WorldWideScience

Sample records for form clinical investigator

  1. Machine learning methods for clinical forms analysis in mental health.

    Science.gov (United States)

    Strauss, John; Peguero, Arturo Martinez; Hirst, Graeme

    2013-01-01

    In preparation for a clinical information system implementation, the Centre for Addiction and Mental Health (CAMH) Clinical Information Transformation project completed multiple preparation steps. An automated process was desired to supplement the onerous task of manual analysis of clinical forms. We used natural language processing (NLP) and machine learning (ML) methods for a series of 266 separate clinical forms. For the investigation, documents were represented by feature vectors. We used four ML algorithms for our examination of the forms: cluster analysis, k-nearest neigh-bours (kNN), decision trees and support vector machines (SVM). Parameters for each algorithm were optimized. SVM had the best performance with a precision of 64.6%. Though we did not find any method sufficiently accurate for practical use, to our knowledge this approach to forms has not been used previously in mental health.

  2. Clinical and morphological investigations on the incidence of forms of rickets and their association with other pathological states in broiler chickens.

    Science.gov (United States)

    Dinev, I

    2012-04-01

    The purpose of investigations was to determine, by means of pathomorphological methods, the incidence of different rickets forms and their role for the occurrence of other illnesses in broiler chickens in Bulgaria. Clinical, blood biochemical, gross anatomy and histological investigations were carried out in broiler chickens with signs of rickets. The studies were performed in 12 broiler flocks in 4 farms located in different regions of the country. Based on macro- and microscopic lesions, alterations specific for hypocalcaemic rickets were observed in two farms, whereas signs of hypophosphataemic rickets - in the other two. The rickets diagnosis was confirmed by analysis of blood serum calcium, magnesium and inorganic phosphate concentrations. At the age of 30-35 days, various pathological states were observed in the same farms. The presented results suggested that existing problems in studied flocks were associated with an earlier occurrence of rickets. Copyright © 2011 Elsevier Ltd. All rights reserved.

  3. Clinical forms of chronic dust-induced bronchitis

    Energy Technology Data Exchange (ETDEWEB)

    Levin, A.I.; Blokhina, L.M.

    1984-08-01

    Clinical study of 837 coal miners with chronic dust-induced bronchitis reveals three different forms of the disease: emphysematous, asthmatic and infectious. From development of clinical manifestations different etiologies of the disease are apparent. In early stages, three different types of chronic dust-induced bronchitis (CDB) are clearly distinguishable. With progression of condition differences are obliterated. Formulation of a diagnosis must reflect the form of illness, stage of respiratory insufficiency and status of blood exchange. Discrimination of different varieties of CDB has significant practical value in determining tactics for treating patients. Emphysematous CDB is treated by improvement of draining function of bronchi and elimination of respiratory insufficiency by prescribing respiratory gymnastics, broncholytic preparations and oxygen therapy. Treatment of asthmatic form of CDB is directed at restoring disturbances of bronchial passability by use of broncholytics and expectorants. In inflammatory form of CDB in addition to restoring the draining function of the lungs, active antibacterial therapy is introduced. 5 references.

  4. Clinical Investigator Inspector List (CLIIL)

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who...

  5. Plasma Biomarkers Discriminate Clinical Forms of Multiple Sclerosis

    Science.gov (United States)

    Tejera-Alhambra, Marta; Casrouge, Armanda; de Andrés, Clara; Seyfferth, Ansgar; Ramos-Medina, Rocío; Alonso, Bárbara; Vega, Janet; Fernández-Paredes, Lidia; Albert, Matthew L.; Sánchez-Ramón, Silvia

    2015-01-01

    Multiple sclerosis, the most common cause of neurological disability in young population after trauma, represents a significant public health burden. Current challenges associated with management of multiple sclerosis (MS) patients stem from the lack of biomarkers that might enable stratification of the different clinical forms of MS and thus prompt treatment for those patients with progressive MS, for whom there is currently no therapy available. In the present work we analyzed a set of thirty different plasma cytokines, chemokines and growth factors present in circulation of 129 MS patients with different clinical forms (relapsing remitting, secondary progressive and primary progressive MS) and 53 healthy controls, across two independent cohorts. The set of plasma analytes was quantified with Luminex xMAP technology and their predictive power regarding clinical outcome was evaluated both individually using ROC curves and in combination using logistic regression analysis. Our results from two independent cohorts of MS patients demonstrate that the divergent clinical and histology-based MS forms are associated with distinct profiles of circulating plasma protein biomarkers, with distinct signatures being composed of chemokines and growth/angiogenic factors. With this work, we propose that an evaluation of a set of 4 circulating biomarkers (HGF, Eotaxin/CCL11, EGF and MIP-1β/CCL4) in MS patients might serve as an effective tool in the diagnosis and more personalized therapeutic targeting of MS patients. PMID:26039252

  6. [Support Team for Investigator-Initiated Clinical Research].

    Science.gov (United States)

    Fujii, Hisako

    2017-07-01

    Investigator-initiated clinical research is that in which investigators plan and carry out their own clinical research in academia. For large-scale clinical research, a team should be organized and implemented. This team should include investigators and supporting staff, who will promote smooth research performance by fulfilling their respective roles. The supporting staff should include project managers, administrative personnel, billing personnel, data managers, and clinical research coordinators. In this article, I will present the current status of clinical research support and introduce the research organization of the Dominantly Inherited Alzheimer Network (DIAN) study, an investigator-initiated international clinical research study, with particular emphasis on the role of the project management staff and clinical research coordinators.

  7. Genetic Susceptibility to Cardiac and Digestive Clinical Forms of Chronic Chagas Disease: Involvement of the CCR5 59029 A/G Polymorphism

    OpenAIRE

    de Oliveira, Amanda Priscila; Bernardo, C?ssia Rubia; Camargo, Ana Vit?ria da Silveira; Ronchi, Luiz S?rgio; Borim, Aldenis Albaneze; Brand?o de Mattos, Cinara C?ssia; de Campos J?nior, Eumildo; Castiglioni, L?lian; Netinho, Jo?o Gomes; Cavasini, Carlos Eug?nio; Bestetti, Reinaldo Bulgarelli; de Mattos, Luiz Carlos

    2015-01-01

    The clinical manifestations of chronic Chagas disease include the cardiac form of the disease and the digestive form. Not all the factors that act in the variable clinical course of this disease are known. This study investigated whether the CCR5Δ32 (rs333) and CCR5 59029 A/G (promoter region--rs1799987) polymorphisms of the CCR5 gene are associated with different clinical forms of chronic Chagas disease and with the severity of left ventricular systolic dysfunction in patients with chronic C...

  8. Role of Mesenchymal-Derived Stem Cells in Stimulating Dormant Tumor Cells to Proliferate and Form Clinical Metastases

    Science.gov (United States)

    2017-07-01

    Clinical Metastases PRINCIPAL INVESTIGATOR: Rosandra Kaplan CONTRACTING ORGANIZATION: The Geneva Foundation Tacoma, WA 98402 REPORT DATE: July 2017...2017 4. TITLE AND SUBTITLE Role of Mesenchymal-Derived Stem Cells in Stimulating Dormant Tumor Cells to Proliferate and Form Clinical Metastases 5a...PRODUCTS:  publications, conference papers, and presentations ; Jennifer Zhu submitted an abstract and will present this work at the Annual

  9. Metallothionein, a marker of antiapoptosis, is associated with clinical forms of oral lichen planus.

    Science.gov (United States)

    Allon, Irit; Ofir, Merav; Vered, Hanna; Hirshberg, Abraham

    2014-11-01

    To investigate the expression of anti- and proapoptosis markers, metallothionein (MT), and caspase-2, in the epithelial and inflammatory cells of oral lichen planus (OLP) patients, and to investigate the association with clinical parameters. Included were biopsies of 70 OLP patients. The clinical data were collected from patients' charts. The expression of MT and caspase-2 was immunomorphometrically analyzed in the epithelial and inflammatory cells, and the results were correlated with the clinical presentation. The epithelial and inflammatory cells expressed MT (10.2 ± 5.75 and 0.68 ± 0.86) and caspase-2 (1.54 ± 2.6 and 0.98 ± 1.15) which show a trend toward an inverse expression. The expression of MT in the epithelium was significantly higher in patients presenting with keratotic lichen planus than in patients with the atrophic and erosive forms (P = 0.0008). In the inflammatory cells, the expression of MT was inversely correlated with increasing age (R = 0.34, P = 0.0069). The pattern of expression of MT and caspase-2 in OLP suggests an extensive antiapoptotic response in the keratotic form of the disease. Symptomatic patients may benefit from therapy targeted to apoptosis in the future. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  10. Visual form-processing deficits: a global clinical classification.

    Science.gov (United States)

    Unzueta-Arce, J; García-García, R; Ladera-Fernández, V; Perea-Bartolomé, M V; Mora-Simón, S; Cacho-Gutiérrez, J

    2014-10-01

    Patients who have difficulties recognising visual form stimuli are usually labelled as having visual agnosia. However, recent studies let us identify different clinical manifestations corresponding to discrete diagnostic entities which reflect a variety of deficits along the continuum of cortical visual processing. We reviewed different clinical cases published in medical literature as well as proposals for classifying deficits in order to provide a global perspective of the subject. Here, we present the main findings on the neuroanatomical basis of visual form processing and discuss the criteria for evaluating processing which may be abnormal. We also include an inclusive diagram of visual form processing deficits which represents the different clinical cases described in the literature. Lastly, we propose a boosted decision tree to serve as a guide in the process of diagnosing such cases. Although the medical community largely agrees on which cortical areas and neuronal circuits are involved in visual processing, future studies making use of new functional neuroimaging techniques will provide more in-depth information. A well-structured and exhaustive assessment of the different stages of visual processing, designed with a global view of the deficit in mind, will give a better idea of the prognosis and serve as a basis for planning personalised psychostimulation and rehabilitation strategies. Copyright © 2011 Sociedad Española de Neurología. Published by Elsevier Espana. All rights reserved.

  11. 77 FR 60440 - Clinical Investigator Training Course

    Science.gov (United States)

    2012-10-03

    ... concerns, adverse event monitoring, compliance with the legal and ethical obligations of clinical research... with knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine...

  12. 76 FR 45577 - Clinical Investigator Training Course

    Science.gov (United States)

    2011-07-29

    ... concerns, adverse event monitoring, compliance with the legal and ethical obligations of clinical research... knowledge, experience, and commitment to investigational medicine; Promote communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in experimental medicine; and Improve...

  13. 78 FR 63988 - Clinical Investigator Training Course

    Science.gov (United States)

    2013-10-25

    ... communication between clinical investigators and FDA; Enhance investigators' understanding of FDA's role in... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1214... support regulatory decisions. This course is intended to assist clinical investigators in understanding...

  14. Role of Mesenchymal Derived Stem Cells in Stimulating Dormant Tumor Cells to Proliferate and Form Clinical Metastases

    Science.gov (United States)

    2017-07-01

    Clinical Metastases PRINCIPAL INVESTIGATOR: Jeffrey Green CONTRACTING ORGANIZATION: The Geneva Foundation Tacoma, WA 98402 REPORT DATE: July 2017 TYPE...2016 - 14 June 2017 4. TITLE AND SUBTITLE Role of Mesenchymal-Derived Stem Cells in Stimulating Dormant Tumor Cells to Proliferate and Form Clinical ...and/or select agents. Nothing to report. 6. PRODUCTS: • publications, conference papers, and presentations ; Jennifer Zhu submitted an abstract and will

  15. Study on biofilm-forming properties of clinical isolates of Staphylococcus aureus.

    Science.gov (United States)

    Taj, Yasmeen; Essa, Farhan; Aziz, Faisal; Kazmi, Shahana Urooj

    2012-05-14

    The purpose of this study was to observe the formation of biofilm, an important virulence factor, by isolates of Staphylococcus aureus (S. aureus) in Pakistan by different conventional methods and through electron microscopy. We screened 115 strains of S. aureus isolated from different clinical specimens by tube method (TM), air-liquid interface coverslip assay method, Congo red agar (CRA) method, and scanning electron microscopy (SEM). Out of 115 S. aureus isolates, 63 (54.78%) showed biofilm formation by tube method. Biofilm forming bacteria were further categorized as high producers (n = 23, 20%) and moderate producers (n = 40, 34.78%). TM coordinated well with the coverslip assay for strong biofilm-producing strains in 19 (16.5%) isolates. By coverslip method, weak producers were difficult to differentiate from biofilm negative isolates. Screening on CRA showed biofilm formation only in four (3.47%) strains. Scanning electron micrographs showed the biofilm-forming strains of S. aureus arranged in a matrix on the propylene surface and correlated well with the TM. Biofilm production is a marker of virulence for clinically relevant staphylococcal infections. It can be studied by various methods but screening on CRA is not recommended for investigation of biofilm formation in Staphylococcus aureus. Electron micrograph images correlate well with the biofilm production as observed by TM.

  16. [THE RESULTS OF CLINICAL AND PSYCHOPATHOLOGICAL AND PSYCHOLOGICAL DIAGNOSTIC INVESTIGATIONS EMPLOYEES OF FINANCIAL INSTITUTIONS WHICH WERE IDENTIFIED NEUROTIC DISORDERS].

    Science.gov (United States)

    Solovyova, M

    2014-12-01

    The article presents the results of the clinical and psychopathological and psychological diagnostic, investigations mental health employees of financial institutions, description and analysis of clinical forms identified disorders.

  17. Clinical Epidemiology of Buruli Ulcer from Benin (2005-2013: Effect of Time-Delay to Diagnosis on Clinical Forms and Severe Phenotypes.

    Directory of Open Access Journals (Sweden)

    Carlos Capela

    /multi-focal progression. Therefore, in future studies on BU epidemiology, severe clinical forms should be systematically considered as distinct phenotypes of the same disease and thus subjected to specific risk factor investigation.

  18. 75 FR 57472 - Clinical Investigator Training Course

    Science.gov (United States)

    2010-09-21

    ... days in advance. SUPPLEMENTARY INFORMATION: Clinical trial investigators play a critical role in the... toxicological, pharmacological, and manufacturing data to support investigational use in humans; Fundamental issues in the design and conduct of clinical trials; Statistical and analytic considerations in the...

  19. A programmable rules engine to provide clinical decision support using HTML forms.

    Science.gov (United States)

    Heusinkveld, J; Geissbuhler, A; Sheshelidze, D; Miller, R

    1999-01-01

    The authors have developed a simple method for specifying rules to be applied to information on HTML forms. This approach allows clinical experts, who lack the programming expertise needed to write CGI scripts, to construct and maintain domain-specific knowledge and ordering capabilities within WizOrder, the order-entry and decision support system used at Vanderbilt Hospital. The clinical knowledge base maintainers use HTML editors to create forms and spreadsheet programs for rule entry. A test environment has been developed which uses Netscape to display forms; the production environment displays forms using an embedded browser.

  20. A Study Investigating the Feasibility of Creating a Short Form of the WISC-R for Disabled Readers.

    Science.gov (United States)

    Brown, David M.; Otts, David A.

    The purpose of this study was to investigate the feasibility of creating a short form of the Wechsler Intelligence Scale for Children-Revised (WISC-R) for use in a clinical setting with disabled readers. The subjects were 100 clients ages six to sixteen of the Belser-Parton Reading Center at the University of Alabama whose files contained scores…

  1. Familial forms of diabetes insipidus: clinical and molecular characteristics.

    Science.gov (United States)

    Babey, Muriel; Kopp, Peter; Robertson, Gary L

    2011-07-05

    Over the past two decades, the genetic and molecular basis of familial forms of diabetes insipidus has been elucidated. Diabetes insipidus is a clinical syndrome characterized by the excretion of abnormally large volumes of diluted urine (polyuria) and increased fluid intake (polydipsia). The most common type of diabetes insipidus is caused by lack of the antidiuretic hormone arginine vasopressin (vasopressin), which is produced in the hypothalamus and secreted by the neurohypophysis. This type of diabetes insipidus is referred to here as neurohypophyseal diabetes insipidus. The syndrome can also result from resistance to the antidiuretic effects of vasopressin on the kidney, either at the level of the vasopressin 2 receptor or the aquaporin 2 water channel (which mediates the re-absorption of water from urine), and is referred to as renal or nephrogenic diabetes insipidus. Differentiation between these two types of diabetes insipidus and primary polydipsia can be difficult owing to the existence of partial as well as complete forms of vasopressin deficiency or resistance. Seven different familial forms of diabetes insipidus are known to exist. The clinical presentation, genetic basis and cellular mechanisms responsible for them vary considerably. This information has led to improved methods of differential diagnosis and could provide the basis of new forms of therapy.

  2. Ethics in clinical research: need for assessing comprehension of informed consent form?

    Science.gov (United States)

    Shafiq, Nusrat; Malhotra, Samir

    2011-03-01

    Comprehension of informed consent form has not achieved the attention it deserves. We made a 24-item questionnaire to assess clinical research participants' comprehension of informed consent form (Contemp Clin Trials 2009;30:427-30). Due to repeated requests by clinical researchers in our country and abroad, we are publishing the questionnaire in this article. Copyright © 2010 Elsevier Inc. All rights reserved.

  3. [Clinical and neurophysiological aspects of severe forms of autism in children].

    Science.gov (United States)

    Simashkova, N V; Iakupova, L P; Bashina, V M

    2006-01-01

    The aim of the study was to elucidate fundamentals for the phenomenon of universality of childhood autism by comparison of clinical and neurophysiological features of its severest forms--children endogenous autism (CEA) and Rett's syndrome (RS). Each group included 20 patients. Both groups were similar by age-at-disease-onset, clinical appearances during the disease course and dynamics of psychopathological syndromes. The theta-rhythm is common for CEA and RS at the disease stage with marked signs of disease acuity, autism, regress and, therefore, may be regarded as a marker of severity and development delay. The universality of autism phenomenon in its severe forms was confirmed both at the clinical and neurophysiological levels.

  4. A realistic closed-form radiobiological model of clinical tumor-control data incorporating intertumor heterogeneity

    International Nuclear Information System (INIS)

    Roberts, Stephen A.; Hendry, Jolyon H.

    1998-01-01

    Purpose: To investigate the role of intertumor heterogeneity in clinical tumor control datasets and the relationship to in vitro measurements of tumor biopsy samples. Specifically, to develop a modified linear-quadratic (LQ) model incorporating such heterogeneity that it is practical to fit to clinical tumor-control datasets. Methods and Materials: We developed a modified version of the linear-quadratic (LQ) model for tumor control, incorporating a (lagged) time factor to allow for tumor cell repopulation. We explicitly took into account the interpatient heterogeneity in clonogen number, radiosensitivity, and repopulation rate. Using this model, we could generate realistic TCP curves using parameter estimates consistent with those reported from in vitro studies, subject to the inclusion of a radiosensitivity (or dose)-modifying factor. We then demonstrated that the model was dominated by the heterogeneity in α (tumor radiosensitivity) and derived an approximate simplified model incorporating this heterogeneity. This simplified model is expressible in a compact closed form, which it is practical to fit to clinical datasets. Using two previously analysed datasets, we fit the model using direct maximum-likelihood techniques and obtained parameter estimates that were, again, consistent with the experimental data on the radiosensitivity of primary human tumor cells. This heterogeneity model includes the same number of adjustable parameters as the standard LQ model. Results: The modified model provides parameter estimates that can easily be reconciled with the in vitro measurements. The simplified (approximate) form of the heterogeneity model is a compact, closed-form probit function that can readily be fitted to clinical series by conventional maximum-likelihood methodology. This heterogeneity model provides a slightly better fit to the datasets than the conventional LQ model, with the same numbers of fitted parameters. The parameter estimates of the clinically

  5. Basics of case report form designing in clinical research.

    Science.gov (United States)

    Bellary, Shantala; Krishnankutty, Binny; Latha, M S

    2014-10-01

    Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

  6. A sheeppox outbreak in Morocco: isolation and identification of virus responsible for the new clinical form of disease.

    Science.gov (United States)

    Zro, Khalil; Zakham, Fathiah; Melloul, Marouane; El Fahime, Elmostafa; Ennaji, Moulay Mustapha

    2014-01-27

    Sheeppoxvirus (SPPV) is a member of the Capripoxvirus genus of the Poxviridae family, which causes significant economic losses in Morocco. The resurgence of the sheeppox disease during 2010 was characterized by an emergence of a classical nodular form for the first time in Morocco. However, little is known about the virus strain responsible for nodular form. In this study, thirty three sheep, from the eastern region of Morocco, clinically infected were examined and dead animals were autopsied.A rapid diagnostic assay for SPPV using different type of clinical samples would be useful for outbreak management. The aim of this work was to isolate the virus strain responsible for nodular form and we identified and compared by phylogenetic analysis the field strain with Moroccan vaccine strain targeting the thymidine kinase (TK) gene and the chemokine analogue receptor of interleukin (IL8) gene. Further, it was important to investigate and validate a real-time PCR using different clinical and post-mortem samples to manage epidemic sheeppox disease. The nodular form of sheeppox disease observed in Morocco was clinically characterized by fever, depression, lacrimation, diarrhea in lambs and nodule. At necropsy, the most affected organ was the lung. The etiological strain was successfully isolated from lung nodule in a dead lamb and was identified by using real-time PCR that has been tested and validated on different types of clinical and post mortem samples from naturally infected animals. Sequence and phylogenetic analysis of TK and IL8 gene showed that there was a very close relationship between field and vaccine strain. They were clustered within other SPPV strains. In the current study, we show for the first time the nodular form of sheeppox in Morocco. We demonstrate a robust real-time PCR-based diagnostic assay to detect the sheeppox virus in multiple sample that can be implemented to efficiently manage the disease outbreak. Our study also offers the prospect for

  7. PSEUDOTUMORAL FORM OF MULTIPLE SCLEROSIS WITH SYMPTOMATIC CONVULSIVE SEIZURES (A CLINICAL CASE

    Directory of Open Access Journals (Sweden)

    Yu. A. Belova

    2015-01-01

    Full Text Available Multiple sclerosis (MS is prominent among central nervous system diseases. It affects chiefly young people and almost inevitably results in disability. In the past decade, there has been an upward trend for the prevalence of MS worldwide; in particular, the higher prevalence of this disease has been registered in the Moscow Region, which is associated with both an objective increase in its morbidity and improvement of specialized care to the population in the region. MS is characterized by a variety of clinical manifestations. However, paroxysmal disturbances are referred to as the rare symptoms of MS: the incidence of epileptic seizures in this condition is 0.89 to 7.5% according to the literature data. In addition to the clinical form of MS, there are its rare malignant atypical forms that also include its pseudotumoral form characterized by intrinsic neuroimaging and clinical signs that are different from the classical form of MS and another abnormality of the central nervous system. The pseudotumoral form of MS is characterized by the development of acute focal demyelination that appears as a large focus of an increased magnetic resonance signal with perifocal edema as evidenced by magnetic resonance imaging. A pseudotumoral focus of demyelination can occur both at the onset of MS and during its recurrent course. The atypical onset of MS is a special challenge because of diagnostic problems, which may lead to erroneous therapeutic policy and have a negative impact on the late prognosis of the disease. The authors provide a clinical case of the pseudotumoral form of MS with convulsive seizures at the onset of demyelinating disease. The problems of diagnosis and therapeutic approaches are discussed.

  8. Reliability and equivalence of alternate forms for the Symbol Digit Modalities Test: implications for multiple sclerosis clinical trials.

    Science.gov (United States)

    Benedict, Ralph H B; Smerbeck, Audrey; Parikh, Rajavi; Rodgers, Jonathan; Cadavid, Diego; Erlanger, David

    2012-09-01

    Cognitive impairment is common in multiple sclerosis (MS), but is seldom assessed in clinical trials investigating the effects of disease-modifying therapies. The Symbol Digit Modalities Test (SDMT) is a particularly promising tool due to its sensitivity and robust correlation with brain magnetic resonance imaging (MRI) and vocational disability. Unfortunately, there are no validated alternate SDMT forms, which are needed to mitigate practice effects. The aim of the study was to assess the reliability and equivalence of SDMT alternate forms. Twenty-five healthy participants completed each of five alternate versions of the SDMT - the standard form, two versions from the Rao Brief Repeatable Battery, and two forms specifically designed for this study. Order effects were controlled using a Latin-square research design. All five versions of the SDMT produced mean values within 3 raw score points of one another. Three forms were very consistent, and not different by conservative statistical tests. The SDMT test-retest reliability using these forms was good to excellent, with all r values exceeding 0.80. For the first time, we find good evidence that at least three alternate versions of the SDMT are of equivalent difficulty in healthy adults. The forms are reliable, and can be implemented in clinical trials emphasizing cognitive outcomes.

  9. Spondylolysis and spondylolisthesis: prevalence of different forms of instability and clinical implications.

    Science.gov (United States)

    Niggemann, Pascal; Kuchta, Johannes; Beyer, Hans-Konrad; Grosskurth, D; Schulze, Thorsten; Delank, Karl-Stefan

    2011-10-15

    Imaging study with an evaluation of incidences and clinical correlation. To evaluate the incidence of 3 different types of instabilities in patients with spondylolysis or isthmic spondylolisthesis. Clinical findings are correlated with imaging findings, and the imaging findings are analyzed with regard to their clinical implications. Spondylolysis and isthmic spondylolisthesis are common disorders. An unstable slip is the most well-known form of instability, but other forms also exist. However, the incidence of these instabilities and their clinical implications are yet unclear. A total of 140 patients with 141 levels of spondylolysis identified by MRI (magnetic resonance imaging) were included in this study. Using positional MRI, the instability of the slip, an increased angular movement, and movement in the spondylolytic cleft were assessed. On the basis of clinical findings, the patients were classified as presenting with either radicular or nonradicular symptoms. The incidence of the instabilities was recorded and correlated with the incidence of radicular symptoms. Fifteen patients had an unstable slip (anterior instability); 35, an increased angular movement (angular instability); and 34 patients, a movement in the spondylolytic cleft (posterior instability). All forms of instability could be found together. No instability at all was found in 76 patients. Radicular symptoms were found significantly more often in patients with one or more of the described instabilities compared with patients without instability. All 3 described forms of instability are common in spondylolysis or isthmic spondylolisthesis and associated with radicular pain. This finding stresses the value of positional MRI in the evaluation of patients with spondylolysis and isthmic spondylolisthesis, especially if radicular symptoms are present.

  10. Basics of case report form designing in clinical research

    Directory of Open Access Journals (Sweden)

    Shantala Bellary

    2014-01-01

    Full Text Available Case report form (CRF is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

  11. How novice, skilled and advanced clinical researchers include variables in a case report form for clinical research: a qualitative study.

    Science.gov (United States)

    Chu, Hongling; Zeng, Lin; Fetters, Micheal D; Li, Nan; Tao, Liyuan; Shi, Yanyan; Zhang, Hua; Wang, Xiaoxiao; Li, Fengwei; Zhao, Yiming

    2017-09-18

    Despite varying degrees in research training, most academic clinicians are expected to conduct clinical research. The objective of this research was to understand how clinical researchers of different skill levels include variables in a case report form for their clinical research. The setting for this research was a major academic institution in Beijing, China. The target population was clinical researchers with three levels of experience, namely, limited clinical research experience, clinicians with rich clinical research experience and clinical research experts. Using a qualitative approach, we conducted 13 individual interviews (face to face) and one group interview (n=4) with clinical researchers from June to September 2016. Based on maximum variation sampling to identify researchers with three levels of research experience: eight clinicians with limited clinical research experience, five clinicians with rich clinical research experience and four clinical research experts. These 17 researchers had diverse hospital-based medical specialties and or specialisation in clinical research. Our analysis yields a typology of three processes developing a case report form that varies according to research experience level. Novice clinician researchers often have an incomplete protocol or none at all, and conduct data collection and publication based on a general framework. Experienced clinician researchers include variables in the case report form based on previous experience with attention to including domains or items at risk for omission and by eliminating unnecessary variables. Expert researchers consider comprehensively in advance data collection and implementation needs and plan accordingly. These results illustrate increasing levels of sophistication in research planning that increase sophistication in selection for variables in the case report form. These findings suggest that novice and intermediate-level researchers could benefit by emulating the comprehensive

  12. 59th Medical Wing Clinical Research Division Clinical Investigations Program Pathology Poster

    Science.gov (United States)

    2017-04-28

    59 MDW/SGVU SUBJECT: Professional Presentation Approval 1. Your paper, entitled 59th Medical Wing Clinical Research Division Clinical Investigations...Program Pathology Poster presented at/published to For hanging in a hallway of the 591h Medical Wing Clinical Research Division, Bldg 4430 in...Graduate Health Sciences Education student and your department has told you they cannot fund your publication, the 59th Clinical Research Division may

  13. Validity of Two WPPSI Short Forms in Outpatient Clinic Settings.

    Science.gov (United States)

    Haynes, Jack P.; Atkinson, David

    1983-01-01

    Investigated the validity of subtest short forms for the Wechsler Preschool and Primary Scale of Intelligence in an outpatient population of 116 children. Data showed that the short forms underestimated actual level of intelligence and supported use of a short form only as a brief screening device. (LLL)

  14. Investigating antibiotic resistance in non-clinical environments

    Directory of Open Access Journals (Sweden)

    Fiona eWalsh

    2013-02-01

    Full Text Available There have been many calls for more information about the natural resistome and these have also highlighted the importance of understanding the soil resistome in the preservation of antibiotics for the treatment of infections. However, to date there have been few studies which have investigated the culturable soil resistome, which highlights the difficulties faced by microbiologists in designing these experiments to produce meaningful data. The World Health Organization definition of resistance is the most fitting to non-clinical environmental studies: Antimicrobial resistance is resistance of a microorganism to an antimicrobial medicine to which it was previously sensitive. The ideal investigation of non-clinical environments for antibiotic resistance of clinical relevance would be using standardized guidelines and breakpoints. This review outlines different definitions and methodologies used to understand antibiotic resistance and suggests how this can be performed outside of the clinical environment.

  15. Finite element investigation of explosively formed projectiles (EFP)

    International Nuclear Information System (INIS)

    Ahmad, I.

    1999-01-01

    This thesis report represents the numerical simulation of explosively formed projectiles (EFP), a type of linear self-forging fragment device. The simulation is performed using a finite element code DYNA2D. It also explicates that how the shape, velocity and kinetic energy of an explosively formed projectile is effected by various parameters. Different parameters investigated are mesh density, material, thickness, contour and types of liner. Effect of shape of casing and material model is also analyzed. The shapes of projectiles at different times after detonation are shown. The maximum velocity and kinetic energy of the projectile have been used to ascertain the effect of above mentioned parameters. (author)

  16. Genetic Susceptibility to Cardiac and Digestive Clinical Forms of Chronic Chagas Disease: Involvement of the CCR5 59029 A/G Polymorphism.

    Science.gov (United States)

    de Oliveira, Amanda Priscila; Bernardo, Cássia Rubia; Camargo, Ana Vitória da Silveira; Ronchi, Luiz Sérgio; Borim, Aldenis Albaneze; de Mattos, Cinara Cássia Brandão; de Campos Júnior, Eumildo; Castiglioni, Lílian; Netinho, João Gomes; Cavasini, Carlos Eugênio; Bestetti, Reinaldo Bulgarelli; de Mattos, Luiz Carlos

    2015-01-01

    The clinical manifestations of chronic Chagas disease include the cardiac form of the disease and the digestive form. Not all the factors that act in the variable clinical course of this disease are known. This study investigated whether the CCR5Δ32 (rs333) and CCR5 59029 A/G (promoter region--rs1799987) polymorphisms of the CCR5 gene are associated with different clinical forms of chronic Chagas disease and with the severity of left ventricular systolic dysfunction in patients with chronic Chagas heart disease (CCHD). The antibodies anti-T. cruzi were identified by ELISA. PCR and PCR-RFLP were used to identify the CCR5Δ32 and CCR5 59029 A/G polymorphisms. The chi-square test was used to compare variables between groups. There was a higher frequency of the AA genotype in patients with CCHD compared with patients with the digestive form of the disease and the control group. The results also showed a high frequency of the AG genotype in patients with the digestive form of the disease compared to the other groups. The results of this study show that the CCR5Δ32 polymorphism does not seem to influence the different clinical manifestations of Chagas disease but there is involvement of the CCR5 59029 A/G polymorphism in susceptibility to the different forms of chronic Chagas disease. Besides, these polymorphisms do not influence left ventricular systolic dysfunction in patients with CCHD.

  17. Genetic Susceptibility to Cardiac and Digestive Clinical Forms of Chronic Chagas Disease: Involvement of the CCR5 59029 A/G Polymorphism.

    Directory of Open Access Journals (Sweden)

    Amanda Priscila de Oliveira

    Full Text Available The clinical manifestations of chronic Chagas disease include the cardiac form of the disease and the digestive form. Not all the factors that act in the variable clinical course of this disease are known. This study investigated whether the CCR5Δ32 (rs333 and CCR5 59029 A/G (promoter region--rs1799987 polymorphisms of the CCR5 gene are associated with different clinical forms of chronic Chagas disease and with the severity of left ventricular systolic dysfunction in patients with chronic Chagas heart disease (CCHD. The antibodies anti-T. cruzi were identified by ELISA. PCR and PCR-RFLP were used to identify the CCR5Δ32 and CCR5 59029 A/G polymorphisms. The chi-square test was used to compare variables between groups. There was a higher frequency of the AA genotype in patients with CCHD compared with patients with the digestive form of the disease and the control group. The results also showed a high frequency of the AG genotype in patients with the digestive form of the disease compared to the other groups. The results of this study show that the CCR5Δ32 polymorphism does not seem to influence the different clinical manifestations of Chagas disease but there is involvement of the CCR5 59029 A/G polymorphism in susceptibility to the different forms of chronic Chagas disease. Besides, these polymorphisms do not influence left ventricular systolic dysfunction in patients with CCHD.

  18. Atomoxetine for hoarding disorder: A pre-clinical and clinical investigation.

    Science.gov (United States)

    Grassi, Giacomo; Micheli, Laura; Di Cesare Mannelli, Lorenzo; Compagno, Elisa; Righi, Lorenzo; Ghelardini, Carla; Pallanti, Stefano

    2016-12-01

    Despite several studies suggested that inattention and impulsivity-compulsivity could represent two core dimensions of hoarding disorder (HD), only a small case series study investigated the effectiveness of attention-deficit-hyperactivity-disorder (ADHD) medications in HD. The aim of the present study was to target attentional and inhibitory control networks in HD patients through the ADHD medication atomoxetine, moving from a preclinical investigation on an animal model of compulsive-like behavior (marble burying test) to a clinical investigation on both medicated and unmedicated patients with a primary diagnosis of HD without ADHD. Our preclinical investigation showed that acute administration of atomoxetine significantly reduced the compulsive-like behaviours of mice in the marble burying test without affecting neither locomotor activity and coordination nor exploration behaviours. When compared, atomoxetine and fluoxetine showed similar effects on the marble burying test. However, fluoxetine impaired both locomotor and exploratory activity. In our clinical investigation 12 patients were enrolled and 11 patients completed an open trial with atomoxetine at flexible dose (40-80 mg) for 12 weeks. At the endpoint the mean UCLA Hoarding Severity Scale score decreased by 41.3% for the whole group (p = 0003). Six patients were classified as full responders (mean symptom reduction of 57.2%) and three patients as partial responders (mean symptom reduction of 27.3%). Inattentive and impulsivity symptoms showed a significant mean score reduction of 18.5% from baseline to the endpoint (F (1,9) = 20.9, p = 0.0013). Hoarding symptoms improvement was correlated to reduction of patients' disability and increased in their global functioning. These preclinical and clinical data suggest that atomoxetine may be effective for HD and therefore should be considered for future controlled trials. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. Clinical forms of shoulder instability in pediatric patients

    Directory of Open Access Journals (Sweden)

    Yaroslav N. Proshchenko

    2016-12-01

    Full Text Available Background. The recurrence rate of adolescent chronic shoulder instability is approximately 56%–68%. However, this pathology is often missed in childhood and adolescence. Aim. To identify the clinical forms of shoulder joint instability in pediatric patients. Materials and methods. The authors present the data from 57 pediatric patients aged 3−17 years with a total of 61 unstable shoulder joints. All patients were divided into groups according to the form of instability. Traumatic chronic shoulder instability was identified in 40 patients (Bankart and Hill–Sachs injuries. Of these, non-traumatic shoulder instability was diagnose in 17, including five with recurrent dislocation, and spontaneous shoulder dislocation due to dysplasia of glenoid and labrum was diagnosed in 12. Of the 57 patients in the study cohort, 53 underwent surgery. Postoperatively, two patients developed recurrent shoulder dislocation (Andreev–Boichev technique due type III shoulder dysplasia in the first patient and multidirectional injury in the second. Conclusions. Shoulder joint instability should be considered as the traumatic or non-traumatic form. Treatment decisions should be based on anatomical characteristics that predispose to recurrent dislocation.

  20. Investigation of In vitro Mineral Forming Bacterial Isolates from ...

    African Journals Online (AJOL)

    2018-01-30

    Jan 30, 2018 ... Keywords: Bacteria, biomineralization, supragingival dental calculus. Investigation of In vitro ... of damage that is associated with plaque‑forming ... Materials and Methods ... Amplification reaction mixture was prepared in a 30 μL .... gingiva, palatine tonsils, and throat), skin (right and .... Neisseria mucosa.

  1. Medical teachers conceptualize a distinctive form of clinical knowledge.

    Science.gov (United States)

    Barrett, J; Yates, L; McColl, G

    2015-05-01

    For over four decades, there have been efforts to specify the types of knowledge that medical students need, how that knowledge is acquired and how its constituent parts are related. It is one of the areas of continuing concern underlying medical education reform. Despite their importance to medical students' learning and development, the perspectives of medical teachers in hospitals are not always considered in such discourse. This study sought to generate an understanding of these teachers' values, perspectives and approaches by listening to them and seeing them in their everyday teaching work, finding and understanding the meanings they bring to the work of medical teaching in hospitals. In interviews, all of the teachers talked more about the optimal forms of knowledge that are important for students than they talked about the form of the teaching itself. Many revealed to students what knowledge they do and do not value. They had a particular way of thinking about clinical knowledge as existing in the people and the places in which the teaching and the clinical practice happen, and represented this as 'real' knowledge. By implication, there is other knowledge in medical education or in students' heads that is not real and needs to be transformed. Their values, practices and passions add texture and vitality to existing ways of thinking about the characteristics of clinical knowledge, how it is depicted in the discourse and the curriculum and how it is more dynamically related to other knowledge than is suggested in traditional conceptualizations of knowledge relationships.

  2. Applying Low-Frequency Vibration for the Experimental Investigation of Clutch Hub Forming

    Directory of Open Access Journals (Sweden)

    De’an Meng

    2018-05-01

    Full Text Available A vibration-assisted plastic-forming method was proposed, and its influence on clutch hub forming process was investigated. The experiments were conducted on a vibration-assisted hydraulic extrusion press with adjustable frequency and amplitude. Vibration frequency and amplitude were considered in investigating the effect of vibration on forming load and surface quality. Results showed that applying vibration can effectively reduce forming force and improve surface quality. The drop in forming load was proportional to the vibration frequency and amplitude, and the load decreased by up to 25%. Such reduction in forming load raised with amplitude increase because the increase in amplitude would accelerate punch relative speed, which then weakened the adhesion between workpiece and dies. By increasing the vibration frequency, the punch movement was enhanced, and the number of attempts to drag the lubricant out of the pits was increased. In this manner, the lubrication condition was improved greatly. The 3D surface topography testing confirmed the assumption. Moreover, vibration frequency exerted a more significant effect on the forming load reduction than vibration amplitude.

  3. Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

    Science.gov (United States)

    Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

    2015-10-01

    Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard. Published by Elsevier Inc.

  4. Clinical investigation of radioallergosorbent test (RAST)

    International Nuclear Information System (INIS)

    Okuda, Minoru; Usami, Atsushi

    1974-01-01

    Relationship of radioallergosorbent test (RAST), intracutaneous reaction, serum IgE determination and RMCD (Rat Mast Cell Degranulation Test) in subjects with tick allergy was compared in order to investigate clinical application for nasal allergy. 1. RAST is suitable for clinical examinations as determination of IgE. Because it is simple in technique, a technical expert can treat many subjects within a short time, and the result can be decleared within 2 days. 2. RAST was high in specificity and was consistent with clinical findings. RAST positive was thought to be allergy by the antigen, but RAST negative could not deny allergy by the antigen. 3. Correlation of some degree was found to exist between RAST and intracutaneous reaction or degree of induced reaction or threshold value of antigen intracutaneous reaction. But degree of intracutaneous reaction and induced reaction and threshold value of intracutaneous reaction could not be determined from the result of RAST. 4. Determination of IgE antibody by RAST was more useful in clinical study than that of IgE or IgE antibody by RMCD. (Oyama, S.)

  5. Root form and clinical radiographic estimation of the number of root ...

    African Journals Online (AJOL)

    The root form of 100 extracted maxillary premolars, the pre-operative radiographic estimation and clinical radiographic determination of the number of root canals in 340 maxillary premolars of Nigerian patients attending the dental hospital for endodontic treatment were studied. The maxillary second premolars had one root ...

  6. [Nostalgia as a state of mind and as a clinical form].

    Science.gov (United States)

    Borgna, E

    2001-01-01

    Psychiatry, as human science, necessarily concerns emotions too and, among these, nostalgia. Nostalgia is not only a mind condition but also a psychopathological and clinical state which can be defined nostalgic depression form. At the beginning of this work, on the base of a clinical case-report, we describe the phenomenological and space-temporal aspects of nostalgia, we analyse some psychopathological situations that, marked by nostalgic emotions, come from moving house, exile and rooting out. Each of these situations go with depression models thematically different, that are explained in the work.

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

    Directory of Open Access Journals (Sweden)

    Laura E. Chess

    2016-02-01

    Full Text Available Abstract Background Clinical heterogeneity can be defined as differences in participant characteristics, types or timing of outcome measurements and intervention characteristics. Clinical heterogeneity in systematic reviews has the possibility to significantly affect statistical heterogeneity leading to inaccurate conclusions and misled decision making. The aim of this study is to identify to what extent investigators are assessing clinical heterogeneity in both Cochrane and non-Cochrane systematic reviews. Methods The most recent 100 systematic reviews from the top five journals in medicine—JAMA, Archives of Internal Medicine, British Medical Journal, The Lancet, and PLOS Medicine—and the 100 most recently published and/or updated systematic reviews from Cochrane were collected. Various defined items of clinical heterogeneity were extracted from the included reviews. Investigators used chi-squared tests, logarithmic modeling and linear regressions to determine if the presence of such items served as a predictor for clinical heterogeneity when comparing Cochrane to non-Cochrane reviews. Extracted variables include number of studies, number of participants, presence of quantitative synthesis, exploration of clinical heterogeneity, heterogeneous characteristics explored, basis and methods used for investigating clinical heterogeneity, plotting/visual aids, author contact, inferences from clinical heterogeneity investigation, reporting assessment, and the presence of a priori or post-hoc analysis. Results A total of 317 systematic reviews were considered, of which 199 were in the final analysis. A total of 81 % of Cochrane reviews and 90 % of non-Cochrane reviews explored characteristics that are considered aspects of clinical heterogeneity and also described the methods they planned to use to investigate the influence of those characteristics. Only 1 % of non-Cochrane reviews and 8 % of Cochrane reviews explored the clinical

  8. XPS investigations of tribofilms formed on CrN coatings

    Energy Technology Data Exchange (ETDEWEB)

    Mandrino, Djordje, E-mail: djordje.mandrino@imt.si; Podgornik, Bojan

    2017-02-28

    Highlights: • Formation of tribofilms from lubricant additives on CrN surfaces during tribological contact confirmed by XPS. • Chemistry & chemical state of tribofilms obtained by XPS. • Thin sulphate film forms at the top of sulphide tribofilm. • Final type of sulphide in tribolayer depends on additive chemistry and testing temperature. - Abstract: Action of lubrication additives in the case of uncoated steel surfaces, including the type and mechanism of tribofilm formation is well known and understood. However, contact type of tribofilms which might form under the tribological contact between CrN coated surfaces, remains more or less unexplored. The aim of this investigation was to study the type of tribofilms formed on the CrN coated steel samples subjected to lubricated reciprocating sliding contact under different contact conditions Contact surface and tribofilms formed were studied by X-ray Photoelectron Spectroscopy (XPS). Sample surfaces were first imaged by Scanning Electron Microscopy (SEM) to determine areas of tribofilm formation as well as areas not affected by tribological contact. In these areas survey and high resolution (HR) XPS measurements were performed to obtain information about surface chemistry and oxidation states of the constituent elements. It was found that differences between different samples, observed by the XPS measurements, may reflect differences in chemistry of tribofilms formed under different contact conditions.

  9. Disclosure of investigators' recruitment performance in multicenter clinical trials

    DEFF Research Database (Denmark)

    Dal-Ré, Rafael; Moher, David; Gluud, Christian

    2011-01-01

    Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends.......Rafael Dal-Ré and colleagues argue that the recruitment targets and performance of all site investigators in multi-centre clinical trials should be disclosed in trial registration sites before a trial starts, and when it ends....

  10. [Is the structure of surgical clinics in Germany changing? A current investigation into the structure of surgical clinics in the Federal Republic of Germany].

    Science.gov (United States)

    Lob, G; Lob, T; Bauer, H; Niethard, F; Polonius, J; Siebert, H

    2009-04-01

    Medical developments have led to extensive specialization in the field of surgery. This has already been reflected for many years in altered structure and organization forms of surgical clinics. Indispensable quality standards, statutory general conditions, increasing competition in service providers and health insurance with transparency of the service procedure all intensify this trend. The aim of this investigation was, therefore, to determine how far this differentiation of service supply in the field of surgery is also reflected in the area and in surgical departments and clinics of basic and routine supply. To achieve this, all available published information on the structure and organization of surgical clinics in the Federal Republic of Germany was classified according to current departmentalization into "undivided" or general/visceral surgery facilities compared to orthopedic/trauma surgery departments.

  11. Investigation into the feasibility of alternative plutonium shipping forms

    International Nuclear Information System (INIS)

    Mishima, J.; Lindsey, C.G.

    1983-06-01

    Pacific Northwest Laboratory (PNL), operated for the Department of Energy by the Battelle Memorial Institute, is conducting a study for the Nuclear Regulatory Commission on the feasibility of altering current plutonium shipping forms to reduce or eliminate the airborne dispersibility of PuO 2 which might occur during a shipping accident. Plutonium used for fuel fabrication is currently shipped as a PuO 2 powder with a significant fraction in the respirable size range. If the high-strength container is breached due to stresses imposed during a transportation accident, the PuO 2 powder could be subject to airborne dispersion. The available information indicated that a potential accident involving fire accompanied by crush/impact forces would lead to failure of current surface shipping containers (no assumptions were made on the possibility of such a severe accident). Criteria were defined for an alternate shipping form to mitigate the effects of such an accident. Candidate techniques and materials were evaluated as alternate shipping forms by a task team consisting of personnel from PNL and Rockwell Hanford Operations (RHO). At this time, the most promising candidate for an alternate plutonium shipping form appears to be pressing PuO 2 into unsintered (green) pellets. These green pellets satisfy the criteria for a less dispersible form without requiring significant process changes. Discussions of all candidates considered are contained in a series of appendices. Recommendations for further investigations of the applicability of green pellets as an alternate shipping form are given, including the need for a cost-benefit study

  12. Raman spectroscopy used for structural investigations of anodically formed ZrO2

    International Nuclear Information System (INIS)

    Koneska, Zagorka; Arsova, Irena

    2003-01-01

    The structure of the oxide formed on Zr(99% + Hf) with anodic oxidation at different potentials in 1 mol/dm 3 H 3 PO 4 and 2 mol/dm 3 KOH solutions were investigated using Raman spectroscopy. Normally the anodic oxides of Zr form only crystals. Under certain circumstances, amorphous anodic ZrO 2 can be observed. Amorphous phase is observed for the anodically formed zirconium oxides in H 3 PO 4 . The oxide formed in KOH at potential of 80 V, where sparks appears on the Zr electrode showed crystalline structure. (Original)

  13. [Clinical investigation of the positioning accuracy of acute pulpitis pain].

    Science.gov (United States)

    Wang, Jin; Sun, Wei; Ji, Aiping

    2013-10-01

    This study aims to investigate the positioning accuracy of acute pulpitis pain and its possible factors. The clinical symptoms and physical signs of 3 432 cases of acute pulpitis were recorded and analyzed by using questionnaire forms, which included age, gender, tooth position, infection origin, pain history, time of acute attack, duration and nature of pain, pain frequency, referred pain areas, percussion examination, temperature pulp test, pulp bleeding, and positioning accuracy. Univariate analysis and multivariate stepwise regression analysis were used for data processing. Pain location was accurately identified by 39.1% of the patients with acute pulpitis. Referred pain could reduce the positioning accuracy of pain (P 0.05). Some cases of acute pulpitis pain can be located accurately. Referred pain and periodontium infection origin are related to the positioning accuracy of acute pulpitis pain. The exact cause of this correlation needs further study.

  14. Clinical investigations for SUS, the Brazilian public health system.

    Science.gov (United States)

    Paula, Ana Patrícia de; Giozza, Silvana Pereira; Pereira, Michelle Zanon; Boaventura, Patrícia Souza; Santos, Leonor Maria Pacheco; Sachetti, Camile Giaretta; Tamayo, César Omar Carranza; Kowalski, Clarissa Campos Guaragna; Elias, Flavia Tavares Silva; Serruya, Suzanne Jacob; Guimarães, Reinaldo

    2012-01-01

    Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa), especially with regard to establishing a National Clinical Research Network. The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

  15. Investigation of Forming Performance of Laminated Steel Sheets Using Finite Element Analyses

    International Nuclear Information System (INIS)

    Liu Wenning; Sun Xin; Ruokolainen, Robert; Gayden Xiaohong

    2007-01-01

    Laminated steel sheets have been used in automotive structures for reducing in-cabin noise. However, due to the marked difference in material properties of the different laminated layers, integrating laminated steel parts into the manufacturing processes can be challenging. Especially, the behavior of laminated sheets during forming processes is very different from that of monolithic steel sheets. During the deep-draw forming process, large shear deformation and corresponding high interfacial stress may initiate and propagate interfacial cracks between the core polymer and the metal skin, hence degrading the performance of the laminated sheets. In this paper, the formability of the laminated steel sheets is investigated by means of numerical analysis. The goal of this work is to gain insight into the relationship between the individual properties of the laminated sheet layers and the corresponding formability of the laminated sheet as a whole, eventually leading to reliable design and successful forming process development of such materials. Finite element analyses of laminate sheet forming are presented. Effects of polymer core thickness and viscoelastic properties of the polymer core, as well as punching velocity, are also investigated

  16. PHOTODYNAMIC THERAPY IN PATIENTS WITH DIFFERENT CLINICAL FORMS OF BASAL CELL CARCINOMA OF THE SKIN

    Directory of Open Access Journals (Sweden)

    O. V. Matveeva

    2014-01-01

    Full Text Available Background: Photodynamic therapy is frequently applied for non-invasive destruction of basal cell carcinomas (BCC of the skin; though, there is lack of evidence for efficacy of the method. Aim: To assess objective response of BCCs to photodynamic therapy with intralesional administration of photosensitizer Radachlorin in patients with different clinical forms, stages, flow patterns and localization of BCC. Materials and methods: 45  stage I–II BCCs patients with primary and recurrent solitary (ulcerative, superficial, scleroderma-like and nodular forms and multiple lesions (predominantly Т₁– Т₂N₀M₀, with difficult to treat localization and high risk of recurrence were included during the period from March 2004 to March 2007. All patients received one cycle of photodynamic therapy with intralesional Radachlorin (0.5–1  ml/1  cm² tumor surface and irradiation dose 300  J/cm² (wavelength 662 nm. A primary outcome measure was grade of clinical and cytological lesion regression after three months. Secondary outcome measure was stable clinical and cytological reaction at the lesion site. In the long-term, lesion recurrence was assessed yearly during 5 years. Results: Complete regression of BCCs was found in 43  (95.5% patients and 47  (95.9% lesions. In 2 (4.5% patients with partial regression of 2 (4.1% lesions repeated cycles of photodynamic therapy resulted in complete response. In BCCs Т₁N₀M₀, early outcome was independent from the clinical form of the diseases; by contrast, in BCCs Т₂N₀M₀, treatment of scleroderma-like BCCs was non-significantly less effective (66.7% compared to nodular, surface (100% for both and ulcerative (92.8% forms. In the long-term, 1  tumor recurrence was observed after 29 months at the site of completely regressed ulcerative lesion. Conclusion: Photodynamic therapy with intralesional administration of photosensitizer Radachlorin is an effective treatment method for different

  17. CFD investigation of pentamaran ship model with chine hull form on the resistance characteristics

    Science.gov (United States)

    Yanuar; Sulistyawati, W.

    2018-03-01

    This paper presents an investigation of pentamaran hull form with chine hull form to the effects of outriggers position, asymmetry, and deadrise angles on the resistance characteristics. The investigation to the resistance characteristics by modelling pentamaran hull form using chine with symmetrical main hull and asymmetric outboard on the variation deadrise angles: 25°, 30°, 35° and Froude number 0,1 to 0,7. On calm water resistance characteristics of six pentamaran models with chine-hull form examined by variation of deadrise angles by using CFD. Comparation with Wigley hull form, the maximum resistance drag reduction of the chine hull form was reduced by 15.81% on deadrise 25°, 13.8% on deadrise 30°, and 20.38% on deadrise 35°. While the smallest value of total resistance coefficient was generated from chine 35° at R/L:1/14 and R/L:1/7. Optimum hull form for minimum resistance has been obtained, so it is interesting to continue with angle of entrance and stem angle of hull for further research.

  18. [An Investigation of the Role Responsibilities of Clinical Research Nurses in Conducting Clinical Trials].

    Science.gov (United States)

    Kao, Chi-Yin; Huang, Guey-Shiun; Dai, Yu-Tzu; Pai, Ya-Ying; Hu, Wen-Yu

    2015-06-01

    Clinical research nurses (CRNs) play an important role in improving the quality of clinical trials. In Taiwan, the increasing number of clinical trials has increased the number of practicing CRNs. Understanding the role responsibilities of CRNs is necessary to promote professionalism in this nursing category. This study investigates the role responsibilities of CRNs in conducting clinical trials / research. A questionnaire survey was conducted in a medical center in Taipei City, Taiwan. Eighty CRNs that were registered to facilitate and conduct clinical trials at this research site completed the survey. "Subject protection" was the CRN role responsibility most recognized by participants, followed by "research coordination and management", "subject clinical care", and "advanced professional nursing". Higher recognition scores were associated with higher importance scores and lower difficulty scores. Participants with trial training had significantly higher difficulty scores for "subject clinical care" and "research coordination and management" than their peers without this training (p research coordination and management" (p clinical practice.

  19. Clinical investigations for SUS, the Brazilian public health system

    Directory of Open Access Journals (Sweden)

    Ana Patrícia de Paula

    Full Text Available CONTEXT AND OBJECTIVE: Scientific and technological development is crucial for advancing the Brazilian health system and for promoting quality of life. The way in which the Brazilian Ministry of Health has supported clinical research to provide autonomy, self-sufficiency, competitiveness and innovation for the healthcare industrial production complex, in accordance with the National Policy on Science, Technology and Innovation in Healthcare, was analyzed. DESIGN AND SETTING: Descriptive investigation, based on secondary data, conducted at the Department of Science and Technology, Ministry of Health. METHODS: The Ministry of Health's research management database, PesquisaSaúde, was analyzed from 2002 to 2009, using the key word "clinical research" in the fields "primary sub-agenda" or "secondary sub-agenda". The 368 projects retrieved were sorted into six categories: basic biomedical research, preclinical studies, expanded clinical research, clinical trials, infrastructure support and health technology assessment. From a structured review on "clinical research funding", results from selected countries are presented and discussed. RESULTS: The amount invested was R$ 140 million. The largest number of projects supported "basic biomedical research", while the highest amounts invested were in "clinical trials" and "infrastructure support". The southeastern region had the greatest proportion of projects and financial resources. In some respects, Brazil is ahead of other BRICS countries (Russia, India, China and South Africa, especially with regard to establishing a National Clinical Research Network. CONCLUSION: The Ministry of Health ensured investments to encourage clinical research in Brazil and contributed towards promoting cohesion between investigators, health policies and the healthcare industrial production complex.

  20. Glass Forming Ability of Amorphous Drugs Investigated by Continuous Cooling and Isothermal Transformation.

    Science.gov (United States)

    Blaabjerg, Lasse I; Lindenberg, Eleanor; Löbmann, Korbinian; Grohganz, Holger; Rades, Thomas

    2016-09-06

    The aim of this study was to investigate the glass forming ability of 12 different drugs by the determination of continuous cooling and isothermal transformation diagrams in order to elucidate if an inherent differentiation between the drugs with respect to their the glass forming ability can be made. Continuous-cooling-transformation (CCT) and time-temperature-transformation (TTT) diagrams of the drugs were developed in order to predict the critical cooling rate necessary to convert the drug from the melt into an amorphous form. While TTT diagrams overestimated the actual critical cooling rate, they allowed an inherent differentiation of glass forming ability for the investigated drugs into drugs that are extremely difficult to amorphize (>750 °C/min), drugs that require modest cooling rates (>10 °C/min), and drugs that can be made amorphous even at very slow cooling rates (>2 °C/min). Thus, the glass forming ability can be predicted by the use of TTT diagrams. In contrast to TTT diagrams, CCT diagrams may not be suitable for small organic molecules due to poor separation of exothermic events, which makes it difficult to determine the zone of recrystallization. In conclusion, this study shows that glass forming ability of drugs can be predicted by TTT diagrams.

  1. Clinical investigation on Theileria equi and Babesia caballi infections in Italian donkeys.

    Science.gov (United States)

    Laus, Fulvio; Spaterna, Andrea; Faillace, Vanessa; Veronesi, Fabrizia; Ravagnan, Silvia; Beribé, Francesca; Cerquetella, Matteo; Meligrana, Marina; Tesei, Beniamino

    2015-04-28

    Interest in the welfare and diseases of donkeys is constantly increasing in several countries. Despite this, clinical research into donkeys needs to be in continual development since they show different reactions compared to horses in many conditions, including infectious diseases, and need specific clinical and therapeutic approaches. No reports are currently available on clinical and clinical pathology data regarding donkeys with natural piroplasms infection. Venous blood samples were taken from one hundred and thirty eight donkeys and underwent indirect fluorescent antibody test (IFAT) to detect IgG antibodies against Theileria equi and Babesia caballi and real-time polimerase chain reaction (PCR) to detect Babesia spp. and Theileria spp. Clinical examinations, haematological analyses and serum bilirubin evaluation were also performed and compared with positive or negative status. A seroprevalence of 40.6% and 47.8% was found for T. equi and B. caballi, respectively; double positivity was detected in 19.6% of the animals. PCR results showed that 17.4% of the animals tested positive for T.equi and 3.6% for B. caballi with no double positivity. Twelve donkeys (8.7%) had clinical signs consistent with chronic forms of the disease and no acute forms were detected. Fifty-eight donkeys had haematological and serum bilirubin alterations and 56 (96.6%) of them were IFAT and/or PCR positive. Changes in erythrocyte number, packed cell volume, hemoglobin concentration, mean corpuscular hemoglobin, platelets number and total bilirubin were significantly associated with positive and symptomatic animals. Nonspecific clinical presentation seems to be very common in donkeys and several clinical pathology alterations persist after natural infection. Therefore, apparently healthy donkeys can have masked but severe clinical pathology alterations. Acute forms are very seldom observed in donkeys. Clinical monitoring of chronically infected donkeys is recommended since such animals

  2. Transcranial magnetic stimulation techniques in clinical investigation.

    Science.gov (United States)

    Currà, A; Modugno, N; Inghilleri, M; Manfredi, M; Hallett, M; Berardelli, A

    2002-12-24

    Transcranial magnetic stimulation (TMS) is a technique that can activate cortical motor areas and the corticospinal tract without causing the subject discomfort. Since TMS was introduced, numerous applications of the technique have been developed for the evaluation of neurologic diseases. Standard TMS applications (central motor conduction time, threshold and amplitude of motor evoked potentials) allow the evaluation of motor conduction in the CNS. Conduction studies provide specific information in neurologic conditions characterized by clinical and subclinical upper motor neuron involvement. In addition, they have proved useful in monitoring motor abnormalities and the recovery of motor function. TMS also gives information on the pathophysiology of the processes underlying the various clinical conditions. More complex TMS applications (paired-pulse stimulation, silent period, ipsilateral silent period, input-output curve, and evaluation of central fatigue) allow investigation into the mechanisms of diseases causing changes in the excitability of cortical motor areas. These techniques are also useful in monitoring the effects of neurotrophic drugs on cortical activity. TMS applications have an important place among the investigative tools to study patients with motor disorders.

  3. Investigation of paramedics' compliance with clinical practice guidelines for the management of chest pain.

    LENUS (Irish Health Repository)

    Figgis, Ken

    2012-01-31

    BACKGROUND: Acute coronary syndromes remain a leading cause of preventable early deaths. However, previous studies have indicated that paramedics\\' compliance with chest pain protocols is suboptimal and that many patients do not receive the benefits of appropriate prehospital treatment. AIMS: To evaluate paramedics\\' level of compliance with national clinical practice guidelines and to investigate why, in certain circumstances, they may deviate from the clinical guidelines. SETTING: The Health Service Executive Mid-Western Regional Ambulance Service which serves a mixed urban and rural population across three counties in the west of Ireland. METHOD: A retrospective review of completed ambulance Patient Care Report Forms was conducted for all adult patients with non-traumatic chest pain treated between 1 December 2007 and 31 March 2008. During the same study period, paramedics were asked to complete a prospective questionnaire survey investigating the rationale behind their treatment decisions, their estimation of patient risk and their attitudes towards the clinical practice guidelines and training. RESULTS: 382 completed Patient Care Report Forms were identified for patients with chest pain, of whom 84.8% received ECG monitoring, 75.9% were given oxygen, 44.8% were treated with sublingual glyceryl trinitrate (GTN) and 50.8% were treated with aspirin. Only 20.4% of patients had a prehospital 12-lead ECG recorded. 58 completed questionnaires were returned (response rate 15%); 64% of respondents said they had received insufficient training to identify ECG abnormalities. CONCLUSIONS: Prehospital treatment with oxygen, aspirin, sublingual GTN and ECG monitoring remains underused by paramedics, even though only a small number of patients had documented contraindications to their use. The small number of patients who received a prehospital 12-lead ECG is a cause of particular concern and suggests that incomplete patient assessment may contribute to undertreatment

  4. Investigators' viewpoint of clinical trials in India: Past, present and future

    Directory of Open Access Journals (Sweden)

    Mohandas K Mallath

    2017-01-01

    Full Text Available India's success in producing food and milk for its population (Green Revolution and White Revolution happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials.

  5. Clinical and electroencephalographic characteristics of some forms of epileptic encephalopathies in infants: The data of the authors' follow-up observations

    Directory of Open Access Journals (Sweden)

    I. D. Lemeshko

    2016-01-01

    Full Text Available Objective: to study clinical symptoms and brain activity in new forms of infantile epilepsy, such as malignant migrating partial seizures in infancy (MMPSI and Markand-Blume-Ohtahara syndrome (MBOS and to elaborate their differential diagnostic criteria for the timely choice of treatment policy and for the prediction of the disease.Patients and methods. Thirty-eight children aged 1.5 months to 3 years with MMPSI and MBOS were examined. Their medical history and neurological examination data, electroencephalographic and neuroimaging characteristics, and the efficiency of chosen anticonvulsant therapy were investigated.Results and discussion. The investigators revealed the following characteristics of these forms: the causes of these syndromes were highly diverse and unspecific; the neurological status was characterized by a variety of symptoms with an obvious delay in psycho-prespeech development concurrent with a high rate of partial focal (in MMPSI and generalized (in MBOS status epilepticus; The EEC characteristic sign was MISF and«lafa» patterns in the children with MBOS and continuous migrating partial ictal status epilepticus patterns in those with MMPSI. These forms of epileptic encephalopathies are extremely drug-resistant and characterized by a high risk for a fatal outcome.

  6. Investigation of the deformation stability in the incremental sheet forming process

    Directory of Open Access Journals (Sweden)

    Ai S.

    2015-01-01

    Full Text Available Incremental sheet forming (ISF is a highly versatile and flexible process for rapid manufacturing of complex sheet metal parts. One of the unique characters of the ISF process is the improved formability comparing to conventional sheet forming process. This may be due to the localized deformation nature, which increases the deformation stability in the ISF process. Although many hypotheses have been proposed, there is no direct modelling and calculation of the ISF deformation stability. Aiming to obtain a better understanding of the ISF process, an analytical model was developed to investigate and analyse the material deformation stability in this work. Based on the analytical evaluation of stress variations and force equilibrium, a mathematical relationship between the maximum forming angle and the process stability condition was established. To validate the developed model, experiments were carried out by forming a hyperbolic part made of AA1100 material. The maximum forming angle, as an indicator to the ISF formability, was employed compare the analytical evaluation and experimental result. It was found that the ISF deformation stability is one of the key factors that affect the ISF formability.

  7. Clinical spectrum and various forms of thyrotoxcosis in endocrine clinic of Jinnah Postgraduate Medical Centre

    International Nuclear Information System (INIS)

    Ahsan, T.; Banu, Z.; Jabeen, R.; Farooq, M. U.

    2013-01-01

    Objective: To evaluate clinical symptoms, signs and various forms of thyrotoxicosis, and to assess the thyroid function status at the first 6-week follow-up. Methods: The retrospective chart review involved thyrotoxic patients presenting at the Endocrine Clinic of Jinnah Postgraduate Medical Centre, Karachi, between April 2007 and January 2011. All hyperthyroid patients were included with the exception of those with suspected or proven malignancy. The records were maintained on a structured proforma and analysed statistically to work out frequencies and percentages. Results: A total of 507 patients were included. Most common form of thyrotoxicosis was Graves disease, with diffuse toxic goiter affecting 269 (53%) patients; followed by toxic multinodular goiter in 102 (20.1%); solitary toxic nodule in 56 (11%); thyrotoxicosis without goiter in 44 (8.7%); subclinical hyperthyroidism in 22 (4.3.%); thyroiditis in 9 (1.8%); and thyrotoxicosis with solitary cold nodule in 4 (0.9%). The common presenting symptoms and signs were goiter (n=415; 85.7%), with eye signs present in 137 (27.7%) patients and heart failure in 20 (4.8%) patients. Of the 321 patients who attended the first six-week follow-up, 309 (94.4%) had their FT4 levels checked. Out of them, 130(42.1%) had euthyroid levels; 113 (36.6%) had lower but still toxic level; 36 (11.7%) had no change; and 30(9.7%) became hypothyroid. TSH levels at first follow-up remained suppressed in 211 (73%) patients; normal in 47(16.3%); and increased in 31 (10.7%). Conclusions: Graves disease was found to be the most common cause of hyperthyroidism. At first follow-up 10.4% of patients had become hypothyroid. Therefore the starting dose of antithyroid drugs was reduced in the clinic. Thyroid stimulating hormone assay was of little help in adjusting treatment at the 6-week follow-up, as almost all cases of hypothyroidism could have been picked up on FT4 assay alone. (author)

  8. 76 FR 20575 - Disqualification of a Clinical Investigator

    Science.gov (United States)

    2011-04-13

    ... research or marketing permit for products regulated by FDA. This proposal is based in part upon.... SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Background III. Description of the Proposed.... References I. Introduction Under current regulations, a clinical investigator disqualified by the...

  9. Clinical trials in orthopaedics and the future direction of clinical investigations for femoroacetabular impingement

    DEFF Research Database (Denmark)

    Clohisy, John C; Kim, Young-Jo; Lurie, Jon

    2013-01-01

    to be further defined. To date, clinical research reports have included primarily surgical case series. Future clinical investigations are needed to establish improved clinical evidence to guide patient care. Most urgent is the need to better understand the potential role of standardized nonsurgical treatment......Femoroacetabular impingement (FAI) represents a heterogeneous group of disorders that affect a diverse patient population. The natural history of the disease, the role of nonsurgical management, the indications for surgery, optimal surgical techniques, and the predictors of treatment outcomes need...... options for FAI and to define the predictors of surgical and nonsurgical outcomes. Future randomized controlled trials and large observational cohort studies targeted at these clinical research deficiencies will strengthen the evidence and improve informed decision making regarding the management...

