia we can easily identify one of the problems they face –inability to use affected upper limb. On a closer analysis we can see that this incapacity is determined, at many of them, by the incapacity to open the hand and grasp. They follow therapies for months and the results are often mediocre therefore respectively upper limb is neglected and forgotten and its activities are taken up by the healthy upper limb. These observations have prompted the search for other type of solutions to help / assist them and facilitate participation. In this way were created twodynamic devices/orthotics that assists finger extension, facilitates grasping and increase, at least in theory, the possibilities of participation. Objective - The main purpose of this study is to test the effectiveness of using these devices on short and medium term. Material and method - For this study we will select 60 patients with single stroke. Patients will be randomized into two groups. Patients in the control group will receive a physical therapy session per day for 10 days. Patients in the experimental group will receive in addition a functional workout (20-30 minutes of handling small objects and few simple functional gestures of the "activities of daily living" using one of the two devices –the one that will allow the patient to best accomplish the given tasks. We will perform an initial assessment, one final and one to three months. The initiation of this study will be made after obtaining the opinion of the ethics committee, and the inclusion of patients will occur only after obtaining informed consent. Conclusions - Creation of two dynamic devices/orthotics witch assist finger extension and facilitate prehension opened the possibility of carrying out a clinical trial to test the effectiveness of their use. To what extent that this will happen remains to be seen.

  14. Arthroscopically assisted reduction of acute acromioclavicular joint dislocation using a single double-button device: Medium-term clinical and radiological outcomes.

    Science.gov (United States)

    Issa, S-P; Payan, C; Le Hanneur, M; Loriaut, P; Boyer, P

    2018-02-01

    Double-button devices for endoscopic management of acute acromioclavicular joint dislocation (ACJD) provide satisfactory short-term functional and radiological results. However, little exists in the literature regarding the long- and medium-term results of these implants, especially regarding the evolution of the acromioclavicular joint (ACJ). Satisfactory and steady long- and medium-term outcomes can be achieved in patients with acute ACJD undergoing endoscopically assisted ACJ repair using a single double-button device. A retrospective single-center study was conducted in patients with acute Rockwood III and IV ACJD treated endoscopically with a single double-button device from October 2008 to October 2010, allowing a minimum 5-year follow-up. Functional evaluation used Constant and Quick-DASH scores. Clinical evidence of dislocation recurrence was combined with bilateral Zanca views to assess coracoclavicular distance. Acromioclavicular osteoarthritis was evaluated on the Paxinos test and Zanca views. Nineteen of the 25 operated patients were seen at a mean 76.9±8.5 months' follow-up. Mean age was 34.4±8.3 years. Mean Constant and Quick-DASH scores were 96.2±5.1 and 0.9±1.6 points, respectively. Four patients had a recurrence of their initial dislocation, 3 of whom had positive Paxinos test, whereas the 15 patients without recurrence had a negative test (p=0.004). Five patients had radiological evidence of ACJ osteoarthritis: all 4 patients with recurrence and 1 without (p=0.001). Long- and medium-term radioclinical outcome of endoscopically assisted management of acute ACJD using a single double-button device seems to be satisfactory and steady over time. Recurrence of the initial dislocation appears to be related to onset of degenerative ACJ arthropathy. Therapeutic type IV-Retrospective case series. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  15. Translation of First North American 50 and 70 cc Total Artificial Heart Virtual and Clinical Implantations: Utility of 3D Computed Tomography to Test Fit Devices.

