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Sample records for active clinical investigation

  1. Application of near-infrared spectroscopy to investigate brain activity: clinical research

    NASA Astrophysics Data System (ADS)

    Lichty, Wemara; Sakatania, Kaoru; Xie, Yuxiao; Zou, Huangcong

    2000-07-01

    Near infrared spectroscopy has recently been used to measure changes of optical parameters (i.e., light absorption or scattering) of brain tissue. The fact that the equipment is generally compact, portable, noninvasive, and reasonably prices makes it ideal for clinical and nonclinical evaluation and monitoring of brain function. Clinical and nonclinical studies evaluating changes related to light absorption are discussed, with an emphasis on cerebral blood oxygenation (CBO) changes and hemodynamic responses while performing cognitive tasks. With respect to the clinical studies, the focus is on variations in patterns of oxygenated hemoglobin (Oxy-Hb), deoxygentated hemoglobin (Deoxy-Hb) and Total-Hb (sum of Oxy-Hb and Deoxy-Hb). The studies about clinical applications includes research we have conducted with older adults and aphasics. Implications regarding the use of NIRS for clincal purposes are considered.

  2. Clinical investigation program, fiscal year 1991

    NASA Astrophysics Data System (ADS)

    Schydlower, Manuel

    1992-02-01

    Subject report identifies the research activities conducted at William Beaumont Army Medical Center by investigators who had protocols approved by the Clinical Investigation Committee, the Institutional Review Board, and the Animal Use Committee. This report includes all protocols registered with the Department of Clinical Investigation during FY 1991. All known presentations and publications are also included. The research protocols described were conducted under the provisions of AR 40-38 (Clinical Investigation Program); AR 40-7 (Use of Investigational Drugs in Humans and the Use of Schedule 1 Controlled Substances); AR 70-25 (Usle of Volunteers as Subjects of Research); HSC 40-32 (Management of Clinical Investigation Protocols and Reports); and AR 70-18 (The Use of Animals in DOS programs).

  3. Clinical Investigation program report. Annual report for FY83

    SciTech Connect

    Not Available

    1983-10-01

    This report identifies the research activities conducted by Letterman Army Medical Center investigators through protocols approved by the Clinical Investigation, Human and Animal Use Committees during FY 1983.

  4. Comparison of the antibiotic activities of Daptomycin, Vancomycin, and the investigational Fluoroquinolone Delafloxacin against biofilms from Staphylococcus aureus clinical isolates.

    PubMed

    Siala, Wafi; Mingeot-Leclercq, Marie-Paule; Tulkens, Paul M; Hallin, Marie; Denis, Olivier; Van Bambeke, Françoise

    2014-11-01

    Biofilm-related infections remain a scourge. In an in vitro model of biofilms using Staphylococcus aureus reference strains, delafloxacin and daptomycin were found to be the most active among the antibiotics from 8 different pharmacological classes (J. Bauer, W. Siala, P. M. Tulkens, and F. Van Bambeke, Antimicrob. Agents Chemother. 57:2726-2737, 2013, doi:10.1128/AAC.00181-13). In this study, we compared delafloxacin to daptomycin and vancomycin using biofilms produced by 7 clinical strains (S. aureus epidemic clones CC5 and CC8) in order to rationalize the differences observed between the antibiotics and strains. The effects of the antibiotics on bacterial viability (resazurin reduction assay) and biomass (crystal violet staining) were measured and correlated with the proportion of polysaccharides in the matrix, the local microenvironmental pH (micro-pH), and the antibiotic penetration in the biofilm. At clinically meaningful concentrations, delafloxacin, daptomycin, and vancomycin caused a ≥25% reduction in viability against the biofilms formed by 5, 4, and 3 strains, respectively. The antibiotic penetration within the biofilms ranged from 0.6 to 52% for delafloxacin, 0.2 to 10% for daptomycin, and 0.2 to 1% for vancomycin; for delafloxacin, this was inversely related to the polysaccharide proportion in the matrix. Six biofilms were acidic, explaining the high potency of delafloxacin (lower MICs at acidic pH). Norspermidine and norspermine (disassembling the biofilm matrix) drastically increased delafloxacin potency and efficacy (50% reduction in viability for 6 biofilms at clinically meaningful concentrations) in direct correlation with its increased penetration within the biofilm, while they only modestly improved daptomycin efficacy (50% reduction in viability for 2 biofilms) and penetration, and they showed marginal effects with vancomycin. Delafloxacin potency and efficacy against biofilms are benefited by its penetration into the matrix and the local

  5. [Antibacterial activity for clinical isolates from pediatric patients of clavulanic acid/amoxicillin (1: 14) -outcomes of special drug use investigation on antibacterial activity (annual changes)].

    PubMed

    Ishida, Atsuko; Hasegawa, Naomi; Okano, Hideyuki; Hara, Terufumi; Yoshida, Pascal

    2013-06-01

    As a special drug use investigation, we monitored and assessed trends in antibacterial activity of clavulanic acid/amoxicillin (1:14) (hereafter, "CVA/AMPC (1:14)") and other antimicrobial agents for clinical isolates from pediatric patients with otitis media or respiratory, skin, and urinary tract infections. Against Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis isolated and identified from otorrhea, epipharynx and rhinorrhea of pediatric patients with otitis media, the MIC90s of CVA/AMPC (1:14) in five years between 2006-2010 were 1 microg/mL for S. pneumoniae and 8 microg/mL for H. influenzae and 0.25-0.5microg/mL for M catarrhalis. The changes of MIC90s of CVA/AMPC (1:14) for penicillin-resistant S. pneumoniae (PRSP) and beta-lactamase non-producing H. influenzae were two times, and no decrease in drug susceptibility was found in the period of the present investigation. In addition, the MIC changes of other antimicrobial agents for these three organisms were approximately two to four times as well. Against organisms isolated and identified from pus, sputum, pharynx, skin and urine of pediatric patients with respiratory, skin, and urinary tract infections, the MIC90s of CVA/AMPC (1:14) in four years between 2008-2011 were 1 microg/mL for S. pneumoniae, < or =0.06microg/mL for penicillin susceptible S. pneumoniae (PSSP) without any change, 0.5-1 microg/mL for penicillin intermediate resistant S. pneumoniae (PISP) with a twofold change and 1 microg/mL for PRSP with no change. The MIC90s of CVA/AMPC (1:14) were 2-8 microg/mL for S. aureus with a fourfold change, 2 microg/mL for methicillin-sensitive S. aureus without any change, 4-8 microg/mL for H. influenzae with a twofold change. Against beta-lactamase non-producing H. influenzae, MIC90s of CVA/AMPC (1:14) were 1 microg/mL for beta-lactamase negative ampicillin susceptible (BLNAS), 8 microg/mL for beta-lactamase negative ampicillin resistant (BLNAR), showing no change. Neither

  6. 77 FR 60440 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ... regulatory aspects of clinical trials. This training course is intended to provide clinical investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical... access to electrical outlets. I. Background Clinical trial investigators play a critical role in...

  7. 75 FR 57472 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... Programs, in cosponsorship with the Clinical Trials Transformation Initiative (CTTI), is announcing a 3-day... clinical trials (clinical investigators). This course is intended to assist clinical investigators in... clinical trials. DATES: The training course will be held on November 8 and 9, 2010, from 8 a.m. to 5...

  8. Clinical investigations in primary care.

    PubMed

    de Souza, Leonardo Cruz; Sarazin, Marie; Goetz, Celine; Dubois, Bruno

    2009-01-01

    Alzheimer's disease (AD) is a progressive neurodegenerative disorder that represents the most common form of dementia. The most prominent feature of AD is the decline in cognitive function, with an early impairment of episodic memory. The memory deficit of an AD patient is characterized by the amnestic syndrome of the medial temporal type. As the disease progresses, the condition often manifests in language disorders, visuospatial deficits and executive dysfunctions. Patients often have neuropsychiatric disturbances, as apathy and psychotic symptoms. Loss of autonomy follows cognitive impairment. The clinical diagnosis of AD is based on a complete medical examination with a neuropsychological evaluation. The FCSRT (free and cued selective reminding test) is recommended for the identification of the amnestic syndrome of the medial temporal type, which is defined by: (1) a very poor free recall and (2) a decreased total recall due to an insufficient effect of cueing. The neuropsychological tests should also assess other cognitive functions that may be perturbed in AD, such as executive functions, praxis, visuospatial capacities and language. Neuroimaging and biological exams (genetics, biomarkers) are of great utility in the evaluation. Other medical, neurological, or psychiatric disorders which could account for the impairment in memory and related symptoms must be always investigated. PMID:19182457

  9. 76 FR 45577 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... Programs and the Clinical Trials Transformation Initiative (CTTI) are cosponsoring a 3-day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This... clinical trials; improve the ] quality of clinical trials; and enhance the safety of trial...

  10. Reasoning with Linear Orders: Differential Parietal Cortex Activation in Sub-Clinical Depression. An fMRI Investigation in Sub-Clinical Depression and Controls

    PubMed Central

    Hinton, Elanor C.; Wise, Richard G.; Singh, Krish D.; von Hecker, Ulrich

    2015-01-01

    The capacity to learn new information and manipulate it for efficient retrieval has long been studied through reasoning paradigms, which also has applicability to the study of social behavior. Humans can learn about the linear order within groups using reasoning, and the success of such reasoning may vary according to affective state, such as depression. We investigated the neural basis of these latter findings using functional neuroimaging. Using BDI-II criteria, 14 non-depressed (ND) and 12 mildly depressed volunteers took part in a linear-order reasoning task during functional magnetic resonance imaging. The hippocampus, parietal, and prefrontal cortices were activated during the task, in accordance with previous studies. In the learning phase and in the test phase, greater activation of the parietal cortex was found in the depressed group, which may be a compensatory mechanism in order to reach the same behavioral performance as the ND group, or evidence for a different reasoning strategy in the depressed group. PMID:25646078

  11. A double-blind randomized vehicle-controlled clinical trial investigating the effect of ZnPTO dose on the scalp vs. antidandruff efficacy and antimycotic activity.

    PubMed

    Bailey, P; Arrowsmith, C; Darling, K; Dexter, J; Eklund, J; Lane, A; Little, C; Murray, B; Scott, A; Williams, A; Wilson, D

    2003-08-01

    Dandruff is a common problem in approximately 30% of the world's population. Reports in the literature regarding treatment of this condition with various antidandruff shampoos usually report the level of active ingredient within the formulation. However, we propose that a more important parameter relating to antidandruff efficacy is the amount of active ingredient delivered to the scalp from the shampoo. This report describes the results from two studies designed to investigate the relationship between the level of zinc pyrithione (ZnPTO) deposited onto the scalp and the resultant scalp condition. A double-blind randomized vehicle-controlled clinical study comparing three shampoos - a vehicle, a low-depositing ZnPTO shampoo and a high-depositing ZnPTO shampoo - was carried out in the U.K. with 53 panelists with dandruff or mild-to-moderate seborrheic dermatitis of the scalp. Both shampoos containing ZnPTO were significantly superior in antidandruff efficacy to the vehicle. Furthermore, the high-depositing ZnPTO shampoo was significantly superior compared with the low-depositing ZnPTO shampoo in terms of both antidandruff efficacy and antimycotic activity. Antidandruff performance and antimycotic activity of ZnPTO-containing shampoos is highly dependent on the amount of active ingredient delivered to the scalp. Furthermore, careful manipulation of the formulation parameters of an antidandruff shampoo can result in enhanced levels of delivery of the active ingredient without having to increase the level of active ingredient within the formulation.

  12. A double-blind randomized vehicle-controlled clinical trial investigating the effect of ZnPTO dose on the scalp vs. antidandruff efficacy and antimycotic activity.

    PubMed

    Bailey, P; Arrowsmith, C; Darling, K; Dexter, J; Eklund, J; Lane, A; Little, C; Murray, B; Scott, A; Williams, A; Wilson, D

    2003-08-01

    Dandruff is a common problem in approximately 30% of the world's population. Reports in the literature regarding treatment of this condition with various antidandruff shampoos usually report the level of active ingredient within the formulation. However, we propose that a more important parameter relating to antidandruff efficacy is the amount of active ingredient delivered to the scalp from the shampoo. This report describes the results from two studies designed to investigate the relationship between the level of zinc pyrithione (ZnPTO) deposited onto the scalp and the resultant scalp condition. A double-blind randomized vehicle-controlled clinical study comparing three shampoos - a vehicle, a low-depositing ZnPTO shampoo and a high-depositing ZnPTO shampoo - was carried out in the U.K. with 53 panelists with dandruff or mild-to-moderate seborrheic dermatitis of the scalp. Both shampoos containing ZnPTO were significantly superior in antidandruff efficacy to the vehicle. Furthermore, the high-depositing ZnPTO shampoo was significantly superior compared with the low-depositing ZnPTO shampoo in terms of both antidandruff efficacy and antimycotic activity. Antidandruff performance and antimycotic activity of ZnPTO-containing shampoos is highly dependent on the amount of active ingredient delivered to the scalp. Furthermore, careful manipulation of the formulation parameters of an antidandruff shampoo can result in enhanced levels of delivery of the active ingredient without having to increase the level of active ingredient within the formulation. PMID:18494899

  13. A European approach to clinical investigator training.

    PubMed

    Boeynaems, Jean-Marie; Canivet, Cindy; Chan, Anthony; Clarke, Mary J; Cornu, Catherine; Daemen, Esther; Demotes, Jacques; Nys, Katelijne De; Hirst, Barry; Hundt, Ferdinand; Kassai, Behrouz; Kerpel-Fronius, Sandor; Kiessig, Lucy; Klech, Heinrich; Kraehenbuhl, Jean-Pierre; Lafolie, Pierre; Lucht, Martin; Niese, Detlef; Pauli-Magnus, Christiane; Peters, Barbara; Schaltenbrand, Ralf; Stockis, Armel; Stykova, Martina; Verheus, Nicolette; Klingmann, Ingrid

    2013-01-01

    A better education and training of clinical investigators and their teams is one of the factors that could foster the development of clinical research in Europe, a key objective of the Innovative Medicines Initiative (IMI). PharmaTrain (an IMI programme on training in medicines development), and European Clinical Research Infrastructures Network (ECRIN) have joined forces to address this issue. An advisory group composed of representatives of universities, pharmaceutical companies and other organisations met four times between June 2011 and July 2012. This resulted in a position paper proposing a strategy to improve and harmonize clinical investigator training in Europe, and including a detailed syllabus and list of learning outcomes. Major recommendations are the establishment of minimal and mutually recognized certification requirement for investigators throughout the EU and the creation of a European platform to provide a suitable course and examination infrastructure. PMID:24058345

  14. A European approach to clinical investigator training.

    PubMed

    Boeynaems, Jean-Marie; Canivet, Cindy; Chan, Anthony; Clarke, Mary J; Cornu, Catherine; Daemen, Esther; Demotes, Jacques; Nys, Katelijne De; Hirst, Barry; Hundt, Ferdinand; Kassai, Behrouz; Kerpel-Fronius, Sandor; Kiessig, Lucy; Klech, Heinrich; Kraehenbuhl, Jean-Pierre; Lafolie, Pierre; Lucht, Martin; Niese, Detlef; Pauli-Magnus, Christiane; Peters, Barbara; Schaltenbrand, Ralf; Stockis, Armel; Stykova, Martina; Verheus, Nicolette; Klingmann, Ingrid

    2013-09-09

    A better education and training of clinical investigators and their teams is one of the factors that could foster the development of clinical research in Europe, a key objective of the Innovative Medicines Initiative (IMI). PharmaTrain (an IMI programme on training in medicines development), and European Clinical Research Infrastructures Network (ECRIN) have joined forces to address this issue. An advisory group composed of representatives of universities, pharmaceutical companies and other organisations met four times between June 2011 and July 2012. This resulted in a position paper proposing a strategy to improve and harmonize clinical investigator training in Europe, and including a detailed syllabus and list of learning outcomes. Major recommendations are the establishment of minimal and mutually recognized certification requirement for investigators throughout the EU and the creation of a European platform to provide a suitable course and examination infrastructure.

  15. 78 FR 63988 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... at the registration Web site: http://continuingeducation.dcri.duke.edu/fda-clinical-investigators... your registration. (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) Attendees are...

  16. Clinical and Histopathological Investigation of Seborrheic Keratosis

    PubMed Central

    Roh, Nam Kyung; Hahn, Hyung Jin; Lee, Yang Won; Choe, Yong Beom

    2016-01-01

    Background Seborrheic keratosis (SK) is one of the most common epidermal tumors of the skin. However, only a few large-scale clinicohistopathological investigations have been conducted on SK or on the possible correlation between histopathological SK subtype and location. Objective The aim of this study was to analyze the clinical and histopathological features of a relatively large number of cases of diagnosed SK. Methods Two hundred and seventy-one pathology slides of skin tissue from patients with clinically diagnosed SK and 206 cases of biopsy-proven SK were analyzed. The biopsy-proven cases of SK were assessed for histopathological subclassification. The demographic, clinical, and histopathological data of the patients were collected for analysis of associated factors. Results The most frequent histopathological subtype was the acanthotic type, followed by mixed, hyperkeratotic, melanoacanthoma, clonal, irritated, and adenoid types; an unexpectedly high percentage (9.2%) of the melanoacanthoma variant was observed. The adenoid type was more common in sun-exposed sites than in sun-protected sites (p=0.028). Premalignant and malignant entities together represented almost one-quarter (24.2%) of the clinicopathological mismatch cases (i.e., mismatch between the clinical and histopathological diagnoses). Regarding the location of SK development, the frequency of mismatch for the sun-exposed areas was significantly higher than that for sun-protected areas (p=0.043). Conclusion The adenoid type was more common in sun-exposed sites. Biopsy sampling should be performed for lesions situated in sun-exposed areas to exclude other premalignant or malignant diseases. PMID:27081260

  17. Clinical features of dysthymia and age: a clinical investigation.

    PubMed

    Bellino, S; Patria, L; Ziero, S; Rocca, G; Bogetto, F

    2001-09-20

    A few authors have described the clinical picture of dysthymia in groups of elderly patients and pointed out differences from literature reports of dysthymia in younger adults. The present study, an attempt to analyze age effects on clinical characteristics of dysthymia throughout a lifetime, was performed in a sample of 106 patients, all aged > or =18 years, who were diagnosed according to DSM-IV. The patients were evaluated using: (1) a semistructured interview to assess clinical features, family history and previous treatments; (2) the Hamilton Depression Rating Scale; (3) the Interview for Recent Life Events; and (4) the Structured Clinical Interview for DSM-IV Disorders. Statistical analysis with stepwise logistic regression revealed that age was positively related to concomitant medical illnesses and to the total score of recent life events, but negatively related to the presence of avoidant or dependent personality disorders. The data suggested different etiologic pathways in older and younger patients. Dysthymia appeared to be associated in younger adults with abnormalities of personality; in the elderly, with a history of health problems and life losses.

  18. [CLINICAL INVESTIGATION OF AN EXCESSIVE SLEEPINESS COMPLAINT].

    PubMed

    Evangelista, Elisa; Barateau, Lucie; Dauvilliers, Yves

    2016-06-01

    Excessive sleepiness is a common problem, defined by a complaint of excessive daytime sleepiness almost daily with an inability to stay awake and alert dosing periods at sleep, with episodes of irresistible sleep need or drowsiness or non-intentional sleep, or by a night's sleep time overly extended often associated with sleep inertia. This sleepiness is variable in terms of phenotype and severity to be specified by the out-patient clinic. It is considered to be chronic beyond three months and often responsible for significant functional impairment of school and professional performance, of the accidents and cardiovascular risk. We need to decipher the causes of excessive sleepiness: sleep deprivation, toxic and iatrogenic, psychiatric disorders (including depression), non-psychiatric medical problems (obesity, neurological pathologies...), sleep disorders (as for example the sleep apnea syndrome), and finally the central hypersomnias namely narcolepsy type 1 and 2, idiopathic hypersomnia, and Kleine-Levin syndrome. If careful questioning often towards one of these etiologies, need most of the time a paraclinical balance with a sleep recording to confirm the diagnosis. Patients affected with potential central hypersomnia must be referred to the Sleep Study Centers that have the skills and the appropriate means to achieve this balance sheet. PMID:27538325

  19. Clinics in endocrinology and metabolism. Investigative procedures.

    PubMed

    Marshall, J C

    1975-11-01

    In patients with hypogonadism, the exact cause of the deficient androgenisation is not always clinically apparent. The data presented demonstrate that by means of hormone measurements, basally or after stimulation tests, the exact level of the lesion can usually be determined. This allows a decision with regard to appropriate therapy to be made on the basis of an accurate diagnosis. In many instances basal measurements of pituitary and gonadal hormones are all that is required to decide the level of the lesion. Care in interpreting basal levels is required, however, in view of methodological limitations and of known physiological variations with age, time of day and hour-to-hour fluctuations. If the basal hormone levels are borderline, or if the 'reserve function' of part or all of the hypothalamic-pituitary-gonadal axis needs to be assessed, than the appropriate stimulation test should be performed. The indication for these stimulation procedures and results obtained in different conditions are described and problems of interpretation discussed.

  20. Active Spacecraft Potential Control Investigation

    NASA Astrophysics Data System (ADS)

    Torkar, K.; Nakamura, R.; Tajmar, M.; Scharlemann, C.; Jeszenszky, H.; Laky, G.; Fremuth, G.; Escoubet, C. P.; Svenes, K.

    2016-03-01

    In tenuous plasma the floating potential of sunlit spacecraft reaches tens of volts, positive. The corresponding field disturbs measurements of the ambient plasma by electron and ion sensors and can reduce micro-channel plate lifetime in electron detectors owing to large fluxes of attracted photoelectrons. Also the accuracy of electric field measurements may suffer from a high spacecraft potential. The Active Spacecraft Potential Control (ASPOC) neutralizes the spacecraft potential by releasing positive charge produced by indium ion emitters. The method has been successfully applied on other spacecraft such as Cluster and Double Star. Two ASPOC units are present on each spacecraft. Each unit contains four ion emitters, whereby one emitter per instrument is operated at a time. ASPOC for the Magnetospheric Multiscale (MMS) mission includes new developments in the design of the emitters and the electronics. New features include the use of capillaries instead of needles, new materials for the emitters and their internal thermal insulators, an extended voltage and current range of the electronics, both for ion emission and heating purposes, and a more capable control software. This enables lower spacecraft potentials, higher reliability, and a more uniform potential structure in the spacecraft's sheath compared to previous missions. Results from on-ground testing demonstrate compliance with requirements. Model calculations confirm the findings from previous applications that the plasma measurements will not be affected by the beam's space charge. Finally, the various operating modes to adapt to changing boundary conditions are described along with the main data products.

  1. Understanding clinical investigations in children's endocrinology.

    PubMed

    Davies, Kate; Collin, Jacqueline

    2015-10-01

    Children and young people referred to paediatric endocrinology services present with a wide range of illnesses and disorders varying from minor to life-threatening conditions. This article introduces the role of the children's endocrine nurse in caring for children and families undergoing investigations that are frequently undertaken to identify specific problems associated with pituitary, adrenal and thyroid glands. Although children with endocrine problems may be cared for in specialist centres, they may also present, for other health reasons, in secondary and primary care. In schools some children may need teachers to administer emergency medication. There is a high incidence of children diagnosed with growth hormone deficiency and an even higher incidence of congenital hypothyroidism. These children would benefit from health professionals having a broader understanding of their conditions. This article--the third in the endocrinology nursing series--aims to disseminate information and educate colleagues in children's nursing to raise the profile of children with long-term endocrine conditions.

  2. Gamete activation: basic knowledge and clinical applications

    PubMed Central

    Tosti, Elisabetta; Ménézo, Yves

    2016-01-01

    Background The first clues to the process of gamete activation date back to nearly 60 years ago. The mutual activation of gametes is a crucial event during fertilization. In the testis and ovaries, spermatozoa and oocytes are in a state of meiotic and metabolic quiescence and require reciprocal signals in order to undergo functional changes that lead to competence for fertilization. First, the oocyte activates sperm by triggering motility, chemoattraction, binding and the acrosome reaction, culminating with the fusion of the two plasma membranes. At the end of this cascade of events, collectively known as sperm capacitation, sperm-induced oocyte activation occurs, generating electrical, morphological and metabolic modifications in the oocyte. Objective and rationale The aim of this review is to provide the current state of knowledge regarding the entire process of gamete activation in selected specific animal models that have contributed to our understanding of fertilization in mammals, including humans. Here we describe in detail the reciprocal induction of the two activation processes, the molecules involved and the mechanisms of cell interaction and signal transduction that ultimately result in successful embryo development and creation of a new individual. Search methods We carried out a literature survey with no restrictions on publication date (from the early 1950s to March 2016) using PubMed/Medline, Google Scholar and Web of Knowledge by utilizing common keywords applied in the field of fertilization and embryo development. We also screened the complete list of references published in the most recent research articles and relevant reviews published in English (both animal and human studies) on the topics investigated. Outcomes Literature on the principal animal models demonstrates that gamete activation is a pre-requisite for successful fertilization, and is a process common to all species studied to date. We provide a detailed description of the dramatic

  3. Zirconia abutments and restorations: from laboratory to clinical investigations.

    PubMed

    Ferrari, M; Vichi, A; Zarone, F

    2015-03-01

    In last years the use of zirconia in dentistry has become very popular. Unfortunately, the clinical indications for a dental use of zirconia are not completely clear yet, neither are their limitations. The objective of this review was to evaluate the basic science knowledge on zirconia and to discuss some aspects of the clinical behavior of zirconia-based restorations. In particular, one of the goals was highlighting the possible correlation between in vitro and in vivo studies. The definition of concepts like success, survival and failure was still debated and the correlation between in vitro results and predictability of clinical behavior was investigated. PMID:25576437

  4. 78 FR 55262 - Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ..., studies using foods or dietary supplements, studies using endogenous compounds, pathogenesis studies using... regulations to a planned clinical investigation. In the Federal Register of October 14, 2010 (75 FR...

  5. Cost and effectiveness of clinical investigation: the state of the art.

    PubMed

    Clarke, R M; Mason, B; Leeder, S R

    1980-10-01

    Clinical investigation by means of special technical tests has increased in clinical practice during recent years. Pressures causing this increase are said to include: rapid technological change making many more tests available, clinical uncertainty, peer pressure, greater patient awareness, and concern for diagnostic completeness. Cost factors do not appear to have influenced test-ordering behaviour to any large extent, and those ordering investigations are frequently ignorant of the cost of the test which they are ordering, both to the patient and the community. The relation of clinical investigational activity to quality of outcome of patient care remains largely unestablished. Studies of the possible modification of test-ordering behaviour through educational and institutional policy pressures are reviewed. A rational approach to investigating the effectiveness of techniques designed to encourage the more economic and effective use of investigations is presented in brief on the basis of this review of previously published work.

  6. Investigation into stereoselective pharmacological activity of phenotropil.

    PubMed

    Zvejniece, Liga; Svalbe, Baiba; Veinberg, Grigory; Grinberga, Solveiga; Vorona, Maksims; Kalvinsh, Ivars; Dambrova, Maija

    2011-11-01

    Phenotropil [N-carbamoylmethyl-4-aryl-2-pyrrolidone (2-(2-oxo-4-phenyl-pyrrolidin-1-yl) acetamide; carphedon)] is clinically used in its racemic form as a nootropic drug that improves physical condition and cognition. The aim of this study was to compare the stereoselective pharmacological activity of R- and S-enantiomers of phenotropil in different behavioural tests. Racemic phenotropil and its enantiomers were tested for locomotor, antidepressant and memory-improving activity and influence on the central nervous system (CNS) using general pharmacological tests in mice. After a single administration, the amount of compound in brain tissue extracts was determined using an ultra performance liquid chromatography-tandem mass spectrometry (UPLC/MS/MS) method in a positive ion electrospray mode. In the open-field test, a significant increase in locomotor activity was observed after a single administration of R-phenotropil at doses of 10 and 50 mg/kg and S-phenotropil at a dose of 50 mg/kg. In the forced swim test, R-phenotropil induced an antidepressant effect at doses of 100 and 50 mg/kg, and S-phenotropil was active at a dose of 100 mg/kg. R-phenotropil significantly enhanced memory function in a passive avoidance response test at a dose of 1 mg/kg; the S-enantiomer did not show any activity in this test. However, the concentrations of R- and S-phenotropils in brain tissue were similar. In conclusion, the antidepressant and increased locomotor activity relies on both R- and S-phenotropils, but the memory-improving activity is only characteristic of R-phenotropil. These results may be important for the clinical use of optically pure isomers of phenotropil.

  7. Math Activities Using LogoWriter--Investigations.

    ERIC Educational Resources Information Center

    Flewelling, Gary

    This book is one in a series of teacher resource books developed to: (1) rescue students from the clutches of computers that drill and control; and (2) supply teachers with computer activities compatible with a mathematics program that emphasizes investigation, problem solving, creativity, and hypothesis making and testing. This is not a book…

  8. [Antiarrhythmic drug allapinin: review of results of clinical investigation].

    PubMed

    Sokolov, S F; Dzhakhangirov, F N

    2002-01-01

    Antiarrhythmic drug allapinin has been used in clinical practice for a long time but data of investigation of its effects and mechanism of action are scanty. The aim of this review is to summarize results of clinical studies of allapinin supplementing them with personal unpublished data. The review embraces pharmacokinetics and pharmacodynamics of the drug, its efficacy in the treatment of various cardiac rhythm disturbances and side effects. The conclusion is made that clinical application of allapinin as class 1C antiarrhythmic drug according to Vaughan-Williams classification should be guided by general recommendations concerning indications and contraindications for this class of antiarrhythmic drugs. Special feature of allapinin is its high efficacy for prevention of attacks of paroxysmal atrial fibrillation.

  9. A history of the American Society for Clinical Investigation

    PubMed Central

    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

  10. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... HUMAN SERVICES Food and Drug Administration Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for Industry, Clinical Investigators, Institutional Review Boards and... entitled ``Design Considerations for Pivotal Clinical Investigations for Medical Devices.'' This...

  11. Education of research ethics for clinical investigators with Moodle tool

    PubMed Central

    2013-01-01

    Background In clinical research scientific, legal as well as ethical aspects are important. It is well known that clinical investigators at university hospitals have to undertake their PhD-studies alongside their daily work and reconciling work and study can be challenging. The aim of this project was to create a web based course in clinical research bioethics (5 credits) and to examine whether the method is suitable for teaching bioethics. The course comprised of six modules: an initial examination (to assess knowledge in bioethics), information on research legislation, obtaining permissions from authorities, writing an essay on research ethics, preparing one’s own study protocol, and a final exam. All assignments were designed with an idea of supporting students to reflect on their learning with their own research. Methods 57 PhD-students (medical, nursing and dental sciences) enrolled and 46 completed the course. Course evaluation was done using a questionnaire. The response rate was 78%. Data were analyzed using quantitative methods and qualitative content analysis. Results The course was viewed as useful and technically easy to perform. Students were pleased with the guidance offered. Personal feedback from teachers about students’ own performance was seen advantageous and helped them to appreciate how these aspects could be applied their own studies. The course was also considered valuable for future research projects. Conclusions Ethical issues and legislation of clinical research can be understood more easily when students can reflect the principles upon their own research project. Web based teaching environment is a feasible learning method for clinical investigators. PMID:24330709

  12. Cefuroxime: antimicrobial activity, Pharmacology, and clinical efficacy.

    PubMed

    Smith, B R; LeFrock, J L

    1983-06-01

    The antimicrobial activity, pharmacology, toxicity, and clinical efficacy of cefuroxime are reviewed. Cefuroxime has a second-generation cephalosporin spectrum of activity similar to cefamandole. Addition of a methoxyimino side chain has enhanced its beta-lactamase stability. Cefuroxime is active against certain cephalothin-, cefamandole-, and gentamicin-resistant bacteria. Cefuroxime has an extended half-life which allows dosing every 8 h. If penetrates into bodily tissues and fluids, including the cerebrospinal fluid, in therapeutic concentrations. Cefuroxime has been used successfully in the treatment of meningitis; sepsis; urinary tract, bone and joint, pulmonary, skin, and soft tissue infections; and gonorrhea. Competitive pricing of cefuroxime should provide a cost-effective substitute for cefamandole and, in certain situations, third-generation cephalosporins.

  13. NAA TECHNIQUE FOR CLINICAL INVESTIGATION OF MICE IMMUNIZED WITH BOTHROP VENOM

    SciTech Connect

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

    2009-06-03

    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. Modified Activated Carbon to be Used in Clinical Applications

    NASA Astrophysics Data System (ADS)

    Fernando, M. S.; de Silva, W. R. M.; de Silva, K. M. N.

    2014-11-01

    In this study a novel nano composite of hydroxyapatite nano particles impregnated activated carbon (C-HAp), which was synthesized in our own method, was used in iron adsorption studies. The study was conducted in order to investigate the potential of using C-HAp nanocomposite to be used in clinical detoxifications such as acute iron toxicity where the use of Activated carbon (GAC) is not very effective. Adsorption studies were conducted for synthetic solutions of Fe2+, Fe3+ and iron syrup using GAC, C-HAp and neat HAp as adsorbents. According to the results C-HAp nano composite showed improved properties than GAC in adsorbing Fe2+, Fe3+ and also Fe ions in iron syrup solutions. Thus the results of the in-vitro studies of iron adsorption studies indicated the potential of using C-HAp as an alternative to activated carbon in such clinical applications.

  15. Chronic idiopathic and secondary neutropenia: clinical and serological investigations.

    PubMed

    van der Veen, J P; Hack, C E; Engelfriet, C P; Pegels, J G; von dem Borne, A E

    1986-05-01

    Clinical data on 49 patients with chronic idiopathic neutropenia (CIN) and 42 patients with neutropenia secondary to a well-defined immunological disorder (SN) were collected and related to serological parameters. In 47% of the patients with CIN and 53% of those with SN, a positive direct immunofluorescence test was obtained with granulocytes from the patients. In the sera from the patients in the two groups, antibodies against donor granulocytes were detected by the indirect immunofluorescence test, the leucoagglutination test and/or the granulocytotoxicity test in 15%, 19% and 15%, respectively. The results of the above tests could not be correlated with any clinical or haematological parameter. Immune complexes in the serum were detected by the 125I-Clq-binding test in 29% of patients with CIN and in 58% of those with SN. The presence of serum immune complexes correlated well with the existence of a low neutrophil count, but not with the presence of recurrent infections, with bone-marrow abnormalities, or with positive reactions in other serological tests. The sera of eight out of 14 patients with CIN and seven out of 12 patients with SN had inhibitory activity for myeloid colony formation in vitro (CFU-GM). This CFU-GM inhibitory activity was correlated with the presence of recurrent infections and with hypoplasia of the myeloid compartment of the bone marrow, but not with positive reactions in other tests. We conclude that the 125I-Clq-binding test probably detects circulating immune complexes that induce a shift neutropenia, whereas serum activity inhibitory for CFU-GM possibly relates to clinically more serious forms of neutropenia. The significance of neutrophil-bound Ig and granulocyte-reactive antibodies in the serum is not clear.

  16. [Clinical application of skin sympathetic nerve activity].

    PubMed

    Iwase, Satoshi

    2009-03-01

    Skin sympathetic nerve activity (SSNA) is microneurographically recorded from the skin nerve fascicle in the peripheral nerves. It is characterized by the following features: 1) irregular, pulse asynchronous, burst activity with respiratory variation, 2) burst activity followed by vasoconstriction and/or sweating, 3) elicited by mental stress and arousal stimuli, e.g., sound, pain, electric stimulation, 4) burst with longer duration as compared with sympathetic outflow to muscles, and 5) burst activity following sudden inspiratory action. It comprises vasoconstrictor (VC) and sudomotor(SM) activity, as well as vasodilator (VD) activity. VC and SM discharge independently, whereas VD is the same activity with different neurotransmission. The VC and SM are differentiated by effector response, e.g., laser Doppler flowmetry and skin potential changes. SSNA function in thermoregulation in the human body; however it is also elicited by mental stress. SSNA is the lowest at thermoneutral ambient temperature (approximately 27 degrees C), and is enhanced in the pressence of ambient warm and cool air. The burst amplitude is well-correlated to both skin blood flow reduction rate or sweat rate change. The clinical application of SSNA comprises the following: 1) clarification of sweating phenomenon, 2) clarification and diagnosis of anhidrosis, 3) clarification and diagnosis of hyperhidrosis, 4) clarification of thermoregulatory function and diagnosis of thermoregulatory disorder, 5) clarification of pathophysiology and diagnosis of vascular diseases, e.g., Raynaud and Buerger diseases. 6) clarification of the relation between cognitive function and SSNA and 7) determination of pharmacological effect attributable to change in neuroeffector responses. PMID:19301594

  17. Geometric investigation of a gaming active device

    NASA Astrophysics Data System (ADS)

    Menna, Fabio; Remondino, Fabio; Battisti, Roberto; Nocerino, Erica

    2011-07-01

    3D imaging systems are widely available and used for surveying, modeling and entertainment applications, but clear statements regarding their characteristics, performances and limitations are still missing. The VDI/VDE and the ASTME57 committees are trying to set some standards but the commercial market is not reacting properly. Since many new users are approaching these 3D recording methodologies, clear statements and information clarifying if a package or system satisfies certain requirements before investing are fundamental for those users who are not really familiar with these technologies. Recently small and portable consumer-grade active sensors came on the market, like TOF rangeimaging cameras or low-cost triangulation-based range sensor. A quite interesting active system was produced by PrimeSense and launched on the market thanks to the Microsoft Xbox project with the name of Kinect. The article reports the geometric investigation of the Kinect active sensors, considering its measurement performances, the accuracy of the retrieved range data and the possibility to use it for 3D modeling application.

  18. [The Clinical Investigation Centers in France: Whatzat? What for? How does it work?].

    PubMed

    Montagne, O; Le Corvoisier, P

    2008-01-01

    For the last 15 years, French university-affiliated hospitals have dramatically modified how biomedical research is conducted in France. Multidisciplinary and technically complex research projects are increasingly difficult to conduct in clinical units. To ensure quality, good clinical practice, and security, platforms dedicated to clinical research with specific staff have been implanted. These units, called Clinical Investigation Centers (CICs), are open to academic and industrial investigators working in the medical fields involving patients and healthy volunteers. The CICs' activities are always closely related to the university hospital research programs and can also serve as a tool for locally implanted clinical and fundamental research teams (INSERM). Nowadays, clinical research requires specific tools and platforms. To enhance French university hospital research efficiency and provide a more open research environment, all investigators, on-site as well as from other institutions, are invited to use these cohesive research facilities and skills to conduct protocols that are fully adapted to their needs in optimal conditions of professional clinical research. PMID:18401306

  19. Emotion Understanding in Clinically Anxious Children: A Preliminary Investigation.

    PubMed

    Bender, Patrick K; Pons, Francisco; Harris, Paul L; Esbjørn, Barbara H; Reinholdt-Dunne, Marie L

    2015-01-01

    Children's understanding of the nature, origins and consequences of emotions has been intensively investigated over the last 30-40 years. However, few empirical studies have looked at the relation between emotion understanding and anxiety in children and their results are mixed. The aim of the present study was to perform a preliminary investigation of the relationships between emotion understanding, anxiety, emotion dysregulation, and attachment security in clinically anxious children. A sample of 16 clinically anxious children (age 8-12, eight girls/boys) was assessed for emotion understanding (Test of Emotion Comprehension), anxiety (Screening for Child Anxiety Related Emotional Disorders-Revised and Anxiety Disorder Interview Schedule), emotion dysregulation (Difficulties in Emotion Regulation Scale) and attachment security (Security Scale). Children who reported more overall anxiety also reported greater difficulties in regulating their emotions, and were less securely attached to their parents. The results also showed that more specific symptoms of anxiety (i.e., OCD and PTSD) correlated not only with emotion dysregulation and attachment insecurity but also with emotion understanding. Finally, there were interrelations among emotion understanding, attachment security, and emotion dysregulation. The present results provide the first comprehensive evidence for a socio-emotional framework and its relevance to childhood anxiety.

  20. Investigation of biofilm formation in clinical isolates of Staphylococcus aureus.

    PubMed

    Cassat, James E; Smeltzer, Mark S; Lee, Chia Y

    2014-01-01

    Invasive methicillin-resistant Staphylococcus aureus (MRSA) infections are often characterized by recalcitrance to antimicrobial therapy, which is a function not only of widespread antimicrobial resistance among clinical isolates, but also the capacity to form biofilms. Biofilms consist of ordered populations of bacterial colonies encased in a polysaccharide and/or proteinaceous matrix. This unique physiologic adaptation limits penetration of antimicrobial molecules and innate immune effectors to the infectious focus, increasing the likelihood of treatment failure and progression to chronic infection. Investigation of mechanisms of biofilm formation and dispersal, as well as the physiologic adaptations to the biofilm lifestyle, is therefore critical to developing new therapies to combat MRSA infections. In this chapter, we describe two in vitro methods for the investigation of staphylococcal biofilm formation, a microtiter plate-based assay of biofilm formation under static conditions and a flow cell-based assay of biofilm formation under fluid shear. We also detail an in vivo murine model of catheter-associated biofilm formation that is amenable to imaging and microbiologic analyses. Special consideration is given to the conditions necessary to support biofilm formation by clinical isolates of S. aureus. PMID:24085698

  1. Emotion Understanding in Clinically Anxious Children: A Preliminary Investigation

    PubMed Central

    Bender, Patrick K.; Pons, Francisco; Harris, Paul L.; Esbjørn, Barbara H.; Reinholdt-Dunne, Marie L.

    2015-01-01

    Children’s understanding of the nature, origins and consequences of emotions has been intensively investigated over the last 30–40 years. However, few empirical studies have looked at the relation between emotion understanding and anxiety in children and their results are mixed. The aim of the present study was to perform a preliminary investigation of the relationships between emotion understanding, anxiety, emotion dysregulation, and attachment security in clinically anxious children. A sample of 16 clinically anxious children (age 8–12, eight girls/boys) was assessed for emotion understanding (Test of Emotion Comprehension), anxiety (Screening for Child Anxiety Related Emotional Disorders-Revised and Anxiety Disorder Interview Schedule), emotion dysregulation (Difficulties in Emotion Regulation Scale) and attachment security (Security Scale). Children who reported more overall anxiety also reported greater difficulties in regulating their emotions, and were less securely attached to their parents. The results also showed that more specific symptoms of anxiety (i.e., OCD and PTSD) correlated not only with emotion dysregulation and attachment insecurity but also with emotion understanding. Finally, there were interrelations among emotion understanding, attachment security, and emotion dysregulation. The present results provide the first comprehensive evidence for a socio-emotional framework and its relevance to childhood anxiety. PMID:26733909

  2. Clinical activity of alvocidib (flavopiridol) in acute myeloid leukemia.

    PubMed

    Zeidner, Joshua F; Karp, Judith E

    2015-12-01

    There have been minimal therapeutic advancements in acute myeloid leukemia (AML) over the past 4 decades and outcomes remain unsatisfactory. Alvocidib (formerly flavopiridol) is a multi-serine threonine cyclin-dependent kinase inhibitor with demonstrable in vitro and clinical activity in AML when combined in a timed sequential chemotherapy regimen, FLAM (alvocidib followed by cytarabine continuous infusion and mitoxantrone). FLAM has been evaluated in sequential phase 1 and phase 2 studies in 149 and 256 relapsed/refractory and newly diagnosed non-favorable risk AML patients, respectively, with encouraging findings in both patient populations warranting further investigation. This review highlights the mechanism of action of alvocidib, pre-clinical studies of alvocidib in AML, and the clinical trials evaluating alvocidib alone and in combination with cytotoxic agents (FLAM) in AML.

  3. Clinical activity of alvocidib (flavopiridol) in acute myeloid leukemia.

    PubMed

    Zeidner, Joshua F; Karp, Judith E

    2015-12-01

    There have been minimal therapeutic advancements in acute myeloid leukemia (AML) over the past 4 decades and outcomes remain unsatisfactory. Alvocidib (formerly flavopiridol) is a multi-serine threonine cyclin-dependent kinase inhibitor with demonstrable in vitro and clinical activity in AML when combined in a timed sequential chemotherapy regimen, FLAM (alvocidib followed by cytarabine continuous infusion and mitoxantrone). FLAM has been evaluated in sequential phase 1 and phase 2 studies in 149 and 256 relapsed/refractory and newly diagnosed non-favorable risk AML patients, respectively, with encouraging findings in both patient populations warranting further investigation. This review highlights the mechanism of action of alvocidib, pre-clinical studies of alvocidib in AML, and the clinical trials evaluating alvocidib alone and in combination with cytotoxic agents (FLAM) in AML. PMID:26521988

  4. 77 FR 34958 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... Investigators, and Sponsors: Considerations When Transferring Clinical Investigation Oversight to Another... ``Considerations When Transferring Clinical Investigation Oversight to Another IRB.'' The draft guidance discusses... IRB to another IRB. The draft guidance also addresses questions that have been previously...