  10. The congenital hypothyroidism: the incidence and clinical features of different forms

    Directory of Open Access Journals (Sweden)

    T.V. Sorokman

    2017-04-01

    Full Text Available Background. Congenital hypothyroidism (CH as the most common hereditary thyroid pathology is a serious social, economic and psychological burden for a family, where the sick child was born, as well as for the society. The purpose of our study was to evaluate the disease incidence and to detect the clinical features of various forms of congenital hypothyroidism in children. Materials and methods. Twenty two medical records of patients with CH (14 girls, 8 boys aged 1 month to 6 years (experimental group and 20 healthy children of the correspondent age were analyzed, and the further assessment of their physical and neuropsychological development was conducted. All children underwent the ultrasound examination of the neck region, indirect laryngoscopy; thyroid-stimulating hormone (TSH, thyroglobulin antibodies, free thyroxine (fT4, thyroglobulin tests were also performed. Clinical signs of CH in the neonatal period were estimated according to the Apgar scores. Statistical analysis was performed with the aid of the Statistica 6.0 program. Results. The thyroid dystopia was diagnosed in 59.1 % of cases, in particular: in the hyoid area (5, the root of the tongue (2, submandibular area (2, jugular fossa (1, unspecified (2. The median of TSH in the first stage of screening in children of the main group was 38 mU/l (24.2–122.4 mU/l, in the comparison group — 2.03 mU/l (1.7–2.6 mU/l. The fT4 level ranged from 0.49 to 14.7 pmol/l, on average — 2.37 pmol/l. The number of clinical signs was not dependent on the age neither on the form of hypothyroidism at the moment of diagnosis. With age, children’s development increasingly lags behind those of correspondent age contributing to further development of fine motor delay. In 40.9 % of patients with CH, the relatives suffered from thyroid disease. Conclusions. The thyroid dystopia is the most common among various forms of congenital hypothyroidism (59.1 %. The reliable differences in TSH and fT4 levels

  11. Clinical Investigation Program. Annual Progress Report. Volume 1

    Science.gov (United States)

    1994-01-20

    Components Surgical Day, Bethesda, MD, in April 1993. 2. Planned for FY-94 The Department of Clinical Investigation hopes to maintain the essence of the...sclerosing cholangitis after choledochojejun- ostomy : radiographic and biochemical improvement with antibiotic therapN. Am J Gastroenterol 1993;88:1635

  12. Annual Progress Report FY 93 (Walter Reed Army Medical Center, Department of Clinical Investigation). Clinical Investigation Program. Volume 2

    Science.gov (United States)

    1993-01-01

    129 REPORT DATE: 03/04/93 WORK UNIT a 1332-91 DETAIL SUMMARY SHEET TITLE: Thermogenic Agent Promotion of Weight Loss in Obese Soldiers KEYWORDS...thermogenic, promotion, obese PRINCIPAL INVESTIGATOR: Solomon, Barbara DNSc DEPARTMENT: Department of Medicine STATUS: Completed SERVICE: Endocrine...are: possible variance between adult and chilhood forms of HD, patterns of previous infectious disease exposure, socioeconomic patterns, familial

  13. Clinical Investigation Program, RCS MED-300 (RI).

    Science.gov (United States)

    1984-10-01

    protocol is a clinical validation study uti - lizing the BIOTRONIK DIPLOS 04 Dual Chamber Pulse Generator. This study is being conducted under an...recurrence-rates, survival-rates, and pattern of recurrence for patients receiving therapy uti - lizing surgery and postoperative radiation vs combined...placed in the treatment qroup or control aroup by the pharmacist . Progress: Terminate. Both the principal and associate investigators have ETS d. 7

  14. Clinical forms of actinic keratosis and levels of dysplasia of the epidermis.

    Science.gov (United States)

    Oshyvalova, Olena O; Kaliuzhna, Lydia D; Kropelnytskyi, Vladislav O

    Introduction: Actinic keratosis (AK) is precancerous skin lesion that occurs in the sun-exposedskin areas characterized by local intraepidermal dysplasia of different severity (KIN I, KIN II and KIN III). The aim of this research was to study distribution patterns and morphological features of AK histological types. Materials and Methods: The study included skin biopsy material from 68 patients with different clinical forms of AK. The diagnosis of AK was histologically confirmed in 100% of cases. Results: There were 63.21% of men and 36.8% of women among all patients with AK. The average age of patients was 73.3 ± 8.3.The most common clinico-histological forms of actinic keratosis were typical (41.2%), hypertrophic (16.2%), atrophic (14.7%) and pigmentary (11.7%), bowenoid (8.8%), acantholytic (7.4%). Among the rate of epidermal dysplasia there diagnosed cases of KIN І (50%), KIN ІІ (36.8%) and KIN III (13.2%). Conclusions: It was found a direct correlation between KIN I and typical and pigment forms of AK, KIN II and hypertrophic and bowenoid forms of AK.

  15. Informed consent for clinical trials: a comparative study of standard versus simplified forms.

    Science.gov (United States)

    Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

    1998-05-06

    A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (Pinformed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

  16. Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology.

    Science.gov (United States)

    Rorie, David A; Flynn, Robert W V; Grieve, Kerr; Doney, Alexander; Mackenzie, Isla; MacDonald, Thomas M; Rogers, Amy

    2017-09-01

    Researchers in clinical and pharmacoepidemiology fields have adopted information technology (IT) and electronic data capture, but these remain underused despite the benefits. This review discusses electronic case report forms and electronic data capture, specifically within pharmacoepidemiology and clinical research. The review used PubMed and the Institute of Electrical and Electronic Engineers library. Search terms used were agreed by the authors and documented. PubMed is medical and health based, whereas Institute of Electrical and Electronic Engineers is technology based. The review focuses on electronic case report forms and electronic data capture, but briefly considers other relevant topics; consent, ethics and security. There were 1126 papers found using the search terms. Manual filtering and reviewing of abstracts further condensed this number to 136 relevant manuscripts. The papers were further categorized: 17 contained study data; 40 observational data; 27 anecdotal data; 47 covering methodology or design of systems; one case study; one literature review; two feasibility studies; and one cost analysis. Electronic case report forms, electronic data capture and IT in general are viewed with enthusiasm and are seen as a cost-effective means of improving research efficiency, educating participants and improving trial recruitment, provided concerns about how data will be protected from misuse can be addressed. Clear operational guidelines and best practises are key for healthcare providers, and researchers adopting IT, and further work is needed on improving integration of new technologies with current systems. A robust method of evaluation for technical innovation is required. © 2017 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society.

  17. Clinical application of oral form of ANGIPARSTM and in combination with topical form as a new treatment for diabetic foot ulcers: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Bahrami A

    2008-04-01

    Full Text Available ANGIPARSTM is a new herbal extract which has been produced in oral, topical, and intravenous forms. The present article contains preliminary results of the study which was planned to evaluate the efficacy and safety of orally applied ANGIPARSTM and to compare it with the combination of oral and topical forms and also with conventional therapy in patients with diabetic ulcers of the lower extremities."nTwenty one patients with diabetic foot ulcers were divided into 3 groups. The first group received 100 mg of oral ANGIPARSTM twice a day for 6 weeks in addition to conventional therapies. In the second group, ANGIPARSTM gel 3% was added to the oral form of the same product besides the conventional therapies for the same period of time. Finally, in the third group which was considered as control, only conventional therapies were performed. The patients were followed for 6 weeks. Parameters such as granulation tissue formation, skin epithelization, and wound surface areas changes were analyzed to determine the effectiveness of the compound in wounds healing. Furthermore, drug safety was assessed by monitoring adverse events and by clinical and laboratory evaluations."nThe study data showed significant differences between the intervention and control groups with respect to efficacy and tolerability. In each intervention group, primary wound healings occurred following 2 weeks. Complete wound healing which was greater than 70% improvement in wounds surface areas was achieved in 83% and 100% of group 1 and group 2 participants, respectively after 6 weeks. On the other hand, at the same period of time, only 22.2% of patients in control group revealed complete healing. Therefore, ANGIPARSTM had significant positive effect in increasing the incidence of complete wound closure compared with control group (p = 0.042. However, our evaluations indicated that adding topical treatment with 3% gel once a day to the oral therapy with the same product did not make

  18. Clinical and biochemical manifestations of undifferentiated forms of connective tissue dysplasia in pregnant women with varicose veins of small pelvis

    Directory of Open Access Journals (Sweden)

    N.M. Shibelgut

    2010-03-01

    Full Text Available Research objective is to define the pathogenesis of varicous veins of small pelvis in women. at Ultrasonic investigation of venous system of small pelvis has been carried out in 290 pregnant women. It revealed 190 patients with varicose veins of small pelvis (VVSP. By means of V.M. Jakovleva's technique phenotypic menifestation of connective tissue dysplasia was determined in all pregnant women. Biochemical manifestations of connective tissue dysplasia were identified by sialic acid level in blood serum, daily excretion of glycosaminoglycans and oxyproline. High frequency of clinical and biochemical manifestations of undifferentiated forms of connective tissue dysplasia was revealed in pregnant women with VVSP. Patients with VVSP developed tooth and jaw, facial and locomotor damages. Patients with VVSP characterized by visceral undifferentiated forms of connective tissue dysplasia demonstrated by refraction involvement, ventral hernias, flat feet, varicous veins of lower extremities, hypermobile syndrome, mitral valve prolapse of different degree. Biochemical manifestations of undifferentiated forms of connective tissue dysplasia in pregnant women with VVSP were insignificant

  19. Clinical Investigation of Treatment Failure in Type 2 Diabetic ...

    African Journals Online (AJOL)

    Clinical Investigation of Treatment Failure in Type 2 Diabetic Patients ... Purpose: To examine body mass index (BMI), occupation, sex, age, and ... development of secondary failure in type 2 diabetics receiving metformin and glibenclamide.

  20. Future requirements. Clinical investigations

    DEFF Research Database (Denmark)

    Qvist, V.

    2002-01-01

    Biocompatability, Cariology, Clinical trials, Dental materials, Helath services research, Human, Pedodontics......Biocompatability, Cariology, Clinical trials, Dental materials, Helath services research, Human, Pedodontics...

  1. Clinical investigation of CT-guided ozone-blowing and fumigation ...

    African Journals Online (AJOL)

    Clinical investigation of CT-guided ozone-blowing and fumigation therapy for the chronic ... African Journal of Biotechnology ... In control group, seven patients were completely cured in 45 days after being treated by traditional surgery.

  2. CLINICAL-EPIDEMIOLOGICAL FEATURES AND OUTCOME OF GENERALIZED FORMS OF MENINGOCOCCAL INFECTION IN CHILDREN

    Directory of Open Access Journals (Sweden)

    G. P. Martynova

    2017-01-01

    Full Text Available The objective of the research was to study clinical and epidemiological features and outcomes of generalized forms of meningococcal infection in children from Krasnoyarsk and Krasnoyarsk Territory during the period from 2012 to 2016. Materials and methods. A retrospective analysis of 57 medical records of hospital patients with generalized forms of meningococcal infection was carried out in the infectious and resuscitative departments of the Krasnoyarsk Clinical Hospital No. 1 from 2012 to 2016, including 12 protocols of pathologoanatomical studies of the deceased patients and 45 medical cards of ambulatory patients – convalescents of the disease from 2012 to 2016. Results. The epidemic situation for meningococcal infection in Krasnoyarsk Territory from 2012 to 2016 is characterized by signs of inter-epidemic period. Children of the first 3 years of life are in the group of high risk for the development of GFMI, which accounts for 74% of the total number of cases of children aged 14. There are signs of meningococcal infection «aging» – in the age structure the number of children in the first year of life decreased, while the proportion of children aged 4–7 and 7–14 increased compared to previous decades. There is a tendency to a decrease in the proportion of the combined forms with an increase in the frequency of «pure» meningococcemia. In recent years there has been an «atypical» course of generalized forms of the disease, when classical hemorrhagic necrotic rashes appear only on the 3rd – 4th day of the disease. In convalescents who underwent a combined form of MI and «pure» meningitis severe residual effects leading patients to disability are possible to develop. Conclusion. The use of polyvalent conjugated vaccines in potential risk groups will allow us to reduce the morbidity and mortality from generalized forms of meningococcal infection, including younger children.

  3. Investigation of fatigue strength of tool steels in sheet-bulk metal forming

    Science.gov (United States)

    Pilz, F.; Gröbel, D.; Merklein, M.

    2018-05-01

    To encounter trends regarding an efficient production of complex functional components in forming technology, the process class of sheet-bulk metal forming (SBMF) can be applied. SBMF is characterized by the application of bulk forming operations on sheet metal, often in combination with sheet forming operations [1]. The combination of these conventional process classes leads to locally varying load conditions. The resulting load conditions cause high tool loads, which lead to a reduced tool life, and an uncontrolled material flow. Several studies have shown that locally modified tool surfaces, so-called tailored surfaces, have the potential to control the material flow and thus to increase the die filling of functional elements [2]. A combination of these modified tool surfaces and high tool loads in SBMF is furthermore critical for the tool life and leads to fatigue. Tool fatigue is hardly predictable and due to a lack of data [3], a challenge in tool design. Thus, it is necessary to provide such data for tool steels used in SBMF. The aim of this study is the investigation of the influence of tailored surfaces on the fatigue strength of the powder metallurgical tool steel ASP2023 (1.3344, AISI M3:2), which is typically used in cold forging applications, with a hardness 60 HRC ± 1 HRC. To conduct this investigation, the rotating bending test is chosen. As tailored surfaces, a DLC-coating and a surface manufactured by a high-feed-milling process are chosen. As reference a polished surface which is typical for cold forging tools is used. Before the rotating bending test, the surface integrity is characterized by measuring topography and residual stresses. After testing, the determined values of the surface integrity are correlated with the reached fracture load cycle to derive functional relations. Based on the gained results the investigated tailored surfaces are evaluated regarding their feasibility to modify tool surfaces within SBMF.

  4. What nanomedicine in the clinic right now really forms nanoparticles?

    Science.gov (United States)

    Svenson, Sonke

    2014-01-01

    Some researchers believe nanomedicine will revolutionize healthcare and medicine through transformative new therapeutic tools. Nanocarriers, utilized to transport actives to the target site, are constructed from a wide range of materials. Nanocarriers can be grouped into self-assembling (liposomes, micelles), processed (nanoparticles, emulsions), and chemically bound (dendrimers, silica-based carriers, carbon nanotubes) structures. A review of nanomedicines on the market and in clinical translation reveals that the vast majority is based on liposomes, polymeric micelles, and nanoparticles. The increasing presence of these novel nanomedicines raises the question what nanomedicines in the clinic right now really form nanoparticles, i.e., are improvements we see from nanomedicines structure-related or do they result from improved formulations? Do we even have sufficient data to address this question? The formation of nanocarriers is usually confirmed in vitro but little if any in vivo (let alone clinical) information is available. Given the large number of nanomedicines on the market and under clinical evaluation one clearly cannot expect to find a 'one size fits all' answer. Therefore, two case studies are discussed: the paclitaxel formulation Taxol® and its nanomedicine companions LEP-ETU (liposome), Genexol®-PM and NK105 (micelles), and Abraxane® (nanoparticle). Published pharmacokinetic data is utilized to find differences indicating nanocarrier delivery. The second case study involves structurally related camptothecin-polymer conjugates CRLX101 (nanoparticles) and XMT-1001 (prodrug). Structural differences are evaluated to discuss the different aggregation behavior. This opinion can only serve as first attempt to find a more general answer; clearly more data is needed from future studies. © 2014 Wiley Periodicals, Inc.

  5. An Investigation of New Distribution Forms for Traditional Media Online

    OpenAIRE

    Näsman, Markus

    2008-01-01

    For decades watching the news, movies or television series has been something you do in front of your TV. But things are changing, more and more TV-channels make parts of their playlists available online. But exacly how much broadcast material is available online? And is it possible to collect all available broadcast material on a single web portal and enable users not only to watch but also to record this material? The objectives of this thesis were to investigate how much and in which form ...

  6. Methodology Series Module 9: Designing Questionnaires and Clinical Record Forms - Part II.

    Science.gov (United States)

    Setia, Maninder Singh

    2017-01-01

    This article is a continuation of the previous module on designing questionnaires and clinical record form in which we have discussed some basic points about designing the questionnaire and clinical record forms. In this section, we will discuss the reliability and validity of questionnaires. The different types of validity are face validity, content validity, criterion validity, and construct validity. The different types of reliability are test-retest reliability, inter-rater reliability, and intra-rater reliability. Some of these parameters are assessed by subject area experts. However, statistical tests should be used for evaluation of other parameters. Once the questionnaire has been designed, the researcher should pilot test the questionnaire. The items in the questionnaire should be changed based on the feedback from the pilot study participants and the researcher's experience. After the basic structure of the questionnaire has been finalized, the researcher should assess the validity and reliability of the questionnaire or the scale. If an existing standard questionnaire is translated in the local language, the researcher should assess the reliability and validity of the translated questionnaire, and these values should be presented in the manuscript. The decision to use a self- or interviewer-administered, paper- or computer-based questionnaire depends on the nature of the questions, literacy levels of the target population, and resources.

  7. The MMPI-2-Restructured Form and the Standard MMPI-2 Clinical Scales in Relation to DSM-IV

    NARCIS (Netherlands)

    Heijden, P.T. van der; Egger, J.I.M.; Rossi, G.M.P.; Grundel, G.; Derksen, J.J.L.

    2013-01-01

    In a Dutch sample of psychiatric outpatients (N = 94), we linked the Minnesota Multiphasic Personality Inventory–2 (MMPI-2; Butcher et al., 2001) Clinical scales and MMPI-2-Restructured Form (MMPI-2-RF; Ben-Porath & Tellegen, 2008) Higher-Order (H-O) scales, Restructured Clinical (RC) scales and

  8. Clinical Investigations

    Science.gov (United States)

    1977-09-30

    conducted at WBAV’S is categorized as t basic experimental medicine or trials and testing of clinical medicine pro- cedures using the indigenous population...Unit No. 77/20 (FY77, 0) An Analysis of Ameloblastic Fibro-odontoma ....................... 27 Department of Medicine Nork Unit No, 69/338 (FY69, T...Unit No. 71/38 (FY71, T) Injected Marihuana : Effects of Cannabinol ....................... 71 Department of Pediatrics Wfork Unit No. 74/23 (FY74, T

  9. Does forming implementation intentions help people with mental health problems to achieve goals? A meta-analysis of experimental studies with clinical and analogue samples.

    Science.gov (United States)

    Toli, Agoro; Webb, Thomas L; Hardy, Gillian E

    2016-03-01

    People struggle to act on the goals that they set themselves, and this gap between intention and action is likely to be exacerbated by mental health problems. Evidence suggests that forming specific if-then plans (or 'implementation intentions') can promote goal attainment and a number of studies have applied such techniques in clinical contexts. However, to date, the extent to which planning can help people with mental health problems has not been systematically examined. The present review used meta-analysis to investigate the effect of if-then planning on goal attainment among people with a DSM-IV/ICD-10 diagnosis (i.e., clinical samples) or scores above a relevant cut-off on clinical measures (i.e., analogue samples). In total, 29 experimental studies, from 18 records, met the inclusion criteria. Excluding one outlying (very large) effect, forming implementation intentions had a large-sized effect on goal attainment (d+ = 0.99, k = 28, N = 1,636). Implementation intentions proved effective across different mental health problems and goals, and in studies with different methodological approaches. Taken together, the findings suggest that forming implementation intentions can be a useful strategy for helping people with mental health problems to achieve various goals and might be usefully integrated into existing treatment approaches. However, further studies are needed addressing a wider range of mental health problems. © 2015 The British Psychological Society.

  10. Clinical and neurophysiological investigation of a large family with dominant Charcot-Marie-Tooth type 2 disease with pyramidal signs

    Directory of Open Access Journals (Sweden)

    Eduardo Luis de Aquino Neves

    2011-06-01

    Full Text Available Charcot-Marie-Tooth (CMT disease is a hereditary neuropathy of motor and sensory impairment with distal predominance. Atrophy and weakness of lower limbs are the first signs of the disease. It can be classified, with the aid of electromyography and nerve conduction studies, as demyelinating (CMT1 or axonal (CMT2. OBJECTIVE: Clinical and neurophysiological investigation of a large multigenerational family with CMT2 with autosomal dominant mode of transmission. METHOD: Fifty individuals were evaluated and neurophysiological studies performed in 22 patients. RESULTS: Thirty individuals had clinical signs of motor-sensory neuropathy. Babinski sign was present in 14 individuals. Neurophysiological study showed motor-sensory axonal polyneuropathy. CONCLUSION: The clinical and neurophysiological characteristics of this family does not differ from those observed with other forms of CMT, except for the high prevalence of Babinski sign.

  11. [Morphological signs of inflammatory activity in different clinical forms of drug-resistant pulmonary tuberculosis].

    Science.gov (United States)

    Elipashev, A A; Nikolsky, V O; Shprykov, A S

    to determine whether the activity of tuberculous inflammation is associated with different clinical forms of drug-resistant pulmonary tuberculosis. The material taken from 310 patients operated on in 2010-2015 were retrospectively examined. The patients underwent economical lung resections of limited extent (typical and atypical ones of up to 3 segments) for circumscribed forms of tuberculosis with bacterial excretion. A study group consisted of 161 (51.9%) patients with drug-resistant variants of pulmonary tuberculosis. A control group included 149 (48.1%) patients with preserved susceptibility of Mycobacterium tuberculosis to anti-TB drugs. The activity of specific changes in tuberculosis was morphologically evaluated in accordance with the classification proposed by B.M. Ariel in 1998. The highest activity of fourth-to-fifth degree specific inflammation, including that outside the primary involvement focus, was obtained in the drug-resistant pulmonary tuberculosis group due to the predominance of patients with cavernous and fibrous-cavernous tuberculosis versus those in whom the susceptibility to chemotherapeutic agents was preserved. A macroscopic study showed that the primary lesion focus had a median size in one-half of the all the examinees; but large tuberculomas, caverns, and fibrous caverns over 4 cm in diameter were multiple and detected in the drug-resistant pulmonary tuberculosis group. Multidrug resistance was observed in more than 60% of the patients with fibrous-cavernous pulmonary tuberculosis, extensive drug resistance was seen in those with cavernous tuberculosis, which is an aggravating factor. The data obtained from the morphological study of the intraoperative material can specify the clinical form of tuberculosis and evaluate the efficiency of preoperative specific therapy. The highest activity of specific inflammation was observed in patients with multiple drug-resistant pulmonary tuberculosis, the prevalence of third-to-fourth degree

  12. [Etiological, clinical and neuroradiological investigation of deaf children with additional neuropsychiatric disabilities].

    Science.gov (United States)

    Chilosi, A M; Scusa, M F; Comparini, A; Genovese, E; Forli, F; Berrettini, S; Cipriani, P

    2012-04-01

    Sensorineural hearing loss (SNHL) is complicated by additional disabilities in about 30% of cases, but the epidemiology of associated disorders, in terms of type, frequency and aetiology is still not clearly defined. Additional disabilities in a deaf child have important consequences in assessing and choosing a therapeutic treatment, in particular when considering cochlear implantation (CI) or hearing aids (HA). The aim of this paper was to evaluate frequency, type and severity of additional neurodevelopmental disabilities in children with profound bilateral sensorineural hearing loss and to investigate the relationship between disability and the etiology of deafness. Eighty children with profound bilateral sensorineural hearing loss (mean age 5.4 years) were investigated by means of a diagnostic protocol including clinical, neurodevelopmental, and audiological procedures together with genetic and neurometabolic tests and neuroradiological investigation by brain MRI. Fifty-five percent of the sample exhibited one or more disabilities in addition to deafness, with cognitive, behavioural-emotional and motor disorders being the most frequent. The risk of additional disabilities varied according to aetiology, with a higher incidence in hereditary syndromic deafness, in cases due to pre-perinatal pathology (in comparison to unknown and hereditary non syndromic forms) and in the presence of major brain abnormalities at MRI. Our results suggest that the aetiology of deafness may be a significant risk indicator for the presence of neuropsychiatric disorders. A multidimensional evaluation, including aetiological, neurodevelopmental and MRI investigation is needed for formulating prognosis and for planning therapeutic intervention, especially in those children candidated to cochlear implant.

  13. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Science.gov (United States)

    2011-05-24

    ... consider public release of financial disclosure information related to an approved marketing application...] (Formerly FDA-1999-D-0792) Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial... entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical...

  14. A clinical scoring system to prioritise investigation for tuberculosis among adults attending HIV clinics in South Africa.

    Directory of Open Access Journals (Sweden)

    Yasmeen Hanifa

    Full Text Available The World Health Organization (WHO recommendation for regular tuberculosis (TB screening of HIV-positive individuals with Xpert MTB/RIF as the first diagnostic test has major resource implications.To develop a diagnostic prediction model for TB, for symptomatic adults attending for routine HIV care, to prioritise TB investigation.Cohort study exploring a TB testing algorithm.HIV clinics, South Africa.Representative sample of adult HIV clinic attendees; data from participants reporting ≥1 symptom on the WHO screening tool were split 50:50 to derive, then internally validate, a prediction model.TB, defined as "confirmed" if Xpert MTB/RIF, line probe assay or M. tuberculosis culture were positive; and "clinical" if TB treatment started without microbiological confirmation, within six months of enrolment.Overall, 79/2602 (3.0% participants on ART fulfilled TB case definitions, compared to 65/906 (7.2% pre-ART. Among 1133/3508 (32.3% participants screening positive on the WHO tool, 1048 met inclusion criteria for this analysis: 52/515 (10.1% in the derivation and 58/533 (10.9% in the validation dataset had TB. Our final model comprised ART status (on ART > 3 months vs. pre-ART or ART 1 symptom. We converted this to a clinical score, using clinically-relevant CD4 and BMI categories. A cut-off score of ≥3 identified those with TB with sensitivity and specificity of 91.8% and 34.3% respectively. If investigation was prioritised for individuals with score of ≥3, 68% (717/1048 symptomatic individuals would be tested, among whom the prevalence of TB would be 14.1% (101/717; 32% (331/1048 of tests would be avoided, but 3% (9/331 with TB would be missed amongst those not tested.Our clinical score may help prioritise TB investigation among symptomatic individuals.

  15. Investigation of Resistance to Mechanical Effect of Braille Formed on Different Materials

    Directory of Open Access Journals (Sweden)

    Ingrida VENYTĖ

    2014-06-01

    Full Text Available Qualitative analysis of stresses emerged in paperboard during Braille embossing, using specialized polarimetric equipment, was carried out. Resistance to mechanical effect of Braille dot surfaces, formed with different printing types on different materials (paper, paperboard, polymer, textile, Al foil was investigated. It was determined that Braille dot height change after period mechanical effect is different.

  16. Investigating animal health effects of sour gas acid forming emissions

    International Nuclear Information System (INIS)

    Edwards, W.C.

    1992-01-01

    The effects of sour gas well blowout emissions on livestock are reviewed. Guidelines for safe drilling operations in hydrogen sulfide environments, general hazards and characteristics of hydrogen sulfide, and guidelines for field investigation into the effects of sour gas and acid emissions on livestock are discussed. A case history involving the Ross No. 2 gas well blowout of July 1985 in Rankin County, Mississippi is presented. The blowout lasted for 72 days, and at peak discharge the 500 ppM radius was ca 3.5 miles. A cattle embryo transplant operation located one half mile from the well was affected by the blowout. Examination by a local veterinarian of the cattle demonstrated eye irritation, epiphora, nasal discharge and coughing. After one and a half months of exposure, most animals showed clinical signs of a severe dry hacking cough, epiphora, dry rales over the thoracic inlet, and a bronchial popping sound over the lateral thorax. All animals had eye irritation. Of 55 animals showing signs of respiratory distress and eye irritations, 15 were still clinically ill in May of 1986. 7 refs., 1 tab

  17. Clinical validation of three short forms of the Dutch Wechsler Memory Scale-Fourth Edition (WMS-IV-NL) in a mixed clinical sample.

    Science.gov (United States)

    Bouman, Zita; Hendriks, Marc P H; Van Der Veld, William M; Aldenkamp, Albert P; Kessels, Roy P C

    2016-06-01

    The reliability and validity of three short forms of the Dutch version of the Wechsler Memory Scale-Fourth Edition (WMS-IV-NL) were evaluated in a mixed clinical sample of 235 patients. The short forms were based on the WMS-IV Flexible Approach, that is, a 3-subtest combination (Older Adult Battery for Adults) and two 2-subtest combinations (Logical Memory and Visual Reproduction and Logical Memory and Designs), which can be used to estimate the Immediate, Delayed, Auditory and Visual Memory Indices. All short forms showed good reliability coefficients. As expected, for adults (16-69 years old) the 3-subtest short form was consistently more accurate (predictive accuracy ranged from 73% to 100%) than both 2-subtest short forms (range = 61%-80%). Furthermore, for older adults (65-90 years old), the predictive accuracy of the 2-subtest short form ranged from 75% to 100%. These results suggest that caution is warranted when using the WMS-IV-NL Flexible Approach short forms to estimate all four indices. © The Author(s) 2015.

  18. A history of the American Society for Clinical Investigation

    Science.gov (United States)

    Howell, Joel D.

    2009-01-01

    One hundred years ago, in 1909, the American Society for Clinical Investigation (ASCI) held its first annual meeting. The founding members based this new society on a revolutionary approach to research that emphasized newer physiological methods. In 1924 the ASCI started a new journal, the Journal of Clinical Investigation. The ASCI has also held an annual meeting almost every year. The society has long debated who could be a member, with discussions about whether members must be physicians, what sorts of research they could do, and the role of women within the society. The ASCI has also grappled with what else the society should do, especially whether it ought to take a stand on policy issues. ASCI history has reflected changing social, political, and economic contexts, including several wars, concerns about the ethics of biomedical research, massive increases in federal research funding, and an increasingly large and specialized medical environment. PMID:19348041

  19. 59th Medical Wing Clinical Research Division Clinical Investigations Program Posters (Count: 2)

    Science.gov (United States)

    2017-05-08

    Investigations Program Posters (Count: 2) presented at/published to Graduate School Faculty Development and Research Symposium, Gateway Club, JBSA...copy of your abstract, paper. poster and other supporting documentation. 5. Save and forward, via email, the processing form and all supporting...you a final letter of approval or disapproval. g, Once your manuscript, poster or presentation has been approved for a one-lime public release, you may

  20. The "Measuring Outcomes of Clinical Connectivity" (MOCC) trial: investigating data entry errors in the Electronic Primary Care Research Network (ePCRN).

    Science.gov (United States)

    Fontaine, Patricia; Mendenhall, Tai J; Peterson, Kevin; Speedie, Stuart M

    2007-01-01

    The electronic Primary Care Research Network (ePCRN) enrolled PBRN researchers in a feasibility trial to test the functionality of the network's electronic architecture and investigate error rates associated with two data entry strategies used in clinical trials. PBRN physicians and research assistants who registered with the ePCRN were eligible to participate. After online consent and randomization, participants viewed simulated patient records, presented as either abstracted data (short form) or progress notes (long form). Participants transcribed 50 data elements onto electronic case report forms (CRFs) without integrated field restrictions. Data errors were analyzed. Ten geographically dispersed PBRNs enrolled 100 members and completed the study in less than 7 weeks. The estimated overall error rate if field restrictions had been applied was 2.3%. Participants entering data from the short form had a higher rate of correctly entered data fields (94.5% vs 90.8%, P = .004) and significantly more error-free records (P = .003). Feasibility outcomes integral to completion of an Internet-based, multisite study were successfully achieved. Further development of programmable electronic safeguards is indicated. The error analysis conducted in this study will aid design of specific field restrictions for electronic CRFs, an important component of clinical trial management systems.

  1. Staphylococcus aureus Clinical Isolates: Antibiotic Susceptibility, Molecular Characteristics, and Ability to Form Biofilm

    Directory of Open Access Journals (Sweden)

    N. Indrawattana

    2013-01-01

    Full Text Available Periodic monitoring of Staphylococcus aureus characteristics in a locality is imperative as their drug-resistant variants cause treatment problem. In this study, antibiograms, prevalence of toxin genes (sea-see, seg-ser, seu, tsst-1, eta, etb, and etd, PFGE types, accessory gene regulator (agr groups, and ability to form biofilm of 92 S. aureus Thailand clinical isolates were investigated. They were classified into 10 drug groups: groups 1–7 (56 isolates were methicillin resistant (MRSA and 8–10 (36 isolates were methicillin sensitive (MSSA. One isolate did not have any toxin gene, 4 isolates carried one toxin gene (seq, and 87 isolates had two or more toxin genes. No isolate had see, etb, or tsst-1; six isolates had eta or etd. Combined seg-sei-sem-sen-seo of the highly prevalent egc locus was 26.1%. The seb, sec, sel, seu, and eta associated significantly with MSSA; sek was more in MRSA. The sek-seq association was 52.17% while combined sed-sej was not found. Twenty-three PFGE types were revealed, no association of toxin genes with PFGE types. All four agr groups were present; agr group 1 was predominant (58.70% but agr group 2 strains carried more toxin genes and were more frequent toxin producers. Biofilm formation was found in 72.83% of the isolates but there was no association with antibiograms. This study provides insight information on molecular and phenotypic markers of Thailand S. aureus clinical isolates which should be useful for future active surveillance that aimed to control a spread of existing antimicrobial resistant bacteria and early recognition of a newly emerged variant.

  2. Investigation of Clinical Characteristics and Etiological Factors in Children with Molar Incisor Hypomineralization

    Science.gov (United States)

    Giuca, Maria Rita; Cappè, Maria; Carli, Elisabetta; Lardani, Lisa

    2018-01-01

    Aim The purpose of the present study was to evaluate the clinical defects and etiological factors potentially involved in the onset of MIH in a pediatric sample. Methods 120 children, selected from the university dental clinic, were included: 60 children (25 boys and 35 girls; average age: 9.8 ± 1.8 years) with MIH formed the test group and 60 children (27 boys and 33 girls; average age: 10.1 ± 2 years) without MIH constituted the control group. Distribution and severity of MIH defects were evaluated, and a questionnaire was used to investigate the etiological variables; chi-square, univariate, and multivariate statistical tests were performed (significance level set at p MIH defects: 55 molars and 75 incisors showed mild defects, 91 molars and 20 incisors had moderate lesions, and 40 molars and 3 incisors showed severe lesions. Univariate and multivariate statistical analysis showed a significant association (p MIH and ear, nose, and throat (ENT) disorders and the antibiotics used during pregnancy (0.019). Conclusions Moderate defects were more frequent in the molars, while mild lesions were more frequent in the incisors. Antibiotics used during pregnancy and ENT may be directly involved in the etiology of MIH in children. PMID:29861729

  3. Investigation of an Alternative Fuel Form for the Liquid Salt Cooled Very High Temperature Reactor (LS-VHTR)

    International Nuclear Information System (INIS)

    Casino, William A. Jr.

    2006-01-01

    Much of the recent studies investigating the use of liquid salts as reactor coolants have utilized a core configuration of graphite prismatic fuel block assemblies with TRISO particles embedded into cylindrical fuel compacts arranged in a triangular pitch lattice. Although many calculations have been performed for this fuel form in gas cooled reactors, it would be instructive to investigate whether an alternative fuel form may yield improved performance for the liquid salt-cooled Very High Temperature Reactor (LS-VHTR). This study investigates how variations in the fuel form will impact the performance of the LS-VHTR during normal and accident conditions and compares the results with a similar analysis that was recently completed for a LS-VHTR core made up of prismatic block fuel. (author)

  4. Plan for glass waste form testing for NNWSI [Nevada Nuclear Waste Storage Investigations

    International Nuclear Information System (INIS)

    Aines, R.D.

    1987-09-01

    The purpose of glass waste form testing is to determine the rate of release of radionuclides from breached glass waste containers. This information will be used to qualify glass waste forms with respect to the release requirements. It will be the basis of the source term from glass waste for repository performance assessment modeling. This information will also serve as part of the source term in the calculation of cumulative releases after 100,000 years in the site evaluation process. It will also serve as part of the source term input for calculation of cumulative releases to the accessible environment for 10,000 years after disposal, to determine compliance with EPA regulations. This investigation will provide data to resolve information needs. Information about the waste forms which is provided by the producer will be accumulated and evaluated; the waste form will be tested, properties determined, and mechanisms of degradation determined; and models providing long-term evaluation of release rates designed and tested. 23 refs

  5. Re-examining psychometric properties of the Turkish form of the Guilt Inventory in a non-clinical and depression sample (Turkish

    Directory of Open Access Journals (Sweden)

    Burçin Akın

    2018-03-01

    Full Text Available Object: In the most general sense, guilt is conceptualized as a strong, intense and negative emotion that quickly emerges when people do not live up according to internal values, judgements and social standards or violate them. The aim of the present study was to investigate the factor structure of Guilt Inventory that developed by Kugler and Jones with confirmatory and explanatory factor analyses and reevaluate the psychometric properties of the new Turkish form in depression and non-clinical samples. Methods: For this purpose, 448 university students, 107 healthy controls and 56 adults diagnosed with depression were asked to fill out the questionnaire set consisted of the Guilt Inventory, Beck Depression Inventory, Disgust Scale- Revised Form and The State-Trait Anxiety Inventory-State Anxiety Form.Results: According to the results, original form of Guilt Inventory did not work at the desired level in Turkish culture. Confirmatory and exploratory factor analyzes revealed that the new form with 35 items and 3 subscales works much more appropriately. The analyses of group comparison and correlations with other scales indicated that Turkish version of the Guilt Inventory had satisfactory convergent, divergent and criterion validity. Additively, internal consistency, item-total correlations and Guttman split-half reliability coefficients showed that the Turkish form of Guilt Inventory had good reliability values which were comparable to the original version of the scale. Discussion: In conclusion, results revealed that the Turkish version of Guilt Inventory is a reliable and valid measurement tool.

  6. A clinical and investigational study of donovanosis

    Directory of Open Access Journals (Sweden)

    Veeranna S

    2003-03-01

    Full Text Available A clinical and investigational study of 25 cases of Donovanosis was undertaken. The incidence was found to be 1.53% of all STD cases and 2.9% of GUD. M:F ratio was 2.12:1. Incidence was more in unmarried people. Fleshy exuberant type was seen in 88% of cases. Two patients (8% had extragenital ulcers. Donovan bodies were found in 88%. Pseudo elephantiasis was seen in 8 patients. Biopsy was done in 8 cases and showed ocanthosis, plasma cell infiltration and pseudo epitheliomatous hyperplasia. One patient developed squamous cell carcinoma of vulva.

  7. Clinical manifestations and computed tomography of the pseudovascular form of metastatic brain tumor

    International Nuclear Information System (INIS)

    Kurimoto, Tadahisa; Mizuno, Makoto; Tani, Sadayasu; Miki, Kazuhito; Kawamura, Yasuo; Matsumura, Hiroshi

    1982-01-01

    Forty-two cases of metastatic brain tumor were subdivided into 3 groups (acute, subacute, and chronic) from their mode of the onset of symptoms and signs. The clinical symptoms and signs and the computed tomogram were all analyzed and compared with each other. The acute form was found in 14 cases (33%), of which 7% (3 cases) were seizures and 26% (11 cases) were acute neurological deficits, including hemorrhages from tumors (3 cases, 7%). There were no significant differences in their age, sex, or primary lesions. The characteristic course of the acute form, other than seizure and hemorrhage, involved acutely and progressively developing neurological symptoms, symptoms and signs of increased intracranial pressure were rare. In computed tomogram, the solitary metastasis in the parietal and occipital lesions was much more in the acute form than in other forms, and the perifocal low-density area showed a tendency to be larger than the other forms. In these cases, acute symptoms and signs appeared to occur easily when perifocal edema was joined in the above locations. The pathogenesis of acute neurological symptoms and signs other than seizure and hemorrhage is unclear. We suggest that the location of a tumor and peritumoral edema be important factors in causing acute symptoms and signs, but, in addition to that, abrupt hemodynamic changes in the peritumoral edema may also be of importance. (J.P.N.)

  8. Novel Aminoglycoside Resistance Transposons and Transposon-Derived Circular Forms Detected in Carbapenem-Resistant Acinetobacter baumannii Clinical Isolates

    Science.gov (United States)

    Dwibedi, Chinmay Kumar; Sjöström, Karin; Edquist, Petra; Wai, Sun Nyunt; Uhlin, Bernt Eric

    2016-01-01

    Acinetobacter baumannii has emerged as an important opportunistic pathogen equipped with a growing number of antibiotic resistance genes. Our study investigated the molecular epidemiology and antibiotic resistance features of 28 consecutive carbapenem-resistant clinical isolates of A. baumannii collected throughout Sweden in 2012 and 2013. The isolates mainly belonged to clonal complexes (CCs) with an extensive international distribution, such as CC2 (n = 16) and CC25 (n = 7). Resistance to carbapenems was related to blaOXA-23 (20 isolates), blaOXA-24/40-like (6 isolates), blaOXA-467 (1 isolate), and ISAba1-blaOXA-69 (1 isolate). Ceftazidime resistance was associated with blaPER-7 in the CC25 isolates. Two classical point mutations were responsible for resistance to quinolones in all the isolates. Isolates with high levels of resistance to aminoglycosides carried the 16S rRNA methylase armA gene. The isolates also carried a variety of genes encoding aminoglycoside-modifying enzymes. Several novel structures involved in aminoglycoside resistance were identified, including Tn6279, ΔTn6279, Ab-ST3-aadB, and different assemblies of Tn6020 and TnaphA6. Importantly, a number of circular forms related to the IS26 or ISAba125 composite transposons were detected. The frequent occurrence of these circular forms in the populations of several isolates indicates a potential role of these circular forms in the dissemination of antibiotic resistance genes. PMID:26824943

  9. Clinical trials using a radiopharmaceutical investigational drug: What legal environment and what authorizations required?

    International Nuclear Information System (INIS)

    El-Deeb, G.; Nguon, B.; Tibi, A.; Rizzo-Padoin, N.

    2009-01-01

    Recent revision of the legal environment for clinical research in France provided an opportunity to review what a hospital needs to carry out clinical trials using a radiopharmaceutical investigational drug. Legal measures concerning radiopharmaceutical investigational drugs are indeed more complex than those of classical clinical trials because of the additional legal provisions governing the use of ionizing radiation. Thus, requirements by the concerned staff (sponsor, pharmacist, person in charge of the nuclear activity) are described here. (authors) [fr

  10. Clinical dosimetry in photon radiotherapy. A Monte Carlo based investigation

    International Nuclear Information System (INIS)

    Wulff, Joerg

    2010-01-01

    -Attix theory with corresponding perturbation factors is valid. A further investigation of these conditions when measuring dose profiles was used to determine the type of detector with minimal change in response for regions of charged particle dis-equilibrium and high dose gradients. In terms of penumbra broadening, radiochromic film shows the smallest deviation from dose to water. Monte Carlo simulations will replace or at least extend the existing data in clinical dosimetry protocols in order to reduce the uncertainty in radiotherapy. For corrections under non-reference conditions as occuring in modern radiotherapy techniques, Monte Carlo calculations will be a crucial part. This work and the developed methods accordingly form an important step towards reduced uncertainties in radiotherapy for cancer treatment.

  11. System of automated processing of radionuclide investigations (SAPRI-01) in clinical practice

    International Nuclear Information System (INIS)

    Sivachenko, T.P.; Mechev, D.S.; Krupka, I.N.

    1988-01-01

    The author described the results of clinical testing of a system SAPRI-01 designed for automated collection, storage and processing of data on radionuclide investigations. He gave examples of automated processing of RCG and the results of positive scintigraphy of tumors of different sites using 67 Ga-citrate and 99m Tc pertechnetate in statistical and dynamic investigations. Short-comings and ways for updating 4 the system during its serial production were pointed out. The introduction of the system into clinical practice on a wide scale was shown to hold promise

  12. Mobile electronic versus paper case report forms in clinical trials: a randomized controlled trial.

    Science.gov (United States)

    Fleischmann, Robert; Decker, Anne-Marie; Kraft, Antje; Mai, Knut; Schmidt, Sein

    2017-12-01

    Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity. This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics. All randomized patients were included in the study (eCRF group n = 13, pCRF group n = 14). eCRF, as compared to pCRF, data collection was associated with significant time savings  across all conditions (8.29 ± 5.15 min vs. 10.54 ± 6.98 min, p = .047). This effect was not defined by participant type, i.e. patients or study nurses (F (1,112)  = .15, p = .699), CRF length (F (2,112)  = .49, p = .609) or patient age (Beta = .09, p = .534). Additional 5.16 ± 2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was

  13. GCP compliance and readability of informed consent forms from an emerging hub for clinical trials

    Directory of Open Access Journals (Sweden)

    Satish Chandrasekhar Nair

    2015-01-01

    Full Text Available Background: The rapid expansion of trials in emerging regions has raised valid concerns about research subject protection, particularly related to informed consent. The purpose of this study is to assess informed consent form (ICF compliance with Good Clinical Practice (GCP guidelines and the readability easeof the ICFs in Abu Dhabi, a potential destination for clinical trials in the UAE. Materials and Methods: A multicenter retrospective cross-sectional analysis of 140 ICFs from industry sponsored and non-sponsored studies was conducted by comparing against a local standard ICF. Flesch-Kincaid Reading Scale was used to assess the readability ease of the forms. Results: Non-sponsored studies had signifi cantly lower overall GCP compliance of 55.8% when compared to 79.5% for industry sponsored studies. Only 33% of sponsored and 16% of non-sponsored studies included basic information on the participants′ rights and responsibilities. Flesch-Kincaid Reading ease score for the informed consent forms from industry sponsored studies was signifi cantly higher 48.9 ± 4.8 as compared to 38.5 ± 8.0 for non-sponsored studies, though both were more complex than recommended. Reading Grade Level score was also higher than expected, but scores for the ICFs from the industry sponsored studies were 9.7 ± 0.7, signifi cantly lower as compared to 12.2 ± 1.3 for non-sponsored studies. Conclusion: In spite of the undisputed benefits of conducting research in emerging markets readability, comprehension issues and the lack of basic essential information call for improvements in the ICFs to protect the rights of future research subjects enrolled in clinical trials in the UAE.

  14. qPCR detection of Mycobacterium leprae in biopsies and slit skin smear of different leprosy clinical forms

    Directory of Open Access Journals (Sweden)

    Michelle de Campos Soriani Azevedo

    2017-01-01

    Full Text Available Leprosy, whose etiological agent is Mycobacterium leprae, is a chronic infectious disease that mainly affects the skin and peripheral nervous system. The diagnosis of leprosy is based on clinical evaluation, whereas histopathological analysis and bacilloscopy are complementary diagnostic tools. Quantitative PCR (qPCR, a current useful tool for diagnosis of infectious diseases, has been used to detect several pathogens including Mycobacterium leprae. The validation of this technique in a robust set of samples comprising the different clinical forms of leprosy is still necessary. Thus, in this study samples from 126 skin biopsies (collected from patients on all clinical forms and reactional states of leprosy and 25 slit skin smear of leprosy patients were comparatively analyzed by qPCR (performed with primers for the RLEP region of M. leprae DNA and routine bacilloscopy performed in histological sections or in slit skin smear. Considering clinical diagnostic as the gold standard, 84.9% of the leprosy patients were qPCR positive in skin biopsies, resulting in 84.92% sensitivity, with 84.92 and 61.22% positive (PPV and negative (NPV predictive values, respectively. Concerning bacilloscopy of histological sections (BI/H, the sensitivity was 80.15% and the PPV and NPV were 80.15 and 44.44%, respectively. The concordance between qPCR and BI/H was 87.30%. Regarding the slit skin smear, 84% of the samples tested positive in the qPCR. Additionally, qPCR showed 100% specificity, since all samples from different mycobacteria, from healthy individuals, and from other granulomatous diseases presented negative results. In conclusion, the qPCR technique for detection of M. leprae using RLEP primers proved to be specific and sensitive, and qPCR can be used as a complementary test to diagnose leprosy irrespective of the clinical form of disease.

  15. qPCR detection of Mycobacterium leprae in biopsies and slit skin smear of different leprosy clinical forms.

    Science.gov (United States)

    Azevedo, Michelle de Campos Soriani; Ramuno, Natália Mortari; Fachin, Luciana Raquel Vincenzi; Tassa, Mônica; Rosa, Patrícia Sammarco; Belone, Andrea de Faria Fernandes; Diório, Suzana Madeira; Soares, Cleverson Teixeira; Garlet, Gustavo Pompermaier; Trombone, Ana Paula Favaro

    Leprosy, whose etiological agent is Mycobacterium leprae, is a chronic infectious disease that mainly affects the skin and peripheral nervous system. The diagnosis of leprosy is based on clinical evaluation, whereas histopathological analysis and bacilloscopy are complementary diagnostic tools. Quantitative PCR (qPCR), a current useful tool for diagnosis of infectious diseases, has been used to detect several pathogens including Mycobacterium leprae. The validation of this technique in a robust set of samples comprising the different clinical forms of leprosy is still necessary. Thus, in this study samples from 126 skin biopsies (collected from patients on all clinical forms and reactional states of leprosy) and 25 slit skin smear of leprosy patients were comparatively analyzed by qPCR (performed with primers for the RLEP region of M. leprae DNA) and routine bacilloscopy performed in histological sections or in slit skin smear. Considering clinical diagnostic as the gold standard, 84.9% of the leprosy patients were qPCR positive in skin biopsies, resulting in 84.92% sensitivity, with 84.92 and 61.22% positive (PPV) and negative (NPV) predictive values, respectively. Concerning bacilloscopy of histological sections (BI/H), the sensitivity was 80.15% and the PPV and NPV were 80.15 and 44.44%, respectively. The concordance between qPCR and BI/H was 87.30%. Regarding the slit skin smear, 84% of the samples tested positive in the qPCR. Additionally, qPCR showed 100% specificity, since all samples from different mycobacteria, from healthy individuals, and from other granulomatous diseases presented negative results. In conclusion, the qPCR technique for detection of M. leprae using RLEP primers proved to be specific and sensitive, and qPCR can be used as a complementary test to diagnose leprosy irrespective of the clinical form of disease. Copyright © 2016 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

  16. Readability of informed consent forms in clinical trials conducted in a skin research center

    Science.gov (United States)

    Samadi, Aniseh; Asghari, Fariba

    2016-01-01

    Obtaining informed consents is one of the most fundamental principles in conducting a clinical trial. In order for the consent to be informed, the patient must receive and comprehend the information appropriately. Complexity of the consent form is a common problem that has been shown to be a major barrier to comprehension for many patients. The objective of this study was to assess the readability of different templates of informed consent forms (ICFs) used in clinical trials in the Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran, Iran. This study was conducted on ICFs of 45 clinical trials of the CRTSDL affiliated with Tehran University of Medical Sciences. ICFs were tested for reading difficulty, using the readability assessments formula adjusted for the Persian language including the Flesch–Kincaid reading ease score, Flesch–Kincaid grade level, and Gunning fog index. Mean readability score of the whole text of ICFs as well as their 7 main information parts were calculated. The mean ± SD Flesch Reading Ease score for all ICFs was 31.96 ± 5.62 that is in the difficult range. The mean ± SD grade level was calculated as 10.71 ± 1.8 (8.23–14.09) using the Flesch–Kincaid formula and 14.64 ± 1.22 (12.67–18.27) using the Gunning fog index. These results indicate that the text is expected to be understandable for an average student in the 11th grade, while the ethics committee recommend grade level 8 as the standard readability level for ICFs. The results showed that the readability scores of ICFs assessed in our study were not in the acceptable range. This means they were too complex to be understood by the general population. Ethics committees must examine the simplicity and readability of ICFs used in clinical trials. PMID:27471590

  17. Investigating Resulting Residual Stresses during Mechanical Forming Process

    Science.gov (United States)

    Akinlabi, Stephen A.; Fatoba, Olawale S.; Mashinini, Peter M.; Akinlabi, Esther T.

    2018-03-01

    Most manufacturing processes such as machining, welding, heat treatment, laser forming, laser cladding and, laser metal deposition, etc. are subjected to a form of heat or energy to change the geometrical shape thus changing the inherent engineering and structural properties of the material. These changes often cause the development of locked up stresses referred to as residual stresses as a result of these activities. This study reports on the residual stresses developed due to the mechanical forming process to maintain a suitable structural integrity for the formed components. The result of the analysis through the X-ray diffraction confirmed that residual stresses were induced in the manufactured parts and further revealed that residual stresses were compressive in nature as found in the parent material but with values less than the parent material.

  18. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Science.gov (United States)

    2013-02-26

    ... marketing applications, (2) what is meant by ``due diligence'' in obtaining financial disclosures from...: Financial Disclosure by Clinical Investigators; Availability AGENCY: Food and Drug Administration, HHS... guidance entitled ``Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

  19. Investigation of Clinical Characteristics and Etiological Factors in Children with Molar Incisor Hypomineralization

    Directory of Open Access Journals (Sweden)

    Maria Rita Giuca

    2018-01-01

    Full Text Available Aim. The purpose of the present study was to evaluate the clinical defects and etiological factors potentially involved in the onset of MIH in a pediatric sample. Methods. 120 children, selected from the university dental clinic, were included: 60 children (25 boys and 35 girls; average age: 9.8 ± 1.8 years with MIH formed the test group and 60 children (27 boys and 33 girls; average age: 10.1 ± 2 years without MIH constituted the control group. Distribution and severity of MIH defects were evaluated, and a questionnaire was used to investigate the etiological variables; chi-square, univariate, and multivariate statistical tests were performed (significance level set at p<0.05. Results. A total of 186 molars and 98 incisors exhibited MIH defects: 55 molars and 75 incisors showed mild defects, 91 molars and 20 incisors had moderate lesions, and 40 molars and 3 incisors showed severe lesions. Univariate and multivariate statistical analysis showed a significant association (p<0.05 between MIH and ear, nose, and throat (ENT disorders and the antibiotics used during pregnancy (0.019. Conclusions. Moderate defects were more frequent in the molars, while mild lesions were more frequent in the incisors. Antibiotics used during pregnancy and ENT may be directly involved in the etiology of MIH in children.

  20. Diagnostic investigation of patients with chronic polyneuropathy: evaluation of a clinical guideline

    NARCIS (Netherlands)

    Rosenberg, N. R.; Portegies, P.; de Visser, M.; Vermeulen, M.

    2001-01-01

    OBJECTIVE: (1) To evaluate a clinical guideline for the diagnostic investigation of patients presenting with signs and symptoms (present for longer than 6 weeks) suggesting a chronic polyneuropathy. (2) To investigate the contribution of electrophysiological studies to a focused search for aetiology

  1. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Science.gov (United States)

    2011-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0790] Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

  2. Methodology Series Module 9: Designing Questionnaires and Clinical Record Forms – Part II

    Science.gov (United States)

    Setia, Maninder Singh

    2017-01-01

    This article is a continuation of the previous module on designing questionnaires and clinical record form in which we have discussed some basic points about designing the questionnaire and clinical record forms. In this section, we will discuss the reliability and validity of questionnaires. The different types of validity are face validity, content validity, criterion validity, and construct validity. The different types of reliability are test-retest reliability, inter-rater reliability, and intra-rater reliability. Some of these parameters are assessed by subject area experts. However, statistical tests should be used for evaluation of other parameters. Once the questionnaire has been designed, the researcher should pilot test the questionnaire. The items in the questionnaire should be changed based on the feedback from the pilot study participants and the researcher's experience. After the basic structure of the questionnaire has been finalized, the researcher should assess the validity and reliability of the questionnaire or the scale. If an existing standard questionnaire is translated in the local language, the researcher should assess the reliability and validity of the translated questionnaire, and these values should be presented in the manuscript. The decision to use a self- or interviewer-administered, paper- or computer-based questionnaire depends on the nature of the questions, literacy levels of the target population, and resources. PMID:28584367

  3. Time perspective in hereditary cancer: psychometric properties of a short form of the Zimbardo Time Perspective Inventory in a community and clinical sample.

    Science.gov (United States)

    Wakefield, Claire E; Homewood, Judi; Taylor, Alan; Mahmut, Mehmet; Meiser, Bettina

    2010-10-01

    We aimed to assess the psychometric properties of a 25-item short form of the Zimbardo Time Perspective Inventory in a community sample (N = 276) and in individuals with a strong family history of cancer, considering genetic testing for cancer risk (N = 338). In the community sample, individuals with high past-negative or present-fatalistic scores had higher levels of distress, as measured by depression, anxiety, and aggression. Similarly, in the patient sample, past-negative time perspective was positively correlated with distress, uncertainty, and postdecision regret when making a decision about genetic testing. Past-negative-oriented individuals were also more likely to be undecided about, or against, genetic testing. Hedonism was associated with being less likely to read the educational materials they received at their clinic, and fatalism was associated with having lower knowledge levels about genetic testing. The assessment of time perspective in individuals at increased risk of cancer can provide valuable clinical insights. However, further investigation of the psychometric properties of the short form of this scale is warranted, as it did not meet the currently accepted criteria for psychometric validation studies.

  4. Correlation of Diffusion and Metabolic Alterations in Different Clinical Forms of Multiple Sclerosis

    Science.gov (United States)

    Hannoun, Salem; Bagory, Matthieu; Durand-Dubief, Francoise; Ibarrola, Danielle; Comte, Jean-Christophe; Confavreux, Christian; Cotton, Francois; Sappey-Marinier, Dominique

    2012-01-01

    Diffusion tensor imaging (DTI) and MR spectroscopic imaging (MRSI) provide greater sensitivity than conventional MRI to detect diffuse alterations in normal appearing white matter (NAWM) of Multiple Sclerosis (MS) patients with different clinical forms. Therefore, the goal of this study is to combine DTI and MRSI measurements to analyze the relation between diffusion and metabolic markers, T2-weighted lesion load (T2-LL) and the patients clinical status. The sensitivity and specificity of both methods were then compared in terms of MS clinical forms differentiation. MR examination was performed on 71 MS patients (27 relapsing remitting (RR), 26 secondary progressive (SP) and 18 primary progressive (PP)) and 24 control subjects. DTI and MRSI measurements were obtained from two identical regions of interest selected in left and right centrum semioval (CSO) WM. DTI metrics and metabolic contents were significantly altered in MS patients with the exception of N-acetyl-aspartate (NAA) and NAA/Choline (Cho) ratio in RR patients. Significant correlations were observed between diffusion and metabolic measures to various degrees in every MS patients group. Most DTI metrics were significantly correlated with the T2-LL while only NAA/Cr ratio was correlated in RR patients. A comparison analysis of MR methods efficiency demonstrated a better sensitivity/specificity of DTI over MRSI. Nevertheless, NAA/Cr ratio could distinguish all MS and SP patients groups from controls, while NAA/Cho ratio differentiated PP patients from controls. This study demonstrated that diffusivity changes related to microstructural alterations were correlated with metabolic changes and provided a better sensitivity to detect early changes, particularly in RR patients who are more subject to inflammatory processes. In contrast, the better specificity of metabolic ratios to detect axonal damage and demyelination may provide a better index for identification of PP patients. PMID:22479330

  5. An interactive data management and analysis system for clinical investigators.

    Science.gov (United States)

    Groner, G F; Hopwood, M D; Palley, N A; Sibley, W L; Baker, W R; Christopher, T G; Thompson, H K

    1978-09-01

    An interactive minicomputer-based system has been developed that enables the clinical research investigator to personally explore and analyze his research data and, as a consequence of these explorations, to acquire more information. This system, which does not require extensive training or computer programming, enables the investigator to describe his data interactively in his own terms, enter data values while having them checked for validity, store time-oriented patient data in a carefully controlled on-line data base, retrieve data by patient, variable, and time, create subsets of patients with common characteristics, perform statistical analyses, and produce tables and graphs. It also permits data to be transferred to and from other computers. The system is well accepted and is being used by a variety of medical specialists at the three clinical research centers where it is operational. Reported benefits include less elapsed and nonproductive time, more thorough analysis of more data, greater and earlier insight into the meaning of research data, and increased publishable results.

  6. Direct and indirect forms of childhood maltreatment and nonsuicidal self-injury among clinically-referred children and youth.

    Science.gov (United States)

    Armiento, Jenna; Hamza, Chloe A; Stewart, Shannon L; Leschied, Alan

    2016-08-01

    Although exposure to direct forms of childhood maltreatment is among the most widely studied risk factors for nonsuicidal self-injury (NSSI), research on NSSI has largely overlooked the role of exposure to indirect forms of child maltreatment (i.e., witnessing domestic violence). To address this gap in the literature, the present study examined associations among both direct and indirect forms of child maltreatment and NSSI among clinically-referred children and youth. Data was collected using the interRAI Child and Youth Mental Health Assessment (ChYMH) at ten mental health agencies. The ChYMH is a comprehensive standardized clinical assessment tool completed by trained assessors using multiple sources. The study included a convenience sample of 747 children and youth (68% male) between ages 8-18 with complex mental health histories referred for inpatient or outpatient care in Ontario, Canada. Univariate chi-square analyses indicated positive associations with NSSI and both direct (i.e., physical, sexual) and indirect child maltreatment (i.e., witnessing domestic violence). In a binary multivariate logistic regression analysis controlling for participant age and sex, only exposure to indirect child maltreatment emerged as multivariate predictor of NSSI. The sample was limited to only 10 mental health agencies and only consenting parents/guardians referred to mental health services suggesting the study may not be generalizable to all clinical samples. The present study provides evidence that witnessing domestic violence in childhood is an important risk factor for NSSI. Clinical relevance includes implications for clinicians to develop targeted intervention and prevention strategies for NSSI for children who have witnessed domestic violence. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

    Science.gov (United States)

    Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

    2016-12-15

    Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

  8. Clinical assessment of early language development: a simplified short form of the Mandarin communicative development inventory.

    Science.gov (United States)

    Soli, Sigfrid D; Zheng, Yun; Meng, Zhaoli; Li, Gang

    2012-09-01

    The purpose of this study was to develop a practical mean for clinical evaluation of early pediatric language development by establishing developmental trajectories for receptive and expressive vocabulary growth in children between 6 and 32 months of age using a simple, time-efficient assessment tool. Simplified short form versions of the Words and Gestures and Words and Sentences vocabulary inventories in the Mandarin Communicative Development Inventory [1] were developed and used to assess early language development in developmentally normal children from 6 to 32 months of age during routine health checks. Developmental trajectories characterizing the rate of receptive and expressive vocabulary growth between 6 and 32 months of age are reported. These trajectories allow the equivalent age corresponding to a score to be determined after a brief structured interview with the child's parents that can be conducted in a busy clinical setting. The simplified short forms of the Mandarin Communicative Development Inventories can serve as a clinically useful tool to assess early child language development, providing a practical mean of objectively assessing early language development following early interventions to treat young children with hearing impairment as well as speech and language delays. Objective evidence of language development is essential for achievement of effective (re)habilitation outcomes. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  9. Anatomical-clinical investigations of variations of the human coronary arteries

    OpenAIRE

    Aida Hasanović; Faruk Dilberović; Fehim Ovčina

    2003-01-01

    Variations of the human coronary arteries have always attracted the attention of many researchers. A review of the literature shows that variations can cause ischemic heart disease or sudden cardiac death. The aim of the investigations was to examine the existence and clinical significance of variations of the human coronary arteries. Special attention has been focused on myocardial bridging of the coronary arteries and coronary arteriovenous fistula. Our investigations were carried out on th...

  10. Numerical and experimental investigation of stretch-flange forming

    International Nuclear Information System (INIS)

    Cinotti, N.; Shakeri, H.R.; Worswick, M.J.; Truttmann, S.; Finn, M.J.; Jain, M.; Lloyd, D.J.

    2000-01-01

    Simulations of stretch flange forming operations are undertaken using explicit dynamic finite element calculations incorporating anisotropic yield criteria. Simple circular stretch flanges utilizing a single circular punch to expand the cut-out were considered. Experiments were performed using 101mm diameter tooling on AA 5754 and AA 5182 aluminum alloy sheets, with varying cut-out and gauge size. Metallurgical aspects of the formability of these aluminum alloys and damage mechanisms were studied. Both optical and Scanning Electron Microscopy (SEM) were used to study ductile fracture behaviour in these materials during the forming operation. The limit strains obtained from the circular stretch flange formability experiments are compared to forming limit diagram (FLD) data from hemispherical dome specimens. (author)

  11. Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

    Science.gov (United States)

    Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

    2006-05-01

    To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

  12. 75 FR 31794 - Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked...

    Science.gov (United States)

    2010-06-04

    ... various blocks within the form, and when the form might need to be updated. In addition, we clarify... outside the United States that may or may not be under an investigational new drug application. This... guidance represents the agency's current thinking on completing the Form FDA 1572. It does not create or...

  13. Naa Technique for Clinical Investigation of Mice Immunized with BOTHROP Venom

    Science.gov (United States)

    Zamboni, C. B.; Aguiar, R. O.; Kovacs, L.; Suzuki, M.; Sant'Anna, O. A.

    2009-06-01

    In the present study Neutron Activation Analysis (NAA) technique was used to determine sodium concentration in whole blood of mice immunized with Bothrops venom. With this value it was possible to perform clinical investigation in this animal model using whole blood.

  14. Clinical investigation of 14C-urea breath test

    International Nuclear Information System (INIS)

    Yu Yongli; Zhu Ruisen; Ji Hong; Luo Quanyong

    2000-01-01

    To investigate clinical value of 14 C-urea breath test ( 14 C-UBT) for the diagnosis of Helicobacter pylori(Hp), 70 patients were both performed gastroscopy (taking gastric mucosae biopsy for rapid urease test and histology) and 14 C-UBT (some patients by Hp-IgG or DNAHp test also) within two days. The positive cases of both rapid urease test and histology was defined as 'gold standard' of Hp-positive, whereas the negative cases of both rapid urease test and histology as 'gold standard' of Hp-negative. The sensitivity of 14 C-UBT was 93.2%, the specificity 73.1%, and the diagnostic accuracy 85.7%. The difference (comparing with 'gold standard') was not marked (x 2 = 0.9 0.05(1) 2 = 3.84, P>0.05). But the diagnostic accuracy of 14 C-UBT (85.7%) and Hp-IgG (50%) had a marked difference (x 2 13.80>x 0.01(1) 2 = 6.64, P 14 C-UBT was easy to operate, reliable and suitable for clinical application

  15. How GPs implement clinical guidelines in everyday clinical practice

    DEFF Research Database (Denmark)

    Videbæk Le, Jette; Hansen, Helle P; Riisgaard, Helle

    2015-01-01

    BACKGROUND: Clinical guidelines are considered to be essential for improving quality and safety of health care. However, interventions to promote implementation of guidelines have demonstrated only partial effectiveness and the reasons for this apparent failure are not yet fully understood....... OBJECTIVE: To investigate how GPs implement clinical guidelines in everyday clinical practice and how implementation approaches differ between practices. METHODS: Individual semi-structured open-ended interviews with seven GPs who were purposefully sampled with regard to gender, age and practice form....... Interviews were recorded, transcribed verbatim and then analysed using systematic text condensation. RESULTS: Analysis of the interviews revealed three different approaches to the implementation of guidelines in clinical practice. In some practices the GPs prioritized time and resources on collective...

  16. Clinical investigation on RBE estimation for heavy particle radiotherapy

    International Nuclear Information System (INIS)

    Tsuji, Hiroshi; Kamada, Tadashi; Yanagi, Takeshi; Mizoe, Junetsu; Tsujii, Hirohiko

    2004-01-01

    Analysis of the clinical updated data of the prostate cancer patients treated with carbon-ions was performed for the purpose of investigating the clinical relative biological effectiveness (RBE) values of carbon ion beams. Most of the patients received the carbon ion radiotherapy (C-ion RT) with the dose of 66.0 GyE/20 fractions. Probabilities of the late urethral morbidity and biochemical tumor control with this dose fractionation were calculated using the actual updated clinical data. The linear energy transfer (LET) values and physical carbon ion doses of urethra were obtained from treatment planning data. RBE values were calculated from the ratio of average carbon physical doses and photon doses which cause the same grade of urethra reaction with the same probabilities. Obtained RBE values were compared with the values that are being used in actual carbon ion radiotherapy in National Institute of Radiological Sciences (NIRS). In addition, relative RBE of carbon ion beams for biochemical tumor control was calculated using the data from the literature. As a result, the RBE values being used for the treatment were thought to be proper enough for both the urethra reaction and tumor control. (author)

  17. Subclinical form of the American visceral leishmaniasis

    Directory of Open Access Journals (Sweden)

    Mônica Elinor Alves Gama

    2004-12-01

    Full Text Available The subclinical form of visceral leishmaniasis (VL shows nonspecific clinical manifestations, with difficulties being frequently met in its clinical characterization and diagnostic confirmation. Thus, the objective of the present study was to define the clinical-laboratory profile of this clinical form. A cohort study was conducted in the state of Maranhão, Brazil, from January/1998 to December/2000, with monthly follow-up of 784 children aged 0-5 years. Based on the clinical-laboratory parameters reported in the literature, four categories were established, with the children being classified (according to their clinical-evolutive behavior as asymptomatic (N = 144, as having the subclinical form (N = 33 or the acute form (N = 12 or as subjects "without VL" (N = 595. Multiple discriminant analysis demonstrated that the combination of fever, hepatomegaly, hyperglobulinemia, and increased blood sedimentation rate (BSR can predict the subclinical form of VL as long as it is not associated with splenomegaly or leukopenia. Subjects with the subclinical form did not show prolonged or intermittent evolution or progression to the acute form of VL. Subclinical cases have a profile differing from the remaining clinical forms of VL, being best characterized by the combination of fever, hepatomegaly, hyperglobulinemia, and increased BSR.

  18. Clinical Investigation.

    Science.gov (United States)

    1979-09-30

    Zbylski, LaRossa, Cullington: A Simple Method of Rapid Assessment of Malar Depression . Annals of Plastic Surgery, Aug 79. Urology Service Fauver, H.E...J.R.: ST Depression Suggesting Subendocardial Ischemia in Neonates with PDA. Presented: Eighth Annual Army Association of Cardiok yy tt,eting, Tacoma...79/100 Investigation of the Tumor Reduction Effect of Combined Sodium-L-Ascorbate and 5FU Chemotherapy in Transplanted B16 Melanoma of Mice. (O

  19. Plan for spent fuel waste form testing for NNWSI [Nevada Nuclear Waste Storage Investigations

    International Nuclear Information System (INIS)

    Shaw, H.F.

    1987-11-01

    The purpose of spent fuel waste form testing is to determine the rate of release of radionuclides from failed disposal containers holding spent fuel, under conditions appropriate to the Nevada Nuclear Waste Storage Investigations (NNWSI) Project tuff repository. The information gathered in the activities discussed in this document will be used: to assess the performance of the waste package and engineered barrier system (EBS) with respect to the containment and release rate requirements of the Nuclear Regulatory Commission, as the basis for the spent fuel waste form source term in repository-scale performance assessment modeling to calculate the cumulative releases to the accessible environment over 10,000 years to determine compliance with the Environmental Protection Agency, and as the basis for the spent fuel waste form source term in repository-scale performance assessment modeling to calculate cumulative releases over 100,000 years as required by the site evaluation process specified in the DOE siting guidelines. 34 refs

  20. Long-term cryopreservation of non-spore-forming fungi in Microbank™ beads for plant pathological investigations.

    Science.gov (United States)

    Lakshman, Dilip K; Singh, Vimla; Camacho, Manuel E

    2018-05-01

    Long-term preservation of experimental fungi without genetic, morphological, and pathogenic changes is of paramount importance in mycological and plant pathological investigations. Several cryogenic and non-cryogenic methods are available for the preservation of fungi, but the methods can be cumbersome, hazardous, expensive, and often not suitable for long-term storage of non-spore-forming (sterile) fungi. A method of preservation of spore-forming fungi in commercially available porous beads (Micrbank™) under cryogenic condition was successfully tested for three non-spore-forming basidiomycetes genera: Rhizoctonia solani (teleomorph: Thanatephorus cucumeris) (n = 19), Ceratobasidium species (n = 1), and Waitea circinata (n = 3), and a non-spore forming ascomycetes, Sclerotinia sclerotiorum (n = 1). For comparison, spore-forming ascomycetous fungi, Alternaria alternata (n = 1), Bauveria basiana (n = 2), Botrytis cinerea (n = 1), Fusarium oxysporum f.sp. gladiolii (n = 1), Trichoderma spp. (n = 3), and Thielaviopsis basicola (n = 2) were also cryopreserved in Microbank beads. Viable fungal isolates of all test species were retrieved after five years of storage at -80 °C, which was longer than the viabilities of the corresponding isolates cryopreserved in agar plugs or colonized wheat seeds. Fungi revived from the Microbank beads maintained identical morphology and cultural characteristics of the parent isolates. Randomly selected Rhizoctonia isolates revived from the Microbank beads maintained respective pathological properties of the parent isolates; also, no mutation was detected in the internal transcribed spacer (ITS) ribosomal DNA when compared with respective cultures maintained at ambient temperature. This finding demonstrated the utility of cryopreservation in Microbank beads as a convenient alternative to conventional long-term preservation of a wide group of fungal cultures for plant pathological investigations

  1. Implications of gluten exposure period, CD clinical forms, and HLA typing in the association between celiac disease and dental enamel defects in children. A case-control study.