    Science.gov (United States)

    Ferng, Alice S; Oliva, Isabel; Jokerst, Clinton; Avery, Ryan; Connell, Alana M; Tran, Phat L; Smith, Richard G; Khalpey, Zain

    2017-08-01

    Since the creation of SynCardia's 50 cc Total Artificial Hearts (TAHs), patients with irreversible biventricular failure now have two sizing options. Herein, a case series of three patients who have undergone successful 50 and 70 cc TAH implantation with complete closure of the chest cavity utilizing preoperative "virtual implantation" of different sized devices for surgical planning are presented. Computed tomography (CT) images were used for preoperative planning prior to TAH implantation. Three-dimensional (3D) reconstructions of preoperative chest CT images were generated and both 50 and 70 cc TAHs were virtually implanted into patients' thoracic cavities. During the simulation, the TAHs were projected over the native hearts in a similar position to the actual implantation, and the relationship between the devices and the atria, ventricles, chest wall, and diaphragm were assessed. The 3D reconstructed images and virtual modeling were used to simulate and determine for each patient if the 50 or 70 cc TAH would have a higher likelihood of successful implantation without complications. Subsequently, all three patients received clinical implants of the properly sized TAH based on virtual modeling, and their chest cavities were fully closed. This virtual implantation increases our confidence that the selected TAH will better fit within the thoracic cavity allowing for improved surgical outcome. Clinical implantation of the TAHs showed that our virtual modeling was an effective method for determining the correct fit and sizing of 50 and 70 cc TAHs. © 2016 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

  16. Design, construction, and in vivo feasibility of a positioning device for irradiation of mice brains using a clinical linear accelerator and intensity modulated radiation therapy.

    Science.gov (United States)

    Rancilio, Nicholas J; Dahl, Shaun; Athanasiadi, Ilektra; Perez-Torres, Carlos J

    2017-12-01

    The goal of this study was to design a positioning device that would allow for selective irradiation of the mouse brain with a clinical linear accelerator. We designed and fabricated an immobilization fixture that incorporates three functions: head stabilizer (through ear bars and tooth bar), gaseous anesthesia delivery and scavenging, and tissue mimic/bolus. Cohorts of five mice were irradiated such that each mouse in the cohort received a unique dose between 1000 and 3000 cGy. DNA damage immunohistochemistry was used to validate an increase in biological effect as a function of radiation dose. Mice were then followed with hematoxylin and eosin (H&E) and anatomical magnetic resonance imaging (MRI). There was evidence of DNA damage throughout the brain proportional to radiation dose. Radiation-induced damage at the prescribed doses, as depicted by H&E, appeared to be constrained to the white matter consistent with radiological observation in human patients. The severity of the damage correlated with the radiation dose as expected. We have designed and manufactured a device that allows us to selectively irradiate the mouse brain with a clinical linear accelerator. However, some off-target effects are possible with large prescription doses.

  17. Clinical efficacy and safety evaluation of a novel fractional unipolar radiofrequency device on facial tightening: A preliminary report.

    Science.gov (United States)

    Suh, Dong Hye; Byun, Eun Jung; Lee, Sang Jun; Song, Kye Yong; Kim, Hei Sung

    2017-06-01

    Previous studies have shown that radiofrequency (RF) energy is safe and effective for improving skin laxity. Unlike monopolar and bipolar devices, little has been studied with the unipolar hand piece. We sought to evaluate the safety and efficacy of a novel fractional unipolar RF device on facial tightening. This was a retrospective, single-center study of 14 subjects with age-related facial laxity who underwent five sessions of fractional unipolar RF at an interval of 2 weeks, and then followed-up for 3 months. Standardized photos were taken at baseline and at 3-months follow-up, and were assessed by two independent dermatologists using a 4-point scale (0=no improvement, 1=mild improvement, 2=moderate improvement, 3=significant improvement). Punch biopsies (2 mm) were performed and a questionnaire was used to evaluate the patient's satisfaction and the incidence of adverse reactions. Fourteen subjects with mild to moderate age-related facial laxity were included in the study. The mean age of the subjects was 49.7 years (range 32-80). 35.7% of the subjects showed significant improvement, 50% moderate improvement, and 14.3% slight improvement of facial laxity in their follow-up photos. About 85.7% of the patients replied that they were either greatly satisfied or satisfied with the results at 3-months follow-up. Skin biopsies revealed an increase in collagen in the dermis. None of the subjects experienced any serious adverse events during or after the procedure. Our findings suggest that fractional Unipolar RF can be safely performed on the face and is effective in skin tightening. It has a great advantage over other forms of RF by being entirely painless. © 2017 Wiley Periodicals, Inc.