  5. Clinical symptom presentation in suspected malingerers: an empirical investigation.

    PubMed

    Kucharski, L T; Ryan, W; Vogt, J; Goodloe, E

    1998-01-01

    To empirically investigate the usefulness and validity of clinical presentation and recent history variables in the detection of malingered psychiatric disorder, 30 criminal defendants involved in forensic evaluations, who had a documented history of psychiatric hospitalization preceding their arrest on the instant offense (low risk of malingering group) and 30 defendants who complained of psychiatric difficulties but had no history of psychiatric hospitalization or treatment (suspected malingering group) were studied. Each subject's mental status was rated, blind to psychiatric history, diagnosis, and psycholegal opinions, on a Likert-like scale for the uncommon nature of their symptom presentation. In addition, the final outcome of the court cases, whether they were found competent to stand trial, not guilty by reason of insanity, or evidenced diminished capacity was determined by obtaining the court disposition in each case. Based on the unusual nature of their presentation, the defendants suspected of malingering were discriminated from the low risk of malingering defendants with a 90 percent rate of correct classification. Suspected malingerers were found to evidence current psychiatric presentations inconsistent with their recent Global Assessment of Functioning, unusual symptom presentation, and hallucinatory experiences rated as atypical for psychiatric disorder. A high proportion of suspected malingerers were found competent to proceed. The results are discussed in terms of the usefulness of clinical identification of malingering.

  6. 76 FR 70151 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ...The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.'' This guidance document has been developed to promote the initiation of clinical investigations to evaluate medical devices under FDA's IDE regulations. In an effort to promote timely clinical investigations in......

  7. Preliminary clinical investigations of a new noninvasive venous pulse oximeter

    NASA Astrophysics Data System (ADS)

    Chan, Daniel; Smith, Peter R.; Caine, Michael P.; Spyt, Tomasz; Boehm, Maria; Machin, David

    2003-10-01

    For decades, the monitoring of mixed venous oxygen saturation, SvO2 has been performed invasively using fibre-optic catheters. This procedure is not without risk as complications may arise from catheterisation. The group has devised a new non-invasive venous oximetry method which involves inducing regular modulations of the venous blood volume and associated measurement of those modulations using optical means. A clinical investigation was conducted in Glenfield Hospital, UK to evaluate the sensitivity of the new technique to haemodynamic changes such as Cardiac Output (CO) in intraoperative and postoperative cardiac patients. Preliminary trials on patients recovering from cardiac surgery yielded an average correlation of r = 0.72 between CO at different Intra Aortic Balloon Pump (IABP) augmentation levels and SvO2 measured by the new venous oximeter. In intraoperative patients undergoing off-pump cardiac surgery, SvO2 recorded by the new technique responded to unplanned events such as a cardiac arrest. CONCLUSION: The new venous oximetry technique is a promising technique which responds to haemodynamic changes such as CO and with further development might offer an alternative means of monitoring SvO2 non-invasively.

  8. 76 FR 50484 - Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-15

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for Medical Devices; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The...

  9. Investigating Nitrogen Pollution: Activities and Models.

    ERIC Educational Resources Information Center

    Green Teacher, 2000

    2000-01-01

    Introduces activities on nitrogen, nitrogen pollution from school commuters, nitrogen response in native and introduced species, and nutrient loading models. These activities help students determine the nitrogen contribution from their parents' cars, test native plant responses to nitrogen, and experiment with the results of removing water from…

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

    PubMed

    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

  11. 76 FR 20707 - Notice of Possible Shutdown of Investigative Activities

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... determined to shut down its investigative activities in the event of the absence of an appropriation. FOR... shut down its investigative activities for the duration of the absence of appropriation....

  12. [Investigation of physical activity among adults].

    PubMed

    Meboniia, N M; Kalandadze, I L; Chachava, T D; Sadzhaia, M V

    2006-06-01

    Lack of physical activity as well as smoking, overweight, high blood cholesterol level and hypertension are independent risk factors for development of various chronic diseases. Lack of physical activity is a main cause of non-communicable diseases morbidity and mortality in about 23% of cases (WHO, 2002). Goal of the survey was the identification and characteristics of physical activity among adults. We conducted epidemiologic survey among the school-children and students in Tbilisi. Survey was carried out in 40 schools from all regions of Tbilisi and 9 state and private institutes. Schools were selected by randomized trail in each region of Tbilisi and in each school were questioned all teen-agers from 14-17 year old. For selecting group of survey was used method of "proportional probability of value". There were questioned 2 500 school children and 1000 students, 38% boys and 62% girls. The results of survey ascertained that 23,5%-39,5% of respondents are training or engaged in sport everyday, or several times per week; 17,2% - once in a month; 9,3% once in a year; or 10,5% - never. Adults are less informed about useful effect of physical activity. Respondents had different point of on the role of physical activity: some of them thought it controls weight; others - prevents development of different diseases; the rest thinks that it copes with psycho-emotional stress, and none of them precise about effectiveness of physical activity in all cases mentioned above. Propaganda of healthy life stile must be associated with the effectiveness of physical activity on health.

  13. A fluid collection system for dermal wounds in clinical investigations.

    PubMed

    Klopfer, Michael; Banyard, Derek; Li, G-P; Widgerow, Alan; Bachman, Mark

    2016-03-01

    In this work, we demonstrate the use of a thin, self adherent, and clinically durable patch device that can collect fluid from a wound site for analysis. This device is manufactured from laminated silicone layers using a novel all-silicone double-molding process. In vitro studies for flow and delivery were followed by a clinical demonstration for exudate collection efficiency from a clinically presented partial thickness burn. The demonstrated utility of this device lends itself for use as a research implement used to clinically sample wound exudate for analysis. This device can serve as a platform for future integration of wearable technology into wound monitoring and care. The demonstrated fabrication method can be used for devices requiring thin membrane construction.

  14. Good clinical practice regulatory inspections: Lessons for Indian investigator sites

    PubMed Central

    Marwah, R.; Van de Voorde, K.; Parchman, J.

    2010-01-01

    Regulatory inspections are important to evaluate the integrity of the data submitted to health authorities (HAs), protect patient safety, and assess adequacy of site/sponsor quality systems to achieve the same. Inspections generally occur after submission of data for marketing approval of an investigational drug. In recent years, there has been a significant increase in number of inspections by different HAs, including in India. The assessors/inspectors generally do a thorough review of site data before inspections. All aspects of ICH-GCP, site infrastructure, and quality control systems are assessed during the inspection. Findings are discussed during the close out meeting and a detailed inspection report issued afterward, which has to be responded to within 15–30 days with effective Corrective and Preventive Action Plan (CAPA). Protocol noncompliance, inadequate/inaccurate records, inadequate drug accountability, informed consent issues, and adverse event reporting were some of the most common findings observed during recent Food and Drug Administration (FDA) inspections. Drug development is being increasingly globalized and an increased number of patients enrolled in studies submitted as part of applications come from all over the world including India. Because of the steep increase in research activity in the country, inexperienced sites, and more stakeholders, increased efforts will be required to ensure continuous quality and compliance. HAs have also made clear that enforcement will be increased and be swift, aggressive, and effective. PMID:21350732

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

    PubMed Central

    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

  16. Miniaturization and globalization of clinical laboratory activities.

    PubMed

    Melo, Murilo R; Clark, Samantha; Barrio, Daniel

    2011-04-01

    Clinical laboratories provide an invaluable service to millions of people around the world in the form of quality diagnostic care. Within the clinical laboratory industry the impetus for change has come from technological development (miniaturization, nanotechnology, and their collective effect on point-of-care testing; POCT) and the increasingly global nature of laboratory services. Potential technological gains in POCT include: the development of bio-sensors, microarrays, genetics and proteomics testing, and enhanced web connectivity. In globalization, prospective opportunities lie in: medical tourism, the migration of healthcare workers, cross-border delivery of testing, and the establishment of accredited laboratories in previously unexplored markets. Accompanying these impressive opportunities are equally imposing challenges. Difficulty transitioning from research to clinical use, poor infrastructure in developing countries, cultural differences and national barriers to global trade are only a few examples. Dealing with the issues presented by globalization and the impact of developing technology on POCT, and on the clinical laboratory services industry in general, will be a daunting task. Despite such concerns, with appropriate countermeasures it will be possible to address the challenges posed. Future laboratory success will be largely dependent on one's ability to adapt in this perpetually shifting landscape.

  17. 21 CFR 312.40 - General requirements for use of an investigational new drug in a clinical investigation.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... new drug in a clinical investigation. 312.40 Section 312.40 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Administrative Actions § 312.40 General requirements for use of an investigational new drug in...

  18. Chronic psychosis in epilepsy. A clinical investigation of 29 patients.

    PubMed

    Parnas, J; Korsgaard, S; Krautwald, O; Jensen, P S

    1982-10-01

    A clinical study comprising psychiatric, psychological and neurological examination of 29 patients suffering from long-term psychosis and severe epilepsy was performed. Only five patients fulfilled the diagnostic criteria of schizophrenia. They differed from the rest of the patients by being less organic and having infrequent laterality to the left of their epileptogenic focus. They were regarded as genuine schizophrenics, while the pathogenesis of the remaining sample was considered multifactorial, including both organic and psycho-social causes. PMID:6816012

  19. Acute febrile torticollis in youth: clinical investigation and current management.

    PubMed

    Ouattassi, Naouar; Chmiel, Mohammed; El Kerouiti, Zakaria; Ridal, Mohammed; Alami, Mohammed Nouredine

    2015-01-01

    Acute febrile torticollis in children is a rare and a special clinical picture of variable causes. It may indicate an inflammatory or an infectious pathology affecting any of the anatomical structures of the neck. Treatment is quite clearly defined, and it may be a therapeutic emergency. It is a condition that all ENT specialists must be familiar with since they are most likely to be the first physician to whom such a child is brought.

  20. Acute febrile torticollis in youth: clinical investigation and current management

    PubMed Central

    Ouattassi, Naouar; Chmiel, Mohammed; Kerouiti, Zakaria El; Ridal, Mohammed; Alami, Mohammed Nouredine

    2015-01-01

    Acute febrile torticollis in children is a rare and a special clinical picture of variable causes. It may indicate an inflammatory or an infectious pathology affecting any of the anatomical structures of the neck. Treatment is quite clearly defined, and it may be a therapeutic emergency. It is a condition that all ENT specialists must be familiar with since they are most likely to be the first physician to whom such a child is brought PMID:26328000

  1. Subcortical arteriosclerotic encephalopathy: a clinical and radiological investigation.

    PubMed Central

    Loizou, L A; Kendall, B E; Marshall, J

    1981-01-01

    Subcortical arteriosclerotic encephalopathy (Binswanger's type) was diagnosed in a group of patients with hypertension or arteriosclerosis, who showed acute and subacute neurological deficits, dementia, reduced cerebral blood flow, and white matter low attenuation with mild atrophy and infarcts as the predominant CT scan features. This set of clinical and radiological criteria could be used to make the diagnosis in life, as confirmed neuropathologically in one patient. Images PMID:7241156

  2. Investigational cancer drugs targeting cell metabolism in clinical development

    PubMed Central

    Sborov, Douglas W; Haverkos, Bradley M; Harris, Pamela J

    2015-01-01

    Introduction Malignant cell transformation and tumor progression are associated with alterations in glycolysis, fatty acid synthesis, amino acid delivery and production of reactive oxygen species. With increased understanding of the role of metabolism in tumors, there has been interest in developing agents that target tumor specific metabolic pathways. Numerous promising agents targeting altered metabolic pathways are currently in Phase I – III clinical trials. Areas covered This paper reviews the early phase clinical trial development of these agents and provides perspective on the future direction of this emerging field. Specifically, the authors describe novel and repurposed therapies, focusing on the effects of each agent on tumor metabolism and results from relevant Phase I and II clinical trials. Expert opinion Metabolism modulating agents, alone and in combinations with other classes of agents, have shown efficacy in the treatment of neoplasm, which, the authors believe, will bear positive results in future studies. Because of the significant crosstalk between metabolic pathways and oncogenic signaling pathways, the authors also believe that combining metabolic modifiers with targeted agents will be an important strategy. An increased understanding of cancer metabolism, in addition to the continued study of metabolic modulators, should lead to further advances in this nascent therapeutic field in the future. PMID:25224845

  3. ESU safety and the clinical engineer: purchasing, preventive maintenance, incident investigation.

    PubMed

    Knickerbocker, G G

    1980-01-01

    The clinical engineer and his or her staff, by virtue of their responsibility for the equipment control program, can make a significant contribution in assuring that electrosurgical units and their accessories are effective and cause minimal harm to patients and staff. This is accomplished not only through the preventive maintenance/periodic inspection/repair functions that they are so well known for providing, but also through their active participation in the process of equipment selection and in the investigation of incidents suspected of arising from the use of these devices. This article outlines specific responsibilities in each of these three areas, including a detailed periodic inspection program for electrosurgical units. PMID:7453598

  4. In-vivo neutron activation analysis: principles and clinical applications

    SciTech Connect

    Cohn, S.H.

    1982-01-01

    In vivo neutron activation has opened a new era of both clinical diagnosis and therapy evaluation, and investigation into and modelling of body composition. The techniques are new, but it is already clear that considerable strides can be made in increasing accuracy and precision, increasing the number of elements susceptible to measurement, enhancing uniformity, and reducing the dose required for the measurement. The work presently underway will yield significant data on a variety of environmental contaminants such as Cd. Compositional studies are determining the level of vital constituents such as nitrogen and potassium in both normal subjects and in patients with a variety of metabolic disorders. Therapeutic programs can be assessed while in progress. It seems likely that by the end of this century there will have been significant progress with this research tool, and exciting insights obtained into the nature and dynamics of human body composition.

  5. Clinical applications of in vivo neutron-activation analysis

    SciTech Connect

    Cohn, S.H.

    1982-01-01

    In vivo neutron activation has opened a new era of both clinical diagnosis and therapy evaluation, and investigation into and modelling of body composition. The techniques are new, but it is already clear that considerable strides can be made in increasing accuracy and precision, increasing the number of elements susceptible to measurement, enhancing uniformity, and reducing the dose required for the measurement. The work presently underway will yield significant data on a variety of environmental contaminants such as Cd. Compositional studies are determining the level of vital constituents such as nitrogen and potassium in both normal subjects and in patients with a variety of metabolic disorders. Therapeutic programs can be assessed while in progress.

  6. 21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Clinical investigations not involving greater than minimal risk. 50.51 Section 50.51 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND... Investigations § 50.51 Clinical investigations not involving greater than minimal risk. Any...

  7. Clinical investigation of speech signal features among patients with schizophrenia

    PubMed Central

    ZHANG, Jing; PAN, Zhongde; GUI, Chao; CUI, Donghong

    2016-01-01

    Background A new area of interest in the search for biomarkers for schizophrenia is the study of the acoustic parameters of speech called 'speech signal features'. Several of these features have been shown to be related to emotional responsiveness, a characteristic that is notably restricted in patients with schizophrenia, particularly those with prominent negative symptoms. Aim Assess the relationship of selected acoustic parameters of speech to the severity of clinical symptoms in patients with chronic schizophrenia and compare these characteristics between patients and matched healthy controls. Methods Ten speech signal features-six prosody features, formant bandwidth and amplitude, and two spectral features-were assessed using 15-minute speech samples obtained by smartphone from 26 inpatients with chronic schizophrenia (at enrollment and 1 week later) and from 30 healthy controls (at enrollment only). Clinical symptoms of the patients were also assessed at baseline and 1 week later using the Positive and Negative Syndrome Scale, the Scale for the Assessment of Negative Symptoms, and the Clinical Global Impression-Schizophrenia scale. Results In the patient group the symptoms were stable over the 1-week interval and the 1-week test-retest reliability of the 10 speech features was good (intraclass correlation coefficients [ICC] ranging from 0.55 to 0.88). Comparison of the speech features between patients and controls found no significant differences in the six prosody features or in the formant bandwidth and amplitude features, but the two spectral features were different: the Mel-frequency cepstral coefficient (MFCC) scores were significantly lower in the patient group than in the control group, and the linear prediction coding (LPC) scores were significantly higher in the patient group than in the control group. Within the patient group, 10 of the 170 associations between the 10 speech features considered and the 17 clinical parameters considered were

  8. Clinical investigation of speech signal features among patients with schizophrenia

    PubMed Central

    ZHANG, Jing; PAN, Zhongde; GUI, Chao; CUI, Donghong

    2016-01-01

    Background A new area of interest in the search for biomarkers for schizophrenia is the study of the acoustic parameters of speech called 'speech signal features'. Several of these features have been shown to be related to emotional responsiveness, a characteristic that is notably restricted in patients with schizophrenia, particularly those with prominent negative symptoms. Aim Assess the relationship of selected acoustic parameters of speech to the severity of clinical symptoms in patients with chronic schizophrenia and compare these characteristics between patients and matched healthy controls. Methods Ten speech signal features-six prosody features, formant bandwidth and amplitude, and two spectral features-were assessed using 15-minute speech samples obtained by smartphone from 26 inpatients with chronic schizophrenia (at enrollment and 1 week later) and from 30 healthy controls (at enrollment only). Clinical symptoms of the patients were also assessed at baseline and 1 week later using the Positive and Negative Syndrome Scale, the Scale for the Assessment of Negative Symptoms, and the Clinical Global Impression-Schizophrenia scale. Results In the patient group the symptoms were stable over the 1-week interval and the 1-week test-retest reliability of the 10 speech features was good (intraclass correlation coefficients [ICC] ranging from 0.55 to 0.88). Comparison of the speech features between patients and controls found no significant differences in the six prosody features or in the formant bandwidth and amplitude features, but the two spectral features were different: the Mel-frequency cepstral coefficient (MFCC) scores were significantly lower in the patient group than in the control group, and the linear prediction coding (LPC) scores were significantly higher in the patient group than in the control group. Within the patient group, 10 of the 170 associations between the 10 speech features considered and the 17 clinical parameters considered were

  9. Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD—‘Assessing QbTest Utility in ADHD’ (AQUA): a randomised controlled trial

    PubMed Central

    Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

    2014-01-01

    Introduction The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current ‘gold standard’ ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. Methods and analysis This multisite randomised controlled trial will recruit young people (aged 6–17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. Ethics and dissemination The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost

  10. Artificial oocyte activation: evidence for clinical readiness.

    PubMed

    Ebner, T; Montag, M

    2016-03-01

    Artificial oocyte activation using Ca(2+)ionophores or similar compounds is a widely applied technique in IVF laboratories. This is all the more interesting as most of the agents aiming for intracellular Ca(2+) increase do not result in physiological Ca(2+) oscillations but much rather cause a single Ca(2+) transient. Two observations from mammals may explain why a rather non-physiological single Ca(2+) peak caused by ionophores is sufficient to rescue cycles showing severe male factor infertility, deficient oocyte maturation, developmental problems in humans, or both. On the one hand, it has been shown that it is mainly the initial Ca(2+) rise that drives further downstream events, in particular calcium/calmodulin-dependent protein kinase II (CaMKII) action, and on the other, it is possible that this enzyme remains active even in the absence of Ca(2+). It therefore seems that mammalian oocytes can respond to a wide range of intracellular Ca(2+) signals and have a surprisingly high degree of tolerance for changes in cytosolic Ca(2+). As epigenetic consequences or differences in gene expression have not been studied to date, artificial oocyte activation has to be considered as experimental and should only be applied with a proper indication. PMID:26776820

  11. David Ayman, MD: an early investigator of clinical hypertension.

    PubMed

    Materson, Barry J; Leclercq, Baudouin

    2005-04-01

    Dr. David Ayman (1901-1986) was an astute clinician and observer who challenged medical dogma by performing placebo-controlled studies and by meticulous measurement of blood pressure under standardized conditions. He demonstrated that almost all drugs reported to have an antihypertensive effect in the early 20th century had achieved nothing more than placebo response. He noted the marked variability of blood pressure and devised methods to reduce that variability. These observations led to his publications concerning what is now known as "white coat" or office hypertension. He determined blood pressure personally in 1524 members of 277 families over three generations and made observations on the hereditary nature of hypertension that countered the single-gene thinking of the day. His work is proof that clinical inquisitiveness, hard work, and the courage to challenge conventional wisdom can result in significant contributions to medicine and science. PMID:15860961

  12. Beecher as Clinical Investigator: Pain and the Placebo Effect.

    PubMed

    Benedetti, Fabrizio

    2016-01-01

    Among the many contributions by Henry Beecher to science and clinical practice, pain and the placebo effect certainly represent two of the most important aspects. On the one hand, Beecher considered the pain experience not only as arising from the peripheral injured tissues, but also as an emotional experience that is capable of modulating the nociceptive input. On the other hand, he analyzed the placebo effect at an unprecedented level for that time. His ideas sparked from his work on wounded soldiers during World War II. In spite of the unusual situation and the lack of sophisticated experimental tools on the battlefield, Beecher succeeded in putting forward several important concepts, and his ideas still pervade modern health care and research. PMID:27499483

  13. Dengue haemorrhagic fever in Cuba. II. Clinical investigations.

    PubMed

    Guzman, M G; Kouri, G P; Bravo, J; Soler, M; Vazquez, S; Santos, M; Villaescusa, R; Basanta, P; Indan, G; Ballester, J M

    1984-01-01

    Clinical and serological studies were carried out on 114 patients admitted to hospital in Havana, Cuba with Dengue Haemorrhagic Fever and Dengue Shock Syndrome (DHF/DSS). Serological confirmation of dengue was obtained in 90% of cases, with 5% of cases primary and 95% secondary. Fever, haemorrhagic manifestations, vomiting and headache were the most frequent signs and symptoms. Among haemorrhagic manifestations, petechiae and vaginal bleeding were reported in a larger number of patients. 21 patients presented shock and, of these, 20 were secondary infections. The disease appeared more frequently in white persons and in women. The aetiopathogenicity of the syndromes is discussed. 95% of the cases could be explained on the basis of the secondary infection hypothesis.

  14. Piezoelectric sensing: Evaluation for clinical investigation of deviated nasal septum.

    PubMed

    Manjunatha, Roopa G; Rajanna, Konandur; Mahapatra, Roy D; Dorasala, Srinivas

    2013-01-01

    Noninvasive objective evaluation of nasal airflow is one of the important clinical aspects. The developed polyvinylidene fluoride (PVDF) sensor enables measurement of airflow through each side of the nose using its piezoelectric property. This study was designed to evaluate the diagnostic capability of the PVDF sensor in assessing the deviated nasal septum (DNS). PVDF nasal sensor uses its piezoelectric property to measure the peak-to-peak amplitude (Vp-p) of nasal airflow in both of the nostrils: right nostril (RN) and left nostril (LN), separately and simultaneously. We have compared the results of PVDF nasal sensor, visual analog scale (VAS), and clinician scale for 34 DNS patients and 28 healthy controls. Additionally, the results were further analyzed by receiver operating characteristic curve and correlation between PVDF nasal sensor and VAS in detecting DNS. We found a significant difference in the peak-to-peak amplitude values of the test group and the control group. The correlation between the PVDF nasal sensor measurements and VAS (RN and LN combined) for test group was statistically significant (-0.807; p < 0.001). Sensitivity and specificity of the PVDF nasal sensor measurements in the detection of DNS (RN and LN combined) was 85.3 and 74.4%, respectively, with optimum cutoff value ≤0.34 Vp-p. The developed PVDF nasal sensor is noninvasive and requires less patient efforts. The sensitivity and specificity of the PVDF nasal sensor are reliable. According to our findings, we propose that the said PVDF nasal sensor can be used as a new diagnostic tool to evaluate the DNS in routine clinical practice.

  15. Piezoelectric sensing: Evaluation for clinical investigation of deviated nasal septum

    PubMed Central

    Manjunatha, Roopa G.; Mahapatra, Roy D.; Dorasala, Srinivas

    2013-01-01

    Noninvasive objective evaluation of nasal airflow is one of the important clinical aspects. The developed polyvinylidene fluoride (PVDF) sensor enables measurement of airflow through each side of the nose using its piezoelectric property. This study was designed to evaluate the diagnostic capability of the PVDF sensor in assessing the deviated nasal septum (DNS). PVDF nasal sensor uses its piezoelectric property to measure the peak-to-peak amplitude (Vp-p) of nasal airflow in both of the nostrils: right nostril (RN) and left nostril (LN), separately and simultaneously. We have compared the results of PVDF nasal sensor, visual analog scale (VAS), and clinician scale for 34 DNS patients and 28 healthy controls. Additionally, the results were further analyzed by receiver operating characteristic curve and correlation between PVDF nasal sensor and VAS in detecting DNS. We found a significant difference in the peak-to-peak amplitude values of the test group and the control group. The correlation between the PVDF nasal sensor measurements and VAS (RN and LN combined) for test group was statistically significant (−0.807; p < 0.001). Sensitivity and specificity of the PVDF nasal sensor measurements in the detection of DNS (RN and LN combined) was 85.3 and 74.4%, respectively, with optimum cutoff value ≤0.34 Vp-p. The developed PVDF nasal sensor is noninvasive and requires less patient efforts. The sensitivity and specificity of the PVDF nasal sensor are reliable. According to our findings, we propose that the said PVDF nasal sensor can be used as a new diagnostic tool to evaluate the DNS in routine clinical practice. PMID:24498519

  16. 21 CFR 812.119 - Disqualification of a clinical investigator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... provide a statement of basis for such determination. (c) Each investigational device exemption (IDE) and... chapter. If a danger to the public health exists, however, the Commissioner shall terminate the IDE... of whether the IDE should be reinstated. (e) If the Commissioner determines, after the...

  17. 21 CFR 812.119 - Disqualification of a clinical investigator.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... provide a statement of basis for such determination. (c) Each investigational device exemption (IDE) and... chapter. If a danger to the public health exists, however, the Commissioner shall terminate the IDE... of whether the IDE should be reinstated. (e) If the Commissioner determines, after the...

  18. Expectations and experiences of investigators and parents involved in a clinical trial for Duchenne/Becker muscular dystrophy

    PubMed Central

    Peay, Holly L; Tibben, Aad; Fisher, Tyler; Brenna, Ethan; Biesecker, Barbara B

    2014-01-01

    Background The social context of rare disease research is changing, with increased community engagement around drug development and clinical trials. This engagement may benefit patients and families, but may also lead to heightened trial expectations and therapeutic misconception. Clinical investigators are also susceptible to harboring high expectations. Little is known about parental motivations and expectations for clinical trials for rare pediatric disorders. Purpose We describe the experience of parents and clinical investigators involved in a phase II clinical trial for Duchenne and Becker muscular dystrophy: their expectations, hopes, motivations, and reactions to the termination of the trial. Methods This qualitative study was based on interviews with clinical investigators and parents of sons with DBMD who participated in the phase IIa or IIb ataluren clinical trial in the United States. Interviews were transcribed and coded for thematic analysis. Results Participants were twelve parents of affected boys receiving active drug and nine clinical investigators. High trial expectations of direct benefit were reported by parents and many clinicians. Investigators described monitoring and managing parents’ expectations; several worried about their own involvement in increasing parents’ expectations. Most parents were able to differentiate their expectations from their optimistic hopes for a cure. Parents’ expectations arose from other parents, advocacy organizations, and the sponsor. All parents reported some degree of clinical benefit to their children. Secondary benefits were hopefulness and powerful feelings associated with active efforts to affect the disease course. Parents and clinical investigators reported strong, close relationships that were mutually important. Parents and clinicians felt valued by the sponsor for the majority of the trial. When the trial abruptly stopped, they described loss of engagement, distress, and feeling unprepared for

  19. Investigating clinical heterogeneity in systematic reviews: a methodologic review of guidance in the literature

    PubMed Central

    2012-01-01

    Background While there is some consensus on methods for investigating statistical and methodological heterogeneity, little attention has been paid to clinical aspects of heterogeneity. The objective of this study is to summarize and collate suggested methods for investigating clinical heterogeneity in systematic reviews. Methods We searched databases (Medline, EMBASE, CINAHL, Cochrane Library, and CONSORT, to December 2010) and reference lists and contacted experts to identify resources providing suggestions for investigating clinical heterogeneity between controlled clinical trials included in systematic reviews. We extracted recommendations, assessed resources for risk of bias, and collated the recommendations. Results One hundred and one resources were collected, including narrative reviews, methodological reviews, statistical methods papers, and textbooks. These resources generally had a low risk of bias, but there was minimal consensus among them. Resources suggested that planned investigations of clinical heterogeneity should be made explicit in the protocol of the review; clinical experts should be included on the review team; a set of clinical covariates should be chosen considering variables from the participant level, intervention level, outcome level, research setting, or others unique to the research question; covariates should have a clear scientific rationale; there should be a sufficient number of trials per covariate; and results of any such investigations should be interpreted with caution. Conclusions Though the consensus was minimal, there were many recommendations in the literature for investigating clinical heterogeneity in systematic reviews. Formal recommendations for investigating clinical heterogeneity in systematic reviews of controlled trials are required. PMID:22846171

  20. Introducing and adapting a novel method for investigating learning experiences in clinical learning environments.

    PubMed

    Lachmann, Hanna; Ponzer, Sari; Johansson, Unn-Britt; Karlgren, Klas

    2012-09-01

    The Contextual Activity Sampling System (CASS) is a novel methodology designed for collecting data of on-going learning experiences through frequent sampling by using mobile phones. This paper describes how it for the first time has been introduced to clinical learning environments. The purposes of this study were to cross-culturally adapt the CASS tool and questionnaire for use in clinical learning environments, investigate whether the methodology is suitable for collecting data and how it is experienced by students. A study was carried out with 51 students who reported about their activities and experiences five times a day during a 2-week course on an interprofessional training ward. Interviews were conducted after the course. The study showed that CASS provided a range of detailed and interesting qualitative and quantitative data, which we would not have been able to collect using traditional methods such as post-course questionnaires or interviews. Moreover, the participants reported that CASS worked well, was easy to use, helped them structure their days and reflect on their learning activities. This methodology proved to be a fruitful way of collecting information about experiences, which could be useful for not only researchers but also students, teachers and course designers.

  1. Psychogenic or dissociative fugue: a clinical investigation of five cases.

    PubMed

    Coons, P M

    1999-06-01

    Dissociative fugue (formerly psychogenic fugue) is a rare and little understood dissociative disorder. Following a review of the pertinent literature, five cases of dissociative fugue are described. These cases were systematically studied with a comprehensive history, mental status examination, physical and neurological evaluation, review of previous medical and psychiatric records, and psychological testing including MMPI, WAIS-R, electroencephalogram, and Dissociative Experiences Scale. An unexpected finding was that, in some cases, associated criminal activity may allow the person with dissociative fugue to continue to function in spite of their loss of memory and original identity.

  2. 19 CFR 207.20 - Investigative activity following preliminary determination.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 3 2010-04-01 2010-04-01 false Investigative activity following preliminary determination. 207.20 Section 207.20 Customs Duties UNITED STATES INTERNATIONAL TRADE COMMISSION NONADJUDICATIVE INVESTIGATIONS INVESTIGATIONS OF WHETHER INJURY TO DOMESTIC INDUSTRIES RESULTS FROM IMPORTS SOLD AT LESS THAN FAIR VALUE OR FROM...

  3. Academic physiatry. Balancing clinical practice and academic activities.

    PubMed

    Grabois, M

    1992-04-01

    The need for continued and diversified growth of both scholarly and clinical activities within academic physical medicine and rehabilitation (PM&R) departments is discussed with reference to the demands placed on academic departments by the various components of their mission, such as administration, clinical service, education and research. The expansion and improvement of clinical services should include the following components: program development, resources needed, finances required and marketing. Clinical subspecialization of faculty and solid affiliation with nonacademic hospitals and rehabilitation facilities is essential for academic PM&R. The faculty should include three categories: clinical faculty, clinical-research faculty and research faculty. Adequate financial resources must comprise an appropriate balance of academic funds, clinical income and grant sources. Clinical funds will play a greater role as other sources of funds diminish. Any practice plan must recognize the equality of the differing faculty members' practices, whether their interests are clinical, educational or research-oriented. The expansion and intensification of clinical programs by academy PM&R departments could increase competition in the medical community. Sensitivity to the perceptions of other practitioners and institutions, careful planning and cooperation will help the field grow and improve levels of care for the patients we serve in light of the changing medical care environment.

  4. Patient engagement: an investigation at a primary care clinic

    PubMed Central

    Gill, Preetinder Singh

    2013-01-01

    Background Engaged employees are an asset to any organization. They are instrumental in ensuring good commercial outcomes through continuous innovation and incremental improvement. A health care facility is similar to a regular work setting in many ways. A health care provider and a patient have roles akin to a team leader and a team member/stakeholder, respectively. Hence it can be argued that the concept of employee engagement can be applied to patients in health care settings in order to improve health outcomes. Methods Patient engagement data were collected using a survey instrument from a primary care clinic in the northern Indian state of Punjab. Canonical correlation equations were formulated to identify combinations which were strongly related to each other. In addition, the cause-effect relationship between patient engagement and patient-perceived health outcomes was described using structural equation modeling. Results Canonical correlation analysis showed that the first set of canonical variables had a fairly strong relationship, ie, a magnitude > 0.80 at the 95% confidence interval, for five dimensions of patient engagement. Structural equation modeling analysis yielded a β ≥ 0.10 and a Student’s t statistic ≥ 2.96 for these five dimensions. The threshold Student’s t statistic was 1.99. Hence it was found the β values were significant at the 95% confidence interval for all census regions. Conclusion A scaled reliable survey instrument was developed to measured patient engagement. Better patient engagement is associated with better patient-perceived health outcomes. This study provides preliminary evidence that patient engagement has a causal relationship with patient-perceived health outcomes. PMID:23515133

  5. Clinical investigations of receptive and expressive musical functions after stroke.

    PubMed

    Rosslau, Ken; Steinwede, Daniel; Schröder, C; Herholz, Sibylle C; Lappe, Claudia; Dobel, Christian; Altenmüller, Eckart

    2015-01-01

    There is a long tradition of investigating various disorders of musical abilities after stroke. These impairments, associated with acquired amusia, can be highly selective, affecting only music perception (i.e., receptive abilities/functions) or expression (music production abilities), and some patients report that these may dramatically influence their emotional state. The aim of this study was to systematically test both the melodic and rhythmic domains of music perception and expression in left- and right-sided stroke patients compared to healthy subjects. Music perception was assessed using rhythmic and melodic discrimination tasks, while tests of expressive function involved the vocal or instrumental reproduction of rhythms and melodies. Our approach revealed deficits in receptive and expressive functions in stroke patients, mediated by musical expertise. Those patients who had experienced a short period of musical training in childhood and adolescence performed better in the receptive and expressive subtests compared to those without any previous musical training. While discrimination of specific musical patterns was unimpaired after a left-sided stroke, patients with a right-sided stroke had worse results for fine melodic and rhythmic analysis. In terms of expressive testing, the most consistent results were obtained from a test that required patients to reproduce sung melodies. This implies that the means of investigating production abilities can impact the identification of deficits. PMID:26124731

  6. Clinical investigations of receptive and expressive musical functions after stroke

    PubMed Central

    Rosslau, Ken; Steinwede, Daniel; Schröder, C.; Herholz, Sibylle C.; Lappe, Claudia; Dobel, Christian; Altenmüller, Eckart

    2015-01-01

    There is a long tradition of investigating various disorders of musical abilities after stroke. These impairments, associated with acquired amusia, can be highly selective, affecting only music perception (i.e., receptive abilities/functions) or expression (music production abilities), and some patients report that these may dramatically influence their emotional state. The aim of this study was to systematically test both the melodic and rhythmic domains of music perception and expression in left- and right-sided stroke patients compared to healthy subjects. Music perception was assessed using rhythmic and melodic discrimination tasks, while tests of expressive function involved the vocal or instrumental reproduction of rhythms and melodies. Our approach revealed deficits in receptive and expressive functions in stroke patients, mediated by musical expertise. Those patients who had experienced a short period of musical training in childhood and adolescence performed better in the receptive and expressive subtests compared to those without any previous musical training. While discrimination of specific musical patterns was unimpaired after a left-sided stroke, patients with a right-sided stroke had worse results for fine melodic and rhythmic analysis. In terms of expressive testing, the most consistent results were obtained from a test that required patients to reproduce sung melodies. This implies that the means of investigating production abilities can impact the identification of deficits. PMID:26124731

  7. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. It... traceability of electronic source data and source records maintained at the site for FDA inspection....

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

    NASA Astrophysics Data System (ADS)

    Lepri, Bernard P.

    2009-06-01

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

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

    PubMed

    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. PMID:15163593

  10. “There Are Too Many, but Never Enough": Qualitative Case Study Investigating Routine Coding of Clinical Information in Depression

    PubMed Central

    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

  11. Clinical and laboratory investigation of allergy to genetically modified foods.

    PubMed

    Bernstein, Jonathan A; Bernstein, I Leonard; Bucchini, Luca; Goldman, Lynn R; Hamilton, Robert G; Lehrer, Samuel; Rubin, Carol; Sampson, Hugh A

    2003-06-01

    Technology has improved the food supply since the first cultivation of crops. Genetic engineering facilitates the transfer of genes among organisms. Generally, only minute amounts of a specific protein need to be expressed to obtain the desired trait. Food allergy affects only individuals with an abnormal immunologic response to food--6% of children and 1.5-2% of adults in the United States. Not all diseases caused by food allergy are mediated by IgE. A number of expert committees have advised the U.S. government and international organizations on risk assessment for allergenicity of food proteins. These committees have created decision trees largely based on assessment of IgE-mediated food allergenicity. Difficulties include the limited availability of allergen-specific IgE antisera from allergic persons as validated source material, the utility of specific IgE assays, limited characterization of food proteins, cross-reactivity between food and other allergens, and modifications of food proteins by processing. StarLink was a corn variety modified to produce a (Italic)Bacillus thuringiensis(/Italic) (Bt) endotoxin, Cry9C. The Centers for Disease Control and Prevention investigated 51 reports of possible adverse reactions to corn that occurred after the announcement that StarLink, allowed for animal feed, was found in the human food supply. Allergic reactions were not confirmed, but tools for postmarket assessment were limited. Workers in agricultural and food preparation facilities have potential inhalation exposure to plant dusts and flours. In 1999, researchers found that migrant health workers can become sensitized to certain Bt spore extracts after exposure to Bt spraying.

  12. Clinical and laboratory investigation of allergy to genetically modified foods.

    PubMed Central

    Bernstein, Jonathan A; Bernstein, I Leonard; Bucchini, Luca; Goldman, Lynn R; Hamilton, Robert G; Lehrer, Samuel; Rubin, Carol; Sampson, Hugh A

    2003-01-01

    Technology has improved the food supply since the first cultivation of crops. Genetic engineering facilitates the transfer of genes among organisms. Generally, only minute amounts of a specific protein need to be expressed to obtain the desired trait. Food allergy affects only individuals with an abnormal immunologic response to food--6% of children and 1.5-2% of adults in the United States. Not all diseases caused by food allergy are mediated by IgE. A number of expert committees have advised the U.S. government and international organizations on risk assessment for allergenicity of food proteins. These committees have created decision trees largely based on assessment of IgE-mediated food allergenicity. Difficulties include the limited availability of allergen-specific IgE antisera from allergic persons as validated source material, the utility of specific IgE assays, limited characterization of food proteins, cross-reactivity between food and other allergens, and modifications of food proteins by processing. StarLink was a corn variety modified to produce a (Italic)Bacillus thuringiensis(/Italic) (Bt) endotoxin, Cry9C. The Centers for Disease Control and Prevention investigated 51 reports of possible adverse reactions to corn that occurred after the announcement that StarLink, allowed for animal feed, was found in the human food supply. Allergic reactions were not confirmed, but tools for postmarket assessment were limited. Workers in agricultural and food preparation facilities have potential inhalation exposure to plant dusts and flours. In 1999, researchers found that migrant health workers can become sensitized to certain Bt spore extracts after exposure to Bt spraying. PMID:12826483

  13. Antifungal Activity of Bee Venom and Sweet Bee Venom against Clinically Isolated Candida albicans

    PubMed Central

    Lee, Seung-Bae

    2016-01-01

    Objectives: The purpose of this study was to investigate the antifungal effect of bee venom (BV) and sweet bee venom (SBV) against Candida albicans (C. albicans) clinical isolates. Methods: In this study, BV and SBV were examined for antifungal activities against the Korean Collection for Type Cultures (KCTC) strain and 10 clinical isolates of C. albicans. The disk diffusion method was used to measure the antifungal activity and minimum inhibitory concentration (MIC) assays were performed by using a broth microdilution method. Also, a killing curve assay was conducted to investigate the kinetics of the anti- fungal action. Results: BV and SBV showed antifungal activity against 10 clinical isolates of C. albicans that were cultured from blood and the vagina by using disk diffusion method. The MIC values obtained for clinical isolates by using the broth microdilution method varied from 62.5 μg/ mL to 125 μg/mL for BV and from 15.63 μg/mL to 62.5 μg/mL for SBV. In the killing-curve assay, SBV behaved as amphotericin B, which was used as positive control, did. The antifungal efficacy of SBV was much higher than that of BV. Conclusion: BV and SBV showed antifungal activity against C. albicans clinical strains that were isolated from blood and the vagina. Especially, SBV might be a candidate for a new antifungal agent against C. albicans clinical isolates. PMID:27280049

  14. Disclosure of investigators' recruitment performance in multicenter clinical trials: a further step for research transparency.

    PubMed

    Dal-Ré, Rafael; Moher, David; Gluud, Christian; Treweek, Shaun; Demotes-Mainard, Jacques; Carné, Xavier

    2011-12-01

    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.

  15. Active Interventions in Clinical Practice: Contributions of Gestalt Therapy.

    ERIC Educational Resources Information Center

    Lammert, Marilyn; Dolan, Mary M.

    1983-01-01

    Describes two dimensions of Gestalt therapy that can enhance clinical practice--orientation to the present and active-experimental style--and examines them in relation to some traditional principles of practice. Gestalt theory offers a method of discovery that is a combination of phenomenology and behaviorism. (JAC)

  16. Exploring Patient Activation in the Clinic: Measurement from Three Perspectives

    ERIC Educational Resources Information Center

    Ledford, Christy J. W.; Ledford, Christopher C.; Childress, Marc A.

    2013-01-01

    Objective. To further conceptualize and operationalize patient activation (PA), using measures from patient, physician, and researcher perspectives. Data Source/Study Setting. Multimethod observation in 2010 within a family medicine clinic. Study Design. Part of an intervention with 130 patients with type 2 diabetes, this observational study…

  17. Applying Active Learning to Assertion Classification of Concepts in Clinical Text

    PubMed Central

    Chen, Yukun; Mani, Subramani; Xu, Hua

    2012-01-01

    Supervised machine learning methods for clinical natural language processing (NLP) research require a large number of annotated samples, which are very expensive to build because of the involvement of physicians. Active learning, an approach that actively samples from a large pool, provides an alternative solution. Its major goal in classification is to reduce the annotation effort while maintaining the quality of the predictive model. However, few studies have investigated its uses in clinical NLP. This paper reports an application of active learning to a clinical text classification task: to determine the assertion status of clinical concepts. The annotated corpus for the assertion classification task in the 2010 i2b2/VA Clinical NLP Challenge was used in this study. We implemented several existing and newly developed active learning algorithms and assessed their uses. The outcome is reported in the global ALC score, based on the Area under the average Learning Curve of the AUC (Area Under the Curve) score. Results showed that when the same number of annotated samples was used, active learning strategies could generate better classification models (best ALC – 0.7715) than the passive learning method (random sampling) (ALC – 0.7411). Moreover, to achieve the same classification performance, active learning strategies required fewer samples than the random sampling method. For example, to achieve an AUC of 0.79, the random sampling method used 32 samples, while our best active learning algorithm required only 12 samples, a reduction of 62.5% in manual annotation effort. PMID:22127105

  18. Practising Active Science with Child Refugees: A Clinical Perspective

    ERIC Educational Resources Information Center

    Perrier, Frédéric

    2004-01-01

    In this paper, pilot sessions in Rwanda and Nepal are analysed to evaluate the therapeutic benefit of active science for traumatised child refugees. The nature of the activities, choice of tools, organisation of the sessions, group size, and the role of the educators are investigated. Despite the lack of quantitative assessment, practical…

  19. Advances with the Chinese anthelminthic drug tribendimidine in clinical trials and laboratory investigations.

    PubMed

    Xiao, Shu-Hua; Utzinger, Jürg; Tanner, Marcel; Keiser, Jennifer; Xue, Jian

    2013-05-01

    The anthelminthic drug tribendimidine has been approved by Chinese authorities for human use in 2004, and a first comprehensive review was published in Acta Tropica in 2005. Here, we summarise further advances made through additional clinical trials and laboratory investigations. Two phase IV trials have been conducted in the People's Republic of China, the first one enrolling 1292 adolescents and adults aged 15-70 years and the second one conducted with 899 children aged 4-14 years who were infected with one or multiple species of soil-transmitted helminths. Oral tribendimidine (single 400mg enteric-coated tablet given to adolescents/adults and 200mg to children) showed high cure rates against Ascaris lumbricoides (90.1-95.0%) and moderate-to-high cure rates against hookworm (82.0-88.4%). Another trial done in school-aged children using a rigorous diagnostic approach found a cure rate against hookworm of 76.5%. A single oral dose of tribendimidine showed only low cure rates against Trichuris trichiura (23.9-36.8%) confirming previous results. Tribendimidine administered to children infected with Enterobius vermicularis (two doses of 200mg each on consecutive days) resulted in a high cure rate (97.1%). Importantly, a series of randomised, exploratory trials revealed that tribendimidine shows interesting activity against the liver flukes Opisthorchis viverrini and Clonorchis sinensis, the tapeworm Taenia spp. and the threadworm Strongyloides stercoralis with respective cure rates of 70.0%, 40.0%, 53.3% and 36.4%. Pharmacokinetic studies in healthy Chinese volunteers indicated that after oral administration of tribendimidine, no parent drug was detected in plasma, but its primary metabolite, p-(1-dimethylamino ethylimino) aniline (aminoamidine, deacylated amidantel) (dADT), was found in plasma. dADT is then further metabolised to acetylated dADT (AdADT). dADT exhibits activity against several species of hookworm and C. sinensis in experimental studies, similar to

  20. 76 FR 80948 - Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ..., November, 10, 2011 (76 FR 70151). In the notice, FDA requested comments on the draft guidance that has been... (76 FR 70151), FDA published a notice announcing the availability of the draft guidance entitled ``FDA... Investigational Device Exemption (IDE) Clinical Investigations; Extension of Comment Period AGENCY: Food and...

