WorldWideScience

Sample records for background clinical considerations

  1. Antipsychotic drug treatment for patients with schizophrenia: theoretical background, clinical considerations and patients preferences

    DEFF Research Database (Denmark)

    Nielsen, René Ernst; Nielsen, Jimmi

    2009-01-01

      The cornerstone in treatment of psychosis is antipsychotic drugs. Treatment options have increased over the years; newer antipsychotic drugs with a proposed efficacy regarding negative and cognitive symptoms, but also a shift in side-effects from neurological side-effects to metabolic side-effe...... treatment. The clinically relevant aspects of antipsychotic drug treatment are reviewed; mechanism of antipsychotic drug action, clinical considerations in treatment, switching antipsychotic drugs, polypharmacy, safety and patient preference.  ...

  2. Biological component of the NIMH clinical research branch collaborative program on the psychobiology of depression: I. Background and theoretical considerations.

    Science.gov (United States)

    Maas, J W; Koslow, S H; Davis, J M; Katz, M M; Mendels, J; Robins, E; Stokes, P E; Bowden, C L

    1980-11-01

    There are many reports which suggest that patients with effective illness (mania and/or depression) have abnormalities in the functioning of one or more neurobiological systems. At a conference convened by the Clinical Research Branch, Division of Extramural Research Programs, National Institute of Mental Health, these findings were reviewed and some of the factors impeding movement towards a more complete and integrated view of the functioning of neurobiological systems in patients with mania or depression were identified. As a result, a multi-research centre, collaborative approach to the study of the psychobiology of affective disorders was developed. In this collaborative programme, which has now been underway for several years, the focus has been upon: (a) the assessment of the functioning of several different types of biological systems in the same patient, both before and during treatment; (b) obtaining a reasonably large number of patients and comparison subjects; and (c) the use within and across centres of standardized diagnostic categories and behavioural rating methodologies. In this paper the history, background, and rationale for this collaborative effort are reviewed. Those biological systems chosen for study are noted, and issues such as reliability and validity of diagnoses, measurement of state variables, assessment of change with treatment, and logistical and coordinating problems are discussed.

  3. Genetic testing in asymptomatic minors: background considerations towards ESHG Recommendations

    DEFF Research Database (Denmark)

    Borry, Pascal; Evers-Kiebooms, Gerry; Cornel, Martina C

    2009-01-01

    Although various guidelines and position papers have discussed, in the past, the ethical aspects of genetic testing in asymptomatic minors, the European Society of Human Genetics had not earlier endorsed any set of guidelines exclusively focused on this issue. This paper has served as a background...... document in preparation of the development of the policy recommendations of the Public and Professional Committee of the European Society of Human Genetics. This background paper first discusses some general considerations with regard to the provision of genetic tests to minors. It discusses the concept...... of best interests, participation of minors in health-care decisions, parents' responsibilities to share genetic information, the role of clinical genetics and the health-care system in communication within the family. Second, it discusses, respectively, the presymptomatic and predictive genetic testing...

  4. Local anesthesia in dentistry - Clinical Considerations

    OpenAIRE

    Sharmraaj Subramaniam; Prasanna Neelakantan

    2013-01-01

    Local anaesthesia is commonly employed prior to most dental procedures. It is imperative to understand the mechanisms by which local anaesthetics work, so that their efficacy can be improved for painless dental care. Local anaesthesia also has major clinical implications in that it can precipitate emergencies in patients with an underlying systemic disease. It is imperative that a dentist have a thorough knowledge of the considerations one must take when administering local anaesthesia in pat...

  5. Combining offshore wind energy and large-scale mussel farming: background & technical, ecological and economic considerations

    NARCIS (Netherlands)

    Lagerveld, S.; Rockmann, C.; Scholl, M.M.; Bartelings, H.; Burg, van den S.W.K.; Jak, R.G.; Jansen, H.M.; Klijnstra, J.; Leopold, M.F.; Poelman, M.; Smith, S.R.; Stavenuiter, J.; Veenstra, F.A.; Veltman, C.; Westra, C.

    2014-01-01

    This Blauwdruk project report presents background and technical, ecological and economic considerations of the potential combination of offshore wind energy production and large-scale mussel farming in offshore areas in the North Sea. The main objective of the Blauwdruk project was to study the feas

  6. Spinal cord stimulation: Background and clinical application

    DEFF Research Database (Denmark)

    Meier, Kaare

    2014-01-01

    Background Spinal cord stimulation (SCS) is a surgical treatment for chronic neuropathic pain refractory to conventional treatment. SCS treatment consists of one or more leads implanted in the epidural space of the spinal canal, connected to an implantable pulse generator (IPG). Each lead carries...... is described in detail and illustrated with a series of intraoperative pictures. Finally, indications for SCS are discussed along with some of the controversies surrounding the therapy. Implications The reader is presented with a broad overview of spinal cord stimulation, including the historical...... a number of contacts capable of delivering a weak electrical current to the spinal cord, evoking a feeling of peripheral paresthesia. With correct indication and if implanted by an experienced implanter, success rates generally are in the range of about 50–75%. Common indications include complex regional...

  7. Characterization of Vacuum Facility Background Gas Through Simulation and Considerations for Electric Propulsion Ground Testing

    Science.gov (United States)

    Yim, John T.; Burt, Jonathan M.

    2015-01-01

    The background gas in a vacuum facility for electric propulsion ground testing is examined in detail through a series of cold flow simulations using a direct simulation Monte Carlo (DSMC) code. The focus here is on the background gas itself, its structure and characteristics, rather than assessing its interaction and impact on thruster operation. The background gas, which is often incorrectly characterized as uniform, is found to have a notable velocity within a test facility. The gas velocity has an impact on the proper measurement of pressure and the calculation of ingestion flux to a thruster. There are also considerations for best practices for tests that involve the introduction of supplemental gas flows to artificially increase the background pressure. All of these effects need to be accounted for to properly characterize the operation of electric propulsion thrusters across different ground test vacuum facilities.

  8. Statistics in clinical research: Important considerations.

    Science.gov (United States)

    Barkan, Howard

    2015-01-01

    Statistical analysis is one of the foundations of evidence-based clinical practice, a key in conducting new clinical research and in evaluating and applying prior research. In this paper, we review the choice of statistical procedures, analyses of the associations among variables and techniques used when the clinical processes being examined are still in process. We discuss methods for building predictive models in clinical situations, and ways to assess the stability of these models and other quantitative conclusions. Techniques for comparing independent events are distinguished from those used with events in a causal chain or otherwise linked. Attention then turns to study design, to the determination of the sample size needed to make a given comparison, and to statistically negative studies.

  9. Clinical pharmacology considerations in biologics development

    Science.gov (United States)

    Zhao, Liang; Ren, Tian-hua; Wang, Diane D

    2012-01-01

    Biologics, including monoclonal antibodies (mAbs) and other therapeutic proteins such as cytokines and growth hormones, have unique characteristics compared to small molecules. This paper starts from an overview of the pharmacokinetics (PK) of biologics from a mechanistic perspective, the determination of a starting dose for first-in-human (FIH) studies, and dosing regimen optimisation for phase II/III clinical trials. Subsequently, typical clinical pharmacology issues along the corresponding pathways for biologics development are summarised, including drug-drug interactions, QTc prolongation, immunogenicity, and studies in specific populations. The relationships between the molecular structure of biologics, their pharmacokinetic and pharmacodynamic characteristics, and the corresponding clinical pharmacology strategies are summarised and depicted in a schematic diagram. PMID:23001474

  10. Clinical pharmacology considerations in biologics development

    Institute of Scientific and Technical Information of China (English)

    Liang ZHAO; Tian-hua REN; Diane D WANG

    2012-01-01

    Biologics,including monoclonal antibodies (mAbs) and other therapeutic proteins such as cytokines and growth hormones,have unique characteristics compared to small molecules.This paper starts from an overview of the pharmacokinetics (PK) of biologics from a mechanistic perspective,the determination of a starting dose for first-in-human(FIH) studies,and dosing regimen optimisation for phase Ⅱ/Ⅲ clinical trials.Subsequently,typical clinical pharmacology issues along the corresponding pathways for biologics development are summarised,including drug-drug interactions,QTc prolongation,immunogenicity,and studies in specific populations.The relationships between the molecular structure of biologics,their pharmacokinetic and pharmacodynamic characteristics,and the corresponding clinical pharmacology strategies are summarised and depicted in a schematic diagram.

  11. Smallpox: clinical highlights and considerations for vaccination.

    Directory of Open Access Journals (Sweden)

    Mahoney M

    2003-01-01

    Full Text Available Smallpox virus has gained considerable attention as a potential bioterrorism agent. Recommendations for smallpox (vaccinia vaccination presume a low risk for use of smallpox as a terrorist biological agent and vaccination is currently recommended for selected groups of individuals such as health care workers, public health authorities, and emergency/rescue workers, among others. Information about adverse reactions to the smallpox vaccine is based upon studies completed during the 1950s and 1960s. The prevalence of various diseases has changed over the last four decades and new disease entities have been described during this period. The smallpox vaccination may be contra-indicated in many of these conditions. This has made pre-screening of potential vaccines necessary. It is believed that at present, the risks of vaccine-associated complications far outweigh the potential benefits of vaccination in the general population.

  12. Generalized periodic discharges: Pathophysiology and clinical considerations

    NARCIS (Netherlands)

    van Putten, Michel Johannes Antonius Maria; Hofmeijer, Jeannette

    2015-01-01

    Generalized periodic discharges (GPDs) are commonly encountered in metabolic encephalopathy and cerebral hypoxia/ischemia. The clinical significance of this EEG pattern is indistinct, and it is unclear whether treatment with antiepileptic drugs is beneficial. In this study, we discuss potential

  13. Detecting somatic mosaicism: considerations and clinical implications.

    Science.gov (United States)

    Cohen, A S A; Wilson, S L; Trinh, J; Ye, X C

    2015-06-01

    Human disease is rarely a matter of all or nothing; variable expressivity is generally observed. Part of this variability is explained by somatic mosaicism, which can arise by a myriad of genetic alterations. These can take place at any stage of development, possibly leading to unusual features visible at birth, but can also occur later in life, conceivably leading to cancer. Previously, detection of somatic mosaicism was extremely challenging, as many gold standard tests lacked the necessary resolution. However, with the advances in high-throughput sequencing, mosaicism is being detected more frequently and at lower levels. This raises the issue of normal variation within each individual vs mosaicism leading to disease, and how to distinguish between the two. In this article, we will define somatic mosaicism with a brief overview of its main mechanisms in concrete clinical examples, discuss the impact of next-generation sequencing technologies in its detection, and expand on the clinical implications associated with a discovery of somatic mosaicism in the clinic.

  14. Prescription and Cost Consideration at a Diabetic Clinic in Ibadan ...

    African Journals Online (AJOL)

    opsig

    Prescription and Cost Consideration at a Diabetic Clinic in Ibadan,. Nigeria: A Report ... drugs with proven efficacy based on best evidence, the prevailing social ... pharmacy using the current hospital drug-pricing list calculated the cost of the ...

  15. ISR: background, evolution and implementation, with specific consideration for ligand-binding assays.

    Science.gov (United States)

    Findlay, John W A; Kelley, Marian M

    2014-02-01

    ISR was highlighted as a topic of major interest to the US FDA in 2006, having been previously required, then discontinued, by Canadian regulatory authorities. Following an FDA focus on ISR, this topic has also been emphasized by regulatory agencies in Europe, Asia and Latin America. Extensive discussions on proper implementation of programs have taken place in multiple settings, including pharmaceutical companies, regulatory agencies, professional associations and CROs. These efforts have led to recommendations for ISR conduct that are now included in a final guideline on bioanalytical method validation from the European Medicines Agency, a draft validation guidance from the Ministry of Health, Labor and Welfare in Japan and a revised draft validation guidance from the FDA. In this Review we look at the background, evolution and implementation of ISR for all assays, while including some specific considerations on this topic for ligand-binding assays.

  16. Research design considerations for chronic pain prevention clinical trials

    DEFF Research Database (Denmark)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C

    2015-01-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations...... for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment...... element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have...

  17. Influence of Task Difficulty and Background Music on Working Memory Activity: Developmental Considerations.

    Science.gov (United States)

    Kaniel, Shlomo; Aram, Dorit

    1998-01-01

    A study of 300 children in kindergarten, grade 2, and grade 6 found that background music improved visual discrimination task performance at the youngest and middle ages and had no effect on the oldest participants. On a square identification task, background music had no influence on easy and difficult tasks but lowered performance on…

  18. Best Practices in Employment Background Screening: Tips and Considerations for Implementing a Comprehensive Program

    Science.gov (United States)

    Lashier, Ron

    2005-01-01

    Pre-employment background screening is becoming more commonplace as employers strive to provide a safe, secure environment for their employees and customers. However, in order for background screening policies to work properly, they must be consistent, fair and within the boundaries of the law. One way to ensure that these criteria are being met…

  19. Clinical and practical considerations in the pharmacologic management of narcolepsy.

    Science.gov (United States)

    Thorpy, Michael J; Dauvilliers, Yves

    2015-01-01

    Despite published treatment recommendations and the availability of approved and off-label pharmacologic therapies for narcolepsy, the clinical management of this incurable, chronic neurologic disorder remains challenging. While treatment is generally symptomatically driven, decisions regarding which drug(s) to use need to take into account a variety of factors that may affect adherence, efficacy, and tolerability. Type 1 narcolepsy (predominantly excessive daytime sleepiness with cataplexy) or type 2 narcolepsy (excessive daytime sleepiness without cataplexy) may drive treatment decisions, with consideration given either to a single drug that targets multiple symptoms or to multiple drugs that each treat a specific symptom. Other drug-related characteristics that affect drug choice are dosing regimens, tolerability, and potential drug-drug interactions. Additionally, the patient should be an active participant in treatment decisions, and the main symptomatic complaints, treatment goals, psychosocial setting, and use of lifestyle substances (ie, alcohol, nicotine, caffeine, and cannabis) need to be discussed with respect to treatment decisions. Although there is a lack of narcolepsy-specific instruments for monitoring therapeutic effects, clinically relevant subjective and objective measures of daytime sleepiness (eg, Epworth Sleepiness Scale and Maintenance of Wakefulness Test) can be used to provide guidance on whether treatment goals are being met. These considerations are discussed with the objective of providing clinically relevant recommendations for making treatment decisions that can enhance the effective management of patients with narcolepsy.

  20. Biomarkers of Metabolic Syndrome: Biochemical Background and Clinical Significance.

    Science.gov (United States)

    Robberecht, Harry; Hermans, Nina

    2016-03-01

    Biomarkers of the metabolic syndrome are divided into four subgroups. Although dividing them in groups has some limitations, it can be used to draw some conclusions. In a first part, the dyslipidemias and markers of oxidative stress are discussed, while inflammatory markers and cardiometabolic biomarkers are reviewed in a second part. For most of them, the biochemical background and clinical significance are discussed, although here also a well-cut separation cannot always be made. Altered levels cannot always be claimed as the cause, risk, or consequence of the syndrome. Several factors are interrelated to each other and act in a concerted, antagonistic, synergistic, or modulating way. Most important conclusions are summarized at the end of every reviewed subgroup. Genetic biomarkers or influences of various food components on concentration levels are not included in this review article.

  1. Signal and background considerations for the MRSt on the National Ignition Facility (NIF).

    Science.gov (United States)

    Wink, C W; Frenje, J A; Hilsabeck, T J; Bionta, R; Khater, H Y; Gatu Johnson, M; Kilkenny, J D; Li, C K; Séguin, F H; Petrasso, R D

    2016-11-01

    A Magnetic Recoil Spectrometer (MRSt) has been conceptually designed for time-resolved measurements of the neutron spectrum at the National Ignition Facility. Using the MRSt, the goals are to measure the time-evolution of the spectrum with a time resolution of ∼20-ps and absolute accuracy better than 5%. To meet these goals, a detailed understanding and optimization of the signal and background characteristics are required. Through ion-optics, MCNP simulations, and detector-response calculations, it is demonstrated that the goals and a signal-to background >5-10 for the down-scattered neutron measurement are met if the background, consisting of ambient neutrons and gammas, at the MRSt is reduced 50-100 times.

  2. Signal and background considerations for the MRSt on the National Ignition Facility (NIF)

    Science.gov (United States)

    Wink, C. W.; Frenje, J. A.; Hilsabeck, T. J.; Bionta, R.; Khater, H. Y.; Gatu Johnson, M.; Kilkenny, J. D.; Li, C. K.; Séguin, F. H.; Petrasso, R. D.

    2016-11-01

    A Magnetic Recoil Spectrometer (MRSt) has been conceptually designed for time-resolved measurements of the neutron spectrum at the National Ignition Facility. Using the MRSt, the goals are to measure the time-evolution of the spectrum with a time resolution of ˜20-ps and absolute accuracy better than 5%. To meet these goals, a detailed understanding and optimization of the signal and background characteristics are required. Through ion-optics, MCNP simulations, and detector-response calculations, it is demonstrated that the goals and a signal-to background >5-10 for the down-scattered neutron measurement are met if the background, consisting of ambient neutrons and gammas, at the MRSt is reduced 50-100 times.

  3. Signal and background considerations for the MRSt on the National Ignition Facility (NIF)

    Energy Technology Data Exchange (ETDEWEB)

    Wink, C. W., E-mail: cwink@mit.edu; Frenje, J. A.; Gatu Johnson, M.; Li, C. K.; Séguin, F. H.; Petrasso, R. D. [Massachusetts Institute of Technology, Cambridge, Massachusetts 02139 (United States); Hilsabeck, T. J.; Kilkenny, J. D. [General Atomics, San Diego, California 92186 (United States); Bionta, R.; Khater, H. Y. [Lawrence Livermore National Laboratory, Livermore, California 94550 (United States)

    2016-11-15

    A Magnetic Recoil Spectrometer (MRSt) has been conceptually designed for time-resolved measurements of the neutron spectrum at the National Ignition Facility. Using the MRSt, the goals are to measure the time-evolution of the spectrum with a time resolution of ∼20-ps and absolute accuracy better than 5%. To meet these goals, a detailed understanding and optimization of the signal and background characteristics are required. Through ion-optics, MCNP simulations, and detector-response calculations, it is demonstrated that the goals and a signal-to background >5–10 for the down-scattered neutron measurement are met if the background, consisting of ambient neutrons and gammas, at the MRSt is reduced 50–100 times.

  4. Clinical considerations on the posology of direct oral anticoagulants.

    Science.gov (United States)

    Sáez-Peñataro, J; Avendaño-Solá, C; González-Juanatey, J R

    2016-10-01

    The efficacy of dicoumarin anticoagulants has been shown in patients with nonvalvular atrial fibrillation. However, they have drawbacks such as the need to adjust the dosage and the interaction with drugs and food. Direct oral anticoagulants are an effective and safe alternative and have a less complicated clinical management. There is considerable debate on the selection criteria for the posology regimens of direct oral anticoagulants. The differences among them and their administration regimens have raised questions about the clinical, pharmacokinetic and pharmacodynamic selection criteria that support the posology. This review critically analyses the available evidence and its impact on the final selection of the dosage regimen. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  5. Targeting Opioid-Induced Hyperalgesia in Clinical Treatment: Neurobiological Considerations.

    Science.gov (United States)

    Arout, Caroline A; Edens, Ellen; Petrakis, Ismene L; Sofuoglu, Mehmet

    2015-06-01

    Opioid analgesics have become a cornerstone in the treatment of moderate to severe pain, resulting in a steady rise of opioid prescriptions. Subsequently, there has been a striking increase in the number of opioid-dependent individuals, opioid-related overdoses, and fatalities. Clinical use of opioids is further complicated by an increasingly deleterious profile of side effects beyond addiction, including tolerance and opioid-induced hyperalgesia (OIH), where OIH is defined as an increased sensitivity to already painful stimuli. This paradoxical state of increased nociception results from acute and long-term exposure to opioids, and appears to develop in a substantial subset of patients using opioids. Recently, there has been considerable interest in developing an efficacious treatment regimen for acute and chronic pain. However, there are currently no well-established treatments for OIH. Several substrates have emerged as potential modulators of OIH, including the N-methyl-D-aspartate and γ-aminobutyric acid receptors, and most notably, the innate neuroimmune system. This review summarizes the neurobiology of OIH in the context of clinical treatment; specifically, we review evidence for several pathways that show promise for the treatment of pain going forward, as prospective adjuvants to opioid analgesics. Overall, we suggest that this paradoxical state be considered an additional target of clinical treatment for chronic pain.

  6. Ethical considerations in clinical training, care and research in psychopharmacology.

    Science.gov (United States)

    Strous, Rael D

    2011-04-01

    Psychopharmacology is a powerful tool in psychiatry; however, it is one that demands responsibility in order to deal with the ethical complexities that accompany advances in the field. It is important that questions are asked and that ethical mindfulness and sensitivity are developed along with clinical skills. In order to cultivate and deepen ethical awareness and subsequently solve issues in optimal fashion, investment should be made in the development of an ethical decision-making process as well as in education in the ethics of psychopharmacology to trainees in the field at all stages of their educational development. A clear approach to identifying ethical problems, engaging various ethical concepts in considering solutions and then applying these principles in problem resolution is demanded. An openness in identifying and exploring issues has become crucial to the future development and maturation of psychopharmacologists, both research and clinical. Consideration must be given to the social implications of psychopharmacological practice, with the best interests of patients always paramount. From both a research and clinical perspective, psychopharmacology has to be practised with fairness, sensitivity and ethical relevance to all. While ethical issues related to psychopharmacological practice are varied and plentiful, this review focuses on advances in technology and biological sciences, personal integrity, special populations, and education and training.

  7. Statistical considerations for confirmatory clinical trials for similar biotherapeutic products.

    Science.gov (United States)

    Njue, Catherine

    2011-09-01

    For the purpose of comparing the efficacy and safety of a Similar Biotherapeutic Product (SBP) to a Reference Biotherapeutic Product (RBP), the "Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)" issued by the World Health Organisation (WHO), states that equivalence or non-inferiority studies may be acceptable. While in principle, equivalence trials are preferred, non-inferiority trials may be considered if appropriately justified, such as for a medicinal product with a wide safety margin. However, the statistical issues involved in the design, conduct, analysis and interpretation of equivalence and non-inferiority trials are complex and subtle, and require that all aspects of these trials be given careful consideration. These issues are important in order to ensure that equivalence and non-inferiority trials provide valid data that are necessary to draw reliable conclusions regarding the clinical similarity of an SBP to an RBP. Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

  8. Clinical considerations in restorative dentistry - A narrative review

    Directory of Open Access Journals (Sweden)

    Ashwini Tumkur Shivakumar

    2015-01-01

    Full Text Available The relationship between periodontal health and the restoration of teeth is intimate and inseparable. Human teeth are designed in such a way that the individual tooth contributes significantly to their own support as well as collectively the teeth in the arch. Decay on the proximal surfaces occurs mainly due to the faulty interrelationship between the contact area, marginal ridge, the embrasures and the gingiva. An adequate understanding of the relationship between periodontal tissues and restorative dentistry is paramount to ensure an adequate form, function, aesthetics and comfort of the dentition. For long-term survival of restoration, both functionally and esthetically, certain biological considerations are very critical to preserve the health of the periodontium and thus must be given due importance in clinical practice. While most clinicians are aware of this important relationship, uncertainly remains regarding specific concept such as biologic width and its maintainces.

  9. Meningioma involving Meckel's cave: transpetrosal surgical anatomy and clinical considerations.

    Science.gov (United States)

    Choo, Daniel I; Steward, David L; Pensak, Myles L

    2002-09-01

    Meningiomas originating in Meckel's cave (MC) are uncommon lesions that represent 1% of all intracranial meningiomas. Innovations in skull base surgery have enabled resection of these lesions with less morbidity, but require an intimate knowledge of both lesional pathology and regional microneuroanatomy. To review the surgical and clinical considerations involved in the management of MC meningiomas, we retrospectively reviewed data from patients who underwent transpetrosal resection of primary MC meningiomas between 1984 and 1998. Of 146 patients who underwent transpetrosal removal of meningiomas, 7 were believed to have tumors originating in MC. All 7 patients presented with trigeminal dysfunction, facial pain, and/or headache. Complete tumor removal was achieved in 5 of the 7 patients. Facial hypoesthesia or anesthesia, paralysis of cranial nerve VI, and ophthalmoplegia were among the postoperative complications encountered. Meningiomas of MC represent treatable lesions whose diagnosis requires prompt imaging of patients with trigeminal dysfunction and symptoms of facial pain and headache.

  10. Good clinical practice : Historical background and key aspects

    NARCIS (Netherlands)

    Otte, Andreas; Maier-Lenz, Herbert; Dierckx, Rudi A.

    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for

  11. Good clinical practice: Historical background and key aspects

    NARCIS (Netherlands)

    Otte, A.; Maier-Lenz, H.; Dierckx, R.A.

    2005-01-01

    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyo

  12. Good clinical practice : Historical background and key aspects

    NARCIS (Netherlands)

    Otte, A; Maier-Lenz, H; Dierckx, RA

    2005-01-01

    Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyo

  13. Emerging drugs of abuse: clinical and legal considerations.

    Science.gov (United States)

    Aoun, Elie G; Christopher, Paul P; Ingraham, James W

    2014-06-02

    Over the past several decades, nontraditional drugs of abuse, including bath salts, synthetic cannabinoids, and salvia, have increased in popularity and use. Despite this fact, they remain unfamiliar to many healthcare providers. Commonly marketed as "legal highs," these substances are being used for their desired neuropsychiatric effects, taking advantage of their accessibility, low cost, variable legality, and limited detection on traditional urine drug screens. Similar to traditional drugs of abuse, these substances have varying degrees of toxicity and may lead to potentially adverse effects, ranging from benign to life threatening. This paper offers a review of three of the more widely-used emerging drugs (or classes of drugs): bath salts, synthetic cannabinoids, and salvia. For each we review its history and development, the neurochemical basis for its clinical effects, the nature and route of ingestion, the range of desired effects, potential toxicities, diagnostic and therapeutic approaches, as well as social and legal considerations. [Full text available at http://rimed.org/rimedicaljournal-2014-06.asp, free with no login].

  14. Clinical considerations for increasing occlusal vertical dimension: a review.

    Science.gov (United States)

    Abduo, J; Lyons, K

    2012-03-01

    The purpose of this article is to discuss the clinical considerations related to increasing the occlusal vertical dimension (OVD) when restoring a patient's dentition. Thorough extraoral and intraoral evaluations are mandatory to assess the suitability of increasing OVD. In the literature, multiple techniques have been proposed to quantify OVD loss. However, the techniques lack consistency and reliability, which in turn affects the decision of whether to increase the OVD. Therefore, increasing OVD should be determined on the basis of the dental restorative needs and aesthetic demands. In general, a minimal increase in OVD should be applied, though a 5 mm maximum increase in OVD can be justified to provide adequate occlusal space for the restorative material and to improve anterior teeth aesthetics. The literature reflects the safety of increasing the OVD permanently, and although signs and symptoms may develop, these are usually of an interim nature. Whenever indicated, the increase in OVD should be achieved with fixed restorations rather than a removable appliance, due to the predictable patient adaptation. The exception to this is for patients with TMD, where increasing the OVD should still be achieved using removable appliances to control TMD-associated symptoms before considering any form of irreversible procedure.

  15. Psychotherapist self-disclosure: ethical and clinical considerations.

    Science.gov (United States)

    Barnett, Jeffrey E

    2011-12-01

    Self-disclosure is an ever present and unavoidable aspect of psychotherapy. But, why, how, and when it is done requires careful forethought. The use of self-disclosure is discussed in the context of boundaries, highlighting its ethical and appropriate use in psychotherapy. Rather than avoiding self-disclosure out of a fear of violating ethical and professional standards, a thoughtful approach to addressing self-disclosure is presented. Recommendations for the ethical and effective use of self-disclosure are provided to include the use of ethical decision-making models and thoughtful consideration of contextual factors that include the psychotherapist's motivations, the client's treatment needs and personal history, the psychotherapist's theoretical orientation, and individual differences to include each aspect of the client's and psychotherapist's diversity. Recommendations for psychotherapists considering the use of self-disclosure with clients are made along with specific recommendations for the profession of psychology to provide greater guidance on the ethical, effective, and clinically appropriate use of self-disclosure.

  16. Flowable Resin Composites: A Systematic Review and Clinical Considerations

    Science.gov (United States)

    Rodrigues, Jean C.

    2015-01-01

    Background Little is known about flowable composite materials. Most literature mentions conventional composite materials at large, giving minimal emphasis to flowables in particular. This paper briefly gives an in depth insight to the multiple facets of this versatile material. Aim To exclusively review the most salient features of flowable composite materials in comparison to conventional composites and to give clinicians a detailed understanding of the advantages, drawbacks, indications and contraindications based on composition and physical/mechanical properties. Methodology Data Sources: A thorough literature search from the year 1996 up to January 2015 was done on PubMed Central, The Cochrane Library, Science Direct, Wiley Online Library, and Google Scholar. Grey literature (pending patents, technical reports etc.) was also screened. The search terms used were “dental flowable resin composites”. Search Strategy After omitting the duplicates/repetitions, a total of 491 full text articles were assessed. As including all articles were out of the scope of this paper. Only relevant articles that fulfilled the reviewer’s objectives {mentioning indications, contraindications, applications, assessment of physical/mechanical/biological properties (in vitro/ in vivo /ex vivo)} were considered. A total of 92 full text articles were selected. Conclusion Flowable composites exhibit a variable composition and consequently variable mechanical/ physical properties. Clinicians must be aware of this aspect to make a proper material selection based on specific properties and indications of each material relevant to a particular clinical situation. PMID:26266238

  17. Practical and clinical considerations in Cobalt-60 tomotherapy

    Directory of Open Access Journals (Sweden)

    Joshi Chandra

    2009-01-01

    Full Text Available Cobalt-60 (Co-60 based radiation therapy continues to play a significant role in not only developing countries, where access to radiation therapy is extremely limited, but also in industrialized countries. Howver, technology has to be developed to accommodate modern techniques, in-clud-ing image guided and adaptive radiation therapy (IGART. In this paper we describe some of the practical and clinical considerations for Co-60 based tomotherapy by comparing Co-60 and 6 MV linac-based tomotherapy plans for a head and neck (HandN cancer and a prostate cancer case. The tomotherapy IMRT plans were obtained by modeling a MIMiC binary multi-leaf collimator attached to a Theratron-780c Co-60 unit and a 6 MV linear accelerator (CL2100EX. The EGSnrc/BEAMnrc Monte Carlo (MC code was used for the modeling of the treatment units with the MIMiC collimator and EGSnrc/DOSXYZnrc code was used for beamlet dose data. An in-house inverse treatment planning program was then used to generate optimized tomotherapy dose distributions for the H and N and prostate cases. The dose distributions, cumulative dose area histograms (DAHs and dose difference maps were used to evaluate and compare Co-60 and 6 MV based tomotherapy plans. A quantitative analysis of the dose distributions and dose-volume histograms shows that both Co-60 and 6 MV plans achieve the plan objectives for the targets (CTV and nodes and OARs (spinal cord in HandN case, and rectum in prostate case.

  18. Focus on oral ciprofloxacin; clinical and economic considerations.

    Science.gov (United States)

    Pastel, D

    1989-10-01

    Ciprofloxacin, a recently released oral fluorinated quinolone structurally related to nalidixic acid, joins norfloxacin as the second drug of this class to be released. Ciprofloxacin has a wide spectrum of antimicrobial activity and importantly demonstrates little cross resistance to non-quinolone drug classes (e.g. ureidopenicillins, cephalosporins, monobactams, carbapenems, aminoglycosides). Unlike other antibacterial classes such as the beta-lactams or aminoglycosides, ciprofloxacin does not suffer from transferable plasmid-mediated (i.e. R-factor) antibiotic resistance. Against gram-positive (including penicillin-resistant and methicillin-resistant staphylococci aureus) and gram-negative aerobic bacteria including Pseudomonas aeruginosa, ciprofloxacin demonstrates excellent activity. Ciprofloxacin is inactive against Trichomonas sp., treponemes, and fungi and anaerobes are considered resistant. Ciprofloxacin is rapidly absorbed from the gastrointestinal tract (i.e. 70-80% bioavailable), demonstrates extensive extravascular distribution, and its 3.5-5 hour half-life allows twice daily dosing. The bacteriologic and clinical efficacy of oral ciprofloxacin was shown to be comparable to third generation cephalosporins or aminoglycosides for osteomyelitis, cefotaxime for skin structure infections, and to a combination of tobramycin with azlocillin for pulmonary exacerbation of cystic fibrosis. Adverse events associated with ciprofloxacin are related mostly to gastrointestinal disturbance and consist of nausea/vomiting or diarrhea. Concomitant administration of ciprofloxacin and theophylline may lead to decreased theophylline clearance and necessitates periodic measurements of theophylline levels to avoid toxic levels. Treatment with oral ciprofloxacin should offer substantial cost savings over a variety of parenteral antimicrobial regimens (e.g. aminoglycoside + beta-lactams) for difficult to treat infections such as chronic pyelonephritis, osteomyelitis, and skin

  19. Ethical Dimensions of Diagnosing: Considerations for Clinical Mental Health Counselors

    Science.gov (United States)

    Kress, Victoria E.; Hoffman, Rachel M.; Eriksen, Karen

    2010-01-01

    There are numerous ethical considerations inherent within the process of assigning a "Diagnostic and Statistical Manual of Mental Disorders" (4th ed., text rev.; "DSM-IV-TR"; American Psychiatric Association, 2000) diagnosis. In this article, general ethics considerations such as informed consent and confidentiality, accuracy of diagnosis, and…

  20. Heart Xenotransplantation: Historical Background, Experimental Progress, and Clinical Prospects.

    Science.gov (United States)

    Murthy, Raghav; Bajona, Pietro; Bhama, Jay K; Cooper, David K C

    2016-04-01

    If pig hearts could be transplanted successfully into patients with end-stage cardiac failure, the critical shortage of hearts from deceased human donors would be overcome. The several attempts at cardiac xenotransplantation carried out in the 20th century, usually with hearts from nonhuman primates (NHPs), are reviewed, as are the surgical techniques used in experimental heart transplantation in animals. For a number of reasons, the pig has been selected as the potential source of organs for clinical transplantation. The major pathobiological barriers that the pig presents, and progress in overcoming these barriers either by genetic engineering of the pig or by the administration of novel immunosuppressive agents, are described. Currently, non-life-supporting pig heterotopic heart transplantation in NHPs has extended to more than 2 years in 1 case, with life-supporting orthotopic heart transplantation of almost 2 months. Future approaches to resolve the remaining problems and the selection of patients for the initial clinical trials are briefly discussed.

  1. Genetic background of clinical homogeneity of phenylketonuria in Poland.

    OpenAIRE

    Jaruzelska, J; Matuszak, R; Lyonnet, S; Rey, F; Rey, J; Filipowicz, J; Borski, K; Munnich, A.

    1993-01-01

    In order to elucidate the clinical homogeneity and severity of the hyperphenylalaninaemias in Poland, a total of 71 children with typical phenylketonuria (PKU) originating from western and northern Poland were screened for 13 mutations in the phenylalanine hydroxylase (PAH) gene. Eighty percent of all PKU alleles tested were found to carry an identified mutation. One mutation, namely the R408W mutation, accounted for more than 63% of mutant PAH alleles in Poland, the other 27% being accounted...

  2. [Basic considerations during outsourcing of clinical data management services].

    Science.gov (United States)

    Shen, Tong; Liu, Yan

    2015-11-01

    With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

  3. Short clinical crowns (SCC) – treatment considerations and techniques

    OpenAIRE

    Sharma, Ashu; Rahul, G. R.; Poduval, Soorya T.; Shetty, Karunakar

    2012-01-01

    When the clinical crowns of teeth are dimensionally inadequate, esthetically and biologically acceptable restoration of these dental units is difficult. Often an acceptable restoration cannot be accomplished without first surgically increasing the length of the existing clinical crowns; therefore, successful management requires an understanding of both the dental and periodontal parameters of treatment. The complications presented by teeth with short clinical crowns demand a comprehensive tre...

  4. Key considerations for conducting Chinese medicine clinical trials in hospitals

    OpenAIRE

    Shergis Johannah L; Parker Shefton; Coyle Meaghan E; Zhang Anthony L; Xue Charlie C

    2013-01-01

    Abstract Conducting clinical trials of Chinese medicines (CM) in hospitals presents challenges for researchers. The success of hospital-based CM clinical trials may be influenced by the protocol design, including the maintenance of CM theory in compliance with scientific rigour and hospital guidelines and justified treatment approaches with results that can translate into clinical practice. Other influences include personnel and resources such as a dedicated team open to CM with an establishe...

  5. Lupus erythematosus: considerations about clinical, cutaneous and therapeutic aspects*

    OpenAIRE

    Moura Filho,Jucelio Pereira; Peixoto,Raiza Luna; Martins,Livia Gomes; de Melo, Sillas Duarte; Carvalho,Ligiana Leite de; Pereira,Ana Karine F. da Trindade C.; Freire,Eutilia Andrade Medeiros

    2014-01-01

    Systemic Lupus Erythematosus is a chronic inflammatory disease with multifactorial etiology. Although clinical manifestations are varied, the skin is an important target-organ, which contributes to the inclusion of skin lesions in 4 out of the 17 new criteria for the diagnosis of the disease, according to the Systemic Lupus International Collaborating Clinics. The cutaneous manifestations of lupus are pleomorphic. Depending on their clinical characteristics, they can be classified into Acute ...

  6. Short clinical crowns (SCC) – treatment considerations and techniques

    OpenAIRE

    Sharma, Ashu; G. R. Rahul; Poduval, Soorya T.; Shetty, Karunakar

    2012-01-01

    When the clinical crowns of teeth are dimensionally inadequate, esthetically and biologically acceptable restoration of these dental units is difficult. Often an acceptable restoration cannot be accomplished without first surgically increasing the length of the existing clinical crowns; therefore, successful management requires an understanding of both the dental and periodontal parameters of treatment. The complications presented by teeth with short clinical crowns demand a comprehensive tre...

  7. Physician to investigator: clinical practice to clinical research--ethical, operational, and financial considerations.

    Science.gov (United States)

    Pierre, Christine

    2008-01-01

    Physicians who participate in clinical research studies gain benefits for themselves, their practice, and their patients. Historically, private practice physicians have chosen to defer to their counterparts in academic medicine when it comes to contributing to scientific advancement through clinical studies. A growing number of private practice physicians are now taking a serious second look and deciding that there are unique benefits for both the practice and the patient. Physicians who decide to participate in clinical research should give serious consideration to the time and resources that are required to meet both federal regulations and industry standards. In addition, ethical and scientific principles for assuring the protection of human research subjects must be a paramount commitment.

  8. Key considerations for conducting Chinese medicine clinical trials in hospitals

    Directory of Open Access Journals (Sweden)

    Shergis Johannah L

    2013-02-01

    Full Text Available Abstract Conducting clinical trials of Chinese medicines (CM in hospitals presents challenges for researchers. The success of hospital-based CM clinical trials may be influenced by the protocol design, including the maintenance of CM theory in compliance with scientific rigour and hospital guidelines and justified treatment approaches with results that can translate into clinical practice. Other influences include personnel and resources such as a dedicated team open to CM with an established research culture and the ability to maximise participant recruitment. This article identifies the key challenges and limitations of conducting CM clinical trials in Australian hospitals.

  9. Clinical Considerations in the Assessment of Adolescent Chemical Dependency.

    Science.gov (United States)

    Winters, Ken

    1990-01-01

    Discusses relevant research findings of clinical assessment of adolescent chemical dependency so that service providers can better address these concerns. Three major issues are discussed: the definition of adolescent chemical dependency, clinical domains of assessment (chemical use problem severity, precipitating and perpetuating risk factors,…

  10. Sex and gender considerations in Canadian clinical practice guidelines: a systematic review

    Science.gov (United States)

    Tannenbaum, Cara; Clow, Barbara; Haworth-Brockman, Margaret; Voss, Patrice

    2017-01-01

    Background: The importance of sex and gender in the diagnosis and management of health conditions is well established, but the extent to which this evidence is integrated into clinical practice guidelines remains unknown. We aimed to determine the proportion of Canadian clinical practice guidelines that integrate evidence on sex and gender considerations. Methods: We searched the Canadian Medical Association's CPG Infobase, PubMed, all provincial/territorial websites and websites of professional organizations for English- and French-language Canadian clinical practice guidelines published between January 2013 and June 2015 on selected conditions identified as priorities by policy-makers and practitioners. Citations and text were searched electronically using keyword terms related to sex and gender. Three investigators independently analyzed and categorized the content of text-positive clinical practice guidelines based on clinical relevance for practitioners. Results: Of the 118 clinical practice guidelines that met the inclusion criteria, 79 (66.9%) were text-positive for sex and/or gender keywords; 8 (10%) of the 79 used the keywords only in relation to pregnancy. Of the remaining 71 guidelines, 25 (35%) contained sex-related diagnostic or management recommendations. An additional 5 (7%) contained recommendations for sex-specific laboratory reference values, 29 (41%) referred to differences in epidemiologic features or risk factors only, and 12 (17%) contained nonrelevant mentions of search keywords. Twenty-five (35%) of the text-positive guidelines used the terms "sex" and/or "gender" correctly. Interpretation: Recommendations related to sex and gender are inconsistently reported in Canadian clinical practice guidelines. Guidelines such as the Sex and Gender Equity in Research guidelines may help inform the meaningful inclusion of sex and gender evidence in the development of clinical practice guidelines.

  11. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    2013-11-07

    ... for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and... entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document... premarket submissions for medical devices and for FDA staff who review those submissions. This...

  12. Distance Supervision in Rehabilitation Counseling: Ethical and Clinical Considerations

    Science.gov (United States)

    Lund, Emily M.; Schultz, Jared C.

    2015-01-01

    Background: The use of technology-mediated distance supervision is a rapidly growing area in rehabilitation counseling and other fields. Distance supervision has both tremendous potential and notable challenges to address, including questions of ethics and evidence. Purpose: This article examines both the ethical and nonethical principles that…

  13. Short clinical crowns (SCC) – treatment considerations and techniques

    Science.gov (United States)

    Rahul, G. R.; Poduval, Soorya T.; Shetty, Karunakar

    2012-01-01

    When the clinical crowns of teeth are dimensionally inadequate, esthetically and biologically acceptable restoration of these dental units is difficult. Often an acceptable restoration cannot be accomplished without first surgically increasing the length of the existing clinical crowns; therefore, successful management requires an understanding of both the dental and periodontal parameters of treatment. The complications presented by teeth with short clinical crowns demand a comprehensive treatment plan and proper sequencing of therapy to ensure a satisfactory result. Visualization of the desired result is a prerequisite of successful therapy. This review examines the periodontal and restorative factors related to restoring teeth with short clinical crowns. Modes of therapy are usually combined to meet the biologic, restorative, and esthetic requirements imposed by short clinical crowns. In this study various methods for treating short clinical crowns are reviewed, the role that restoration margin location play in the maintenance of periodontal and dental symbiosis and the effects of violation of the supracrestal gingivae by improper full-coverage restorations has also been discussed. Key words:Short clinical crown, surgical crown lengthening, forced eruption, diagnostic wax up, alveoloplasty, gingivectomy. PMID:24558561

  14. Diagnostic Consideration for Sinonasal Wegener's Granulomatosis Clinically Mistaken for Carcinoma

    Science.gov (United States)

    La Rosa, Cristina; Emmanuele, Carmela; Tranchina, Maria Grazia; Ippolito, Massimo; Cosentino, Sebastiano; Saita, Vincenzo; Fraggetta, Filippo

    2013-01-01

    We report a case of Wegener's granulomatosis clinically mistaken for carcinoma in a 21-year-old girl presenting with an ulcerated mass of the nasopharynx associated with enlarged laterocervical nodes. The lesion was clinically suspected as malignant on the basis of clinical and radiological findings (namely, computed tomography scan and positron emission tomography). However, multiple biopsies were not conclusive for malignancy showing histological change suggestive of Wegener's granulomatosis. A serum determination of cANCA supported the diagnosis of Wegener's granulomatosis. Clinical findings and image studies suggested an erroneous diagnosis of malignancy whereas a definitive diagnosis of Wegener's granulomatosis was achieved only after repeated biopsies thus leading to a correct therapeutic approach. The Wegener granulomatosis must be added to the list of the differential diagnoses of the masses of the nasopharynx associated with or without enlarged laterocervical nodes. PMID:24106630

  15. Clinical trials in "emerging markets": regulatory considerations and other factors.

    Science.gov (United States)

    Singh, Romi; Wang, Ouhong

    2013-11-01

    Clinical studies are being placed in emerging markets as part of global drug development programs to access large pool of eligible patients and to benefit from a cost effective structure. However, over the last few years, the definition of "emerging markets" is being revisited, especially from a regulatory perspective. For purposes of this article, countries outside US, EU and the traditional "western countries" are discussed. Multiple factors are considered for placement of clinical studies such as adherence to Good Clinical Practice (GCP), medical infrastructure & standard of care, number of eligible patients, etc. This article also discusses other quantitative factors such as country's GDP, patent applications, healthcare expenditure, healthcare infrastructure, corruption, innovation, etc. These different factors and indexes are correlated to the number of clinical studies ongoing in the "emerging markets". R&D, healthcare expenditure, technology infrastructure, transparency, and level of innovation, show a significant correlation with the number of clinical trials being conducted in these countries. This is the first analysis of its kind to evaluate and correlate the various other factors to the number of clinical studies in a country.

  16. Higher concentration insulins: an overview of clinical considerations.

    Science.gov (United States)

    Reid, Timothy S; Schafer, Fryn; Brusko, Cynthia

    2017-06-01

    Three higher concentration insulin products (insulin lispro 200 units/mL, insulin degludec 200 units/mL, and insulin glargine 300 units/mL) received US Food and Drug Administration (FDA) approval in 2015. Although human regular insulin 500 units/mL (U-500) was approved in 1997, a pen and dedicated U-500 syringe became available in 2016. These products offer more treatment options for the increasing numbers of patients requiring insulin to achieve and maintain glycemic targets. Higher concentration insulins have some unique safety and efficacy considerations. Important considerations when transitioning patients from the 100 unit/mL concentration (U-100) to the higher concentration include bioequivalence, pen dose increments, and pen appearance. Bioequivalent insulins have similar pharmacokinetic properties and no dose adjustments are expected when transitioning from the U-100 to the higher concentration. In contrast, higher concentration insulins with different pharmacokinetic and pharmacodynamic properties compared with the U-100 formulation may require dose adjustments. In order to provide safe and effective therapy to patients with higher daily insulin dose requirements, it is important for healthcare professionals to become very familiar with the characteristics of and differences between each of the higher concentration insulins. This paper highlights differences between the U-100 and higher concentration insulins and focuses on practical aspects of use.

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

    Science.gov (United States)

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

    2015-04-01

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

  18. Self-adhesive resin cements - chemistry, properties and clinical considerations.

    Science.gov (United States)

    Ferracane, J L; Stansbury, J W; Burke, F J T

    2011-04-01

    Self-adhesive resin cements were introduced to dentistry within the past decade but have gained rapidly in popularity with more than a dozen commercial brands now available. This review article explores their chemical composition and its effect on the setting reaction and adhesion to various substrates, their physical and biological properties that may help to predict their ultimate performance and their clinical performance to date and handling characteristics. The result of this review of self-adhesive resin cements would suggest that these materials may be expected to show similar clinical performance as other resin-based and non-resin based dental cements. © 2010 Blackwell Publishing Ltd.

  19. Clinical considerations for an effective medical therapy in Wilson's disease.

    Science.gov (United States)

    Weiss, Karl Heinz; Stremmel, Wolfgang

    2014-05-01

    Wilson's disease is an autosomal recessively inherited copper overload disorder that leads to hepatic and/or neurologic symptoms. More than a century after the first description of Wilson's disease, the available medical treatment options have not been standardized. The efficacy of the commonly used drugs is satisfactory for hepatic disease, but disappointing in the neurologic patients, including the risk of neurologic deterioration after the initiation of chelation therapy. An approach to overcome this problem is the careful and systematic assessment of biochemical response patterns and the quantitative monitoring of symptoms using validated rating scales. Standardized dosage strategies that address changes in copper pools might improve adherence and reduce side effects. Such an approach may reduce long-term morbidity. In this paper, we discuss considerations for an effective medical treatment and requirements for future studies in Wilson's disease.

  20. Managing Opioid Abuse in Older Adults: Clinical Considerations and Challenges.

    Science.gov (United States)

    Loreck, David; Brandt, Nicole J; DiPaula, Bethany

    2016-04-01

    Opioid use disorder is a public health epidemic. There is increasing attention being given to opioid abuse and overdose in the United States. The overall use of illicit substances by older adults is on the rise and in part can be attributed to the aging of Baby Boomers. Furthermore, much attention is being given to prescription opioid drug overdose, but it is important to note that heroin-related deaths have also increased sharply. Heroin use is part of a larger substance abuse problem, with more than nine in 10 individuals who use heroin also using at least one other drug (e.g., cocaine, prescription opioid medication). The current article highlights treatment approaches, namely buprenorphine, buprenorphine/naloxone, and naltrexone; insurance considerations; and resources to aid in understanding and managing this public health crisis.

  1. The 'Self' and Borderline Personality Disorder: Conceptual and Clinical Considerations.

    Science.gov (United States)

    Kerr, Ian B; Finlayson-Short, Laura; McCutcheon, Louise K; Beard, Hilary; Chanen, Andrew M

    2015-01-01

    Some concept of self has been used by many, although not all, researchers and clinicians as an 'organising construct' for borderline personality disorder (BPD). There is considerable variation in this usage and how clearly researchers have defined the self. Given this diversity, and that 'self' is often used interchangeably with parallel concepts (e.g., psyche, brain-mind, 'person') or with features of self (e.g., self-awareness, identity), unqualified use of the term is problematic. This is further complicated by the heterogeneity and 'comorbidity' of BPD and the limitations of syndromally based psychiatric nosology. Still, BPD remains in current classification systems and can be reliably diagnosed. A considerable body of research on self and BPD has accrued, including a recent profusion and confluence of neuroscientific and sociopsychological findings. These have generated supporting evidence for a supra-ordinate, functionally constituted entity of the self ranging over multiple, interacting levels from an unconscious, 'core' self, through to a reflective, phenotypic, 'idiographic' and relational self constituted by interpersonal and sociocultural experience. Important insights have been generated regarding emotional and social-cognitive dysregulation, disorder of self-awareness, relationality, identity, and coherence and continuity of the self. Many of these are shared by various trauma-related, dissociative disorders. A construct of the self could be useful as an explanatory principle in BPD, which could be construed as a 'self-state' (and relational) disorder, as opposed to a less severe disorder of aspects of the self (e.g., mood or memory). We offer a tentative description of 'Self' in this context, noting that any such construct will require a clear definition and to be evaluable. © 2015 S. Karger AG, Basel.

  2. Clinical considerations of anticoagulation therapy for patients with atrial fibrillation

    Institute of Scientific and Technical Information of China (English)

    Shu ZHANG

    2012-01-01

    Atrial fibrillation (AF) increases the risk of stroke.New anticoagulation agents have recently provided alternative and promising approaches.This paper reviews the current state of anticoagulation therapy in AF patients,focusing on various clinical scenarios and on comparisons,where possible,between western and eastern populations.

  3. Considerations for clinical pharmacology studies for biologics in emerging markets.

    Science.gov (United States)

    Damle, Bharat; White, Robert; Wang, Huifen Faye

    2015-03-01

    Registration of innovative biologics in Emerging Markets (EMs) poses many opportunities and challenges. The BRIC-MT countries (Brazil, Russia, India, China, Mexico, and Turkey) that are the fastest growing markets and regulators in these countries have imposed certain requirements, including the need for local clinical studies, for registration of biologics. The regulatory landscape in these countries is rapidly evolving, which necessitates an up-to-date understanding of such requirements. There is growing evidence which suggests that race, after accounting for body weight differences, may not influence the pharmacokinetics of biologics to the same extent that it does for small molecules. Thus, the requirements for clinical pharmacology trials in EMs are driven mainly by regulatory needs set forth by local Ministry of Health. In addition to the clinical Phase I to III studies done in the global program that supports registration in large geographies, countries such as China require local single and multiple dose Phase I studies. Participating in global studies with clinical sites within their country may be sufficient for some markets, while other regulators may be satisfied with a Certificate of Pharmaceutical Product. This paper discusses the current requirements for registration of innovative biologics in key EMs.

  4. Diagnostic and clinical considerations in prolonged grief disorder.

    Science.gov (United States)

    Maercker, Andreas; Lalor, John

    2012-06-01

    This review focuses on the similarities and differences between prolonged grief disorder (PGD) and post-traumatic stress disorder (PTSD). It highlights how a PTSD-related understanding aids the investigation and clinical management of PGD. Grief has long been understood as a natural response to bereavement, as serious psychological and physiological stress has been regarded as a potential outcome of extreme or traumatic stress. PTSD was first included in DSM-III in 1980. In the mid-1980s, the first systematic investigation began into whether there is an extreme or pathological form of mourning. Meanwhile, there is much research literature on complicated, traumatic, or prolonged grief This literature is reviewed in this article, with the following questions: Is it possible to distinguish normal from non-normal grief? Which clinical presentation does PGD have-and how does this compare with PTSD? Finally, diagnostic, preventive, and therapeutic approaches and existing tools are presented.

  5. Incentives to participate in clinical trials: practical and ethical considerations.

    Science.gov (United States)

    Bernstein, Steven L; Feldman, James

    2015-09-01

    Clinical trials often offer incentives to encourage individuals to enroll and to enhance follow-up. The scope and nature of incentives used in emergency department (ED)-based trials are unknown. The objective of this study is to characterize the quantity and quality of incentives and other forms of compensation used in clinical trials of human subjects recruited in US EDs. A secondary goal is to provide an historical and ethical analysis of the use of incentives in clinical trials. We reviewed English-language randomized clinical trials conducted in US EDs from 2009 to 2013. Full text of the studies was reviewed to identify whether incentives were used, their value, and timing. Funding source was noted as well. Data are presented with descriptive statistics. Of 1151 articles identified, 76 (6.6%) fit criteria for review. Of these, 7 (9.2%) provided incentive payments. A recently published eighth trial was included as well. The total cash value of incentives offered ranged from $10 to $195. Four studies offered payment at enrollment only. Incentives included cash, debit cards, and gift cards. The use of financial incentives in ED-based trials is uncommon. Studies that use incentives are generally extramurally funded, usually by a federal agency, and include waves of follow-up that continue after discharge from the ED. Payment size is modest. Incentives may improve recruitment and retention in ED-based trials, but authoritative data are lacking. Investigators need to take care to avoid incentives that may be coercive or unduly influence research participants. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. A clinical and radiologic consideration of Ameloblastoma of the jaw

    Energy Technology Data Exchange (ETDEWEB)

    Park, Chang Seo; Kim, Kee Deog [Dept. of Dental Radiology, College of Dentistry, Yensei University, Seoul (Korea, Republic of)

    1995-02-15

    A clinical and radiologic study of 46 intrabony ameloblastomas were undertaken from the files of the Department Oral and Maxillofacial Surgery, Dental Hospital, Yonsei University for the years January 1979 through December 1993. The following results were obtained; 1. In the clinical findings, the mean age of patients was 34 years, with no sex predilection noted and the most frequent sign was swelling of the face or jaw. 2. In the radiological findings, the majority of tumors, 97.8% involved the mandible with the posterior regions favored, and 56.5% of the lesions were multilocular type. Radiologic types had no correlation with the age of patients. 3. In the histologic findings, 23.9% of lesions were follicular or mixed type. Histologic types had no correlation between the unicystic type and first decade of age was found by X2 test (P<0.05). 4. Among the qualified 18 patients treated with radical or conservative surgery, the recurrence rate was 33.3%. The difference of recurrent rate between the multilocular type (36.4%) and the unilocular type (28.6%)was not much. Conclusively, more detailed clinical and radiologic parameters should be added to clearly predict the biologic behavior of ameloblastoma.

  7. Regulations and guidelines governing stem cell based products: Clinical considerations

    Directory of Open Access Journals (Sweden)

    Bobby George

    2011-01-01

    Full Text Available The use of stem cells as medicines is a promising and upcoming area of research as they may be able to help the body to regenerate damaged or lost tissue in a host of diseases like Parkinson′s, multiple sclerosis, heart disease, liver disease, spinal cord damage, cancer and many more. Translating basic stem cell research into routine therapies is a complex multi-step process which entails the challenge related to managing the expected therapeutic benefits with the potential risks while complying with the existing regulations and guidelines. While in the United States (US and European Union (EU regulations are in place, in India, we do not have a well-defined regulatory framework for "stem cell based products (SCBP". There are several areas that need to be addressed as it is quite different from that of pharmaceuticals. These range from establishing batch consistency, product stability to product safety and efficacy through pre-clinical, clinical studies and marketing authorization. This review summarizes the existing regulations/guidelines in US, EU, India, and the associated challenges in developing SCBP with emphasis on clinical aspects.

  8. Mandibular condylar hyperplasia: clinical, histopathological, and treatment considerations.

    Science.gov (United States)

    Angiero, Francesca; Farronato, Giampietro; Benedicenti, Stefano; Vinci, Raffaele; Farronato, Davide; Magistro, Sarah; Stefani, Michele

    2009-01-01

    Condylar hyperplasia is a rare disorder characterized by an increased volume of the condyle, ramus, and mandibular body leading to facial asymmetry. We present three cases of condylar hyperplasia: two women and one man, age range 27 to 34. Clinically, all three patients showed a deviation of the mandible to the opposite side and a protruded position of the chin, hypertrophy of the lower border of the mandible, combined with an elongation of the mandibular ramus, open-bite on the deformed side, and cross-bite on the opposite side. In all three cases, scintigraphy showed an increased uptake. Radiography and CT scanning confirmed the clinical diagnosis and patients were subjected to surgery, comprising high condylectomy on the affected side with access in the pre-tragus area. The surgical piece sent to the Institute of Pathological Anatomy for histological examination revealed a nonuniform picture, in terms of both the depth of cartilage islands and the thickness of the fibrous layer covering the joint surface. Common to all three cases, however, was the apparent evolution of fibrous tissue to cartilage, and of this to compact bone tissue. At two-four years, all cases have maintained a good occlusal response. The asymmetric deformity of the mandible resulting from the rare condition of hemimandibular hyperplasia is presented and the clinical, histopathological and therapeutic aspects discussed.

  9. Atopic dermatitis in adults: clinical and epidemiological considerations

    Directory of Open Access Journals (Sweden)

    Raquel Leão Orfali

    2013-06-01

    Full Text Available OBJECTIVE: Atopic dermatitis (AD is a chronic inflammatory disease causing intense pruritus, and with typical clinical features. There are few epidemiological studies concerning AD in adults, as well as little information about its prognostic. The aim of this study was to evaluate the clinical and epidemiological course of adults with AD. METHODS: 80 patients aged above 18 years (mean age = 29 years were selected (30 males and 50 females and interviewed about hospitalization, systemic corticoid usage, age of AD onset, and personal and/or familial history of atopy. Disease severity was evaluated through the Scoring Atopic Dermatitis (SCORAD tool. Laboratory examination included IgE serum levels and eosinophil blood count. RESULTS: 71 out of 80 patients referred association with respiratory symptoms (18 had asthma, 17 had rhinitis, and 36 had both conditions; nine out of 80 patients denied any respiratory disease. AD patients were divided in mild (n = 25, moderate (n = 30, and severe (n = 25; 56% had one or more hospitalizations due to AD. A positive association was found between IgE serum levels, eosinophil blood count, and disease severity. CONCLUSION: Adult AD represents a clinical challenge that needs to be better characterized, since it can be misdiagnosed and interferes with the patient's social and personal life. The association of skin and respiratory atopic disease is frequent, and laboratory parameters such as circulating IgE levels and eosinophil blood count may be helpful to assess disease severity.

  10. Clinical management considerations for dyslipidemia in HIV-infected individuals.

    Science.gov (United States)

    Kirchner, Jeffrey T

    2012-01-01

    Dyslipidemia is common in patients with human immunodeficiency virus (HIV) and may result in significant morbidity, including coronary heart disease (CHD). Treatment of dyslipidemia in these patients is generally based on the National Cholesterol Education Program Adult Treatment Panel III goals for individuals without HIV. For individuals with ≥ 2 cardiovascular risk factors, the risk of CHD should be evaluated using the Framingham risk calculator and managed accordingly. Switching to an antiretroviral regimen with a favorable lipid profile should be considered before pharmacologic management if virologic suppression can be maintained. Statins are the first-choice therapy for elevated low-density lipoprotein cholesterol, but in HIV-infected individuals, special consideration must be given to drug-drug interactions, specifically those between protease inhibitors and statins. Management of dyslipidemia in HIV-infected individuals is a challenging but important aspect of chronic disease management. Additional research, specifically related to the role of chronic inflammation, is needed to better define the relationship between HIV infection and cardiovascular disease.

  11. Clinical trials in the development of biosimilars: future considerations

    Directory of Open Access Journals (Sweden)

    Huneycutt BJ

    2015-07-01

    Full Text Available Brenda J Huneycutt,1 Earl Gillespie,2 Gillian R Woollett1 1FDA Regulatory Strategy and Policy, Avalere Health, LLC, Washington, DC, 2Health Advances, LLC, Weston, MA, USA Abstract: A number of biosimilars have been approved in highly regulated markets throughout the world. Biosimilar development follows its own unique path – relying primarily on analytics to compare a potential biosimilar to its reference product and giving a reduced, confirmatory role to clinical trials. In addition, the ability to extrapolate data to support approval for indications without a clinical trial gives this abbreviated pathway potential significant value. In fact, so far, all the approved biosimilars in Europe received approval for all the reference product's indications. However, this is not the case in other regions. Regulatory agencies of the highly regulated markets agree in general on many principles underlying biosimilar product development and approval, but differ in important aspects as reflected by the data burdens and approval decisions for four classes of products explored in this paper – somatropins, filgrastims, epoetins, and infliximabs. These case studies also highlight some biosimilar sponsor latitude as reflected in the varying clinical data packages submitted to the same regulatory agency for biosimilars to the same reference product. There also exists biosimilar sponsor latitude in deciding whether to use the biosimilar pathway at all or seek approval through the stand-alone biologics regulatory pathway. This, of course, is a commercial decision based on the weights each biosimilar sponsor gives to the various risks and benefits for each option, for each product, and for each market. Further, it remains an open question whether a single, biosimilar development plan for global commercialization can be used to satisfy each regulatory agency. Keywords: somatropin, filgrastim, epoetin, infliximab

  12. Clinical considerations in the interpretation of elevated troponin levels

    DEFF Research Database (Denmark)

    Rujic, Dragana; Pareek, Manan; Egholm, Gro

    2015-01-01

    The essential role of cardiac troponin (cTn) in the diagnosis of acute myocardial infarction has led to the development of high-sensitivity assays, which are able to detect very small amounts of myocardial necrosis. However, although elevated blood levels of cTn indicate myocardial injury, they do...... not provide a causal explanation. The differential diagnosis of minor elevations of the cTn-level is broad and includes both acute and chronic cardiac and non-cardiac conditions. The purpose of this paper is to review common causes of elevated cTn-levels in daily clinical practice....