    Science.gov (United States)

    Majorana, Alessandra; Bardellini, Elena; Ravelli, Alberto; Plebani, Alessandro; Polimeni, Antonella; Campus, Guglielmo

    2010-03-01

    The association between coeliac disease (CD) and dental enamel defects (DED) is well known. The aim of this study was to investigate the prevalence of DED in children with CD and to specifically find the association of DED and gluten exposure period, CD clinical forms, HLA class II haplotype. This study was designed as a matched case-control study: 250 children were enrolled (125 coeliac children - 79 female and 46 male, 7.2 +/- 2.8 years and 125 healthy children). Data about age at CD diagnosis, CD clinical form, and HLA haplotype were recorded. Dental enamel defects were detected in 58 coeliac subjects (46.4%) against seven (5.6%) controls (P < 0.005). We found an association between DED and gluten exposure period, as among CD subjects the mean age at CD diagnosis was significantly (P = 0.0004) higher in the group with DED (3.41 +/- 1.27) than without DED (1.26 +/- 0.7). DED resulted more frequent (100%) in atypical and silent CD forms than in the typical one (30.93%). The presence of HLA DR 52-53 and DQ7antigens significantly increased the risk of DED (P = 0.0017) in coeliac children. Our results confirmed a possible correlation between HLA antigens and DED.

  2. [Non-commercial clinical trials--who will be the legal sponsor? Sponsorship of investigator-initiated clinical trials according to the German Drug Law].

    Science.gov (United States)

    Benninger-Döring, G; Boos, J

    2006-07-01

    Non-commercial clinical trials may be of great benefit to the patients concerned. The 12th amendment to the German Drug Law (AMG) changed legal liability of the initiators of investigator-initiated clinical trials with extensive consequences for traditional project leaders. The central point under discussion is the sponsor's responsibility according to the AMG. Presently leading management divisions of university hospitals and universities are developing proceedings to assume sponsor responsibility by institutions (institutional sponsorship), which should enable investigator-initiated clinical trials to be conducted according to legal requirements in the future. Detailed problems and special questions can only be resolved in a single-minded fashion, and if necessary political processes should be catalyzed.

  3. On-site management of investigational products and drug delivery systems in conformity with Good Clinical Practices (GCPs).

    Science.gov (United States)

    Méthot, Julie; Brisson, Diane; Gaudet, Daniel

    2012-04-01

    Investigators and research teams participating in clinical trials have to deal with complex investigational products, study designs, and research environments. The emergence of new drug delivery systems and investigational products combining more than one drug and the development of biodrugs such as monoclonal antibodies, peptides, siRNA, and gene therapy to treat orphan or common diseases constitute a new challenge for investigators and clinical sites. We describe the requirements and challenges of drug management in conformity with Good Clinical Practices (GCPs) for investigators and sites participating in clinical trials. Review At all sites participating in clinical trials, standard operating procedures (SOPs) covering the critical path of drug and drug delivery systems management are required. All steps should be auditable, including reception, validation, storage, access, preparation, distribution, techniques of administration, use, return, and destruction of research products. Biodrugs require traceability and specific SOPs on the management of potential immune reactions. Investigational products must be stored under standard auditable conditions. The traceability of storage conditions (including temperature) requires these conditions to be monitored on a continuous basis. A dedicated space with restricted access limited to authorized qualified personnel facilitates the monitoring. The development of standardized, auditable settings and the application of dedicated, site-specific SOPs for the management of investigational products and drug delivery systems contribute to guarantee the compliance to GCP requirements.

  4. Comparison of WAIS-III Short Forms for Measuring Index and Full-Scale Scores

    Science.gov (United States)

    Girard, Todd A.; Axelrod, Bradley N.; Wilkins, Leanne K.

    2010-01-01

    This investigation assessed the ability of the Wechsler Adult Intelligence Scale-Third Edition (WAIS-III) short forms to estimate both index and IQ scores in a large, mixed clinical sample (N = 809). More specifically, a commonly used modification of Ward's seven-subtest short form (SF7-A), a recently proposed index-based SF7-C and eight-subtest…

  5. Infrared and Raman investigation of rare-earth phosphate glasses for potential use as radioactive waste forms

    International Nuclear Information System (INIS)

    Morgan, S.H.

    1989-01-01

    This project was designed to investigate the properties of the rare-earth phosphate glass systems CeO 2 -P 2 O 5 and Pr 2 O 3 -P 2 O 5 for potential use as radioactive waste glasses. The glass-forming region and optimum processing parameters of these glass systems were investigated. The structure of the host glasses and glassed loaded with simulated waste elements was investigated using Raman and infrared spectroscopy. Because of the radical differences in the spectra of the molybdenum-loaded glasses, the structure of the MoO 3 -P 2 O 5 glass system was also investigated. 29 refs., 8 figs., 2 tabs

  6. EXAFS investigation of uranium(6) complexes formed at Acidithiobacillus ferro oxidans types

    International Nuclear Information System (INIS)

    Merroun, M.; Reich, T.; Hennig, Ch.; Selenska-Pobell, S.

    2002-01-01

    Mining activities have brought excessive amounts of uranium into the environment. In uranium deposits a number of acidophilic chemo-litho-autotrophic bacteria have been identified which are able to oxidize sulphide minerals, elemental sulphur, ferrous iron and also (in the presence of uranium mineral) U(IV). In particular, the interaction of one representative of the group Acidithiobacillus ferro oxidans (new designation of Thiobacillus ferro oxidans) with uranium has been investigated. Uranium(VI) complex formations at the surfaces of Acidithiobacillus ferro oxidans were studied using uranium L III -edge extended X-ray absorption fine structure (EXAFS) spectroscopy. In all samples uranium is co-ordinated by two axial oxygen atoms (O ax ) at a distance of 1.77-1.78 angstrom. The average distance between uranium and the equatorial oxygen atoms (O eq ) is 2.35 angstrom. The co-ordination number for O eq is 5-6. In comparison to the uranium crystal structure data, the U-O eq distance indicates a co-ordination number of the equatorial oxygen of 5. Within the experimental error, there are no differences in the U-O bond distances between samples from the three types of A. ferro oxidans investigated. The fit to the EXAFS data of samples measured as wet pastes gave the same results as for dried samples. No significant structural differences were observed for the uranium complexes formed by the eco-types of A. ferro oxidans. However, the EXAFS spectra do indicate a formation of uranium complexes which are different from those formed by Bacilli where the bond length of 2.28 angstrom indicates a co-ordination number of 4 for the equatorial oxygen atoms. (authors)

  7. Clinical Investigation of Adrenal Incidentalomas in Japanese Patients of the Fukuoka Region with Updated Diagnostic Criteria for Sub-clinical Cushing's Syndrome.

    Science.gov (United States)

    Abe, Ichiro; Sugimoto, Kaoru; Miyajima, Tetsumasa; Ide, Tomoko; Minezaki, Midori; Takeshita, Kaori; Takahara, Saori; Nakagawa, Midori; Fujimura, Yuki; Kudo, Tadachika; Miyajima, Shigero; Taira, Hiroshi; Ohe, Kenji; Ishii, Tatsu; Yanase, Toshihiko; Kobayashi, Kunihisa

    2018-04-27

    Objectives We retrospectively investigated the clinical and endocrinological characteristics of adrenal incidentalomas. Methods We studied 61 patients who had been diagnosed with adrenal incidentalomas and had undergone detailed clinical and endocrinological evaluations while hospitalized. We used common criteria to diagnose the functional tumors, but for sub-clinical Cushing's syndrome, we used an updated set of diagnosis criteria: serum cortisol ≥1.8 μg/dL after a positive response to a 1-mg dexamethasone suppression test if the patient has a low morning ACTH level (Cushing's syndrome and sub-clinical Cushing's syndrome), and 25 (41.0%) had non-functional tumors. Compared with the non-functional tumor group, the primary aldosteronism group and the cortisol-secreting adenoma group were significantly younger and had significantly lower rates of hypokalemia, whereas the pheochromocytoma group had significantly larger tumors and a significantly lower body mass index. Conclusion Our study found a larger percentage of functional tumors among adrenal incidentalomas than past reports, partly because we used a lower serum cortisol level after a dexamethasone suppression test to diagnose sub-clinical Cushing's syndrome and because all of the patients were hospitalized and could therefore receive more detailed examinations. Young patients with hypokalemia or lean patients with large adrenal tumors warrant particularly careful investigation.

  8. Patient Acceptance of Sexual Orientation and Gender Identity Questions on Intake Forms in Outpatient Clinics: A Pragmatic Randomized Multisite Trial.

    Science.gov (United States)

    Rullo, Jordan E; Foxen, Jilian L; Griffin, Joan M; Geske, Jennifer R; Gonzalez, Cesar A; Faubion, Stephanie S; van Ryn, Michelle

    2018-03-09

    To (1) test whether patient attitudes toward intake forms at three Midwestern outpatient clinics are significantly more negative among those who are asked to complete SOGI questions versus those who are not; and (2) gain an in-depth understanding of patient concerns about SOGI questions. Data were collected between 6/29/2015 and 2/29/2016 from new patients (N = 491) who presented at three outpatient clinics in a large academic medical center. This study was originally a quality improvement project, and later, institutional review board approval was obtained for secondary data analysis. Two-stage mixed-methods study. (1) Experimental: New patients at three sites were randomly assigned to complete either routine intake forms (control) or routine intake forms with SOGI questions (experimental); and (2) qualitative: interviews with patients who responded negatively to SOGI questions. There were no significant differences in patient attitudes between experimental and control groups (p > .05). Of those who received SOGI questions, only 3 percent reported being distressed, upset, or offended by the SOGI questions. Collection of SOGI data as a part of the routine clinical patient intake process is not distressing to 97 percent of patients who are heterosexual, cisgender, and older than 50 years. © Health Research and Educational Trust.

  9. An empirical investigation of the relationship among forms of workplace mistreatment.

    Science.gov (United States)

    Walsh, Benjamin M; Magley, Vicki J

    2014-01-01

    Organizational researchers argue that workplace mistreatment scholarship is hampered because of the wide variety of constructs studied. To investigate this concern, we conducted an item-level analysis of the relationship among workplace mistreatment experiences to assess construct overlap. Employed students reported how similar 17 mistreatment experiences were to one another (i.e., from measures of sexual harassment, generalized harassment, and incivility) and subject matter experts indicated the degree to which each experience represented several dimensions including Buss's (1961) dimensions (i.e., verbal/physical, active/passive, and direct/indirect) and others (i.e., sexual/ nonsexual and intentional/accidental). Nonsexual forms of mistreatment (i.e., generalized harassment and incivility) were perceived similarly despite their different conceptual definitions, whereas sexual harassment experiences were relatively distinct. Implications of the findings are discussed.

  10. An Investigation into the Clinical Reasoning Development of Veterinary Students.

    Science.gov (United States)

    Vinten, Claire E K; Cobb, Kate A; Freeman, Sarah L; Mossop, Liz H

    Clinical reasoning is a fundamental skill for veterinary clinicians and a competency required of graduates by the Royal College of Veterinary Surgeons. However, it is unknown how veterinary students develop reasoning skills and where strengths and shortcomings of curricula lie. This research aimed to use the University of Nottingham School of Veterinary Medicine and Science (SVMS) as a case study to investigate the development of clinical reasoning among veterinary students. The analysis was framed in consideration of the taught, learned, and declared curricula. Sixteen staff and sixteen students from the SVMS participated separately in a total of four focus groups. In addition, five interviews were conducted with recent SVMS graduates. Audio transcriptions were used to conduct a thematic analysis. A content analysis was performed on all curriculum documentation. It was found that SVMS graduates feel they have a good level of reasoning ability, but they still experience a deficit in their reasoning capabilities when starting their first job. Overarching themes arising from the data suggest that a lack of responsibility for clinical decisions during the program and the embedded nature of the clinical reasoning skill within the curriculum could be restricting development. In addition, SVMS students would benefit from clinical reasoning training where factors influencing "real life" decisions (e.g., finances) are explored in more depth. Integrating these factors into the curriculum could lead to improved decision-making ability among SVMS graduates and better prepare students for the stressful transition to practice. These findings are likely to have implications for other veterinary curricula.

  11. Clinical report of an extremely severe bone marrow form of acute radiation sickness

    International Nuclear Information System (INIS)

    Qiao Jianhui; Yu Changlin; Luo Weidong; Guo Mei; Wang Danhong; Sun Qiyun; Zhang Shi; Zhang Xigang; Li Guang; Niu Wenkai; Chen Jiankui; Li Xiaobing; Ge Feijiao; Ai Huisheng

    2007-01-01

    Objective: To sum up the experiences from the diagnosis and treatment of patient B subjected to an accidental 60 Co exposure on October 21st, 2004, in Jining, Shandong Province, China. Methods: Radiation dose of B was assessed by analysis of chromosome aberration and microneucleus assay, simulation test of the accident site, autopsy and electron spin resonance (ESR). The ultimate clinical diagnosis was based on analysis of irradiation dose, clinical manifestations and laboratory results. In therapeutical aspects, total environmental protection, HLA-identical allogeneic peripheral blood stem cell transplantation (PBSCT), anti- infection and protection managements of organs were given. Results: Patient B was diagnosed as extremely severe bone marrow form of acute radiation sickness (ARS). HLA-identical allogeneic PBSCT was performed on the patient from his brother on the 7th day after the accident. The hematopoietic recovery began on the 9th day after transplantation. The patient acquired permanent full donor' engraftment without graft versus host disease (GVHD), But the radiation injury was continuing and the patient complicated with polyinfection in lung, and cardiac insufficiency. On the 45th day after the accident, patient B was performed with tracheotomy and maintained ventilation with respirator. On the 75th day after the accident, patient B died of multiple organ failure. Conclusions: Early triage diagnosis and total environmental protection should be performed as soon as possible for extremely severe bone marrow form of ARS. It is very important to perform a successful HLA-identical allogeneic PBSCT, in order to extend the life time of the patient. Multiple organ injuries and infections of bacteria and fungi usually occurred on this kind of patients, so intense measures of anti-infection and protection of multiple organs should be taken. The important and difficult point in the treatment of this kind ARS might be for help the immune-reconstruction and tissue

  12. EM-GE-5 Regulation. Standard for the first-rate application clinical practices in the execution of the clinical investigations for medical teams' evaluation

    International Nuclear Information System (INIS)

    2015-01-01

    This guide has the following objectives: a) To guide methodologically the implementation of Good Clinical Practice for the execution of clinical research with medical devices that need to be evaluated, in addition to the Regulation E R-6. Requirements for the Conduct of Clinical Trials for Medical Devices , b) Provide the fundamental aspects to be taken into count for quality control to clinical investigations.

  13. Comparative clinical, roentgenological, scintigraphic and thermographic investigations in psoriasis arthropathica

    International Nuclear Information System (INIS)

    Loreck, D.; Lips, H.; Schulze, P.

    1988-01-01

    20 patients with psoriasis arthropatica and different duration of the articular symptoms were examined. Besides clinical investigation radiographs of both hands and feet (central and phalanges), scintigraphy of hands, feet and the sacroiliac joints as well as liquid crystal thermograhy of both hands were performed and the results are compared. The conclusions drawn characterize the diagnostic value of the methods. Scintigraphy as well as thermography are very good means for the early detection of psoriasis arthropathica. (author)

  14. Experimental and numerical investigation of laser forming of cylindrical surfaces with arbitrary radius of curvature

    Directory of Open Access Journals (Sweden)

    Mehdi Safari

    2016-09-01

    Full Text Available In this work, laser forming of cylindrical surfaces with arbitrary radius of curvature is investigated experimentally and numerically. For laser forming of cylindrical surfaces with arbitrary radius of curvature, a new and comprehensive method is proposed in this paper. This method contains simple linear irradiating lines and using an analytical method, required process parameters for laser forming of a cylindrical surface with a specific radius of curvature is proposed. In this method, laser output power, laser scanning speed and laser beam diameter are selected based on laser machine and process limitations. As in the laser forming of a cylindrical surface, parallel irradiating lines are needed; therefore key parameter for production of a cylindrical surface with a specific radius of curvature is the number of irradiating lines. Hence, in the proposed analytical method, the required number of irradiating lines for production of a cylindrical surface with a specific radius of curvature is suggested. Performance of the proposed method for production of cylindrical surface with a specific radius of curvature is verified with experimental tests. The results show that using proposed analytical method, cylindrical surfaces with any radius of curvature can be produced successfully.

  15. Clinical investigation in Wilson's disease

    International Nuclear Information System (INIS)

    Mizutani, Naoki; Maehara, Mitsuo; Negoro, Tamiko; Watanabe, Kazuyoshi

    1983-01-01

    Wilson's disease of cerebral type with a chief complaint of tremor occurred in 3 brothers and sisters of a certain family line. Treatment with D-penicillamine produced remarkable clinical improvement as shown by the disappearance of tremor and Kayser-Fleischer ring. Cranial CT scans made before the treatment revealed abnormal findings such as low density areas in the (bilateral) thalamus and the lenticular nucleus, atrophy of the cerebral cortex, and enlargement of the ventricles. After the treatment, cranial CT revealed that the low density areas in the thalamus and the lenticular nucleus disappeared corresponding to the clinical improvement. However, the atrophy of the cerebral cortex and the enlargement of the ventricles were not ameliorated. (Ueda, J.)

  16. Sesame seed allergy: Clinical manifestations and laboratory investigations

    Directory of Open Access Journals (Sweden)

    Fazlollahi MR.

    2007-10-01

    Full Text Available Background: Plant-origin foods are among the most important sources of food allergic reactions. An increase in the incidence of sesame seed allergy among children and adults has been reported in recent years. The aim of this preliminary study was to investigate the prevalence, importance and clinical manifestations of sesame allergy among Iranian patients.Methods: In a cross-sectional survey, 250 patients with suspected IgE-mediated food allergies completed a questionnaire and underwent skin prick tests with sesame extract as well as cross-reacting foods (walnut, soya and peanut. Total IgE and sesame-specific IgE levels were measured. Patients with positive skin test reactions and/or IgE specific for sesame without clinical symptoms were considered sensitive to sesame. The patients who also had clinical symptoms with sesame consumption were diagnosed as allergic to sesame.Results: Of the 250 patients enrolled in this study, 129 were male and 121 female, with a mean age of 11.7 years. The most common food allergens were cow's milk, egg, curry, tomato and sesame. Sesame sensitivity was found in 35 patients (14.1%. Only five patients (2% had sesame allergy. Sesame-sensitive patients had a significantly higher frequency of positive prick test to cross-reacting foods when compared to non-sensitized patients (p=0.00. The type of symptom was independent of gender and age of the patients, but urticaria and dermatitis-eczema were significantly more frequent in sensitized patients (p=0.008.Conclusions: This is the first study addressing the prevalence of sesame seed allergy in Iranian population. We found sesame to be a common and important cause of food allergy. The panel of foods recommended for use in diagnostic allergy tests should be adjusted.

  17. Molecular and clinical characterization of the myopathic form of mitochondrial DNA depletion syndrome caused by mutations in the thymidine kinase (TK2) gene.

    Science.gov (United States)

    Chanprasert, Sirisak; Wang, Jing; Weng, Shao-Wen; Enns, Gregory M; Boué, Daniel R; Wong, Brenda L; Mendell, Jerry R; Perry, Deborah A; Sahenk, Zarife; Craigen, William J; Alcala, Francisco J Climent; Pascual, Juan M; Melancon, Serge; Zhang, Victor Wei; Scaglia, Fernando; Wong, Lee-Jun C

    2013-01-01

    Mitochondrial DNA (mtDNA) depletion syndromes (MDSs) are a clinically and molecularly heterogeneous group of mitochondrial cytopathies characterized by severe mtDNA copy number reduction in affected tissues. Clinically, MDSs are mainly categorized as myopathic, encephalomyopathic, hepatocerebral, or multi-systemic forms. To date, the myopathic form of MDS is mainly caused by mutations in the TK2 gene, which encodes thymidine kinase 2, the first and rate limiting step enzyme in the phosphorylation of pyrimidine nucleosides. We analyzed 9 unrelated families with 11 affected subjects exhibiting the myopathic form of MDS, by sequencing the TK2 gene. Twelve mutations including 4 novel mutations were detected in 9 families. Skeletal muscle specimens were available from 7 out of 11 subjects. Respiratory chain enzymatic activities in skeletal muscle were measured in 6 subjects, and enzymatic activities were reduced in 3 subjects. Quantitative analysis of mtDNA content in skeletal muscle was performed in 5 subjects, and marked mtDNA content reduction was observed in each. In addition, we outline the molecular and clinical characteristics of this syndrome in a total of 52 patients including those previously reported, and a total of 36 TK2 mutations are summarized. Clinically, hypotonia and proximal muscle weakness are the major phenotypes present in all subjects. In summary, our study expands the molecular and clinical spectrum associated with TK2 deficiency. © 2013.

  18. An investigation of nurse educator's perceptions and experiences of undertaking clinical practice.

    Science.gov (United States)

    Williams, Angela; Taylor, Cathy

    2008-11-01

    Educational policy (DOH, 1999. Making a difference: strengthening the nursing, midwifery and health visiting contribution to health and healthcare. Department of Health, London; UKCC, 1999. Fitness for Practice. United Kingdom Central Council for Nursing, Midwifery and Health Visiting, London; Nursing and Midwifery Council, 2006. Standards to support learning and assessment in practice. Nursing and Midwifery Council, London) and current nursing literature (Griscti, O., Jacono, B., Jacono, J., 2005. The nurse educator's clinical role. Journal of Advanced Nursing 50 (1), 84-92; Owen, S., Ferguson, K., Baguley, I., 2005. The clinical activity of mental health nurse lecturers. Journal of Psychiatric and Mental Health Nursing 12, 310-316), place increasing emphasis on nurse educators undertaking clinical practice to facilitate their clinical confidence and competence. This study investigated nurse educators' perceptions and experiences of undertaking clinical practice. A qualitative design and descriptive, exploratory approach were used. A purposive sample of 11 nurse educators in one nursing department, took part in two focus group interviews, one with 5 and the other with 6 respondents, to identify and discuss their perceptions and experiences of undertaking clinical practice. A process of thematic content analysis revealed three broad themes relating to the meaning and importance of clinical practice, perceived benefits and barriers which are examined and discussed. The paper concludes that despite policy recommendations, barriers highlighted in this study such as insufficient time, heavy workload and a lack of valuing of the clinical role have been raised over the past few decades. The effect of undertaking clinical practice, particularly on the quality of teaching is argued to be valuable armoury in the battle to secure sufficient resources to support engagement in clinical practice. Financial and organisational commitment; valuing of clinical practice and research

  19. Investigation of conspicuous infrared star cluster and star-forming region RCW 38 IR Cluster

    International Nuclear Information System (INIS)

    Gyulbudaghian, A.L.; May, J.

    2008-01-01

    An infrared star cluster RCW 38 IR Cluster, which is also a massive star-forming region, is investigated. The results of observations with SEST (Cerro is Silla, Chile) telescope on 2.6-mm 12 CO spectral line and with SIMBA on 1.2-mm continuum are given. The 12 CO observations revealed the existence of several molecular clouds, two of which (clouds I and 2) are connected with the object RCW 38 IR Cluster. Cloud 1 is a massive cloud, which has a depression in which the investigated object is embedded. It is not excluded that the depression was formed by the wind and/or emission from the young bright stars belonging to the star cluster. Rotation of cloud 2, around the axis having SE-NW direction, with an angular velocity ω 4.6 · 10 -14 s -1 is also found. A red-shifted outflow with velocity ∼+5.6 km/s, in the SE direction and perpendicular to the elongation of cloud 2 has been also found. The investigated cluster is associated with an IR point source IRAS 08573-4718, which has IR colours typical for a, non-evolved embedded (in the cloud) stellar object. The cluster is also connected with a water maser. The SIMBA image shoves the existence of a central bright condensation, coinciding with the cluster itself, and two extensions. One of these extensions (the one with SW-NE direction) coincides, both in place and shape, with cloud 2, so that it is not excluded the possibility that this extension might be also rotating like cloud 2. In the vicinity of these extensions there are condensations resembling HH objects

  20. Clinical and radiological aspects of limited forms of infiltrative pulmonary tuberculosis and slowly resolving pneumonia

    International Nuclear Information System (INIS)

    Caraiani, Olga; Lesnic, Evelina; Niguleanu, Adriana; Niguleanu, Radu

    2016-01-01

    Despite of a clearly defined diagnostic algorithm of pulmonary tuberculosis, low sensibility of contemporary laboratory methods in limited forms of pulmonary tuberculosis contributes to a difficult differential diagnosis with community acquired pneumonia, especially with slowly resolving pneumonia. A case-control, prospective, selective, comparative and descriptive study was performed using a group of 180 patients, divided into two samples: I group - 125 cases with limited form of pulmonary infiltrative tuberculosis; II group - 55 cases with slowly resolving community-acquired pneumonia. The findings identified the prevalence of intoxication syndrome in the slowly resolving pneumonia sample. Lung destructions and bronchogenous dissemination was identified only in the tuberculosis sample. A higher impact of comorbidities and old age was more relevant in slowly resolving pneumonia sample. Clinical and radiological improvement was established in most patients of both groups, but the considerable resorption of lung infiltrates predominated in slowly resolving pneumonia sample. (authors)

  1. Wechsler Intelligence Scale for Children-fourth edition (WISC-IV) short-form validity: a comparison study in pediatric epilepsy.

    Science.gov (United States)

    Hrabok, Marianne; Brooks, Brian L; Fay-McClymont, Taryn B; Sherman, Elisabeth M S

    2014-01-01

    The purpose of this article was to investigate the accuracy of the WISC-IV short forms in estimating Full Scale Intelligence Quotient (FSIQ) and General Ability Index (GAI) in pediatric epilepsy. One hundred and four children with epilepsy completed the WISC-IV as part of a neuropsychological assessment at a tertiary-level children's hospital. The clinical accuracy of eight short forms was assessed in two ways: (a) accuracy within +/- 5 index points of FSIQ and (b) the clinical classification rate according to Wechsler conventions. The sample was further subdivided into low FSIQ (≤ 80) and high FSIQ (> 80). All short forms were significantly correlated with FSIQ. Seven-subtest (Crawford et al. [2010] FSIQ) and 5-subtest (BdSiCdVcLn) short forms yielded the highest clinical accuracy rates (77%-89%). Overall, a 2-subtest (VcMr) short form yielded the lowest clinical classification rates for FSIQ (35%-63%). The short form yielding the most accurate estimate of GAI was VcSiMrBd (73%-84%). Short forms show promise as useful estimates. The 7-subtest (Crawford et al., 2010) and 5-subtest (BdSiVcLnCd) short forms yielded the most accurate estimates of FSIQ. VcSiMrBd yielded the most accurate estimate of GAI. Clinical recommendations are provided for use of short forms in pediatric epilepsy.

  2. Reiter′s Disease - Clinical Profile of Epidemic Form

    Directory of Open Access Journals (Sweden)

    H S Girgia

    1980-01-01

    Full Text Available Absence of urethritis need not exclude the possiblity of Reiter′s disease in young males where conjunctivitis and polyarthritis are cardinal features. Appearance of cutaneous lesion early in the course of the disease heralds a poor prognosis specially in the rare epidemic form of the disease. Two cases of Reiter′s disease are reported. Both belonged to the dysentric type of the disease; sometimes ref to as the epidemic form. Relatively high dose of steroids necessary to control symptoms.

  3. A short version of the revised 'experience of close relationships questionnaire': investigating non-clinical and clinical samples.

    Science.gov (United States)

    Wongpakaran, Tinakon; Wongpakaran, Nahathai

    2012-01-01

    This study seeks to investigate the psychometric properties of the short version of the revised 'Experience of Close Relationships' questionnaire, comparing non-clinical and clinical samples. In total 702 subjects participated in this study, of whom 531 were non-clinical participants and 171 were psychiatric patients. They completed the short version of the revised 'Experience of Close Relationships' questionnaire (ECR-R-18), the Perceived Stress Scale-10(PSS-10), the Rosenberg Self-Esteem Scale (RSES) and the UCLA Loneliness scale. A retest of the ECR-R-18 was then performed at four-week intervals. Then, confirmatory factor analyses were performed to test the validity of the new scale. The ECR-R-18 showed a fair to good internal consistency (α 0.77 to 0.87) for both samples, and the test-retest reliability was found to be satisfactory (ICC = 0.75). The anxiety sub-scale demonstrated concurrent validity with PSS-10 and RSES, while the avoidance sub-scale showed concurrent validity with the UCLA Loneliness Scale. Confirmatory factor analysis using method factors yielded two factors with an acceptable model fit for both groups. An invariance test revealed that the ECR-R-18 when used on the clinical group differed from when used with the non-clinical group. The ECR-R-18 questionnaire revealed an overall better level of fit than the original 36 item questionnaire, indicating its suitability for use with a broader group of samples, including clinical samples. The reliability of the ECR-R- 18 might be increased if a modified scoring system is used and if our suggestions with regard to future studies are followed up.

  4. Clinical report of one case of intestinal form of acute radiation sickness

    International Nuclear Information System (INIS)

    Yu Changlin; Qiao Jianhui; Luo Weidong; Guo Mei; Wang Danhong; Sun Qiyun; Zhang Shi; Chen Jiankui; Li Xiaobing; Ai Huisheng

    2007-01-01

    Objective: To summarize the irradiation course, estimation of radiation dosage, clinical course, diagnosis and treatment of the patient A in a 60 Co radiation accident on October 21, 2004 in Jining, Shandong Province, China. Methods: According to the simulated test of the scene, chromosome aberration analysis, clinical course and tooth enamel ESR measurement, the total body dose of A was 20-25 Gy and diagnosed as intestinal form of acute radiation sickness. The patient was transferred to our hospital on day 3 post- irradiation, total environmental protection (TEP), antibiotics and emergency HLA-typing from his elder sister were given. On day 7 HLA haplo-identical peripheral blood stem cell transplantation was performed. Results: On day 10 post-transplant (+ 10 d), the counts of WBC began to increase and up to 5.1 x 10 9 /L on + 12 d. Bone marrow feature showed hematopoietic recovery of the three lineage blood cells. Continuous detection of the implantation ratio of donor's cells by STR-PCR showed stable 100% donor-derived chimera. On day 13, severe acute peritonitis and intestinal obstruction occurred; imipenem was much effective to control intestinal bacteria infection. Three days later, hematopoiesis reconstructed rapidly, peritonitis and intestinal obstruction were cured. On day 19, chest X-ray picture and CT scanning suggested that pulmonary mixed infection of bacteria and fungi appeared. The most severe skin irradiation burn damage occurred on day 25 which occupied the 14% of whole body skin surface. The functions of lung, heart and kidney were deteriorated sequentially. On day 30, tracheotomy had to be conducted and respirator was used. The patient died of multiple organ failure (MOF) on day 33. Conclusions: Patient A was exposed to relative well-distributed high dose and high dose rate of irradiation up to 20-25 Gy. This is the first case report of successful HLA haplo-identical peripheral blood stem cell transplantation for intestinal form of acute

  5. Remote preenrollment checking of consent forms to reduce nonconformity.

    Science.gov (United States)

    Journot, Valérie; Pérusat-Villetorte, Sophie; Bouyssou, Caroline; Couffin-Cadiergues, Sandrine; Tall, Aminata; Chêne, Geneviève

    2013-01-01

    In biomedical research, the signed consent form must be checked for compliance with regulatory requirements. Checking usually is performed on site, most frequently after a participant's final enrollment. We piloted a procedure for remote preenrollment consent forms checking. We applied it in five trials and assessed its efficiency to reduce form nonconformity before participant enrollment. Our clinical trials unit (CTU) routinely uses a consent form with an additional copy that contains a pattern that partially masks the participant's name and signature. After completion and signatures by the participant and investigator, this masked copy is faxed to the CTU for checking. In case of detected nonconformity, the CTU suspends the participant's enrollment until the form is brought into compliance. We checked nonconformities of consent forms both remotely before enrollment and on site in five trials conducted in our CTU. We tabulated the number and nature of nonconformities by location of detection: at the CTU or on site. We used these data for a pseudo before-and-after analysis and estimated the efficiency of this remote checking procedure in terms of reduction of nonconformities before enrollment as compared to the standard on-site checking procedure. We searched for nonconformity determinants among characteristics of trials, consent forms, investigator sites, and participants through multivariate logistic regression so as to identify opportunities for improvement in our procedure. Five trials, starting sequentially but running concurrently, with remote preenrollment and on-site checking of consent forms from 415 participants screened in 2006-2009 led to 518 consent forms checked; 94 nonconformities were detected in 75 forms, 75 (80%) remotely and 19 more (20%) on site. Nonconformities infrequently concerned dates of signatures (7%) and information about participants (12%). Most nonconformities dealt with investigator information (76%), primarily contact information

  6. Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

    DEFF Research Database (Denmark)

    Gluud, Christian; Kubiak, Christine; Whitfield, Kate

    2012-01-01

    In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.......In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe....

  7. The analysis of the clinical and tool parameters characterizing a cardiomyopathyat various forms of the progressing muscular dystrophies

    Directory of Open Access Journals (Sweden)

    Poverennova I.E.

    2017-03-01

    Full Text Available Purpose: studying of clinical and tool characteristics of cardiomyopathies at various forms of the progressing muscular dystrophies. Material and methods. There had been 103 patients with hereditary forms of the progressing muscular dystrophies examined, among which 35 persons were with Duchenne muscular dystrophy, 28 with an atrophic myo-tonia, and 40 with a limb girdle dystrophy is conducted. Assessment of clinical and tool features of cardiomyopathies at these types of the hereditary progressing muscular dystrophies had been carried out. Results. In the group of patients with diffusion damage of a myocardium in the form of dystrophic violations had been revealed. Existence of a negative tooth of T in some assignments and lengthenings of an interval of QT is noted. With a dystrophic myotonia violation of a warm rhythm occurred at patients by 87 times more often than in the group of comparison. Violation of a rhythm of heart in group of patients with a limb girdle dystrophy came to light 91 times more often in reference to the group of comparison. Conclusion. Violations in a cardiovascular system at Duchenne muscular dystrophy are preferentially diffusion changes in a myocardium. At a dystrophic myotonia and a limb girdle dystrophy cardial violations concern mainly excitability and the conductivity of heart which are the main reason of developing of this disease at these patients.

  8. Clinical examination, spondylolysis and adolescent athletes.

    Science.gov (United States)

    Sundell, C-G; Jonsson, H; Ådin, L; Larsén, K H

    2013-03-01

    Symptomatic spondylolysis is a stress reaction caused by microtrauma during physical exercise, an imaging diagnostic subgroup of Adolescent Low Back Pain (ALBP), found in adolescent athletes. Early diagnosis increases the possibility of healing. Thus, it is important to divide ALBP into subgroups. The aim of this study was to evaluate clinical tests that can distinguish symptomatic spondylolysis from other forms of ALBP in order to facilitate early referral for diagnostic imaging. The investigation subjects were a prospective case series with a control group, 25 subjects with ALBP and 13 subjects that had no history of LBP. The 2 groups were examined using the same clinical protocol. MRI of the whole lumbar spine was performed in both the case and control groups and CT investigations of the L4 and L5 vertebrae were performed in the case group. Significant differences between the 2 groups were found in 8 of our clinical tests. No clinical test, alone or in combination, could distinguish between spondylolysis and other forms of ALBP. As 88% of the subjects in the case group had MRI findings and almost 50% had spondylolysis, MRI should be performed at an early age in young athletes with ALBP. © Georg Thieme Verlag KG Stuttgart · New York.

  9. Clinical relevance of "withdrawal therapy" as a form of hormonal manipulation for breast cancer

    Directory of Open Access Journals (Sweden)

    Robertson John FR

    2011-09-01

    Full Text Available Abstract Background It has been shown in in-vitro experiments that "withdrawal" of tamoxifen inhibits growth of tumor cells. However, evidence is scarce when this is extrapolated into clinical context. We report our experience to verify the clinical relevance of "withdrawal therapy". Methods Breast cancer patients since 1998 who fulfilled the following criteria were selected from the departmental database and the case-notes were retrospectively reviewed: (1 estrogen receptor positive, operable primary breast cancer in elderly (age > 70 years, locally advanced or metastatic breast cancer; (2 disease deemed suitable for treatment by hormonal manipulation; (3 disease assessable by UICC criteria; (4 received "withdrawal" from a prior endocrine agent as a form of therapy; (5 on "withdrawal therapy" for ≥ 6 months unless they progressed prior. Results Seventeen patients with median age of 84.3 (53.7-92.5 had "withdrawal therapy" as second to tenth line of treatment following prior endocrine therapy using tamoxifen (n = 10, an aromatase inhibitor (n = 5, megestrol acetate (n = 1 or fulvestrant (n = 1. Ten patients (58.8% had clinical benefit (CB (complete response/partial response/stable disease ≥ 6 months with a median duration of Clinical Benefit (DoCB of 10+ (7-27 months. Two patients remain on "withdrawal therapy" at the time of analysis. Conclusion "Withdrawal therapy" appears to produce sustained CB in a significant proportion of patients. This applies not only to "withdrawal" from tamoxifen, but also from other categories of endocrine agents. "Withdrawal" from endocrine therapy is, therefore, a viable intercalating option between endocrine agents to minimise resistance and provide additional line of therapy. It should be considered as part of the sequencing of endocrine therapy.

  10. Gas-phase complexes formed between amidoxime ligands and vanadium or iron investigated using electrospray ionization mass spectrometry.

    Science.gov (United States)

    Mustapha, Adetayo M; Pasilis, Sofie P

    2016-08-15

    Amidoxime-functionalized sorbents can be used to extract uranium from seawater. Iron(III) and vanadium(V) may compete with uranium for adsorption sites. We use 2,6-dihydroxyiminopiperidine (DHIP) and N(1) ,N(5) -dihydroxypentanediimidamide (DHPD) to model amidoxime functional groups and characterize the vanadium(V) and iron(III) complexes with these ligands. We also examine the effect of iron(III) and vanadium(V) on uranyl(VI) complexation by DHIP and DHPD. The experiments were carried out in positive ion mode using a quadrupole ion trap mass spectrometer equipped with an electrospray ionization source. The effect on the mass spectra of changes in ligand, metal:ligand mole ratio, and pH was examined. Iron(III) formed a 1:2 metal:ligand complex with DHIP at all metal:ligand mole ratios and pH values investigated; it formed both 1:2 and 1:3 metal:ligand complexes with DHPD. Vanadium(V) formed 1:1 and 1:2 metal:ligand complexes with DHIP. A 1:2 metal:ligand complex was formed with DHPD at all vanadium(V):DHPD mole ratios investigated. Changes in solution pH did not affect the ions observed. The relative binding affinities of the metal ions towards DHIP followed the order iron(III) > vanadium(V) > uranyl(VI). This study presents a first look at the gas-phase vanadium(V)- and iron(III)-DHIP and -DHPD complexes using electrospray ionization mass spectrometry. These metals form stronger complexes with amidoxime ligands than uranyl(VI), and will affect uranyl(VI) adsorption to amidoxime-based sorbents. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  11. How do clinical genetics consent forms address the familial approach to confidentiality and incidental findings? A mixed-methods study.

    Science.gov (United States)

    Dheensa, Sandi; Crawford, Gillian; Salter, Claire; Parker, Michael; Fenwick, Angela; Lucassen, Anneke

    2018-01-01

    Genetic test results can be relevant to patients and their relatives. Questions thus arise around whether clinicians regard genetic information as confidential to individuals or to families, and about how they broach this and other issues, including the potential for incidental findings, in consent (forms) for genetic testing. We conducted a content analysis of UK-wide genetic testing consent forms and interviewed 128 clinicians/laboratory scientists. We found that almost all genetic services offered patients multiple, sometimes unworkable, choices on forms, including an option to veto the use of familial genetic information to benefit relatives. Participants worried that documented choices were overriding professional judgement and cautioned against any future forms dictating practice around incidental findings. We conclude that 'tick-box' forms, which do little to enhance autonomy, are masking valid consent processes in clinical practice. As genome-wide testing becomes commonplace, we must re-consider consent processes, so that they protects patients'-and relatives'-interests.

  12. OCT investigation of dental lesions

    Science.gov (United States)

    Osiac, Eugen; Popescu, Sanda Mihaela; Scrieciu, Monica; Mercuţ, Rǎzvan; Mercuţ, Veronica; Vǎtu, Mihaela

    2018-03-01

    There are several important non carious lesions affecting the tooth structure, lesions which may be classified into four clinical forms of dental wear: abfraction, erosion, attrition and abrasion, and different types of root resorption. Search for new, non-invasive and fast methods able to detect and describe such injuries is of utmost importance. Optical coherence tomography (OCT) proved itself as an appropriate investigation method for several medical fields including ophthalmology, dermatology, cardiology etc. Our study reveals OCT preliminary investigations as a promising tool for detecting and evaluating of the mentioned lesions.

  13. Clinical characteristics in genetically distinct forms of the congenital long QT syndrome

    International Nuclear Information System (INIS)

    Kawahara, Yosuke; Sawayama, Toshitami; Samukawa, Masanobu; Nezuo, Shoso; Tanaka, Junji; Suetsuna, Ryoji; Kamiyama, Norio

    1998-01-01

    The clinical characteristics in genetically distinct forms of the congenital long QT syndrome (LQTs) were examined on the balance of bilateral sympathetic nerves, and ECG findings. The subjects (mean: 19.4 years old) were three genetically distinct forms of LQTs, including 3 patients in A-family (the high risk family with sudden death), 2 patients in B-family and 3 patients in C-family. All patients met the standard diagnostic criteria according to Schwartz. As the index of the balance of bilateral sympathetic nerves, the dissociation of Tl and MIBG uptake (D) was examined and the radioactivity ratio (the A/L ratio) of anteroseptal wall to posterolateral wall was calculated. The T-wave patterns of ECG and the situation at syncope were examined. In A-family, all 3 patients showed the lowered A/L ratio, D(+), and similar T-wave patterns in ECG. The syndrome developed at exercise, and their QTc extended at exercise. In B-family, all 2 patients showed normal A/L ratio and long T-wave at QT onset, and their QTc shortened at exercise. All patients had developed syncope at rest. In C-family, all 3 patients showed a little decrease of A/L ratio and similar T-wave patterns. Their QTc extended at exercise. These results suggest that the characteristics of the sympathetic nerve balance, ECG wave patterns and the syndrome may depend on each family. (K.H.)

  14. Clinical investigations of the therapeutic potential of ayahuasca: rationale and regulatory challenges.

    Science.gov (United States)

    McKenna, Dennis J

    2004-05-01

    Ayahuasca is a hallucinogenic beverage that is prominent in the ethnomedicine and shamanism of indigenous Amazonian tribes. Its unique pharmacology depends on the oral activity of the hallucinogen, N,N-dimethyltryptamine (DMT), which results from inhibition of monoamine oxidase (MAO) by beta-carboline alkaloids. MAO is the enzyme that normally degrades DMT in the liver and gut. Ayahuasca has long been integrated into mestizo folk medicine in the northwest Amazon. In Brazil, it is used as a sacrament by several syncretic churches. Some of these organizations have incorporated in the United States. The recreational and religious use of ayahuasca in the United States, as well as "ayahuasca tourism" in the Amazon, is increasing. The current legal status of ayahuasca or its source plants in the United States is unclear, although DMT is a Schedule I controlled substance. One ayahuasca church has received favorable rulings in 2 federal courts in response to its petition to the Department of Justice for the right to use ayahuasca under the Religious Freedom Restoration Act. A biomedical study of one of the churches, the Uñiao do Vegetal (UDV), indicated that ayahuasca may have therapeutic applications for the treatment of alcoholism, substance abuse, and possibly other disorders. Clinical studies conducted in Spain have demonstrated that ayahuasca can be used safely in normal healthy adults, but have done little to clarify its potential therapeutic uses. Because of ayahuasca's ill-defined legal status and variable botanical and chemical composition, clinical investigations in the United States, ideally under an approved Investigational New Drug (IND) protocol, are complicated by both regulatory and methodological issues. This article provides an overview of ayahuasca and discusses some of the challenges that must be overcome before it can be clinically investigated in the United States.

  15. [The role of gonadal peptides in clinical investigation].

    Science.gov (United States)

    Lahlou, N; Bouvattier, C; Linglart, A; Rodrigue, D; Teinturier, C

    2009-01-01

    Inhibins, activins, and anti-Mullerian hormone (AMH) are gonadal dimeric peptides produced in ovaries and testes by homologous cells, granulosa cells and Sertoli cells, respectively. The production of inhibins is driven by FSH, that of AMH may indirectly depends on FSH, while it is down regulated, at least in the male, by testosterone. In the past decade, measurements of serum inhibin and AMH have provided useful tools for clinical investigation in gonadal disorders: pseudohermaphroditism, androgen insensitivity, anorchidism, gonadal dysgenesis, disorders of pubertal developpement. Inhibins, activins, and AMH are also reliable markers of gonadal tumors. They are extensively used as indexes of fertility: in the male the production of inhibin B reflects the spermatogenetic activity, in women both inhibin B and AMH levels are correlated with the number of preantral and early antral follicles and reflect the ovarian reserve of follicles available for recruitment.

  16. Interconnecting smartphone, image analysis server, and case report forms in clinical trials for automatic skin lesion tracking in clinical trials

    Science.gov (United States)

    Haak, Daniel; Doma, Aliaa; Gombert, Alexander; Deserno, Thomas M.

    2016-03-01

    Today, subject's medical data in controlled clinical trials is captured digitally in electronic case report forms (eCRFs). However, eCRFs only insufficiently support integration of subject's image data, although medical imaging is looming large in studies today. For bed-side image integration, we present a mobile application (App) that utilizes the smartphone-integrated camera. To ensure high image quality with this inexpensive consumer hardware, color reference cards are placed in the camera's field of view next to the lesion. The cards are used for automatic calibration of geometry, color, and contrast. In addition, a personalized code is read from the cards that allows subject identification. For data integration, the App is connected to an communication and image analysis server that also holds the code-study-subject relation. In a second system interconnection, web services are used to connect the smartphone with OpenClinica, an open-source, Food and Drug Administration (FDA)-approved electronic data capture (EDC) system in clinical trials. Once the photographs have been securely stored on the server, they are released automatically from the mobile device. The workflow of the system is demonstrated by an ongoing clinical trial, in which photographic documentation is frequently performed to measure the effect of wound incision management systems. All 205 images, which have been collected in the study so far, have been correctly identified and successfully integrated into the corresponding subject's eCRF. Using this system, manual steps for the study personnel are reduced, and, therefore, errors, latency and costs decreased. Our approach also increases data security and privacy.

  17. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Science.gov (United States)

    2013-11-07

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

  18. Investigation on the effect of lubrication and forming parameters to the green compact generated from iron powder through warm forming route

    International Nuclear Information System (INIS)

    Rahman, M.M.; Nor, S.S.M.; Rahman, H.Y.

    2011-01-01

    In order to generate green compacts of iron ASC 100.29 powder at above ambient temperature and below its recrystallization temperature, a warm compaction rig is designed and fabricated which can be operated at various temperature and load. The aim of this paper is to present the outcomes of an investigation on the effect of lubrication and forming parameters, i.e., load and temperature to the green compacts generated through warm compaction route. The feedstock was prepared by mechanically mixing the main powder constituent, i.e., iron ASC 100.29 powder with different weight percent of zinc stearate at different mixing time. Compaction load was varied from 105 kN to 125 kN using simultaneous compaction mechanism. The microstructures of the green compacts were analyzed by Scanning Electron Microscopy (SEM), and the mechanical properties are measured through density measurement, hardness test and electrical conductivity test. The study found that increase in compaction load as well as forming temperature give improved microstructure and mechanical properties. It is also found that effects of lubrication to the mechanical properties of green compacts are strongly dependant on the lubricant content as well as mixing time of iron powder with the lubricant.

  19. Using Hermeneutic Phenomenology to Investigate How Experienced Practitioners Learn to Communicate Clinical Reasoning

    Science.gov (United States)

    Ajjawi, Rola; Higgs, Joy

    2007-01-01

    This paper is primarily targeted at doctoral students and other researchers considering using hermeneutic phenomenology as a research strategy. We present interpretive paradigm research designed to investigate how experienced practitioners learn to communicate their clinical reasoning in professional practice. Twelve experienced physiotherapy…

  20. Theoretical investigation of radical species formed from L-α-alanine under gamma-irradiation

    International Nuclear Information System (INIS)

    Simion, C.

    2008-01-01

    Gamma-irradiated L-α-alanine used in EPR-coupled dosimetry has a complex EPR spectrum at room temperature. Changing the temperature or other conditions of the irradiated samples leads to varied EPR spectrum, i.e., some components disappear and/or new ones are formed. We used both molecular mechanics (MM+) and semiempirical (AM1) methods to perform a theoretical investigation of the seven radical species that have been experimentally detected. We established their order of priority in the given simulation conditions (at 0 K, in vacuo). The formation stages advanced for these long-lived radical species were characterized by a theoretical determination of the reaction enthalpies. (author)

  1. Investigation of chemical forms of elements in surface waters

    International Nuclear Information System (INIS)

    Varshal, G.M.; Velyukhanova, T.K.; Koshcheeva, I.Ya.; Dorofeeva, V.A.; Buachidze, N.S.; Kasimova, O.G.; Makharadze, G.A.

    1983-01-01

    The main trends in the research of the state of elements in natural waters are examined. The hydrolysis of CU(2), Hg(2), Au(3), Sb(3), Ru(4) over a pH range, specific for natural waters, has been studied by solubility and paper electrophoresis technnques and by filtration through cellulose ionites. The regions of predominating different forms of hydroxo complexes have been found and the thermodynamic constants of hydrolysis equilibria have been calculated. Solubility, filtration through sephadexes and cellulose ionites, paper electrophoresis techniques were used to study the complexation of Cu(2), Hg(2), Au(3), Sb(3), Ru(4) with fulvic acids. Some data have been obtained on the composition, stability and molecular-mass distribution of fulvate complexes of ten elements in different oxidation states. High-molecular anionic fulvate complexes are among main forms of most easily hydrolysed elments in solution. The possibility has been shown of prediction of the ratio of coexisting forms of trace elements in solution by theoretical calculations and experimentally Using fractionation on cellulose ionites and sephadexes

  2. Clinical Investigation Program.

    Science.gov (United States)

    1985-10-01

    Tracheoesophageal Fistula: Diagnosis with CT. Pediatr Radiol 15:134-135, 1985 Sueoka BL, Johnson JF, Enzenauer RW, Kolina JS: Infantile Infectious Sacroiliitis...C) Stokes WS: Spontaneous Diabetes Mellitus in a Baboon (Papio anubis). 35th Annual Session, American Association for Laboratory Animal Science...Summary Sheet Prot No: 21H/85 Status: Ongoing TITLE: Efficacy of Cholestyramine in Acute Infantile Diarrhea Principal Investigator: CPT George M. Maher

  3. Using thermographic cameras to investigate eye temperature and clinical severity in depression

    Science.gov (United States)

    Maller, Jerome J.; George, Shefin Sam; Viswanathan, Rekha Puzhavakkathumadom; Fitzgerald, Paul B.; Junor, Paul

    2016-02-01

    Previous studies suggest that altered corneal temperature may be a feature of schizophrenia, but the association between major depressive disorder (MDD) and corneal temperature has yet to be assessed. The aim of this study is to investigate whether eye temperature is different among MDD patients than among healthy individuals. We used a thermographic camera to measure and compare the temperature profile across the corneas of 16 patients with MDD and 16 age- and sex-matched healthy subjects. We found that the average corneal temperature between the two groups did not differ statistically, although clinical severity correlated positively with right corneal temperature. Corneal temperature may be an indicator of clinical severity in psychiatric disorders, including depression.

  4. Investigation into Composites Property Effect on the Forming Limits of Multi-Layer Hybrid Sheets Using Hydroforming Technology

    Science.gov (United States)

    Liu, Shichen; Lang, Lihui; Guan, Shiwei; Alexandrov, Seigei; Zeng, Yipan

    2018-04-01

    Fiber-metal laminates (FMLs) such as Kevlar reinforced aluminum laminate (ARALL), Carbon reinforced aluminum laminate (CARALL), and Glass reinforced aluminum laminate (GLARE) offer great potential for weight reduction applications in automobile and aerospace construction. In order to investigate the feasibility for utilizing such materials in the form of laminates, sheet hydroforming technology are studied under the condition of uniform blank holder force for three-layered aluminum and aluminum-composite laminates using orthogonal carbon and Kevlar as well as glass fiber in the middle. The experimental results validate the finite element results and they exhibited that the forming limit of glass fiber in the middle is the highest among the studied materials, while carbon fiber material performs the worst. Furthermore, the crack modes are different for the three kinds of fiber materials investigated in the research. This study provides fundamental guidance for the selection of multi-layer sheet materials in the future manufacturing field.

  5. Seminoma testicular form unusual presentation and clinical course

    International Nuclear Information System (INIS)

    Roldán G, Arén O.; Varangot, M.; Levin, R.; Delgado, L.; Viola, A.; Vázquez, A.; Musé, I.

    2004-01-01

    Introduction: The recognized sensitivity to treatment (tto) onco specific tumors testicular germ, and in particular the range seminoma, makes the finding of patients (ptes) having a poor outcome and lack of response to it, represents a striking fact. The high rate of redemption described in ptes relapsing after response to first line tto, confronted with identifying ptes that require the design of therapeutic strategies multidisciplinary individualized resistant to the presence of residual masses. Patients and methods: From the presentation of 6 clinical cases of carriers ptes seminoma (TS) with unusual clinical presentation and evolution, is performed literature review including: 1 Relapse of stage I ptes with TS after adjuvant radiotherapy - Cases No. 1 and 2 2 primary retroperitoneal seminoma - Clinical Case 3 3 oncospecific treatment refractory seminoma - Clinical cases 4, 5 and 6 discussion:1. TS stage I ptes with complementary receiving interval reaches radiant tto Progression-free 98% at 5 years and an overall survival of 94% at 10 years. In cases we report only the lung relapse (case 1) and bone (case 2) are evident to 17 and 12 months after diagnosis. The role of surgery and salvage chemotherapy is emphasized, and the poor prognosis of the unusual second relapse. 2 TS retroperitoneal extragonadal start is, according to the literature, less frequent than primarily mediastinal. Moreover, within this group 83% corresponds to non-seminoma. Chemotherapy is the tto of choice with 88% of without overall differences from the beginning of mediastinal survival. 3 Carriers ptes advanced seminoma treated with cisplatin-based chemotherapy (cisplatin with or without bleomycin -etopósido) achieve 70-90% complete responses. approximately 50% of carriers, a second relapse achieved complete response with vinblastine - ifosfamide and cisplatin (VIP). Given the low frequency of this situation, the role of High-dose chemotherapy with stem cell transplantation in patients

  6. Methodology Series Module 8: Designing Questionnaires and Clinical Record Forms.

    Science.gov (United States)

    Setia, Maninder Singh

    2017-01-01

    As researchers, we often collect data on a clinical record form or a questionnaire. It is an important part of study design. If the questionnaire is not well designed, the data collected will not be useful. In this section of the module, we have discussed some practical aspects of designing a questionnaire. It is useful to make a list of all the variables that will be assessed in the study before preparing the questionnaire. The researcher should review all the existing questionnaires. It may be efficient to use an existing standardized questionnaire or scale. Many of these scales are freely available and may be used with an appropriate reference. However, some may be under copyright protection and permissions may be required to use the same questionnaire. While designing their own questionnaire, researchers may use open- or close-ended questions. It is important to design the responses appropriately as the format of responses will influence the analysis. Sometimes, one can collect the same information in multiple ways - continuous or categorical response. Besides these, the researcher can also use visual analog scales or Likert's scale in the questionnaire. Some practical take-home points are: (1) Use specific language while framing the questions; (2) write detailed instructions in the questionnaire; (3) use mutually exclusive response categories; (4) use skip patterns; (5) avoid double-barreled questions; and (6) anchor the time period if required.

  7. Investigation into the Fiber Orientation Effect on the Formability of GLARE Materials in the Stamp Forming Process

    Science.gov (United States)

    Liu, Shichen; Lang, Lihui; Sherkatghanad, Ehsan; Wang, Yao; Xu, Wencai

    2018-04-01

    Glass-reinforced aluminum laminate (GLARE) is a new class of fiber metal laminates (FMLs) which has the advantages such as high tensile strength, outstanding fatigue, impact resistance, and excellent corrosion properties. GLARE has been extensively applied in advanced aerospace and automobile industries. However, the deformation behavior of the glass fiber during forming must be studied to the benefits of the good-quality part we form. In this research, we focus on the effect of fiber layer orientation on the GLARE laminate formability in stamp forming process. Experimental and numerical analysis of stamping a hemisphere part in different fiber orientation is investigated. The results indicate that unidirectional and multi-directional fiber in the middle layer make a significant effect on the thinning and also surface forming quality of the three layer sheet. Furthermore, the stress-strain distribution of the aluminum alloy and the unique anisotropic property of the fiber layer exhibit that fiber layer orientation can also affect the forming depths as well as the fracture modes of the laminate. According to the obtained results, it is revealed that multi-directional fiber layers are a good alternative compared to the unidirectional fibers especially when a better formability is the purpose.

  8. Form measurements in an industrial CT scanner investigated using a polymer step gauge

    DEFF Research Database (Denmark)

    Angel, J.; Stolfi, Alessandro; De Chiffre, Leonardo

    2015-01-01

    . The present investigation concerns the measurement of flatness at different positions in the CT measurement volume using a milled miniature step gauge. The artifact is a 42 mm long step gauge with 11 grooves at 2 mm steps, made of polyphenylene sulphide PPS (? = 1.650 g/cm3), with limited form...... error and good surface finish. A total of 132 flatness measurements were performed on the left step gauge grooves. The linear distribution of the grooves pointed out a non-uniform CT performance over the step gauge length with max deviation up to 25 μm. However, an appropriate choice of parameters...... yielded a reduction of the max deviation along the step gauge length by approximately 13 μm....

  9. Retooling Institutional Support Infrastructure for Clinical Research

    Science.gov (United States)

    Snyder, Denise C.; Brouwer, Rebecca N.; Ennis, Cory L.; Spangler, Lindsey L.; Ainsworth, Terry L.; Budinger, Susan; Mullen, Catherine; Hawley, Jeffrey; Uhlenbrauck, Gina; Stacy, Mark

    2016-01-01

    Clinical research activities at academic medical centers are challenging to oversee. Without effective research administration, a continually evolving set of regulatory and institutional requirements can detract investigator and study team attention away from a focus on scientific gain, study conduct, and patient safety. However, even when the need for research administration is recognized, there can be struggles over what form it should take. Central research administration may be viewed negatively, with individual groups preferring to maintain autonomy over processes. Conversely, a proliferation of individualized approaches across an institution can create inefficiencies or invite risk. This article describes experiences establishing a unified research support office at the Duke University School of Medicine based on a framework of customer support. The Duke Office of Clinical Research was formed in 2012 with a vision that research administration at academic medical centers should help clinical investigators navigate the complex research environment and operationalize research ideas. The office provides an array of services that have received high satisfaction ratings. The authors describe the ongoing culture change necessary for success of the unified research support office. Lessons learned from implementation of the Duke Office of Clinical Research may serve as a model for other institutions undergoing a transition to unified research support. PMID:27125563

  10. 77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Science.gov (United States)

    2012-02-27

    ..., Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the Agencies... criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of... review to assure the protection of the rights and welfare of subjects in clinical investigations. The...

  11. [ISO 9001certification of a quality management system in a clinical investigation center].

    Science.gov (United States)

    Chesnais, Jimmy; Fougerou-Leurent, Claire; Laforest, Claire; Renault, Alain; Bellissant, Eric; Laviolle, Bruno

    2018-05-03

    Beyond the application of legal requirements, clinical trials must have a permanent approach of quality control. The clinical investigation centers (CICs) are academic structures of clinical research certified by the French National institute of health and medical research (Inserm) and whose functioning relies on recommendations of good practice. It is important to accompany this standardization of practices by the implementation of a quality management system. This article presents the process that enabled the CIC of Rennes to become certified ISO 9001 by French standards association (Afnor) certification in May, 2016. The application of the fundamental principles of the standard ISO 9001 in the domain of clinical research is approached. The problem of the perimeter for the certification and the related process mapping are exposed. The activities of methodology, management and analysis of clinical studies were chosen for the initial certification of the CIC of Rennes. The perspectives for the extension of the perimeter of certification are also approached at the end of article. Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.

  12. Clinical outcomes of isolated renal failure compared to other forms of organ failure in patients with severe acute pancreatitis.

    Science.gov (United States)

    Gougol, Amir; Dugum, Mohannad; Dudekula, Anwar; Greer, Phil; Slivka, Adam; Whitcomb, David C; Yadav, Dhiraj; Papachristou, Georgios I

    2017-08-07

    To assess differences in clinical outcomes of isolated renal failure (RF) compared to other forms of organ failure (OF) in patients with severe acute pancreatitis (SAP). Using a prospectively maintained database of patients with acute pancreatitis admitted to a tertiary medical center between 2003 and 2016, those with evidence of persistent OF were classified to renal, respiratory, cardiovascular, or multi-organ (2 or more organs). Data regarding demographics, comorbidities, etiology of acute pancreatitis, and clinical outcomes were prospectively recorded. Differences in clinical outcomes after development of isolated RF in comparison to other forms of OF were determined using independent t and Mann-Whitney U tests for continues variables, and χ 2 test for discrete variables. Among 500 patients with acute pancreatitis, 111 patients developed persistent OF: mean age was 54 years, and 75 (67.6%) were male. Forty-three patients had isolated OF: 17 (15.3%) renal, 25 (21.6%) respiratory, and 1 (0.9%) patient with cardiovascular failure. No differences in demographics, etiology of acute pancreatitis, systemic inflammatory response syndrome scores, or development of pancreatic necrosis were seen between patients with isolated RF vs isolated respiratory failure. Patients with isolated RF were less likely to require nutritional support (76.5% vs 96%, P = 0.001), ICU admission (58.8% vs 100%, P = 0.001), and had shorter mean ICU stay (2.4 d vs 15.7 d, P pancreatitis.

  13. Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms.

    Science.gov (United States)

    Hermans, Andre; Abend, Andreas M; Kesisoglou, Filippos; Flanagan, Talia; Cohen, Michael J; Diaz, Dorys A; Mao, Y; Zhang, Limin; Webster, Gregory K; Lin, Yiqing; Hahn, David A; Coutant, Carrie A; Grady, Haiyan

    2017-11-01

    This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS) for immediate release (IR) solid oral dosage forms. A roadmap toward the development of CRS for IR products containing active ingredients with a non-narrow therapeutic window is discussed, within the context of mechanistic dissolution understanding, supported by in-human pharmacokinetic (PK) data. Two case studies present potential outcomes of following the CRS roadmap and setting dissolution specifications. These cases reveal some benefits and challenges of pursuing CRS with additional PK data, in light of current regulatory positions, including that of the US Food and Drug Administration (FDA), who generally favor this approach, but with the understanding that both industry and regulatory agency perspectives are still evolving in this relatively new field. The CRS roadmap discussed in this manuscript also describes a way to develop clinically relevant dissolution specifications based primarily on dissolution data for batches used in pivotal clinical studies, acknowledging that not all IR product development efforts need to be supported by additional PK studies, albeit with the associated risk of potentially unnecessarily tight manufacturing controls. Recommendations are provided on what stages during the life cycle investment into in vivo studies may be valuable. Finally, the opportunities for CRS within the context of post-approval changes, Modeling and Simulation (M&S), and the application of biowaivers, are briefly discussed.

  14. Provider-to-provider communication in dermatology and implications of missing clinical information in skin biopsy requisition forms: a systematic review.

    Science.gov (United States)

    Comfere, Nneka I; Sokumbi, Olayemi; Montori, Victor M; LeBlanc, Annie; Prokop, Larry J; Murad, M Hassan; Tilburt, Jon C

    2014-05-01

    Various components of the skin biopsy requisition form (SBRF) may contribute to accurate dermatopathologic interpretation. A search of electronic databases, including those of Ovid MEDLINE In-Process & Other Non-Indexed Citations, Ovid MEDLINE, Ovid EMBASE, the Cochrane Database of Systematic Reviews, the Cochrane Central Register of Controlled Trials, and Scopus, was conducted from inception to October 2011. Two authors independently screened all articles for eligibility. Inclusion criteria required material to represent original studies on skin biopsy and pathology requisition forms. Data abstracted from each article that met the inclusion criteria included details of the study characteristics, including the study location, type of pathology practice, specimen type, type of dermatoses, medical specialty of the requesting provider, suggested clinical components, and format of the SBRF. Of 32 titles and abstracts reviewed, seven articles were included. From these, we determined that dermatologists, general practitioners and surgeons completed SBRFs. Commonly included components were patient demographics and requesting clinician characteristics. Clinical information and differential diagnosis were provided in 4% (two of 48 surgeons) to 36% (18 of 50 dermatologists) of requisitions. Most SBRFs did not include information on specimen type, clinical morphology, photographs or clinical history. The limited medical literature demonstrates variation in the content of SBRFs across clinicians and practices, and suggests an important target for improvement in the quality of communication and dermatologic care by requesting clinicians and pathologists. © 2013 The International Society of Dermatology.

  15. Clinical investigation of thyroid disorders

    International Nuclear Information System (INIS)

    Miller, J.L.

    1981-01-01

    Current investigations of thyroid dysfunction available to the clinician are reviewed and correlated with disease processes. The aim is to provide a simplified guide to the investigation of thyroid disorders

  16. Understanding Career Success and Its Contributing Factors for Clinical and Translational Investigators

    Science.gov (United States)

    Robinson, Georgeanna F.W.B.; Schwartz, Lisa S.; DiMeglio, Linda A.; Ahluwalia, Jasjit S.; Gabrilove, Janice L.

    2015-01-01

    Purpose To understand the factors that facilitate career success for career development awardees in clinical and translational science and to reconceptualize understanding of career success for this population. Method In 2013–2014, the authors conducted semi-structured interviews with former NIH KL2 or K12 scholars from nine Clinical and Translational Science Award-funded institutions. Participants either had or had not secured independent funding at least two years after the end of their last K award. Questions covered the factors that facilitate or hinder junior investigators’ transition to independent funding. Interviews were recorded and transcribed and the transcripts analyzed thematically. Results Forty individuals participated, with equal representation by men and women and by independently and not independently funded investigators. Personal factors that facilitated success included: networks, persistence and resilience, initiative, autonomy, and personal and professional balance. Organizational factors included: appropriate mentorship, protected research time, and institutional resources and support. Even independently funded participants described challenges regarding career direction. Five participants without independent funding modeled a broad spectrum of successful career paths, having assumed leadership positions not reliant on grant funding. Alternative definitions of career success included: improving public health, enjoying work, seeing mentees succeed, and receiving external acknowledgement of successes. Conclusions Awareness of the factors that facilitate or hinder career success can help junior faculty, mentors, and institutional leaders support career development in clinical and translational science. New definitions of career success are needed, as are career paths for faculty who want to engage in research in roles other than principal investigator. PMID:26509600

  17. Diagnostic Construct Validity of MMPI-2 Restructured Form (MMPI-2-RF) Scale Scores

    Science.gov (United States)

    Sellbom, Martin; Bagby, R. Michael; Kushner, Shauna; Quilty, Lena C.; Ayearst, Lindsay E.

    2012-01-01

    In the current investigation, the authors examined the diagnostic construct validity of the "Minnesota Multiphasic Personality Inventory-2-Restructured Form" (MMPI-2-RF) in a patient sample. All participants were diagnosed via the "Structured Clinical Interview" for DSM-IV Axis I Disorders (SCID-I/P). The data set used in this…

  18. Basic and clinical investigation of T3 immunoassay kit

    International Nuclear Information System (INIS)

    Konishi, Junji; Nakajima, Akiko; Morita, Rikushi; Endo, Keigo; Ikekubo, Katsuji

    1976-01-01

    T 3 immunoassay kit was investigated basically and clinically. A good result was obtained at the prescribed incubation temperature and for 16 hours of incubation time. Moreover, it was thought to be possible that incubation time could be shortened to 1 - 4 hours at 37 0 C. Specificity of antibody was good. Recovery of added T 3 was 100+-5 (S.D.) % on an average and parallel of dilution curve of high T 3 serum was also good. Variation coefficient of accuracy of this kit was 1.5 - 2.1 % and that of reproducibility was 1.3 - 6.6 %. Mild hemolysis did not affect measurement value. Serum T 3 level in normals, untreated patients with Basedow's disease and patients with primary hypothyroidism was 142+-21 ng/100 ml, 452+-156 ng/100 ml and 67+-17 ng/100 ml, respectively. Serum T 3 level in patients with Hashimoto's disease was distributed to a wide extent, but that of patients with goiter and simple goiter ranged within normal range. On the other side, serum T 3 level of normal pregnant woman was high and that of patients with anorexia nervosa showed low level. From the above mentioned results, it was concluded that this kit was simple in method and good in sensitivity, specificity and reproducibility and it was also useful for clinical applications. (M. Tsunoda)

  19. Experimental Investigation of Tensile Test on Connection of Cold-formed Cut-curved Steel Section

    Science.gov (United States)

    Sani, Mohd Syahrul Hisyam Mohd; Muftah, Fadhluhartini; Rahman, Nurul Farraheeda Abdul; Fakri Muda, Mohd

    2017-08-01

    Cold-formed steel (CFS) is widely used as structural and non-structural components such as roof trusses and purlin. A CFS channel section with double intermediate web stiffener and lipped is chosen based on the broader usage in roof truss construction. CFS section is cut to form cold-formed pre-cut-curved steel section and lastly strengthened by several types of method or likely known as connection to establish the cold-formed cut-curved steel (CFCCS) section. CFCCS is proposed to be used as a top chord section in the roof truss system. The CFCCS is to resist the buckling phenomena of the roof truss structure and reduced the compression effect on the top chord. The tensile test connection of CFCCS section, especially at the flange element with eight types of connection by welding, plate with self-drilling screw and combination is investigated. The flange element is the weakest part that must be solved first other than the web element because they are being cut totally, 100% of their length for curving process. The testing is done using a universal testing machine for a tensile load. From the experiment, specimen with full welding has shown as a good result with an ultimate load of 13.37 kN and reported having 35.41% when compared with normal specimen without any of connection methods. Furthermore, the experimental result is distinguished by using Eurocode 3. The failure of a full welding specimen is due to breaking at the welding location. Additionally, all specimens with either full weld or spot weld or combination failed due to breaking on weld connection, but specimen with flange plate and self-drilling screw failed due to tilting and bearing. Finally, the full welding specimen is chosen as a good connection to perform the strengthening method of CFCCS section.