  1. 78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Decisions for Investigational Device Exemption Clinical Investigations; Draft Guidance for Industry and Food and Drug Administration... revised and is being reissued for comment because the Food and Drug Administration Safety and...

  2. Male sexual function and its disorders: physiology, pathophysiology, clinical investigation, and treatment.

    PubMed

    Kandeel, F R; Koussa, V K; Swerdloff, R S

    2001-06-01

    This review is designed to help the reproductive endocrinologist integrate his or her professional activity with those of other disciplines including urology, radiology, neurology, and psychology in order to successfully manage all of the inseparable aspects of male sexual and reproductive functioning. Significant advances in the field of male sexual physiology and pathophysiology and new methods of investigation and treatment of male sexual disorders are outlined. The review synthesizes available data on the following: norms of sexual organs, aging and sexuality, role of central and peripheral neurochemicals in each stage of the sexual cycle, role of corporeal smooth muscles in the hemodynamic control of erection and detumescence, influence of psychological factors, drugs, and disease on all aspects of sexual functioning, and use of nocturnal penile tumescence monitoring, imaging investigations, and neurophysiologic studies in the diagnostic workup of males with sexual dysfunction. Clinical algorithms are presented where appropriate. Extensive discussions on newly developed strategies in psychological and behavioral counseling, drug therapy, tissue engineering, nonsurgical devices, and surgical treatments for all forms of sexual disorders are also provided. Lastly, the effect of sexual dysfunction and its treatment on quality of life in affected men is addressed, along with recommendations for future research endeavors.

  3. Experimental investigation of active loads control for aircraft landing gear

    NASA Technical Reports Server (NTRS)

    Mcgehee, J. R.; Dreher, R. C.

    1982-01-01

    Aircraft dynamic loads and vibrations resulting from landing impact and from runway and taxiway unevenness are recognized as significant in causing fatigue damage, dynamic stress on the airframe, crew and passenger discomfort, and reduction of the pilot's ability to control the aircraft during ground operations. One potential method for improving operational characteistics of aircraft on the ground is the application of active control technology to the landing gears to reduce ground loads applied to the airframe. An experimental investigation was conducted which simulated the landing dynamics of a light airplane to determine the feasibility and potential of a series hydraulic active control main landing gear. The experiments involved a passive gear and an active control gear. Results of this investigation show that a series hydraulically controlled gear is feasible and that such a gear is very effective in reducing the loads transmitted by the gear to the airframe during ground operations.

  4. [Investigation of the antibacterial activity of faropenem against Streptococcus pneumoniae].

    PubMed

    Hanaki, H; Inaba, Y; Hiramatsu, K

    1999-09-01

    We evaluated the antibacterial activity of faropenem against penicillin-susceptible Streptococcus pneumoniae (PSSP) and penicillin-resistant S. pneumoniae (PRSP). It was shown that the minimum inhibitory concentrations against 90% of the clinically isolated strains (MIC90) of faropenem, penicillin G, cefaclor, cefcapene, and cefditoren against PSSP were 0.032, 0.063, 2, 0.25, and 0.125 micrograms/ml, respectively. While those against PRSP were 0.5, 2, > 128, 1, and 1 micrograms/ml, respectively. Furthermore, we evaluated the bactericidal activity, at the level of 1/4, 1, and 4 MIC, of faropenem and the above four reference antibacterial agents against PSSP and PRSP. Against PSSP No. 127, a sensitive strain to both penicillin G and cefcapene, faropenem showed almost the same bactericidal activity as those of reference agents. Against PSSP No. 108, a penicillin-susceptible and cephem-resistant strain, and PRSP No. 57, a resistant strain to both of penicillin and cephem, faropenem of 1 MIC showed bactericidal activity, but reference agents needed 4 MIC to show bactericidal activity. PMID:10746191

  5. Tools to investigate how interprofessional education activities link to competencies.

    PubMed

    West, Courtney; Veronin, Michael; Landry, Karen; Kurz, Terri; Watzak, Bree; Quiram, Barbara; Graham, Lori

    2015-01-01

    Integrating interprofessional education (IPE) activities and curricular components in health professions education has been emphasized recently by the inclusion of accreditation standards across disciplines. The Interprofessional Education Collaborative (IPEC) established IPE competencies in 2009, but evaluating how activities link to competencies has not been investigated in depth. The purpose of this project is to investigate how well two IPE activities align with IPEC competencies. To evaluate how our IPE activities met IPEC competencies, we developed a checklist and an observation instrument. A brief description of each is included as well as the outcomes. We analyzed Disaster Day, a simulation exercise that includes participants from Nursing, Medicine, and Pharmacy, and Interprofessional Healthcare Ethics (IPHCE), a course that introduced medical, nursing, and pharmacy students to ethical issues using didactic sessions and case discussions. While both activities appeared to facilitate the development of IPE competencies, Disaster Day aligned more with IPEC competencies than the IPHCE course and appears to be a more comprehensive way of addressing IPEC competencies. However, offering one IPE activity or curricular element is not sufficient. Having several IPE options available, utilizing the tools we developed to map the IPE curriculum and evaluating competency coverage is recommended.

  6. AMPA workshop on challenges faced by investigators conducting Alzheimer's disease clinical trials.

    PubMed

    Vellas, Bruno; Pesce, Alain; Robert, Philippe H; Aisen, Paul S; Ancoli-Israel, Sonia; Andrieu, Sandrine; Cedarbaum, Jesse; Dubois, Bruno; Siemers, Eric; Spire, Jean-Paul; Weiner, Michael W; May, Thomas S

    2011-07-01

    The recruitment and retention of patients are among the greatest challenges currently being faced by researchers who conduct Alzheimer's disease (AD) clinical trials. To discuss these challenges and other major issues associated with clinical research in AD, an international workshop was organized by the Association Monégasque pour la recherche sur la Maladie d'Alzheimer at Monte Carlo, Monaco, in February 2010, with the participation of leading research experts in the field of Alzheimer's. Key topics discussed were as follows: (1) the selection, recruitment, and retention of clinical trial subjects; (2) international co-operation among researchers; and (3) patient rights and informed consent for participants in clinical trials. This article highlights some of the challenges faced by investigators when conducting clinical trials in AD, and it also offers some recommendations aimed at overcoming these challenges.

  7. Investigating magnetic activity of F stars with the Kepler mission

    NASA Astrophysics Data System (ADS)

    Mathur, S.; García, R. A.; Ballot, J.; Ceillier, T.; Salabert, D.; Metcalfe, T. S.; Régulo, C.; Jiménez, A.; Bloemen, S.

    2014-08-01

    The dynamo process is believed to drive the magnetic activity of stars like the Sun that have an outer convection zone. Large spectroscopic surveys showed that there is a relation between the rotation periods and the cycle periods: the longer the rotation period is, the longer the magnetic activity cycle period will be. We present the analysis of F stars observed by Kepler for which individual p modes have been measure and with surface rotation periods shorter than 12 days. We defined magnetic indicators and proxies based on photometric observations to help characterise the activity levels of the stars. With the Kepler data, we investigate the existence of stars with cycles (regular or not), stars with a modulation that could be related to magnetic activity, and stars that seem to show a flat behaviour.

  8. An Initial Investigation of Active Galaxies in RESOLVE and ECO

    NASA Astrophysics Data System (ADS)

    Norman, Dara J.; Kannappan, Sheila; Bittner, Ashley; Yarber, Aara'L.; Hoversten, Erik A.; Stark, David; RESOLVE Team

    2016-01-01

    The volume-limited REsolved Spectroscopy Of a Local VolumE (RESOLVE) survey and its complementary Environmental COntext (ECO) catalog are dominated by low mass, gas-rich galaxies, as is typical of the bulk of large-scale structure in the local universe. These surveys, therefore, provide an excellent opportunity to investigate the complete large-scale environments of low-redshift AGN and nuclear starbursts in such galaxies, in order to search for external triggering, examine activity in relation to gas supply, and investigate the role of feedback. By data-mining multi-wavelength catalogs that use varied techniques, we identify known AGN in RESOLVE and ECO, including a population of gas-dominated low-mass galaxies. We take advantage of these surveys' multi-wavelength supporting data to investigate triggering, feedback, and the roles of environment and gas supply in this initial sample of active galaxies. Because biases in standard AGN candidate selection techniques (e.g. BPT, X-ray luminosity) make them individually poor selectors of AGN activity in star-forming and low mass (<10^10 Msun) host galaxies, we also seek to improve the identification of nuclear activity in such galaxies via combined analysis of star formation and AGN signatures. RESOLVE is supported by NSF grant AST-0955368

  9. Investigation of Antiulcer and Antioxidant Activity of Moclobemide in Rats

    PubMed Central

    Albayrak, Abdulmecit; Alp, Hamit H.; Suleyman, Halis

    2015-01-01

    Objective: Even though there are many drugs for the treatment of gastric ulcers, these drugs sometimes cannot succeed. Since the 1950s, antidepressant drugs have been used for several non-psychiatric indications. Many antidepressant drugs have been shown experimentally to produce antiulcer activity in various ulcer models. Moclobemide is an antidepressant drug which inhibits monoamine oxidase-A (MAO) enzyme selectively. When it is compared to the classic antidepressants drugs, moclobemide is the first choice in depression treatment because of its effectiveness and less side effects. This study aimed to investigate the antiulcer effects of moclobemide and to determine its relationship with antioxidant mechanisms in rat gastric tissue. Materials and Methods: The antiulcer activities of 10, 20, 40, 80, 150 mg/kg moclobemide and 20 mg/kg famotidine have been investigated on indomethacin-induced ulcers in rats, and the results have been compared with that of the control group. Results: Moclobemide decreased the indomethacin-induced ulcers significantly at all doses used. While used doses of moclobemide increased the glutathione (GSH), nitric oxide (NO) level and superoxide dismutase (SOD) activity, it decreased the malondialdehyde (MDA) level and myeloperoxidase (MPO) activity in stomach tissue when compared to the control group. Conclusion: It is determined that an antidepressant drug, moclobemide is a potent anti-ulcer agent. Inhibition of toxic oxidant radicals and activation of antioxidant mechanisms play a role in its anti-ulcer effect mechanisms. PMID:25745343

  10. Students' Performance in Investigative Activity and Their Understanding of Activity Aims

    ERIC Educational Resources Information Center

    Gomes, Alessandro Damasio Trani; Borges, A. Tarciso; Justi, Rosaria

    2008-01-01

    This study investigates the relationship between the students' understanding of the aims of an investigative activity and their performance when conducting it. One hundred and eighty-one year nine students from a public middle school in Brazil took part in the study. Students working in pairs were asked to investigate two problems using a…

  11. Investigations into the immunomodulatory activity of Argyreia speciosa.

    PubMed

    Gokhale, A B; Damre, A S; Saraf, M N

    2003-01-01

    The objective of the present study was to investigate the immunomodulatory activity of Argyreia speciosa on cellular and humoral immunity. Oral administration of the ethanolic extract of A. speciosa root (ASEE), at the doses of 50, 100 and 200 mg/kg in mice, dose-dependently potentiated the delayed-type hypersensitivity reaction induced both by sheep red blood cells (SRBC) and oxazolone. It significantly enhanced the production of circulating antibody titre in mice in response to SRBC. ASEE failed to show any effect on macrophage phagocytosis. Chronic administration of ASEE significantly ameliorated the total white blood cell count and also restored the myelosuppressive effects induced by cyclophosphamide. The present investigation reveals that ASEE possesses immunomodulatory activity.

  12. [Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

    PubMed

    Shimada, Yasuhiro

    2016-04-01

    The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".

  13. [Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

    PubMed

    Shimada, Yasuhiro

    2016-04-01

    The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment". PMID:27220797

  14. Cleveland Clinic Lerner College of Medicine: an innovative approach to medical education and the training of physician investigators.

    PubMed

    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.

  15. Cleveland Clinic Lerner College of Medicine: an innovative approach to medical education and the training of physician investigators.

    PubMed

    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. PMID:17414197

  16. Investigations on the sporicidal and fungicidal activity of disinfectants.

    PubMed

    Lensing, H H; Oei, H L

    1985-12-01

    The sporicidal and fungicidal activity of disinfectants was studied in a suspension test. Glutaraldehyde 4%, sodium-dichloroisocyanurate-dihydrate (2400 ppm active chlorine) and peracetic acid 0.25% demonstrated after 30 min of exposure at 20 degrees C in the presence of 4% horse serum a clear activity against spores of Bacillus cereus. Under the same conditions formaldehyde 4% and glutaraldehyde 2% were also found to be sporicidal, but only after a longer time of exposure. Spores of Bacillus anthracis and B. cereus appeared to be comparably resistant against the investigated disinfectants, whereas conidiospores of Aspergillus fumigatus and Aspergillus niger were less resistant. Of the micro-organisms tested Candida albicans proved to be slightest resistant, while spores of Bacillus subtilis were found the most resistant. PMID:3938146

  17. Investigating Deformylase and Deacylase Activity of Mammalian and Bacterial Sirtuins.

    PubMed

    Seidel, Julian; Klockenbusch, Cordula; Schwarzer, Dirk

    2016-03-01

    Lysine acylation constitutes a major group of post-translational modifications of proteins, and is found in the proteomes of organisms from all kingdoms of life. Sirtuins are considered the main erasers of these modification marks, and thus contribute to acylation-dependent regulation of enzyme activity, and potentially of protein quality control. We have established a substrate scaffold to enable the analysis of sirtuin activity with a broad range of acyl-lysine modifications, including hydrophobic fatty acids. Characterization of the deacylase activity of the bacterial SrtN, which is encoded by the yhdZ gene of Bacillus subtilis, showed that this enzyme is capable of removing a broad range of acyl groups. These investigations further showed that SrtN and human SIRT1 are efficient lysine-deformylases, thereby providing a first clue as to how this nonenzymatic modification might be removed from affected proteins.

  18. A phenomenological investigation into the role of the clinical nurse specialist.

    PubMed

    Bousfield, C

    1997-02-01

    This research study adopts a phenomenological approach to investigate how a group of clinical nurse specialists think and experience their role. It reviews the literature on the clinical nurse specialist from 1943, when Frances Reiter first coined the phrase "nurse clinician', to the present time, when individuals are committed to a range of initiatives aimed at improving the quality of the British National Health Service and patient care. The study investigates and analyses their views and conveys the personal meaning of clinical nurse specialists' "lived experience' in the role. Findings of the study suggest that clinical nurse specialists are experienced practitioners who strive to be in positions in which they influence patient care and utilize advanced knowledge, expertise and leadership skills in a multidisciplinary environment. The literature proposes that for the role to be recognized and accepted individuals need to be educated at an advanced level, demonstrate practice based in research and have a firm base as a specialist in nursing. The findings clearly suggest that while the role of the clinical nurse specialist can be influenced in a positive manner by the organization and guided by the individual, it is important to acknowledge that the role is in a transitional phase. Finally, the research suggests the importance of establishing a clear role definition in a creative and supportive environment allowing for autonomy, professional growth and the development of individuals as clinically competent nurse specialists.

  19. Clinical outcome of Crohn's disease: analysis according to the vienna classification and clinical activity.

    PubMed

    Veloso, F T; Ferreira, J T; Barros, L; Almeida, S

    2001-11-01

    The aim of this study was to describe the clinical course of Crohn's disease (CD) in a well-defined, homogeneous groups of patients. A total of 480 patients with CD were followed up from diagnosis up to 20 years. Definitions of patient subgroups were made according to the Vienna Classification. Markov chain analysis was used to estimate the probabilities of remissions and relapses during the disease course. Both age at diagnosis and behavior were associated with different disease locations. Patients with ileal disease had a greater need for surgical and a lesser need for immunosuppressive treatment; patients with ileocolonic disease were diagnosed at an earlier age and showed a lower probability of remaining in remission during the disease course; patients with colonic disease needed less surgical or steroid treatments; patients with intestinal penetrating disease were frequently submitted to abdominal surgery, whereas those with anal-penetrating disease often needed immunosuppressive treatment. Approximately 40% of the patients were in clinical remission at any time, but only about 10% maintained a long-term remission free of steroids after their initial presentation. A more benign clinical course could be predicted in patients who stay in remission in the year after diagnosis. The grouping of patients with CD according to the Vienna Classification and/or the clinical activity in the year after diagnosis is useful in predicting the subsequent course of disease. PMID:11720320

  20. Physical activity in adolescence. A review with clinical suggestions.

    PubMed

    Lotan, Meir; Merrick, Joav; Carmeli, Eli

    2005-01-01

    Despite some inconsistencies in research methodologies, most findings support a positive correlation between participation in physical activities and well-being in adulthood. The results are consistent across the life span of both genders. Favorable connection between physical exercise to physical, psychological, emotional and educational benefits has been constantly proven. Despite such results a comparison between present to past findings show a global tendency for sedentary life style and reduced physical activities in many countries across ages and genders. There are claims that achieving an adult healthy life style is rooted in habits acquired at early ages, thus pointing at childhood and adolescence as the starting point of an active and healthy adulthood. The present article reviews the current literature and findings relating to physical activity with better health and an emphasis on adolescence. Factors correlated to participation of adolescents in physical activities are presented and some clinical issues to promote such activity are discussed. The authors strongly recommend enhanced initiation of community based easily accessed physical exercise programs, for children and adolescents.

  1. Microneurography as a tool in clinical neurophysiology to investigate peripheral neural traffic in humans.

    PubMed

    Mano, Tadaaki; Iwase, Satoshi; Toma, Shinobu

    2006-11-01

    Microneurography is a method using metal microelectrodes to investigate directly identified neural traffic in myelinated as well as unmyelinated efferent and afferent nerves leading to and coming from muscle and skin in human peripheral nerves in situ. The present paper reviews how this technique has been used in clinical neurophysiology to elucidate the neural mechanisms of autonomic regulation, motor control and sensory functions in humans under physiological and pathological conditions. Microneurography is particularly important to investigate efferent and afferent neural traffic in unmyelinated C fibers. The recording of efferent discharges in postganglionic sympathetic C efferent fibers innervating muscle and skin (muscle sympathetic nerve activity; MSNA and skin sympathetic nerve activity; SSNA) provides direct information about neural control of autonomic effector organs including blood vessels and sweat glands. Sympathetic microneurography has become a potent tool to reveal neural functions and dysfunctions concerning blood pressure control and thermoregulation. This recording has been used not only in wake conditions but also in sleep to investigate changes in sympathetic neural traffic during sleep and sleep-related events such as sleep apnea. The same recording was also successfully carried out by astronauts during spaceflight. Recordings of afferent discharges from muscle mechanoreceptors have been used to understand the mechanisms of motor control. Muscle spindle afferent information is particularly important for the control of fine precise movements. It may also play important roles to predict behavior outcomes during learning of a motor task. Recordings of discharges in myelinated afferent fibers from skin mechanoreceptors have provided not only objective information about mechanoreceptive cutaneous sensation but also the roles of these signals in fine motor control. Unmyelinated mechanoreceptive afferent discharges from hairy skin seem to be

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

    PubMed

    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. PMID:27268401

  3. Is daily routine important for sleep? An investigation of social rhythms in a clinical insomnia population.

    PubMed

    Moss, Taryn G; Carney, Colleen E; Haynes, Patricia; Harris, Andrea L

    2015-02-01

    Social rhythms, also known as daily routines (e.g. exercise, of school or work, recreation, social activities), have been identified as potential time cues to help to regulate the biological clock. Past research has shown links between regularity and healthy sleep. This study examined the regularity and frequency of daytime activities in a clinical insomnia population and a good sleeper comparison group. Participants (N = 69) prospectively monitored their sleep and daily activities for a 2-week period. Although participants with insomnia and good sleepers had similar levels of activity, relative to good sleepers, those with insomnia were less regular in their activities. Findings from this study add to the growing number of studies that highlight the relative importance of the regularity of daytime activities on sleep. Accordingly, future research should test treatment components that focus on regulating daytime activities, which would likely improve treatment outcomes.

  4. 78 FR 57395 - Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... accurate and complete data. In the Federal Register of November 20, 2012 (77 FR 69632), FDA issued a draft... FR 76049)). Most of the comments sought clarification on the topics discussed in the guidance. We... Clinical Investigations,'' as mentioned in the guidance, is discussed in the May 10, 2007 (72 FR...

  5. Template protocol for clinical trials investigating vaccines—Focus on safety elements☆

    PubMed Central

    Bonhoeffer, Jan; Imoukhuede, Egeruan B.; Aldrovandi, Grace; Bachtiar, Novilia S.; Chan, Eng-Soon; Chang, Soju; Chen, Robert T.; Fernandopulle, Rohini; Goldenthal, Karen L.; Heffelfinger, James D.; Hossain, Shah; Jevaji, Indira; Khamesipour, Ali; Kochhar, Sonali; Makhene, Mamodikoe; Malkin, Elissa; Nalin, David; Prevots, Rebecca; Ramasamy, Ranjan; Sellers, Sarah; Vekemans, Johan; Walker, Kenneth B.; Wilson, Pam; Wong, Virginia; Zaman, Khalequz; Heininger, Ulrich

    2015-01-01

    This document is intended as a guide to the protocol development for trials of prophylactic vaccines. The template may serve phases I–IV clinical trials protocol development to include safety relevant information as required by the regulatory authorities and as deemed useful by the investigators. This document may also be helpful for future site strengthening efforts. PMID:23499603

  6. 76 FR 32367 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Draft Guidance for Clinical Investigators, Industry, and FDA... notice that appeared in the Federal Register of May 24, 2011 (76 FR 30175). The document announced...

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

    ERIC Educational Resources Information Center

    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…

  8. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... comprehensive tutorial on best clinical practices for investigational medical device studies. Concurrent with the publication of this guidance in draft, November 10, 2011 (76 FR 70150), FDA initiated a pilot program for early feasibility study IDE applications (November 10, 2011, 76 FR 70152) to...

  9. Activity-based costing for clinical paths. An example to improve clinical cost & efficiency.

    PubMed

    Asadi, M J; Baltz, W A

    1996-01-01

    How much does this medical service or surgical procedure cost the hospital to provide? What is the most efficient clinical pathway that maximizes the quality of patient care while minimizing costs? More and more hospitals are discovering that they don't have solid answers to these critically important questions. In an age of managed care and capitation, however, it is imperative for management to know if the patient care services they provide are making or losing money-and by how much. This article discusses how a powerful new tool called activity-based costing (ABC) can be used to help hospitals accurately determine patient care costs. We show how to build a model that combines both clinical and financial data to measure how efficiently the operation allocates human, material and capital resources to provide its services. The modeling approach described in this article can be used to better analyze a wide range of important operational and financial issues, including: How to efficiently allocate resources, and what resources will be needed as patient demand changes-ideal for operational management and planning; How efficiently activities and processes are performed to meet patient needs-effective for measuring performance and improving quality; Determining clinical pathway profitability-essential for understanding where you're making or losing money; Cycle time, throughput and the impact of resource capacity constraints-critical for meeting patient demand; Costs of idle capacity-important for using resources more efficiently. We will illustrate with an example how this modeling technique can be used to develop and implement efficient clinical pathways. PMID:8982988

  10. Activity-based costing for clinical paths. An example to improve clinical cost & efficiency.

    PubMed

    Asadi, M J; Baltz, W A

    1996-01-01

    How much does this medical service or surgical procedure cost the hospital to provide? What is the most efficient clinical pathway that maximizes the quality of patient care while minimizing costs? More and more hospitals are discovering that they don't have solid answers to these critically important questions. In an age of managed care and capitation, however, it is imperative for management to know if the patient care services they provide are making or losing money-and by how much. This article discusses how a powerful new tool called activity-based costing (ABC) can be used to help hospitals accurately determine patient care costs. We show how to build a model that combines both clinical and financial data to measure how efficiently the operation allocates human, material and capital resources to provide its services. The modeling approach described in this article can be used to better analyze a wide range of important operational and financial issues, including: How to efficiently allocate resources, and what resources will be needed as patient demand changes-ideal for operational management and planning; How efficiently activities and processes are performed to meet patient needs-effective for measuring performance and improving quality; Determining clinical pathway profitability-essential for understanding where you're making or losing money; Cycle time, throughput and the impact of resource capacity constraints-critical for meeting patient demand; Costs of idle capacity-important for using resources more efficiently. We will illustrate with an example how this modeling technique can be used to develop and implement efficient clinical pathways.

  11. Drilling to investigate processes in active tectonics and magmatism

    NASA Astrophysics Data System (ADS)

    Shervais, J.; Evans, J.; Toy, V.; Kirkpatrick, J.; Clarke, A.; Eichelberger, J.

    2014-12-01

    Coordinated drilling efforts are an important method to investigate active tectonics and magmatic processes related to faults and volcanoes. The US National Science Foundation (NSF) recently sponsored a series of workshops to define the nature of future continental drilling efforts. As part of this series, we convened a workshop to explore how continental scientific drilling can be used to better understand active tectonic and magmatic processes. The workshop, held in Park City, Utah, in May 2013, was attended by 41 investigators from seven countries. Participants were asked to define compelling scientific justifications for examining problems that can be addressed by coordinated programs of continental scientific drilling and related site investigations. They were also asked to evaluate a wide range of proposed drilling projects, based on white papers submitted prior to the workshop. Participants working on faults and fault zone processes highlighted two overarching topics with exciting potential for future scientific drilling research: (1) the seismic cycle and (2) the mechanics and architecture of fault zones. Recommended projects target fundamental mechanical processes and controls on faulting, and range from induced earthquakes and earthquake initiation to investigations of detachment fault mechanics and fluid flow in fault zones. Participants working on active volcanism identified five themes: the volcano eruption cycle; eruption sustainability, near-field stresses, and system recovery; eruption hazards; verification of geophysical models; and interactions with other Earth systems. Recommended projects address problems that are transferrable to other volcanic systems, such as improved methods for identifying eruption history and constraining the rheological structure of shallow caldera regions. Participants working on chemical geodynamics identified four major themes: large igneous provinces (LIPs), ocean islands, continental hotspot tracks and rifts, and

  12. The growth hormone receptor: mechanism of activation and clinical implications.

    PubMed

    Brooks, Andrew J; Waters, Michael J

    2010-09-01

    Growth hormone is widely used clinically to promote growth and anabolism and for other purposes. Its actions are mediated via the growth hormone receptor, both directly by tyrosine kinase activation and indirectly by induction of insulin-like growth factor 1 (IGF-1). Insensitivity to growth hormone (Laron syndrome) can result from mutations in the growth hormone receptor and can be treated with IGF-1. This treatment is, however, not fully effective owing to the loss of the direct actions of growth hormone and altered availability of exogenous IGF-1. Excessive activation of the growth hormone receptor by circulating growth hormone results in gigantism and acromegaly, whereas cell transformation and cancer can occur in response to autocrine activation of the receptor. Advances in understanding the mechanism of receptor activation have led to a model in which the growth hormone receptor exists as a constitutive dimer. Binding of the hormone realigns the subunits by rotation and closer apposition, resulting in juxtaposition of the catalytic domains of the associated tyrosine-protein kinase JAK2 below the cell membrane. This change results in activation of JAK2 by transphosphorylation, then phosphorylation of receptor tyrosines in the cytoplasmic domain, which enables binding of adaptor proteins, as well as direct phosphorylation of target proteins. This model is discussed in the light of salient information from closely related class 1 cytokine receptors, such as the erythropoietin, prolactin and thrombopoietin receptors. PMID:20664532

  13. Investigating the physiology of brain activation with MRI

    NASA Astrophysics Data System (ADS)

    Buxton, Richard B.; Uludag, Kamil; Dubowitz, David J.

    2004-04-01

    Functional magnetic resonance imaging (fMRI) has become a powerful tool for investigating the working human brain based on the blood oxygenation level dependent (BOLD) effect on the MR signal. However, despite the widespread use of fMRI techniques for mapping brain activation, the basic physiological mechanisms underlying the observed signal changes are still poorly understood. Arterial spin labeling (ASL) techniques, which measure cerebral blood flow (CBF) and the BOLD effect simultaneously, provide a useful tool for investigating these physiological questions. In this paper, recent results of studies manipulating the baseline CBF both pharmacologically and physiologically will be discussed. These data are consistent with a feed-forward mechanism of neurovascular coupling, and suggest that the CBF change itself may be a more robust reflection of neural activity changes than the BOLD effect. Consistent with these data, a new thermodynamic hypothesis is proposed for the physiological function of CBF regulation: maintenance of the [O2]/[CO2] concentration ratio at the mitochondria in order to preserve the free energy available from oxidative metabolism. A kinetic model based on this hypothesis provides a reasonable quantitative description of the CBF changes associated with neural activity and altered blood gases (CO2 and O2).

  14. Worksite Physical Activity Intervention for Ambulatory Clinic Nursing Staff.

    PubMed

    Tucker, Sharon; Farrington, Michele; Lanningham-Foster, Lorraine M; Clark, M Kathleen; Dawson, Cindy; Quinn, Geralyn J; Laffoon, Trudy; Perkhounkova, Yelena

    2016-07-01

    Health behaviors, including physical activity (PA), of registered nurses (RNs) and medical assistants (MAs) are suboptimal but may improve with worksite programs. Using a repeated-measures crossover design, the authors explored if integrating a 6-month worksite non-exercise activity thermogenesis (NEAT) intervention, with and without personalized health coaching via text messaging into workflow could positively affect sedentary time, PA, and body composition of nursing staff without jeopardizing work productivity. Two ambulatory clinics were randomly assigned to an environmental NEAT intervention plus a mobile text message coaching for either the first 3 months (early texting group, n = 27) or the last 3 months (delayed texting group, n = 13), with baseline 3-month and 6-month measurements. Sedentary and PA levels, fat mass, and weight improved for both groups, significantly only for the early text group. Productivity did not decline for either group. This worksite intervention is feasible and may benefit nursing staff. PMID:27143144

  15. Activities and interactions of baccalaureate nursing students in clinical practica.

    PubMed

    Polifroni, E C; Packard, S A; Shah, H S; MacAvoy, S

    1995-01-01

    Basic nursing education is governed by individual state rules and regulations lacking in uniformity across the United States and based on unstated and perhaps mistaken assumptions. At the same time, there is increasing evidence of problems and difficulties with the current traditional model of nursing education. Before proposing changes in said model, the authors chose to examine what it is that a nursing student does in a clinical area. The perspective of activities and interactions was chosen to illustrate, through a nonparticipant observation study, the patterns and utilization of time during a scheduled clinical experience for baccalaureate nursing students. The goal of the study was to determine who, other than the client/patient, influences the student learning at the clinical site and how learning time is spent. Two schools (one private and one public) and nine clinical sites with 37 observations were used to collect the data for this study. Findings are best summarized in four (overlapping) categories of school time, registered nurse (RN) staff time, hospital staff time, and supervised time. School time, or time spent interacting with the instructor, another student, and/or the student on his/her own in the practice setting (time exclusive of staff input) constituted 84 per cent of all time. RN staff time that was time spent with either the primary nurse or other RNs on the unit used 10 per cent of the student time, Fourteen per cent of student time was spent in hospital staff time, which includes interactions with any nursing staff or other hospital personnel.(ABSTRACT TRUNCATED AT 250 WORDS)

  16. Optical Tools to Investigate Cellular Activity in the Intestinal Wall

    PubMed Central

    Boesmans, Werend; Hao, Marlene M; Berghe, Pieter Vanden

    2015-01-01

    Live imaging has become an essential tool to investigate the coordinated activity and output of cellular networks. Within the last decade, 2 Nobel prizes have been awarded to recognize innovations in the field of imaging: one for the discovery, use, and optimization of the green fluorescent protein (2008) and the second for the development of super-resolved fluorescence microscopy (2014). New advances in both optogenetics and microscopy now enable researchers to record and manipulate activity from specific populations of cells with better contrast and resolution, at higher speeds, and deeper into live tissues. In this review, we will discuss some of the recent developments in microscope technology and in the synthesis of fluorescent probes, both synthetic and genetically encoded. We focus on how live imaging of cellular physiology has progressed our understanding of the control of gastrointestinal motility, and we discuss the hurdles to overcome in order to apply the novel tools in the field of neurogastroenterology and motility. PMID:26130630

  17. AN ULTRAVIOLET INVESTIGATION OF ACTIVITY ON EXOPLANET HOST STARS

    SciTech Connect

    Shkolnik, Evgenya L.

    2013-03-20

    Using the far-UV (FUV) and near-UV (NUV) photometry from the NASA Galaxy Evolution Explorer (GALEX), we searched for evidence of increased stellar activity due to tidal and/or magnetic star-planet interactions (SPI) in the 272 known FGK planetary hosts observed by GALEX. With the increased sensitivity of GALEX, we are able probe systems with lower activity levels and at larger distances than what has been done to date with X-ray satellites. We compared samples of stars with close-in planets (a < 0.1 AU) to those with far-out planets (a > 0.5 AU) and looked for correlations of excess activity with other system parameters. This statistical investigation found no clear correlations with a, M{sub p} , or M{sub p} /a, in contrast to some X-ray and Ca II studies. However, there is tentative evidence (at a level of 1.8{sigma}) that stars with radial-velocity-(RV)-detected close-in planets are more FUV-active than stars with far-out planets, in agreement with several published X-ray and Ca II results. The case is strengthened to a level of significance to 2.3{sigma} when transit-detected close-in planets are included. This is most likely because the RV-selected sample of stars is significantly less active than the field population of comparable stars, while the transit-selected sample is similarly active. Given the factor of 2-3 scatter in fractional FUV luminosity for a given stellar effective temperature, it is necessary to conduct a time-resolved study of the planet hosts in order to better characterize their UV variability and generate a firmer statistical result.

  18. Investigation of some biologic activities of Swertia longifolia Boiss.

    PubMed

    Hajimehdipoor, H; Esmaeili, S; Shekarchi, M; Emrarian, T; Naghibi, F

    2013-10-01

    Swertia species are widespread in Eastern and Southern Asian countries and used in traditional medicine as anti-pyretic, analgesic, gastro and liver tonic. Among different species, only Swertia longifolia grows in Iran. In this investigation, antioxidant, cytotoxic and acetylcholinesterase inhibitory activities of S. longifolia have been studied. Aerial parts and roots of the plant were collected, dried and extracted with methanol 80% (total extract). Different extracts of the plant were obtained using hexane, chloroform, ethyl acetate, methanol, methanol:water (1:1) and water, respectively. Cytotoxic activity was determined by MTT assay on MDBK, HepG2, MCF7, HT29 and A549 cell lines. Antioxidant activity was measured by 2,2-diphenyl-1-picryl hydrazyl (DPPH) free radicals and acetylcholinesterase inhibitory (AChEI) effect was evaluated based on Ellman's method in 96-well microplates.The results showed no cytotoxicity of the plant extracts on MDBK, HepG2, MCF7, HT29 and A549 cell lines up to 100 μg/ml. All samples showed radical scavenging activity but methanol extract of aerial parts and ethyl acetate extract of the roots showed the highest effects.Total extract of the roots showed higher AChEI activity than the aerial parts. Among different extracts, chloroform and ethyl acetate extracts of the roots and chloroform and methanol:water extracts of the aerial parts were more potent in AChEI assay. It is concluded that aerial parts and roots of the plant are rich in antioxidant agents with no cytotoxicity on selected cell lines up to 100 μg/ml. Moreover, since antioxidant and AChEI activity of compounds play an important role in the treatment of Alzheimer's disorder, this plant might be a potential candidate for isolation of antioxidant and AChEI compounds which could be used as supportive treatment of Alzheimer's disease. PMID:24082894

  19. Laboratory investigations in genetic syndromes: examples of clinical approach in the neonatal unit.

    PubMed

    De Sanctis, L; Giuffrè, M

    2010-06-01

    Contiguous gene deletion syndromes: the importance of an accurate genetic definition for a careful clinical monitoring. Contiguous gene deletion syndromes are so named because the deletion manifests as a distinctive cluster of otherwise unrelated single-gene disorders in the same subject. An accurate genetic definition of the deleted region is extremely important for the appropriate management of these patients and for unravelling the function of the involved genes. The microarray-based comparative genomic hybridization (CGH arrays) analysis is the actual molecular method able to accurately define the bounds of a deleted region, since it allows an evaluation of DNA copy number alterations associated to chromosome abnormalities, with higher resolution than classical cytogenetics or chromosomal banding. The clinical presentation, the diagnostic course, the genetic investigations and the follow-up of a patient harbouring a contiguous gene deletion syndrome will be presented during the seminar. The newborn with ambiguous genitalia: diagnostic approach toward clinical and genetic definition. Disorders of sexual differentiation may depend on several different causes and pathogenetic mechanisms, which may interfere at different stages of the complex pathway of sexual determination and differentiation. Several genes are involved, together with hormones and receptors. The main disorders of sexual differentiation are characterized by dissociation between chromosomes and gonads or gonads and external genitalia appearance. Clinical phenotypes may be distinguished in true hermaphroditism and male or female pseudohermaphroditism. Diagnostic definition is based on clinical and instrumental evaluation and laboratory investigations (hormonal, cytogenetic and molecular genetic investigations). Early diagnosis may allow an appropriate medical and/or surgical treatment, involving a multidisciplinary equipe. The correct gender assessment must be guided by clinical and genetic diagnosis

  20. The porphyrias: clinic, diagnostics, novel investigative tools and evolving molecular therapeutic strategies.

    PubMed

    van Serooskerken, A-M van Tuyll; Poblete-Gutiérrez, P; Frank, J

    2010-01-01

    The porphyrias are clinically and genetically heterogeneous metabolic disorders resulting from a predominantly hereditary dysfunction of specific enzymes involved in heme biosynthesis. Today, the clinical, biochemical, and genetic characteristics of this fascinating group of diseases are well established. Recently, different in vitro and animal models have facilitated the investigation of etiopathologic mechanisms in the different types of porphyria and the development of causal treatment strategies such as pathway interference, enzyme replacement, and gene therapy. The continuous progress in basic science has made an invaluable contribution to the rapid translation of discoveries made in the laboratory into new diagnostics and therapeutics in the near future.

  1. The importance of active efflux systems in the quinolone resistance of clinical isolates of Salmonella spp.

    PubMed

    Escribano, Isabel; Rodríguez, Juan Carlos; Cebrian, Laura; Royo, Gloria

    2004-11-01

    The aim of this study was to determine the importance of the active elimination of antibiotics by active efflux systems, in the decrease in fluoroquinolone sensitivity of clinical isolates of Salmonella spp. as well as the intrinsic antibiotic activity of certain active efflux system inhibitors. The effect of the active efflux system on the decrease in sensitivity to nalidixic acid, ciprofloxacin, ofloxacin and sparfloxacin was studied by investigating the variation in the in vitro activity of these compounds when assayed in association with reserpine and MC 207.110. The active efflux systems inhibited by reserpine displayed low activity in the elimination of these compounds, whereas those inhibited by MC 207.110 showed high activity in the elimination of nalidixic acid and sparfloxacin, but were less effective in the elimination of ofloxacin and ciprofloxacin. These two compounds did not exhibit intrinsic inhibitory activity against Salmonella spp. at the concentrations assayed. These mechanisms of resistance to antibiotics are complex and vary depending on the chemical composition of the antibiotics used, and perhaps the inhibitors of these systems, although they do not exhibit any intrinsic antibiotic activity, may be used as adjuvants to increase the activity of certain antibiotics. These mechanisms complement the mutations in the gyrA gene and this supports the thesis that it is necessary to lower the breakpoint established by the NCCLS for ciprofloxacin, since the strains studied have resistance mechanisms that reduce the activity of this drug and may favour the emergence of resistant mutants during treatment.

  2. Evaluation of Clinical Biomaterial Surface Effects on T Lymphocyte Activation

    PubMed Central

    Rodriguez, Analiz; Anderson, James M.

    2009-01-01

    Previous in vitro studies in our laboratory have shown that lymphocytes can influence macrophage adhesion and fusion on biomaterial surfaces. However, few studies have evaluated how material adherent macrophages can influence lymphocyte behavior, specifically T cells. In this study, we cultured human peripheral blood mononuclear cells from healthy donors on three synthetic non-biodegradable biomedical polymers: Elasthane 80A (PEU), Silicone rubber (SR), or polyethylene terephthalate (PET) and tissue culture polystyrene (TCPS). Upregulation of T cell surface activation markers (CD69 and CD25), lymphocyte proliferation, and interleukin-2 (IL-2) and interferon-γ (IFNγ) concentrations were evaluated by flow cytometry, carboxy-fluorescein diacetate, succinimydyl ester (CFSE) incorporation, and multiplex cytokine immunoassay, respectively, to assess T cell activation. Following 3 and 7 days of culture, CD4+ helper T cells from cultures of any of the material groups did not express the activation markers CD69 and CD25 and lymphocyte proliferation was not present. IL-2 and IFNγ levels were produced, but dependent on donor. These data indicate that T cells are not activated in response to clinically relevant synthetic biomaterials. The data also suggest that lymphocyte subsets exclusive of T cells are the source of the lymphokines, IL-2 and IFN-γ, in certain donors. PMID:19172618

  3. LDEF meteoroid and debris special investigation group investigations and activities at the Johnson Space Center

    NASA Technical Reports Server (NTRS)

    See, Thomas H.; Warren, Jack L.; Zolensky, Michael E.; Sapp, Clyde A.; Bernhard, Ronald P.; Dardano, Claire B.

    1995-01-01

    Since the return of the Long Duration Exposure Facility (LDEF) in January, 1990, members of the Meteoroid and Debris Special Investigation Group (M&D SIG) at the Johnson Space Center (JSC) in Houston, Texas have been examining LDEF hardware in an effort to expand the knowledge base regarding the low-Earth orbit (LEO) particulate environment. In addition to the various investigative activities, JSC is also the location of the general Meteoroid & Debris database. This publicly accessible database contains information obtained from the various M&D SIG investigations, as well as limited data obtained by individual LDEF Principal Investigators. LDEF exposed approximately 130 m(exp 2) of surface area to the LEO particulate environment, approximately 15.4 m(exp 2) of which was occupied by structural frame components (i.e., longerons and intercoastals) of the spacecraft. The data reported here was obtained as a result of detailed scans of LDEF intercoastals, 68 of which reside at JSC. The limited amount of data presently available on the A0178 thermal control blankets was reported last year and will not be reiterated here. The data presented here are limited to measurements of crater diameters and their frequency of occurrence (i.e., flux).

  4. Retrospective clinical investigation and survival analysis on ceramic inlays and partial ceramic crowns: results up to 7 years.