  18. THE FUTURE OF TOXICOLOGY-PREDICTIVE TOXICOLOGY: AN EXPANDED VIEW OF CHEMICAL TOXICITY

    Science.gov (United States)

    A chemistry approach to predictive toxicology relies on structure−activity relationship (SAR) modeling to predict biological activity from chemical structure. Such approaches have proven capabilities when applied to well-defined toxicity end points or regions of chemical space. T...

  19. Drug shortages: Implications for medical toxicology.

    Science.gov (United States)

    Mazer-Amirshahi, Maryann; Hawley, Kristy L; Zocchi, Mark; Fox, Erin; Pines, Jesse M; Nelson, Lewis S

    2015-07-01

    Drug shortages have significantly increased over the past decade. There are limited data describing how shortages impact medical toxicology of drugs. To characterize drug shortages affecting the management of poisoned patients. Drug shortage data from January 2001 to December 2013 were obtained from the University of Utah Drug Information Service. Shortage data for agents used to treat poisonings were analyzed. Information on drug type, formulation, reason for shortage, shortage duration, marketing, and whether the drug was available from a single source was collected. The availability of a substitute therapy and whether substitutes were in shortage during the study period were also investigated. Of 1,751 shortages, 141 (8.1%) impacted drugs used to treat poisoned patients, and as of December 2013, 21 (14.9%) remained unresolved. New toxicology shortages increased steadily from the mid-2000s, reaching a high of 26 in 2011. Median shortage duration was 164 days (interquartile range: 76-434). Generic drugs were involved in 85.1% of shortages and 41.1% were single-source products. Parenteral formulations were often involved in shortages (89.4%). The most common medications in shortage were sedative/hypnotics (15.6%). An alternative agent was available for 121 (85.8%) drugs; however, 88 (72.7%) alternatives were also affected by shortages at some point during the study period. When present, the most common reasons reported were manufacturing delays (22.0%) and supply/demand issues (17.0%). Shortage reason was not reported for 48.2% of drugs. Toxicology drug shortages are becoming increasingly prevalent, which can result in both suboptimal treatment and medication errors from using less familiar alternatives. Drug shortages affected a substantial number of critical agents used in the management of poisoned patients. Shortages were often of long duration and for drugs without alternatives. Providers caring for poisoned patients should be aware of current shortages and

  20. ALiEM Blog and Podcast Watch: Toxicology.

    Science.gov (United States)

    Zaver, Fareen; Craddick, Michael; Sanford, Audrey; Sefa, Nana; Hughes, George; Lin, Michelle

    2017-10-01

    The WestJEM Blog and Podcast Watch presents high-quality open-access educational blogs and podcasts in emergency medicine based on the ongoing Academic Life in Emergency Medicine (ALiEM) Approved Instructional Resources (AIR) and AIR-Professional (Pro) series. Both series critically appraise open-access educational blogs and podcasts in EM using an objective scoring instrument. This installment of the blog and podcast watch series curated and scored relevant posts in the specific topic of toxicology emergencies from the AIR-Pro Series. The AIR-Pro Series is a continuously building curriculum covering a new subject area every two months. For each area, eight EM chief residents identify 3-5 advanced clinical questions. Using FOAMsearch.net and FOAMSearcher to search blogs and podcasts, relevant posts are scored by eight reviewers from the AIR-Pro editorial board, which is comprised of EM faculty and chief residents at various institutions across North America. The scoring instrument contains five measurement outcomes based on seven-point Likert scales: recency, accuracy, educational utility, evidence based, and references. The AIR-Pro label is awarded to posts with a score of ≥28 (out of 35) points. An "honorable mention" label is awarded if board members collectively felt that the blogs were valuable and the scores were > 25. A total of 31 blog posts and podcasts were included. Key educational pearls from the six high-quality AIR-Pro posts and four honorable mentions are summarized. The WestJEM ALiEM Blog and Podcast Watch series is based on the AIR and AIR-Pro Series, which attempts to identify high-quality educational content on open-access blogs and podcasts. This series provides an expert-based, crowdsourced approach towards critically appraising educational social media content for EM clinicians. This installment focuses on toxicology emergencies.