  13. Vulvar and Vaginal Atrophy: Physiology, Clinical Presentation, and Treatment Considerations.

    Science.gov (United States)

    Lev-Sagie, Ahinoam

    2015-09-01

    Vulvovaginal atrophy is a common condition associated with decreased estrogenization of the vaginal tissue. Symptoms include vaginal dryness, irritation, itching, soreness, burning, dyspareunia, discharge, urinary frequency, and urgency. It can occur at any time in a woman's life cycle, although more commonly in the postmenopausal phase, during which the prevalence is approximately 50%. Despite the high prevalence and the substantial effect on quality of life, vulvovaginal atrophy often remains underreported and undertreated. This article aims to review the physiology, clinical presentation, assessment, and current recommendations for treatment, including aspects of effectiveness and safety of local vaginal estrogen therapies.

  14. Toxicological considerations of herbal medicines in clinical use

    Institute of Scientific and Technical Information of China (English)

    IkegF; FujiY

    2002-01-01

    Based on herbal crude drugs listed in WHO monographs,the clinical uses and toxicity such as acute,chronic and mutagenic of 16 herbal medicines among 210 medicinal prescriptions used in present-day Japan are summarized.These herbal medicines are claddified into two categories:8 kinds of prescription containing Bupleurum root such as Sho-saiko-to and Saiko-keishi-to,or 8 kinds of prescription not containing Bupleurum root such as Juzen-taiho-to and Ninjin-yoei-to.Some potential interactions between herbal medicine and the Western drugs are also described.

  15. From the scientific method to the clinical method: theoretical considerations

    Directory of Open Access Journals (Sweden)

    Roberto Hernández Hernández

    2010-12-01

    Full Text Available The scientific method is a general method composed of several stages necessary for the development of any scientific research. It is the focus to approach reality and to study natural phenomenon, reality itself and thoughts in order to find their essence and interrelationships. The clinical method is the particular application of the scientific method and in the present economic conditions its use is crucial because of the advantages that it reports from this point of view, as well as for the wellbeing of the patient.

  16. Huge parathyroid carcinoma: Clinical considerations and literature review

    Directory of Open Access Journals (Sweden)

    Marone Ugo

    2005-06-01

    Full Text Available Abstract Background Parathyroid carcinoma is a rare malignancy, with an incidence of 0.5 to 4% of all cases of primary hyperparathyroidism. Surgery is the only curative treatment. Case presentation We report the case of a 66-year-old man referred for a large suspicious substernal goitre associated with severe hypercalcemia due to hyperparathyroidism. After normalization of serum calcium levels, patient underwent surgery. The voluminous cervicomediastinal firm mass could not be removed through the cervical incision; therefore a cervicothoracic approach was employed. Histopathology revealed a giant parathyroid cancer of 450 grams. A review of the literature was also undertaken to summarize the current treatment approaches for this rare malignancy. Conclusion Parathyroid cancer is usually not recognized either preoperatively or intra-operatively. En bloc resection of the tumour with the adjacent tissue is the treatment of choice and it is very important to avoid the rupture of the capsule during operation. Neither tumour size, nor the lymph node status appears to play a role in prognosis. The management of parathyroid carcinoma is a challenge even for experienced surgeons.

  17. Clinical utility of metabolic syndrome severity scores: considerations for practitioners

    Science.gov (United States)

    DeBoer, Mark D; Gurka, Matthew J

    2017-01-01

    The metabolic syndrome (MetS) is marked by abnormalities in central obesity, high blood pressure, high triglycerides, low high-density lipoprotein-cholesterol, and high fasting glucose and appears to be produced by underlying processes of inflammation, oxidative stress, and adipocyte dysfunction. MetS has traditionally been classified based on dichotomous criteria that deny that MetS-related risk likely exists as a spectrum. Continuous MetS scores provide a way to track MetS-related risk over time. We generated MetS severity scores that are sex- and race/ethnicity-specific, acknowledging that the way MetS is manifested may be different by sex and racial/ethnic subgroup. These scores are correlated with long-term risk for type 2 diabetes mellitus and cardiovascular disease. Clinical use of scores like these provide a potential opportunity to identify patients at highest risk, motivate patients toward lifestyle change, and follow treatment progress over time.

  18. Sleep Health Issues for Children with FASD: Clinical Considerations

    Directory of Open Access Journals (Sweden)

    James E. Jan

    2010-01-01

    Full Text Available This article describes the combined clinical experience of a multidisciplinary group of professionals on the sleep disturbances of children with fetal alcohol spectrum disorders (FASD focusing on sleep hygiene interventions. Such practical and comprehensive information is not available in the literature. Severe, persistent sleep difficulties are frequently associated with this condition but few health professionals are familiar with both FASD and sleep disorders. The sleep promotion techniques used for typical children are less suitable for children with FASD who need individually designed interventions. The types, causes, and adverse effects of sleep disorders, the modification of environment, scheduling and preparation for sleep, and sleep health for their caregivers are discussed. It is our hope that parents and also researchers, who are interested in the sleep disorders of children with FASD, will benefit from this presentation and that this discussion will stimulate much needed evidence-based research.

  19. Transient stress cardiomyopathies in the elderly: Clinical & Pathophysiologic considerations

    Institute of Scientific and Technical Information of China (English)

    Michael A Chen

    2012-01-01

    Transient stress-induced cardiomyopathies have been increasingly recognized and while rare,they tend to affect elderly women more than other demographic groups.One type,often called tako-tsubo cardiomyopathy (TTC),is typically triggered by significant emotional or physical stress and is associated with chest pain,electrocardiogram (ECG) changes and abnormal cardiac enzymes.Significant left ventricular regional wall motion abnormalities usually include an akinetic "ballooning" apex with normal or hyperdynamic function of the base.A second type,often called neurogenic stunned myocardium,typically associated with subarachnoid hemorrhage,also usually presents with ECG changes and positive enzymes,but the typical wall motion abnormalities seen include normal basal and apical left ventricular contraction with akinesis of the mid-cavity in a circumferential fashion.The pathophysiology,clinical care and typical courses,are reviewed.

  20. Clinical, microbiological and radiographic considerations observed around dental implants

    Directory of Open Access Journals (Sweden)

    Fabiana Amaral Chiapinotto

    2012-01-01

    Full Text Available Introduction: Periimplantitis is characterized by the inflammation of the soft tissues, bleeding, and suppuration, as well as rapid bone loss around dental implants that are in function. The lesion is associated with the presence of subgingival plaque, which contains a wide variety of Gram-negative anaerobic microorganisms. Objective: This review aimed to expose some clinical, microbiological and radiographic characteristics found in periodontal tissues and around dental implants. Literature review: Despite the anatomical differences between the periodontium and the tissues around implants, several studies have indicated some similarities, such as the production of inflammatory mediators and active microbiota. Conclusion: Regular maintenance and daily plaque control may be important factors in the long-term maintenance of implant-supported prostheses.

  1. Assessment scales in stroke: clinimetric and clinical considerations

    Directory of Open Access Journals (Sweden)

    Harrison JK

    2013-02-01

    Full Text Available Jennifer K Harrison,1 Katherine S McArthur,2 Terence J Quinn21Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; 2Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UKAbstract: As stroke care has developed, there has been a need to robustly assess the efficacy of interventions both at the level of the individual stroke survivor and in the context of clinical trials. To describe stroke-survivor recovery meaningfully, more sophisticated measures are required than simple dichotomous end points, such as mortality or stroke recurrence. As stroke is an exemplar disabling long-term condition, measures of function are well suited as outcome assessment. In this review, we will describe functional assessment scales in stroke, concentrating on three of the more commonly used tools: the National Institutes of Health Stroke Scale, the modified Rankin Scale, and the Barthel Index. We will discuss the strengths, limitations, and application of these scales and use the scales to highlight important properties that are relevant to all assessment tools. We will frame much of this discussion in the context of "clinimetric" analysis. As they are increasingly used to inform stroke-survivor assessments, we will also discuss some of the commonly used quality-of-life measures. A recurring theme when considering functional assessment is that no tool suits all situations. Clinicians and researchers should chose their assessment tool based on the question of interest and the evidence base around clinimetric properties.Keywords: Barthel Index, clinimetrics, clinical trial, disability, methodology, modified Rankin Scale, National Institutes Health Stroke Scale, scales, stroke, outcomes

  2. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations.

    Science.gov (United States)

    Ajeganova, Sofia; Huizinga, Tom

    2017-10-01

    Sustained remission is an ultimate treatment goal in the management of patients with rheumatoid arthritis (RA). Historically the frequency of sustained remission was low but the frequency of achieved sustained remission is increasing over time. The last years' clinical studies of tight control targeted treatment and intervention trials of early use of intensive strategy suggest that these treatment strategies are associated with higher rates of sustained remission. Achievement of sustained remission, in particular but not limited to early sustained remission, can provide tapering and stopping disease-modifying antirheumatic drugs (DMARDs). With new treatment strategies drug-free sustained remission is becoming an achievable goal. Sustained remission is associated with improved outcomes in regard to function, patient-reported outcomes and survival. Drug-free sustained remission is characterized by normalized function ability and survival. Sustained remission and, in particular, drug-free sustained remission offer hope that early identification of patients with arthritis, early improved novel treatments and treatment with target to achieve remission may potentially transform the progressive course of RA disease and disrupt RA chronicity. In this review we summarize the recent evidence on sustained remission in patients with RA, treatment strategies to achieve sustained remission, management of patients in sustained remission and significance of sustained remission from the patient perspective.

  3. The clinical utility of lurasidone in schizophrenia: patient considerations

    Directory of Open Access Journals (Sweden)

    Harvey PD

    2015-04-01

    Full Text Available Philip D Harvey1Department of Psychiatry and Behavioral Sciences, University of Miami, Miller School of Medicine, Miami, FL, USA; 2Bruce W Carter VA Medical Center, Miami, FL, USAAbstract: Lurasidone is a novel antipsychotic agent approved for the treatment of schizophrenia in a number of countries including the United Kingdom, other European countries, the United States, and Canada. In addition to full antagonist activity at the dopamine D2 (Ki, 1 nM and serotonin 5-HT2A (Ki, 0.5 nM receptors, the pharmacodynamic profile of lurasidone is notable for its high affinity for serotonin 5-HT7 receptors (0.5 nM and its partial agonist activity at 5-HT1A receptors (Ki, 6.4 nM. Long-term treatment of schizophrenia with lurasidone has been shown to reduce the risk of relapse in patients with schizophrenia. Lurasidone appears to be associated with minimal effects on body weight, and low risk for clinically meaningful alterations in glucose, lipids, or electrocardiography parameters. Evidence from two randomized trials also suggests improvement in functional capacity and cognitive functioning in people with schizophrenia. A significant evidence base supports the use of lurasidone as a promising agent for the treatment of schizophrenia. Keywords: long-term treatment, antagonist, pharmacodynamic profile

  4. Clinical utility of metabolic syndrome severity scores: considerations for practitioners

    Directory of Open Access Journals (Sweden)

    DeBoer MD

    2017-02-01

    Full Text Available Mark D DeBoer,1,2 Matthew J Gurka2 11Division of Pediatric Endocrinology, Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, 2Department of Health Outcomes and Policy, College of Medicine, University of Florida, Gainesville, FL, USA Abstract: The metabolic syndrome (MetS is marked by abnormalities in central obesity, high blood pressure, high triglycerides, low high-density lipoprotein-cholesterol, and high fasting glucose and appears to be produced by underlying processes of inflammation, oxidative stress, and adipocyte dysfunction. MetS has traditionally been classified based on dichotomous criteria that deny that MetS-related risk likely exists as a spectrum. Continuous MetS scores provide a way to track MetS-related risk over time. We generated MetS severity scores that are sex- and race/ethnicity-specific, acknowledging that the way MetS is manifested may be different by sex and racial/ethnic subgroup. These scores are correlated with long-term risk for type 2 diabetes mellitus and cardiovascular disease. Clinical use of scores like these provide a potential opportunity to identify patients at highest risk, motivate patients toward lifestyle change, and follow treatment progress over time. Keywords: metabolic syndrome, insulin resistance, cardiovascular disease, type 2 diabetes, risk prediction

  5. [Clinical consideration of coagulase negative Staphylococci isolated in blood culture].

    Science.gov (United States)

    Oshitani, Yohei; Ishikawa, Tomoyuki; Murata, Ken; Aoyagi, Yoshiki; Yabe, Yasuyo; Aoshima, Masahiro

    2012-01-01

    Despite blood culture's usefulness in antimicrobial therapy, fewer blood cultures and the infrequency of more than 1 set in cultures appear to be problems in Japan. Since June 2007 infection control team (ICT) recommended more than 1 set in blood sampling and intervention in positive blood culture, coagulase negative Staphylococci (CNS) has frequently been isolated from blood culture and its clinical significance is often difficult to judge. To determine the effect of ICT intervention, we evaluated the number of blood culture specimens, the frequency of more than 1 set in all blood culture specimens, and decision-making on antimicrobial treatment for CNS isolated retrospectively from blood. The study was divided into term I in August 2007 to July 2008, term II in August 2008 to July 2009, and term III in August 2009 to February 2010. We also analyzed how physicians treated infection or its suspicion after CNS and its drug susceptibility. The monthly number of blood culture specimens increased from 40.3 to 51.6 between terms I and III. The frequency of more than 1 set in a single blood culture session rose significantly from 67% to 89% between these terms (p blood culture specimens, enable more than 1 set in blood sampling, make it easier to judge the presence of infection, and increase appropriate treatment by physicians. We thus believe that the quality of antimicrobial treatment could be improved through education such as ICT action.

  6. Mindfulness Meditation for Fibromyalgia: Mechanistic and Clinical Considerations.

    Science.gov (United States)

    Adler-Neal, Adrienne L; Zeidan, Fadel

    2017-09-01

    Fibromyalgia is a disorder characterized by widespread pain and a spectrum of psychological comorbidities, rendering treatment difficult and often a financial burden. Fibromyalgia is a complicated chronic pain condition that requires a multimodal therapeutic approach to optimize treatment efficacy. Thus, it has been postulated that mind-body techniques may prove fruitful in treating fibromyalgia. Mindfulness meditation, a behavioral technique premised on non-reactive sensory awareness, attenuates pain and improves mental health outcomes. However, the impact of mindfulness meditation on fibromyalgia-related outcomes has not been comprehensively characterized. The present review delineates the existing evidence supporting the effectiveness and hypothesized mechanisms of mindfulness meditation in treating fibromyalgia-related outcomes. Mindfulness-based interventions premised on cultivating acceptance, non-attachment, and social engagement may be most effective in decreasing fibromyalgia-related pain and psychological symptoms. Mindfulness-based therapies may alleviate fibromyalgia-related outcomes through multiple neural, psychological, and physiological processes. Mindfulness meditation may provide an effective complementary treatment approach for fibromyalgia patients, especially when combined with other reliable techniques (exercise; cognitive behavioral therapy). However, characterizing the specific analgesic mechanisms supporting mindfulness meditation is a critical step to fostering the clinical validity of this technique. Identification of the specific analgesic mechanisms supporting mindfulness-based pain relief could be utilized to better design behavioral interventions to specifically target fibromyalgia-related outcomes.

  7. Clinical, immunopathologic, and therapeutic considerations of inflammatory myopathies.

    Science.gov (United States)

    Dalakas, M C

    1992-10-01

    The inflammatory myopathies encompass a group of heterogenous muscle diseases which have in common an acquired myopathy with histological signs of endomysial inflammation. We present evidence based on recently emerged clinical, histologic, immunopathologic, demographic and therapeutic observations that these myopathies comprise three major and distinct groups: polymyositis (PM), dermatomyositis (DM), and inclusion-body myositis (IBM). Immune-mediated mechanisms characteristic for each group appear to play a primary role in the pathogenesis of these diseases. In DM there is an intramuscular microangiopathy mediated by the C5b-9 membranolytic attack complex, leading sequentially to loss of capillaries, muscle ischemia, muscle fiber necrosis and perifascicular atrophy. In contrast, in PM and IBM the muscle fiber injury is initiated by sensitized CD8+ cytotoxic T cells that recognize MHC-I restricted muscle antigens, leading to phagocytosis and fiber necrosis. Among the viruses implicated in the cause of inflammatory myopathies, only the retroviruses, HIV, HTLV-1 and simian retroviruses, have been convincingly associated with PM. Retroviruses, therefore, appear to be the leading group of viruses capable of triggering these diseases. The treatment of inflammatory myopathies has been largely empirical. A detailed therapeutic plan based on our experience with a large number of patients is presented. Patients with bona fide PM or DM respond to steroids to some degree and for some period of time. In contrast, patients with IBM do not respond to any therapy and the disease should be suspected when a patient with presumed PM has failed treatment. Methotrexate and cyclophosphamide are disappointing. Cyclosporine and Azathioprine are commonly used but they are of uncertain benefit. Plasmapheresis is ineffective. High-dose intravenous immunoglobulin is a promising new therapeutic modality.

  8. Rationale for tilted implants: FEA considerations and clinical reports.

    Science.gov (United States)

    DE Vico, G; Bonino, M; Spinelli, D; Schiavetti, R; Sannino, G; Pozzi, A; Ottria, L

    2011-07-01

    The prevalence of the elderly population, as well as life expectancy, increased in the final decades of the 20th century, as described in the World Health Organization 2004 Annual Report. The edentulous condition therefore has a negative impact on the oral health-related quality of life. Patients wearing complete dentures for many years infact, and especially in the mandible, are often unsatisfied because of the instability of the prosthesis during speaking and eating. To date dental implant treatment is well documented as a predictable treatment for partial or complete edentulism. On the other hand the rehabilitation of atrophied edentulous arches with endosseous implants (> 10 mm) in the posterior regions is often associated with anatomic problems such as bone resorption, poor bone quality, mandibular canal, and the presence of maxillary sinuses. Different procedures have been proposed to overcome these anatomic limitations. The use of tilted implants parallel to the anterior wall of the maxillary sinus or the mental foramen/inferior alveolar nerve has been proposed as a conservative solution for the treatment of the atrophic edentulous maxilla. Aim of this study was to describe, through a detailed literature review, the clinical and biomechanical rationale for tilting implants and to evaluate the long-term prognosis of immediately loaded full fixed prostheses for the treatment of edentulous patients (#35) with extreme bone atrophy rehabilited with both axial (#70) and tilted (#70) implants from 2008 to 2010. The results of the present study would suggest that this new surgical technique may reduce patient morbidity and extend the indications for immediate loading full fixed rehabilitations. This improves the predictability of treatment goal, allows for a better risk management, and provides more individual information for the patient. These are the most important aspects of this technology, which may contribute to establish higher-quality standards in

  9. The thoracolumbar fascia: anatomy, function and clinical considerations

    Science.gov (United States)

    Willard, F H; Vleeming, A; Schuenke, M D; Danneels, L; Schleip, R

    2012-01-01

    In this overview, new and existent material on the organization and composition of the thoracolumbar fascia (TLF) will be evaluated in respect to its anatomy, innervation biomechanics and clinical relevance. The integration of the passive connective tissues of the TLF and active muscular structures surrounding this structure are discussed, and the relevance of their mutual interactions in relation to low back and pelvic pain reviewed. The TLF is a girdling structure consisting of several aponeurotic and fascial layers that separates the paraspinal muscles from the muscles of the posterior abdominal wall. The superficial lamina of the posterior layer of the TLF (PLF) is dominated by the aponeuroses of the latissimus dorsi and the serratus posterior inferior. The deeper lamina of the PLF forms an encapsulating retinacular sheath around the paraspinal muscles. The middle layer of the TLF (MLF) appears to derive from an intermuscular septum that developmentally separates the epaxial from the hypaxial musculature. This septum forms during the fifth and sixth weeks of gestation. The paraspinal retinacular sheath (PRS) is in a key position to act as a ‘hydraulic amplifier’, assisting the paraspinal muscles in supporting the lumbosacral spine. This sheath forms a lumbar interfascial triangle (LIFT) with the MLF and PLF. Along the lateral border of the PRS, a raphe forms where the sheath meets the aponeurosis of the transversus abdominis. This lateral raphe is a thickened complex of dense connective tissue marked by the presence of the LIFT, and represents the junction of the hypaxial myofascial compartment (the abdominal muscles) with the paraspinal sheath of the epaxial muscles. The lateral raphe is in a position to distribute tension from the surrounding hypaxial and extremity muscles into the layers of the TLF. At the base of the lumbar spine all of the layers of the TLF fuse together into a thick composite that attaches firmly to the posterior superior iliac spine

  10. 76 FR 68768 - Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines; Availability

    Science.gov (United States)

    2011-11-07

    ... No. FDA-2009-D-0427] Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines... Considerations for Therapeutic Cancer Vaccines'' dated October 2011. The guidance document provides sponsors who wish to submit an Investigational New Drug application (IND) for a therapeutic cancer vaccine with...

  11. Extracorporeal membrane oxygenation - An anesthesiologist′s perspective - Part II: Clinical and technical consideration

    Directory of Open Access Journals (Sweden)

    Sandeep Chauhan

    2012-01-01

    Full Text Available Although the concept of extracorporeal membrane oxygenation (ECMO has remained unchanged, component technology has evolved considerably over the past three decades. Presently the clinical conditions requiring ECMO support have been updated with input from the outcome data of patient registries. Modern circuit configuration has become less cumbersome, safer, and more efficient. Technological advances now allow prolonged support with fewer complications compared to the past eras and facilitate transition to a single bedside caregiver model, similar to hemofiltration or ventricular-assist devices. The clinical considerations and indicators for placing the patient on ECMO, the various circuit configurations, clinical and technical issues, and management aspects are considered in this article.

  12. A re-consideration of the HEAO-1 A2 Measurements of the Cosmic X-ray Background Surface Brightness

    Science.gov (United States)

    Jahoda, K.

    2005-12-01

    The HEAO-1 A2 experiment was designed to make high precision and low systematics measurements of the Cosmic X-ray Background from 0.1 - 60 keV. No subsequent experiment has been capable of similarly clean separation of cosmic and instrumental background. Most more recent measurements of the 2-10 keV surface brightness are 20% higher than values derived from the spectral parameterization of the 3-50 keV spectrum given in the original A2 analysis of Marshall et al. (1980, ApJ 235, 4 (M80)). A recent analysis of archival A2 data by Revnivtsev et al. (astro-ph/0412304 (R05)) finds a surface brightness 15-20% higher than M80, an uncomfortably large discrepancy for data taken from a single experiment. We present a third analysis of the A2 data and identify two effects neglected in the comparison of previous A2 results: (a) the extrapolation of the M80 parameterization below 3 keV fails to describe the data; (b) R05 uses an unabsorbed, and high, value for the flux from the Crab nebula plus pulsar which results in a high value for the inferred count rate to CXB surface brightness conversion. Correcting for these effects, our best estimate of the 2-10 keV surface brightness is 1.84 × 10-11 ergs cm-2 s-1 deg-2 on a flux scale where the (absorbed) 2-10 Crab flux is 2.32 × 10-8 ergs cm-2 s-1. This value is only about 10% below the average compiled by Moretti et al. (2003, ApJ, 588, 696). We discuss how well the X-ray brightness of the Crab, to which this measurement is normalized, is known. This research made use of data from the High Energy Astrophysics Science Archive Research Center (HEASARC), provided by NASA's Goddard Space Flight Center.

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

    Science.gov (United States)

    Tsai, Jung-Mei

    2014-12-01

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

  14. Research design considerations for single-dose analgesic clinical trials in acute pain

    DEFF Research Database (Denmark)

    Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C

    2016-01-01

    This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials......, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay...... sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable...

  15. Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations.

    Science.gov (United States)

    Cooper, Stephen A; Desjardins, Paul J; Turk, Dennis C; Dworkin, Robert H; Katz, Nathaniel P; Kehlet, Henrik; Ballantyne, Jane C; Burke, Laurie B; Carragee, Eugene; Cowan, Penney; Croll, Scott; Dionne, Raymond A; Farrar, John T; Gilron, Ian; Gordon, Debra B; Iyengar, Smriti; Jay, Gary W; Kalso, Eija A; Kerns, Robert D; McDermott, Michael P; Raja, Srinivasa N; Rappaport, Bob A; Rauschkolb, Christine; Royal, Mike A; Segerdahl, Märta; Stauffer, Joseph W; Todd, Knox H; Vanhove, Geertrui F; Wallace, Mark S; West, Christine; White, Richard E; Wu, Christopher

    2016-02-01

    This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity. Recommendations are presented on assessment measures, study designs, and operational factors. Although most of the methodological advances have come from studies of postoperative pain after dental impaction, bunionectomy, and other surgeries, the design considerations discussed are applicable to many other acute pain studies conducted in different settings.

  16. Restorative space management: treatment planning and clinical considerations for insufficient space.

    Science.gov (United States)

    Kim, Jason; Chu, Stephen; Gürel, Galip; Cisneros, George

    2005-01-01

    In attempting to provide a restorative solution for cases that have been compromised by spatial considerations, clinicians have traditionally opted for an orthodontic approach that did not provide optimal aesthetics due to changes in tooth morphology, specifically tooth size and shape as a result of dental deterioration. With the advent of contemporary aesthetic materials and preparation techniques, clinicians and technicians are now empowered to deliver a penultimate result with minimal compromise to the surrounding dentition. This article presents the clinical and laboratory considerations that must be addressed when providing a prosthetic restoration for crowded teeth.

  17. Important considerations for designing and reporting epidemiologic and clinical studies in dental traumatology

    DEFF Research Database (Denmark)

    Andersson, Lars; Andreasen, Jens O

    2011-01-01

    The purpose of this article is to suggest important considerations for epidemiologic and clinical studies in the field of dental traumatology. The article is based on the authors' experiences from research in this field and editorial board work for the scientific journal Dental Traumatology....... Examples are given of issues where development is important. The importance of planning ahead of the study and consulting with experts in other fields is emphasized....

  18. Ethical considerations in clinical research on herbal medicine for prevention of cardiovascular disease in the ageing.

    Science.gov (United States)

    Koonrungsesomboon, Nut; Karbwang, Juntra

    2016-10-15

    Cardiovascular disease (CVD) in the ageing is a major public health problem worldwide. The nature of most CVD is subclinical with pathological processes that can span over years. Use of preventive measures could be an appropriate approach to prevailing over CVD in the ageing, and herbal medicine is one of the promising preventive approaches and is currently of interest among medical societies. In the evidence-based era, herbal medicine is, however, often underestimated and approached with skepticism, mainly due to the paucity of scientific evidence. Properly designed clinical trials on herbal medicine for prevention of CVD in a geriatric population are thus of importance and of clinical value. To review ethical issues and discuss considerations when such research is proposed. Four ethical issues, including the scientific validity of research, risk-benefit assessments, subject selection and vulnerability, and informed consent, are structured and extensively discussed in this article. Ethical core considerations of prevention research of CVD on herbal medicine involve particular attention on the scientific validity of research, risk-benefit assessments, subject selection and vulnerability, and informed consent. These issues and considerations are keys, although they must be adapted to an individual research setting in which a clinical study is proposed. Copyright © 2015 Elsevier GmbH. All rights reserved.

  19. Research design considerations for chronic pain prevention clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Gewandter, Jennifer S; Dworkin, Robert H; Turk, Dennis C; Farrar, John T; Fillingim, Roger B; Gilron, Ian; Markman, John D; Oaklander, Anne Louise; Polydefkis, Michael J; Raja, Srinivasa N; Robinson, James P; Woolf, Clifford J; Ziegler, Dan; Ashburn, Michael A; Burke, Laurie B; Cowan, Penney; George, Steven Z; Goli, Veeraindar; Graff, Ole X; Iyengar, Smriti; Jay, Gary W; Katz, Joel; Kehlet, Henrik; Kitt, Rachel A; Kopecky, Ernest A; Malamut, Richard; McDermott, Michael P; Palmer, Pamela; Rappaport, Bob A; Rauschkolb, Christine; Steigerwald, Ilona; Tobias, Jeffrey; Walco, Gary A

    2015-07-01

    Although certain risk factors can identify individuals who are most likely to develop chronic pain, few interventions to prevent chronic pain have been identified. To facilitate the identification of preventive interventions, an IMMPACT meeting was convened to discuss research design considerations for clinical trials investigating the prevention of chronic pain. We present general design considerations for prevention trials in populations that are at relatively high risk for developing chronic pain. Specific design considerations included subject identification, timing and duration of treatment, outcomes, timing of assessment, and adjusting for risk factors in the analyses. We provide a detailed examination of 4 models of chronic pain prevention (ie, chronic postsurgical pain, postherpetic neuralgia, chronic low back pain, and painful chemotherapy-induced peripheral neuropathy). The issues discussed can, in many instances, be extrapolated to other chronic pain conditions. These examples were selected because they are representative models of primary and secondary prevention, reflect persistent pain resulting from multiple insults (ie, surgery, viral infection, injury, and toxic or noxious element exposure), and are chronically painful conditions that are treated with a range of interventions. Improvements in the design of chronic pain prevention trials could improve assay sensitivity and thus accelerate the identification of efficacious interventions. Such interventions would have the potential to reduce the prevalence of chronic pain in the population. Additionally, standardization of outcomes in prevention clinical trials will facilitate meta-analyses and systematic reviews and improve detection of preventive strategies emerging from clinical trials.

  20. Surgical treatment of symptomatic Rathke's cleft cysts: clinical features, therapy considerations and outcomes

    Institute of Scientific and Technical Information of China (English)

    FAN Ming-chao; WANG Qiao-ling; WANG Jing-feng; DENG Wen-shuai; LI Lian-di; WANG Zhi-hong; SUN Peng

    2012-01-01

    Background Rathke's cleft cyst (RCC) is one of the most common incidentally discovered sellar lesions,while symptomatic cases are relatively rare.Surgical treatment is recommended for symptomatic patients to drain the cyst content and to remove the capsule safely.The aim of this study was to clarify the clinical features,surgery considerations and therapy outcomes of symptomatic RCCs.Methods Totally 42 patients (19 males and 23 females) were retrospectively reviewed with the diagnosis of RCCs under surgery resection at the Affiliated Hospital of Medical College,Qingdao University between January 2005 and December 2010.Results Patients' age ranged from 6 to 67 years (mean of 41.6 years).The duration of symptoms ranged from 4 days to 10 years.Headache (69%),visual impairment (36%),and pituitary dysfunction (10%) were the most common presenting symptoms.The maximum diameter of cysts ranged from 6.0 to 46.7 mm (mean of 20.07 mm).Of the 42 patients,36 underwent endonasal transsphenoidal approach and the others underwent transcranial approach.Thirty patients had a subtotal resection and decompression,while 12 patients had a total cyst resection.Cysts of 28 patients were lined by simple cubical or columnar epithelium,and cysts of 34 patients were filled by amorphous colloid material,that was the characteristic of RCCs.The majority of patients presented with a simple headache,and 93% of this group experienced a complete improvement after surgery.Twelve of 15 patients (80%) with preoperative visual deficits experienced an improvement in their vision after surgery.All of those patients with pituitary dysfunction experienced an improved endocrine status.The endocrinological complication usually was diabetes insipidus,and postoperative transient diabetes insipidus occurred in 13 (31%) patients without any permanent diabetes insipidus.The overall recurrence rate was 7% at a mean follow-up of 22 months (range 12-60 months).Conclusions Surgical treatment is to drain

  1. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Baron, Ralf; Bellamy, Nicholas; Burke, Laurie B; Chappell, Amy; Chartier, Kevin; Cleeland, Charles S; Costello, Ann; Cowan, Penney; Dimitrova, Rozalina; Ellenberg, Susan; Farrar, John T; French, Jacqueline A; Gilron, Ian; Hertz, Sharon; Jadad, Alejandro R; Jay, Gary W; Kalliomäki, Jarkko; Katz, Nathaniel P; Kerns, Robert D; Manning, Donald C; McDermott, Michael P; McGrath, Patrick J; Narayana, Arvind; Porter, Linda; Quessy, Steve; Rappaport, Bob A; Rauschkolb, Christine; Reeve, Bryce B; Rhodes, Thomas; Sampaio, Cristina; Simpson, David M; Stauffer, Joseph W; Stucki, Gerold; Tobias, Jeffrey; White, Richard E; Witter, James

    2010-05-01

    There has been an increase in the number of chronic pain clinical trials in which the treatments being evaluated did not differ significantly from placebo in the primary efficacy analyses despite previous research suggesting that efficacy could be expected. These findings could reflect a true lack of efficacy or methodological and other aspects of these trials that compromise the demonstration of efficacy. There is substantial variability among chronic pain clinical trials with respect to important research design considerations, and identifying and addressing any methodological weaknesses would enhance the likelihood of demonstrating the analgesic effects of new interventions. An IMMPACT consensus meeting was therefore convened to identify the critical research design considerations for confirmatory chronic pain trials and to make recommendations for their conduct. We present recommendations for the major components of confirmatory chronic pain clinical trials, including participant selection, trial phases and duration, treatment groups and dosing regimens, and types of trials. Increased attention to and research on the methodological aspects of confirmatory chronic pain clinical trials has the potential to enhance their assay sensitivity and ultimately provide more meaningful evaluations of treatments for chronic pain.

  2. In silico imaging clinical trials for regulatory evaluation: initial considerations for VICTRE, a demonstration study

    Science.gov (United States)

    Badano, Aldo; Badal, Andreu; Glick, Stephen; Graff, Christian G.; Samuelson, Frank; Sharma, Diksha; Zeng, Rongping

    2017-03-01

    Expensive and lengthy clinical trials can delay regulatory evaluation and add significant burden that stifles innovation affecting patient access to novel, high-quality imaging technologies. In silico imaging holds promise for evaluating the safety and effectiveness of imaging technologies with much less burden than clinical trials. We define in silico imaging as a computer simulation of an entire imaging system (including source, object, task, and observer components) used for research, development, optimization, technology assessment, and regulatory evaluation of new technology. In this work we describe VICTRE (our study of virtual imaging clinical trials for regulatory evaluation) and the considerations for building an entire imaging pipeline in silico including device (physics), patient (anatomy, disease), and image interpretation models for regulatory evaluation using open-source tools.

  3. Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng (Univ. of Florida Proton Therapy Inst., Jacksonville, Florida (United States)), e-mail: menden@shands.ufl.edu

    2011-08-15

    There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

  4. Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

    Science.gov (United States)

    Kudrin, Alex; Knezevic, Ivana; Joung, Jeewon; Kang, Hye-Na

    2015-01-01

    The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia. The following topics were discussed by the working groups: clinical criteria for biosimilarity, extrapolation approach and the overall regulatory decision making process. In order to determine typical pitfalls in the design of a SBP clinical programme and evaluate the gap of knowledge, amongst different industry and regulatory stakeholders on the appraisal of the data arising from SBP clinical studies, we have presented two fictional but realistic clinical case studies. The first case consists of the fictional development programme for an infliximab SBP candidate. The second case describes clinical studies proposed for a fictional rituximab SBP candidate. In the first scenario a highly similar quality profile has been taken forward into clinical studies whereas there was an important residual difference in functional attributes for the rituximab SBP candidate. These case studies were presented at the WHO implementation workshop for the WHO guidelines on evaluation of similar biotherapeutic products held in Seoul, Republic of Korea, in May 2014. The goal was to illustrate the interpretation of the clinical data arising from studies with SBP candidates and elicit knowledge gaps in clinical assessment. This paper reflects the outcome of the exercise and discussions held in Seoul and offers an analysis of the case studies as a learning opportunity on clinical development and evaluation of SBPs.

  5. Clinical outcomes, not clinical utility, should be the major consideration for saxagliptin with or without metformin

    Directory of Open Access Journals (Sweden)

    Doggrell SA

    2014-04-01

    Full Text Available Sheila A DoggrellDepartment of Pharmacology, School of Biomedical Sciences, Faculty of Health, Queensland University of Technology, Brisbane, QLD, AustraliaA recent review by Panagoulias and Doupis, published in Patient Preference and Adherence, concerned the saxagliptin/metformin fixed combination (SAXA/MET FDC, and was titled "Clinical utility in the treatment of type 2 diabetes with the saxagliptin/metformin fixed combination."1 This review concluded that "The SAXA/MET FDC is a patient-friendly, dosage-flexible, and hypoglycemia-safe regimen with very few adverse events and a neutral or even favorable effect on body weight. It achieves significant glycosylated hemoglobin A1c reduction helping the patient to achieve his/her individual glycemic goals."1View original paper by Panagoulias and Doupis.

  6. Oral surgery in elderly patients: clinical/surgical considerations and risk assessment

    Directory of Open Access Journals (Sweden)

    Catarina Ribeiro Barros de Alencar

    2011-04-01

    Full Text Available Introduction: The need for oral surgery has been considerably increasing in elderly population in order to allow the balance of their masticatory, aesthetic, and phonetic functions through adapting the oral tissues for the appropriate placement of the prosthetic devices, thereby impacting positively on the subject’s health. Objective: This article aimed to review the literature on both clinical and surgical considerations required to the satisfactory treatment of elderly patients in clinical routine practice, focusing particularly on cases whose treatment choice is a surgical procedure. Literature review: The most commonly performed surgeries in elderly patients, nowadays, are tooth extractions, pre-prosthetic surgeries and osseointegrated implants. Therefore, the physiological features inherent to such cases should be considered, especially those that involve the monitoring of glycemic and blood pressure levels, osteoporosis, medication use, and many other conditions demanding special attention for elderly patient treatment at dental office. Conclusion: Due to the fragility intrinsic to elderly individuals, the surgery at this stage of life requires caution in relation to a comprehensive clinical examination and also to a careful evaluation of the surgical risks in order to analyze the correct indication of the surgery and thereby to ensure patient’s well-being.

  7. Intimacy and Sexuality in Institutionalized Dementia Care: Clinical-Ethical Considerations.

    Science.gov (United States)

    Mahieu, Lieslot; Anckaert, Luc; Gastmans, Chris

    2017-03-01

    Intimacy and sexuality expressed by nursing home residents with dementia remains an ethically sensitive issue for care facilities, nursing staff and family members. Dealing with residents' sexual longings and behaviour is extremely difficult, putting a burden on the caregivers as well as on the residents themselves and their relatives. The parties in question often do not know how to react when residents express themselves sexually. The overall aim of this article is to provide a number of clinical-ethical considerations addressing the following question: 'How can expressions of intimacy and sexuality by residents with dementia be dealt with in an ethically responsible way?' The considerations formulated are based on two cornerstones: (1) the current literature on older peoples' experiences regarding intimacy and sexuality after the onset of dementia, and (2) an anthropological-ethical framework addressing four fundamental pillars of human existence namely the decentred self, human embodiment, being-in-the-world and being-with-others. The resulting considerations are oriented toward the individual sphere, the partnership sphere, and the institutional sphere. The continuous interaction between these spheres leads to orientations that both empower the residents in question and respect the complex network of relationships that surrounds them.

  8. Ethical Considerations for Acupuncture and Chinese Herbal Medicine Clinical Trials: A Cross-Cultural Perspective

    Directory of Open Access Journals (Sweden)

    Christopher Zaslawski

    2010-01-01

    Full Text Available Many ethical concerns revolve around the four basic principles of research: merit and integrity, respect for human beings, weighting of risk–benefit and justice. These principles form the basis for any discussion concerning human research ethics and are applicable to all areas of research including acupuncture and Chinese herbal medicine. World Health Organisation document, Guidelines for Clinical Research on Acupuncture, states that ‘consideration should be given to the different value systems that are involved in human rights such as social, cultural and historical issues’ and that ‘further studies should be conducted in relation to ethical issues involved in clinical research on acupuncture’. In addition to outlining the four basic principles, this paper will also examine the effect of Asian culture on Western human research ethics and how this may impact upon issues such as informed consent and weighting of risk–benefit.

  9. Novel dose-finding designs and considerations on practical implementations in oncology clinical trials.

    Science.gov (United States)

    Huang, Bo; Bycott, Paul; Talukder, Enayet

    2017-01-01

    One of the main objectives in phase I oncology trials is to evaluate safety and tolerability of an experimental treatment by estimating the maximum tolerated dose (MTD) based on the rate of dose-limiting toxicities (DLT). To meet emerging challenges in dose-finding studies, over the past two decades, extensive research has been conducted by statistical and medical researchers to create innovative dose finding designs that perform better than the standard 3 + 3 design, which often exhibits undesirable statistical and operational properties. However, clinical implementation and practical usage of these new designs have been limited. This article begins with a review of the most recent literature and then provides some perspectives on implementing novel adaptive dose finding designs in oncology phase I trials from a pharmaceutical industry perspective. Statistical planning and logistical considerations on how to effectively execute such designs in multi-center clinical trials are discussed using two recent case studies.

  10. Considerations for improving assay sensitivity in chronic pain clinical trials: IMMPACT recommendations.

    Science.gov (United States)

    Dworkin, Robert H; Turk, Dennis C; Peirce-Sandner, Sarah; Burke, Laurie B; Farrar, John T; Gilron, Ian; Jensen, Mark P; Katz, Nathaniel P; Raja, Srinivasa N; Rappaport, Bob A; Rowbotham, Michael C; Backonja, Misha-Miroslav; Baron, Ralf; Bellamy, Nicholas; Bhagwagar, Zubin; Costello, Ann; Cowan, Penney; Fang, Weikai Christopher; Hertz, Sharon; Jay, Gary W; Junor, Roderick; Kerns, Robert D; Kerwin, Rosemary; Kopecky, Ernest A; Lissin, Dmitri; Malamut, Richard; Markman, John D; McDermott, Michael P; Munera, Catherine; Porter, Linda; Rauschkolb, Christine; Rice, Andrew S C; Sampaio, Cristina; Skljarevski, Vladimir; Sommerville, Kenneth; Stacey, Brett R; Steigerwald, Ilona; Tobias, Jeffrey; Trentacosti, Ann Marie; Wasan, Ajay D; Wells, George A; Williams, Jim; Witter, James; Ziegler, Dan

    2012-06-01

    A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of limitations in the ability of these RCTs to demonstrate the benefits of efficacious analgesic treatments vs placebo ("assay sensitivity"). Efforts to improve the assay sensitivity of analgesic trials could reduce the rate of falsely negative trials of efficacious medications and improve the efficiency of analgesic drug development. Therefore, an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting was convened in which the assay sensitivity of chronic pain trials was reviewed and discussed. On the basis of this meeting and subsequent discussions, the authors recommend consideration of a number of patient, study design, study site, and outcome measurement factors that have the potential to affect the assay sensitivity of RCTs of chronic pain treatments. Increased attention to and research on methodological aspects of clinical trials and their relationships with assay sensitivity have the potential to provide the foundation for an evidence-based approach to the design of analgesic clinical trials and expedite the identification of analgesic treatments with improved efficacy and safety.

  11. Is acuity enough? Other considerations in clinical investigations of visual prostheses.

    Science.gov (United States)

    Lepri, Bernard P

    2009-06-01

    Visual impairing eye diseases are the major frontier facing ophthalmic research today in light of our rapidly aging population. The visual skills necessary for improving the quality of daily function and life are inextricably linked to these impairing diseases. Both research and reimbursement programs are emphasizing outcome-based results. Is improvement in visual acuity alone enough to improve the function and quality of life of visually impaired persons? This perspective summarizes the types of effectiveness endpoints for clinical investigations of visual prostheses that go beyond visual acuity. The clinical investigation of visual prostheses should include visual function, functional vision and quality of life measures. Specifically, they encompass contrast sensitivity, orientation and mobility, activities of daily living and quality of life assessments. The perspective focuses on the design of clinical trials for visual prostheses and the methods of determining effectiveness above and beyond visual acuity that will yield outcomes that are measured by improved function in the visual world and quality of life. The visually impaired population is the primary consideration in this presentation with particular emphases on retinitis pigmentosa and age-related macular degeneration. Clinical trials for visual prostheses cannot be isolated from the need for medical rehabilitation in order to obtain measurements of effectiveness that produce outcomes/evidence-based success. This approach will facilitate improvement in daily function and quality of life of patients with diseases that cause chronic vision impairment.

  12. Thermochemoradiotherapy for advanced or recurrent head and neck cancer. Analysis of clinical results and background variables

    Energy Technology Data Exchange (ETDEWEB)

    Hoshina, Hideyuki; Takagi, Ritsuo; Nagashima, Katsuhiro; Fujita, Hajime; Miyamoto, Takeshi; Sohma, Yoh; Fukuda, Jun-ichi; Imai, Nobuyuki; Nagata, Masaki [Niigata Univ. (Japan). Faculty of Dentistry

    2001-03-01

    Eighteen patients with 25 unresectable advanced or recurrent head and neck cancers (squamous cell carcinomas) received thermochemotherapy in combination with radiotherapy. The total radiation dose ranged from 50 to 82 Gy (mean, 65.6 Gy). Patients received thermochemotherapy twice a week, for a total number of 8.8 sessions, on average. The temperature in the tumor, as a result of the hyperthermia, was over 42 deg C in 185 (84.5%) of the 219 treatments. Three kinds of heating systems were used: a 13.56-MHz radiofrequency system, a 2450-MHz microwave system, and a radiofrequency interstitial system. The total amount of administered CDDP ranged from 40 to 300 mg (mean, 110 mg), combined with PEP and/or 5FU. Background factors (tumor factors and treatment factors) were investigated in detail, and the clinical results (tumor response and the 5-year cumulative focal control rate) were evaluated. The relationship between these two results was then analyzed using univariate and multivariate statistics. The clinical results of patients with a WHO histological classification of grade 3 were poor compared with patients with a classification of grade 1 or 2. The difference between these two results was significant when analyzed using univariate statistics, but not significant when analyzed using multivariate statistics. The clinical results of patients with primary lesions surrounded by bony tissues were slightly poor compared with those of patients whose lesions were surrounded by soft tissues, but the difference between these two results was not significant. Successful treatment of refractory recurrent tumors, large tumor masses, and diffuse invasive carcinomas was not affected by the treatment factors (heating systems, heating sessions, radiation dose, and CDDP dose and drug combination). These results suggest that refractory recurrence, proximity to bony tissues, tumor size, and histological malignancy might not be prognostic variables for thermochemoradiotherapy strategy

  13. Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy.

    Science.gov (United States)

    Roberts, Jeffrey N; Gruber, Marion F

    2015-02-18

    Despite supportive public health policies (e.g., ACIP recommendations), the potential for providing clinical benefit through maternal immunization has yet to be fully realized. For vaccines already licensed and approved for use in adults, specific FDA approval for use during pregnancy to prevent disease in the mother and/or infant may have a significant impact on uptake and usage in pregnant women. In addition, for either a licensed vaccine or a novel vaccine, FDA approval for use during pregnancy would result in labeling that would serve as a resource for practitioners and would facilitate the safe and effective use of the vaccine during pregnancy. In the U.S., while many vaccines are approved for use in adults and most are not contraindicated for use in pregnant women, no vaccine is licensed for use specifically during pregnancy. Among the perceived obstacles hindering the clinical development of vaccines for use in pregnancy, regulatory issues are frequently cited. One aim of this article is to address the perceived regulatory obstacles. General concepts and regulatory considerations for clinical safety and effectiveness evaluations for vaccines indicated for use during pregnancy will be discussed. This discussion is not intended to establish data requirements or to articulate agency policy or guidance regarding specific vaccine products.

  14. Solid organ transplant recipients: clinical considerations in the application of exercise.

    Science.gov (United States)

    McKenzie, K-J L; McKenzie, D C; Yoshida, E M

    2015-01-01

    Over 100 000 solid organ transplants are performed worldwide each year and this has a significant impact on physical function and quality of life. However, the capacity for exercise in solid-organ recipients is reduced. Regular physical activity improves most of the indices of fitness in these patients but, with few exceptions, they do not reach the values seen in healthy controls. The reason for the 40-60% reduction in maximal exercise capacity is not clear; the disease process, need for life long immunosuppression and sedentary lifestyle all contribute. The interaction between exercise and immunosuppressing medication merits research as does the specifics of the exercise prescription for these patients. This paper reviews important features of this rapidly expanding group of patients and suggests clinical considerations in the application of exercise in this population.

  15. Clinical utility and patient consideration in the use of lenalidomide for multiple myeloma in Chinese patients

    Directory of Open Access Journals (Sweden)

    Wang J

    2015-06-01

    Full Text Available Jing Wang, Hongfeng Guo, Xin Zhou Department of Hematology, Wuxi People’s Hospital, Nanjing Medical University, Wuxi, People’s Republic of China Abstract: Multiple myeloma (MM is an incurable hematologic malignancy caused by the autonomous growth of malignant plasma cells. In the last decade, the introduction of novel targeted agents such as thalidomide, bortezomib, and lenalidomide has dramatically improved the clinical outcome of MM patients in both the frontline and recurrent settings. Lenalidomide is a synthetic derivative of thalidomide, which has been shown to significantly improve overall survival, time to progression, and overall response rates in patients with MM. The China Food and Drug Administration approved the use of lenalidomide in patients with MM in 2013. In a Phase II trial, lenalidomide plus low-dose dexamethasone was associated with a high response rate and acceptable safety profile in heavily pretreated Chinese patients with relapsed/refractory MM, including those with renal impairment and IgD subtype. However, lenalidomide will remain as a second-line antimyeloma drug in the near future because of its high price and the policy of health insurance reimbursement in People’s Republic of China. In this review, we summarize the clinical utility and patient considerations in the use of lenalidomide for MM in Chinese patients. Further studies with larger sample sizes are required to investigate the better quality, longer duration, and more clinically meaningful outcomes of lenalidomide in the treatment of MM in Chinese patients. Keywords: lenalidomide, multiple myeloma, clinical efficacy, Chinese patients

  16. PERSPECTIVE: Is acuity enough? Other considerations in clinical investigations of visual prostheses

    Science.gov (United States)

    Lepri, Bernard P.

    2009-06-01

    Visual impairing eye diseases are the major frontier facing ophthalmic research today in light of our rapidly aging population. The visual skills necessary for improving the quality of daily function and life are inextricably linked to these impairing diseases. Both research and reimbursement programs are emphasizing outcome-based results. Is improvement in visual acuity alone enough to improve the function and quality of life of visually impaired persons? This perspective summarizes the types of effectiveness endpoints for clinical investigations of visual prostheses that go beyond visual acuity. The clinical investigation of visual prostheses should include visual function, functional vision and quality of life measures. Specifically, they encompass contrast sensitivity, orientation and mobility, activities of daily living and quality of life assessments. The perspective focuses on the design of clinical trials for visual prostheses and the methods of determining effectiveness above and beyond visual acuity that will yield outcomes that are measured by improved function in the visual world and quality of life. The visually impaired population is the primary consideration in this presentation with particular emphases on retinitis pigmentosa and age-related macular degeneration. Clinical trials for visual prostheses cannot be isolated from the need for medical rehabilitation in order to obtain measurements of effectiveness that produce outcomes/evidence-based success. This approach will facilitate improvement in daily function and quality of life of patients with diseases that cause chronic vision impairment. The views and opinions are those of the author and do not necessarily reflect those of the US Food and Drug Administration, the US Department of Health and Human Services or the Public Health Service.

  17. Body packing: a review of general background, clinical and imaging aspects.

    Science.gov (United States)

    Berger, Ferco H; Nieboer, Koenraad H; Goh, Gerard S; Pinto, Antonio; Scaglione, Mariano

    2015-01-01

    To avoid detection at border crossings or airport customs, drug trafficking is increasingly performed by intra-corporeal concealment. Body packers may ingest packets of varying size and containing varying drugs (mostly cocaine, heroin and cannabis) mixed with other compounds, while body pushers will insert packets in the rectum or vaginal cavity. Body packing may lead to potential life-threatening complications with acute overdose syndromes after packet rupture and intestinal obstruction with possible ensuing bowel rupture being the most significant complications. Physicians including radiologists should be aware of the capabilities of imaging techniques to screen for presence of drug packets as well as the potential complications. Although conventional radiography has long been and still is the most important imaging modality for screening for presence of intestinal packets, the better test characteristics in conjunction with the decreasing radiation exposure, will likely render computed tomography (CT) more important in the future. For imaging of symptomatic patients, CT already is the modality of choice. Besides these modalities, ultrasound and magnetic resonance imaging will be discussed in this paper, together with more general background and clinical information.

  18. Patient attributes warranting consideration in clinical practice guidelines, health workforce planning and policy

    Directory of Open Access Journals (Sweden)

    Segal Leonie

    2011-09-01

    Full Text Available Abstract Background In order for clinical practice guidelines (CPGs to meet their broad objective of enhancing the quality of care and supporting improved patient outcomes, they must address the needs of diverse patient populations. We set out to explore the patient attributes that are likely to demand a unique approach to the management of chronic disease, and which are crucial if evidence or services planning is to reflect clinic populations. These were incorporated into a new conceptual framework; using diabetes mellitus as an exemplar. Methods The patient attributes that informed the framework were identified from CPGs, the diabetes literature, an expert academic panel, and two cross-disciplinary panels; and agreed upon using a modified nominal group technique. Results Full consensus was reached on twenty-four attributes. These factors fell into one of three themes: (1 type/stage of disease, (2 morbid events, and (3 factors impacting on capacity to self-care. These three themes were incorporated in a convenient way in the workforce evidence-based (WEB model. Conclusions While biomedical factors are frequently recognised in published clinical practice guidelines, little attention is given to attributes influencing a person's capacity to self-care. Paying explicit attention to predictable threats to effective self-care in clinical practice guidelines, by drawing on the WEB model, may assist in refinements that would address observed disparities in health outcomes across socio-economic groups. The WEB model also provides a framework to inform clinical training, and health services and workforce planning and research; including the assessment of healthcare needs, and the allocation of healthcare resources.

  19. Connecting Gaucher and Parkinson Disease: Considerations for Clinical and Research Genetic Counseling Settings.

    Science.gov (United States)

    Cook, Lola; Schulze, Jeanine

    2017-06-30

    There are multiple autosomal recessive disorders in which carriers may be at risk for other diseases. This observation calls into question the previous understanding that carriers of autosomal recessive disorders escape clinical consequences. We also know that childhood genetic conditions may have adult disease counterparts (Zimran et al., The Israel Medical Association Journal: IMAJ, 16(11), 723-724, 2014). Individuals who have Gaucher disease and carriers of the disorder are at increased risk for a seemingly unrelated and complex neurological condition, Parkinson disease. Parkinson disease is, in part, caused by the same mutations in the GBA gene that lead to Gaucher disease, and the two conditions are thought to have shared pathophysiology. Briefly reviewed are how these two diseases historically became linked, where their paths cross, potential problems and considerations in disclosure of the link, and current guidelines and research in this area. Genetic counseling experience with a large Parkinson disease cohort is used as a starting point to question the state of clinical and nonclinical practice in disclosing this unusual connection We conclude that more research and discussion are needed to inform practice regarding the crossroads of Gaucher and Parkinson disease.

  20. Mind-body CAM interventions: current status and considerations for integration into clinical health psychology.

    Science.gov (United States)

    Park, Crystal

    2013-01-01

    Complementary and alternative medicine (CAM) is increasingly used for treating myriad health conditions and for maintaining general health. The present article provides an overview of current CAM use with a specific focus on mind-body CAM and its efficacy in treating health conditions. Characteristics of CAM users are presented, and then evidence regarding the efficacy of mind-body treatments (biofeedback, meditation, guided imagery, progressive muscle relaxation, deep breathing, hypnosis, yoga, tai chi, and qi gong) is reviewed. Demographics associated with CAM use are fairly well-established, but less is known about their psychological characteristics. Although the efficacy of mind-body CAM modalities for health conditions is receiving a great deal of research attention, studies have thus far produced a weak base of evidence. Methodological limitations of current research are reviewed. Suggestions are made for future research that will provide more conclusive knowledge regarding efficacy and, ultimately, effectiveness of mind-body CAM. Considerations for clinical applications, including training and competence, ethics, treatment tailoring, prevention efforts, and diversity, conclude the article. Integration of CAM modalities into clinical health psychology can be useful for researchers taking a broader perspective on stress and coping processes, illness behaviors, and culture; for practitioners seeking to incorporate CAM perspectives into their work; and for policy makers in directing healthcare resources wisely. © 2012 Wiley Periodicals, Inc.

  1. Biofluid infrared spectro-diagnostics: pre-analytical considerations for clinical applications.

    Science.gov (United States)

    Lovergne, L; Bouzy, P; Untereiner, V; Garnotel, R; Baker, M J; Thiéfin, G; Sockalingum, G D

    2016-06-23

    Several proof-of-concept studies on the vibrational spectroscopy of biofluids have demonstrated that the methodology has promising potential as a clinical diagnostic tool. However, these studies also show that there is a lack of a standardised protocol in sample handling and preparation prior to spectroscopic analysis. One of the most important sources of analytical errors is the pre-analytical phase. For the technique to be translated into clinics, it is clear that a very strict protocol needs to be established for such biological samples. This study focuses on some of the aspects of the pre-analytical phase in the development of the high-throughput Fourier Transform Infrared (FTIR) spectroscopy of some of the most common biofluids such as serum, plasma and bile. Pre-analytical considerations that can impact either the samples (solvents, anti-coagulants, freeze-thaw cycles…) and/or spectroscopic analysis (sample preparation such as drying, deposit methods, volumes, substrates, operators dependence…) and consequently the quality and the reproducibility of spectral data will be discussed in this report.

  2. Neuroendocrine Tumors and Lanreotide Depot: Clinical Considerations and Nurse and Patient Preferences.

    Science.gov (United States)

    Ryan, Pamela; Phan, Alexandria T; Adelman, Daphne T; Iwasaki, Michiko

    2016-12-01

    Somatostatin analogs (SSAs) are a mainstay therapy for the treatment of carcinoid syndrome associated with neuroendocrine tumors (NETs). They are effective for a range of gastroenteropancreatic NETs (GEP-NETs). Lanreotide depot (Somatuline®) is an SSA that is approved for the treatment of GEP-NETs to improve progression-free survival (PFS). The article reviews the efficacy, safety, and administration of lanreotide depot and relates those attributes to considerations and preferences of oncology nurses and their patients. A review of the literature on the use of lanreotide for the treatment of NETs and carcinoid syndrome was conducted. In addition, the literature on drug delivery and routes of administration was surveyed to provide context for comparative studies related to clinical and patient preferences. Lanreotide depot prolongs PFS and is well tolerated by patients who expressed satisfaction in the ability to control symptoms related to carcinoid syndrome. Nurses cited several benefits to using lanreotide depot in the clinical setting, including more time saved to address other patient care issues. Attributes of lanreotide depot-including its efficacy, safety and tolerability, dosing and administration, and cost-may contribute to healthcare decisions regarding the treatment and management of NETs.

  3. Practical considerations for noise power spectra estimation for clinical CT scanners.

    Science.gov (United States)

    Dolly, Steven; Chen, Hsin-Chen; Anastasio, Mark; Mutic, Sasa; Li, Hua

    2016-05-08

    Local noise power spectra (NPS) have been commonly calculated to represent the noise properties of CT imaging systems, but their properties are significantly affected by the utilized calculation schemes. In this study, the effects of varied calculation parameters on the local NPS were analyzed, and practical suggestions were provided regarding the estimation of local NPS for clinical CT scanners. The uniformity module of a Catphan phantom was scanned with a Philips Brilliance 64 slice CT simulator with varied scanning protocols. Images were reconstructed using FBP and iDose4 iterative reconstruction with noise reduction levels 1, 3, and 6. Local NPS were calculated and compared for varied region of interest (ROI) locations and sizes, image background removal methods, and window functions. Additionally, with a predetermined NPS as a ground truth, local NPS calculation accuracy was compared for computer simulated ROIs, varying the aforementioned parameters in addition to ROI number. An analysis of the effects of these varied calculation parameters on the magnitude and shape of the NPS was conducted. The local NPS varied depending on calculation parameters, particularly at low spatial frequencies below ~ 0.15 mm-1. For the simulation study, NPS calculation error decreased exponentially as ROI number increased. For the Catphan study the NPS magnitude varied as a function of ROI location, which was better observed when using smaller ROI sizes. The image subtraction method for background removal was the most effective at reducing low-frequency background noise, and produced similar results no matter which ROI size or window function was used. The PCA background removal method with a Hann window function produced the closest match to image subtraction, with an average percent difference of 17.5%. Image noise should be analyzed locally by calculating the NPS for small ROI sizes. A minimum ROI size is recommended based on the chosen radial bin size and image pixel

  4. Updating to the WAIS-III and WMS-III: considerations for research and clinical practice.

    Science.gov (United States)

    Tulsky, D S; Ledbetter, M F

    2000-09-01

    The Wechsler Adult Intelligence Scale-Revised (WAIS-R) and the Wechsler Memory Scale-Revised (WMS-R) are the most commonly used intelligence and memory scales in both clinical and neuropsychology. In 1997, updated versions of these instruments (the WAIS-III and WMS-III) were published. Because of the extensive use of the WAIS-R and WMS-R in the field and the body of accumulated research, there is naturally some reluctance by clinicians and researchers to update to the new versions. It is sometimes difficult for clinicians who test individuals on repeated occasions to switch over to the new versions of the scales because of the difficulty of interpreting score discrepancy between the 2 versions. Researchers, especially those conducting longitudinal research, have a similar difficulty in changing measurement devices because of the possible threat of internal validity. This article reviews the substantive revisions of the scales and outlines those issues that users should take into consideration when updating to the new versions.

  5. The clinical and radiologic consideration of cementifying and ossifying fibroma of the jaws

    Energy Technology Data Exchange (ETDEWEB)

    Jo, Eun Young; Kim, Kee Deog; Park, Chang Seo [Dept. of Oral Radiology, College of Dentistry, Yensei University, Seoul (Korea, Republic of)

    1997-08-15

    The purpose of this study was to know the proper diagnosis and to establish the treatment plan of cementifying and ossifying fibroma in the jaws through the clinical, radiological, and histopathologic considerations. The authors compared and analyzed the clinicoradiologic features of the thirteen cases of cementifying and ossifying fibroma, diagnosed at the Dental college hospital in Yonsei university, Seoul, Korea, during the period from 1980 to 1995. The obtained results were as follows : 1. Cementifying and ossifying fibroma occurred in the mean age, 44 years, ranged from 29 to 65 years and the male to female ratio was approximately 1:5. 2. Swelling was the most common frequent presenting complaints. Other reported symptoms included pain, tooth mobility and symptom. 3. The frequency of the lesions was twelve cases in the mandible and one case in the maxilla. And eleven of thirteen cases were distributed on the premolar and molar region. 4. Radiologically, eight of thirteen cases were well defined lesions, five cases were relatively well defined lesions. And nine of thirteen cases were mixed lesions, three cases were radiopaque lesions, and only one case was purely radiolucent lesion. 5. Histologically, seven of thirteen cases were classified ossifying fibroma, four cases were cemento-ossifying fibroma, and two cases were cementifying fibroma.

  6. Current protocols in the generation of pluripotent stem cells: theoretical, methodological and clinical considerations

    Directory of Open Access Journals (Sweden)

    Brad B Swelstad

    2009-12-01

    Full Text Available Brad B Swelstad, Candace L KerrInstitute for Cell Engineering, Department of Obstetrics and Gynecology, Johns Hopkins University, Baltimore, MA, USAAbstract: Pluripotent stem cells have been derived from various embryonic, fetal and adult sources. Embryonic stem cells (ESCs and parthenogenic ESCs (pESCs are derived from the embryo proper while embryonic germ cells (EGCs, embryonal carcinoma cells (ECCs, and germ-line stem cells (GSC are produced from germ cells. ECCs were the first pluripotent stem cell lines established from adult testicular tumors while EGCs are generated in vitro from primordial germ cells (PGCs isolated in late embryonic development. More recently, studies have also demonstrated the ability to produce GSCs from adult germ cells, known as spermatogonial stem cells. Unlike ECCs, the source of GSCs are normal, non-cancerous adult tissue. The study of these unique cell lines has provided information that has led to the ability to reprogram somatic cells into an ESC-like state. These cells, called induced pluripotent stem cells (iPSCs, have been derived from a number of human fetal and adult origins. With the promises pluripotent stem cells bring to cell-based therapies there remain several considerations that need to be carefully studied prior to their clinical use. Many of these issues involve understanding key factors regulating their generation, including those which define pluripotency. In this regard, the following article discusses critical aspects of pluripotent stem cell derivation and current issues about their therapeutic potential.Keywords: pluripotency, stem cells, derivation, human

  7. Current protocols in the generation of pluripotent stem cells: theoretical, methodological and clinical considerations.