    PubMed

    Felden, A; Schmalz, G; Federlin, M; Hiller, K A

    1998-12-01

    This study retrospectively evaluated the clinical performance of 287 all-ceramic restorations placed during routine patient care in the University setting in the past 7 years. All patients (n = 106) with ceramic inlays or partial ceramic crowns (PCC), placed during 1988-1994 (n = 327) by five experienced dentists were asked to take part in a clinical investigation, and 92 patients with 287 restorations (232 inlays, 55 PCC) agreed to do so. The following ceramics were used: 44 (15.3%) Dicor (Dentsply), 126 (43.9%) IPS-Empress (Ivoclar), 82 (28.7%) Mirage II, 33 (11.5%) Cerec-Vita-Mark 1 (Vita), and 2 (0.7%) Duceram LFC (Ducera) restorations. The restorations were placed using the following luting composites: 73 (25.4%) Dual Cure Luting Cement (Optec), 81 (28.3%) Variolink high viscosity (Ivoclar), 32 (11.1%) Microfill Pontic C (Kulzer), 51 (17.8%) Dual Zement (Ivoclar), 40 (13.9%) Dicor Light Activated Cement (Dentsply), and 10 (3.5%) Vita Cerec Duo Cement (Vita). Restorations were evaluated according to the modified USPHS criteria. Kaplan-Meier analysis was used to calculate the probability of survival. Of the 287 restorations 270 (94.2%) were still in function without any need of intervention. Fourteen restorations (4.8%) had failed before starting the clinical investigation, and in three a fracture was found during the investigation. These 17 failed restorations consisted of 14 PCC and 3 ceramic inlays. The results of the clinical investigation revealed 59.2% Alpha-ratings for marginal adaptation. Only one restored tooth showed recurrent caries. The probability of survival (95% confidence interval) for 7 years was 98% (97.99-98.01%) for ceramic inlays and 56% (46-66%) for PCC. Our findings show that ceramic inlays can be regarded as an acceptable alternative to cast gold restorations within the methodological limitations of the present study. For PCC further experience with more recent ceramics is warranted.

  5. Investigating Seasonal Gravity Wave Activity in the Summer Polar Mesosphere

    NASA Astrophysics Data System (ADS)

    Zhao, Y.; Taylor, M. J.; Randall, C. E.; Lumpe, J. D., Jr.; Siskind, D. E.; Bailey, S. M.; Russell, J. M., III

    2014-12-01

    The NASA Aeronomy of Ice in the Mesosphere (AIM) satellite is the first satellite mission dedicated to studying polar mesospheric clouds (PMCs). In particular, the Cloud Imaging and Particle Size (CIPS) instrument onboard AIM obtains large-field PMC images enabling a unique investigation of the mesospheric gravity waves, as the satellite traverses over the summer polar regions. The high quality of CIPS data has provided an exceptional capability to investigate the gravity wave signatures in the summer polar mesosphere where previous measurements have been sparse. We have utilized 12 consecutive seasons of AIM/CIPS PMC albedo data to derive the statistical properties of a broad spectrum of gravity waves present in the PMC data. Over 60,000 waves with horizontal scale sizes ranging from ~50 to >2000 km were identified and measured, revealing a well-developed, consistent distribution for their horizontal wavelengths with a peak in occurrence frequency centered around 400 km. The same result was found from season to season and in both hemispheres. Throughout this study, the wave activity in the southern hemisphere was found to be 10-15% higher than in the northern hemisphere and both northern and southern wave activity was found to decrease systematically (average ~15%) during the course of each summer season. We present new results of the intra-seasonal, inter-annual and hemispheric variability of these waves observed over the whole summer polar cap regions. The systematic decrease in wave activity is consistent with background wind filtering in the northern hemisphere but is not apparently associated with the critical level filtering in the southern hemisphere.

  6. Investigation of MEK activity in COS7 cells entering mitosis.

    PubMed

    Shi, Huaiping; Zhang, Tianying; Yi, Yongqing; Luo, Jun

    2014-12-01

    Although the mitogen-activated protein kinase (MAPK) pathway has been extensively investigated, numerous events remain unclear. In the present study, we examined mitogen-activated protein kinase kinase (MEK) expression from interphase to mitosis. Following nocodazole treatment, COS7 cells gradually became round as early as 4 h after treatment. Cyclin B1 expression gradually increased from 4 to 24 h in the presence of nocodazole. When cells were treated with nocodazole for 4 h, the level of epidermal growth factor (EGF)-mediated MEK phosphorylation did not significantly change between nocodazole-untreated and -treated (4 h) cells (P>0.05). However, EGF-mediated MEK phosphorylation was significantly inhibited upon treatment with nocodazole for 8 and 24 h compared to nocodazole-untreated cells (P<0.05). MEK phosphorylation levels were comparable between 1, 5, 10 and 50 ng/ml EGF treatments. Phorbol 12-myristic 13-acetate (PMA) did not activate MEK in mitotic cells. Following treatment of COS7 cells at the interphase with AG1478 or U0126, MEK phosphorylation was blocked. In addition, the investigation of the expression of proteins downstream of MEK demonstrated that EGF does not significantly affect the phosphorylation level of extracellular-signal-regulated kinase (ERK), ribosomal protein S6 kinase (RSK) and Elk in mitotic cells (P>0.05). The results showed that MEK expression is gradually inhibited from cell interphase to mitosis, and that MEK downstream signaling is affected by this inhibition, which probably reflects the requirements of cell physiology during mitosis.

  7. Investigating seasonal gravity wave activity in the summer polar mesosphere

    NASA Astrophysics Data System (ADS)

    Zhao, Y.; Taylor, M. J.; Randall, C. E.; Lumpe, J. D.; Siskind, D. E.; Bailey, S. M.; Russell, J. M.

    2015-05-01

    The NASA Aeronomy of Ice in the Mesosphere (AIM) satellite is the first spaceborne mission dedicated to studying high-altitude (~83 km) Polar Mesospheric Clouds (PMCs). Since its launch in 2007, the Cloud Imaging and Particle Size (CIPS) instrument onboard AIM has obtained large-field, high resolution (25 km2/pixel) images of the PMCs, enabling a unique investigation of mesospheric gravity wave activity in the summer polar mesosphere where previous measurements have been sparse. In this study, we have analyzed 12 consecutive seasons of AIM/CIPS PMC albedo data to determine the statistical properties of medium and large horizontal scale (>100 km) gravity waves present in the PMC data. Over 60,000 wave events with horizontal scale-sizes ranging up to >2000 km have been identified and measured, revealing a wealth of wave events particularly in the ~300-800 km range where our analysis sensitivity is largest. These data are ideal for investigating the intra-seasonal, inter-annual and hemispheric variability of these waves as observed over the whole summer polar cap regions. Throughout this 6 year study, the wave activity in the southern hemisphere was found to be consistently 10-15% higher than in the northern hemisphere and both the northern and southern hemisphere wave activity was determined to decrease systematically (by ~15%) during the course of each summer season. This decrease agrees well with previous seasonal stratospheric studies of variations in the wave energy, suggesting a direct influence of the lower atmospheric sources on polar mesospheric dynamics. Very similar and consistent results were also found from season to season in both hemispheres providing new information for gravity wave modeling and dynamical studies of the high-latitude summer-time mesosphere.

  8. Active control: an investigation method for combustion instabilities

    NASA Astrophysics Data System (ADS)

    Poinsot, T.; Yip, B.; Veynante, D.; Trouvé, A.; Samaniego, J. M.; Candel, S.

    1992-07-01

    Closed-loop active control methods and their application to combustion instabilities are discussed. In these methods the instability development is impeded with a feedback control loop: the signal provided by a sensor monitoring the flame or pressure oscillations is processed and sent back to actuators mounted on the combustor or on the feeding system. Different active control systems tested on a non-premixed multiple-flame turbulent combustor are described. These systems can suppress all unstable plane modes of oscillation (i.e. low frequency modes). The active instability control (AIC) also constitutes an original and powerful technique for studies of mechanisms leading to instability or resulting from the instability. Two basic applications of this kind are described. In the first case the flame is initially controlled with AIC, the feedback loop is then switched off and the growth of the instability is analysed through high speed Schlieren cinematography and simultaneous sound pressure and reaction rate measurements. Three phases are identified during th growth of the oscillations: (1) a linear phase where acoustic waves induce a flapping motion of the flame sheets without interaction between sheets, (2) a modulation phase, where flame sheets interact randomly and (3) a nonlinear phase where the flame sheets are broken and a limit cycle is reached. In the second case we investigate different types of flame extinctions associated with combustion instability. It is shown that pressure oscillations may lead to partial or total extinctions. Extinctions occur in various forms but usually follow a rapid growth of pressure oscillations. The flame is extinguished during the modulation phase observed in the initiation experiments. In these studies devoted to transient instability phenomena, the control system constitutes a unique investigation tool because it is difficult to obtain the same information by other means. Implications for modelling and prediction of

  9. Seal Investigations of an Active Clearance Control System Concept

    NASA Technical Reports Server (NTRS)

    Steinetz, Bruce M.; Taylor, Shawn; Oswald, Jay; DeCastro, Jonathan A.

    2006-01-01

    In an effort to improve upon current thermal active clearance control methods, a first generation, fast-acting mechanically actuated, active clearance control system has been designed and installed into a non-rotating test rig. In order to harvest the benefit of tighter blade tip clearances, low-leakage seals are required for the actuated carrier segments of the seal shroud to prevent excessive leakage of compressor discharge (P3) cooling air. The test rig was designed and fabricated to facilitate the evaluation of these types of seals, identify seal leakage sources, and test other active clearance control system concepts. The objective of this paper is to present both experimental and analytical investigations into the nature of the face-seal to seal-carrier interface. Finite element analyses were used to examine face seal contact pressures and edge-loading under multiple loading conditions, varied E-seal positions and two new face seal heights. The analyses indicated that moving the E-seal inward radially and reducing face seal height would lead to more uniform contact conditions between the face seal and the carriers. Lab testing confirmed that moving the balance diameter inward radially caused a decrease in overall system leakage.

  10. SAHIT Investigators--on the outcome of some subarachnoid hemorrhage clinical trials.

    PubMed

    Macdonald, R Loch; Jaja, Blessing; Cusimano, Michael D; Etminan, Nima; Hanggi, Daniel; Hasan, David; Ilodigwe, Don; Lantigua, Hector; Le Roux, Peter; Lo, Benjamin; Louffat-Olivares, Ada; Mayer, Stephan; Molyneux, Andrew; Quinn, Audrey; Schweizer, Tom A; Schenk, Thomas; Spears, Julian; Todd, Michael; Torner, James; Vergouwen, Mervyn D I; Wong, George K C; Singh, Jeff

    2013-06-01

    Outcome of patients with aneurysmal subarachnoid hemorrhage (SAH) has improved over the last decades. Yet, case fatality remains nearly 40% and survivors often have permanent neurological, cognitive and/or behavioural sequelae. Other than nimodipine drug or clinical trials have not consistently improved outcome. We formed a collaboration of SAH investigators to create a resource for prognostic analysis and for studies aimed at optimizing the design and analysis of phase 3 trials in aneurysmal SAH. We identified investigators with data from randomized, clinical trials of patients with aneurysmal SAH or prospectively collected single- or multicentre databases of aneurysmal SAH patients. Data are being collected and proposals to use the data and to design future phase 3 clinical trials are being discussed. This paper reviews some issues discussed at the first meeting of the SAH international trialists (SAHIT) repository meeting. Investigators contributed or have agreed to contribute data from several phase 3 trials including the tirilazad trials, intraoperative hypothermia for aneurysmal SAH trial, nicardipine clinical trials, international subarachnoid aneurysm trial, intravenous magnesium sulphate for aneurysmal SAH, magnesium for aneurysmal SAH and from prospectively-collected data from four institutions. The number of patients should reach 15,000. Some industry investigators refused to provide data and others reported that their institutional research ethics boards would not permit even deidentified or anonymized data to be included. Others reported conflict of interest that prevented them from submitting data. The problems with merging data were related to lack of common definitions and coding of variables, differences in outcome scales used, and times of assessment. Some questions for investigation that arose are discussed. SAHIT demonstrates the possibility of SAH investigators to contribute data for collaborative research. The problems are similar to those

  11. Strategies for promoting physical activity in clinical practice.

    PubMed

    Sallis, Robert; Franklin, Barry; Joy, Liz; Ross, Robert; Sabgir, David; Stone, James

    2015-01-01

    The time has come for healthcare systems to take an active role in the promotion of physical activity (PA). The connection between PA and health has been clearly established and exercise should be viewed as a cost effective medication that is universally prescribed as a first line treatment for virtually every chronic disease. While there are potential risks associated with exercise, these can be minimized with a proper approach and are far outweighed by the benefits. Key to promoting PA in the clinical setting is the use of a PA Vital Sign in which every patient's exercise habits are assessed and recorded in their medical record. Those not meeting the recommended 150min per week of moderate intensity PA should be encouraged to increase their PA levels with a proper exercise prescription. We can improve compliance by assessing our patient's barriers to being more active and employing new and evolving technology like accelerometers and smart phones applications, along with various websites and programs that have proven efficacy.

  12. Electrochemical Impedance Spectroscopy Investigation on the Clinical Lifetime of ProTaper Rotary File System

    PubMed Central

    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. PMID:24605336

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

    PubMed

    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.

  14. Investigation of Cytotoxic Activity in Four Stachys Species from Iran

    PubMed Central

    Khanavi, Mahnaz; Manayi, Azadeh; Lotfi, Mahnaz; Abbasi, Rofeyde; Majdzadeh, Maryam; Ostad, Seyed Nasser

    2012-01-01

    The aerial parts of Stachys laxa Boiss. and Buhse. from Siah-bishe in Mazandaran province, Stachys trinervis Aitch. and Hemsl. from Karaj in Alborz province, Stachys subaphylla Rech. F. and Stachys turcomanica Trautv. from Golestan province have been collected in May 2008. Total extracts were obtained through MeOH/H2O (80/20) and then partitioned between CHCl3, EtOAc and MeOH. These fractions and total extracts have been investigated for in-vitro cytotoxic activity against the colon carcinoma (HT-29), colorectal adenocarcinoma (Caco-2), breast ductal carcinoma (T47D) and Swiss mouse embryo fibroblast (NIH 3T3) cell lines using MTT assay (3-(4,5-di methyl thiazol-2-yl)-2,5-di phenyltetrazolium bromide). At each cell line, doses of 3.125, 6.25, 12.5, 25, 100, 200, 400 and 800 µg/mL in 1% (v/v) DMSO of all samples were tested. Ethyl acetate and chloroform fractions of Stachys laxa against proliferation of T47D and HT-29 cell lines and chloroform fraction of Stachys subaphylla and Stachys subaphylla ethyl acetate fraction toward T47D cell line exhibited highest cytotoxic activity (IC50 < 50 µg/mL). Ethyl acetate and chloroform fractions of Stachys turcomanica against HT-29 cell line, except methanol fraction of Stachys subaphylla, the other extrcts on T47D cell line, represented moderate cytotoxic activity (IC50 < 70 µg/mL). All fractions of S. trinervis demonstrated no effective cytotoxic activity. IC50 values confirmed that the growth and proliferation of HT-29 and T47D cells were most affected by chloroform and ethyl acetate fractions of Stachys laxa and Stachys turcomanica due to their nonpolar compounds. PMID:24250483

  15. [Influence of prostatilen on smooth muscle organs functional activity in surgical patients (clinical and experimental study)].

    PubMed

    Al'-Shukri, S Kh; Aĭvazian, A I; Barabanov, S V; Barabanova, V V; Bobkov, Iu A; Gorbachev, A G; Parastaeva, M M

    1999-01-01

    The action of prostatilen on contractile activity of smooth muscles of isolated line slices of urine bladder of Wistar rats (myography) and arterial vessels of cat kidneys (resistography) was studied. On the basis of clinical cases effectiveness of prostatilen was analysed as a treatment restorting urine bladder function in acute reflex urinary retention after operations in the area of rectal sphincter, as well as in treatment of patients with chronic prostatitis. It is shown, that prostatilen produces contractile action on smooth muscles of renal blood vessels in cats and urine bladder walls in rats and it raises contractile activity of smooth muscles of human urine bladder. The results of experimental and clinical investigations make it possible to recommend the application of this bioregulating preparation for treatment and prophylaxis of disturbances in urination.

  16. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection

    PubMed Central

    Chollet, John L.; Jozwiakowski, Michael J.

    2012-01-01

    The purpose of this study was to investigate the quality of hydroxyprogesterone caproate (HPC) active pharmaceutical ingredient (API) sources that may be used by compounding pharmacies, compared to the FDA-approved source of the API; and to investigate the quality of HPC injection samples obtained from compounding pharmacies in the US, compared to the FDA-approved product (Makena®). Samples of API were obtained from every source confirmed to be an original manufacturer of the drug for human use, which were all companies in China that were not registered with FDA. Eight of the ten API samples (80%) did not meet the impurity specifications required by FDA for the API used in the approved product. One API sample was found to not be HPC at all; additional laboratory testing showed that it was glucose. Thirty samples of HPC injection obtained from com pounding pharmacies throughout the US were also tested, and eight of these samples (27%) failed to meet the potency requirement listed in the USP monograph for HPC injection and/or the HPLC assay. Sixteen of the thirty injection samples (53%) exceeded the impurity limit setforthe FDA-approved drug product. These results confirm the inconsistency of compounded HPC Injections and suggest that the risk-benefit ratio of using an unapproved compounded preparation, when an FDA-approved drug product is available, is not favorable. PMID:22329865

  17. Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia

    PubMed Central

    Franzen, Samuel R P; Chandler, Clare; Enquselassie, Fikre; Siribaddana, Sisira; Atashili, Julius; Angus, Brian; Lang, Trudie

    2013-01-01

    Objectives Clinical trials provide ‘gold standard’ evidence for policy, but insufficient locally relevant trials are conducted in low-income and middle-income countries. Local investigator-initiated trials could generate highly relevant data for national governments, but information is lacking on how to facilitate them. We aimed to identify barriers and enablers to investigator-initiated trials in Ethiopia to inform and direct capacity strengthening initiatives. Design Exploratory, qualitative study comprising of in-depth interviews (n=7) and focus group discussions (n=3). Setting Fieldwork took place in Ethiopia during March 2011. Participants Local health researchers with previous experiences of clinical trials or stakeholders with an interest in trials were recruited through snowball sampling (n=20). Outcome measures Detailed discussion notes were analysed using thematic coding analysis and key themes were identified. Results All participants perceived investigator-initiated trials as important for generating local evidence. System and organisational barriers included: limited funding allocation, weak regulatory and administrative systems, few learning opportunities, limited human and material capacity and poor incentives for conducting research. Operational hurdles were symptomatic of these barriers. Lack of awareness, confidence and motivation to undertake trials were important individual barriers. Training, knowledge sharing and experience exchange were key enablers to trial conduct and collaboration was unanimously regarded as important for improving capacity. Conclusions Barriers to trial conduct were found at individual, operational, organisational and system levels. These findings indicate that to increase locally led trial conduct in Ethiopia, system wide changes are needed to create a more receptive and enabling research environment. Crucially, the creation of research networks between potential trial groups could provide much needed practical

  18. Characterizing Primary Care Visit Activities at Veterans Health Administration Clinics.

    PubMed

    Gutierrez, Jennifer C; Terwiesch, Christian; Pelak, Mary; Pettit, Amy R; Marcus, Steven C

    2015-01-01

    Medical home models seek to increase efficiency and maximize the use of resources by ensuring that all care team members work at the top of their licenses. We sought to break down primary care office visits into measurable activities to better under stand how primary care providers (PCPs) currently spend visit time and to provide insight into potential opportunities for revision or redistribution of healthcare tasks. We videotaped 27 PCPs during office visits with 121 patients at four Veterans Health Administration medical centers. Based on patterns emerging from the data, we identified a taxonomy of 12 provider activity categories that enabled us to quantify the frequency and duration of activities occurring during routine primary care visits. We conducted descriptive and multivariate analyses to examine associations between visit characteristics and provider and clinic characteristics. We found that PCPs spent the greatest percentage of their visit time discussing existing conditions (20%), discussing new conditions (18%), record keeping (13%), and examining patients (13%). Providers spent the smallest percentage of time on preventive care and coordination of care. Mean visit length was 22.9 minutes (range 7.9-58.0 minutes). Site-level ratings of medical home implementation were not associated with differences in how visit time was spent. These data provide a window into how PCPs are spending face-to-face time with patients. The methodology and taxonomy presented here may prove useful for future quality improvement and research endeavors, particularly those focused on opportunities to increase nonappointment care and to ensure that team members work at the top of their skill level.

  19. Bifunctional antibody retargeting in vivo-activated T lymphocytes: simplifying clinical application.

    PubMed

    Chapoval, A I; Nelson, H; Thibault, C; Penna, C; Dean, P

    1995-12-01

    For antitumor x anti-CD3 bifunctional antibody (BFA) therapy to be clinically relevant in solid tumors, activated lymphocytes must be present within tumors. Toward that end, three uniquely different in vivo activation approaches were investigated in a p97 human antigen expressing syngeneic murine melanoma model. beta-Glucan (200 micrograms), staphylococcal enterotoxin B (SEB) (50 micrograms), and F(ab')2 BFA (10 micrograms) were tested for their ability to activate lymphocytes, neutralize pulmonary metastases, and treat established tumors. Systemic activation, measured as the ability of splenocytes to lyse tumor cells in vitro in the presence of BFA, was enhanced by the in vivo administration of SEB but not by beta-glucan or F(ab')2 BFA. Despite lacking a systemic effect, F(ab')2 BFA increased both direct and BFA-mediated cytotoxicity in fresh tumor infiltrating lymphocytes. beta-Glucan did not increase systemic or intratumor T cell activation. However, it significantly enhanced the ability of splenocytes to lyse NK-sensitive YAC-1 cells. When tested in a pulmonary metastases model, all three forms of immune modulation combined with F(ab')2 BFA significantly reduced the number of metastases. BFA were more effective at tumor neutralization when combined with SEB compared with adoptively transferred, in vitro-activated splenocytes. These studies demonstrate that immune modulators when combined with F(ab')2 BFA can provide effective antitumor therapy. Several clinical obstacles may be overcome by the application of these reagents. PMID:8846018

  20. Clinical, histopathologic, and genetic investigation in two large families with dentinogenesis imperfecta type II.

    PubMed

    Malmgren, B; Lindskog, S; Elgadi, A; Norgren, S

    2004-04-01

    Dentinogenesis imperfecta (DI) type II, an inherited disorder affecting dentin, has been linked to mutations in the dentin sialophosphoprotein ( DSPP) gene on chromosome 4q21. The gene product is cleaved into two dentin-specific matrix proteins, dentin sialoprotein (DSP) and dentin phosphoprotein. The aim of this investigation was to study genotypes and phenotypes in two affected families with special reference to clinical, radiographic, and histopathologic manifestations. Seven affected members of Family A and five of Family B were documented clinically and radiographically; 14 and 10 teeth, respectively, were available for histopathologic investigation and prepared for ground sections, which were assessed semiquantitatively for dysplastic manifestations in the dentin according to the scoring system, dysplastic dentin score (DDS). Venous blood samples were collected from six affected and ten unaffected members of Family A, and from eight affected and six unaffected members of Family B. Genomic DNA was extracted and used for sequence analyses. The two families presented with different missense mutations. An Arg68Trp missense mutation in the DSP part of the gene was revealed in all six analyzed affected individuals in Family A. This mutation was not present in any of the ten healthy members. In Family B, an Ala15Val missense mutation involving the last residue of the signal peptide was found in all eight affected but in none of the six healthy members. The clinical and radiographic disturbances and DDS were more severe in Family B. The data indicate the presence of a genotype-phenotype correlation in DI type II.

  1. 78 FR 13067 - Agency Information Collection Activities: Proposed Collection; Comment Request; Foreign Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... Collection; Comment Request; Foreign Clinical Studies Not Conducted Under an Investigational New Drug... contained in FDA's regulations on foreign clinical studies not conducted under an investigational new drug... appropriate, and other forms of information technology. Foreign Clinical Studies Not Conducted Under an...

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

    NASA Astrophysics Data System (ADS)

    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.

  3. Investigate the Child's Scientific Activities on Practical Child's Activity Books for the Kindergarten's Children

    ERIC Educational Resources Information Center

    Aldarabah, Intisar Turki; Al-Mouhtadi, Reham

    2015-01-01

    This research aimed to investigate the extent to which the interactive international curriculum is included in the "Child's Scientific Activities" issued by the Ministry of Education in Jordan, for the kindergarten stage according to the global criterion (NRC). In order to answer the study questions, an instrument was developed to…

  4. Clinical Investigations in Mathematics Education. Thematic Addresses from the Fourth National Conference on Diagnostic and Prescriptive Mathematics.

    ERIC Educational Resources Information Center

    Speer, William R.

    Five invitational addresses presented at the Fourth National Conference of the Research Council for Diagnostic and Prescriptive Mathematics are included in this document. "The Nature of the Clinical Investigation" (Romberg and Uprichard) discusses the validity of clinical investigations and suggests guidelines for conducting such studies of…

  5. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Safeguards for Children in Clinical Investigations § 50.53 Clinical investigations involving greater than... in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an... involve children as subjects only if the IRB finds and documents that: (a) The risk represents a...

  6. Electroencephalogram associations to cognitive performance in clinically active nurses.

    PubMed

    Lees, Ty; Khushaba, Rami; Lal, Sara

    2016-07-01

    Cognitive impairment is traditionally identified via cognitive screening tools that have limited ability in detecting early or transitional stages of impairment. The dynamic nature of physiological variables such as the electroencephalogram (EEG) may provide alternate means for detecting these transitions. However, previous research examining EEG and cognitive performance is largely confined to samples with diagnosed cognitive impairments, and research examining non-impaired, and occupation specific samples, is limited. The present study aimed to investigate the associations between frontal pole and central EEG and cognitive performance in a sample of male and female nurses, and to determine the significance of these associations. Fifty seven nurses participated in the study, in which two lead bipolar EEG was recorded at positions Fp1 (frontal polar), Fp2, C3 (central) and C4 during a baseline and an active phase involving the common neuropsychological Stroop test. Participants' cognitive performance was assessed using the mini-mental state exam (MMSE) and Cognistat screening tools. Significant correlations between EEG beta activity and the outcome of MMSE and Cognistat were revealed, where an increased beta activity was associated to an increased global cognitive performance. Additionally, domain specific cognitive performance was also significantly associated to various EEG variables. The study identified potential EEG biomarkers for global and domain specific cognitive performance, and provides initial groundwork for the development of future EEG based biomarkers for detection of cognitive pathologies. PMID:27244262

  7. Investigation of the skin sensitizing activity of linalool.

    PubMed

    Basketter, David A; Wright, Zoë M; Colson, Neil R; Patlewicz, Grace Y; Pease, Camilla K Smith

    2002-09-01

    An increasing range of chemicals appears to be capable of causing skin sensitization as a result of their capacity to undergo air oxidation (autoxidation) with the consequent formation of reactive species such as epoxides and hydroperoxides. In this small investigation, the ability of linalool, a common fragrance ingredient, to cause such effects was quantified using the local lymph node assay before and after careful purification by vacuum distillation. The commercially available grade of linalool (97% purity) was shown to be a weak skin sensitizer. Various impurities, including linalool oxide, dihydrolinalool, epoxylinalool, 3-hexenyl butyrate and 3,7-dimethyl-1,7-octadiene-3,6-diol were identified and were completely removed (except for the dihydrolinalool remaining at 1.4%) and the re-purified linalool retested. Neither linalool or dihydrolinalool are protein-reactive compounds. The sensitization potency of the re-purified linalool sample was considerably reduced, but not entirely eliminated, suggesting either that an allergenic impurity could be very quickly reformed by mechanisms of activation or that certain potent undetectable allergens remained. Both possibilities are consistent with what is understood of the chemistry and composition of commercially available linalool.

  8. Preliminary investigations of active pixel sensors in Nuclear Medicine imaging

    NASA Astrophysics Data System (ADS)

    Ott, Robert; Evans, Noel; Evans, Phil; Osmond, J.; Clark, A.; Turchetta, R.

    2009-06-01

    Three CMOS active pixel sensors have been investigated for their application to Nuclear Medicine imaging. Startracker with 525×525 25 μm square pixels has been coupled via a fibre optic stud to a 2 mm thick segmented CsI(Tl) crystal. Imaging tests were performed using 99mTc sources, which emit 140 keV gamma rays. The system was interfaced to a PC via FPGA-based DAQ and optical link enabling imaging rates of 10 f/s. System noise was measured to be >100e and it was shown that the majority of this noise was fixed pattern in nature. The intrinsic spatial resolution was measured to be ˜80 μm and the system spatial resolution measured with a slit was ˜450 μm. The second sensor, On Pixel Intelligent CMOS (OPIC), had 64×72 40 μm pixels and was used to evaluate noise characteristics and to develop a method of differentiation between fixed pattern and statistical noise. The third sensor, Vanilla, had 520×520 25 μm pixels and a measured system noise of ˜25e. This sensor was coupled directly to the segmented phosphor. Imaging results show that even at this lower level of noise the signal from 140 keV gamma rays is small as the light from the phosphor is spread over a large number of pixels. Suggestions for the 'ideal' sensor are made.

  9. Browser Based Platform in Maintaining Clinical Activities - Use of The iPads in Head and Neck Clinics

    NASA Astrophysics Data System (ADS)

    Yang, W. Y.; Moore, J.; Quon, H.; Evans, K.; Sharabi, A.; Herman, J.; Hacker-Prietz, A.; McNutt, T.

    2014-03-01

    Purpose: Incompatibility between documentation and clinical workflow causes physician resistance in organized data collection, which in turn complicates the use of data in patient care improvement. To resolve the gap, we developed an iPad compatible in situ browser-based platform that integrates clinical activity with data collection and analysis presentation. The ability to perform in-clinic activities and monitor decision making using the iPad was evaluated. Methods: A browser-based platform that can exchange and present analysed data from the MOSAIQ database was developed in situ, the iPads were distributed in head and neck clinics to present the browser for clinical activities, data collection and assessment monitoring. Performance of the iPads for in-clinic activities was observed. Results: All in-clinic documentation activities can be performed without workstation computers. Accessing patient record and previous assessments was significantly faster without having to open the MOSAIQ application. Patient assessments can be completed with the physician facing the patient. Graphical presentation of toxicity progression and patient radiation plans to the patient can be performed in single interface without patient leaving the seating area. Updates in patient treatment status and medical history were presented in real time without having to move paper charts around. Conclusions: The iPad can be used in clinical activities independent of computer workstations. Improvements in clinical workflow can be critical in reducing physician resistance in data maintenance. Using the iPad in providing real-time quality monitoring is intuitive to both providers and patients.

  10. The Effects of Sex Steroids on Spatial Performance: A Review and an Experimental Clinical Investigation.

    ERIC Educational Resources Information Center

    Liben, Lynn S.; Susman, Elizabeth J.; Finkelstein, Jordan W.; Chinchilli, Vernon M.; Kunselman, Susan; Schwab, Jacqueline; Dubas, Judith Semon; Demers, Laurence M.; Lookingbill, Georgia; D'Arcangelo, M. Rose; Krogh, Holleen R.; Kulin, Howard E.

    2002-01-01

    Investigated the relationship between sex hormones and spatial performance among adolescents treated with sex steroids for delayed puberty. Found that spatial performance varied according to gender but did not vary with levels of actively circulating sex steroids. Reviewed physiological mechanisms, developmental periods, and past empirical work…

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

    PubMed

    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.

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

    PubMed

    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. PMID:26414054

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

    PubMed Central

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

    2015-01-01

    There is mounting concern that clinician scientists are a vanishing species, and that the pipeline for clinical 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 Translational Science Awards National Consortium is well positioned to test existing models aimed at shortening the timeframe, increasing the rate of K2R transition, and identifying strategies that improve success. PMID:26414054

  14. Increased Enterococcus faecalis infection is associated with clinically active Crohn disease.

    PubMed

    Zhou, Youlian; Chen, Huiting; He, Hanchang; Du, Yanlei; Hu, Jiaqi; Li, Yingfei; Li, Yuyuan; Zhou, Yongjian; Wang, Hong; Chen, Ye; Nie, Yuqiang

    2016-09-01

    This study was performed to investigate the relationship between the abundance of pathogenic gut microbes in Chinese patients with inflammatory bowel disease (IBD) and disease severity.We collected clinical data and fecal samples from 47 therapy-naive Chinese patients with ulcerative colitis (UC), 67 patients with Crohn disease (CD), and 48 healthy volunteers. Bacteria levels of Fusobacterium species (spp), enterotoxigenic Bacteroides fragilis (B fragilis), enteropathogenic Escherichia coli (E coli), and Enterococcus faecalis (E faecalis) were assessed by quantitative real-time PCR (qRT-PCR). Spearman correlation coefficients were calculated to test associations between bacterial content and clinical parameters.Compared to healthy controls, the levels of both Fusobacterium spp and E faecalis were significantly increased in the feces of patients with IBD (P < 0.01). B fragilis levels were higher (P < 0.05) and E faecalis levels lower (P < 0.05) in patients with CD compared to those with UC. Increased E faecalis colonization in CD associated positively with disease activity (P = 0.015), Crohn disease activity index (CDAI; R = 0.3118, P = 0.0108), and fecal calprotectin (P = 0.016).E faecalis and Fusobacterium spp are significantly enriched in patients with IBD, and increased E faecalis infection is associated with clinically active CD. PMID:27684872

  15. Antiasthmatic activity of Moringa oleifera Lam: A clinical study

    PubMed Central

    Agrawal, Babita; Mehta, Anita

    2008-01-01

    The present study was carried out to investigate the efficacy and safety of seed kernels of Moringa oleifera in the treatment of bronchial asthma. Twenty patients of either sex with mild-to-moderate asthma were given finely powdered dried seed kernels in dose of 3 g for 3 weeks. The clinical efficacy with respect to symptoms and respiratory functions were assessed using a spirometer prior to and at the end of the treatment. Hematological parameters were not changed markedly by treatment with M. oleifera. However, the majority of patients showed a significant increase in hemoglobin (Hb) values and Erythrocyte sedimentation rate (ESR) was significantly reduced. Significant improvement was also observed in symptom score and severity of asthmatic attacks. Treatment with the drug for 3 weeks produced significant improvement in forced vital capacity, forced expiratory volume in one second, and peak expiratory flow rate values by 32.97 ± 6.03%, 30.05 ± 8.12%, and 32.09 ± 11.75%, respectively, in asthmatic subjects. Improvement was also observed in % predicted values. None of the patients showed any adverse effects with M. oleifera. The results of the present study suggest the usefulness of M. oleifera seed kernel in patients of bronchial asthma. PMID:21264158

  16. Clinical application of transcriptional activators of bile salt transporters☆

    PubMed Central

    Baghdasaryan, Anna; Chiba, Peter; Trauner, Michael

    2014-01-01

    Hepatobiliary bile salt (BS) transporters are critical determinants of BS homeostasis controlling intracellular concentrations of BSs and their enterohepatic circulation. Genetic or acquired dysfunction of specific transport systems causes intrahepatic and systemic retention of potentially cytotoxic BSs, which, in high concentrations, may disturb integrity of cell membranes and subcellular organelles resulting in cell death, inflammation and fibrosis. Transcriptional regulation of canalicular BS efflux through bile salt export pump (BSEP), basolateral elimination through organic solute transporters alpha and beta (OSTα/OSTβ) as well as inhibition of hepatocellular BS uptake through basolateral Na+-taurocholate cotransporting polypeptide (NTCP) represent critical steps in protection from hepatocellular BS overload and can be targeted therapeutically. In this article, we review the potential clinical implications of the major BS transporters BSEP, OSTα/OSTβ and NTCP in the pathogenesis of hereditary and acquired cholestatic syndromes, provide an overview on transcriptional control of these transporters by the key regulatory nuclear receptors and discuss the potential therapeutic role of novel transcriptional activators of BS transporters in cholestasis. PMID:24333169

  17. Clinical investigation of doxorubicin, daunomycin, and 6-thioguanine in normal cats.

    PubMed

    Henness, A M; Theilen, G H; Lewis, J P

    1977-04-01

    Cats frequently develop a variety of spontaneous hemolymphatic noeplasias. Long-term remissions in the nonlymphatic leukemic cat are difficult to obtain; therefore, more successful chemotherapeutic agents are sought for disease control. The purpose in the present study is to describe the clinical investigation of 3 antineoplastic drugs given to 23 normal cats. The cats tolerated doxorubican given at the dose level of 30 mg/m2 of body surface area once every 3 weeks; daunomycin, 15 to 30 mg/m2 once every 3 weeks; and 6-thioguanine, 25 mg/m2 for 5 days every 20 to 30 days.

  18. Identification, clinical distribution, and susceptibility to methicillin and 18 additional antibiotics of clinical Staphylococcus isolates: nationwide investigation in Italy.

    PubMed

    Varaldo, P E; Cipriani, P; Focá, A; Geraci, C; Giordano, A; Madeddu, M A; Orsi, A; Pompei, R; Prenna, M; Repetto, A

    1984-06-01

    A multicentric study of clinical Staphylococcus isolates was performed by seven operative units working in different areas of Italy. Over a 6-month period, a total of 3,226 staphylococci, isolated from in- and outpatients, were identified and tested for antimicrobial susceptibility by a protocol agreed upon by all units. On the basis of their bacteriolytic-activity patterns and other conventional tests, the isolates were identified by lyogroups , which closely correlate with human Staphylococcus species. Lyogroup I (Staphylococcus aureus) and lyogroup III (Staphylococcus capitis) were the most and the least frequently isolated staphylococci, respectively. Significant differences depending on strain origin from in- or outpatients were only observed with lyogroup IV (i.e., novobiocin- resistant staphylococci), whose isolation from outpatients was three times greater than from inpatients. Lyogroup I was predominant among isolates from most clinical sources. Lyogroup IV predominated in strains isolated from the urinary tract; lyogroup V (Staphylococcus epidermidis) predominated in strains from blood, cerebrospinal fluid, and indwelling artificial devices; and lyogroup VI ( Staphylococcus hominis, Staphylococcus haemolyticus, and Staphylococcus warneri ) predominated in strains from bile and the male genital tract. The incidence of methicillin resistance within the different lyogroups varied from unit to unit, suggesting epidemiological differences among different hospitals and different geographical areas. On the whole, methicillin resistance was more frequent in coagulase-negative staphylococci than in S. aureus and ranged from 19% for lyogroups I and III to 30% for lyogroup II (Staphylococcus simulans). Laboratory testing with 18 additional antibiotics suggested the occurrence of some specific differences in susceptibility among the different lyogroups . The rate of organisms resistant to the various antibiotics was greater among methicillin-resistant than among

  19. Identification, clinical distribution, and susceptibility to methicillin and 18 additional antibiotics of clinical Staphylococcus isolates: nationwide investigation in Italy.

    PubMed

    Varaldo, P E; Cipriani, P; Focá, A; Geraci, C; Giordano, A; Madeddu, M A; Orsi, A; Pompei, R; Prenna, M; Repetto, A

    1984-06-01

    A multicentric study of clinical Staphylococcus isolates was performed by seven operative units working in different areas of Italy. Over a 6-month period, a total of 3,226 staphylococci, isolated from in- and outpatients, were identified and tested for antimicrobial susceptibility by a protocol agreed upon by all units. On the basis of their bacteriolytic-activity patterns and other conventional tests, the isolates were identified by lyogroups , which closely correlate with human Staphylococcus species. Lyogroup I (Staphylococcus aureus) and lyogroup III (Staphylococcus capitis) were the most and the least frequently isolated staphylococci, respectively. Significant differences depending on strain origin from in- or outpatients were only observed with lyogroup IV (i.e., novobiocin- resistant staphylococci), whose isolation from outpatients was three times greater than from inpatients. Lyogroup I was predominant among isolates from most clinical sources. Lyogroup IV predominated in strains isolated from the urinary tract; lyogroup V (Staphylococcus epidermidis) predominated in strains from blood, cerebrospinal fluid, and indwelling artificial devices; and lyogroup VI ( Staphylococcus hominis, Staphylococcus haemolyticus, and Staphylococcus warneri ) predominated in strains from bile and the male genital tract. The incidence of methicillin resistance within the different lyogroups varied from unit to unit, suggesting epidemiological differences among different hospitals and different geographical areas. On the whole, methicillin resistance was more frequent in coagulase-negative staphylococci than in S. aureus and ranged from 19% for lyogroups I and III to 30% for lyogroup II (Staphylococcus simulans). Laboratory testing with 18 additional antibiotics suggested the occurrence of some specific differences in susceptibility among the different lyogroups . The rate of organisms resistant to the various antibiotics was greater among methicillin-resistant than among

  20. Clinical experience and results of a Sentinel Health Investigation related to indoor fungal exposure.

    PubMed Central

    Johanning, E; Landsbergis, P; Gareis, M; Yang, C S; Olmsted, E

    1999-01-01

    This is a review of exposure conditions, clinical presentation, and morbidity of children and adults with indoor fungal exposure such as toxic Stachybotrys chartarum. Indoor exposure was characterized using different methods including microscopic, culture, cytotoxicity screening tests, and chemical analyses. Clinical case histories and physical and laboratory findings are presented of children (age < 18 years, n = 22; mean age 9 years; 60% females) and adults (age >18 years, n = 125; mean age 39 years, 67% females) who consulted an environmental health specialty clinic. In the pediatric patients' exposure history, widespread fungal contamination of water-damaged building materials with known toxic or allergic fungi was identified. Primarily disorders of the respiratory system, skin, mucous membranes, and central nervous system were reported. Some enumeration and functional laboratory abnormalities, mainly of the lymphatic blood cells, were observed, although no statistically significant differences were found. IgE or IgG fungi-specific antibodies, used as exposure markers, were positive in less than 25% of all tested cases. In an evaluation of a symptomatic girl 11 years of age (sentinel case investigation) living in an apartment with verified toxigenic fungi (i.e., S. chartarum), several health indicators showed improvement after exposure cessation. Images Figure 1 PMID:10346997

  1. Serotonin content of platelets in inflammatory rheumatic diseases. Correlation with clinical activity.

    PubMed

    Zeller, J; Weissbarth, E; Baruth, B; Mielke, H; Deicher, H

    1983-04-01

    Significantly decreased platelet serotonin contents were measured in rheumatoid arthritis, systemic lupus erythematosus (SLE), progressive systemic sclerosis, and mixed connective tissue disease. An inverse relationship between platelet serotonin levels and clinical disease activity was observed in both rheumatoid arthritis and systemic lupus erythematosus. SLE patients with multiple organ involvement showed the lowest platelet serotonin values. No correlation was observed between platelet serotonin contents and nonsteroidal antiinflammatory drug treatment, presence of circulating platelet reactive IgG, or the amount of circulating immune complexes. The results are interpreted as indicating platelet release occurring in vivo during inflammatory episodes of the rheumatic disorders investigated. PMID:6838676

  2. [Participation and support of clinical studies and other scientific investigations. Statement of the German Society for Pathology].

    PubMed

    Röcken, C; Höfler, H; Hummel, M; Meyermann, R; Zietz, C; Schirmacher, P

    2013-09-01

    Clinical studies and preclinical investigations are essential in order to test new therapies and diagnostics with the aim of sustained improvement in the treatment of patients. Fortunately, the number of clinical studies is continuously increasing and pathology and tissue-based research are included more often. The German Society for Pathology (DGP) and the pathologists it represents want to and can support this process and our clinical partners as best as possible as an equal partner. With our technologies and our specific expertise we can make a substantial contribution to the quality and the success of preclinical investigations, clinical studies and implementation of the results into clinical pathological diagnostics. In order to support this process the DGP has formulated a statement on the participation and support of clinical studies and other scientific investigations.

  3. Clinical investigation of EGFR mutation detection by pyrosequencing in lung cancer patients

    PubMed Central

    KIM, HEE JOUNG; OH, SEO YOUNG; KIM, WAN SEOP; KIM, SUN JONG; YOO, GWANG HA; KIM, WON DONG; LEE, KYE YOUNG

    2013-01-01

    Direct sequencing is the standard method for the detection of epidermal growth factor receptor (EGFR) mutations in lung cancer, however, its relatively low sensitivity limits its clinical use. Pyrosequencing is a bioluminometric, real-time non-electrophoretic DNA sequencing technique with a number of advantages compared with direct sequencing, including higher sensitivity, speed, automation and cost-effectiveness. Clinical specimens from 202 lung cancer patients were analyzed for EGFR mutations in exons 18, 19, 20 and 21 using the pyrosequencing method following genomic DNA extraction from paraffin-embedded tissue specimens. All clinical data and tumor specimens were obtained from the Konkuk University Hospital (Korea) between July 2006 and December 2008. The results and clinical responses to EGFR-tyrosine kinase inhibitors (TKIs) were compared. Overall, EGFR mutation-positive rate was 26.7% (54/202). Activating EGFR mutations were observed more frequently in female (52.1 vs. 13.0%), non-smoking (47.8 vs. 15.8%) and adenocarcinoma (35.2 vs. 5.2%) patients. However, significant numbers of EGFR mutation-positive patients were identified as male, former or current smokers and non-adenocarcinoma patients. The combinations of favorable clinicopathological factors, including female, non-smoking and adenocarcinoma, were not identified to significantly increase the positive EGFR mutation rate (female, 52.1%; female and non-smoker, 52.6%; female, non-smoker and adenocarcinoma, 51.9%). The present findings indicate that EGFR mutation analysis is a highly useful method for the prediction of response to EGFR-TKI and the use of favorable clinicopathological factors to perform this analysis is not suitable. Exon 19 deletion was the most common mutation (63.6%) and exon 21 L858R substitution was measured at 32.7%. The exon 20 T790M mutation was identified in 1 patient prior to EGFR-TKI treatment. EGFR mutation status is associated with response to EGFR-TKI and the overall

  4. Direct-detection EPID dosimetry: investigation of a potential clinical configuration for IMRT verification

    NASA Astrophysics Data System (ADS)

    Vial, Philip; Gustafsson, Helen; Oliver, Lyn; Baldock, Clive; Greer, Peter B.