  20. Clinical data miner: an electronic case report form system with integrated data preprocessing and machine-learning libraries supporting clinical diagnostic model research.

    Science.gov (United States)

    Installé, Arnaud Jf; Van den Bosch, Thierry; De Moor, Bart; Timmerman, Dirk

    2014-10-20

    Using machine-learning techniques, clinical diagnostic model research extracts diagnostic models from patient data. Traditionally, patient data are often collected using electronic Case Report Form (eCRF) systems, while mathematical software is used for analyzing these data using machine-learning techniques. Due to the lack of integration between eCRF systems and mathematical software, extracting diagnostic models is a complex, error-prone process. Moreover, due to the complexity of this process, it is usually only performed once, after a predetermined number of data points have been collected, without insight into the predictive performance of the resulting models. The objective of the study of Clinical Data Miner (CDM) software framework is to offer an eCRF system with integrated data preprocessing and machine-learning libraries, improving efficiency of the clinical diagnostic model research workflow, and to enable optimization of patient inclusion numbers through study performance monitoring. The CDM software framework was developed using a test-driven development (TDD) approach, to ensure high software quality. Architecturally, CDM's design is split over a number of modules, to ensure future extendability. The TDD approach has enabled us to deliver high software quality. CDM's eCRF Web interface is in active use by the studies of the International Endometrial Tumor Analysis consortium, with over 4000 enrolled patients, and more studies planned. Additionally, a derived user interface has been used in six separate interrater agreement studies. CDM's integrated data preprocessing and machine-learning libraries simplify some otherwise manual and error-prone steps in the clinical diagnostic model research workflow. Furthermore, CDM's libraries provide study coordinators with a method to monitor a study's predictive performance as patient inclusions increase. To our knowledge, CDM is the only eCRF system integrating data preprocessing and machine-learning libraries

  1. Investigating the connections between health lean management and clinical risk management.

    Science.gov (United States)

    Crema, Maria; Verbano, Chiara

    2015-01-01

    The purpose of this paper is to investigate connections and overlaps between health lean management (HLM) and clinical risk management (CRM) understanding whether and how these two approaches can be combined together to pursue efficiency and patient safety improvements simultaneously. A systematic literature review has been carried out. Searching in academic databases, papers that focus not only on HLM, but also on clinical errors and risk reduction, were included. The general characteristics of the selected papers were analysed and a content analysis was conducted. In most of the papers, pursing objectives of HLM and CRM and adopting tools and practices of both approaches, results of quality and, particularly, of safety improvements were obtained. A two-way arrow between HLM and CRM emerged but so far, none of the studies has been focused on the relationship between HLM and CRM. Results highlight an emerging research stream, with many useful theoretical and practical implications and opportunities for further research.

  2. Acne vulgaris: prevalence and clinical forms in adolescents from São Paulo, Brazil*

    Science.gov (United States)

    Bagatin, Ediléia; Timpano, Denise Lourenço; Guadanhim, Lilia Ramos dos Santos; Nogueira, Vanessa Mussupapo Andraus; Terzian, Luiz Roberto; Steiner, Denise; Florez, Mercedes

    2014-01-01

    BACKGROUND Acne is a common disease in adolescents, but there are no epidemiological data for acne in Brazil. OBJECTIVES To estimate the prevalence and degree of acne in adolescents from Sao Paulo and study socio-demographic factors, family history and lifestyle, associated with the disease. METHODS Cross-sectional study with 452 adolescents aged between 10 and 17 (mean=13.3 years), students from elementary and high school, examined by 3 independent evaluators. RESULTS 62.4% were female, 85.8% white and 6.4% were aged 14. The prevalence was 96.0% and increased with age - all students over 14 had acne. The most prevalent form of acne was comedonal (61.1%), followed by mild (30.6%) and moderate (7.6%) papular-pustular, which affected mostly the face (97.5%). About half of the adolescents reported family history for acne in mother or father, and 20.6% reported previous treatment for acne. There was a higher chance of presenting non-comedonal acne with increased age (pacne in adolescents varies widely due to the clinical features and diagnostic methods used. Adolescents whose brothers/sisters had acne (OR=1.7-p=0.027) and those over 13 (OR=8.3-pacne. CONCLUSION This study showed high prevalence of acne in adolescents from Sao Paulo, predominantly the comedonal form on the face, with a higher chance of presenting non-comedonal acne with increased age. PMID:24937816

  3. 25 (OH) D3 levels, incidence and recurrence of different clinical forms of BPPV.

    Science.gov (United States)

    Maslovara, Sinisa; Butkovic Soldo, Silva; Sestak, Anamarija; Milinkovic, Katarina; Rogic-Namacinski, Jasna; Soldo, Anamarija

    2017-06-11

    Benign Paroxysmal Positional Vertigo (BPPV) is the most common cause of dizziness in the general population. It is a condition with potential impact of reduced levels of vitamin D on its recurrent attacks. The aim of this study was to measure the serum levels of 25-hydroxyvitamin D3 (25-OH D3) in patients with BPPV and determine whether there is a difference in the serum levels of vitamin D3 between patients with and without recurrence, as well as between the different clinical forms of BPPV. The study included 40 patients who came to the regular medical examination, diagnosed with PC-BPPV based on the positive Dix-Hallpike's test. All patients underwent Epley manoeuvre after the diagnosis. Patients were classified according to current guidelines for levels of vitamin D3 in the serum in three groups: the deficiency, insufficiency and adequate level. The average serum level of 25-OH D3 among respondents was 20.78ng/mL, indicating a lack or insufficiency of the aforementioned 25-OH D3. According to the levels of 25-OH D3, most patients suffer from deficiency (47.5%). 7 (17.5%) respondents had adequate blood level of 25-OH D3, and 14 (35%) respondents suffer from insufficiency. A significant difference was not found in the serum level of 25-OH D3 between patients with and without BPPV recurrence. There was a significant difference in the serum levels of 25-OH D3 in comparison to the clinical form of the disease. Lower 25-OH D3 values were found in patients with canalithiasis compared to those with cupulolithiasis. There were no significant differences in the vitamin D3 serum level in patients with and without recurrence. The study showed a low level of serum vitamin D3 in most patients, indicating the need for supplemental therapy. Copyright © 2017 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

  4. An Investigation into the Effect of Aging on the Forming Limit Diagram of 6063 Aluminum Alloy

    International Nuclear Information System (INIS)

    Hosseini, S. M.; Hosseimpour, S. J.; Nourouzi, S.; Gorji, A. H.

    2011-01-01

    In this study, the effect of ageing on the forming limit diagram of a commercially available 6063 aluminum alloy has been investigated. For this purpose, initially the specimens have been aged at 200 deg. C and at various times. The hardness tests have been carried out and the hardness-aging time curve has been obtained for this alloy. Moreover, the mechanical properties were determined by tensile test. Then, the forming limit diagrams have been achieved by using the out-of-plane formability test method at four different conditions containing: annealed, under-aged, peak-aged, and over-aged. The results indicate that in comparing with the annealed condition the FLD 0 decreases significantly from the under-aged condition to the peak-aged condition and increases slightly from the peak-aged condition to the over-aged condition.

  5. Investigation of the intermediate- and high-density forms of amorphous ice by molecular dynamics calculations and diffraction experiments

    International Nuclear Information System (INIS)

    Tse, John S.; Klug, Dennis D.; Guthrie, Malcolm; Benmore, Chris J.; Urquidi, Jacob; Tulk, Chris A.

    2005-01-01

    The lack of an 'isosbestic' point in the oxygen-oxygen atom radial distribution functions (RDFs) for the HDA→LDA ice transformation at ambient pressure derived from molecular dynamics (MD) calculations show unequivocally that intermediate phases are not equilibrium mixtures of these two amorphous forms. This is supported by x-ray structure factor data, where it is found that linear combinations of the starting and end amorphous forms do not describe intermediate forms of amorphous ice formed during the transformation. This reflects the fact that the x-ray data are heavily weighted to O-O correlations and therefore sensitive to the basic structural changes that occur during the relaxation process. The ice Ih→HDA transformation is also reexamined using MD to identify its thermodynamic nature. This apparently first-order transition induced by a mechanical instability is investigated by compression followed by decompression to negative pressures. In this study we demonstrated that the full van der Waals loop for this transition can be identified

  6. Electron probe microanalysis for clinical investigations: Microdrop and soft tissue analysis

    International Nuclear Information System (INIS)

    Ingram, M.J.; Ingram, F.D.

    1984-01-01

    The most important advantage offered by electron probe microanalysis (EPA) for clinical investigations is the ability to analyze smaller volumes of tissue than is possible with conventional techniques. The sample can be a biological soft tissue specimen, which involves subcellular localization, or a picoliter fluid droplet. In either case, the analysis can be nondestructive and permit multiple analyses for a number of elements in a given sample. The most highly developed electron microprobe analytical technique is fluid drop analysis, popularly referred to as microdrop analysis. This method provides the investigator with an analytic capability that has an accuracy of measurement often 1% or better on 20 to 30 picoliter fluid droplets. Electron microprobe techniques have been used for studies of animal hard tissue and for studies that involve insoluble inclusions. However, the development of techniques for studies of labile constituents in animal soft tissue has been much slower. It has been necessary not only to develop appropriate methods of tissue preparation, but also to establish sound techniques for tissue collection. Although there are adequate methods for collection of most types of tissue from laboratory animals, many of these methods are not suitable for human subjects. In order to provide the reader with a better understanding of the capabilities and potential for the application of electron microprobe methodology to problems in clinical medicine, the authors discuss some of their experiences with liquid droplet analysis and quantitative electrolyte distribution measurements in animal soft tissue

  7. Intestinal morphological effect of brachytherapy of low rate of dose, administrated in therapeutic form and its clinical manifestations in uterine cervix tumors

    International Nuclear Information System (INIS)

    Mendoza, Carmen; Contreras, Manuel

    2005-01-01

    Brachytherapy is effective to eradicate cancer in the cervix, in order to obtain the control of disease we use high dose with vesical and rectum toxicity. The objective is to investigate if brachytherapy by itself is the cause of intestinal damage, to know in addition if the intensity of the clinic manifestations is in direct relation to the given radiation dose and this gets worse when it is received in several applications. Hypothesis: The intensity of the radiation with brachytherapy of low rate of dose is proportional to the degree of clinical manifestations and morphologic damage of the intestine. A prospective analysis was made inpatients with cancer of cervix from september 2000 to june 2004. Each patient who enters to the department of brachytherapy of the hospital must be done laboratory examination that includes plaque and coagulation test before being accepted. We use the clinical card and a table in order to register data concerning teletherapy, implants of brachytherapy of low rate of dose, symptoms of intestinal toxicity and details of colonoscopia. Subsequent to the hospitable discharge the patient is sent to gastroenterology for clinical evaluation and to realize colonoscopia. From september 2000 to june 2004, 540 patients entered, 80 patients (15%) displayed intestinal manifestations, all received teletherapy and brachytherapy, nobody else received brachytherapy in exclusive form and only one patient (0.1%) received the total of the dose in 2 applications. The equipment of teletherapy Primus with energy of 6 and 18 Mv and implants of brachytherapy Manchester were used (70/55 patients). 79 (98%) patients received dose between 85-75 Gy in one single application, 58 (72%) received the total of the dose to the tumor, 21 (26%) in vaginal mucosa. Discussion: Brachytherapy is the cause of the damages in the intestinal mucosa. (The author)

  8. Clinical characteristics of post-neurosurgical Klebsiella pneumoniae meningitis in adults and a clinical comparison to the spontaneous form in a Taiwanese population.

    Science.gov (United States)

    Chang, Wen-Neng; Lu, Chen-Hsien; Huang, Chi-Ren; Chuang, Yao-Chung; Tsai, Nai-Wen; Chang, Chiung-Chih; Chen, Shu-Fang; Wang, Hung-Chen; Yang, Tzu-Ming; Hsieh, Mei-Jen; Chien, Chun-Chih

    2010-03-01

    A total of 46 patients (nine post-neurosurgical, 37 spontaneous) with adult bacterial meningitis (ABM) caused by Klebsiellapneumoniae infection were included in this study. The nine patients in the post-neurosurgical K. pneumoniae ABM group (seven male, two female) had a mean age of 48.9 years. Two patients in this group also had diabetes mellitus (DM) and one had liver disease. The most common presentation of patients in post-neurosurgical K. pneumoniae ABM group was fever (nine patients), followed by altered consciousness (seven patients) and hydrocephalus (six patients). With medical and/or surgical treatment, a mortality of 22.2% (2/9) occurred. Compared to patients who had spontaneous K. pneumoniae ABM, those with the post-neurosurgical form had a lower incidence of community-acquired infection, seizure and DM, but had a higher incidence of leukocytosis, hydrocephalus, cerebrospinal fluid leak and bacterial strains with extended-spectrum beta-lactamase. Univariate analysis found these clinical differences to be statistically significant, however they were not significant on multivariate analysis. This study reveals that there are clinical differences between the post-neurosurgical and spontaneous presentations of K. pneumoniae ABM. Copyright 2009 Elsevier Ltd. All rights reserved.

  9. Investigating self-esteem in individuals with schizophrenia: relevance of the Self-Esteem Rating Scale-Short Form.

    Science.gov (United States)

    Lecomte, Tania; Corbière, Marc; Laisné, François

    2006-06-30

    Studies investigating self-esteem in individuals with severe mental illness, either as a treatment goal, outcome or correlate to other variables, have increased over the past few years. One of the main difficulties in assessing self-esteem is the assessment itself, often measuring global and stable self-esteem as in the Rosenberg Self-Esteem Scale, or requiring extensive training and long interviews. The present article aims at demonstrating the relevance of the French and English versions of the Self-Esteem Rating Scale-Short Form with individuals with severe mental illness. The instrument's reliability and validity were investigated in a sample of 250 French Canadian college students, 247 British college students and three samples of English- or French-speaking individuals with severe mental illness (N=254, N=150 and N=171). Confirmatory factor analysis revealed that a shorter version of the instrument (20 items), with a positive and a negative self-esteem factor, had a great validity for all the samples studied. The Self-Esteem Rating Scale-Short Form, with its positive and negative self-esteem subscales, appears to be a valid and reliable self-esteem measure for individuals with mental health problems. Limitations of this study and future directions are discussed.

  10. Subsurface injection of dissolved ferric chloride to form a chemical barrier: Laboratory investigations

    International Nuclear Information System (INIS)

    Morrison, S.J.; Spangler, R.R.; Morris, S.A.

    1996-01-01

    A chemical barrier is a permeable zone of reactive materials emplaced in the subsurface to remove ground-water contaminants while allowing clean ground water to pass through. Because dissolved ferric chloride hydrolyzes to amorphous ferric oxyhydroxide when it contacts calcite (CaCO 3 ), it may be viable to emplace a zone of amorphous ferric oxyhydroxide (an absorbent for U, Mo, and other inorganic contaminants) into calcite-bearing geologic units by injecting ferric chloride through wells. For a chemical barrier to be successful, it must remain permeable and must be immobile. This investigation monitored chemical compositions, hydraulic conductivity, and iron mobility in laboratory columns and in a two-dimensional tank to determine the viability of injecting ferric chloride to form an amorphous ferric oxyhydroxide chemical barrier. The authors introduced a ferric chloride solution (1,345 mg/1[0.024 m] Fe) to calcite-bearing alluvial gravel to form a chemical barrier of amorphous ferric oxyhydroxide, followed by solutions contaminated with U and Mo. The simulated chemical barriers decreased U and Mo concentrations to less than 0.05 mg/l (2.1 x 10 -7 m) and 0.01 (1.0 x 10 -7 m), respectively; however, the breakthrough front is spread out with concentrations increasing to more than regulatory guideline values sooner than predicted. The hydraulic conductivity of calcite-bearing alluvial gravel decreased substantially during ferric chloride introduction because of the formation of carbon dioxide but increased to within factors of 1 to 5 of the original value as synthetic ground water flowed through the system. Amorphous ferric oxyhydroxide that formed in these experiments remained immobile at flow rates exceeding those typical of ground water. These laboratory results, in conjunction with site-specific characterization data, can be used to design chemical barriers emplaced by injection of ferric chloride

  11. Patterns and contrasts in ophthalmic investigation.

    Science.gov (United States)

    Drasdo, N

    1988-01-01

    The Snellen test has been the most popular clinical measurement of spatial vision for over a century, but it does not fully express the visual ability of an individual. For more analytical purposes the information capacity of the visual system may be assessed by tests of contrast sensitivity and peripheral vision. The visual system selectively reduces the spatial information content of the visual field to avoid overloading the limited capacity for perception and decision making in the brain. The ways in which this reduction occurs and the processing of spatial information is of interest in many disciplines, and theoretical knowledge has been accelerated by the study of artificial intelligence. These processes may be investigated in human subjects by psychophysical and electrophysiological techniques. This provides additional information for diagnostic purposes and will form the basis of new systems of clinical investigation.

  12. Clinical and ECG investigations in subjects with acute carbon monoxide poisoning

    Energy Technology Data Exchange (ETDEWEB)

    Capellini, A; Tomasini, M; Limonta, A

    1974-01-01

    Research carried out on more than 100 workers hospitalized for acute CO poisoning at the Milan Clinica del Lavoro and some 50 subjects undergoing treatment at the Milan polyclinic. The purpose of the research was to investigate the incidence and frequency of myocardial and coronary impairment in cases of acute CO poisoning. The authors concluded from their clinical and ECG findings that myocardial and coronary impairment in subjects suffering from acute CO poisoning was rarely serious or irreversible unless there was preexistent coronary disease. (CIS Abstr. Vol. 2)

  13. In vitro characterization of biofilms formed by Kingella kingae.

    Science.gov (United States)

    Kaplan, J B; Sampathkumar, V; Bendaoud, M; Giannakakis, A K; Lally, E T; Balashova, N V

    2017-08-01

    The Gram-negative bacterium Kingella kingae is part of the normal oropharyngeal mucosal flora of children biofilm formation has been coupled with pharyngeal colonization, osteoarticular infections, and infective endocarditis, no studies have investigated biofilm formation in K. kingae. In this study we measured biofilm formation by 79 K. kingae clinical isolates using a 96-well microtiter plate crystal violet binding assay. We found that 37 of 79 strains (47%) formed biofilms. All strains that formed biofilms produced corroding colonies on agar. Biofilm formation was inhibited by proteinase K and DNase I. DNase I also caused the detachment of pre-formed K. kingae biofilm colonies. A mutant strain carrying a deletion of the pilus gene cluster pilA1pilA2fimB did not produce corroding colonies on agar, autoaggregate in broth, or form biofilms. Biofilm forming strains have higher levels of pilA1 expression. The extracellular components of biofilms contained 490 μg cm -2 of protein, 0.68 μg cm -2 of DNA, and 0.4 μg cm -2 of total carbohydrates. We concluded that biofilm formation is common among K. kingae clinical isolates, and that biofilm formation is dependent on the production of proteinaceous pili and extracellular DNA. Biofilm development may have relevance to the colonization, transmission, and pathogenesis of this bacterium. Extracellular DNA production by K. kingae may facilitate horizontal gene transfer within the oral microbial community. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Science.gov (United States)

    2010-01-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0605... clinical investigators and sponsors better understand their responsibilities related to continuing review...-463-6332 or 301-796-3400); or the Office of Communication, Outreach and Development (HFM-40), Center...

  15. Investigation of microscopic radiation damage in waste forms using ODNMR and AEM techniques. (EMSP Project Final Report)

    International Nuclear Information System (INIS)

    Liu, G.; Luo, J.; Beitz, J.; Li, S.; Williams, C.; Zhorin, V.

    2000-01-01

    This project seeks to understand the microscopic effects of radiation damage in nuclear waste forms. The authors' approach to this challenge encompasses studies of ceramics and glasses containing short-lived alpha- and beta-emitting actinides with electron microscopy, laser and X-ray spectroscopic techniques, and computational modeling and simulations. In order to obtain information on long-term radiation effects on waste forms, much of the effort is to investigate α-decay induced microscopic damage in 18-year old samples of crystalline yttrium and lutetium orthophosphates that initially contained ∼ 1(wt)% of the alpha-emitting isotope 244 Cm (18.1 y half life). Studies also are conducted on borosilicate glasses that contain 244 Cm, 241 Am, or 249 Bk, respectively. The authors attempt to gain clear insights into the properties of radiation-induced structure defects and the consequences of collective defect-environment interactions, which are critical factors in assessing the long-term performance of high-level nuclear waste forms

  16. Investigation of microscopic radiation damage in waste forms using ODNMR and AEM techniques. (EMSP Project Final Report)

    Energy Technology Data Exchange (ETDEWEB)

    Liu, G.; Luo, J.; Beitz, J.; Li, S.; Williams, C.; Zhorin, V.

    2000-04-21

    This project seeks to understand the microscopic effects of radiation damage in nuclear waste forms. The authors' approach to this challenge encompasses studies of ceramics and glasses containing short-lived alpha- and beta-emitting actinides with electron microscopy, laser and X-ray spectroscopic techniques, and computational modeling and simulations. In order to obtain information on long-term radiation effects on waste forms, much of the effort is to investigate {alpha}-decay induced microscopic damage in 18-year old samples of crystalline yttrium and lutetium orthophosphates that initially contained {approximately} 1(wt)% of the alpha-emitting isotope {sup 244}Cm (18.1 y half life). Studies also are conducted on borosilicate glasses that contain {sup 244}Cm, {sup 241}Am, or {sup 249}Bk, respectively. The authors attempt to gain clear insights into the properties of radiation-induced structure defects and the consequences of collective defect-environment interactions, which are critical factors in assessing the long-term performance of high-level nuclear waste forms.

  17. An empirical investigation of incompleteness in a large clinical sample of obsessive compulsive disorder.

    Science.gov (United States)

    Sibrava, Nicholas J; Boisseau, Christina L; Eisen, Jane L; Mancebo, Maria C; Rasmussen, Steven A

    2016-08-01

    Obsessive Compulsive Disorder (OCD) is a disorder with heterogeneous clinical presentations. To advance our understanding of this heterogeneity we investigated the prevalence and clinical features associated with incompleteness (INC), a putative underlying core feature of OCD. We predicted INC would be prominent in individuals with OCD and associated with greater severity and impairment. We examined the impact of INC in 307 adults with primary OCD. Participants with clinically significant INC (22.8% of the sample) had significantly greater OCD severity, greater rates of comorbidity, poorer ratings of functioning, lower quality of life, and higher rates of unemployment and disability. Participants with clinically significant INC were also more likely to be diagnosed with OCPD and to endorse symmetry/exactness obsessions and ordering/arranging compulsions than those who reported low INC. Our findings provide evidence that INC is associated with greater severity, comorbidity, and impairment, highlighting the need for improved assessment and treatment of INC in OCD. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Radiochemical studies, pre-clinical investigation and preliminary clinical evaluation of "1"7"0Tm-EDTMP prepared using in-house freeze-dried EDTMP kit

    International Nuclear Information System (INIS)

    Das, Tapas; Shinto, Ajit; Kamaleshwaran, Koramadai K.; Sarma, Haladhar D.; Mohammed, Sahiralam Khan; Mitra, Arpit; Lad, Sangita; Rajan, M.G.R.; Banerjee, Sharmila

    2017-01-01

    The objective of the present work is to formulate "1"7"0Tm-EDTMP using an in-house freeze-dried EDTMP kit and evaluate its potential as a bone pain palliation agent. Patient dose of "1"7"0Tm-EDTMP was prepared with high radiochemical purity using the lyophilized kit at room temperature within 15 min. Pre-clinical evaluation in normal Wistar rats revealed selective skeletal accumulation with extended retention. Preliminary clinical investigation in 8 patients with disseminated skeletal metastases exhibited selective uptake in the bone and retention therein for a long duration. - Highlights: • Formulation of patient dose of "1"7"0Tm-EDTMP using freeze-dried EDTMP kit. • Radiochemical studies and pre-clinical evaluation of the agent in animal model. • Clinical evaluation in eight cancer patients with disseminated skeletal metastases.

  19. [What role for paraclinical investigations within clinical trials conducted in psychiatric patients?

    Science.gov (United States)

    Kaladjian, A; Adida, M; Simon, N; Belzeaux, R; Blin, O; Fakra, E; Azorin, J-M

    2016-12-01

    As in the usual care of patients, paraclinical investigations have today only a very modest role in clinical trials in psychiatry, mainly to complete the pre-therapeutical assessments prior to inclusion of subjects or to monitor treatment tolerance. Yet, the accumulation of data in neurosciences suggests the next emergence of biomarkers, whose interest is that they are closely associated to the biological disturbances underlying psychiatric illnesses, and that they are accessible by means of technological tools such as imaging devices. These tools allow to explore the effects on brain of psychotropic medications, such as antidepressants, antipsychotics, or mood stabilizers, in relation to their therapeutic action. The obtained results allow to consider the use of such biomarkers in clinical trials in addition to more conventional approaches. In particular, they could be used as targets to measure brain response to treatment in association with clinical response, to predict a therapeutic response from the neurofunctional characteristics of patients, or to establish the safety profile of drugs on the nervous system. The use of such biomarkers in clinical trials would help to better define the explored populations and their characteristics, as well as the variables to assess, and to better measure the impact of the treatments and their potential harmful effects on the nervous system. © L’Encéphale, Paris, 2016.

  20. Investigating Plagiarism: The Form and The Motivation in Performing Plagiarism in High Education

    Directory of Open Access Journals (Sweden)

    S Sariffuddin

    2017-05-01

    Full Text Available The rapid development of information technology, especially the Internet is pointed out to be factor driving the student to practice plagiarism. Prevention efforts continue to be made both from government policies and stakeholder by creating software anti-plagiarism. However, in the reality the practice of plagiarism re-mains common and relatively more widespread. This practice continues to be varied, so that we need to up-date the information and findings through investigations plagiarism practices in student assign-ments. The method used was a mixed-method approach or mix of quantitative and quali-tative approaches. A quantitative approach was done by using software turnitin.com to scan for plagiarism indication of the level of student assignment in common. To study the behavior of plagiarism, the interview process was also done informally to students who commit high plagiarism. The results showed that the pattern of students’ plagiarism consists of five forms: sham paraphrasing, illicit paraphrasing, other plagiarism, copying verbatim and purloining. Illicit paraphrasing practices are a form of copy-paste literature review and did not pay attention to the bibliography. Besides, the practice of plagiarism is closely associated with low academic writing knowledge. Therefore, the practice of plagiarism should not only be viewed from the perspective of the academic violations, but also from the other perspectives.

  1. [Ethics in clinical research: contextualizing and reductionist problem definitions, forms of ethical reflection and some particular implications].

    Science.gov (United States)

    Roelcke, Volker

    2003-12-01

    The present paper starts off with a short outline of issues, conflicts, and goals of ethical reflection about clinical research. It is then argued that non-reductionist, patient-centred ethics should critically reflect on medically preformed problem definitions, ways of problem solution, and evaluations. The shortcomings of such preformed perceptions and interpretations are illustrated using the examples of dementia research, and the complexities of the notion of risk. A more comprehensive approach including the perceptions, interpretations, and evaluations of the patients' perspective necessitates a form of ethical reflection which takes into account the social and cultural contexts of clinical research, and which therefore relies on concepts and methods of the cultural sciences (in particular history, sociology, and cultural anthropology). The decision for a reductionist, or for a contextualising mode of ethical reflection represents in itself a value decision and needs to be explicitly justified.

  2. Modeling and Investigation of Elongation in Free Explosive Forming of Aluminum Alloy Plate

    OpenAIRE

    R. Alipour; F.Najarian

    2011-01-01

    Because of high ductility, aluminum alloys, have been widely used as an important base of metal forming industries. But the main week point of these alloys is their low strength so in forming them with conventional methods like deep drawing, hydro forming, etc have been always faced with problems like fracture during of forming process. Because of this, recently using of explosive forming method for forming of these plates has been recommended. In this paper free explosive forming of A2024 al...

  3. [Clinical and genetic investigation of families with Waardenburg syndrome type 2].

    Science.gov (United States)

    Chen, H S; Liao, X B; Liu, Y L; He, C F; Zhang, H; Jiang, L; Feng, Y; Mei, L Y

    2016-12-01

    Objective: To investigate the clinical chacteration and molecular pathology of Waardenburg syndrome type 2 in seven families, and provide genetic diagnosis and hereditary counseling for family members. Method: Clinical data of seven families with WS2(14 patients)were collected. Peripheral blood samples of the probands and related family members were collected and genomic DNA was extracted. The coding sequences of microphthalmia associated transcription factor (MITF), sex-determining region Y-box 10(SOX10), snail family zinc finger 2 (SNAI2) and endothelin receptor type B(EDNRB)were analyzed by polymerase chain reaction and DNA sequencing. Then the raw data was analyzed. Result: The most common manifestations of WS2 are sensorineural hearing loss(10/14,71.4%), freckle(7/14, 50.0%),heterochromia iridis(6/14, 42.9%) and premature greying(5/14,35.7%). All the deafness phenotype is congenital, bilateral profound sensorineural hearing loss. Freckles phenotype is different from cutaneous pigment abnormalities of WS in Westerners. The heterozygous mutation, c.328C>T in exon 3 of the MITF gene was detected in the proband and all patients of pedigree 2. However, no pathological mutation of the relevant genes (SOX10,SNAI2 and EDNRB) was detected in other pedigrees. Conclusion: There are obvious variations in clinical features of WS, while freckles may be a special subtype of cutaneous pigment disturbances. The MITF gene mutation, R110X,is therefore considered the disease causing mutation in pedigree WS02.However, there are novel disease causing genes or copy number variations in Waardenburg syndrome type 2, which require further research. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

  4. On New Means or New Forms of Investigation. A Methodological Proposal for Online Social Investigation through a Virtual Forum

    Directory of Open Access Journals (Sweden)

    Rubén Arriazu Muñoz

    2007-09-01

    Full Text Available Processes and instruments of communication have constituted an important object for Internet researchers, and have been investigated using qualitative methodologies in social research. The most common strategy has been to adapt orthodox instruments and procedures to the virtual context. In this paper I address the following questions in order to develop a framework for virtual research. Using a virtual forum as starting point, I ask: Is virtual research a new taxonomy or an extension of conventional social research techniques? Is virtual research located at the same level as face-to-face research? Is it a new communicational research form? This paper presents a methodological approach using virtual forums as tools where asynchronous communication flows. I analyze the use of virtual forums in interaction with the social context, and articulate the method that emerges from this fieldwork situation. URN: urn:nbn:de:0114-fqs0703374

  5. Investigating the effect of clinical governess approach on patients' length of stay in emergency department: an action research study.

    Directory of Open Access Journals (Sweden)

    Tahmine Salehi

    2014-02-01

    Full Text Available Over the past decade, clinical governance approach with aims to improve the quality of health services has been proposed in Iran. Considering the obvious problems especially patients' length of stay (LOS in the emergency departments (EDs; the present study has been carried out with the purpose of Investigating the effect of clinical governess approach on patients' LOS in the one of the largest medical centers in the country. After the problem was specified by the 17 interviews with employees and managers of the ED; the emergency clinical governance committee was formed by two academic researchers and seven ED staff (key participants that had the most involvement with the subject of study. The activities of the committee, including planning, acting, observing and reflecting, was organized by using participatory action research approach and action research cycle (Kemmis 1995. During this time, three formal meetings with key participants were held in 6-month intervals. Monthly records of patients' average LOS and interview with ED staff were used to analyze the findings. The research was completed with two cycles in one year. Committee members took the following actions. As a result, the patients' LOS reduced from 2.68 days to 1.73 days. Make regular patients visits by medical groups especially orthopedists and neurologists; Decision making about patients situation by emergency physicians and transferring patients to the relevant units by bed managers; Refusing to admit elective patients during overcrowding times; to regulate the list of patients requiring ICU by anesthesiologists. Prolonged LOS can be due to various causes and a team approach, which is one of the requirements of clinical governance approach, is needed to manage it. The results showed that the multidisciplinary team could make positive changes and reduce LOS in emergency setting.

  6. Electrochemical impedance spectroscopy investigation on the clinical lifetime of ProTaper rotary file system.

    Science.gov (United States)

    Penta, Virgil; Pirvu, Cristian; Demetrescu, Ioana

    2014-01-01

    The main objective of the current paper is to show that electrochemical impedance spectroscopy (EIS) could be a method for evaluating and predicting of ProTaper rotary file system clinical lifespan. This particular aspect of everyday use of the endodontic files is of great importance in each dental practice and has profound clinical implications. The method used for quantification resides in the electrochemical impedance spectroscopy theory and has in its main focus the characteristics of the surface titanium oxide layer. This electrochemical technique has been adapted successfully to identify the quality of the Ni-Ti files oxide layer. The modification of this protective layer induces changes in corrosion behavior of the alloy modifying the impedance value of the file. In order to assess the method, 14 ProTaper sets utilized on different patients in a dental clinic have been submitted for testing using EIS. The information obtained in regard to the surface oxide layer has offered an indication of use and proves that the said layer evolves with each clinical application. The novelty of this research is related to an electrochemical technique successfully adapted for Ni-Ti file investigation and correlation with surface and clinical aspects.

  7. Study of compartmentalization in the visna clinical form of small ruminant lentivirus infection in sheep

    Directory of Open Access Journals (Sweden)

    Ramírez Hugo

    2012-01-01

    Full Text Available Abstract Background A central nervous system (CNS disease outbreak caused by small ruminant lentiviruses (SRLV has triggered interest in Spain due to the rapid onset of clinical signs and relevant production losses. In a previous study on this outbreak, the role of LTR in tropism was unclear and env encoded sequences, likely involved in tropism, were not investigated. This study aimed to analyze heterogeneity of SRLV Env regions - TM amino terminal and SU V4, C4 and V5 segments - in order to assess virus compartmentalization in CNS. Results Eight Visna (neurologically affected sheep of the outbreak were used. Of the 350 clones obtained after PCR amplification, 142 corresponded to CNS samples (spinal cord and choroid plexus and the remaining to mammary gland, blood cells, bronchoalveolar lavage cells and/or lung. The diversity of the env sequences from CNS was 11.1-16.1% between animals and 0.35-11.6% within each animal, except in one animal presenting two sequence types (30% diversity in the CNS (one grouping with those of the outbreak, indicative of CNS virus sequence heterogeneity. Outbreak sequences were of genotype A, clustering per animal and compartmentalizing in the animal tissues. No CNS specific signature patterns were found. Conclusions Bayesian approach inferences suggested that proviruses from broncoalveolar lavage cells and peripheral blood mononuclear cells represented the common ancestors (infecting viruses in the animal and that neuroinvasion in the outbreak involved microevolution after initial infection with an A-type strain. This study demonstrates virus compartmentalization in the CNS and other body tissues in sheep presenting the neurological form of SRLV infection.

  8. Dosimetry investigation of MOSFET for clinical IMRT dose verification.

    Science.gov (United States)

    Deshpande, Sudesh; Kumar, Rajesh; Ghadi, Yogesh; Neharu, R M; Kannan, V

    2013-06-01

    In IMRT, patient-specific dose verification is followed regularly at each centre. Simple and efficient dosimetry techniques play a very important role in routine clinical dosimetry QA. The MOSFET dosimeter offers several advantages over the conventional dosimeters such as its small detector size, immediate readout, immediate reuse, multiple point dose measurements. To use the MOSFET as routine clinical dosimetry system for pre-treatment dose verification in IMRT, a comprehensive set of experiments has been conducted, to investigate its linearity, reproducibility, dose rate effect and angular dependence for 6 MV x-ray beam. The MOSFETs shows a linear response with linearity coefficient of 0.992 for a dose range of 35 cGy to 427 cGy. The reproducibility of the MOSFET was measured by irradiating the MOSFET for ten consecutive irradiations in the dose range of 35 cGy to 427 cGy. The measured reproducibility of MOSFET was found to be within 4% up to 70 cGy and within 1.4% above 70 cGy. The dose rate effect on the MOSFET was investigated in the dose rate range 100 MU/min to 600 MU/min. The response of the MOSFET varies from -1.7% to 2.1%. The angular responses of the MOSFETs were measured at 10 degrees intervals from 90 to 270 degrees in an anticlockwise direction and normalized at gantry angle zero and it was found to be in the range of 0.98 ± 0.014 to 1.01 ± 0.014. The MOSFETs were calibrated in a phantom which was later used for IMRT verification. The measured calibration coefficients were found to be 1 mV/cGy and 2.995 mV/cGy in standard and high sensitivity mode respectively. The MOSFETs were used for pre-treatment dose verification in IMRT. Nine dosimeters were used for each patient to measure the dose in different plane. The average variation between calculated and measured dose at any location was within 3%. Dose verification using MOSFET and IMRT phantom was found to quick and efficient and well suited for a busy radiotherapy

  9. Time dependent enhanced resistance against antibiotics & metal salts by planktonic & biofilm form of Acinetobacter haemolyticus MMC 8 clinical isolate

    Directory of Open Access Journals (Sweden)

    Sharvari Vijaykumar Gaidhani

    2014-01-01

    Full Text Available Background & objectives: Available literature shows paucity of reports describing antibiotic and metal resistance profile of biofilm forming clinical isolates of Acinetobacter haemolyticus. The present study was undertaken to evaluate the antibiotic and metal resistance profile of Indian clinical isolate of A. haemolyticus MMC 8 isolated from human pus sample in planktonic and biofilm form. Methods: Antibiotic susceptibility and minimum inhibitory concentration were determined employing broth and agar dilution techniques. Biofilm formation was evaluated quantitatively by microtiter plate method and variation in complex architecture was determined by scanning electron microscopy. Minimum biofilm inhibiting concentration was checked by Calgary biofilm device. Results: Planktonic A. haemolyticus MMC 8 was sensitive to 14 antibiotics, AgNO 3 and HgC1 2 resistant to streptomycin and intermediately resistant to netilmycin and kanamycin. MMC 8 exhibited temporal variation in amount and structure of biofilm. There was 32 - 4000 and 4 - 256 fold increase in antibiotic and metal salt concentration, respectively to inhibit biofilm over a period of 72 h as against susceptible planktonic counterparts. Total viable count in the range of 10 5 -10 6 cfu / ml was observed on plating minimum biofilm inhibiting concentration on Muller-Hinton Agar plate without antimicrobial agents. Biofilm forming cells were several folds more resistant to antibiotics and metal salts in comparison to planktonic cells. Presence of unaffected residual cell population indicated presence of persister cells. Interpretation & conclusions: The results indicate that biofilm formation causes enhanced resistance against antibiotics and metal salts in otherwise susceptible planktonic A. haemolyticus MMC 8.

  10. Duplex investigations in children: Are clinical signs in children with venous disorders relevant?

    Science.gov (United States)

    Birgitte Maessen-Visch, M; Smeets, L; van Vleuten, C

    2015-12-01

    Ultra sound colored duplex sonography is the preferred method in diagnosing chronic venous disease. Data in children on incidence, indications, and results are lacking. From the total of 9180 duplex investigations performed in our hospital from 2009 to 2012, data on indication and results of the investigation as well as patient characteristics were evaluated retrospectively for the proportion of pediatric patients. Duplex investigations were performed 49 times in 38 children (6-18 years), with an average of 1.3 times (1-6 times) per child. Forty percent showed abnormalities: 17 times deep venous thrombosis was suspected; deep venous thrombosis was objectified in 18%. In the 21 investigations performed for varicosis-related complaints, varicose veins or venous malformations were objectified in 57%. Edema was never a symptom of chronic venous disease. Duplex investigation is not often performed in children. In children with established deep venous thrombosis, a family history with deep venous thrombosis is common. In general, edema was not seen in children with varicose veins and, therefore, does not seem a reliable clinical sign at young age. © The Author(s) 2014.

  11. Clinical investigation of large perfusion defect cases with 201Tl exercise myocardial scintigraphy

    International Nuclear Information System (INIS)

    Morota, Motoi; Kobayashi, Yasuhiko

    1999-01-01

    We investigated retrospectively the clinical significance of large perfusion defect on 201 Thallium myocardial scintigraphy from the records of 833 patients during the past 3 years from 1991 to 1994. The patients were divided into 3 groups according to the extent of perfusion defect; cases with normal perfusion (n=561), with small perfusion defect (n=211) and with large perfusion defect (n=61). We found that the proportions of cases with large perfusion defect was significantly larger than that of cases with small perfusion defect in myocardial disease (MD; hypertrophic cardiomyopathy, dilated cardiomyopathy, and post myocarditis combined) (P 201 Thallium myocardial scintigraphy and that complication of diabetes mellitus and clinical symptoms may be useful in differentiating IHD from MD. (author)

  12. Measuring volitional competences: psychometric properties of a short form of the Volitional Components Questionnaire (VCQ) in a clinical sample

    OpenAIRE

    Forstmeier, Simon; Rüddel, H

    2008-01-01

    Volitional competences (skills of will), including self-regulation skills such as self-motivation and emotion regulation and self-control skills such as impulse control, are particularly necessary for patients with psychiatric and psychosomatic disorders. The Volitional Components Questionnaire (VCQ) is an instrument designed to measure volitional competences. However, its length of 190 items prevents its routine application in clinical settings. This study evaluates a new 36-item short form ...

  13. Clinical isolates of Acinetobacter baumannii from a Portuguese hospital: PFGE characterization, antibiotic susceptibility and biofilm-forming ability.

    Science.gov (United States)

    Duarte, Andreia; Ferreira, Susana; Almeida, Sofia; Domingues, Fernanda C

    2016-04-01

    Acinetobacter baumannii is an emerging pathogen associated with nosocomial infections that in addition has shown an increasing resistance to antibiotics. In this work the genetic diversity of A. baumannii isolates from a Portuguese hospital, their antibiotic resistance profiles and ability to form biofilms was studied. Seventy-nine clinical A. baumannii isolates were characterized by pulsed-field gel electrophoresis (PFGE) with 9 different PFGE profiles being obtained. Concerning the antimicrobial susceptibility, all A. baumannii isolates were resistant to 12 of the 17 tested antibiotics and classified as multidrug-resistant (MDR). In addition, 74.7% of the isolates showed biofilm formation ability, however no statistical significance with antibiotic resistance was observed. In contrast, urine samples isolates were more likely to form biofilms than strains isolated from other sources. Our findings highlight the high number of MDR A. baumannii isolates and the importance of the formation of biofilms as a potential virulence factor. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Investigation Clinical Competence and Its Relationship with Professional Ethics and Spiritual Health in Nurses

    Directory of Open Access Journals (Sweden)

    Elahe Ramezanzade Tabriz

    2017-03-01

    Full Text Available Abstract Background and Objectives: Study of clinical competence in nursing helps determine the quality of health care delivered to patients. Given the priority of observance of principles over caretaking and necessity of spirituality existence at the core of health care provision, this study was conducted to investigate clinical competence and its relationship with professional ethics and spiritual health in nurses. Methods: In this cross-sectional, descriptive, and correlational study, 281 nurses were enrolled by consensus sampling. Sampling was conducted from February, 2016 till June, 2016. The data were gathered by a demographics questionnaire, a self-assessment scale of clinical competence, a nursing ethics questionnaire, and a spiritual health questionnaire, and analyzed by descriptive statistics and t-test, Pearson's correlation coefficient, ANOVA, and linear regression analysis in SPSS 21. Results: The total scores for self-assessment scale of nurses' clinical competence, professional ethics, and spiritual health were moderate. In the light of the results of Spearman's correlation coefficient, there was a significant and positive correlation between clinical competence and spiritual health. Moreover, a significant positive correlation was observed between professional ethics and spiritual health but there was no correlation between professional ethics and clinical competence. Conclusion: Managers' and personnel's Knowledge about the level of nurses clinical competence, professional ethics, and spiritual health in teaching health care centers provides valuable information to develop in-service and efficacious education programs and ultimately to improve the quality of nursing services.

  15. Behavioral and emotional problems on the Teacher's Report Form: a cross-national, cross-clinic comparative analysis of gender dysphoric children and adolescents.

    Science.gov (United States)

    Steensma, Thomas D; Zucker, Kenneth J; Kreukels, Baudewijntje P C; Vanderlaan, Doug P; Wood, Hayley; Fuentes, Amanda; Cohen-Kettenis, Peggy T

    2014-05-01

    For gender dysphoric children and adolescents, the school environment may be challenging due to peer social ostracism and rejection. To date, information on the psychological functioning and the quality of peer relations in gender dysphoric children and adolescents has been studied via parental report, peer sociometric methods, and social interactions in laboratory play groups. The present study was the first cross-national investigation that assessed behavior and emotional problems and the quality of peer relations, both measured by the Teacher's Report Form (TRF), in a sample of 728 gender dysphoric patients (554 children, 174 adolescents), who were referred to specialized gender identity clinics in the Netherlands and Canada. The gender dysphoric adolescents had significantly more teacher-reported emotional and behavioral problems than the gender dysphoric children. In both countries, gender dysphoric natal boys had poorer peer relations and more internalizing than externalizing problems compared to the gender dysphoric natal girls. Furthermore, there were significant between-clinic differences: both the children and the adolescents from Canada had more emotional and behavioral problems and a poorer quality of peer relations than the children and adolescents from the Netherlands. In conclusion, gender dysphoric children and adolescents showed the same pattern of emotional and behavioral problems in both countries. The extent of behavior and emotional problems was, however, higher in Canada than in the Netherlands, which appeared, in part, an effect of a poorer quality of peer relations. Per Bronfenbrenner's (American Psychologist, 32, 513-531, 1977) ecological model of human development and well-being, we consider various interpretations of the cross-national, cross-clinic differences on TRF behavior problems at the level of the family, the peer group, and the culture at large.

  16. Clinical Investigation of Radiation Retinopathy Fundus and Fluorescein Angiographic Features

    Institute of Scientific and Technical Information of China (English)

    LiMei; QiuGT

    1999-01-01

    Purpose:To investigate the fundus and fluorescein angiographic features in the patients with radiation retinopathy.Clinical Materials:Color fundus photography and/or fluorescein angiography from 13 patients with nasopharyngeal carcinomas received external beam radiation were retrospectively analyzed.Reslts:In this study,26 damaged eyes of 13 patients eveloped some degree of radiation retinopathy.The earliest and most common finding was macular microvascular changes (microaneurysms and/or telangiectasia),which was observed in 100%(26/26)of the eyes.Intraretinal hemorrhages,macular capillary nonperfusion,and macular edema were noted in 84%,50%,and 42% of the eyes,respectively.Conclusions:Radiation retinopathy is common after external beam radiation of nasopharyngeal carcinomas.The prominent changes include maular microvascular changes,intraretinal hemorrhages and macular capillary nonperfusion.

  17. Theory as metaphor: clinical knowledge and its communication.

    Science.gov (United States)

    Colman, Warren

    2009-04-01

    This paper investigates the relationship between clinical knowledge and psychological theory and considers the implications for clinical writing. I argue that clinical knowledge is a way of understanding rather than a body of facts and compare clinical material to 'texts' that generate multiple and indeterminate meanings. Analytic theories, which represent the crystallization of ways of understanding clinical phenomena, have an inherently metaphorical 'as if' quality since they are derived from and adapted to the clinical process of making meaning by representing psychic states in symbolic form. Thus good clinical writing demonstrates an integration of theory and clinical material into a unified network of symbolic meanings. Redfearn's paper, 'The captive, the treasure, the hero and the "anal" stage of development' (1979), is discussed as an exemplar of such integration. It is suggested that clinical knowledge is equivalent to the skill of making effective interpretations.

  18. Clinical neurophysiology and quantitative sensory testing in the investigation of orofacial pain and sensory function.

    Science.gov (United States)

    Jääskeläinen, Satu K

    2004-01-01

    Chronic orofacial pain represents a diagnostic and treatment challenge for the clinician. Some conditions, such as atypical facial pain, still lack proper diagnostic criteria, and their etiology is not known. The recent development of neurophysiological methods and quantitative sensory testing for the examination of the trigeminal somatosensory system offers several tools for diagnostic and etiological investigation of orofacial pain. This review presents some of these techniques and the results of their application in studies on orofacial pain and sensory dysfunction. Clinical neurophysiological investigation has greater diagnostic accuracy and sensitivity than clinical examination in the detection of the neurogenic abnormalities of either peripheral or central origin that may underlie symptoms of orofacial pain and sensory dysfunction. Neurophysiological testing may also reveal trigeminal pathology when magnetic resonance imaging has failed to detect it, so these methods should be considered complementary to each other in the investigation of orofacial pain patients. The blink reflex, corneal reflex, jaw jerk, sensory neurography of the inferior alveolar nerve, and the recording of trigeminal somatosensory-evoked potentials with near-nerve stimulation have all proved to be sensitive and reliable in the detection of dysfunction of the myelinated sensory fibers of the trigeminal nerve or its central connections within the brainstem. With appropriately small thermodes, thermal quantitative sensory testing is useful for the detection of trigeminal small-fiber dysfunction (Adelta and C). In neuropathic conditions, it is most sensitive to lesions causing axonal injury. By combining different techniques for investigation of the trigeminal system, an accurate topographical diagnosis and profile of sensory fiber pathology can be determined. Neurophysiological and quantitative sensory tests have already highlighted some similarities among various orofacial pain conditions

  19. The Ethics of Clinical Care and the Ethics of Clinical Research: Yin and Yang.

    Science.gov (United States)

    Kowalski, Charles J; Hutchinson, Raymond J; Mrdjenovich, Adam J

    2017-02-01

    The Belmont Report's distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  20. 21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

    Science.gov (United States)

    2010-04-01

    ... that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health... opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children... clinical investigation presents a reasonable opportunity to further the understanding, prevention, or...

  1. A clinical study to evaluate the correlation between maxillary central incisor tooth form and face form in an Indian population.

    Science.gov (United States)

    Koralakunte, Pavankumar R; Budihal, Dhanyakumar H

    2012-09-01

    A study was performed to examine the correlation between maxillary central incisor tooth form and face form in males and females in an Indian population. The selection of prosthetic teeth for edentulous patients is a primary issue in denture esthetics, especially in the case of maxillary central incisors, which are the most prominent teeth in the arch. Two hundred dental students of Indian origin comprising 79 males and 121 females aged 18-28 years studying at Bapuji Dental College and Hospital were randomly selected as the study subjects. A standardized photographic procedure was used to obtain images of the face and the maxillary central incisors. The outline forms of the face and the maxillary right central incisor tooth were determined using a standardized method. The outline forms obtained were used to classify both face form and tooth form on the basis of visual and William's methods. The means were considered after evaluation by five prosthodontists, and the results were tabulated. Statistical analysis was performed using the chi-squared test for association and Z-test for equality of proportions. A correlation greater than 50% was observed between tooth form and face form by the visual method, compared with one of 31.5% by William's method. There was no highly defined correlation between maxillary central incisor tooth form and face form among the male and female Indian subjects studied.

  2. An investigation of some quantum systems using modified quantization rule form

    Energy Technology Data Exchange (ETDEWEB)

    Maiz, F., E-mail: fethimaiz@gmail.com [University of Cartage, Nabeul Engineering Preparatory Institute, Merazka, 8000 Nabeul (Tunisia); King Khalid University, Faculty of Science, Physics Department, P.O. Box 9004, Abha 61413 (Saudi Arabia)

    2014-09-15

    We propose a new simple quantization rule form: J{sub n}=nπ+δ(n), for exactly solvable and nonsolvable quantum systems. Here, J{sub n} is the momentum integral between two turning points, n the principal quantum number, and δ(n) is a function of potential parameters and n. This new quantization rule form is a generalization of the conventional one, already developed for exactly solvable quantum systems. We found that δ(n) is a constant independent of n for exactly solvable quantum systems. We carry out the expression of δ(n) for V-shape potential, and show that it takes this form δ(n)=(π/2)+(1/a+bn+cn{sup 2}) for anharmonic oscillators potential V(x)=αx{sup p}+βx{sup 2}.

  3. Readability and comprehensibility of informed consent forms for clinical trials

    Directory of Open Access Journals (Sweden)

    Anvita Pandiya

    2010-01-01

    A shortened Informed Consent Form, with information that a reasonable person would want to understand along with specific information that the person wants in particular would be a good option to improve understanding or comprehensibility. Additional informational meetings with a qualified person like a counselor could help in comprehension. Questionnaires designed to test comprehension of patient, peer review, patient writing the salient features could help evaluate the comprehensibility of the Informed Consent Form.

  4. Clinical Trials

    Medline Plus

    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  5. Investigations on the long-term behaviour of high level waste forms

    International Nuclear Information System (INIS)

    Lemmens, K.

    2009-01-01

    The Belgian Nuclear Research Centre (SCK-CEN) has a long-standing expertise in research concerning the compatibility of waste forms with the final disposal environment, in collaboration with NIRAS/ONDRAS. For high level waste, most attention goes to two waste forms that are relevant for Belgium, namely (1) vitrified HLW (High Level Waste) from the reprocessing of spent fuel, and (2) spent fuel as such, referring to the direct disposal scenario. The expertise lies especially in the study of the chemical interactions between the waste forms and the disposal environment. This is done by laboratory experiments, supported by modeling. Until 2004, the reference disposal design for HLW glass and spent fuel in Belgium was based on the use of a bentonite buffer. The experiments performed in that period therefore involved mostly the study of the influence of clay on the waste form behaviour. Since 2004 the Supercontainer design with Ordinary Portland Cement as buffer material (without bentonite) has been selected as the reference. The experiments related to this new design are therefore predominant now. Clay based disposal designs are still the reference in several other European countries. For this reason, the study of clay-waste interactions was not completely abandoned in the period 2004-2008, but continued in the framework of EC programmes. The first experiments focused on the Supercontainer design were started in 2006 (HLW) and 2007 (spent fuel). The first results are available now for HLW glass. Most results generated recently are, however, still related to the bentonite concept. The objectives of the present study were to evaluate the minimum guaranteed durability of the waste form, which will be used as input in the safety assessment. The objective is not to obtain an absolute value for the durability or an interval of values, which will always be subject to caution, but rather to determine a lower limit for the life time of the waste form, which is conservative

  6. Sustaining the Clinical and Translational Research Workforce: Training and Empowering the Next Generation of Investigators.

    Science.gov (United States)

    Yin, Helen L; Gabrilove, Janice; Jackson, Rebecca; Sweeney, Carol; Fair, Alecia M; Toto, Robert

    2015-07-01

    There is mounting concern that clinician-scientists are a vanishing species and that the pipeline for clinical and translational research (CTR) investigators is in jeopardy. For the majority of current junior CTR investigators, the career path involves first obtaining a National Institutes of Health (NIH)-funded K-type career development award, particularly K08 and K23, and subsequently an NIH R01. This transition, popularly referred to as K2R, is a major hurdle with a low success rate and gaps in funding. In this Perspective, the authors identify factors that facilitate K2R transition and important aspects of increasing and sustaining the pipeline of CTR investigators. They also highlight significant differences in success rates of women and those underrepresented in biomedical research. Early career exposure to research methodology, protected time, multidisciplinary mentoring, and institutional "culture shift" are important for fostering and rewarding team science. Mentoring is the single most important contributor to K2R success, and emerging evidence suggests that formal mentor training and team mentoring are effective. Leadership training can empower junior investigators to thrive as independent CTR investigators. Future research should focus on delineating the difference between essential and supplemental factors to achieve this transition, and mentoring methods that foster success, including those that promote K2R transition of women and those underrepresented in biomedical research. The Clinical and Translational Science Awards National Consortium is well positioned to test existing models aimed at shortening the time frame, increasing the rate of K2R transition, and identifying strategies that improve success.

  7. Clinical Trials

    Medline Plus

    Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

  8. 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.

  9. Measurement of leukocyte rheology in vascular disease: clinical rationale and methodology. International Society of Clinical Hemorheology.

    Science.gov (United States)

    Wautier, J L; Schmid-Schönbein, G W; Nash, G B

    1999-01-01

    The measurement of leukocyte rheology in vascular disease is a recent development with a wide range of new opportunities. The International Society of Clinical Hemorheology has asked an expert panel to propose guidelines for the investigation of leukocyte rheology in clinical situations. This article first discusses the mechanical, adhesive and related functional properties of leukocytes (especially neutrophils) which influence their circulation, and establishes the rationale for clinically-related measurements of parameters which describe them. It is concluded that quantitation of leukocyte adhesion molecules, and of their endothelial receptors may assist understanding of leukocyte behaviour in vascular disease, along with measurements of flow resistance of leukocytes, free radical production, degranulation and gene expression. For instance, vascular cell adhesion molecule (VCAM-1) is abnormally present on endothelial cells in atherosclerosis, diabetes mellitus and inflammatory conditions. Soluble forms of intercellular adhesion molecule (ICAM-1) or VCAM can be found elevated in the blood of patients with rheumatoid arthritis or infections disease. In the second part of the article, possible technical approaches are presented and possible avenues for leukocyte rheological investigations are discussed.

  10. A severe form of Crouzon's Syndrome: clinical and radiological correlation

    International Nuclear Information System (INIS)

    Abdallah, Ahmad M.

    2003-01-01

    Craniofacial dysostosis (Crouzon's syndrome) is a well defined, dominantly inherited disorder, described by Crouzon in 1912. It is characterized by several deformities involving the skull,face and eyes. This case report details a rare form of Crouzon's syndrome in which proptosis was so severe that globes were completely proptotic outside the patient's extremely shallow orbits, and the eyelids were undeveloped bilaterally and replaced by small folds of skin. It appears that this is the first report of such a severe form of Crouzon's syndrome. (author)

  11. Dysmorphic disorders: clinical and nosological heterogeneity

    Directory of Open Access Journals (Sweden)

    V. E. Medvedev

    2016-01-01

    Full Text Available The clinical picture of dysmorphophobia (DMP (dysmorphia, DM has been inadequately investigated; its descriptions are contradictory.Objective: to study the clinical structure of DMP (DM on a sample of plastic or cosmetic surgery patients.Patients and methods. An examination was made in of 103 patients, including 81 (78.6% women (mean age, 35.8±4.9 years and 22 (21.4% men (mean age, 30.9±5.7 years, who had gone to a clinic of cosmetic or plastic surgery with complaints of objectively unverified appearance defects and DM signs and given consent to take part in the investigation. All the patients underwent clinical and psychopathological examination; in so doing the follow-up data in the past 1-3 tears were borne in mind. Their somatic condition was analyzed on the basis of the data available in the medical documents and the results of laboratory, clinical, and instrumental studies.Results. The dysmorphic syndrome has been found to have overvalued, hypochondriacal, obsessive-compulsive, depressive, and delusional forms. It has been established that DM can manifest within schizophrenia, personality disorders, affective disorders, and organic mental diseases. Differential diagnostic criteria for different types of DM in heterogeneous psychopathological disorders are given.

  12. Clinical and X-ray investigations on congenital radio-ulnar synostosis

    International Nuclear Information System (INIS)

    Heisel, A.

    1982-01-01

    Out of 13 patients with cogenital radio-ulnar synostosis, 10 could be subjected to clinical and X-ray examination and chromosome analysis. In all the family histories the radio-ulnar synostosis was an isolated event. In no case was definite heredity of the same malformation confirmed. In most cases the radio-ulnar synostosis was an isolated malformation. 7 patients were of female, 6 of male sex. In 5 cases the synostosis was bi-lateral, in 8 cases it was unilateral without preference of either side of the body. In 2 out of 10 patients subjected to chromosome analysis gonosomal aneuploidy was found. More often than hitherto supposed, radio-ulnar synostosis seems to be associated with lower forms of polysomia of the x-chromosomes. 15 out of 18 synostoses belonged to type II, 3 to type I. The different types represent merely differring degrees of manifestation of the same deformity occurring bilaterally in one person. All patients with radio-ulnar synostosis exhibited a high degree of functional tolerance to the malformation. The development in child age and the educational and professional record were hardly impaired. (orig./MG) [de

  13. Rotavirus infection in children: mono-and combines forms, especially clinics and course

    Directory of Open Access Journals (Sweden)

    N. B. Denisyuk

    2012-01-01

    Full Text Available Analyzed 74 case histories of children under one year with rotavirus infection. The most commonly detected rotavirus gastroenteritis in the form of mono-and combined forms. Mono-infection in 78.3% of cases occurred in the moderate form with a leading syndrome in the form of gastroenteritis, severe dehydration proceeded with symptoms of varying severity. Mixed variants in 98.7% of cases are in the unfavorable premorbid background, in 42.8% of children were registered in the severe forms, and children younger than 6 months were erased within. The diagnosis of intestinal infection was confirmed by PCR, bacteriological and immunological methods.

  14. Completion of Limitation of Medical Treatment forms by junior doctors for patients with dementia: clinical, medicolegal and education perspectives.

    Science.gov (United States)

    Yoong, Jaclyn; MacPhail, Aleece; Trytel, Gael; Rajendram, Prashanti Yalini; Winbolt, Margaret; Ibrahim, Joseph E

    2017-10-01

    Objective Limitation of Medical Treatment (LMT) forms are an essential element of end-of-life care. Decision making around LMT is complex and often involves patients with dementia. Despite the complexity, junior doctors frequently play a central role in completing LMT forms. The present study sought perspectives from a range of stakeholders (hospital clinicians, medical education personnel, legal and advocacy staff) about junior doctors' roles in completing LMT forms in general and for patients with dementia. Methods Qualitative data were gathered in semi-structured interviews (SSI) and theoretical concepts were explored in roundtable discussion (RD). Participants were recruited through purposive and convenience sampling drawing on healthcare and legal personnel employed in the public hospital and aged care systems, selected from major metropolitan hospitals, healthcare and legal professional bodies and advocacy organisations in Victoria, Australia. The contents of the SSIs and RD were subject to thematic analysis using a framework approach. Data were indexed according to the topics established in the study aim; categories were systematically scrutinised, from which key themes were distilled. Results Stakeholders reported that completing LMT forms was difficult for junior doctors because of a lack of medical and legal knowledge, as well as clinical inexperience and inadequate training. Healthcare organisations (HCOs) either lacked policies about the role of junior doctors or had practices that were discordant with policy. In this process, there were substantial gaps pertaining to patients with dementia. Recommendations made by the study participants included the provision of supervised clinical exposure and additional training for junior doctors, strengthening HCO policies and explicit consideration of the needs of patients with dementia. Conclusions LMT forms should be designed for clarity and consistency across HCOs. Enhancing patient care requires appropriate

  15. Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1993. Volume 2

    Science.gov (United States)

    1993-10-01

    A-5-90 Production of Mouse Positive and Negative Control Slides for 382 Use in Rabies FRA Test. (0) A-7-90 Clinical Investigation on the...Possible 402 Diagnostic and Therapeutic Manuever as Tested in a Mouse Model Utilizing PET Scanning. (0) A-93-04 Production of Monoclonal Antibodies to...xlv Project Page Number POG 9005 ALinC 15: Dose Intensification of Methotrexate and 583 6- Mercaptopurine for ALL in Childhood. (0) P00 9006 ALinC 15

  16. Antimicrobial blue light inactivation of biofilms formed by clinical isolates of multidrug-resistant microorganisms

    Science.gov (United States)

    Ferrer-Espada, Raquel; Fang, Yanyan; Dai, Tianhong

    2018-02-01

    Antibiotic resistance is one of the most serious threats to public health. It is estimated that at least 23,000 people die each year in the USA as a direct result of antibiotic-resistant infections. In addition, many antibiotic-resistant microorganisms develop biofilms, surface-associated microbial communities that are extremely resistant to antibiotics and the immune system. A light-based approach, antimicrobial blue light (aBL), has attracted increasing attention due to its intrinsic antimicrobial effect without the involvement of exogenous photosensitizers. In this study, we investigated the effectiveness of this non-antibiotic approach against biofilms formed by multidrug-resistant (MDR) microorganisms. MDR Acinetobacter baumannii, Escherichia coli, Candida albicans, and Pseudomonas aeruginosa biofilms were grown either in 96-well microtiter plates for 24 h or in a CDC biofilm reactor for 48 h, and then exposed to aBL at 405 nm emitted from a light-emitting diode (LED). We demonstrated that, for the biofilms grown in the CDC biofilm reactor, approximately 1.88 log10 CFU reduction was achieved in A. baumannii, 2.78 log10 CFU in E. coli and 3.18 log10 CFU in P. aeruginosa after 162 J/cm2 , 576 J/cm2 and 500 J/cm2 aBL were delivered, respectively. For the biofilms formed in the 96-well microtiter plates, 5.67 and 2.46 log10 CFU reduction was observed in P. aeruginosa and C. albicans polymicrobial biofilm after an exposure of 216 J/cm2 . In conclusion, aBL is potentially an alternative non-antibiotic approach against MDR biofilm-related infections. Future studies are warranted to investigate other important MDR microorganisms, the mechanism of action of aBL, and aBL efficacy in vivo.

  17. Validation Study of the Korean Version of the Brief Clinical Form of the Neuropsychiatric Inventory

    Directory of Open Access Journals (Sweden)

    Hee-Jin Kim

    2016-06-01

    Full Text Available Aim: This study aims to provide a brief questionnaire form of the Neuropsychiatric Inventory (NPI-Q in Korean translated from the original NPI-Q that is intended for the evaluation of behavioral and psychological symptoms of dementia in routine clinical practice. Patients and Methods: We developed a Korean version of the NPI-Q (KNPI-Q and compared subitems with those of the Korean version of the NPI (KNPI in 63 dementia patients; 47 patients had been diagnosed with Alzheimer's disease with dementia, 8 with vascular dementia, and 8 with dementia with Lewy body disease. The diagnosis was based on the National Institute of Neurological and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association criteria for possible and probable Alzheimer's disease and the International Statistical Classification of Diseases and Related Health Problems, 10th revision, criteria for vascular dementia and other dementing diseases. All patients received the Korean version of the Mini-Mental State Examination and the Clinical Dementia Rating within 1 month of the KNPI-Q. Results: Test-retest reliability of the KNPI-Q using a Pearson correlation index was r = 0.89 for the total symptom scale and r = 0.90 for the distress scale. The prevalence of analogous symptom ratings differed by less than 6.7%. Convergent validity between the KNPI-Q and the NPI using a Pearson correlation index was r = 0.879 for the total symptom scale and r = 0.92 for the distress scale. Conclusions: The KNPI-Q is a reliable and brief instrument that can be employed for screening in the evaluation of neuropsychiatric symptoms of dementia and associated caregiver distress. It may be suitable for use in general clinical practice and could be administered as a brief neuropsychiatric interview.

  18. Methods to reduce medication errors in a clinical trial of an investigational parenteral medication

    Directory of Open Access Journals (Sweden)

    Gillian L. Fell

    2016-12-01

    Full Text Available There are few evidence-based guidelines to inform optimal design of complex clinical trials, such as those assessing the safety and efficacy of intravenous drugs administered daily with infusion times over many hours per day and treatment durations that may span years. This study is a retrospective review of inpatient administration deviation reports for an investigational drug that is administered daily with infusion times of 8–24 h, and variable treatment durations for each patient. We report study design modifications made in 2007–2008 aimed at minimizing deviations from an investigational drug infusion protocol approved by an institutional review board and the United States Food and Drug Administration. Modifications were specifically aimed at minimizing errors of infusion rate, incorrect dose, incorrect patient, or wrong drug administered. We found that the rate of these types of administration errors of the study drug was significantly decreased following adoption of the specific study design changes. This report provides guidance in the design of clinical trials testing the safety and efficacy of study drugs administered via intravenous infusion in an inpatient setting so as to minimize drug administration protocol deviations and optimize patient safety.

  19. Research Capacity at Traditional Chinese Medicine (TCM) Centers in China: A Survey of Clinical Investigators.

    Science.gov (United States)

    Feng, Shuo; Han, Mei; Lai, Lily; Wang, Si-Cheng; Liu, Jian-Ping

    2017-01-01

    Background. The development of an evidence-based approach to traditional Chinese medicine (TCM), which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82%) were qualified to at least a Master's degree, whilst a smaller proportion (40.24%) held a senior professional title. We found that academic outputs were low with the majority (62.16%) authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43%) and identification of research questions (86.81%), whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%), and time (37.15%). Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators' research capacity and the development of an evidence-based approach of TCM.

  20. A descriptive survey investigating pre-registration student nurses' perceptions of clinical skill development in clinical placements.