    Science.gov (United States)

    Swelstad, Brad B; Kerr, Candace L

    2009-12-22

    Pluripotent stem cells have been derived from various embryonic, fetal and adult sources. Embryonic stem cells (ESCs) and parthenogenic ESCs (pESCs) are derived from the embryo proper while embryonic germ cells (EGCs), embryonal carcinoma cells (ECCs), and germ-line stem cells (GSC) are produced from germ cells. ECCs were the first pluripotent stem cell lines established from adult testicular tumors while EGCs are generated in vitro from primordial germ cells (PGCs) isolated in late embryonic development. More recently, studies have also demonstrated the ability to produce GSCs from adult germ cells, known as spermatogonial stem cells. Unlike ECCs, the source of GSCs are normal, non-cancerous adult tissue. The study of these unique cell lines has provided information that has led to the ability to reprogram somatic cells into an ESC-like state. These cells, called induced pluripotent stem cells (iPSCs), have been derived from a number of human fetal and adult origins. With the promises pluripotent stem cells bring to cell-based therapies there remain several considerations that need to be carefully studied prior to their clinical use. Many of these issues involve understanding key factors regulating their generation, including those which define pluripotency. In this regard, the following article discusses critical aspects of pluripotent stem cell derivation and current issues about their therapeutic potential.

  8. A novel misoprostol delivery system for induction of labor: clinical utility and patient considerations.

    Science.gov (United States)

    Stephenson, Megan L; Wing, Deborah A

    2015-01-01

    Induction of labor is one of the most commonly performed obstetric procedures and will likely become more common as the reproductive population in developed nations changes. As the proportion of women undergoing induction grows, there is a constant search for more efficacious ways to induce labor while maintaining fetal and maternal safety as well as patient satisfaction. With almost half of induced labors requiring cervical ripening, methods for achieving active labor and vaginal delivery are constantly being investigated. Prostaglandins have been shown to be effective induction agents, and specifically vaginal misoprostol, used off-label, have been widely utilized to initiate cervical ripening and active labor. The challenge is to administer this medication accurately while maintaining the ability to discontinue the medication when needed. The misoprostol vaginal insert initiates cervical ripening utilizing a delivery system that controls medication release and can be rapidly removed. This paper reviews the design, development, and clinical utility of the misoprostol vaginal insert for induction of labor as well as patient considerations related to the delivery system.

  9. A novel misoprostol delivery system for induction of labor: clinical utility and patient considerations

    Directory of Open Access Journals (Sweden)

    Stephenson ML

    2015-04-01

    Full Text Available Megan L Stephenson, Deborah A WingDivision of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of California, Irvine Medical Center, Orange, CA, USAAbstract: Induction of labor is one of the most commonly performed obstetric procedures and will likely become more common as the reproductive population in developed nations changes. As the proportion of women undergoing induction grows, there is a constant search for more efficacious ways to induce labor while maintaining fetal and maternal safety as well as patient satisfaction. With almost half of induced labors requiring cervical ripening, methods for achieving active labor and vaginal delivery are constantly being investigated. Prostaglandins have been shown to be effective induction agents, and specifically vaginal misoprostol, used off-label, have been widely utilized to initiate cervical ripening and active labor. The challenge is to administer this medication accurately while maintaining the ability to discontinue the medication when needed. The misoprostol vaginal insert initiates cervical ripening utilizing a delivery system that controls medication release and can be rapidly removed. This paper reviews the design, development, and clinical utility of the misoprostol vaginal insert for induction of labor as well as patient considerations related to the delivery system.Keywords: misoprostol, induction, cervical ripening, vaginal insert

  10. Clinical pharmacokinetics of anxiolytics and hypnotics in the elderly. Therapeutic considerations (Part I).

    Science.gov (United States)

    Greenblatt, D J; Harmatz, J S; Shader, R I

    1991-09-01

    Anxiolytic and hypnotic drugs are extensively prescribed for elderly individuals throughout Western society. Old age may be associated with an altered clinical response to this class of compounds, and there is a considerable ethical and economic stake in understanding these changes so that therapy may be approached with a maximum likelihood of therapeutic benefit and a minimum risk of side effects. Old age may lead to altered pharmacokinetics of sedative-anxiolytic drugs, causing higher plasma concentrations (relative to young individuals) after single or multiple doses. By far the majority of the available scientific data refer to the benzodiazepines, which have become the most widely prescribed class of sedative-anxiolytic drugs. Although there is not complete consistency in the available data, the weight of evidence indicates that old age is associated with impaired clearance of the benzodiazepines which are biotransformed by microsomal oxidation (such as diazepam, desmethyldiazepam, desalkylflurazepam, bromazepam, alprazolam, triazolam and others). For those benzodiazepines metabolised mainly by glucuronide conjugation (oxazepam, lorazepam, temazepam) or nitroreduction (nitrazepam), there are minimal, if any, age-related decrements in clearance. Only in the case of triazolam is there direct evidence linking impaired clearance to enhanced clinical effects in the elderly. The logical suggestion that benzodiazepines biotransformed by conjugation or by nitroreduction may be safer for the elderly than those biotransformed by oxidation has not yet been directly validated. Reasonable epidemiological evidence has linked the use of long (versus short) half-life benzodiazepines (regardless of the specific metabolic pathway) with an increased incidence of adverse reactions such as confusion, falls and hip fractures in elderly persons. However, the decreased clearance and increased accumulation of the benzodiazepines in question are not clearly validated as the cause of

  11. Medical specialty considerations by medical students early in their clinical experience

    Directory of Open Access Journals (Sweden)

    Weissman Charles

    2012-03-01

    Full Text Available Abstract Background Specialty selection by medical students determines the future composition of the physician workforce. Selection of career specialties begins in earnest during the clinical rotations with exposure to the clinical and intellectual environments of various specialties. Career specialty selection is followed by choosing a residency program. This is the period where insight into the decision process might help healthcare leaders ascertain whether, when, and how to intervene and attempt to influence students' decisions. The criteria students consider important in selecting a specialty and a residency program during the early phases of their clinical rotations were examined. Methods Questionnaires distributed to fifth-year medical students at two Israeli medical schools. Results 229 of 275 (83% questionnaires were returned. 80% of the students had considered specialties; 62% considered one specialty, 25% two, the remainder 3-5 specialties. Students took a long-range view; 55% considered working conditions after residency more important than those during residency, another 42% considered both equally important. More than two-thirds wanted an interesting and challenging bedside specialty affording control over lifestyle and providing a reasonable relationship between salary and lifestyle. Men were more interested in well-remunerated procedure-oriented specialties that allowed for private practice. Most students rated as important selecting a challenging and interesting residency program characterized by good relationships between staff members, with positive treatment by the institution, and that provided much teaching. More women wanted short residencies with few on-calls and limited hours. More men rated as important residencies affording much responsibility for making clinical decisions and providing research opportunities. More than 50% of the students considered it important that their residency be in a leading department, and in

  12. The EuroPrevall outpatient clinic study on food allergy : Background and methodology

    NARCIS (Netherlands)

    Fernández-Rivas, Montserrat; Barreales, L.; Mackie, A. R.; Fritsche, P.; Vázquez-Cortés, S.; Jedrzejczak-Czechowicz, M.; Kowalski, M. L.; Clausen, M.; Gislason, D.; Sinaniotis, A.; Kompoti, E.; Le, T. M.; Knulst, A. C.; Purohit, A.; De Blay, F.; Kralimarkova, T.; Popov, T.; Asero, R.; Belohlavkova, S.; Seneviratne, S. L.; Dubakiene, R.; Lidholm, J.; Hoffmann-Sommergruber, K.; Burney, P.; Crevel, R.; Brill, M.; Fernández-Pérez, C.; Vieths, S.; Clare Mills, E. N.; Van Ree, R.; Ballmer-Weber, B. K.

    2015-01-01

    Background The EuroPrevall project aimed to develop effective management strategies in food allergy through a suite of interconnected studies and a multidisciplinary integrated approach. To address some of the gaps in food allergy diagnosis, allergen risk management and socio-economic impact and to

  13. 78 FR 69690 - Draft Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of...

    Science.gov (United States)

    2013-11-20

    ...The Food and Drug Administration (FDA) is extending the comment period for the draft guidance for industry entitled ``Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products'' that appeared in the Federal Register of July 2, 2013 (78 FR 39736). The draft guidance document provides sponsors of Investigational New Drug......

  14. Prostatic Artery Embolization (PAE) for Symptomatic Benign Prostatic Hyperplasia (BPH): Part 1, Pathological Background and Clinical Implications

    Energy Technology Data Exchange (ETDEWEB)

    Sun, Fei, E-mail: feisun@ccmijesususon.com; Crisóstomo, Verónica, E-mail: crisosto@ccmijesususon.com; Báez-Díaz, Claudia, E-mail: cbaez@ccmijesususon.com; Sánchez, Francisco M., E-mail: msanchez@ccmijesususon.com [Jesús Usón Minimally Invasive Surgery Centre (Spain)

    2016-01-15

    Pathological features of benign prostatic hyperplasia (BPH) dictate various responses to prostatic artery embolization (PAE). Typically, BPH originates in the transition zone and periurethral region, where should be considered the primary target area in PAE procedures. Given that histological heterogeneity of components in hyperplasia nodules, epithelial or stromal, identifying the more responsive nodules to PAE will have clinical implications. Since some lower urinary tract symptoms (LUTS) in patients with BPH are usually related to bladder outlet obstruction-induced changes in bladder function rather than to outflow obstruction directly, proper selection of candidate patients prior to PAE is of great clinical importance. BPH is a typical chronic progressive condition, suggesting PAE could aim not only to relieve LUTS but also to delay or prevent the clinical progression. Awareness of the pathological background of BPH is essential for interventional radiologists to improve clinical outcomes and develop new treatment strategies in clinical practice of PAE.

  15. Prostatic Artery Embolization (PAE) for Symptomatic Benign Prostatic Hyperplasia (BPH): Part 1, Pathological Background and Clinical Implications.

    Science.gov (United States)

    Sun, Fei; Crisóstomo, Verónica; Báez-Díaz, Claudia; Sánchez, Francisco M

    2016-01-01

    Pathological features of benign prostatic hyperplasia (BPH) dictate various responses to prostatic artery embolization (PAE). Typically, BPH originates in the transition zone and periurethral region, where should be considered the primary target area in PAE procedures. Given that histological heterogeneity of components in hyperplasia nodules, epithelial or stromal, identifying the more responsive nodules to PAE will have clinical implications. Since some lower urinary tract symptoms (LUTS) in patients with BPH are usually related to bladder outlet obstruction-induced changes in bladder function rather than to outflow obstruction directly, proper selection of candidate patients prior to PAE is of great clinical importance. BPH is a typical chronic progressive condition, suggesting PAE could aim not only to relieve LUTS but also to delay or prevent the clinical progression. Awareness of the pathological background of BPH is essential for interventional radiologists to improve clinical outcomes and develop new treatment strategies in clinical practice of PAE.

  16. The Non-Recurrent Laryngeal Nerve: a meta-analysis and clinical considerations

    Science.gov (United States)

    Sanna, Silvia; Graves, Matthew J.; Vikse, Jens; Sanna, Beatrice; Tomaszewska, Iwona M.; Tubbs, R. Shane; Walocha, Jerzy A.; Tomaszewski, Krzysztof A.

    2017-01-01

    Background The Non-Recurrent Laryngeal Nerve (NRLN) is a rare embryologically-derived variant of the Recurrent Laryngeal Nerve (RLN). The presence of an NRLN significantly increases the risk of iatrogenic injury and operative complications. Our aim was to provide a comprehensive meta-analysis of the overall prevalence of the NRLN, its origin, and its association with an aberrant subclavian artery. Methods Through March 2016, a database search was performed of PubMed, CNKI, ScienceDirect, EMBASE, BIOSIS, SciELO, and Web of Science. The references in the included articles were also extensively searched. At least two reviewers judged eligibility and assessed and extracted articles. MetaXL was used for analysis, with all pooled prevalence rates calculated using a random effects model. Heterogeneity among the included studies was assessed using the Chi2 test and the I2 statistic. Results Fifty-three studies (33,571 right RLNs) reported data on the prevalence of a right NRLN. The pooled prevalence estimate was 0.7% (95% CI [0.6–0.9]). The NRLN was found to originate from the vagus nerve at or above the laryngotracheal junction in 58.3% and below it in 41.7%. A right NRLN was associated with an aberrant subclavian artery in 86.7% of cases. Conclusion The NRLN is a rare yet very clinically relevant structure for surgeons and is associated with increased risk of iatrogenic injury, most often leading to temporary or permanent vocal cord paralysis. A thorough understanding of the prevalence, origin, and associated pathologies is vital for preventing injuries and complications. PMID:28344898

  17. Left atrial decompression pump for severe heart failure with preserved ejection fraction: theoretical and clinical considerations.

    Science.gov (United States)

    Burkhoff, Daniel; Maurer, Mathew S; Joseph, Susan M; Rogers, Joseph G; Birati, Edo Y; Rame, J Eduardo; Shah, Sanjiv J

    2015-04-01

    The purpose of this study was to provide insight into the potential for left atrium (LA) to aortic mechanical circulatory support as a treatment for patients with heart failure with preserved ejection fraction (HFpEF). Although HFpEF arises from different etiologies, 1 hallmark of all forms of this syndrome is a small or minimally-dilated left ventricle (LV). Consequently, the use of traditional mechanical circulatory support in end-stage patients has been difficult. In contrast, HFpEF is also characterized by a large LA. Hemodynamic characteristics of 4 distinct HFpEF phenotypes were characterized from the published data: 1) hypertrophic cardiomyopathies; 2) infiltrative diseases; 3) nonhypertrophic HFpEF; and 4) HFpEF with common cardiovascular comorbidities (e.g., hypertension). Employing a previously-described cardiovascular simulation, the effects of a low-flow, micropump-based LA decompression device were modeled. The effect of sourcing blood from the LV versus the LA was compared. For all HFpEF phenotypes, mechanical circulatory support significantly increased cardiac output, provided a mild increase in blood pressure, and markedly reduced pulmonary and LA pressures. LV sourcing of blood reduced LV end-systolic volume into a range likely to induce suction. With LA sourcing, however, LV end-systolic volume increased compared with baseline. Due to pre-existing LA enlargement, LA volumes remained sufficiently elevated, thus minimizing the risk of suction. This theoretical analysis suggests that a strategy involving pumping blood from the LA to the arterial system may provide a viable option for end-stage HFpEF. Special considerations apply to each of the 4 types of HFpEF phenotypes described. Finally, an HFpEF-specific clinical profile scoring system (such as that of INTERMACS [Interagency Registry for Mechanically Assisted Circulatory Support]) would aid in the selection of patients with the appropriate risk-benefit ratio for implantation of an active pump

  18. [Modern ultrasound methods of examination in clinical ophthalmology. Background problems and future prospects].

    Science.gov (United States)

    Kharlap, S I

    2003-01-01

    Historic aspects of ultrasound diagnostics in ophthalmology are described. The technological development of ultrasound diagnostic systems and the clinical application of different ultrasound modes in examining the eye and its choroids are traced back. The efficiency of Doppler mapping in the mode of three-dimension reconstruction at examining the orbital vascular system is evaluated. An experience obtained at the Research Institute for Eye Disease of the Russian Academy of Medical Sciences and outlooks for the diagnostic usage of computer ultrasound in clinical ophthalmology and angiologia are presented.

  19. The Myth of the Nuclear Family: Historical Background and Clinical Implications.

    Science.gov (United States)

    Uzoka, Azubike Felix

    1979-01-01

    Research reviewed indicates that the concept of the nuclear family is inadequate and misleading for an understanding of family dynamics or a guide for therapeutic intervention. Nonetheless, clinical practitioners and psychological theorists foster the nuclear myth. A new approach to the study of human relationships is needed. (Author/GC)

  20. Clinical and Immunological Features of Bronchial Asthma in Children on the Background of Persistent Intracellular Infections

    Directory of Open Access Journals (Sweden)

    O.Ye. Chernyshova

    2015-03-01

    Full Text Available The article presents information on the impact of persistent intracellular infections on the course of the di­sease and the state of immune system in children with bronchial asthma. Clinical features of bronchial asthma, the degree of sensitization, level of proinflammatory (IL-1, IL-2, IL-6, ­IL-8, IFN-α and IFN-γ, TNF-α and antiinflammatory (IL-4, ­IL-10 cytokines in the blood serum are described.

  1. A mathematical analysis of nuclear intensity dynamics for Mig1-GFP under consideration of bleaching effects and background noise in Saccharomyces cerevisiae.

    Science.gov (United States)

    Frey, Simone; Sott, Kristin; Smedh, Maria; Millat, Thomas; Dahl, Peter; Wolkenhauer, Olaf; Goksör, Mattias

    2011-01-01

    Fluorescence microscopy is an imaging technique that provides insights into signal transduction pathways through the generation of quantitative data, such as the spatiotemporal distribution of GFP-tagged proteins in signaling pathways. The data acquired are, however, usually a composition of both the GFP-tagged proteins of interest and of an autofluorescent background, which both undergo photobleaching during imaging. We here present a mathematical model based on ordinary differential equations that successfully describes the shuttling of intracellular Mig1-GFP under changing environmental conditions regarding glucose concentration. Our analysis separates the different bleaching rates of Mig1-GFP and background, and the background-to-Mig1-GFP ratio. By applying our model to experimental data, we can thus extract the Mig1-GFP signal from the overall acquired signal and investigate the influence of kinase and phosphatase on Mig1. We found a stronger regulation of Mig1 through its kinase than through its phosphatase when controlled by the glucose concentration, with a constant (de)phosphorylation rate independent of the glucose concentration. By replacing the term for decreasing excited Mig1-GFP concentration with a constant, we were able to reconstruct the dynamics of Mig1-GFP, as it would occur without bleaching and background noise. Our model effectively demonstrates how data, acquired with an optical microscope, can be processed and used for a systems biology analysis of signal transduction pathways.

  2. Clinical features of development of chronic cerebral ischemia against background of pronounced decrease of cognitive functions

    Directory of Open Access Journals (Sweden)

    Zalisna Yu.D.

    2013-12-01

    Full Text Available The paper presents the results of analyses of cognitive failure in chronic cerebral ischemia (CCI with lesion of deep divisions of the brain white matter and basal ganglia, leading to disruption of communication of frontal and subcortical brain structures (the phenomenon of separation. Mechanism of separation primarily is associated with hypertension, which leads to secondary changes of the vascular wall microvasculature. For cerebral vascular insufficiency and for diseases, primarily involving basal ganglia, intellectual inertia, bradyphreniya and decreased concentration are more common. According to studies, chronic cerebral ischemia (CCI is recorded in 20-30% of people of working age. The main etiological forms of CCI are considered to be hypertensive, atherosclerotic and mixed. For CCI of the second stage formation of neurological syndromes (pseu¬dobulbar, pyramidal, extrapyramidal, atactic, increased cognitive disorder that causes temporary or permanent disa¬bility of patients, reduction of their quality of life are characteristic. The aim of the study was to determine the cha¬racteristics of cognitive impairment in patients with CCI (hypertonic and mixed origin and their relationship to clinical and neurological manifestations of the disease. Based on the data obtained through clinical examination and neu¬ropsychological testing, marked processes of attention exhaustion and a higher risk of progression of cognitive impairment in the group with a mixed form (hypertension and atherosclerotic were revealed.

  3. Ethical considerations of clinical photography in an area of emerging technology and smartphones.

    Science.gov (United States)

    Van der Rijt, Rhys; Hoffman, Stuart

    2014-03-01

    Recent advances in digital technology including internet, email and smartphones has revolutionised clinical photography and medical record data storage. The use of smartphones is becoming ubiquitous among medical professionals and the use of clinical photography has become an integral component of the management of patients in a variety of visually orientated specialties. Although clinical photography has its benefits, with this evolving technology also emerge new ethical, legal and social issues, which clinicians must be aware of.

  4. Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial

    Directory of Open Access Journals (Sweden)

    Rabbi Moshe D. Tendler

    2015-07-01

    Full Text Available The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal.

  5. Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial

    Science.gov (United States)

    Tendler, Rabbi Moshe D.; Loike, John D.

    2015-01-01

    The transition of new biotechnologies into clinical trials is a critical step in approving a new drug or therapy in health care. Ethically recruiting appropriate volunteers for these clinical trials can be a challenging task for both the pharmaceutical companies and the US Food and Drug Administration. In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy. The halachic perspective encourages individuals to volunteer for such clinical trials under the ethical principles of beneficence and social responsibility, when animal studies have shown that health risks are minimal. PMID:26241230

  6. Mitochondrial Replacement Therapy: Halachic Considerations for Enrolling in an Experimental Clinical Trial

    National Research Council Canada - National Science Library

    Tendler, Rabbi Moshe D; Loike, John D

    2015-01-01

    .... In this paper we analyze the Jewish halachic perspectives of volunteering for clinical trials by focusing on an innovative technology in reproductive medicine, mitochondrial replacement therapy...

  7. The Way Forward: Practical Clinical Considerations for the Use of Canakinumab in Patients With Difficult-to-Treat Gouty Arthritis.

    Science.gov (United States)

    Bardin, Thomas; van de Laar, Martinus A F J

    2015-10-01

    Canakinumab is indicated for patients with frequent gouty arthritis attacks who cannot be managed with standard-of-care medication, and should be used according to the labeled indication. Given its mechanism of action, physicians need to be aware of the potential contraindications and precautions with its use. When deciding as to whether a patient with gouty arthritis is an appropriate candidate for canakinumab treatment, several key clinical considerations should be kept in mind, which are discussed herein.

  8. WE-D-207-01: Background and Clinical Implementation of a Screening Program

    Energy Technology Data Exchange (ETDEWEB)

    Aberle, D. [UCLA, Los Angeles, CA (United States)

    2015-06-15

    In the United States, Lung Cancer is responsible for more cancer deaths than the next four cancers combined. In addition, the 5 year survival rate for lung cancer patients has not improved over the past 40 to 50 years. To combat this deadly disease, in 2002 the National Cancer Institute launched a very large Randomized Control Trial called the National Lung Screening Trial (NLST). This trial would randomize subjects who had substantial risk of lung cancer (due to age and smoking history) into either a Chest X-ray arm or a low dose CT arm. In November 2010, the National Cancer Institute announced that the NLST had demonstrated 20% fewer lung cancer deaths among those who were screened with low-dose CT than with chest X-ray. In December 2013, the US Preventive Services Task Force recommended the use of Lung Cancer Screening using low dose CT and a little over a year later (Feb. 2015), CMS announced that Medicare would also cover Lung Cancer Screening using low dose CT. Thus private and public insurers are required to provide Lung Cancer Screening programs using CT to the appropriate population(s). The purpose of this Symposium is to inform medical physicists and prepare them to support the implementation of Lung Screening programs. This Symposium will focus on the clinical aspects of lung cancer screening, requirements of a screening registry for systematically capturing and tracking screening patients and results (such as required Medicare data elements) as well as the role of the medical physicist in screening programs, including the development of low dose CT screening protocols. Learning Objectives: To understand the clinical basis and clinical components of a lung cancer screening program, including eligibility criteria and other requirements. To understand the data collection requirements, workflow, and informatics infrastructure needed to support the tracking and reporting components of a screening program. To understand the role of the medical physicist in

  9. [Clinical and genetic background of familial myelodysplasia and acute myeloid leukemia].

    Science.gov (United States)

    Király, Péter Attila; Kállay, Krisztián; Marosvári, Dóra; Benyó, Gábor; Szőke, Anita; Csomor, Judit; Bödör, Csaba

    2016-02-21

    Myelodysplastic syndrome and acute myeloid leukaemia are mainly sporadic diseases, however, rare familial cases exist. These disorders are considered rare, but are likely to be more common than currently appreciated, and are characterized by the autosomal dominant mutations of hematopoietic transcription factors. These syndromes have typical phenotypic features and are associated with an increased risk for developing overt malignancy. Currently, four recognized syndromes could be separated: familial acute myeloid leukemia with mutated CEBPA, familial myelodysplastic syndrome/acute myeloid leukemia with mutated GATA2, familial platelet disorder with propensity to myeloid malignancy with RUNX1 mutations, and telomere biology disorders due to mutations of TERC or TERT. Furthermore, there are new, emerging syndromes associated with germline mutations in novel genes including ANKRD26, ETV6, SRP72 or DDX41. This review will discuss the current understanding of the genetic basis and clinical presentation of familial leukemia and myelodysplasia.

  10. [Percutaneous interventions in an open MR system: technical background and clinical indications].

    Science.gov (United States)

    Fischbach, F; Fischbach, K; Ricke, J

    2013-11-01

    The latest and therefore more efficient open magnetic resonance (MR) scanners with a field strength of 1 T allow freehand fluoroscopic interventions with excellent image quality. Specifically designed interactive software simplifies examination planning and performance. Guidance in two imaging planes allows fast and accurate device positioning and interventional procedures during free breathing. The diagnostic and therapeutic spectrum includes a wide variety of interstitial percutaneous interventions. The most important are periradicular therapy (PRT), intra-abdominal drainage and nephrostoma placement, biopsies, especially in the breasts and liver and focal ablation therapy of malignant hepatic or renal lesions. As the approach is fast and robotic devices are not needed the method is increasingly being carried out in the clinical routine. A drawback of MR-guided interventions is the limitation in verbal communication during image acquisition. Furthermore, the portfolio of MR compatible instruments needs to be extended.

  11. Theoretical and practical considerations for teaching diagnostic electronic-nose technologies to clinical laboratory technicians

    Science.gov (United States)

    Alphus D. Wilson

    2012-01-01

    The rapid development of new electronic technologies and instruments, utilized to perform many current clinical operations in the biomedical field, is changing the way medical health care is delivered to patients. The majority of test results from laboratory analyses, performed with these analytical instruments often prior to clinical examinations, are frequently used...

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

    Directory of Open Access Journals (Sweden)

    Parkinson David R

    2012-07-01

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

  13. Lead - nutritional considerations

    Science.gov (United States)

    Lead poisoning - nutritional considerations; Toxic metal - nutritional considerations ... Markowitz M. Lead poisoning. In: Kliegman RM, Behrman RE, Jenson HB, ... Emergency Medicine: Concepts and Clinical Practice . 8th ed. ...

  14. Diagnostic Consideration for Sinonasal Wegener’s Granulomatosis Clinically Mistaken for Carcinoma

    Directory of Open Access Journals (Sweden)

    Cristina La Rosa

    2013-01-01

    Full Text Available We report a case of Wegener’s granulomatosis clinically mistaken for carcinoma in a 21-year-old girl presenting with an ulcerated mass of the nasopharynx associated with enlarged laterocervical nodes. The lesion was clinically suspected as malignant on the basis of clinical and radiological findings (namely, computed tomography scan and positron emission tomography. However, multiple biopsies were not conclusive for malignancy showing histological change suggestive of Wegener’s granulomatosis. A serum determination of cANCA supported the diagnosis of Wegener’s granulomatosis. Clinical findings and image studies suggested an erroneous diagnosis of malignancy whereas a definitive diagnosis of Wegener’s granulomatosis was achieved only after repeated biopsies thus leading to a correct therapeutic approach. The Wegener granulomatosis must be added to the list of the differential diagnoses of the masses of the nasopharynx associated with or without enlarged laterocervical nodes.

  15. [Consideration of the Work Content of the Clinic Pharmacist and Its Usefulness].

    Science.gov (United States)

    Imajo, Hirofumi; Imai, Kazutaka; Hisajima, Kazuhiro; Kishimoto, Masato; Sekiya, Kyosuke; Kagawa, Yoshihiko; Talman-Teramoto, Honami; Soga, Yukihiro; Yasukawa, Keigo; Hirohara, Masayoshi; Kushida, Kazuki

    2016-12-01

    "Medical teams"have been promoted in the home care setting. For the pharmacist, it is possible to maintain the safety and improve the quality of medical care by working with a multidisciplinary team. The arrangement of the pharmacist with the clinic is specified in Article 18 of the Medical Care Law, but there is no medical treatment fee for the clinic pharmacist. We examined the work content and usefulness of the clinic pharmacist. The work content was to participate in visiting consultation, introduce pharmacotherapy management based on the clinic pharmacist's working protocol, propose prescriptions, provide drug information service, and cooperate with insurance pharmacy pharmacists. Because the pharmacist was working in the clinic, he or she was able to actively intervene in drug treatment. Intervention in medication requires organizing and gathering information, which is difficult in the position of the insurance pharmacy pharmacist. The fact that the clinic pharmacist assumes this role and works with insurance pharmacy pharmacists makes it possible to maintain the safety and improve the quality of medical care.

  16. Neck Rhabdoid Tumors: Clinical Features and Consideration of Autologous Stem Cell Transplant.

    Science.gov (United States)

    Wolfe, Adam D; Capitini, Christian M; Salamat, Shahriar M; DeSantes, Kenneth; Bradley, Kristin A; Kennedy, Tabassum; Dehner, Louis P; Patel, Neha J

    2017-04-03

    Extrarenal malignant rhabdoid tumors (MRT) have a poor prognosis despite aggressive therapy. Adding high-dose chemotherapy with autologous stem cell rescue (HDC-ASCR) as consolidative therapy for MRT is controversial. We describe 2 patients, age 13 years and 19 months, with unresectable neck MRT. After chemotherapy and radiotherapy, both underwent HDC-ASCR and remain in remission over 4 years later. We reviewed all published cases of neck MRT, and found poorer outcomes and more variable age of presentation and time to progression than MRT at other sites. Neck MRT may represent a higher-risk subset of MRT, and addition of HDC-ASCR merits consideration.

  17. Automated Disambiguation of Acronyms and Abbreviations in Clinical Texts: Window and Training Size Considerations

    Science.gov (United States)

    Moon, Sungrim; Pakhomov, Serguei; Melton, Genevieve B.

    2012-01-01

    Acronyms and abbreviations within electronic clinical texts are widespread and often associated with multiple senses. Automated acronym sense disambiguation (WSD), a task of assigning the context-appropriate sense to ambiguous clinical acronyms and abbreviations, represents an active problem for medical natural language processing (NLP) systems. In this paper, fifty clinical acronyms and abbreviations with 500 samples each were studied using supervised machine-learning techniques (Support Vector Machines (SVM), Naïve Bayes (NB), and Decision Trees (DT)) to optimize the window size and orientation and determine the minimum training sample size needed for optimal performance. Our analysis of window size and orientation showed best performance using a larger left-sided and smaller right-sided window. To achieve an accuracy of over 90%, the minimum required training sample size was approximately 125 samples for SVM classifiers with inverted cross-validation. These findings support future work in clinical acronym and abbreviation WSD and require validation with other clinical texts. PMID:23304410

  18. Training-Based Interventions in Motor Rehabilitation after Stroke: Theoretical and Clinical Considerations

    Directory of Open Access Journals (Sweden)

    Annette Sterr

    2004-01-01

    Full Text Available Basic neuroscience research on brain plasticity, motor learning and recovery has stimulated new concepts in neurological rehabilitation. Combined with the development of set methodological standards in clinical outcome research, these findings have led to a double-paradigm shift in motor rehabilitation: (a the move towards evidence-based procedures for the assessment of clinical outcome & the employment of disablement models to anchor outcome parameters, and (b the introduction of practice-based concepts that are derived from testable models that specify treatment mechanisms. In this context, constraint-induced movement therapy (CIT has played a catalytic role in taking motor rehabilitation forward into the scientific arena. As a theoretically founded and hypothesis-driven intervention, CIT research focuses on two main issues. The first issue is the assessment of long-term clinical benefits in an increasing range of patient groups, and the second issue is the investigation of neuronal and behavioural treatment mechanisms and their interactive contribution to treatment success. These studies are mainly conducted in the research environment and will eventually lead to increased treatment benefits for patients in standard health care. However, gradual but presumably more immediate benefits for patients may be achieved by introducing and testing derivates of the CIT concept that are more compatible with current clinical practice. Here, we summarize the theoretical and empirical issues related to the translation of research-based CIT work into the clinical context of standard health care.

  19. Considerations for clinical read alignment and mutational profiling using next-generation sequencing

    Directory of Open Access Journals (Sweden)

    Gavin R Oliver

    2012-07-01

    Full Text Available Next-generation sequencing technologies are increasingly being applied in clinical settings, however the data are characterized by a range of platform-specific artifacts making downstream analysis problematic and error prone. One major application of NGS is in the profiling of clinically relevant mutations whereby sequences are aligned to a reference genome and potential mutations assessed and scored. Accurate sequence alignment is pivotal in reliable assessment of potential mutations however selection of appropriate alignment tools is a non-trivial task complicated by the availability of multiple solutions each with its own performance characteristics. Using BRCA1 as an example, we have simulated and mutated a test dataset based on Illumina sequencing technology. Our findings reveal key differences in the performances of a range of common commercial and open source tools and will be of importance to anyone using NGS to profile mutations in clinical or basic research.

  20. Sham neurosurgical procedures in clinical trials for neurodegenerative diseases: scientific and ethical considerations.

    Science.gov (United States)

    Galpern, Wendy R; Corrigan-Curay, Jacqueline; Lang, Anthony E; Kahn, Jeffrey; Tagle, Danilo; Barker, Roger A; Freeman, Thomas B; Goetz, Christopher G; Kieburtz, Karl; Kim, Scott Y H; Piantadosi, Steven; Comstock Rick, Amy; Federoff, Howard J

    2012-07-01

    There have been several recent scientific advances in gene-based and cell-based therapies that might translate into novel therapeutic approaches for neurodegenerative disorders. Such therapies might need to be directly delivered into the CNS, and complex scientific and ethical assessment will be needed to determine whether a sham neurosurgical arm should be included in clinical trials assessing these agents. We have developed a framework of points for investigators to consider when designing trials that involve direct delivery of a therapeutic agent to the CNS. The inclusion of a sham neurosurgical arm will be guided in part by the objectives of the clinical study (preliminary safety, optimisation, and feasibility vs preliminary efficacy vs confirmatory efficacy) and the need to minimise bias and confounds. Throughout the clinical development process, the perspectives of researchers, ethicists, and patients must be considered, and risks should be minimised whenever possible in a manner that is consistent with good trial design.

  1. Mindfulness-based stress reduction for comorbid anxiety and depression: case report and clinical considerations.

    Science.gov (United States)

    Hazlett-Stevens, Holly

    2012-11-01

    Growing research literature has documented the effectiveness of mindfulness-based interventions for anxiety and depressive disorders. Mindfulness-based stress reduction (MBSR) teaches a series of mindfulness meditation and yoga practices, delivered in a group format during eight weekly sessions plus one full-day session. This case report demonstrates how MBSR was associated with dramatic clinical improvement of an individual with symptoms of panic, generalized anxiety, and depression. Scores on clinical assessment measures suggested clinically severe levels of anxious arousal, generalized anxiety, worry, fear of negative evaluation, and depression at the beginning of the intervention. The scores on all these measures fell well within normal limits 7 weeks later at the end of the intervention, and no remaining symptoms were reported afterward. Increased life satisfaction and quality of life were documented as well. This case illustrates the potential benefit of MBSR as an alternative or adjunctive treatment for comorbid anxiety and depressive disorder symptoms.

  2. Cumulative clinical experience with use of insulin lispro: critical appraisal, role in therapy, and patient considerations

    Directory of Open Access Journals (Sweden)

    Uy J

    2012-01-01

    Full Text Available J Uy, L Fogelfeld, Y GuerraDivision of Endocrinology, Diabetes and Metabolism, John H Stroger Jr Hospital of Cook County, Chicago; Department of Endocrinology, Diabetes and Metabolism, Rush University Hospital, Chicago, IL, USAAbstract: We have now at our disposal the new rapid-acting insulin analogs, of which insulin lispro was the first to become commercially available. While the differences in pharmacokinetic and pharmacodynamic characteristics are indisputable, the clinical benefits attained by these changes have not been as clear. In the present review, we discuss the structure, pharmacology, and landmark studies related to insulin lispro. The clinical characteristics of insulin lispro are compared with those of insulin regular and other insulin analogs in different clinical situations. Also included are the aspects of quality of life and cost-effectiveness that may modify the modern practitioner's decision to adopt one type of insulin over another.Keywords: insulin lispro, rapid-acting, insulin, analog

  3. [Clinical and diagnostic considerations on degenerative spino-cerebellar diseases. A clinical and instrumental description of 2 cases].

    Science.gov (United States)

    Trebini, F; Appiotti, A; Scarzella, G

    1990-11-01

    Two cases of spino-cerebellar heredoataxia are reported. The first patient, aged 18, presented the clinical peculiarities of Friedreich's disease; subjected to encephalic CT and encephalomedullary NMR the proved normal; EMG study and visual, acoustic and somatosensorial evoked potentials were not normal but there was nothing specifically wrong. The second patient, aged 30, followed up for more than 10 years, presented the clinical aspects of Pierre Marie disease; stress is laid on encephalic CT examinations carried out at the age of 20 and 30. These were pathological due to the marked dilatation of the IVth ventricle and the basal cisternae; evoked potential changes were aspecific. The nosography is discussed, especially as regards clinical diagnosis, in the absence of typical neuroradiological or other instrumental aspects and, obviously, in the absence of anatomopathological signs.

  4. Developing students' time management skills in clinical settings: practical considerations for busy nursing staff.

    Science.gov (United States)

    Cleary, Michelle; Horsfall, Jan

    2011-06-01

    In clinical settings, nursing staff often find themselves responsible for students who have varying time management skills. Nurses need to respond sensitively and appropriately, and to teach nursing students how to prioritize and better allocate time. This is important not only for developing students' clinical skills but also for shaping their perceptions about the quality of the placement and their willingness to consider it as a potential work specialty. In this column, some simple, practical strategies that nurses can use to assist students with improving their time management skills are identified.

  5. Clinical Considerations on the Root Coverage of Gingival Recessions in Thin or Thick Biotype.

    Science.gov (United States)

    Kahn, Sergio; Almeida, Renato Alves da Rocha; Dias, Alexandra Tavares; Rodrigues, Walmir Júnior; Barceleiro, Marcos Oliveira; Taba, Mario

    2016-01-01

    Gingival biotype is a clinical term used to describe the thickness of the gingiva. It has been classified as being thick or thin and may be related to the clinical outcome of root coverage procedures. This study evaluated the impact of gingival biotype on the clinical outcome of root coverage procedures following subepithelial connective tissue graft plus coronally positioned flap. A total of 19 patients, 10 with thin and 9 with thick gingival biotype, were treated for localized Miller Class I or II gingival recessions. After 6 months, 14 patients achieved complete root coverage, 7 from each group. The overall mean pooled root coverage rate was 90.93%. The thin biotype cases yielded a reduced mean root coverage of 88.51% compared with 93.63% for patients who had the thick biotype classification. Although the thin gingival biotype may impair the clinical outcome of root coverage procedures, this limitation does not appear to have a strong influence on the success of the root coverage therapy when subepithelial connective tissue graft was associated with the coronal positioning of the flap.

  6. Alemtuzumab in the treatment of multiple sclerosis: key clinical trial results and considerations for use.

    Science.gov (United States)

    Havrdova, Eva; Horakova, Dana; Kovarova, Ivana

    2015-01-01

    Alemtuzumab is a humanized monoclonal antibody therapy that has recently been approved in over 30 countries for patients with active relapsing-remitting multiple sclerosis. It acts by targeting CD52, an antigen primarily expressed on T and B lymphocytes, resulting in their depletion and subsequent repopulation. The alemtuzumab clinical development program used an active comparator, subcutaneous interferon beta-1a, to show that alemtuzumab is a highly efficacious disease-modifying therapy, with benefits on relapses, disability outcomes, and freedom from clinical disease and magnetic resonance imaging activity. The safety profile was consistent across studies and no new safety signals have emerged during follow-up in the extension study. Infusion-associated reactions are common with alemtuzumab, but rarely serious. Infection incidence was elevated with alemtuzumab in clinical studies; most infections were mild or moderate in severity. Autoimmune adverse events occurred in approximately a third of patients, manifesting mainly as thyroid disorders, and less frequently as immune thrombocytopenia or nephropathy. A comprehensive monitoring program lasting at least 4 years after the last alemtuzumab dose allows early detection and effective management of autoimmune adverse events. Further experience with alemtuzumab in the clinic will provide needed long-term data.

  7. Antibiotic use in acne vulgaris and rosacea: clinical considerations and resistance issues of significance to dermatologists.

    Science.gov (United States)

    Del Rosso, James Q; Leyden, James J; Thiboutot, Diane; Webster, Guy F

    2008-08-01

    Antibiotics are commonly prescribed in dermatology practice for a variety of disorders, including acne vulgaris and rosacea. Importantly, they often are used long-term for these inflammatory dermatoses. Changes in bacterial ecology related to antibiotic prescribing have led to the decreased sensitivity of some bacterial organisms, such as Propionibacterium acnes, to antibiotics commonly prescribed by dermatologists. The potential clinical outcomes of altered bacterial sensitivities may vary among specific disease states and include decreased therapeutic response and the need to alter approaches in disease management. Additionally, changing patterns of antibiotic sensitivity and the emergence of more virulent pathogens, such as community-acquired methicillin-resistant Staphylococcus aureus, macrolide-resistant staphylococci and streptococci, and mupirocin-resistant S aureus, have led to marked changes in how clinicians use antibiotics in clinical practice. This article reviews antibiotic prescribing in dermatology practice and provides important clinical perspectives and recommendations to preserve the therapeutic value of antibiotics based on a thorough review of current literature and clinical experience.

  8. Pertuzumab in human epidermal growth-factor receptor 2-positive breast cancer: clinical and economic considerations

    Directory of Open Access Journals (Sweden)

    Lamond NW

    2014-05-01

    Full Text Available Nathan WD Lamond, Tallal YounisDepartment of Medicine, Dalhousie University at the Queen Elizabeth II Health Sciences Centre, Halifax, NS, CanadaAbstract: In the absence of specific therapy, the 15%–20% of breast cancers demonstrating human epidermal growth-factor receptor 2 (HER2 protein overexpression and/or gene amplification are characterized by a more aggressive phenotype and poorer prognosis compared to their HER2-negative counterparts. Trastuzumab (Herceptin, the first anti-HER2-targeted therapy, has been associated with improved survival outcomes in HER2-positive breast cancer. However, many patients with early stage disease continue to relapse, and metastatic disease remains incurable. In order to further improve these outcomes, several novel HER2-targeted agents have recently been developed. Pertuzumab (Perjeta, a monoclonal antibody against the HER2 dimerization domain, has also been associated with improved patient outcomes in clinical trials, and has recently been approved in combination with chemotherapy and trastuzumab for neoadjuvant therapy of early stage, HER2-positive breast cancer and first-line treatment of metastatic disease. This review briefly summarizes pertuzumab's clinical development as well as the published evidence supporting its use, and highlights some of the currently unanswered questions that will influence pertuzumab’s incorporation into clinical practice.Keywords: HER2/neu, clinical trials, drug development, novel therapies, targeted anticancer therapy

  9. Serving transgender people: clinical care considerations and service delivery models in transgender health.

    Science.gov (United States)

    Wylie, Kevan; Knudson, Gail; Khan, Sharful Islam; Bonierbale, Mireille; Watanyusakul, Suporn; Baral, Stefan

    2016-07-23

    The World Professional Association for Transgender Health (WPATH) standards of care for transsexual, transgender, and gender non-conforming people (version 7) represent international normative standards for clinical care for these populations. Standards for optimal individual clinical care are consistent around the world, although the implementation of services for transgender populations will depend on health system infrastructure and sociocultural contexts. Some clinical services for transgender people, including gender-affirming surgery, are best delivered in the context of more specialised facilities; however, the majority of health-care needs can be delivered by a primary care practitioner. Across high-income and low-income settings alike, there often remains a dearth of educational programming for health-care professionals in transgender health, although the best evidence supports introducing modules on transgender health early during clinical education of clinicians and allied health professionals. While these challenges remain, we review the increasing evidence and examples of the defined roles of the mental health professional in transgender health-care decisions, effective models of health service provision, and available surgical interventions for transgender people.

  10. Beyond research: a primer for considerations on using viral metagenomics in the field and clinic

    NARCIS (Netherlands)

    Hall, Richard J; Draper, Jenny L; Nielsen, Fiona G G; Dutilh, Bas E

    2015-01-01

    Powered by recent advances in next-generation sequencing technologies, metagenomics has already unveiled vast microbial biodiversity in a range of environments, and is increasingly being applied in clinics for difficult-to-diagnose cases. It can be tempting to suggest that metagenomics could be used

  11. Ruby laser for treatment of tattoos: technical considerations affecting clinical use

    Science.gov (United States)

    Grove, Robert E.

    1990-06-01

    Recent clinical research on the use of ruby lasers for the treatment of tattoos and FIlk approval of a commercial system have renewed interest in this device. In this paper the principles of Q-switched ruby laser operation are reviewed, and potential sources of error in the estimation of delivered fluence are discussed.

  12. Clinical photography in dermatology: ethical and medico-legal considerations in the age of digital and smartphone technology.

    Science.gov (United States)

    Kunde, Lauren; McMeniman, Erin; Parker, Malcolm

    2013-08-01

    Clinical photography has long been an important aspect in the management of dermatological pathology and has many applications in contemporary dermatology practice. With the continuous evolution of digital and smartphone technology, clinicians must maintain ethical and medico-legal standards. This article reviews how dermatology trainees are utilising this technology in their clinical practice and what procedures they follow when taking photos of patients. We review the ethical and legal considerations of clinical photography in dermatology and present a hypothetical medico-legal scenario. Dermatology registrars were surveyed on their use of personal smartphones and digital equipment for photographing patients in their clinical practice. Numerous medico-legal providers were approached to provide medico-legal advice about a hypothetical scenario. We found that the use of these technologies is prevalent among dermatology registrars and all respondents reported regular use. Clinicians should routinely obtain and document adequate patient consent in relation to clinical photography, utilise strict privacy settings on smartphones and other digital devices and ensure that the images are stored on these devices for minimal periods. Express consent documentation in the clinical file puts the clinician in a more defensible position if a complaint is made to the medical board or privacy commissioner. © 2013 The Authors. Australasian Journal of Dermatology © 2013 The Australasian College of Dermatologists.

  13. The Effects of Music Intervention on Background Pain and Anxiety in Burn Patients: Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Najafi Ghezeljeh, Tahereh; Mohades Ardebili, Fatimah; Rafii, Forough; Haghani, Hamid

    2016-01-01

    This study aimed to investigate the effect of music on the background pain, anxiety, and relaxation levels in burn patients. In this pretest-posttest randomized controlled clinical trial, 100 hospitalized burn patients were selected through convenience sampling. Subjects randomly assigned to music and control groups. Data related to demographic and clinical characteristics, analgesics, and physiologic measures were collected by researcher-made tools. Visual analog scale was used to determine pain, anxiety, and relaxation levels before and after the intervention in 3 consecutive days. Patients' preferred music was offered once a day for 3 days. The control group only received routine care. Data were analyzed using SPSS-PC (V. 20.0). According to paired t-test, there were significant differences between mean scores of pain (P music group. Independent t-test indicated a significant difference between the mean scores of changes in pain, anxiety, and relaxation levels before and after intervention in music and control groups (P music intervention. Music is an inexpensive, appropriate, and safe intervention for applying to burn patients with background pain and anxiety at rest. To produce more effective comfort for patients, it is necessary to compare different types and time lengths of music intervention to find the best approach.

  14. Ethical and clinical practice considerations for genetic counselors related to direct-to-consumer marketing of genetic tests.

    Science.gov (United States)

    Wade, Christopher H; Wilfond, Benjamin S

    2006-11-15

    Several companies utilize direct-to-consumer (DTC) advertising for genetic tests and some, but not all, bypass clinician involvement by offering DTC purchase of the tests. This article examines how DTC marketing strategies may affect genetic counselors, using available cardiovascular disease susceptibility tests as an illustration. The interpretation of these tests is complex and includes consideration of clinical validity and utility, and the further complications of gene-environment interactions and pleiotropy. Although it is unclear to what extent genetic counselors will encounter clients who have been exposed to DTC marketing strategies, these strategies may influence genetic counseling interactions if they produce directed interest in specific tests and unrealistic expectations for the tests' capacity to predict disease. Often, a client's concern about risk for cardiovascular diseases is best addressed by established clinical tests and a family history assessment. Ethical dilemmas may arise for genetic counselors who consider whether to accept clients who request test interpretation or to order DTC-advertised tests that require a clinician's authorization. Genetic counselors' obligations to care for clients extend to interpreting DTC tests, although this obligation may be fulfilled by referral or consultation with specialists. Genetic counselors do not have an obligation to order DTC-advertised tests that have minimal clinical validity and utility at a client's request. This can be a justified restriction on autonomy based on consideration of risks to the client, the costs, and the implications for society.

  15. Best practices for single-laboratory validation of chemical methods for trace elements in foods. Part I--background and general considerations.

    Science.gov (United States)

    Murphy, Cory J; MacNeil, James D; Capar, Stephen G

    2013-01-01

    The metals subgroup of AOAC INTERNATIONAL's Community on Chemical Contaminants and Residues in Food has been engaged for the past several years in discussions concerning the requirements for the single-laboratory validation (SLV) of methods for the determination of trace elements in foods. This paper reviews the general guidance currently available related to validation of chemical analytical methods and current typical validation practices found in publications on the analysis of elements in food and other matrixes, such as environmental and clinical samples. Based on the available guidance on SLV requirements and a review of current practices in elemental analysis, a general approach based on best practices is proposed for SLV of a method for elements in food to demonstrate the method as "fit-for-purpose."

  16. Practice and considerations of teaching reform of integrated nervous system course for the clinical medicine program

    Institute of Scientific and Technical Information of China (English)

    Juan LI; Liang ZHU; Feng LI; Wen-long DING

    2015-01-01

    Basic Medicine Faculty of Shanghai Jiao Tong University organically integrates basic medicine courses relevant to the central nervous system(including anatomy,physiology,pathology,and pharmacology)and clinical medicine courses(including imaging and diagnostics)into the nervous system module according to course arrangement of domestic and abroad medical schools and has offered to students of eight-year clinical medicine program since 2009.This paper summarizes experiences of the teaching team of nervous system course in nearly six years,explores the development and optimization of the integrated nervous system course from perspectives of arrangement of teaching contents,development of the teaching team,reform of teaching models,and optimization of teaching resources,and considers existing problems and countermeasures during the course development,so as to provide strategic guidance for further optimization and perfection of the integrated nervous system course.

  17. SPECIAL CONSIDERATIONS REGARDING WARFARIN DOSE TITRATION IN PATIENTS WITH ATRIAL FIBRILLATION DEPENDING ON CLINICAL FACTORS

    Directory of Open Access Journals (Sweden)

    E. L. Artanova

    2011-01-01

    Full Text Available Aim. To study the relations of clinical characteristics and individual warfarin dose titration in patients with atrial fibrillation. Material and methods. Period of warfarin dose titration was analyzed in 68 patients with atrial fibrillation due to ischemic heart disease. Adjusted warfarin dose in milligram, duration of dose titration in days and maximal international normalized ratio (INR were taken into account. Sex, age, history of myocardial infarction and stroke, concomitant diseases, amiodarone therapy were considered among clinical characteristics. Results. Adjusted warfarin dose was significantly higher in obesity , and it was lower in case of experienced myocardial infarction. The INR highest levels and maximal amplitudes of its fluctuations were observed in patients with thyroid gland nodes and smokers. Period of warfarin dose titration was longer in patients treated with amiodarone. Conclusion. Warfarin dose titration in patients with atrial fibrillation depends on the presence of myocardial infarction, obesity , thyroid nodular changes, smoking and amiodarone treatment.

  18. Apogeotropic Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo: Some Clinical and Therapeutic Considerations

    Science.gov (United States)

    Vannucchi, Paolo; Pecci, Rudi; Giannoni, Beatrice; Di Giustino, Fabio; Santimone, Rossana; Mengucci, Arianna

    2015-01-01

    We lately reported the cases of patients complaining positional vertigo whose nystagmic pattern was that of a peripheral torsional vertical positional down beating nystagmus originating from a lithiasis of the non-ampullary arm of the posterior semicircular canal (PSC). We considered this particular pathological picture the apogeotropic variant of PSC benign paroxysmal positional vertigo (BPPV). Since the description of the pilot cases we observed more than 150 patients showing the same clinical sign and course of symptoms. In this paper we describe, in detail, both nystagmus of apogeotropic PSC BPPV (A-PSC BPPV) and symptoms reported by patients trying to give a reasonable explanation for these clinical features. Moreover we developed two specific physical therapies directed to cure A-PSC BPPV. Preliminary results of these techniques are related. PMID:26557364

  19. Apogeotropic posterior semicircular canal benign paroxysmal positional vertigo: some clinical and therapeutic considerations

    Directory of Open Access Journals (Sweden)

    Paolo Vannucchi

    2015-03-01

    Full Text Available We lately reported the cases of patients complaining positional vertigo whose nystagmic pattern was that of a peripheral torsional vertical positional down beating nystagmus originating from a lithiasis of the non-ampullary arm of the posterior semicircular canal (PSC. We considered this particular pathological picture the apogeotropic variant of PSC benign paroxysmal positional vertigo (BPPV. Since the description of the pilot cases we observed more than 150 patients showing the same clinical sign and course of symptoms. In this paper we describe, in detail, both nystagmus of apogeotropic PSC BPPV (A-PSC BPPV and symptoms reported by patients trying to give a reasonable explanation for these clinical features. Moreover we developed two specific physical therapies directed to cure A-PSC BPPV. Preliminary results of these techniques are related.

  20. Clinical utility of risedronate in postmenopausal osteoporosis: patient considerations with delayed-release formulation

    Directory of Open Access Journals (Sweden)

    Boyanov M

    2012-04-01

    Full Text Available Plamen Kinov1, Mihail Boyanov21Department of Orthopedics and Traumatology, University Hospital Queen Giovanna – ISUL, 2Department of Internal Medicine, Clinic of Endocrinology, University Hospital Alexandrovska, Medical University of Sofia, Sofia, BulgariaAbstract: Bisphosphonates are the most widely prescribed treatment for postmenopausal osteoporosis, secondary osteoporosis, and male osteoporosis. Notwithstanding their high effectiveness and favorable safety profile, the adherence to bisphosphonate treatment remains low. Different treatment strategies aim to improve the clinical effectiveness of bisphosphonate therapy. This review paper assesses the clinical utility of oral intermittent risedronate in the treatment of postmenopausal osteoporosis. The new delayed-release risedronate formulation is a safer and easy to use alternative to other risedronate therapy. Oral risedronate, a potent nitrogen-containing bisphosphonate, has been extensively studied using daily regimens. A new intermittent (weekly dosing regimen confirmed its clinical effectiveness in relation to vertebral and nonvertebral fracture prevention. The absence of significant differences in the incidence of adverse effects confirmed the favorable tolerability of the weekly dosage. In efforts to improve patient adherence to treatment, an innovative, delayed-release formulation of risedronate, which ensures adequate bioavailability of the active compound when taken with food, was introduced. The once-weekly delayed-release formulation of risedronate proved to be noninferior to the daily dosage of risedronate in terms of bone mineral density and markers of bone turnover. In addition, the incidence of new morphometric vertebral fractures was comparable in both treatment regimens. The new delayed-release formulation of risedronate showed a favorable safety profile. Delayed-release risedronate is a promising, new, effective, and convenient alternative to current bisphosphonate

  1. Invited review: study design considerations for clinical research in veterinary radiology and radiation oncology.

    Science.gov (United States)

    Scrivani, Peter V; Erb, Hollis N

    2013-01-01

    High quality clinical research is essential for advancing knowledge in the areas of veterinary radiology and radiation oncology. Types of clinical research studies may include experimental studies, method-comparison studies, and patient-based studies. Experimental studies explore issues relative to pathophysiology, patient safety, and treatment efficacy. Method-comparison studies evaluate agreement between techniques or between observers. Patient-based studies investigate naturally acquired disease and focus on questions asked in clinical practice that relate to individuals or populations (e.g., risk, accuracy, or prognosis). Careful preplanning and study design are essential in order to achieve valid results. A key point to planning studies is ensuring that the design is tailored to the study objectives. Good design includes a comprehensive literature review, asking suitable questions, selecting the proper sample population, collecting the appropriate data, performing the correct statistical analyses, and drawing conclusions supported by the available evidence. Most study designs are classified by whether they are experimental or observational, longitudinal or cross-sectional, and prospective or retrospective. Additional features (e.g., controlled, randomized, or blinded) may be described that address bias. Two related challenging aspects of study design are defining an important research question and selecting an appropriate sample population. The sample population should represent the target population as much as possible. Furthermore, when comparing groups, it is important that the groups are as alike to each other as possible except for the variables of interest. Medical images are well suited for clinical research because imaging signs are categorical or numerical variables that might be predictors or outcomes of diseases or treatments. © 2013 Veterinary Radiology & Ultrasound.

  2. An outbreak of horseshoe crab poisoning in Chon Buri, Thailand: clinical, toxicologic and therapeutic considerations.

    Science.gov (United States)

    Kanchanapongkul, J; Kungsuwan, A; Tantisiriwan, V; Punthawangkun, C; Krittayapoositpot, P

    1996-12-01

    In 1994-1996, an outbreak of horseshoe crab poisoning by eating toxic eggs of the horseshoe crab Carcinoscorpius rotundicauda affected over 100 persons in Chon Buri which located on the eastern coast of Thailand. We discuss clinical description and management of this first major outbreak. The responsible toxin has been partially purified by means of ultrafiltration and high performance liquid chromatography. The horseshoe crab toxin is identified as tetrodotoxin (TTX) and anhydro TTX.

  3. Amyotrophic lateral sclerosis and Alzheimer's disease--clinical and neuropathological considerations in two cases.

    Science.gov (United States)

    Rusina, R; Sheardová, K; Rektorová, I; Ridzon, P; Kulist'ák, P; Matej, R

    2007-07-01

    Amyotrophic lateral sclerosis (ALS) may be accompanied by cognitive impairment; when present, it is mainly in the form of frontotemporal impairment. We report on two cases with clinically defined ALS that subsequently developed dementia. Neuropathological examination showed not only the typical neuropathological hallmarks characteristic of ALS but, surprisingly, also showed neurofibrillary tangles and neuritic plaques in sufficient numbers to fulfill the diagnostic criteria of definite Alzheimer's disease.

  4. Research Biopsies in the Context of Early Phase Oncology Studies: Clinical and Ethical Considerations

    OpenAIRE

    Matilde Saggese; Divyanshu Dua; Emily Simmons; Charlotte Lemech; Hendrik-Tobias Arkenau

    2013-01-01

    The Personalized Medicine approach in oncology is a direct result of an improved understanding of complex tumor biology and advances in diagnostic technologies. In recent years, there has been an increased demand for archival and fresh tumor analysis in early clinical trials to foster proof-of-concept biomarker development, to understand resistance mechanisms, and ultimately to assess biological response. Although phase I studies are aimed at defining drug safety, pharmacokinetics, and to rec...

  5. Regulatory considerations in production of a cell therapy medicinal product in Europe to clinical research.

    Science.gov (United States)

    Martín, Patricia Gálvez; Martinez, Adolfina Ruiz; Lara, Visitación Gallardo; Naveros, Beatriz Clares

    2014-02-01

    The development of new drugs using stem cells has become a clinic alternative for the treatment of different diseases such as Alzheimer's, diabetes and myocardial infarction. Similar to conventional medicines, stem cells as new medicinal products for cell therapy are subjected to current legislation concerning their manufacture process. Besides, their legality is determined by the Regulatory Agencies belonging to the Member State of the European Union in which they are being registered. With the evolution of therapy that uses cells as medicines, there is a need to develop the appropriate legislative and regulatory framework capable of ensuring their safety and effectiveness. However, few works have been published regarding the regulations that these products must comply through production and commercialization processes. The present work is focused on the description of key events during clinical development and cell production of stem cells as drugs. Such as the regulations, requirements and directives involved in the production of cell therapy medicinal products, from the clinical design stage to its commercialization in Europe.

  6. Clinical and economic considerations of antiobesity treatment: a review of orlistat

    Directory of Open Access Journals (Sweden)

    Armineh Zohrabian

    2010-07-01

    Full Text Available Armineh ZohrabianDivision of Adult and Community Health, Centers for Disease Control and Prevention, Atlanta, GA, USAAbstract: The objective of this study was to review the current knowledge about the use of orlistat from clinical and economic perspectives, and to assess this drug’s public health impact. Weight reduction by current antiobesity drugs, compared to placebo, is at most around 5 kg. Orlistat, the most studied antiobesity drug, is associated with the least-severe adverse effects, but compared with other drugs in its class it also delivers the most modest weight loss versus placebo (less than 3 kg. Orlistat appears to have a favorable risk/benefit profile, and cost-effectiveness ratios seem to be within a range that is generally considered acceptable. In the short-term, orlistat is related to reduced diabetes incidence and to slightly improved blood pressure and lipid profiles. Long-term clinical effects have been largely unstudied, however, and this study did not find reports that considered mortality as an endpoint. Given a very low continuation with orlistat treatment in the population and very modest and, apparently, only short-term clinical effects, orlistat is not likely to have a significant impact on the population health. Public health approaches of improving environmental and social factors to foster healthier food choices and increase physical activity remain essential for addressing the obesity epidemic.Keywords: obesity, orlistat, weight loss, cost-effectiveness

  7. Drug-related disorders and the criminal and clinical background of the prison population of Sao Paulo State, Brazil.

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    Maíra Mendes dos Santos

    Full Text Available OBJECTIVE: To analyze the association between drug (DAD and alcohol (AAD abuse and dependency and criminal and clinical background by gender of prisoners in São Paulo, Brazil. METHOD: Cross-sectional study, random sample stratified by administrative district, from which prisons and prisoners were selected via random, multistage sampling. Psychiatric diagnoses were made with the CIDI 2.1. Lifetime prevalence and 95% CI were calculated and adjusted via analysis of complex samples. Multinomial logistic regression analysis was carried out with four categories of dependent variables: presence AAD; presence DAD; presence of another mental disorder; no mental disorders. For female alcohol and drug abuse and dependency (ADAD were combined into a single category. RESULTS: The sample was composed by 1809 interviewed prisoners (1192 men and 617 women. Prevalence of DAD and AAD was 25.2% and 15.6%, respectively, among female prisoners, and 26.5% and 18.5% among males. Male prisoners with DAD were more likely to have a criminal record as an adolescent (OR 2.17, to be a repeat offender (OR 2.85, and to have committed a property crime (OR 2.18. Prisoners with AAD were repeat offenders (OR 2.18. Among female prisoners, ADAD was associated with repeat offenses (OR 3.39, a criminal record as an adolescent (OR 9.24, a clinical or infectious condition (OR 5.09, another health problem (OR 3.04, and violent crime (OR 2.5. CONCLUSION: The study confirmed an association between drug-use disorders and the criminal and clinical background in the study population. Prisoners with such disorders were more likely to be repeat offenders and to have a criminal record as adolescents. Among female prisoners disorders were also associated with violent crime and health problems, while among males they were associated with property crime. These patterns in clinical and criminal backgrounds illustrate the need for social rehabilitation programs and specific medical treatment for

  8. Clinical and therapeutic considerations of rectal lymphoma: A case report and literature review

    Institute of Scientific and Technical Information of China (English)

    Yilmaz Bilsel; Emre Balik; Sumer Yamaner; Dursun Bugra

    2005-01-01

    Primary rectal lymphoma is a rare presentation of gastrointestinal lymphomas. Its clinical presentation is indistinguishable from that of rectal carcinoma. Although surgical resection is often technically feasible, optimal therapy for colorectal lymphoma has not yet been identified.We report a case of primary rectal lymphoma (nonHodgkin's large cell lymphoma of type B) with high-grade features that disappeared completely after chemoradiotherapy. This case underlines that primary treatment with systemic chemotherapy and involved-field radiotherapy can be successful for rectal lymphoma, with surgery reserved for complications and chemotherapy failures.