    2009-12-01

    The routine use of electronic portal imaging devices (EPIDs) as dosimeters for radiotherapy quality assurance is complicated by the non-water equivalence of the EPID's dose response. A commercial EPID modified to a direct-detection configuration was previously demonstrated to provide water-equivalent dose response with dmax solid water build-up and 10 cm solid water backscatter. Clinical implementation of the direct EPID (dEPID) requires a design that maintains the water-equivalent dose response, can be incorporated onto existing EPID support arms and maintains sufficient image quality for clinical imaging. This study investigated the dEPID dose response with different configurations of build-up and backscatter using varying thickness of solid water and copper. Field size output factors and beam profiles measured with the dEPID were compared with ionization chamber measurements of dose in water for both 6 MV and 18 MV. The dEPID configured with dmax solid water build-up and no backscatter (except for the support arm) was within 1.5% of dose in water data for both energies. The dEPID was maintained in this configuration for clinical dosimetry and image quality studies. Close agreement between the dEPID and treatment planning system was obtained for an IMRT field with 98.4% of pixels within the field meeting a gamma criterion of 3% and 3 mm. The reduced sensitivity of the dEPID resulted in a poorer image quality based on quantitative (contrast-to-noise ratio) and qualitative (anthropomorphic phantom) studies. However, clinically useful images were obtained with the dEPID using typical treatment field doses. The dEPID is a water-equivalent dosimeter that can be implemented with minimal modifications to the standard commercial EPID design. The proposed dEPID design greatly simplifies the verification of IMRT dose delivery.

  5. Direct-detection EPID dosimetry: investigation of a potential clinical configuration for IMRT verification.

    PubMed

    Vial, Philip; Gustafsson, Helen; Oliver, Lyn; Baldock, Clive; Greer, Peter B

    2009-12-01

    The routine use of electronic portal imaging devices (EPIDs) as dosimeters for radiotherapy quality assurance is complicated by the non-water equivalence of the EPID's dose response. A commercial EPID modified to a direct-detection configuration was previously demonstrated to provide water-equivalent dose response with d(max) solid water build-up and 10 cm solid water backscatter. Clinical implementation of the direct EPID (dEPID) requires a design that maintains the water-equivalent dose response, can be incorporated onto existing EPID support arms and maintains sufficient image quality for clinical imaging. This study investigated the dEPID dose response with different configurations of build-up and backscatter using varying thickness of solid water and copper. Field size output factors and beam profiles measured with the dEPID were compared with ionization chamber measurements of dose in water for both 6 MV and 18 MV. The dEPID configured with d(max) solid water build-up and no backscatter (except for the support arm) was within 1.5% of dose in water data for both energies. The dEPID was maintained in this configuration for clinical dosimetry and image quality studies. Close agreement between the dEPID and treatment planning system was obtained for an IMRT field with 98.4% of pixels within the field meeting a gamma criterion of 3% and 3 mm. The reduced sensitivity of the dEPID resulted in a poorer image quality based on quantitative (contrast-to-noise ratio) and qualitative (anthropomorphic phantom) studies. However, clinically useful images were obtained with the dEPID using typical treatment field doses. The dEPID is a water-equivalent dosimeter that can be implemented with minimal modifications to the standard commercial EPID design. The proposed dEPID design greatly simplifies the verification of IMRT dose delivery. PMID:19904032

  6. In Vitro Activities of Polycationic Peptides Alone and in Combination with Clinically Used Antimicrobial Agents against Rhodococcus equi

    PubMed Central

    Giacometti, A.; Cirioni, O.; Ancarani, F.; Del Prete, M. S.; Fortuna, M.; Scalise, G.

    1999-01-01

    The in vitro activities of magainin II, nisin, and ranalexin alone and in combination with other antimicrobial agents against six clinical isolates of Rhodococcus equi were investigated by MIC and time-kill studies. All isolates were more susceptible to nisin. A positive interaction was observed when the peptides were combined with ampicillin, ceftriaxone, rifabutin, rifampin, azithromycin, clarithromycin, and vancomycin. PMID:10428947

  7. In vitro activities of polycationic peptides alone and in combination with clinically used antimicrobial agents against Rhodococcus equi.

    PubMed

    Giacometti, A; Cirioni, O; Ancarani, F; Del Prete, M S; Fortuna, M; Scalise, G

    1999-08-01

    The in vitro activities of magainin II, nisin, and ranalexin alone and in combination with other antimicrobial agents against six clinical isolates of Rhodococcus equi were investigated by MIC and time-kill studies. All isolates were more susceptible to nisin. A positive interaction was observed when the peptides were combined with ampicillin, ceftriaxone, rifabutin, rifampin, azithromycin, clarithromycin, and vancomycin. PMID:10428947

  8. Tractography Activation Patterns in Dorsolateral Prefrontal Cortex Suggest Better Clinical Responses in OCD DBS

    PubMed Central

    Hartmann, Christian J.; Lujan, J. Luis; Chaturvedi, Ashutosh; Goodman, Wayne K.; Okun, Michael S.; McIntyre, Cameron C.; Haq, Ihtsham U.

    2016-01-01

    Background: Medication resistant obsessive-compulsive disorder (OCD) patients can be successfully treated with Deep Brain Stimulation (DBS) which targets the anterior limb of the internal capsule (ALIC) and the nucleus accumbens (NA). Growing evidence suggests that in patients who respond to DBS, axonal fiber bundles surrounding the electrode are activated, but it is currently unknown which discrete pathways are critical for optimal benefit. Our aim was to identify axonal pathways mediating clinical effects of ALIC-NA DBS. Methods: We created computational models of ALIC-NA DBS to simulate the activation of fiber tracts and to identify connected cerebral regions. The pattern of activated axons and their cortical targets was investigated in six OCD patients who underwent ALIC-NA DBS. Results: Modulation of the right anterior middle frontal gyrus (dorsolateral prefrontal cortex) was associated with an excellent response. In contrast, non-responders showed high activation in the orbital part of the right inferior frontal gyrus (lateral orbitofrontal cortex/anterior ventrolateral prefrontal cortex). Factor analysis followed by step-wise linear regression indicated that YBOCS improvement was inversely associated with factors that were predominantly determined by gray matter activation results. Discussion: Our findings support the hypothesis that optimal therapeutic results are associated with the activation of distinct fiber pathways. This suggests that in DBS for OCD, focused stimulation of specific fiber pathways, which would allow for stimulation with lower amplitudes, may be superior to activation of a wide array of pathways, typically associated with higher stimulation amplitudes. PMID:26834544

  9. Project Zero Delay: a process for accelerating the activation of cancer clinical trials.

    PubMed

    Kurzrock, Razelle; Pilat, Susan; Bartolazzi, Marcel; Sanders, Dwana; Van Wart Hood, Jill; Tucker, Stanley D; Webster, Kevin; Mallamaci, Michael A; Strand, Steven; Babcock, Eileen; Bast, Robert C

    2009-09-10

    Drug development in cancer research is lengthy and expensive. One of the rate-limiting steps is the initiation of first-in-human (phase I) trials. Three to 6 months can elapse between investigational new drug (IND) approval by the US Food and Drug Administration and the entry of a first patient. Issues related to patient participation have been well analyzed, but the administrative processes relevant to implementing clinical trials have received less attention. While industry and academia often partner for the performance of phase I studies, their administrative processes are generally performed independently, and their timelines driven by different priorities: safety reviews, clinical operations, regulatory submissions, and contracting of clinical delivery vendors for industry; contracts, budgets, and institutional review board approval for academia. Both processes converge on US Food and Drug Administration approval of an IND. In the context of a strategic alliance between M. D. Anderson Cancer Center and AstraZeneca Pharmaceuticals LP, a concerted effort has been made to eliminate delays in implementing clinical trials. These efforts focused on close communications, identifying and matching key timelines, alignment of priorities, and tackling administrative processes in parallel, rather than sequentially. In a recent, first-in-human trial, the study was activated and the first patient identified in 46 days from completion of the final study protocol and about 48 hours after final US Food and Drug Administration IND approval, reducing the overall timeline by about 3 months, while meeting all clinical good practice guidelines. Eliminating administrative delays can accelerate the evaluation of new drugs without compromising patient safety or the quality of clinical research. PMID:19652061

  10. [Clinical reasoning learning (CRL) sessions. An example of a contextualized teaching activity adapted to clinical stages in medicine].

    PubMed

    Chamberland, M

    1998-12-01

    Clinical reasoning learning (CRL) sessions stem from an educational reform brought about since 1987 at the Faculty of Medicine of the Université de Sherbrooke. This reform is student-centered and based on situated learning and teaching. The objective of the CRL sessions, designed and implemented at the clerkship level, is to help students develop problem solving competencies through the use of effective general clinical reasoning strategies and the development of a highly organized network of specific knowledge. These sessions also strive to offset the difficulties of random clinical exposure and often highly complex cases encountered by trainees during clinical rotations in teaching hospitals. Formed of small groups, sessions recreate a clinical consultation setting focused on a specific priority problem and clinical condition identified among the mandatory objectives of the rotation. Emphasis is placed on early generation and subsequent testing of diagnostic hypothesis, and the active search and gradual disclosure of clinical data using hypothesis-driven inquiry strategy. Students are asked to verbalize their reasoning process under the close supervision of a clinical expert in the field under discussion. Implemented in 5 different clinical disciplines since 1990 in Sherbrooke, assessment data are now available and support the relevance and usefulness of CRL sessions.

  11. Association of nailfold capillary changes with disease activity, clinical and laboratory findings in patients with dermatomyositis

    PubMed Central

    Shenavandeh, Saeedeh; Zarei Nezhad, Maryam

    2015-01-01

    Background: The present study aimed to investigate the Nailfold Capillaroscopy (NC) features of the patients with dermatomyositis (DM) and its correlation with their disease activity indices, physical findings, and laboratory results. Methods: The present cross-sectional study was conducted on 27 DM patients above 16 years old who had referred to an(there are 3 clinics not one) outpatient rheumatology clinics from 2012 to 2013. Nailfold capillaroscopy and calculation of disease activity indices were performed separately for all the patients by two rheumatologists who were blinded to each other's results. Statistical analyses were performed using chi-square and Mann-Whitney U tests. Results: The mean age of the patients was 39.2±14.1 years with the mean disease duration of 13.1±15.2 months (range: 1-72 months). Myopathic electromyography (EMG) findings showed a strong association with scleroderma pattern (p=0.015). However, disease activity in each organ system and global disease activity showed no significant association between scleroderma pattern and other NC findings. (Disease activity in each organ system and also global disease activity were both assessed to see if they are associated with scleroderma pattern and other NC findings so if we use between it means we are looking for an association between scleroderma pattern and other NC findings and this is not what we have done and is wrong.) Conclusion: This study revealed no significant relationship between disease activity indices and NC features. Thus, it may be more precise to interpret the results of NC in conjunction with other physical and laboratory findings. PMID:26793626

  12. Anti-tumor activity of calcitriol: pre-clinical and clinical studies.

    PubMed

    Trump, Donald L; Hershberger, Pamela A; Bernardi, Ronald J; Ahmed, Sharmilla; Muindi, Josephia; Fakih, Marwan; Yu, Wei-Dong; Johnson, Candace S

    2004-05-01

    1,25-Dihydroxycholecalciferol (calcitriol) is recognized widely for its effects on bone and mineral metabolism. Epidemiological data suggest that low Vitamin D levels may play a role in the genesis of prostate cancer and perhaps other tumors. Calcitriol is a potent anti-proliferative agent in a wide variety of malignant cell types. In prostate, breast, colorectal, head/neck and lung cancer as well as lymphoma, leukemia and myeloma model systems calcitriol has significant anti-tumor activity in vitro and in vivo. Calcitriol effects are associated with an increase in G0/G1 arrest, induction of apoptosis and differentiation, modulation of expression of growth factor receptors. Glucocorticoids potentiate the anti-tumor effect of calcitriol and decrease calcitriol-induced hypercalcemia. Calcitriol potentiates the antitumor effects of many cytotoxic agents and inhibits motility and invasiveness of tumor cells and formation of new blood vessels. Phase I and II trials of calcitriol either alone or in combination with carboplatin, taxanes or dexamethasone have been initiated in patients with androgen dependent and independent prostate cancer and advanced cancer. Data indicate that high-dose calcitriol is feasible on an intermittent schedule, no dose-limiting toxicity has been encountered and optimal dose and schedule are being delineated. Clinical responses have been seen with the combination of high dose calcitriol+dexamethasone in androgen independent prostate cancer (AIPC) and apparent potentiation of the antitumor effects of docetaxel have been seen in AIPC. These results demonstrate that high intermittent doses of calcitriol can be administered to patients without toxicity, that the MTD is yet to be determined and that calcitriol has potential as an anti-cancer agent. PMID:15225831

  13. Anti-tumor activity of calcitriol: pre-clinical and clinical studies.

    PubMed

    Trump, Donald L; Hershberger, Pamela A; Bernardi, Ronald J; Ahmed, Sharmilla; Muindi, Josephia; Fakih, Marwan; Yu, Wei-Dong; Johnson, Candace S

    2004-05-01

    1,25-Dihydroxycholecalciferol (calcitriol) is recognized widely for its effects on bone and mineral metabolism. Epidemiological data suggest that low Vitamin D levels may play a role in the genesis of prostate cancer and perhaps other tumors. Calcitriol is a potent anti-proliferative agent in a wide variety of malignant cell types. In prostate, breast, colorectal, head/neck and lung cancer as well as lymphoma, leukemia and myeloma model systems calcitriol has significant anti-tumor activity in vitro and in vivo. Calcitriol effects are associated with an increase in G0/G1 arrest, induction of apoptosis and differentiation, modulation of expression of growth factor receptors. Glucocorticoids potentiate the anti-tumor effect of calcitriol and decrease calcitriol-induced hypercalcemia. Calcitriol potentiates the antitumor effects of many cytotoxic agents and inhibits motility and invasiveness of tumor cells and formation of new blood vessels. Phase I and II trials of calcitriol either alone or in combination with carboplatin, taxanes or dexamethasone have been initiated in patients with androgen dependent and independent prostate cancer and advanced cancer. Data indicate that high-dose calcitriol is feasible on an intermittent schedule, no dose-limiting toxicity has been encountered and optimal dose and schedule are being delineated. Clinical responses have been seen with the combination of high dose calcitriol+dexamethasone in androgen independent prostate cancer (AIPC) and apparent potentiation of the antitumor effects of docetaxel have been seen in AIPC. These results demonstrate that high intermittent doses of calcitriol can be administered to patients without toxicity, that the MTD is yet to be determined and that calcitriol has potential as an anti-cancer agent.

  14. Investigating the Jack the Ripper Case: Engaging Students in a Criminal Investigations Class through Active Learning

    ERIC Educational Resources Information Center

    Gutierrez, Daniel; Kazmi, Syed

    2010-01-01

    The present study examines the utilization of a class project involving the Jack the Ripper murders. Students enrolled in a criminal investigations class were required to investigate the five canonical murders associated with the infamous serial killer known as Jack the Ripper and the murders that occurred in London during 1888. This paper…

  15. Peering into the Pharmaceutical “Pipeline”: Investigational Drugs, Clinical Trials, and Industry Priorities

    PubMed Central

    Cottingham, Marci D.; Kalbaugh, Corey A.

    2014-01-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry’s investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding – and often problematic – role of pharmaceuticals in society. To access the pharmaceutical industry’s pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2,477 different drugs in 4,182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline were being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered. PMID:25159693

  16. Peering into the pharmaceutical "pipeline": investigational drugs, clinical trials, and industry priorities.

    PubMed

    Fisher, Jill A; Cottingham, Marci D; Kalbaugh, Corey A

    2015-04-01

    In spite of a growing literature on pharmaceuticalization, little is known about the pharmaceutical industry's investments in research and development (R&D). Information about the drugs being developed can provide important context for existing case studies detailing the expanding--and often problematic--role of pharmaceuticals in society. To access the pharmaceutical industry's pipeline, we constructed a database of drugs for which pharmaceutical companies reported initiating clinical trials over a five-year period (July 2006-June 2011), capturing 2477 different drugs in 4182 clinical trials. Comparing drugs in the pipeline that target diseases in high-income and low-income countries, we found that the number of drugs for diseases prevalent in high-income countries was 3.46 times higher than drugs for diseases prevalent in low-income countries. We also found that the plurality of drugs in the pipeline was being developed to treat cancers (26.2%). Interpreting our findings through the lens of pharmaceuticalization, we illustrate how investigating the entire drug development pipeline provides important information about patterns of pharmaceuticalization that are invisible when only marketed drugs are considered.

  17. Connecting clinical and experimental investigations of awareness in traumatic brain injury.

    PubMed

    Dockree, Paul M; O'Connell, Redmond G; Robertson, Ian H

    2015-01-01

    Questionnaire-based demonstrations of impaired self-awareness (SA) after traumatic brain injury (TBI) are not always supported by experimental studies of in-the-moment or online awareness. This chapter begins by describing the clinical phenomenon of impaired SA, how it is measured, and why its interdependency with mechanisms of online awareness may provide the scaffolding from which appraisals of cognitive functioning can be accurately revised following a brain injury. We review research that has measured unawareness of errors in routine action in TBI patients and propose more rigorous methodological approaches to studying the emergent properties of awareness with greater clarity in the laboratory. We discuss how neuropsychological and electrophysiologic studies are beginning to inform our understanding of impaired error processing in TBI patients and we highlight recent theory proposing that online metacognitive processes accumulate evidence of erroneous responses in a graded fashion. Neural signals with amplitudes that scale with the strength of accruing evidence and peak latencies that mark the threshold at which awareness emerges represent important neural mechanisms to examine the breakdown of error awareness after brain injury. We also discuss how errors can be investigated in relation to different sources of evidence that contribute to aware experiences after brain injury. Finally, we explore conditions beyond error signaling, and how different "objects of insight" that require retrospective and prospective judgments of confidence need to be examined in relation to the clinical phenomenon of impaired SA. PMID:25701904

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

    PubMed

    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. PMID:26906246

  19. A clinical investigation of the effects of omission of pumice prophylaxis on band and bond failure.

    PubMed

    Barry, G R

    1995-08-01

    One hundred and twelve first molar bands and 614 directly bonded brackets on incisor, canine, and premolar teeth were included in a clinical trail to investigate the importance of omission of pumice prophylaxis at the time of banding and bonding, on their possible subsequent failure. Half of the sample were selected for the non-pumiced test groups using a random number allocation method, the remaining pumiced teeth acting as control groups. Two etch times were used for the direct bonding part of the study, 15 and 60 seconds, with non-pumiced test and pumiced control groups included within both etch-time groups. Results showed no statistical difference in the failure rate of attachments in either test or control groups during the course of treatment. The different etch times had no significant effects in the direct bonding part of the study.

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

    PubMed

    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.

  1. Clinical Relevance of Telomere Status and Telomerase Activity in Colorectal Cancer.

    PubMed

    Fernández-Marcelo, Tamara; Sánchez-Pernaute, Andrés; Pascua, Irene; De Juan, Carmen; Head, Jacqueline; Torres-García, Antonio-José; Iniesta, Pilar

    2016-01-01

    The role of telomeres and telomerase in colorectal cancer (CRC) is well established as the major driving force in generating chromosomal instability. However, their potential as prognostic markers remains unclear. We investigated the outcome implications of telomeres and telomerase in this tumour type. We considered telomere length (TL), ratio of telomere length in cancer to non-cancer tissue (T/N ratio), telomerase activity and TERT levels; their relation with clinical variables and their role as prognostic markers. We analyzed 132 CRCs and paired non-cancer tissues. Kaplan-Meier curves for disease-free survival were calculated for TL, T/N ratio, telomerase activity and TERT levels. Overall, tumours had shorter telomeres than non-tumour tissues (P < 0.001) and more than 80% of CRCs displayed telomerase activity. Telomere lengths of non-tumour tissues and CRCs were positively correlated (P < 0.001). Considering telomere status and clinical variables, the lowest degree of telomere shortening was shown by tumours located in the rectum (P = 0.021). Regarding prognosis studies, patients with tumours showing a mean TL < 6.35 Kb experienced a significantly better clinical evolution (P < 0.001) and none of them with the highest degree of tumour telomere shortening relapsed during the follow-up period (P = 0.043). The mean TL in CRCs emerged as an independent prognostic factor in the Cox analysis (P = 0.017). Telomerase-positive activity was identified as a marker that confers a trend toward a poor prognosis. In CRC, our results support the use of telomere status as an independent prognostic factor. Telomere status may contribute to explaining the different molecular identities of this tumour type.

  2. Hand function and performance of daily activities in systemic lupus erythematosus: a clinical study.

    PubMed

    Malcus Johnsson, P; Sandqvist, G; Nilsson, J-Å; Bengtsson, A A; Sturfelt, G; Nived, O

    2015-07-01

    This clinical study was performed to investigate hand problems in individuals with systemic lupus erythematosus (SLE) in comparison with healthy controls, and to explore problems in the performance of daily activities related to these hand problems, in order to objectify findings from a previous mail survey. We also investigated whether a simple hand test could detect hand problems in SLE. All individuals, 71 with SLE and 71 healthy controls, were examined for manifestations in body structures and body functions of the hands with a study-specific protocol. The simple hand test was performed by all the individuals and the arthritis impact measurement scale (AIMS 2) questionnaire was completed by the SLE individuals. In the SLE group, 58% had some kind of difficulty in the simple hand test, compared with 8% in the control group. Fifty percent of the SLE individuals experienced problems in performing daily activities due to hand deficits. Pain in the hands, reduced strength and dexterity, Raynaud's phenomenon and trigger finger were the most prominent body functions affecting the performance of daily activities. Deficits in hand function are common in SLE and affect the performance of daily activities. The simple hand test may be a useful tool in detecting hand problems.

  3. In vitro antimicrobial activity of five essential oils on multidrug resistant Gram-negative clinical isolates

    PubMed Central

    Sakkas, Hercules; Gousia, Panagiota; Economou, Vangelis; Sakkas, Vassilios; Petsios, Stefanos; Papadopoulou, Chrissanthy

    2016-01-01

    Aim/Background: The emergence of drug-resistant pathogens has drawn attention on medicinal plants for potential antimicrobial properties. The objective of the present study was the investigation of the antimicrobial activity of five plant essential oils on multidrug resistant Gram-negative bacteria. Materials and Methods: Basil, chamomile blue, origanum, thyme, and tea tree oil were tested against clinical isolates of Acinetobacter baumannii (n = 6), Escherichia coli (n = 4), Klebsiella pneumoniae (n = 7), and Pseudomonas aeruginosa (n = 5) using the broth macrodilution method. Results: The tested essential oils produced variable antibacterial effect, while Chamomile blue oil demonstrated no antibacterial activity. Origanum, Thyme, and Basil oils were ineffective on P. aeruginosa isolates. The minimum inhibitory concentration (MIC) and minimum bactericidal concentration values ranged from 0.12% to 1.50% (v/v) for tea tree oil, 0.25-4% (v/v) for origanum and thyme oil, 0.50% to >4% for basil oil and >4% for chamomile blue oil. Compared to literature data on reference strains, the reported MIC values were different by 2SD, denoting less successful antimicrobial activity against multidrug resistant isolates. Conclusions: The antimicrobial activities of the essential oils are influenced by the strain origin (wild, reference, drug sensitive, or resistant) and it should be taken into consideration whenever investigating the plants’ potential for developing new antimicrobials. PMID:27366345

  4. Clinical value of fecal calprotectin in determining disease activity of ulcerative colitis

    PubMed Central

    Xiang, Jun-Ying; Ouyang, Qin; Li, Guo-Dong; Xiao, Nan-Ping

    2008-01-01

    AIM: To investigate possibility and clinical application of fecal calprotectin in determining disease activity of ulcerative colitis (UC). METHODS: The enzyme-linked immunosorbent assay (ELISA) was used to measure the concentrations of calprotectin in feces obtained from 66 patients with UC and 20 controls. C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), acid glycoprotein (AGP) were also measured and were compared with calprotectin in determining disease activity of UC. The disease activity of UC was also determined by the Sutherland criteria. RESULTS: The fecal calprotectin concentration in the patients with active UC was significantly higher than that in the inactive UC and in the controls (402.16 ± 48.0 μg/g vs 35.93 ± 3.39 μg/g, 11.5 ± 3.42 μg/g, P < 0.01). The fecal calprotectin concentration in the inactive UC group was significantly higher than that in the control group (P < 0.05). A significant difference was also found in the patients with active UC of mild, moderate and severe degrees. The area under the curve of the receiver operating characteristics (AUCROC) was 0.975, 0.740, 0.692 and 0.737 for fecal calprotectin, CRP, ESR and AGP, respectively. There was a strong correlation between the fecal calprotectin concentration and the endoscopic gradings for UC (r = 0.866, P < 0.001). CONCLUSION: Calprotectin in the patient’s feces can reflect the disease activity of UC and can be used as a rational fecal marker for intestinal inflammation in clinical practice. This kind of marker is relatively precise, simple and noninvasive when compared with other commonly-used markers such as CRP, ESR and AGP. PMID:18176961

  5. Investigations of the use of bioavailability data to adjust occupational exposure limits for active pharmaceutical ingredients.

    PubMed

    Naumann, Bruce D; Weideman, Patricia A; Sarangapani, Ramesh; Hu, Shu-Cheih; Dixit, Rakesh; Sargent, Edward V

    2009-11-01

    Occupational exposure limits (OELs) for active pharmaceutical ingredients have traditionally been established using no-observed-adverse-effect levels derived from clinical studies employing po and iv routes of administration and by applying default uncertainty factors or chemical-specific adjustment factors. However, exposure by the inhalation or dermal route is more relevant in terms of occupational safety. In this investigation, to explore new methods for route-to-route extrapolation, the bioavailability of MK-0679, a leukotriene D(4) receptor antagonist, was compared following iv, po, intranasal (in), or intratracheal (it) administration. The relative bioavailability of MK-0679 was iv congruent with it > po congruent with in. Bioavailability correction factors (BCFs) of 2.0 and 0.6 were derived from these data to adjust a hypothetical OEL of 0.1 mg/m(3) for MK-0679 with particle sizes of 10 and 50 mum, respectively. These BCFs were used to adjust the OEL established using po clinical data, to reflect the differences in bioavailability following deposition in different regions of the respiratory tract. To further investigate how bioavailability data could be used in setting OELs, a preliminary pharmacokinetic (PK) model was developed to describe the time course of plasma concentrations using the data from the route comparison study. An inhalation study was then performed to test the validity of using either empirical data or modeling approaches to derive BCFs when setting OELs. These investigations demonstrated how the use of route-specific PK data could reduce some of the uncertainties associated with route-to-route extrapolation and allow for improved precision and quantitative adjustments when establishing OELs. Further investigations are needed to better understand the factors responsible for differences in systemic uptake following deposition in different regions of the respiratory tract and how these can be generalized across different classes of soluble

  6. An Investigation of Implicit Active Contours for Scientific Image Segmentation

    SciTech Connect

    Weeratunga, S K; Kamath, C

    2003-10-29

    The use of partial differential equations in image processing has become an active area of research in the last few years. In particular, active contours are being used for image segmentation, either explicitly as snakes, or implicitly through the level set approach. In this paper, we consider the use of the implicit active contour approach for segmenting scientific images of pollen grains obtained using a scanning electron microscope. Our goal is to better understand the pros and cons of these techniques and to compare them with the traditional approaches such as the Canny and SUSAN edge detectors. The preliminary results of our study show that the level set method is computationally expensive and requires the setting of several different parameters. However, it results in closed contours, which may be useful in separating objects from the background in an image.

  7. Investigating Stellar Activity with CoRoT Observations

    NASA Astrophysics Data System (ADS)

    Mathur, S.; Salabert, D.; García, R. A.; Régulo, C.; Ballot, J.; Metcalfe, T. S.

    2012-09-01

    The recent study of the CoRoT target HD 49933 found evidence of variability in its magnetic activity. This was the first time that stellar activity had been detected using asteroseismic data. For the Sun and HD 49933, we observe an increase of the p-mode frequencies and a decrease of the maximum amplitude per radial mode when the activity level is higher. Moreover a similar behavior of the frequency shifts with frequency has been found for the Sun and HD 49933. We study three other CoRoT targets, for which modes have been detected and well identified: HD 181420, HD 49385, and HD 52265 (which is hosting a planet). We report on how the seismic parameters (frequency shifts and amplitude) vary during the observation of these stars.

  8. Cleveland Clinic television series enhances branding in active market.

    PubMed

    Rees, T

    2001-01-01

    "Medical Miracles" premiered April 26. It is an information-packed series of programs showcasing The Cleveland Clinic's advanced medical practices. The Cleveland Clinic teamed with local NBC-affiliate, WKYC to develop half-hour shows on topics including neuro-sciences, orthopedics, eye, heart, pediatrics and cancer. As of this writing, three of the half-hour shows already have aired. They will resume in September, October and November, following a summer break. The collaboration is a healthy prospect all the way around. For Cleveland Clinic, it provides highly credible visibility in a competitive marketplace. And, according to WKYC president and general manager, Brooke Spectorsky, " Medical news and information is a high priority among our viewers."

  9. Investigation of Fast and Slow CMEs Effect on Geomagnetic Activity

    NASA Astrophysics Data System (ADS)

    Donmez, Burcin; Kilcik, Ali

    2016-07-01

    Here we investigate the relationship between the fast (v>800 km/s) and slow (v<400 km/s) coronal mass ejections (CMEs) and geomagnetic Ap and Dst indices during the last two solar cycles (cycle 23 and 24). In result of our analysis we found following results 1) Fast CMEs show much better relationship with geomagnetic Ap and Dst indices compared to slow ones, 2) Similar to geomagnetic indices, the number of fast CMEs decreased seriously during solar cycle 24th, while the number of slow CMEs are almost the same during the investigated whole time interval (1996 through 2016).

  10. Phytochemical investigation and antimicrobial activity of Psidium guajava L. leaves

    PubMed Central

    Metwally, A. M.; Omar, A. A.; Harraz, F. M.; El Sohafy, S. M.

    2010-01-01

    Psidium guajava L. leaves were subjected to extraction, fractionation and isolation of the flavonoidal compounds. Five flavonoidal compounds were isolated which are quercetin, quercetin-3-O-α-L-arabinofuranoside, quercetin-3-O-β-D-arabinopyranoside, quercetin-3-O-β-D-glucoside and quercetin-3-O-β-D-galactoside. Quercetin-3-O-β-D-arabinopyranoside was isolated for the first time from the leaves. Fractions together with the isolates were tested for their antimicrobial activity. The antimicrobial studies showed good activities for the extracts and the isolated compounds. PMID:20931082

  11. Developing Clinical Competency in Crisis Event Management: An Integrated Simulation Problem-Based Learning Activity

    ERIC Educational Resources Information Center

    Liaw, S. Y.; Chen, F. G.; Klainin, P.; Brammer, J.; O'Brien, A.; Samarasekera, D. D.

    2010-01-01

    This study aimed to evaluate the integration of a simulation based learning activity on nursing students' clinical crisis management performance in a problem-based learning (PBL) curriculum. It was hypothesized that the clinical performance of first year nursing students who participated in a simulated learning activity during the PBL session…

  12. Clinical and Pathological Findings in Green Turtles (Chelonia mydas) from Gladstone, Queensland: Investigations of a Stranding Epidemic.

    PubMed

    Flint, Mark; Eden, Paul A; Limpus, Colin J; Owen, Helen; Gaus, Caroline; Mills, Paul C

    2015-06-01

    An investigation into the health of green turtles was undertaken near Gladstone, Queensland, in response to a dramatic increase in stranding numbers in the first half of 2011. A total of 56 live turtles were subject to clinical examination and blood sampling for routine blood profiles, and 12 deceased turtles underwent a thorough necropsy examination. This population of green turtles was found to be in poor body condition and a range of infectious and non-infectious conditions were identified in the unhealthy turtles, including hepato-renal insufficiency (up to 81%, 27/33 based on clinical pathology), cachexia (92%, 11/12), parasitism (75%, 9/12), cardiopulmonary anomalies (42%, 5/12), gastroenteritis (25%, 3/12), masses (25%, 3/12) and mechanical impediments (17%, 2/12 based on necropsy). Overall, there was no evidence to indicate a unifying disease as a primary cause of the mass mortality. Recent adverse weather events, historic regional contamination and nearby industrial activities are discussed as potential causative factors. PMID:25256011

  13. [Outbreak of carpal tunnel syndrome of the upper limbs in automobile seat assemblers: results of exposure evaluation and clinical investigation].

    PubMed

    Barbieri, P G; Colombini, D; Rocco, A; Custureri, F; Paderno, G

    1996-01-01

    A group of 59 female workers in the sewing and upholstery departments of a factory manufacturing automobile seats underwent clinical and instrumental tests following reports of several cases of suspected carpal tunnel syndrome. A risk evaluation analysis for disorders attributable to repeated trauma of the upper limbs (WMSDs) was simultaneously carried out using the protocol recommended by the EPM Research Unit in Milan. Evidence was found of a high frequency of elementary actions associated with considerable muscular involvement along with inadequate recovery periods. The clinical investigation revealed an unusually high percentage of carpal tunnel syndromes, often associated with Guyon channel syndrome. This disorder affects males and females equally, is often bilateral, and is not associated with known non-occupational factors. The widespread outbreak of work-related musculo-skeletal disorders reported in the departments in question may have arisen from a combination of significant risk factors relating to the types of activities performed, and the long service of the workers. It is reasonable to assume that failure to adopt technical preventive and organisational measures may have stemmed primarily from a poor evaluation of the relevant occupational risks, and from many years of substandard health surveillance practices.

  14. Clinical and Pathological Findings in Green Turtles (Chelonia mydas) from Gladstone, Queensland: Investigations of a Stranding Epidemic.

    PubMed

    Flint, Mark; Eden, Paul A; Limpus, Colin J; Owen, Helen; Gaus, Caroline; Mills, Paul C

    2015-06-01

    An investigation into the health of green turtles was undertaken near Gladstone, Queensland, in response to a dramatic increase in stranding numbers in the first half of 2011. A total of 56 live turtles were subject to clinical examination and blood sampling for routine blood profiles, and 12 deceased turtles underwent a thorough necropsy examination. This population of green turtles was found to be in poor body condition and a range of infectious and non-infectious conditions were identified in the unhealthy turtles, including hepato-renal insufficiency (up to 81%, 27/33 based on clinical pathology), cachexia (92%, 11/12), parasitism (75%, 9/12), cardiopulmonary anomalies (42%, 5/12), gastroenteritis (25%, 3/12), masses (25%, 3/12) and mechanical impediments (17%, 2/12 based on necropsy). Overall, there was no evidence to indicate a unifying disease as a primary cause of the mass mortality. Recent adverse weather events, historic regional contamination and nearby industrial activities are discussed as potential causative factors.

  15. Clinical investigation of TROP-2 as an independent biomarker and potential therapeutic target in colon cancer.

    PubMed

    Zhao, Peng; Yu, Hai-Zheng; Cai, Jian-Hui

    2015-09-01

    Colon cancer is associated with a severe demographic and economic burden worldwide. The pathogenesis of colon cancer is highly complex and involves sequential genetic and epigenetic mechanisms. Despite extensive investigation, the pathogenesis of colon cancer remains to be elucidated. As the third most common type of cancer worldwide, the treatment options for colon cancer are currently limited. Human trophoblast cell‑surface marker (TROP‑2), is a cell‑surface transmembrane glycoprotein overexpressed by several types of epithelial carcinoma. In addition, TROP‑2 has been demonstrated to be associated with tumorigenesis and invasiveness in solid types of tumor. The aim of the present study was to investigate the protein expression of TROP‑2 in colon cancer tissues, and further explore the association between the expression of TROP‑2 and clinicopathological features of patients with colon cancer. The expression and localization of the TROP‑2 protein was examined using western blot analysis and immunofluorescence staining. Finally, the expression of TROP‑2 expression was correlated to conventional clinicopathological features of colon cancer using a χ2 test. The results revealed that TROP‑2 protein was expressed at high levels in the colon cancer tissues, which was associated with the development and pathological process of colon cancer. Therefore, TROP‑2 may be used as a biomarker to determine the clinical prognosis, and as a potential therapeutic target in colon cancer.

  16. Anatomical investigation of the esophageal and aortic hiatuses: physiologic, clinical and surgical considerations.

    PubMed

    Costa, Milton Melciades Barbosa; Pires-Neto, Mario Ary

    2004-03-01

    Precise knowledge about the anatomical constitution of the diaphragmatic pillars is essential to understand the physiologic, clinical and surgical roles of the esophageal and aortic hiatuses. Because anatomical descriptions found in the literature are dubious, we have decided to investigate this subject. Anatomical dissections and histologic sections of the right and left diaphragmatic pillars (diaphragma crura) from 43 human bodies were analyzed, comprising both non-fixed and fixed specimens. We have described a classification of the diaphragmatic pillars and their muscular branches, forming two basic arrangements (patterns I and II) around the esophageal and aortic hiatuses. Such anatomical and functional relationships between the esophagus and its diaphragmatic hiatus help explain why, during normal inspiration, a hiatal enlargement is observed first but is followed, thereafter, during deep inspiration, by a hiatal narrowing exerted by the contraction of the diaphragmatic pillars. Our results also show that the aortic hiatus does not seem to constitute a rigid ventral tendinous arc around the aorta that could impose any considerable degree of vascular compression, as suggested by other investigators. The present study provides anatomical data useful for a better understanding of gastroesophageal reflux physiology, antireflux surgery and abdominal angina.

  17. Evolution & Phylogenetic Analysis: Classroom Activities for Investigating Molecular & Morphological Concepts

    ERIC Educational Resources Information Center

    Franklin, Wilfred A.

    2010-01-01

    In a flexible multisession laboratory, students investigate concepts of phylogenetic analysis at both the molecular and the morphological level. Students finish by conducting their own analysis on a collection of skeletons representing the major phyla of vertebrates, a collection of primate skulls, or a collection of hominid skulls.

  18. The delayed sleep phase syndrome: clinical and investigative findings in 14 subjects.

    PubMed

    Alvarez, B; Dahlitz, M J; Vignau, J; Parkes, J D

    1992-08-01

    Fourteen subjects are described in whom a clinical diagnosis of the delayed sleep phase syndrome was made. The condition is multi-factorial, dependent on lifestyle, mood and personality, as well as on familial factors but no single factor in isolation is sufficient to explain the delay in sleep timing. Refusal to attend school may be important in some instances but will not explain cases with delayed age of onset. In half the subjects the delay in sleep phase started in childhood or adolescence. The syndrome causes severe disruption to education, work and family life. Polysomnography, motor activity monitoring of rest-activity cycles, plasma melatonin profiles and urinary melatonin metabolite excretion are normal. Different patterns of sleep phase delay seen in the syndrome include stable, progressive, irregular and non-24 hour sleep-wake cycles. These patterns may result from different social and other Zeitgebers ("time-markers", for example sunrise, sunset) in the normal environment. Treatment by forced sleep-wake phase advance or with melatonin resulted in a partial sleep-phase advance but this was not maintained on stopping treatment. PMID:1527536

  19. [Investigation of Aerosol Mixed State and CCN Activity in Nanjing].

    PubMed

    Zhu, Lin; Ma, Yan; Zheng, Jun; Li, Shi-zheng; Wang, Li-peng

    2016-04-15

    During 11-18 September 2014, the size-resolved aerosol Cloud Condensation Nuclei (CCN) activity and mixing state were measured using Cloud Condensation Nuclei Counter (CCNC), Aerosol Particle Mass (APM) and Scanning Mobility Particle Sizer (SMPS). The results showed that aerosols mainly existed as an internal mixture. For 76, 111, 138 and 181 nm particles, black carbon (BC) accounted for 5.4%, 10%, l0.7% and 6.7% of the particle mass, but as high as 51%, 57%, 70% and 59% of the particle number concentrations, respectively, suggesting that BC was a type of important condensation nuclei in the atmosphere and made significant contributions to particle numbers. The occasionally observed external mixtures were mainly present in 111 and 138 nm particles. The critical supersaturation was 0.25%, 0.13%, 0.06% and 0.015% for 76, 111, 138 and 181 nm particles, respectively. Precipitation and haze had significant effects on the particle CCN activity. The hygroscopicity parameter K was 0.37, 0.29 and 0.39 in rainy, clear and hazy days, respectively. Particle density and CCN activity were impacted by chemical compositions. Compared with clear days, higher contents of inorganic salts and lower contents of organics were found on hazy days, accompanied by lower particle density and higher CCN activity. PMID:27548938

  20. Flow Cytometric Investigation of Classical and Alternative Platelet Activation Markers

    PubMed Central

    Debreceni, Ildikó Beke; Kappelmayer, János

    2013-01-01

    Platelets show a substantial role in the maintenance of vascular integrity when these cells after a rapid activation adhere to the vessel wall lesion, aggregate with other platelets and leukocytes resulting in an arterial thrombosis. Analysis of in vivo platelet activation at an early time point is crucial in the detection of developing thrombotic events. In addition, the forecast of future complications as well as the evaluation of the efficacy of anti- platelet medication are also essential in a large group of patients. Changes in the levels of platelet receptors or alteration in other surface properties due to intra- and extracellular responses to a stimulus can be measurable primarily by flow cytometry with specific antibodies via the assessment of classical and alternative platelet activation markers. Some of these biomarkers have been already used in routine laboratory settings in many cases, while others still stand in the phase of research applications. Deficiency in platelet receptors is also accessible with this technique for the diagnosis of certain bleeding disorders. We here describe the most important types of platelet activation markers, and give an overview how the levels of these markers are altered in different diseases.

  1. Our Economy: How It Works. Activities and Investigation. Teacher's Edition.

    ERIC Educational Resources Information Center

    Clawson, Elmer U.

    To help junior and senior high school students develop a better understanding of the United States' economy, this teacher's guide presents a series of learning activities centered around eight general themes. The topics (corresponding to the document's eight chapters) include both international and global economic issues as well as current…

  2. Designing the Perfect Plant: Activities to Investigate Plant Ecology

    ERIC Educational Resources Information Center

    Lehnhoff, Erik; Woolbaugh, Walt; Rew, Lisa

    2008-01-01

    Plant ecology is an important subject that often receives little attention in middle school, as more time during science classes is devoted to plant biology. Therefore, the authors have developed a series of activities, including a card game--Designing the Perfect Plant--to introduce student's to plant ecology and the ecological trade offs…

  3. Development and Pilot Investigation of Behavioral Activation for Negative Symptoms

    ERIC Educational Resources Information Center

    Mairs, Hilary; Lovell, Karina; Campbell, Malcolm; Keeley, Philip

    2011-01-01

    Negative symptoms cause functional impairment and impede recovery from psychosis, not least, because of limited developments in empirically validated treatments. This article details a pilot evaluation of a behavioral activation (BA) treatment with eight people presenting with psychosis and marked negative symptoms. The rationale for this…

  4. STRUCTURE-ACTIVITY RELATIONSHIP STUIDES AND THEIR ROLE IN PREDICTING AND INVESTIGATING CHEMICAL TOXICITY

    EPA Science Inventory

    Structure-Activity Relationship Studies and their Role in Predicting and Investigating Chemical Toxicity

    Structure-activity relationships (SAR) represent attempts to generalize chemical information relative to biological activity for the twin purposes of generating insigh...

  5. [The para-clinic investigation of temporo-mandibular joint changes in patients with acromegaly].

    PubMed

    Morăraşu, C; Burlui, V; Olaru, C; Boza, C; Bortă, C; Morăraşu, G; Brînză, M

    2001-01-01

    The Acromegaly is an endocrinological disease determined by the hypersecretion of STH in a certain period of the body evolution and it causes the hypertrophy of bones in general and of mandible and cranio-facial bones, determining a disorder due to this development of bones, associated with troubles in the activity of muscles and of the phospho-calcium metabolism. This study was made on a group of 33 acromegaly patients. Their temporo-mandibular joint was investigated by ortopantomography, tomography, computer tomography and scintigraphy. All of these exams shows the changes in temporo-mandibular joint due to the cells hyperactivity determined by the hypersecretion of STH. PMID:12092142

  6. [The para-clinic investigation of temporo-mandibular joint changes in patients with acromegaly].