    Science.gov (United States)

    Stayt, Louise C; Merriman, Clair

    2013-04-01

    Clinical skill development is essential to nurse education. Clinical skills are frequently taught in higher education institutions using clinical simulation. It is unclear if clinical skills are subsequently consolidated and developed in clinical placements. The aim of this survey was to evaluate pre-registration student nurses perceptions of the frequency of opportunities to practise, the level of supervision and assessment of, clinical skills in their clinical placements. This was a cross-sectional survey design using an online, self-report questionnaire including a Likert-type scale and open ended comments. Four hundred and twenty one students, from all year groups, from a university in the south of England on a wide variety of clinical placements participated. Participants evaluated the frequency of opportunity to practise, level of supervision and assessment of and feedback on performance of specific clinical skills. Clinical skills evaluated were measurement of vital signs, aseptic non-touch technique, assisting with eating and drinking, and assisting with comfort and hygiene. Data were analysed utilising Statistical Package for the Social Sciences Version 19. The frequency of opportunities to practise skills in clinical placement was variable with some participants reporting that they never had opportunity to practise essential skills. Similarly the level of supervision and assessment was also inconsistent suggesting that participants frequently practised clinical skills unsupervised without being assessed as competent. Inconsistencies in clinical skill development may lead to graduates who are not work ready and as a result, insufficient clinical competence potentially leads to unsafe practice and poor patient care. This calls for stronger partnerships between educators and clinical areas and the prioritisation of mentor preparation and education as well as organisational support in terms of mentor workload planning. Copyright © 2012 Elsevier Ltd. All

  1. Clinical and electroencephalographic characteristics of benign occipital epilepsy of childhood in two tertiary Brazilian hospitals

    Directory of Open Access Journals (Sweden)

    Soniza Vieira Alves-Leon

    2011-08-01

    Full Text Available This study intended to investigate the clinical and electroencephalographic benign occipital epilepsy of childhood (BOEC characteristics in a population sample of patients from two tertiary Brazilian hospitals. We analyzed retrospectively 4912 electroencephalograms (EEGs records, and the included patients were submitted to a new clinical and EEG evaluation. Were included 12 (0.92% patients; 4 (33.3% with criteria for early BOEC; 6 (50% for late form and 2 (16.7% with superimposed early and late onset forms. After new investigation, 2 (16.7% had normal EEG; 4 (33.3% had paroxysms over the occipital region; 3 (25% over the temporal posterior regions and 3 (25% over the posterior regions. Sharp waves were the predominant change, occurring in 8 (66.6%; spike and slow wave complexes in 1 (8.3% and sharp and slow wave complexes in 1 (8.3%. Vomiting, headache and visual hallucinations were the most common ictal manifestations, presented in 100% of patients with superimposed forms. Vomiting were absent in the late form and headache was present in all forms of BOEC.

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

    Science.gov (United States)

    2011-03-08

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

  3. Analytical investigations of toxic p-phenylenediamine (PPD) levels in clinical urine samples with special focus on MALDI-MS/MS.

    Science.gov (United States)

    Hooff, Gero P; van Huizen, Nick A; Meesters, Roland J W; Zijlstra, Eduard E; Abdelraheem, Mohamed; Abdelraheem, Waleed; Hamdouk, Mohamed; Lindemans, Jan; Luider, Theo M

    2011-01-01

    Para-phenylenediamine (PPD) is a common chromophoric ingredient in oxidative hair-dyes. In some African countries like Sudan, Egypt and Morocco but also in India this chemical is used alone or in combination with colouring extracts like Henna for dyeing of the hair or the skin. Excessive dermal exposure to PPD mainly leads to the N-mono- and N,N'-diacetylated products (MAPPD, DAPPD) by N-acetyltransferase 1 and 2 (NAT1 and 2) catalyzed reactions. Metabolites and PPD are mainly excreted via renal clearance. Despite a low risk of intoxication when used in due form, there are numerous cases of acute intoxication in those countries every year. At the ENT Hospital - Khartoum (Sudan) alone more than 300 cases are reported every year (~10% fatal), mostly caused by either an accidental or intended (suicidal) high systemic exposure to pure PPD. Intoxication leads to a severe clinical syndrome including laryngeal edema, rhabdomyolysis and subsequent renal failure, neurotoxicity and acute toxic hepatitis. To date, there is no defined clinical treatment or antidote available and treatment is largely supportive. Herein, we show the development of a quick on-site identification assay to facilitate differential diagnosis in the clinic and, more importantly, the implementation of an advanced analytical platform for future in-depth investigations of PPD intoxication and metabolism is described. The current work shows a sensitive (~25 µM) wet chemistry assay, a validated MALDI-MS/MS and HPLC-UV assay for the determination of PPD and its metabolites in human urine. We show the feasibility of the methods for measuring PPD over a range of 50-1000 µM. The validation criteria included linearity, lower limit of quantification (LLOQ), accuracy and precision, recovery and stability. Finally, PPD concentrations were determined in clinical urine samples of cases of acute intoxication and the applied technique was expanded to identify MAPPD and DAPPD in the identical samples.

  4. The relationship between senior management team culture and clinical governance: Empirical investigation and managerial implications.

    Science.gov (United States)

    Prenestini, Anna; Calciolari, Stefano; Lega, Federico; Grilli, Roberto

    2015-01-01

    Health care organizations are pressured to improve the cost-effectiveness of service delivery. Clinical governance is an important trigger to improve care quality and safety and rank high in the reform agenda of health systems. The senior management team culture plays a major role in establishing clinical governance practices, because it strongly influences the values, attitudes, and behaviors of the members of an organization. The aim of this study was to investigate the relationship between senior management team culture and clinical governance in the public health care organizations of three Italian regions. The assessment of senior management culture was conducted using the Competing Values Framework and a corresponding instrument adapted for the Italian context. Clinical governance was assessed using an ad hoc instrument focused on the senior management team's perception and attitude toward clinical governance. The survey achieved a 54% response rate. The results of four different models demonstrate that organizations characterized by different dominant cultures are associated with significant differences in attitudes toward clinical governance. In particular, on average, dominant cultures with a prevailing external focus are associated with a more positive attitude toward clinical governance. The selection and appointments of top managers should consider the style of leadership that is most apt to facilitate the growth of rational and developmental cultures. Furthermore, the training of top managers and leading doctors should reinforce leadership aptitude and approaches that are consistent with the desired organizational cultures.

  5. Clinical trials integrity: a CRO perspective.

    Science.gov (United States)

    Beach, J E

    2001-01-01

    When contract research organizations (CROs) were first formed, pharmaceutical companies outsourced to them only certain aspects of the conduct of their clinical trials. At first CROs were highly specialized entities, providing, for example, either biostatistical advice, clinical research associates who monitored investigational sites for regulatory compliance, or regulatory support. Gradually, full service CROs emerged, offering a full range of services for clinical trials, including the selection of investigators and investigational sites, assistance with patient recruitment, safety surveillance and reporting, site audits, and data management and biostatistics. This evolving relationship between CROs and the pharmaceutical and medical device industries has resulted in CROs assuming more and more of the regulatory and ethical risks and responsibilities inherent in the conduct of clinical trials. In this full service role, CROs, unlike sponsors, are not interested in the outcome of study, but like sponsors, are subject to heavy regulation by the federal government, must follow applicable state laws, must respect international guidelines, and are obliged to follow their own operating procedures. Moreover, they are judged by the industry on the basis of the scope and quality of services provided, including the degree of adherence to the research protocol, regulatory requirements, and timelines; the quality of the professional working relationships with investigators and institutions, both academic and community-based; and the validity of the data. Further, CROs are subject to comprehensive audits by sponsoring companies, FDA, and other regulatory authorities. For all these reasons, CROs are being tasked with strict vigilance of all stages of the clinical trial process to ensure that the laws, regulations, and industry standards designed for the protection of human subjects and data integrity are maintained.

  6. Investigation on the geographical distribution and life form of plant species in sub alpine zone Karsanak region, Shahrekord

    Directory of Open Access Journals (Sweden)

    Jahanbakhsh Pairanj

    2011-09-01

    Full Text Available This study was carried out in rangelands of Karsanak, Chaharmahal and Bakhtiari province, which is regarded as one of the rich rangelands. Phytogeographically, this region is located in Irano-Turanian (zone of sub alpine. Endemic and rare plants were identified and geographical distribution and life form of identified plant species were investigated as well. Overall, 100 species from 17 families were identified from which 20 percent of identified species was endemic element of Irano-Turanian region. Results indicated that 75.7 percent of identified plants belonged to the Irano-Turanian and only 3 and 2 percent belonged to Euro-Siberian and Mediterranean regions respectively. The reason of high percentage of Irano-Turanian elements is probably the long distance of this region from other regions. Similarities of Irano-Turanian and Mediterranean were included 6.1 percent of identified plants and Irano-Turanian and Euro-Siberian included 2 percent. Results of life forms showed hemichryptophytes including 60 percent of life forms which indicate the cold and mountainous weather.

  7. Feedback in Clinical Education, Part I: Characteristics of Feedback Provided by Approved Clinical Instructors

    Science.gov (United States)

    Nottingham, Sara; Henning, Jolene

    2014-01-01

    Context Providing students with feedback is an important component of athletic training clinical education; however, little information is known about the feedback that Approved Clinical Instructors (ACIs; now known as preceptors) currently provide to athletic training students (ATSs). Objective To characterize the feedback provided by ACIs to ATSs during clinical education experiences. Design Qualitative study. Setting One National Collegiate Athletic Association Division I athletic training facility and 1 outpatient rehabilitation clinic that were clinical sites for 1 entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. Patients or Other Participants A total of 4 ACIs with various experience levels and 4 second-year ATSs. Data Collection and Analysis Extensive field observations were audio recorded, transcribed, and integrated with field notes for analysis. The constant comparative approach of open, axial, and selective coding was used to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. Results The ACIs gave 88 feedback statements in 45 hours and 10 minutes of observation. Characteristics of feedback categories included purpose, timing, specificity, content, form, and privacy. Conclusions Feedback that ACIs provided included several components that made each feedback exchange unique. The ACIs in our study provided feedback that is supported by the literature, suggesting that ACIs are using current recommendations for providing feedback. Feedback needs to be investigated across multiple athletic training education programs to gain more understanding of certain areas of feedback, including frequency, privacy, and form. PMID:24143902

  8. Practice databases and their uses in clinical research.

    Science.gov (United States)

    Tierney, W M; McDonald, C J

    1991-04-01

    A few large clinical information databases have been established within larger medical information systems. Although they are smaller than claims databases, these clinical databases offer several advantages: accurate and timely data, rich clinical detail, and continuous parameters (for example, vital signs and laboratory results). However, the nature of the data vary considerably, which affects the kinds of secondary analyses that can be performed. These databases have been used to investigate clinical epidemiology, risk assessment, post-marketing surveillance of drugs, practice variation, resource use, quality assurance, and decision analysis. In addition, practice databases can be used to identify subjects for prospective studies. Further methodologic developments are necessary to deal with the prevalent problems of missing data and various forms of bias if such databases are to grow and contribute valuable clinical information.

  9. An Exploratory Study Investigating the Non-Clinical Benefits of Evidence-Based Veterinary Medicine

    Directory of Open Access Journals (Sweden)

    Elizabeth Jackson

    2017-05-01

    Full Text Available Objective: As little prior research exists about the non-clinical benefits of evidence-based veterinary medicine (EBVM, this exploratory study was conducted to identify non-clinical benefits of EBVM to veterinary practices, as well as highlighting the barriers to further implementation, and ways to overcome them.Background: A PICO-based literature review (Hauser and Jackson, 2016 was conducted to establish current knowledge about the non-clinical benefits of EBVM. It found that while there are some papers suggesting a link between the practice of EBVM and better non-clinical benefits such as client satisfaction and client retention, a single study, focusing on the non-clinical benefits of EBVM, had yet to be conducted.Evidentiary value: This exploratory study provides a solid basis for the further development of a confirmatory study of the themes identified in the interviews. The impact on practice from our findings is significant as it details the key areas where the use of EBVM can yield commercial benefits from the perspective of a group of EBVM experts via interview. It is entirely possible that international veterinary environments which mirror that of the UK will find this research beneficial.Methods: Due to the paucity of data about the non-clinical benefits of EBVM, an exploratory, qualitative approach was taken to this research in order to build a platform for further confirmatory, quantitative investigation (Zikmund, 2003. In February and March 2016 interviews with 16 RCVS Knowledge Group chairs[1] were conducted. The interview guide contained broad, open-ended questions to explore existing tacit knowledge about the non-commercial benefits of EBVM. The interviews were audio recorded and transcribed verbatim and subsequently analysed using NVivo 11 software.Results: This qualitative enquiry showed that the key areas where the use of EBVM can yield non-clinical benefits are through increased client satisfaction and retention, improved

  10. Microstructural investigation of the oxide formed on TP 347H FG during long-term steam oxidation

    DEFF Research Database (Denmark)

    Hansson, Anette Nørgaard; Danielsen, Hilmar Kjartansson; Grumsen, Flemming Bjerg

    2010-01-01

    The long-term oxidation behaviour of TP347H FG in ultra supercritical steam conditions was assessed by exposing the steel in test superheater loops in a Danish coal-fired power plant and characterising the oxide layer with reflective light and electron microscopy. Double layered oxide scales formed...... during steam oxidation. TEM investigations reveal that the inner oxide layer consists of particles of metallic Ni/Fe and Fe-Cr spinel in the interior of the former alloy grains and a compact layer of Fe-Cr spinel and Cr2O3 along the former alloy grain boundaries. The morphology suggests that the inner...

  11. Investigation of uranium binding forms in environmentally relevant waters and bio-fluids

    International Nuclear Information System (INIS)

    Osman, Alfatih Ahmed Alamin

    2014-01-01

    Uranium from natural and anthropogenic sources is continuously and increasingly released into the environment, enters the food chain, and eventually accumulates into the bio-systems including humans. Therefore, uranium exposure to human becomes more and more a subject of interest in many scientific disciplines such as environmental medicine, toxicology, and radiation protection. Ingestion of uranium via food and drinking water is one of the important pathways of exposure. The ongoing discussion in Germany and the European Union (EU) on the maximum uranium levels in drinking water reflects the increasing awareness of uranium as a public health problem. For water suppliers in many countries around the world, uranium contamination of drinking water also becomes a salient issue. Nevertheless, the health consequences are dependent not only on the level and duration of exposure, but mainly on the physical and chemical forms of uranium (speciation). Unlike total concentration, speciation can provide more information on uranium behavior (mobility, bioavailability, and toxicity) in both geo-systems and bio-systems. The aim of the current work is to elucidate uranium speciation in natural samples (water, bio-fluids) by both spectroscopic means and theoretical modeling. For this purpose, environmentally relevant waters (mineral water, groundwater, acid drainage waters) and natural human body fluids have been investigated. The cryogenic time-resolved laser-induced fluorescence spectroscopy (cryo-TRLFS) at 153 K has successfully been used to identify the speciation in such complex matrices of high organic content and low uranium concentrations without any prior treatment. Data about uranium binding forms in natural waters could be used for more insight research on uranium chemo-toxicity in drinking water since there is no available information on the long-term exposure of low uranium concentrations via ingestion on humans. Altogether the obtained data provides a comprehensive

  12. Investigation of uranium binding forms in environmentally relevant waters and bio-fluids

    Energy Technology Data Exchange (ETDEWEB)

    Osman, Alfatih Ahmed Alamin

    2014-06-04

    Uranium from natural and anthropogenic sources is continuously and increasingly released into the environment, enters the food chain, and eventually accumulates into the bio-systems including humans. Therefore, uranium exposure to human becomes more and more a subject of interest in many scientific disciplines such as environmental medicine, toxicology, and radiation protection. Ingestion of uranium via food and drinking water is one of the important pathways of exposure. The ongoing discussion in Germany and the European Union (EU) on the maximum uranium levels in drinking water reflects the increasing awareness of uranium as a public health problem. For water suppliers in many countries around the world, uranium contamination of drinking water also becomes a salient issue. Nevertheless, the health consequences are dependent not only on the level and duration of exposure, but mainly on the physical and chemical forms of uranium (speciation). Unlike total concentration, speciation can provide more information on uranium behavior (mobility, bioavailability, and toxicity) in both geo-systems and bio-systems. The aim of the current work is to elucidate uranium speciation in natural samples (water, bio-fluids) by both spectroscopic means and theoretical modeling. For this purpose, environmentally relevant waters (mineral water, groundwater, acid drainage waters) and natural human body fluids have been investigated. The cryogenic time-resolved laser-induced fluorescence spectroscopy (cryo-TRLFS) at 153 K has successfully been used to identify the speciation in such complex matrices of high organic content and low uranium concentrations without any prior treatment. Data about uranium binding forms in natural waters could be used for more insight research on uranium chemo-toxicity in drinking water since there is no available information on the long-term exposure of low uranium concentrations via ingestion on humans. Altogether the obtained data provides a comprehensive

  13. Voice as Form of Life and Life Form

    Directory of Open Access Journals (Sweden)

    Sandra Laugier

    2015-10-01

    Full Text Available This paper studies the concept of form of life as central to ordinary language philosophy (as understood in Wittgenstein’s, Austin’s and Stanley Cavell’s work: philosophy of our language as spoken; pronounced by a human voice within a form of life. Such an approach to Wittgenstein’s later philosophy shifts the question of the common use of language – central to Wittgenstein’s Investigations – to the definition of the subject as voice, and to the reinvention of subjectivity in language. The voice is both a subjective and common expression: it is what makes it possible for my individual voice, or claim, to become shared and for our forms of life to be intertwined with a lifeform.

  14. Investigation of the thermal degradation of PET, zinc phosphinate, OMPOSS and their blends-Identification of the formed species

    Energy Technology Data Exchange (ETDEWEB)

    Vannier, Aurore [Centre de Recherche et d' Etude sur les Procedes d' Ignifugation des Materiaux (CREPIM), Parc de la porte Nord, F-62200 Bruay-la-Buissiere (France); Duquesne, Sophie, E-mail: Sophie.duquesne@ensc-lille.fr [Laboratoire des Procedes d' Elaboration de Revetements Fonctionnels (PERF), UMR-CNRS 8008/LSPES - Ecole Nationale Superieure de Chimie de Lille, BP 90108, F-59652 Villeneuve d' Ascq (France); Bourbigot, Serge [Laboratoire des Procedes d' Elaboration de Revetements Fonctionnels (PERF), UMR-CNRS 8008/LSPES - Ecole Nationale Superieure de Chimie de Lille, BP 90108, F-59652 Villeneuve d' Ascq (France); Alongi, Jenny; Camino, Giovanni [Centro di Cultura per l' Ingegneria delle Materie Plastiche - Politechnico di Torino, V.le T. Michel, 5, 15100 Alessandria (Italy); Delobel, Rene [Centre de Recherche et d' Etude sur les Procedes d' Ignifugation des Materiaux (CREPIM), Parc de la porte Nord, F-62200 Bruay-la-Buissiere (France)

    2009-11-10

    The incorporation of both OMPOSS and Exolit OP950 (zinc phosphinate) into PET leads to increased fire retarding properties and a synergistic effect has been established between the three components. Here the thermal degradation of OMPOSS, Exolit OP950, PET and blends of them is investigated via thermal degradation in pyrolytic and thermo-oxidative conditions. All species formed during the degradation of the additives or the blends are identified by solid state NMR and X-ray diffraction in the condensed phase and by GC-MS in the gas phase. The investigation shows that no chemical interaction occurs between the additives, which suggests that the synergy responsible for the improvement of fire properties of the material has a physical origin.

  15. Investigation of the thermal degradation of PET, zinc phosphinate, OMPOSS and their blends-Identification of the formed species

    International Nuclear Information System (INIS)

    Vannier, Aurore; Duquesne, Sophie; Bourbigot, Serge; Alongi, Jenny; Camino, Giovanni; Delobel, Rene

    2009-01-01

    The incorporation of both OMPOSS and Exolit OP950 (zinc phosphinate) into PET leads to increased fire retarding properties and a synergistic effect has been established between the three components. Here the thermal degradation of OMPOSS, Exolit OP950, PET and blends of them is investigated via thermal degradation in pyrolytic and thermo-oxidative conditions. All species formed during the degradation of the additives or the blends are identified by solid state NMR and X-ray diffraction in the condensed phase and by GC-MS in the gas phase. The investigation shows that no chemical interaction occurs between the additives, which suggests that the synergy responsible for the improvement of fire properties of the material has a physical origin.

  16. Major and minor form of hereditary hyperekplexia

    NARCIS (Netherlands)

    Tijssen, MAJ; Vergouwe, MN; van Dijk, JG; Rees, M; Frants, RR; Brown, P

    Hyperekplexia is a hereditary neurological disorder characterized by excessive startle responses. Within the disorder two clinical forms can be distinguished. The major form is characterized by continuous generalized stiffness in the first year of life and an exaggerated startle reflex, accompanied

  17. An Investigation of Factors Influencing Nurses' Clinical Decision-Making Skills.

    Science.gov (United States)

    Wu, Min; Yang, Jinqiu; Liu, Lingying; Ye, Benlan

    2016-08-01

    This study aims to investigate the influencing factors on nurses' clinical decision-making (CDM) skills. A cross-sectional nonexperimental research design was conducted in the medical, surgical, and emergency departments of two university hospitals, between May and June 2014. We used a quantile regression method to identify the influencing factors across different quantiles of the CDM skills distribution and compared the results with the corresponding ordinary least squares (OLS) estimates. Our findings revealed that nurses were best at the skills of managing oneself. Educational level, experience, and the total structural empowerment had significant positive impacts on nurses' CDM skills, while the nurse-patient relationship, patient care and interaction, formal empowerment, and information empowerment were negatively correlated with nurses' CDM skills. These variables explained no more than 30% of the variance in nurses' CDM skills and mainly explained the lower quantiles of nurses' CDM skills distribution. © The Author(s) 2016.

  18. A sense inventory for clinical abbreviations and acronyms created using clinical notes and medical dictionary resources.

    Science.gov (United States)

    Moon, Sungrim; Pakhomov, Serguei; Liu, Nathan; Ryan, James O; Melton, Genevieve B

    2014-01-01

    To create a sense inventory of abbreviations and acronyms from clinical texts. The most frequently occurring abbreviations and acronyms from 352,267 dictated clinical notes were used to create a clinical sense inventory. Senses of each abbreviation and acronym were manually annotated from 500 random instances and lexically matched with long forms within the Unified Medical Language System (UMLS V.2011AB), Another Database of Abbreviations in Medline (ADAM), and Stedman's Dictionary, Medical Abbreviations, Acronyms & Symbols, 4th edition (Stedman's). Redundant long forms were merged after they were lexically normalized using Lexical Variant Generation (LVG). The clinical sense inventory was found to have skewed sense distributions, practice-specific senses, and incorrect uses. Of 440 abbreviations and acronyms analyzed in this study, 949 long forms were identified in clinical notes. This set was mapped to 17,359, 5233, and 4879 long forms in UMLS, ADAM, and Stedman's, respectively. After merging long forms, only 2.3% matched across all medical resources. The UMLS, ADAM, and Stedman's covered 5.7%, 8.4%, and 11% of the merged clinical long forms, respectively. The sense inventory of clinical abbreviations and acronyms and anonymized datasets generated from this study are available for public use at http://www.bmhi.umn.edu/ihi/research/nlpie/resources/index.htm ('Sense Inventories', website). Clinical sense inventories of abbreviations and acronyms created using clinical notes and medical dictionary resources demonstrate challenges with term coverage and resource integration. Further work is needed to help with standardizing abbreviations and acronyms in clinical care and biomedicine to facilitate automated processes such as text-mining and information extraction.

  19. Benign bone-forming lesions: osteoma, osteoid osteoma, and osteoblastoma; Clinical, imaging, pathologic, and differential considerations

    Energy Technology Data Exchange (ETDEWEB)

    Greenspan, A. (Depts. of Radiology and Orthopedic Surgery, California Univ., Davis School of Medicine, Sacramento, CA (United States) Section of Musculoskeletal Radiology, UC Davis Medical Center, Sacramento, CA (United States))

    1993-10-01

    The benign bone lesions - osteoma, osteoid osteoma, and osteoblastoma - are characterized as bone-forming because tumor cells produce osteoid or mature bone. Osteoma is a slow-growing lesion most commonly seen in the paranasal sinuses and in the calvaria. When it occurs in the long bones, it is invariably juxtacortical and may need to be differentiated from, among others, parosteal osteosarcoma, sessile osteochondroma, and a matured juxtacortical focus of myositis ossificans. Osteoid osteoma and osteoblastoma appear histologically very similar. Their clinical presentations and distribution in the skeleton, however, are distinct: osteoid osteoma is usually accompanied by nocturnal pain promptly relieved by salicylates; osteoblastoma arises predominantly in the axial skeleton, spinal lesions constituting one-third of reported cases. This review focuses on the application of the various imaging modalities in the diagnosis, differential diagnosis, and evaluation of these lesions. Their histopathology also is discussed, and their treatment briefly outlined. (orig.)

  20. Functional form comparison between the population and the individual Poisson based TCP models

    International Nuclear Information System (INIS)

    Schinkel, C.; Stavreva, N.; Stavrev, P.; Carlone, M.; Fallone, B.G.

    2007-01-01

    In this work, the functional form similarity between the individual and fundamental population TCP models is investigated. Using the fact that both models can be expressed in terms of the geometric parameters γ 50 and D 50 , we show that they have almost identical functional form for values of γ 50 ≥1. The conceptual inadequacy of applying an individual model to clinical data is also discussed. A general individual response TCP expression is given, parameterized by D f and γ f - the dose corresponding to a control level of f, and the normalized slope at that point. It is shown that the dose-response may be interpreted as an individual response only if γ 50 is sufficiently high. Based on the functional form equivalency between the individual and the population TCP models, we discuss the possibility of applying the individual TCP model for the case of heterogeneous irradiations. Due to the fact that the fundamental population TCP model is derived for homogeneous irradiations only, we propose the use of the EUD, given by the generalized mean dose, when the fundamental population TCP model is used to fit clinical data. (author)

  1. Genetic testing in congenital heart disease:A clinical approach

    Institute of Scientific and Technical Information of China (English)

    Marie A Chaix; Gregor Andelfinger; Paul Khairy

    2016-01-01

    Congenital heart disease(CHD) is the most common type of birth defect. Traditionally, a polygenic model defined by the interaction of multiple genes and environmental factors was hypothesized to account for different forms of CHD. It is now understood that the contribution of genetics to CHD extends beyond a single unified paradigm. For example, monogenic models and chromosomal abnormalities have been associated with various syndromic and non-syndromic forms of CHD. In such instances, genetic investigation and testing may potentially play an important role in clinical care. A family tree with a detailed phenotypic description serves as the initial screening tool to identify potentially inherited defects and to guide further genetic investigation. The selection of a genetic test is contingent upon the particular diagnostic hypothesis generated by clinical examination. Genetic investigation in CHD may carry the potential to improve prognosis by yielding valuable information with regards to personalized medical care, confidence in the clinical diagnosis, and/or targeted patient followup. Moreover, genetic assessment may serve as a tool to predict recurrence risk, define the pattern of inheritance within a family, and evaluate the need for further family screening. In some circumstances, prenatal or preimplantation genetic screening could identify fetuses or embryos at high risk for CHD. Although genetics may appear to constitute a highly specialized sector of cardiology, basic knowledge regarding inheritance patterns, recurrence risks, and available screening and diagnostic tools, including their strengths and limitations, could assist the treating physician in providing sound counsel.

  2. CASE OF DIAGNOSIS OF APICAL FORM OF HYPERTROPHIC CARDIOMYOPATHY WITH A PATIENT WITH PROGRESSIVE ANGINA CLINIC

    Directory of Open Access Journals (Sweden)

    N. S. Krylova

    2015-01-01

    Full Text Available Objective of work: to describe the apical form of hypertrophic cardiomyopathy (AFHC developing under the "mask" of the ischemic heart disease not diagnosed for a long period.Materials and methods. Patient B., 73 y.o., female, was brought to the cardiology department with complains of severe pressing pain behind the breastbone caused with no apparent reason and lasting for over 4 hours. The following examination of the patient was performed: electrocardiography (ECG, echocardiography (EchoCG, Holter ECG monitoring, coronary angiography (CAG, ventriculography.Results. The final diagnosis for the patient was set on the basis of the following readings: ECG data (basic rhythm – atrial fibrillation, left ventricle (LV hypertrophy, negative T-waves in leads V1–6, ST segment depression up to 1–2 mm in leads V4–6, EchoCG (hypertrophy of apical segments of the LV with decreasing of its cavity, moderate dilatation of the left atrium, intraventricular obstruction in the apical third of the LV with the maximum pressure gradient of up to 48 mm Hg., CAG (stenotic lesions of coronary arteries were found, ventriculography (LV volume is not increased, no violations of local contractility, narrowing of the LV cavity in the lower third is observed with thinning in the apex, which indicatesexpressed apical hypertrophy of the LV myocard. AFHC, apical form with moderate obstruction in the lower third of the left ventricle. Stress angina syndrome. CAG and ventriculography were main diagnostic methods that allowed setting the final diagnosis.Conclusion. The clinical case sets forth the peculiarities of diagnostics, therapy, and post-therapy management of patients with this form of AFHC.

  3. 75 FR 24706 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2010-05-05

    ... parent consent 214 1 10/60 form. Child Clinic Visit--Case 107 1 1.5 children packet. Parent Clinic Visit...] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention...; (4) a telephone interview focusing on pregnancy-related events and early life history (biological...

  4. Ultrastructural changes in biofilm forms of staphylococci cultivated in a mixed culture with lactobacilli

    Directory of Open Access Journals (Sweden)

    G. Lavryk

    2017-02-01

    Full Text Available The capacity of opportunistic bacteria for biofilm formation plays an important role in the development of chronic inflammatory processes, which are difficult to treat. To improve antimicrobial therapy methods, the influence of lactobacilli on the ultrastructure of biofilm-forming clinical strains of staphylococci when co-cultured was investigated. 5 biofilm-forming clinical strains of S. aureus from the skin of acne vulgaris patients (n = 24 were isolated. Using transmission electron microscopy (TEM the morphological changes of S. aureus cells in the mixed culture with standard strains of Lactobacillus plantarum 8P-A3 and clinical strains of L. fermentum (n = 4 were studied. It was found that in 48 hours after the inoculation on the medium of samples of mixed cultures of L. plantarum 8P-A3 and S. aureus growth of staphylococci was not revealed. Only in some cases of mixed cultures of L. fermentum and biofilm-forming staphylococci was growth of S. aureus obtained. In electron diffraction patterns of control samples of 24-hour staphylococcal monocultures and 48-hour lactobacilli monocultures, natural development of the population at the cellular level was observed. Destructive changes under the influence of lactobacilli (probiotic and clinical strains were detected in all ultrathin sections of the cells of biofilm-forming and planktonic staphylococci. Significant destructive changes in the cell wall of the staphylococci were observed: thickening, obtaining of irregular form, detachment of the cytoplasmic membrane, the complete destruction of the peptidoglycan layer and the emergence of "shadow cells". On all electron diffraction patterns fibrillar-threadlike structures of DNA could not be observed, but in some cases mesosome-like formations were poorly contrasted. It was established that the surface S-layer of lactobacilli was expressed on a significantly larger scale in the mixed culture with staphylococci. In mixed culture of clinical strains

  5. Is There Any Difference between the In Situ and Systemic IL-10 and IFN-γ Production when Clinical Forms of Cutaneous Sporotrichosis Are Compared?

    Directory of Open Access Journals (Sweden)

    Fernanda N Morgado

    Full Text Available Fungus of the Sporothrix schenckii complex can produce skin lesions in humans, commonly lymphocutaneous (LC and fixed (F forms of sporotrichosis. Some authors have suggested that clinical forms are influenced by differences in virulence and genetic profile of isolates. But little is known about the role of immune response in determining the clinical outcome of sporotrichosis. To verify the profile of systemic and in situ IFN-γ and IL-10 expression in sporotrichosis patients, and consequently to detect any difference between the two compartments and/or clinical presentation, we quantified the number of IFN-γ and IL-10 producer peripheral blood mononuclear cells stimulated with S. schenckii antigen (Ss-Ag by Elispot, and quantified cytokines expression by in situ immunohistochemistry in the same patient. Three groups were formed: 1- LC (n = 9; 2- F (n = 10; 3- healthy individuals (n = 14. All sporotrichosis patients produced high amounts of systemic IFN- γ when compared to uninfected individuals. No differences were observed between LC and F groups. Regarding in situ IL-10 expression, a difference between LC and F groups was observed: LC lesions presented higher amounts of IL-10 than F lesions differently from systemic IL-10 which showed similarities. Our data suggests that LC lesions present higher IL-10 expression which could be related to regulatory mechanisms for compensating the tissue injury, however favoring fungal persistence in the lesions. Surprisingly, there were no differences in systemic and in situ IFN- γ expression between CL and F patients, although it was significantly higher expressed in these patients than in healthy individuals.

  6. Is There Any Difference between the In Situ and Systemic IL-10 and IFN-γ Production when Clinical Forms of Cutaneous Sporotrichosis Are Compared?

    Science.gov (United States)

    Morgado, Fernanda N; Schubach, Armando O; Pimentel, Maria Inês; Lyra, Marcelo R; Vasconcellos, Érica C F; Valete-Rosalino, Claudia M; Conceição-Silva, Fátima

    2016-01-01

    Fungus of the Sporothrix schenckii complex can produce skin lesions in humans, commonly lymphocutaneous (LC) and fixed (F) forms of sporotrichosis. Some authors have suggested that clinical forms are influenced by differences in virulence and genetic profile of isolates. But little is known about the role of immune response in determining the clinical outcome of sporotrichosis. To verify the profile of systemic and in situ IFN-γ and IL-10 expression in sporotrichosis patients, and consequently to detect any difference between the two compartments and/or clinical presentation, we quantified the number of IFN-γ and IL-10 producer peripheral blood mononuclear cells stimulated with S. schenckii antigen (Ss-Ag) by Elispot, and quantified cytokines expression by in situ immunohistochemistry in the same patient. Three groups were formed: 1- LC (n = 9); 2- F (n = 10); 3- healthy individuals (n = 14). All sporotrichosis patients produced high amounts of systemic IFN- γ when compared to uninfected individuals. No differences were observed between LC and F groups. Regarding in situ IL-10 expression, a difference between LC and F groups was observed: LC lesions presented higher amounts of IL-10 than F lesions differently from systemic IL-10 which showed similarities. Our data suggests that LC lesions present higher IL-10 expression which could be related to regulatory mechanisms for compensating the tissue injury, however favoring fungal persistence in the lesions. Surprisingly, there were no differences in systemic and in situ IFN- γ expression between CL and F patients, although it was significantly higher expressed in these patients than in healthy individuals.

  7. Is There Any Difference between the In Situ and Systemic IL-10 and IFN-γ Production when Clinical Forms of Cutaneous Sporotrichosis Are Compared?

    Science.gov (United States)

    Morgado, Fernanda N.; Schubach, Armando O.; Pimentel, Maria Inês; Lyra, Marcelo R.; Vasconcellos, Érica C. F.; Valete-Rosalino, Claudia M.; Conceição-Silva, Fátima

    2016-01-01

    Fungus of the Sporothrix schenckii complex can produce skin lesions in humans, commonly lymphocutaneous (LC) and fixed (F) forms of sporotrichosis. Some authors have suggested that clinical forms are influenced by differences in virulence and genetic profile of isolates. But little is known about the role of immune response in determining the clinical outcome of sporotrichosis. To verify the profile of systemic and in situ IFN-γ and IL-10 expression in sporotrichosis patients, and consequently to detect any difference between the two compartments and/or clinical presentation, we quantified the number of IFN-γ and IL-10 producer peripheral blood mononuclear cells stimulated with S. schenckii antigen (Ss-Ag) by Elispot, and quantified cytokines expression by in situ immunohistochemistry in the same patient. Three groups were formed: 1- LC (n = 9); 2- F (n = 10); 3- healthy individuals (n = 14). All sporotrichosis patients produced high amounts of systemic IFN- γ when compared to uninfected individuals. No differences were observed between LC and F groups. Regarding in situ IL-10 expression, a difference between LC and F groups was observed: LC lesions presented higher amounts of IL-10 than F lesions differently from systemic IL-10 which showed similarities. Our data suggests that LC lesions present higher IL-10 expression which could be related to regulatory mechanisms for compensating the tissue injury, however favoring fungal persistence in the lesions. Surprisingly, there were no differences in systemic and in situ IFN- γ expression between CL and F patients, although it was significantly higher expressed in these patients than in healthy individuals. PMID:27622513

  8. Investigation of arcing on fiber-formed nanostructured tungsten by pulsed plasma during steady state plasma irradiation

    Energy Technology Data Exchange (ETDEWEB)

    Yajima, M., E-mail: yajima.miyuki@LHD.nifs.ac.jp [National Institute for Fusion Science, 322-6 Oroshi-cho, Toki, 509-5292 Japan (Japan); Ohno, N. [Graduate School of Engineering, Nagoya University, Furo-cho, Chikusa-ku, Nagoya 464-8603 (Japan); Kajita, S. [EcoTopia Science Institute, Nagoya University, Furo-cho, Chikusa-ku, Nagoya 464-8603 (Japan); De Temmerman, G. [ITER Organization, Route de Vinon sur Verdon, CS 90 046-13067 St Paul Lez Durance Cedex (France); Bystrov, K.; Bardin, S.; Morgan, T.W. [FOM Institute DIFFER, Dutch Institute for Fundamental Energy Research, Partner in the Trilateral Euregio Cluster, 5612 AJ Eindhoven (Netherlands); Masuzaki, S. [National Institute for Fusion Science, 322-6 Oroshi-cho, Toki, 509-5292 Japan (Japan)

    2016-11-15

    Arcing on fiber-formed nanostructured tungsten samples during ELM-like pulses was investigated using the superimposition of high power pulsed plasma on a steady state plasma with hydrogen gas in the linear plasma device Pilot-PSI. The ignition of arcing was observed when the floating potential of the samples was less than −75 V with sufficient heat flux. The surface observation showed that the arc spots were not in the center, but in the peripheral area of the plasma column. Considering the plasma potential profile in the Pilot-PSI, the arcing occurred at the position where the heat flux and the sheath potential drop are sufficiently large.

  9. Radiochemistry, pre-clinical studies and first clinical investigation of 90Y-labeled hydroxyapatite (HA) particles prepared utilizing 90Y produced by (n,γ) route

    International Nuclear Information System (INIS)

    Vimalnath, K.V.; Chakraborty, Sudipta; Rajeswari, A.; Sarma, H.D.; Nuwad, Jitendra; Pandey, Usha; Kamaleshwaran, K.; Shinto, Ajit; Dash, Ashutosh

    2015-01-01

    Introduction: The scope of using no carrier added (NCA) 90 Y [T 1/2 = 64.1 h, E β(max) = 2.28 MeV] obtained from 90 Sr/ 90 Y generator in radiation synovectomy (RSV) is widely accepted. In the present study, the prospect of using 90 Y produced by (n,γ) route in a medium flux research reactor for use in RSV was explored. Methods: Yttrium-90 was produced by thermal neutron irradiation of Y 2 O 3 target at a neutron flux of ~ 1 × 10 14 n/cm 2 .s for 14 d. The influence of various experimental parameters were systematically investigated and optimized to arrive at the most favorable conditions for the formulation of 90 Y labeled hydroxyapatite (HA) using HA particles of 1–10 μm size range. An optimized kit formulation strategy was developed for convenient one-step compounding of 90 Y-HA, which is easily adaptable at hospital radiopharmacy. The pre-clinical biological evaluation of 90 Y-HA particles was studied by carrying out biodistribution and bioluminiscence imaging studies in Wistar rats. The first clinical investigation using the radiolabeled preparation was performed on a patient suffering from chronic arthritis in knee joint by administering 185 MBq 90 Y-HA formulated at the hospital radiopharmacy deploying the proposed strategy. Results: Yttrium-90 was produced with a specific activity of 851 ± 111 MBq/mg and radionuclidic purity of 99.95 ± 0.02%. 90 Y-labeled HA particles (185 ± 10 MBq doses) were formulated in high radiochemical purity (> 99%) and excellent in vitro stability. The preparation showed promising results in pre-clinical studies carried out in Wistar rats. The preliminary results of the first clinical investigation of 90 Y-HA preparation in a patient with rheumatoid arthritis in knee joints demonstrated the effectiveness of the formulation prepared using 90 Y produced via (n,γ) route in the management of the disease. Conclusion: The studies revealed that effective utilization of 90 Y produced via (n,γ) route in a medium flux research

  10. A sense inventory for clinical abbreviations and acronyms created using clinical notes and medical dictionary resources

    Science.gov (United States)

    Moon, Sungrim; Pakhomov, Serguei; Liu, Nathan; Ryan, James O; Melton, Genevieve B

    2014-01-01

    Objective To create a sense inventory of abbreviations and acronyms from clinical texts. Methods The most frequently occurring abbreviations and acronyms from 352 267 dictated clinical notes were used to create a clinical sense inventory. Senses of each abbreviation and acronym were manually annotated from 500 random instances and lexically matched with long forms within the Unified Medical Language System (UMLS V.2011AB), Another Database of Abbreviations in Medline (ADAM), and Stedman's Dictionary, Medical Abbreviations, Acronyms & Symbols, 4th edition (Stedman's). Redundant long forms were merged after they were lexically normalized using Lexical Variant Generation (LVG). Results The clinical sense inventory was found to have skewed sense distributions, practice-specific senses, and incorrect uses. Of 440 abbreviations and acronyms analyzed in this study, 949 long forms were identified in clinical notes. This set was mapped to 17 359, 5233, and 4879 long forms in UMLS, ADAM, and Stedman's, respectively. After merging long forms, only 2.3% matched across all medical resources. The UMLS, ADAM, and Stedman's covered 5.7%, 8.4%, and 11% of the merged clinical long forms, respectively. The sense inventory of clinical abbreviations and acronyms and anonymized datasets generated from this study are available for public use at http://www.bmhi.umn.edu/ihi/research/nlpie/resources/index.htm (‘Sense Inventories’, website). Conclusions Clinical sense inventories of abbreviations and acronyms created using clinical notes and medical dictionary resources demonstrate challenges with term coverage and resource integration. Further work is needed to help with standardizing abbreviations and acronyms in clinical care and biomedicine to facilitate automated processes such as text-mining and information extraction. PMID:23813539

  11. Underestimated clinical features of postadolescent acne.

    Science.gov (United States)

    Capitanio, Bruno; Sinagra, Jo Linda; Bordignon, Valentina; Cordiali Fei, Paola; Picardo, Mauro; Zouboulis, Christos C

    2010-11-01

    Postadolescent acne is usually described as an inflammatory, mild-to-moderate dermatosis, frequently involving the lower third of the face, the jawline, and the neck. However, we have also frequently observed a clinical form predominantly characterized by retention lesions (microcomedones and macrocomedones), with few inflammatory lesions (comedonal postadolescent acne [CPAA]), which appears significantly correlated with cigarette smoking. We sought to investigate the clinical features of postadolescent acne in a group of female patients affected by acne and its relationship with cigarette smoking. A total of 226 women with acne (25-50 years) attending our department were examined by a team of 3 dermatologists, to assess the age of onset of the disease, and the number, type, and distribution of acne lesions. In all, 192 of 226 patients (85.0%) were classified as having CPAA and 34 as having papulopustular postadolescent acne. A smoking habit was confirmed in 150 of 226 (66.3%). Remarkably, 72.9% of patients with CPAA were smokers as compared with only 29.4% of those with papulopustular postadolescent acne (P < .0001). Possible limitations are related to geographic area or to the prevalence of darker skin types (III and IV) (data about skin types have not been collected). Other possible aggravating factors (ie, stress and diet) have not been investigated. According to our results, CPAA appears as the most frequent clinical form of postadolescent acne and seems to be strictly correlated with cigarette smoking. Copyright © 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  12. Using systematically observed clinical encounters (SOCEs to assess medical students’ skills in clinical settings

    Directory of Open Access Journals (Sweden)

    George R Bergus

    2010-11-01

    Full Text Available George R Bergus1–3, Jerold C Woodhead4, Clarence D Kreiter2,51Performance Based Assessment Program, Office of Student Affairs and Curriculum, 2Department of Family Medicine, 3Department of Psychiatry, 4Department of Pediatrics, 5Office of Consultation and Research in Medical Education, Roy J and Lucille A Carver College of Medicine, The University of Iowa, Iowa City, IA, USAIntroduction: The Objective Structured Clinical Examination (OSCE is widely used to assess the clinical performance of medical students. However, concerns related to cost, availability, and validity, have led educators to investigate alternatives to the OSCE. Some alternatives involve assessing students while they provide care to patients – the mini-CEX (mini-Clinical Evaluation Exercise and the Long Case are examples. We investigated the psychometrics of systematically observed clinical encounters (SOCEs, in which physicians are supplemented by lay trained observers, as a means of assessing the clinical performances of medical students.Methods: During the pediatrics clerkship at the University of Iowa, trained lay observers assessed the communication skills of third-year medical students using a communication checklist while the students interviewed and examined pediatric patients. Students then verbally presented their findings to faculty, who assessed students’ clinical skills using a standardized form. The reliability of the combined communication and clinical skills scores was calculated using generalizability theory.Results: Fifty-one medical students completed 199 observed patient encounters. The mean combined clinical and communication skills score (out of a maximum 45 points was 40.8 (standard deviation 3.3. The calculated reliability of the SOCE scores, using generalizability theory, from 10 observed patient encounters was 0.81. Students reported receiving helpful feedback from faculty after 97% of their observed clinical encounters.Conclusion: The SOCE can

  13. Beyond Readability: Investigating Coherence of Clinical Text for Consumers

    Science.gov (United States)

    Hetzel, Scott; Dalrymple, Prudence; Keselman, Alla

    2011-01-01

    Background A basic tenet of consumer health informatics is that understandable health resources empower the public. Text comprehension holds great promise for helping to characterize consumer problems in understanding health texts. The need for efficient ways to assess consumer-oriented health texts and the availability of computationally supported tools led us to explore the effect of various text characteristics on readers’ understanding of health texts, as well as to develop novel approaches to assessing these characteristics. Objective The goal of this study was to compare the impact of two different approaches to enhancing readability, and three interventions, on individuals’ comprehension of short, complex passages of health text. Methods Participants were 80 university staff, faculty, or students. Each participant was asked to “retell” the content of two health texts: one a clinical trial in the domain of diabetes mellitus, and the other typical Visit Notes. These texts were transformed for the intervention arms of the study. Two interventions provided terminology support via (1) standard dictionary or (2) contextualized vocabulary definitions. The third intervention provided coherence improvement. We assessed participants’ comprehension of the clinical texts through propositional analysis, an open-ended questionnaire, and analysis of the number of errors made. Results For the clinical trial text, the effect of text condition was not significant in any of the comparisons, suggesting no differences in recall, despite the varying levels of support (P = .84). For the Visit Note, however, the difference in the median total propositions recalled between the Coherent and the (Original + Dictionary) conditions was significant (P = .04). This suggests that participants in the Coherent condition recalled more of the original Visit Notes content than did participants in the Original and the Dictionary conditions combined. However, no difference was seen

  14. Clinical Trials

    Medline Plus

    Full Text Available ... What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might ... enroll in a clinical trial, a doctor or nurse will give you an informed consent form that ...

  15. Observed Antagonistic Effect of Linezolid on Daptomycin or Vancomycin Activity against Biofilm-Forming Methicillin-Resistant Staphylococcus aureus in an In Vitro Pharmacodynamic Model

    Science.gov (United States)

    Luther, Megan K.

    2015-01-01

    Pharmacodynamic activity in antibiotic combinations of daptomycin, vancomycin, and linezolid was investigated in a 48-h in vitro pharmacodynamic model. Using human-simulated free drug concentrations, activity against clinical biofilm-forming methicillin-resistant Staphylococcus aureus isolates was evaluated. Linezolid antagonized vancomycin activity at 24 and 48 h. Linezolid antagonized daptomycin at 24 and 48 h depending on dose and strain. Adding daptomycin increased vancomycin activity at 48 h (P < 0.03). These results may be strain dependent and require further clinical investigation. PMID:26369963

  16. Differential thermal, Thermogravimetric and X-ray diffraction investigation of hydration phases in cementitious waste form

    International Nuclear Information System (INIS)

    Khalil, M.Y.; Nagy, M.E.; El-Sourougy, M.R.; Zaki, A.A.

    1996-01-01

    Hydration phases of cement determine the final properties of the product. Adding other components to the cement paste may alter the final phases formed and affect properties of the hardened products. In this work ordinary portland cement and/or blast furnace slag cement were hardened with low-or intermediate-level radioactive liquid wastes and different additives. Hydration phases were investigated using differential thermal, thermogravimetric, and X-ray diffraction techniques. Low-and intermediate-level liquid wastes were found not to affect the hydration phases of cement. The addition of inorganic exchangers and latex were found to affect the hydration properties of the cement waste system. This resulted in a reduction of compressive strength. On the contrary, addition of epoxy also affected the hydration causing increase in compressive strength. 10 figs., 2 tabs

  17. Clinical investigation of proximate exposed group, 1

    International Nuclear Information System (INIS)

    Ito, Chikako; Hasegawa, Kazuyo; Kato, Masafumi; Kumasawa, Toshihiko

    1984-01-01

    In order to investigate effects of the A-bombing on prevalence of diabetes mellitus, follow-up studies were made on 5907 A-bomb survivors who received glucose tolerance test (GTT) during 20 years between 1963 and 1983. The A-bomb survivors were divided into the group A (1899 men and 1165 women exposed within 1.9 km from the hypocenter) and the group B (1725 men and 1118 women exposed 3.0 km or farther from it). Among non-obese survivors, 21.9% and 21.8% were being treated for diabetes mellitus or were evaluated as having diabetic type on GTT in the group A and the group B, respectively; while this was seen in 52.1% of obese survivors in the group A and 49.9% in the group B. There was no difference between the groups. In non-obese survivors, the annual development rate from the normal type to the diabetic type was 0.89% in the group A and 0.65% in the group B; the annual development rate from the borderline type to the diabetic type was 5.73% in the group A and 5.49% in the group B, showing no differences between the groups. The annual development rate from the normal or borderline type to the diabetic type was two times or higher in obese survivors than in non-obese survivors irrespective of exposure status. Regarding the number of diabetic survivors who became non-diabetic type in spite of having no treatment, and prevalence of diabetic complications, no difference was seen between the groups. These results suggest that the A-bombing has scarcely influenced the prevalence of diabetes mellitus and clinical course. (Namekawa, K.)

  18. Unstable argininosuccinate lyase in variant forms of the urea cycle disorder argininosuccinic aciduria.

    Science.gov (United States)

    Hu, Liyan; Pandey, Amit V; Balmer, Cécile; Eggimann, Sandra; Rüfenacht, Véronique; Nuoffer, Jean-Marc; Häberle, Johannes

    2015-09-01

    Loss of function of the urea cycle enzyme argininosuccinate lyase (ASL) is caused by mutations in the ASL gene leading to ASL deficiency (ASLD). ASLD has a broad clinical spectrum ranging from life-threatening severe neonatal to asymptomatic forms. Different levels of residual ASL activity probably contribute to the phenotypic variability but reliable expression systems allowing clinically useful conclusions are not yet available. In order to define the molecular characteristics underlying the phenotypic variability, we investigated all ASL mutations that were hitherto identified in patients with late onset or mild clinical and biochemical courses by ASL expression in human embryonic kidney 293 T cells. We found residual activities >3% of ASL wild type (WT) in nine of 11 ASL mutations. Six ASL mutations (p.Arg95Cys, p.Ile100Thr, p.Val178Met, p.Glu189Gly, p.Val335Leu, and p.Arg379Cys) with residual activities ≥16% of ASL WT showed no significant or less than twofold reduced Km values, but displayed thermal instability. Computational structural analysis supported the biochemical findings by revealing multiple effects including protein instability, disruption of ionic interactions and hydrogen bonds between residues in the monomeric form of the protein, and disruption of contacts between adjacent monomeric units in the ASL tetramer. These findings suggest that the clinical and biochemical course in variant forms of ASLD is associated with relevant residual levels of ASL activity as well as instability of mutant ASL proteins. Since about 30% of known ASLD genotypes are affected by mutations studied here, ASLD should be considered as a candidate for chaperone treatment to improve mutant protein stability.

  19. Department of Clinical Investigation: Annual Research Progress Report for Fiscal Year 1992. Volume 2

    Science.gov (United States)

    1993-01-01

    A-5-90 Production of Mouse Positive and Negative Control Slides for 295 Use in Rabies FRA Test. (0) A-7-90 Clinical Investigation on the...Dose Intensification of Methotrexate and 519 6- Mercaptopurine for ALL in Childhood. (0) POG 9006 ALinC 15: Up-Front 6-MP/MTX vs. Up-Front Alternating 520...for the mouse bioassay as a means for detecting Clostridium botulinum toxin in cultures, food products , serum and fecal specimens. Technical Approach

  20. Genomic investigation of Staphylococcus aureus isolates from bulk tank milk and dairy cows with clinical mastitis.

    Science.gov (United States)

    Ronco, Troels; Klaas, Ilka C; Stegger, Marc; Svennesen, Line; Astrup, Lærke B; Farre, Michael; Pedersen, Karl

    2018-02-01

    Staphylococcus aureus is one of the most common pathogens that cause mastitis in dairy cows. Various subtypes, virulence genes and mobile genetic elements have been associated with isolates from bulk tank milk and clinical mastitis. So far, no Danish cattle associated S. aureus isolates have been whole-genome sequenced and further analyzed. Thus, the main objective was to investigate the population structure and genomic content of isolates from bulk tank milk and clinical mastitis, using whole-genome sequencing. This may reveal the origin of strains that cause clinical mastitis. S. aureus isolates from bulk tank milk (n = 94) and clinical mastitis (n = 63) were collected from 91 and 24 different farms, respectively and whole-genome sequenced. The genomic content was analyzed and a phylogenetic tree based on single nucleotide polymorphisms was constructed. In general, the isolates from both bulk tank milk and clinical mastitis were of similar genetic background. This suggests that dairy cows are natural carriers of the S. aureus subtypes that cause clinical mastitis if the right conditions are present and that a broad range of subtypes cause mastitis. A phylogenetic cluster that mostly consisted of ST151 isolates carried three mobile genetic elements that were primarily found in this group. The prevalence of resistance genes was generally low. However, the first ST398 methicillin resistant S. aureus isolate from a Danish dairy cow with clinical mastitis was detected. Copyright © 2018 Elsevier B.V. All rights reserved.

  1. Investigation of Factors Affecting Body Temperature Changes During Routine Clinical Head Magnetic Resonance Imaging

    Science.gov (United States)

    Kim, Myeong Seong

    2016-01-01

    Background Pulsed radiofrequency (RF) magnetic fields, required to produce magnetic resonance imaging (MRI) signals from tissue during the MRI procedure have been shown to heat tissues. Objectives To investigate the relationship between body temperature rise and the RF power deposited during routine clinical MRI procedures, and to determine the correlation between this effect and the body’s physiological response. Patients and Methods We investigated 69 patients from the Korean national cancer center to identify the main factors that contribute to an increase in body temperature (external factors and the body’s response) during a clinical brain MRI. A routine protocol sequence of MRI scans (1.5 T and 3.0 T) was performed. The patient’s tympanic temperature was recorded before and immediately after the MRI procedure and compared with changes in variables related to the body’s physiological response to heat. Results Our investigation of the physiological response to RF heating indicated a link between increasing age and body temperature. A higher increase in body temperature was observed in older patients after a 3.0-T MRI (r = 0.07, P = 0.29 for 1.5-T MRI; r = 0.45, P = 0.002 for 3.0-T MRI). The relationship between age and body heat was related to the heart rate (HR) and changes in HR during the MRI procedure; a higher RF power combined with a reduction in HR resulted in an increase in body temperature. Conclusion A higher magnetic field strength and a decrease in the HR resulted in an increase in body temperature during the MRI procedure. PMID:27895872

  2. [Is childhood migraine an immature form of adult migraine?].

    Science.gov (United States)

    Ozge, Aynur

    2007-01-01

    Childhood migraine is a common problem among the primary complaints of the pediatric population. But for the general practitioners there are little known about clinical characteristics and management strategies. Headache practitioners commonly notice the age related differences of headache characteristics and management schedules. This paper primarily aimed to answer the question if pediatric migraine is an unmaturated form of adult migraine, by discussing the pathophysiological basis, clinical forms and management strategies.

  3. Detection of biofilm production of Yersinia enterocolitica strains isolated from infected children and comparative antimicrobial susceptibility of biofilm versus planktonic forms.

    Science.gov (United States)

    Ioannidis, A; Kyratsa, A; Ioannidou, V; Bersimis, S; Chatzipanagiotou, S

    2014-06-01

    The ability of Yersinia species to produce biofilms has not been hitherto systematically studied, although there is evidence, that Y. enterocolitica is able to form biofilms on inanimate surfaces. The present study aimed to detect the production of biofilms by 60 clinical strains of Y. enterocolitica and to compare the antimicrobial susceptibility of planktonic versus biofilm-forming bacteria. Y. enterocolitica strains were collected from stool and blood cultures collected from β-thalassaemic children, with gastroenteritis and/or septicemia. The isolated bacterial strains were grouped by biotyping and serotyping and the antimicrobial susceptibility of the planktonic forms was investigated by MIC determination. Biofilm formation was detected by the use of silicone disks and for the biofilm forming strains the minimum inhibitory concentration for bacterial regrowth (MICBR) of 11 clinically important antimicrobials was determined. The presence of the waaE, a gene reported to be related with biofilm formation was investigated in all the strains. All of 60 strains were positive for biofilm production by the use of silicone disks. The great majority of the biofilm forms were resistant to all the antimicrobials. In antimicrobial concentrations far higher than the CLSI breakpoints, bacterial regrowth from the biofilms was still possible. None of the strains bore the waaE gene. These results, indicate that biofilm formation by Y. enterocolitica might be an inherent feature. The presence of biofilms increased dramatically the MICBR in all antimicrobials. The way in which biofilms could contribute to Y. enterocolitica pathogenicity in humans is a matter needing further investigation.

  4. Investigations of the form and flow of ice sheets and glaciers using radio-echo sounding

    Energy Technology Data Exchange (ETDEWEB)

    Dowdeswell, J A; Evans, S [Scott Polar Research Institute, University of Cambridge, Cambridge CB2 1ER (United Kingdom)

    2004-10-01

    Radio-echo sounding (RES), utilizing a variety of radio frequencies, was developed to allow glaciologists to measure the thickness of ice sheets and glaciers. We review the nature of electromagnetic wave propagation in ice and snow, including the permittivity of ice, signal attenuation and volume scattering, along with reflection from rough and specular surfaces. The variety of instruments used in RES of polar ice sheets and temperate glaciers is discussed. The applications and insights that a knowledge of ice thickness, and the wider nature of the form and flow of ice sheets, provides are also considered. The thickest ice measured is 4.7 km in East Antarctica. The morphology of the Antarctic and Greenland ice sheets, and many of the smaller ice caps and glaciers of the polar regions, has been investigated using RES. These findings are being used in three-dimensional numerical models of the response of the cryosphere to environmental change. In addition, the distribution and character of internal and basal reflectors within ice sheets contains information on, for example, ice-sheet layering and its chrono-stratigraphic significance, and has enabled the discovery and investigation of large lakes beneath the Antarctic Ice Sheet. Today, RES from ground-based and airborne platforms remains the most effective tool for measuring ice thickness and internal character.

  5. How GPs implement clinical guidelines in everyday clinical practice--a qualitative interview study.

    Science.gov (United States)

    Le, Jette V; Hansen, Helle P; Riisgaard, Helle; Lykkegaard, Jesper; Nexøe, Jørgen; Bro, Flemming; Søndergaard, Jens

    2015-12-01

    Clinical guidelines are considered to be essential for improving quality and safety of health care. However, interventions to promote implementation of guidelines have demonstrated only partial effectiveness and the reasons for this apparent failure are not yet fully understood. To investigate how GPs implement clinical guidelines in everyday clinical practice and how implementation approaches differ between practices. Individual semi-structured open-ended interviews with seven GPs who were purposefully sampled with regard to gender, age and practice form. Interviews were recorded, transcribed verbatim and then analysed using systematic text condensation. Analysis of the interviews revealed three different approaches to the implementation of guidelines in clinical practice. In some practices the GPs prioritized time and resources on collective implementation activities and organized their everyday practice to support these activities. In other practices GPs discussed guidelines collectively but left the application up to the individual GP whilst others again saw no need for discussion or collective activities depending entirely on the individual GP's decision on whether and how to manage implementation. Approaches to implementation of clinical guidelines vary substantially between practices. Supporting activities should take this into account. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. Forms of Life

    Directory of Open Access Journals (Sweden)

    Peter Hacker

    2015-10-01

    Full Text Available The phrase ‘Lebensform’ (form of life had a long and varied history prior to Wittgenstein’s use of it on a mere three occasions in the Philosophical Investigations. It is not a pivotal concept in Wittgenstein’s philosophy. But it is a minor signpost of a major reorientation of philosophy, philosophy of language and logic, and philosophy of mathematics that Wittgenstein instigated. For Wittgenstein sought to replace the conception of a language as a meaning calculus (Frege, Russell, the Tractatus by an anthropological or ethnological conception. A language is not a class of sentences that can be formed from a set of axioms (definitions, formation and transformation rules and the meanings of which is given by their truth-conditions, but an open-ended series of interlocking language-games constituting a form of life or way of living (a culture. Wittgenstein’s uses of ‘Lebensform’ and its cognates, both in the Investigations and in his Nachlass are severally analysed, and various exegetical misinterpretations are clarified.

  7. Genetic testing in congenital heart disease: A clinical approach

    Science.gov (United States)

    Chaix, Marie A; Andelfinger, Gregor; Khairy, Paul

    2016-01-01

    Congenital heart disease (CHD) is the most common type of birth defect. Traditionally, a polygenic model defined by the interaction of multiple genes and environmental factors was hypothesized to account for different forms of CHD. It is now understood that the contribution of genetics to CHD extends beyond a single unified paradigm. For example, monogenic models and chromosomal abnormalities have been associated with various syndromic and non-syndromic forms of CHD. In such instances, genetic investigation and testing may potentially play an important role in clinical care. A family tree with a detailed phenotypic description serves as the initial screening tool to identify potentially inherited defects and to guide further genetic investigation. The selection of a genetic test is contingent upon the particular diagnostic hypothesis generated by clinical examination. Genetic investigation in CHD may carry the potential to improve prognosis by yielding valuable information with regards to personalized medical care, confidence in the clinical diagnosis, and/or targeted patient follow-up. Moreover, genetic assessment may serve as a tool to predict recurrence risk, define the pattern of inheritance within a family, and evaluate the need for further family screening. In some circumstances, prenatal or preimplantation genetic screening could identify fetuses or embryos at high risk for CHD. Although genetics may appear to constitute a highly specialized sector of cardiology, basic knowledge regarding inheritance patterns, recurrence risks, and available screening and diagnostic tools, including their strengths and limitations, could assist the treating physician in providing sound counsel. PMID:26981213

  8. "There are too many, but never enough": qualitative case study investigating routine coding of clinical information in depression.

    Science.gov (United States)

    Cresswell, Kathrin; Morrison, Zoe; Kalra, Dipak; Sheikh, Aziz

    2012-01-01

    We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined.

  9. Investigation of the antibiotic resistance and biofilm-forming ability of Staphylococcus aureus from subclinical bovine mastitis cases.

    Science.gov (United States)

    Aslantaş, Özkan; Demir, Cemil

    2016-11-01

    A total of 112 Staphylococcus aureus isolates obtained from subclinical bovine mastitis cases were examined for antibiotic susceptibility and biofilm-forming ability as well as genes responsible for antibiotic resistance, biofilm-forming ability, and adhesin. Antimicrobial susceptibility of the isolates were determined by disk diffusion method. Biofilm forming ability of the isolates were investigated by Congo red agar method, standard tube method, and microplate method. The genes responsible for antibiotic resistance, biofilm-forming ability, and adhesion were examined by PCR. Five isolates (4.5%) were identified as methicillin-resistant Staph. aureus by antibiotic susceptibility testing and confirmed by mecA detection. The resistance rates to penicillin, ampicillin, tetracycline, erythromycin, trimethoprim-sulfamethoxazole, enrofloxacin, and amoxicillin-clavulanic acid were 45.5, 39.3, 33, 26.8, 5.4, 0.9, and 0.9%, respectively. All isolates were susceptible against vancomycin and gentamicin. The blaZ (100%), tetK (67.6%), and ermA (70%) genes were the most common antibiotic-resistance genes. Using Congo red agar, microplate, and standard tube methods, 70.5, 67, and 62.5% of the isolates were found to be biofilm producers, respectively. The percentage rate of icaA, icaD, and bap genes in Staph. aureus isolates were 86.6, 86.6, and 13.4%, respectively. The adhesion molecules fnbA, can, and clfA were detected in 87 (77.7%), 98 (87.5%), and 75 (70%) isolates, respectively. The results indicated that Staph. aureus from sublinical bovine mastitis cases were mainly resistant to β-lactams and, to a lesser extent, to tetracycline and erythromycin. Also, biofilm- and adhesion-related genes, which are increasingly accepted as an important virulence factor in the pathogenesis of Staph. aureus infections, were detected at a high rate. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  10. Heterogeneity prevails: the state of clinical trial data management in Europe - results of a survey of ECRIN centres

    DEFF Research Database (Denmark)

    Kuchinke, Wolfgang; Ohmann, Christian; Yang, Qin

    2010-01-01

    The use of Clinical Data Management Systems (CDMS) has become essential in clinical trials to handle the increasing amount of data that must be collected and analyzed. With a CDMS trial data are captured at investigator sites with "electronic Case Report Forms". Although more and more of these el...

  11. Investigation of activity release from bituminized intermediate-level waste forms under thermal stresses

    International Nuclear Information System (INIS)

    Kluger, W.; Vejmelka, P.; Koester, R.

    1983-01-01

    To determine the consequences of a fire during fabrication, intermediate storage and transport of bituminized NaNO 3 waste forms, the fractions of plutonium released from the waste forms were assessed. For this purpose, laboratory tests were made with PuO 2 -containing specimens as well as a field test with specimens containing Eu 2 O 3 . By the evaluation of plutonium release in the laboratory and by the determination of the total sodium release and the relative Eu/Na release in the field tests the plutonium release can be deduced from full-scale specimens. The results show that for bituminized waste forms with high NaNO 3 contents (approx. 36 wt%) the average plutonium release obtained in laboratory testing is 15%. In the field tests (IAEA fire test conditions) an average Eu release of 8% was found. These results justify the statement that also for waste forms in open 175 L drum inserts a maximum plutonium release of about 15% can be expected. From the time-dependence of Eu/Na release in the field tests an induction period of 15-20 minutes between the start of testing and the first Na/Eu release can be derived. The maximum differential Na/Eu release occurs after a test period of 45 to 60 minutes duration and after 90 to 105 minutes (tests K2 and K4, respectively); after that time also the highest temperatures in the products are measured. The release values were determined for products in open 175 L drum inserts which in this form are not eligible for intermediate and ultimate storage. For bituminized waste forms in concrete packages (lost concrete shieldings) a delayed increase in temperature to only 70-80 deg. C takes place (4-5 hours after extinction of the fire) if the fire lasts 45 minutes. The concrete package remains intact under test conditions. This means that activity release from bituminized waste forms packaged in this way can be ruled out in the case under consideration. (author)

  12. Using Rasch Measurement To Investigate the Cross-form Equivalence and Clinical Utility of Spanish and English Versions of a Diabetes Questionnaire: A Pilot Study.

    Science.gov (United States)

    Gerber, Ben; Smith, Everett V., Jr.; Girotti, Mariela; Pelaez, Lourdes; Lawless, Kimberly; Smolin, Louanne; Brodsky, Irwin; Eiser, Arnold

    2002-01-01

    Used Rasch measurement to study the psychometric properties of data obtained from a newly developed Diabetes Questionnaire designed to measure diabetes knowledge, attitudes, and self-care. Responses of 26 diabetes patients to the English version of the questionnaire and 24 patients to the Spanish version support the cross-form equivalence and…

  13. Methodological and Clinical Issues in Studies of the Performance of Emotionally Disturbed Children and Adolescents on Abbreviated Forms of the WISC-R: A Review.

    Science.gov (United States)

    Zimet, Sara G.; Adler, Shoshana Shapiro

    1990-01-01

    Reviews research from 1974 to 1988 that suggests there is promise in valid and reliable use of a short form of the Wechsler Intelligence Scale for Children as a means of obtaining clinically relevant information and as an emergency screening device with children with serious emotional disorders. Discusses situations in which children should…

  14. Applications of High Energy Ion Beam Techniques in Environmental Science: Investigation Associated with Glass and Ceramic Waste Forms

    Energy Technology Data Exchange (ETDEWEB)

    Thevuthasan, Suntharampillai; Shutthanandan, V; Zhang, Yanwen

    2006-02-01

    High energy ion beam capabilities including Rutherford backscattering spectrometry (RBS) and nuclear reaction analysis (NRA) have been very effectively used in environmental science to investigate the ion exchange mechanisms in glass waste forms and the effects of irradiation in glass and ceramic waste forms in the past. In this study, RBS and NRA along with SIMNRA simulations were used to monitor the Na depletion and D and 18O uptake in alumina silicate glasses, respectively, after the glass coupons were exposed to aqueous solution. These results show that the formation of a reaction layer and an establishment of a region where diffusion limited ion exchange occur in these glasses during exposure to silica-saturated solutions. Different regions including reaction and diffusion regions were identified on the basis of the depth distributions of these elements. In the case of ceramics, damage accumulation was studied as a function of ion dose at different irradiation temperatures. A sigmoidal dependence of relative disorder on the ion dose was observed. The defect dechanneling factors were calculated for two irradiated regions in SrTiO? using the critical angles determined from the angular yield curves. The dependence of defect dechanneling parameter on the incident energy was investigated and it was observed that the generated defects are mostly interstitial atoms and amorphous clusters. Thermal recovery experiments were performed to study the damage recovery processes up to a maximum temperature of 870 K.

  15. Report of an investigation into deterioration of the Plutonium Fuel Form Fabrication Facility (PuFF) at the DOE Savannah River Site

    Energy Technology Data Exchange (ETDEWEB)

    1991-10-01

    This investigations of the Savannah River Site's Plutonium Fuel Form fabrication facility located in Building 235-F was initiated in April 1991. The purpose of the investigation was to determine whether, as has been alleged, operation of the facility's argon inert gas system was terminated with the knowledge that continued inoperability of the argon system would cause accelerated corrosion damage to the equipment in the plutonium 238 processing cells. The investigation quickly established that the decision to discontinue operation of the argon system, by not repairing it, was merely one of the measures, and not the most important one, which led to the current deteriorated state of the facility. As a result, the scope of the investigation was broadened to more identify and assess those factors which contributed to the facility's current condition. This document discusses the backgrounds, results, and recommendations of this investigation.