  1. Collaborative development of predictive toxicology applications.

    Science.gov (United States)

    Hardy, Barry; Douglas, Nicki; Helma, Christoph; Rautenberg, Micha; Jeliazkova, Nina; Jeliazkov, Vedrin; Nikolova, Ivelina; Benigni, Romualdo; Tcheremenskaia, Olga; Kramer, Stefan; Girschick, Tobias; Buchwald, Fabian; Wicker, Joerg; Karwath, Andreas; Gütlein, Martin; Maunz, Andreas; Sarimveis, Haralambos; Melagraki, Georgia; Afantitis, Antreas; Sopasakis, Pantelis; Gallagher, David; Poroikov, Vladimir; Filimonov, Dmitry; Zakharov, Alexey; Lagunin, Alexey; Gloriozova, Tatyana; Novikov, Sergey; Skvortsova, Natalia; Druzhilovsky, Dmitry; Chawla, Sunil; Ghosh, Indira; Ray, Surajit; Patel, Hitesh; Escher, Sylvia

    2010-08-31

    OpenTox provides an interoperable, standards-based Framework for the support of predictive toxicology data management, algorithms, modelling, validation and reporting. It is relevant to satisfying the chemical safety assessment requirements of the REACH legislation as it supports access to experimental data, (Quantitative) Structure-Activity Relationship models, and toxicological information through an integrating platform that adheres to regulatory requirements and OECD validation principles. Initial research defined the essential components of the Framework including the approach to data access, schema and management, use of controlled vocabularies and ontologies, architecture, web service and communications protocols, and selection and integration of algorithms for predictive modelling. OpenTox provides end-user oriented tools to non-computational specialists, risk assessors, and toxicological experts in addition to Application Programming Interfaces (APIs) for developers of new applications. OpenTox actively supports public standards for data representation, interfaces, vocabularies and ontologies, Open Source approaches to core platform components, and community-based collaboration approaches, so as to progress system interoperability goals.The OpenTox Framework includes APIs and services for compounds, datasets, features, algorithms, models, ontologies, tasks, validation, and reporting which may be combined into multiple applications satisfying a variety of different user needs. OpenTox applications are based on a set of distributed, interoperable OpenTox API-compliant REST web services. The OpenTox approach to ontology allows for efficient mapping of complementary data coming from different datasets into a unifying structure having a shared terminology and representation.Two initial OpenTox applications are presented as an illustration of the potential impact of OpenTox for high-quality and consistent structure-activity relationship modelling of REACH

  2. Collaborative development of predictive toxicology applications

    Directory of Open Access Journals (Sweden)

    Hardy Barry

    2010-08-01

    Full Text Available Abstract OpenTox provides an interoperable, standards-based Framework for the support of predictive toxicology data management, algorithms, modelling, validation and reporting. It is relevant to satisfying the chemical safety assessment requirements of the REACH legislation as it supports access to experimental data, (Quantitative Structure-Activity Relationship models, and toxicological information through an integrating platform that adheres to regulatory requirements and OECD validation principles. Initial research defined the essential components of the Framework including the approach to data access, schema and management, use of controlled vocabularies and ontologies, architecture, web service and communications protocols, and selection and integration of algorithms for predictive modelling. OpenTox provides end-user oriented tools to non-computational specialists, risk assessors, and toxicological experts in addition to Application Programming Interfaces (APIs for developers of new applications. OpenTox actively supports public standards for data representation, interfaces, vocabularies and ontologies, Open Source approaches to core platform components, and community-based collaboration approaches, so as to progress system interoperability goals. The OpenTox Framework includes APIs and services for compounds, datasets, features, algorithms, models, ontologies, tasks, validation, and reporting which may be combined into multiple applications satisfying a variety of different user needs. OpenTox applications are based on a set of distributed, interoperable OpenTox API-compliant REST web services. The OpenTox approach to ontology allows for efficient mapping of complementary data coming from different datasets into a unifying structure having a shared terminology and representation. Two initial OpenTox applications are presented as an illustration of the potential impact of OpenTox for high-quality and consistent structure