  9. Clinical, histopathological and therapeutic considerations in non-neoplastic abnormal uterine bleeding in menopause transition.

    Science.gov (United States)

    Corniţescu, F I; Tănase, Florentina; Simionescu, Cristiana; Iliescu, D

    2011-01-01

    With the decline of ovarian hormonal function, from the fifth decade of life, women enter the menopause transition, during which bleeding becomes irregular in duration and time of occurrence. Secondary to ovarian dysfunction, developmental and maturation endometrial anomalies occur, which are clinically translated by abnormal uterine bleeding, which in many cases at this age can be caused by organic lesions (fibroma, polyps, endometritis, endometrial hyperplasia, adenomyosis, etc.). The retrospective study included a total of 256 patients with abnormal uterine bleeding in menopause transition. Statistics showed that the incidence of these types of bleeding increases with age (64.5%) and parity (30.5%), with symptoms consisting mostly in different clinical forms of abnormal uterine bleeding (62.1%), and leiomyomas prevailing at histopathological examination (49.6%). Progesterone replacement therapy was the first therapeutic choice for correcting these types of bleeding. Progesterone therapy is useful not only for therapeutic purposes to amend the bleeding, but also as a precaution against the development of endometrial carcinoma. Progestogens cancel the proliferative and mitogenic effect of estrogens, even when administered in sequential regimen 10-12 days per month.

  10. Research design considerations for clinical studies of abuse-deterrent opioid analgesics: IMMPACT recommendations

    Science.gov (United States)

    Turk, Dennis C.; O’Connor, Alec B.; Dworkin, Robert H.; Chaudhry, Amina; Katz, Nathaniel P.; Adams, Edgar H.; Brownstein, John S.; Comer, Sandra D.; Dart, Richard; Dasgupta, Nabarun; Denisco, Richard A.; Klein, Michael; Leiderman, Deborah B.; Lubran, Robert; Rappaport, Bob A.; Zacny, James P.; Ahdieh, Harry; Burke, Laurie B.; Cowan, Penney; Jacobs, Petra; Malamut, Richard; Markman, John; Michna, Edward; Palmer, Pamela; Peirce-Sandner, Sarah; Potter, Jennifer S.; Raja, Srinivasa N.; Rauschkolb, Christine; Roland, Carl L.; Webster, Lynn R.; Weiss, Roger D.; Wolf, Kerry

    2013-01-01

    Opioids are essential to the management of pain in many patients, but they also are associated with potential risks for abuse, overdose, and diversion. A number of efforts have been devoted to the development of abuse-deterrent formulations of opioids to reduce these risks. This article summarizes a consensus meeting that was organized to propose recommendations for the types of clinical studies that can be used to assess the abuse deterrence of different opioid formulations. Due to the many types of individuals who may be exposed to opioids, an opioid formulation will need to be studied in several populations using various study designs in order to determine its abuse-deterrent capabilities. It is recommended that the research conducted to evaluate abuse deterrence should include studies assessing: (1) abuse liability; (2) the likelihood that opioid abusers will find methods to circumvent the deterrent properties of the formulation; (3) measures of misuse and abuse in randomized clinical trials involving pain patients with both low risk and high risk of abuse; and (4) post-marketing epidemiological studies. PMID:22770841

  11. Key feasibility considerations when conducting vaccine clinical trials in Asia–Pacific countries

    Directory of Open Access Journals (Sweden)

    Lansang EZ

    2013-03-01

    Full Text Available Elvira Zenaida Lansang,1 Kenneth Tan,2 Saumya Nayak,1 Ken J Lee,1 Karen Wai1 1Feasibility and Site Identification – Asia, Quintiles East Asia Pte Ltd, Singapore; 2National University of Singapore, Singapore Introduction: Conducting clinical trial feasibility is an important first step in initiating a clinical trial. A robust feasibility process ensures that a realistic capability assessment is made before conducting a trial. A retrospective analysis of vaccine clinical trials was performed to understand changes which could affect feasibility recommendations. Methods: Feasibilities conducted by Quintiles between January 2011 and August 2012 were reviewed. Vaccine studies only involving Asia–Pacific countries were selected, and common study parameters were identified. Information from Quintiles’ database was retrieved to examine changes in parameters over time. Results: A total of six vaccine studies were identified within the 1.7-year period. Two studies were excluded because they did not contain feasibility information or had involved sites that were sponsor selected. Four studies were analyzed. Three cases required healthy volunteers, while one case involved a specific patient population. Age requirement and seasonality of disease mainly influenced recommendations for Study 1. Sponsor’s marketing strategy influenced the recommendations for Study 2. Study 3 showed the effect of a country’s immunization program and reimbursement of vaccines on a study’s success. In contrast to the other studies, Study 4 demonstrated the impact of eligibility criteria in recruitment recommendations for a vaccine trial requiring specific patient pools. Conclusion: Feasibility recommendations for vaccine trials are largely based on (1 eligibility criteria; (2 cultural beliefs; (3 country’s past recruitment performance; (4 use of advertising; (5 site’s access to subject populations; (6 cooperation with local health professionals and government; (7

  12. [Clinical and therapeutical considerations regarding a rare case of pre-pyloric stenosis].

    Science.gov (United States)

    Sabetay, C; Zavate, A; Ciuca, M; Ciobanu, O; Malos, A

    2009-01-01

    The neonatal obstacle caused by a pre-pyloric diaphragm represent a rare cause of high oclusion in new-born. We present the case of a 6 days old new-born admitted in our department for nonbilious vomiting and feeding intolerance in which the clinical exam and the imagistic explorations (plain and contrast abdominal X-Rays, and ultrasound) could not reveal an evident cause for the oclusion. The surgical intervention imposed by the simptoms revealed the existece of a complete diaphragm in the prepyloric region. The initial excision of the diaphragm was not sufficient, the patient undergoing a second surgical intervention of gastrojejunal anastromosis with favorable evolution this time. The authors are presenting diagnosis and theraputical management peculiarities of this rare condition.

  13. Quagmires for clinical psychology and executive coaching? Ethical considerations and practice challenges.

    Science.gov (United States)

    Gebhardt, Judith Ann

    2016-04-01

    As the coaching field burgeons, both the mental health and coaching professionals, and their respective professions, face a myriad of potential quagmires, especially if the unique challenges encountered are ignored. After a short introduction and presentation on ethics and morals related to executive coaching and clinical therapy, a discussion follows on the lengthy and intimate relationship between executive coaching and psychology. Next are definitions and comparisons and 6 areas that are potential quagmires. This includes roles, skill sets/core competencies, education/training, licensing/credentialing-certification, governing bodies and confidentiality, and fees/reimbursement. Each section includes a discussion and several questions to highlight potentially problematic areas, practice challenges, and/or ethical issues, followed with brief responses. This paper concludes with the inquiry, "Where do we go from here?"

  14. Use of physical restraint in nursing homes: clinical-ethical considerations.

    Science.gov (United States)

    Gastmans, C; Milisen, K

    2006-03-01

    This article gives a brief overview of the state of the art concerning physical restraint use among older persons in nursing homes. Within this context we identify some essential values and norms that must be observed in an ethical evaluation of physical restraint. These values and norms provide the ethical foundation for a number of concrete recommendations that could give clinical and ethical support to caregivers when they make decisions about physical restraint. Respect for the autonomy and overall wellbeing of older persons, a proportional assessment of the advantages and disadvantages, a priority focus on the alternatives to physical restraint, individualised care, interdisciplinary decision making, and an institutional policy are the central points that make it possible to deal responsibly with the use of physical restraint for older persons in nursing homes.

  15. Endoscopic expand transnasal approach to the suprasellar region :anatomical study and clinical considerations

    Institute of Scientific and Technical Information of China (English)

    LU Xiao-jie; CHEN Kai-lai; WANG Qin; JI Wei-yang; LI Bing; SUN Ji-yong; LI Jiang-an

    2009-01-01

    Backgroud The expanded endonasal approach (EEA) is used sparingly by surgeons for resection of lesions in the ventrocranial base. Herein, we examined the anatomy of the ventrocranial base by endoscopy and comment on the use of EEA in clinical practice.Methods Twenty artery-injected adult cadaveric heads were studied under surgical conditions using the endoscopic EEA. The extent of the surgical exposure, the endoscopic anatomic view and the maneuverability of surgical instruments about the suprasellar region were studied by the endoscopic EEA.Results The EEA by endoscope can reach the suprasellar region. In this approach, the optocarotid recess, supra and infra-optic chiasm interspace, the ophthalmic artery and others were important anatomical landmarks for identification of the suprasellar region.Conclusions The endoscopic EEA can be used to remove many types of lesions in the ventrocranial base. The microanatorny observed using the endoscope provides important anatomical information on the suprasellar region for neurosurgeons.

  16. Perspectives for clinical measures of dynamic foot function-reference data and methodological considerations.

    Science.gov (United States)

    Rathleff, M S; Nielsen, R G; Simonsen, O; Olesen, C G; Kersting, U G

    2010-02-01

    Several studies have investigated if static posture assessments qualify to predict dynamic function of the foot showing diverse outcomes. However, it was suggested that dynamic measures may be better suited to predict foot-related overuse problems. The purpose of this study was to establish the reliability for dynamic measures of longitudinal arch angle (LAA) and navicular height (NH) and to examine to what extent static and dynamic measures thereof are related. Intra-rater reliability of LAA and NH measures was tested on a sample of 17 control subjects. Subsequently, 79 subjects were tested while walking on a treadmill. The ranges and minimum values for LAA and NH during ground contact were identified over 20 consecutive steps. A geometric error model was used to simulate effects of marker placement uncertainty and skin movement artifacts. Results demonstrated the highest reliability for the minimum NH (MinNH), followed by the minimum LAA (MinLAA), the dynamic range of navicular height (DeltaNH) and the range of LAA (DeltaLAA) while all measures were highly reliable. Marker location uncertainty and skin movement artifacts had the smallest effects on measures of NH. The use of an alignment device for marker placement was shown to reduce error ranges for NH measures. Therefore, DeltaNH and MinNH were recommended for functional dynamic foot characterization in the sagittal plane. There is potential for such measures to be a suitable predictor for overuse injuries while being obtainable in clinical settings. Future research needs to include such dynamic but simple foot assessments in large-scale clinical studies.

  17. Adrenal Disorders and the Paediatric Brain: Pathophysiological Considerations and Clinical Implications

    Directory of Open Access Journals (Sweden)

    Vincenzo Salpietro

    2014-01-01

    Full Text Available Various neurological and psychiatric manifestations have been recorded in children with adrenal disorders. Based on literature review and on personal case-studies and case-series we focused on the pathophysiological and clinical implications of glucocorticoid-related, mineralcorticoid-related, and catecholamine-related paediatric nervous system involvement. Childhood Cushing syndrome can be associated with long-lasting cognitive deficits and abnormal behaviour, even after resolution of the hypercortisolism. Exposure to excessive replacement of exogenous glucocorticoids in the paediatric age group (e.g., during treatments for adrenal insufficiency has been reported with neurological and magnetic resonance imaging (MRI abnormalities (e.g., delayed myelination and brain atrophy due to potential corticosteroid-related myelin damage in the developing brain and the possible impairment of limbic system ontogenesis. Idiopathic intracranial hypertension (IIH, a disorder of unclear pathophysiology characterised by increased cerebrospinal fluid (CSF pressure, has been described in children with hypercortisolism, adrenal insufficiency, and hyperaldosteronism, reflecting the potential underlying involvement of the adrenal-brain axis in the regulation of CSF pressure homeostasis. Arterial hypertension caused by paediatric adenomas or tumours of the adrenal cortex or medulla has been associated with various hypertension-related neurological manifestations. The development and maturation of the central nervous system (CNS through childhood is tightly regulated by intrinsic, paracrine, endocrine, and external modulators, and perturbations in any of these factors, including those related to adrenal hormone imbalance, could result in consequences that affect the structure and function of the paediatric brain. Animal experiments and clinical studies demonstrated that the developing (i.e., paediatric CNS seems to be particularly vulnerable to alterations induced by

  18. Progress with palbociclib in breast cancer: latest evidence and clinical considerations.

    Science.gov (United States)

    Rocca, Andrea; Schirone, Alessio; Maltoni, Roberta; Bravaccini, Sara; Cecconetto, Lorenzo; Farolfi, Alberto; Bronte, Giuseppe; Andreis, Daniele

    2017-02-01

    Deregulation of the cell cycle is a hallmark of cancer, and research on cell cycle control has allowed identification of potential targets for anticancer treatment. Palbociclib is a selective inhibitor of the cyclin-dependent kinases 4 and 6 (CDK4/6), which are involved, with their coregulatory partners cyclin D, in the G1-S transition. Inhibition of this step halts cell cycle progression in cells in which the involved pathway, including the retinoblastoma protein (Rb) and the E2F family of transcription factors, is functioning, although having been deregulated. Among breast cancers, those with functioning cyclin D-CDK4/6-Rb-E2F are mainly hormone-receptor (HR) positive, with some HER2-positive and rare triple-negative cases. Deregulation results from genetic or otherwise occurring hyperactivation of molecules subtending cell cycle progression, or inactivation of cell cycle inhibitors. Based on results of randomized clinical trials, palbociclib was granted accelerated approval by the US Food and Drug Administration (FDA) for use in combination with letrozole as initial endocrine-based therapy for metastatic disease in postmenopausal women with HR-positive, HER2-negative breast cancer, and was approved for use in combination with fulvestrant in women with HR-positive, HER2-negative advanced breast cancer with disease progression following endocrine therapy. This review provides an update of the available knowledge on the cell cycle and its regulation, on the alterations in cyclin D-CDK4/6-Rb-E2F axis in breast cancer and their roles in endocrine resistance, on the preclinical activity of CDK4/6 inhibitors in breast cancer, both as monotherapy and as partners of combinatorial synergic treatments, and on the clinical development of palbociclib in breast cancer.

  19. Focus on the Novel Cardiovascular Drug LZC696: from Evidence to Clinical Consideration.

    Science.gov (United States)

    Lin, L M; Wu, Y; Wu, M F; Lin, J X

    2016-12-01

    LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor (ARNI), is comprised of the angiotensin receptor blocker valsartan and the neprilysin inhibitor pro-drug sacubitril (AHU377). After oral administration, AHU377 is rapidly metabolized to the active neprilysin inhibitor LBQ657. LCZ696 exerts its effects of diuresis, natriuresis, vasodilation and aldosterone secretion inhibition through simultaneous renin-angiotensin-aldosterone system (RAAS) blockade and natriuretic peptides system (NPS) enhancement. Powerful evidence including PARAMETER and PRARDIGM-HF trials have shown that LCZ696 outperforms RAAS inhibition in treating patients with hypertension and heart failure with reduced ejection fraction (HFrEF), and is well tolerated. In addition, accumulating evidence also suggests its potential use in heart failure with preserved ejection fraction (HFpEF), chronic kidney disease (CKD), post-myocardium infarction (post-MI) and stroke. Both the FDA and CHMP have approved LCZ696 for treatment of HFrEF. Despite all this, some special issues (e.g. use in specific subgroups, adverse events, contraindications and cost-effectiveness analysis) should be considered before its implementation in clinical practice.

  20. Donor Selection for Allogenic Hemopoietic Stem Cell Transplantation: Clinical and Ethical Considerations

    Directory of Open Access Journals (Sweden)

    Irene Riezzo

    2017-01-01

    Full Text Available Allogenic hematopoietic progenitor cell transplantation (allo-HSCT is an established treatment for many diseases. Stem cells may be obtained from different sources: mobilized peripheral blood stem cells, bone marrow, and umbilical cord blood. The progress in transplantation procedures, the establishment of experienced transplant centres, and the creation of unrelated adult donor registries and cord blood banks gave those without an human leucocyte antigen- (HLA- identical sibling donor the opportunity to find a donor and cord blood units worldwide. HSCT imposes operative cautions so that the entire donation/transplantation procedure is safe for both donors and recipients; it carries with it significant clinical, moral, and ethical concerns, mostly when donors are minors. The following points have been stressed: the donation should be excluded when excessive risks for the donor are reasonable, donors must receive an accurate information regarding eventual adverse events and health burden for the donors themselves, a valid consent is required, and the recipient’s risks must be outweighed by the expected benefits. The issue of conflict of interest, when the same physician has the responsibility for both donor selection and recipient care, is highlighted as well as the need of an adequate insurance protection for all the parties involved.

  1. Clinical considerations and mechanistic determinants of postprandial lipemia in older adults.

    Science.gov (United States)

    Katsanos, Christos S

    2014-05-01

    The typical diet of individuals in Western societies results in metabolic responses associated with fed-state fat metabolism for most of the daily life of the individual. This fat metabolism is characterized specifically by an increase in the concentration of plasma lipids, primarily triglycerides. Increased postprandial lipemia, which is typically observed in older individuals (i.e., >65 y old), has now emerged as an important correlate of cardiovascular disease risk. An understanding of the mechanisms contributing to the increased postprandial lipemia in older individuals becomes, therefore, of particular clinical importance in any effort to explain and address the well-documented increase in cardiovascular disease risk as individuals age. Current evidence points to an increase in the accumulation of ingested lipid in lipoprotein particles of hepatic origin, together with an overall accumulation of lipid in these lipoproteins during the postprandial period, as primary contributors to the postprandial lipemia in older persons. When this evidence is considered together with the evidence suggesting large atherogenic potential of lipoproteins of hepatic origin, this can, at least in part, explain the increased risk of cardiovascular disease in older individuals. Understanding changes in the metabolism of ingested fat in the immediate postprandial period with advancing age, and how lifestyle interventions such as diet and physical exercise can ameliorate the increase in postprandial lipemia in older individuals, is important in order to address the increased cardiovascular disease risk in this particularly affected and growing segment of the population.

  2. Intracellular Cytokine Staining and Flow Cytometry: Considerations for Application in Clinical Trials of Novel Tuberculosis Vaccines.

    Directory of Open Access Journals (Sweden)

    Steven G Smith

    Full Text Available Intracellular cytokine staining combined with flow cytometry is one of a number of assays designed to assess T-cell immune responses. It has the specific advantage of enabling the simultaneous assessment of multiple phenotypic, differentiation and functional parameters pertaining to responding T-cells, most notably, the expression of multiple effector cytokines. These attributes make the technique particularly suitable for the assessment of T-cell immune responses induced by novel tuberculosis vaccines in clinical trials. However, depending upon the particular nature of a given vaccine and trial setting, there are approaches that may be taken at different stages of the assay that are more suitable than other alternatives. In this paper, the Tuberculosis Vaccine Initiative (TBVI TB Biomarker Working group reports on efforts to assess the conditions that will determine when particular assay approaches should be employed. We have found that choices relating to the use of fresh whole blood or peripheral blood mononuclear cells (PBMC and frozen PBMC; use of serum-containing or serum-free medium; length of stimulation period and use of co-stimulatory antibodies can all affect the sensitivity of intracellular cytokine assays. In the case of sample material, frozen PBMC, despite some loss of sensitivity, may be more advantageous for batch analysis. We also recommend that for multi-site studies, common antibody panels, gating strategies and analysis approaches should be employed for better comparability.

  3. Azilsartan alone and in combination for the treatment of hypertension – clinical utility and patient considerations

    Directory of Open Access Journals (Sweden)

    Jones JD

    2013-08-01

    Full Text Available Jocelyn D Jones,1 Sylvia H Jackson,1 Charlie Colquitt21College of Pharmacy and Pharmaceutical Sciences, Florida A&M University, Jacksonville, FL, USA; 2College of Pharmacy and Pharmaceutical Sciences, Florida A&M University, Tampa, FL, USAAbstract: Hypertension is a common disease that leads to significant cardiovascular morbidity and mortality. Adequate blood pressure control is essential in preventing end organ complications. One of the most popular antihypertensive strategies for the treatment of elevated blood pressure is to attenuate the actions of the renin-angiotensin-aldosterone system. The agents include the angiotensin converting enzyme inhibitors, angiotensin II receptor blockers (ARBs, direct renin inhibitors, and aldosterone antagonists. The ARBs inhibit the action of angiotensin II by binding to the angiotensin II type 1 receptor. The inhibition of angiotensin II results in a dose dependent decrease in peripheral resistance, reduction in vascular smooth muscle contraction, and reduced synthesis of aldosterone in the kidneys. Azilsartan medoxomil is a highly selective ARB. It was approved by the US Food and Drug Administration in February 2011 for the treatment of hypertension in adults. It is the eighth ARB to be added to the market. This article will discuss the pharmacologic and clinical characteristics of azilsartan medoxomil to help differentiate it from other ARBs that are used for the management of hypertension.Keywords: hypertension, azilsartan medoxomil, angiotensin II receptor blocker, ARB

  4. Clinical and Epidemiologic Profile of Cutaneous Leishmaniasis in Colombian Children: Considerations for Local Treatment

    Science.gov (United States)

    Blanco, Victor M.; Cossio, Alexandra; Martinez, Javier D.; Saravia, Nancy Gore

    2013-01-01

    Treatment alternatives have seldom been evaluated in children with cutaneous leishmaniasis (CL). We examine the clinical/epidemiological profile of children with CL considering international guidelines for local treatment. Descriptive analyses were conducted using International Center for Medical Research and Training (CIDEIM) case reports of parasitologically diagnosed patients ≤ 14 years of age from 2004 to 2010. Eligibility for local treatment based on World Health Organization/Pan American Health Organization (WHO/PAHO) criteria was determined. Among 380 children, 90% presented lesions of < 3 months duration, 54% presented single lesions < 30 mm in diameter, and 45% were ≤ 5 years old. Lesions on the head and neck were more frequent among children 0–5 years, and lesions below the head/neck were more frequent among 11- to 14-year-old children (P = 0.004). Using PAHO and WHO criteria, 26% and 53% of children, respectively, were eligible for local treatment. Recommended local treatments for New World CL have potential but limited applicability in children. Individual risk–benefit assessment and effectiveness data in children may increase eligibility. PMID:23798581

  5. Submitted for your consideration: potential advantages of a novel clinical trial design and initial patient reaction

    Directory of Open Access Journals (Sweden)

    Matthew Shane Loop

    2012-08-01

    Full Text Available In many circumstances, individuals do not respond identically to the same treatment. This phenomenon, which is called treatment response heterogeneity (TRH, appears to be present in treatments for many conditions, including obesity. Estimating the total amount of TRH, predicting an individual’s response, and identifying the mediators of TRH are of interest to biomedical researchers. Clinical investigators and physicians commonly postulate that some of these mediators could be genetic. Current designs can estimate TRH as a function of specific, measurable observed factors; however, they cannot estimate the total amount of TRH, nor provide reliable estimates of individual persons’ responses. We propose a new repeated randomizations design (RRD, which can be conceived as a generalization of the Balaam design, that would allow estimates of that variability and facilitate estimation of the total amount of TRH, prediction of an individual’s response, and identification of the mediators of TRH. In a pilot study, we asked 118 subjects entering a weight loss trial for their opinion of the RRD, and they stated a preference for the RRD over the conventional 2-arm parallel groups design. Research is needed as to how the RRD will work in practice and its relative statistical properties, and we invite dialogue about it.

  6. Type III B dens invaginatus: Diagnostic and clinical considerations using 128-slice computed tomography

    Directory of Open Access Journals (Sweden)

    Radhika Muppa

    2014-01-01

    Full Text Available Endodontic therapy is successful only when thorough knowledge of root canal morphology is understood. Dens invaginatus is malformation of teeth resulting from invagination of tooth before biological mineralization occurs. It is clinically significant with an early pulpal involvement and chronic periapical lesion, which are often associated with this anomaly. The present case report describes a 13-year-old female patient who reported to our institution with complaint of pain and swelling in the right maxillary region. Intraoral examination revealed Ellis Type II fracture of right maxillary central incisor and normal appearing right maxillary lateral incisor. On radiographic examination right maxillary, lateral incisor roots are morphologically altered with an immature apex and a large periradicular lesion. Conventional radiographs help in the assessment of complex root morphology, but certain limitations pertaining to detail of complexity needs for the use of more advance imaging modalities. Complex anatomic variations can best be diagnosed with the use of computed tomography (CT. A combined endodontic and surgical treatment was performed followed by postobturation CT images which were reviewed as axial slices and in volume rendering multiplanar reconstruction. The scope of using spiral CT in the endodontic diagnosis and treatments is increasing as it provides better resolution than other methods.

  7. The clinical and radiological consideration of calcifying odontogenic cyst of the jaw

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Hae Rym; Kim, Kee Deog; Park, Chang Seo [Dept. of Dental radiology, College of Dentistry, Yensei University, (Korea, Republic of)

    1996-08-15

    Nine cases presented with a calcifying odontogenic cyst to the Dental Hospital of the College of Dentistry, Yonsei University, from January 1987 to September June, 1996, Clinical or histopathological findings were observed according to each radiologic criteria. The results obtained are as follows:1. The male to female ratio was 2 : 1 with a mean age of 25 years. 2. The radiographic appearances of nine caes were well-defined radiolucent lesions in which eight cases were shown until ocular lesions and only one lesion was seen multilocular lesion. 3. Radiologically, three of nine cases were pure radiolucent lesion and others, six cases were radiolucent contained a variable amount of radiopaque material. 4. Histologically, two cases were classified simple cyst, five were cyst associated odontoma, two were neoplastic type. 5. Histological findings according to the radiological classification, two of three radiolucent lesions were simple cys ts; another was a cyst associated with odontoma. While, four of six radiologic mixed lesions turned out to be a cyst associated with odontoma, two was the neoplastic type.

  8. Human papillomavirus infection in the oromaxillofacial area: Clinical anatomy and histological considerations.

    Science.gov (United States)

    Ilea, Aranka; Boşca, Bianca; MiclĂuş, Viorel; Rus, Vasile; BĂbţan, Anida Maria; CÂmpian, Radu Septimiu

    2015-11-01

    Clinical manifestations of human papillomavirus (HPV) infection in the head and neck can range from benign lesions, which are the most frequent, to malignant lesions. The prevalence of head and neck cancer is increasing, despite currently decreasing trends in known risk factors such as smoking and alcohol use. A new patient profile has appeared in recent practice: most frequently a middle-aged male patient who does not smoke or drink alcohol, is sexually active (possibly having multiple partners), and presents with oral or cervicofacial lesions requiring diagnosis and treatment. Another risk factor that should be considered in these patients is HPV infection. The association of oral potentially malignant disorders (OPMD) with HPV is a challenge for the medical practitioner. The gold standard for diagnosis is histopathological examination, which can also yield evidence suggesting HPV infection. Determination of the viral genotype provides additional data for assessing the oncological risk of an HPV infection. Treatment of these patients is aimed at removing the lesions, in association or not with antiviral treatment and recurrence control. © 2015 Wiley Periodicals, Inc.

  9. Clinical advances in the management of chronic myelogenous leukemia: focus on bosutinib and patient considerations

    Directory of Open Access Journals (Sweden)

    Sweet K

    2014-07-01

    Full Text Available Kendra Sweet,1 Javier Pinilla-Ibarz,1 Ling Zhang21Malignant Hematology, 2Hematopathology, H Lee Moffitt Cancer Center, Tampa, FL, USAAbstract: The treatment for chronic myeloid leukemia has changed significantly over the past 15 years, and as of now, there are five BCR-ABL1 (breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 tyrosine kinase inhibitors that have gained approval for treatment of this disease. All five are very effective drugs, and the decision surrounding which to use in specific patients is based on numerous factors. Bosutinib is one of the newer tyrosine kinase inhibitors to gain approval, and has been studied in the first-line setting as well as after failure of other tyrosine kinase inhibitors. It is an SRC-ABL1 (steroid receptor co-activator-ABL1 inhibitor that works in the presence of most kinase domain mutations. The primary side effects of bosutinib are gastrointestinal upsets. In the appropriate clinical setting, bosutinib can be considered a valuable addition to the armamentarium of treatments available for chronic myeloid leukemia.Keywords: chronic myeloid leukemia, bosutinib, treatment options

  10. Clinical, ethical and legal considerations in the treatment of newborns with non-ketotic hyperglycinaemia.

    Science.gov (United States)

    Boneh, A; Allan, S; Mendelson, D; Spriggs, M; Gillam, L H; Korman, S H

    2008-06-01

    Non-ketotic hyperglycinaemia (NKH) is a devastating neurometabolic disorder leading, in its classical form, to early death or severe disability and poor quality of life in survivors. Affected neonates may need ventilatory support during a short period of respiratory depression. The transient dependence on ventilation dictates urgency in decision-making regarding withdrawal of therapy. The occurrence of patients with apparent transient forms of the disease, albeit rare, adds uncertainty to the prediction of clinical outcome and dictates that the current practice of withholding or withdrawing therapy in these neonates be reviewed. Both bioethics and law take the view that treatment decisions should be based on the best interests of the patient. The medical-ethics approach is based on the principles of non-maleficence, beneficence, autonomy and justice. The law relating to withholding or withdrawing life-sustaining treatment is complex and varies between jurisdictions. Physicians treating newborns with NKH need to provide families with accurate and complete information regarding the disease and the relative probability of possible outcomes of the neonatal presentation and to explore the extent to which family members are willing to take part in the decision making process. Cultural and religious attitudes, which may potentially clash with bioethical and juridical principles, need to be considered.

  11. Will Regulatory and Financial Considerations Dampen Innovation in the Clinical Microbiology Laboratory?

    Science.gov (United States)

    Gilligan, Peter H; Miller, Melissa B

    2016-02-02

    Over a million prosthetic joints are placed in patients in the United States annually. Of those that fail, 25% will be due to infection, with an estimated cost approaching 1 billion dollars. Despite the clinical and economic importance of these infections, the techniques for their detection are relatively insensitive. An innovative method for detecting these infections by using blood culture bottles (BCB) to culture specimens of periprosthetic tissue (PPT) was described in a recent article [T. N. Peel, et al., mBio 7(1):e01776-15, 2016, doi:10.1128/mBio.01776-15]. There are two potential stumbling blocks to the widespread implementation of this innovation. First, the FDA judges such an application of BCB as an "off-label use" and as such, a laboratory-developed test (LDT). LDTs are coming under greater scrutiny by the FDA and may require extensive, costly validation studies in laboratories that adopt this methodology. Second, the Center for Medicare and Medicaid Services has established a Hospital Acquired Condition Reduction Act under which institutions performing in the lowest quartile forfeit 1% of their Medicare reimbursement. Hospital-acquired infections are an important component of this quality metric. Although prosthetic joint infection (PJI) rates are not currently a hospital quality metric, given their cost and increasing frequency, it is reasonable to expect that they may become one. Will those with financial oversight allow an innovative technique that will require an expensive validation and may put the institution at risk for loss of CMS reimbursement?

  12. Clinical considerations and therapeutic strategy for sigmoid volvulus in the elderly: A study of 33 cases

    Institute of Scientific and Technical Information of China (English)

    Michael Safioleas; Constantinos Chatziconstantinou; Evangelos Felekouras; Michael Stamatakos; Ioannis Papaconstantinou; Anastasios Smirnis; Panagiotis Safioleas; Alkiviades Kostakis

    2007-01-01

    AIM: To evaluate different types of treatment for sigmoid volvulus and clarify the role of endoscopic intervention versus surgery.METHODS: A retrospective review of the clinical presentation and imaging characteristics of 33 sigmoid volvulus patients was presented, as well as their diagnosis and treatment, in combination with a literature review.RESULTS: In 26 patients endoscopic detorsion was achieved after the first attempt and one patient died because of uncontrollable sepsis despite prompt operative treatment. Seven patients had unsuccessful endoscopic derotation and were operated on. On two patients with gangrenous sigmoid, Hartmann's procedure was performed. In five patients with viable colon, a sigmoid resection and primary anastomosis was carried out. Three patients had a lavage "on table" prior to anastomosis, while in the remaining 2 patients a diverting stoma was performed according to the procedure of the first author. Ten patients were operated on during their first hospital stay (3 to 8 d after the deflation). All patients had viable colon; 7 patients had a sigmoid resection and primary anastomosis, 2 patients had sigmoidopexy and one patient underwent a near-total colectomy. Two patients (sigmoidectomy-sigmoidopexy) had recurrences of volvulus 43 and 28 mo after the initial surgery. Among 15 patients who were discharged from the hospital after non-operative deflation, 3 patients were lost to follow-up. Of the remaining 12 patients, 5 had a recurrence of volvulus at a time in between 23 d and 14 mo. All the five patients had been operated on and in four a gangrenous sigmoid was found. Three patients died during the 30 d postoperative course. The remaining seven patients were admitted to our department for elective surgery. In these patients, 2 subtotal colectomies, 3 sigmoid resections and 2 sigmoidopexies were carried out. One patient with subtotal colectomy died. Taken together of the results, it is evident that after 17 elective operations we had

  13. Amplified fragment length polymorphism of Streptococcus suis strains correlates with their profile of virulence-associated genes and clinical background.

    Science.gov (United States)

    Rehm, Thomas; Baums, Christoph G; Strommenger, Birgit; Beyerbach, Martin; Valentin-Weigand, Peter; Goethe, Ralph

    2007-01-01

    Amplified fragment length polymorphism (AFLP) typing was applied to 116 Streptococcus suis isolates with different clinical backgrounds (invasive/pneumonia/carrier/human) and with known profiles of virulence-associated genes (cps1, -2, -7 and -9, as well as mrp, epf and sly). A dendrogram was generated that allowed identification of two clusters (A and C) with different subclusters (A1, A2, C1 and C2) and two heterogeneous groups of strains (B and D). For comparison, three strains from each AFLP subcluster and group were subjected to multilocus sequence typing (MLST) analysis. The closest relationship and lowest diversity were found for patterns clustering within AFLP subcluster A1, which corresponded with sequence type (ST) complex 1. Strains within subcluster A1 were mainly invasive cps1 and mrp+ epf+ (or epf*) sly+ cps2+ strains of porcine or human origin. A new finding of this study was the clustering of invasive mrp* cps9 isolates within subcluster A2. MLST analysis suggested that A2 correlates with a single ST complex (ST87). In contrast to A1 and A2, subclusters C1 and C2 contained mainly pneumonia isolates of genotype cps7 or cps2 and epf- sly-. In conclusion, this study demonstrates that AFLP allows identification of clusters of S. suis strains with clinical relevance.

  14. Survey of young patients with polio and a foreign background at a Swedish post-polio outpatient clinic.

    Science.gov (United States)

    Werhagen, Lars; Borg, Kristian

    2016-10-01

    Nowadays, polio survivors aged under 60 years are non-native Swedes which pose new aspects and challenges to a post-polio outpatient clinic. To analyze the medical data, walking aids, occupational, and family situation in non-native polio survivors aged less than 60 years at a Swedish post-polio outpatient clinic. Retrospective data analysis. Data were retrieved from medical records at the post-polio outpatient clinic. Actual age, age at acute polio infection, walking capacity, pain, concomitant diseases, working and family situation, and ethnical origin were analyzed. Data are presented in numbers and percentage. 153 patients were included. Mean age was 45 (17-60) years, and mean age at acute polio infection was 2 (0-12) years. Paresis of the lower extremities was the most common disability. 10 % were wheelchair dependent. Pain occurred in 70 % with a mean intensity of 55 measured with the visual analog scale. Hypertension was the most common concomitant disease. Half of the polio survivors were working at least part time, and roughly half were singles. Data were comparable with data earlier published in Swedish native polio survivors. Non-native polio survivors aged under 60 years showed similarities in age at acute polio infection, paresis, prevalence, and intensity of pain when compared with native Swedish polio survivors. They were, however, younger, and were less often working and married/cohabitants than native Swedish polio survivors. The results of this study underline the importance of social and vocational rehabilitation tailoring rehabilitation suitable for polio survivors with a foreign background.

  15. 'You find yourself.' Perceptions of nursing students from non-English speaking backgrounds of the effect of an intensive language support program on their oral clinical communication skills.

    Science.gov (United States)

    Rogan, Fran; San Miguel, Caroline; Brown, Di; Kilstoff, Kathleen

    2006-10-01

    Nurses of ethnically diverse backgrounds are essential in providing multicultural populations in western societies with culturally and linguistically competent health care. However, many nurses from non-English speaking backgrounds (NESB) are at high risk of failure in university programs particularly during clinical placements. Few studies investigate the clinical experiences of students from NESB and strategies to support their learning. This study describes perceptions of fifteen undergraduate nursing students from NESB about their first clinical placement in an Australian university program and the effect of a language support program on their oral clinical communication skills. Three categories arose: *Wanting to belong but feeling excluded; *Wanting to learn how to...; and *You find yourself. While many students find clinical placement challenging, it appeared difficult for students in this study as language and cultural adjustments required some modification of their usual ways of thinking and communicating, often without coping strategies available to other students.

  16. Role of Large Clinical Datasets From Physiologic Monitors in Improving the Safety of Clinical Alarm Systems and Methodological Considerations: A Case From Philips Monitors

    Science.gov (United States)

    Reed, Charles Calhoun; Staggers, Nancy

    2016-01-01

    Background Large datasets of the audit log of modern physiologic monitoring devices have rarely been used for predictive modeling, capturing unsafe practices, or guiding initiatives on alarm systems safety. Objective This paper (1) describes a large clinical dataset using the audit log of the physiologic monitors, (2) discusses benefits and challenges of using the audit log in identifying the most important alarm signals and improving the safety of clinical alarm systems, and (3) provides suggestions for presenting alarm data and improving the audit log of the physiologic monitors. Methods At a 20-bed transplant cardiac intensive care unit, alarm data recorded via the audit log of bedside monitors were retrieved from the server of the central station monitor. Results Benefits of the audit log are many. They include easily retrievable data at no cost, complete alarm records, easy capture of inconsistent and unsafe practices, and easy identification of bedside monitors missed from a unit change of alarm settings adjustments. Challenges in analyzing the audit log are related to the time-consuming processes of data cleaning and analysis, and limited storage and retrieval capabilities of the monitors. Conclusions The audit log is a function of current capabilities of the physiologic monitoring systems, monitor’s configuration, and alarm management practices by clinicians. Despite current challenges in data retrieval and analysis, large digitalized clinical datasets hold great promise in performance, safety, and quality improvement. Vendors, clinicians, researchers, and professional organizations should work closely to identify the most useful format and type of clinical data to expand medical devices’ log capacity. PMID:27694097

  17. Management of venous thrombosis in fibular free osseomusculocutaneous flaps used for mandibular reconstruction: clinical techniques and treatment considerations

    Directory of Open Access Journals (Sweden)

    Draenert Florian G

    2010-06-01

    Full Text Available Abstract Background Mandibular reconstruction by means of fibula transplants is the standard therapy for severe bone loss after subtotal mandibulectomy. Venous failure still represents the most common complication in free flap surgery. We present the injection of heparine into the arterial pedicle as modification of the revising both anastomoses in these cases and illustrate the application with a clinical case example. Methods Methods consist of immediate revision surgery with clot removal, heparin perfusion by direct injection in the arterial vessel of the pedicle, subsequent high dose low-molecular weight heparin therapy, and leeches. After 6 hours postoperatively, images of early flap recovery show first sings of recovery by fading livid skin color. Results The application of this technique in a patient with venous thrombosis resulted in the complete recovery of the flap 60 hours postoperatively. Other cases achieved similar success without additional lysis Therapy or revision of the arterial anastomosis. Conclusion Rescue of fibular flaps is possible even in patients with massive thrombosis if surgical revision is done quickly.

  18. Quality and clinical supply considerations of Paediatric Investigation Plans for IV preparations-A case study with the FP7 CloSed project.

    Science.gov (United States)

    Hanning, Sara M; Orlu Gul, Mine; Winslade, Jackie; Baarslag, Manuel A; Neubert, Antje; Tuleu, Catherine

    2016-09-25

    A Paediatric Investigation Plan (PIP) is a development plan that aims to ensure that sufficient data are obtained through studies in paediatrics to support the generation of marketing authorisation of medicines for children. This paper highlights some practical considerations and challenges with respect to PIP submissions and paediatric clinical trials during the pharmaceutical development phase, using the FP7-funded Clonidine for Sedation of Paediatric Patients in the Intensive Care Unit (CloSed) project as a case study. Examples discussed include challenges and considerations regarding formulation development, blinding and randomisation, product labelling and shipment and clinical trial requirements versus requirements for marketing authorisation. A significant quantity of information is required for PIP submissions and it is hoped that future applicants may benefit from an insight into some critical considerations and challenges faced in the CloSed project.

  19. Anti-VEGF strategies - from antibodies to tyrosine kinase inhibitors: background and clinical development in human cancer.

    LENUS (Irish Health Repository)

    Korpanty, Grzegorz

    2012-01-01

    Tumour angiogenesis (formation of new blood vessels supporting tumour growth and metastasis) is a result of complex interactions between the tumour and the surrounding microenvironment. Targeting tumours with anti-angiogenic therapy remains an exciting area of preclinical and clinical studies. Although many significant advances have been achieved and the clinical use of anti-angiogenic drugs is now well recognized in many solid malignancies, these therapies fall short of their anticipated clinical benefits and leave many unanswered questions like exact mechanism of action, patients\\' selection and monitoring response to anti-angiogenic drugs. Tumour angiogenesis is controlled by complex signaling cascades and ongoing research into molecular mechanisms of tumour angiogenesis not only helps to understand its basic mechanisms but hopefully will identify new therapeutic targets. In 2012, both monoclonal antibodies and small molecule tyrosine kinase inhibitors remain the two major clinically useful therapeutic options that interfere with tumour angiogenesis in many solid malignancies.

  20. Anaesthesiological considerations in small-incision and laparoscopic cholecystectomy in symptomatic cholecystolithiasis : implications for pulmonary function. A randomized clinical trial

    NARCIS (Netherlands)

    Keus, F.; Ali, U. Ahmed; Noordergraaf, G. J.; Roukema, J. A.; Gooszen, H. G.; van Laarhoven, C. J. H. M.

    2007-01-01

    Background: Upper abdominal surgery, including laparoscopic cholecystectomy (LC), is associated with post-operative pulmonary dysfunction. LC has, by consensus, become the treatment of choice for symptomatic cholecystolithiasis. Small-incision cholecystectomy (SIC), a procedure that does not require

  1. Fluoroquinolone-resistance mechanisms and phylogenetic background of clinical Escherichia coli strains isolated in south-east Poland.

    Science.gov (United States)

    Korona-Glowniak, Izabela; Skrzypek, Kinga; Siwiec, Radosław; Wrobel, Andrzej; Malm, Anna

    2016-07-01

    Fluorochinolones are a class of broad-spectrum antimicrobials in the treatment of several infections, including those caused by Escherichia coli. Due to the increasing resistance of bacteria to antimicrobials, an understanding of fluoroquinolone resistance is important for infection control. The aim of this study was to determine susceptibility of clinical E. coli strains to fluoroquinolones and characterize their mechanisms of quinolone resistance. Totally, 79 non-duplicate clinical E. coli isolates included in this study were mainly from skin lesion -36 (45.6%) isolates; 54 (68.4%) isolates were assigned to phylogenetic B2 group. Resistance to ciprofloxacin was found in 20 isolates. In the quinolone resistance-determining region (QRDR) region of gyrA and parC, 4 types of point mutations were detected. Mutations in parC gene were found in all strains with gyrA mutations. Predominance of double mutation in codon 83 and 87 of gyrA (90%) and in codon 80 of parC (90%) was found. Moreover, plasmid-mediated quinolone resistance (PMRQ) determinants (qnrA or qnrB and/or aac(6')-Ib-cr) were present in 5 (25%) out of 20 fluoroquinolone-resistant isolates. Resistance to fluoroquinolones in all of the tested clinical E. coli isolates correlated with point mutations in both gyrA and parC. The majority of fluoroquinolone-resistant strains belonged to D and B2 phylogenetic groups.

  2. Hydrocephalus in a patient with an unruptured pial arteriovenous fistula: hydrodynamic considerations, endovascular treatment, and clinical course.

    Science.gov (United States)

    Morales-Gómez, Jesús A; Garza-Oyervides, Vicente V; Arenas-Ruiz, José A; Mercado-Flores, Mariana; Elizondo-Riojas, C Guillermo; Boop, Frederick A; de León, Ángel Martínez-Ponce

    2017-03-01

    Intracranial pial arteriovenous fistulas, also known as nongalenic fistulas, are rare vascular malformations affecting predominantly the pediatric population. Hydrocephalus is an unusual presentation in which the exact pathophysiology is not fully understood. The aim of treatment in these cases is occlusion of the fistula prior to considering ventricular shunting. Here, the authors describe the hydrodynamic considerations of the paravascular pathway and the resolution of hydrocephalus with endovascular treatment of the fistula.

  3. Quality control for the in-clinic veterinary laboratory and pre-analytic considerations for specialized diagnostic testing.

    Science.gov (United States)

    Camus, Melinda S

    2016-09-01

    This review, aimed primarily at general practitioners, focuses on quality assurance/quality control principles for all three phases of clinical pathology testing: preanalytic, analytic, and postanalytic. Specific emphasis is placed on the preanalytic phase of diagnostic modalities for identifying neoplastic cells, specifically flow cytometry, PCR for antigen receptor rearrangement, and immunocytochemistry. Recommendations for establishing an in-clinic quality assurance system are provided.

  4. CLINICAL AND LABORATORY ASPECTS OF CHRONIC HEPATITIS B ON THE BACKGROUND OF REFRACTORY ANEMIA OF INFLAMMATION IN CHILDREN OF UZBEKISTAN

    Directory of Open Access Journals (Sweden)

    F. I. Inoyatova

    2017-01-01

    Full Text Available A total of 75 children with chronic hepatitis B (ChHB with a refractory variant of anemia of inflammation (AV course were examined, the pathogenetic manifestation of which was the development of iron overload syndrome (IOS. It was revealed that against the background of an increase in the severity of the IOS, the incidence of progressive forms of the disease with persistent prevalence of asthenovegetative, hemorrhagic syndromes and severe hepatosplenomegaly increased. At the same time, the leading biochemical syndromes were the presence of cytolysis with prolonged hyperfermentemia, endotoxemia and mesenchymal inflammatory syndrome. A directly proportional dependence of the hepcidin-25 peptide level on the degree of expression of the IOS, the higher the presentation of the IOS, the higher the level of suppression of peptide expression in hepatocytes. Diagnostically significant tests of severe forms of IOS in ChHB in children are the presence of hemosiderin in the urine and an increase in the level of sIL-6R in the serum.  

  5. Background Material

    DEFF Research Database (Denmark)

    Zandersen, Marianne; Hyytiäinen, Kari; Saraiva, Sofia

    2016-01-01

    This document serves as a background material to the BONUS Pilot Scenario Workshop, which aims to develop harmonised regional storylines of socio-ecological futures in the Baltic Sea region in a collaborative effort together with other BONUS projects and stakeholders.......This document serves as a background material to the BONUS Pilot Scenario Workshop, which aims to develop harmonised regional storylines of socio-ecological futures in the Baltic Sea region in a collaborative effort together with other BONUS projects and stakeholders....

  6. Osteoarthritis treatment using autologous conditioned serum after placebo: Patient considerations and clinical response in a non-randomized case series

    NARCIS (Netherlands)

    Rutgers, M.; Creemers, L.B.; Yang, K.G.A.; Raijmakers, N.J.H.; Dhert, W.J.A.; Saris, Daniël B.F.

    2015-01-01

    Background and purpose Autologous conditioned serum (ACS) is a disease-modifying drug for treatment of knee osteoarthritis, and modest superiority over placebo was reported in an earlier randomized controlled trial (RCT). We hypothesized that when given the opportunity, placebo-treated patients from

  7. Treatment Considerations and the Role of the Clinical Pharmacist Throughout Transitions of Care for Patients With Acute Heart Failure.

    Science.gov (United States)

    McNeely, Elizabeth B

    2016-04-28

    Heart failure is associated with increased risk of morbidity and mortality, resulting in substantial health-care costs. Clinical pharmacists have an opportunity to reduce health-care costs and improve disease management as patients transition from inpatient to outpatient care by leading interventions to develop patient care plans, educate patients and clinicians, prevent adverse drug reactions, reconcile medications, monitor drug levels, and improve medication access and adherence. Through these methods, clinical pharmacists are able to reduce rates of hospitalization, readmission, and mortality. In addition, care by clinical pharmacists can improve dosing levels and adherence to guideline-directed therapies. A greater benefit in patient management occurs when clinical pharmacists collaborate with other members of the health-care team, emphasizing the importance of heart failure treatment by a multidisciplinary health-care team. Education is a key area in which clinical pharmacists can improve care of patients with heart failure and should not be limited to patients. Clinical pharmacists should provide education to all members of the health-care team and introduce them to new therapies that may further improve the management of heart failure. The objective of this review is to detail the numerous opportunities that clinical pharmacists have to improve the management of heart failure and reduce health-care costs as part of a multidisciplinary health-care team.

  8. Conduct, Oversight, and Ethical Considerations of Clinical Trials in Companion Animals with Cancer: Report of a Workshop on Best Practice Recommendations.

    Science.gov (United States)

    Page, R; Baneux, P; Vail, D; Duda, L; Olson, P; Anestidou, L; Dybdal, N; Golab, G; Shelton, W; Salgaller, M; Hardy, C

    2016-01-01

    Development of effective and safe treatments for companion animals with cancer requires the collaboration of numerous animal health professionals and the full engagement of animal owners. Establishing 'Best Practice Recommendations' for clinical trials in veterinary oncology represents an important step toward meeting the goal of rigorous clinical trial design and conduct that is required to establish valid evidence. Likewise, optimizing patient welfare and owner education and advocacy is crucial to meet the unique ethical obligations to both owners and animals enrolled in these clinical trials and to ensure trust in the team conducting the research. To date, 'Best Practice Recommendations' for clinical trial conduct have not been reported for veterinary oncology. This document summarizes the consensus of a workshop held in November, 2014 to identify relevant ethical principles and to ensure responsible conduct of clinical research in companion animals with cancer. It is intended as a working document that will be updated as advances in science and ethical considerations require. To the extent possible, existing guidelines for the conduct and oversight of clinical trials in humans have been adapted for veterinary trials to avoid duplicative effort and to facilitate integration of clinical trials such that translational research with benefits for both companion animals and humans are encouraged. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  9. The ideal restoration of endodontically treated teeth - structural and esthetic considerations: a review of the literature and clinical guidelines for the restorative clinician.

    Science.gov (United States)

    Meyenberg, Konrad

    2013-01-01

    In restorative dentistry, the non-vital tooth and its restoration have been extensively studied from both its structural and esthetic aspects. The restoration of endodontically treated teeth has much in common with modern implantology: both must include multifaceted biological, biomechanical and esthetic considerations with a profound understanding of materials and techniques; both are technique sensitive and both require a multidisciplinary approach. And for both, two fundamental principles from team sports apply well: firstly, the weakest link determines the limits, and secondly, it is a very long way to the top, but a very short way to failure. Nevertheless, there is one major difference: if the tooth fails, there is the option of the implant, but if the implant fails, there is only another implant or nothing. The aim of this essay is to try to answer some clinically relevant conceptual questions and to give some clinical guidelines regarding the reconstructive aspects, based on scientific evidence and clinical expertise.

  10. Change in anatomic distribution and incidence of colorectal carcinoma over a period of 15 years - Clinical considerations

    NARCIS (Netherlands)

    Mensink, PBF; Kolkman, JJ; van Baarlen, J; Kleibeuker, JH

    2002-01-01

    PURPOSE: Colorectal cancer is the second most common cancer in the Netherlands. Its incidence rates are among the highest in Europe. In the past decades, a right-sided shift of the subsite location of colorectal cancer has been reported. These changes in anatomic distribution might have clinical

  11. Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases

    OpenAIRE

    Smedslund Geir; Zangi Heidi Andersen; Mowinckel Petter; Hagen Kåre Birger

    2013-01-01

    Abstract Background Patient reported outcomes are accepted as important outcome measures in rheumatology. The fluctuating symptoms in patients with rheumatic diseases have serious implications for sample size in clinical trials. We estimated the effects of measuring the outcome 1-5 times on the sample size required in a two-armed trial. Findings In a randomized controlled trial that evaluated the effects of a mindfulness-based group intervention for patients with inflammatory arthritis (n=71)...

  12. Combination dolutegravir–abacavir–lamivudine in the management of HIV/AIDS: clinical utility and patient considerations

    Directory of Open Access Journals (Sweden)

    Cruciani M

    2015-02-01

    Full Text Available Mario Cruciani, Marina Malena Center of Community Medicine and HIV Outpatient Clinic, Infectious Diseases Unit, San Bonifacio Hospital, Verona, Italy Abstract: The current standard of care for human immunodeficiency virus (HIV treatment is a three-drug regimen containing a nonnucleoside reverse transcriptase inhibitor, a protease inhibitor, or an integrase strand transfer inhibitor (INSTI plus two nucleoside/tide reverse transcriptase inhibitors. Given their potency, safety, and distinctive mechanism of action, INSTIs represent an important advance in HIV type 1 (HIV-1 therapy. Dolutegravir (DTG is a new-generation INSTI recently approved for the treatment of HIV-1-infected adult patients, with distinct advantages compared with other available antiretroviral agents. In well-designed, large clinical trials, DTG-containing regimens have demonstrated either noninferiority or superiority to current first-line agents such as raltegravir-, darunavir/ritonavir-, and efavirenz-containing regimens. The favorable safety profile, low potential for drug interactions, minimal impact on lipids, good tolerability, and high resistance barrier of DTG makes this compound one of the preferred choices for HIV therapy in multiple clinical scenarios, including treatment-naïve and treatment-experienced patients. DTG is the only antiretroviral drug not yet associated with de novo emergence of resistance mutations in treatment-naïve individuals. However, data from in vitro studies and clinical trial suggest the possibility of cross-resistance between first- and second-generation INSTIs. Even though these profiles are infrequent at the moment, they need to be monitored in all current patients treated with INSTIs. With its potent activity, good tolerability, simplicity of dosing, and minimal drug interaction profile, DTG will likely play a major role in the management of patients with HIV-1 infection. On the basis of clinical trial data, current guidelines endorse DTG

  13. Combination dolutegravir-abacavir-lamivudine in the management of HIV/AIDS: clinical utility and patient considerations.

    Science.gov (United States)

    Cruciani, Mario; Malena, Marina

    2015-01-01

    The current standard of care for human immunodeficiency virus (HIV) treatment is a three-drug regimen containing a nonnucleoside reverse transcriptase inhibitor, a protease inhibitor, or an integrase strand transfer inhibitor (INSTI) plus two nucleoside/tide reverse transcriptase inhibitors. Given their potency, safety, and distinctive mechanism of action, INSTIs represent an important advance in HIV type 1 (HIV-1) therapy. Dolutegravir (DTG) is a new-generation INSTI recently approved for the treatment of HIV-1-infected adult patients, with distinct advantages compared with other available antiretroviral agents. In well-designed, large clinical trials, DTG-containing regimens have demonstrated either noninferiority or superiority to current first-line agents such as raltegravir-, darunavir/ritonavir-, and efavirenz-containing regimens. The favorable safety profile, low potential for drug interactions, minimal impact on lipids, good tolerability, and high resistance barrier of DTG makes this compound one of the preferred choices for HIV therapy in multiple clinical scenarios, including treatment-naïve and treatment-experienced patients. DTG is the only antiretroviral drug not yet associated with de novo emergence of resistance mutations in treatment-naïve individuals. However, data from in vitro studies and clinical trial suggest the possibility of cross-resistance between first- and second-generation INSTIs. Even though these profiles are infrequent at the moment, they need to be monitored in all current patients treated with INSTIs. With its potent activity, good tolerability, simplicity of dosing, and minimal drug interaction profile, DTG will likely play a major role in the management of patients with HIV-1 infection. On the basis of clinical trial data, current guidelines endorse DTG in combination with nucleoside/tide reverse transcriptase inhibitors as one of the recommended regimens in antiretroviral therapy-naïve patients. Most of the favorable clinical

  14. Duplication of complete dentures using general-purpose handheld optical scanner and 3-dimensional printer: Introduction and clinical considerations.

    Science.gov (United States)

    Kurahashi, Kosuke; Matsuda, Takashi; Goto, Takaharu; Ishida, Yuichi; Ito, Teruaki; Ichikawa, Tetsuo

    2017-01-01

    To introduce a new clinical procedure for fabricating duplicates of complete dentures by bite pressure impression using digital technology, and to discuss its clinical significance. The denture is placed on a rotary table and the 3-dimensional form of the denture is digitized using a general-purpose handheld optical scanner. The duplicate denture is made of polylactic acid by a 3-dimensional printer using the 3-dimensional data. This procedure has the advantages of wasting less material, employing less human power, decreasing treatment time at the chair side, lowering the rates of contamination, and being readily fabricated at the time of the treatment visit. Copyright © 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

  15. The Body as a Site of Gender-Related Distress: Ethical Considerations for Gender Variant Youth in Clinical Settings.

    Science.gov (United States)

    Roen, Katrina

    2016-01-01

    The present article maps out understandings about embodied distress among gender-nonconforming youth. Feminist bioethics and queer-inflected clinical perspectives are used to inform thinking about ethical, nonpathologizing health care in the case of gender-related distress. Specific attention is directed at self-harming among gender variant and trans youth. This is contextualized in relation to the role that self-harm plays for some LGBT youth, where it may be seen as a rite of passage or as reasonable and inevitable way of coping. The particular complexities of self-harm among trans youth seeking clinical intervention are examined. Queer bioethics is proposed as potentially facilitating productive uncertainty with regard to the diverse imagined futures of gender variant and trans youth.

  16. Stem cell-based treatments against stroke: observations from human proof-of-concept studies and considerations regarding clinical applicability

    Directory of Open Access Journals (Sweden)

    Thorsten Roland Doeppner

    2014-10-01

    Full Text Available Ischemic stroke remains a heavy burden for industrialized countries. The only causal therapy is the recanalization of occluded vessels via thrombolysis, which due to a narrow time window still can be offered only to a minority of patients. Since the majority of patients continues to exhibit neurological deficits even following successful thrombolysis, restorative therapies are urgently needed that promote brain remodeling and repair once stroke injury has occurred. Due to their unique properties of action, stem cell-based strategies gained increasing interest during recent years. Using various stroke models in both rodents and primates, the transplantation of stem cells, namely of bone marrow derived mesenchymal stem cells (MSCs or neural progenitor cells (NPCs, has been shown to promote neurological recovery most likely via indirect bystander actions. In view of promising observations, clinical proof-of-concept studies are currently under way, in which effects of stem and precursor cells are evaluated in human stroke patients. In this review we summarize already published studies, which due to the broad experience in other medical contexts mostly employed bone marrow-derived MSCs by means of intravenous transplantation. With the overall number of clinical trials limited in number, only a fraction of these studies used non-treated control groups, and only single studies were adequately blinded. Despite these limitations, first promising results justify the need for more elaborate clinical trials in order to make stem cell transplantation a success for stroke treatment in the future.

  17. Clinical Aspects, Imaging Features, and Considerations on Bisphosphonate-Related Osteonecrosis Risk in a Pediatric Patient with Osteogenesis Imperfecta

    Directory of Open Access Journals (Sweden)

    Fábio Wildson Gurgel Costa

    2014-01-01

    Full Text Available Osteogenesis imperfecta (OI is a rare hereditary condition caused by changes in collagen metabolism. It is classified into four types according to clinical, genetic, and radiological criteria. Clinically, bone fragility, short stature, blue sclerae, and locomotion difficulties may be observed in this disease. OI is often associated to severe dental problems, such as dentinogenesis imperfecta (DI and malocclusions. Radiographically, affected teeth may have crowns with bulbous appearance, accentuated constriction in the cementoenamel junction, narrowed roots, large root canals due to defective dentin formation, and taurodontism (enlarged pulp chambers. There is no definitive cure, but bisphosphonate therapy is reported to improve bone quality; however, there is a potential risk of bisphosphonate-related osteonecrosis of the jaw. In this study we report a case of OI in a male pediatric patient with no family history of OI who was receiving ongoing treatment with intravenous perfusion of bisphosphonate and who required dental surgery. In addition, we discussed the clinical and imaging findings and briefly reviewed the literature.

  18. Benefits, risks and ethical considerations in translation of stem cell research to clinical applications in Parkinson's disease.

    Science.gov (United States)

    Master, Zubin; McLeod, Marcus; Mendez, Ivar

    2007-03-01

    Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson's disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical studies transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson's disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinical research of Parkinson's disease are derived. The potential benefits to research participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson's disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potential risk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit to risk calculus and to provide participants with a reasonable choice before they enroll in clinical studies.

  19. Osteopathic Manipulative Treatment in Pediatric and Neonatal Patients and Disorders: Clinical Considerations and Updated Review of the Existing Literature.

    Science.gov (United States)

    Bagagiolo, Donatella; Didio, Alessia; Sbarbaro, Marco; Priolo, Claudio Giuseppe; Borro, Tiziana; Farina, Daniele

    2016-09-01

    Osteopathic medicine is a form of complementary and alternative medicine. Osteopathic practitioners treat patients of all ages: according to the Osteopathic International Alliance's 2012 survey, about one-third of all treated patients are aged between 31 and 50 years and nearly a quarter (23.4%) are pediatric patients, with 8.7% of them being younger than 2 years. In 2013 a systematic review evaluated the effectiveness of osteopathic manipulative treatment (OMT) in pediatric patients with different underlying disorders, but due to the paucity and low methodological quality of the primary studies the results were inconclusive. The aim of this review is therefore to update the evidence concerning OMT in perinatal and pediatric disorders and to assess its clinical impact. Most published studies favor OMT, but the generally small sample sizes in these studies cannot support ultimate conclusions about the efficacy of osteopathic therapy in pediatric age. In turn, clinical trials of OMT in premature infants might represent an important step in the osteopathic research because they can address both cost-effectiveness issues, and an innovative, multidisciplinary approach to the management of specific pediatric diseases cared for by the same, common health care system. The available studies in neonatal settings provide evidence that OMT is effective in reducing the hospital length of stay of the treated infants, therefore, suggesting that robust cost-effectiveness analyses should be included in the future clinical trials' design to establish new possible OMT-shared strategies within the health care services provided to newborns.

  20. An historical, biographical, literary, and clinical consideration of Freud's 'Analysis Terminable and Interminable' on its fiftieth birthday.

    Science.gov (United States)

    Loewenberg, P

    1988-01-01

    Freud's paper is re-examined and placed in biographical and historical context, Moses and monotheism (1934-1938) is treated as a parallel text. Freud's ironic scepticism is viewed against the background of Thomas Mann's 1936 idealization of psychoanalysis. Freud was a sick and dying man in 1937 with every reason for personal pessimism. The political setting was the triumph of fascism in Austria and the impending seizure of Austria by Hitler. Freud fantasized the protection of psychoanalysis by the Roman Catholic Church. The paper is a polemic against the theories of Ferenczi, Adler, and Rank. Contemporaneous defence of prophylactic analysis by Fenichel is reviewed. Freud's political judgement of the moral equivalence of Social Democracy and fascism is critiqued. Freud's injunction to periodic re-analysis and his vision of analysis as 'unending' is supported. The possibility of intergenerational prophylaxis is presented.