  16. Report of an investigation into deterioration of the Plutonium Fuel Form Fabrication Facility (PuFF) at the DOE Savannah River Site

    International Nuclear Information System (INIS)

    1991-10-01

    This investigations of the Savannah River Site's Plutonium Fuel Form fabrication facility located in Building 235-F was initiated in April 1991. The purpose of the investigation was to determine whether, as has been alleged, operation of the facility's argon inert gas system was terminated with the knowledge that continued inoperability of the argon system would cause accelerated corrosion damage to the equipment in the plutonium 238 processing cells. The investigation quickly established that the decision to discontinue operation of the argon system, by not repairing it, was merely one of the measures, and not the most important one, which led to the current deteriorated state of the facility. As a result, the scope of the investigation was broadened to more identify and assess those factors which contributed to the facility's current condition. This document discusses the backgrounds, results, and recommendations of this investigation

  17. Effect modification, interaction and mediation: an overview of theoretical insights for clinical investigators

    Directory of Open Access Journals (Sweden)

    Corraini P

    2017-06-01

    Full Text Available Priscila Corraini,1 Morten Olsen,1 Lars Pedersen,1 Olaf M Dekkers,1,2 Jan P Vandenbroucke1–3 1Department of Clinical Epidemiology, Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark; 2Leiden University Medical Center, Leiden, the Netherlands; 3Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK Abstract: We revisited the three interrelated epidemiological concepts of effect modification, interaction and mediation for clinical investigators and examined their applicability when using research databases. The standard methods that are available to assess interaction, effect modification and mediation are explained and exemplified. For each concept, we first give a simple “best-case” example from a randomized controlled trial, followed by a structurally similar example from an observational study using research databases. Our explanation of the examples is based on recent theoretical developments and insights in the context of large health care databases. Terminology is sometimes ambiguous for what constitutes effect modification and interaction. The strong assumptions underlying the assessment of interaction, and particularly mediation, require clinicians and epidemiologists to take extra care when conducting observational studies in the context of health care databases. These strong assumptions may limit the applicability of interaction and mediation assessments, at least until the biases and limitations of these assessments when using large research databases are clarified. Keywords: methods, epidemiology, effect modifiers, stratified analyses, health care administrative claims

  18. Investigation of clinical pharmacokinetic variability of an opioid antagonist through physiologically based absorption modeling.

    Science.gov (United States)

    Ding, Xuan; He, Minxia; Kulkarni, Rajesh; Patel, Nita; Zhang, Xiaoyu

    2013-08-01

    Identifying the source of inter- and/or intrasubject variability in pharmacokinetics (PK) provides fundamental information in understanding the pharmacokinetics-pharmacodynamics relationship of a drug and project its efficacy and safety in clinical populations. This identification process can be challenging given that a large number of potential causes could lead to PK variability. Here we present an integrated approach of physiologically based absorption modeling to investigate the root cause of unexpectedly high PK variability of a Phase I clinical trial drug. LY2196044 exhibited high intersubject variability in the absorption phase of plasma concentration-time profiles in humans. This could not be explained by in vitro measurements of drug properties and excellent bioavailability with low variability observed in preclinical species. GastroPlus™ modeling suggested that the compound's optimal solubility and permeability characteristics would enable rapid and complete absorption in preclinical species and in humans. However, simulations of human plasma concentration-time profiles indicated that despite sufficient solubility and rapid dissolution of LY2196044 in humans, permeability and/or transit in the gastrointestinal (GI) tract may have been negatively affected. It was concluded that clinical PK variability was potentially due to the drug's antagonism on opioid receptors that affected its transit and absorption in the GI tract. Copyright © 2013 Wiley Periodicals, Inc.

  19. Spray forming: A numerical investigation of the influence of the gas to melt ratio on the billet surface temperature

    DEFF Research Database (Denmark)

    Pryds, Nini; Hattel, Jesper

    2005-01-01

    atomisation taking thermal coupling into consideration and the deposition of material at the surface of the billet taking geometrical aspects such as shading into account. The coupling between these two models is accomplished by ensuring that the total droplet size distribution of the spray is the summation......The relationship between the Gas to Melt Ratio (GMR) and the surface temperature of an evolving billet surface in spray forming is investigated numerically. The basis for the analysis is an integrated approach for modelling the entire spray forming process. This model includes the droplet...... of "local" droplet size distributions along the r-axis of the spray cone. The criterion for a successful process has been a predefined process window characterised by a desired fraction solid range at a certain distance from the atomizer. Inside this process window, the gas and melt flows have been varied...

  20. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates

    KAUST Repository

    Heunis, Tiaan

    2017-08-18

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach we identified 59 peptides containing single amino acid variants, which covered ~9% of all total coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e. large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  1. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates

    KAUST Repository

    Heunis, Tiaan; Dippenaar, Anzaan; Warren, Robin M.; van Helden, Paul D.; van der Merwe, Ruben G.; Gey van Pittius, Nicolaas C.; Pain, Arnab; Sampson, Samantha L.; Tabb, David L.

    2017-01-01

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach we identified 59 peptides containing single amino acid variants, which covered ~9% of all total coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e. large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  2. Proteogenomic Investigation of Strain Variation in Clinical Mycobacterium tuberculosis Isolates.

    Science.gov (United States)

    Heunis, Tiaan; Dippenaar, Anzaan; Warren, Robin M; van Helden, Paul D; van der Merwe, Ruben G; Gey van Pittius, Nicolaas C; Pain, Arnab; Sampson, Samantha L; Tabb, David L

    2017-10-06

    Mycobacterium tuberculosis consists of a large number of different strains that display unique virulence characteristics. Whole-genome sequencing has revealed substantial genetic diversity among clinical M. tuberculosis isolates, and elucidating the phenotypic variation encoded by this genetic diversity will be of the utmost importance to fully understand M. tuberculosis biology and pathogenicity. In this study, we integrated whole-genome sequencing and mass spectrometry (GeLC-MS/MS) to reveal strain-specific characteristics in the proteomes of two clinical M. tuberculosis Latin American-Mediterranean isolates. Using this approach, we identified 59 peptides containing single amino acid variants, which covered ∼9% of all coding nonsynonymous single nucleotide variants detected by whole-genome sequencing. Furthermore, we identified 29 distinct peptides that mapped to a hypothetical protein not present in the M. tuberculosis H37Rv reference proteome. Here, we provide evidence for the expression of this protein in the clinical M. tuberculosis SAWC3651 isolate. The strain-specific databases enabled confirmation of genomic differences (i.e., large genomic regions of difference and nonsynonymous single nucleotide variants) in these two clinical M. tuberculosis isolates and allowed strain differentiation at the proteome level. Our results contribute to the growing field of clinical microbial proteogenomics and can improve our understanding of phenotypic variation in clinical M. tuberculosis isolates.

  3. Research Capacity at Traditional Chinese Medicine (TCM Centers in China: A Survey of Clinical Investigators

    Directory of Open Access Journals (Sweden)

    Shuo Feng

    2017-01-01

    Full Text Available Background. The development of an evidence-based approach to traditional Chinese medicine (TCM, which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82% were qualified to at least a Master’s degree, whilst a smaller proportion (40.24% held a senior professional title. We found that academic outputs were low with the majority (62.16% authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43% and identification of research questions (86.81%, whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%, and time (37.15%. Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators’ research capacity and the development of an evidence-based approach of TCM.

  4. Investigation of the Electrohydraulic Forming Process with respect to the Design of Sharp Edged Contours

    OpenAIRE

    Beerwald, C.; Homberg, W.; Pröbsting, A.

    2010-01-01

    The overcoming of design constraints with respect to forming of sharply contoured sheet metal workpieces made of high strength steel or other materials which are difficult to form is an important aspect in sheet metal part production. One interesting solution to extend existing forming limits can be the use of electrohydraulic forming as single forming operation or in combination with quasi-static hydroforming. Apart from promising results regarding the feasible part geometries this process a...

  5. Investigation of reliability, validity and normality Persian version of the California Critical Thinking Skills Test; Form B (CCTST

    Directory of Open Access Journals (Sweden)

    Khallli H

    2003-04-01

    Full Text Available Background: To evaluate the effectiveness of the present educational programs in terms of students' achieving problem solving, decision making and critical thinking skills, reliable, valid and standard instrument are needed. Purposes: To Investigate the Reliability, validity and Norm of CCTST Form.B .The California Critical Thinking Skills Test contain 34 multi-choice questions with a correct answer in the jive Critical Thinking (CT cognitive skills domain. Methods: The translated CCTST Form.B were given t0405 BSN nursing students ojNursing Faculties located in Tehran (Tehran, Iran and Shahid Beheshti Universitiesthat were selected in the through random sampling. In order to determine the face and content validity the test was translated and edited by Persian and English language professor and researchers. it was also confirmed by judgments of a panel of medical education experts and psychology professor's. CCTST reliability was determined with internal consistency and use of KR-20. The construct validity of the test was investigated with factor analysis and internal consistency and group difference. Results: The test coefficien for reliablity was 0.62. Factor Analysis indicated that CCTST has been formed from 5 factor (element namely: Analysis, Evaluation, lriference, Inductive and Deductive Reasoning. Internal consistency method shows that All subscales have been high and positive correlation with total test score. Group difference method between nursing and philosophy students (n=50 indicated that there is meaningfUl difference between nursing and philosophy students scores (t=-4.95,p=0.OOO1. Scores percentile norm also show that percentile offifty scores related to 11 raw score and 95, 5 percentiles are related to 17 and 6 raw score ordinary. Conclusions: The Results revealed that the questions test is sufficiently reliable as a research tool, and all subscales measure a single construct (Critical Thinking and are able to distinguished the

  6. The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC): verification of nasal allergen challenge procedures in a study utilizing an investigational immunotherapy for cat allergy.

    Science.gov (United States)

    Neighbour, Helen; Soliman, Mena; Steacy, Lisa M; Hickey, Pascal; Forbes, Beth; Larché, Mark; Ellis, Anne K

    2018-01-01

    The Allergic Rhinitis Clinical Investigator Collaborative (AR-CIC) is a network of experienced Allergic Rhinitis (AR) researchers developing better research tools based on the nasal allergen challenge (NAC). A key objective of such is the ability to detect efficacy in a small population. AR-CIC sought to test its NAC protocol as a secondary objective in two small mechanistic research trials of a novel form of immunotherapy [Cat Peptide Antigen Desensitisation (Cat-PAD)] for which efficacy had previously been demonstrated. The primary objective (not presented here) was to identify potential biomarkers of efficacy for peptide immunotherapy, and this provided an ideal opportunity to corroborate the NAC protocol. We aim to clinically validate the AR-CIC NAC methodology in a pooled analysis of secondary endpoints measured in two open label mechanistic studies of cat allergic participants treated with Cat-PAD. Cat allergic AR sufferers with ongoing cat exposure were included. Participants had to demonstrate a total nasal symptom score (TNSS) of at least 8 (max 12) and/or achieve a reduction in peak nasal inspiratory flow (PNIF) of ≥ 50% during a screening titrated NAC. Eligible participants then underwent a baseline NAC visit with the allergen dose that produced a positive challenge at screening, followed by four monthly injections of 6 nmol Cat-PAD. A follow up NAC visit documented changes in nasal response 1 month following the completion of treatment. Nineteen subjects completed the study protocol in the two studies combined. Four injections of Cat-PAD resulted in a significant reduction in TNSS responses generated via NAC following allergen challenge (15 min p  < 0.05, 30 min p  < 0.05, 1 h p  < 0.01, 2 h p  < 0.05). There was modest correlation between symptom scores and PNIF measurements. This study supports the validity of the AR-CIC's optimised NAC protocol for conducting research of the potential efficacy of novel therapeutics in multi

  7. Stock market returns and clinical trial results of investigational compounds: an event study analysis of large biopharmaceutical companies.

    Science.gov (United States)

    Hwang, Thomas J

    2013-01-01

    For biopharmaceutical companies, investments in research and development are risky, and the results from clinical trials are key inflection points in the process. Few studies have explored how and to what extent the public equity market values clinical trial results. Our study dataset matched announcements of clinical trial results for investigational compounds from January 2011 to May 2013 with daily stock market returns of large United States-listed pharmaceutical and biotechnology companies. Event study methodology was used to examine the relationship between clinical research events and changes in stock returns. We identified public announcements for clinical trials of 24 investigational compounds, including 16 (67%) positive and 8 (33%) negative events. The majority of announcements were for Phase 3 clinical trials (N = 13, 54%), and for oncologic (N = 7, 29%) and neurologic (N = 6, 24%) indications. The median cumulative abnormal returns on the day of the announcement were 0.8% (95% confidence interval [CI]: -2.3, 13.4%; P = 0.02) for positive events and -2.0% (95% CI: -9.1, 0.7%; P = 0.04) for negative events, with statistically significant differences from zero. In the day immediately following the announcement, firms with positive events were associated with stock price corrections, with median cumulative abnormal returns falling to 0.4% (95% CI: -3.8, 12.3%; P = 0.33). For firms with negative announcements, the median cumulative abnormal returns were -1.7% (95% CI: -9.5, 1.0%; P = 0.03), and remained significantly negative over the two day event window. The magnitude of abnormal returns did not differ statistically by indication, by trial phase, or between biotechnology and pharmaceutical firms. The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return underperformance due to negative events is greater in magnitude and persists longer than

  8. Immunologic and clinical responses to "Monday morning miseries" antigens.

    Science.gov (United States)

    Cernelc, S; Stropnik, Z

    1987-01-01

    Authors analysed 96 workers exposed to air conditioning system (Group A), and 71 workers (Group B) breathing normal ambient air. 38 workers in group A had a positive clinical history of "Monday morning miseries". Eight cases with the diagnosis hypersensitivity pneumonitis, acute and chronic form was based on environmental history, clinical investigations, physical examination, Chest-X-ray examination, immunological test "in vivo" and "in vitro" with common allergens and antigen "Monday morning miseries", ELISA, spirometry and PEFR (Peak Expiratory Flow-Rate) measurements. Exposure to contaminated air may be responsible for morbidity and reduced performance of workers.

  9. [Clinical investigation of basophil activation test as a complementary test for house dust mite allergen].

    Science.gov (United States)

    Ren, H L; Li, J D; Miao, Y H; Xu, T

    2018-03-01

    Objective: To investigate the clinical application of glass micro fiber basophil activation test (BAT) used as a complementary test for house dust mite allergen. Method: Forty patients with clinical diagnosed allergic rhinitis was test by three methods for house dust mite allergen, skin prick test(SPT),Immuno CAP sIgE, and BAT in vitro. The sensitivity and specificity of glass micro fiber were accessed, and the consistency between BAT, SPT, and Immuno sIgE was analyzed. As in vivo provocation was not performed, gold standard is regarded as the combination of medical history and positive reports of SPT and/or ImmunoCAP sIgE test. Result: Twentythree patients are diagnosed as house dust mite allergic rhinitis by gold standard. The sensitivity and specificity of glass micro fiber BAT were 60.9% and 88.2%, the sensitivity of SPT and sIgE was 87.0% and sIgE 73.9%. The correlation rates between BAT with SPT is 0.67( P house dust mite allergic rhinitis, BAT have a good consistency with SPT and sIgE, while as it has only moderate consistency with "gold standard", further studies are needed to prove its clinical significance. Copyright© by the Editorial Department of Journal of Clinical Otorhinolaryngology Head and Neck Surgery.

  10. Inherited dystonias: clinical features and molecular pathways.

    Science.gov (United States)

    Weisheit, Corinne E; Pappas, Samuel S; Dauer, William T

    2018-01-01

    Recent decades have witnessed dramatic increases in understanding of the genetics of dystonia - a movement disorder characterized by involuntary twisting and abnormal posture. Hampered by a lack of overt neuropathology, researchers are investigating isolated monogenic causes to pinpoint common molecular mechanisms in this heterogeneous disease. Evidence from imaging, cellular, and murine work implicates deficiencies in dopamine neurotransmission, transcriptional dysregulation, and selective vulnerability of distinct neuronal populations to disease mutations. Studies of genetic forms of dystonia are also illuminating the developmental dependence of disease symptoms that is typical of many forms of the disease. As understanding of monogenic forms of dystonia grows, a clearer picture will develop of the abnormal motor circuitry behind this relatively common phenomenology. This chapter focuses on the current data covering the etiology and epidemiology, clinical presentation, and pathogenesis of four monogenic forms of isolated dystonia: DYT-TOR1A, DYT-THAP1, DYT-GCH1, and DYT-GNAL. Copyright © 2018 Elsevier B.V. All rights reserved.

  11. Clinical Investigations and Management of Refractive Changes in ...

    African Journals Online (AJOL)

    AJRH Managing Editor

    Pregnancy: A Case Report ... condition therefore requires clinical observation and monitoring until the resolution of the serous detachment is ... bilateral involvement in 40% cases of CSCR. .... edema, acute hypertensive retinopathy, retinal.

  12. Investigating the Relationship of Organizational Commitment and Clinical Competence (Case study: Nurses Working in Montazeri Hospital, City of Najafabad, Iran, 2015

    Directory of Open Access Journals (Sweden)

    Neda Khodadadei

    2016-05-01

    Full Text Available Human resources committed to the organization not only reduces absence, delay, and replacement, but also causes the increase of organizational performance, employees’ mental freshness, better attainment to organizational excellent goals, and achieving individual’s objectives. Hence, organizational commitment has special importance among the employees of hospital. The nurses’ competence is an important criterion required for providing patients’ health-cares. The change in nurses’ roles and duties has changed the job to a complicated one and requires having various skills, and has caused the clinical competence to be considered more. The present study was performed with the aim of investigating the relationship of organizational commitment and clinical competence in nurses. The research was descriptive correlation type, and the statistical population was all nurses (176 persons working in Montazeri Hospital, Najafabad city, selected by Census method and 135 persons were investigated. The data collection tool included three questionnaires of personal information, Allen and Meyer’s questionnaire of organizational commitment, and questionnaire of clinical competence, that their validity and reliability were confirmed. Data was analyzed with independent t-test, ANOVA, Mann-Whitney, and Pearson’s correlation coefficient using the software SPSS 17. The average score of organizational commitment was 91± 10.76, and at medium level. The average score of clinical competence was 74.42±11.69, and at good level. There was no significant relationship between organizational commitment and clinical competence in the nurses. Only, the emotional commitment dimension had significant relationship with the quality assurance area of clinical competence (P<0.05. Organizational commitment of nurses did not have significant relationship with demographic variables under investigation, while their clinical competence had significant relationship with age

  13. Phase transitions of antibiotic clarithromycin forms I, IV and new form VII crystals.

    Science.gov (United States)

    Ito, Masataka; Shiba, Rika; Watanabe, Miteki; Iwao, Yasunori; Itai, Shigeru; Noguchi, Shuji

    2018-06-01

    Metastable crystal form I of the antibiotic clarithromycin has a pharmaceutically valuable characteristic that its crystalline phase transition can be applied for its sustained release from tablets. The phase transition of form I was investigated in detail by single crystal and powder X-ray analyses, dynamic vapor sorption analysis and thermal analysis. The single crystal structure of form I revealed that form I was not an anhydrate crystal but contained a partially occupied water molecule in the channel-like void space. Dynamic vapor sorption (DVS) analysis demonstrated that form I crystals reversibly sorbed water molecules in two steps when the relative humidity (RH) increased and finally transited to hydrate form IV at 95% RH. DVS analysis also showed that when the RH decreased form IV crystals lost water molecules at 40% RH and transited to the newly identified anhydrate crystal form VII. Form VII reversibly transited to form IV at lower RH than form I, suggesting that form I is more suitable for manufacturing a sustained-release tablet of CAM utilizing the crystalline phase transition. Copyright © 2018 Elsevier B.V. All rights reserved.

  14. Investigations of efficacy of intramammary applied antimicrobials and glucocorticosteroides in the treatment of subclinical and clinical mastitis in cows

    OpenAIRE

    Vakanjac, Slobodanka; Pavlović, Vojislav; Magaš, Vladimir; Pavlović, Miloš; Đurić, Miloje; Maletić, Milan; Nedić, Svetlana; Sočo, Ivan

    2013-01-01

    Inflammation of the mammary gland, mastitis in cows, presents one of the most acute problems in intensive dairy production, inflicting huge economic losses. In the course of one year, 80 samples were taken at investigated farms from udder quarters of cows with clinical mastitis and 160 samples from udder quarters of cows with subclinical mastitis. The efficacy of three preparations, A, B, and C, was examined in the treatment of clinical and subclinical mast...

  15. FEG-SEM investigation of α-alumina scales formed on FeCrAlY alloys oxidised at 1200 celsius degree

    International Nuclear Information System (INIS)

    Al-Badairy, H.; Tatlock, G.; Beahan, P.; Fawcett, S.; Hunt, J.

    2004-01-01

    Full text.The work presented here is part of an ongoing European funded project, SMILER, with the aim of improving the performance of alumina forming Fe-20 Cr-5 Al during high temperature industrial applications. One aspect of the project is to investigate the influence of additives on the oxidation behaviour of these alloys. During this study a LEO 1550 FESEM (field emission scanning electron microscope), equipped with INCA x-ray microanalysis facilities was used. Ultra-high-purity model alloys, where the levels of additives (Hf, Zr, Ti, Si and Y) were carefully controlled, and one commercial YHfAl alloy were oxidised at 1200 degree celsius for up to 3100h (100h/cycle). The YHfAl, (Ti+Zr)- and (Zr+Hf)-containing alloys showed the highest oxidation rates when oxidised, whereas the Si-containing alloy showed the lowest oxidation rate. However, the Si-containing alloy spalled the most while the (Zr+Hf)-containing and YHfAl alloys showed little spallation. The additives appeared to influence the spallation of the formed α-alumina scale. On the alloy with Si, the scale spalled at the scale/metal interface (adhesively). Whereas on alloys containing (Hf+Ti) and (Hf+Zr) and the YHfAl alloy, the scale mainly spalled in a cohesive manner (within the scale). Also, the added elements affected the scale topography. In general the formed scale has a columnar at the scale/metal interface whereas the grains are equiaxed at the scale/gas interface. However, in the cas of YHfAl and (Zr+Hf)-containing alloys, a sunflower type structure was observed in both fractured samples in the regions where the scale spalled cohesively. Preliminary EDX analysis revealed that the center of the sunflower structure was rich in Mg, for example in the case of YHfAl. This suggests that there may be inhomogeneities in the metal substrate, prior to oxidation, where high concentrations of Mg increase the local oxide growth rate. However, the exact reason behind the formation of sunflower type structure

  16. Clinical measuring system for the form and position errors of circular workpieces using optical fiber sensors

    Science.gov (United States)

    Tan, Jiubin; Qiang, Xifu; Ding, Xuemei

    1991-08-01

    Optical sensors have two notable advantages in modern precision measurement. One is that they can be used in nondestructive measurement because the sensors need not touch the surfaces of workpieces in measuring. The other one is that they can strongly resist electromagnetic interferences, vibrations, and noises, so they are suitable to be used in machining sites. But the drift of light intensity and the changing of the reflection coefficient at different measuring positions of a workpiece may have great influence on measured results. To solve the problem, a spectroscopic differential characteristic compensating method is put forward. The method can be used effectively not only in compensating the measuring errors resulted from the drift of light intensity but also in eliminating the influence to measured results caused by the changing of the reflection coefficient. Also, the article analyzes the possibility of and the means of separating data errors of a clinical measuring system for form and position errors of circular workpieces.

  17. [How to prevent hazards and to reduce risk in clinical trials?].

    Science.gov (United States)

    Czarkowski, Marek

    2008-12-01

    Different stakeholders involved in clinical trials are exposed to hazards related with this biomedical research. Beside clinical trials participants other important stakeholders are: investigators, sponsors, centers and clinical research organizations. Hazard prevention needs effective methods of hazard disclosure and analysis. A reduction of risks related with clinical trials is possible due to education, training, inspections, research discipline and penalties. Effective ways of hazard elimination or hazard reduction should be developed as well. Education and training should be offered to all stakeholders but their forms and contents should be adapted to different types of stakeholders. Direct control of the clinical trials should be held by stakeholders conducting clinical trials and outside inspections should be done by other institutions like clinical research organizations, research ethics committees and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. Serious oversight is an absence of any independent inspection during a phase of publication of clinical trial results. We should not accept any exception from the golden rule that results of all clinical trials must be published. Indemnity for damages is a popular way of compensation for clinical trials participants. Investigators, sponsors and centers should have valid liability insurance. Drastic measures for reduction of risks in clinical trials are different kinds of penalties. They should prevent participation of unreliable stakeholders and promote those who respect regulations and high ethical standards.

  18. A clinical trial with combined transcranial direct current stimulation and alcohol approach bias retraining

    NARCIS (Netherlands)

    den Uyl, T.E.; Gladwin, T.E.; Rinck, M.; Lindenmeyer, J.; Wiers, R.W.

    2017-01-01

    Two studies showed an improvement in clinical outcomes after alcohol approach bias retraining, a form of Cognitive Bias Modification (CBM). We investigated whether transcranial direct current stimulation (tDCS) could enhance effects of CBM. TDCS is a neuromodulation technique that can increase

  19. Protonated form: the potent form of potassium-competitive acid blockers.

    Directory of Open Access Journals (Sweden)

    Hua-Jun Luo

    Full Text Available Potassium-competitive acid blockers (P-CABs are highly safe and active drugs targeting H+,K+-ATPase to cure acid-related gastric diseases. In this study, we for the first time investigate the interaction mechanism between the protonated form of P-CABs and human H+,K+-ATPase using homology modeling, molecular docking, molecular dynamics and binding free energy calculation methods. The results explain why P-CABs have higher activities with higher pKa values or at lower pH. With positive charge, the protonated forms of P-CABs have more competitive advantage to block potassium ion into luminal channel and to bind with H+,K+-ATPase via electrostatic interactions. The binding affinity of the protonated form is more favorable than that of the neutral P-CABs. In particular, Asp139 should be a very important binding site for the protonated form of P-CABs through hydrogen bonds and electrostatic interactions. These findings could promote the rational design of novel P-CABs.

  20. Protonated form: the potent form of potassium-competitive acid blockers.

    Science.gov (United States)

    Luo, Hua-Jun; Deng, Wei-Qiao; Zou, Kun

    2014-01-01

    Potassium-competitive acid blockers (P-CABs) are highly safe and active drugs targeting H+,K+-ATPase to cure acid-related gastric diseases. In this study, we for the first time investigate the interaction mechanism between the protonated form of P-CABs and human H+,K+-ATPase using homology modeling, molecular docking, molecular dynamics and binding free energy calculation methods. The results explain why P-CABs have higher activities with higher pKa values or at lower pH. With positive charge, the protonated forms of P-CABs have more competitive advantage to block potassium ion into luminal channel and to bind with H+,K+-ATPase via electrostatic interactions. The binding affinity of the protonated form is more favorable than that of the neutral P-CABs. In particular, Asp139 should be a very important binding site for the protonated form of P-CABs through hydrogen bonds and electrostatic interactions. These findings could promote the rational design of novel P-CABs.

  1. Comparative clinical and haematological investigations in lactating cows with subclinical and clinical ketosis

    Directory of Open Access Journals (Sweden)

    Vania Marutsova

    2015-10-01

    Full Text Available Ketosis of lactating cows is among the most common metabolic diseases in modern dairy farms. The economic importance of the disease is caused by the reduced milk yield and body weight loss, poor feed conversion, lower conception rates, culling and increased mortality of affected animals. In the present study, a total of 47 high-yielding dairy cows up to 45 days in milk (DIM are included. All animals were submitted to physical examination wich included checking the rectal body temperature, heart rate, respiratory and rumen contraction rates, and inspection of visible mucous coats. The body condition was scored, and blood β-hydroxybutyrate (BHBA concentrations were assayed. The cows were divided into 3 groups: first group (control (n=24 with blood β-hydroxybutyrate level 2.6 mmol/l (clinical ketosis. Whole blood samples were obtained and analyzed for Red Blood Cell (RBC, 1012/l, Hemoglobin (HGB, g/l, Hematocrit (HCT, %, Mean Corpuscular Volume (MCV, fl, Mean Corpuscular Hemoglobin (MCH, pg, Mean Corpuscular Hemoglobin Concentration (MCHC, g/l, White Blood Cell (WBC, 109/l, Lymphocytes (LYM, 109/l, Monocytes (MON, 109/l, Granulocytes (GRA, 109/l, Red Blood Distribution Width (RDW, %, Red Blood Cell Distribution Width Absolute (RDWa, fl, Platelets (PLT, 109/l and Mean Platelet Volume (MPV, fl. In this study, deviations in the clinical parameters in the control group and in those with subclinical ketosis were not identified. The cows from the third group (clinical ketosis exhibited hypotonia, anorexia and body weight loss vs. control group. Hematological analysis showed leukocytosis and lymphocytosis in cows with subclinical ketosis vs. control group. In cows with clinical ketosis WBC counts decreased (leukopenia, while hemoglobin content and hematocrit values are higher vs. control group. Blood BHBA values are higher in both groups of ketotic cows vs. the control group. The other analyzed parameters (RBC, MCH, MCHC, MCV, RDW, RDWa, MON, GRA, PLT

  2. Phase II drugs under clinical investigation for the treatment of chronic constipation.

    Science.gov (United States)

    Mozaffari, Shilan; Didari, Tina; Nikfar, Shekoufeh; Abdollahi, Mohammad

    2014-11-01

    Chronic constipation (CC) is a common gastrointestinal (GI) motility disorder that significantly impairs the quality of life in affected subjects. As almost half of the patients suffering from CC are not satisfied with currently available medicines, there is a need to develop new molecules with better effectiveness and tolerability. The authors include all experimental and clinical trials (up to Phase II) about new investigational drugs for the treatment of CC. The article identifies nine new agents: mitemcinal, TD-8954, YKP10811, itopride, RM-131, KWA-0711, elobixibat, velusetrag, and naronapride. All nine agents have shown prokinetic effects in different stages of the development. The mechanisms of new developing drugs include: the activation of 5-hydroxytryptamine type-4 (5-HT4), ghrelin and motilin receptors, antagonizing dopamine type-2 (D2) receptors, inhibition of ileal bile acid reabsorption and acetylcholine esterase, as well as water absorption from the GI tract. At this current point in time, new generations of 5-HT4 receptor agonists (velusetrag, noranopride and YKP10811) are hoped to progress, further in the future, due to better efficiency and safety. However, it is not possible to make a concise conclusion at this current time due to a lack of evidence. Further clinical trials with a longer duration and a larger sample size are warranted.

  3. Importance of magnesium depletion with hypofunction of the biological clock in the pathophysiology of headhaches with photophobia, sudden infant death and some clinical forms of multiple sclerosis.

    Science.gov (United States)

    Durlach, J; Pagès, N; Bac, P; Bara, M; Guiet-Bara, A

    2004-12-01

    Mg depletion is a type of Mg deficit due to a dysregulation of the Mg status. It cannot be corrected through nutritional supplementation only, but requires the most specific correction of the dysregulating mechanism. Among those, Biological Clock (BC) dysrhythmias are to be considered. The aim of this study is to analyze the clinical forms of Mg depletion with hypofunction of the Biological Clock (hBC). hBC may be due to either Primary disorders of BC [Suprachiasmatic Nuclei (SCN) and pineal gland (PG)] or Secondary with homeostatic response [reactive Photophobia (Pphi] to light neurostimulating effects [Nervous Hyper Excitability (NHE)]. The symptomatology is mainly diurnal and observed during fair weather (Spring,Summer). The elective marker of hBC is represented by a decrease in melatonin and in its metabolites in various fluids. The clinical forms of NHE due to Mg depletion with hBC are central and peripheral. The central forms associate anxiety, headaches and dyssomnia. The peripheral manifestations are neuromuscular: photosensitive epilepsia mainly. Three chronopathological forms of Mg depletion with hBC have been highlighted: 1. Headaches with Pphi: mainly migraine; 2. Sudden Infant Death Syndrome (SIDS); 3. Multiple Sclerosis (MS).- Headaches with Pphi, migraine particularly. These cephalalgias are diurnal with Pphi and are aggravated during the fair seasons (particularly during midnight sun-summer). Migraine is their typical form with its dishabituation to visual stimuli and its occipital cortex hyperexcitability. Comorbidity with anxiety is frequent. In 2/3 of the cases, it appears first.- SIDS might be linked to an impaired maturation of both photoendocrine system and brown adipose tissue. MS may be associated with primary disorders of BC Clinical forms of Mg depletion with hBC in MS present diurnal exacerbations and relapses during fair seasons. They have been underestimated because they disagree with the dogma of the , presently questioned

  4. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

    Science.gov (United States)

    2008-07-15

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

  5. Investigation of interfacial heat transfer mechanism for 7075-T6 aluminum alloy in HFQ hot forming process

    International Nuclear Information System (INIS)

    Ying, Liang; Gao, Tianhan; Dai, Minghua; Hu, Ping

    2017-01-01

    Highlights: • The transient IHTC between 7075 alloy and die in HFQ process is investigated. • The accuracy of IHTC calculated by Beck and heat balance method is compared. • The relationship between IHTC and process parameter of 7075 alloy is studied. • The transient IHTC law is verified by U-type HFQ forming experiment. - Abstract: The IHTC (Interfacial-Heat-Transfer-Coefficient) between aluminum alloy and die during HFQ (Heat-Forming-Quenching) process is an important thermal parameter to reflect the heat transfer efficiency. In the present work, the instantaneous heat transfer law for high strength 7075-T6 alloy during HFQ process based on cylindrical-die model was investigated. The accuracy of IHTC calculated by Beck’s non-linear estimation method (Beck’s method) and heat balance method (HBM) were compared, and instantaneous IHTC of 7075-T6 alloy was acquired in experiment and analyzed in consideration of different contact pressure, surface roughness and lubricate conditions. Furthermore, the obtained IHTC was applied to the simulation process of typical U-type experimental model in order to validate the universality of heat transfer law. The result shows that the average IHTC goes near to 3300 W/m"2·K when pressure is above 80 MPa; Surface roughness can also affect the IHTC in HFQ process, but the effect mechanism is different from the boron steel in hot stamping process. The average IHTC decreases sharply when surface roughness increases in the range of 0.570–0.836 μm, the value is from 3453 W/m"2·K to 2001 W/m"2·K under 80 MPa. Furthermore, surface lubrication can promote heat transfer efficiency and increase IHTC value when contact pressure is relatively high.

  6. [Evaluation of the clinical efficacy of a new composition of tizol with triamcinolon in complex treatment of patients with erosive ulcerous form of lichen planus of the oral mucosa].

    Science.gov (United States)

    Ron', G I; Akmalova, G M; Emel'yanova, I V

    2015-01-01

    The most significant of the primary stages of complex therapy of oral lichen planus (OLP), among causal and pathogenetic therapy is a local conservative treatment. The aim of the study was to evaluate the clinical efficacy of the local use of the new compositions TIZOL with triamcinolon in complex therapy of erosive-ulcerous forms OLP oral mucosa. The study was performed with 47 patients with lichen planus in age from 24 to 70 years with erosive-ulcerous form OLP whose diagnosis was confirmed histologically. The first group included 25 patients in the complex treatment of locally applied composition TIZOL with triamcinolon. The second group of 22 people, who in the complex treatment applied locally 0.5% prednisone ointment. The high efficiency of topical TIZOL with a highly topical steroid in the complex therapy of erosive-ulcerous forms OLP, which was confirmed by the positive clinical dynamics in all patients (100%) and high self-esteem of patients (84% positive ratings), reduced life complete epithelialization of erosions.

  7. Clinical Investigation of Benign Asbestos Pleural Effusion

    Directory of Open Access Journals (Sweden)

    Nobukazu Fujimoto

    2015-01-01

    Full Text Available There is no detailed information about benign asbestos pleural effusion (BAPE. The aim of the study was to clarify the clinical features of BAPE. The criteria of enrolled patients were as follows: (1 history of asbestos exposure; (2 presence of pleural effusion determined by chest X-ray, CT, and thoracentesis; and (3 the absence of other causes of effusion. Clinical information was retrospectively analysed and the radiological images were reviewed. There were 110 BAPE patients between 1991 and 2012. All were males and the median age at diagnosis was 74 years. The median duration of asbestos exposure and period of latency for disease onset of BAPE were 31 and 48 years, respectively. Mean values of hyaluronic acid, adenosine deaminase, and carcinoembryonic antigen in the pleural fluid were 39,840 ng/mL, 23.9 IU/L, and 1.8 ng/mL, respectively. Pleural plaques were detected in 98 cases (89.1%. Asbestosis was present in 6 (5.5% cases, rounded atelectasis was detected in 41 (37.3% cases, and diffuse pleural thickening (DPT was detected in 30 (27.3% cases. One case developed lung cancer (LC before and after BAPE. None of the cases developed malignant pleural mesothelioma (MPM during the follow-up.

  8. Clinical pattern of systemic sclerosis in Central Ukraine. Association between clinical manifestations of systemic sclerosis and hypertension.

    Science.gov (United States)

    Semenov, Viktor; Kuryata, Olexandr; Lysunets, Tatiana

    2018-01-01

    Systemic sclerosis (SSc) is a rare disease of connective tissue, manifestations of which may vary in different geographical areas. We aimed to describe the clinical portrait of patients with SSc in Dnipropetrovsk region and to investigate how initial clinical and laboratory characteristics are connected with the presence of hypertension in SSc onset. Patients were enrolled to this study from the registry of SSc patients, established in the Rheumatology Department, Mechnikov Dnipropetrovsk Regional Clinic, Dnipro. This registry contains histories of new cases of SSc from 1993 to 2014. Patients are followed-up and receive treatment according to EULAR and local standards. Diagnosis of SSc was based on ACR and EULAR Criteria for systemic Sclerosis. Two patients developed scleroderma renal crisis during follow-up. This report is a cross-sectional study. We analysed only data of the first visit to a rheumatologist. In total 148 patients (median age [IQR] - 47 [40; 52] years) fulfilled the inclusion criteria. Male/female ratio was 1 : 20.1. The most frequent clinical signs were Raynaud's phenomenon and arthritis. The prevalence of skin lesion in dcSSc patients was twice as high as in lcSSc patients. Pulmonary fibrosis occurred significantly more commonly in dcSSc patients. Hypertension occurred in 26-33% in both groups. Patients with hypertension at the SSc onset were seven years older than normotensive patients. More hypertensive patients were classified as lcSSc. Mean GFR was dramatically lower in hypertensive patients. The most common clinical form in our study was diffuse cutaneous subset of SSc. Hypertension in patients with SSc may be associated with local cutaneous subset of SSc and renal impairment. The strongest predictors of clinical form of SSc are signs of fibrosis (skin lesion and pulmonary fibrosis) and inflammation (arthritis and elevated CRP).

  9. A mild form of Proteus syndrome

    Energy Technology Data Exchange (ETDEWEB)

    Hauer, M.P.; Allmann, K.H.; Langer, M. [Abteilung Roentgendiagnostik, Radiologische Universitaetsklinik, Albert-Ludwigs-Universitaet Freiburg (Germany); Uhl, M. [Sektion Kinderradiologie, Albert-Ludwigs-Universitaet (Germany); Darge, K. [Radiologische Universitaetsklinik, Abteilung Kinderradiologie, Universitaet Heidelberg (Germany)

    1998-05-01

    Proteus syndrome is a rare congenital hamartomatous syndrome. We report on the clinical and radiological appearances of a boy in order to illustrate the typical signs which include subcutaneous masses, in mild forms partial gigantism of hands and feet, hemihypertrophy, and bony abnormalities. We discuss how to make the definitive diagnosis on the basis of using a known rating scale, important aspects of differential diagnosis and clinical features, and diagnostic management. (orig.) With 3 figs., 1 tab., 14 refs.

  10. Site Characteristics Influencing the Translation of Clinical Research Into Clinical Practice

    DEFF Research Database (Denmark)

    Smed, Marie; Getz, Kenneth A.

    2014-01-01

    Investigative sites participating in clinical trials play an instrumental role in aiding market adoption. Site experiences in clinical research help physician investigators and research professionals gain familiarity with and exposure to investigational treatments. This knowledge may be passed...

  11. Electronic health record tools' support of nurses' clinical judgment and team communication.

    Science.gov (United States)

    Kossman, Susan P; Bonney, Leigh Ann; Kim, Myoung Jin

    2013-11-01

    Nurses need to quickly process information to form clinical judgments, communicate with the healthcare team, and guide optimal patient care. Electronic health records not only offer potential for enhanced care but also introduce unintended consequences through changes in workflow, clinical judgment, and communication. We investigated nurses' use of improvised (self-made) and electronic health record-generated cognitive artifacts on clinical judgment and team communication. Tanner's Clinical Judgment Model provided a framework and basis for questions in an online survey and focus group interviews. Findings indicated that (1) nurses rated self-made work lists and medication administration records highest for both clinical judgment and communication, (2) tools aided different dimensions of clinical judgment, and (3) interdisciplinary tools enhance team communication. Implications are that electronic health record tool redesign could better support nursing work.

  12. Model for investigating the benefits of clinical supervision in psychiatric nursing

    DEFF Research Database (Denmark)

    Gonge, Henrik; Buus, Niels

    2011-01-01

    with the effectiveness of clinical supervision, as measured by the Manchester Clinical Supervision Scale (MCSS). Furthermore, MCSS scores were associated with benefits, such as increased job satisfaction, vitality, rational coping and less stress, emotional exhaustion, and depersonalization. Multivariate analyses......The objective of this study was to test a model for analysing the possible benefits of clinical supervision. The model suggested a pathway from participation to effectiveness to benefits of clinical supervision, and included possible influences of individual and workplace factors. The study sample...

  13. Sheet-bulk metal formingforming of functional components from sheet metals

    Directory of Open Access Journals (Sweden)

    Merklein Marion

    2015-01-01

    Full Text Available The paper gives an overview on the application of sheet-bulk metal forming operations in both scientific and industrial environment. Beginning with the need for an innovative forming technology, the definition of this new process class is introduced. The rising challenges of the application of bulk metal forming operations on sheet metals are presented and the demand on a holistic investigation of this topic is motivated. With the help of examples from established production processes, the latest state of technology and the lack on fundamental knowledge is shown. Furthermore, perspectives regarding new research topics within sheet-bulk metal forming are presented. These focus on processing strategies to improve the quality of functional components by the application of process-adapted semi-finished products as well as the local adaption of the tribological system.

  14. Clinical Practice Guideline: Improving Nasal Form and Function after Rhinoplasty.

    Science.gov (United States)

    Ishii, Lisa E; Tollefson, Travis T; Basura, Gregory J; Rosenfeld, Richard M; Abramson, Peter J; Chaiet, Scott R; Davis, Kara S; Doghramji, Karl; Farrior, Edward H; Finestone, Sandra A; Ishman, Stacey L; Murphy, Robert X; Park, John G; Setzen, Michael; Strike, Deborah J; Walsh, Sandra A; Warner, Jeremy P; Nnacheta, Lorraine C

    2017-02-01

    variations, and clinical concerns associated with this surgical procedure; it is not intended to be a comprehensive reference for improving nasal form and function after rhinoplasty. Recommendations in this guideline concerning education and counseling to the patient are also intended to include the caregiver if the patient is 24 hours after surgery. (2) Surgeons should not routinely place packing in the nasal cavity of rhinoplasty patients (with or without septoplasty) at the conclusion of surgery. The panel group made the following statement an option: (1) The surgeon, or the surgeon's designee, may administer perioperative systemic steroids to the rhinoplasty patient.

  15. Investigating the atomic level influencing factors of glass forming ability in NiAl and CuZr metallic glasses

    Energy Technology Data Exchange (ETDEWEB)

    Sedighi, Sina; Kirk, Donald Walter; Singh, Chandra Veer, E-mail: chandraveer.singh@utoronto.ca; Thorpe, Steven John [Department of Materials Science and Engineering, University of Toronto, Room 140, 184 College Street, Toronto, Ontario M5S 3E4 (Canada)

    2015-09-21

    Bulk metallic glasses are a relatively new class of amorphous metal alloy which possess unique mechanical and magnetic properties. The specific concentrations and combinations of alloy elements needed to prevent crystallization during melt quenching remains poorly understood. A correlation between atomic properties that can explain some of the previously identified glass forming ability (GFA) anomalies of the NiAl and CuZr systems has been identified, with these findings likely extensible to other transition metal–transition metal and transition metal–metalloid (TM–M) alloy classes as a whole. In this work, molecular dynamics simulation methods are utilized to study thermodynamic, kinetic, and structural properties of equiatomic CuZr and NiAl metallic glasses in an attempt to further understand the underlying connections between glass forming ability, nature of atomic level bonding, short and medium range ordering, and the evolution of structure and relaxation properties in the disordered phase. The anomalous breakdown of the fragility parameter as a useful GFA indicator in TM–M alloy systems is addressed through an in-depth investigation of bulk stiffness properties and the evolution of (pseudo)Gruneisen parameters over the quench domain, with the efficacy of other common glass forming ability indicators similarly being analyzed through direct computation in respective CuZr and NiAl systems. Comparison of fractional liquid-crystal density differences in the two systems revealed 2-3 times higher values for the NiAl system, providing further support for its efficacy as a general purpose GFA indicator.

  16. Preclinical and clinical investigation of a CCR5 antagonist, AZD5672, in patients with rheumatoid arthritis receiving methotrexate

    NARCIS (Netherlands)

    Gerlag, Daniëlle M.; Hollis, Sally; Layton, Mark; Vencovský, Jiří; Szekanecz, Zoltán; Braddock, Martin; Tak, Paul P.; Oparanov, Boycho; Stoilov, Rumen; Yaneva, Tanya; Batalov, Anastas; Arteaga, Edgardo Tobias; Escalante, William Otero; Velez, Patricia; Restrepo, Jose Molina; Augustinova, Sevda; Blahova, Anna; Dvorak, Zdenek; Novosad, Libor; Rosa, Jan; Stehlikova, Helena; Vitek, Petr; Balazs, Tibor; Seregely, Katalin; Szombati, Istvan; Tarjan, Katalin; Csengei, Gabor; Galeazzi, Mauro; Saleniece, Sarmite; Saulite-Kandevica, Daina; Coleiro, Bernard; Badurski, Janusz; Brzosko, Marek; Chudzik, Dariusz; Gruszecka-Marczynska, Katarzyna; Hensel, Joanna; Pokrzywnicka-Gajek, Ines; Korpanty-Danda, Joanna; Sochocka-Bykowska, Malgorzata; Tlustochowicz, Witold; Stopinska-Polaszewska, Maria; Gluszko, Piotr; Nedelcovici, Corina; Radulescu, Florin; Gavrila, Mirea; Tanasescu, Coman; Korshunov, Nikolay; Matsievskaia, Galina; Damjanov, Nemanja; Dimic, Aleksandar

    2010-01-01

    To investigate both the preclinical effects of blocking the chemokine receptor CCR5 and the clinical effects of this approach on the signs and symptoms of rheumatoid arthritis (RA) in patients with active disease. Preclinical evaluations of AZD5672, a small-molecule antagonist of CCR5, were

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

    OpenAIRE

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

    2013-01-01

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

  18. Circle of Form

    DEFF Research Database (Denmark)

    Jaeger, Thomas Arvid

    2012-01-01

    a common professional language like in mathematics, colour and music. The result is a weaker professionalism in the aesthetic competences compared to the professionalism and competences in other areas. A research project [1] on contrasts or opposites in form investigated the phenomenon in the fields...

  19. Health literacy and usability of clinical trial search engines.

    Science.gov (United States)

    Utami, Dina; Bickmore, Timothy W; Barry, Barbara; Paasche-Orlow, Michael K

    2014-01-01

    Several web-based search engines have been developed to assist individuals to find clinical trials for which they may be interested in volunteering. However, these search engines may be difficult for individuals with low health and computer literacy to navigate. The authors present findings from a usability evaluation of clinical trial search tools with 41 participants across the health and computer literacy spectrum. The study consisted of 3 parts: (a) a usability study of an existing web-based clinical trial search tool; (b) a usability study of a keyword-based clinical trial search tool; and (c) an exploratory study investigating users' information needs when deciding among 2 or more candidate clinical trials. From the first 2 studies, the authors found that users with low health literacy have difficulty forming queries using keywords and have significantly more difficulty using a standard web-based clinical trial search tool compared with users with adequate health literacy. From the third study, the authors identified the search factors most important to individuals searching for clinical trials and how these varied by health literacy level.

  20. Tumor necrosis factor-alfa and interleukin-4 in cerbrospinal fluid and plasma in different clinical forms of multiple sclerosis

    Directory of Open Access Journals (Sweden)

    Obradović Dragana

    2012-01-01

    Full Text Available Background/Aim. Multiple sclerosis (MS is an immunemediated central nervous system disease characterized by inflammation, demyelination and axonal degeneration. Cytokines are proven mediators of immunological process in MS. The aim of this study was to investigate whether there is a difference in the production of the tumor necrosis factor alpha (TNF-alpha and interleukin-4 (IL-4 in cerebrospinal fluid (CSF and plasma in the MS patients and the controls (other neurological non-inflammatory diseases and to determine a possible difference in these cytokines in plasma and CSF in different clinical forms of MS. Methods. This study involved 60 consecutive MS patients - 48 patients with relapsing-remitting MS (RRMS and 12 patients with secondary progressive MS (SPMS. The control group consisted of 20, age and sex matched, nonimmunological, neurological patients. According to the clinical presentation of MS at the time of this investigation, 34 (56.7% patients had relapse (RRMS, 14 (23.3% were in remission (RRMS, while the rest of the patients, 12 (20.0%, were SPMS. TNF-alpha and IL-4 concentrations were measured in the same time in CSF and plasma in the MS patients and the controls. Extended disability status score (EDSS, albumin ratio and IgG index were determined in all MS patients. Results. The MS patients had significantly higher CSF and plasma levels of TNF-alpha than the controls (p < 0.001 for both samples. IL-4 CSF levels were significantly lower in the MS patients than in the controls (p < 0.001, however plasma levels were similar. The patients in relapse (RRMS and with progressive disease (SPMS had higher concentrations of CSF TNF-alpha levels than the patients in remission (p < 0.001. IL-4 CSF levels in relapse (RRMS and SPMS groups were lower than in the patients in remission. The patients in remission had an unmeasurable plasma TNF-alpha level and the patients with SPMS had significantly lower IL-4 levels in plasma than the patients in

  1. An investigation on clinical radiological diagnosis of hereditary osteogenesis imperfect (a report of 42 patients in a family)

    International Nuclear Information System (INIS)

    He Junxiang; Jiang Xuzhou; Zhang Shunzhi; Huang Guomei; Mu Huinian; Li Yi; Li Meihe

    1998-01-01

    Purpose: To investigate the main points of diagnosing hereditary osteogenesis imperfect. Methods: Retrospective analysis of clinical and radiological diagnosis of hereditary osteogenesis imperfect was done in 35 surviving patients and 7 deaths in a family. Results: (1) A family was described in which hereditary osteogenesis imperfect occurred in 5 generations. Forty-two patients (18 males, 24 females) ranged in age from 10 months to 67 years. (2) Both modes of inheritance existed simultaneously (dominant in 35 patients, recessive in 7 patients). (3) Blue sclera of different shades was found in all 42 patients. (4) Radiological change of bone was recognised in 35 surviving patients. The conditions were as follows: in 29 patients, general decreased bone density, thin bone cortex and long slender tubular bones were observed; six patients were normal; twenty-two patients had fracture. (5) Twenty-four patients (including 3 deaths) suffered form progressive deafness. (6) Twenty-one patients (including 3 deaths) had the triad of blue sclera, osteopsathyrosis and progressive deafness. (7) An increase in alkaline phosphatase level (in 17 patients) was confirmed by the tests in our laboratory. Conclusion: The authors suggested that the triad of blue sclera, osteopsathyrosis and progressive deafness is the characteristic manifestations of the disease, especially blue sclera, which may be regarded as an initial and suggestible physical sign, and an essential criterion for diagnosis

  2. A comment on Watson, Deary, and Austin and Watson, Roberts, Gow, and Deary : How to investigate whether personality items form a hierarchical scale?

    NARCIS (Netherlands)

    Meijer, Rob R.

    I comment on two recent papers by Watson et al. (2007, 2008) who investigated whether personality items form a hierarchical scale. I discuss that the methods they used are inappropriate and discuss alternative methods presented in the literature. (C) 2009 Elsevier Ltd All rights reserved..

  3. SuperFormLab: showing SuperFormLab

    DEFF Research Database (Denmark)

    2013-01-01

    bachelor program, followed by two years of master studies. The courses are offered equally to students from other design disciplines, e.g. industrial design. Teaching is mainly in English as the program is attended by a relatively large group of non-Danish students, who seek exactly this combination......3D-printing in clay and ceramic objects shaped by your own sounds and movements! Digital form transferred via CNC-milling to ornamental ceramic wall-cladding. Brave New World… Students and their teacher at SuperFormLab, the new ceramic workshop of the School of Design at the Royal Danish Academy...... of Fine Arts in Copenhagen, will be showing results of their investigations into the potential of combining digital technologies with ceramic materials. It is now possible to shape the most complex mathematical, virtual 3D objects through the use of advanced software-programs. And more than that – you can...

  4. Audit of Completion of Radiology Request Form in a Nigerian ...

    African Journals Online (AJOL)

    Background: Clinical audit is one approach to improve the quality of patient care, completion of request form inclusive. Radiology request forms are essential communication tools between the clinician and the radiologist. The aim of this study is to audit the adequacy of completion of X-ray request forms. Methodology: A ...

  5. “There Are Too Many, but Never Enough": Qualitative Case Study Investigating Routine Coding of Clinical Information in Depression

    Science.gov (United States)

    Cresswell, Kathrin; Morrison, Zoe; Sheikh, Aziz; Kalra, Dipak

    2012-01-01

    Background We sought to understand how clinical information relating to the management of depression is routinely coded in different clinical settings and the perspectives of and implications for different stakeholders with a view to understanding how these may be aligned. Materials and Methods Qualitative investigation exploring the views of a purposefully selected range of healthcare professionals, managers, and clinical coders spanning primary and secondary care. Results Our dataset comprised 28 semi-structured interviews, a focus group, documents relating to clinical coding standards and participant observation of clinical coding activities. We identified a range of approaches to coding clinical information including templates and order entry systems. The challenges inherent in clearly establishing a diagnosis, identifying appropriate clinical codes and possible implications of diagnoses for patients were particularly prominent in primary care. Although a range of managerial and research benefits were identified, there were no direct benefits from coded clinical data for patients or professionals. Secondary care staff emphasized the role of clinical coders in ensuring data quality, which was at odds with the policy drive to increase real-time clinical coding. Conclusions There was overall no evidence of clear-cut direct patient care benefits to inform immediate care decisions, even in primary care where data on patients with depression were more extensively coded. A number of important secondary uses were recognized by healthcare staff, but the coding of clinical data to serve these ends was often poorly aligned with clinical practice and patient-centered considerations. The current international drive to encourage clinical coding by healthcare professionals during the clinical encounter may need to be critically examined. PMID:22937106

  6. Ongoing Evaluation of Clinical Ethics Consultations as a Form of Continuous Quality Improvement.

    Science.gov (United States)

    Volpe, Rebecca

    2017-01-01

    Ongoing evaluation of a clinical ethics consultation service (ECS) allows for continuous quality improvement, a process-based, data-driven approach for improving the quality of a service. Evaluations by stakeholders involved in a consultation can provide real-time feedback about what is working well and what might need to be improved. Although numerous authors have previously presented data from research studies on the effectiveness of clinical ethics consultation, few ECSs routinely send evaluations as an ongoing component of their everyday clinical activities. The primary purpose of this article is to equip and encourage others to engage in ongoing evaluation of their own ECS. Toward that end, the following resources are shared: (1) the survey tool used to gather the evaluation data, (2) the procedure used to elicit and collate responses, and (3) how the resulting data are used to support continuous quality improvement and justify the continued financial support of the ECS to hospital administration. Copyright 2017 The Journal of Clinical Ethics. All rights reserved.

  7. Forms of Knowledge Incorporated in Clinical Decision-making among Newly-Graduated Nurses: A Metasynthesis

    DEFF Research Database (Denmark)

    Voldbjerg, Siri; Elgaard Sørensen, Erik; Grønkjær, Mette

    2014-01-01

    Clinical-decision-making is of decisive importance to how evidence-based practice is put into practice. Schools of Nursing have a responsibility to teach and train nursing students to make clinical decisions within a frame of evidence-based practice. Clinical decision-making among nurses has been...... explored from numerous angles using a diversity of methodologies. Existing research has mainly focused on promoting and inhibiting factors for implementation of evidence-based practice and incorporation of research evidence in the clinical-decision. Little attention has been given to the nurses' behavior......, including the knowledge that actually informs the newly graduated nurses’ clinical decision. The aim of the study is to combine and synthesize results from qualitative research. Noblit and Hare’s meta-ethnographic approach is used to conduct a metasynthesis of qualitative research that has studied...

  8. Anticipation of visual form independent of knowing where the form will occur/

    DEFF Research Database (Denmark)

    Bruhn, Pernille; Bundesen, Claus

    2012-01-01

    We investigated how selective preparation for specific forms is affected by concurrent preknowledge of location when upcoming visual stimuli are anticipated. In three experiments, participants performed a two-choice response time (RT) task in which they discriminated between standard upright...... of our effects suggested that preknowledge of form and location, respectively, affected two functionally independent, serial stages of processing. We suggest that the two stages were, first, direction of attention to the stimulus location and, subsequently, discrimination between upright and rotated...... stimuli. Presumably, preknowledge of location advanced the point in time at which attention was directed at the stimulus location, whereas preknowledge of form reduced the time subsequently taken for stimulus discrimination....

  9. Research needs in cement-based waste forms

    International Nuclear Information System (INIS)

    McDaniel, E.W.; Spence, R.D.; Tallent, O.K.

    1990-01-01

    Cement-based waste forms are one of the most widely used waste disposal options, yet definitive knowledge of the fate of the waste species inside the waste form is lacking. A fundamental understanding of the chemistry and microstructure of the waste forms would lead to a better understanding of the mass transfer of the waste species, more confidence in predicting and extrapolating waste form performance, and design of better waste forms. Better and cheaper leach tests would lead to quicker and more cost effective screening of waste form alternatives. In addition, assessment of durability may be important to predicting waste form performance in the field. It should be noted that the research needs discussed in this report are from the perspective of investigators working in applied waste management areas, while the proposed investigations are fundamental or basic. Details as to experimental methods and tools to be used in achieving the objectives of the proposed are research beyond the scope of this paper and are better filled in by others. In broad terms, the research topics discussed are correlation of cement-based waste form physical properties to performance, waste-form fundamental chemistry and microstructure, and product performance testing

  10. Why do women not return family history forms when referred to breast cancer genetics services? A mixed-method study.

    Science.gov (United States)

    Hanning, Kirstie A; Steel, Michael; Goudie, David; McLeish, Lorna; Dunlop, Jackie; Myring, Jessica; Sullivan, Frank; Berg, Jonathan; Humphris, Gerry; Ozakinci, Gozde

    2015-10-01

    Personal and family data forms, completed by women referred to breast cancer genetics clinics, are valuable tools for verification and extension of family history, crucial steps in accurate risk evaluation. A significant minority of women do not complete and return these forms, despite reminders, even when completion is a pre-requisite for a clinic appointment. To facilitate access of women at increased familial risk of breast cancer to screening and counselling services by investigating reasons for non-return of the forms. Based on a single regional 'breast cancer family' service in the UK, Analysis of quantitative data comparing women who did not return forms (n = 55) with those who had done so (n = 59), together with qualitative evaluation of potential barriers to form-completion through semi-structured telephone interviews with a random subset of 'non-returners' (n = 23). Non-returners have higher proportions of the very young (below the age at which surveillance could be offered) and of women from lower social deprivation categories. Interviews revealed that the majority of non-returners are anxious, rather than unconcerned about their breast cancer risk and circumstances and attitudes contributed to non-compliance. Twenty-one participants confirmed that they would welcome an appointment at a 'breast cancer family' clinic, but nine did not attend for the appointment. They were significantly younger than those who attend, but were not at lower familial risk. Many women who fail to complete and return a family history form would benefit from risk assessment and genetic counselling. Several steps are suggested that might help them access the relevant services. © 2014 John Wiley & Sons Ltd.

  11. Clinical phenotype analysis of paroxysmal kinesigenic dyskinesia

    Directory of Open Access Journals (Sweden)

    Wo-tu TIAN

    2017-07-01

    Full Text Available Background Paroxysmal kinesigenic dyskinesia (PKD is a disorder characterized by recurrent and brief dystonic or choreoathetoid attacks that are induced by sudden voluntary movement with highly clinical and genetic heterogeneity. We aimed to investigate the clinical features of PKD in a large Chinese population. Methods One hundred and ninety five patients diagnosed as primary PKD were recruited. For all of the participants, neurological examinations were conducted and clinical manifestations were recorded and summarized in self - made uniform registration form for PKD patients. Clinical characteristics were statistically analyzed and compared between familial and sporadic PKD patients.  Results Among all of the 195 PKD patients in the present study, the gender ratio was 4.42∶1 (male∶ female. The average age of onset was (12.32 ± 3.49 years. There were 162 patients (83.08% manifestated with pure form and 33 (16.92% with complicated form of PKD. Among them 16 patients (8.21% had essential tremor (ET, and 144 patients (73.85% had premonitory symptom. The percentage of patients manifested as dystonia, chorea and mixed form during episodic attacks were 68.72% (134/195, 4.10% (8/195 and 27.18% (53/195 repectively. There were 134 cases (68.72% had facial involvement. It was recorded that 115 (58.97%, 54 (27.69% and 26 (13.33% patients had frequency of attack < 10 times/d, 10-20 times/d and > 20-30 times/d respectively. The percentages of patients whose duration of attack <10 s, 10-30 s and > 30-60 s were 60% (117/195, 29.74% (58/195 and 10.26% (20/195 respectively. There were 64 patietns (32.82% with family history of PKD and 131 (67.18% were sporadic PKD patients. Up to 40% (78/195 of patients did not require/take medications, as they had minor clinical manifestations or concerns about the side effects of anticonvulsants. Among 117 patients (60% prescribed with anticonvulsants, 114 patients showed a good response, including complete control (N

  12. Pyrexia in cats: Retrospective analysis of signalment, clinical investigations, diagnosis and influence of prior treatment in 106 referred cases.

    Science.gov (United States)

    Spencer, Sarah E; Knowles, Toby; Ramsey, Ian K; Tasker, Séverine

    2017-11-01

    The main aim of the study was to describe the features and diagnoses of a population of cats referred with pyrexia. Other aims were to report and evaluate the utility of clinical investigations performed, and describe any effect of treatment before referral on temperature at presentation and ability to make a diagnosis. Clinical records of cats with pyrexia (⩾39.2°C) documented at least twice were retrospectively reviewed. Cases were assigned to disease categories (infectious, inflammatory, immune-mediated, neoplastic, miscellaneous and no diagnosis [pyrexia of unknown origin, PUO]) based on diagnosis. The overall value of clinical investigations was assessed by classifying them as 'enabling', 'assisting' or 'no assistance' in achieving each diagnosis. The effect of treatment before referral was assessed for any association with temperature at presentation and ability to make a diagnosis (PUO vs other disease categories). One hundred and six cases were identified. The most common cause of pyrexia was feline infectious peritonitis (22 cats, 20.8%) and the largest disease category was infectious (41/106, 38.7%). Inflammatory conditions were found in 19 (17.9%) cats, neoplasia in 13 (12.3%), miscellaneous causes in 11 (10.4%) and immune-mediated disease in six (5.7%). No diagnosis was reached in 16 (15.0%) cats, often despite extensive diagnostic investigations. Cytology and histopathology most often 'enabled' or 'assisted' in obtaining a diagnosis. Most cats (91, 85.8%) received treatment before referral, with antimicrobial treatment given to 87 (82.1%). Prior treatment before referral was not associated with temperature at presentation nor with success in establishing a diagnosis. This is the first study investigating causes of pyrexia in cats. Infectious diseases were most common and immune-mediated diseases were comparatively rare.

  13. Pseudotumoral form of primary progressive tuberculosis: a diagnosis to be considered

    Directory of Open Access Journals (Sweden)

    Franco Rosana

    2003-01-01

    Full Text Available The diversity of clinical presentations of primary progressive tuberculosis (TB and the difficulty in establishing the diagnosis of paucibacillary forms is the subject of painstaking research, as well as a cause of delay in therapy. We report the case of a 10-year-old black child who presented with chest pain and progressive widening of the upper mediastinum. Computerized tomography of the chest revealed multiple calcifications that were not identified with X-rays. Biopsy through mediastinoscopy was compatible with a diagnosis of tuberculosis. Despite exhaustive investigation that included direct examination, culture for mycobacteria and PCR (Polymerase Chain Reaction of tissue samples, the etiologic agent was not revealed. Tuberculin conversion was observed during the follow-up and resolution period of the lesion, after administration of isoniazid, rifampicin and pyrazinamide. The nodal pseudotumoral form of tuberculosis is rare in immunocompetent children and it may simulate neoplastic disease; therefore, it should be included in the list of differential diagnoses of masses located in the anterosuperior mediastinum.

  14. Clinical physiopathology of hypernatremia

    Directory of Open Access Journals (Sweden)

    F. Sgambato

    2013-05-01

    Full Text Available BACKGROUND The maintenance of sodium levels at normal ranges has to be considered one of the most important and crucial physiological balance in order to preserve life. The increase of natremia determines the leakage of H2O from the inside of cells and the consequent brain cells withering, that causes encephalopathy at different stages and in some cases it can even lead to death. AIM OF THE STUDY The fundamentals of general physiopathology are analysed together with systems of compensation and brain adaptation in the three different aetiopathogenetic forms: primary increase of sodium (hypervolemic and haedematose form; missed introduction of pure water (mainly euvolemic form, with no aedema; loss of hypotonic fluids (hypovolemic form with dehydration. The three different clinical entities with their relative clinical approaches have been described.

  15. Effect of multiple forming tools on geometrical and mechanical properties in incremental sheet forming

    Science.gov (United States)

    Wernicke, S.; Dang, T.; Gies, S.; Tekkaya, A. E.

    2018-05-01

    The tendency to a higher variety of products requires economical manufacturing processes suitable for the production of prototypes and small batches. In the case of complex hollow-shaped parts, single point incremental forming (SPIF) represents a highly flexible process. The flexibility of this process comes along with a very long process time. To decrease the process time, a new incremental forming approach with multiple forming tools is investigated. The influence of two incremental forming tools on the resulting mechanical and geometrical component properties compared to SPIF is presented. Sheets made of EN AW-1050A were formed to frustums of a pyramid using different tool-path strategies. Furthermore, several variations of the tool-path strategy are analyzed. A time saving between 40% and 60% was observed depending on the tool-path and the radii of the forming tools while the mechanical properties remained unchanged. This knowledge can increase the cost efficiency of incremental forming processes.

  16. Missed Opportunities for TB Investigation in Primary Care Clinics in South Africa: Experience from the XTEND Trial.

    Directory of Open Access Journals (Sweden)

    Violet N Chihota

    Full Text Available 40 primary health clinics (PHCs in four provinces in South Africa, June 2012 -February 2013.To determine whether health care worker (HCW practice in investigating people with TB symptoms was altered when the initial test for TB was changed from smear microscopy to Xpert MTB/RIF.Cross-sectional substudy at clinics participating in a pragmatic cluster randomised trial, Xpert for TB: Evaluating a New Diagnostic "XTEND", which evaluated the effect of Xpert MTB/RIF implementation in South Africa.Consecutive adults exiting PHCs reporting at least one TB symptom (defined as any of cough, weight loss, night sweats and fever were enrolled. The main outcome was the proportion who self-reported having sputum requested by HCW during the clinic encounter just completed.3604 adults exiting PHCs (1676 in Xpert arm, 1928 in microscopy arm were enrolled (median age 38 years, 71.4% female, 38.8% reported being HIV-positive, 70% reported cough. For 1267 participants (35.2% the main reason for attending the clinic was TB symptom(s. Overall 2130/3604 (59.1% said they reported their symptom(s to HCW. 22.7% (818/3604 reported having been asked to give sputum for TB investigation. Though participants in the Xpert vs. microscopy arm were more likely to have sputum requested by HCW, this was not significantly different: overall (26.0% [436/1676] vs 19.8% [382/1928]; adjusted prevalence ratio [aPR] 1.31, [95% CI 0.78-2.20] and when restricted to those presenting at clinics due to symptoms (49.1% [260/530] vs 29.9% [220/737]; aPR 1.38 [0.89-2.13] and those reporting being HIV-positive (29.4% [190/647] vs 20.8% [156/749]; aPR 1.38[0.88-2.16]. Those attending clinic due to TB symptoms, were more likely to have sputum requested if they had increasing number of symptoms; longer duration of cough, unintentional weight loss and night sweats and if they reported symptoms to HCW.A large proportion of people exiting PHCs reporting TB symptoms did not get tested. Implementation of

  17. Simplified methods for the evaluation of the risk of forming renal stones and the follow-up of stone-forming propensity during the preventive treatment of stone-formation.

    Science.gov (United States)

    Grases, Fèlix; Costa-Bauzá, Antonia

    2016-02-01

    Renal lithiasis is a complex multifactorial disease in which recurrence is common. Thus, simple and reliable procedures are needed to evaluate patients with previous kidney stones to determine the risk of recurrence. In this paper we review simple biochemical procedures that can be used to determine the risk for renal stone formation when the stone is available or unavailable for analysis. Our present knowledge of renal lithiasis indicates that renal stones form due to several well-defined factors. Analysis of the renal stone itself can provide important information about clinical factors that require further investigation. When the stone is unavailable, it is necessary to perform a general evaluation of main urinary risk factors associated to renal stone formation, but this study should be complemented considering information related to direct familial antecedents, recidivant degree, radiological images, medical history, and life style habits. Finally, tools for patient follow-up of stone-forming propensity during the preventive treatment are discussed .