  3. Toxicological Problems with the Redy System

    DEFF Research Database (Denmark)

    Broch Møller, B.; Bahnsen, M.; Solgaard, Per Bent

    1976-01-01

    be substituted by another antiseptic. Of special interest was the finding of a very high concentration of boron in the dialysate. It is suggested that this metal, which is a potentially toxic substance, may emanate from the patient. It is concluded that use of the REDY system carries no obvious toxicological......Dialysate from the REDY dialysis system was examined for toxic elements, special attention being paid to the content of zirconium and aluminium. Also investigated was the concentration of formaldehyde in the rinsing fluid of three consecutive washings. The amount of zirconium and aluminium found...

  4. IRIS Toxicological Review of Dichloromethane (Methylene ...

    Science.gov (United States)

    EPA has finalized the Toxicological Review of Dichloromethane (Methylene Chloride): In support of the Integrated Risk Information System (IRIS). Now final, this assessment may be used by EPA’s program and regional offices to inform decisions to protect human health. This document presents background information and justification for the Intergrated Risk Information System (IRIS) Summary of the hazard and dose-response assessment of dichloromethane. IRIS Summaries may include oral reference dose (RfD) and inhalation reference concentration (RfC) values for chronic and other exposure durations, and a carcinogencity assessment. Internet/NCEA web site

  5. Toxicological applications of neutron-activation analysis

    International Nuclear Information System (INIS)

    Cross, J.D.; Dale, I.M.; Smith, H.

    1975-01-01

    Thermal neutron-activation analysis is recognised as a useful tool for trace element studies in toxicology. This paper describes some recent applications of the technique to three elements when ingested by people in excess of normal intake Two of the elements (copper and chromium) are essential to life and one (bromine) is as yet unclassified. Three deaths were investiagted and trace element levels compared with normal levels from healthy subjects in the same geographical area who had died as a result of violence. (author)

  6. Objective Assessment of Joint Stiffness: A Clinically Oriented Hardware and Software Device with an Application to the Shoulder Joint

    OpenAIRE

    McQuade, Kevin; Price, Robert; Liu, Nelson; Ciol, Marcia A

    2012-01-01

    Examination of articular joints is largely based on subjective assessment of the “end-feel” of the joint in response to manually applied forces at different joint orientations. This technical report aims to describe the development of an objective method to examine joints in general, with specific application to the shoulder, and suitable for clinical use. We adapted existing hardware and developed laptop-based software to objectively record the force/displacement behavior of the glenohumeral...

  7. Data-intensive drug development in the information age: applications of Systems Biology/Pharmacology/Toxicology.

    Science.gov (United States)