    PubMed

    Morăraşu, C; Burlui, V; Olaru, C; Boza, C; Bortă, C; Morăraşu, G; Brînză, M

    2001-01-01

    The Acromegaly is an endocrinological disease determined by the hypersecretion of STH in a certain period of the body evolution and it causes the hypertrophy of bones in general and of mandible and cranio-facial bones, determining a disorder due to this development of bones, associated with troubles in the activity of muscles and of the phospho-calcium metabolism. This study was made on a group of 33 acromegaly patients. Their temporo-mandibular joint was investigated by ortopantomography, tomography, computer tomography and scintigraphy. All of these exams shows the changes in temporo-mandibular joint due to the cells hyperactivity determined by the hypersecretion of STH.

  7. An investigation of the impact of selected prereading activities on student content learning through laboratory activities

    NASA Astrophysics Data System (ADS)

    Kass, Jesse (Shaya)

    This study investigated whether two prereading activities impacted student learning from hands-on science activities. The study was based on constructivist learning theory. Based on the work of Piaget, it was hypothesized that students who activated prior knowledge would learn more from the activities. Based on the work of Vygotsky it was hypothesized that students who talk more and write more would learn more from the activity. The K-W-L chart and anticipation guide strategies were used with eighth grade students at Graves Middle School in Whittier, California before learning about levers and convection currents. D. M. Ogle (1986) created the three-column K-W-L chart to have students activate prior knowledge. In the first column, the students write what they already know about a subject, in the second column, the students write what they want to know about the subject, and the students complete the third column after learning about a subject by writing answers to the questions that they asked in the second column. Duffelmeyer (1994) created the anticipation guide based on Herber's (1978) reasoning guide. In the anticipation guide, the teacher creates three or four sentences that convey the major ideas of the topic and the students either agree or disagree with the statements. After learning about the topic, students revisit their answers and decide if they were correct or incorrect and they must defend their choices. This research used the Solomon (1947) four-square design and compared both the experimental groups to a control group that simply discussed the concepts before completing the activity. The research showed no significant difference between the control group and either of the treatment groups. The reasons for the lack of significant differences are considered. It was hypothesized that since the students were unfamiliar with the prereading activities and did not have much experience with using either writing-to-learn or talking-to-learn strategies, the

  8. Automation of o-dianisidine assay for ceruloplasmin activity analyses: usefulness of investigation in Wilson's disease and in hepatic encephalopathy.

    PubMed

    Siotto, Mariacristina; Pasqualetti, Patrizio; Marano, Massimo; Squitti, Rosanna

    2014-10-01

    Ceruloplasmin (Cp) is a serum ferroxidase that plays an essential role in iron metabolism. It is routinely tested by immunoturbidimetric assays that quantify the concentration of the protein both in its active and inactive forms. Cp activity is generally analyzed manually; the process is time-consuming, has a limited repeatability, and is not suitable for a clinical setting. To overcome these inconveniences, we have set the automation of the o-dianisidine Cp activity assay on a Cobas Mira Plus apparatus. The automation was rapid and repeatable, and the data were provided in terms of IU/L. The assay was adapted for human sera and showed a good precision [coefficient of variation (CV) 3.7 %] and low limit of detection (LoD 11.58 IU/L). The simultaneous analysis of Cp concentration and activity in the same run allowed us to calculate the Cp-specific activity that provides a better index of the overall Cp status. To test the usefulness of this automation, we tested this assay on 104 healthy volunteers and 36 patients with Wilson's disease, hepatic encephalopathy, and chronic liver disease. Cp activity and specific activity distinguished better patients between groups with respect to Cp concentration alone, and providing support for the clinical investigation of neurological diseases in which liver failure is one of the clinical hallmarks.

  9. Similar barriers and facilitators to physical activity across different clinical groups experiencing lower limb spasticity.

    PubMed

    Hundza, Sandra; Quartly, Caroline; Kim, Jasmine M; Dunnett, James; Dobrinsky, Jill; Loots, Iris; Choy, Kim; Chow, Brayley; Hampshire, Alexis; Temple, Viviene A

    2016-07-01

    Purpose Given the importance of physical activity in maintaining health and wellness, an improved understanding of physical activity patterns across different clinical populations is required. This study examines the facilitators for, and barriers to, participation in physical activity across multiple contexts for three clinical groups with chronic lower limb spasticity (individuals with stroke, multiple sclerosis and incomplete spinal cord injury). Method This cross-sectional study employed quantitative measures for spasticity, ankle range of motion, pain, falls, cognition, mobility, and physical activity as well as qualitative semi-structured interviews. Results There were similar impairments in body functions and structures and limitations in activities across the clinical groups. These impairments and limitations negatively impacted participation in physical activity, which was low. Environmental and personal factors exacerbated or mitigated the limiting effects of body functions and structures and activities on physical activity in many areas of life. Conclusions In this population, participation in physical activity includes activities such as housework which are different than what is typically considered as physical activity. Further, the presence of similar barriers and facilitators across the groups suggests that support and services to promote valued forms of physical activity could be organised and delivered based on limitations in mobility and functioning rather than clinical diagnosis. Implications for rehabilitation Physical activity is of utmost importance in maintaining health and wellness in clinical populations. This research highlights the desired and actual physical activity for these populations can look different than what may traditionally be considered as physical activity (e.g. housework is not typically considered participation physical activity). Therefore, rehabilitation interventions need to be directly designed to enhance clients

  10. Investigation into biologically active constituents of Geum rivale L.

    PubMed

    Owczarek, Aleksandra; Gudej, Jan

    2013-01-01

    Aerial and underground parts of Geum rivale (Rosaceae) were investigated. Tiliroside, gallic acid, ellagic acid and a sterol fraction were isolated from aerial parts of the plant. The sterol fraction was analyzed using GC-MS. Eleven phenolic acids were identified in aerial parts of the plant, and eight in underground parts, by means of RP-HPLC analysis. The quantitative determination of phenolic acids, tannins and flavonoids was also carried out.

  11. Preclinical and Clinical Investigations of Mood Stabilizers for Huntington's Disease: What Have We Learned?

    PubMed Central

    Scheuing, Lisa; Chiu, Chi-Tso; Liao, Hsiao-Mei; Linares, Gabriel R.; Chuang, De-Maw

    2014-01-01

    Huntington's disease (HD) is a lethal, autosomal dominant neurodegenerative disorder caused by CAG repeat expansions at exon 1 of the huntingtin (Htt) gene, which encodes for a mutant huntingtin protein (mHtt). Prominent symptoms of HD include motor dysfunction, characterized by chorea; psychiatric disturbances such as mood and personality changes; and cognitive decline that may lead to dementia. Pathologically multiple complex processes and pathways are involved in the development of HD, including selective loss of neurons in the striatum and cortex, dysregulation of cellular autophagy, mitochondrial dysfunction, decreased neurotrophic and growth factor levels, and aberrant regulation of gene expression and epigenetic patterns. No cure for HD presently exists, nor are there drugs that can halt the progression of this devastating disease. Therefore, the need to discover neuroprotective modalities to combat HD is critical. In basic and preclinical studies using cellular and animal HD models, the mood stabilizers lithium and valproic acid (VPA) have shown multiple beneficial effects, including behavioral and motor improvement, enhanced neuroprotection, and lifespan extension. Recent studies in transgenic HD mice support the notion that combined lithium/VPA treatment is more effective than treatment with either drug alone. In humans, several clinical studies of HD patients found that lithium treatment improved mood, and that VPA treatment both stabilized mood and moderately reduced chorea. In contrast, other studies observed that the hallmark features of HD were unaffected by treatment with either lithium or VPA. The current review discusses preclinical and clinical investigations of the beneficial effects of lithium and VPA on HD pathophysiology. PMID:25285035

  12. Electrochemical investigations on the oxygen activation by cytochrome P-450.

    PubMed

    Scheller, F; Renneberg, R; Schwarze, W; Strnad, G; Pommerening, K; Prümke, H J; Mohr, P

    1979-01-01

    The application of cytochrome P-450 in substrate conversion is complicated both due to the limited stability and the cofactor regeneration problems. To overcome the disadvantages of NADPH consumption the transfer of the reduction equivalents from an electrode into the cytochrome P-450-system was studied: 1. NADPH was cathodically reduced at a mercury pool electrode. By immobilization of NADP on dialdehyde Sephadex the reductive recycling was possible. 2. Different forms of reduced oxygen were produced by the cathode: a) The reaction of O2- with deoxycorticosterone yields a carboxylic acid derivative. In contrast the cytochrome P-450 catalyzed NADPH-dependent reaction with the same substrate gives corticosterone, O2- represents only an intermediate in the activation of oxygen and is not the "activated oxygen" species. b) Molecular oxygen was reduced to HO2- and H2O2, respectively. The interaction of adsorbed cytochrome P-450 on the electrode surface with the reduced oxygen species in the absence of NADPH was studied. The electrochemically generated peroxide seems to be more active than added H2O2. 3. In a model of electro-enzyme-reactor several substrates were hydroxylated by microsomal cytochrome P-450 with cathodically reduced oxygen which substitutes NADPH.

  13. Investigation of antibacterial activity of aspidin BB against Propionibacterium acnes.

    PubMed

    Gao, Chang; Guo, Na; Li, Na; Peng, Xiao; Wang, Peng; Wang, Wei; Luo, Meng; Fu, Yu-Jie

    2016-03-01

    In the present study, antibacterial activity of four kinds of phloroglucinol derivatives extracted from Dryopteris fragrans (L.) Schott against S. aureus, S. epidermidis and P. acnes has been tested. Aspidin BB exerted the strongest antibacterial activity with minimal inhibition concentration (MIC) values ranging from 7.81 to 15.63 μg/mL. The time-kill assay indicated that aspidin BB could kill P. acnes completely at 2 MIC (MBC) within 4 h. By using AFM, we demonstrated extensive cell surface alterations of aspidin BB-treated P. acnes. SDS-PAGE of supernatant proteins and lipid peroxidation results showed that aspidin BB dose-dependently affected membrane permeability of P. acnes. DNA damage and protein degradation of P. acnes were also verified. SDS-PAGE of precipitated proteins revealed possible targets of aspidin BB, i.e., heat shock proteins (26 kDa) and lipase (33 kDa) which could all cause inflammation. Aspidin BB also seriously increased the inhibition rate of lipase activity from 10.20 to 65.20 % to possibly inhibit the inflammation. In conclusions, the effective constituents of D. fragrans (L.) Schott to treat acne might be phloroglucinol derivatives including aspidin BB, aspidin PB, aspidinol and dryofragin. Among this, aspidin BB inhibited the growth of P. acnes by disrupting their membrane, DNA and proteins and finally leaded to the cell death. The obtained data highlighted the potential of using aspidin BB as an alternative treatment for acne vulgaris. PMID:26596576

  14. [The 12th amendment to the German Drug Law. Chances and obstacles for investigator-initiated clinical trials].

    PubMed

    Dreier, G; Marx, C; Schmoor, C; Maier-Lenz, H

    2005-04-01

    The European Union's so called Clinical Trials Directive 2001/20/EC was implemented in national law in Germany in August 2004, leading to the 12th amendment of the German Drug Law (Arzneimittelgesetz). The directive is intended to harmonize the clinical trial's regulatory environment across the European Union and to improve protection of human subjects. It lays down the principles and guidelines of Good Clinical Practice (GCP). As the regulation applies to all clinical trials on medicinal products for human use, and as only non-interventional studies are excluded, academic, investigator-initiated clinical trials will also have to comply with the EU clinical trials directive implemented in the German Drug Law. In an investigator-initiated trial in which the investigator takes the responsibility of a sponsor, the investigator-sponsor must take total legal and financial responsibility for the clinical trial. Since publicly funded clinical trials make a large contribution to improved care, concern has been expressed that non-commercial research projects will be reduced and the vital medical research conducted at academic institutions curtailed. Nonetheless GCP ensures a valid study design, qualified data management, analysis and monitoring of the trial and thereby promotes more valid data and protection of study participants. The trials are more likely to lead to reliable results leading to new therapies, strategies or a better understanding of diseases. What is needed, therefore, is an increase in public funding and the establishment of clinical trial units/organizations associated with the universities or hospitals where independent researchers have the possibility to obtain theoretical advice and practical help, professional training and support. In the end, the directive may serve as a stimulus to build a better national research environment and to promote public funding, and may lead to fewer but more valid clinical trials. PMID:15830256

  15. Childhood pyogenic meningitis: clinical and investigative indicators of etiology and outcome.

    PubMed Central

    Johnson, Abdul-Wahab B. R.; Adedoyin, Olanrewaju T.; Abdul-Karim, Aishat A.; Olanrewaju, Abdul-Waheed I.

    2007-01-01

    The relevant parameters of 71 consecutive pediatric admissions for pyogenic meningitis at the University of Ilorin Teaching Hospital, Ilorin, Nigeria, were analyzed to identify possible clinical and nonmicrobiologic investigative clues of disease etiology and mortality. Cerebrospinal fluid (CSF) was Gram-smear positive (GSP) in 41 (57.6%) of the 71 cases. Twenty-three (56.1%) had Gram-positive cocci (GPC), 14 (34.2%) Gram-negative bacilli (GNB) and three (7.3%) Gram-negative diplococci (GND). The respective mean ages of GPC, GNB and GND cases were 4.49 +/- 5.3, 3.06 +/- 4.8 and 4.47 +/-4.9 years. Streptococcus pneumoniae accounted for 22 (78.6%) of the 28 CSF isolates (p=0.00), Haemophilus influenzae for two (7.1%) cases and Neisseria meningitides in one (3.5%). Anemia was significantly more common among GSP cases (p=0.04), as was convulsion among those with GNB-positive smears (p=0.03) and a bulging fontanelle in the Gram-smear-negative category. Otherwise, the prevalence and resolution times of the other clinical parameters were comparable across the etiological categories. There were 30 deaths (42.3%) among which GNB-positive cases had significantly shorter stay (p=0.045). Mortality was significantly higher in those with an abnormal respiratory rhythm at admission (p=0.04), purulent/turbid CSF (p=0.03), CSF protein of >150 mg/dl (p=0.02) and glucose <1 mg/dl (p=0.047). Our findings highlight the inherent limitations of predicting the etiology of pediatric meningitides from the clinical parameters as well as the poor prognostic import of respiratory dysrhythmia and a profoundly deranged CSF protein and glucose. The etiological burden of GPC/S. pneumoniae in childhood meningitides in sub-Saharan Africa, the propensity of GNB/H. influenzae for quick fatality and the need for the relevant preventive vaccines are expounded in the discussion. PMID:17722674

  16. Brief of the Canadian Society for Clinical Investigation to the science and technology review.

    PubMed

    1995-02-01

    In the context of new realities, perceptions, and concerns, it is fitting that the government has undertaken this Science and Technology Review, questioning not only how much to spend but also the justification and the best ways to carry out federally-funded research. We share the government's concern about the lack of economic competitiveness of our industries and agree that government-sponsored research should make a bigger contribution to the nation's global economic position. The CSCI, which represents the clinical investigators/scientists in this country, is grateful for having been given the opportunity to make this "tour d'horizon" of Canadian clinical research. In this brief, we have attempted to articulate the needs for, and the benefits of, basic biomedical research because it is the only type of research which will provide us with final answers. However, it should be more closely articulated with applied research, as well as with epidemiological, evaluative, and operational approaches which have been neglected. This brief has emphasized that CSCI is committed to PUTTING MORE SCIENCE INTO MEDICINE by encouraging a greater flow of discoveries from the laboratory research bench to the bedside and the community. We made the point that there is a crisis in patient-oriented research and a decrease of young physicians opting for research careers. The Royal College of Physicians and Surgeons of Canada and the MRC are responsive to this situation, which may compromise our capacity to discharge our broader mission. The MRC has given itself valid instruments to foster the creation of wealth through special programs such as the NCE, the University/Industry program, and the MRC-PMAC partnership. Some refining is in order, and close scrutiny of outcome is essential. Both the academic community and industry have their share of responsibility for the less-than-optimal transfer of knowledge to the market place. Lack of venture capital is also a serious issue. A unified

  17. Brief of the Canadian Society for Clinical Investigation to the science and technology review.

    PubMed

    1995-02-01

    In the context of new realities, perceptions, and concerns, it is fitting that the government has undertaken this Science and Technology Review, questioning not only how much to spend but also the justification and the best ways to carry out federally-funded research. We share the government's concern about the lack of economic competitiveness of our industries and agree that government-sponsored research should make a bigger contribution to the nation's global economic position. The CSCI, which represents the clinical investigators/scientists in this country, is grateful for having been given the opportunity to make this "tour d'horizon" of Canadian clinical research. In this brief, we have attempted to articulate the needs for, and the benefits of, basic biomedical research because it is the only type of research which will provide us with final answers. However, it should be more closely articulated with applied research, as well as with epidemiological, evaluative, and operational approaches which have been neglected. This brief has emphasized that CSCI is committed to PUTTING MORE SCIENCE INTO MEDICINE by encouraging a greater flow of discoveries from the laboratory research bench to the bedside and the community. We made the point that there is a crisis in patient-oriented research and a decrease of young physicians opting for research careers. The Royal College of Physicians and Surgeons of Canada and the MRC are responsive to this situation, which may compromise our capacity to discharge our broader mission. The MRC has given itself valid instruments to foster the creation of wealth through special programs such as the NCE, the University/Industry program, and the MRC-PMAC partnership. Some refining is in order, and close scrutiny of outcome is essential. Both the academic community and industry have their share of responsibility for the less-than-optimal transfer of knowledge to the market place. Lack of venture capital is also a serious issue. A unified

  18. An investigation of the theoretical content of physical activity brochures

    PubMed Central

    Gainforth, Heather L.; Barg, Carolyn J.; Latimer, Amy E.; Schmid, Kristina L.; O'Malley, Deborah; Salovey, Peter

    2011-01-01

    New evidence-based physical activity guidelines and recommendations for constructing messages supplementing the guidelines have been put forth. As well, recent reviewshave identified theoretical constructs that hold promise as targets for intervention: self-regulation, outcome expectancies and self-efficacy. The purpose of this study was to examine the integration of messages targeting self-regulation, self-efficacy and outcome expectancies in existing physical activity brochures. Twenty-two PA brochures from Canadian and American National Health Organizations were assessed for their use self-efficacy, self-regulatory processes and outcome expectancies. Brochures were analyzed line-by-line using a modified version of the validated Content Analysis Approach to Theory-Specified Persuasive Educational Communication (CAATSPEC; Abraham et al., 2007). One third of the brochures were coded by two independent raters coded a third of the brochures (n = 7). Inter-rater reliability was acceptable for 17 of the 20 categories (rs> .79). Discrepancies in all categories were discussed and agreement was reached. The remaining brochures were coded by one of the two raters. Usage of thethree key theoretical constructs accounted for only 36.43% of brochure content (20.23% self-efficacy, 10.40% outcome expectancies, 5.80% self-regulation). Brochures lacked the use of a variety of theoretical strategies, specifically goal-setting, planning and verbal persuasion and rarely highlighted the affective benefits of physical activity. In the future brochures should aim to place increased emphasis on self-regulation, self-efficacy, and affective outcome expectancies. PMID:22125418

  19. Clinically Available Medicines Demonstrating Anti-Toxoplasma Activity

    PubMed Central

    Neville, Andrew J.; Zach, Sydney J.; Wang, Xiaofang; Larson, Joshua J.; Judge, Abigail K.; Davis, Lisa A.; Vennerstrom, Jonathan L.

    2015-01-01

    Toxoplasma gondii is an apicomplexan parasite of humans and other mammals, including livestock and companion animals. While chemotherapeutic regimens, including pyrimethamine and sulfadiazine regimens, ameliorate acute or recrudescent disease such as toxoplasmic encephalitis or ocular toxoplasmosis, these drugs are often toxic to the host. Moreover, no approved options are available to treat infected women who are pregnant. Lastly, no drug regimen has shown the ability to eradicate the chronic stage of infection, which is characterized by chemoresistant intracellular cysts that persist for the life of the host. In an effort to promote additional chemotherapeutic options, we now evaluate clinically available drugs that have shown efficacy in disease models but which lack clinical case reports. Ideally, less-toxic treatments for the acute disease can be identified and developed, with an additional goal of cyst clearance from human and animal hosts. PMID:26392504

  20. In-vitro activity of cationic peptides alone and in combination with clinically used antimicrobial agents against Pseudomonas aeruginosa.

    PubMed

    Giacometti, A; Cirioni, O; Barchiesi, F; Fortuna, M; Scalise, G

    1999-11-01

    The in-vitro activity of cecropin P1, indolicidin, magainin II, nisin and ranalexin alone and in combination with nine clinically used antimicrobial agents was investigated against a control strain, Pseudomonas aeruginosa ATCC 27853 and 40 clinical isolates of P. aeruginosa. Antimicrobial activities were measured by MIC, MBC and viable count. In the combination study, the clinically used antibiotics were used at concentrations close to their mean serum level in humans in order to establish the clinical relevance of the results. To select peptide-resistant mutants, P. aeruginosa ATCC 27853 was treated with consecutive cycles of exposure to each peptide at 1 x MIC. The peptides had a varied range of inhibitory values: all isolates were more susceptible to cecropin P1, while ranalexin showed the lowest activity. Nevertheless, synergy was observed when the peptides were combined with polymyxin E and clarithromycin. Consecutive exposures to each peptide at 1 x MIC resulted in the selection of stable resistant mutants. Cationic peptides might be valuable as new antimicrobial agents. Our findings show that they are effective against P. aeruginosa, and that their activity is enhanced when they are combined with clinically used antimicrobial agents, particularly with polymyxin E and clarithromycin. PMID:10552980

  1. Virtual Investigations of an Active Deep Sea Volcano

    NASA Astrophysics Data System (ADS)

    Sautter, L.; Taylor, M. M.; Fundis, A.; Kelley, D. S.; Elend, M.

    2013-12-01

    Axial Seamount, located on the Juan de Fuca spreading ridge 300 miles off the Oregon coast, is an active volcano whose summit caldera lies 1500 m beneath the sea surface. Ongoing construction of the Regional Scale Nodes (RSN) cabled observatory by the University of Washington (funded by the NSF Ocean Observatories Initiative) has allowed for exploration of recent lava flows and active hydrothermal vents using HD video mounted on the ROVs, ROPOS and JASON II. College level oceanography/marine geology online laboratory exercises referred to as Online Concept Modules (OCMs) have been created using video and video frame-captured mosaics to promote skill development for characterizing and quantifying deep sea environments. Students proceed at their own pace through a sequence of short movies with which they (a) gain background knowledge, (b) learn skills to identify and classify features or biota within a targeted environment, (c) practice these skills, and (d) use their knowledge and skills to make interpretations regarding the environment. Part (d) serves as the necessary assessment component of the laboratory exercise. Two Axial Seamount-focused OCMs will be presented: 1) Lava Flow Characterization: Identifying a Suitable Cable Route, and 2) Assessing Hydrothermal Vent Communities: Comparisons Among Multiple Sulfide Chimneys.

  2. Synthesis of marmycin A and investigation into its cellular activity

    NASA Astrophysics Data System (ADS)

    Cañeque, Tatiana; Gomes, Filipe; Mai, Trang Thi; Maestri, Giovanni; Malacria, Max; Rodriguez, Raphaël

    2015-09-01

    Anthracyclines such as doxorubicin are used extensively in the treatment of cancers. Anthraquinone-related angucyclines also exhibit antiproliferative properties and have been proposed to operate via similar mechanisms, including direct genome targeting. Here, we report the chemical synthesis of marmycin A and the study of its cellular activity. The aromatic core was constructed by means of a one-pot multistep reaction comprising a regioselective Diels-Alder cycloaddition, and the complex sugar backbone was introduced through a copper-catalysed Ullmann cross-coupling, followed by a challenging Friedel-Crafts cyclization. Remarkably, fluorescence microscopy revealed that marmycin A does not target the nucleus but instead accumulates in lysosomes, thereby promoting cell death independently of genome targeting. Furthermore, a synthetic dimer of marmycin A and the lysosome-targeting agent artesunate exhibited a synergistic activity against the invasive MDA-MB-231 cancer cell line. These findings shed light on the elusive pathways through which anthraquinone derivatives act in cells, pointing towards unanticipated biological and therapeutic applications.

  3. Green synthesis, spectroscopic investigation and photocatalytic activity of lead nanoparticles.

    PubMed

    Elango, Ganesh; Roopan, Selvaraj Mohana

    2015-03-15

    Most of researcher focused their research towards synthesize of nanoparticles by the method of applied chemical method which was one of the costliest method. We have focused cheapest and simplest method for the synthesizing of lead nanoparticles (Pb-NPs) using cocos nucifera L extract. The methanolic extract of cocos nucifera L was efficiently used as a reducing agent for synthesizing Pb-NPs. On treatment of lead acetate with cocos nucifera coir extracts, stable Pb-NPs were formed. The synthesized Pb-NPs were further confirmed by UV-visible spectroscopy, X-ray diffraction (XRD), Transmission electron microscope (TEM) and Energy Dispersive (EDAX) analysis. The secondary metabolites present in methanolic extract which can mainly act as a reducing and capping agents for the formation of Pb-NPs were identified by GC-MS. Anti-microbial activity for Pb-NPs against four pathogenic strain's such as Staphylococcus aureus, Escheria coli, Staphylococcus epidermis and Bacillus subtilis. Result states that Pb-NPs size was 47 nm and also shows good activity against S. aureus. Further we report on photocatalytic absorption of malachite green dye processed in short UV wavelength at 254 nm. UV spectral analysis showed peak absorbance at 613 nm with special reference to the excitation of surfaces plasmon vibration by Pb-NPs. PMID:25574657

  4. Green synthesis, spectroscopic investigation and photocatalytic activity of lead nanoparticles

    NASA Astrophysics Data System (ADS)

    Elango, Ganesh; Roopan, Selvaraj Mohana

    2015-03-01

    Most of researcher focused their research towards synthesize of nanoparticles by the method of applied chemical method which was one of the costliest method. We have focused cheapest and simplest method for the synthesizing of lead nanoparticles (Pb-NPs) using cocos nucifera L extract. The methanolic extract of cocos nucifera L was efficiently used as a reducing agent for synthesizing Pb-NPs. On treatment of lead acetate with cocos nucifera coir extracts, stable Pb-NPs were formed. The synthesized Pb-NPs were further confirmed by UV-visible spectroscopy, X-ray diffraction (XRD), Transmission electron microscope (TEM) and Energy Dispersive (EDAX) analysis. The secondary metabolites present in methanolic extract which can mainly act as a reducing and capping agents for the formation of Pb-NPs were identified by GC-MS. Anti-microbial activity for Pb-NPs against four pathogenic strain's such as Staphylococcus aureus, Escheria coli, Staphylococcus epidermis and Bacillus subtilis. Result states that Pb-NPs size was 47 nm and also shows good activity against S. aureus. Further we report on photocatalytic absorption of malachite green dye processed in short UV wavelength at 254 nm. UV spectral analysis showed peak absorbance at 613 nm with special reference to the excitation of surfaces plasmon vibration by Pb-NPs.

  5. 25 CFR 900.196 - Do covered services include the conduct of clinical studies and investigations and the provision...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... studies and investigations and the provision of emergency services, including the operation of emergency motor vehicles? 900.196 Section 900.196 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR... Claims § 900.196 Do covered services include the conduct of clinical studies and investigations and...

  6. 25 CFR 900.196 - Do covered services include the conduct of clinical studies and investigations and the provision...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... studies and investigations and the provision of emergency services, including the operation of emergency motor vehicles? 900.196 Section 900.196 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR... Claims § 900.196 Do covered services include the conduct of clinical studies and investigations and...

  7. 25 CFR 900.196 - Do covered services include the conduct of clinical studies and investigations and the provision...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... studies and investigations and the provision of emergency services, including the operation of emergency motor vehicles? 900.196 Section 900.196 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR... Claims § 900.196 Do covered services include the conduct of clinical studies and investigations and...

  8. 25 CFR 900.196 - Do covered services include the conduct of clinical studies and investigations and the provision...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... studies and investigations and the provision of emergency services, including the operation of emergency motor vehicles? 900.196 Section 900.196 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR... Claims § 900.196 Do covered services include the conduct of clinical studies and investigations and...

  9. 25 CFR 900.196 - Do covered services include the conduct of clinical studies and investigations and the provision...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... studies and investigations and the provision of emergency services, including the operation of emergency motor vehicles? 900.196 Section 900.196 Indians BUREAU OF INDIAN AFFAIRS, DEPARTMENT OF THE INTERIOR... Claims § 900.196 Do covered services include the conduct of clinical studies and investigations and...

  10. 78 FR 48173 - Guidance for Industry on Oversight of Clinical Investigations-A Risk-Based Approach to Monitoring...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND... Investigations--A Risk-Based Approach to Monitoring; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Oversight of Clinical Investigations--A Risk-Based Approach to...

  11. Non-inflammatory destructive periodontal disease: a clinical, microbiological, immunological and genetic investigation

    PubMed Central

    REPEKE, Carlos Eduardo; CARDOSO, Cristina Ribeiro; CLAUDINO, Marcela; SILVEIRA, Elcia Maria; TROMBONE, Ana Paula Favaro; CAMPANELLI, Ana Paula; SILVA, João Santana; MARTINS JÚNIOR, Walter; GARLET, Gustavo Pompermaier

    2012-01-01

    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-α 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. PMID:22437688

  12. Clinical study on thermography, as modern investigation method for Candida-associated denture stomatitis.

    PubMed

    Iosif, Laura; Preoteasa, Cristina Teodora; Murariu-Măgureanu, Cătălina; Preoteasa, Elena

    2016-01-01

    Candida-associated denture stomatitis is an infectious inflammatory condition of the oral mucosa, with frequent recurrences. The aim of this study was to assess the use of infrared thermography as investigation method for Candida-associated denture stomatitis (as inflammatory disorder of the maxillary denture bearing area), by comparing disease and non-disease groups. An observational study was conducted on maxillary edentulous patients treated by acrylic dentures, with and without Candida-associated denture stomatitis. Diagnostic test methods used were clinical examination for denture stomatitis and conventional microbiological culture method for oral candidiasis. Thermography analysis of the maxillary denture bearing area was made using the ThermaCAM PM350 infrared camera (Inframetrics, Flir Systems) and ThermaGram Pro 95 software, data being acquired by usage of standard protocol of thermographic registrations. The sample included 52 patients, 21 with and 31 without Candida-associated denture stomatitis. The temperature of the maxillary mucosa corresponding to the denture bearing area was found to be statistically significantly higher in Candida-associated denture stomatitis (mean 36.20°C), compared to healthy oral mucosa (mean 34.85°C). The thermal threshold value of 35.44°C was identified as best differentiating a pathological from normal state of the maxillary mucosa corresponding to the denture bearing area. In conclusion, infrared thermography, a rapid non-invasive investigation method, has the premises to bring valuable data in inflammatory disorders of the maxillary denture bearing area, as Candida-associated denture stomatitis that may be used for screening, diagnostic or monitoring purposes.

  13. Investigation of the clinical performance of a novel solid-state diagnostic dosimeter.

    PubMed

    Tse, Jason; McLean, Donald

    2015-01-01

    This study investigated the clinical performance of a novel solid-state diagnostic dosimeter, the RaySafe Xi transparent detector, by comparing its performance to a reference-class ionization chamber. Firstly a comparison of dosimeter response "free-in-air" with standard beam qualities was made, followed by an investigation into its relative transparency in an X-ray field and angular sensitivity dependence. The second part of the study looked at the overall performance of the transparent detector under scatter conditions with a number of beam qualities, including standard beam and those hardened by copper (Cu) filtration of thickness up to 0.9 mm, as would be encountered in the equipment testing of fluoroscopy systems. Overall, the transparent detector has demonstrated equivalent measurement properties to the ionization chamber under standard conditions and provided similar X-ray attenuation as reflected by the nearly identical radiographic parameters selected for both dosimeters by the automatic dose rate control (ADRC) system. Yet, it also possessed an asymmetric angular response which respectively under- and overestimated the dose contribution from the rear and lateral directions by the same amount of 50%. The transparent detector provided comparable dose reading of ± 3% to the ionization chamber with standard beam qualities and backscatter radiation present. These results were in good agreement with those of free-in-air measurement, indicating that the angular under- and overresponse might potentially compensate one another for accurate measurement. However, for identical Cu filtered beam qualities and setups, the transparent detector on average overresponded by 5.4% across the useful tube voltage range. In conclusion, the transparent detector, with its novel design, is essentially equivalent, within a 5% tolerance, to an ionization chamber, except in situations where beams hardened with Cu filtration are used with backscatter radiation present requiring

  14. New investigational drugs with single-agent activity in multiple myeloma

    PubMed Central

    Rajan, A M; Kumar, S

    2016-01-01

    The treatment of multiple myeloma (MM) is rapidly evolving. In the United States, four drugs (panobinostat, ixazomib, daratumumab and elotuzumab) were approved for the treatment of MM in 2015. As a result of improved diagnosis and therapy, there has been a dramatic improvement in the outcome of MM in the last decade, probably more than any other malignancy. Numerous agents continue to be studied in preclinical models and in clinical trials, with many demonstrating clinical efficacy that appears promising enough to have a trajectory for regulatory approval. The purpose of this article is to summarize the current data and provide perspective on new investigational agents with promising single-agent activity in MM. The agents reviewed include Isatuximab, an anti-CD38 monoclonal antibody; marizomib, a new proteasome inhibitor; oprozomib, an oral proteasome inhibitor; filanesib (ARRY-520), a kinesin spindle protein inhibitor; dinaciclib, a cyclin-dependent kinase inhibitor; venetoclax (ABT-199), a selective BCL-2 inhibitor; and LGH-447, pan PIM kinase inhibitor. PMID:27471867

  15. Investigations of biomechanical activity of macrophages during phagocytosis

    NASA Astrophysics Data System (ADS)

    Kovari, Daniel; Curtis, Jennifer

    2012-02-01

    Phagocytosis has traditionally been investigated in terms of the relevant biochemical signaling pathways that trigger the process and lead to the deformation of the cell as it engulfs a target. Physical changes in the cell include rearrangement and polymerization of actin in the phagocytic cup, large membrane deformations, increased membrane area via exocytosis, and closure of the phagocytic cup through membrane fusion. Hence, phagocytosis is a fine-tuned balance between biophysical cellular events and chemical signaling, which are responsible for driving these materials and mechanical changes. We present a series of assays designed to probe the physical/mechanical parameters that govern a cell during phagocytosis. Custom built micropipette manipulators are used to manipulate individual cells, facilitating high-resolution microscopy of individual phagocytic events. This work has been supported by NSF PoLS #0848797.

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

    PubMed

    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. PMID:16763801

  17. Investigating Molecular Hydrogen in Active Regions with IRIS

    NASA Astrophysics Data System (ADS)

    Jaeggli, Sarah A.; Saar, Steven H.; Daw, Adrian N.; Innes, Davina

    2014-06-01

    Molecular hydrogen should be the most abundant molecular species in sunspots, but recent observations with IRIS show that its florescent signature is absent from above the sunspot umbra, but appears brightly during flares. In this poster we continue the analysis of FUV observations of H2 in active regions, examining the correlation between the intensity of the H2 lines and the lines of C II and Si IV which are responsible for their excitation. We particularly focus on differentiating places where H2 is abundant, holes in the chromospheric opacity where FUV photons can enter more deeply into the solar atmosphere, and places where the FUV radiation field is intense, as in flares.

  18. Infantile hepatic hemangiomas. Clinical features, radiologic investigations, and treatment of 20 patients

    SciTech Connect

    Stanley, P.; Geer, G.D.; Miller, J.H.; Gilsanz, V.; Landing, B.H.; Boechat, I.M. )

    1989-08-15

    The clinical features, radiologic investigation, and treatment of 20 infants with hepatic hemangiomas are presented. Palpable abdominal mass (n = 18) and cardiac failure (n = 11) were the common presenting features. Nine patients had hyperconsumptive coagulopathy. Seven patients had other hemangiomas. Ultrasound (n = 15) showed the number and distribution of the hemangiomas within the liver. Hypoechoic and hyperechoic elements were present in addition to prominent vascular channels and diminished caliber of the distal aorta. Radionuclide sulfur colloid (n = 12) and labeled red blood cell (n = 7) studies showed the distribution and vascularity of the hemangiomas. Computed tomography (n = 8) revealed central hypointensity with marked peripheral enhancement after contrast. Arteriography now performed only as a prelude to therapeutic embolization demonstrated hypervascularity in each patient, contrast pooling in six and early draining veins in five. Magnetic resonance scanning (n = 3) showed decreased signal intensity on T1 images and high intensity signal on T2. In two patients, there was resolution or improvement of the hemangiomas without therapy. Four patients had surgery (lobectomy (2), trisegmentectomy (1), and surgical evacuation of a central hematoma (1)). Steroids and radiation were given to seven patients, and one patient also required therapeutic embolization. Steroids were the initial therapy in five patients, one of whom later required therapeutic embolization and another cyclophosphamide. Two patients were treated initially with radiation therapy, one of whom also needed emergency hepatic artery ligation. Seventeen of the 20 patients are alive and well from 6 months to 14 years after diagnosis.

  19. Report on activities and attitudes of organizations active in the clinical practice guidelines field.

    PubMed

    Carter, A O; Battista, R N; Hodge, M J; Lewis, S; Basinski, A; Davis, D

    1995-10-01

    The organizing committee of a workshop on clinical practice guidelines (CPGs) surveyed invited organizations on their attitudes and activities related to five topics to be covered during the workshop sessions: organizational roles, priority setting, guidelines implementation, guidelines evaluation and development of a network of those active in the CPG field. Organizational roles: The national specialty societies were felt to have the largest role to play; the smallest roles were assigned to consumers, who were seen to have a role mainly in priority setting, and to industry and government, both of which were seen to have primarily a funding role. Many barriers to collaboration were identified, the solutions to all of which appeared to be better communication, establishment of common principles and clear role definitions. Priority setting: There was considerable agreement on the criteria that should be used to set priorities for CPG activities: the burden of disease on population health, the state of scientific knowledge, the cost of treatment and the economic burden of disease on society were seen as important factors, whereas the costs of guidelines development and practitioner interest in guidelines development were seen as less important. Organizations were unable to give much information on how they set priorities. Guidelines implementation: Most of the organizations surveyed did not actively try to ensure the implementation of guidelines, although a considerable minority devoted resources to implementation. The 38% of organizations that implemented guidelines actively listed a wide variety of activities, including training, use of local opinion leaders, information technology, local consensus processes and counter detailing. Guidelines evaluation: Formal evaluation of guidelines was undertaken by fewer than 13% of the responding organizations. All the evaluations incorporated assessments before and after guideline implementation, and some used primary patient

  20. Altered relationships between age and functional brain activation in adolescents at clinical high risk for psychosis

    PubMed Central

    Karlsgodt, Katherine H.; van Erp, Theo G.M.; Bearden, Carrie E.; Cannon, Tyrone D.

    2014-01-01

    Schizophrenia is considered a neurodevelopmental disorder, but whether the adolescent period, proximal to onset, is associated with aberrant development in individuals at clinical high risk (CHR) for psychosis is incompletely understood. While abnormal gray and white matter development has been observed, alterations in functional neuroimaging (fMRI) parameters during adolescence as related to conversion to psychosis have not yet been investigated. Twenty CHR individuals and 19 typically developing controls (TDC), (ages 14-21), were recruited from the Center for Assessment and Prevention of Prodromal States (CAPPS) at UCLA. Participants performed a Sternberg-style verbal working memory (WMem) task during fMRI and data were analyzed using a cross-sectional design to test the hypothesis that there is a deviant developmental trajectory in WMem associated neural circuitry in those at risk for psychosis. Eight of the CHR adolescents converted to psychosis within 2 years of initial assessment. A voxel-wise regression examining the relationship between age and activation revealed a significant group-by-age interaction. TDC showed a negative association between age and functional activation in the WMem circuitry while CHR adolescents showed a positive association. Moreover, CHR patients who later converted to overt psychosis showed a distinct pattern of abnormal age-associated activation in the frontal cortex relative to controls, while non-converters showed a more diffuse posterior pattern. Finding that age related variation in baseline patterns of neural activity differentiate individuals who subsequently convert to psychosis from healthy subjects suggests that these differences are likely to be clinically relevant. PMID:24144510

  1. Altered relationships between age and functional brain activation in adolescents at clinical high risk for psychosis.

    PubMed

    Karlsgodt, Katherine H; van Erp, Theo G M; Bearden, Carrie E; Cannon, Tyrone D

    2014-01-30

    Schizophrenia is considered a neurodevelopmental disorder, but whether the adolescent period, proximal to onset, is associated with aberrant development in individuals at clinical high risk (CHR) for psychosis is incompletely understood. While abnormal gray and white matter development has been observed, alterations in functional neuroimaging (fMRI) parameters during adolescence as related to conversion to psychosis have not yet been investigated. Twenty CHR individuals and 19 typically developing controls (TDC), (ages 14-21), were recruited from the Center for Assessment and Prevention of Prodromal States (CAPPS) at UCLA. Participants performed a Sternberg-style verbal working memory (WMem) task during fMRI and data were analyzed using a cross-sectional design to test the hypothesis that there is a deviant developmental trajectory in WMem associated neural circuitry in those at risk for psychosis. Eight of the CHR adolescents converted to psychosis within 2 years of initial assessment. A voxel-wise regression examining the relationship between age and activation revealed a significant group-by-age interaction. TDC showed a negative association between age and functional activation in the WMem circuitry while CHR adolescents showed a positive association. Moreover, CHR patients who later converted to overt psychosis showed a distinct pattern of abnormal age-associated activation in the frontal cortex relative to controls, while non-converters showed a more diffuse posterior pattern. Finding that age related variation in baseline patterns of neural activity differentiate individuals who subsequently convert to psychosis from healthy subjects suggests that these differences are likely to be clinically relevant. PMID:24144510

  2. Theory, Investigation and Stability of Cathode Electrocatalytic Activity

    SciTech Connect

    Ding, Dong; Liu, Mingfei; Lai, Samson; Blinn, Kevin; Liu, Meilin

    2012-09-30

    The main objective of this project is to systematically characterize the surface composition, morphology, and electro-catalytic properties of catalysts coated on LSCF, aiming to establish the scientific basis for rational design of high-performance cathodes by combining a porous backbone (such as LSCF) with a thin catalyst coating. The understanding gained will help us to optimize the composition and morphology of the catalyst layer and microstructure of the LSCF backbone for better performance. More specifically, the technical objectives include: (1) to characterize the surface composition, morphology, and electro-catalytic properties of catalysts coated on LSCF; (2) to characterize the microscopic details and stability of the LSCF-catalyst (e.g., LSM) interfaces; (3) to establish the scientific basis for rational design of high-performance cathodes by combining a porous backbone (such as LSCF) with a thin catalyst coating; and (4) to demonstrate that the performance and stability of porous LSCF cathodes can be enhanced by the application of a thin-film coating of LSM through a solution infiltration process in small homemade button cells and in commercially available cells of larger dimension. We have successfully developed dense, conformal LSM films with desired structure, composition, morphology, and thickness on the LSCF surfaces by two different infiltration processes: a non-aqueous and a water-based sol-gel process. It is demonstrated that the activity and stability of LSCF cathodes can be improved by the introduction of a thin-film LSM coating through an infiltration process. Surface and interface of the LSM-coated LSCF cathode were systematically characterized using advanced microscopy and spectroscopy techniques. TEM observation suggests that a layer of La and Sr oxide was formed on LSCF surfaces after annealing. With LSM infiltration, in contrast, we no longer observe such La/Sr oxide layer on the LSM-coated LSCF samples after annealing under similar

  3. Investigating the Structure of Active Galactic Nuclei: The Dusty Torus

    NASA Astrophysics Data System (ADS)

    Stalevski, Marko

    2012-11-01

    Active galactic nuclei Nowadays it is widely accepted that every massive galaxy harbors a supermassive black hole (SMBH) at its center. A number of apparent correlations between SMBH mass and host galaxy structural and dynamical properties have been observed. The correlation between the masses of SMBHs and their host galactic bulges suggest a link between their growth (Kormendy & Richstone, 1995; Kormendy & Gebhardt, 2001). Active galactic nucleus (AGN) represents a phase in the life of a galaxy, during which the SMBH growth is directly observable. The term AGN encompasses a variety of energetic phenomena in galactic centers triggered by the matter spiralling into a SMBH at a relatively high rate. The radiation coming from AGNs originates in the conversion of gravitational potential energy into thermal energy as matter spirals towards the SMBH through an accretion disk (Lynden- Bell, 1969). Their luminosity can be up to 10000 greater then the total luminosity of a normal galaxy. The radiated AGN continuum covers a broad range of spectrum, from the X to radio domain, it is partially polarized and variable in time. Radiation from the central engine is ionizing the surrounding medium, creating conditions for the strong emission line spectrum, superimposed on the continuum. Sometimes, highly collimated and fast outflows (“jets”) emerge perpendicular to the accretion disk. Since the discovery of Keel (1980) that the orientation of Seyfert 1 galaxies is not random, it xxx has been recognized that the appearance of an AGN varies with the viewing angle. This has led to the picture of “orientation unification” (see Antonucci, 1993; Urry & Padovani, 1995) where the structure of AGNs is believed to be basically similar but what we see is a strong function of orientation (see Fig. 9). In this unified model, the central black hole is surrounded by a geometrically-thin accretion disk which is the source of the strong X-ray emission and UV/optical continuum (see Jovanovic

  4. Clinical effectiveness of the activator adjusting instrument in the management of musculoskeletal disorders: a systematic review of the literature

    PubMed Central

    Huggins, Tiffany; Boras, Ana Luburic; Gleberzon, Brian J.; Popescu, Mara; Bahry, Lianna A.