  1. 精神科病人对背景音乐需求的调查分析%Needs analysis of the clinical background music in psychiatric patients

    Institute of Scientific and Technical Information of China (English)

    徐柳柳; 张燕红; 杜鹃; 张婧

    2015-01-01

    Objective To explore the needs of clinical background music in psychiatric patients. Methods 200 cases of psychiat-ric inpatients who were hospitalized from August to October in 2011 were investigated to know their cognition about background music, inclu-ding its connection with emotion, its advantages and disadvantages, patients' needs for it and the periods used to broadcast by using a self-designed questionnaire. Results 89. 5% of the patients agreed with the connection of background music and emotion. 62. 5% of them a-greed that background music had more advantages than disadvantages. 87% of them required to broadcast it in wards. 1/3 patients confirmed the necessity of playing it in different periods. 91. 6% of them agreed that broadcasting the background music was necessary and satisfying, because appropriate background music could elicit pleasant mood, joyful and comfortable emotion. Conclusion In psychiatric wards, selec-ting appropriate background music in different periods of the day could provide the inpatients with a safe, happy environment as well as emo-tional wellness and stress relief. In short, background music has the advantages of less investment, low cost, high demand of patients, good response and simple use, deserving to be popularized in clinic.%目的:分析精神科病人对病区播放背景音乐的需求。方法选取2011年8~10月我院住院的精神科病人200例,利用自制调查问卷,调查病人对背景音乐的认知,包括背景音乐与情绪的关联、背景音乐的利弊、对背景音乐的需求和背景音乐播放时段的要求4个方面。结果89.50%的病人认为音乐与情绪有关联;62.50%的病人认为背景音乐利大于弊;87%的病人需要病房播放背景音乐;1/3的病人认为在不同时段播放背景音乐非常必要;91.60%病人认为病区播放背景音乐非常必要,合适的背景音乐可以引起愉快的情绪和舒适的欢乐的情感。结论在精神科病区

  2. Provision of Private Care by Doctors Employed in Public Health Institutions: Ethical Considerations and Implications for Clinical Training.

    Science.gov (United States)

    Benbassat, Jochanan

    2015-06-01

    This paper summarizes the difficulties that may emerge when the same care-provider attends to private and public patients within the same or different clinical settings. First, I argue that blurring the boundaries between public and private care may start a slippery slope leading to "black" under-the-table payments for preferential patient care. Second, I question whether public hospitals that allow their doctors to attend to private patients provide an appropriate learning environment for medical students and residents. Finally, I propose a way to both maintain the advantages of private care and avoid its negative consequences: complete separation between the public and the private health care systems.

  3. Sipuleucel-T for the Treatment of Patients With Metastatic Castrate-resistant Prostate Cancer: Considerations for Clinical Practice.

    Science.gov (United States)

    Pieczonka, Christopher M; Telonis, Dimitrios; Mouraviev, Vladimir; Albala, David

    2015-01-01

    Sipuleucel-T treatment is associated with a significant and consistent survival benefit in patients with metastatic castrate-resistant prostate cancer. Most adverse events are infusion related, manageable, and of short duration. Early screening and diagnosis of metastatic disease is important, as the greatest survival benefit may occur in patients with a lower disease burden. The short duration of sipuleucel-T treatment facilitates the use of subsequent therapies. Sipuleucel-T is now being used in the clinic for patients with a lower disease burden. We present our own experience with the use of sipuleucel-T in the setting of a large urology practice.

  4. Statistical design considerations applicable to clinical trials of iodine supplementation in pregnant women who may be mildly iodine deficient.

    Science.gov (United States)

    Troendle, James F

    2016-09-01

    No large, randomized, placebo-controlled trial of iodine supplementation in pregnant women in a region of mild or moderate iodine deficiency has been completed in which a primary outcome measure was an assessment of the neurobehavioral development of the offspring at age ≥2 y. In this article, I discuss considerations for the design of such a trial in a region of mild iodine deficiency, with a focus on statistical methods and approaches. Exposure and design issues include the ethics of using a placebo, the potential for overexposure to iodine, and the possibility of community randomization. The main scientific goal of the trial is important in determining the follow-up period. If the goal is to determine whether iodine supplementation during pregnancy improves neurobehavioral development in the offspring, then follow-up should continue until a reasonably reliable assessment can be conducted, which might be at age ≥2 y. Once the timing of assessment is decided, the impact of potential loss to follow-up should be considered so that appropriate statistical methods can be incorporated into the design. The minimum sample size can be calculated by using a sample size formula that incorporates noncompliance and assumes that a certain proportion of study participants do not have any outcome observed. To have sufficient power to detect a reasonably modest difference in neurobehavioral development scores using an assessment tool with an SD of 15, a large number of participants (>500/group) is required. The minimum adequate number of participants may be even larger (>1300/group) depending on the magnitude of the difference in outcome between the supplementation and placebo groups, the estimated proportion of the iodine-supplementation group that fails to take the supplement, and the estimated proportion of pregnancies that do not produce outcome measurements.

  5. Translating stem cell research to the clinic: a primer on translational considerations for your first stem cell protocol.

    Science.gov (United States)

    O'Brien, Timothy; Creane, Michael; Windebank, Anthony J; Terzic, Andre; Dietz, Allan B

    2015-08-22

    Over the last two decades, a new therapeutic paradigm has emerged which has changed the way debilitating diseases may be treated in the future. Instead of using small-molecule drugs and devices to ameliorate the symptoms of disease, clinicians may harness the therapeutic power of cells to regenerate and cure diseases which currently represent a major unmet medical need. Advancements in the scientific knowledge of stem cell biology, along with highly encouraging preclinical proof-of-concept studies, in the last several years have served as a launch pad for testing such therapeutics in humans with life-threatening diseases. However, translating basic research findings into human therapy has not been straightforward and has presented many scientific, clinical, and regulatory challenges for scientists and clinicians. In this article, we provide a guidance framework for investigators for the design of early-phase clinical studies using stem cell-based therapeutics. Furthermore, important trial parameters and design features which must be considered before regulatory submission of such studies are highlighted.

  6. MRI-based brain atrophy rates in ADNI phase 2: acceleration and enrichment considerations for clinical trials.

    Science.gov (United States)

    Hua, Xue; Ching, Christopher R K; Mezher, Adam; Gutman, Boris A; Hibar, Derrek P; Bhatt, Priya; Leow, Alex D; Jack, Clifford R; Bernstein, Matt A; Weiner, Michael W; Thompson, Paul M

    2016-01-01

    The goal of this work was to assess statistical power to detect treatment effects in Alzheimer's disease (AD) clinical trials using magnetic resonance imaging (MRI)-derived brain biomarkers. We used unbiased tensor-based morphometry (TBM) to analyze n = 5,738 scans, from Alzheimer's Disease Neuroimaging Initiative 2 participants scanned with both accelerated and nonaccelerated T1-weighted MRI at 3T. The study cohort included 198 healthy controls, 111 participants with significant memory complaint, 182 with early mild cognitive impairment (EMCI) and 177 late mild cognitive impairment (LMCI), and 155 AD patients, scanned at screening and 3, 6, 12, and 24 months. The statistical power to track brain change in TBM-based imaging biomarkers depends on the interscan interval, disease stage, and methods used to extract numerical summaries. To achieve reasonable sample size estimates for potential clinical trials, the minimal scan interval was 6 months for LMCI and AD and 12 months for EMCI. TBM-based imaging biomarkers were not sensitive to MRI scan acceleration, which gave results comparable with nonaccelerated sequences. ApoE status and baseline amyloid-beta positron emission tomography data improved statistical power. Among healthy, EMCI, and LMCI participants, sample size requirements were significantly lower in the amyloid+/ApoE4+ group than for the amyloid-/ApoE4- group. ApoE4 strongly predicted atrophy rates across brain regions most affected by AD, but the remaining 9 of the top 10 AD risk genes offered no added predictive value in this cohort.

  7. Clinical utility and patient considerations in the use of the sitagliptin-metformin combination in Chinese patients

    Directory of Open Access Journals (Sweden)

    Du Q

    2015-02-01

    Full Text Available Qiang Du, Yan-Jun Wang, Sheng Yang, Ping HanDepartment of Endocrinology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People’s Republic of ChinaAbstract: The prevalence of diabetes mellitus (DM continues to increase each year. However, the efficacy of glucose-lowering therapies remains unsatisfactory. Moreover, the clinical characteristics and manifestations of DM in Chinese patients are different from those in Western patients. Thus, it is imperative to develop an optimal treatment protocol for lowering blood glucose levels in Chinese patients with DM. Sitagliptin has been used in People’s Republic of China, and sitagliptin and metformin combination therapy may not alter their individual pharmacokinetics. To date, several clinical trials undertaken to investigate the efficacy of sitagliptin and metformin combination therapy have revealed that it effectively controlled glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose levels to a greater extent than sitagliptin or metformin alone. In addition, the combined therapy was well tolerated and induced few side effects, which were largely mild. Furthermore, the combined therapy was easy to administer, and the patients receiving this therapy showed good compliance. Therefore, for Chinese patients with type 2 DM, sitagliptin and metformin combination therapy is preferred.Keywords: type 2 diabetes mellitus, sitagliptin, metformin

  8. [Inhalation of foreign bodies: epidemiological data and clinical considerations in the light of a statistical review of 92 cases].

    Science.gov (United States)

    Carluccio, F; Romeo, R

    1997-02-01

    In the present work 92 patients were studied all of whom had inhaled a foreign body (FB) into one of the tracheobronchial branch. The following factors were evaluated: sex, age, nature of the FB, localization in the respiratory tree, clinical symptoms, radiological findings, time lapse between diagnosis and removal. The peak incidence (61.9%) was in children under 3 years of age with a male-female ratio of 2:1. The most frequently inhaled FBs were of organic nature (31.5%); of these 58.6% were peanuts. The time lapse between inhalation and removal of the FB was as follows: in 20.5% the object was removed within 24 hours; in 66.4% within one week; in 12% in more than a week; and in 1.1% it took more than 8 weeks. In 53.2% of the cases the right bronchial branches were involved while in 28.2% the left side was affected. The most frequent symptoms were coughing (73.9%), wheezing (69.5%), dyspnea (51%) and fever (17.3%). Radiography detected the FB in only 7 cases (8.7%); in the remaining cases only indirect signs of the FB could be found: atelectasia (11.9%), emphysema (19.5%), cardio-mediastinic shift controlateral to the FB (10.8%). As regards complications, only 6 patients showed signs of slight endobronchial bleeding, 2 cases showed a pneumothorax and one other patient required a tracheotomy because of the particular shape of the FB which proved unable to pass backward through the glottis. In all cases the FB was removed using stiff bronchoscopy under either local or general anesthesia. The authors feel that, even if no clinical signs are found and radiography proves negative, one must always consider the possibility of a FB in the tracheal-bronchial branches, particularly in patients within the age range most at risk (under 3 years) and in those having a highly suspicious clinical history. In addition, the authors assert that the use of corticosteroids before and after the bronchoscopy markedly decreases the incidence of post-operative subglottic edema which

  9. Clinical considerations in the treatment of acne vulgaris and other inflammatory skin disorders: focus on antibiotic resistance.

    Science.gov (United States)

    Leyden, James J; Del Rosso, James Q; Webster, Guy F

    2007-06-01

    Propionibacterium acnes is an anaerobic bacterium that plays an important role in the pathogenesis of acne. Certain antibiotics that can inhibit P acnes colonization also have demonstrated anti-inflammatory activities in the treatment of acne, rosacea, and other noninfectious diseases. Decreased sensitivity of P acnes to antibiotics, such as erythromycin and tetracycline, has developed and may be associated with therapeutic failure. Benzoyl peroxide (BPO) is a nonantibiotic antibacterial agent that is highly effective against P acnes and for which no resistance against it has been detected to date. Retinoids are important components in combination therapy for acne, including use with antibiotics, and can serve as an alternative to these agents in maintenance therapy. By increasing our understanding of the multifaceted actions of antibiotics and the known clinical implications of antibiotic resistance, physicians can improve their decision making in prescribing these agents.

  10. Rapid detection of methicillin-resistant Staphylococcus aureus directly from clinical samples: methods, effectiveness and cost considerations

    Directory of Open Access Journals (Sweden)

    Stürenburg, Enno

    2009-07-01

    Full Text Available Methicillin-resistant Staphylococcus aureus (MRSA isolates is a serious public health problem whose ever-increasing rate is commensurate with the pressure it is exerting on the healthcare system. At present, more than 20% of clinical S. aureus isolates in German hospitals are methicillin resistant. Strategies from low-prevalence countries show that this development is not necessarily inevitable. In the Scandinavian countries and the Netherlands, thanks to a rigorous prevention programme, MRSA prevalence has been kept at an acceptably low level (<1–3%. Central to these ‘search and destroy’ control strategies is an admission screening using several MRSA swabs taken from mucocutaneous colonisation sites of high-risk patients (‘MRSA surveillance’. It has also been reported that the speed with which MRSA carriage is detected has an important role to play, as it is a key component of any effective strategy to prevent the pathogen from spreading. Since MRSA culturing involves a 2–3 day delay before the final results are available, rapid detection techniques (commonly referred to as ‘MRSA rapid tests’ using PCR methods and, most recently, rapid culturing methods have been developed. The implementation of rapid tests reduces the time of detection of MRSA carriers from 48–72 to 2–5 h. Clinical evaluation data have shown that MRSA can thus be detected with very high sensitivity. Specificity however is sometimes impaired due to false-positive PCR signals occurring in mixed flora specimens. In order to rule out any false-positive PCR results, a culture screen must always be carried out simultaneously.The data provide preliminary evidence that a PCR assay can reduce nosocomial MRSA transmission in high-risk patients or high-risk areas, whereas an approach that screens all patients admitted to the hospital is probably not effective. Information concerning the cost-effectiveness of rapid MRSA tests is still sparse and thus the issue remains

  11. Role of Large Clinical Datasets From Physiologic Monitors in Improving the Safety of Clinical Alarm Systems and Methodological Considerations: A Case From Philips Monitors.

    Science.gov (United States)

    Sowan, Azizeh Khaled; Reed, Charles Calhoun; Staggers, Nancy

    2016-09-30

    Large datasets of the audit log of modern physiologic monitoring devices have rarely been used for predictive modeling, capturing unsafe practices, or guiding initiatives on alarm systems safety. This paper (1) describes a large clinical dataset using the audit log of the physiologic monitors, (2) discusses benefits and challenges of using the audit log in identifying the most important alarm signals and improving the safety of clinical alarm systems, and (3) provides suggestions for presenting alarm data and improving the audit log of the physiologic monitors. At a 20-bed transplant cardiac intensive care unit, alarm data recorded via the audit log of bedside monitors were retrieved from the server of the central station monitor. Benefits of the audit log are many. They include easily retrievable data at no cost, complete alarm records, easy capture of inconsistent and unsafe practices, and easy identification of bedside monitors missed from a unit change of alarm settings adjustments. Challenges in analyzing the audit log are related to the time-consuming processes of data cleaning and analysis, and limited storage and retrieval capabilities of the monitors. The audit log is a function of current capabilities of the physiologic monitoring systems, monitor's configuration, and alarm management practices by clinicians. Despite current challenges in data retrieval and analysis, large digitalized clinical datasets hold great promise in performance, safety, and quality improvement. Vendors, clinicians, researchers, and professional organizations should work closely to identify the most useful format and type of clinical data to expand medical devices' log capacity.

  12. Clinical trial design in chronic obstructive pulmonary disease: current perspectives and considerations with regard to blinding of tiotropium

    Directory of Open Access Journals (Sweden)

    Beeh Kai-Michael

    2012-06-01

    Full Text Available Abstract Randomised, double-blind, controlled trials are considered the gold standard for evaluating a pharmacological agent, as they minimise any potential bias. However, it is not always possible to perform double-blind trials, particularly for medications delivered via specific devices, e.g. inhalers. In such cases, open-label studies can be employed instead. Methods used to minimise any potential bias introduced by open-label study design include randomisation, crossover study design, and objective measurements of primary efficacy and safety variables. Concise reviews analysing the effect of blinding procedures of comparator drugs on outcomes in respiratory trials are limited. Here, we compare data from different chronic obstructive pulmonary disease trials with once-daily indacaterol versus a blinded or non-blinded comparator. The clinical trial programme for indacaterol, a once-daily, long-acting β2-agonist, used tiotropium as a comparator either in an open-label or blinded fashion. Data from these studies showed that the effects of tiotropium were consistent for forced expiratory volume in 1 second, an objective measure, across blinded and non-blinded studies. The data were consistent with previous studies of double-blind tiotropium, suggesting that the open-label use of tiotropium did not introduce treatment bias. The effect of tiotropium on subjective measures (St George’s Respiratory Questionnaire; transition dyspnoea index varied slightly across blinded and non-blinded studies, indicating that minimal bias was introduced by using open-label tiotropium. Importantly, the studies used randomised, open-label tiotropium patients to treatment allocation, a method shown to minimise bias to a greater degree than blinding. In conclusion, it is important when reporting a clinical trial to be transparent about who was blinded and how the blinding was performed; if the design is open-label, additional efforts must be made to minimise risk of

  13. The dual aspect of fantasy: flight from reality or imaginative realm? Considerations and hypotheses from clinical psychoanalysis.

    Science.gov (United States)

    Colombi, Laura

    2010-10-01

    This paper discusses the view that fantasizing, understood as a flight into fantasy, belongs to a type of mental functioning distinct from imaginative fantasy. From this the idea emerges, proposed by Winnicott, that withdrawal into fantasy assumes a dissociative quality, which is formed early on as a defensive solution following the loss of hope in object relations. Such a defence becomes the foundation for a dangerous enclave in which the individual ends up enclosing himself, experiencing an illusory self-sufficiency. In this perspective, the author maintains that the flight into fantasy must be understood as a risk factor for the draining of the self or for a crystallization into psychopathological structures, becoming an automatic activity of 'non-thought' that substitutes for the working-through processes necessary for the development of the mind. The paper investigates this psychopathological dynamic, which was already present in Breuer and Freud's writings, examining subsequent contributions of various authors. Clinical material (of both children and adults) illustrates how the flight into fantasy may take the form of an anti-relational realm of the mind, compromising the operations necessary to the integration of psychic life. There is also a discussion of which therapeutic tools may help the patient to gradually abandon the withdrawal in favour of an authentically nourishing relational nature.

  14. Stem cell therapy in heart diseases: a review of selected new perspectives, practical considerations and clinical applications.

    Science.gov (United States)

    Abdelwahid, Eltyeb; Siminiak, Tomasz; Guarita-Souza, Luiz Cesar; Teixeira de Carvalho, Katherine Athayde; Gallo, Pasquale; Shim, Winston; Condorelli, Gianluigi

    2011-08-01

    Degeneration of cardiac tissues is considered a major cause of mortality in the western world and is expected to be a greater problem in the forthcoming decades. Cardiac damage is associated with dysfunction and irreversible loss of cardiomyocytes. Stem cell therapy for ischemic heart failure is very promising approach in cardiovascular medicine. Initial trials have indicated the ability of cardiomyocytes to regenerate after myocardial injury. These preliminary trials aim to translate cardiac regeneration strategies into clinical practice. In spite of advances, current therapeutic strategies to ischemic heart failure remain very limited. Moreover, major obstacles still need to be solved before stem cell therapy can be fully applied. This review addresses the current state of research and experimental data regarding embryonic stem cells (ESCs), myoblast transplantation, histological and functional analysis of transplantation of co-cultured myoblasts and mesenchymal stem cells, as well as comparison between mononuclear and mesenchymal stem cells in a model of myocardium infarction. We also discuss how research with stem cell transplantation could translate to improvement of cardiac function.

  15. Current methods of assessing the accuracy of three-dimensional soft tissue facial predictions: technical and clinical considerations.

    Science.gov (United States)

    Khambay, B; Ullah, R

    2015-01-01

    Since the introduction of three-dimensional (3D) orthognathic planning software, studies have reported on their predictive ability. The aim of this study was to highlight the limitations of the current methods of analysis. The predicted 3D soft tissue image was compared to the postoperative soft tissue. For the full face, the maximum and 95th and 90th percentiles, the percentage of 3D mesh points ≤ 2 mm, and the root mean square (RMS) error, were calculated. For specific anatomical regions, the percentage of 3D mesh points ≤ 2 mm and the distance between the two meshes at 10 landmarks were determined. For the 95th and 90th percentiles, the maximum difference ranged from 7.7 mm to 2.2 mm and from 3.7 mm to 1.5 mm, respectively. The absolute mean distance ranged from 0.98 mm to 0.56 mm and from 0.91 mm to 0.50 mm, respectively. The percentage of mesh with ≤ 2 mm for the full face was 94.4-85.2% and 100-31.3% for anatomical regions. The RMS error ranged from 2.49 mm to 0.94 mm. The majority of mean linear distances between the surfaces were ≤ 0.8 mm, but increased for the mean absolute distance. At present the use of specific anatomical regions is more clinically meaningful than the full face. It is crucial to understand these and adopt a protocol for conducting such studies.

  16. CLINICAL AND EPIDEMIOLOGIC CONSIDERATIONS OF CLOSTRIDIUM DIFFICILE IN HARBOR SEALS (PHOCA VITULINA) AT A MARINE MAMMAL REHABILITATION CENTER.

    Science.gov (United States)

    Anderson, Chelsea E; Haulena, Martin; Zabek, Erin; Habing, Gregory; Raverty, Stephen

    2015-06-01

    Between 1998 and 2008, 15 cases of segmental to diffuse hemorrhagic to necrohemorrhagic enterocolitis were diagnosed in neonatal and weaned juvenile harbor seals (Phoca vitulina) presented from the Vancouver Aquarium Marine Mammal Rescue Centre for rehabilitation. Based on a combination of gross pathology, histopathology, bacterial isolation, and toxin testing, Clostridium difficile enterocolitis was diagnosed. Most pups were anorexic or inappetant and died acutely with few other premonitory signs. Due to ongoing clinical concerns and possible emergence of this pathogen at the facility, efforts to better characterize the disease and understand the epidemiology of C. difficile was initiated in 95 harbor seal pups presented for rehabilitation in a single stranding season. Fecal samples were collected on admission, following completion of antibiotic treatment, and also prerelease or postmortem. All samples were collected fresh and submitted either directly or stored frozen. Fecal samples were inoculated into selective media for culture and screened by enzyme-linked immunosorbant assay (ELISA) for C. difficile toxins A, B, or both. Results of the 95 seals in the study were as follows: on hospital admit 72 seals were sampled, 10 were culture positive, 12 were ELISA positive; following antibiotic therapy 46 seals were sampled noting three culture positive and nine ELISA positive; prior to release 58 seals were sampled noting zero culture positive and one ELISA positive; and on postmortem exam seven seals were sampled noting zero culture positive and two ELISA positive. Clostridium difficile was not deemed to be the cause of death in any of the animals. Although the exact mechanism of disease is unknown, this study suggests that C. difficile infection is not a significant cause of mortality and may be part of the normal flora in harbor seals undergoing rehabilitation. Morbidity and mortality from this bacterium can likely be minimized by judicious use of antibiotics

  17. Clinical appraisal of abiraterone in the treatment of metastatic prostatic cancer: patient considerations, novel opportunities, and future directions

    Directory of Open Access Journals (Sweden)

    Mitsiades N

    2013-01-01

    Full Text Available Diego J Bedoya,1 Nicholas Mitsiades2,31Clearview Cancer Institute, Huntsville, AL, USA; 2Department of Medicine, 3Department of Molecular and Cellular Biology, Baylor College of Medicine, Houston, TX, USAAbstract: While androgen-deprivation therapy can induce dramatic clinical responses in advanced and metastatic prostate cancer, refractory disease (castration-resistant prostate cancer [CRPC] eventually emerges. In recent years, several studies have demonstrated the importance of residual intratumoral androgens in maintaining androgen receptor (AR transcriptional activity in CRPC. The cytochrome P450 enzyme CYP17 is an obligatory step in androgen synthesis, and therefore a critical therapeutic target in CRPC. Abiraterone acetate is a selective, irreversible inhibitor of CYP17 and can suppress adrenal synthesis of androgen precursors, and possibly in situ steroidogenesis in the tumor microenvironment. In a phase III multicenter study, abiraterone in combination with prednisone improved median overall survival of men with docetaxel-refractory CRPC by 3.9 months compared to placebo plus prednisone, and also resulted in higher objective prostate-specific antigen and radiographic response rates. The study led to the FDA approval in April 2011 of abiraterone for treatment of chemotherapy-refractory CRPC patients, validating steroidogenesis and the AR axis in general as therapeutic targets in CRPC. The FDA indication for abiraterone was expanded to all CRPCs in December 2012, while evaluation in even earlier disease states is ongoing. We propose a comprehensive AR axis-targeting approach via simultaneous, frontline enzymatic blockade of several steroidogenic enzymes (eg, CYP17 and AKR1C3 in combination with gonadotropin-releasing hormone analogs and potent, second-generation AR antagonists (eg, enzalutamide in order to improve outcomes in patients with prostate cancer.Keywords: androgen synthesis, testosterone, dihydrotestosterone, CYP17, AKR1C3, MDV

  18. Relatedness of Streptococcus suis isolates of various serotypes and clinical backgrounds as evaluated by macrorestriction analysis and expression of potential virulence traits.

    Science.gov (United States)

    Allgaier, A; Goethe, R; Wisselink, H J; Smith, H E; Valentin-Weigand, P

    2001-02-01

    We evaluated the genetic diversity of Streptococcus suis isolates of different serotypes by macrorestriction analysis and elucidated possible relationships between the genetic background, expression of potential virulence traits, and source of isolation. Virulence traits included expression of serotype-specific polysaccharides, muramidase-released protein (MRP), extracellular protein factor (EF), hemolysin activity, and adherence to epithelial cells. Macrorestriction analysis of streptococcal DNA digested with restriction enzymes SmaI and ApaI allowed differentiation of single isolates that could be assigned to four major clusters, named A1, A2, B1, and B2. Comparison of the genotypic and phenotypic features of the isolates with their source of isolation showed that (i) the S. suis population examined, which originated mainly from German pigs, exhibited a genetic diversity and phenotypic patterns comparable to those found for isolates from other European countries; (ii) certain phenotypic features, such as the presence of capsular antigens of serotypes 2, 1, and 9, expression of MRP and EF, and hemolysin activity (and in particular, combinations of these features), were strongly associated with the clinical background of meningitis and septicemia; and (iii) isolates from pigs with meningitis and septicemia showed a significantly higher degree of genetic homogeneity compared to that for isolates from pigs with pneumonia and healthy pigs. Since the former isolates are considered highly virulent, this supports the theory of a clonal relationship among highly virulent strains.

  19. Ensayos clínicos en Cirugía Pediátrica: Consideraciones bioéticas Clinical trials in Pediatric Surgery: Bioethical considerations

    Directory of Open Access Journals (Sweden)

    José Carlos Bueno Rodríguez

    2010-04-01

    Full Text Available Los ensayos clínicos son considerados como una de las mejores fuentes primarias de evidencia; sin embargo, este tipo de estudio es poco utilizado en Cirugía. El presente trabajo revisa algunas particularidades bioéticas de los ensayos clínicos en Cirugía Pediátrica. Las principales dificultades y limitaciones bioéticas son: la poca tradición de los cirujanos en la realización de ensayos clínicos, la irreversibilidad del tratamiento quirúrgico, la necesidad de entrenamiento técnico y experiencia manual, la ausencia de criterios de calidad de la técnica empleada y la influencia del periodo de aprendizaje en los resultados. Se presentan posibles soluciones para estas particularidades. Cuando se utilice el ensayo clínico como la mejor opción de diseño para contestar una pregunta de investigación clínica en cirugía con niños, deberán valorarse tanto las ventajas como las limitaciones y las dificultades bioéticas de este tipo de estudio.Clinical trials are considered the best primary source of evidence; however, this kind of study is slightly used in surgery. This paper revises some of the bioethical characteristics of clinical trials in Pediatric Surgery. The main bioethical difficulties and limitations are: surgeons´ little experience in clinical trials, irreversibility of surgical treatments, need of technical training and manual experience, absence of quality criteria concerning the technique used, and influence of the learning period in the results. Possible solutions to these aspects are presented. When clinical trials are used as the best option to answer any clinical research questions in pediatric surgery, their advantages and bioethical limitations and difficulties should taken into consideration.

  20. [Clinical-chemical studies in schizophrenic out-patients under neuroleptic long-term treatment with particular consideration of the hepatic metabolism (author's transl)].

    Science.gov (United States)

    Gonçalves, N; Grüneberg, F

    1977-01-01

    A series of clinical-chemical tests was conducted in 68 schizophrenic out-patients under long-term neuroleptic medication, with particular consideration of the hepatic metabolism, i.e.: Erythrocyte sedimentation rate, alpha 1-glycoprotein, ceruloplasmin, fibrinogen, GPT, GOT, gamma-GT, total protein and serum-protein-electrophoresis. Furthermore, the glucose tolerance tests was carried out. In 44% of the patients an increased erythrocyte sedimentation rate and positive correlations with increased fibrinogen values were found. Increased gamma-GT-values were proven in 33% of the patients; they correlated positively with the increased GPT-and/or GOT-values as well as with pathological glucose tolerance values. Overweight of more than 10 kilos was found in 46% of the patients. A significant correlation between overweight and pathological glucose tolerance values existed. The results were interpreted as consequence of a light fatty liver.

  1. On transcending the impasse of respiratory motion correction applications in routine clinical imaging - a consideration of a fully automated data driven motion control framework.

    Science.gov (United States)

    Kesner, Adam L; Schleyer, Paul J; Büther, Florian; Walter, Martin A; Schäfers, Klaus P; Koo, Phillip J

    2014-12-01

    Positron emission tomography (PET) is increasingly used for the detection, characterization, and follow-up of tumors located in the thorax. However, patient respiratory motion presents a unique limitation that hinders the application of high-resolution PET technology for this type of imaging. Efforts to transcend this limitation have been underway for more than a decade, yet PET remains for practical considerations a modality vulnerable to motion-induced image degradation. Respiratory motion control is not employed in routine clinical operations. In this article, we take an opportunity to highlight some of the recent advancements in data-driven motion control strategies and how they may form an underpinning for what we are presenting as a fully automated data-driven motion control framework. This framework represents an alternative direction for future endeavors in motion control and can conceptually connect individual focused studies with a strategy for addressing big picture challenges and goals.

  2. Design and methodological considerations of an effectiveness trial of a computer-assisted intervention: an example from the NIDA Clinical Trials Network.

    Science.gov (United States)

    Campbell, Aimee N C; Nunes, Edward V; Miele, Gloria M; Matthews, Abigail; Polsky, Daniel; Ghitza, Udi E; Turrigiano, Eva; Bailey, Genie L; VanVeldhuisen, Paul; Chapdelaine, Rita; Froias, Autumn; Stitzer, Maxine L; Carroll, Kathleen M; Winhusen, Theresa; Clingerman, Sara; Perez, Livangelie; McClure, Erin; Goldman, Bruce; Crowell, A Rebecca

    2012-03-01

    Computer-assisted interventions hold the promise of minimizing two problems that are ubiquitous in substance abuse treatment: the lack of ready access to treatment and the challenges to providing empirically-supported treatments. Reviews of research on computer-assisted treatments for mental health and substance abuse report promising findings, but study quality and methodological limitations remain an issue. In addition, relatively few computer-assisted treatments have been tested among illicit substance users. This manuscript describes the methodological considerations of a multi-site effectiveness trial conducted within the National Institute on Drug Abuse's (NIDA's) National Drug Abuse Treatment Clinical Trials Network (CTN). The study is evaluating a web-based version of the Community Reinforcement Approach, in addition to prize-based contingency management, among 500 participants enrolled in 10 outpatient substance abuse treatment programs. Several potential effectiveness trial designs were considered and the rationale for the choice of design in this study is described. The study uses a randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis. Input from community providers during protocol development highlighted potential concerns and helped to address issues of practicality and feasibility. Collaboration between providers and investigators supports the utility of infrastructures that enhance research partnerships to facilitate effectiveness trials and dissemination of promising, technologically innovative treatments. Outcomes from this study will further the empirical knowledge base on the effectiveness and cost-effectiveness of computer-assisted treatment in clinical treatment settings.

  3. A review of foot-and-mouth disease with special consideration for the clinical and epidemiological factors relevant to predictive modelling of the disease.

    Science.gov (United States)

    Kitching, R P; Hutber, A M; Thrusfield, M V

    2005-03-01

    Modelling the epidemiology of foot-and-mouth disease (FMD) has been undertaken since the early 1970s. We review here clinical factors and modelling procedures that have been used in the past, differentiating between those that have proved to be more relevant in controlling FMD epidemics, and those that have showed less significance. During the 2001 UK FMD epidemic, many previously developed FMD models were available for consideration and use. Accurate epidemiological models can become useful tools for determining relevant control policies for different scenarios and, conversely, inaccurate models may become an abuse for disease control. Inaccuracy presents two opposing difficulties. Firstly, too much control (in terms of animal slaughter for 2001) would negatively impact the farming community for many subsequent years, whilst too little control would permit an epidemic to persist. Accuracy however, presents the optimal permutation of control measures that could be implemented for a given set of conditions, and is a prerequisite to boosting public confidence in the use of epidemiological models for future epidemics.

  4. Design considerations in a clinical trial of a cognitive behavioural intervention for the management of low back pain in primary care: Back Skills Training Trial

    Directory of Open Access Journals (Sweden)

    Griffiths Frances E

    2007-02-01

    Full Text Available Abstract Background Low back pain (LBP is a major public health problem. Risk factors for the development and persistence of LBP include physical and psychological factors. However, most research activity has focused on physical solutions including manipulation, exercise training and activity promotion. Methods/Design This randomised controlled trial will establish the clinical and cost-effectiveness of a group programme, based on cognitive behavioural principles, for the management of sub-acute and chronic LBP in primary care. Our primary outcomes are disease specific measures of pain and function. Secondary outcomes include back beliefs, generic health related quality of life and resource use. All outcomes are measured over 12 months. Participants randomised to the intervention arm are invited to attend up to six weekly sessions each of 90 minutes; each group has 6–8 participants. A parallel qualitative study will aid the evaluation of the intervention. Discussion In this paper we describe the rationale and design of a randomised evaluation of a group based cognitive behavioural intervention for low back pain.

  5. Líquen plano bucal: considerações clínicas e histopatológicas Oral lichen planus: clinical and histopathological considerations

    Directory of Open Access Journals (Sweden)

    Fernando Augusto Cervantes Garcia de Sousa

    2008-04-01

    Full Text Available O líquen plano é uma das doenças dermatológicas mais comuns que acometem a cavidade bucal, com prevalência de 1% a 2% na população geral. Contudo, apesar de relativamente freqüente, o líquen plano bucal é alvo de muita controvérsia, especialmente em relação ao seu potencial de malignização. OBJETIVO: O presente trabalho tem como objetivo tecer considerações clínicas e histopatológicas a respeito do líquen plano bucal, favorecendo seu entendimento por parte dos profissionais da saúde e, conseqüentemente, reforçando a importância do acompanhamento a longo prazo dos pacientes acometidos pela doença. CONCLUSÃO: A possibilidade da lesão sofrer transformação maligna justifica a importância do acompanhamento a longo prazo dos pacientes com a doença.Oral lichen planus is one of the most common dermatological diseases presenting in the oral cavity; the prevalence in the general population is 1% to 2%. Although relatively frequent, oral lichen planus is the target of much controversy, especially in relation to its potential for malignancy. AIM: This study aimed to make clinical and histopathological considerations regarding oral lichen planus to increase the level of knowledge about this condition among health professionals, underlining the importance of long-term follow-up of these patients. CONCLUSION: The possibility of this lesion to turn malignant justifies the importance of long term follow up for patients with such disease.

  6. Considerations for the sensible use of rodent models of inflammatory disease in predicting efficacy of new biological therapeutics in the clinic.

    Science.gov (United States)

    Arnett, Heather A; Viney, Joanne L

    2007-09-30

    Successful therapeutics for treating autoimmune and inflammatory diseases must be able to significantly dampen, and ideally reverse, the complex processes involved in the manifestation of inflammatory pathology in intact tissues and organs. Studies on human cells and tissues - both normal and diseased - are obviously critical for moving forward with a particular therapeutic strategy, but these types of studies are oftentimes limited in their complexity and usually fail to fully replicate the biology of the intact inflammatory environment and disease process. It is for this reason that development of a new drug generally relies on data generated from in vivo animal models that have been created to mimic aspects of the complex disease process in whole organs and whole animals. Although the intact animal model of disease provides the opportunity for key elements involved in inflammatory processes to be investigated in natural surroundings, the primary trigger for inflammatory activation in animal models is, by necessity, artificial and, of course, differs from the natural pathogenesis driving disease in humans. Despite the artificial way of inducing inflammatory responses, animal models of disease have proven invaluable for providing insight into the potential efficacy of new drugs, particularly when careful consideration has been given to ensure that the model system under study resembles the inflammatory pathway expected in human disease. The most common artificial approaches for stimulating inflammatory diseases in mice are quite varied, and range from overexpression or targeted deletion of genes in transgenic or knockout animals, immunization of animals with putative autoantigens, all the way to synthetic, chemical challenges. None of these artificial systems or triggers is wholly perfect at mimicking the complexity of human autoimmune and inflammatory diseases, but animal disease model data is an important, and very necessary, step in the path of drug development

  7. Two to five repeated measurements per patient reduced the required sample size considerably in a randomized clinical trial for patients with inflammatory rheumatic diseases

    Directory of Open Access Journals (Sweden)

    Smedslund Geir

    2013-02-01

    Full Text Available Abstract Background Patient reported outcomes are accepted as important outcome measures in rheumatology. The fluctuating symptoms in patients with rheumatic diseases have serious implications for sample size in clinical trials. We estimated the effects of measuring the outcome 1-5 times on the sample size required in a two-armed trial. Findings In a randomized controlled trial that evaluated the effects of a mindfulness-based group intervention for patients with inflammatory arthritis (n=71, the outcome variables Numerical Rating Scales (NRS (pain, fatigue, disease activity, self-care ability, and emotional wellbeing and General Health Questionnaire (GHQ-20 were measured five times before and after the intervention. For each variable we calculated the necessary sample sizes for obtaining 80% power (α=.05 for one up to five measurements. Two, three, and four measures reduced the required sample sizes by 15%, 21%, and 24%, respectively. With three (and five measures, the required sample size per group was reduced from 56 to 39 (32 for the GHQ-20, from 71 to 60 (55 for pain, 96 to 71 (73 for fatigue, 57 to 51 (48 for disease activity, 59 to 44 (45 for self-care, and 47 to 37 (33 for emotional wellbeing. Conclusions Measuring the outcomes five times rather than once reduced the necessary sample size by an average of 27%. When planning a study, researchers should carefully compare the advantages and disadvantages of increasing sample size versus employing three to five repeated measurements in order to obtain the required statistical power.

  8. Different IMRT solutions vs. 3D-Conformal Radiotherapy in early stage Hodgkin’s lymphoma: dosimetric comparison and clinical considerations

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    Fiandra Christian

    2012-11-01

    Full Text Available Abstract Background Radiotherapy in Hodgkin’s Lymphoma (HL is currently evolving with new attempts to further reduce radiation volumes to the involved-node concept (Involved Nodes Radiation Therapy, INRT and with the use of intensity modulated radiotherapy (IMRT. Currently, IMRT can be planned and delivered with several techniques, and its role is not completely clear. We designed a planning study on a typical dataset drawn from clinical routine with the aim of comparing different IMRT solutions in terms of plan quality and treatment delivery efficiency. Methods A total of 10 young female patients affected with early stage mediastinal HL and treated with 30 Gy INRT after ABVD-based chemotherapy were selected from our database. Five different treatment techniques were compared: 3D-CRT, VMAT (single arc, B-VMAT (“butterfly”, multiple arcs, Helical Tomotherapy (HT and Tomodirect (TD. Beam energy was 6 MV, and all IMRT planning solutions were optimized by inverse planning with specific dose-volume constraints on OAR (breasts, lungs, thyroid gland, coronary ostia, heart. Dose-Volume Histograms (DVHs and Conformity Number (CN were calculated and then compared, both for target and OAR by a statistical analysis (Wilcoxon’s Test. Results PTV coverage was reached for all plans (V95% ≥ 95%; highest mean CN were obtained with HT (0.77 and VMAT (0.76. B-VMAT showed intermediate CN mean values (0.67, while the lowest CN were obtained with TD (0.30 and 3D-CRT techniques (0.30. A trend of inverse correlation between higher CN and larger healthy tissues volumes receiving low radiation doses was shown for lungs and breasts. For thyroid gland and heart/coronary ostia, HT, VMAT and B-VMAT techniques allowed a better sparing in terms of both Dmean and volumes receiving intermediate-high doses compared to 3D-CRT and TD. Conclusions IMRT techniques showed superior target coverage and OAR sparing, with, as an expected consequence, larger volumes of healthy

  9. Clinical Features and Genetic Background of the Periodic Fever Syndrome with Aphthous Stomatitis, Pharyngitis, and Adenitis: A Single Center Longitudinal Study of 81 Patients

    Directory of Open Access Journals (Sweden)

    Daša Perko

    2015-01-01

    Full Text Available PFAPA syndrome is the most common autoinflammatory disorder in childhood with unknown etiology. The aim of our study was clinical evaluation of PFAPA patients from a single tertiary care center and to determine whether variations of AIM2, MEFV, NLRP3, and MVK genes are involved in PFAPA pathogenesis. Clinical and laboratory data of consecutive patients with PFAPA syndrome followed up at the University Children’s Hospital, Ljubljana, were collected from 2008 to 2014. All four genes were PCR amplified and directly sequenced. Eighty-one patients fulfilled criteria for PFAPA syndrome, 50 (63% boys and 31 (37% girls, with mean age at disease onset of 2.1 ± 1.5 years. Adenitis, pharyngitis, and aphthae were present in 94%, 98%, and 56%, respectively. Family history of recurrent fevers in childhood was positive in 78%. Nineteen variants were found in 17/62 (27% patients, 4 different variants in NLRP3 gene in 13 patients, and 6 different variants in MEFV gene in 5 patients, and 2 patients had 2 different variants. No variants of clinical significance were found in MVK and AIM2 genes. Our data suggest that PFAPA could be the result of multiple low-penetrant variants in different genes in combination with epigenetic and environmental factors leading to uniform clinical picture.

  10. Clinical Features and Genetic Background of the Periodic Fever Syndrome with Aphthous Stomatitis, Pharyngitis, and Adenitis: A Single Center Longitudinal Study of 81 Patients

    Science.gov (United States)

    Perko, Daša; Debeljak, Maruša; Toplak, Nataša; Avčin, Tadej

    2015-01-01

    PFAPA syndrome is the most common autoinflammatory disorder in childhood with unknown etiology. The aim of our study was clinical evaluation of PFAPA patients from a single tertiary care center and to determine whether variations of AIM2, MEFV, NLRP3, and MVK genes are involved in PFAPA pathogenesis. Clinical and laboratory data of consecutive patients with PFAPA syndrome followed up at the University Children's Hospital, Ljubljana, were collected from 2008 to 2014. All four genes were PCR amplified and directly sequenced. Eighty-one patients fulfilled criteria for PFAPA syndrome, 50 (63%) boys and 31 (37%) girls, with mean age at disease onset of 2.1 ± 1.5 years. Adenitis, pharyngitis, and aphthae were present in 94%, 98%, and 56%, respectively. Family history of recurrent fevers in childhood was positive in 78%. Nineteen variants were found in 17/62 (27%) patients, 4 different variants in NLRP3 gene in 13 patients, and 6 different variants in MEFV gene in 5 patients, and 2 patients had 2 different variants. No variants of clinical significance were found in MVK and AIM2 genes. Our data suggest that PFAPA could be the result of multiple low-penetrant variants in different genes in combination with epigenetic and environmental factors leading to uniform clinical picture. PMID:25821352

  11. Ultraviolet Background Radiation

    Science.gov (United States)

    Henry, R. C.; Murthy, J.

    1993-12-01

    The UVX experiment was carried on the Space Shuttle Columbia between 1986 January 12 and 19 (STS-61C). Several ultraviolet spectrometers were used to obtain measurements of the diffuse ultraviolet background at 8 locations in the sky. We have reanalysed the UVX measurements of the surface brightness of the diffuse ultraviolet background above b = 40 using the dust-scattering model of Onaka & Kodaira (1991), which explicitly takes into account the variation of the source function with galactic longitude. The range of allowed values of interstellar grain albedoJa, and scattering asymmetry parameter g, is considerably expanded over those of a previous analysis. The new chi square probability contours come close to, but do not include, the values of a and g found for the interstellar grains by Witt et al. (1992) using the Ultraviolet Imaging Telescope (UIT) on the Astro mission. If we hypothesize in additon to the dust-scattered light an extragalactic component, of 300 1 100 photons cm-2 s-1 sr-1 A-1, attenuated by a cosecant b law, the new reduction of the UVX data gives complete consistency with the Witt et al. determination of the optical parameters of the grains in the ultraviolet. This work was supported by United States Air Force Contract F19628-93-K-0004, and by National Aeronautics and Space Administration grant NASA NAG5-619. We are grateful for the encouragement of Dr. Stephan Price, and we thank Dr. L. Danly for information. Onaka, T., & Kodaira, K. 1991, ApJ, 379, 532 Witt, A. N., Petersohn, J. K., Bohlin, R. C., O'Connell, R. W., Roberts, M. S., Smith, A. M., & Stecher, T. P. 1992, ApJ, 395, L5

  12. Paediatric pharmacokinetics: key considerations

    Science.gov (United States)

    Batchelor, Hannah Katharine; Marriott, John Francis

    2015-01-01

    A number of anatomical and physiological factors determine the pharmacokinetic profile of a drug. Differences in physiology in paediatric populations compared with adults can influence the concentration of drug within the plasma or tissue. Healthcare professionals need to be aware of anatomical and physiological changes that affect pharmacokinetic profiles of drugs to understand consequences of dose adjustments in infants and children. Pharmacokinetic clinical trials in children are complicated owing to the limitations on blood sample volumes and perception of pain in children resulting from blood sampling. There are alternative sampling techniques that can minimize the invasive nature of such trials. Population based models can also limit the sampling required from each individual by increasing the overall sample size to generate robust pharmacokinetic data. This review details key considerations in the design and development of paediatric pharmacokinetic clinical trials. PMID:25855821

  13. Methodological background and strategy for the 2012-2013 updated consensus definitions and clinical practice guidelines from the abdominal compartment society.

    Science.gov (United States)

    Kirkpatrick, Andrew W; Roberts, Derek J; Jaeschke, Roman; De Waele, Jan J; De Keulenaer, Bart L; Duchesne, Juan; Bjorck, Martin; Leppäniemi, Ari; Ejike, Janeth C; Sugrue, Michael; Cheatham, Michael L; Ivatury, Rao; Ball, Chad G; Reintam Blaser, Annika; Regli, Adrian; Balogh, Zsolt; D'Amours, Scott; De Laet, Inneke; Malbrain, Manu L N G

    2015-01-01

    The Abdominal Compartment Society (www.wsacs.org) previously created highly cited Consensus Definitions/Management Guidelines related to intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS). Implicit in this previous work, was a commitment to regularly reassess and update in relation to evolving research. Two years preceding the Fifth World Congress on Abdominal Compartment Syndrome, an International Guidelines committee began preparation. An oversight/steering committee formulated key clinical questions regarding IAH/ /ACS based on polling of the Executive to redundancy, structured according to the Patient, Intervention, Comparator, and Outcome (PICO) format. Scientific consultations were obtained from Methodological GRADE experts and a series of educational teleconferences were conducted to educate scientific review teams from among the wscacs. org membership. Each team conducted systematic or structured reviews to identify relevant studies and prepared evidence summaries and draft Grades of Recommendation Assessment, Development and Evaluation (GRADE) recommendations. The evidence and draft recommendations were presented and debated in person over four days. Updated consensus definitions and management statements were derived using a modified Delphi method. A writingcommittee subsequently compiled the results utilizing frequent Internet discussion and Delphi voting methods to compile a robust online Master Report and a concise peer-reviewed summarizing publication. A dedicated Paediatric Guidelines Subcommittee reviewed all recommendations and either accepted or revised them for appropriateness in children. Of the original 12 IAH/ACS definitions proposed in 2006, three (25%) were accepted unanimously, with four (33%) accepted by > 80%, and four (33%) accepted by > 50%, but required discussion to produce revised definitions. One (8%) was rejected by > 50%. In addition to previous 2006 definitions, the panel also defined the open abdomen

  14. Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain.

    NARCIS (Netherlands)

    Hertogh, W. de; Vaes, P.; Devroey, D.; Louis, P.; Carpay, H.; Truijen, S.; Duquet, W.; Oostendorp, R.A.B.

    2009-01-01

    BACKGROUND: Headache is a highly prevalent disorder. Irrespective of the headache diagnosis it is often accompanied with neck pain and -stiffness. Due to this common combination of headache and neck pain, physical treatments of the cervical spine are often considered. The additional value of these t

  15. [Two cases of patients with hepatocellular carcinoma (HCC) that developed in cryptogenic cirrhosis suggestive of nonalcoholic steatohepatitis (NASH) as background liver disease after clinical courses of 26 years].

    Science.gov (United States)

    Tsutsumi, Koichiro; Nakayama, Haruo; Sakai, Yoshitaka; Kojima, Yasuhiro; Dairaku, Naohiro; Ojima, Toshiaki; Kusano, Masao; Ikeya, Shinichi; Sugai, Yoshiki; Hiwatashi, Nobuo

    2007-05-01

    We report two cases of patients with hepatocellular carcinoma (HCC) that developed in cryptogenic cirrhosis suggestive of nonalcoholic steatohepatitis (NASH) as background liver disease. Case 1 was a 68-year-old woman, and case 2 was a 46-year-old man. They were admitted to our department for evaluation and treatment of HCC. The causes of the underlying liver disease were not determined from blood tests. However, histological analysis of non-tumor tissues of the liver revealed cirrhosis with few fat droplets. Both patients had undergone liver biopsy 26 years before the treatment of HCC. Histological review of the biopsy specimens revealed NASH (case 1) and fatty liver (case 2), respectively. It was suggested that these cases progressed from NASH and fatty liver, respectively, to NASH-related cirrhosis (so called burned-out NASH), eventually, developing HCC. These findings suggest that substantial number of burned-out NASH cases may be included in those with cryptogenic cirrhosis. These two patients are indicative cases that may reveal the long-term natural course of fatty liver and NASH.

  16. Variation in resistance traits, phylogenetic backgrounds, and virulence genotypes among Escherichia coli clinical isolates from adjacent hospital campuses serving distinct patient populations.

    Science.gov (United States)

    Drawz, Sarah M; Porter, Stephen; Kuskowski, Michael A; Johnston, Brian; Clabots, Connie; Kline, Susan; Ferrieri, Patricia; Johnson, James R

    2015-09-01

    Escherichia coli sequence type 13 (ST131), an emergent cause of multidrug-resistant extraintestinal infections, has important phylogenetic subsets, notably the H30 and H30Rx subclones, with distinctive resistance profiles and, possibly, clinical associations. To clarify the local prevalence of these ST131 subclones and their associations with antimicrobial resistance, ecological source, and virulence traits, we extensively characterized 233 consecutive E. coli clinical isolates (July and August 2013) from the University of Minnesota Medical Center-Fairview Infectious Diseases and Diagnostic Laboratory, Minneapolis, MN, which serves three adjacent facilities (a children's hospital and low- and high-acuity adult facilities). ST131 accounted for 26% of the study isolates (more than any other clonal group), was distributed similarly by facility, and was closely associated with ciprofloxacin resistance and extended-spectrum β-lactamase (ESBL) production. The H30 and H30Rx subclones accounted for most ST131 isolates and for the association of ST131 with fluoroquinolone resistance and ESBL production. Unlike ST131 per se, these subclones were distributed differentially by hospital, being most prevalent at the high-acuity adult facility and were absent from the children's hospital. The virulence gene profiles of ST131 and its subclones were distinctive and more extensive than those of other fluoroquinolone-resistant or ESBL-producing isolates. Within ST131, bla CTX-M-15 was confined to H30Rx isolates and other bla CTX-M variants to non-Rx H30 isolates. Pulsed-field gel electrophoresis documented a predominance of globally distributed pulsotypes and no local outbreak pattern. These findings help clarify the epidemiology, ecology, and bacterial correlates of the H30 and H30Rx ST131 subclones by documenting a high overall prevalence but significant segregation by facility, strong associations with fluoroquinolone resistance and specific ESBL variants, and distinctive

  17. Dosing considerations for rufinamide in patients with Lennox-Gastaut syndrome: Phase III trial results and real-world clinical data.

    Science.gov (United States)

    Kothare, Sanjeev; Kluger, Gerhard; Sachdeo, Rajesh; Williams, Betsy; Olhaye, Omar; Perdomo, Carlos; Bibbiani, Francesco

    2017-04-01

    Lennox-Gastaut syndrome (LGS), a rare, severe form of childhood-onset epilepsy, is difficult to control. Rufinamide is indicated for adjunctive treatment of seizures associated with LGS in adults and pediatric patients aged ≥1 year. In clinical practice, rufinamide dosing and titration may differ from the trial setting. Here, rufinamide clinical trial data are compared with real-world experience to provide insight into optimal dosing and titration strategies. Rufinamide Phase III and open-label extension (OLE) studies were reviewed; effect of titration and dose on adverse events (AEs) and concomitant AED use were analyzed. Real-world studies of rufinamide in LGS were identified via PubMed search. Clinical data were extracted and compared. Results demonstrated that a rapid titration schedule (7 or 14 days) of rufinamide was tolerable for most patients and resulted in highly significant reductions in total and tonic-atonic seizures, with efficacy and tolerability sustained over 3 years. The most common AEs during the Phase III study - somnolence, vomiting, and pyrexia - occurred during the first 3 weeks of treatment, and a small subset of patients were unable to reach target dose in that time. Use of concomitant AEDs had no clinically significant effect on plasma concentrations of rufinamide. Data from real-world clinical studies are consistent with the Phase III and OLE study results. However, relative to those used in clinical trials, lower doses and slower titration schedules were commonly employed in real-world settings. A lower dose and slower titration schedule ("low and slow") may reduce incidence of AEs without compromising efficacy of rufinamide in LGS. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  18. 主要农作物转基因飘流频率和距离的数据调研与分析Ⅰ.背景、调研目的及所考虑的问题%Data Survey and Analysis of the Tansgene Flow Frequencies and Distances in Major Crops Ⅰ .The Background, Aim and General Consideration

    Institute of Scientific and Technical Information of China (English)

    王志兴; 王旭静; 贾士荣

    2011-01-01

    Transgene flow's potential risk on environment and food is one of the hot spots that major public concerned.The data and information on tansgene flow in major corps published internationally until 2010 have been surveyed and analyzed.The distances of transgene flow at certain threshold level for different major crops are particularly defined.In this article, the background, aim and general consideration for this survey were discussed.On the scientific basis,the principle of classification management and threshold management are proposed to control the risk of transgene flow.%转基因飘流及其可能引起的环境和食品潜在风险是公众关注的热点之一.对2010年前主要农作物转基因飘流的数据和信息进行了调研与分析,特别是对一定允许阈值下的基因飘流距离进行了归纳.在分别报道各种作物的基因飘流数据前,对调研的背景、目的及所考虑的问题进行了讨论,基于科学分析,建议采用分类管理和阈值管理的原则来控制转基因飘流的风险.

  19. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

    Science.gov (United States)

    Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

    2014-01-01

    The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

  20. Metabolic and clinical response to Escherichia coli lipopolysaccharide in layer pullets of different genetic backgrounds supplied with graded dietary L-arginine.

    Science.gov (United States)

    Lieboldt, M A; Frahm, J; Halle, I; Görs, S; Schrader, L; Weigend, S; Preisinger, R; Metges, C C; Breves, G; Dänicke, S

    2016-03-01

    L-arginine (Arg) is an essential amino acid in birds that plays a decisive role in avian protein synthesis and immune response. Effects of graded dietary Arg supply on metabolic and clinical response to Escherichia coli lipopolysaccharide (LPS) were studied over 48 hours after a single intramuscular LPS injection in 18-week-old genetically diverse purebred pullets. LPS induced a genotype-specific fever response within 4 hours post injectionem. Whereas brown genotypes showed an initial hypothermia followed by longer-lasting moderate hyperthermia, white genotypes exhibited a biphasic hyperthermia without initial hypothermia. Furthermore, within 2 hours after LPS injection, sickness behavior characterized by lethargy, anorexia, intensified respiration, and ruffled feathers appeared, persisted for 3 to 5 hours and recovered 12 hours post injectionem. The varying grades of Arg did not alter the examined traits named above, whereas insufficient Arg reduced body growth and increased relative weights of liver and pancreas significantly. At 48 hours post injectionem, increased relative weights of liver and spleen were also found in LPS treated pullets, whereas LPS decreased those of pancreas, bursa, thymus, and cecal tonsils. Moreover, LPS lowered the sum of plasma amino acids and decreased plasma concentrations of Arg, citrulline, glutamate, methionine, ornithine, phenylalanine, proline, tryptophan, and tyrosine, and increased those of aspartate, glutamine, lysine, 1- and 3-methyl-histidine. Elevating concentrations of dietary Arg led to increasing plasma concentrations of Arg, citrulline, ornithine, and 3-methyl-histidine subsequently. As quantitative expression of LPS-induced anorexia, proteolysis, and the following changes in plasma amino acids, pullets showed a significant decrease of feed and nitrogen intake and catabolic metabolism characterized by negative nitrogen balance and body weight loss in the first 24 hours post injectionem. Pullets recovered from the

  1. Background sources at PEP

    Energy Technology Data Exchange (ETDEWEB)

    Lynch, H.; Schwitters, R.F.; Toner, W.T.

    1988-01-01

    Important sources of background for PEP experiments are studied. Background particles originate from high-energy electrons and positrons which have been lost from stable orbits, ..gamma..-rays emitted by the primary beams through bremsstrahlung in the residual gas, and synchrotron radiation x-rays. The effect of these processes on the beam lifetime are calculated and estimates of background rates at the interaction region are given. Recommendations for the PEP design, aimed at minimizing background are presented. 7 figs., 4 tabs.

  2. Considerations on Ethical Issues of Clinical Research Based on Case Study%基于案例探讨临床研究中的伦理难题

    Institute of Scientific and Technical Information of China (English)

    梁立智; 柴华旗; 李红英; 徐溢涛; 眭文洁

    2015-01-01

    In recent years , with dramatic increase of the number of clinical studies , researchers and ethical committees face with the new challenge of ethical issues about protection of subjects .Based on the experience of previous ethical review , this article summed up a few typical cases of clinical research , involving the practical ethi-cal issues, such as the goal of research , informed consent, and compensation for damage caused by research .And then it analyzed the ethical issues in these cases , and proposed some suggestions for the reference of clinical re-searchers , ethical committees and policy makers .%近年来随着临床研究数量的大幅提升,有关受试者保护的新问题不断挑战着研究者和伦理委员会的伦理智慧。基于既往伦理审查的经验,总结梳理几个典型的临床研究案例,涉及研究目的、知情同意、研究损害赔偿等实践伦理内容,分析其伦理问题,并提出相应的对策,供临床研究者、机构伦理委员会及决策部门参考。

  3. Building Background Knowledge

    Science.gov (United States)

    Neuman, Susan B.; Kaefer, Tanya; Pinkham, Ashley

    2014-01-01

    This article make a case for the importance of background knowledge in children's comprehension. It suggests that differences in background knowledge may account for differences in understanding text for low- and middle-income children. It then describes strategies for building background knowledge in the age of common core standards.

  4. The considerations for the clinical trials on drug for the treatment of bipolar disorder%治疗双相障碍的药物临床试验设计考虑要点

    Institute of Scientific and Technical Information of China (English)

    郑冬瑞; 赵德恒; 杨焕; 杨志敏

    2013-01-01

    The article introduces considerations for the clinical trials on drugs for the treatment of bipolar disorder in the drug discovery and development. It contains the requirements for the key trial design with specific claims and the requirements for special population.%本文概述了研发治疗双相障碍的药物进行临床试验的基本设计要求及针对特定适应证的关键性试验设计要求和特殊人群研究相关考虑要点.

  5. Extraskeletal myxoid chondrosarcoma presenting as an intradural spinal mass: report of a rare clinical presentation with an emphasis on differential diagnostic considerations

    Directory of Open Access Journals (Sweden)

    Priya Rao

    2014-12-01

    Full Text Available Extraskeletal myxoid chondrosarcoma is a rare soft tissue neoplasm that occurs predominantly in the soft tissues of the lower extremities. Herein we present a case of a 29 year old male who presented with bilateral femoral numbness believed to be the result of prior injury to his back. A magnetic resonance imaging revealed a mass in the T4-T5 epidural space compressing the spinal cord. Laminectomy was performed and the lesion removed piecemeal. The pathology specimen consisted of multiple fragments of dura involved by a myxoid neoplasm with a nodular growth pattern. The tumor cells were arranged in anastomosing cords and strands. Individual tumor cells were small, of uniform size and shape, with small hyperchromatic nuclei and scant eosinophilic cytoplasm. Immunohistochemical stains were performed which showed the tumor cells were diffusely positive for vimentin and focally positive for EMA, S-100 protein and cytokeratin, whereas they were negative for CD34 and CD99. Fluorescence in situ hybridization (FISH studies showed a clonal population of cells with re-arrangement of the EWSR1 locus, confirming the histologic impression of extraskeletal myxoid chondrosarcoma. This is the first report of a case of an extraskeletal myxoid chondrosarcoma arising from the dura, confirmed to have rearrangement of the EWSR1 gene by FISH. There have only been two other cases of dural based extraskeletal myxoid chondrosarcoma reported prior to our case. We also briefly review the published literature and discuss differential diagnostic considerations for this rare tumor.

  6. What, why, and when we image: considerations for diagnostic imaging and clinical research in the Children's Oncology Group

    Energy Technology Data Exchange (ETDEWEB)

    Reaman, Gregory H. [The George Washington University, School of Medicine and Health Sciences, Division of Hematology Oncology, Children' s National Medical Center, Washington, DC (United States)

    2009-02-15

    Success in improving treatment outcomes in childhood cancer has been achieved almost exclusively through multicenter and multidisciplinary clinical and applied research over several decades. While biologically rational as well as empirical approaches have led to combination chemotherapy and multimodality approaches to therapy, which have given rise to evidence-based practice standards, similar scientific rigor has not always been as evidently applied to modalities utilized to assess initial disease burden and, more important, response to investigational approaches to therapy. As the empirical approach to therapeutic advances has likely maximized its benefit, future progress will require translation of biologic discovery most notably from the areas of genomics and proteomics. Hence, attempts to improve efficacy of therapy will require a parallel effort to minimize collateral damage of future therapeutic approaches, and such a parallel approach will mandate the continued dependence on advances in diagnostic imaging for improvements in staging methodologies to best define risk groups for risk-adjusted therapy. In addition, anatomic and functional assessment of response and surveillance for disease recurrence will require improved understanding of the biology as well as natural history of individual diseases, which one hopes will better inform investigators in designing trials. Clinical and research expertise is urgently needed in the selection of specific imaging studies and frequencies that best assess a response as well as to define disease-free intervals. Despite limited resources to develop sufficient infrastructure, emphasis on enabling early assessment of new technology to minimize risks associated with treatment advances and with those critical diagnostic and staging procedures must continue to be a focus of pediatric cancer clinical research. (orig.)