    Kiyosawa, Naoki; Manabe, Sunao

    2016-01-01

    Pharmaceutical companies continuously face challenges to deliver new drugs with true medical value. R&D productivity of drug development projects depends on 1) the value of the drug concept and 2) data and in-depth knowledge that are used rationally to evaluate the drug concept's validity. A model-based data-intensive drug development approach is a key competitive factor used by innovative pharmaceutical companies to reduce information bias and rationally demonstrate the value of drug concepts. Owing to the accumulation of publicly available biomedical information, our understanding of the pathophysiological mechanisms of diseases has developed considerably; it is the basis for identifying the right drug target and creating a drug concept with true medical value. Our understanding of the pathophysiological mechanisms of disease animal models can also be improved; it can thus support rational extrapolation of animal experiment results to clinical settings. The Systems Biology approach, which leverages publicly available transcriptome data, is useful for these purposes. Furthermore, applying Systems Pharmacology enables dynamic simulation of drug responses, from which key research questions to be addressed in the subsequent studies can be adequately informed. Application of Systems Biology/Pharmacology to toxicology research, namely Systems Toxicology, should considerably improve the predictability of drug-induced toxicities in clinical situations that are difficult to predict from conventional preclinical toxicology studies. Systems Biology/Pharmacology/Toxicology models can be continuously improved using iterative learn-confirm processes throughout preclinical and clinical drug discovery and development processes. Successful implementation of data-intensive drug development approaches requires cultivation of an adequate R&D culture to appreciate this approach.

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

    Science.gov (United States)

    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.

  9. Male Reproductive Toxicology: Environmental Exposures vs Reproductive Competence

    Science.gov (United States)

    Like the lecture this chapter begins with an overview of male reproductive biology and transitions into male reproductive toxicology. It ends with a brief discussion of the strengths and weaknesses in male reproductive toxicology and epidemiology today. This chapter is highly il...

  10. Toxicological risks of selected flame-retardant chemicals

    National Research Council Canada - National Science Library

    2000-01-01

    ... Committee on Toxicology Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C. i Copyrighttrue Please breaks inserted. are Page files. accidentally typesetting been have may original from the errors not typographic original retained, and from the created ca...

  11. IRIS Toxicological Review of Methanol (Noncancer) (Interagency Science Discussion Draft)

    Science.gov (United States)

    On May 3, 2013, the Toxicological Review of Methanol (noncancer) (Revised External Review Draft) was posted for public review and comment. Subsequently, the draft Toxicological Review, Appendices, and draft IRIS Summary were reviewed internally by EPA and by other federal agenci...

  12. Recent developments in analytical toxicology : for better or for worse

    NARCIS (Netherlands)

    de Zeeuw, RA

    1998-01-01

    When considering the state of the art in toxicology from an analytical perspective, the key developments relate to three major areas. (1) Forensic horizon: Today forensic analysis has broadened its scope dramatically, to include workplace toxicology, drug abuse testing, drugs and driving, doping,

  13. Toxicological Risks of Selected Flame-Retardant Chemicals

    National Research Council Canada - National Science Library

    2000-01-01

    ... Committee on Toxicology Board on Environmental Studies and Toxicology Commission on Life Sciences National Research Council NATIONAL ACADEMY PRESS Washington, D.C. i Copyrighttrue Please breaks inserted. are Page files. accidentally typesetting been have may original from the errors not typographic original retained, and from the created ca...

  14. IRIS Toxicological Review of Trichloroethylene (Interagency Science Consultation Draft)

    Science.gov (United States)

    On November 3, 2009, the Toxicological Review of Trichloroethylene and the charge to external peer reviewers were released for external peer review and public comment. The Toxicological Review and charge were reviewed internally by EPA and by other federal agencies and White Hous...

  15. TOXICOLOGICAL RESEARCH INVOLVING HUMANS: ETHICAL AND REGULATORY CONSIDERATIONS

    Science.gov (United States)

    This paper discusses the need for the Society of Toxicology (SOT) to develop a policy for ethical research in humans, and a review for publication of these studies. Observations on human beings have been the foundation upon which toxicologic knowledge has been built since the in...

  16. Toxicological and performance aspects of oxygenated motor vehicle fuels

    National Research Council Canada - National Science Library

    National Research Council Staff; Commission on Life Sciences; Division on Earth and Life Studies; National Research Council; National Academy of Sciences

    ... COMMITTEE ON TOXICOLOGICAL PERFORMANCE ASPECTS OXYGENATED MOTOR VEHICLE FUELS ENVIRONMENTAL STUDIES TOXICOLOGY COMMISSION LIFE SCIENCES NATIONAL RESEARCH COUNCIL AND OF BOARD ON AND ON NATIONAL ACADEMY PRESS Washington, D.C. 1996 i Copyrightoriginal retained, the be not from cannot book, paper original however, for version formatting, authoritative the t...