    2012-01-01

    Objective: The purpose of this study was to conduct a systematic review of the literature investigating clinical outcomes involving the use of the Activator Adjusting Instrument (AAI) or Activator Methods Chiropractic Technique (AMCT). Methods: A literature synthesis was performed on the available research and electronic databases, along with hand-searching of journals and reference tracking for any studies that investigated the AAI in terms of clinical effectiveness. Studies that met the inclusion criteria were evaluated using an instrument that assessed their methodological quality. Results: Eight articles met the inclusion criteria. Overall, the AAI provided comparable clinically meaningful benefits to patients when compared to high-velocity, low-amplitude (HVLA) manual manipulation or trigger point therapy for patients with acute and chronic spinal pain, temporomandibular joint (TMJ) dysfunction and trigger points of the trapezius muscles. Conclusion: This systematic review of 8 clinical trials involving the use of the AAI found reported benefits to patients with a spinal pain and trigger points, although the clinical trials reviewed suffered from many methodological limitations, including small sample size, relatively brief follow-up period and lack of control or sham treatment groups. PMID:22457541

  5. Mean Deviation of Inter-rater Scoring (MDIS): a simple tool for introducing conformity into groups of clinical investigators.

    PubMed

    Bourin, Michel; Deplanque, Dominique; Zins-Ritter, Marcel

    2004-07-01

    In spite of considerable progress over the past decade, training investigators for inter-rater reliability for clinical trials remains a major problem. The aim of the present study was to promote a new tool to increase data homogeneity by introducing conformity into groups of clinical investigators. The investigators scoring grid we are proposing-the Mean Deviation of Inter-rater Scoring (MDIS)-involves the calculation of the score deviation for each investigator relative to the median score of an expert group who had evaluated the same videotape-recorded clinical case. Whatever the scale, the score deviation is calculated as the absolute deviation value from the median score obtained by the experts for each item. The MDIS value is then evaluated from all the scores given by an investigator by dividing the total sum of the previously defined values by the number of items of the scale. Some examples from practice are given using several rating scales: (i) Hamilton Anxiety Rating Scale; (ii) Hamilton Depression Rating Scale; (iii) Montgomery Asberg Depression Rating Scale; and (iv) Positive And Negative Symptoms Scale. Finally, such a method could also be employed by experts to evaluate the quality of videotape-recorded clinical cases used in clinical trials, as well as by teachers to evaluate initial or continuous medical training.

  6. An expanding universe of noncoding RNAs between the poles of basic science and clinical investigations.

    PubMed

    Weil, Patrick P; Hensel, Kai O; Weber, David; Postberg, Jan

    2016-03-01

    The Keystone Symposium 'MicroRNAs and Noncoding RNAs in Cancer', Keystone, CO, USA, 7-12 June 2015 Since the discovery of RNAi, great efforts have been undertaken to unleash the potential biomedical applicability of small noncoding RNAs, mainly miRNAs, involving their use as biomarkers for personalized diagnostics or their usability as active agents or therapy targets. The research's focus on the noncoding RNA world is now slowly moving from a phase of basic discoveries into a new phase, where every single molecule out of many hundreds of cataloged noncoding RNAs becomes dissected in order to investigate these molecules' biomedical relevance. In addition, RNA classes neglected before, such as long noncoding RNAs or circular RNAs attract more attention. Numerous timely results and hypotheses were presented at the 2015 Keystone Symposium 'MicroRNAs and Noncoding RNAs in Cancer'.

  7. Insights and clinical questions about the active surveillance of low-risk papillary thyroid microcarcinomas [Review].

    PubMed

    Ito, Yasuhiro; Oda, Hitomi; Miyauchi, Akira

    2016-04-25

    Over 20 years ago, two Japanese institutions initiated an active surveillance policy for papillary microcarcinomas (PMCs) without high-risk features (such as clinical lymph node and distant metastases) and suspected trachea or recurrent laryngeal nerve invasion. Since the most recent American Thyroid Association (ATA) guidelines adopt active surveillance as a therapy option for low-risk PMCs, the number of institutions worldwide carrying out this policy can be expected to increase. However, before adopting an active surveillance strategy, some important clinical questions must be considered. In this review, conceivable clinical questions with our answers based on the present accumulation of low-risk PMC surveillance data are presented. PMID:26632168

  8. Peer assisted learning in the clinical setting: an activity systems analysis.

    PubMed

    Bennett, Deirdre; O'Flynn, Siun; Kelly, Martina

    2015-08-01

    Peer assisted learning (PAL) is a common feature of medical education. Understanding of PAL has been based on processes and outcomes in controlled settings, such as clinical skills labs. PAL in the clinical setting, a complex learning environment, requires fresh evaluation. Socio-cultural theory is proposed as a means to understand educational interventions in ways that are practical and meaningful. We describe the evaluation of a PAL intervention, introduced to support students' transition into full time clinical attachments, using activity theory and activity systems analysis (ASA). Our research question was How does PAL transfer to the clinical environment? Junior students on their first clinical attachments undertook a weekly same-level, reciprocal PAL activity. Qualitative data was collected after each session, and focus groups (n = 3) were held on completion. Data was analysed using ASA. ASA revealed two competing activity systems on clinical attachment; Learning from Experts, which students saw as the primary function of the attachment and Learning with Peers, the PAL intervention. The latter took time from the first and was in tension with it. Tensions arose from student beliefs about how learning takes place in clinical settings, and the importance of social relationships, leading to variable engagement with PAL. Differing perspectives within the group were opportunities for expansive learning. PAL in the clinical environment presents challenges specific to that context. Using ASA helped to describe student activity on clinical attachment and to highlight tensions and contradictions relating PAL in that setting. Planning learning opportunities on clinical placements, must take account of how students learn in workplaces, and the complexity of the multiple competing activity systems related to learning and social activities.

  9. Investigating the Clinical Usefulness of the Social Responsiveness Scale (SRS) in a Tertiary Level, Autism Spectrum Disorder Specific Assessment Clinic

    ERIC Educational Resources Information Center

    Aldridge, Fiona J.; Gibbs, Vicki M.; Schmidhofer, Katherine; Williams, Megan

    2012-01-01

    The Social Responsiveness Scale (SRS; Constantino and Gruber in Social Responsiveness Scale (SRS). Western Psychological Services, Los Angeles, 2005) is a commonly used screening tool for identifying children with possible autism spectrum disorder (ASD). This study investigated the relationship between SRS scores and eventual diagnostic outcome…

  10. Disaccharidase activities in camel small intestine: biochemical investigations of maltase-glucoamylase activity.

    PubMed

    Mohamed, Saleh A; Fahmy, Afaf S; Salah, Hala A

    2007-01-01

    Disaccharidases (maltase, cellobiase, lactase, and sucrase), alpha-amylase, and glucoamylase in the camel small intestine were investigated to integrate the enzymatic digestion profile in camel. High activities were detected for maltase and glucoamylase, followed by moderate levels of sucrase and alpha-amylase. Very low activity levels were detected for lactase and cellobiase. Camel intestinal maltase-glucoamylase (MG) was purified by DEAE-Sepharose and Sephacryl S-200 columns. The molecular weight of camel small intestinal MG4 and MG6 were estimated to be 140,000 and 180,000 using Sephacryl S-200. These values were confirmed by SDS-PAGE, where the two enzymes migrated as single subunits. This study encompassed characterization of MGs from camel intestine. The Km values of MG4 and MG6 were estimated to be 13.3 mM and 20 mM maltose, respectively. Substrate specificity for MG4 and MG6 indicated that the two enzymes are maltase-glucoamylases because they catalysed the hydrolysis of maltose and starch with alpha-1,4 and alpha-1,6 glycosidic bonds, but not sucrose with alpha-1,2 glycosidic bond which was hydrolyzed by sucrase-isomaltase. Camel intestinal MG4 and MG6 had the same optimum pH at 7.0 and temperature optimum at 50 degrees C and 40 degrees C, respectively. The two enzymes were stable up to 50 degrees C and 40 degrees C, followed by strong decrease in activity at 60 degrees C and 50 degrees C, respectively. The effect of divalent cations on the activity of camel intestinal MG4 and MG6 was studied. All the examined divalent cations Ca(2+), Mn(2+), Mg(2+), Co(2+) and Fe(3+) had slight effects on the two enzymes except Hg(2+) which had a strong inhibitory effect. The effect of different inhibitors on MG4 and MG6 indicated that the two enzymes had a cysteine residue. PMID:17098455

  11. Pilot clinical study to investigate the human whole blood spectrum characteristics in the sub-THz region

    NASA Astrophysics Data System (ADS)

    Tseng, Tzu-Fang; You, Borwen; Gao, Hao-Cheng; Wang, Tzung-Dau; Sun, Chi-Kuang

    2015-04-01

    We have conducted a pilot clinical study to not only investigate the THz spectra of ex-vivo fresh human whole blood of 28 patients following 8-hours fasting guideline, but also to find out the critical blood ingredients of which the concentration dominantly affects those THz spectra. A great difference between the THz absorption properties of human blood among different people was observed, while the difference can be up to ~15% of the averaged absorption coefficient of the 28 samples. Our pilot clinical study indicates that triglyceride and red blood cell were two dominant factors to have significant clinically defined negative correlation to the sub-THz absorption coefficients.

  12. Barriers to medical research participation as perceived by clinical trial investigators: communicating with rural and african american communities.

    PubMed

    Tanner, Andrea; Kim, Sei-Hill; Friedman, Daniela B; Foster, Caroline; Bergeron, Caroline D

    2015-01-01

    Clinical trials help advance public health and medical research on prevention, diagnosis, screening, treatment, and quality of life. Despite the need for access to quality care in medically underserved areas, clinical trial participation remains low among individuals in rural and African American communities. This study assessed clinical trial research in South Carolina's five main academic medical centers, focusing specifically on clinical trial investigators' perceived barriers to recruitment in the general population and in rural and African American communities. Online survey responses (N = 119) revealed that it was most difficult for investigators to recruit from rural areas and that rural residents were least likely to be represented in medical research, behind both the general public and African Americans. Barriers focusing on communication or awareness proved to be the biggest hurdles to finding potential participants in both the general public and rural communities. Psychological barriers to recruitment were perceived to be most prevalent in African American communities. Study findings provide important insights from the perspective of the clinical trial investigator that will aid in the development of effective communication and education strategies for reaching rural and African American residents with information about clinical trials. PMID:25204763

  13. Reply to B. Rimland's "Comments on 'Secretin and Autism: A Two-Part Clinical Investigation'".

    ERIC Educational Resources Information Center

    Chez, Michael G.; Buchanan, Cathleen P.

    2000-01-01

    The authors of a study (EC 625 006) of the clinical effects of the hormone secretin on autism respond to critical comments (EC 625 007) by defending their conclusion that secretin offers no observable clinical improvement in children with autism, their choice of methodology, and use of the Childhood Autism Rating Scales. (Contains references.) (DB)

  14. Critical role of bioanalytical strategies in investigation of clinical PK observations, a Phase I case study.

    PubMed

    Peng, Kun; Xu, Keyang; Liu, Luna; Hendricks, Robert; Delarosa, Reginald; Erickson, Rich; Budha, Nageshwar; Leabman, Maya; Song, An; Kaur, Surinder; Fischer, Saloumeh K

    2014-01-01

    RG7652 is a human immunoglobulin 1 (IgG1) monoclonal antibody (mAb) targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) and is designed for the treatment of hypercholesterolemia. A target-binding enzyme-linked immunosorbent assay (ELISA) was developed to measure RG7652 levels in human serum in a Phase I study. Although target-binding assay formats are generally used to quantify free therapeutic, the actual therapeutic species being measured are affected by assay conditions, such as sample dilution and incubation time, and levels of soluble target in the samples. Therefore, in the presence of high concentrations of circulating target, the choice of reagents and assay conditions can have a significant effect on the observed pharmacokinetic (PK) profiles. Phase I RG7652 PK analysis using the ELISA data resulted in a nonlinear dose normalized exposure. An investigation was conducted to characterize the ELISA to determine whether the assay format and reagents may have contributed to the PK observation. In addition, to confirm the ELISA results, a second orthogonal method, liquid chromatography tandem mass spectrometry (LC-MS/MS) using a signature peptide as surrogate, was developed and implemented. A subset of PK samples, randomly selected from half of the subjects in the 6 single ascending dose (SAD) cohorts in the Phase I clinical study, was analyzed with the LC-MS/MS assay, and the data were found to be comparable to the ELISA data. This paper illustrates the importance of reagent characterization, as well as the benefits of using an orthogonal approach to eliminate bioanalytical contributions when encountering unexpected observations.

  15. Investigation of a clinical PET detector module design that employs large-area avalanche photodetectors

    NASA Astrophysics Data System (ADS)

    Peng, Hao; Olcott, Peter D.; Spanoudaki, Virginia; Levin, Craig S.

    2011-06-01

    We investigated the feasibility of designing an Anger-logic PET detector module using large-area high-gain avalanche photodiodes (APDs) for a brain-dedicated PET/MRI system. Using Monte Carlo simulations, we systematically optimized the detector design with regard to the scintillation crystal, optical diffuser, surface treatment, layout of large-area APDs, and signal-to-noise ratio (SNR, defined as the 511 keV photopeak position divided by the standard deviation of noise floor in an energy spectrum) of the APD devices. A detector prototype was built comprising an 8 × 8 array of 2.75 × 3.00 × 20.0 mm3 LYSO (lutetium-yttrium-oxyorthosilicate) crystals and a 22.0 × 24.0 × 9.0 mm3 optical diffuser. From the four designs of the optical diffuser tested, two designs employing a slotted diffuser are able to resolve all 64 crystals within the block with good uniformity and peak-to-valley ratio. Good agreement was found between the simulation and experimental results. For the detector employing a slotted optical diffuser, the energy resolution of the global energy spectrum after normalization is 13.4 ± 0.4%. The energy resolution of individual crystals varies between 11.3 ± 0.3% and 17.3 ± 0.4%. The time resolution varies between 4.85 ± 0.04 (center crystal), 5.17 ± 0.06 (edge crystal), and 5.18 ± 0.07 ns (corner crystal). The generalized framework proposed in this work helps to guide the design of detector modules for selected PET system configurations, including scaling the design down to a preclinical PET system, scaling up to a whole-body clinical scanner, as well as replacing APDs with other novel photodetectors that have higher gain or SNR such as silicon photomultipliers.

  16. Simultaneous Bilateral Carotid Stenting for Symptomatic Bilateral High-Grade Carotid Stenosis: A Retrospective Clinical Investigation.

    PubMed

    Ye, Ziming; Liu, Ying; Deng, Xiao; Chen, Xiangren; Lin, Cuiting; Tang, Yanyan; Su, Ying; Fang, Lanji; Wu, Yuan; Qin, Chao

    2016-01-01

    BACKGROUND This retrospective clinical investigation aimed to evaluate the short-term effectiveness and safety of SBCAS for symptomatic bilateral high-grade CS. MATERIAL AND METHODS From 2009 to 2014, 145 patients were recruited. Among them, 70 underwent SBCAS, and other 75 patients underwent SAMM and served as controls. The immediate postprocedural complications and postprocedural neurological evaluation, as well as restenosis at 6-month and 1-year follow-ups in the SBCAS group are reported. Additionally, baseline risk factors for ischemic stroke, adverse effects of drugs, and outcomes at 30-day, 6-month, and 1-year follow-ups were compared between the 2 groups. RESULTS Our data did not reveal significant differences between the 2 groups in baseline risk factors for ischemic stroke. In the SBCAS group, both HPS (5.7%) and HD (40%) occurred, but they were not very severe, and no patients had postprocedural neurological deficit. Moreover, restenosis only occurred in 3 patients at 3 stent placement sites (4.3%) at 1-year follow-up. Adverse effects of drugs did not occur in SBCAS group, but adverse effects of Bayer aspirin and Lipitor occurred in 4 patients (5.4%) and 18 patients (24.3%), respectively, at 6-month follow-up in the control group. Furthermore, there were significant differences in outcomes between the 2 groups at 30-day, 6-month, and 1-year follow-ups, in that NIHSS, CS ratio, and incidence of endpoint events, as well as 1-year cumulative probability of endpoint events, were all lower in the SBCAS group than in the control group (p<0.05). CONCLUSIONS Compared to SAMM, we found that SBCAS was more effective and safer for symptomatic bilateral high-grade CS. PMID:27542158

  17. Simultaneous Bilateral Carotid Stenting for Symptomatic Bilateral High-Grade Carotid Stenosis: A Retrospective Clinical Investigation

    PubMed Central

    Ye, Ziming; Liu, Ying; Deng, Xiao; Chen, Xiangren; Lin, Cuiting; Tang, Yanyan; Su, Ying; Fang, Lanji; Wu, Yuan; Qin, Chao

    2016-01-01

    Background This retrospective clinical investigation aimed to evaluate the short-term effectiveness and safety of SBCAS for symptomatic bilateral high-grade CS. Material/Methods From 2009 to 2014, 145 patients were recruited. Among them, 70 underwent SBCAS, and other 75 patients underwent SAMM and served as controls. The immediate postprocedural complications and postprocedural neurological evaluation, as well as restenosis at 6-month and 1-year follow-ups in the SBCAS group are reported. Additionally, baseline risk factors for ischemic stroke, adverse effects of drugs, and outcomes at 30-day, 6-month, and 1-year follow-ups were compared between the 2 groups. Results Our data did not reveal significant differences between the 2 groups in baseline risk factors for ischemic stroke. In the SBCAS group, both HPS (5.7%) and HD (40%) occurred, but they were not very severe, and no patients had postprocedural neurological deficit. Moreover, restenosis only occurred in 3 patients at 3 stent placement sites (4.3%) at 1-year follow-up. Adverse effects of drugs did not occur in SBCAS group, but adverse effects of Bayer aspirin and Lipitor occurred in 4 patients (5.4%) and 18 patients (24.3%), respectively, at 6-month follow-up in the control group. Furthermore, there were significant differences in outcomes between the 2 groups at 30-day, 6-month, and 1-year follow-ups, in that NIHSS, CS ratio, and incidence of endpoint events, as well as 1-year cumulative probability of endpoint events, were all lower in the SBCAS group than in the control group (p<0.05). Conclusions Compared to SAMM, we found that SBCAS was more effective and safer for symptomatic bilateral high-grade CS. PMID:27542158

  18. An investigation of the clinical experiences of dentists within the national dental foundation training programme in the North West of England.

    PubMed

    Palmer, N O A; Kirton, J A; Speechley, D

    2016-09-23

    Objective To investigate the clinical experiences of foundation dentists (FDs) in the North West of England.Methods Three research methods were used: a questionnaire completed by FDs at the end of their training; an analysis of the clinical logs of experience recorded in the educational portfolios; and analysis of NHS Business Services Authority (NHSBSA) activity data for the 12 month period of training of FDs.Results A response rate of 100% (N = 50) was achieved for the questionnaire and complete data for 49 of the 50 FDs was available from the NHSBSA and clinical logs in the educational portfolios.Discussion Trainees were satisfied with the clinical experience and believed their workload and patient mix provided a broad experience of clinical conditions, although 40% felt there were gaps in their clinical experience. There were wide ranges in the number of individual clinical procedures performed by FDs with some providing very few endodontic treatments, crowns, bridges, metal dentures and fissure sealants. There was a statistically significant difference (P <0.0005) in self- reporting of procedures recorded in the portfolio log when compared to the NHSBSA data.Conclusion The results from this study suggest that there is satisfaction amongst FDs with FT, but there is wide range in the level of clinical experience amongst FDs with some gaps which need to be addressed. In order to provide a consistent, cost effective approach to the delivery of FT changes are required to ensure minimum levels of clinical procedures are achieved during FT. The information collected in the training portfolio must be robust in order to make valid judgements on progress. PMID:27659636

  19. Activity restriction in mild COPD: a challenging clinical problem.

    PubMed

    O'Donnell, Denis E; Gebke, Kevin B

    2014-01-01

    Dyspnea, exercise intolerance, and activity restriction are already apparent in mild chronic obstructive pulmonary disease (COPD). However, patients may not seek medical help until their symptoms become troublesome and persistent and significant respiratory impairment is already present; as a consequence, further sustained physical inactivity may contribute to disease progression. Ventilatory and gas exchange impairment, cardiac dysfunction, and skeletal muscle dysfunction are present to a variable degree in patients with mild COPD, and collectively may contribute to exercise intolerance. As such, there is increasing interest in evaluating exercise tolerance and physical activity in symptomatic patients with COPD who have mild airway obstruction, as defined by spirometry. Simple questionnaires, eg, the modified British Medical Research Council dyspnea scale and the COPD Assessment Test, or exercise tests, eg, the 6-minute or incremental and endurance exercise tests can be used to assess exercise performance and functional status. Pedometers and accelerometers are used to evaluate physical activity, and endurance tests (cycle or treadmill) using constant work rate protocols are used to assess the effects of interventions such as pulmonary rehabilitation. In addition, alternative outcome measurements, such as tests of small airway dysfunction and laboratory-based exercise tests, are used to measure the extent of physiological impairment in individuals with persistent dyspnea. This review describes the mechanisms of exercise limitation in patients with mild COPD and the interventions that can potentially improve exercise tolerance. Also discussed are the benefits of pulmonary rehabilitation and the potential role of pharmacologic treatment in symptomatic patients with mild COPD. PMID:24940054

  20. Pilot investigation of the quantitative EEG and clinical effects of ketazolam and the novel antiemetic nonabine in normal subjects.

    PubMed

    McClelland, G R; Sutton, J A

    1985-01-01

    Nonabine is a chromenol structurally related to the cannabinoids which has shown antiemetic efficacy in clinical trials. Oral doses of 5, 10, and 15 mg were given to healthy volunteers in a crossover study with the benzodiazepine ketazolam, 30 and 45 mg. Ketazolam produced sedative effects, with decreased quantitative EEG alpha activity and increased beta activity. Nonabine also produced sedative clinical effects, but with an EEG profile which resembled that reportedly caused by cannabinoids. In contrast to cannabinoids, nonabine did not cause changes of mood or perception, suggesting that nonabine lacks the potential for social abuse at antiemetic doses.

  1. Doppler echocardiographic evidence of pulmonary hypertension in dogs: a retrospective clinical investigation.

    PubMed

    Paradies, P; Spagnolo, P P; Amato, M E; Pulpito, D; Sasanelli, M

    2014-03-01

    Pulmonary hypertension (PH) decreases resistance to fatigue and life expectancy. The aim of this study was to correlate some indirect Doppler indices of PH with tricuspid and pulmonary regurgitation criteria and to relate PH on different indices with the severity of clinical signs. Furthermore the pathogenetic mechanisms associated to PH development were discussed. Dogs with Doppler echocardiographic evidence of PH diagnosed by assessment of pulmonary and tricuspid regurgitant jet velocity were selected, their clinical records were reviewed and a clinical score was computed. Seventeen cases of PH were identified. The degree of PH was assessed based on systolic or diastolic pulmonary pressure and the indirect Doppler indices (AT/ET and Tei Index) were calculated; data were statistically evaluated. Indirect Doppler indices were calculated also in a control group of seven healthy dogs. The most common clinical signs were coughing, dyspnea and syncope; the most common condition associated to PH development was the left-sided valvular heart disease. A significant positive correlation was found between Tei Index and both the systolic pressure and the severity of PH while no correlations were found between PH on different indices and clinical score and/or severity of clinical signs. Results of this study suggest that Tei-index could be an useful support not only to reveal PH but also to give information on the severity of PH. The clinical picture in dogs with PH is apparently unpredictable and not strictly correlated with the severity of PH.

  2. [Active acromegaly and gigantism: some clinical characteristics of 50 patients].

    PubMed

    Pumarino, H; Oviedo, S; Michelsen, H; Campino, C

    1991-08-01

    50 patients with autonomous growth hormone excess (48 with adult acromegaly and 2 with gigantism) were studied between 1966 to 1986 (2.38 pts/year). Characteristic clinical presentation, an increase in growth hormone (GH) uninhibited by glucose, and/or hyperphosphemia and hyperhydroxiprolinuria were present in all patients. No cases of hypercalcemia were recorded. Phosphemia was increased in 55.8%, alkaline phosphatases in 61.7%, calciuria in 26.9% and hydroxyprolinuria in 74.2% of the patients. Basal GH was over 5 ng/ml (89.9 DS +/- 170.9) in 42 pts, and in 37 was not suppressed after glucose administration, 38% had an increased (paradoxical response) and 62% a flat response (less than 50% change of basal values). TRH test was performed in 14 patients, 8 presented an increase in GH titer. Hyperprolactinemia was seen in 4 of 12 patients in whom this hormone was measured. The size of the sella turcica was increased in 93%, and although the larger sellar size correlated to higher levels of GH, correlation was not significant. 20% of the pts had rheumatological disease, 14% goiter, 12% cardiac disease, 26.5% had diastolic hypertension and 4% renal lithiasis (hypercalciuric pts). 38% had hyperglycemia with a diabetic glucose tolerance test and 18% had non-diabetic abnormal glucose tolerance test. PMID:1844771

  3. Characteristics of admissions and variations in the use of basic investigations, treatments and outcomes in Kenyan hospitals within a new Clinical Information Network

    PubMed Central

    Ayieko, Philip; Ogero, Morris; Makone, Boniface; Julius, Thomas; Mbevi, George; Nyachiro, Wycliffe; Nyamai, Rachel; Were, Fred; Githanga, David; Irimu, Grace; English, Mike

    2016-01-01

    Background Lack of detailed information about hospital activities, processes and outcomes hampers planning, performance monitoring and improvement in low-income countries (LIC). Clinical networks offer one means to advance methods for data collection and use, informing wider health system development in time, but are rare in LIC. We report baseline data from a new Clinical Information Network (CIN) in Kenya seeking to promote data-informed improvement and learning. Methods Data from 13 hospitals engaged in the Kenyan CIN between April 2014 and March 2015 were captured from medical and laboratory records. We use these data to characterise clinical care and outcomes of hospital admission. Results Data were available for a total of 30 042 children aged between 2 months and 15 years. Malaria (in five hospitals), pneumonia and diarrhoea/dehydration (all hospitals) accounted for the majority of diagnoses and comorbidity was found in 17 710 (59%) patients. Overall, 1808 deaths (6%) occurred (range per hospital 2.5%–11.1%) with 1037 deaths (57.4%) occurring by day 2 of admission (range 41%–67.8%). While malaria investigations are commonly done, clinical health workers rarely investigate for other possible causes of fever, test for blood glucose in severe illness or ascertain HIV status of admissions. Adherence to clinical guideline-recommended treatment for malaria, pneumonia, meningitis and acute severe malnutrition varied widely across hospitals. Conclusion Developing clinical networks is feasible with appropriate support. Early data demonstrate that hospital mortality remains high in Kenya, that resources to investigate severe illness are limited, that care provided and outcomes vary widely and that adoption of effective interventions remains slow. Findings suggest considerable scope for improving care within and across sites. PMID:26662925

  4. Clinical and mutational investigations of tyrosinemia type II in Northern Tunisia: identification and structural characterization of two novel TAT mutations.

    PubMed

    Charfeddine, C; Monastiri, K; Mokni, M; Laadjimi, A; Kaabachi, N; Perin, O; Nilges, M; Kassar, S; Keirallah, M; Guediche, M N; Kamoun, M R; Tebib, N; Ben Dridi, M F; Boubaker, S; Ben Osman, A; Abdelhak, S

    2006-06-01

    Tyrosinemia type II or Richner-Hanhart Syndrome (RHS) is an autosomal recessive disorder characterized by keratitis, palmoplantar keratosis, mental retardation, and elevated blood tyrosine levels. The disease is due to a deficiency of hepatic cytosolic tyrosine aminotransferase (TATc), an enzyme involved in the tyrosine catabolic pathway. Because of the high rate of consanguinity this disorder seems to be relatively common among the Arab and Mediterranean populations. RHS is characterized by inter and intrafamilial phenotypic variability. A large spectrum of mutations within TATc gene has been shown to be responsible for RHS. In the present study, we report the clinical features and the molecular investigation of RHS in three unrelated consanguineous Tunisian families including 7 patients with confirmed biochemical diagnosis of tyrosinemia type II. Mutation analyses were performed and two novel missense mutations were identified (C151Y) and (L273P) within exon 5 and exon 8, respectively. The 3D-structural characterization of these mutations provides evidence of defective folding of the mutant proteins, and likely alteration of the enzymatic activity. Phenotype variability was observed even among individuals sharing the same pathogenic mutation.

  5. Investigating the clinical usefulness of the Social Responsiveness Scale (SRS) in a tertiary level, autism spectrum disorder specific assessment clinic.

    PubMed

    Aldridge, Fiona J; Gibbs, Vicki M; Schmidhofer, Katherine; Williams, Megan

    2012-02-01

    The Social Responsiveness Scale (SRS; Constantino and Gruber in Social Responsiveness Scale (SRS). Western Psychological Services, Los Angeles, 2005) is a commonly used screening tool for identifying children with possible autism spectrum disorder (ASD). This study investigated the relationship between SRS scores and eventual diagnostic outcome for children referred to a tertiary level, autism specific assessment service. Forty eight children (mean age = 8.10; 92% male) underwent a comprehensive ASD assessment. Parent and teacher SRS scores were subsequently compared with diagnostic outcome. Sensitivity was high (91% for parent report; 84% for teacher report), however specificity was much lower (8% for parent report; 41% for teacher report). Results demonstrate a need for caution when interpreting SRS results based on current cut-off scores, particularly in children with previously identified social developmental problems. PMID:21516433

  6. Clinical significance of diffuse delta EEG activity in chronic schizophrenia.

    PubMed

    Matsuura, M; Yoshino, M; Ohta, K; Onda, H; Nakajima, K; Kojima, T

    1994-07-01

    1) Forty-three chronic schizophrenics with diffuse delta activity (DDA) in their rest-awake EEGs were compared with 23 chronic schizophrenics with normal EEGs. 2) The DDA group was divided into three sub-groups according to the temporal persistence of DDA: brief, intermittent, and prolonged. The intermittent DDA is analogous to intermittent rhythmic delta activity (IRDA). 3) The disorganized type of schizophrenia was frequent in the DDA group and the residual type was frequent in the normal EEG group. 4) The doses of neuroleptics, as well as those of phenothiazines and butyrophenones, were higher in the DDA than in the normal group. 5) The frequency of co-administration of carbamazepine was higher in the DDA than in the normal group, and the rate increased with the degree of abnormality. 6) In a 1 year follow-up of the DDA group, reducing doses of neuroleptics resulted in a tendency for DDA to disappear, and reducing the doses of adjunctive carbamazepine caused DDA to disappear. 7) There was no correlation between DDA and the psychiatric symptoms, intelligence level, or CT findings.

  7. Antibacterial Activity of Salvadora persica L. (Miswak) Extracts against Multidrug Resistant Bacterial Clinical Isolates

    PubMed Central

    Al-Ayed, Mohamed Saeed Zayed; Asaad, Ahmed Morad; Qureshi, Mohamed Ansar; Attia, Hany Goda; AlMarrani, Abduljabbar Hadi

    2016-01-01

    Much effort has focused on examining the inhibitory effect of Salvadora persica (miswak) on oral microorganisms, but information concerning its antibacterial activity against other human pathogens, particularly multidrug resistant (MDR) isolates, is scarce. Therefore, this study aimed to assess the in vitro antibacterial activities of Salvadora persica L. extracts against 10 MDR bacterial clinical isolates other than oral pathogens. The antibacterial activity of aqueous and methanol miswak extracts was assessed using the agar dilution and minimum inhibitory concentration (MIC) methods. Overall, the 400 mg/mL of miswak extract was the most effective on all strains. The methanol extract exhibited a stronger antibacterial activity against Gram-negative (3.3–13.6 mm) than Gram-positive (1.8–8.3 mm) bacteria. The lowest MIC value was seen for E. coli (0.39, 1.56 µg/mL), followed by Streptococcus pyogenes (1.56 µg/mL). The highest MIC value (6.25, 12.5 µg/mL) was recorded for methicillin-resistant Staphylococcus aureus (MRSA), Acinetobacter baumannii, and Stenotrophomonas maltophilia. This study demonstrates, for the first time, the moderate to strong antibacterial activity of miswak extracts against all tested MDR-pathogens. Methanol extract appears to be a potent antimicrobial agent that could be considered as complementary and alternative medicine against resistant pathogens. Further studies on a large number of MDR organisms are necessary to investigate and standardize the inhibitory effect of miswak extracts against these emerging pathogens. PMID:26904146

  8. Antibacterial Activity of Salvadora persica L. (Miswak) Extracts against Multidrug Resistant Bacterial Clinical Isolates.

    PubMed

    Al-Ayed, Mohamed Saeed Zayed; Asaad, Ahmed Morad; Qureshi, Mohamed Ansar; Attia, Hany Goda; AlMarrani, Abduljabbar Hadi

    2016-01-01

    Much effort has focused on examining the inhibitory effect of Salvadora persica (miswak) on oral microorganisms, but information concerning its antibacterial activity against other human pathogens, particularly multidrug resistant (MDR) isolates, is scarce. Therefore, this study aimed to assess the in vitro antibacterial activities of Salvadora persica L. extracts against 10 MDR bacterial clinical isolates other than oral pathogens. The antibacterial activity of aqueous and methanol miswak extracts was assessed using the agar dilution and minimum inhibitory concentration (MIC) methods. Overall, the 400 mg/mL of miswak extract was the most effective on all strains. The methanol extract exhibited a stronger antibacterial activity against Gram-negative (3.3-13.6 mm) than Gram-positive (1.8-8.3 mm) bacteria. The lowest MIC value was seen for E. coli (0.39, 1.56 µg/mL), followed by Streptococcus pyogenes (1.56 µg/mL). The highest MIC value (6.25, 12.5 µg/mL) was recorded for methicillin-resistant Staphylococcus aureus (MRSA), Acinetobacter baumannii, and Stenotrophomonas maltophilia. This study demonstrates, for the first time, the moderate to strong antibacterial activity of miswak extracts against all tested MDR-pathogens. Methanol extract appears to be a potent antimicrobial agent that could be considered as complementary and alternative medicine against resistant pathogens. Further studies on a large number of MDR organisms are necessary to investigate and standardize the inhibitory effect of miswak extracts against these emerging pathogens. PMID:26904146

  9. 78 FR 52932 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug... sites, and determining whether an investigational new drug (IND) application or investigational device... Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201,...

  10. Clinical relevance of autophagic therapy in cancer: Investigating the current trends, challenges, and future prospects.

    PubMed

    Mukhopadhyay, Subhadip; Sinha, Niharika; Das, Durgesh Nandini; Panda, Prashanta Kumar; Naik, Prajna Paramita; Bhutia, Sujit Kumar

    2016-08-01

    Oncophagy (cancer-related autophagy) has a complex dual character at different stages of tumor progression. It remains an important clinical problem to unravel the reasons that propel the shift in the role of oncophagy from tumor inhibition to a protective mechanism that shields full-blown malignancy. Most treatment strategies emphasize curbing protective oncophagy while triggering the oncophagy that is lethal to tumor cells. In this review, we focus on the trends in current therapeutics as well as various challenges in clinical trials to address the oncophagic dilemma and evaluate the potential of these developing therapies. A detailed analysis of the clinical and pre-clinical scenario of the anticancer medicines highlights the various inducers and inhibitors of autophagy. The ways in which tumor stage, the microenvironment and combination drug treatment continue to play an important tactical role are discussed. Moreover, autophagy targets also play a crucial role in developing the best possible solution to this oncophagy paradox. In this review, we provide a comprehensive update on the current clinical impact of autophagy-based cancer therapeutic drugs and try to lessen the gap between translational medicine and clinical science.

  11. Subliminal affective priming in clinical depression and comorbid anxiety: a longitudinal investigation.

    PubMed

    Dannlowski, Udo; Kersting, Anette; Lalee-Mentzel, Judith; Donges, Uta-Susan; Arolt, Volker; Suslow, Thomas

    2006-06-30

    In the present study, the sequential affective priming paradigm developed by Fazio et al. [Fazio, R.H., Sanbonmatsu, D.M., Powell, M.C., Kardes, F.R., 1986. On the automatic activation of attitudes. Journal of Personality and Social Psychology 50, 229-238.] was applied for the first time to investigate automatic cognitive bias in depressed patients. Unipolar depressed patients (n=22) were tested on admission and after about 7 weeks of inpatient psychotherapy. Half of the patients (n=11) were suffering from a comorbid anxiety disorder. Twenty-two healthy subjects served as controls. Affectively polarized prime words were presented subliminally followed by positive or negative target words, which had to be evaluated. Subjects' affective state was assessed by self-report measures. In the course of psychotherapy, patients recovered significantly. Study groups exhibited qualitatively different affective priming effects: In non-comorbid depressed patients, no affective priming was found. Instead, a highly significant main effect of prime valence emerged, indicating a Stroop-like interference of negative prime words at time 1. This negative bias was associated with depression level at time 1 and could not be found after recovery. Affective priming was observed in controls and comorbid patients, but in opposite directions. Direction and strength of affective priming was directly associated with anxiety level at both times. The affective priming paradigm provides evidence for differential group effects regarding unconscious emotional information processing. PMID:16725208

  12. Preliminary clinical investigation of cataract surgery with a noncontact femtosecond laser system

    PubMed Central

    Ni, Li‐Yang; Wang, Qin‐Mei; Huang, Fang; Zhu, Shuang‐Qian; Zheng, Lin‐Yan; Su, Yan‐Feng

    2015-01-01

    Background and Objective Femtosecond laser‐assisted cataract surgery (FLACS) is rapidly gaining popularity due to the improved consistency and predictability for capsulorhexis. This study aimed to investigate the preliminary clinical outcomes of FLACS with a noncontact femtosecond laser system. Patients and Methods This prospective study enrolled 25 eyes in the trial group underwent FLACS (LLS‐fs 3D, LENSAR, USA), and 29 eyes in the control group underwent conventional cataract surgery (Stellaris, Bausch & Lomb, USA). The phacoemulsification time, energy, and complications during operation were recorded. Postoperative refraction at 1 day, 1 week, 1 and 3 months, the capsulorhexis size and corneal endothelial density at 1 and 3 months were also measured. Results Compared to the control group, reduction in phacoemulsification time was 51.5% (P = 0.02), and in overall energy, 65.1% (P = 0.02) in the trial group. In the trial group and the control group, total time of cataract procedure was 10.04 ± 1.37 minutes, 10.52 ± 1.92 minutes, respectively (P = 0.31); the absolute difference between attempted and achieved capsulorhexis diameter at 1 month was 192.9 ± 212.0 µm, 626.9 ± 656.6 µm, respectively (P = 0.04), and at 3 months, 256.6 ± 181.9 µm, 572.1 ± 337.0 µm, respectively (P= 0.03); the absolute difference between attempted and achieved spherical equivalent at 3 months was 0.16 ± 0.16 D, 0.74 ± 0.65 D, respectively (P < 0.01); mean corneal endothelial cell loss at 1 month was 15.6% and 14.2%, respectively (P = 0.77), and at 3 months, 2.9%, 4.2%, respectively (P = 0.50). Conclusions With the noncontact femtosecond laser system, FLACS can significantly improve the accuracy and repeatability of capsulorhexis, reduce the phacoemulsification time and overall energy, and enhance the predictability and stability of postoperative refraction. Lasers Surg. Med. 47:698–703, 2015. © 2015

  13. Associations of prepartum body condition score with occurrence of clinical endometritis and resumption of postpartum ovarian activity in dairy cattle.

    PubMed

    Kadivar, Ali; Ahmadi, Mohammad Rahim; Vatankhah, Mahmood

    2014-01-01

    This study was performed to investigate the effect of periparturient body condition score on the occurrence of clinical endometritis and postpartum resumption of ovarian activity in dairy cows. Eighty-seven lactating Holstein cows, fed with a total mixed ration diet, were included into the study. Body condition scoring (using a 5-point scale with quarter-point divisions) was performed by the same investigator using the visual technique every 2 weeks, from 2 weeks before until 6 weeks after calving. Palpation of the reproductive tract and ultrasonographic assessment of ovaries for detection of corpus luteum using a rectal linear probe was also performed at 2, 4, and 6 weeks after calving. Cows with clinical endometritis had significantly lower body condition score (BCS) than normal cows at all weeks pre- and postcalving, and cows that did not ovulate until 45 days after calving had a significantly lower BCS pre- and postpartum. Cows that did not ovulate until 45 days after calving also lost more BCS from 2 weeks before to 4 weeks after calving. Besides, first ovulation after calving take occurred later in cows with clinical endometritis compared to normal cows (P < 0.05). In conclusion, low BCS is a risk factor for postpartum endometritis and delayed cyclicity in dairy cows. BCS loss from dry-off to early lactation and occurrence of clinical endometritis can significantly affect postpartum ovarian activity.

  14. Chronic vegetative state after severe head injury: clinical study; electrophysiological investigations and CT scan in 15 cases.

    PubMed

    Danze, F; Brule, J F; Haddad, K

    1989-01-01

    Fifteen cases of chronic vegetative state (CVS), following severe head injury and lasting for two years or more, are reported. Vegetative state, in most instances after a period of coma, consists of a return of wakefulness accompanied by an apparent total lack of higher mental activity. A protracted period of vegetative state has been chosen to ensure that the possibility of further recovery could virtually be excluded. The term of CVS could therefore be reasonably used to designate these cases. Moreover, cerebral lesions were then thought to be the same as in neuropathological studies. Severe head injury, responsible for CVS, initially affected adults in 11 cases and children in four cases. The range of duration of the vegetative state was 2 to 14 years, with a mean of five years. The data of clinical study and electrophysiological investigations (EEG, brain stem auditory evoked potentials, somatosensory evoked potentials) are reported. A CT scan was carried out in each case to study the impairment of cerebral hemispheres and brain stem, with particular attention to the ventricular size. The results confirm that in the CVS, lesions affect mainly the hemispheres, while brain stem functions are mainly preserved. Vegetative State (VS) is the term proposed by Jennett and Plum (1972) to describe the condition that sometimes emerges after a period of coma, after a severe head injury (SHI). This condition consists of a return of wakefulness accompanied by an apparent total lack of higher mental activity. A practical definition of this state characterised by wakefulness without responsiveness is that the eyes open spontaneously and/or in response to verbal stimuli. Sleep-wake cycles exist. The patients can neither obey simple orders nor locate painful stimuli. They utter no comprehensible words. Blood pressure and breathing remain steady. It is much more difficult to specify exactly how long such a state must persist before it can be confidently declared permanent

  15. Experimenting Clinical Pathways in General Practice: a Focus Group Investigation with Italian General Practitioners

    PubMed Central

    Zannini, Lucia; Cattaneo, Cesarina; Peduzzi, Paolo; Lopiccoli, Silvia; Auxilia, Francesco

    2012-01-01

    Background Clinical governance is considered crucial in primary care. Since 2005, clinical pathways have been experimentally implemented at the Local Health Authority of Monza Brianza (ASLMB), Italy, to develop general practitioners’ (GPs) care of patients affected by some chronic diseases. The experimentation was aimed at introducing clinical governance in primary care, increasing GPs’ involvement in the care of their patients, and improving both patients’ and professionals’ satisfaction. In the period 2005-2006, 12% of the 763 employed GPs in the ASLMB were involved in the experiment, while this percentage increased to 15-20% in 2007-2008. Design and Methods Twenty-four GPs were purposively sampled, randomly divided into two groups and asked to participate in focus groups (FGs) held in 2008, aimed at evaluating their perception of the experiment. The FGs were audio-recorded, dialogues were typed out and undergone to a thematic analysis, according to the Interpretative Phenomenological Approach. Results Four major themes emerged: i) clinical pathways can result in GPs working in a more efficient and effective fashion; ii) they can assure higher levels of both patient and professional satisfaction, since they sustain a caring approach and strengthen the GPs’ role; iii) nevertheless, clinical pathways increase the bureaucratic workload and problems can arise in relationships among GPs and the LHA; iv) the implementation of clinical pathways can be improved, especially by reducing bureaucracy and by assuring their continuity. Conclusions Managerial aspects should be considered with care in order to experimentally introduce clinical pathways in general practice, and continuity of the experimentation should be guaranteed to improve GPs’ adherence and commitment. Acknowledgments the Authors thank Dr. AP. Cantù and Dr D. Cereda who participated in the two focus groups as observers. PMID:25181354

  16. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... knowledge about the subjects' disorder or condition. 50.53 Section 50.53 Food and Drugs FOOD AND DRUG... knowledge about the subjects' disorder or condition. Any clinical investigation within the scope described... knowledge about the subjects' disorder or condition that is of vital importance for the understanding...