  18. Investigation of nucleon electromagnetic form factors in the unphysical region by means of the N bar N → πl+l- reactions

    International Nuclear Information System (INIS)

    Dubnickova, A.Z.; Dubnicka, S.; Rekalo, M.P.

    1995-01-01

    A theoretical investigation of N bar N → πl + l - processes is carried out. First, the general structure of the differential probability of annihilation of very slow antinucleons on nucleons at rest into pion and lepton pairs is derived, then the structure of the electromagnetic current of N bar N → πγ * transition in case of the S-state annihilation is restored and general properties of the corresponding form factors are demonstrated. Next, by using the three-diagram approximation of the amplitude, those form factors are calculated explicitly and for the special process (p bar p) → π 0 γ * → π 0 l + l - they are shown to be completely described by the magnetic form factor of the proton in the unphysical region. Finally, the effective mass spectra of lepton pairs and the integral coefficients of internal conversion for the p bar p → π 0 l + l - and p bar n → π - l + l - processes are predicted. 15 refs., 7 figs

  19. Adapting Cognitive Task Analysis to Investigate Clinical Decision Making and Medication Safety Incidents.

    Science.gov (United States)

    Russ, Alissa L; Militello, Laura G; Glassman, Peter A; Arthur, Karen J; Zillich, Alan J; Weiner, Michael

    2017-05-03

    Cognitive task analysis (CTA) can yield valuable insights into healthcare professionals' cognition and inform system design to promote safe, quality care. Our objective was to adapt CTA-the critical decision method, specifically-to investigate patient safety incidents, overcome barriers to implementing this method, and facilitate more widespread use of cognitive task analysis in healthcare. We adapted CTA to facilitate recruitment of healthcare professionals and developed a data collection tool to capture incidents as they occurred. We also leveraged the electronic health record (EHR) to expand data capture and used EHR-stimulated recall to aid reconstruction of safety incidents. We investigated 3 categories of medication-related incidents: adverse drug reactions, drug-drug interactions, and drug-disease interactions. Healthcare professionals submitted incidents, and a subset of incidents was selected for CTA. We analyzed several outcomes to characterize incident capture and completed CTA interviews. We captured 101 incidents. Eighty incidents (79%) met eligibility criteria. We completed 60 CTA interviews, 20 for each incident category. Capturing incidents before interviews allowed us to shorten the interview duration and reduced reliance on healthcare professionals' recall. Incorporating the EHR into CTA enriched data collection. The adapted CTA technique was successful in capturing specific categories of safety incidents. Our approach may be especially useful for investigating safety incidents that healthcare professionals "fix and forget." Our innovations to CTA are expected to expand the application of this method in healthcare and inform a wide range of studies on clinical decision making and patient safety.

  20. Reference line-pair values of panoramic radiographs using an arch-form phantom stand to assess clinical image quality

    International Nuclear Information System (INIS)

    Choi, Da Hye; Choi, Bo Ram; Huh, Kyung Hoe; Heo, Min Suk; Choi, Soon Chul; Choi, Jin Woo; Yi, Won Jin; Lee, Sam Sun

    2013-01-01

    This study was performed to suggest reference line-pair values of panoramic images with clinically desirable qualities using an arch-form phantom stand. The line-pair test phantom was chosen. A real skull model was selected for setting the arch-form model of the phantom stand. The phantom stand had slits in four regions (incisor, premolar, molar, TMJ). Four raw images of the test phantom in each region and one raw image of the real skull were converted into 50 test phantom images and 50 skull phantom images with various line-pair values. 50 post-processed real skull phantom images were divided into 4 groups and were randomly submitted to 14 evaluators. Image quality was graded on a 4 point scale (1. good, 2. normal, 3. poor but interpretable, and 4. not interpretable). The reference line pair was determined as the first line-pair value scored less than 2 points. The mean scores tended to decrease as the line-pair values increased. The reference line-pair values were 3.19 LP/mm in the incisor, 2.32 LP/mm in the premolar and TMJ, and 1.88 LP/mm in the molar region. Image quality evaluation methods and criteria should be able to assess various regions considering the characteristics of panoramic systems. This study suggested overall and regional reference line-pair values and established a set of standard values for them.

  1. Reference line-pair values of panoramic radiographs using an arch-form phantom stand to assess clinical image quality

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Da Hye; Choi, Bo Ram; Huh, Kyung Hoe; Heo, Min Suk; Choi, Soon Chul [Dept. of Oral and Maxillofacial Radiology and Dental Research Institute, School of Dentistry, Seoul National University, Seoul (Korea, Republic of); Choi, Jin Woo [Dept. of Oral and Maxillofacial Radiology, College of Dentistry, Dankook University, Cheonan (Korea, Republic of); Yi, Won Jin; Lee, Sam Sun [Dept. of Oral and Maxillofacial Radiology, BK21 Craniomaxillofacial Life Science, and Dental Research Institute, School of Dentistry, Seoul National University, Seoul (Korea, Republic of)

    2013-03-15

    This study was performed to suggest reference line-pair values of panoramic images with clinically desirable qualities using an arch-form phantom stand. The line-pair test phantom was chosen. A real skull model was selected for setting the arch-form model of the phantom stand. The phantom stand had slits in four regions (incisor, premolar, molar, TMJ). Four raw images of the test phantom in each region and one raw image of the real skull were converted into 50 test phantom images and 50 skull phantom images with various line-pair values. 50 post-processed real skull phantom images were divided into 4 groups and were randomly submitted to 14 evaluators. Image quality was graded on a 4 point scale (1. good, 2. normal, 3. poor but interpretable, and 4. not interpretable). The reference line pair was determined as the first line-pair value scored less than 2 points. The mean scores tended to decrease as the line-pair values increased. The reference line-pair values were 3.19 LP/mm in the incisor, 2.32 LP/mm in the premolar and TMJ, and 1.88 LP/mm in the molar region. Image quality evaluation methods and criteria should be able to assess various regions considering the characteristics of panoramic systems. This study suggested overall and regional reference line-pair values and established a set of standard values for them.

  2. Surface sensitivity of nuclear-knock-out form factors

    International Nuclear Information System (INIS)

    Fratamico, G.

    1984-01-01

    A numerical calculation has been performed to investigate the sensitivity of nuclear-knock-out form factors to nuclear-surface behaviour of bound-state wave functions. The result of our investigation suggests that one can extract the bound-state behaviour at the surface from experimental information on nuclear-knock-out form factors

  3. Amorphous drugs and dosage forms

    DEFF Research Database (Denmark)

    Grohganz, Holger; Löbmann, K.; Priemel, P.

    2013-01-01

    The transformation to an amorphous form is one of the most promising approaches to address the low solubility of drug compounds, the latter being an increasing challenge in the development of new drug candidates. However, amorphous forms are high energy solids and tend to recry stallize. New...... formulation principles are needed to ensure the stability of amorphous drug forms. The formation of solid dispersions is still the most investigated approach, but additional approaches are desirable to overcome the shortcomings of solid dispersions. Spatial separation by either coating or the use of micro-containers...... before single molecules are available for the formation of crystal nuclei, thus stabilizing the amorphous form....

  4. Mobile phones in clinical practice: reducing the risk of bacterial contamination.

    Science.gov (United States)

    Mark, D; Leonard, C; Breen, H; Graydon, R; O'Gorman, C; Kirk, S

    2014-09-01

    Mobile smart phones have become increasingly integrated into the practice of doctors and allied medical professionals. Recent studies suggest them to represent reservoirs for pathogens with potential to cause nosocomial infections. This study aimed to investigate the level of contamination on phones used on surgical wards and identify strategies for their safe use within clinical areas. Fifty mobile phones were taken from members of the multidisciplinary team working in a surgical unit. Phones were swabbed by two trained investigators using a standardised technique and samples streaked out using an automated specimen inoculator onto two types of culture media (Columbia blood agar and MacConkey agar). Colonies were identified and counted by a single trained investigator in a blinded fashion. Simultaneously a questionnaire investigating usage levels of phones was given to 150 healthcare workers. Sixty per cent of phones sampled had some form of contaminant isolated from their phone. Thirty-one (62%) of phones had only three colonies or less isolated on medium. No pathogenic or drug resistant strains of bacteria were identified. A total of 88% of individuals sampled by questionnaire used their phone within the workplace of which 55% used it for clinical purposes. Sixty-three per cent expected there to be some form of contaminant on their phone with only 37% admitting to cleaning it regularly. Seventy-five per cent of people did not view a ban on phones as a practical solution was they found to be an infection risk. Touch screen smart phones may be used safely in a clinical environment, with a low risk of cross-contamination of nosocomial bacteria to patients, in the setting of effective adherence to hand hygiene policies. © 2014 John Wiley & Sons Ltd.

  5. Forming of protective nanostructure coatings on metals and glasses and their properties investigation

    International Nuclear Information System (INIS)

    Deshkovskaya, A.; Lynkov, L.; Nagibarov, A.; Glybin, V.; Richter, E.; Pham, M.

    2013-01-01

    Transparent heat-resistant coatings of 10-30 nm thickness described by (ZrO 2 ) x •(Y 2 O 3 ) y composition are formed on the surface of metals and glasses by thermolysis technique. Produced coatings possess high adhesive strength, high corrosive and abrasive resistance. Nanocrystalline formations are revealed on samples surface, with quantity of these formations depending on basic solution concentration, formed layers number and thermal treatment mode. Ion-beam modification of obtained coatings under mixing mode enables said properties enhancing owing to zirconium oxiboride formation at substrate-coating interface as a result of ion-beam synthesis. (authors)

  6. Investigating Clinically and Scientifically Useful Cut Points on the Compulsive Sexual Behavior Inventory.

    Science.gov (United States)

    Miner, Michael H; Raymond, Nancy; Coleman, Eli; Swinburne Romine, Rebecca

    2017-05-01

    clinical screening tool and the other, more conservative measurement that is useful for etiologic and epidemiologic research. Miner MH, Raymond N, Coleman E, Swinburne Romine R. Investigating Clinically and Scientifically Useful Cut Points on the Compulsive Sexual Behavior Inventory. J Sex Med 2017;14:715-720. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

  7. The clinical features of osteogenesis imperfecta in Vietnam.

    Science.gov (United States)

    Binh, Ho Duy; Maasalu, Katre; Dung, Vu Chi; Ngoc, Can T Bich; Hung, Ton That; Nam, Tran V; Nhan, Le N Thanh; Prans, Ele; Reimann, Ene; Zhytnik, Lidiia; Kõks, Sulev; Märtson, Aare

    2017-01-01

    Osteogenesis imperfecta (OI) has not been studied in a Vietnamese population before. The aim of this study was to systematically collect epidemiological information, investigate clinical features and create a clinical database of OI patients in Vietnam for future research and treatment strategy development. Participants underwent clinical and physical examinations; also medical records were reviewed. Genealogical information was collected and family members' phenotypical manifestations recorded. Cases were classified according to the Sillence classification. In total, 146 OI patients from 120 families were studied: 46 with OI Type I, 46 with Type III and 54 with Type IV. Almost patients had skeletal deformations. One hundred and forty-two had a history of fractures, 117 blue sclera, 89 dentinogenesis imperfecta and 26 hearing loss. The total number of fractures was 1,932. Thirty-four patients had intra-uterine fractures and nine had perinatal fractures. Surgery was performed 163 times in 58 patients; 100 osteosyntheses and 63 osteotomies. Bisphosphonate treatment was used in 37 patients. The number of affected individuals and predominance of severe forms of OI indicate that the disease is under diagnosed in Vietnam, especially in cases without a family history or with mild form of OI. Deformities appeared in all patients with different severity and localisation, affecting mostly the lower limbs. OI medical and surgical treatment rates are low and in most cases surgery was performed due to fractures. Compared to previous studies, our results indicate a lower OI prevalence and greater severity of symptoms in the Vietnamese population when compared with other areas. Further investigation, improved diagnosis and treatment are needed to increase the patients' quality of life.

  8. Thermogravimetric investigations of cream with minoxidil

    Directory of Open Access Journals (Sweden)

    I. V. Gnitko

    2016-12-01

    Full Text Available Minoxidil is one of the most effective and modern medications, which is used in modern trichology for hair growth stimulation in case of androgenic and other forms of alopecia. Clinical effect of this substance is caused by the intensification of metabolic processes in the skin due to intensification of microcirculation. For local application domestic dermatology uses imported minoxidil medicines in form of alcohol-water lotions and aerosols. The use of semisolid dosage form with minoxidil for external administration will allow to increase its efficacy and will widen the arsenal of domestic pharmacotherapeutic agents for hair growth stimulation. Rational composition of minoxidil semisolid dosage form for external use with 2% of active substance has been developed at the Department of Medicinal Preparations Technology, Zaporozhye State Medical University as a result of complex physical-chemical, microbiological and biopharmaceutical investigations. The aim of this work is the study of thermal treatment effects of cream-mask with minoxidil for external use over the temperature range, which is used in technological process of this dosage form manufacturing. Materials and methods. Cream with 2% of minoxidil on the emulsion base and its excipients have been used as the object for the thermogravimetric investigations. Thermogravimetric analysis has been carried out on the derivatograph «Shimadzu DTG-60», Japan, with the platinum and platinum-rhodium thermopair with samples’ heating in aluminium crucibles from 25 to 200ºС. Results. According to thermogravimetric experimental data minoxidil is a thermal stable substance from 26 to 240ºС. During experimental process insignificant endothermic effect was determined at 191,72ºС. However the mass of the example to the end of experiment practically didn’t change (decrease on 0,32%. Thermal effects on the derivatogram of minoxidil emulsion cream match with thermal effects of the base components and

  9. Driving Organizational Change From the Bedside: The AACN Clinical Scene Investigator Academy.

    Science.gov (United States)

    Lacey, Susan R; Goodyear-Bruch, Caryl; Olney, Adrienne; Hanson, Dave; Altman, Marian S; Varn-Davis, Natasha S; Brinker, Debbie; Lavandero, Ramón; Cox, Karen S

    2017-08-01

    Staff nurses are pivotal in leading change related to quality improvement efforts, although many lack skills to steer change from the bedside. The American Association of Critical-Care Nurses (AACN) staff nurse leadership program, Clinical Scene Investigator (CSI) Academy, teaches and empowers staff nurses in leadership skills and change concepts to translate evidence into practice affecting patient outcomes. To describe the curriculum of the AACN CSI Academy that provides staff nurses with the leadership skills required to create unit-based change projects that positively impact patient/family outcomes. The curriculum of the Academy included leadership topics, communication, change concepts, quality improvement methods, project management, and data management and analysis. Each team of participants collected project data to show improvements in patient care. The program evaluation used many data sources to assess the program effectiveness, relating to the professional growth of the participant nurses. The participants assessed project patient outcomes, sustainability, and spread. The first cohort of CSI participants included 164 direct care nurses from 42 hospitals in 6 cities. They rated the Academy highly in the program evaluation, and they reported that the Academy contributed to their professional development. The individual hospital quality improvement projects resulted in positive patient and estimated fiscal outcomes that were generally sustained 1 year after the program. With the skills, tools, and support obtained from participation in the CSI Academy, staff nurses can make substantial contributions to their organizations in clinical and possibly fiscal outcomes. ©2017 American Association of Critical-Care Nurses.

  10. Deriving Competencies for Mentors of Clinical and Translational Scholars

    Science.gov (United States)

    Abedin, Zainab; Biskup, Ewelina; Silet, Karin; Garbutt, Jane M.; Kroenke, Kurt; Feldman, Mitchell D.; McGee, Jr, Richard; Fleming, Michael; Pincus, Harold Alan

    2012-01-01

    Abstract Although the importance of research mentorship has been well established, the role of mentors of junior clinical and translational science investigators is not clearly defined. The authors attempt to derive a list of actionable competencies for mentors from a series of complementary methods. We examined focus groups, the literature, competencies derived for clinical and translational scholars, mentor training curricula, mentor evaluation forms and finally conducted an expert panel process in order to compose this list. These efforts resulted in a set of competencies that include generic competencies expected of all mentors, competencies specific to scientists, and competencies that are clinical and translational research specific. They are divided into six thematic areas: (1) Communication and managing the relationship, (2) Psychosocial support, (3) Career and professional development, (4) Professional enculturation and scientific integrity, (5) Research development, and (6) Clinical and translational investigator development. For each thematic area, we have listed associated competencies, 19 in total. For each competency, we list examples that are actionable and measurable. Although a comprehensive approach was used to derive this list of competencies, further work will be required to parse out how to apply and adapt them, as well future research directions and evaluation processes. Clin Trans Sci 2012; Volume 5: 273–280 PMID:22686206

  11. Clinical Investigation Program: Annual Progress Report

    Science.gov (United States)

    1992-09-30

    Diamminedichloroplatinum (II), Methotrexate and Bleomycin in the Treatment of Advanced Epidermoid Carcinoma of the Penis , Phase II...II), Methotrexate and Bleomycin in the Treatment of Advanced Epidermoid Carcinoma of the Penis , Phase II (5) Start Date: (6) Est Compl Date: (7...Associate Investigators (11) Key Words: constitutional delay delayed puberty (12) Accumulative MEDCASE:* (13) Est Accum OKA Cost:* *Refer to Unit Summary

  12. Data-based control of a multi-step forming process

    Science.gov (United States)

    Schulte, R.; Frey, P.; Hildenbrand, P.; Vogel, M.; Betz, C.; Lechner, M.; Merklein, M.

    2017-09-01

    The fourth industrial revolution represents a new stage in the organization and management of the entire value chain. However, concerning the field of forming technology, the fourth industrial revolution has only arrived gradually until now. In order to make a valuable contribution to the digital factory the controlling of a multistage forming process was investigated. Within the framework of the investigation, an abstracted and transferable model is used to outline which data have to be collected, how an interface between the different forming machines can be designed tangible and which control tasks must be fulfilled. The goal of this investigation was to control the subsequent process step based on the data recorded in the first step. The investigated process chain links various metal forming processes, which are typical elements of a multi-step forming process. Data recorded in the first step of the process chain is analyzed and processed for an improved process control of the subsequent process. On the basis of the gained scientific knowledge, it is possible to make forming operations more robust and at the same time more flexible, and thus create the fundament for linking various production processes in an efficient way.

  13. Quantifying and visualizing site performance in clinical trials.

    Science.gov (United States)

    Yang, Eric; O'Donovan, Christopher; Phillips, JodiLyn; Atkinson, Leone; Ghosh, Krishnendu; Agrafiotis, Dimitris K

    2018-03-01

    One of the keys to running a successful clinical trial is the selection of high quality clinical sites, i.e., sites that are able to enroll patients quickly, engage them on an ongoing basis to prevent drop-out, and execute the trial in strict accordance to the clinical protocol. Intuitively, the historical track record of a site is one of the strongest predictors of its future performance; however, issues such as data availability and wide differences in protocol complexity can complicate interpretation. Here, we demonstrate how operational data derived from central laboratory services can provide key insights into the performance of clinical sites and help guide operational planning and site selection for new clinical trials. Our methodology uses the metadata associated with laboratory kit shipments to clinical sites (such as trial and anonymized patient identifiers, investigator names and addresses, sample collection and shipment dates, etc.) to reconstruct the complete schedule of patient visits and derive insights about the operational performance of those sites, including screening, enrollment, and drop-out rates and other quality indicators. This information can be displayed in its raw form or normalized to enable direct comparison of site performance across studies of varied design and complexity. Leveraging Covance's market leadership in central laboratory services, we have assembled a database of operational metrics that spans more than 14,000 protocols, 1400 indications, 230,000 unique investigators, and 23 million patient visits and represents a significant fraction of all clinical trials run globally in the last few years. By analyzing this historical data, we are able to assess and compare the performance of clinical investigators across a wide range of therapeutic areas and study designs. This information can be aggregated across trials and geographies to gain further insights into country and regional trends, sometimes with surprising results. The

  14. Terra firma-forme dermatosis

    Directory of Open Access Journals (Sweden)

    Emel Erkek

    2012-01-01

    Full Text Available Terra firma-forme dermatosis is characterized by ′dirty′ brown-grey cutaneous patches and plaques that can simply be eradicated by forceful swabbing with alcohol pads. The pathogenesis has been attributed to abnormal and delayed keratinization. Although affected patients present with typical lesions, the disorder is not well-known by dermatologists. In this report, we describe two patients with terra firma-forme dermatosis in the setting of xerosis cutis and atopic dermatitis. From a clinical point of view, we lay emphasis on its unique expression and diagnosis/treatment. From a histological perspective, we highlight its resemblance to dermatosis neglecta and speculate on the role of ′neglect′ in a patient with seemingly adequate hygiene. The role of urea containing emollients in the development of this disorder remains to be determined.

  15. Clinical utility of FDG-PET for the differential diagnosis among the main forms of dementia.

    Science.gov (United States)

    Nestor, Peter J; Altomare, Daniele; Festari, Cristina; Drzezga, Alexander; Rivolta, Jasmine; Walker, Zuzana; Bouwman, Femke; Orini, Stefania; Law, Ian; Agosta, Federica; Arbizu, Javier; Boccardi, Marina; Nobili, Flavio; Frisoni, Giovanni Battista

    2018-05-07

    To assess the clinical utility of FDG-PET as a diagnostic aid for differentiating Alzheimer's disease (AD; both typical and atypical forms), dementia with Lewy bodies (DLB), frontotemporal lobar degeneration (FTLD), vascular dementia (VaD) and non-degenerative pseudodementia. A comprehensive literature search was conducted using the PICO model to extract evidence from relevant studies. An expert panel then voted on six different diagnostic scenarios using the Delphi method. The level of empirical study evidence for the use of FDG-PET was considered good for the discrimination of DLB and AD; fair for discriminating FTLD from AD; poor for atypical AD; and lacking for discriminating DLB from FTLD, AD from VaD, and for pseudodementia. Delphi voting led to consensus in all scenarios within two iterations. Panellists supported the use of FDG-PET for all PICOs-including those where study evidence was poor or lacking-based on its negative predictive value and on the assistance it provides when typical patterns of hypometabolism for a given diagnosis are observed. Although there is an overall lack of evidence on which to base strong recommendations, it was generally concluded that FDG-PET has a diagnostic role in all scenarios. Prospective studies targeting diagnostically uncertain patients for assessing the added value of FDG-PET would be highly desirable.

  16. Waste-form development

    International Nuclear Information System (INIS)

    Neilson, R.M. Jr.; Colombo, P.

    1982-01-01

    Contemporary solidification agents are being investigated relative to their applications to major fuel cycle and non-fuel cycle low-level waste (LLW) streams. Work is being conducted to determine the range of conditions under which these solidification agents can be applied to specific LLW streams. These studies are directed primarily towards defining operating parameters for both improved solidification of problem wastes and solidification of new LLW streams generated from advanced volume reduction technologies. Work is being conducted to measure relevant waste form properties. These data will be compiled and evaluated to demonstrate compliance with waste form performance and shallow land burial acceptance criteria and transportation requirements

  17. Clinical reasoning in neurology: use of the repertory grid technique to investigate the reasoning of an experienced occupational therapist.

    Science.gov (United States)

    Kuipers, Kathy; Grice, James W

    2009-08-01

    The aim of this paper is to describe the use of a structured interview methodology, the repertory grid technique, for investigating the clinical reasoning of an experienced occupational therapist in the domain of upper limb hypertonia as a result of brain injury. Repertory grid interviews were completed before and after exposure to a protocol designed to guide clinical reasoning and decision-making in relation to upper limb neurological rehabilitation. Data were subjected to both qualitative and quantitative analyses. Qualitative analysis focussed on clinical reasoning content. Common themes across the pre- and post-exposure interviews were the use of theoretical frameworks and practice models, the significance of clinical expertise, and discrimination of 'broad' and 'specific' aspects, as well as differentiation between 'therapist and client-related' aspects of the clinical situation. Quantitative analysis indicated that for both pre- and post-exposure repertory grids, clinical reasoning was structured in terms of two main concepts. In the pre-exposure grid, these were related to the therapist's role, and to the 'scope' of practice tasks (either broad or specific). In the post-exposure grid the two main concepts were upper limb performance, and client-centred aspects of the therapy process. The repertory grid technique is proposed as an effective tool for exploring occupational therapy clinical reasoning, based on its capacity for accessing personal frames of reference, and elucidating both the meaning and the structure supporting clinical reasoning.

  18. Rapidly-administered short forms of the Wechsler Adult Intelligence Scale-3rd edition.

    Science.gov (United States)

    Donnell, Alison J; Pliskin, Neil; Holdnack, James; Axelrod, Bradley; Randolph, Christopher

    2007-11-01

    Although the Wechsler Full Scale IQ (FSIQ) is a common component of most neuropsychological evaluations, there are many clinical situations where the complete administration of this battery is precluded by various constraints, including limitations of time and patient compliance. These constraints are particularly true for dementia evaluations involving elderly patients. The present study reports data on two short forms particularly suited to dementia evaluations, each requiring less than 20min of administration time. One of the short forms was previously validated in dementia for the WAIS-R [Randolph, C., Mohr, E., & Chase, T. N. (1993). Assessment of intellectual function in dementing disorders: Validity of WAIS-R short forms for patients with Alzheimer's, Huntington's, and Parkinson's disease. Journal of Clinical and Experimental Neuropsychology, 15, 743-753]; the second was developed specifically for patients with motor disabilities. These short forms were validated using the WAIS-III normative standardization sample (N=2450), neurologic sample (N=63), and matched controls (N=49), and a separate mixed clinical sample (N=70). The results suggest that each short form provides an accurate and reliable estimate of WAIS-III FSIQ, validating their use in appropriate clinical contexts. The present data support the use of these short forms for dementia evaluations, and suggests that they may be applicable for the evaluation of other neurological and neuropsychiatric disorders that involve acquired neurocognitive impairment.

  19. Cleveland Clinic Lerner College of Medicine: an innovative approach to medical education and the training of physician investigators.

    Science.gov (United States)

    Fishleder, Andrew J; Henson, Lindsey C; Hull, Alan L

    2007-04-01

    Cleveland Clinic Lerner College of Medicine (CCLCM) is an innovative, five-year medical education track within Case Western Reserve University School of Medicine (Case) with a focused mission to attract and educate a limited number of highly qualified persons who seek to become physician investigators. CCLCM curriculum governance, faculty appointments and promotions, and admissions committees are integrated with respective Case committees. The CCLCM curriculum is based on faculty-defined professional attributes that graduates are expected to develop. These attributes were used to create curricular and assessment principles that guided the development of an integrated basic science, clinical science, and research curriculum, conducted in an active learning environment. An organ-system approach is used to solidify an understanding of basic science discipline threads in the context of relevant clinical problems presented in PBL and case-based discussion formats. Clinical skills are introduced in the first year as part of the two-year longitudinal experience with a family practice or internal medicine physician. The research program provides all students with opportunities to learn and experience basic and translational research and clinical research before selecting a research topic for their 12- to 15-month master-level thesis project. All Case students participate in required and elective clinical curriculum after the second year, but CCLCM students return to the Cleveland Clinic on selected Friday afternoons for program-specific research and professionalism-learning activities. A unique portfolio-based assessment system is used to assess student achievements in nine competency areas, seven of which reflect the Accreditation Council for Graduate Medical Education competencies.

  20. In Situ Monitoring and Modeling of the Solution-Mediated Polymorphic Transformation of Rifampicin: From Form II to Form I.

    Science.gov (United States)

    Guo, Nannan; Hou, Baohong; Wang, Na; Xiao, Yan; Huang, Jingjing; Guo, Yanmei; Zong, Shuyi; Hao, Hongxun

    2018-01-01

    In this article, the solution-mediated polymorphic transformation of rifampicin was investigated and simulated in 3 solvents at 30°C. The solid-state form I and form II of rifampicin was characterized by powder X-ray diffraction, scanning electron microscopy, thermogravimetric analysis, Raman spectroscopy, and Fourier transform infrared spectroscopy (FTIR). To explore the relative stability, solubility data of form I and form II of rifampicin in butan-1-ol were determined using a dynamical method. In addition, Raman spectroscopy and focused beam reflectance measurement were used to in situ monitor the transformation of rifampicin from form II to form I. The liquid state concentration of rifampicin was measured by UV spectroscopic method. To investigate the effect of solvent on transformation, the transformation experiments were carried out in 3 solvents. Furthermore, a mathematical model was built to describe the kinetics of dissolution, nucleation, and growth processes during transformation by using experimental data. By combination of experimental and simulation results, it was found that the transformation process of rifampicin is controlled by dissolution of form II in heptane, whereas the transformation in hexane and octane was firstly controlled by dissolution of solid-state form and then controlled by growth of form I. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  1. Forms of Address in Chilean Spanish

    Science.gov (United States)

    Bishop, Kelley; Michnowicz, Jim

    2010-01-01

    The present investigation examines possible social and linguistic factors that influence forms of address used in Chilean Spanish with various interlocutors. A characteristic of the Spanish of Chile is the use of a variety of forms of address for the second person singular, "tu", "vos", and "usted", with corresponding…

  2. Psychometric properties of the Ruminative Response Scale-short form in a clinical sample of patients with major depressive disorder

    Directory of Open Access Journals (Sweden)

    Parola N

    2017-05-01

    Full Text Available Nathalie Parola,1,2,* Xavier Yves Zendjidjian,1,3,* Marine Alessandrini,1 Karine Baumstarck,1 Anderson Loundou,1 Guillaume Fond,4,5 Fabrice Berna,4,6 Christophe Lançon,1–3 Pascal Auquier,1 Laurent Boyer1 1Public Health, Chronic Diseases and Quality of Life – Research Unit EA 3279, Aix-Marseille University, Marseille, 2Department of Psychiatry, Sainte-Marguerite University Hospital, Marseille, 3Department of Psychiatry, La Conception University Hospital, Marseille, 4Fondation FondaMental, Créteil, 5Department of Psychiatry and Addictology, Henri Mondor University Hospital, INSERM U955, Eq 15 Genetic Psychiatry and Psychopathology, Paris Est-Créteil University, Créteil, 6Department of Psychiatry, INSERM U1114, Fédération de Médecine Translationnelle de Strasbourg, Strasbourg University Hospital, Strasbourg, France *These authors contributed equally to this work Background: The Ruminative Response Scale (RRS-short form is one of the most widely used measures of rumination, comprising ten items and two components: reflection and brooding. The aim of this study was to investigate RRS validity and reliability in a clinical sample of French patients with major depressive disorder (MDD.Subjects and methods: Outpatients with a DSM-IV-TR diagnosis of MDD were recruited from a public academic hospital in France. Depressive symptoms were evaluated by the Beck Depression Inventory, anxiety by the State-Trait Anxiety Inventory – state scale, and quality of life by the 36-Item Short Form Health Survey (SF-36 questionnaire. Confirmatory factor analyses, item-dimension correlations, Cronbach’s α-coefficients, Rasch statistics, and external validity were tested. Differential item functioning analyses were performed for sex.Results: A total of 109 patients participated. The final reflection–brooding two-factor model of the RRS showed a good fit (root-mean-square error of approximation 0.041, comparative fit index 0.987, standardized root

  3. Influence and evolution mechanism of different sharpness contact forms to mechanical property of cortical bone by nanoindentation

    Science.gov (United States)

    Sun, Xingdong; Guo, Yue; Li, Lijia; Liu, Zeyang; Wu, Di; Shi, Dong; Zhao, Hongwei; Zhang, Shizhong

    2018-03-01

    Based on different damage forms of various contact forms to bone, the mechanical response and mechanism were investigated by nanoindentation under different sharpness contact forms. For the purpose of simulating the different sharpness contact forms, two kinds of indenters were used in experiments and finite elements simulations. Through nanoindentation experiments, it was concluded that the residual depth of sharp indenter was bigger than that of blunt indenter with small penetration depth. However, the contrary law was obtained with bigger penetration depth. There was a turning point of transition from blunt tendency to sharp tendency. By calculation, it was concluded that the sharper the indenter was, the bigger the proportion of plastic energy in total energy was. Basically, results of finite elements simulation could correspond with the experimental conclusions. By the observation of FE-SEM, the surface of cortical bone compressed was more seriously directly below the blunt indenter than the lateral face. For the berkovich indenter, the surface of indentation compressed was less directly below the indenter, but seriously on three lateral faces. This research may provide some new references to the studies of bone fracture mechanism in different load patterns in the initial press-in stage and offer new explanation for bone trauma diagnosis in clinical treatment and criminal investigation.

  4. Influence and evolution mechanism of different sharpness contact forms to mechanical property of cortical bone by nanoindentation

    Directory of Open Access Journals (Sweden)

    Xingdong Sun

    2018-03-01

    Full Text Available Based on different damage forms of various contact forms to bone, the mechanical response and mechanism were investigated by nanoindentation under different sharpness contact forms. For the purpose of simulating the different sharpness contact forms, two kinds of indenters were used in experiments and finite elements simulations. Through nanoindentation experiments, it was concluded that the residual depth of sharp indenter was bigger than that of blunt indenter with small penetration depth. However, the contrary law was obtained with bigger penetration depth. There was a turning point of transition from blunt tendency to sharp tendency. By calculation, it was concluded that the sharper the indenter was, the bigger the proportion of plastic energy in total energy was. Basically, results of finite elements simulation could correspond with the experimental conclusions. By the observation of FE-SEM, the surface of cortical bone compressed was more seriously directly below the blunt indenter than the lateral face. For the berkovich indenter, the surface of indentation compressed was less directly below the indenter, but seriously on three lateral faces. This research may provide some new references to the studies of bone fracture mechanism in different load patterns in the initial press-in stage and offer new explanation for bone trauma diagnosis in clinical treatment and criminal investigation.

  5. Clinical investigation of set-shifting subtypes in anorexia nervosa.

    Science.gov (United States)

    Abbate-Daga, Giovanni; Buzzichelli, Sara; Marzola, Enrica; Amianto, Federico; Fassino, Secondo

    2014-11-30

    While evidence continues to accumulate on the relevance of cognitive inflexibility in anorexia nervosa (AN), its clinical correlates remain unclear. We aimed at examining the relationship between set-shifting and clinical variables (i.e., eating psychopathology, depression, and personality) in AN. Ninety-four individuals affected by AN and 59 healthy controls (HC) were recruited. All participants were assessed using: Eating Disorders Inventory-2 (EDI-2), Temperament and Character Inventory (TCI), Beck Depression Inventory (BDI), and Wisconsin Card Sorting Test (WCST). The AN group scored worse than HCs on set-shifting. According to their neuropsychological performances, AN patients were split into two groups corresponding to poor (N=30) and intact (N=64) set-shifting subtypes. Interoceptive awareness, impulse regulation, and maturity fears on the EDI-2 and depression on the BDI differed across all groups (HC, intact, and poor set-shifting subtype). Self-directedness on the TCI differed significantly among all groups. Cooperativeness and reward dependence differed instead only between HC and AN poor set-shifting subtype. After controlling for depression, only interoceptive awareness remained significant with reward dependence showing a trend towards statistical significance. These findings suggest that multiple clinical variables may be correlated with set-shifting performances in AN. The factors contributing to impaired cognitive inflexibility could be more complex than heretofore generally considered. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  6. Clinical Investigation Program Annual Progress Report

    Science.gov (United States)

    1988-10-20

    Presented: Interna- tional Symposium on Orthopedics, Mexico , September 1987. Publications: In preparation. 147 FAMC A.P.R. (RCS MED 300) Detail Summary...Infection: A Prospective Study. Presented: 2nd Annual Symposium of the Rocky Moun- tain Flow Cytometry Users Group, Albuquerque, New Mexico , 10-11...Podgore, COL, MC (9) Dept/ISvc: Pediatrics (10) Associate Investigators (11) Key Words: Myron J. Levin, M.D. varicella vaccine U Co. HSC (12

  7. Clinical Investigation Program Annual Progress Report

    Science.gov (United States)

    1993-09-30

    The assigned staff of the Molecular Biology Service are Dr. Anthony G. Gutierrez , Chef , GSl3, Ph. D. in Molecular Genetics, and Ms. Judith O’Brien...Node-Negative Breast Cancer Patients Using a Panel of Prognostic Factors. A Companion Protocol to SWOG 8897 ................................ . 103 91...of Prog- nostic Factors. A companion protocol to 8897 (5) Start Date: 1991 (6) Est Compl Date: (7) Principal Investigator: (8) Facility: FAMC Thomas

  8. An investigation of clinical studies suggests those with multiple objectives should have at least 90% power for each endpoint.

    NARCIS (Netherlands)

    Borm, G.F.; Houben, R.; Welsing, P.M.J.; Zielhuis, G.A.

    2006-01-01

    BACKGROUND AND OBJECTIVES: Many clinical studies have more than one objective, either formally or informally, but this is not usually taken into account in the determination of the sample size. We investigated the overall power of a study, that is, the probability that all the objectives will be

  9. Hysterosalpingographic picture encountered during the investigation of female infertility clinic has Lemba of Saint Raphael

    International Nuclear Information System (INIS)

    Kitenge, N.; Nzeza, N.; Mbanzulu, P.; Ndaye, B.

    2010-01-01

    A cross-sectional study was conducted at the St Raphael Lemba Clinic on a sample of 115 patients suspected of infertility during the period from june 1 1997 in 1 march 2003 (6 years). The technique of hysterosalpingography has allowed the identification of female infertility presents images that can diagnose one or more causes utero-tubal. Men also carry a significant responsibility in the genesis of the sterility of the couple: thus, they must also undergo exploration. Hormonal factors also have an important contribution in the investigation of infertility in women and must be taken in addition to hysterosalpingography

  10. Acute form of multiple sclerosis in a child simulation encephalitis

    International Nuclear Information System (INIS)

    Niagolova, S.; Karapasheva, V.; Nikolova, M.

    2007-01-01

    Multiple sclerosis (MS) is considered the most common demyelinating process involving the CNS. Although usually considered an adult disease multiple sclerosis can begin to manifest during childhood. The clinical presentation of the disease in early childhood can range from paraesthesias to dramatic presentations, suggesting diffuse encephalopathy with cerebral oedema, meningismus and impaired consciousness. Multiple sclerosis is usually characterized by a typical relapsing-remitting clinical course. But there are acute, clinically fulminant forms with atypical. neurologic symptoms and death in months. MRI has become increasingly relevant in the diagnosis of multiple sclerosis in the past years. Yet, the specificity is limited. Atypical forms of MS and other diseases of CNS may show similar patterns on MRI. We report a case of 7 years old boy with clinically fulminant Marburg type of multiple sclerosis that ended with death in two months. The patient was a diagnostic problem despite the certain degree of clinical and radiological suspicion. The postmortem diagnosis is based on pathomorphologic changes (gross pathologic and microscopic features) in CNS.The present case is of clinical, radiological and pathomorphologic interest because of its early onset in childhood, unusual clinical course and acute progression. Awareness of the MRI features of multiple sclerosis and MS-variants (subtypes) may help in such atypical presentations in childhood. (authors)

  11. Construct Validity of Medical Clinical Competence Measures: A Multitrait-Multimethod Matrix Study Using Confirmatory Factor Analysis.

    Science.gov (United States)

    Forsythe, George B.; And Others

    1986-01-01

    Construct validity was investigated for three tests of clinical competence in medicine: National Board of Medical Examiners examination (NBME), California Psychological Inventory (CPI), and Resident Evaluation Form (REF). Scores from 166 residents were analyzed. Results suggested low construct validity for CPI and REF scales, and moderate…

  12. Decision analysis. Clinical art or Clinical Science

    Science.gov (United States)

    1977-05-01

    having helped some clients. Over the past half century, psychotherapy has faced a series of crises concerned with its transformation from an art to a...clinical science . These include validation of the effectiveness of various forms of therapy, validating elements of treatment programs and

  13. Validity of the MMPI-2-RF (Restructured Form) L-r and K-r Scales in Detecting Underreporting in Clinical and Nonclinical Samples

    Science.gov (United States)

    Sellbom, Martin; Bagby, R. Michael

    2008-01-01

    In the current investigation, the authors examined the validity of the L-r and K-r scales on the recently developed Minnesota Multiphasic Personality Inventory-2-Restructured Form (MMPI-2-RF; Y. S. Ben-Porath & A. Tellegen, in press) in measuring underreported response bias. Three archival samples previously collected for examining MMPI-2…

  14. Pre-exposure to moving form enhances static form sensitivity.

    Directory of Open Access Journals (Sweden)

    Thomas S A Wallis

    Full Text Available BACKGROUND: Motion-defined form can seem to persist briefly after motion ceases, before seeming to gradually disappear into the background. Here we investigate if this subjective persistence reflects a signal capable of improving objective measures of sensitivity to static form. METHODOLOGY/PRINCIPAL FINDINGS: We presented a sinusoidal modulation of luminance, masked by a background noise pattern. The sinusoidal luminance modulation was usually subjectively invisible when static, but visible when moving. We found that drifting then stopping the waveform resulted in a transient subjective persistence of the waveform in the static display. Observers' objective sensitivity to the position of the static waveform was also improved after viewing moving waveforms, compared to viewing static waveforms for a matched duration. This facilitation did not occur simply because movement provided more perspectives of the waveform, since performance following pre-exposure to scrambled animations did not match that following pre-exposure to smooth motion. Observers did not simply remember waveform positions at motion offset, since removing the waveform before testing reduced performance. CONCLUSIONS/SIGNIFICANCE: Motion processing therefore interacts with subsequent static visual inputs in a way that can improve performance in objective sensitivity measures. We suggest that the brief subjective persistence of motion-defined forms that can occur after motion offsets is a consequence of the decay of a static form signal that has been transiently enhanced by motion processing.

  15. Nanoscale investigation of the interface situation of plated nickel and thermally formed nickel silicide for silicon solar cell metallization

    Science.gov (United States)

    Mondon, A.; Wang, D.; Zuschlag, A.; Bartsch, J.; Glatthaar, M.; Glunz, S. W.

    2014-12-01

    In the context of nickel silicide formation from plated nickel layers for solar cell metallization, there are several open questions regarding contact adhesion and electrical properties. Nanoscale characterization by transmission electron microscopy has been employed to support these investigations. Interfacial oxides and silicide phases were investigated on differently prepared samples by different analytical methods associated with transmission electron microscopy analysis. Processing variations included the pre-treatment of samples before nickel plating, the used plating solution and the thermal budget for the nickel-silicon solid-state reaction. It was shown that interface oxides of only few nm thickness on both silicon and nickel silicide are present on the samples, depending on the chosen process sequence, which have been shown to play an important role in adhesion of nickel on silicide in an earlier publication. From sample pretreatment variations, conclusions about the role of an interfacial oxide in silicide formation and its influence on phase formation were drawn. Such an oxide layer hinders silicide formation except for pinhole sites. This reduces the availability of Ni and causes a silicide with low Ni content to form. Without an interfacial oxide a continuous nickel silicide of greater depth, polycrystalline modification and expected phase according to thermal budget is formed. Information about the nature of silicide growth on typical solar cell surfaces could be obtained from silicide phase and geometric observations, which were supported by FIB tomography. The theory of isotropic NiSi growth and orientation dependent NiSi2 growth was derived. By this, a very well performing low-cost metallization for silicon solar cells has been brought an important step closer to industrial introduction.

  16. Nursing students' clinical competencies: a survey on clinical education objectives.

    Science.gov (United States)

    Arrigoni, C; Grugnetti, A M; Caruso, R; Gallotti, M L; Borrelli, P; Puci, M

    2017-01-01

    Developing clearly defined competencies and identifying strategies for their measurement remain unfortunately a critical aspect of nursing training. In the current international context, which continues to be characterised by deep economic crisis, universities have a fundamental role to play in redefining the educational goals to respond to the expectations of certain geographical areas of interest, as underscored in the Bologna Process (Joint Declaration of the European Ministers of Education Convened in Bologna 19 June 1999). The aim of this observational study was to examine the clinical learning context of nursing students using a tool developed by a team of teachers for the analysis of clinical learning. Redefinition of the clinical learning objectives with reference to the competencies set out in the questionnaire validated by Venturini et al. (2012) and the subsequent use of the tool created by the team of teachers for students in the first, second and third-year courses of the 2013/14 academic year, covering all the internships called for in those years. All nursing students enrolled in the first, second and third year of the nursing undergraduate degree program at the University of Pavia (no. 471) participated in this survey. A total of 1,758 clinical internships were carried out: 461 for the first year, 471 for the second year and 826 for the third year. Setting objectives, beginning with the educational offerings in the several clinical contexts, represents a strong point for this process. The results highlight a level of heterogeneity and complexity intrinsic to the University of Pavia educational system, characterized by clinical settings with different clinical levels (Research hospital and other traditional hospitals) that offering different levels of training. The use of the self-evaluation form for clinical learning made it possible to perform real-time observations of the training activities of the entire student body. An educational model

  17. Clinical and genetic investigation of families with type II Waardenburg syndrome.

    Science.gov (United States)

    Chen, Yong; Yang, Fuwei; Zheng, Hexin; Zhou, Jianda; Zhu, Ganghua; Hu, Peng; Wu, Weijing

    2016-03-01

    The present study aimed to investigate the molecular pathology of Waardenburg syndrome type II in three families, in order to provide genetic diagnosis and hereditary counseling for family members. Relevant clinical examinations were conducted on the probands of the three pedigrees. Peripheral blood samples of the probands and related family members were collected and genomic DNA was extracted. The coding sequences of paired box 3 (PAX3), microphthalmia‑associated transcription factor (MITF), sex‑determining region Y‑box 10 (SOX10) and snail family zinc finger 2 (SNAI2) were analyzed by polymerase chain reaction and DNA sequencing. The heterozygous mutation, c.649_651delAGA in exon 7 of the MITF gene was detected in the proband and all patients of pedigree 1; however, no pathological mutation of the relevant genes (MITF, SNAI2, SOX10 or PAX3) was detected in pedigrees 2 and 3. The heterozygous mutation c.649_651delAGA in exon 7 of the MITF gene is therefore considered the disease‑causing mutation in pedigree 1. However, there are novel disease‑causing genes in Waardenburg syndrome type II, which require further research.

  18. Child in a Form: The Definition of Normality and Production of Expertise in Teacher Statement Forms--The Case of Northern Finland, 1951-1990

    Science.gov (United States)

    Koskela, Anne; Vehkalahti, Kaisa

    2017-01-01

    This article shows the importance of paying attention to the role of professional devices, such as standardised forms, as producers of normality and deviance in the history of education. Our case study focused on the standardised forms used by teachers during child guidance clinic referrals and transfers to special education in northern Finland,…

  19. "Nudge" in the clinical consultation--an acceptable form of medical paternalism?

    Science.gov (United States)

    Aggarwal, Ajay; Davies, Joanna; Sullivan, Richard

    2014-04-17

    Libertarian paternalism is a concept derived from cognitive psychology and behavioural science. It is behind policies that frame information in such a way as to encourage individuals to make choices which are in their best interests, while maintaining their freedom of choice. Clinicians may view their clinical consultations as far removed from the realms of cognitive psychology but on closer examination there are a number of striking similarities. Evidence has shown that decision making is prone to bias and not necessarily rational or logical, particularly during ill health. Clinicians will usually have an opinion about what course of action represents the patient's best interests and thus may "frame" information in a way which "nudges" patients into making choices which are considered likely to maximise their welfare. This may be viewed as interfering with patient autonomy and constitute medical paternalism and appear in direct opposition to the tenets of modern practice. However, we argue that clinicians have a responsibility to try and correct "reasoning failure" in patients. Some compromise between patient autonomy and medical paternalism is justified on these grounds and transparency of how these techniques may be used should be promoted. Overall the extremes of autonomy and paternalism are not compatible in a responsive, responsible and moral health care environment, and thus some compromise of these values is unavoidable. Nudge techniques are widely used in policy making and we demonstrate how they can be applied in shared medical decision making. Whether or not this is ethically sound is a matter of continued debate but health care professionals cannot avoid the fact they are likely to be using nudge within clinical consultations. Acknowledgment of this will lead to greater self-awareness, reflection and provide further avenues for debate on the art and science of clinical communication.

  20. The clinical benefit of imaging striatal dopamine transporters with [123I]FP-CIT SPET in differentiating patients with presynaptic parkinsonism from those with other forms of parkinsonism

    International Nuclear Information System (INIS)

    Booij, J.; Speelman, J.DE.; Horstink, M. W.I.M.; Wolters, E.C.

    2001-01-01

    [ 123 I]FP-CIT (N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-iodophenyl)nortropane) has been developed successfully as a radioligand for single-photon emission tomography (SPET) imaging of dopamine transporters, which are situated in the membrane of dopaminergic neurons. Imaging of these transporters has shown promise as a clinical tool to detect degeneration of the dopaminergic nigrostriatal pathway. Several ''presynaptic parkinsonian'' syndromes, such as Parkinson's disease or multiple system atrophy, are characterised by degeneration of the nigrostriatal pathway. [ 123 I]FP-CIT SPET imaging studies have shown the ability to detect loss of striatal dopamine transporters in such syndromes. However, in clinical practice it is sometimes difficult, but important, to discriminate patients with ''presynaptic parkinsonism'' from those with other forms of parkinsonism not characterised by loss of presynaptic dopaminergic cells (e.g. psychogenic parkinsonism or drug-induced postsynaptic parkinsonism). In these inconclusive cases, it may be of value to confirm or exclude the existence of degeneration of nigrostriatal dopaminergic cells by using imaging techniques such as [ 123 I]FP-CIT SPET. Using [ 123 I]FP-CIT SPET, we have imaged the striatal dopamine transporters in a group of patients with inconclusive forms of parkinsonism, and, moreover, have been able to perform clinical follow-up of these patients 2-4 years after imaging. In 33 inconclusive cases, ratios of specific to non-specific binding were calculated for the caudate nucleus and putamen following [ 123 I]FP-CIT SPET imaging and compared with ratios obtained in healthy controls. In nine of the patients, degeneration of the nigrostriatal pathway was found scintigraphically and in all these cases, presynaptic parkinsonism was confirmed by clinical follow-up. In the other 24 subjects no degeneration was found scintigraphically. Forms of parkinsonism other than the presynaptic were confirmed at follow-up in 19 cases

  1. Computer controlled experimental device for investigations of tribological influences in sheet metal forming

    Directory of Open Access Journals (Sweden)

    Milan Djordjevic

    2012-05-01

    Full Text Available Sheet metal forming, especially deep drawing process, is influenced by many factors. Blank holding force and drawbead displacement are two of them that can be controlled during the forming process. For this purpose, electro-hydraulic computerized sheet-metal strip sliding device has been constructed. Basic characteristic of this device is realization of variable contact pressure and drawbead height as functions of time or stripe displacement. There are both, pressure and drawbead, ten linear and nonlinear functions. Additional features consist of the ability to measure drawing force, contact pressure, drawbead displacement etc. Presented in the paper are the device overview and the first results of steel sheet stripe sliding over rounded  drawbead.

  2. COMPUTER CONTROLLED EXPERIMENTAL DEVICE FOR INVESTIGATIONS OF TRIBOLOGICAL INFLUENCES IN SHEET METAL FORMING

    Directory of Open Access Journals (Sweden)

    Tomislav Vujinović

    2012-05-01

    Full Text Available Sheet metal forming, especially deep drawing process is influenced by many factors. Blank holding force and drawbead displacement are two of them that can be controlled during the forming process.For this purpose, an electro-hydraulic computerized sheet-metal strip sliding device has been constructed. The basic characteristic of this device is realization of variable contact pressure and drawbead height as functions of time or stripe displacement. There are both, pressure and drawbead, ten linear and nonlinear functions. Additional features consist of the ability to measure drawing force, contact pressure, drawbead displacement etc.The device overview and first results of steel sheet stripe sliding over rounded drawbead are presented in the paper.

  3. Clinical utility of color-form naming in Alzheimer's disease: preliminary evidence

    DEFF Research Database (Denmark)

    Nielsen, Niels Peter; Wiig, Elisabeth H; Warkentin, Siegbert

    2004-01-01

    Performances on Alzheimer's Quick Test color-form naming and Mini-Mental State Examination were compared for 38 adults with Alzheimer's disease and 38 age- and sex-matched normal controls. Group means differed significantly and indicated longer naming times by adults with Alzheimer's disease...... associated with Alzheimer's disease, are preliminary given the relatively small sample....

  4. [Clinical and neurophysiological heterogeneity of attention deficit hyperactivity disorder].

    Science.gov (United States)

    Chutko, L S; Yakovenko, E A; Surushkina, S Yu; Anisimova, T I; Kropotov, Yu D

    To determine clinical/neurophysiological characteristics of different forms of attention deficit hyperactivity disorder (ADHD) and the efficacy of treatment with cerebrolysin. Sixty children, aged 9 to 12 years, with ADHD were examined using clinical and electroencephalographic methods. Idiopathic and residual-organic forms were compared. The study shows significantly higher levels of impulsivity and hyperactivity in children with residual-organic form of the disease. There were significant differences in the amplitude component of engaging in action (P3 Go) and the amplitude of the action suppression component (P3 NOGO) in patients with different forms of ADHD. The high clinical efficacy (improvement in 70.0% of patients with idiopathic form of ADHD and 86.7% of patients with residual-organic form of the disease) was found.

  5. DNA methylation patterns of genes related to immune response in the different clinical forms of oral lichen planus.

    Science.gov (United States)

    Cruz, Aline Fernanda; de Resende, Renata Gonçalves; de Lacerda, Júlio César Tanos; Pereira, Núbia Braga; Melo, Leonardo Augusto; Diniz, Marina Gonçalves; Gomes, Carolina Cavalieri; Gomez, Ricardo Santiago

    2018-01-01

    The oral lichen planus is a chronic inflammatory disease. Although its aetiology is not well understood, the role of T lymphocytes in its inflammatory events is recognised. Identifying the epigenetic mechanisms involved in the pathogenesis of this immune-mediated condition is fundamental for understanding the inflammatory reaction that occurs in the disease. The purpose of this work was to evaluate the methylation pattern of 21 immune response-related genes in the different clinical forms of oral lichen planus. A cross-sectional study was performed to analyse the DNA methylation patterns in three distinct groups of oral lichen planus: (i) reticular/plaque lesions; (ii) erosive lesions; (iii) normal oral mucosa (control group). After DNA extraction from biopsies, the samples were submitted to digestions by methylation-sensitive and methylation-dependent enzymes and double digestion. The relative percentage of methylated DNA for each gene was provided using real-time polymerase chain reaction arrays. Hypermethylation of the STAT5A gene was observed only in the control group (59.0%). A higher hypermethylation of the ELANE gene was found in reticular/plaque lesions (72.1%) compared to the erosive lesions (50.0%). Our results show variations in the methylation profile of immune response-related genes, according to the clinical type of oral lichen planus after comparing with the normal oral mucosa. Further studies are necessary to validate these findings using gene expression analysis. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  6. Effects of Processing Parameters on the Forming Quality of C-Shaped Thermosetting Composite Laminates in Hot Diaphragm Forming Process

    Science.gov (United States)

    Bian, X. X.; Gu, Y. Z.; Sun, J.; Li, M.; Liu, W. P.; Zhang, Z. G.

    2013-10-01

    In this study, the effects of processing temperature and vacuum applying rate on the forming quality of C-shaped carbon fiber reinforced epoxy resin matrix composite laminates during hot diaphragm forming process were investigated. C-shaped prepreg preforms were produced using a home-made hot diaphragm forming equipment. The thickness variations of the preforms and the manufacturing defects after diaphragm forming process, including fiber wrinkling and voids, were evaluated to understand the forming mechanism. Furthermore, both interlaminar slipping friction and compaction behavior of the prepreg stacks were experimentally analyzed for showing the importance of the processing parameters. In addition, autoclave processing was used to cure the C-shaped preforms to investigate the changes of the defects before and after cure process. The results show that the C-shaped prepreg preforms with good forming quality can be achieved through increasing processing temperature and reducing vacuum applying rate, which obviously promote prepreg interlaminar slipping process. The process temperature and forming rate in hot diaphragm forming process strongly influence prepreg interply frictional force, and the maximum interlaminar frictional force can be taken as a key parameter for processing parameter optimization. Autoclave process is effective in eliminating voids in the preforms and can alleviate fiber wrinkles to a certain extent.

  7. Teaching Form as Form

    DEFF Research Database (Denmark)

    Keiding, Tina Bering

    2012-01-01

    understanding of form per se, or, to use an expression from this text, of form as form. This challenge can be reduced to one question: how can design teaching support students in achieving not only the ability to recognize and describe different form-related concepts in existing design (i.e. analytical...

  8. Encephalic magnetic resonance imaging in spinal clinical forms of multiple sclerosis

    International Nuclear Information System (INIS)

    Lubetzki, C.; Lyon-Caen, O.; Lhermitte, F.; Iba-Zizen, M.T.

    1988-01-01

    The diagnosis of multiple sclerosis (MS) in patients presenting with signs and symptoms of pure spinal cord involvement is always difficult. Previous studies have shown the usefulness of encephalic magnetic resonance imaging (MRI) of the brain in those cases. The aim was to evaluate the diagnosis value of brain MRI in medullar forms of MS. 3 refs

  9. 77 FR 25353 - Disqualification of a Clinical Investigator

    Science.gov (United States)

    2012-04-30

    .... * * * * * Sec. 312.70, relating to whether an investigator is eligible to receive test articles under part 312... ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also... marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon...

  10. Undercuts by Laser Shock Forming

    International Nuclear Information System (INIS)

    Wielage, Hanna; Vollertsen, Frank

    2011-01-01

    In laser shock forming TEA-CO 2 -laser induced shock waves are used to form metal foils, such as aluminum or copper. The process utilizes an initiated plasma shock wave on the target surface, which leads to a forming of the foil. A challenge in forming technologies is the manufacturing of undercuts. By conventional forming methods these special forms are not feasible. In this article, it is presented that undercuts in the micro range can be produced by laser shock deep drawing. Different drawing die diameters, drawing die depths and the material aluminum in the thicknesses 20 and 50 μm were investigated. It will be presented that smaller die diameters facilitate undercuts compared to bigger die diameters. The phenomena can be explained by Barlow's formula. Furthermore, it is shown which maximum undercut depth at different die diameters can be reached. To this end, cross-sections of the different parameter combinations are displayed.

  11. Stability of the spherical form of nuclei

    International Nuclear Information System (INIS)

    Sabry, A.A.

    1976-08-01

    An extension of the mass formula for a spherical nucleus in the drop model to include a largely deformed nucleus of different forms is investigated. It is found that although the spherical form is stable under small deformations from equilibrium, there exists for heavier nuclei another more favourable stable form, which can be approximated by two, or three touching prolate ellipsoids of revolution

  12. [Adult form of Pompe disease].

    Science.gov (United States)

    Ziółkowska-Graca, Bozena; Kania, Aleksander; Zwolińska, Grazyna; Nizankowska-Mogilnicka, Ewa

    2008-01-01

    Pompe disease (glycogen-storage disease type II) is an autosomal recessive disorder caused by a deficiency of lysosomal acid alpha-glucosidase (GAA), leading to the accumulation of glycogen in the lysosomes primarily in muscle cells. In the adult form of the disease, proximal muscle weakness is noted and muscle volume is decreased. The infantile form is usually fatal. In the adult form of the disease the prognosis is relatively good. Muscle weakness may, however, interfere with normal daily activities, and respiratory insufficiency may be associated with obstructive sleep apnea. Death usually results from respiratory failure. Effective specific treatment is not available. Enzyme replacement therapy with recombinant human GAA (rh-GAA) still remains a research area. We report the case of a 24-year-old student admitted to the Department of Pulmonary Diseases because of severe respiratory insufficiency. Clinical symptoms such as dyspnea, muscular weakness and increased daytime sleepiness had been progressing for 2 years. Clinical examination and increased blood levels of CK suggested muscle pathology. Histopathological analysis of muscle biopsy, performed under electron microscope, confirmed the presence of vacuoles containing glycogen. Specific enzymatic activity of alpha-glucosidase was analyzed confirming Pompe disease. The only effective method to treat respiratory insufficiency was bi-level positive pressure ventilation. Respiratory rehabilitation was instituted and is still continued by the patient at home. A high-protein, low-sugar diet was proposed for the patient. Because of poliglobulia low molecular weight heparin was prescribed. The patient is eligible for experimental replacement therapy with rh-GAA.

  13. Ankle foot orthosis-footwear combination tuning: an investigation into common clinical practice in the United Kingdom.

    Science.gov (United States)

    Eddison, Nicola; Chockalingam, Nachiappan; Osborne, Stephen

    2015-04-01

    Ankle foot orthoses are used to treat a wide variety of gait pathologies. Ankle foot orthosis-footwear combination tuning should be routine clinical practice when prescribing an ankle foot orthosis. Current research suggests that failure to tune ankle foot orthosis-footwear combinations can lead to immediate detrimental effect on function, and in the longer term, it may actually contribute to deterioration. The purpose of this preliminary study was to identify the current level of knowledge clinicians have in the United Kingdom regarding ankle foot orthosis-footwear combination tuning and to investigate common clinical practice regarding ankle foot orthosis-footwear combination tuning among UK orthotists. Cross-sectional survey. A prospective study employing a multi-item questionnaire was sent out to registered orthotists and uploaded on to the official website of British Association of Prosthetists and Orthotists to be accessed by their members. A total of 41 completed questionnaires were received. The results demonstrate that only 50% of participants use ankle foot orthosis-footwear combination tuning as standard clinical practice. The most prevalent factors preventing participants from carrying out ankle foot orthosis-footwear combination tuning are a lack of access to three-dimensional gait analysis equipment (37%) and a lack of time available in their clinics (27%). Although, ankle foot orthosis-footwear combination tuning has been identified as an essential aspect of the prescription of ankle foot orthoses, the results of this study show a lack of understanding of the key principles behind ankle foot orthosis-footwear combination tuning. © The International Society for Prosthetics and Orthotics 2014.

  14. [Methods of investigation in clinical cardiology. VIII. Socioeconomic evaluation of clinical cardiology practice].

    Science.gov (United States)

    Lázaro de Mercado, P

    1997-06-01

    Health services are systems whose mission is to improve the health status of both individuals and society in general. In recent decades, these systems have faced challenges such as their increasing complexity, limited resources, rapid innovation and diffusion of medical technologies, pressures on demand from society and professionals, and the lack of knowledge of the effects of these factors on costs and society's health. In addition, health care expenditures have grown twice as fast as wealth in industrialized countries during the last 25 years. These problems have prompted cost containment as a key issue in health policy and, at the same time, have promoted the development of socioeconomic evaluation as a scientific activity in the frame of health services research. Socioeconomic evaluation tries to determine if the sacrifice made by society, which devotes part of its limited resources to health care, maximizes the outcomes for population. This article describes basic concepts and methods of economic appraisal in health services which are illustrated with examples of clinical practice in cardiology. Common methods of evaluation are described; the relation between the clinical outcome of a procedure and its associated costs is emphasized in explaining the types of efficiency analysis (cost-efficacy, cost-effectiveness, cost-utility, and cost-benefit); and finally a guide for socioeconomic evaluation is provided.

  15. Clinical-epidemiologic profile of the schistosomal myeloradiculopathy in Pernambuco, Brazil

    Directory of Open Access Journals (Sweden)

    Karina Conceição GM de Araújo

    2010-07-01

    Full Text Available This was a retrospective descriptive study on a series of cases of schistosomal myeloradiculopathy (SMR and the aim was to investigate the incidence of this disease and its clinical and epidemiological characteristics in cases diagnosed at three healthcare units in Pernambuco, Brazil between 1994-2006. The data were collected by reviewing the medical records from both the neurological and paediatric outpatient clinics and wards of the Hospital Clinics, Hospital of the Restoration and Pernambuco Mother and Child Institute. To gather the data, a spinal cord schistosomiasis evaluation protocol was used. The diagnoses were based on positive epidemiological evidence of schistosomiasis, clinical findings and laboratory tests (stool parasitological examination or rectal biopsies, magnetic resonance imaging findings and cerebrospinal fluid investigations. A total of 139 cases aged between 2-83 years were found. The most important determinants of SMR were male sex (66.2%, contact with fresh water (91%, origin in endemic regions (39.5%, lower-limb muscle weakness (100%, sensory level at the lower thoracic medulla (40.3%, myeloradicular form (76% and presence of eggs in the stool parasitological examination (48%. This sample indicates the need for intervention policies guided by diagnostic standardization, thereby avoiding disease under-notification.

  16. Single point incremental forming: Formability of PC sheets

    Science.gov (United States)

    Formisano, A.; Boccarusso, L.; Carrino, L.; Lambiase, F.; Minutolo, F. Memola Capece

    2018-05-01

    Recent research on Single Point Incremental Forming of polymers has slightly covered the possibility of expanding the materials capability window of this flexible forming process beyond metals, by demonstrating the workability of thermoplastic polymers at room temperature. Given the different behaviour of polymers compared to metals, different aspects need to be deepened to better understand the behaviour of these materials when incrementally formed. Thus, the aim of the work is to investigate the formability of incrementally formed polycarbonate thin sheets. To this end, an experimental investigation at room temperature was conducted involving formability tests; varying wall angle cone and pyramid frusta were manufactured by processing polycarbonate sheets with different thicknesses and using tools with different diameters, in order to draw conclusions on the formability of polymer sheets through the evaluation of the forming angles and the observation of the failure mechanisms.

  17. CliniProteus: A flexible clinical trials information management system

    Science.gov (United States)

    Mathura, Venkatarajan S; Rangareddy, Mahendiranath; Gupta, Pankaj; Mullan, Michael

    2007-01-01

    Clinical trials involve multi-site heterogeneous data generation with complex data input-formats and forms. The data should be captured and queried in an integrated fashion to facilitate further analysis. Electronic case-report forms (eCRF) are gaining popularity since it allows capture of clinical information in a rapid manner. We have designed and developed an XML based flexible clinical trials data management framework in .NET environment that can be used for efficient design and deployment of eCRFs to efficiently collate data and analyze information from multi-site clinical trials. The main components of our system include an XML form designer, a Patient registration eForm, reusable eForms, multiple-visit data capture and consolidated reports. A unique id is used for tracking the trial, site of occurrence, the patient and the year of recruitment. Availability http://www.rfdn.org/bioinfo/CTMS/ctms.html. PMID:21670796

  18. Investigating nearby star-forming galaxies in the ultraviolet with HST/COS spectroscopy. I. Spectral analysis and interstellar abundance determinations

    International Nuclear Information System (INIS)

    James, B. L.; Aloisi, A.; Sohn, S. T.; Wolfe, M. A.; Heckman, T.

    2014-01-01

    This is the first in a series of three papers describing a project with the Cosmic Origins Spectrograph on the Hubble Space Telescope to measure abundances of the neutral interstellar medium (ISM) in a sample of nine nearby star-forming galaxies. The goal is to assess the (in)homogeneities of the multiphase ISM in galaxies where the bulk of metals can be hidden in the neutral phase, yet the metallicity is inferred from the ionized gas in the H II regions. The sample, spanning a wide range in physical properties, is to date the best suited to investigate the metallicity behavior of the neutral gas at redshift z = 0. ISM absorption lines were detected against the far-ultraviolet spectra of the brightest star-forming region(s) within each galaxy. Here we report on the observations, data reduction, and analysis of these spectra. Column densities were measured by a multicomponent line-profile fitting technique, and neutral-gas abundances were obtained for a wide range of elements. Several caveats were considered, including line saturation, ionization corrections, and dust depletion. Ionization effects were quantified with ad hoc CLOUDY models reproducing the complex photoionization structure of the ionized and neutral gas surrounding the UV-bright sources. An 'average spectrum of a redshift z = 0 star-forming galaxy' was obtained from the average column densities of unsaturated profiles of neutral-gas species. This template can be used as a powerful tool for studies of the neutral ISM at both low and high redshift.

  19. BALO’S CONCENTRIC SCLEROSIS: CLINICAL CASE ОF REMISSION

    Directory of Open Access Journals (Sweden)

    L. V. Lorina

    2017-01-01

    Full Text Available Objective. Case report of a rare form of multiple sclerosis, Balo’s concentric sclerosis (BCS.Materials and methods. 66 year old female patient L., admitted with complaints of gait disorder with tendency to fall towards the left side, left upper limb weakness and decreased memory. Neurological examination revealed left sided hemiparesis, and left sided positive Romberg’s test. Contrast brain magnetic resonance imaging (MRI was performed. Treatment was prescribed as well as dynamic follow up during the course of 1.5 years.Results. Based on complaints, clinical picture and MRI result, patient was diagnosed with an atypical form of multiple sclerosis, Balo’s concentric sclerosis. The main diagnostic method used confirm the diagnosis was contrast brain MRI: Non homogenous circular-form space occupying lesion with dimensions 3.7 × 3.4 × 3.5 cm was visualized in the supraventricular area of right parietal lobe with increased and decreased signals on T2 and T1 weighted images respectively. Following intravenous administration of contrast substance, an increased T1-WI signal is observed along the periphery of the described lesion in the right parietal lobe. MRI conclusion: brain demyelination disease with large foci in the right post-frontal lobe region, typical of Balo’s concentric sclerosis. Following the acute clinical state, cytostatic and immunomodulation therapy was prescribed. MRI dynamic observation revealed decrease in dimensions of the significantly enhanced concentric areas. Follow up demonstrated marked remission.Conclusion. This clinical case is of interest due to the rarity of this disease. The basis of diagnosis in our study was MRI investigation which allows for in vivo diagnosis of this pathology. These observations confirm the fact that timely use of modern methods of treatment can achieve not only stabilization of the patients’ state, but also positive clinical and MRI dynamics.

  20. Symptomatology, Clinical Presentation and Basic Work up in Patients with Suspected Pulmonary Embolism

    DEFF Research Database (Denmark)

    Madsen, Poul Henning; Hess, Søren

    2017-01-01

    Basic knowledge of pulmonary embolism is relevant to most practicing physicians. Many medical specialties care for patients with increased risk of pulmonary embolism, why recognition of relevant symptoms, a thorough medical history, assessment of the clinical condition of the patient and possibly......-ray and biochemical analyses are appropriate. In addition, lung ultrasound and echocardiography are indicated in many of these patients. The information available from the medical history, clinical assessment and basic investigation form the basis on which the decision about further diagnostic imaging and intensity...... of treatment and monitoring can be made. These decisions can be guided by clinical scoring systems like the Wells score, revised Geneva score and the PESI....