  17. Toward the Rational Use of Exposure Information in Mixtures Toxicology

    Science.gov (United States)

    Of all the disciplines of toxicology, perhaps none is as dependent on exposure information as Mixtures Toxicology. Identifying real world mixtures and replicating them in the laboratory (or in silico) is critical to understanding their risks. Complex mixtures such as cigarett...

  18. 75 FR 74053 - Availability of Final Toxicological Profiles

    Science.gov (United States)

    2010-11-30

    ... CONTACT: Ms. Olga Dawkins, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances... Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, 4700 Buford Highway..., except legal holidays. Availability This notice announces the availability of one new and six updated...

  19. Initial clinical experience with a new percutaneous peripheral atherectomy device for the treatment of femoro-popliteal stenoses

    International Nuclear Information System (INIS)

    Zeller, T.; Frank, U.; Buergelin, K.; Schwarzwaelder, U.; Neumann, F.J.; Reimers, B.

    2004-01-01

    Background: Evaluation of the efficacy and safety of a new 7F-atherectomy device (30-day endpoint) for the treatment of short and mid-length arterial lesions with a reference diameter of 2.5-7 mm. Material and Methods: Fifty-eight femoto-popliteal stenoses in 46 patients (67% male, mean age 66± 9 years) with chronic peripheral occlusive disease of the lower limbs [Rutherford stage 2: n = 13 (28%); stage 3: n = 29 (63%); stage 4: 2 (4%), stage 5: n = 2 (4%]), were treated with directional atherectomy. Target lesion characteristics: Common femoral artery: n = 1 (2%), superficial femoral artery: n = 47 (81%); popliteal artery, n = 10 (17%); instent n = 3 (5%). Thirty (65%) of the interventions were performed using an antegrade approach, 16 (35%) interventions in cross-over technique. Mean degree of stenosis was 83 ± 11 mm, mean length of lesion was 37 ± 37 mm. Results: 6.5 ± 2 (4-10) passes of the lesion were performed with the catheter. Three lesions were treated after predilatation, 55 (95%) interventions as primary atherectomy. In 31/58 lesions (53%) additional balloon angioplasty was performed, in 1 lesion (2%) additional stent placement was needed. The mean degree of stenosis after atherectomy was reduced to 29 ± 20% (0-60%) after additional balloon angioplasty, it was 11 ± 10% (0-30%). A residual stenosis of [de

  20. The Chemistry and Toxicology of Depleted Uranium

    Directory of Open Access Journals (Sweden)

    Sidney A. Katz

    2014-03-01

    Full Text Available Natural uranium is comprised of three radioactive isotopes: 238U, 235U, and 234U. Depleted uranium (DU is a byproduct of the processes for the enrichment of the naturally occurring 235U isotope. The world wide stock pile contains some 1½ million tons of depleted uranium. Some of it has been used to dilute weapons grade uranium (~90% 235U down to reactor grade uranium (~5% 235U, and some of it has been used for heavy tank armor and for the fabrication of armor-piercing bullets and missiles. Such weapons were used by the military in the Persian Gulf, the Balkans and elsewhere. The testing of depleted uranium weapons and their use in combat has resulted in environmental contamination and human exposure. Although the chemical and the toxicological behaviors of depleted uranium are essentially the same as those of natural uranium, the respective chemical forms and isotopic compositions in which they usually occur are different. The chemical and radiological toxicity of depleted uranium can injure biological systems. Normal functioning of the kidney, liver, lung, and heart can be adversely affected by depleted uranium intoxication. The focus of this review is on the chemical and toxicological properties of depleted and natural uranium and some of the possible consequences from long term, low dose exposure to depleted uranium in the environment.