  7. Disorders related to sexuality and gender identity in the ICD-11: revising the ICD-10 classification based on current scientific evidence, best clinical practices, and human rights considerations.

    Science.gov (United States)

    Reed, Geoffrey M; Drescher, Jack; Krueger, Richard B; Atalla, Elham; Cochran, Susan D; First, Michael B; Cohen-Kettenis, Peggy T; Arango-de Montis, Iván; Parish, Sharon J; Cottler, Sara; Briken, Peer; Saxena, Shekhar

    2016-10-01

    In the World Health Organization's forthcoming eleventh revision of the International Classification of Diseases and Related Health Problems (ICD-11), substantial changes have been proposed to the ICD-10 classification of mental and behavioural disorders related to sexuality and gender identity. These concern the following ICD-10 disorder groupings: F52 Sexual dysfunctions, not caused by organic disorder or disease; F64 Gender identity disorders; F65 Disorders of sexual preference; and F66 Psychological and behavioural disorders associated with sexual development and orientation. Changes have been proposed based on advances in research and clinical practice, and major shifts in social attitudes and in relevant policies, laws, and human rights standards. This paper describes the main recommended changes, the rationale and evidence considered, and important differences from the DSM-5. An integrated classification of sexual dysfunctions has been proposed for a new chapter on Conditions Related to Sexual Health, overcoming the mind/body separation that is inherent in ICD-10. Gender identity disorders in ICD-10 have been reconceptualized as Gender incongruence, and also proposed to be moved to the new chapter on sexual health. The proposed classification of Paraphilic disorders distinguishes between conditions that are relevant to public health and clinical psychopathology and those that merely reflect private behaviour. ICD-10 categories related to sexual orientation have been recommended for deletion from the ICD-11.

  8. New developments in oral contraception: clinical utility of estradiol valerate/dienogest (Natazia® for contraception and for treatment of heavy menstrual bleeding: patient considerations

    Directory of Open Access Journals (Sweden)

    Nelson AL

    2012-12-01

    Full Text Available Anita L NelsonObstetrics and Gynecology, David Geffen School of Medicine at UCLA, Harbor UCLA Medical Center, Torrance, California, USAAbstract: Natazia® is a new oral contraceptive with estradiol valerate and dienogest in a unique multiphasic formulation that includes a shortened hormone-free interval. This new formulation has been approved for both contraception and also as a treatment for heavy menstrual bleeding in women who desire to use oral contraceptives as their method of birth control. It is marketed in the US as Natazia® and elsewhere as Qlaira®. This article will review the properties of each of the major new features of this pill: estradiol used in place of ethinyl estradiol, dienogest as the progestin, and the unique dosing pattern of this product. It will also summarize the results of the pivotal clinical trials of contraceptive effectiveness, bleeding patterns, safety and tolerability. The lessons learned from the clinical trials about the effectiveness of this formulation in the treatment of excessive menstrual bleeding will be summarized. Also, results of trials comparing this new pill to other popular formulations for "menstrually-related" symptoms and for potential female sexual dysfunction related to use of oral contraceptives will be presented. This review will suggest how all this information might be used to counsel women about how to use this pill most successfully.Keywords: oral contraceptives, estradiol valerate, dienogest, heavy menstrual bleeding, menorrhagia, dynamic dosing

  9. Disorders related to sexuality and gender identity in the ICD‐11: revising the ICD‐10 classification based on current scientific evidence, best clinical practices, and human rights considerations

    Science.gov (United States)

    Reed, Geoffrey M.; Drescher, Jack; Krueger, Richard B.; Atalla, Elham; Cochran, Susan D.; First, Michael B.; Cohen‐Kettenis, Peggy T.; Arango‐de Montis, Iván; Parish, Sharon J.; Cottler, Sara; Briken, Peer; Saxena, Shekhar

    2016-01-01

    In the World Health Organization's forthcoming eleventh revision of the International Classification of Diseases and Related Health Problems (ICD‐11), substantial changes have been proposed to the ICD‐10 classification of mental and behavioural disorders related to sexuality and gender identity. These concern the following ICD‐10 disorder groupings: F52 Sexual dysfunctions, not caused by organic disorder or disease; F64 Gender identity disorders; F65 Disorders of sexual preference; and F66 Psychological and behavioural disorders associated with sexual development and orientation. Changes have been proposed based on advances in research and clinical practice, and major shifts in social attitudes and in relevant policies, laws, and human rights standards. This paper describes the main recommended changes, the rationale and evidence considered, and important differences from the DSM‐5. An integrated classification of sexual dysfunctions has been proposed for a new chapter on Conditions Related to Sexual Health, overcoming the mind/body separation that is inherent in ICD‐10. Gender identity disorders in ICD‐10 have been reconceptualized as Gender incongruence, and also proposed to be moved to the new chapter on sexual health. The proposed classification of Paraphilic disorders distinguishes between conditions that are relevant to public health and clinical psychopathology and those that merely reflect private behaviour. ICD‐10 categories related to sexual orientation have been recommended for deletion from the ICD‐11. PMID:27717275

  10. [Strategic considerations on the design and choice of animal models for non-clinical investigations of cell-based medicinal products].

    Science.gov (United States)

    Lehmann, Jörg; Schulz, Ronny M; Sanzenbacher, Ralf

    2015-11-01

    For the development of medicinal products animal models are still indispensable to demonstrate efficacy and safety prior to first use in humans. Advanced therapy medicinal products (ATMP), which include cell-based medicinal products (CBMP), differ in their pharmacology and toxicology compared to conventional pharmaceuticals, and thus, require an adapted regime for non-clinical development. Developers are, therefore, challenged to develop particular individual concepts and to reconcile these with regulatory agencies. Guidelines issued by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA) and other sources can provide direction.The published approaches for non-clinical testing of efficacy document that homologous animal models where the therapeutic effect is investigated in a disease-relevant animal model utilizing cells derived from the same species are commonly used. The challenge is that the selected model should reflect the human disease in all critical features and that the cells should be comparable to the investigated human medicinal product in terms of quality and biological activity. This is not achievable in all cases. In these cases, alternative methods may provide supplemental information. To demonstrate the scientific proof-of-concept (PoC), small animal models such as mice or rats are preferred. During the subsequent product development phase, large animal models (i.e. sheep, minipigs, dogs) must be considered, as they may better reflect the anatomical or physiological situation in humans. In addition to efficacy, those models may also be suitable to prove some safety aspects of ATMP (e.g. regarding dose finding, local tolerance, or undesired interactions and effects of the administered cells in the target tissue). In contrast, for evaluation of the two prominent endpoints for characterizing the safety of ATMP (i.e. biodistribution, tumorigenicity) heterologous small animal models, especially immunodeficient mouse strains

  11. Statistical considerations on missing data in clinical trials%临床试验缺失数据的统计学考量

    Institute of Scientific and Technical Information of China (English)

    王骏; 韩景静; 黄钦

    2016-01-01

    Missing data is a common and important issue in clinical tri-als.It could make the results difficult to be explained , even influence the inference and conclusion of the trial.Currently , not enough emphasis has been given to the problem in China.In the real world of statistical opera-tion in dealing with clinical trial missing data , sponsors often applied va-rious methods without any rational , which introduced many difficulties for evaluating and confirming the safety and efficacy of new drugs.In this paper , three real cases were specifically brought out for illustration and analysis , meanwhile , the prevention of missing data , the choice of esti-mator , statistical analysis methods and sensitivity analysis were also discussed.The aim is to attract the sponsors to focus attention on prevention and treatment of missing data in clinical trials.%缺失数据是临床试验中常见的重要问题,可能引起试验结果难于解释,甚至影响整个试验的推断和结论,但目前在国内临床研究中尚未引起足够的重视。实际应用中,申请人对待缺失数据的处理存在盲目应用统计学方法的现象,给新药安全有效性的评价和确证带来诸多困难。本文针对三个实际案例进行深入地阐述和分析,探讨对缺失数据的预防、估计量的选择、缺失数据的统计分析方法以及敏感性分析等,以期有助于申请人在临床试验中加强对缺失数据预防和处理方法的重视。

  12. 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.

  13. Longitudinal observations of typical English voicing acquisition in a 2-year-old child: Stability of the contrast and considerations for clinical assessment.

    Science.gov (United States)

    Hitchcock, Elaine R; Koenig, Laura L

    2015-01-01

    Early assessment of phonetic and phonological development requires knowledge of typical versus atypical speech patterns, as well as the range of individual developmental trajectories. The nature of data reporting in previous literature on typical voicing acquisition left aspects of the developmental process unclear and limited clinical applicability. This work extends a previous four-month group study to present data for one child over 12 months. Words containing initial /b p d t/ were elicited from a monolingual English-speaking 2-year-old child biweekly for 25 sessions. Voice onset time (VOT) was measured for each stop. For each consonant and recording session, we measured range as well as accuracy, overshoot and discreteness calculated for means and individual tokens. The results underscore the value of token-by-token analyses. They further reveal that typical development may involve an extended period of fluctuating voicing patterns, suggesting that the voiced/voiceless contrast may take months or years to stabilise.

  14. Genetic counselors' current use of personal health records-based family histories in genetic clinics and considerations for their future adoption.

    Science.gov (United States)

    Widmer, Chaney; Deshazo, Jonathan P; Bodurtha, Joann; Quillin, John; Creswick, Heather

    2013-06-01

    Given the widespread adoption of electronic medical records and recent emergence of electronic family history tools, we examined genetic counselors' perspectives on the emerging technology of the personal health record (PHR)-based family history tool that links to an electronic medical record (EMR). Two-hundred thirty-three genetic counselors responded to an on-line survey eliciting current use of electronic family history (EFH) tools and familiarity with PHR-based family history tools. Additionally, after being shown a series of screen shots of a newly developed PHR-based family history tool based on the U.S. Surgeon General's My Family Health Portrait (United States Department of Health and Human Services 2009), participants were surveyed about the perceived usefulness, ease of use, and impact on current workflow that this kind of tool would have in their practices. Eighty-three percent reported that their institution has an EMR, yet only 35 % have a dedicated space for family history. Eighty-two percent reported that less than 5 % of their patients have a PHR, and only 16 % have worked with patients who have a PHR. Seventy-two percent or more agreed that a PHR-based family history tool would facilitate communication, increase accuracy of information, ensure consistency in recording information, increase focus on actual counseling, reduce repetitive questions, improve efficiency, and increase the legibility and clarity. Our findings suggest that participants were familiar with existing EFH tools, but that the majority did not use them in practice. Genetic counselors' adoption of such tools is limited due to non-existence of this kind of technology or inability to integrate it into their clinics. They are also strongly in favor of adopting a PHR-based family history tool in genetics clinics, but have practical concerns that must be addressed before the tool can be implemented.

  15. Evaluation Considerations for Secondary Uses of Clinical Data: Principles for an Evidence-based Approach to Policy and Implementation of Secondary Analysis. A Position Paper from the IMIA Technology Assessment & Quality Development in Health Informatics Working Group.

    Science.gov (United States)

    Scott, P J; Rigby, M; Ammenwerth, E; Brender McNair, J; Georgiou, A; Hyppönen, H; de Keizer, N; Magrabi, F; Nykänen, P; Gude, W T; Hackl, W

    2017-05-08

    To set the scientific context and then suggest principles for an evidence-based approach to secondary uses of clinical data, covering both evaluation of the secondary uses of data and evaluation of health systems and services based upon secondary uses of data. Working Group review of selected literature and policy approaches. We present important considerations in the evaluation of secondary uses of clinical data from the angles of governance and trust, theory, semantics, and policy. We make the case for a multi-level and multi-factorial approach to the evaluation of secondary uses of clinical data and describe a methodological framework for best practice. We emphasise the importance of evaluating the governance of secondary uses of health data in maintaining trust, which is essential for such uses. We also offer examples of the re-use of routine health data to demonstrate how it can support evaluation of clinical performance and optimize health IT system design. Great expectations are resting upon "Big Data" and innovative analytics. However, to build and maintain public trust, improve data reliability, and assure the validity of analytic inferences, there must be independent and transparent evaluation. A mature and evidence-based approach needs not merely data science, but must be guided by the broader concerns of applied health informatics.

  16. Clinical risk assessment for gastric cancer in asymptomatic population after a health check-up: An individualized consideration of the risk factors.

    Science.gov (United States)

    Park, Yoo Mi; Kim, Jie-Hyun; Baik, Su Jung; Park, Jae Jun; Youn, Young Hoon; Park, Hyojin

    2016-11-01

    For the prevention of gastric cancer, the detection of risk factors associated with precancerous conditions may be more informative. The aim of this study was to identify the risk factors of gastric cancer, including precancerous conditions: atrophic gastritis (AG), intestinal metaplasia (IM), and dysplasia.The clinical and endoscopic findings of 60,261 adults who underwent gastroduodenoscopy as part of a health check-up were reviewed retrospectively. Subgroup analysis was conducted according to age, sex, cancer stage, and histology based on Lauren classification.Gastric cancer was diagnosed in 75 patients (0.12%). Both IM and AG were independent risk factors for gastric cancer in all subgroups. Male, older age, obesity, diabetes mellitus (DM), a salty and spicy diet, and Helicobacter pylori (H. pylori) were significantly associated with precancerous conditions. However, risk factors related to precancerous conditions were different according to age and sex. In obesity was significant risk factor for precancerous conditions as well as H. pylori infection.AG and IM are independent risk factors for gastric cancer. To prevent gastric cancer, H. pylori eradication may be more useful in obesity, salty and spicy diet may be important in female or ≥40 years.

  17. Clinical validation protocols for noninvasive blood pressure monitors and their recognition by regulatory authorities and professional organizations: rationale and considerations for a single unified protocol or standard.

    Science.gov (United States)

    Ng, Kim-Gau

    2013-10-01

    Standardized protocols for validating the clinical accuracy of noninvasive blood pressure (NIBP) monitors have been available since 1987. Some of them were developed by standards bodies and others by professional organizations. They have been well-tested through use and progressively improved through multiple revisions; however, many methodological differences exist between them. In addition, for the purpose of regulatory approval or marketing clearance, some protocols are recognized in some countries but not in others; thus, manufacturers have to validate their NIBP monitors to more than one protocol in order to market them worldwide. The use of different protocols not only makes it difficult to compare one device with another but also complicates the validation, regulatory approval, marketing, and public acceptance of NIBP monitors, creating undue burden on manufacturers and unnecessary confusion among users. There is a need for protocol developers, standards bodies, and regulatory authorities to work together to develop and agree on a single unified protocol or standard, one that builds on the strengths of the various protocols that have been developed so far. It is apparent that there is already a trend toward convergence of the various protocols into two protocols, namely, the ISO 81060-2:2009 standard and the 2010 European Society of Hypertension International Protocol. With further reconciliation and consensus, it should be possible to integrate the best features of the ISO, European Society of Hypertension, and other protocols, along with further improvements, into a single unified protocol or standard.

  18. The Spanish Society of Neurology's official clinical practice guidelines for epilepsy. Special considerations in epilepsy: comorbidities, women of childbearing age, and elderly patients.

    Science.gov (United States)

    Mauri Llerda, J A; Suller Marti, A; de la Peña Mayor, P; Martínez Ferri, M; Poza Aldea, J J; Gomez Alonso, J; Mercadé Cerdá, J M

    2015-10-01

    The characteristics of some population groups (patients with comorbidities, women of childbearing age, the elderly) may limit epilepsy management. Antiepileptic treatment in these patients may require adjustments. We searched articles in Pubmed, clinical practice guidelines for epilepsy, and recommendations by the most relevant medical societies regarding epilepsy in special situations (patients with comorbidities, women of childbearing age, the elderly). Evidence and recommendations are classified according to the prognostic criteria of Oxford Centre of Evidence-Based Medicine (2001) and the European Federation of Neurological Societies (2004) for therapeutic interventions. Epilepsy treatment in special cases of comorbidities must be selected properly to improve efficacy with the fewest side effects. Adjusting antiepileptic medication and/or hormone therapy is necessary for proper seizure management in catamenial epilepsy. Exposure to antiepileptic drugs (AED) during pregnancy increases the risk of birth defects and may affect fetal growth and/or cognitive development. Postpartum breastfeeding is recommended, with monitoring for adverse effects if sedative AEDs are used. Finally, the elderly are prone to epilepsy, and diagnostic and treatment characteristics in this group differ from those of other age groups. Although therapeutic limitations may be more frequent in older patients due to comorbidities, they usually respond better to lower doses of AEDs than do other age groups. Copyright © 2014 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

  19. Clinical considerations on glaucomatocylitic crisis%青光眼睫状体炎综合征的临床思考

    Institute of Scientific and Technical Information of China (English)

    李树宁

    2013-01-01

    Glaucomatocylitic crisis is a common type of secondary glaucoma ,which is characterized by anterioruveitis and intraocular hypertension .The treatment is mainly control the development of inflammation by local application of corticosteroids during the attack .In present theory , it is not difficult to diagnose glaucomatocylitic crisis.But in clinical work,many problems still exist.The aim of this paper is to explore the blind area of diagnosis of glaucomatocylitic crisis , the exisisting dispute and the issues that required attention .%青光眼睫状体炎综合征为常见的继发性青光眼,是前部葡萄膜炎伴青光眼的一种特殊形式,治疗方法主要是在发作期间局部应用皮质类固醇,控制炎症发展。目前理论认为青光眼睫状体炎综合征的诊断较容易,但在实际的临床工作中,对于诊断和治疗该疾病还存在很多的模糊问题困扰着广大医护工作者。本文就临床工作中医生在诊断青光眼睫状体炎综合征出现的误区、鉴别要点、存在的争论以及需要注意的问题进行分析和评论。

  20. The Cosmic Microwave Background

    OpenAIRE

    Silk, Joseph

    2002-01-01

    This set of lectures provides an overview of the basic theory and phenomenology of the cosmic microwave background. Topics include a brief historical review; the physics of temperature and polarization fluctuations; acoustic oscillations of the primordial plasma; the space of inflationary cosmological models; current and potential constraints on these models from the microwave background; and constraints on inflation.

  1. Supersymmetric heterotic string backgrounds

    NARCIS (Netherlands)

    Gran, U.; Papadopoulos, G.; Roest, D.; Cvetič, M.

    2007-01-01

    We present the main features of the solution of the gravitino and dilatino Killing spinor equations derived in hep-th/0510176 and hep-th/0703143 which have led to the classification of geometric types of all type I backgrounds. We then apply these results to the supersymmetric backgrounds of the het

  2. The Athena Background

    Science.gov (United States)

    Piro, Luigi; Lotti, Simone; Macculi, Claudio; Molendi, Silvano; Eraerds, Tanja; Laurent, Philippe

    2015-09-01

    Estimating, reducing and controlling the residual particle background is fundamental for achieving the objectives of several science topics of Athena, in particular those connected with background dominated observations of faint and/or diffuse sources. This requires assessing the particle environment in L2, propagating the various particle components throughout the mirror, spacecraft, and instruments via proper modelling and simulations of various physical processes, implementing design and h/w measures at instrument and mission level to reduce the un-rejected background and identifying proper calibration methods to control the background variations. Likewise, an adequate knowledge of the XRB, made of components that may vary spatially or temporally, is required as well. Here we will review the present status of the background knowledge, and summarize the activities on-going within Athena at various levels.

  3. Considerações clínicas e cirúrgicas sobre aneurismas intracranianos Clinical and surgical considerations on intracranial aneurysms

    Directory of Open Access Journals (Sweden)

    Mário S. Cademartori

    1969-09-01

    Full Text Available São revistos os principais sintomas apresentados por 83 pacientes com aneurismas intracranianos nas seguintes localizações: 41 no sistema carotídeo, 19 no da artéria silviana, 19 no da artéria cerebral anterior e 4 no da artéria basilar. Como método de tratamento, a cirurgia intracraniana foi realizada em 49 pacientes, dos quais 27 apresentavam aneurisma no sifão carotídeo, 14 na cerebral média e 8 na cerebral anterior. A mortalidade operatoria foi de 37% entre os pacientes com aneurisma do sifão carotídeo, de 28,5% nos do grupo da artéria silviana e de 50% nos do grupo da artéria cerebral anterior. Não houve óbito nos 7 pacientes nos quais foi feita oclusão da carótida. A morbilidade foi de 12% nos casos de aneurismas carotídeos, de 20% nos de aneurismas da cerebral média, de 50% nos de cerebral anterior e de 29% naqueles em que a carótida primitiva foi ligada. Como métodos auxiliares, foi utilizada a hipotermia com circulação extra-corpórea em dois pacientes com aneurismas da artéria comunicante anterior e drenagem espinhal contínua em 19 casos. Controles arteriográficos pós-operatórios, feitos em 16 casos, permitiram verificar a eficácia dos procedimentos utilizados bem como algumas falhas de técnica cirúrgica.The clinical manifestations presented by 83 patients with intracranial aneurysms are reviewed. The site of the aneurysms were: 41 in the internal carotid, 19 in the middle cerebral, 19 in the anterior cerebral and 4 in the basilar artery. Rebleeding occurred in 17 cases; 12 of these patients died, Intracranial surgery was undertaken in 27 cases of aneuysms of the carotid, 14 the middle cerebral and 8 of the anterior cerebral artery. Seven patients were treated by occlusion of the internal carotid in the neck. Surgical mortality was of 37% among the cases of aneurysms of the carotid, of 28,5% among the middle cerebral artery cases and of 50% in those with aneurysms in the anterior cerebral artery system

  4. 幽门螺杆菌非临床研究试验的评价和思考%Evaluation and consideration on pre-clinical tests of Helicobacter pylori

    Institute of Scientific and Technical Information of China (English)

    笪红远

    2013-01-01

    根除幽门螺杆菌(Helicobacter pylori,简称HP)可以明显减低消化性溃疡复发率或使溃疡愈合是被普遍认可的事实,随着对HP研究的深入,认知评判非临床药效学HP试验结果的意义和研究价值逐渐清晰,在研究新药(包括化学药品、中药和天然药物)作用特点、支持临床试验方案设计等方面具有突出意义,众多HP非临床试验研究报道反映的问题值得在新药评价中关注和思考.%It is a generally accepted fact that Helicobacter pylori HP) eradication can reduce the recurrence of peptic ulcer and promote ulcer healing significantly.The significance of understanding and evaluating the value of the results of pre-clinical pharmacodynamic tests of HP has become progressively clear for investigating the characteristics of drug action (including chemical drugs,traditional Chinese medicines and natural medicines) and design of clinical trials on HP.The problems reflected by numerous pre-clinical tests on HP are worth of our attention and consideration in new drug evaluation.

  5. The considerations for the clinical trials on drugs intended for the treatment of neu-ropathic pain%神经病理性疼痛药物的临床研究设计考虑要点

    Institute of Scientific and Technical Information of China (English)

    耿莹; 赵德恒; 杨焕; 杨志敏

    2014-01-01

    神经病理性疼痛的治疗是全球性的医学难题,需要多学科参与,但药物治疗仍占据核心地位,研发安全有效的治疗药物是临床迫切需求。本文简要介绍研发神经病理性疼痛治疗药物的临床试验设计考虑要点,供制药企业和临床研究者参考。%Neuropathic pain is one of the global medical difficulties , and it requires a multidisciplinary participation , but the core method still is the drug.To develop safe and effective drugs intended for the treatment of neuropathic pain is very important for clinical treatment.This article introduces considerations for the clinical trial designs of developing drugs intended for the treatment of neuropathic pain , offering helps for pharma-ceutical enteprises and clinical investigators.

  6. Cosmogenic Backgrounds to 0{\

    CERN Document Server

    :,; Auty, D J; Barbeau, P S; Beck, D; Belov, V; Breidenbach, M; Brunner, T; Burenkov, A; Cao, G F; Chambers, C; Cleveland, B; Coon, M; Craycraft, A; Daniels, T; Danilov, M; Daugherty, S J; Davis, J; Delaquis, S; Der Mesrobian-Kabakian, A; DeVoe, R; Didberidze, T; Dilling, J; Dolgolenko, A; Dolinski, M J; Dunford, M; Fairbank, W; Farine, J; Feldmeier, W; Feyzbakhsh, S; Fierlinger, P; Fudenberg, D; Gornea, R; Graham, K; Gratta, G; Hall, C; Herrin, S; Hughes, M; Jewell, M J; Johnson, A; Johnson, T N; Johnston, S; Karelin, A; Kaufman, L J; Killick, R; Koffas, T; Kravitz, S; Krücken, R; Kuchenkov, A; Kumar, K S; Leonard, D S; Licciardi, C; Lin, Y H; Ling, J; MacLellan, R; Marino, M G; Mong, B; Moore, D; Njoya, O; Nelson, R; Odian, A; Ostrovskiy, I; Piepke, A; Pocar, A; Prescott, C Y; Retière, F; Rowson, P C; Russell, J J; Schubert, A; Sinclair, D; Smith, E; Stekhanov, V; Tarka, M; Tolba, T; Tsang, R; Twelker, K; Vuilleumier, J -L; Waite, A; Walton, J; Walton, T; Weber, M; Wen, L J; Wichoski, U; Wood, J; Yang, L; Yen, Y -R; Zeldovich, O Ya

    2015-01-01

    As neutrinoless double-beta decay experiments become more sensitive and intrinsic radioactivity in detector materials is reduced, previously minor contributions to the background must be understood and eliminated. With this in mind, cosmogenic backgrounds have been studied with the EXO-200 experiment. Using the EXO-200 TPC, the muon flux (through a flat horizontal surface) underground at the Waste Isolation Pilot Plant (WIPP) has been measured to be {\\Phi} = 4.07 $\\pm$ 0.14 (sys) $\\pm$ 0.03 (stat) $\\times$ $10^{-7}$cm$^{-2}$ s$^{-1}$, with a vertical intensity of $I_{v}$ = 2.97$^{+0.14}_{-0.13}$ (sys) $\\pm$ 0.02 (stat) $\\times$ $10^{-7}$cm$^{-2}$ s$^{-1}$ sr$^{-1}$. Simulations of muon-induced backgrounds identified several potential cosmogenic radionuclides, though only 137Xe is a significant background for the 136Xe 0{\

  7. On Background Independence

    CERN Document Server

    Anderson, Edward

    2013-01-01

    This paper concerns what Background Independence itself is (as opposed to some particular physical theory that is background independent). The notions presented mostly arose from a layer-by-layer analysis of the facets of the Problem of Time in Quantum Gravity. Part of this coincides with two relational postulates which are thus identified as classical precursors of two of the facets of the Problem of Time. These are furthemore tied to the forms of each of the GR Hamiltonian and momentum constraints. Other aspects of Background Independence include the algebraic closure of these constraints, expressing physics in terms of beables, foliation independence as implemented by refoliation invariance, the reconstruction of spacetime from space. The final picture is that Background Independence - a philosophically desirable and physically implementable feature for a theory to have - has the facets of the Problem of Time among its consequences. Thus these arise naturally and are problems to be resolved, as opposed to ...

  8. Zambia Country Background Report

    DEFF Research Database (Denmark)

    Hampwaye, Godfrey; Jeppesen, Søren; Kragelund, Peter

    This paper provides background data and general information for the Zambia studies focusing on local food processing sub­‐sector; and the local suppliers to the mines as part of the SAFIC project (Successful African Firms and Institutional Change).......This paper provides background data and general information for the Zambia studies focusing on local food processing sub­‐sector; and the local suppliers to the mines as part of the SAFIC project (Successful African Firms and Institutional Change)....

  9. 7 CFR 799.1 - Background.

    Science.gov (United States)

    2010-01-01

    ... ENVIRONMENTAL PROTECTION ENVIRONMENTAL QUALITY AND RELATED ENVIRONMENTAL CONCERNS-COMPLIANCE WITH THE NATIONAL ENVIRONMENTAL POLICY ACT § 799.1 Background. The National Environmental Policy Act (NEPA) of 1969 (42 U.S.C.... Section (102)(2) also requires all Federal agencies to give appropriate consideration to the...

  10. 糖尿病肾病中药临床试验伦理调查与思考%Ethical Investigations and Considerations of Clinical Trials of TCM in Diabetic Nephropathy Management

    Institute of Scientific and Technical Information of China (English)

    王珍; 商建伟; 田金洲; 柳红芳

    2013-01-01

    With the high incidence of diabetic nephropathy, the clinical trials of traditional Chinese medicine (TCM) in diabetic nephropathy area play an important role in the development of this subject. Therefore, follow-ing the principles of medical ethics, issues of fully understanding professional requirements of ethics review for clinical research of diabetic nephropathy and the protection of patients' rights are questions which should be solved. This article was based on the investigations on ethical needs of experts and patients in diabetic nephropathy area of TCM clinical trials . Discussions and considerations were made on results . A the more per-fect and regulated medical informed consent formwork for diabetic nephropathy of TCM clinical trials was made based on these consultations .%随着糖尿病肾病的发病率日益升高,目前有关糖尿病肾病的中药临床试验越来越多。因此在遵循医学伦理原则前提下,如何充分了解糖尿病肾病临床研究伦理审查的专业需求,保障受试者权益,是糖尿病肾病中药临床研究亟需解决的问题。本课题分别对糖尿病肾病领域专家和患者进行有关中药临床试验的伦理研究调查,并对结果进行了讨论与思考,在此基础上制定了更为规范完善的糖尿病肾病中药临床试验知情同意书模板。

  11. Early spay-neuter: clinical considerations.

    Science.gov (United States)

    Kustritz, Margaret V Root

    2002-08-01

    Early spay-neuter is ovariohysterectomy or castration of puppies or kittens 6 to 14 weeks of age. Pediatric animals may have an enhanced response to relatively low doses of anesthetic agents. Animals should be fasted no more than 3 to 4 hours before surgery to prevent hypoglycemia, and hypothermia should be avoided. Heart and respiratory rates must be monitored carefully throughout anesthesia. Pediatric gonadectomy surgeries are quick with minimal bleeding. Anesthetic recovery is rapid. No significant short-term or long-term effects have been reported. Prepuberal gonadectomy is most useful for humane organizations and conscientious breeders wishing to preclude reproduction of pet dogs and cats while placing animals at a young enough age to optimize socialization and training.

  12. Sphenoidal emissary foramen and its clinical consideration

    Directory of Open Access Journals (Sweden)

    Surekha D. Jadhav

    2016-07-01

    Methods: Two hundred and fifty (right 250; left-250 dry Indian adult skulls of unknown age and sex were used for this study. Middle cranial fossa of each skull was macroscopically observed for the presence, absence of sphenoidal emissary foramen. Patency was confirmed by inserting a bristle through each probable foramen and only patent foramen were calculated. Results: We observed that sphenoidal emissary foramen was present in 72 (28.8% skulls. Unilaterally it was present in 17.6% and bilaterally in 11.2% skulls. Conclusions: Incidence of this foramen is variable and therefore recognition of this anatomical structure is important. Knowledge of their variations will be helpful for neurosurgeons and radiologist. [Int J Res Med Sci 2016; 4(7.000: 2926-2929

  13. Regulatory considerations for biosimilars

    Directory of Open Access Journals (Sweden)

    Ranjani Nellore

    2010-01-01

    Full Text Available Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved "similar" biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products.

  14. Exploring String Theory Backgrounds

    CERN Document Server

    Williams, B P

    2004-01-01

    This thesis examines phenomenological and theoretical questions by exploring string theoretic backgrounds. Part I focuses on cosmology. First we propose that the induced metric along a brane moving through a curved bulk may be interpreted as the cosmology of the brane universe, providing a resolution to the apparent cosmological singularity on the brane. We then look at various decay channels of the certain meta-stable de Sitter vacua and show that there exist NS5-brane meditated decays which are much faster than decays to decompactification. Part II discusses a new class of nongeometric vacua in string theory. These backgrounds may be described locally as T2 fibrations. By enlarging the monodromy group of the fiber to include perturbative stringy duality symmetries we are able to explicitly construct nongeometric backgrounds.

  15. Cosmic Tachyon Background Radiation

    CERN Document Server

    Tomaschitz, R

    1999-01-01

    The equilibrium statistical mechanics of a background radiation of superluminal particles is investigated, based on a vectorial wave equation for tachyons of the Proca type. The partition function, the spectral energy density, and the various thermodynamic variables of an ideal Bose gas of tachyons in an open Robertson-Walker cosmology are derived. The negative mass square in the wave equation changes the frequency scaling in the Rayleigh-Jeans law, and there are also significant changes in the low temperature regime as compared to the microwave background, in particular in the caloric and thermal equations of state.

  16. China: Background Notes Series.

    Science.gov (United States)

    Reams, Joanne Reppert

    Concise background information on the People's Republic of China is provided. The publication begins with a profile of the country, outlining the people, geography, economy, and membership in international organizations. The bulk of the document then discusses in more detail China's people, geography, history, government, education, economy, and…

  17. 从贝尔蒙报告审视医疗器械临床试验的伦理问题%Considerations of ethical issues in clinical trials for medical equipments from the perspective of the Belmont Report

    Institute of Scientific and Technical Information of China (English)

    嵇承栋; 蒋燕; 朱明; 吴炜敏; 周珏榕; 张勘

    2013-01-01

    医疗器械临床试验是最直接最有效地检测医疗器械性能的方式,贝尔蒙报告是对基本的道德原则及方针的陈述,用来帮助在解决涉及人体实验对象的科研中所产生的道德问题.本文从贝尔蒙报告角度来审视医疗器械临床试验的伦理问题,介绍了贝尔蒙报告产生的背景概念和医疗器械临床试验的概念及基本流程;贝尔蒙报告中的三项原则尊重个人、善行和平等公正原则在医疗器械临床试验中的体现以及针对贝尔蒙报告来解决医疗器械临床试验中产生的伦理问题的重大意义.通过知情同意的具体体现、对风险和好处的评估及受试者的选择和研究成果的分配三方面来解决临床试验中产生的伦理问题.%Clinical trial is the most direct and the most effective way to test the performance of medical equipments.The Belmont Report is the statement of the basic moral principles and guidelines,used to help solve the moral problems produced in scientific researches involving human subjects.This apaper examines the ethical issues in clinical trials for medical equipments from the perspective of the Belmont report.It first introduces the background and basic concepts of Belmont report,background concept and the concept and the basic process of medical equipment clinical trials.Then the three principles of the Belmont Report is presented and how to apply the Report to solve ethical problems arising in medical equipment trials.Application of informed consent risk and benefits assessment,and selection of subjects participants and the distribution of research results to address the ethical issues arising in clinical trials.

  18. Clinical Competence: General Ability or Case-Specific?

    Science.gov (United States)

    Wimmers, Paul F.; Splinter, Ted A. W.; Hancock, Gregory R.; Schmidt, Henk G.

    2007-01-01

    Background: Before the 1970s, research into the development of clinical competence was mainly focused on general problem-solving abilities. The scope of research changed when Elstein and colleagues discovered that individual ability to solve clinical problems varies considerably across cases. It was concluded that problem solving abilities are…

  19. Clinical competence : General ability or case-specific?

    NARCIS (Netherlands)

    Wimmers, Paul F.; Splinter, Ted A. W.; Hancock, Gregory R.; Schmidt, Henk G.

    2007-01-01

    Background: Before the 1970s, research into the development of clinical competence was mainly focused on general problem-solving abilities. The scope of research changed when Elstein and colleagues discovered that individual ability to solve clinical problems varies considerably across cases. It was

  20. Self-Neglect: Ethical Considerations.

    Science.gov (United States)

    Day, Mary Rose; Leahy-Warren, Patricia; McCarthy, Geraldine

    2016-01-01

    Self-neglect is a significant international public health issue. Estimates suggest that there may be over one million cases per year in the United States. Aging populations will put more people at risk of self-neglect. This chapter presents background literature, self-neglect definitions and policy context, risk factors, and a brief overview of research on perspectives of self-neglect from both clients and community health and social care professionals. A case study is presented from the perspective of an individual and is used to explore ethical issues therein. A person-centered assessment within a multidisciplinary team approach is required for building a therapeutic relationship with clients. Capacity is a central issue in the management of responses to self-neglect. Ethical considerations of importance for community health and social care professionals include beneficence and nonmaleficence, autonomy and capacity, and respect for people's rights and dignity. A model of ethical justification is presented to explain dilemmas, challenges, and actions. Competence of professionals, multidisciplinary team working, informed consent, privacy, confidentiality, and best interest are also critical considerations. Effective decision making by an interdisciplinary team of professionals needs to be person-centered and give due consideration to the best interest of self-neglecting clients. The purpose of this chapter is to provide an in-depth discussion and examination of ethical issues and challenges relating to self-neglecting clients.

  1. Celiac disease - nutritional considerations

    Science.gov (United States)

    ... this page: //medlineplus.gov/ency/article/002443.htm Celiac disease - nutritional considerations To use the sharing features on this page, please enable JavaScript. Celiac disease is an immune disorder passed down through families. ...

  2. The extragalactic IR background

    CERN Document Server

    De Zotti, G; Mazzei, P; Toffolatti, L; Danese, L; De Zotti, G; Franceschini, A; Mazzei, P; Toffolatti, L; Danese, L

    1994-01-01

    Current limits on the intensity of the extragalactic infrared background are consistent with the expected contribution from evolving galaxies. Depending on the behaviour of the star formation rate and of the initial mass function, we can expect that dust extinction during early evolutionary phases ranges from moderate to strong. An example of the latter case may be the ultraluminous galaxy IRAS F10214 + 4724. The remarkable lack of high redshift galaxies in faint optically selected samples may be indirect evidence that strong extinction is common during early phases. Testable implications of different scenarios are discussed; ISO can play a key role in this context. Estimates of possible contributions of galaxies to the background under different assumptions are presented. The COBE/FIRAS limits on deviations from a blackbody spectrum at sub-mm wavelengths already set important constraints on the evolution of the far-IR emission of galaxies and on the density of obscured (``Type 2'') AGNs. A major progress in ...

  3. Background and introduction

    DEFF Research Database (Denmark)

    2012-01-01

    background information to understand the following chapters in this book. Research limitations: The chapter is mainly based on the experience and knowledge of the editors. It does not include original research but provides an introductory overview of the book. Originality/value: This chapter takes a look......Purpose: To explain the purpose and background of this book and introduce the three basic perspectives behind the research presented as well as the structure and editing process of the book. Methodology: The editors shared and discussed individual contributions to this chapter, based on their own...... expertise, the involvement in the process leading to this the book including a number of workshops, and a literature review of the development of their disciplinary fields: Facilities Management (FM), Corporate Real Estate Management (CREM) and Business to Business (B2B) Marketing. Findings: The difference...

  4. The Cosmic Microwave Background

    Directory of Open Access Journals (Sweden)

    Jones Aled

    1998-01-01

    Full Text Available We present a brief review of current theory and observations of the cosmic microwave background (CMB. New predictions for cosmological defect theories and an overview of the inflationary theory are discussed. Recent results from various observations of the anisotropies of the microwave background are described and a summary of the proposed experiments is presented. A new analysis technique based on Bayesian statistics that can be used to reconstruct the underlying sky fluctuations is summarised. Current CMB data is used to set some preliminary constraints on the values of fundamental cosmological parameters $Omega$ and $H_circ$ using the maximum likelihood technique. In addition, secondary anisotropies due to the Sunyaev-Zel'dovich effect are described.

  5. DOE handbook: Design considerations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-04-01

    The Design Considerations Handbook includes information and suggestions for the design of systems typical to nuclear facilities, information specific to various types of special facilities, and information useful to various design disciplines. The handbook is presented in two parts. Part 1, which addresses design considerations, includes two sections. The first addresses the design of systems typically used in nuclear facilities to control radiation or radioactive materials. Specifically, this part addresses the design of confinement systems and radiation protection and effluent monitoring systems. The second section of Part 1 addresses the design of special facilities (i.e., specific types of nonreactor nuclear facilities). The specific design considerations provided in this section were developed from review of DOE 6430.1A and are supplemented with specific suggestions and considerations from designers with experience designing and operating such facilities. Part 2 of the Design Considerations Handbook describes good practices and design principles that should be considered in specific design disciplines, such as mechanical systems and electrical systems. These good practices are based on specific experiences in the design of nuclear facilities by design engineers with related experience. This part of the Design Considerations Handbook contains five sections, each of which applies to a particular engineering discipline.

  6. Application of Ridit method with consideration of medical risk in clinical departments'performance appraisal%Ridit 分析法结合医疗风险在临床科室绩效考核中的应用

    Institute of Scientific and Technical Information of China (English)

    赵娜

    2015-01-01

    目的:探讨公平公正的临床科室绩效考核方法,为绩效工资分级提供参考。方法Ridit分析法结合医疗风险综合评价各临床科室工作业绩。结果分级医疗质量以及医疗风险,医疗质量与医疗风险叠加,得出综合评价值,将绩效工资分为Ⅰ、Ⅱ、Ⅲ、Ⅳ4个等级,综合评价值为7~8为Ⅰ级;6为Ⅱ级;4~5为Ⅲ级;2~3为Ⅳ级。结论建立按工作业绩取酬的公平、公正的科室绩效评价体系对医院的长远发展起着至关重要的作用,Ridit 分析法结合医疗风险综合评价体现向业绩优、风险大、效率高倾斜的绩效评价准则。%Objective To develop a fair performance appraisal method for clinical departments,as a reference for grading performance pay.Methods Ridit method with consideration of medical risks is used to evaluate clinical departments'performance.Results Both quality of care and medical risk are graded and overlaid,to arrive at the comprehensive values on which the performance pay is divided into grades Ⅰ,Ⅱ,Ⅲ,and Ⅳ.In this practice,values 7 ~8 is grade Ⅰ,6 grade Ⅱ,4 ~ 5 grade Ⅲ,and 2~3 gradeⅣ.Conclusion A fair and justifiable department performance evaluation system that is based on performance proves vital for the sustainable development of the hospital. Ridit method with consideration of medical risk evaluation advocates the performance appraisal principle of encouraging better performance,high risk and high efficiency.

  7. [Hypertension In pregnancy: practical considerations].

    Science.gov (United States)

    Jaafar, Jaafar; Pechère-Bertschi, Antoinette; Ditisheim, Agnès

    2014-09-10

    Hypertension is the most frequent medical disorder of pregnancy. Whether in the form of a chronic hypertension or a pregnancy induced-hypertension, or preeclampsia, it is associated with major maternal and neonatal morbidity and mortality. Improvement of prenatal care allowed a reduction in the number of poor outcomes. However, our partial understanding of the origin of gestational hypertension and preeclampsia limits the establishment of robust prediction models and efficient preventive interventions. This review discusses actual considerations on the clinical approach to hypertension in pregnancy.

  8. Malaysia; Background Paper

    OpenAIRE

    International Monetary Fund

    1996-01-01

    This Background Paper on Malaysia examines developments and trends in the labor market since the mid-1980s. The paper describes the changes in the employment structure and the labor force. It reviews wages and productivity trends and their effects on unit labor cost. The paper highlights that Malaysia’s rapid growth, sustained since 1987, has had a major impact on the labor market. The paper outlines the major policy measures to address the labor constraints. It also analyzes Malaysia’s r...

  9. Family Background and Entrepreneurship

    DEFF Research Database (Denmark)

    Lindquist, Matthew J.; Sol, Joeri; Van Praag, Mirjam

    Vast amounts of money are currently being spent on policies aimed at promoting entrepreneurship. The success of such policies, however, rests in part on the assumption that individuals are not ‘born entrepreneurs’. In this paper, we assess the importance of family background and neighborhood...... treatment within families by gender and birth order does little to further increase our estimates of the importance of family-wide factors. We then go on to show that neighborhood effects, sibling peer effects, and parental income and education explain very little of these correlations. Parental...

  10. Ultraviolet Background Radiation (Preprint)

    Science.gov (United States)

    1991-03-01

    importance is that the sky may be truly outstandingly black in the far ultraviolet, offering a "dark site " that is unprecedented in astronomy...Estimated spectral energy distribution of the night-sky background near the zenith at an excellent ground-based site on a moonless night and in a...1977. Ap. J. Suppl. 33:451 31. Henry, R. C. 1981. Ap. J. Lett. 244: L69 32. Henry, R. C. 1981. 16th Rencontre de Moriond, ed. J. Tran Thanh Van, p

  11. Family Background and Entrepreneurship

    DEFF Research Database (Denmark)

    Lindquist, Matthew J.; Sol, Joeri; Van Praag, Mirjam

    Vast amounts of money are currently being spent on policies aimed at promoting entrepreneurship. The success of such policies, however, rests in part on the assumption that individuals are not ‘born entrepreneurs’. In this paper, we assess the importance of family background and neighborhood...... treatment within families by gender and birth order does little to further increase our estimates of the importance of family-wide factors. We then go on to show that neighborhood effects, sibling peer effects, and parental income and education explain very little of these correlations. Parental...

  12. Background and introduction

    DEFF Research Database (Denmark)

    2012-01-01

    by their particular theories and conceptual analyses, data, tools, and best practices, with a focus on respectively costs and benefits of facilities and services, alignment of corporate and public real estate to organizational objectives and organisational performance, and relationship management in market...... background information to understand the following chapters in this book. Research limitations: The chapter is mainly based on the experience and knowledge of the editors. It does not include original research but provides an introductory overview of the book. Originality/value: This chapter takes a look...... behind the scenes of the making of this book and connects contributions from three different fields - FM, CREM, and B2B marketing - to shed more light on the concept of added value of FM. It serves as an introduction to the research presented in the other chapters in this book....

  13. Backgrounded but not peripheral

    DEFF Research Database (Denmark)

    Hovmark, Henrik

    2013-01-01

    In this paper I pay a closer look at the use of the CENTRE-PERIPHERY schema in context. I address two specific issues: first, I show how the CENTRE-PERIPHERY schema, encoded in the DDAs, enters into discourses that conceptualize and characterize a local community as both CENTRE and PERIPHERY, i...... in question contribute to the socio-cultural construction of identity, i.e. that they play a rather specific role in discursive communication and socio-cultural meaning construction. On the other hand it is clear that the semantics of the DDAs in question, seen in isolation, is very abstract or general......; furthermore, the DDAs are backgrounded in discourse. Is it reasonable to claim, rather boldly, that “the informants express their identity in the use of the directional adverb ud ‘out’ etc.”? In the course of this article, however, I suggest that the DDAs in question do contribute to the socio...

  14. Cosmic microwave background theory.

    Science.gov (United States)

    Bond, J R

    1998-01-06

    A long-standing goal of theorists has been to constrain cosmological parameters that define the structure formation theory from cosmic microwave background (CMB) anisotropy experiments and large-scale structure (LSS) observations. The status and future promise of this enterprise is described. Current band-powers in -space are consistent with a DeltaT flat in frequency and broadly follow inflation-based expectations. That the levels are approximately (10(-5))2 provides strong support for the gravitational instability theory, while the Far Infrared Absolute Spectrophotometer (FIRAS) constraints on energy injection rule out cosmic explosions as a dominant source of LSS. Band-powers at 100 suggest that the universe could not have re-ionized too early. To get the LSS of Cosmic Background Explorer (COBE)-normalized fluctuations right provides encouraging support that the initial fluctuation spectrum was not far off the scale invariant form that inflation models prefer: e.g., for tilted Lambda cold dark matter sequences of fixed 13-Gyr age (with the Hubble constant H0 marginalized), ns = 1.17 +/- 0.3 for Differential Microwave Radiometer (DMR) only; 1.15 +/- 0.08 for DMR plus the SK95 experiment; 1.00 +/- 0.04 for DMR plus all smaller angle experiments; 1.00 +/- 0.05 when LSS constraints are included as well. The CMB alone currently gives weak constraints on Lambda and moderate constraints on Omegatot, but theoretical forecasts of future long duration balloon and satellite experiments are shown which predict percent-level accuracy among a large fraction of the 10+ parameters characterizing the cosmic structure formation theory, at least if it is an inflation variant.

  15. Cosmic Microwave Background Mapping

    Science.gov (United States)

    Verkhodanov, O. V.; Doroshkevich, A. G.

    2012-03-01

    The last decade of research in cosmology was connected with the ambitious experiments including space and ground base observations. Among the most impressive results of these investigations are the measurements of the cosmic microwave background (CMB) radiation like WMAP* and Planck. Exactly from the CMB studies, we have started the epoch of the precision cosmology when generally the values of cosmological parameters have been known and present research is devoted to improvement of the precision. These achievements are connected with both the creation of the new facilities in millimeter and submillimeter astronomy (e.g., satellites, receivers, antennas, computers) and development of the methods for the CMB data analysis. Actually, the process of data analysis contains several technical stages including 1. Registration of time-ordered data (TOD) 2. Pixelization of the CMB data - map preparation 3. Component separation 4. Map statistics analysis 5. Map - spherical harmonics transformation 6. C(l)-spectrum calculation and spectrum statistics analysis 7. Cosmological parameters estimation Starting from the cosmic background explorer (COBE) experiment using the so-called Quadrilateralized Sky Cube Projection (see [1-3]), the problem of the whole sky CMB pixelization has attracted great interest and many such schemes were developed. Let us note however that accurate pixelization of the CMB data on the sphere is very important but not the final step of analysis. Usually, the next step implies the determination of the coefficients of the spherical harmonic decomposition of the CMB signal for both anisotropy and polarization. This means that some of the pixelization schemes provide a very accurate map but are inconvenient for further decomposition. This also means that the choice of suitable pixelization schemes depends upon the general goals of the investigation. In this review, we consider several of the most popular sky map pixelization schemes and link them with the

  16. Low background infrared (LBIR) facility

    Data.gov (United States)

    Federal Laboratory Consortium — The Low background infrared (LBIR) facility was originally designed to calibrate user supplied blackbody sources and to characterize low-background IR detectors and...

  17. 临床不同背景情况下血友病A的产前诊断方案%Prenatal diagnosis strategy of hemophilia A with different clinical backgrounds

    Institute of Scientific and Technical Information of China (English)

    唐少华; 陈栋; 林晓; 徐峰; 李焕铮; 刘晓丹; 徐献宗; 秦方; 吕建新

    2010-01-01

    Objective To prenatally diagnose HA fetus with different clinical backgrounds. Methods Genetic tests were performed on 15 gravidas subjected for prenatal diagnosis of HA and different methods were employed for diagnosis according to the gestational weeks and clinical data. Amniotic fluid were taken from pregnant women within 23 gestational weeks for direct genotyping and indirect linkage analysis, since these women had probands with clear-cut mutations. Cordocentesis was performed for linkage analysis in pregnant women over 23 gestational weeks with probands whose types of mutation were unknown, while the FⅧ activity tests were carried out simultaneously. For the pregnant women over 23 gestational weeks without proband, cordocentesis was operated for measurement of FⅧ activity and karyotyping, but carriers of hemophilia A could not be detected in these cases. The introns 22 and 1 inversion of F8 gene were identified by long distance-polymerase chain reaction. Nucleotide sequencing was employed if the gene inversion could not be found and linkage analysis of 7 polymorphic markers, including DXS1108, F8Civs13, INTRON22,DXS1073,DXS9901, DXS15, DXS8069 and sex site (Amelo) were applied eventually. Identification of maternal blood contamination must be done before the tests. Results Fifteen samples were identified without maternal blood contamination. Five fetuses were diagnosed with hemophilia A. Meanwhile there were three pregnant women whose cord blood FⅧ activities were less than 1%. One of them was accompanied by trisomy 21; another had inversion mutation in introns 22 of F8 gene; the remaining one was identified with missense mutation in exon 23 (p. Arg2182Cys) of F8 gene. Conclusions Diverse methods should be applied in prenatal diagnosis of hemophilia A with different clinical backgrounds, for the sake of birth defects prevention.%目的建立临床不同背景情况下HA患儿产前诊断方案.方法对前来要求作HA产前诊断的15例孕妇进行

  18. 非侵入性产前检测技术在产前唐氏检测中的伦理思辨%Ethical considerations of non-invasive prenatal testing in Down syndrome prenatal clinical practice

    Institute of Scientific and Technical Information of China (English)

    周萍; 许艳; 明坚; 黄葭燕; 陈英耀

    2015-01-01

    The emerging technique with noninvasive prenatal testing(NIPT) using cell-free fetal deoxyribonucleic acid(DNA) and ribonucleic acid(RNA) in maternal peripheral blood has been reported to be greatly promising for trisomy 21. It has attracted much attention because of its high precision,early and safe testing for the abnormality. However,it has also caused a series of ethical debates and health policy challenges. Through reviewing and analyzing on domestic and international literature and documents,this paper summarized the relative ethical considerations of NIPT in Down’s prenatal clinical practice.%目前,利用孕妇外周血中游离胎儿的脱氧核糖核酸(DNA)、核糖核酸(RNA)测序的非侵入性产前检测技术(non-invasive prenatal testing,NIPT)成为唐氏产前检测中极具应用前景的新兴技术,由于它具有精度高、孕早期即可实施、安全等特性,而备受关注。然而,这项技术也同样引起了一系列伦理争论与卫生政策挑战。文章通过国内外相关文献文件分析,对该技术可能引发的伦理问题进行梳理与总结。

  19. Does treatment of intestinal helminth infections influence malaria? Background and methodology of a longitudinal study of clinical, parasitological and immunological parameters in Nangapanda, Flores, Indonesia (ImmunoSPIN Study

    Directory of Open Access Journals (Sweden)

    Sutanto Inge

    2010-03-01

    Full Text Available Abstract Background Given that helminth infections are thought to have strong immunomodulatory activity, the question whether helminth infections might affect responses to malaria antigens needs to be addressed. Different cross-sectional studies using diverse methodologies have reported that helminth infections might either exacerbate or reduce the severity of malaria attacks. The same discrepancies have been reported for parasitemia. Methods/Design To determine the effect of geohelminth infections and their treatment on malaria infection and disease outcome, as well as on immunological parameters, the area of Nangapanda on Flores Island, Indonesia, where malaria and helminth parasites are co-endemic was selected for a longitudinal study. Here a Double-blind randomized trial will be performed, incorporating repeated treatment with albendazole (400 mg or placebo at three monthly intervals. Household characteristic data, anthropometry, the presence of intestinal helminth and Plasmodium spp infections, and the incidence of malaria episodes are recorded. In vitro cultures of whole blood, stimulated with a number of antigens, mitogens and toll like receptor ligands provide relevant immunological parameters at baseline and following 1 and 2 years of treatment rounds. The primary outcome of the study is the prevalence of Plasmodium falciparum and P. vivax infection. The secondary outcome will be incidence and severity of malaria episodes detected via both passive and active follow-up. The tertiary outcome is the inflammatory cytokine profile in response to parasite antigens. The project also facilitates the transfer of state of the art methodologies and technologies, molecular diagnosis of parasitic diseases, immunology and epidemiology from Europe to Indonesia. Discussion The study will provide data on the effect of helminth infections on malaria. It will also give information on anthelminthic treatment efficacy and effectiveness and could help

  20. Percutaneous vertebroplasty: technical considerations

    Institute of Scientific and Technical Information of China (English)

    Gao-jun TENG; Shi-cheng HE

    2005-01-01

    Percutaneous vertebroplasty (PVP) is a relative new interventional technique, which is widely used in treatment of vertebral collapse caused by vertebral neoplasms and osteoporotic compression fractures. The general technical considerations of PVP techniques are discussed based on authors' experience obtained over 400 patients in the past years in this article, including preparation of PMMA, instrument of PVP, guidance and puncture approaches, and technique of the procedure, etc. The conclusion is that PVP is a safe procedure if the physicians handle it properly.

  1. Implant treatment planning considerations.

    Science.gov (United States)

    Kao, Richard T

    2008-04-01

    As dental implants become a more accepted treatment modality, there is a need for all parties involved with implant dentistry to be familiar with various treatment planning issues. Though the success can be highly rewarding, failure to forecast treatment planning issues can result in an increase of surgical needs, surgical cost, and even case failure. In this issue, the focus is on implant treatment planning considerations.

  2. Does treatment of intestinal helminth infections influence malaria? Background and methodology of a longitudinal study of clinical, parasitological and immunological parameters in Nangapanda, Flores, Indonesia (ImmunoSPIN Study).

    NARCIS (Netherlands)

    Wiria, A.E.; Prasetyani, M.A.; Hamid, F.; Wammes, L.J.; Lell, B.; Ariawan, I.; Uh, H.W.; Wibowo, H.; Djuardi, Y.; Wahyuni, S.; Sutanto, I.; May, L.; Luty, A.J.F.; Verweij, J.J.; Sartono, E.; Yazdanbakhsh, M.; Supali, T.

    2010-01-01

    BACKGROUND: Given that helminth infections are thought to have strong immunomodulatory activity, the question whether helminth infections might affect responses to malaria antigens needs to be addressed. Different cross-sectional studies using diverse methodologies have reported that helminth infect

  3. Cultural Considerations in Translation

    Institute of Scientific and Technical Information of China (English)

    陈嫔荣

    2009-01-01

    Language is the expression of human communication through which knowledge, belief, and behavior can be experi-enced, explained, and shared. It influences the way the speakers perceive the world. But as it has been long taken for granted, translation deals only with language. Cultural perspective, however, has never been brought into discussion. This paper first analyses the definitions of translation and culture, and then discusses why we should take culture into consideration and in the end, two translating strategies:domestication and foreignization are introduced.

  4. Cultural Considerations in Translation

    Institute of Scientific and Technical Information of China (English)

    陈嫔荣

    2009-01-01

    Language is the expression of human communication through which knowledge, belief, and behavior can be experi- enced, explained, and shared. It influences the way the speakers perceive the world. But as it has been long taken for granted, translation deals only with language. Cultural perspective, however, has never been brought into discussion. This paper first analyses the definitions of translation and culture, and then discusses why we should take culture into consideration and in the end, two translating strategies: domestication and foreignization are introduced.

  5. 不同学历护生实习前护理伦理认知水平的调查分析%Investigation on awareness of nursing ethics before clinical practice among nursing students with different educational backgrounds

    Institute of Scientific and Technical Information of China (English)

    唐艳华; 陈海金; 刘晓英; 王洪奇; 桑美丽; 郭丹; 张丽红

    2014-01-01

    Objective:To explore the level of nursing ethics awareness in nursing students with different educational backgrounds before clinical practice and to provide theoretical basis for nursing ethics education. Methods:A self-designed questionnaire was used to investigate 30 secondary school nursing students, 104 junior college nursing students and 220 undergraduate nursing students. Results:The total average score of nursing ethics cognitive was 2.27±0.22 in secondary school nursing students, 2.70±0.26 in junior college nursing students, and 3.11±0.26 in undergraduate nursing students. There were statistically signiifcant differences in the total average score of nursing ethics cognitive and all dimensional scores of informed consent, medical optimization, medical conifdentiality, principle of life among different nursing students in educational levels (P<0.05). Conclusion:There are differences about nursing ethics awareness among nursing students with different educational levels. So it is necessary to carry out different teaching methods for students with different academic qualiifcations in order to improve the level of nursing ethics awareness in nursing.%目的:了解实习前不同学历层次护生的护理伦理认知水平,为针对性地开展护理伦理教育提供理论依据。方法:采用自行设计的护生护理伦理认知问卷对30名中专护生、104名大专护生、220名本科护生进行问卷调查。结果:本科护生护理伦理认知总均分为(3.11±0.26)分、大专护生为(2.70±0.26)分,中专护生为(2.27±0.22)分,实习前不同学历护生护理伦理认知总均分和知情同意、医疗最优化、医疗保密、生命价值原则维度得分差异有统计学意义(P<0.05)。结论:不同学历护生的临床护理伦理认知有差异,根据不同学历采取不同的教学方法对提高护生整体的护理伦理认知水平十分必要。

  6. Infrared Background and Missiles Signature Survey

    Directory of Open Access Journals (Sweden)

    D.V. Renuka

    2013-11-01

    Full Text Available The proliferation of the missile threats in the existing threat scenario for airborne platform is a serious point of consideration for any mission planning. Missile warning system is an electronic warfare support system which gives warning to the pilot when a missile is detected in the scenario. The airborne platform has to be installed with missile warning sensors to give a spherical coverage, so that the sensors can detect the IR intensity variation in the ground scenario. This IR intensity variation has to be further analysed to differentiate the raising missile intensity from the varying background clutter. In order to differentiate the threat from the background clutter, the system should have sufficient background data set for online comparison thereby having less false alarm rate. The efficiency and performance of any missile warning system is validated with respect to its probability of declaration against the false alarm rate. Hence, to realize an efficient functioning of missile warning system, building IR background data base and missile signature database are the primary task. This paper details the methodology to be adapted for the building of tactical missile IR signatures and background data.

  7. Infrared Background and Missiles Signature Survey

    Directory of Open Access Journals (Sweden)

    D.V. Renuka

    2013-12-01

    Full Text Available The proliferation of the missile threats in the existing threat scenario for airborne platform is a serious point of consideration for any mission planning. Missile warning system is an electronic warfare support system which gives warning to the pilot when a missile is detected in the scenario. The airborne platform has to be installed with missile warning sensors to give a spherical coverage, so that the sensors can detect the IR intensity variation in the ground scenario. This IR intensity variation has to be further analysed to differentiate the raising missile intensity from the varying background clutter. In order to differentiate the threat from the background clutter, the system should have sufficient background data set for online comparison thereby having less false alarm rate. The efficiency and performance of any missile warning system is validated with respect to its probability of declaration against the false alarm rate. Hence, to realize an efficient functioning of missile warning system, building IR background data base and missile signature database are the primary task. This paper details the methodology to be adapted for the building of tactical missile IR signatures and background data.Defence Science Journal, 2013, 63(6, pp.611-615, DOI:http://dx.doi.org/10.14429/dsj.63.5762

  8. Einstein's cosmological considerations

    CERN Document Server

    Janzen, Daryl

    2014-01-01

    The objective of this paper is not simply to present an historical overview of Einstein's cosmological considerations, but to discuss the central role they played in shaping the paradigm of relativistic cosmology. This, we'll show, was a result of both his actions and, perhaps more importantly, his inactions. Accordingly, discussion won't simply be restricted to Einstein's considerations, as we'll analyse relevant contributions to the relativistic expansion paradigm during the approximately twenty years following Slipher's first redshift measurements in 1912. Our aim is to shed some light on why we think some of the things we do, with the idea that a better understanding of the reasoning that fundamentally influenced the common idea of our expanding universe might help to resolve some of the significant problems that modern cosmology now faces; and we eventually use this knowledge to probe the foundations of the standard model. Much of the information we present, including many of the historical details, we e...