  1. How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study

    NARCIS (Netherlands)

    Berger, M; Kooyman, P.J.; Makkee, M.; van der Zee, J.S.; Sterk, P. J.; van Dijk, J.; Kemper, E. M.

    2016-01-01

    Background: Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper

  2. New developments in tribomechanical modeling of automotive sheet steel forming

    Science.gov (United States)

    Khandeparkar, Tushar; Chezan, Toni; van Beeck, Jeroen

    2018-05-01

    Forming of automotive sheet metal body panels is a complex process influenced by both the material properties and contact conditions in the forming tooling. Material properties are described by the material constitutive behavior and the material flow into the forming die can be described by the tribological system. This paper investigates the prediction accuracy of the forming process using the Tata Steel state of the art description of the material constitutive behavior in combination with different friction models. A cross-die experiment is used to investigate the accuracy of local deformation modes typically seen in automotive sheet metal forming operations. Results of advanced friction models as well as the classical Coulomb friction description are compared to the experimentally measured strain distribution and material draw-in. Two hot-dip galvanized coated steel forming grades were used for the investigations. The results show that the accuracy of the simulation is not guaranteed by the advanced friction models for the entire investigated blank holder force range, both globally and locally. A measurable difference between the calculated and measured local strains is seen for both studied models even in the case where the global indicator, i.e. the draw-in, is well predicted.

  3. Non-inflammatory destructive periodontal disease: a clinical, microbiological, immunological and genetic investigation

    Directory of Open Access Journals (Sweden)

    Carlos Eduardo Repeke

    2012-02-01

    Full Text Available Periodontitis comprises a group of multifactorial diseases in which periodontopathogens accumulate in dental plaque and trigger host chronic inflammatory and immune responses against periodontal structures, which are determinant to the disease outcome. Although unusual cases of non-inflammatory destructive periodontal disease (NIDPD are described, their pathogenesis remains unknown. A unique NIDPD case was investigated by clinical, microbiological, immunological and genetic tools. The patient, a non-smoking dental surgeon with excessive oral hygiene practice, presented a generalized bone resorption and tooth mobility, but not gingival inflammation or occlusion problems. No hematological, immunological or endocrine alterations were found. No periodontopathogens (A. actinomycetemcomitans, P. gingivalis, F. nucleatum and T. denticola or viruses (HCMV, EBV-1 and HSV-1 were detected, along with levels of IL-1β and TNF-a in GCF compatible with healthy tissues. Conversely ALP, ACP and RANKL GCF levels were similar to diseased periodontal sites. Genetic investigation demonstrated that the patient carried some SNPs, as well HLA-DR4 (*0404 and HLA-B27 alleles, considered risk factors for bone loss. Then, a less vigorous and diminished frequency of toothbrushing was recommended to the patient, resulting in the arrest of alveolar bone loss, associated with the return of ALP, ACP and RANKL in GCF to normality levels. In conclusion, the unusual case presented here is compatible with the previous description of NIDPD, and the results that a possible combination of excessive force and frequency of mechanical stimulation with a potentially bone loss prone genotype could result in the alveolar bone loss seen in NIDPD.

  4. Commentary: considerations for using the 'Trials within Cohorts' design in a clinical trial of an investigational medicinal product.

    Science.gov (United States)

    Bibby, Anna C; Torgerson, David J; Leach, Samantha; Lewis-White, Helen; Maskell, Nick A

    2018-01-08

    The 'trials within cohorts' (TwiC) design is a pragmatic approach to randomised trials in which trial participants are randomly selected from an existing cohort. The design has multiple potential benefits, including the option of conducting multiple trials within the same cohort. To date, the TwiC design methodology been used in numerous clinical settings but has never been applied to a clinical trial of an investigational medicinal product (CTIMP). We have recently secured the necessary approvals to undertake the first CTIMP using the TwiC design. In this paper, we describe some of the considerations and modifications required to ensure such a trial is compliant with Good Clinical Practice and international clinical trials regulations. We advocate using a two-stage consent process and using the consent stages to explicitly differentiate between trial participants and cohort participants who are providing control data. This distinction ensured compliance but had consequences with respect to costings, recruitment and the trial assessment schedule. We have demonstrated that it is possible to secure ethical and regulatory approval for a CTIMP TwiC. By including certain considerations at the trial design stage, we believe this pragmatic and efficient methodology could be utilised in other CTIMPs in future.

  5. Metrical results on systems of small linear forms

    DEFF Research Database (Denmark)

    Hussain, M.; Kristensen, Simon

    In this paper the metric theory of Diophantine approximation associated with the small linear forms is investigated. Khintchine--Groshev theorems are established along with Hausdorff measure generalization without the monotonic assumption on the approximating function.......In this paper the metric theory of Diophantine approximation associated with the small linear forms is investigated. Khintchine--Groshev theorems are established along with Hausdorff measure generalization without the monotonic assumption on the approximating function....

  6. Tuberculosis and parenteral viral hepatitides: incidence of mixed forms

    Directory of Open Access Journals (Sweden)

    A. A. Asratyan

    2014-01-01

    Full Text Available Objective: to estimate the frequency of parenteral viral hepatitides (HB and HC (PVH in patients with tuberculosis in Moscow in relation to data on their incidence in the aggregate population of the capital.Materials and methods. The authors analyzed the incidence of (acute, chronic HB and HC (carriage and tuberculosis in Moscow in 2009. A total of 24,220 cards for infectious patients (No. 089/y and federal statistical follow-up forms (No. 2 were first processed to compare and search for personal data among the patients with tuberculosis and all forms of PVH and to establish the evidence of PVH and tuberculosis comorbidity.Results. The infection of tuberculosis patients with parenteral hepatitis B and C viruses was ascertained to be 5.5 to 284.9 times higher (in relation to the form of a hepatitis course than that in the aggregation population of Moscow, which suggests that PVH is of high significance for the tuberculosis patients and that it is necessary to improve a PVH prevention program among this cohort patients. Analysis of the sex-age structure shows that male tuberculosis patients in the 20-39-year-old group should be considered to be a special risk group that should attract special attention when implementing preventive measures. The tuberculosis mortality rate among mixed infected patients was 1.8-fold higher than among those who had PVH-uncomplicated tuberculosis.Conclusion. The results of the investigations are suggestive of the evidence of PVH and tuberculosis comorbidity. The mixed forms of these infections in different combinations have been established to be accompanied by their severer clinical course and high death rates. 

  7. Pediatric scleroderma: systemic or localized forms.

    Science.gov (United States)

    Torok, Kathryn S

    2012-04-01

    Pediatric scleroderma includes 2 major groups of clinical entities, systemic sclerosis (SSc) and localized scleroderma (LS). Although both share a common pathophysiology, their clinical manifestations differ. LS is typically confined to the skin and underlying subcutis, with up to a quarter of patients showing extracutaneous disease manifestations such as arthritis and uveitis. Vascular, cutaneous, gastrointestinal, pulmonary, and musculoskeletal involvement are most commonly seen in children with SSc. Treatment of both forms targets the active inflammatory stage and halts disease progression; however, progress needs to be made toward the development of more effective antifibrotic therapy to help reverse disease damage. Copyright © 2012 Elsevier Inc. All rights reserved.

  8. Waste form development

    International Nuclear Information System (INIS)

    Neilson, R.M. Jr.; Colombo, P.

    1982-01-01

    In this program, contemporary solidification agents are being investigated relative to their applications to major fuel cycle and non-fuel cycle low-level waste (LLW) streams. Work is being conducted to determine the range of conditions under which these solidification agents can be applied to specific LLW streams. These studies are directed primarily towards defining operating parameters for both improved solidification of problem wastes and solidification of new LLW streams generated from advanced volume reduction technologies. Work is being conducted to measure relevant waste form properties. These data will be compiled and evaluated to demonstrate compliance with waste form performance and shallow land burial acceptance criteria and transportation requirements (both as they exist and as they are modified with time). 6 tables

  9. Terra firma-forme dermatosis: a retrospective review of 31 patients.

    Science.gov (United States)

    Berk, David R

    2012-01-01

    Terra firma-forme dermatosis is an idiopathic condition characterized by acquired, dirtlike plaques despite normal hygiene. A diagnosis can be reached by removing lesions with gentle alcohol swabbing. Although Terra firma-forme dermatosis was first described more than 20 years ago and is thought to be not uncommon in clinical practice, it has never been systematically studied. There are few publications about this condition, including no case series of more than six patients. In particular, little is known about the incidence, peak age groups, and most common locations of Terra firma-forme dermatosis. A retrospective review was conducted to identify cases of Terra firma-forme dermatosis in a single-provider practice consisting of 55% pediatric and 45% adult patients. Thirty-one patients with Terra firma-forme dermatosis were identified, including 10 who presented with Terra firma-forme dermatosis as their primary concern. Only two patients were older than 17 years. The median duration of lesions was 4 months. The most common lesion locations were the neck, ankles, and face. Before presenting to the dermatology clinic, three patients had undergone endocrine evaluations, and four had been prescribed topical corticosteroids. Terra firma-forme dermatosis is relatively common and most often occurs in children on the neck or posterior malleolus. This series exemplifies the importance of recognizing Terra firma-forme dermatosis so as to provide rapid relief for patients and avoid unnecessary tests and treatments. © 2011 Wiley Periodicals, Inc.

  10. The role of Clinical Trial Units in investigator- and industry-initiated research projects.

    Science.gov (United States)

    von Niederhäusern, Belinda; Fabbro, Thomas; Pauli-Magnus, Christiane

    2015-01-01

    Six multidisciplinary competence centres (Clinical Trial Units, CTUs) in Basel, Berne, Geneva, Lausanne, St. Gallen and Zurich provide professional support to clinical researchers in the planning, implementation, conduct and evaluation of clinical studies. Through their coordinated network, these units promote high-quality, nationally harmonised and internationally standardised clinical research conduct in Switzerland. We will describe why this network has been established, how it has been successful in stilling the growing need for clinical research support, which training and education opportunities it offers, and how it created national awareness for the still-existing hurdles towards clinical research excellence in Switzerland. Taking the CTU Basel as an example, we show that a considerable number (25%) of the studies submitted for regulatory approval in 2013 were supported by the CTU, decreasing the number of findings in ethics reviews by about one-third. We conclude that these achievements, together with a Swiss national funding model for clinical research, and improved national coordination, will be critical factors to successfully position Swiss clinical research at the international forefront.

  11. Investigating microbial colonization in actively forming hydrothermal deposits using thermocouple arrays

    Science.gov (United States)

    Tivey, M. K.; Reysenbach, A. L.; Hirsch, M.; Steinberg, J.; Flores, G. E.

    2010-12-01

    Investigations of microbial colonization of very young hydrothermal deposits were carried out in 2009 at hydrothermal vents in the Lau Basin (SW Pacific), and in Guaymas Basin, Gulf of California, with a test deployment at the Rainbow vent field on the Mid-Atlantic Ridge in 2008. Our method entailed razing active chimneys and placing arrays of temperature probes (8 titanium-encased probes with their tips placed within a titanium cage) over the active flow. The chimneys that grew back through each array, encasing the temperature probe tips, were recovered after 2 to 15 days, along with temperature records. Molecular phylogenetic methods are being used to reveal the members of the microbial communities that developed in each chimney of known age and thermal history. A total of 15 array deployments were made at 10 vents in 6 different vent fields. Similar morphology beehives (with porous fine-grained interiors and steep temperature gradients across the outermost more-consolidated “wall”) formed at 2 of the 3 vents in Guaymas Basin (in 2 and 5 days at one vent and 3 and 15 days at a second), and at one vent each in the Kilo Moana (in 3 days), Tahi Moana (in 2.5 days), and Tui Malila (in 3 and 8 days) vent fields in the Lau Basin. In contrast, open conduit, thin walled chimneys grew within arrays at the Mariner vent field, Lau Basin, at 3 different vents (in 3 days at one vent, in 3 and 11 days at a second vent, and in 13 days at a third vent). A lower temperature (Archaea showed very little change in diversity over time, with members of the genera Thermococcus and Methanocaldococcus present in all samples analyzed, irrespective of location and timing of sampling. This is very different from a 72-hour test array deployment done in 2008 at Rainbow vent field, where the deposited soft material was colonized only by the sulfate-reducing archaeum, Archaeoglobus. These samples (8 beehives, 4 open conduit smokers, one diffuser spire, from chimneys of known composition

  12. How to achieve safe, high-quality clinical studies with non-Medicinal Investigational Products? A practical guideline by using intra-bronchial carbon nanoparticles as case study

    NARCIS (Netherlands)

    Berger, M.; Kooyman, P. J.; Makkee, M.; van der Zee, J. S.; Sterk, P. J.; van Dijk, J.; Kemper, E. M.

    2016-01-01

    Clinical studies investigating medicinal products need to comply with laws concerning good clinical practice (GCP) and good manufacturing practice (GMP) to guarantee the quality and safety of the product, to protect the health of the participating individual and to assure proper performance of the

  13. Evidence-based clinical practice

    DEFF Research Database (Denmark)

    Gluud, Christian

    2002-01-01

    , and single clinics. Accordingly, there is an urgent need to improve this situation. Guidelines for Good Clinical (Research) Practice, conduct of more trials as multicentre trials, The Consort Statement, and The Cochrane Collaboration may all help in the application of the best research evidence in clinical......Evidence-based medicine combines the patient's preferences with clinical experience and the best research evidence. Randomized clinical trials are considered the most valid research design for evaluating health-care interventions. However, empirical research shows that intervention effects may...... practice. By investments in education, applied research, and The Cochrane Collaboration, evidence-based medicine may form a stronger basis for clinical practice....

  14. Emerging biomarkers in anaplastic oligodendroglioma: implications for clinical investigation and patient management.

    Science.gov (United States)

    Sahebjam, Solmaz; McNamara, Mairéad G; Mason, Warren P

    2013-07-01

    Oligodendrogliomas are heterogeneous tumors with a variable response to treatment. This clinical variability underlines the urgent need for markers that can reliably aid diagnosis and guide clinical decision-making. Long-term follow-up data from the EORTC 26951 and RTOG 9402 clinical trials in newly diagnosed anaplastic oligodendroglioma have established chromosome 1p19q codeletion as a predictive marker of response to procarbazine, lomustine and vincristine chemotherapy in anaplastic oligodendrogliomas. In addition, MGMT promoter hypermethylation has been strongly associated with glioma CpG island hypermethylation phenotype (G-CIMP+) status, this has been suggested as an epiphenomenon of genome-wide methylation, conferring a more favorable prognosis. Molecular profiling of these tumors has identified several other markers with potential clinical significance: mutations of IDH, CIC, FUBP1 and CDKN2A require further validation before they can be implemented as clinical decision-making tools. Additionally, recent data on the clinical significance of intrinsic glioma subtyping appears promising. Indeed, existing evidence suggests that comprehensive analyses such as intrinsic glioma subtyping or G-CIMP status are superior to single molecular markers. Clearly, with evolving treatment strategies and in the era of individualized therapy, broader omics-based molecular evaluations are required to improve outcome prediction and to identify patients who will benefit from specific treatment strategies.

  15. A standard form for generalized CP transformations

    International Nuclear Information System (INIS)

    Ecker, G.; Grimus, W.; Neufeld, H.

    1987-01-01

    The investigation of general CP transformations leads to transformations of the form U → W T UW with unitary matrices U, W. It is shown that a basis for weak eigenstates can always be chosen such that W T UW has a certain real standard form. (Author)

  16. Evaluation of tularemia cases focusing on the oculoglandular form.

    Science.gov (United States)

    Eren Gok, Sebnem; Kocagul Celikbas, Aysel; Baykam, Nurcan; Atay Buyukdemirci, Ayse; Eroglu, Mustafa Necati; Evren Kemer, Ozlem; Dokuzoguz, Basak

    2014-10-15

    Tularemia is a zoonotic disease caused by Francisella tularensis. The oculoglandular form is one of the rarest forms. In this study, evaluated tularemia patients, focusing on the ocular form and the efficacy of early antibiotic therapy. During a tularemia outbreak, the epidemiological and clinical findings, laboratory assays, and drugs used for the treatment of 48 patients were recorded prospectively. The diagnosis of tularemia was confirmed with microagglutination test (MAT) as well as clinical findings. The mean age of the subject was 48.6 years; 23 (47.9%) of them were female. Thirty-six (81.25%) patients had clinical presentation compatible with oropharyngeal tularemia, seven (14.58%) with oculoglandular tularemia, and two (4.1%) with ulceroglandular tularemia. The most common symptoms were fever (91.6%) and sore throat (81.2%), and the most common findings were lymphadenopathy (91.6%) and tonsillopharyngitis (81.2%). In the oculoglandular form, fever, lymphadenopathy, periorbital edema, conjunctival injection, and chemosis were found. The most distinctive ophthalmic feature was follicular conjunctivitis and conjunctival epithelial defects. Forty-five cases had positive serological results with MAT. All the patients were treated with antibiotics considered effective against F. tularensis, and topical antimicrobial treatment was given to the patients with oculoglandular tularemia. Twenty-six (54.16%) patients, who were admitted within three weeks of the onset of symptoms, recovered without sequel. During tularemia outbreaks, ocular involvement should be considered carefully. The early administration of appropriate treatment will be more effective in resolving the infection and preventing complications. Along with systemic antibiotic therapy, topical treatment will help recovery.

  17. Investigating the role of Clinical Nurse Consultants in one health district from multiple stakeholder perspectives: a cooperative inquiry.

    Science.gov (United States)

    Walsh, Kenneth; Bothe, Janine; Edgar, Denise; Beaven, Geraldine; Burgess, Bernadette; Dickson, Vhari; Dunn, Stephen; Horning, Lynda; Jensen, Janice; Kandl, Bronia; Nonu, Miriam; Owen, Fran; Moss, Cheryle

    2015-01-01

    The impetus for this research came from a group of 11 Clinical Nurse Consultants (CNCs) within a health service in NSW, Australia, who wanted to investigate the CNC role from multiple stakeholder perspectives. With support from academic researchers, the CNCs designed and implemented the study. The aim of this research project was to investigate the role of the CNC from the multiple perspectives of CNCs and other stakeholders who work with CNCs in the Health District. This was a co-operative inquiry that utilised qualitative descriptive research approach. Co-operative inquiry methods enabled 11 CNCs to work as co-researchers and to conduct the investigation. The co-researchers implemented a qualitative descriptive design for the research and used interviews (7) and focus groups (16) with CNC stakeholders (n = 103) to gather sufficient data to investigate the role of the CNC in the organisation. Thematic analysis was undertaken to obtain the results. The CNC role is invaluable to all stakeholders and it was seen as the "glue" which holds teams together. Stakeholder expectations of the CNC role were multiple and generally agreed. Five themes derived from the data are reported as "clinical leadership as core", "making a direct difference to patient care", "service development as an outcome", "role breadth or narrowness and boundaries", and "career development". There was clear appreciation of the work that CNCs do in their roles, and the part that the CNC role plays in achieving quality health outcomes. The role of the CNC is complex and the CNCs themselves often negotiate these complexities to ensure beneficial outcomes for the patient and organisation. For the wider audience this study has given further insights into the role of these nurses and the perspectives of those with whom they work.

  18. Clinical Trials

    Medline Plus

    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  19. Elucidation of salvage laryngectomy pathologic and clinical variables to guide further treatment intensification investigation.

    Science.gov (United States)

    Scharpf, Joseph; Ward, Matthew; Adelstein, David; Koyfman, Shlomo; Li, Mingsi

    2018-04-01

    There are limited treatment options beyond surgical salvage for patients who fail nonoperative treatment for laryngeal squamous cell carcinoma. In this study, we examine the failure patterns after surgical salvage and the potential pathologic and clinical prognostic variables that might guide further postoperative intensification investigation. Retrospective analysis at a tertiary academic referral center. From an institutional review board-approved institutional head and neck cancer registry, a consecutive series of 147 patients who underwent salvage laryngectomy for squamous cell cancer recurrence or persistence after radiotherapy with or without chemotherapy between May 1995 and May 2016 were identified. Variables potentially associated with oncologic outcome after surgical salvage were then collected and retrospectively evaluated. The projected 2-year locoregional failure rate was 21.8% (95% confidence interval [CI], 14.6%-29.0%]), and the overall survival 65% (95% CI, 57.5%-74.3%) for the entire cohort after salvage laryngectomy. On multivariable analysis, sarcomatoid/spindle cell pathology (hazard ratio [HR], 3.147; 95% CI, 1.181-8.386; P = 0.022), lymphovascular space invasion (LVSI) (positive vs. negative; HR, 2.31; 95% CI, 1.21-4.42; P = 0.011), and advanced initial American Joint Committee on Cancer 7th Edition grouped stage (stages III-IVB vs. stages I-II; HR, 1.64; 95% CI, 1.04-2.6; P = 0.035) were found to be independently associated with inferior disease-free survival. No other clinical or pathologic variables predicted failure. Salvage laryngectomy after nonoperative treatment failure results in successful locoregional control rates and survival in the majority of patients failing initial therapy. This should temper enthusiasm for routine treatment intensification with postoperative re-irradiation and/or other systemic treatments for the vast majority of patients. Sarcomatoid pathology, LVSI, and an advanced initial stage are associated with inferior

  20. CLINICAL FEATURES OF REFRACTORY FORMS OF ANEMIA IN CHILDREN WITH CHRONIC HEPATITIS В

    Directory of Open Access Journals (Sweden)

    F. I. Inoyаtova

    2013-01-01

    Full Text Available Examination of 125 children with chronic hepatitis В and concomitant anemia has determined the frequency of refractory forms of anemia (52,5%. The disease progressed more severely on the background of anemia, which was indicated by the prevalence of CHВ forms with severe activity (71,4%. The pathognomonic symptoms of anemic processes were revealed. Two pathogenetic variants of the anemia genesis in children with CHВ are being considered: the first is defined by veritable iron deficiency with ferrokinetic markers of iron-deficiency anemia; the second — by relocationable iron deficit that is typical for hemosiderosis and refractoriness development.

  1. [The clinical and microbiological characteristics of oropharyngeal candidiasis in the HIV-infected patients at the late stages of the disease].

    Science.gov (United States)

    Charushin, A O; Elovikov, A M; Charushina, I P; Vorob'eva, N N; Katretskaya, G G

    Oropharyngeal candidiasis in 512 HIV-infected patients at the late stages of the disease was studied with special reference to the clinical and microbiological characteristics of this condition. The diagnosis was established based on the results of the clinical and microbiological examination of the patients including investigation of the tissue samples taken from the oral cavity and the throat with the use of the device specially developed for this purpose. It was shown that the disease existed in various clinical forms the most common of which were monocomponent pathology represented by pseudomembranous candidiasis in 37.5±2.14% of the patients, the two-component mixed form (pseudomembranous candidiasis with concomitant angular chelitis) diagnosed in 27.5±1.97% cases, and the ternary form (the combination of pseudomembranous candidiasis, acute atrophic process, and angular chelitis) documented in 11.9±1.43% patients. The main clinical features of the disease included the combination of its various forms, multiple localization of the pathological process, and its polymorphous manifestations. Changes in the clinical course of oropharyngeal candidiasis associated with the progression of HIV from the 4A to the 4B stage were detected for the first time. They were shown to be accompanied by variations in the species composition and concentration of fungal flora in the crypts of the palatine tonsils and its sensitivity to fluconazole therapy.

  2. Nonlinear dynamics exploration through normal forms

    CERN Document Server

    Kahn, Peter B

    2014-01-01

    Geared toward advanced undergraduates and graduate students, this exposition covers the method of normal forms and its application to ordinary differential equations through perturbation analysis. In addition to its emphasis on the freedom inherent in the normal form expansion, the text features numerous examples of equations, the kind of which are encountered in many areas of science and engineering. The treatment begins with an introduction to the basic concepts underlying the normal forms. Coverage then shifts to an investigation of systems with one degree of freedom that model oscillations

  3. Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT).

    Science.gov (United States)

    Durant, Raegan W; Wenzel, Jennifer A; Scarinci, Isabel C; Paterniti, Debora A; Fouad, Mona N; Hurd, Thelma C; Martin, Michelle Y

    2014-04-01

    The study of disparities in minority recruitment to cancer clinical trials has focused primarily on inquiries among minority populations. Yet very little is known about the perceptions of individuals actively involved in minority recruitment to clinical trials within cancer centers. Therefore, the authors assessed the perspectives of cancer center clinical and research personnel on barriers and facilitators to minority recruitment. In total, 91 qualitative interviews were conducted at 5 US cancer centers among 4 stakeholder groups: cancer center leaders, principal investigators, research staff, and referring clinicians. All interviews were recorded and transcribed. Qualitative analyses of response data was focused on identifying prominent themes related to barriers and facilitators to minority recruitment. The perspectives of the 4 stakeholder groups were largely overlapping with some variations based on their unique roles in minority recruitment. Four prominent themes were identified: 1) racial and ethnic minorities are influenced by varying degrees of skepticism related to trial participation, 2) potential minority participants often face multilevel barriers that preclude them from being offered an opportunity to participate in a clinical trial, 3) facilitators at both the institutional and participant level potentially encourage minority recruitment, and 4) variation between internal and external trial referral procedures may limit clinical trial opportunities for racial and ethnic minorities. Multilevel approaches are needed to address barriers and optimize facilitators within cancer centers to enhance minority recruitment for cancer clinical trials. © 2014 American Cancer Society.

  4. Quality assurance in ultrasound screening for hepatocellular carcinoma using a standardized phantom and standard clinical images: a 3-year national investigation in Korea.

    Science.gov (United States)

    Choi, Joon-Il; Jung, Seung Eun; Kim, Pyo Nyun; Cha, Sang Hoon; Jun, Jae Kwan; Lee, Hoo-Yeon; Park, Eun-Cheol

    2014-06-01

    The purpose of this study was to investigate the quality of ultrasound (US) imaging for hepatocellular carcinoma screening. The investigation was performed at all medical institutes participating in the National Cancer Screening Program in Korea. For assessment of personnel, we inquired who was performing the US screenings. For phantom image evaluation, the dead zone, vertical and horizontal measurements, axial and lateral resolution, sensitivity, and gray scale/dynamic range were evaluated. For clinical image evaluation, US images of patients were evaluated in terms of the standard images, technical information, overall image quality, appropriateness of depth, foci, annotations, and the presence of any artifacts. Failure rates for phantom and clinical image evaluations at general hospitals, smaller hospitals, and private clinics were 20.9%, 24.5%, 24.1% and 5.5%, and 14.8% and 9.5%, respectively. No statistically significant difference was observed in the failure rates for the phantom images among groups of different years of manufacture. For the clinical image evaluation, the results of radiologists were significantly better than those of other professional groups (P = .0001 and .0004 versus nonradiology physicians and nonphysicians, respectively). The failure rate was also higher when the storage format was analog versus digital (P quality of the clinical images obtained by radiologists was the best. © 2014 by the American Institute of Ultrasound in Medicine.

  5. The prevalence of neovascularity in patients clinically diagnosed with rotator cuff tendinopathy

    Directory of Open Access Journals (Sweden)

    Raza Syed A

    2009-12-01

    Full Text Available Abstract Background Shoulder dysfunction is common and pathology of the rotator cuff tendons and subacromial bursa are considered to be a major cause of pain and morbidity. Although many hypotheses exist there is no definitive understanding as to the origin of the pain arising from these structures. Research investigations from other tendons have placed intra-tendinous neovascularity as a potential mechanism of pain production. The prevalence of neovascularity in patients with a clinical diagnosis of rotator cuff tendinopathy is unknown. As such the primary aim of this pilot study was to investigate if neovascularity could be identified and to determine the prevalence of neovascularity in the rotator cuff tendons and subacromial bursa in subjects with unilateral shoulder pain clinically assessed to be rotator cuff tendinopathy. The secondary aims were to investigate the association between the presence of neovascularity and pain, duration of symptoms, and, neovascularity and shoulder function. Methods Patients with a clinical diagnosis of unilateral rotator cuff tendinopathy referred for a routine diagnostic ultrasound (US scan in a major London teaching hospital formed the study population. At referral patients were provided with an information document. On the day of the scan (on average, at least one week later the patients agreeing to participate were taken through the consent process and underwent an additional clinical examination prior to undergoing a bilateral grey scale and colour Doppler US examination (symptomatic and asymptomatic shoulder using a Philips HDI 5000 Sono CT US machine. The ultrasound scans were performed by one of two radiologists who recorded their findings and the final assessment was made by a third radiologist blinded both to the clinical examination and the ultrasound examination. The findings of the radiologists who performed the scans and the blinded radiologist were compared and any disagreements were resolved

  6. Theory of Single Point Incremental Forming

    DEFF Research Database (Denmark)

    Martins, P.A.F.; Bay, Niels; Skjødt, Martin

    2008-01-01

    This paper presents a closed-form theoretical analysis modelling the fundamentals of single point incremental forming and explaining the experimental and numerical results available in the literature for the past couple of years. The model is based on membrane analysis with bi-directional in-plan......-plane contact friction and is focused on the extreme modes of deformation that are likely to be found in single point incremental forming processes. The overall investigation is supported by experimental work performed by the authors and data retrieved from the literature.......This paper presents a closed-form theoretical analysis modelling the fundamentals of single point incremental forming and explaining the experimental and numerical results available in the literature for the past couple of years. The model is based on membrane analysis with bi-directional in...

  7. On the connection between Schroedinger- and Dirichlet forms

    International Nuclear Information System (INIS)

    Albeverio, S.; Bochum Univ.; Gesztesy, F.; Karwowski, W.; Streit, L.; Bielefeld Univ.

    Relations between Schroedinger forms associated with Schroedinger operators in L 2 (Ω;dsup(n)x), Ω is contained in Rsup(n) open, n >= 1 and the corresponding Dirichlet forms are investigated. Various concrete examples are presented. (orig.)

  8. Longitudinal investigation of the relationship between family history of psychosis and affective disorders and Child Behavior Checklist ratings in clinical high-risk adolescents.

    Science.gov (United States)

    Simeonova, Diana I; Lee, Frances J; Walker, Elaine F

    2015-08-01

    This is the first study to investigate whether positive family history (FH) of psychosis and affective disorders moderates the relationship between child diagnostic status and parent-reported social and behavioral problems on the Child Behavior Checklist (CBCL) in clinical high-risk adolescents. This longitudinal investigation assessed 122 participants (mean age=14.25±1.8years) from three groups (at-risk, other personality disorders, non-psychiatric controls) at baseline and one year follow-up. As predicted, there was a main effect of FH for a number of CBCL scales indicating higher scores for adolescents with positive FH. The findings also demonstrate a significant Diagnostic Status×Family History interaction for several behavioral scales providing support for FH as a concurrent and longitudinal moderator of the relationship between diagnostic status and CBCL scales. The moderating effect is present for areas of functioning associated with depression, anxiety, social adjustment, thought problems, attention problems, and aggressive behavior. The findings also indicate that both positive and negative symptoms are related to the genetic vulnerability for developing psychosis in clinical high-risk individuals, particularly those symptoms reflective of emotional, attentional, and interpersonal functioning. The present findings are novel and have significant clinical and research implications. This investigation provides a platform for future studies to clarify further the role of FH in clinical high-risk individuals and contributes to integration of this knowledge in the development of early intervention and prevention approaches in at-risk populations for the emergence of severe mental illness. Copyright © 2015 Elsevier B.V. All rights reserved.

  9. Investigations with FDG-PET Scanning in Prostate Cancer Show Limited Value for Clinical Practice

    Energy Technology Data Exchange (ETDEWEB)

    Salminen, Eeva [Univ. of Turku (Finland). Department of Oncology and Radiotherapy; Hogg, Annette; Binns, David; Hicks, Rodney [The Peter MacCallum Cancer Institute, East Melbourne, Vic (Australia). Dept. of Diagnostic Imaging; Frydenberg, Mark [Monash Medical Centre, Clayton, Vic (Australia)

    2002-09-01

    The aim of this study was to investigate FDG-PET (fluorodeoxyglucose positron emission tomography) imaging in the management of prostate cancer. Twenty-two patients were studied during different disease phases of prostate cancer, for staging or restaging to clarify specific clinical questions. FDG-PET was performed encompassing the thorax, abdomen and pelvis using the Penn PET 300H scanner. Scanning was begun 60 min after {sup 18}F fluorodeoxyglucose marker. Patients were catheterized and administered diuretics to minimize urinary activity. Information obtained with FDG-PET was concordant with findings from other investigations in 7/22 (32%) patients, discordant in 15/22 (68%) patients and equivalent in one patient (4%). PET indicated progressive disease in five patients with prostate-specific antigen (PSA) <4 ng/L. The impact on management of the patients was high in 46% of cases, low in 41% and for 14% there was no impact on management. The accuracy of FDG-PET was 72% (95% CI 50-89) as confirmed by invasive diagnostics/follow-up. FDG-PET can provide useful information and improve the clinician's decision on further management procedures in selected patients with low PSA and bone or lymph node changes. A negative PET scan in prostate cancer should be interpreted with caution.

  10. Positive Discrimination in Education: A Comparative Investigation of Its Bases, Forms, and Outcomes.

    Science.gov (United States)

    Wang, Bee-Lan Chan

    1983-01-01

    Explores some basic theoretical questions pertaining to positive discrimination in education, drawing from empirical experiences of several countries that have practiced it in one form or another--the United States, India, Malaysia, and Sri Lanka. Encompasses policies and practices that have variously been called reverse discrimination,…

  11. Phase separation of in situ forming poly (lactide-co-glycolide acid) implants investigated using a hydrogel-based subcutaneous tissue surrogate and UV-vis imaging.

    Science.gov (United States)

    Sun, Yu; Jensen, Henrik; Petersen, Nickolaj J; Larsen, Susan W; Østergaard, Jesper

    2017-10-25

    Phase separation of in situ forming poly (lactide-co-glycolide acid) (PLGA) implants with agarose hydrogels as the provider of nonsolvent (water) mimicking subcutaneous tissue was investigated using a novel UV-vis imaging-based analytical platform. In situ forming implants of PLGA-1-methyl-2-pyrrolidinone and PLGA-triacetin representing fast and slow phase separating systems, respectively, were evaluated using this platform. Upon contact with the agarose hydrogel, the phase separation of the systems was followed by the study of changes in light transmission and absorbance as a function of time and position. For the PLGA-1-methyl-2-pyrrolidinone system, the rate of spatial phase separation was determined and found to decrease with increasing the PLGA concentration from 20% to 40% (w/w). Hydrogels with different agarose concentrations (1% and 10% (w/v)) were prepared for providing the nonsolvent, water, to the in situ forming PLGA implants simulating the injection site environment. The resulting implant morphology depended on the stiffness of hydrogel matrix, indicating that the matrix in which implants are formed is of importance. Overall, the work showed that the UV-vis imaging-based platform with an agarose hydrogel mimicking the subcutaneous tissue holds potential in providing bio-relevant and mechanistic information on the phase separation processes of in situ forming implants. Copyright © 2017 Elsevier B.V. All rights reserved.

  12. A clinical investigation of force delivery systems for orthodontic space closure.

    Science.gov (United States)

    Nightingale, C; Jones, S P

    2003-09-01

    To investigate the force retention, and rates of space closure achieved by elastomeric chain and nickel titanium coil springs. Randomized clinical trial. Eastman Dental Hospital, London and Queen Mary's University Hospital, Roehampton, 1998-2000. Twenty-two orthodontic patients, wearing the pre-adjusted edgewise appliance undergoing space closure in opposing quadrants, using sliding mechanics on 0.019 x 0.025-inch posted stainless steel archwires. Medium-spaced elastomeric chain [Durachain, OrthoCare (UK) Ltd., Bradford, UK] and 9-mm nickel titanium coil springs [OrthoCare (UK) Ltd.] were placed in opposing quadrants for 15 patients. Elastomeric chain only was used in a further seven patients. The initial forces on placement and residual forces at the subsequent visit were measured with a dial push-pull gauge [Orthocare (UK) Ltd]. Study models of eight patients were taken before and after space closure, from which measurements were made to establish mean space closure. The forces were measured in grammes and space closure in millimetres. Fifty-nine per cent (31/53) of the elastomeric sample maintained at least 50 per cent of the initial force over a time period of 1-15 weeks. No sample lost all its force, and the mean loss was 47 per cent (range: 0-76 per cent). Nickel titanium coil springs lost force rapidly over 6 weeks, following that force levels plateaued. Forty-six per cent (12/26) maintained at least 50 per cent of their initial force over a time period of 1-22 weeks, and mean force loss was 48 per cent (range: 12-68 per cent). The rate of mean weekly space closure for elastomeric chain was 0.21 mm and for nickel titanium coil springs 0.26 mm. There was no relationship between the initial force applied and rate of space closure. None of the sample failed during the study period giving a 100 per cent response rate. In clinical use, the force retention of elastomeric chain was better than previously concluded. High initial forces resulted in high force decay

  13. clinical: dementia

    African Journals Online (AJOL)

    have impairment on multiple cognitive domains, including attention, concentration, memory, executive function, motor functioning and speed of information processing, and sensory perceptual/motor skills deficits. The milder forms of HAND are easily missed. Diagnosis can be made on clinical grounds in the most severe ...

  14. 77 FR 40360 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2012-07-09

    ... Tuberculosis; Smallpox; Yellow fever; and Viral Hemorrhagic Fevers), as well as most communicable diseases in... Death Investigation Forms--Airline, Maritime, Land/Border Crossing Illness and Death Investigation Forms... arrival in the United States. An ``ill person'' is defined in statute by: --Fever (>=100 [deg]F or 38 [deg...

  15. Bovine nucleus caudatus acetylcholinesterase: active site determination and investigation of a dimeric form obtained by selective proteolysis

    Energy Technology Data Exchange (ETDEWEB)

    Landauer, P.; Ruess, K.P.; Lieflaender, M.

    1984-09-01

    The number of catalytic subunits of purified bovine nucleus caudatus acetylcholinesterase (E.C. 3.1.1.7) has been determined by active site labelling with (3H)diisopropyl fluorophosphate ((3H)DFP). The 10.5 S, 16 S, and 20 S forms were estimated to contain two, four, and six active sites, respectively, per molecule. A 4.8 S form, which showed a weak amphiphile-dependent activity behavior, was obtained by selective proteolytic digestion with pronase. The inability of the purified 4.8 S form to aggregate after detergent removal, and the molecular mass in the range of 130-165 kD under nondenaturating conditions, indicate that this form is a dimeric form, lacking those hydrophobic regions responsible for aggregation.

  16. Clinically important deterioration in patients undergoing lumbar spine surgery: a choice of evaluation methods using the Oswestry Disability Index, 36-Item Short Form Health Survey, and pain scales: clinical article.

    Science.gov (United States)

    Gum, Jeffrey L; Glassman, Steven D; Carreon, Leah Y

    2013-11-01

    Health-related quality of life (HRQOL) measures have become the mainstay for outcome appraisal in spine surgery. Clinically meaningful interpretation of HRQOL improvement has centered on the minimum clinically important difference (MCID). The purpose of this study was to calculate clinically important deterioration (CIDET) thresholds and determine a CIDET value for each HRQOL measure for patients undergoing lumbar fusion. Seven hundred twenty-two patients (248 males, 127 smokers, mean age 60.8 years) were identified with complete preoperative and 1-year postoperative HRQOLs including the Oswestry Disability Index (ODI), 36-Item Short Form Health Survey (SF-36), and numeric rating scales (0-10) for back and leg pain following primary, instrumented, posterior lumbar fusion. Anchor-based and distribution-based methods were used to calculate CIDET for each HRQOL. Anchor-based methods included change score, change difference, and receiver operating characteristic curve analysis. The Health Transition Item, an independent item of the SF-36, was used as the external anchor. Patients who responded "somewhat worse" and "much worse" were combined and compared with patients responding "about the same." Distribution-based methods were minimum detectable change and effect size. Diagnoses included spondylolisthesis (n = 332), scoliosis (n = 54), instability (n = 37), disc pathology (n = 146), and stenosis (n = 153). There was a statistically significant change (p < 0.0001) for each HRQOL measure from preoperatively to 1-year postoperatively. Only 107 patients (15%) reported being "somewhat worse" (n = 81) or "much worse" (n = 26). Calculation methods yielded a range of CIDET values for ODI (0.17-9.06), SF-36 physical component summary (-0.32 to 4.43), back pain (0.02-1.50), and leg pain (0.02-1.50). A threshold for clinical deterioration was difficult to identify. This may be due to the small number of patients reporting being worse after surgery and the variability across

  17. Rare primary headaches: clinical insights.

    Science.gov (United States)

    Casucci, G; d'Onofrio, F; Torelli, P

    2004-10-01

    So-called "rare" headaches, whose prevalence rate is lower than 1% or is not known at all and have been reported in only a few dozen cases to date, constitute a very heterogeneous group. Those that are best characterised from the clinical point of view can be classified into forms with prominent autonomic features and forms with sparse or no autonomic features. Among the former are trigeminal autonomic cephalalgias (TACs) and hemicrania continua, while the latter comprise classical trigeminal neuralgia, hypnic headache, primary thunderclap headache, and exploding head syndrome. The major clinical discriminating factor for the differential diagnosis of TACs is the relationship between duration and frequency of attacks: the forms in which pain is shorter lived are those with the higher frequency of daily attacks. Other aspects to be considered are the time pattern of symptoms, intensity and timing of attacks, the patient's behaviour during the attacks, the presence of any triggering factors and of the refractory period after an induced attack, and response to therapy, especially with indomethacin. Often these are little known clinical entities, which are not easily detected in clinical practice. For some of them, e. g., thunderclap headache, it is always necessary to perform instrumental tests to exclude the presence of underlying organic diseases.

  18. Glass forming ability of amorphous drugs investigated by continuous cooling- and isothermal transformation

    DEFF Research Database (Denmark)

    Blaabjerg, Lasse Ingerslev; Lindenberg, Eleanor; Löbmann, Korbinian

    2016-01-01

    /min). Thus, the glass forming ability can be predicted by the use of TTT diagrams. In contrast to TTT diagrams, CCT diagrams may not be suitable for small organic molecules due to poor separation of exothermic events, which makes it difficult to determine the zone of recrystallization. In conclusion...

  19. Creep Forming of Carbon-Reinforced Ceramic-Matrix Composites

    Science.gov (United States)

    Vaughn, Wallace L.; Scotti, Stephan J.; Ashe, Melissa P.; Connolly, Liz

    2007-01-01

    A set of lecture slides describes an investigation of creep forming as a means of imparting desired curvatures to initially flat stock plates of carbon-reinforced ceramic-matrix composite (C-CMC) materials. The investigation is apparently part of a continuing effort to develop improved means of applying small CCMC repair patches to reinforced carbon-carbon leading edges of aerospace vehicles (e.g., space shuttles) prior to re-entry into the atmosphere of the Earth. According to one of the slides, creep forming would be an intermediate step in a process that would yield a fully densified, finished C-CMC part having a desired size and shape (the other steps would include preliminary machining, finish machining, densification by chemical vapor infiltration, and final coating). The investigation included experiments in which C-CMC disks were creep-formed by heating them to unspecified high temperatures for time intervals of the order of 1 hour while they were clamped into single- and double-curvature graphite molds. The creep-formed disks were coated with an oxidation- protection material, then subjected to arc-jet tests, in which the disks exhibited no deterioration after exposure to high-temperature test conditions lasting 490 seconds.

  20. Pre-Clinical and Clinical Investigation of the Impact of Obesity on Ovarian Cancer Pathogenesis

    Science.gov (United States)

    2015-12-01

    clinical cancer drug discovery , including 10 years as a Research Assistant Professor in the Department of Surgery at Duke University Medical Center...cancer therapy. Nature chemical biology . 2015;11(1):9-15. Epub 2014/12/18. doi: 10.1038/nchembio.1712. PubMed PMID: 25517383; PubMed Central PMCID...Assistant Professor of Nutrition, a member of the Nutrition Obesity Research Center, Center for Gastrointestinal Biology and Disease, McCallister Heart

  1. Development and Retrospective Clinical Assessment of a Patient-Specific Closed-Form Integro-Differential Equation Model of Plasma Dilution.

    Science.gov (United States)

    Atlas, Glen; Li, John K-J; Amin, Shawn; Hahn, Robert G

    2017-01-01

    A closed-form integro-differential equation (IDE) model of plasma dilution (PD) has been derived which represents both the intravenous (IV) infusion of crystalloid and the postinfusion period. Specifically, PD is mathematically represented using a combination of constant ratio, differential, and integral components. Furthermore, this model has successfully been applied to preexisting data, from a prior human study, in which crystalloid was infused for a period of 30 minutes at the beginning of thyroid surgery. Using Euler's formula and a Laplace transform solution to the IDE, patients could be divided into two distinct groups based on their response to PD during the infusion period. Explicitly, Group 1 patients had an infusion-based PD response which was modeled using an exponentially decaying hyperbolic sine function, whereas Group 2 patients had an infusion-based PD response which was modeled using an exponentially decaying trigonometric sine function. Both Group 1 and Group 2 patients had postinfusion PD responses which were modeled using the same combination of hyperbolic sine and hyperbolic cosine functions. Statistically significant differences, between Groups 1 and 2, were noted with respect to the area under their PD curves during both the infusion and postinfusion periods. Specifically, Group 2 patients exhibited a response to PD which was most likely consistent with a preoperative hypovolemia. Overall, this IDE model of PD appears to be highly "adaptable" and successfully fits clinically-obtained human data on a patient-specific basis, during both the infusion and postinfusion periods. In addition, patient-specific IDE modeling of PD may be a useful adjunct in perioperative fluid management and in assessing clinical volume kinetics, of crystalloid solutions, in real time.

  2. Digital models: How can dental arch form be verified chairside?

    Directory of Open Access Journals (Sweden)

    Alana Tavares

    Full Text Available ABSTRACT Introduction: Plaster dental casts are routinely used during clinical practice to access maxillary dental arch form and assist on fabrication of individualized orthodontic archwires. Recently introduced, digital model technology may offer a limitation for the obtainment of a dental physical record. In this context, a tool for dental arch form assessment for chairside use is necessary when employing digital models. In this regard, paper print of the dental arch seems thus to be useful. Methods: In the present study, 37 lower arch models were used. Intercanine and intermolar widths and dental arch length measurements were performed and compared using plaster dental casts, digital models and paper print image of the models. Ortho Insight 3D scanner was employed for model digitalization. Results: No statistically significant differences were noted regarding the measurements performed on the plaster or digital models (p> 0.05. Paper print images, however, showed subestimated values for intercanine and intermolar widths and overestimated values for dental arch length. Despite being statistically significant (p< 0.001, the differences were considered clinically negligible. Conclusion: The present study suggests that paper print images obtained from digital models are clinically accurate and can be used as a tool for dental arch form assessment for fabrication of individualized orthodontic archwires.

  3. Digital models: How can dental arch form be verified chairside?

    Science.gov (United States)

    Tavares, Alana; Braga, Emanuel; de Araújo, Telma Martins

    2017-01-01

    ABSTRACT Introduction: Plaster dental casts are routinely used during clinical practice to access maxillary dental arch form and assist on fabrication of individualized orthodontic archwires. Recently introduced, digital model technology may offer a limitation for the obtainment of a dental physical record. In this context, a tool for dental arch form assessment for chairside use is necessary when employing digital models. In this regard, paper print of the dental arch seems thus to be useful. Methods: In the present study, 37 lower arch models were used. Intercanine and intermolar widths and dental arch length measurements were performed and compared using plaster dental casts, digital models and paper print image of the models. Ortho Insight 3D scanner was employed for model digitalization. Results: No statistically significant differences were noted regarding the measurements performed on the plaster or digital models (p> 0.05). Paper print images, however, showed subestimated values for intercanine and intermolar widths and overestimated values for dental arch length. Despite being statistically significant (p< 0.001), the differences were considered clinically negligible. Conclusion: The present study suggests that paper print images obtained from digital models are clinically accurate and can be used as a tool for dental arch form assessment for fabrication of individualized orthodontic archwires. PMID:29364382

  4. Utility of clinical assessment, imaging, and cryptococcal antigen titer to predict AIDS-related complicated forms of cryptococcal meningitis

    Directory of Open Access Journals (Sweden)

    Kandel Sean

    2010-08-01

    Full Text Available Abstract Background This study aimed to evaluate the prevalence and predictors of AIDS-related complicated cryptococcal meningitis. The outcome was complicated cryptococcal meningitis: prolonged (≥ 14 days altered mental status, persistent (≥ 14 days focal neurologic findings, cerebrospinal fluid (CSF shunt placement or death. Predictor variable operating characteristics were estimated using receiver operating characteristic curve (ROC analysis. Multivariate analysis identified independent predictors of the outcome. Results From 1990-2009, 82 patients with first episode of cryptococcal meningitis were identified. Of these, 14 (17% met criteria for complicated forms of cryptococcal meningitis (prolonged altered mental status 6, persistent focal neurologic findings 7, CSF surgical shunt placement 8, and death 5. Patients with complicated cryptococcal meningitis had higher frequency of baseline focal neurological findings, head computed tomography (CT abnormalities, mean CSF opening pressure, and cryptococcal antigen (CRAG titers in serum and CSF. ROC area of log2 serum and CSF CRAG titers to predict complicated forms of cryptococcal meningitis were comparable, 0.78 (95%CI: 0.66 to 0.90 vs. 0.78 (95% CI: 0.67 to 0.89, respectively (χ2, p = 0.95. The ROC areas to predict the outcomes were similar for CSF pressure and CSF CRAG titers. In a multiple logistic regression model, the following were significant predictors of the outcome: baseline focal neurologic findings, head CT abnormalities and log2 CSF CRAG titer. Conclusions During initial clinical evaluation, a focal neurologic exam, abnormal head CT and large cryptococcal burden measured by CRAG titer are associated with the outcome of complicated cryptococcal meningitis following 2 weeks from antifungal therapy initiation.

  5. Chronic recurrent multifocal osteomyelitis: a radiological and clinical investigation of five cases

    International Nuclear Information System (INIS)

    Demharter, J.; Bohndorf, K.; Michl, W.; Vogt, H.

    1997-01-01

    Objective. To make a detailed evaluation of the clinical and radiological course of five children with chronic recurrent multifocal osteomyelitis (CRMO). Emphasis was laid on the correlation between clinical data and radiological findings. Design and patients. Clinical data, histology (n=11), bone scintigraphy (n=17), and the plain radiographs (n=198) of these patients were reviewed. The mean time of observation was 6.6 years (range 1-14.5 years). Thirty-two lesions seen at the time of primary diagnosis (n=22) or during the course of the disease (n=10) were evaluated. Twenty-seven foci were located in bone; in five cases the sacroiliac joints were involved. Results. Bone scintigrams showed nearly all foci (31/32) and were especially helpful in clinically asymptomatic lesions (14/32) or foci which were radiographically difficult to detect or not seen at all (8/32). Only 14 of 32 foci were locally symptomatic clinically. In all cases with a short interval (≤3 weeks) between the onset of local symptoms and evaluation by plain radiographs (n=5) osteolysis was shown without a sclerotic margin. All bone lesions with a longer duration of local symptoms (n=7) revealed a variable radiographic pattern: osteolysis with sclerotic rim in three, a mixed lytic-sclerotic lesion in three and pure sclerosis in one. In two cases low back pain could be ascribed to sacroiliitis. Conclusion. Only careful correlation between clinical, scintigraphy and radiographic features permits an accurate assessment of disease activity in CRMO. The bone lesions detected radiographically soon after the onset of symptoms resemble those of acute osteomyelitis. (orig.)

  6. Inflation and dark energy from three-forms

    International Nuclear Information System (INIS)

    Koivisto, Tomi S.; Nunes, Nelson J.

    2009-01-01

    Three-forms can give rise to viable cosmological scenarios of inflation and dark energy with potentially observable signatures distinct from standard single scalar field models. In this study, the background dynamics and linear perturbations of self-interacting three-form cosmology are investigated. The phase space of cosmological solutions possesses (super)-inflating attractors and saddle points, which can describe three-form driven inflation or dark energy. The quantum generation and the classical evolution of perturbations is considered. The scalar and tensor spectra from a three-form inflation and the impact from the presence of a three-form on matter perturbations are computed. Stability properties and equivalence of the model with alternative formulations are discussed.

  7. Clinical impact of diagnostic SPET investigations with a dopamine re-uptake ligand

    DEFF Research Database (Denmark)

    Løkkegaard, Annemette; Werdelin, Lene M; Friberg, Lars

    2002-01-01

    The diagnosis of Parkinson's disease is based on clinical features with pathological verification. However, autopsy has been found to confirm a specialist diagnosis in only about 75% of cases. Especially early in the course of the disease, the clinical diagnosis can be difficult. Imaging of presy...

  8. Clinical and Paraclinical Indicators of Motor System Impairment in Hereditary Spastic Paraplegia: A Pilot Study.

    Directory of Open Access Journals (Sweden)

    Andrea Martinuzzi

    Full Text Available Hereditary spastic paraplegias (HSP are a composite and genetically heterogeneous group of conditions mainly expressed by the impairment of the central motor system ("pure" forms. The involvement of other components of the central nervous system or of other systems is described in the "complicate" forms. The definition of an investigation protocol capable, by assembling clinical and paraclinical indicators to fully represent the extent of the motor system impairment, would help both the clinical handling of these conditions and contribute to our understanding of their pathogenesis.We applied a clinical and paraclinical protocol which included tools exploring motor and non motor functioning, neurophysiology and MRI to a composite cohort of 70 molecularly defined HSP patients aged 3 to 65, to define for each indicator its significance in detailing the presence and the severity of the pathology.Clinically increased deep tendon reflexes and lower limb (LL weakness are constant findings in all patients. The "complicated" forms are characterized by peripheral motor impairment, cognitive and cerebellar involvement. The Spastic Paraplegia Rating Scale efficiently reflects the severity of functional problems and correlates with disease duration. Neurophysiology consistently documents the impairment of the central motor pathway to the LLs. Nevertheless, the upper extremities and sensory system involvement is a frequent finding. MRI diffusion tensor imaging (DTI highlighted a significant alteration of FA and MD. Combining the sampling of the various portion of the cortico-spinal tract (CST DTI consistently discriminated patients from controls.We propose a graded clinical and paraclinical protocol for HSP phenotype definition, indicating for each tool the discriminative and descriptive capacity. Our protocol applied to 9 different forms of HSP showed that the functional impairment often extends beyond the CST. The novel DTI approach may add significant

  9. Clinical and Paraclinical Indicators of Motor System Impairment in Hereditary Spastic Paraplegia: A Pilot Study.

    Science.gov (United States)

    Martinuzzi, Andrea; Montanaro, Domenico; Vavla, Marinela; Paparella, Gabriella; Bonanni, Paolo; Musumeci, Olimpia; Brighina, Erika; Hlavata, Hana; Rossi, Giuseppe; Aghakhanyan, Gayane; Martino, Nicola; Baratto, Alessandra; D'Angelo, Maria Grazia; Peruch, Francesca; Fantin, Marianna; Arnoldi, Alessia; Citterio, Andrea; Vantaggiato, Chiara; Rizzo, Vincenzo; Toscano, Antonio; Bresolin, Nereo; Bassi, Maria Teresa

    2016-01-01

    Hereditary spastic paraplegias (HSP) are a composite and genetically heterogeneous group of conditions mainly expressed by the impairment of the central motor system ("pure" forms). The involvement of other components of the central nervous system or of other systems is described in the "complicate" forms. The definition of an investigation protocol capable, by assembling clinical and paraclinical indicators to fully represent the extent of the motor system impairment, would help both the clinical handling of these conditions and contribute to our understanding of their pathogenesis. We applied a clinical and paraclinical protocol which included tools exploring motor and non motor functioning, neurophysiology and MRI to a composite cohort of 70 molecularly defined HSP patients aged 3 to 65, to define for each indicator its significance in detailing the presence and the severity of the pathology. Clinically increased deep tendon reflexes and lower limb (LL) weakness are constant findings in all patients. The "complicated" forms are characterized by peripheral motor impairment, cognitive and cerebellar involvement. The Spastic Paraplegia Rating Scale efficiently reflects the severity of functional problems and correlates with disease duration. Neurophysiology consistently documents the impairment of the central motor pathway to the LLs. Nevertheless, the upper extremities and sensory system involvement is a frequent finding. MRI diffusion tensor imaging (DTI) highlighted a significant alteration of FA and MD. Combining the sampling of the various portion of the cortico-spinal tract (CST) DTI consistently discriminated patients from controls. We propose a graded clinical and paraclinical protocol for HSP phenotype definition, indicating for each tool the discriminative and descriptive capacity. Our protocol applied to 9 different forms of HSP showed that the functional impairment often extends beyond the CST. The novel DTI approach may add significant elements in

  10. Readability and Content Assessment of Informed Consent Forms for Phase II-IV Clinical Trials in China.

    Science.gov (United States)

    Wen, Gaiyan; Liu, Xinchun; Huang, Lihua; Shu, Jingxian; Xu, Nana; Chen, Ruifang; Huang, Zhijun; Yang, Guoping; Wang, Xiaomin; Xiang, Yuxia; Lu, Yao; Yuan, Hong

    2016-01-01

    To explore the readability and content integrity of informed consent forms (ICFs) used in China and to compare the quality of Chinese local ICFs with that of international ICFs. The length, readability and content of 155 consent documents from phase II-IV drug clinical trials from the Third Xiangya Hospital Ethics Committee from November 2009 to January 2015 were evaluated. Reading difficulty was tested using a readability formula adapted for the Chinese language. An ICF checklist containing 27 required elements was successfully constructed to evaluate content integrity. The description of alternatives to participation was assessed. The quality of ICFs from different sponsorships were also compared. Among the 155 evaluable trials, the ICFs had a median length of 5286 words, corresponding to 7 pages. The median readability score was 4.31 (4.02-4.41), with 63.9% at the 2nd level and 36.1% at the 3rd level. Five of the 27 elements were frequently neglected. The average score for the description of alternatives to participation was 1.06, and 27.7% of the ICFs did not mention any alternatives. Compared with Chinese local ICFs, international ICFs were longer, more readable and contained more of the required elements (P readability and content integrity than Chinese local ICFs. More efforts should thus be made to improve the quality of consent documents in China.

  11. A flow chamber assay for quantitative evaluation of bacterial surface colonization used to investigate the influence of temperature and surface hydrophilicity on the biofilm forming capacity of uropathogenic Escherichia coli

    DEFF Research Database (Denmark)

    Andersen, Thomas Emil; Kingshott, Peter; Palarasah, Yaseelan

    2010-01-01

    to those found on an implanted device. We have used the method to evaluate the biofilm forming capacity of clinically isolated Escherichia coli on silicone rubber and on silicone rubber containing a hydrophilic coating. It was found that the surface chemistry influenced the colonization of the isolates...... very differently. In addition, the temperature was found to have a considerable influence upon the adhesion and biofilm forming capacity of some of the isolates, and that the influence of surface chemistry depended on temperature. Our results suggest that the step from using E. coli laboratory strains...

  12. Idiopathic Canalicular Inflammatory Disease: New Disease Description of Clinical Patterns, Investigations, Management, and Outcomes.

    Science.gov (United States)

    Ali, Mohammad Javed

    2018-01-25

    The objective of this perspective is to present a separate disease description of "idiopathic canalicular inflammatory disease" and outline the diagnostic criteria and early experiences with its investigations and management. Retrospective case series of 44 canaliculi of 22 eyes of 11 patients presenting at a tertiary care Dacryology service over a period of 2 years with typical clinical patterns of inflammatory canaliculitis and its outcomes were studied. All the patients underwent microbiological work-up with culture and sensitivity, dacryoendoscopy imaging, serial Fourier domain ocular coherence tomography, and collagen vascular profiles. Stages in the evolution of the disease were studied. All patients were treated initially with topical steroids followed by punctal dilatation and placement of mini-monoka stents. Five patients in addition had a small biopsy from the inflamed portion of the vertical canaliculus. Stents were extubated at 6 weeks. Forty-four canaliculi were diagnosed to have idiopathic canalicular inflammatory disease during the study period. There was a female preponderance (81.8%, 9/11) and the mean age at presentation was 57 years. All patients presented with unilateral epiphora without any discharge, pain, or swelling. Collagen vascular profiles and screening for autoimmune diseases were negative. Clinical picture ranged from stages 1 to 5, consisting of edema, progressive centripetal vascularization, pouting of vascularized mucosa, membrane formation, and progressive scarring. The presentation begins in 1 eye and usually involves the other eye at a mean of 6 months. Ocular coherence tomography and dacryoendoscopy were of adjunctive value in the diagnosis. Histopathological examination was suggestive of a chronic inflammation. All patients had relentless progression to end-stage disease, although delayed significantly by steroids and monoka intubation. Idiopathic canalicular inflammatory disease has a distinct and typical clinical behavior and

  13. Variation in clinical phenotype of human infection among genetic groups of Blastomyces dermatitidis

    Science.gov (United States)

    Meece, Jennifer K.; Anderson, Jennifer L.; Gruszka, Sarah; Sloss, Brian L.; Sullivan, Bradley; Reed, Kurt D.

    2013-01-01

    Background. Blastomyces dermatitidis, the etiologic agent of blastomycosis, has 2 genetic groups and shows varied clinical presentation, ranging from silent infections to fulminant respiratory disease and dissemination. The objective of this study was to determine whether clinical phenotype and outcomes vary based on the infecting organism's genetic group.Methods. We used microsatellites to genotype 227 clinical isolates of B. dermatitidis from Wisconsin patients. For each isolate, corresponding clinical disease characteristics and patient demographic information were abstracted from electronic health records and Wisconsin Division of Health reportable disease forms and questionnaires.Results. In univariate analysis, group 1 isolates were more likely to be associated with pulmonary-only infections (P 1 month (P smoking status (P = .0001) remained predictors for group 2 infections.Conclusions. This study identified previously unknown associations between clinical phenotype of human infection and genetic groups of B. dermatitidis and provides a framework for further investigations of the genetic basis for virulence in B. dermatitidis.

  14. Experimental and numerical investigation of form-stable dodecane/hydrophobic fumed silica composite phase change materials for cold energy storage

    International Nuclear Information System (INIS)

    Chen, Jiajie; Ling, Ziye; Fang, Xiaoming; Zhang, Zhengguo

    2015-01-01

    Highlights: • Form-stable dodecane/fumed silica composite for cold storage is prepared. • A suggesting hypothesis that explains infiltration mechanism is proposed. • The performance of the composite phase change material is investigated. • Numerical simulation of system is carried out and results fit well. - Abstract: A kind of form-stable composite phase change materials used for cold thermal energy storage is prepared by absorbing dodecane into the hydrophobic fumed silica. With relatively suitable pore diameter and hydrophobic groups, hydrophobic fumed silica is beneficial to the penetration and infiltration of dodecane and the leakage problem solving. Scanned by electron micrographs and Fourier transformation infrared, the composite phase change material is characterized to be just physical penetration. Besides, the differential scanning calorimeter and thermo gravimetric analysis reveals the high enthalpy, good thermal stability and cycling performance of this composite phase change material. What’s more, Hot-Disk thermal constants analyzer demonstrates that the composite phase change material has low thermal conductivity which is desired in cold storage application. In the experiment, a cold energy storage system is set up and the results from the experiment show that the system has excellent performance of cold storage by incorporating composite phase change material. Apart from that, the experimental data is found to have a great agreement with the numerical simulation which is carried out by using the commercial computational fluid dynamics software FLUENT.

  15. Clinical validity of the Japanese version of WAIS-III short forms: Adaptation for patients with mild neurocognitive disorder and dementia.

    Science.gov (United States)

    Takeda, Mihoko; Nakaya, Makoto; Kikuchi, Yoko; Inoue, Sayaka; Kamata, Tomoyuki

    2018-01-01

    We investigated the Japanese WAIS-III short form utility in mild neurocognitive disorder and dementia. Our sample consisted of 108 old patients (ages: 65-89; mean age = 78.3). Fifteen short forms (SFs) and full-scale (FS) IQs were compared. The SFs included Dyads (SF1, SF2), Triads (SF3), Tetrads (SF4, SF5, SF6, SF7), Pentad (SF8), Six-subtest (SF9), Seven-subtests (SF10(a)(b), SF11(a)(b), SF12), and Nine-subtest (SF13). Correlations between SFIQs and FSIQ were all significant. Significant differences also were found in paired t-test between FSIQ and 5 SFIQs (SF2: t = -4.16, SF5: t = -7.06, SF7; t = 2.59, SF10(a): t = 2.56, SF12: t = -4.82; p Arithmetic, Digit Span, Information, Picture Completion, Digit Symbol-Coding, and Matrix Reasoning (Ryan & Ward, 1999), and the formula (Axelrod et al., 2001) should be adopted to convert scaled scores into estimated IQ scores. Copyright © 2017 Elsevier B.V. All rights reserved.

  16. Investigating the role of feedback and motivation in clinical reaction time assessment.

    Science.gov (United States)

    Eckner, James T; Chandran, Srikrishna; Richardson, James K

    2011-12-01

    To investigate the influence of performance feedback and motivation during 2 tests of simple visuomotor reaction time (RT). Cross-sectional, observational study. Outpatient academic physiatry clinic. Thirty-one healthy adults (mean [SD], 54 ± 15 years). Participants completed a clinical test of RT (RT(clin)) and a computerized test of RT with and without performance feedback (RT(compFB) and RT(compNoFB), respectively) in randomly assigned order. They then ranked their degree of motivation during each test. RT(clin) measured the time required to catch a suspended vertical shaft by hand closure after release of the shaft by the examiner. RT(compFB) and RT(compNoFB) both measured the time required to press a computer key in response to a visual cue displayed on a computer monitor. Performance feedback (visual display of the previous trial and summary results) was provided for RT(compFB), but not for RT(compNoFB). Means and standard deviations of RT(clin), RT(compFB), and RT(compNoFB) and participants' self-reported motivation on a 5-point Likert scale for each test. There were significant differences in both the means and standard deviations of RT(clin), RT(compFB), and RT(compNoFB) (F(2,60) = 81.66, P motivation between RT(clin) and RT(compFB), both of which were reported to be more motivating than RT(compNoFB). The stronger correlation between RT(clin) and RT(compFB) as well as the higher reported motivation during RT(clin) and RT(compFB) testing suggest that performance feedback is a positive motivating factor that is inherent to RT(clin) testing. RT(clin) is a simple, inexpensive technique for measuring RT and appears to be an intrinsically motivating task. This motivation may promote faster, more consistent RT performance compared with currently available computerized programs, which do not typically provide performance feedback. Copyright © 2011 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

  17. Hypericum perforatum: pharmacokinetic, mechanism of action, tolerability, and clinical drug-drug interactions.

    Science.gov (United States)

    Russo, Emilio; Scicchitano, Francesca; Whalley, Benjamin J; Mazzitello, Carmela; Ciriaco, Miriam; Esposito, Stefania; Patanè, Marinella; Upton, Roy; Pugliese, Michela; Chimirri, Serafina; Mammì, Maria; Palleria, Caterina; De Sarro, Giovambattista

    2014-05-01

    Hypericum perforatum (HP) belongs to the Hypericaceae family and is one of the oldest used and most extensively investigated medicinal herbs. The medicinal form comprises the leaves and flowering tops of which the primary ingredients of interest are naphthodianthrones, xanthones, flavonoids, phloroglucinols (e.g. hyperforin), and hypericin. Although several constituents elicit pharmacological effects that are consistent with HP's antidepressant activity, no single mechanism of action underlying these effects has thus far been found. Various clinical trials have shown that HP has a comparable antidepressant efficacy as some currently used antidepressant drugs in the treatment of mild/moderate depression. Interestingly, low-hyperforin-content preparations are effective in the treatment of depression. Moreover, HP is also used to treat certain forms of anxiety. However, HP can induce various cytochrome P450s isozymes and/or P-glycoprotein, of which many drugs are substrates and which are the main origin of HP-drug interactions. Here, we analyse the existing evidence describing the clinical consequence of HP-drug interactions. Although some of the reported interactions are based on findings from in vitro studies, the clinical importance of which remain to be demonstrated, others are based on case reports where causality can, in some cases, be determined to reveal clinically significant interactions that suggest caution, consideration, and disclosure of potential interactions prior to informed use of HP. Copyright © 2013 John Wiley & Sons, Ltd.

  18. Improved quality monitoring of multi-center acupuncture clinical trials in China

    Directory of Open Access Journals (Sweden)

    Zheng Hui

    2009-12-01

    Full Text Available Abstract Background In 2007, the Chinese Science Division of the State Administration of Traditional Chinese Medicine(TCM convened a special conference to discuss quality control for TCM clinical research. Control and assurance standards were established to guarantee the quality of clinical research. This paper provides practical guidelines for implementing strict and reproducible quality control for acupuncture randomized controlled trials (RCTs. Methods A standard quality control program (QCP was established to monitor the quality of acupuncture trials. Case report forms were designed; qualified investigators, study personnel and data management personnel were trained. Monitors, who were directly appointed by the project leader, completed the quality control programs. They guaranteed data accuracy and prevented or detected protocol violations. Clinical centers and clinicians were audited, the randomization system of the centers was inspected, and the treatment processes were audited as well. In addition, the case report forms were reviewed for completeness and internal consistency, the eligibility and validity of the patients in the study was verified, and data was monitored for compliance and accuracy. Results and discussion The monitors complete their reports and submit it to quality assurance and the sponsors. Recommendations and suggestions are made for improving performance. By holding regular meetings to discuss improvements in monitoring standards, the monitors can improve quality and efficiency. Conclusions Supplementing and improving the existed guidelines for quality monitoring will ensure that large multi-centre acupuncture clinical trials will be considered as valid and scientifically stringent as pharmaceutical clinical trials. It will also develop academic excellence and further promote the international recognition of acupuncture.

  19. Design of clinical trials for therapeutic cancer vaccines development.

    Science.gov (United States)

    Mackiewicz, Jacek; Mackiewicz, Andrzej

    2009-12-25

    Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate.

  20. Clinical presentation of thyroid cancer

    International Nuclear Information System (INIS)

    Samuel, A.M.; Shah, D.H.

    1999-01-01

    The clinical manifestation of thyroid cancer (TC) as seen at the Nuclear Medicine Department, where the patients investigated prior to diagnosis of disease are clinically suspected to harbor malignancy and mostly referred for scintigraphic investigations are presented