  9. 不同临床背景精神分裂症患者延误治疗的影响因素%Influential factors of delayed therapy in dementia praecox patients with various clinical backgrounds

    Institute of Scientific and Technical Information of China (English)

    仲照希; 吕路线; 宋学琴; 贾悔志

    2007-01-01

    BACKGROUND:Delayed therapy widely occurs in patients with dementia praecox;therefore,it brings a series of difficulties for clinical treatment and rehabilitation.OBJECTIVE:To analyze the influential factors of delayed therapy in patients with dementia praecox.DESIGN:Cross-sectional study based on patients with dementia praecox.SETTING:The Second Affiliated Hospital of Xinxiang Medical College.PARTICIPANTS:A total of 96 patients with dementia praecox,including 52 males and 44 females,were selected from the Second Affiliated Hospital of Xinxiang Medical College from January to June 2005.Their ages ranged from 16 to 55 years and the mean age was (32.7±12.3) years.Among them,54 patients had middle-school education and 42 patients had high-school education.METHODS:A domestic inventory was used to carefully record basically clinical data of each patient.and the inventory included sex,marriage status,educational level,attack styles,home address,home environment,economic status,family history,etc.All data were classified and analyzed in details.In addition,condition of delayed therapy,which determined as the duration over 1 year from onset of psychiatric symptoms to accepted treatment,in each classification was surveyed gradually.MAIN OUTCOME MEASURES:Delayed therapeutic rate and occurent rate of related factors.RESULTS:Among 96 patients,60 patients had delayed therapy,and the delayed therapeutic rate was 62.5%.Influential factors of delayed therapy:Logistic regression analysis demonstrated that regression equation was involved in educational level,family history,attack style and economic status.Meanwhile,the standard regression coefficient was 0.332 1,0.210 1,0.190 3 and 0.101 2. CONCLUSION:Educationallevel,family history,attack style and economic status of patients with dementia praecox are risk factors of delayed therapy. It is of importance for strengthening these factors to interfere and reduce delayed therapeutic rate at an early phase.%背景:精神分裂症患者

  10. JEM-X background models

    DEFF Research Database (Denmark)

    Huovelin, J.; Maisala, S.; Schultz, J.

    2003-01-01

    on revolution 41 of INTEGRAL. Total observing time used for the analysis was 216 502 s, with the average of 25 cps of background for each of the two JEM-X telescopes. JEM-X1 showed slightly higher average background intensity than JEM-X2. The detectors were stable during the long exposures, and weak orbital...... phase dependence in the background outside radiation belts was observed. The analysis yielded an average of 5 cps for the diffuse background, and 20 cps for the instrument background. The instrument background was found highly dependent on position, both for spectral shape and intensity. Diff use......, with significant difference in spatial signatures between JEM-X units. According to our modelling, instrument background dominates over diffuse background in all positions and for all energies of JEM-X....

  11. WTO 农业协定背景下河南农业政策的选择与考量因素分析%THE CHOICES AND CONSIDERATIONS OF HENAN’S AGRICULTURAL POLICY UNDER THE BACKGROUND OF WTO AGREEMENT ON AGRICULTURE

    Institute of Scientific and Technical Information of China (English)

    罗先云

    2015-01-01

    WTO Agreement on Agriculture and subsequent relevant protocols take into consideration not only the overall requirements of trade liberalization but also the special interests of all its members,and they allow the parties to undertake jointly predetermined reduction commitments with no discrimination against any indi-vidual member country and are very flexible,giving developing countries more preferential and exceptional treatment in such aspects as the international agricultural market access,domestic support measures,agricul-tural export subsidies,food safety and so on.As a major agricultural province and the food base of such a de-veloping country as China,Henan Province should take full advantage of subsidies space and supportive meas-ures permitted by the international rules,work out some agriculture-supporting policies that are in line with China’s situation and circumstances without violating the international rules,normalize and legalize the poli-cies.%世界贸易组织农业协定以及后续的相关协议,既考虑贸易自由化的总体要求又兼顾各成员农业的特殊利益,在规定各方承担共同减让义务的同时,加以区别对待,灵活掌握,给予发展中国家在国际农产品市场准入、国内的支持措施、农产品出口补贴和粮食安全等方面更加优惠的例外待遇。河南作为发展中国家的农业大省和粮食基地,应该充分利用国际规则允许的补贴空间和支持措施,制定既符合省情和国情,又不违背国际规则的农业支持政策,并使之常态化、法制化。

  12. Consideration of Dynamical Balances

    Science.gov (United States)

    Errico, Ronald M.

    2015-01-01

    The quasi-balance of extra-tropical tropospheric dynamics is a fundamental aspect of nature. If an atmospheric analysis does not reflect such balance sufficiently well, the subsequent forecast will exhibit unrealistic behavior associated with spurious fast-propagating gravity waves. Even if these eventually damp, they can create poor background fields for a subsequent analysis or interact with moist physics to create spurious precipitation. The nature of this problem will be described along with the reasons for atmospheric balance and techniques for mitigating imbalances. Attention will be focused on fundamental issues rather than on recipes for various techniques.

  13. Considerations on the Difficulties and Countermeasures of the Chinese Communist Youth League's Work in State-owned Enterprises under the Background of Diversified Employment%多种用工制度下国有企业团工作面临的困难及对策思考

    Institute of Scientific and Technical Information of China (English)

    赵文

    2012-01-01

    With the background of diversified employment in state-owned enterprises, the Chinese Communist Youth League (the C.C.Y.L.) is faced with both problems and challenges, such as the youth's complicated vocational states in enterprises, their diversified concepts, demands for interests, the construction and management of the C.C.Y.L., the difficulties in the conduction of the C.C.Y.L.'s work, and so on. We should take the youth as the basis and serve them faithfully, so as to make both the youth and enterprises develop harmoniously. Further more, we should further emancipate our thoughts and break traditional system fetters so as to conduct the C.C.Y.L.'s work in a innovative way. These are the thoughts and approaches to solve such difficulties and problems.%国有企业多种用工制度并存的条件下,共青团工作面临着企业青年职业状态复杂化、思想观念多元化、利益诉求多样化,以及团的组织建设与管理、团的工作与活动开展困难等诸多问题与挑战。解决现有多种用工制度下国企团工作中的困难和问题的主要思路与方法是:以青年为本,竭诚服务青年,促进青年与企业和谐发展,进一步解放思想,突破体制束缚,创造性地开展企业共青团工作。

  14. Ethical considerations in conducting pediatric research.

    Science.gov (United States)

    Roth-Cline, Michelle; Gerson, Jason; Bright, Patricia; Lee, Catherine S; Nelson, Robert M

    2011-01-01

    The critical need for pediatric research on drugs and biological products underscores the responsibility to ensure that children are enrolled in clinical research that is both scientifically necessary and ethically sound. In this chapter, we review key ethical considerations concerning the participation of children in clinical research. We propose a basic ethical framework to guide pediatric research, and suggest how this framework might be operationalized in linking science and ethics. Topics examined include: the status of children as a vulnerable population; the appropriate balance of risk and potential benefit in research; ethical considerations underlying study design, including clinical equipoise, placebo controls, and non-inferiority designs; the use of data monitoring committees; compensation; and parental permission and child assent to participate in research. We incorporate selected national (USA) and international guidelines, as well as regulatory approaches to pediatric studies that have been adopted in the USA, Canada, and Europe.

  15. Supergravity backgrounds and symmetry superalgebras

    CERN Document Server

    Ertem, Ümit

    2016-01-01

    We consider the bosonic sectors of supergravity theories in ten and eleven dimensions which correspond to the low energy limits of string theories and M-theory. The solutions of supergravity field equations are known as supergravity backgrounds and the number of preserved supersymmetries in those backgrounds are determined by Killing spinors. We provide some examples of supergravity backgrounds which preserve different fractions of supersymmetry. An important invariant for the characterization of supergravity backgrounds is their Killing superalgebras which are constructed out of Killing vectors and Killing spinors of the background. After constructing Killing superalgebras of some special supergravity backgrounds, we discuss about the possibilities of the extensions of these superalgebras to include the higher degree hidden symmetries of the background.

  16. Wilsonian flows and background fields

    CERN Document Server

    Litim, Daniel F; Litim, Daniel F.; Pawlowski, Jan M.

    2002-01-01

    We study exact renormalisation group flows for background field dependent regularisations. It is shown that proper-time flows are approximations to exact background field flows for a specific class of regulators. We clarify the role of the implicit scale dependence introduced by the background field. Its impact on the flow is evaluated numerically for scalar theories at criticality for different approximations and regularisations. Implications for gauge theories are discussed.

  17. Practical considerations on frenectomy

    Science.gov (United States)

    Moldoveanu, Lucia; Badea, Florin Ciprian; Odor, Alin A.

    2014-01-01

    Besides surgically classical frenectomy, modern dentistry currently allows its approach by dental laser. Materials and Method: We proposed clinical observation of the results obtained by frenectomy with/without frenoplasty made by laser Er,Cr:YSGG 2780 nm. Results: The patients reported no pain, bleeding, swelling or major discomfort during the postoperative control of the following day. In terms of psycho-emotional reactions, both patients well behave well, the calm being given by no pain, bleeding, suture or edema. Discussions: The accuracy of this method, as well as the use of additional means of healing, allow satisfactory results both for patient and physician. Working parameters depend on the type of laser that is used, in our case Biolase Waterlase MD Turbo, regularly used in Toldimed Clinic in Constanta. Conclusions: Our study reveals that the possibilities regarding the surgical modeling of the lower lip frenulum are higher due to laser than the classical surgical approach. Moreover, a major role in the prevention of relapse by inappropriate healing is represented by the approach of frenectomy accompanied by frenuloplasty.

  18. Background subtraction theory and practice

    CERN Document Server

    Elgammal, Ahmed

    2014-01-01

    Background subtraction is a widely used concept for detection of moving objects in videos. In the last two decades there has been a lot of development in designing algorithms for background subtraction, as well as wide use of these algorithms in various important applications, such as visual surveillance, sports video analysis, motion capture, etc. Various statistical approaches have been proposed to model scene backgrounds. The concept of background subtraction also has been extended to detect objects from videos captured from moving cameras. This book reviews the concept and practice of back

  19. Stress: pregnancy considerations.

    Science.gov (United States)

    Cardwell, Michael S

    2013-02-01

    Stress-induced pregnancy complications represent a significant cause of maternal and perinatal morbidity and mortality due to preterm labor, low-birth-weight babies, pregnancy-induced hypertension, and neuropsychological developmental delays of affected offspring. Psychosocial factors such as socioeconomic status, work status, marital status, level of education, access to prenatal care, substance abuse, ethnicity, cultural background, and quality of relationships with partners and parents have been identified as determinants of stress during pregnancy. The biopsychosocial model of health and disease aptly explains the interactions of these psychosocial factors in the genesis of stress-induced pregnancy complications. Prenatal screening and intervention for relevant biopsychosocial risk factors may be useful in preventing stress-related perinatal complications. Obstetricians and gynecologists, family physicians. After completing this CME activity, physicians should be better able to describe how stress is manifested biologically, discuss stress and its impact from the biopsychosocial model of health and disease, recognize how stress may lead to pregnancy complications such as preterm labor, preeclampsia, and low-birth-weight infants, explain how stress may impact the neuropsychological development of children whose mothers experienced perinatal stress, and demonstrate how prenatal screening and appropriate interventions may reduce perinatal stress and associated pregnancy complications.

  20. Ethical considerations of therapeutic hypnosis and children.

    Science.gov (United States)

    Etzrodt, Christine M

    2013-04-01

    Historically, therapeutic hypnosis has been met with skepticism within some fields, although acceptance has expanded in recent decades. Development and application of ethical standards and principles has contributed to increased acceptance of hypnosis with children. The Ethics Code of the American Psychological Association (APA, 2002) and the Code of Conduct of the American Society of Clinical Hypnosis (ASCH, 2000) serve as guides to ethical considerations when treating children. From a developmental and practical perspective, children have limited decision-making capacities, therefore special attention should be paid to their rights and welfare. Important ethical considerations relevant to children and hypnosis have emerged, including competence, supervision, informed consent, confidentiality, and boundaries. Considerations are reviewed from a normal and abnormal child development perspective.

  1. Backgrounds and characteristics of arsonists

    NARCIS (Netherlands)

    Labree, W.; Nijman, H.L.I.; Marle, H.J.C. van; Rassin, E.

    2010-01-01

    The aim of this study was to gain more insight in the backgrounds and characteristics of arsonists. For this, the psychiatric, psychological, personal, and criminal backgrounds of all arsonists (n = 25), sentenced to forced treatment in the maximum security forensic hospital “De Kijvelanden”, were

  2. Backgrounds and characteristics of arsonists

    NARCIS (Netherlands)

    Labree, W.; Nijman, H.L.I.; Marle, H.J.C. van; Rassin, E.

    2010-01-01

    The aim of this study was to gain more insight in the backgrounds and characteristics of arsonists. For this, the psychiatric, psychological, personal, and criminal backgrounds of all arsonists (n = 25), sentenced to forced treatment in the maximum security forensic hospital “De Kijvelanden”, were c

  3. Background reduction in cryogenic detectors

    Energy Technology Data Exchange (ETDEWEB)

    Bauer, Daniel A.; /Fermilab

    2005-04-01

    This paper discusses the background reduction and rejection strategy of the Cryogenic Dark Matter Search (CDMS) experiment. Recent measurements of background levels from CDMS II at Soudan are presented, along with estimates for future improvements in sensitivity expected for a proposed SuperCDMS experiment at SNOLAB.

  4. Backgrounds and characteristics of arsonists

    NARCIS (Netherlands)

    Labree, W.; Nijman, H.L.I.; Marle, H.J.C. van; Rassin, E.

    2010-01-01

    The aim of this study was to gain more insight in the backgrounds and characteristics of arsonists. For this, the psychiatric, psychological, personal, and criminal backgrounds of all arsonists (n = 25), sentenced to forced treatment in the maximum security forensic hospital “De Kijvelanden”, were c

  5. Measurement of natural background neutron

    CERN Document Server

    Li Jain, Ping; Tang Jin Hua; Tang, E S; Xie Yan Fong

    1982-01-01

    A high sensitive neutron monitor is described. It has an approximate counting rate of 20 cpm for natural background neutrons. The pulse amplitude resolution, sensitivity and direction dependence of the monitor were determined. This monitor has been used for natural background measurement in Beijing area. The yearly average dose is given and compared with the results of KEK and CERN.

  6. Ethical considerations in adherence research.

    Science.gov (United States)

    Patel, Nupur U; Moore, Blake A; Craver, Rebekah F; Feldman, Steven R

    2016-01-01

    Poor adherence to treatment is a common cause of medical treatment failure. Studying adherence is complicated by the potential for the study environment to impact adherence behavior. Studies performed without informing patients about adherence monitoring must balance the risks of deception against the potential benefits of the knowledge to be gained. Ethically monitoring a patient's adherence to a treatment plan without full disclosure of the monitoring plan requires protecting the patient's rights and upholding the fiduciary obligations of the investigator. Adherence monitoring can utilize different levels of deception varying from stealth monitoring, debriefing after the study while informing the subject that some information had been withheld in regard to the use of adherence monitoring (withholding), informed consent that discloses some form of adherence monitoring is being used and will be disclosed at the end of the study (authorized deception), and full disclosure. Different approaches offer different benefits and potential pitfalls. The approach used must balance the risk of nondisclosure against the potential for confounding the adherence monitoring data and the potential benefits that adherence monitoring data will have for the research subjects and/or other populations. This commentary aims to define various methods of adherence monitoring and to provide a discussion of the ethical considerations that accompany the use of each method and adherence monitoring in general as it is used in clinical research.

  7. Effect of background music on auditory-verbal memory performance

    OpenAIRE

    Sona Matloubi; Ali Mohammadzadeh; Zahra Jafari; Alireza Akbarzade Baghban

    2014-01-01

    Background and Aim: Music exists in all cultures; many scientists are seeking to understand how music effects cognitive development such as comprehension, memory, and reading skills. More recently, a considerable number of neuroscience studies on music have been developed. This study aimed to investigate the effects of null and positive background music in comparison with silence on auditory-verbal memory performance.Methods: Forty young adults (male and female) with normal hearing, aged betw...

  8. Biosimilar Insulins: Basic Considerations.

    Science.gov (United States)

    Heinemann, Lutz; Hompesch, Marcus

    2014-01-01

    Until now most of the insulin used in developed countries has been manufactured and distributed by a small number of multinational companies. Beyond the established insulin manufacturers, a number of new players have developed insulin manufacturing capacities based on modern biotechnological methods. Because the patents for many of the approved insulin formulations have expired or are going to expire soon, these not yet established companies are increasingly interested in seeking market approval for their insulin products as biosimilar insulins (BI) in highly regulated markets like the EU and the United States. Differences in the manufacturing process (none of the insulin manufacturing procedures are 100% identical) can lead to insulins that to some extent may differ from the originator insulin. The key questions are if subtle differences in the structure of the insulins, purity, and so on are clinically relevant and may result in different biological effects. The aim of this article is to introduce and discuss basic aspects that may be of relevance with regard to BI. © 2014 Diabetes Technology Society.

  9. A review of clinical guidelines.

    LENUS (Irish Health Repository)

    Andrews, E J

    2012-02-03

    BACKGROUND: Clinical guidelines are increasingly used in patient management but few clinicians are familiar with their origin or appropriate application. METHODS: A Medline search using the terms \\'clinical guidelines\\' and \\'practice guidelines\\' was conducted. Additional references were sourced by manual searching from the bibliographies of articles located. RESULTS AND CONCLUSION: Clinical guidelines originated in the USA in the early 1980s, initially as a cost containment exercise. Significant improvements in the process and outcomes of care have been demonstrated following their introduction, although the extent of improvement varies considerably. The principles for the development of guidelines are well established but many published guidelines fall short of these basic quality criteria. Guidelines are only one aspect of improving quality and should be used within a wider framework of promoting clinical effectiveness. Understanding their limitations as well as their potential benefits should enable clinicians to have a clearer view of their place in everyday practice.

  10. Lymphoedema of the lower extremities--background, pathophysiology and diagnostic considerations

    DEFF Research Database (Denmark)

    Jensen, Mads R; Simonsen, Lene; Karlsmark, Tonny;

    2010-01-01

    mostly been applied on upper extremity lymphoedema. The aim of this review is to provide a literature-based overview of the aetiology and pathophysiology of lower extremity lymphoedema and to summarize the current knowledge about lymphoscintigraphy and depot clearance techniques. The abundance of factors...... protocol and qualitative interpretation criteria results in a too observer dependent outcome. Methods for objectifying the scintigraphy through quantification have been criticized. Depot clearance rates are an alternative method of quantification of lymphatic drainage capacity. This method however has...

  11. Background and future considerations for human cord blood hematopoietic cell transplantation, including economic concerns.

    Science.gov (United States)

    Broxmeyer, Hal E; Farag, Sherif

    2013-12-01

    Cord blood (CB) has been used since 1988 as a source of hematopoietic stem cells (HSCs) and progenitor cells for hematopoietic cell transplantation (HCT) to treat patients with malignant and nonmalignant disorders. CB has both advantages and disadvantages when compared with other tissue sources of HSCs such as bone marrow and mobilized peripheral blood, which are also being used in the setting of HCT. This short review focuses on some historical information, as well as current efforts that are being assessed to enhance the efficacy of CB HCT. Also of importance are the costs of CB, and the feasibility and economics of using such to be identified, and newly confirmed improvements worldwide for the greatest number of patients. In this context, simple methods that would not necessarily entail the need for selected cell-processing facilities to ex vivo expand or improve the CB graft's functional activity may be of interest, with one such possibility being the use of an orally active inhibitor of the enzyme dipeptidylpeptidase 4, alone or in combination with other new and innovative approaches for improving HSC engraftment and in vivo repopulating capability of CB.

  12. Some Background Considerations to the Establishment of an External Studies Programme.

    Science.gov (United States)

    Gordon, Hopeton L. A.

    A study was made of how conventional, face-to-face teaching methods might be used in conjunction with correspondence study (CS), programed instruction (PI), educational television (ETV) and radio broadcasts, and other approaches to make higher education more widely available throughout the region served by the University of the West Indies. These…

  13. Correction Procedures for Aircraft Noise Data. Volume II. Background Noise Considerations.

    Science.gov (United States)

    1979-12-01

    Virginia 22161 19. security CI...il. to# this repwt) 20. Security Clossed. (&1 Owes peso ) 21. M. of PoT 2 Pries, Unclassified I Unclassified 1 114...at least ’ seco -nds thus satisfying the secWrocitjiletot cocr -~~*orrelation time si;r the previo :s page. frie net reseli ics ’!jt it Aednon11; be

  14. Berkeley Low Background Counting Facility

    Data.gov (United States)

    Federal Laboratory Consortium — Sensitive low background assay detectors and sample analysis are available for non-destructive direct gamma-ray assay of samples. Neutron activation analysis is also...

  15. Backgrounds in AFP Detector Estimation

    CERN Document Server

    Huang, Yicong

    2016-01-01

    The ATLAS Forward Proton (AFP) detectors aim to measure protons that are scattered in the ATLAS interaction point under very small angles ($90-160 \\mu rad$). The diffractive protons detected by the AFP may be accompanied by beam halo. This report presents an estimation of the beam halo backgrounds in the AFP using low pile-up data, and position distributions of the backgrounds in the AFP.

  16. Pneumonia in patients on the background of blood cancer

    Directory of Open Access Journals (Sweden)

    Pertseva T.A.

    2014-03-01

    Full Text Available Problematic issues of etiologic diagnosis and treatment of community-acquired and nosocomial pneumonia are being studied actively. At the same time specific features of pneumonia in patients with severe immune defects, against blood cancer including are studied insufficiently. By the result of microbiological examinations of 149 patients with pneumonia on the background of blood cancer, who have undergone treatment in hematological center of CE “Dnipropetrovsk local multi-field clinical hospital №4” in 2010-2012, bacterial causative agents were determined in 59,7% of accidents, among which gram-negative microorganisms made up 69,7%, gram-positive – 30,3%. In 63% of accidents the asso¬ciations of causative agents were determined: the combination of fungal flora made up 58, 4% bacterial associations – 25, 8%. Invasive methods of research have demonstrated a considerably bigger informativeness in determination of possible etiological diagnosis of pneumonia. In determination of causative agent in fluid of brochoalveolar lavage the part of positive results made up 77,4% against 30,3% in examination of sputum.

  17. 关于加强我国疫苗临床试验监管的思考(下)%Considerations on strengthening the supervision of vaccine clinical trials in China (Part Ⅱ)

    Institute of Scientific and Technical Information of China (English)

    高荣

    2013-01-01

    In the new situation of the development of vaccine clinical trials, the regulatory authorities need to build the comprehensive three-dimensional vaccine clinical trial regulatory model, whose premise and basis is qualification for vaccine clinical trial institution, to improve the effectiveness of supervision. This paper presented the implementation proposals of qualification for vaccine clinical trial institution, and explored the implementation of the building the comprehensive three-dimensional vaccine clinical trial regulatory model, including the process supervision, previous supervision and postmortem supervision.%在新的疫苗临床试验发展形势下,监管部门应通过构建疫苗临床试验全方位立体监管模式来提高疫苗临床试验监管效能,其前提和基础是开展疫苗临床试验机构资格认定.本文提出了疫苗临床试验机构资格认定的实施方案建议,并探索了构建包括过程监管、事前监管和事后监管在内的疫苗临床试验全方位立体监管模式的实施方法.

  18. Ethical considerations in adherence research

    Directory of Open Access Journals (Sweden)

    Patel NU

    2016-12-01

    Full Text Available Nupur U Patel,1 Blake A Moore,1 Rebekah F Craver,2 Steven R Feldman1,2 1Department of Dermatology, Center for Dermatology Research, 2Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA Abstract: Poor adherence to treatment is a common cause of medical treatment failure. Studying adherence is complicated by the potential for the study environment to impact adherence behavior. Studies performed without informing patients about adherence monitoring must balance the risks of deception against the potential benefits of the knowledge to be gained. Ethically monitoring a patient’s adherence to a treatment plan without full disclosure of the monitoring plan requires protecting the patient’s rights and upholding the fiduciary obligations of the investigator. Adherence monitoring can utilize different levels of deception varying from stealth monitoring, debriefing after the study while informing the subject that some information had been withheld in regard to the use of adherence monitoring (withholding, informed consent that discloses some form of adherence monitoring is being used and will be disclosed at the end of the study (authorized deception, and full disclosure. Different approaches offer different benefits and potential pitfalls. The approach used must balance the risk of nondisclosure against the potential for confounding the adherence monitoring data and the potential benefits that adherence monitoring data will have for the research subjects and/or other populations. This commentary aims to define various methods of adherence monitoring and to provide a discussion of the ethical considerations that accompany the use of each method and adherence monitoring in general as it is used in clinical research. Keywords: compliance, stealth monitoring, deception, adherence monitoring 

  19. Advanced LBB methodology and considerations

    Energy Technology Data Exchange (ETDEWEB)

    Olson, R.; Rahman, S.; Scott, P. [Battelle, Columbus, OH (United States)] [and others

    1997-04-01

    LBB applications have existed in many industries and more recently have been applied in the nuclear industry under limited circumstances. Research over the past 10 years has evolved the technology so that more advanced consideration of LBB can now be given. Some of the advanced considerations for nuclear plants subjected to seismic loading evaluations are summarized in this paper.

  20. Ethical Considerations in Technology Transfer.

    Science.gov (United States)

    Froehlich, Thomas J.

    1991-01-01

    Examines ethical considerations involved in the transfer of appropriate information technology to less developed countries. Approaches to technology are considered; two philosophical frameworks for studying ethical considerations are discussed, i.e., the Kantian approach and the utilitarian perspective by John Stuart Mill; and integration of the…

  1. Ethical Considerations in Technology Transfer.

    Science.gov (United States)

    Froehlich, Thomas J.

    1991-01-01

    Examines ethical considerations involved in the transfer of appropriate information technology to less developed countries. Approaches to technology are considered; two philosophical frameworks for studying ethical considerations are discussed, i.e., the Kantian approach and the utilitarian perspective by John Stuart Mill; and integration of the…

  2. Revealed preference with limited consideration

    NARCIS (Netherlands)

    Demuynck, T.; Seel, C.

    2014-01-01

    We derive revealed preference tests for models where individuals use consideration sets to simplify their consumption problem. Our basic test provides necessary and sufficient conditions for consistency of observed choices with the existence of consideration set restrictions. The same conditions can

  3. Questioning assent: how are children's views included as families make decisions about clinical trials?

    OpenAIRE

    Madden, L; Shilling, Valerie; Woolfall, K.; Sowden, E.; Smyth, R L; Williamson, P. R. (Paula R.); Young, B.

    2016-01-01

    BACKGROUND: Assent is used to take children's wishes into account when they are invited into clinical trials, but the concept has attracted considerable criticism. We investigated children's accounts of decision-making with the aim of informing practice in supporting children when invited to join a clinical trial. METHODS: We audio-recorded qualitative, semi-structured interviews with 22 children aged 8-16 years about being invited to take part in a clinical trial. Most children were intervie...

  4. Ethical considerations surrounding the response to Ebola: the Spanish experience

    OpenAIRE

    Royo-Bordonada, Miguel Ángel; García López, Fernando J.

    2016-01-01

    Background The recent Ebola virus disease (EVD) outbreak, with 28,646 reported cases and 11,323 deaths, was declared a public health emergency of international interest by the World Health Organisation. In Spain, a single reported case triggered a public health crisis of a markedly media-centred nature. The approach to the first EVD epidemic has given rise to various ethical considerations around the world. We address the most relevant ethical considerations emanating from the management of E...

  5. The Cosmic Infrared Background Experiment

    CERN Document Server

    Bock, J; Cooray, A R; Kawada, M; Keating, B; Lange, A; Lee, D H; Matsumoto, T; Matsuura, S; Pak, S; Renbarger, T; Sullivan, I; Tsumura, K; Wada, T; Watabe, T; Bock, James; Battle, John; Cooray, Asantha; Kawada, Mitsunobu; Keating, Brian; Lange, Andrew; Lee, Dae-Hea; Matsumoto, Toshio; Matsuura, Shuji; Pak, Soojong; Renbarger, Tom; Sullivan, Ian; Tsumura, Kohji; Wada, Takehiko; Watabe, Toyoki

    2006-01-01

    We are developing a rocket-borne instrument (the Cosmic Infrared Background ExpeRiment, or CIBER) to search for signatures of primordial galaxy formation in the cosmic near-infrared extra-galactic background. CIBER consists of a wide-field two-color camera, a low-resolution absolute spectrometer, and a high-resolution narrow-band imaging spectrometer. The cameras will search for spatial fluctuations in the background on angular scales from 7 arcseconds to 2 degrees over a range of angular scales poorly covered by previous experiments. CIBER will determine if the fluctuations reported by the IRTS arise from first-light galaxies or have a local origin. In a short rocket flight CIBER has sensitivity to probe fluctuations 100 times fainter than IRTS/DIRBE. By jointly observing regions of the sky studied by Spitzer and ASTRO-F, CIBER will build a multi-color view of the near-infrared background, accurately assessing the contribution of local (z = 1-3) galaxies to the observed background fluctuations, allowing a de...

  6. Background Independent String Field Theory

    CERN Document Server

    Bars, Itzhak

    2014-01-01

    We develop a new background independent Moyal star formalism in bosonic open string field theory. The new star product is formulated in a half-phase-space, and because phase space is independent of any background fields, the interactions are background independent. In this basis there is a large amount of symmetry, including a supersymmetry OSp(d|2) that acts on matter and ghost degrees of freedom, and simplifies computations. The BRST operator that defines the quadratic kinetic term of string field theory may be regarded as the solution of the equation of motion A*A=0 of a purely cubic background independent string field theory. We find an infinite number of non-perturbative solutions to this equation, and are able to associate them to the BRST operator of conformal field theories on the worldsheet. Thus, the background emerges from a spontaneous-type breaking of a purely cubic highly symmetric theory. The form of the BRST field breaks the symmetry in a tractable way such that the symmetry continues to be us...

  7. Background simulations and shielding calculations

    Science.gov (United States)

    Kudryavtsev, Vitaly A.

    2011-04-01

    Key improvements in the sensitivity of the underground particle astrophysics experiments can only be achieved if the radiation causing background events in detectors is well understood and proper measures are taken to suppress it. The background radiation arising from radioactivity and cosmic-ray muons is discussed here together with the methods of its suppression. Different shielding designs are considered to attenuate gamma-rays and neutrons coming from radioactivity in rock and lab walls. Purity of materials used in detector construction is analysed and the background event rates due to the presence of radioactive isotopes in detector components are discussed. Event rates in detectors caused by muon-induced neutrons with and without active veto systems are presented leading to the requirements for the depth of an underground laboratory and the efficiency of the veto system.

  8. Neutron background estimates in GESA

    Directory of Open Access Journals (Sweden)

    Fernandes A.C.

    2014-01-01

    Full Text Available The SIMPLE project looks for nuclear recoil events generated by rare dark matter scattering interactions. Nuclear recoils are also produced by more prevalent cosmogenic neutron interactions. While the rock overburden shields against (μ,n neutrons to below 10−8 cm−2 s−1, it itself contributes via radio-impurities. Additional shielding of these is similar, both suppressing and contributing neutrons. We report on the Monte Carlo (MCNP estimation of the on-detector neutron backgrounds for the SIMPLE experiment located in the GESA facility of the Laboratoire Souterrain à Bas Bruit, and its use in defining additional shielding for measurements which have led to a reduction in the extrinsic neutron background to ∼ 5 × 10−3 evts/kgd. The calculated event rate induced by the neutron background is ∼ 0,3 evts/kgd, with a dominant contribution from the detector container.

  9. Pharmacogenetic considerations in the treatment of gout.

    Science.gov (United States)

    Roberts, Rebecca L; Stamp, Lisa K

    2015-01-01

    Gout is one of the most common forms of arthritis and the prevalence is increasing. Management comprises rapid and effective control of the inflammation in acute gout and sustained urate lowering in the long term. Improving the outcomes for cheaper old drugs and for the increasing number of new, more expensive agents is an important clinical goal. The role of pharmacogenetics in predicting response and adverse events to gout therapies is of considerable interest. Currently, prospective screening is employed to detect HLA-B*5801 carriage and glucose-6-phosphate dehydrogenase deficiency, to minimize occurrence of allopurinol hypersensitivity and pegloticase-related hemolytic anemia. In the future it is likely that other genetic markers of drug response will make the transition to clinical practice to further improve the efficacy and safety of gout therapies. In this review, we will examine the potential clinical relevance of specific genetic variants in the management of gout.

  10. Background music and cognitive performance.

    Science.gov (United States)

    Angel, Leslie A; Polzella, Donald J; Elvers, Greg C

    2010-06-01

    The present experiment employed standardized test batteries to assess the effects of fast-tempo music on cognitive performance among 56 male and female university students. A linguistic processing task and a spatial processing task were selected from the Criterion Task Set developed to assess verbal and nonverbal performance. Ten excerpts from Mozart's music matched for tempo were selected. Background music increased the speed of spatial processing and the accuracy of linguistic processing. The findings suggest that background music can have predictable effects on cognitive performance.

  11. The COMPTEL instrumental line background

    OpenAIRE

    Weidenspointner, G.; Varendorff, M.; Oberlack, U.; Morris, D.; Plueschke, S.; Diehl, R.; Kappadath, S. C.; McConnell, M; Ryan, J.; Schoenfelder, V.; Steinle, H.

    2000-01-01

    The instrumental line background of the Compton telescope COMPTEL onboard the Compton Gamma-Ray Observatory is due to the activation and/or decay of many isotopes. The major components of this background can be attributed to eight individual isotopes, namely 2D, 22Na, 24Na, 28Al, 40K, 52Mn, 57Ni, and 208Tl. The identification of instrumental lines with specific isotopes is based on the line energies as well as on the variation of the event rate with time, cosmic-ray intensity, and deposited r...

  12. Exotic branes and nongeometric backgrounds.

    Science.gov (United States)

    de Boer, Jan; Shigemori, Masaki

    2010-06-25

    When string or M theory is compactified to lower dimensions, the U-duality symmetry predicts so-called exotic branes whose higher-dimensional origin cannot be explained by the standard string or M-theory branes. We argue that exotic branes can be understood in higher dimensions as nongeometric backgrounds or U folds, and that they are important for the physics of systems which originally contain no exotic charges, since the supertube effect generically produces such exotic charges. We discuss the implications of exotic backgrounds for black hole microstate (non-)geometries.

  13. Generative electronic background music system

    Energy Technology Data Exchange (ETDEWEB)

    Mazurowski, Lukasz [Faculty of Computer Science, West Pomeranian University of Technology in Szczecin, Zolnierska Street 49, Szczecin, PL (Poland)

    2015-03-10

    In this short paper-extended abstract the new approach to generation of electronic background music has been presented. The Generative Electronic Background Music System (GEBMS) has been located between other related approaches within the musical algorithm positioning framework proposed by Woller et al. The music composition process is performed by a number of mini-models parameterized by further described properties. The mini-models generate fragments of musical patterns used in output composition. Musical pattern and output generation are controlled by container for the mini-models - a host-model. General mechanism has been presented including the example of the synthesized output compositions.

  14. Noise control considerations for patient rooms

    Science.gov (United States)

    Davenny, Benjamin

    2005-09-01

    The patient room envelope is a path between outside noise sources and the patient receiver. Within the patient room there are several sources including televisions, clinical monitor alarms, medical pumps, etc. Noise control in patient rooms relies on a combination of the sound transmission loss of the patient room envelope and the level of background sound at the patient's head. Guidelines published by the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE), American Institute of Architects (AIA), and the U.S. Department of Defense for background noise and sound transmission loss in patient rooms will be discussed. Appropriate levels, spectra, and temporal characteristics of background sound at the patient head location may be helpful in raising the threshold of annoying sounds. Various means of personal hearing protection for patients will be discussed. Sound-pressure levels in patient rooms reported in previous literature will also be discussed.

  15. The clinical method and the evidence-based medicine: some considerations El método clínico y la medicina basada en la evidencia. Algunas consideraciones

    OpenAIRE

    Víctor René Navarro Machado; Arelys Falcón Hernández

    2010-01-01

    The correct application of the clinical method has diminished all over the world and particularly in Cuba in the last years as a result different issues, including the loss of the doctor-patient relationship, the rejection of the values of physical interrogation and examination and the increasingly irrational and excessive use of medical technology applied to the diagnosis process. The evidence-based medicine is a technical tool to quantify and qualify which data or study is the most accurate...

  16. 关于加强我国疫苗临床试验监管的思考(上)%Considerations for strengthening the supervision on clinical trials of vaccine in China ( Part Ⅰ )

    Institute of Scientific and Technical Information of China (English)

    高荣; 李见明

    2012-01-01

    疫苗临床试验的安全性较为特殊,如严重不良反应多为急性过敏性反应、严重不良事件常见群体性心因性反应和偶合反应等;另外,其受试者权益保护问题尤为值得监管部门关注.本文阐述了我国疫苗临床试验运行情况和监管模式,分析了其监管模式形成的原因,指出在疫苗临床试验新的发展形势下,监管部门需要探索疫苗临床试验监管的新模式,以提高监管效能.%The safety of the vaccine clinical trials has its special characteristics. For example, the serious adverse reaction is often acute allergic reactions, and the serious adverse events are more common in mass psycho-genie reactions and coupling reactions. In addition, protecting the rights and interests of its subjects is particularly worthy of regulatory attention. This paper described the operation and regulatory model of the clinical trials on vaccines in China, and analyzed the reasons for the formation of the regulatory model. We pointed out that in the new situation of the development of vaccine clinical trials, the regulatory authorities need to explore new regulatory model of vaccine clinical trials to improve the effectiveness of supervision.

  17. Low Background Micromegas in CAST

    CERN Document Server

    Garza, J G; Aznar, F.; Calvet, D.; Castel, J.F.; Christensen, F.E.; Dafni, T.; Davenport, M.; Decker, T.; Ferrer-Ribas, E.; Galán, J.; García, J.A.; Giomataris, I.; Hill, R.M.; Iguaz, F.J.; Irastorza, I.G.; Jakobsen, A.C.; Jourde, D.; Mirallas, H.; Ortega, I.; Papaevangelou, T.; Pivovaroff, M.J.; Ruz, J.; Tomás, A.; Vafeiadis, T.; Vogel, J.K.

    2015-01-01

    Solar axions could be converted into x-rays inside the strong magnetic field of an axion helioscope, triggering the detection of this elusive particle. Low background x-ray detectors are an essential component for the sensitivity of these searches. We report on the latest developments of the Micromegas detectors for the CERN Axion Solar Telescope (CAST), including technological pathfinder activities for the future International Axion Observatory (IAXO). The use of low background techniques and the application of discrimination algorithms based on the high granularity of the readout have led to background levels below 10$^{-6}$ counts/keV/cm$^2$/s, more than a factor 100 lower than the first generation of Micromegas detectors. The best levels achieved at the Canfranc Underground Laboratory (LSC) are as low as 10$^{-7}$ counts/keV/cm$^2$/s, showing good prospects for the application of this technology in IAXO. The current background model, based on underground and surface measurements, is presented, as well as ...

  18. Low Background Micromegas in CAST

    DEFF Research Database (Denmark)

    Garza, J G; Aune, S.; Aznar, F.

    2014-01-01

    Solar axions could be converted into x-rays inside the strong magnetic field of an axion helioscope, triggering the detection of this elusive particle. Low background x-ray detectors are an essential component for the sensitivity of these searches. We report on the latest developments of the Micr...

  19. Educational Choice. A Background Paper.

    Science.gov (United States)

    Quality Education for Minorities Network, Washington, DC.

    This paper addresses school choice, one proposal to address parental involvement concerns, focusing on historical background, definitions, rationale for advocating choice, implementation strategies, and implications for minorities and low-income families. In the past, transfer payment programs such as tuition tax credits and vouchers were…

  20. A Little Background Music, Please.

    Science.gov (United States)

    Giles, Martha Mead

    1991-01-01

    Background music could be used to provide a pleasant beginning for the school day, to help keep students quiet and relaxed in the school cafeteria at lunchtime, and to provide a midafternoon lift for bored and tired children. The most effective music pleases children without overly exciting them through jarring rhythms and loud dynamics. (nine…

  1. Teaching about Natural Background Radiation

    Science.gov (United States)

    Al-Azmi, Darwish; Karunakara, N.; Mustapha, Amidu O.

    2013-01-01

    Ambient gamma dose rates in air were measured at different locations (indoors and outdoors) to demonstrate the ubiquitous nature of natural background radiation in the environment and to show that levels vary from one location to another, depending on the underlying geology. The effect of a lead shield on a gamma radiation field was also…

  2. Posaconazole for primary antifungal prophylaxis in patients with acute myeloid leukaemia or myelodysplastic syndrome during remission induction chemotherapy: a single-centre retrospective study in Korea and clinical considerations.

    Science.gov (United States)

    Cho, Sung-Yeon; Lee, Dong-Gun; Choi, Su-Mi; Choi, Jae-Ki; Lee, Hyo-Jin; Kim, Si-Hyun; Park, Sun Hee; Choi, Jung-Hyun; Yoo, Jin-Hong; Kim, Yoo-Jin; Kim, Hee-Je; Min, Woo-Sung

    2015-09-01

    Posaconazole was introduced as the primary antifungal prophylaxis (PAP) in acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) patients during remission induction chemotherapy. Data on breakthrough invasive fungal infections (IFIs) from various centres are essential, as there are several considerations in treating IFIs in the posaconazole era. The aim of this study was to evaluate the effectiveness of posaconazole PAP and identify characteristics of IFIs at a single centre in Korea. We retrospectively reviewed consecutive patients with AML/MDS undergoing remission induction chemotherapy between December 2010 and November 2013. Of the 424 patients, 140 received posaconazole and 284 received fluconazole prophylaxis. The incidence of breakthrough proven/probable IFIs (15.5% vs. 2.9%, P posaconazole group compared to the fluconazole group. In the posaconazole PAP group, two cases of breakthrough mucormycosis were noted among 13 proven/probable/possible IFI cases (15.4%). Overall and IFI-related mortality was 12.1% and 1.9% respectively. Fungus-free survival was significantly higher in the posaconazole group (74.7% vs. 87.1%, P = 0.028). Breakthrough IFIs and EAFT decreased significantly after posaconazole PAP. The benefit in fungus-free survival was noted with posaconazole PAP. Clinicians should be vigilant to identify non-Aspergillus IFIs with active diagnostic effort.

  3. The Cosmic Infrared Background Experiment

    Science.gov (United States)

    Bock, James; Battle, J.; Cooray, A.; Hristov, V.; Kawada, M.; Keating, B.; Lee, D.; Matsumoto, T.; Matsuura, S.; Nam, U.; Renbarger, T.; Sullivan, I.; Tsumura, K.; Wada, T.; Zemcov, M.

    2009-01-01

    We are developing the Cosmic Infrared Background ExpeRiment (CIBER) to search for signatures of first-light galaxy emission in the extragalactic background. The first generation of stars produce characteristic signatures in the near-infrared extragalactic background, including a redshifted Ly-cutoff feature and a characteristic fluctuation power spectrum, that may be detectable with a specialized instrument. CIBER consists of two wide-field cameras to measure the fluctuation power spectrum, and a low-resolution and a narrow-band spectrometer to measure the absolute background. The cameras will search for fluctuations on angular scales from 7 arcseconds to 2 degrees, where the first-light galaxy spatial power spectrum peaks. The cameras have the necessary combination of sensitivity, wide field of view, spatial resolution, and multiple bands to make a definitive measurement. CIBER will determine if the fluctuations reported by Spitzer arise from first-light galaxies. The cameras observe in a single wide field of view, eliminating systematic errors associated with mosaicing. Two bands are chosen to maximize the first-light signal contrast, at 1.6 um near the expected spectral maximum, and at 1.0 um; the combination is a powerful discriminant against fluctuations arising from local sources. We will observe regions of the sky surveyed by Spitzer and Akari. The low-resolution spectrometer will search for the redshifted Lyman cutoff feature in the 0.7 - 1.8 um spectral region. The narrow-band spectrometer will measure the absolute Zodiacal brightness using the scattered 854.2 nm Ca II Fraunhofer line. The spectrometers will test if reports of a diffuse extragalactic background in the 1 - 2 um band continues into the optical, or is caused by an under estimation of the Zodiacal foreground. We report performance of the assembled and tested instrument as we prepare for a first sounding rocket flight in early 2009. CIBER is funded by the NASA/APRA sub-orbital program.

  4. CT detector evaluation with complex random backgrounds

    Science.gov (United States)

    Fan, Helen; Barrett, Harrison H.

    2012-02-01

    Modern computed tomography (CT) uses detector arrays consisting of large numbers of photodiodes with scintil- lator crystals. The number of pixels in the array can play an important role in system performance. Considerable research has been performed on signal detection in flat backgrounds under various conditions, but little has been done with complex, random backgrounds in CT; our work investigates in particular the effect of the number of detector elements on signal detection by a channelized Hotelling observer in a complex background. For this project, a simulated three-dimensional phantom is generated with its attenuation equal to that of water. The phantom contains a smaller central section with random variations to simulate random anatomical structures. Cone-beam projections of the phantom are acquired at different angles and used to calculate the covariance matrix of the raw projection data. Laguerre-Gauss channels are used to reduce the dimensionality of each 2D projection and hence the size of the covariance matrix, but the covariance is still a function of two projection angles. A strong cross-channel correlation is observed as a function of the difference between the angles. A signal with known location and size is used, and the performance of the observer is calculated from the channel outputs at multiple projection angles. A contrast-detail diagram is computed for different variables such as signal size, number of incident x-ray photons, pixel size, etc. At a fixed observer signal-to-noise ratio (SNR), the contrast required to detect a signal increases dramatically as the signal size decreases.

  5. Alcohol dependence--classificatory considerations.

    Science.gov (United States)

    Lesch, O M; Ades, J; Badawy, A; Pelc, I; Sasz, H

    1993-01-01

    The term alcoholism or alcohol dependence has acquired a broad range of meanings. The Plinius Maior Society herewith presents new classificatory considerations and suggests additional recording of special dimensions according to the individual hypothesis and design of a study.

  6. [The psychosocial background of sterile patients].

    Science.gov (United States)

    Pusch, H H; Urdl, W; Walcher, W

    1989-01-01

    The psychosocial background of 300 childless couples from the Infertility Clinic of the Department of Gynecology and Obstetrics, University of Graz, was evaluated by means of a questionnaire and statistical analysis of data from their files. Points of special interest were problems such as interactions of the couple, motivations for the desire of children, psychosomatics, andrological investigation within the gynecological department, sexual habits and motivation and compliance concerning investigations and treatment. 72% of the questionnaires were returned. 50% of the sterile couples preferred to attend the infertility clinic together. 26% felt restrictions in their sexual behaviour due to the unrealized desire of children, 48% expected improvements in their partnership if they could have children. Compliance of male partners concerning the regular intake of prescribed medicaments was 83%, 63% accepted to stop smoking in cases of pathospermia.

  7. Robust kernel-based tracking algorithm with background contrasting

    Institute of Scientific and Technical Information of China (English)

    Rongli Liu; Zhongliang Jing

    2012-01-01

    The mean-shift algorithm has achieved considerable success in object tracking due to its simplicity and efficiency. Color histogram is a common feature in the description of an object. However, the kernel-based color histogram may not have the ability to discriminate the object from clutter background. To boost the discriminating ability of the feature, based on background contrasting, this letter presents an improved Bhattacharyya similarity metric for mean-shift tracking. Experiments show that the proposed tracker is more robust in relation to background clutter.%The mean-shift algorithm has achieved considerable success in object tracking due to its simplicity and efficiency.Color histogram is a common feature in the description of an object.However,the kernel-based color histogram may not have the ability to discriminate the object from clutter background.To boost the discriminating ability of the feature,based on background contrasting,this letter presents an improved Bhattacharyya similarity metric for mean-shift tracking.Experiments show that the proposed tracker is more robust in relation to background clutter.

  8. The clinical efficacy and safety of certolizumab pegol (CZP in the treatment of rheumatoid arthritis: focus on long-term use, patient considerations and the impact on quality of life

    Directory of Open Access Journals (Sweden)

    Roy Fleischmann

    2009-07-01

    Full Text Available Roy FleischmannMetroplex Clinical Research Center, Dallas, Texas, USAAbstract: Rheumatoid arthritis can cause chronic pain, disability, fatigue and loss of productivity both in the workplace and at home. Fatigue, not joint pain, swelling or that there may be radiographic damage, is frequently mentioned by patients as their most debilitating problem. In the era prior to biologic therapy in rheumatoid arthritis, it was reported that 40% to 50% of individuals reported work loss within 10 years of the onset of their disease. Rheumatoid arthritis is not just associated with chronic pain and inability to function normally; there is a significant economic burden caused by the disease which affects society as well the individual. Work disability in individuals with rheumatoid arthritis occurs early and increases over time. Early, aggressive treatment has now become the norm in clinical practice with changes of medication dictated by measuring the presence of continued disease activity. The combination of adequately dosed methotrexate and a biologic agent, especially a TNFα inhibitor, has been shown to be far more effective than traditional disease modifying anti-rheumatic drugs in early and long-standing disease, with respect to clinical, radiologic and functional outcomes. Unfortunately, not all patients respond to all medications equally; indeed a patient may fail a number of medications, either alone or in combination, and then respond to another medication. For this reason, there is room in our therapeutic armamentarium for additional effective agents such as certolizumab pegol. The results of up to 100 weeks of treatment with certolizumab pegol with an emphasis on functional outcomes, is the focus of this review.Keywords: certolizumab, rheumatoid arthritis, anti-TNF therapy; efficacy, safety, quality of life

  9. Highlights From the American Association of Pharmaceutical Scientists/ International Transporter Consortium Joint Workshop on Drug Transporters in Absorption, Distribution, Metabolism, and Excretion: From the Bench to the Bedside - Clinical Pharmacology Considerations.

    Science.gov (United States)

    Ronaldson, P T; Bauer, B; El-Kattan, A F; Shen, H; Salphati, L; Louie, S W

    2016-11-01

    The American Association of Pharmaceutical Scientists/International Transporter Consortium Joint Workshop on Drug Transporters in absorption, distribution, metabolism, and excretion was held with the objective of discussing innovative advances in transporter pharmacology. Specific topics included (i) transporters at the blood-brain barrier (BBB); (ii) emerging transport proteins; (iii) recent advances in achieving hepatoselectivity and optimizing clearance for organic anion-transporting polypeptide (OATP) substrates; (iv) utility of animal models for transporter studies; and (v) clinical correlation of transporter polymorphisms. Here, we present state-of-the-art highlights from this workshop in these key areas of focus.

  10. Ethical Considerations on the Reuse of Clinical Laboratory Blood Samples in Research%临床检验血样本科研再利用的伦理考量∗

    Institute of Scientific and Technical Information of China (English)

    陈晓云; 张倩; 王思洁; 樊民胜; 刘胜

    2016-01-01

    By referring to the domestic and foreign relevant regulatory guidelines, this paper analyzed and sum-marized the ethical point in the design phase in the perspective of relevant regulations of clinical waste sample man-agement and biological sample management. It also analyzed the focus problems including the difference in sample library and clinical laboratory remaining sample as well as the ownership of the sample, to provide theoretical basis for ethics committee to review this kind of protocols.%通过查阅目前国内外的相关法规指南,从临床废弃样本处理、科研生物样本管理等相关的国内外法规和流程入手,分析总结方案设计阶段的伦理注意点,并结合样本库与临床检验剩余样本研究的差异及样本的归属权等焦点问题进行分析,为伦理委员会在以后审查此类研究提供理论依据。

  11. Stealths on Anisotropic Holographic Backgrounds

    CERN Document Server

    Ayón-Beato, Eloy; Juárez-Aubry, María Montserrat

    2015-01-01

    In this paper, we are interested in exploring the existence of stealth configurations on anisotropic backgrounds playing a prominent role in the non-relativistic version of the gauge/gravity correspondence. By stealth configuration, we mean a nontrivial scalar field nonminimally coupled to gravity whose energy-momentum tensor evaluated on the anisotropic background vanishes identically. In the case of a Lifshitz spacetime with a nontrivial dynamical exponent z, we spotlight the role played by the anisotropy to establish the holographic character of the stealth configurations, i.e. the scalar field is shown to only depend on the radial holographic direction. This configuration which turns out to be massless and without integration constants is possible for a unique value of the nonminimal coupling parameter. Then, using a simple conformal argument, we map this configuration into a stealth solution defined on the so-called hyperscaling violation metric which is conformally related to the Lifshitz spacetime. Thi...

  12. The Diffuse Supernova Neutrino Background

    CERN Document Server

    Beacom, John F

    2010-01-01

    The Diffuse Supernova Neutrino Background (DSNB) is the weak glow of MeV neutrinos and antineutrinos from distant core-collapse supernovae. The DSNB has not been detected yet, but the Super-Kamiokande (SK) 2003 upper limit on the electron antineutrino flux is close to predictions, now quite precise, based on astrophysical data. If SK is modified with dissolved gadolinium to reduce detector backgrounds and increase the energy range for analysis, then it should detect the DSNB at a rate of a few events per year, providing a new probe of supernova neutrino emission and the cosmic core-collapse rate. If the DSNB is not detected, then new physics will be required. Neutrino astronomy, while uniquely powerful, has proven extremely difficult -- only the Sun and the nearby Supernova 1987A have been detected to date -- so the promise of detecting new sources soon is exciting indeed.

  13. Background independence in a background dependent renormalization group

    CERN Document Server

    Labus, Peter; Slade, Zoë H

    2016-01-01

    Within the derivative expansion of conformally reduced gravity, the modified split Ward identities are shown to be compatible with the flow equations if and only if either the anomalous dimension vanishes or the cutoff profile is chosen to be power law. No solutions exist if the Ward identities are incompatible. In the compatible case, a clear reason is found for why Ward identities can still forbid the existence of fixed points; however, for any cutoff profile, a background independent (and parametrisation independent) flow equation is uncovered. Finally, expanding in vertices, the combined equations are shown generically to become either over-constrained or highly redundant beyond the six-point level.

  14. Closing the Gap between Research Evidence and Clinical Practice: Jordanian Nurses' Perceived Barriers to Research Utilisation

    Science.gov (United States)

    Al Khalaileh, Murad; Al Qadire, Mohammad; Musa, Ahmad S.; Al-Khawaldeh, Omar A.; Al Qudah, Hani; Alhabahbeh, Atalla

    2016-01-01

    Background: The nursing profession is a combination of theory and practical skill, and nurses are required to generate and develop knowledge through implementing research into clinical practice. Considerable number of barriers could hind implementing research findings into practice. Barriers to research utilisation are not identified in the…

  15. A Clinical Study of Phenomenology and Comorbidity of Paediatric Bipolar Disorder

    Science.gov (United States)

    Gupta, Pavan Kumar; T., Sivakumar; Agarwal, Vivek; Sitholey, Prabhat

    2012-01-01

    Background: Considerable controversy exists regarding clinical presentation, diagnosis, and comorbidities especially with Attention Deficit Hyperactivity Disorder (ADHD), in paediatric Bipolar Disorder (BPD). Aims and objectives: To describe phenomenology and comorbidities of paediatric BPD. Method: 78 Subjects (6-16 years) attending child and…

  16. Ultrasound in Rheumatology : Fundamental background and clinical applications

    NARCIS (Netherlands)

    D.F. ten Cate (David)

    2015-01-01

    markdownabstract__Abstract__ Ultrasonography is an imaging modality that is used increasingly in daily practice for the investigation and management of rheumatoid arthritis (RA). This introduction provides an overview on the rationale for using US in RA by discussing relevant events and development

  17. Hyponatremia: Special Considerations in Older Patients

    Directory of Open Access Journals (Sweden)

    Roy L. Soiza

    2014-08-01

    Full Text Available Hyponatremia is especially common in older people. Recent evidence highlights that even mild, chronic hyponatremia can lead to cognitive impairment, falls and fractures, the latter being in part due to bone demineralization and reduced bone quality. Hyponatremia is therefore of special significance in frail older people. Management of hyponatremia in elderly individuals is particularly challenging. The underlying cause is often multi-factorial, a clear history may be difficult to obtain and clinical examination is unreliable. Established treatment modalities are often ineffective and carry considerable risks, especially if the diagnosis of underlying causes is incorrect. Nevertheless, there is some evidence that correction of hyponatremia can improve cognitive performance and postural balance, potentially minimizing the risk of falls and fractures. Oral vasopressin receptor antagonists (vaptans are a promising innovation, but evidence of their safety and effect on important clinical outcomes in frail elderly individuals is limited.

  18. Consideraciones clínicas sobre la resorción radicular externa por impactación dentaria Clinical considerations on external root resorptions caused by dental impactation

    Directory of Open Access Journals (Sweden)

    MA Martínez Lozano

    2003-02-01

    Full Text Available La resorción externa por presión (RREP consiste en una pérdida de tejido dentinario y cementario de las raíces dentarias que se origina a nivel del ligamento periodontal, ocasionada por presiones prolongadas y mantenidas sobre la raíz. Presentamos tres casos con diferente repercusión y tratamiento. Según el distinto grado de afectación se describe y clasifica el tratamiento de RREP a causa de dientes impactados. En cuanto a la restauración de RREP se perfila la cavidad clase V de diseño 5 y el empleo de cermet o amalgamas de plata para su relleno.Pressure external root resorption (PERR is a loss of dental root tissues (dentine and cementum that begin in the periodontal area caused by a impacted teeth. We show three cases with differents clinical situations and therapeutical aspects. Pulpal injurie and difficulty in the post-endodontic cavity acces are characteristiques of these processes. Depending on the level of tissue destruction we discusse the therapeutical orientation in each case. Some treatments like class V type 5 cavities or fillings with cermet glass-ionomer in the more atipical situations (generally after an endodontic treatment are a good choice in these situations.

  19. Family Background and Educational Choices

    DEFF Research Database (Denmark)

    McIntosh, James; D. Munk, Martin

    We examine the participation in secondary and tertiary education of five cohorts of Danish males and females who were aged twenty starting in 1982 and ending in 2002. We find that the large expansion of secondary education in this period was characterized by a phenomenal increase in gymnasium...... enrollments, especially for females. Not only did the educational opportunities for individuals with disadvantaged backgrounds improve absolutely, but their relative position also improved. A similarly dramatic increase in attendance at university for the period 1985-2005 was found for these cohorts when...

  20. Particle propagation in cosmological backgrounds

    CERN Document Server

    Arteaga, Daniel

    2007-01-01

    We study the quantum propagation of particles in cosmological backgrounds, by considering a doublet of massive scalar fields propagating in an expanding universe, possibly filled with radiation. We focus on the dissipative effects related to the expansion rate. At first order, we recover the expected result that the decay rate is determined by the local temperature. Beyond linear order, the decay rate has an additional contribution governed by the expansion parameter. This latter contribution is present even for stable particles in the vacuum. Finally, we analyze the long time behaviour of the propagator and briefly discuss applications to the trans-Planckian question.

  1. The Cosmic Background Explorer Satellite

    Science.gov (United States)

    Mather, J.; Kelsall, T.

    1980-01-01

    The Cosmic Background Explorer (COBE) satellite, planned for launch in 1985, will measure the diffuse infrared and microwave radiation of the universe over the entire wavelength range from a few microns to 1.3 cm. It will include three instruments: a set of microwave isotropy radiometers at 23, 31, 53, and 90 GHz, an interferometer spectrometer from 1 to 100/cm, and a filter photometer from 1 to 300 microns. The COBE satellite is designed to reach the sensitivity limits set by foreground sources such as the interstellar and interplanetary dust, starlight, and galactic synchrotron radiation, so that a diffuse residual radiation may be interpreted unambiguously as extragalactic

  2. Statistical properties of consideration sets

    OpenAIRE

    Carson, RT; Louviere, JJ

    2015-01-01

    © 2015 Elsevier Ltd. The concept of a consideration set has become a central concept in the study of consumer behavior. This paper shows that the common practice of estimating models using only the set of alternatives deemed to be in the set considered by a consumer will usually result in estimated parameters that are biased due to a sample selection effect. This effect is generic to many consideration set models and can be large in practice. To overcome this problem, models of an antecedent ...

  3. [Toothache with a neuropathic background

    NARCIS (Netherlands)

    Khatchaturian, V.; Wijer, A. de; Kalaykova, S.I.; Steenks, M.H.

    2015-01-01

    A 48-year old woman in good general health was referred to the orofacial pain clinic in a centre for special dentistry with a toothache in the premolar region of the left maxillary quadrant. The complaints had existed for 15 years and various dental treatments, including endodontic treatments,

  4. Nature of the Background Ultraviolet Radiation Field at High Redshifts

    Indian Academy of Sciences (India)

    Archana Samantaray; Pushpa Khare

    2000-06-01

    We have tried to determine the flux of the ultraviolet background radiation field from the column density ratios of various ions in several absorption systems observed in the spectra of QSOs. We find that in most cases the flux is considerably higher than what has been estimated to be contributed by the AGNs. The excess flux could originate locally in hot stars. In a few cases we have been able to show that such galactic flux can only contribute a part of the total required flux. The results suggest that the background gets a significant contribution from an unseen QSO population.

  5. Hipnose, dor e subjetividade: considerações teóricas e clínicas Hipnosis, dolor y subjetividad: consideraciones teóricas y clínicas Hypnosis, pain and subjectivity: theoretical and clinical considerations

    Directory of Open Access Journals (Sweden)

    Maurício da Silva Neubern

    2009-06-01

    subjetividad y sujeto en el ámbito de las complejas relaciones entre dolor e hipnosis dentro del contexto clínico.The present article aims to propose a qualitative and clinical approach to the comprehension of the relationship between hypnosis and pain, taking as a reference the notion of subjectivity. Having a criticism of the statistical methodologies as a starting-point, three other points are discussed in that sense. Firstly, the pain is conceived as a subjective process, organized in terms of configurations, senses, emotions and meanings that are built in the actions of the subject in his or her respective social insertion sceneries. Secondly, the relationship between hypnosis and pain is emphasized, giving a highlight to the intersubjective processes that exist in the communication and relationship between therapist and subject. The third point accentuates the importance of the singularity that should range the comprehension of pain, as well as the construction of hypnotic interventions. The article is concluded by emphasizing the relevance of subjectivity and subject notions in what regards the complex relationships between pain and hypnosis in the clinical context.

  6. Fracaso de la osteosíntesis mandibular. Consideraciones biomecánicas y tratamiento: A propósito de dos casos clínicos Mandibular osteosynthesis failure. Biomechanical and therapeutic considerations: Two clinical cases

    Directory of Open Access Journals (Sweden)

    I. Navarro

    2009-04-01

    Full Text Available Introducción: El fracaso de la osteosíntesis mandibular no es una situación frecuente. El objetivo de este artículo es determinar su etiología y esbozar su tratamiento. Material y métodos: Se presentan dos casos clínicos en los que se produjo un fracaso de la osteosíntesis y se indica su tratamiento. Discusión: Se analiza la etiología del fracaso y cómo, con la terapéutica adecuada, se consigue una regeneración ósea. Un conocimiento exacto de las características biomecánicas del sistema masticatorio, ayuda a abordar esta patología. Conclusión: Una fijación rígida con placas tipo "lock" junto a injerto esponjoso autólogo de cresta iliaca es la clave del éxito terapéutico.Introduction: Mandibular osteosynthesis failure is not common. The purpose of this article is to examine the etiology and treatment of mandibular osteosynthesis failure. Material and methods: Two clinical cases of mandibular osteosynthesis failure and its treatment are reported. Discussion: The etiology of osteosynthesis failure and bone regeneration with suitable treatment is analyzed Exact knowledge of the biomechanical characteristics of the masticatory system is useful in approaching this condition. Conclusion: Rigid fixation with locking plates and autologous grafts of iliac crest cancellous bone are the key to therapeutic success.

  7. Considerations for GPU SEE Testing

    Science.gov (United States)

    Wyrwas, Edward J.

    2017-01-01

    This presentation will discuss the considerations an engineer should take to perform Single Event Effects (SEE) testing on GPU devices. Notable topics will include setup complexity, architecture insight which permits cross platform normalization, acquiring a reasonable detail of information from the test suite, and a few lessons learned from preliminary testing.

  8. Ethical considerations in revision rhinoplasty.

    Science.gov (United States)

    Wayne, Ivan

    2012-08-01

    The problems that arise when reviewing another surgeon's work, the financial aspects of revision surgery, and the controversies that present in marketing and advertising will be explored. The technological advances of computer imaging and the Internet have introduced new problems that require our additional consideration.

  9. Counseling Considerations with Gay Couples.

    Science.gov (United States)

    Winkelpleck, Judy M.; Westfeld, John S.

    1982-01-01

    Discusses the unique strengths of gay couples and major issues which need more consideration. Suggests guidelines for counselors and psychologists working with gay couples, based on a survey of homosexuals and professionals who work with them. Urges professionals to accept homosexuality and develop good counseling skills in this area. (Author/JAC)

  10. Considerations on Writing Test Construction

    Institute of Scientific and Technical Information of China (English)

    王欣

    2005-01-01

    Writing test , wins its popularity in measuring the mastery of one's language ability. In view of the significant role writing playing in a test , some considerations on writing test construction are presented in this paper which anticipates the effective ways for measuring one's complex language ability of application.

  11. Texture induced microwave background anisotropies

    Energy Technology Data Exchange (ETDEWEB)

    Borrill, Julian; Copeland, Edmund J.; Liddle, Andrew R.; Stebbins, Albert; Veeraraghavan, Shoba

    1994-03-01

    We use numerical simulations to calculate the cosmic microwave background anisotropy induced by the evolution of a global texture field, with special emphasis on individual textures. Both spherically symmetric and general configurations are analyzed, and in the latter case we consider field configurations which exhibit unwinding events and also ones which do not. We compare the results given by evolving the field numerically under both the expanded core (XCORE) and non-linear sigma model (NLSM) approximations with the analytic predictions of the NLSM exact solution for a spherically symmetric self-similar (SSSS) unwinding. We find that the random unwinding configuration spots' typical peak height is 60-75\\% and angular size typically only 10% of those of the SSSS unwinding, and that random configurations without an unwinding event nonetheless may generate indistinguishable hot and cold spots. A brief comparison is made with other work.

  12. Polarization of Cosmic Microwave Background

    CERN Document Server

    Buzzelli, Alessandro; de Gasperis, Giancarlo; Vittorio, Nicola

    2016-01-01

    In this work we present an extension of the ROMA map-making code for data analysis of Cosmic Microwave Background polarization, with particular attention given to the inflationary polarization B-modes. The new algorithm takes into account a possible cross-correlated noise component among the different detectors of a CMB experiment. We tested the code on the observational data of the BOOMERanG (2003) experiment and we show that we are provided with a better estimate of the power spectra, in particular the error bars of the BB spectrum are smaller up to 20% for low multipoles. We point out the general validity of the new method. A possible future application is the LSPE balloon experiment, devoted to the observation of polarization at large angular scales.

  13. Background illumination and automated perimetry.

    Science.gov (United States)

    Klewin, K M; Radius, R L

    1986-03-01

    Visual field function in the right and left eyes of 31 normal volunteers was evaluated with an automated projection perimeter (OCTOPUS). Serial visual field evaluations were repeated in these same eyes with neutral filters of increasing optical density. We compared the results of threshold determinations with the different neutral filters in place before the examined eye. Significant reduction in threshold sensitivity at several test spots throughout the central 30 degrees visual field was seen with neutral density filters of 0.5 log units or greater. The low level of background illumination of the OCTOPUS perimeter (4.0 apostilbs) may allow relatively minor reduction in light transmission by the ocular media to produce significant changes in the recorded level of threshold sensitivity during visual field evaluation.

  14. Background reionization history from omniscopes

    CERN Document Server

    Clesse, Sebastien; Ringeval, Christophe; Tashiro, Hiroyuki; Tytgat, Michel

    2012-01-01

    The measurements of the 21 cm brightness temperature fluctuations from the neutral hydrogen at the epoch of reionization (EoR) should inaugurate the next generation of cosmological observables. In this respect, many works have concentrated on the disambiguation of the cosmological signals from the dominant reionization foregrounds. However, even after perfect foregrounds removal, our ignorance on the background reionization history can significantly affect the cosmological parameter estimation. In particular, the interdependence between the hydrogen ionized fraction, the baryon density and the optical depth to the redshift of observation induce non-trivial degeneracies between the cosmological parameters that have not been considered so far. Using a simple, but consistent, reionization model, we revisit their expected constraints for a futuristic giant 21 cm omniscope by using for the first time Monte-Carlo-Markov-Chains (MCMC) methods on multi-redshift full sky simulated data. Our results agree well with the...

  15. Background paper on aquaculture research

    DEFF Research Database (Denmark)

    Wenblad, Axel; Jokumsen, Alfred; Eskelinen, Unto

    , retail and consumers). Aiming to enable a progressive change of the Swedish aquaculture sector the Working Group recommends that MISTRA establishes a research program on aquaculture including: 1. Global ecosystem aspects of aquaculture production including diversification, production systems, species......The Board of MISTRA established in 2012 a Working Group (WG) on Aquaculture to provide the Board with background information for its upcoming decision on whether the foundation should invest in aquaculture research. The WG included Senior Advisor Axel Wenblad, Sweden (Chairman), Professor Ole...... Torrissen, Norway, Senior Advisory Scientist Unto Eskelinen, Finland and Senior Advisory Scientist Alfred Jokumsen, Denmark. The WG performed an investigation of the Swedish aquaculture sector including interviews with a range of stakeholders within aquaculture research, farming organisations, authorities...

  16. Does a Rater's Professional Background Influence Communication Skills Assessment?

    Science.gov (United States)

    Artemiou, Elpida; Hecker, Kent G; Adams, Cindy L; Coe, Jason B

    2015-01-01

    There is increasing pressure in veterinary education to teach and assess communication skills, with the Objective Structured Clinical Examination (OSCE) being the most common assessment method. Previous research reveals that raters are a large source of variance in OSCEs. This study focused on examining the effect of raters' professional background as a source of variance when assessing students' communication skills. Twenty-three raters were categorized according to their professional background: clinical sciences (n=11), basic sciences (n=4), clinical communication (n=5), or hospital administrator/clinical skills technicians (n=3). Raters from each professional background were assigned to the same station and assessed the same students during two four-station OSCEs. Students were in year 2 of their pre-clinical program. Repeated-measures ANOVA results showed that OSCE scores awarded by the rater groups differed significantly: (F(matched_station_1) [2,91]=6.97, p=.002), (F(matched_station_2) [3,90]=13.95, p=.001), (F(matched_station_3) [3,90]=8.76, p=.001), and ((Fmatched_station_4) [2,91]=30.60, p=.001). A significant time effect between the two OSCEs was calculated for matched stations 1, 2, and 4, indicating improved student performances. Raters with a clinical communication skills background assigned scores that were significantly lower compared to the other rater groups. Analysis of written feedback provided by the clinical sciences raters showed that they were influenced by the students' clinical knowledge of the case and that they did not rely solely on the communication checklist items. This study shows that it is important to consider rater background both in recruitment and training programs for communication skills' assessment.

  17. Ethnic background and genetic variation in the evaluation of cancer risk: a systematic review.

    Directory of Open Access Journals (Sweden)

    Lijun Jing

    Full Text Available The clinical use of genetic variation in the evaluation of cancer risk is expanding, and thus understanding how determinants of cancer susceptibility identified in one population can be applied to another is of growing importance. However there is considerable debate on the relevance of ethnic background in clinical genetics, reflecting both the significance and complexity of genetic heritage. We address this via a systematic review of reported associations with cancer risk for 82 markers in 68 studies across six different cancer types, comparing association results between ethnic groups and examining linkage disequilibrium between risk alleles and nearby genetic loci. We find that the relevance of ethnic background depends on the question. If asked whether the association of variants with disease risk is conserved across ethnic boundaries, we find that the answer is yes, the majority of markers show insignificant variability in association with cancer risk across ethnic groups. However if the question is whether a significant association between a variant and cancer risk is likely to reproduce, the answer is no, most markers do not validate in an ethnic group other than the discovery cohort's ancestry. This lack of reproducibility is not attributable to studies being inadequately populated due to low allele frequency in other ethnic groups. Instead, differences in local genomic structure between ethnic groups are associated with the strength of association with cancer risk and therefore confound interpretation of the implied physiologic association tracked by the disease allele. This suggest that a biological association for cancer risk alleles may be broadly consistent across ethnic boundaries, but reproduction of a clinical study in another ethnic group is uncommon, in part due to confounding genomic architecture. As clinical studies are increasingly performed globally this has important implications for how cancer risk stratifiers should be

  18. CONSIDERATIONS UPON ASSIMILATED ADMINISTRATIVE ACTS

    OpenAIRE

    2011-01-01

    Although the classic administrative courts know as object the acts against classic administrative acts, it should not be lost sight of the assimilated administrative acts, which also may be subject to acts in this litigation. Taking in consideration this category of acts, this study will examine the documents falling into this category and the impact that such acts have on public authorities. Given the significant increase of administrative cases that have as object assimilated administrative...

  19. Neurobiological background of negative symptoms.

    Science.gov (United States)

    Galderisi, Silvana; Merlotti, Eleonora; Mucci, Armida

    2015-10-01

    Studies investigating neurobiological bases of negative symptoms of schizophrenia failed to provide consistent findings, possibly due to the heterogeneity of this psychopathological construct. We tried to review the findings published to date investigating neurobiological abnormalities after reducing the heterogeneity of the negative symptoms construct. The literature in electronic databases as well as citations and major articles are reviewed with respect to the phenomenology, pathology, genetics and neurobiology of schizophrenia. We searched PubMed with the keywords "negative symptoms," "deficit schizophrenia," "persistent negative symptoms," "neurotransmissions," "neuroimaging" and "genetic." Additional articles were identified by manually checking the reference lists of the relevant publications. Publications in English were considered, and unpublished studies, conference abstracts and poster presentations were not included. Structural and functional imaging studies addressed the issue of neurobiological background of negative symptoms from several perspectives (considering them as a unitary construct, focusing on primary and/or persistent negative symptoms and, more recently, clustering them into factors), but produced discrepant findings. The examined studies provided evidence suggesting that even primary and persistent negative symptoms include different psychopathological constructs, probably reflecting the dysfunction of different neurobiological substrates. Furthermore, they suggest that complex alterations in multiple neurotransmitter systems and genetic variants might influence the expression of negative symptoms in schizophrenia. On the whole, the reviewed findings, representing the distillation of a large body of disparate data, suggest that further deconstruction of negative symptomatology into more elementary components is needed to gain insight into underlying neurobiological mechanisms.

  20. Plenoptic background oriented schlieren imaging

    Science.gov (United States)

    Klemkowsky, Jenna N.; Fahringer, Timothy W.; Clifford, Christopher J.; Bathel, Brett F.; Thurow, Brian S.

    2017-09-01

    The combination of the background oriented schlieren (BOS) technique with the unique imaging capabilities of a plenoptic camera, termed plenoptic BOS, is introduced as a new addition to the family of schlieren techniques. Compared to conventional single camera BOS, plenoptic BOS is capable of sampling multiple lines-of-sight simultaneously. Displacements from each line-of-sight are collectively used to build a four-dimensional displacement field, which is a vector function structured similarly to the original light field captured in a raw plenoptic image. The displacement field is used to render focused BOS images, which qualitatively are narrow depth of field slices of the density gradient field. Unlike focused schlieren methods that require manually changing the focal plane during data collection, plenoptic BOS synthetically changes the focal plane position during post-processing, such that all focal planes are captured in a single snapshot. Through two different experiments, this work demonstrates that plenoptic BOS is capable of isolating narrow depth of field features, qualitatively inferring depth, and quantitatively estimating the location of disturbances in 3D space. Such results motivate future work to transition this single-camera technique towards quantitative reconstructions of 3D density fields.

  1. Biological evolution: Some genetic considerations

    African Journals Online (AJOL)

    Mohammad Saad Zaghloul Salem

    2013-12-08

    Dec 8, 2013 ... Abstract Background: The concept of biological evolution has long been accepted as a palatable ... cept of evolution, viz. genetic memory and evolutionary variations, genomic adaptations .... control of structures and functions of biomolecules, living ... construction of new metabolic pathways or acquisition of.

  2. Cosmic Microwave Background Data Analysis

    Science.gov (United States)

    Paykari, Paniez; Starck, Jean-Luc Starck

    2012-03-01

    About 400,000 years after the Big Bang the temperature of the Universe fell to about a few thousand degrees. As a result, the previously free electrons and protons combined and the Universe became neutral. This released a radiation which we now observe as the cosmic microwave background (CMB). The tiny fluctuations* in the temperature and polarization of the CMB carry a wealth of cosmological information. These so-called temperature anisotropies were predicted as the imprints of the initial density perturbations which gave rise to the present large-scale structures such as galaxies and clusters of galaxies. This relation between the present-day Universe and its initial conditions has made the CMB radiation one of the most preferred tools to understand the history of the Universe. The CMB radiation was discovered by radio astronomers Arno Penzias and Robert Wilson in 1965 [72] and earned them the 1978 Nobel Prize. This discovery was in support of the Big Bang theory and ruled out the only other available theory at that time - the steady-state theory. The crucial observations of the CMB radiation were made by the Far-Infrared Absolute Spectrophotometer (FIRAS) instrument on the Cosmic Background Explorer (COBE) satellite [86]- orbited in 1989-1996. COBE made the most accurate measurements of the CMB frequency spectrum and confirmed it as being a black-body to within experimental limits. This made the CMB spectrum the most precisely measured black-body spectrum in nature. The CMB has a thermal black-body spectrum at a temperature of 2.725 K: the spectrum peaks in the microwave range frequency of 160.2 GHz, corresponding to a 1.9mmwavelength. The results of COBE inspired a series of ground- and balloon-based experiments, which measured CMB anisotropies on smaller scales over the next decade. During the 1990s, the first acoustic peak of the CMB power spectrum (see Figure 5.1) was measured with increasing sensitivity and by 2000 the BOOMERanG experiment [26] reported

  3. Hispanic Masculinity: Myth or Psychological Schema Meriting Clinical Consideration.

    Science.gov (United States)

    Casas, J. Manuel; And Others

    1994-01-01

    Examines machismo (strict adherence to traditional masculine gender identity) in terms of Bem's gender schema theory. Uses the example of a Mexican immigrant family facing social and cultural changes to demonstrate the dynamics of machismo and how it might lead to emotional problems and physical symptoms in Hispanic men and their families.…

  4. Clinical Considerations in Orthodontic Treatment of Teeth with Dentoalveolar Trauma

    OpenAIRE

    2014-01-01

    Dentoalveolar trauma is a very common public health problem. Its influence goes beyond accidents and their impact on teeth, because in the future it becomes a decisive factor if orthodontic treatment is required, because these traumas tend to lead to complications such as root resorption and pulp necrosis. Proper treatment of teeth with a medical history of trauma is essential for successful orthodontic treatment. Los traumas dentoalveolares son un problema de salud pública muy común. La i...

  5. [Occupational diseases: considerations on a clinical case series].

    Science.gov (United States)

    Candura, F; Biscaldi, G; Malamani, T; Fonte, R; Lodigiani, L; Lenoci, A

    1988-05-01

    The authors examine cases of occupational diseases diagnosed between 1982 and 1988 in patients admitted to "Divisione di Medicina del Lavoro I Sezione di medicina del Lavoro del Dipartimento di Medicina preventiva, occupazionale e di comunità dell'Università di Pavia". The most frequent syndromes concerns the auditory apparatus (having losses or deafness due to noise) and the respiratory system, whereas new safety regulations have given rise to the disappearance of benzene-induced hematologic abnormalities. Most of, the "classical" features of occupational diseases have disappeared, since early diagnosis has permitted the adoption of opportune technical and sanitary measures. The authors emphasize the necessity for role of Occupational Medicine (ever following the sentences 179 and 206 of the "Corte Costituzionale") to be not prevention, but also diagnosis, treatment and rehabilitation; therefore there is a need, all over the country, for adequate structures for the diagnosis and treatment of the occupational diseases.

  6. Creatine Kinase Clinical Considerations: Ethnicity, Gender and Genetics

    Science.gov (United States)

    2009-10-01

    contract. CK has five functional forms or isoenzymes, three are cytosolic and two are mitochondrial . The cytosolic forms are composed of two subunits...muscle (33). Both mitochondrial isoenzymes, non-sarcomeric and sarcomeric, are octamers consisting of four dimers each (5). The use of serum CK as a...and to detect various myopathies . However, the large variability in baseline levels may reflect prior exercise (23), muscle damage (7, 18), a

  7. [Clinical and functional considerations in some cases of postoperative endophthalmitis].

    Science.gov (United States)

    Muşat, O; Toma, Oana; Cristescu, R; Coman, Corina; Asandi, R; Burcea, M

    2013-01-01

    We present 3 cases of postsurgery endophthalmitis, with good initial operatory technique, which were admitted in our hospital within variable time, to which a second surgery was performed, with good postoperative evolution, without any inflammatory signs and preserving the eye. We analyse the pre and post-operative treatment of endophthalmitis, but also the ways to prevent the appearance of this post-operative complication.

  8. Clinical and imaging considerations in primary immunodeficiency disorders: an update

    Energy Technology Data Exchange (ETDEWEB)

    Wu, Eveline Y. [University of North Carolina at Chapel Hill, Department of Pediatrics, Chapel Hill, NC (United States); Ehrlich, Lauren [Yale School of Medicine, Department of Diagnostic Radiology, New Haven, CT (United States); Handly, Brian [University of North Carolina at Chapel Hill, Department of Radiology, Chapel Hill, NC (United States); Frush, Donald P. [Duke University Medical Center, Division of Pediatric Radiology, Durham, NC (United States); Buckley, Rebecca H. [Duke University Medical Center, Department of Pediatrics, Durham, NC (United States); Duke University School of Medicine, Department of Immunology, Durham, NC (United States)

    2016-11-15

    Primary immunodeficiencies are a group of genetically determined disorders with diverse presentations. The purpose of this review is to provide a practical and brief description of a select number of these diseases and to discuss the important role the radiologist can have in making an early diagnosis and in detecting and following disease complications. The role of diagnostic imaging and informed performance and interpretation are vital in the diagnosis, surveillance and management of all primary immunodeficiency disorders. (orig.)

  9. Material and clinical considerations for full-coverage indirect restorations.

    Science.gov (United States)

    Martin, Margaret P

    2012-11-01

    Because dental ceramics have been used for decades and continuously improved over the years, there is a plethora of information regarding their material characteristics, applications, and contraindications. Each restorative ceramic material demonstrates benefits and disadvantages, making it difficult for dentists to research, retain, and apply the ideal material for individual restorations and/or combination cases. This article outlines the applications and benefits of dental ceramics in general and examines and reviews the current ceramic alternatives available for restorative dentistry today. It also discusses the material composition and properties of a recently introduced new classification of indirect material: resin nano-ceramic.

  10. Automated external defibrillators: technical considerations and clinical promise.

    Science.gov (United States)

    Takata, T S; Page, R L; Joglar, J A

    2001-12-04

    Early defibrillation is the most important determinant of survival for victims of cardiac arrest due to ventricular fibrillation. The automated external defibrillator (AED) was developed as the result of the American Heart Association's Public Access Defibrillation initiative. The goal of this initiative is to place AEDs in strategic locations so that laypersons with minimal training could promptly defibrillate victims of cardiac arrest. Because of changes in design and the use of alternative waveforms for defibrillation, the modern AED is compact and portable, simple to use, and highly efficacious; in addition, it requires little maintenance. Automated external defibrillators have been used successfully by traditional and nontraditional responders as well as laypersons. In special environments, such as casinos and commercial aircraft, AEDs have performed particularly well. State and federal legislation has eased concerns about AED use by extending legal protection to AED users under Good Samaritan laws. Since the experience continues to be positive, AEDs are being used in increasingly diverse community locations, and public awareness is growing. The American Heart Association's initiative is progressing rapidly.

  11. Hispanic Masculinity: Myth or Psychological Schema Meriting Clinical Consideration.

    Science.gov (United States)

    Casas, J. Manuel; And Others

    1994-01-01

    Examines machismo (strict adherence to traditional masculine gender identity) in terms of Bem's gender schema theory. Uses the example of a Mexican immigrant family facing social and cultural changes to demonstrate the dynamics of machismo and how it might lead to emotional problems and physical symptoms in Hispanic men and their families.…

  12. Enamel microabrasion: An overview of clinical and scientific considerations

    OpenAIRE

    Pini, Núbia Inocencya Pavesi; Sundfeld-Neto, Daniel; Aguiar, Flavio Henrique Baggio; Sundfeld, Renato Herman; Martins, Luis Roberto Marcondes; Lovadino, José Roberto; Lima, Débora Alves Nunes Leite

    2015-01-01

    Superficial stains and irregularities of the enamel are generally what prompt patients to seek dental intervention to improve their smile. These stains or defects may be due to hypoplasia, amelogenesis imperfecta, mineralized white spots, or fluorosis, for which enamel microabrasion is primarily indicated. Enamel microabrasion involves the use of acidic and abrasive agents, such as with 37% phosphoric acid and pumice or 6% hydrochloric acid and silica, applied to the altered enamel surface wi...

  13. [Coronary artery fistulas, a current problem: Clinical and therapeutic considerations].

    Science.gov (United States)

    Tiritilli, A; Iaria, P; Viard, P; Sayah, S; Benali, T; Detienne, J-P; Martis, S; Tchatchum, F; Aouate, P

    2016-02-01

    The coronary fistula is a link between one or more of the coronary arteries and cardiac cavity or great vessel. The exact occurrence is unknown. The majority of these fistulas are congenital in origin. However, they may occasionally be detected after cardiac surgery. For a long time, fistulas are asymptomatic, especially if they are small; the frequency of the symptoms and especially the complications rise with age. The potential complications are: cardiac failure, endocarditis, endarteritis, atrial fibrillation, ventricular arrhythmias, rupture, and thrombosis. The main differential diagnosis is patent arterial duct, while other congenital arteriovenous shunts need to be excluded. Even though echocardiography Doppler can help to differentiate shunts, the coronary angiography remains the main diagnostic tool for the description of the anatomy. For a long time, the surgery was the only therapeutic means, up till now, percutaneous occlusion is the first line therapy of coronary fistulas and that the different devices can be tailored to meet different anatomic and functional characteristics.

  14. Forensic considerations for preprocessing effects on clinical MDCT scans.

    Science.gov (United States)

    Wade, Andrew D; Conlogue, Gerald J

    2013-05-01

    Manipulation of digital photographs destined for medico-legal inquiry must be thoroughly documented and presented with explanation of any manipulations. Unlike digital photography, computed tomography (CT) data must pass through an additional step before viewing. Reconstruction of raw data involves reconstruction algorithms to preprocess the raw information into display data. Preprocessing of raw data, although it occurs at the source, alters the images and must be accounted for in the same way as postprocessing. Repeated CT scans of a gunshot wound phantom were made using the Toshiba Aquilion 64-slice multidetector CT scanner. The appearance of fragments, high-density inclusion artifacts, and soft tissue were assessed. Preprocessing with different algorithms results in substantial differences in image output. It is important to appreciate that preprocessing affects the image, that it does so differently in the presence of high-density inclusions, and that preprocessing algorithms and scanning parameters may be used to overcome the resulting artifacts.

  15. Sample size considerations for clinical research studies in nuclear cardiology.

    Science.gov (United States)

    Chiuzan, Cody; West, Erin A; Duong, Jimmy; Cheung, Ken Y K; Einstein, Andrew J

    2015-12-01

    Sample size calculation is an important element of research design that investigators need to consider in the planning stage of the study. Funding agencies and research review panels request a power analysis, for example, to determine the minimum number of subjects needed for an experiment to be informative. Calculating the right sample size is crucial to gaining accurate information and ensures that research resources are used efficiently and ethically. The simple question "How many subjects do I need?" does not always have a simple answer. Before calculating the sample size requirements, a researcher must address several aspects, such as purpose of the research (descriptive or comparative), type of samples (one or more groups), and data being collected (continuous or categorical). In this article, we describe some of the most frequent methods for calculating the sample size with examples from nuclear cardiology research, including for t tests, analysis of variance (ANOVA), non-parametric tests, correlation, Chi-squared tests, and survival analysis. For the ease of implementation, several examples are also illustrated via user-friendly free statistical software.

  16. [Oral lesions in Kaposi sarcoma: clinical and radiotherapeutic considerations].

    Science.gov (United States)

    Barberis, M; Brenna Betti, N; Lauritano, D; Sangiani, L; Spadari, F; Villa, S

    1996-01-01

    The epidemic form of Kaposi's sarcoma is the most frequent tumor in sieropositive patients. Every part of the body including oral cavity is affected by these lesions. According to modern acknowledgement in treating oropharynge carcinoma, radiotherapy is used for management of oral Kaposi's sarcoma. This paper reports a study of 10 patients suffering from Kaposi's sarcoma correlated to AIDS (EKS) treated with radiotherapy and chemiotherapy, achieving good results, at the Istituto Nazionale per lo Studio e la Cura dei Tumori of Milan (Divisone di Radioterapia C) from 1988 to 1992. Treatment has been performed using linear accelerator (6 Mev) or Co 60 unity in order to reach the deepest layer of mucosa lesions. Radiotherapy schedule consisted of 150-200 cGy daily fractions given 5 times/week (w) for 4-5 w in split-course.

  17. Rationale for tilted implants: FEA considerations and clinical reports

    OpenAIRE

    DE VICO, G.; Bonino, M.; Spinelli,D; SCHIAVETTI, R.; Sannino, G.; Pozzi, A; OTTRIA, L.

    2012-01-01

    The prevalence of the elderly population, as well as life expectancy, increased in the final decades of the 20th century, as described in the World Health Organization 2004 Annual Report. The edentulous condition therefore has a negative impact on the oral health–related quality of life. Patients wearing complete dentures for many years infact, and especially in the mandible, are often unsatisfied because of the instability of the prosthesis during speaking and eating. To date dental implant ...

  18. “5+3”一体化背景下强化临床医学八年制学生临床能力培养的初步思考%Preliminary ideas of strengthening the clinical competence of “eight-year program” medical students under the background of establishment of integrated "5+3" medical education system in China

    Institute of Scientific and Technical Information of China (English)

    闫剑群; 王渊; 程彦斌

    2015-01-01

    "Cooperation of Clinical Practice and Medical Education" is a system guarantee for effectively linking undergraduate, postgraduate and continuing medical education, optimizing educational program, academic degree system and clinical talents training standardization, and strengthening and improving the relevant support mechanism. Under such a background, it is a challenge to advance the clinical competence of "eight-year program" medical students and complete the standardized resident training. In this article, these issues are discussed and preliminary suggestions are presented, based on the education reform for eight-year program medical students at Xi'an Jiaotong University.%“医教协同”是促进我国医学教育链环中院校教育、毕业后教育和继续教育有效衔接,优化医学教育学制学位体系建设和临床医学人才标准化、规范化培养制度建设,加强和完善相应的支撑、保障体系的制度保证。在这一背景下,如何提高临床医学专业八年制学生的临床能力并完成规范化培训,是一个值得认真思考的问题。本文以西安交通大学八年制临床医学专业的培养体系为例进行讨论并提出了初步建议,以期与同行共同探讨。

  19. Ageing and Brugada syndrome: considerations and recommendations

    Institute of Scientific and Technical Information of China (English)

    Pieter G. Postema; Hanno L Tan; Arthur AM Wilde

    2013-01-01

    Brugada syndrome is an inherited disease associated with an increased risk of lethal ventricular arrhythmias. Such arrhythmias stem from innate disruptions in cardiac electrophysiology. Typically, such arrhythmias occur in the third or fourth decade of life. However, Brugada syndrome may also affect geriatric patients. In this paper, we focus on the ageing patient with Brugada syndrome, and specifically, on the interaction between Brugada syndrome and the more usually acquired clinical problems that may occur with increasing age, such as the use of cardiovascular and non-cardiovascular drugs, or the need for surgery. Such common conditions may also disrupt cardiac electrophysiology, thereby conferring added risk for Brugada syndrome patients. We present some considerations and recommendations that may serve as guidance to address these complexities.

  20. Narcissism and the self: psychoanalytic considerations.

    Science.gov (United States)

    Meissner, W W

    2008-01-01

    This article addresses the relation of narcissism to the concept of the self. Based on the concept of the self-as-person, distinction is drawn between the self as a substantial, relatively autonomous source of agency and of both conscious and unconscious mentation and action on one hand and the self as the object of narcissistic investment on the other. The argument presumes abandonment of both the concept of narcissism as libidinal drive cathexis of the self (the most common understanding of narcissism among analysts) and the converse proposition defining the self as derived from and reflecting narcissistic origins. It is proposed that development of self structure arises on the basis of other than narcissistic considerations, but once established it can become the object of narcissistic investment. As such the self cannot be reduced to or defined in terms of narcissistic derivation. Implications for the understanding of self-esteem are explored and clinical implications suggested.

  1. Commercial considerations in tissue engineering.

    Science.gov (United States)

    Mansbridge, Jonathan

    2006-10-01

    Tissue engineering is a field with immense promise. Using the example of an early tissue-engineered skin implant, Dermagraft, factors involved in the successful commercial development of devices of this type are explored. Tissue engineering has to strike a balance between tissue culture, which is a resource-intensive activity, and business considerations that are concerned with minimizing cost and maximizing customer convenience. Bioreactor design takes place in a highly regulated environment, so factors to be incorporated into the concept include not only tissue culture considerations but also matters related to asepsis, scaleup, automation and ease of use by the final customer. Dermagraft is an allogeneic tissue. Stasis preservation, in this case cryopreservation, is essential in allogeneic tissue engineering, allowing sterility testing, inventory control and, in the case of Dermagraft, a cellular stress that may be important for hormesis following implantation. Although the use of allogeneic cells provides advantages in manufacturing under suitable conditions, it raises the spectre of immunological rejection. Such rejection has not been experienced with Dermagraft. Possible reasons for this and the vision of further application of allogeneic tissues are important considerations in future tissue-engineered cellular devices. This review illustrates approaches that indicate some of the criteria that may provide a basis for further developments. Marketing is a further requirement for success, which entails understanding of the mechanism of action of the procedure, and is illustrated for Dermagraft. The success of a tissue-engineered product is dependent on many interacting operations, some discussed here, each of which must be performed simultaneously and well.

  2. Circuit considerations for repetitive railguns

    Energy Technology Data Exchange (ETDEWEB)

    Honih, E.M.

    1986-01-01

    Railgun electromagnetic launchers have significant military and scientific potential. They provide direct conversion of electrical energy to projectile kinetic energy, and they offer the hope of achieving projectile velocities greatly exceeding the limits of conventional guns. With over 10 km/sec already demonstrated, railguns are attracting attention for tactical and strategic weapons systems and for scientific equation-of-state research. The full utilization of railguns will require significant improvements in every aspect of system design - projectile, barrel, and power source - to achieve operation on a large scale. This paper will review fundamental aspects of railguns, with emphasis on circuit considerations and repetitive operation.

  3. Preliminary considerations concerning actinide solubilities

    Energy Technology Data Exchange (ETDEWEB)

    Newton, T.W.; Bayhurst, B.P.; Daniels, W.R.; Erdal, B.R.; Ogard, A.E.

    1980-01-01

    Work at the Los Alamos Scientific Laboratory on the fundamental solution chemistry of the actinides has thus far been confined to preliminary considerations of the problems involved in developing an understanding of the precipitation and dissolution behavior of actinide compounds under environmental conditions. Attempts have been made to calculate solubility as a function of Eh and pH using the appropriate thermodynamic data; results have been presented in terms of contour maps showing lines of constant solubility as a function of Eh and pH. Possible methods of control of the redox potential of rock-groundwater systems by the use of Eh buffers (redox couples) is presented.

  4. 46 CFR 114.550 - Special consideration.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 4 2010-10-01 2010-10-01 false Special consideration. 114.550 Section 114.550 Shipping... consideration. In applying the provisions of this subchapter, the OCMI may give special consideration to... vessel operates must approve any special consideration granted to the vessel....

  5. Considerações clínicas e etiológicas das síndromes epilépticas sintomáticas com paroxismos occipitais bloqueados à abertura dos olhos Clinical and ethiological considerations about the symptomatic epileptic syndromes with occipital paroxism bloqued when the eyes open

    Directory of Open Access Journals (Sweden)

    Gilson Edmar Gonçalves e Silva

    2002-06-01

    Full Text Available A síndrome da epilepsia parcial com paroxismos occipitais no eletrencefalograma (EEG mostra características clínicas heterogêneas. Visando descrever esta rara forma de epilepsia, investigamos a significância dos achados eletrofisiológicos e clínicos em oito pacientes com paroxismos occipitais bloqueados pela abertura dos olhos. Os pacientes foram submetidos a exames radiológicos de RNM do encéfalo e/ou TC de crânio. Houve concordância entre as alterações do EEG e do tipo de crise em 5 pacientes, e entre as anormalidades anatômicas na TC ou RNM com anormalidades focais no EEG em 7 casos. Nossos resultados confirmam que este padrão inusitado origina-se de uma expressão eletrográfica multifatorial.The syndrome of idiophatic partial epilepsy with occipital paroxysms in the EEG shows a considerable clinical heterogeneity. The present paper investigated the signficance of electrophysiologic and clinical characteristics in eigth patients with occipital paroxysms blocked by the eye opening. All patients were submitted to radiological exams including brain MRI and/or CT. There was agreement between EEG findings and type of seizures in 5 patients and between anatomical abnormalities in the MRI or CT and EEG focal abnormalities in 7 patients. Our results confirm that the unusual pattern comes from eletrographic multifactors origins.

  6. Orthodontic treatment considerations in Down syndrome patients

    Directory of Open Access Journals (Sweden)

    Sianiwati Goenharto

    2012-03-01

    Full Text Available Background: Down syndrome is an easily recognized congenital disease anomaly, a common autosomal chromosomal anomaly with high prevalence of malocclusion. Orthodontic treatment demand should be high but it seems difficult to be done because of specific condition of disability. Purpose: The purpose of this literature review was to discribe the orthodontic problems found in Down syndrome patients and several consideration that shoud be done to treat them. Reviews: Many studies report the high prevalence of malocclusion among people with Down syndrome. There is a greater frequency of clas III relationship, crossbite, crowding and also open bite. Several problems might appear in the treatment because of dental, medical, mental, and behavioural factor. Conclusion: It is concluded that orthodonic treatment can be performed in Down syndrome patient, although several difficulties may appear. Good consideration in mental, behavior, medical and also dental condition will influence whether the treatment will success or not. Special care and facilities will support the orthodontic treatment.Latar belakang: Sindroma Down adalah suatu kelainan congenital yang mudah dikenali, merupakan kelaian kromosom autosomal yang cukup banyak terjadi, dengan prevalensi maloklusi cukup tinggi. Seharusnya permintaan akan perawatan ortodonti juga tinggi meskipun tampaknya sulit dilakukan karena adanya kondisi ketidakmampuan/cacat yang spesifik. Tujuan: Tujuan studi pustaka ini adalah untuk menggambarkan problem perawatan ortodonti pada penderita sindroma Down dan pertimbangan apa yang sebaiknya diambil untuk mengatasi masalah tersebut. Tinjauan pustaka: Banyak penelitian melaporkan tentang prevalensi maloklusi yang tinggi pada penderita sindroma Down. Maloklusi yang sering dijumpai adalah relasi klas III, gigitan silang, berdesakan dan juga gigitan terbuka. Problem dapat terjadi saat perawatan ortodonti karena adanya faktor dental, medis, mental dan tingkah laku penderita

  7. The Colorful Brain: Visualization of EEG Background Patterns

    NARCIS (Netherlands)

    Putten, van Michel J.A.M

    2008-01-01

    This article presents a method to transform routine clinical EEG recordings to an alternative visual domain. The method is intended to support the classic visual interpretation of the EEG background pattern and to facilitate communication about relevant EEG characteristics. In addition, it provides

  8. The colorful brain: Visualization of EEG background patterns

    NARCIS (Netherlands)

    van Putten, Michel Johannes Antonius Maria

    2008-01-01

    This article presents a method to transform routine clinical EEG recordings to an alternative visual domain. The method is intended to support the classic visual interpretation of the EEG background pattern and to facilitate communication about relevant EEG characteristics. In addition, it provides

  9. Sepsis pathophysiology and anesthetic consideration.

    Science.gov (United States)

    Yuki, Koichi; Murakami, Naoka

    2015-01-01

    Sepsis remains to be a significant health care issue associated with high mortality and healthcare cost, despite the extensive effort to better understand the pathophysiology of the sepsis. Recently updated clinical guideline for severe sepsis and septic shock, "Surviving Sepsis Campaign 2012", emphasizes the importance of early goal-directed therapy, which can be implemented in intraoperative management of sepsis patients. Herein, we review the updates of current guideline and discuss its application to anesthesic management. Furthermore, we review the recent advance in knowledge of sepsis pathophysiology, focusing on immune modulation, which may lead to new clinical therapeutic approach to sepsis.

  10. Surgical considerations about amyloid goiter.

    Science.gov (United States)

    García Villanueva, Augusto; García Villanueva, María Jesús; García Villanueva, Mercedes; Rojo Blanco, Roberto; Collado Guirao, María Vicenta; Cabañas Montero, Jacobo; Beni Pérez, Rafael; Moreno Montes, Irene

    2013-05-01

    Amyloidosis is an uncommon syndrome consisting of a number of disorders having in common an extracellular deposit of fibrillary proteins. This results in functional and structural changes in the affected organs, depending on deposit location and severity. Amyloid infiltration of the thyroid gland may occur in 50% and up to 80% of patients with primary and secondary amyloidosis respectively. Amyloid goiter (AG) is a true rarity, usually found associated to secondary amyloidosis. AG may require surgical excision, usually because of compressive symptoms. We report the case of a patient with a big AG occurring in the course of a secondary amyloidosis associated to polyarticular onset juvenile idiopathic arthritis who underwent total thyroidectomy. Current literature is reviewed, an attempt is made to provide action guidelines, and some surgical considerations on this rare condition are given.

  11. Nutritional considerations in rheumatoid arthritis.

    Science.gov (United States)

    Touger-Decker, R

    1988-03-01

    Rheumatoid arthritis is a chronic, systemic, inflammatory disorder of unknown etiology. The severity of the disease process adversely affects nutritional status. Articular changes, such as small joint deformities and temporomandibular joint syndrome, alter the ability to self-feed. The inflammatory process may increase metabolic rate. Ingestion, digestion, absorption, and excretion may be compromised by secondary manifestations of the disease. Comprehensive nutrition assessment incorporates evaluation of disease and treatment-specific factors, along with the usual assessment parameters. Abnormal values for certain assessment parameters do not necessarily reflect nutritional status. Treatment methods, including medications, may have an impact on nutritional status, assessment tools, and self-feeding. Nutrition management goals focus on identification and implementation of feeding strategies. Evaluation of the ability to feed oneself includes consideration of functional status, secondary manifestations, and medical treatment. Multiple feeding modalities may be required. Oral supplements, tube feedings, and parenteral nutrition may be employed to meet the nutrition needs of the individual with rheumatoid arthritis.

  12. KIDNEY TRANSPLANT URODYNAMICS: NEUROPHYSIOLOGIC CONSIDERATIONS

    Directory of Open Access Journals (Sweden)

    V. B. Berdichevskiy

    2014-01-01

    Full Text Available By analyzing data from the literature and the results of own clinical the authors suggest the presence of its own physiological rhythmogenesis motility of the urinary system to ensure its functional viability after denervation in the process of donor kidney recоvery and its transplantation to the recipient. 

  13. Ethical considerations in dermatologic photography.

    Science.gov (United States)

    Lakdawala, Nikita; Fontanella, Demian; Grant-Kels, Jane M

    2012-01-01

    In dermatology, clinical photographs are an essential component of patient care, enabling clinicians to document changes in skin pathology over time. Recent advances in digital technology and the electronic medical record have revolutionized clinical photography; however, these advances bring with them new ethical, legal, and social concerns. Photographs, more than other forms of documentation, have the potential to make patients uncomfortable. The act of photography, especially for those images requiring exposure of the genital area or the entire body, can be an uncomfortable experience for patients, necessitating the clinician and photographer to take an empathic stance in this setting. The Internet has elicited an increasing, and a very real, concern for patients about possible distribution and use of images outside of their individual care. The clinician and staff can allay these fears by professionally and empathetically addressing their concerns. In addition, it is important that patients receive appropriate informed consent about clinical photographs and the potential use of the images in their care, education, and research. Given the multitude of methods for recording clinical photographs, combined with the increasing complexity of image storage, standardization becomes a critical tool in providing consistency among images and achieving more equitable and efficacious care. To achieve this goal and improve the baseline standard of continuity of care for dermatological practices, we review the role of photographs, develop a model for patient consent, and establish standards for photography so as to provide the most ethical care for the patient. Copyright © 2012 Elsevier Inc. All rights reserved.

  14. Multipurpose background for standardization in medical photography.

    Science.gov (United States)

    Hallock, G G

    1985-08-01

    A dual photography background system consisting of a quadrilled format on one side and a plain background on the other is described. It is mobile and efficient as a space- and time-saving device for medical photography.

  15. [National Elk Refuge background and operating statement

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This document is a background on National Elk Refuge in Wyoming. Part I is solely background information concerning the physical characteristics, habitat, major...

  16. Backgrounds in Boundary String Field Theory

    CERN Document Server

    Baumgartl, M

    2009-01-01

    We study the role of closed string backgrounds in boundary string field theory. Background independence requires the introduction of dual boundary fields, which are reminiscent of the doubled field formalism. We find a correspondence between closed string backgrounds and collective excitations of open strings described by vertex operators involving dual fields. Renormalization group flow, solutions and stability are discussed in an example.

  17. 16 CFR 1101.1 - General background.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false General background. 1101.1 Section 1101.1 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS INFORMATION DISCLOSURE UNDER SECTION 6(b) OF THE CONSUMER PRODUCT SAFETY ACT Background § 1101.1 General background. (a) Basic purpose. This rule sets...

  18. Overseas Contingency Operations Funding: Background and Status

    Science.gov (United States)

    2017-02-07

    Operations Funding: Background and Status Congressional Research Service Summary The Department of Defense (DOD) estimates that through FY2016...Contingency Operations Funding: Background and Status Congressional Research Service Contents Introduction...Contingency Operations Funding: Background and Status Congressional Research Service 2 budget to which government financiers increasingly turn to

  19. [Limited applications for hydroxyethyl starch : background and alternative concepts].

    Science.gov (United States)

    Rehm, M

    2013-08-01

    Within the framework of a risk assessment procedure the Committee for Risk Assessment of Pharmacovigilance (PRAC) of the European Medicines Agency (EMA) came to the conclusion that the benefits of hydroxylethyl starch infusion solutions (HES) no longer outweighed the risks and on 14 June 2013 recommended that approval should be suspended. Until the procedure has finally been concluded, which could last several months, the Federal Institute for Drugs and Medical Products (BfArM) has recommended that HES should not be used. The aim of this article is to present the data situation in the most objective and compact way and to ultimately give the reader the foundations in order to be able to form a personal opinion. In addition an attempt will be made to describe a concept how infusion therapy can be carried out without using hydroxyethyl starch (HES). The background to this decision is given based on a review of the literature and the relevance for intensive care, emergency and perioperative medicine is assessed. Furthermore, a concept of infusion therapy without hydroxyethyl starch is formulated also based on the results of current studies. For infusion regimens without HES it should be noted that gelatin represents a considerable risk for anaphylactic reactions, that transfer of the new variants of Creutzfeldt-Jacob disease (bovine spongiform encephalopathy BSE) cannot fundamentally be excluded and that some evidence has been found that gelatin can cause kidney injury, probably in a similar way to HES. With respect to the cost-benefit analysis of infusion solutions, blood loss in adults of approximately 1-1.5 l can be substituted by balanced crystalloids (basic therapy 4-5 times compared to the amount of blood lost). For larger blood losses small amounts of hyperoncotic albumin solution (20 %) or alternatively 5 % albumin solution can be used. The 20 % albumin solution seems to have some advantages because it has a higher volume effect (approximately 200 %) and can

  20. Ethical considerations in uterus transplantation

    OpenAIRE

    Kavita Shah Arora, Kavita; Woessner,Jessica; Blake,Valarie

    2015-01-01

    Jessica R Woessner,1 Valarie K Blake,2 Kavita Shah Arora1,3 1Department of Obstetrics and Gynecology, MetroHealth Medical Center, Cleveland, OH, USA; 2College of Law, West Virginia University, Morgantown, WV, USA; 3Department of Bioethics, Case Western Reserve University, Cleveland, OH, USA Abstract: Uterus transplantation offers a novel treatment option for women with uterine factor infertility. While currently in the early clinical research phase, uterus transplantation will likely provide ...

  1. Sepsis Pathophysiology and Anesthetic Consideration

    OpenAIRE

    Yuki, Koichi; Murakami, Naoka

    2015-01-01

    Sepsis remains to be a significant health care issue associated with high mortality and healthcare cost, despite the extensive effort to better understand the pathophysiology of the sepsis. Recently updated clinical guideline for severe sepsis and septic shock, “Surviving Sepsis Campaign 2012”, emphasizes the importance of early goal-directed therapy, which can be implemented in intraoperative management of sepsis patients. Herein, we review the updates of current guideline and discuss its ap...

  2. The Weyl anomaly and the nature of the background geometry

    CERN Document Server

    Quirós, I

    2000-01-01

    The Weyl anomaly problem is treated within a purely geometrical context. Arguments are given that hint at a possible classical origin of the conformal anomaly in the Riemannian nature of the background geometry where the matter fields play out their dynamics. Some considerations allowing for a possible resolution of the Weyl anomaly problem are briefly outlined. Following the spirit of the standard model of the fundamental interactions, it is argued that the Weyl anomaly should be a consequence of the breaking of the gauge symmetry at some stage during the evolution of the universe.

  3. Geometry of manifolds with area metric: Multi-metric backgrounds

    Energy Technology Data Exchange (ETDEWEB)

    Schuller, Frederic P. [Perimeter Institute for Theoretical Physics, 31 Caroline Street N, Waterloo N2L 2Y5 (Canada) and Instituto de Ciencias Nucleares, Universidad Nacional Autonoma de Mexico, A. Postal 70-543, Mexico D.F. 04510 (Mexico)]. E-mail: fschuller@perimeterinstitute.ca; Wohlfarth, Mattias N.R. [II. Institut fuer Theoretische Physik, Universitaet Hamburg, Luruper Chaussee 149, 22761 Hamburg (Germany)]. E-mail: mattias.wohlfarth@desy.de

    2006-07-24

    We construct the differential geometry of smooth manifolds equipped with an algebraic curvature map acting as an area measure. Area metric geometry provides a spacetime structure suitable for the discussion of gauge theories and strings, and is considerably more general than Lorentzian geometry. Our construction of geometrically relevant objects, such as an area metric compatible connection and derived tensors, makes essential use of a decomposition theorem due to Gilkey, whereby we generate the area metric from a finite collection of metrics. Employing curvature invariants for multi-metric backgrounds we devise a class of gravity theories with inherently stringy character, and discuss gauge matter actions.

  4. Technical Considerations for Filler and Neuromodulator Refinements

    Science.gov (United States)

    Wilson, Anthony J.; Chang, Brian L.; Percec, Ivona

    2016-01-01

    Background: The toolbox for cosmetic practitioners is growing at an unprecedented rate. There are novel products every year and expanding off-label indications for neurotoxin and soft-tissue filler applications. Consequently, aesthetic physicians are increasingly challenged by the task of selecting the most appropriate products and techniques to achieve optimal patient outcomes. Methods: We employed a PubMed literature search of facial injectables from the past 10 years (2005–2015), with emphasis on those articles embracing evidence-based medicine. We evaluated the scientific background of every product and the physicochemical properties that make each one ideal for specific indications. The 2 senior authors provide commentary regarding their clinical experience with specific technical refinements of neuromodulators and soft-tissue fillers. Results: Neurotoxins and fillers are characterized by unique physical characteristics that distinguish each product. This results in subtle but important differences in their clinical applications. Specific indications and recommendations for the use of the various neurotoxins and soft-tissue fillers are reviewed. The discussion highlights refinements in combination treatments and product physical modifications, according to specific treatment zones. Conclusions: The field of facial aesthetics has evolved dramatically, mostly secondary to our increased understanding of 3-dimensional structural volume restoration. Our work reviews Food and Drug Administration–approved injectables. In addition, we describe how to modify products to fulfill specific indications such as treatment of the mid face, décolletage, hands, and periorbital regions. Although we cannot directly evaluate the duration or exact physical properties of blended products, we argue that “product customization” is safe and provides natural results with excellent patient outcomes. PMID:28018778

  5. Technical Considerations for Filler and Neuromodulator Refinements.

    Science.gov (United States)

    Montes, José Raúl; Wilson, Anthony J; Chang, Brian L; Percec, Ivona

    2016-12-01

    Background: The toolbox for cosmetic practitioners is growing at an unprecedented rate. There are novel products every year and expanding off-label indications for neurotoxin and soft-tissue filler applications. Consequently, aesthetic physicians are increasingly challenged by the task of selecting the most appropriate products and techniques to achieve optimal patient outcomes. Methods: We employed a PubMed literature search of facial injectables from the past 10 years (2005-2015), with emphasis on those articles embracing evidence-based medicine. We evaluated the scientific background of every product and the physicochemical properties that make each one ideal for specific indications. The 2 senior authors provide commentary regarding their clinical experience with specific technical refinements of neuromodulators and soft-tissue fillers. Results: Neurotoxins and fillers are characterized by unique physical characteristics that distinguish each product. This results in subtle but important differences in their clinical applications. Specific indications and recommendations for the use of the various neurotoxins and soft-tissue fillers are reviewed. The discussion highlights refinements in combination treatments and product physical modifications, according to specific treatment zones. Conclusions: The field of facial aesthetics has evolved dramatically, mostly secondary to our increased understanding of 3-dimensional structural volume restoration. Our work reviews Food and Drug Administration-approved injectables. In addition, we describe how to modify products to fulfill specific indications such as treatment of the mid face, décolletage, hands, and periorbital regions. Although we cannot directly evaluate the duration or exact physical properties of blended products, we argue that "product customization" is safe and provides natural results with excellent patient outcomes.

  6. Space Tourism: Orbital Debris Considerations

    Science.gov (United States)

    Mahmoudian, N.; Shajiee, S.; Moghani, T.; Bahrami, M.

    2002-01-01

    Space activities after a phase of research and development, political competition and national prestige have entered an era of real commercialization. Remote sensing, earth observation, and communication are among the areas in which this growing industry is facing competition and declining government money. A project like International Space Station, which draws from public money, has not only opened a window of real multinational cooperation, but also changed space travel from a mere fantasy into a real world activity. Besides research activities for sending man to moon and Mars and other outer planets, space travel has attracted a considerable attention in recent years in the form of space tourism. Four countries from space fairing nations are actively involved in the development of space tourism. Even, nations which are either in early stages of space technology development or just beginning their space activities, have high ambitions in this area. This is worth noting considering their limited resources. At present, trips to space are available, but limited and expensive. To move beyond this point to generally available trips to orbit and week long stays in LEO, in orbital hotels, some of the required basic transportations, living requirements, and technological developments required for long stay in orbit are already underway. For tourism to develop to a real everyday business, not only the price has to come down to meaningful levels, but also safety considerations should be fully developed to attract travelers' trust. A serious hazard to space activities in general and space tourism in particular is space debris in earth orbit. Orbiting debris are man-made objects left over by space operations, hazardous to space missions. Since the higher density of debris population occurs in low earth orbit, which is also the same orbit of interest to space tourism, a careful attention should be paid to the effect of debris on tourism activities. In this study, after a

  7. Methodological and analytic considerations for blood biomarkers.

    Science.gov (United States)

    Christenson, Robert H; Duh, Show-Hong

    2012-01-01

    Biomarkers typically evolve from a research setting to use in clinical care as evidence for their independent contribution to patient management accumulates. This evidence relies heavily on knowledge of the preanalytical, analytical, and postanalytical characteristics of the biomarker's measurement. For the preanalytical phase, considerations such specimen type, acceptable anticoagulants for blood samples, biologic variation and stability of the biomarker under various conditions are key. The analytical phase entails critical details for development and maintenance of assays having performance characteristics that are "fit for service" for the clinical application at hand. Often, these characteristics describe the ability to measure minute quantities in the biologic matrix used for measurement. Although techniques such as mass spectrometry are used effectively for biomarker discovery, routine quantification often relies on use of immunoassays; early in development, the most common immunoassay used is the enzyme-linked immunosorbent assay format. As biomarkers evolve successfully, they will be adapted to large main laboratory platforms or, depending on the need for speed, point-of-care devices. Users must pay particular attention to performance parameters of assays they are considering for clinical implementation. These parameters include the limit of blank, a term used to describe the limit of analytical noise for an assay; limit of detection, which describes the lowest concentration that can reliably be discriminated from analytical noise; and perhaps most importantly, the limit of quantitation, which is the lowest concentration at which a biomarker can be reliably measured within some predefined specifications for total analytical error that is based on clinical requirements of the test. The postanalytical phase involves reporting biomarker values, which includes reporting units, any normalization factors, and interpretation. Standardization, a process that

  8. Fitting theory to data in the presence of background uncertainties

    CERN Document Server

    Roe, Byron

    2014-01-01

    When fitting theory to data in the presence of background uncertainties, the question of whether the spectral shape of the background happens to be similar to that of the theoretical model of physical interest has not generally been considered previously. These correlations in shape are considered in the present note and found to make important corrections to the calculations. The discussion is phrased in terms of $\\chi^2$ fits, but the general considerations apply to any fits. If these new correlations are not included, the distribution usually does not have a $\\chi^2$ behavior, the $\\chi^2$ probabilities obtained are overestimated, and the confidence regions will be incorrect. Fake data studies, as used at present, will not be optimum. Problems will also occur in comparisons of related $\\chi^2$, such as occur in the Maltoni-Schwetz~\\cite{ms} theorem. Neutrino oscillations are used as examples, but the problems discussed here are general ones.

  9. Dissociating Prediction Failure: Considerations from Music Perception

    DEFF Research Database (Denmark)

    Ross, Suzi; Hansen, Niels Christian

    2016-01-01

    Dissociating Prediction Failure: Considerations from Music Perception The Journal of Neuroscience, 16 March 2016, 36(11): 3103-3105;......Dissociating Prediction Failure: Considerations from Music Perception The Journal of Neuroscience, 16 March 2016, 36(11): 3103-3105;...

  10. MARKETING CONSIDERATIONS ON BRAND COMMUNITIES

    Directory of Open Access Journals (Sweden)

    A.-C. Budac

    2016-12-01

    Full Text Available Most consumers spend an important part of their free time looking for online information about the brands before taking a decision to purchase. The Internet is the main factor which has led to a considerable increase of the time allotted by consumers for search and comparing information about brands, as a step preceding the decision to purchase and also one of the most important factors that influence the interaction between the brand and the consumer. Although the general trend is that the public to become more active and more involved in the choice of the brand, consumer's responses to its messages obviously depend on cultural, social or economic factors. The work has the purpose to clarify what brand community means and how it appeared - if it was really built from scratch or it has already existed in a latent way and it must only be recognized - the characteristics of successful communities, which of the objectives of the brands can be achieved by means of these groups, what is the role of social media in the development of these communities, what kind of types of mem¬bers are likely to be encountered inside of the online communities and what is their proportion for each and which are the research methodologies that can give support to companies in monitoring these groups.

  11. CONSIDERATIONS ON CONSUMER PERCEIVED RISK

    Directory of Open Access Journals (Sweden)

    Laura Catalina Timiras

    2014-12-01

    Full Text Available In this article we identified a number of factors influencing the consumers’ perceived risk. In the first part we conducted a review of the main issues that define the perceived risk by the consumer at the time of purchase, some of the lines of action of the organizations to diminish this risk perception and a number of influencing factors presented in the literature, with significant impact on the intensity with which risk is perceived by consumers. The second part of the article is based on the statistical information regarding e-commerce market, market in which the perceived risk plays an important role in the purchasing decision. Thus, based on available official statistics provided by Eurostat we have revealed the existence of certain links between electronic commerce and orientation towards risk and income levels, age and consumer educational level. The review is not intended to be exhaustive, the study taking into consideration only those links that can be identified from using official statistical data.

  12. Background Extraction Using Random Walk Image Fusion.

    Science.gov (United States)

    Hua, Kai-Lung; Wang, Hong-Cyuan; Yeh, Chih-Hsiang; Cheng, Wen-Huang; Lai, Yu-Chi

    2016-12-23

    It is important to extract a clear background for computer vision and augmented reality. Generally, background extraction assumes the existence of a clean background shot through the input sequence, but realistically, situations may violate this assumption such as highway traffic videos. Therefore, our probabilistic model-based method formulates fusion of candidate background patches of the input sequence as a random walk problem and seeks a globally optimal solution based on their temporal and spatial relationship. Furthermore, we also design two quality measures to consider spatial and temporal coherence and contrast distinctness among pixels as background selection basis. A static background should have high temporal coherence among frames, and thus, we improve our fusion precision with a temporal contrast filter and an optical-flow-based motionless patch extractor. Experiments demonstrate that our algorithm can successfully extract artifact-free background images with low computational cost while comparing to state-of-the-art algorithms.

  13. A Randomized Clinical Trial of Cogmed Working Memory Training in School-Age Children with ADHD: A Replication in a Diverse Sample Using a Control Condition

    Science.gov (United States)

    Chacko, A.; Bedard, A. C.; Marks, D. J.; Feirsen, N.; Uderman, J. Z.; Chimiklis, A.; Rajwan, E.; Cornwell, M.; Anderson, L.; Zwilling, A.; Ramon, M.

    2014-01-01

    Background: Cogmed Working Memory Training (CWMT) has received considerable attention as a promising intervention for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children. At the same time, methodological weaknesses in previous clinical trials call into question reported efficacy of CWMT. In particular, lack of equivalence…

  14. Background based Gaussian mixture model lesion segmentation in PET

    Energy Technology Data Exchange (ETDEWEB)

    Soffientini, Chiara Dolores, E-mail: chiaradolores.soffientini@polimi.it; Baselli, Giuseppe [DEIB, Department of Electronics, Information, and Bioengineering, Politecnico di Milano, Piazza Leonardo da Vinci 32, Milan 20133 (Italy); De Bernardi, Elisabetta [Department of Medicine and Surgery, Tecnomed Foundation, University of Milano—Bicocca, Monza 20900 (Italy); Zito, Felicia; Castellani, Massimo [Nuclear Medicine Department, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, via Francesco Sforza 35, Milan 20122 (Italy)

    2016-05-15

    Purpose: Quantitative {sup 18}F-fluorodeoxyglucose positron emission tomography is limited by the uncertainty in lesion delineation due to poor SNR, low resolution, and partial volume effects, subsequently impacting oncological assessment, treatment planning, and follow-up. The present work develops and validates a segmentation algorithm based on statistical clustering. The introduction of constraints based on background features and contiguity priors is expected to improve robustness vs clinical image characteristics such as lesion dimension, noise, and contrast level. Methods: An eight-class Gaussian mixture model (GMM) clustering algorithm was modified by constraining the mean and variance parameters of four background classes according to the previous analysis of a lesion-free background volume of interest (background modeling). Hence, expectation maximization operated only on the four classes dedicated to lesion detection. To favor the segmentation of connected objects, a further variant was introduced by inserting priors relevant to the classification of neighbors. The algorithm was applied to simulated datasets and acquired phantom data. Feasibility and robustness toward initialization were assessed on a clinical dataset manually contoured by two expert clinicians. Comparisons were performed with respect to a standard eight-class GMM algorithm and to four different state-of-the-art methods in terms of volume error (VE), Dice index, classification error (CE), and Hausdorff distance (HD). Results: The proposed GMM segmentation with background modeling outperformed standard GMM and all the other tested methods. Medians of accuracy indexes were VE <3%, Dice >0.88, CE <0.25, and HD <1.2 in simulations; VE <23%, Dice >0.74, CE <0.43, and HD <1.77 in phantom data. Robustness toward image statistic changes (±15%) was shown by the low index changes: <26% for VE, <17% for Dice, and <15% for CE. Finally, robustness toward the user-dependent volume initialization was

  15. Effect of background electrolytes on gypsum dissolution

    Science.gov (United States)

    Burgos-Cara, Alejandro; Putnis, Christine; Ruiz-Agudo, Encarnacion

    2015-04-01

    Knowledge of the dissolution behaviour of gypsum (CaSO4· 2H2O) in aqueous solutions is of primary importance in many natural and technological processes (Pachon-Rodriguez and Colombani, 2007), including the weathering of rocks and gypsum karst formations, deformation of gypsum-bearing rocks, the quality of drinking water, amelioration of soil acidity, scale formation in the oil and gas industry or measurement of water motion in oceanography. Specific ions in aqueous solutions can play important but very different roles on mineral dissolution. For example, the dissolution rates and the morphology of dissolution features may be considerably modified by the presence of the foreign ions in the solution, which adsorb at the surface and hinder the detachment of the ions building the crystal. Dissolution processes in the aqueous environment are closely related to the rearrangement of water molecules around solute ions and the interaction between the solvent molecules themselves. The rearrangement of water molecules with respect to solute species has been recognized as the main kinetic barrier for crystal dissolution in many systems (Davis, 2000; De Yoreo and Dove 2004; Wasylenki et al. 2005). Current research suggest that the control that electrolytes exert on water structure is limited to the local environment surrounding the ions and is not related to long-range electric fields emanating from the ions but results from effects associated with the hydration shell(s) of the ions (Collins et al. 2007) and the ions' capacity to break or structure water (i.e. chaotropic and kosmotropic ions, respectively). These effects will ultimately affect the kinetics of crystal dissolution, and could be correlated with the water affinity of the respective background ions following a trend known as the lyotropic or Hofmeister series (Kunz et al. 2004; Dove and Craven, 2005). In situ macroscopic and Atomic Force Microscopy (AFM) flow-through dissolution experiments were conducted at a

  16. 28 CFR 51.34 - Expedited consideration.

    Science.gov (United States)

    2010-07-01

    ... consideration. (a) When a submitting authority is required under State law or local ordinance or otherwise finds... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Expedited consideration. 51.34 Section 51... the submission be given expedited consideration. The submission should explain why such...

  17. 32 CFR 643.74 - Consideration.

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    2010-07-01

    ... 32 National Defense 4 2010-07-01 2010-07-01 true Consideration. 643.74 Section 643.74 National... Licenses § 643.74 Consideration. When a license is granted under the authority of an easement or leasing statute, the same rules will apply in regard to consideration as is applicable to the granting of...

  18. 44 CFR 331.4 - Special consideration.

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    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Special consideration. 331.4... AND FACILITIES IN LABOR SURPLUS AREAS § 331.4 Special consideration. When an entire industry that... hearing of interested parties, will give consideration to appropriate measures applicable to the...

  19. 49 CFR 260.7 - Priority consideration.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Priority consideration. 260.7 Section 260.7... REHABILITATION AND IMPROVEMENT FINANCING PROGRAM Overview § 260.7 Priority consideration. When evaluating applications, the Administrator will give priority consideration (but not necessarily in the following...

  20. 46 CFR 175.550 - Special consideration.

    Science.gov (United States)

    2010-10-01

    ... 46 Shipping 7 2010-10-01 2010-10-01 false Special consideration. 175.550 Section 175.550 Shipping...) GENERAL PROVISIONS § 175.550 Special consideration. In applying the provisions of this subchapter, the OCMI may give special consideration to authorizing departures from the specific requirements...