  17. An investigation of the impact of intramammary antibiotic dry cow therapy on clinical coliform mastitis.

    PubMed

    Bradley, A J; Green, M J

    2001-07-01

    The efficacy of an intramammary antibiotic dry cow preparation with significant gram-negative spectrum (product A; Leo Red Dry Cow, Leo Animal Health, UK) was compared with a product with no gram-negative efficacy (product B; Orbenin Extra DC, Pfizer Ltd, UK) as assessed by control of coliform mastitis in the first 100 d of the lactation. The efficacy of both products was also compared for control of noncoliform mastitis and for the ability to control existing and new intramammary infections as measured by individual cow somatic cell counts. Cows treated with product A were significantly less likely to develop clinical Escherichia coli or coliform mastitis during the dry period or the first 100 d of lactation than cows treated with product B. Cows treated with product A were no more likely to develop clinical mastitis due to a noncoliform organism than were cows treated with product B. There was no significant difference between the two groups as measured by individual cow somatic cell count changes across the dry period. This study is the first to have demonstrated the clinical efficacy of an intramammary antibiotic dry cow preparation, as measured by reduction in gram-negative clinical mastitis in the subsequent lactation. These findings demonstrate that selection of a dry cow intramammary preparation with a significant gram-negative spectrum can influence the incidence of clinical coliform mastitis in the subsequent lactation. This finding should be one of the factors taken into account when selecting products. PMID:11467813

  18. Investigating common clinical presentations in first opinion small animal consultations using direct observation

    PubMed Central

    Robinson, N. J.; Dean, R. S.; Cobb, M.; Brennan, M. L.

    2015-01-01

    Understanding more about the clinical presentations encountered in veterinary practice is vital in directing research towards areas relevant to practitioners. The aim of this study was to describe all problems discussed during a convenience sample of consultations using a direct observation method. A data collection tool was used to gather data by direct observation during small animal consultations at eight sentinel practices. Data were recorded for all presenting and non-presenting specific health problems discussed. A total of 1901 patients were presented with 3206 specific health problems discussed. Clinical presentation varied widely between species and between presenting and non-presenting problems. Skin lump, vomiting and inappetence were the most common clinical signs reported by the owner while overweight/obese, dental tartar and skin lump were the most common clinical examination findings. Skin was the most frequently affected body system overall followed by non-specific problems then the gastrointestinal system. Consultations are complex, with a diverse range of different clinical presentations seen. Considering the presenting problem only may give an inaccurate view of the veterinary caseload, as some common problems are rarely the reason for presentation. Understanding the common diagnoses made is the next step and will help to further focus questions for future research. PMID:25564472

  19. Investigating common clinical presentations in first opinion small animal consultations using direct observation.

    PubMed

    Robinson, N J; Dean, R S; Cobb, M; Brennan, M L

    2015-05-01

    Understanding more about the clinical presentations encountered in veterinary practice is vital in directing research towards areas relevant to practitioners. The aim of this study was to describe all problems discussed during a convenience sample of consultations using a direct observation method. A data collection tool was used to gather data by direct observation during small animal consultations at eight sentinel practices. Data were recorded for all presenting and non-presenting specific health problems discussed. A total of 1901 patients were presented with 3206 specific health problems discussed. Clinical presentation varied widely between species and between presenting and non-presenting problems. Skin lump, vomiting and inappetence were the most common clinical signs reported by the owner while overweight/obese, dental tartar and skin lump were the most common clinical examination findings. Skin was the most frequently affected body system overall followed by non-specific problems then the gastrointestinal system. Consultations are complex, with a diverse range of different clinical presentations seen. Considering the presenting problem only may give an inaccurate view of the veterinary caseload, as some common problems are rarely the reason for presentation. Understanding the common diagnoses made is the next step and will help to further focus questions for future research. PMID:25564472

  20. Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

    PubMed Central

    Iwanowski, Piotr; Budaj, Andrzej; Członkowska, Anna; Wąsek, Wojciech; Kozłowska-Boszko, Beata; Olędzka, Urszula; Masełbas, Wojciech

    2008-01-01

    Background During clinical trials in emergency medicine, providing appropriate oral and written information to a patient is usually a challenge. There is little published information regarding patients' opinions and competence to provide informed consent, nor on physicians' attitudes towards the process. We have investigated the problem of obtaining consent from patients in emergency-setting clinical trials (such as acute coronary syndromes (ACS) and stroke) from a physicians' perspective. Methods A standardised anonymous 14-item questionnaire was distributed to Polish cardiac and stroke centres. Results Two hundred and fourteen informative investigator responses were received. Of these investigators, 73.8% had experience with ACS and 25.2% had experience with acute stroke trials (and 1% with both fields). The complete model of informed consent (embracing all aspects required by Good Clinical Practice (GCP) and law) was used in 53.3% of cases in emergency settings, whereas the legal option of proxy consent was not used at all. While less than 15% of respondents considered written information to have been fully read by patients, 80.4% thought that the amount of information being given to emergency patients is too lengthy. Although there is no legal obligation, more than half of the investigators sought parallel consent (assent) from patients' relatives. Most investigators confirmed that they would adopt the model proposed by the GCP guidelines: abbreviated verbal and written consent in emergency conditions with obligatory "all-embracing" deferred consent to continue the trial once the patient is able to provide it. However, this model would not follow current Polish and European legislation. Conclusion An update of national and European regulations is required to enable implementation of the emergency trial consent model referred to in GCP guidelines. PMID:18644120

  1. Regulatory issues surrounding the use of companion animals in clinical investigations, trials, and studies.

    PubMed

    Hampshire, Victoria A

    2003-01-01

    Laboratory animal veterinarians sometimes encounter animals with rare conditions and may subsequently become involved in the performance of related animal research outside the laboratory, in homes, in veterinary clinics, or in universities to which owners have donated their animals for study. Similarly, veterinarians may monitor animal companion vaccination studies, performed to optimize preventive health care or minimize physiological variability and research confounders associated with a preventive medicine program for dogs and cats utilized for research procedures. These nontraditional uses of dogs, cats, and other companion animals in research have spurred the establishment of regulations to ensure that the animals benefit from clinical veterinary products and techniques. Included and described are the 2002 Public Health Service Policy, the Animal Welfare Act (AWA), the Federal Food, Drug, and Cosmetic Act, and the regulations of the US Department of Agriculture in response to the AWA. The complexities of clinical research with companion animals outside standard biomedical research facilities are discussed.

  2. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  3. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  4. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  5. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Active monitoring of conduct and evaluation of clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... to Treat Life-threatening and Severely-debilitating Illnesses § 312.87 Active monitoring of...

  6. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain

    PubMed Central

    Kim, Jin Young; Kwag, Kwang Il

    2016-01-01

    [Purpose] The purpose of this study was to investigate clinical effects of deep cervical flexor (DCF) muscles exercise on pain, Neck Disability Index (NDI), and neck and shoulder postures in patients with chronic neck pain. [Subjects and Methods] Twenty-eight patients with chronic neck pain were randomly assigned into either the general strengthening exercise (GSE) group or the DCF activation group as control and experimental groups, respectively. All exercises were performed three times per week over 4 weeks. NDI and numeric rating scale (NRS) score for pain were determined and radiological assessment of neck-shoulder postures (head tilt angle [HTA], neck flexion angle [NFA], and forward shoulder angle [FSA]) was performed before (baseline), 4 weeks after, and 8 weeks after exercise in order to directly compare the exercise effects between the groups. [Results] In the DCF group, the NDI, NRS score, and neck-shoulder postures (analyzed by uisng HTA, NFA, and FSA) were significantly improved. [Conclusion] DCF activation exercise was effective to alleviate pain, recover functions, and correct forward head posture in the patients with neck pain. Hence, it might be recommended in the rehabilitation of patients with chronic neck pain. PMID:26957772

  7. A Systemic Review on Aloe arborescens Pharmacological Profile: Biological Activities and Pilot Clinical Trials.

    PubMed

    Singab, Abdel-Naser B; El-Hefnawy, Hala M; Esmat, Ahmed; Gad, Haidy A; Nazeam, Jilan A

    2015-12-01

    Since ancient times, plants and herbal preparations have been used as medicine. Research carried out in the last few decades has verified several such claims. Aloe arborescens Miller, belonging to the Aloe genus (Family Asphodelaceae), is one of the main varieties of Aloe used worldwide. The popularity of the plant in traditional medicine for several ailments (antitumor, immunomodulatory, antiinflammatory, antiulcer, antimicrobial and antifungal activity) focused the investigator's interest on this plant. Most importantly, the reported studies have shown the plant effectiveness on various cancer types such as liver, colon, duodenal, skin, pancreatic, intestinal, lung and kidney types. These multiple biological actions make Aloe an important resource for developing new natural therapies. However, the biological activities of isolated compounds such as glycoprotein, polysaccharides, enzyme and phenolics were insufficient. Considering all these, this contribution provides a systematic review outlining the evidence on the biological efficacy of the plant including the pharmacology and the related mechanisms of action, with specific attention to the various safety precautions, and preclinical and clinical studies, indicating the future research prospects of this plant. PMID:26768148

  8. Comparison of the activities of the lantibiotics nisin and lacticin 3147 against clinically significant mycobacteria.

    PubMed

    Carroll, James; Draper, Lorraine A; O'Connor, Paula M; Coffey, Aidan; Hill, Colin; Ross, R Paul; Cotter, Paul D; O'Mahony, Jim

    2010-08-01

    The aim of this study was to use the microtitre alamarBlue assay to investigate and compare the antimycobacterial potential of the lantibiotics nisin and lacticin 3147 against a representative cohort of clinically significant mycobacteria, i.e. Mycobacterium tuberculosis H37Ra, Mycobacterium avium subsp. paratuberculosis (MAP) ATCC 19698 and Mycobacterium kansasii CIT11/06. Lacticin 3147 displayed potent activity against all strains of mycobacteria, with MIC(90) values (lowest concentration of lantibiotic that prevented growth of >90% of the bacterial population) of 60 mg/L and 15 mg/L for M. kansasii and MAP, respectively. Lacticin 3147 was particularly effective against M. tuberculosis H37Ra, with a MIC(90) value of 7.5mg/L. Nisin, although inhibitory, was generally less potent against all strains of mycobacteria, with MIC(90) values of 60 mg/L for M. kansasii and >60 mg/L for MAP and M. tuberculosis H37Ra. Thus, lacticin 3147 is a potent antimycobacterial peptide that shows superior activity compared with nisin at physiological pH. PMID:20547041

  9. 77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    .../ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm... Research (CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring... Development (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration,...

  10. Phase II clinical trials on Investigational drugs for the Treatment of Pancreatic Cancers

    PubMed Central

    Kim, Edward J.; Semrad, Thomas J.; Bold, Richard J.

    2015-01-01

    Introduction Despite some recent advances in treatment options, pancreatic cancer remains a devastating disease with poor outcomes. In a trend contrary to most malignancies, both incidence and mortality continue to rise due to pancreatic cancer. The majority of patients present with advanced disease and there are no treatment options for this stage that have demonstrated a median survival greater than 1 year. As the penultimate step prior to phase III studies involving hundreds of patients, phase II clinical trials provide an early opportunity to evaluate the efficacy of new treatments that are desperately needed for this disease. Areas Covered This review covers the results of published phase II clinical trials in advanced pancreatic adenocarcinoma published within the past 5 years. The treatment results are framed in the context of the current standards of care and the historic challenge of predicting phase III success from phase II trial results. Expert opinion Promising therapies remain elusive in pancreatic cancer based on recent phase II clinical trial results. Optimization and standardization of clinical trial design in the phase II setting, with consistent incorporation of biomarkers, is needed to more accurately identify promising therapies that warrant phase III evaluation. PMID:25809274

  11. An Empirical Investigation of Group Treatment for a Clinical Population of Adult Female Incest Survivors.

    ERIC Educational Resources Information Center

    Saxe, Brenda J.; Johnson, Susan M.

    1999-01-01

    Empirically assesses the effectiveness of a group treatment program on intrapersonal symptomatology and interpersonal difficulties in a clinical population of women with a history of incest. Results indicate that a time-limited group, which focuses on the original trauma, is effective in reducing intrapersonal symptomatology for women with a…

  12. It Takes a Village: Investigating the Critical Role Clinical Faculty Play in Mathematics Teacher Education

    ERIC Educational Resources Information Center

    Bahr, Damon L.

    2013-01-01

    The dispositions of preservice elementary education teachers toward reform-oriented mathematics education were surveyed before and after an extended pre-student teaching practicum. During the practicum, university and school-based personnel served as 'clinical faculty' as they supported the preservice teachers' practicum…

  13. The role of ultrasound simulators in education: an investigation into sonography student experiences and clinical mentor perceptions.

    PubMed

    Gibbs, Vivien

    2015-11-01

    Simulation as an effective pedagogy is gaining momentum at all levels of health care education. Limited research has been undertaken on the role of simulated learning in health care and further evaluation is needed to explore the quality of learning opportunities offered, and their effectiveness in the preparation of students for clinical practice. This study was undertaken to explore ways of integrating simulation-based learning into sonography training to enhance clinical preparation. A qualitative study was undertaken, using interviews to investigate the experiences of a group of sonography students after interacting with an ultrasound simulator. The perceptions of their clinical mentors on the effectiveness of this equipment to support the education and development of sonographers were also explored. The findings confirm that ultrasound simulators provide learning opportunities in an unpressurised environment, which reduces stress for the student and potential harm to patients. Busy clinical departments acknowledge the advantages of opportunities for students to acquire basic psychomotor skills in a classroom setting, thereby avoiding the inevitable reduction in patient throughput which results from clinical training. The limitations of simulation equipment to support the development of the full range of clinical skills required by sonographers were highlighted and suggestions made for more effective integration of simulation into the teaching and learning process. Ultrasound simulators have a role in sonography education, but continued research needs to be undertaken in order to develop appropriate strategies to support students, educators and mentors to effectively integrate this methodology. PMID:27433260

  14. A clinical role for 99mTc-HMPAO SPECT in the investigation of dementia?

    PubMed Central

    Talbot, P.; Lloyd, J.; Snowden, J.; Neary, D.; Testa, H.

    1998-01-01

    OBJECTIVES—To provide the clinician with a guide to the clinical utility of 99mTc-HMPAO single photon emission computed tomography (SPECT) and to the interpretation of specific test results in the differential diagnosis of dementia.
METHODS—Three hundred and sixty three patients with dementia were studied prospectively for a median three (range 1-6) years and classified into disease groups on the basis of established clinical criteria. The degree to which different patterns of cerebral blood flow (CBF) abnormality found on 99mTc-HMPAO SPECT imaging at the time of initial patient presentation modified clinical diagnoses was determined by calculating the likelihood ratios for pairwise disease group comparisons. The optimal clinical usage of 99mTc-HMPAO SPECT was determined by calculating the percentage of significant test results for each pairwise disease group comparison.
RESULTS—Bilateral posterior CBF abnormality was found to significantly increase the odds of a patient having Alzheimer's disease as opposed to vascular dementia or frontotemporal dementia. Bilateral anterior CBF abnormality significantly increased the odds of a patient having frontotemporal dementia as opposed to Alzheimer's disease, vascular dementia, or Lewy body disease. "Patchy" CBF changes significantly increased the odds of a patient having vascular dementia as opposed to Alzheimer's disease. Unilateral anterior, unilateral anterior plus unilateral posterior, and generalised CBF abnormality failed to contribute to the differentiation of any of these forms of dementia.
CONCLUSIONS—99mTc-HMPAO SPECT was found to be most useful in distinguishing Alzheimer's disease from vascular dementia and fronto temporal dementia, and least useful in differentiating between Alzheimer's disease and Lewy body disease, and between vascular dementia, frontotemporal dementia, and progressive aphasia. It is suggested that CBF SPECT should be used selectively and as an adjunct to clinical evaluation

  15. Correlation of alkaline phosphatase activity to clinical parameters of inflammation in smokers suffering from chronic periodontitis

    PubMed Central

    Grover, Vishakha; Malhotra, Ranjan; Kapoor, Anoop; Bither, Rupika; Sachdeva, Sonia

    2016-01-01

    Context: Current clinical periodontal diagnostic techniques emphasize the assessment of clinical and radiographic signs of periodontal diseases which can provide a measure of history of disease. Hence, new methodologies for early identification and determination of periodontal disease activity need to be explored which will eventually result in expedited treatment. Aim: To evaluate the correlation of alkaline phosphatase (ALP) activity in gingival crevicular fluid (GCF) to clinical parameters of periodontal inflammation in smokers with chronic periodontitis. Materials and Methods: Study population included 15 smoker male patients in the age group of 35–55 years suffering from moderate generalized chronic periodontitis with history of smoking present. Following parameters were evaluated at baseline, 1 month and 3 months after scaling and root planing: plaque index, bleeding index, probing pocket depth (PD), relative attachment level (RAL), and GCF ALP activity. Statistical Analysis Used: Independent variables for measurements over time were analyzed by using Wilcoxon signed rank test. Results: A statistically significant reduction in all the clinical parameters and GCF ALP activity was observed from baseline to 1 month and 3 months. A correlation was observed between change in GCF ALP activity and PD reduction as well as gain in RAL at 3 months. Conclusion: The present study emphasizes that total ALP activity could be used as a marker for periodontal disease activity in smokers. Estimation of changes in the levels of this enzyme has a potential to aid in the detection of progression of periodontal disease and monitoring the response to periodontal therapy. PMID:27563197

  16. Funding opportunities for clinical investigators in the early stages of career development in cardiovascular research.

    PubMed

    Mentz, Robert J; Becker, Richard C

    2013-11-01

    Contemporary cardiovascular research offers junior investigators the opportunity to explore the gamut of biomedical questions. Despite the recent reduction in the availability of funding mechanisms that have historically served as the primary pathways for investigators in the early stages of career development, there remain numerous traditional and non-traditional funding opportunities. This article highlights these opportunities in order to assist early career investigators in the development of a personalized research trajectory, which optimizes the potential for career success.

  17. Clinical investigation of biofilm in non-healing wounds by high resolution microscopy techniques

    PubMed Central

    Hurlow, J.; Blanz, E.; Gaddy, J.A.

    2016-01-01

    Objective The aim of this study was to analyse wound biofilm from a clinical perspective. Research has shown that biofilm is the preferred microbial phenotype in health and disease and is present in a majority of chronic wounds. Biofilm has been linked to chronic wound inflammation, impairment in granulation tissue and epithelial migration, yet there lacks the ability to confirm the clinical presence of biofilm. This study links the clinical setting with microscopic laboratory confirmation of the presence of biofilm in carefully selected wound debridement samples. Method Human wound debridement samples were collected from adult patients with chronic non-healing wounds who presented at the wound care centre. Sample choice was guided by an algorithm that was developed based on what is known about the characteristics of wound biofilm. The samples were then evaluated by light microscopy and scanning electron microscopy for the presence of biofilm. Details about subject history and treatment were recorded. Adherence to biofilm-based wound care (BBWC) strategies was inconsistent. Other standard antimicrobial dressings were used and no modern antiseptic wound dressings with the addition of proven antibiofilm agents were available for use. Results Of the patients recruited, 75% of the macroscopic samples contained biofilm despite the prior use of modern antiseptic wound dressings and in some cases, systemic antibiotics. Wounds found to contain biofilm were not all acutely infected but biofilm was present when infection was noted. The clinical histories associated with positive samples were consistent with ideas presented in the algorithm used to guide sample selection. Conclusion Visual cues can be used by the clinician to guide suspicion of the presence of wound biofilm. This suspicion can be further enhanced with the use of a clinical algorithm. Standard antiseptic wound dressings used in this study demonstrated limited antibiofilm efficacy. This study also highlighted a

  18. 76 FR 4914 - Agency Information Collection Activities: Proposed Collection; Comment Request; Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-27

    ...) a protocol for each planned study, (6) chemistry, manufacturing, and control information for each... on requirements under which the clinical investigation of the safety and effectiveness of unapproved... assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be...

  19. Hypothalamic-Ptuitary-Adrenal (HPA) Axis Activity in Adults with Intellectual Disabilities: A Preliminary Investigation

    ERIC Educational Resources Information Center

    Presland, A. D.; Clare, I. C. H.; Broughton, S.; Luke, L.; Wheeler, E.; Fairchild, G.; Watson, P. C.; Chan, W. Y. S.; Kearns, A.; Ring, H. A.

    2013-01-01

    Background: Cortisol is a marker of physiological arousal, exhibiting a characteristic pattern of diurnal activity. The daily cortisol profile has been examined extensively and is atypical in a number of clinical disorders. However, there are very few studies focussing on the cortisol profile in adults with intellectual disabilities (ID). This…

  20. Methodology guideline for clinical studies investigating traditional Chinese medicine and integrative medicine: executive summary.

    PubMed

    Liu, Jian-Ping; Chen, Ke-Ji

    2015-10-01

    This guideline aims to provide a methodological guidance for clinical studies in TCM and integrative medicine in terms of study design, execution, and reporting. The commonly used methods including experimental and observational methods were introduced in this guideline such as randomized clinical trials, cohort study, case-control study, case series, and qualitative method which can be incorporated into above quantitative methods. The guideline can be used for the evaluation of therapeutic effect of TCM therapies or their combination with conventional therapy. TCM therapy refers to one of the followings or their combination: herbal medicine, acupuncture, moxibustion, cupping, Taichi/Qigong, and Guasha,Tuina (therapeutic massage). It is also suitable for research and development of ethnopharmaceuticals or folk medicine.

  1. Investigation of the clinical features in filamentary keratitis in Hangzhou, east of China

    PubMed Central

    Chen, Siming; Ruan, Yimeng; Jin, Xiuming

    2016-01-01

    Abstract Filamentary keratitis (FK) is a chronic and recurrent disorder of the cornea. FK is reportedly associated with various kinds of ocular surface diseases or conditions. Until now, there have been lacks of studies based on quantitative sample analysis concerning FK incidence regularity and inducement characteristics at different ages. This was a retrospective study of 147 patients (162 eyes) with FK who had been continuously and completely recorded from August 2012 to August 2015 at the Second Affiliated Hospital of Zhejiang University in Hangzhou, east of China. Our results suggest that the causative factors of FK varied at different ages and the distribution of filaments on the corneal surface was also diverse with different inducements. By exploring the frequency and clinical features of FK, we believe that the findings from our research will be clinically significant and aid in the early prevention and treatment guidance of the disease. PMID:27583881

  2. An Intelligent Computerized Stretch Reflex Measurement System For Clinical And Investigative Neurology

    NASA Astrophysics Data System (ADS)

    Flanagan, P. M.; Chutkow, J. G.; Riggs, M. T.; Cristiano, V. D.

    1987-05-01

    We describe the design of a reliable, user-friendly preprototype system for quantifying the tendon stretch reflexes in humans and large mammals. A hand-held, instrumented reflex gun, the impactor of which contains a single force sensor, interfaces with a computer. The resulting test system can deliver sequences of reproducible stimuli at graded intensities and adjustable durations to a muscle's tendon ("tendon taps"), measure the impacting force of each tap, and record the subsequent reflex muscle contraction from the same tendon -- all automatically. The parameters of the reflex muscle contraction include latency; mechanical threshold; and peak time, peak magnitude, and settling time. The results of clinical tests presented in this paper illustrate the system's potential usefulness in detecting neurologic dysfunction affecting the tendon stretch reflexes, in documenting the course of neurologic illnesses and their response to therapy, and in clinical and laboratory neurologic research.

  3. Investigation of the clinical features in filamentary keratitis in Hangzhou, east of China.

    PubMed

    Chen, Siming; Ruan, Yimeng; Jin, Xiuming

    2016-08-01

    Filamentary keratitis (FK) is a chronic and recurrent disorder of the cornea. FK is reportedly associated with various kinds of ocular surface diseases or conditions. Until now, there have been lacks of studies based on quantitative sample analysis concerning FK incidence regularity and inducement characteristics at different ages. This was a retrospective study of 147 patients (162 eyes) with FK who had been continuously and completely recorded from August 2012 to August 2015 at the Second Affiliated Hospital of Zhejiang University in Hangzhou, east of China. Our results suggest that the causative factors of FK varied at different ages and the distribution of filaments on the corneal surface was also diverse with different inducements.By exploring the frequency and clinical features of FK, we believe that the findings from our research will be clinically significant and aid in the early prevention and treatment guidance of the disease. PMID:27583881

  4. Health literacy screening of patients attending a student-led osteopathy clinic: A pilot investigation.

    PubMed

    Vaughan, Brett; Mulcahy, Jane; Fitzgerald, Kylie

    2016-08-01

    Adequate levels of health literacy (HL) are required for patients to access appropriate health services and develop an understanding of the options for managing their healthcare needs. There is limited literature on HL of patients seeking care for a musculoskeletal complaint. The present study sought to screen the HL of patients presenting to an Australian osteopathy student-led clinic using a single screening question 'Are you confident completing medical forms?'. Less than 10% of patients attending the clinic were considered to have below adequate levels of HL using this question, consistent with other work in Australian populations. Logistic regression analysis identified that the most significant demographic variables associated with lower HL were patients who did not speak English at home, those with lower education levels, and those who were less satisfied with their life. Evaluation of a patients' HL may assist practitioners to improve patient education and management strategies. PMID:27502799

  5. Methodology guideline for clinical studies investigating traditional Chinese medicine and integrative medicine: executive summary.

    PubMed

    Liu, Jian-Ping; Chen, Ke-Ji

    2015-10-01

    This guideline aims to provide a methodological guidance for clinical studies in TCM and integrative medicine in terms of study design, execution, and reporting. The commonly used methods including experimental and observational methods were introduced in this guideline such as randomized clinical trials, cohort study, case-control study, case series, and qualitative method which can be incorporated into above quantitative methods. The guideline can be used for the evaluation of therapeutic effect of TCM therapies or their combination with conventional therapy. TCM therapy refers to one of the followings or their combination: herbal medicine, acupuncture, moxibustion, cupping, Taichi/Qigong, and Guasha,Tuina (therapeutic massage). It is also suitable for research and development of ethnopharmaceuticals or folk medicine. PMID:26615617

  6. Opinions and perceptions regarding the impact of new regulatory guidelines: A survey in Indian Clinical Trial Investigators

    PubMed Central

    Kadam, Rashmi; Borde, Sanghratna; Madas, Sapna; Nagarkar, Aarti; Salvi, Sundeep; Limaye, Sneha

    2016-01-01

    Background: Clinical research in India experienced dramatic changes with series of stringent guidelines introduced by regulatory authorities. These guidelines posed significant challenges for the clinical trial industry. Objective: To assess the perceptions and opinion of Indian Investigators about the new regulatory guidelines. Methods: We developed a survey questionnaire on recent regulatory guidelines which was hosted on a web portal. Seventy-three investigators from India participated in the survey. Results: Central registration of Ethics Committees (ECs) was agreed by 90.1% participants, 76.8% participants agreed to compensation of subjects for study related Serious Adverse Events (SAE's). The compulsion to include government sites in clinical trials was not agreed by 49.3% participants while 21.2% agreed to it. Restriction on a number of trials per investigator was agreed by 49.3% of participants while 40.9% disagreed. Participants (50.7%) disagreed to the introduction of audio-video (AV) recording of informed consent, 36.6% agreed and 12.7% were neutral. Discussion: Participants observed that post central registration; ECs have improved systems with adequate member composition, functional Standard Operating Procedures, and timely approvals. Participants agreed that compensation of study related SAE's would assure subject protection and safety. The introduction of AV consenting was strongly debated sighting sociocultural issues in the implementation of the same. Conclusion: Participants endorsed guidelines pertaining to the central registration of ECs, SAE related compensation. Restrictions on a number of trials per investigator and AV consenting were debated ardently. The response of the survey participants who are clinical trial investigators in India showed general acceptance, effectiveness and anticipated compliance to the new regulatory guidelines. PMID:27141474

  7. Activities of Tannins--From In Vitro Studies to Clinical Trials.

    PubMed

    Sieniawska, Elwira

    2015-11-01

    Tannins are considered as valuable plant secondary metabolites providing many benefits for human health. In this review information was gathered about bioactivity in vitro and in vivo, as well as about conducted clinical trials. The literature research was based on ScienceDirect, Scopus, and Cochrane databases and presents a wide range of tested activities of tannins. The described clinical trials verify laboratory tests and show the effective health benefits taken from supplementation with tannins.

  8. 75 FR 31794 - Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-04

    ... FR 5861), which describes FDA's intention to update the process for developing, issuing, and making... Guidances as needed. In the Federal Register of July 29, 2008 (73 FR 43940), FDA announced the availability... Investigators, and IRBs; Frequently Asked Questions--Statement of Investigator (Form FDA 1572);...

  9. 77 FR 69631 - Draft Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... Persons with access to the Internet may obtain the document at http://www.fda.gov/ScienceResearch/Special... Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research... Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and...

  10. Clinical and MRI investigation of temporomandibular joint in major depressed patients

    PubMed Central

    Lopes, SLPC; Costa, ALF; Cruz, AD; Li, LM; de Almeida, SM

    2012-01-01

    Objective The aim of the present study was to describe the clinical and MRI findings of the temporomandibular joint (TMJ) in patients with major depressive disorders (MDDs) of the non-psychotic type. Methods 40 patients (80 TMJs) who were diagnosed as having MDDs were selected for this study. The clinical examination of the TMJs was conducted according to the research diagnostic criteria and temporomandibular disorders (TMDs). The MRIs were obtained bilaterally in each patient with axial, parasagittal and paracoronal sections within a real-time dynamic sequence. Two trained oral radiologists assessed all images. For statistical analyses, Fisher's exact test and χ2 test were applied (α = 0.05). Results Migraine was reported in 52.5% of subjects. Considering disc position, statistically significant differences between opening patterns with and without alteration (p = 0.00) and between present and absent joint noises (p = 0.00) were found. Regarding muscular pain, patients with and without abnormalities in disc function and patients with and without abnormalities in disc position were not statistically significant (p = 0.42 and p = 0.40, respectively). Significant differences between mandibular pathway with and without abnormalities (p = 0.00) and between present and absent joint noises (p = 0.00) were observed. Conclusion Based on the preliminary results observed by clinical and MRI examination of the TMJ, no direct relationship could be determined between MDDs and TMDs. PMID:22517997

  11. Investigating genetic discrimination in Australia: a large-scale survey of clinical genetics clients.

    PubMed

    Taylor, S; Treloar, S; Barlow-Stewart, K; Stranger, M; Otlowski, M

    2008-07-01

    We report first results from the Australian Genetic Discrimination Project of clinical genetics services clients' perceptions and experiences regarding alleged differential treatment associated with having genetic information. Adults (n = 2667) who had presented from 1998 to 2003 regarding predictive or presymptomatic testing for designated mature-onset conditions were surveyed; 951/1185 respondents met inclusion criteria for current asymptomatic status. Neurological conditions and familial cancers were primary relevant conditions for 87% of asymptomatic respondents. Specific incidents of alleged negative treatment, reported by 10% (n = 93) of respondents, occurred in life insurance (42%), employment (5%), family (22%), social (11%) and health (20%) domains. Respondents where neuro-degenerative conditions were relevant were more likely overall to report incidents and significantly more likely to report incidents in the social domain. Most incidents in the post-test period occurred in the first year after testing. Only 15% of respondents knew where to complain officially if treated negatively because of genetics issues. Recommendations include the need for increased community and clinical education regarding genetic discrimination, for extended clinical genetics sector engagement and for co-ordinated monitoring, research and policy development at national levels in order for the full benefits of genetic testing technology to be realised. PMID:18492091

  12. Clinical utility of biomarkers of endothelial activation in sepsis-a systematic review

    PubMed Central

    2012-01-01

    Introduction A strong biologic rationale exists for targeting markers of endothelial cell (EC) activation as clinically informative biomarkers to improve diagnosis, prognostic evaluation or risk-stratification of patients with sepsis. Methods The objective was to review the literature on the use of markers of EC activation as prognostic biomarkers in sepsis. MEDLINE was searched for publications using the keyword 'sepsis' and any of the identified endothelial-derived biomarkers in any searchable field. All clinical studies evaluating markers reflecting activation of ECs were included. Studies evaluating other exogenous mediators of EC dysfunction and studies of patients with malaria and febrile neutropenia were excluded. Results Sixty-one studies were identified that fulfilled the inclusion criteria. Overall, published studies report positive correlations between multiple EC-derived molecules and the diagnosis of sepsis, supporting the critical role of EC activation in sepsis. Multiple studies also reported positive associations for mortality and severity of illness, although these results were less consistent than for the presence of sepsis. Very few studies, however, reported thresholds or receiver operating characteristics that would establish these molecules as clinically-relevant biomarkers in sepsis. Conclusions Multiple endothelial-derived molecules are positively correlated with the presence of sepsis in humans, and variably correlated to other clinically-important outcomes. The clinical utility of these biomarkers is limited by a lack of assay standardization, unknown receiver operating characteristics and lack of validation. Additional large-scale prospective clinical trials will be required to determine the clinical utility of biomarkers of endothelial activation in the management of patients with sepsis. PMID:22248019

  13. CSA-131, a ceragenin active against colistin-resistant Acinetobacter baumannii and Pseudomonas aeruginosa clinical isolates.

    PubMed

    Vila-Farrés, Xavier; Callarisa, Anna Elena; Gu, Xiaobo; Savage, Paul B; Giralt, Ernest; Vila, Jordi

    2015-11-01

    In the last decade the number of Acinetobacter baumannii and Pseudomonas aeruginosa isolates showing extended drug resistance and pandrug resistance has steadily increased, thereby limiting or eliminating the antibiotics that can be used to treat infections by these micro-organisms. In addition, few antibiotics have been launched in the last decade. The objective of this study was to investigate the in vitro activity of several ceragenins against A. baumannii and P. aeruginosa. Four ceragenins (CSA-138, -13, -131 and -44) were tested both against colistin-susceptible and colistin-resistant A. baumannii and P. aeruginosa clinical isolates using the microdilution method. Time-kill curves of CSA-131 were performed against colistin-resistant A. baumannii and P. aeruginosa strains. The ceragenin CSA-131 showed the best activity against A. baumannii and P. aeruginosa, with minimum inhibitory concentrations (MICs) of 2 mg/L and <0.5 mg/L, respectively. MIC(50) and MIC(90) values were determined using 15 epidemiologically unrelated A. baumannii and P. aeruginosa strains, with MIC(50) and MIC(90) values for CSA-131 being 2 mg/L for A. baumannii and 1 mg/L and 2 mg/L, respectively, for P. aeruginosa. The killing curves of CSA-131 showed bactericidal behaviour at all of the concentrations tested, with re-growth at the lowest concentrations both in A. baumannii and P. aeruginosa. The good MICs of CSA-131 both against A. baumannii and P. aeruginosa and its high bactericidal activity may make this ceragenin a potential future agent to treat infections caused by these two pathogens even when the strain is resistant to colistin.

  14. In vitro antibacterial activity of some antihistaminics belonging to different groups against multi-drug resistant clinical isolates.

    PubMed

    El-Nakeeb, Moustafa A; Abou-Shleib, Hamida M; Khalil, Amal M; Omar, Hoda G; El-Halfawy, Omar M

    2011-07-01

    Antihistaminics are widely used for various indications during microbial infection. Hence, this paper investigates the antimicrobial activities of 10 antihistaminics belonging to both old and new generations using multiresistant Gram-positive and Gram-negative clinical isolates. The bacteriostatic activity of antihistaminics was investigated by determining their MIC both by broth and agar dilution techniques against 29 bacterial strains. Azelastine, cyproheptadine, mequitazine and promethazine were the most active among the tested drugs. Diphenhydramine and cetirizine possessed weaker activity whereas doxylamine, fexofenadine and loratadine were inactive even at the highest tested concentration (1 mg/ml). The MIC of meclozine could not be determined as it precipitated with the used culture media. The MBC values of antihistaminics were almost identical to the corresponding MIC values. The bactericidal activity of antihistaminics was also studied by the viable count technique in sterile saline solution. Evident killing effects were exerted by mequitazine, meclozine, azelastine and cyproheptadine. Moreover, the dynamics of bactericidal activity of azelastine were studied by the viable count technique in nutrient broth. This activity was found to be concentration-dependant. This effect was reduced on increasing the inoculum size while it was increased on raising the pH. The post-antimicrobial effect of 100 μg/ml azelastine was also determined and reached up to 3.36 h. PMID:24031715

  15. Curcumin, an active component of turmeric in the prevention and treatment of ulcerative colitis: preclinical and clinical observations.

    PubMed

    Baliga, Manjeshwar Shrinath; Joseph, Nandhini; Venkataranganna, Marikunte V; Saxena, Arpit; Ponemone, Venkatesh; Fayad, Raja

    2012-11-01

    Inflammatory bowel disease (IBD) comprising of ulcerative colitis (UC) and Crohn's disease (CD) is a major ailment affecting the small and large bowel. In clinics, IBD is treated using 5-amninosalicylates, antibiotics, the steroids and immunomodulators. Unfortunately, the long term usages of these agents are associated with undue side effects and compromise the therapeutic advantage. Accordingly, there is a need for novel agents that are effective, acceptable and non toxic to humans. Preclinical studies in experimental animals have shown that curcumin, an active principle of the Indian spice turmeric (Curcuma longa Linn) is effective in preventing or ameliorating UC and inflammation. Over the last few decades there has been increasing interest in the possible role of curcumin in IBD and several studies with various experimental models of IBD have shown it to be effective in mediating the inhibitory effects by scavenging free radicals, increasing antioxidants, influencing multiple signaling pathways, especially the kinases (MAPK, ERK), inhibiting myeloperoxidase, COX-1, COX-2, LOX, TNF-α, IFN-γ, iNOS; inhibiting the transcription factor NF-κB. Clinical studies have also shown that co-administration of curcumin with conventional drugs was effective, to be well-tolerated and treated as a safe medication for maintaining remission, to prevent relapse and improve clinical activity index. Large randomized controlled clinical investigations are required to fully understand the potential of oral curcumin for treating IBD. PMID:22833299

  16. In vitro antimicrobial activity of ten medicinal plants against clinical isolates of oral cancer cases

    PubMed Central

    2011-01-01

    Background Suppression of immune system in treated cancer patients may lead to secondary infections that obviate the need of antibiotics. In the present study, an attempt was made to understand the occurrence of secondary infections in immuno-suppressed patients along with herbal control of these infections with the following objectives to: (a) isolate the microbial species from the treated oral cancer patients along with the estimation of absolute neutrophile counts of patients (b) assess the in vitro antimicrobial activity medicinal plants against the above clinical isolates. Methods Blood and oral swab cultures were taken from 40 oral cancer patients undergoing treatment in the radiotherapy unit of Regional Cancer Institute, Pt. B.D.S. Health University, Rohtak, Haryana. Clinical isolates were identified by following general microbiological, staining and biochemical methods. The absolute neutrophile counts were done by following the standard methods. The medicinal plants selected for antimicrobial activity analysis were Asphodelus tenuifolius Cav., Asparagus racemosus Willd., Balanites aegyptiaca L., Cestrum diurnum L., Cordia dichotoma G. Forst, Eclipta alba L., Murraya koenigii (L.) Spreng. , Pedalium murex L., Ricinus communis L. and Trigonella foenum graecum L. The antimicrobial efficacy of medicinal plants was evaluated by modified Kirby-Bauer disc diffusion method. MIC and MFC were investigated by serial two fold microbroth dilution method. Results Prevalent bacterial pathogens isolated were Staphylococcus aureus (23.2%), Escherichia coli (15.62%), Staphylococcus epidermidis (12.5%), Pseudomonas aeruginosa (9.37%), Klebsiella pneumonia (7.81%), Proteus mirabilis (3.6%), Proteus vulgaris (4.2%) and the fungal pathogens were Candida albicans (14.6%), Aspergillus fumigatus (9.37%). Out of 40 cases, 35 (87.5%) were observed as neutropenic. Eight medicinal plants (A. tenuifolius, A. racemosus, B. aegyptiaca, E. alba, M. koenigii, P. murex R. communis and T

  17. How do interprofessional student teams interact in a primary care clinic? A qualitative analysis using activity theory.

    PubMed

    Kent, Fiona; Francis-Cracknell, Alison; McDonald, Rachael; Newton, Jennifer M; Keating, Jennifer L; Dodic, Miodrag

    2016-10-01

    Practice based interprofessional education opportunities are proposed as a mechanism for health professionals to learn teamwork skills and gain an understanding of the roles of others. Primary care is an area of practice that offers a promising option for interprofessional student learning. In this study, we investigated what and how students from differing professions learn together. Our findings inform the design of future interprofessional education initiatives. Using activity theory, we conducted an ethnographic investigation of interprofessional education in primary care. During a 5 months period, we observed 14 clinic sessions involving mixed discipline student teams who interviewed people with chronic disease. Teams were comprised of senior medicine, nursing, occupational therapy, pharmacy and physiotherapy entry level students. Semi-structured interviews were also conducted with seven clinical educators. Data were analysed to ascertain the objectives, tools, rules and division of labour. Two integrated activity systems were identified: (1) student teams gathering information to determine patients' health care needs and (2) patients either as health consumers or student educators. Unwritten rules regarding 'shared contribution', 'patient as key information source' and 'time constraints' were identified. Both the significance of software literacy on team leadership, and a pre-determined structure of enquiry, highlighted the importance of careful consideration of the tools used in interprofessional education, and the way they can influence practice. The systems of practice identified provide evidence of differing priorities and values, and multiple perspectives of how to manage health. The work reinforced the value of the patients' voice in clinical and education processes.

  18. Clinical and financial burden of active lupus in Greece: a nationwide study.

    PubMed

    Bertsias, G; Karampli, E; Sidiropoulos, P; Gergianaki, I; Drosos, A; Sakkas, L; Garyfallos, A; Tzioufas, A; Vassilopoulos, D; Tsalapaki, C; Sfikakis, P; Panopoulos, S; Athanasakis, K; Perna, A; Psomali, D; Kyriopoulos, J; Boumpas, D

    2016-10-01

    Analyses of the medical and economic burden of chronic disorders such as systemic lupus erythematosus (SLE) are valuable for clinical and health policy decisions. We performed a chart-based review of 215 adult SLE patients with active autoantibody-positive disease at the predefined ratio of 30% severe (involvement of major organs requiring treatment) and 70% non-severe, followed at seven hospital centres in Greece. We reviewed 318 patients consecutively registered over three months (sub-study). Disease activity, organ damage, flares and healthcare resource utilization were recorded. Costs were assessed from the third-party payer perspective. Severe SLE patients had chronic active disease more frequently (22.4% vs 4.7%), higher average SLE disease activity index (SLEDAI) (10.5 vs 6.1) and systemic lupus international collaborating clinics (SLICC) damage index (1.1 vs 0.6) than non-severe patients. The mean annual direct medical cost was €3741 for severe vs €1225 for non-severe patients. Severe flares, active renal disease and organ damage were independent cost predictors. In the sub-study, 19% of unselected patients were classified as severe SLE, and 30% of them had chronic active disease. In conclusion, this is the first study to demonstrate the significant clinical and financial burden of Greek SLE patients with active major organ disease. Among them, 30% display chronic activity, in spite of standard care, which represents a significant unmet medical need.

  19. The 'idioglossia' cases of the 1890s and the clinical investigation and treatment of developmental language impairment.

    PubMed

    Lorch, Marjorie; Hellal, Paula

    2012-09-01

    The early history of developmental language impairment in late 19th century Britain is considered through the critical examination of three papers appearing in 1891 by Hadden, Golding-Bird and Hale White, and Taylor. They represent innovative investigations of child language disorders whose themes and concerns are resonant today. The term 'idioglossia' was coined to identify this new impairment and reflected the belief by some that these children spoke an invented language. Rather than viewing these children as having some constitutional deficiency, these 19th century physicians were novel in insisting that children with language impairments merited extensive clinical investigation and treatment. Their case descriptions and the subsequent debates regarding classification and prognosis are reviewed. Further consideration is given to how these cases led to questioning the relation between language and speech and other aspects of child development and disorder. Reflection on the early sources of clinical categories provides a new perspective on our current formulations for variation in developmental language trajectories.

  20. Structural Investigation of Alkali Activated Clay Minerals for Application in Water Treatment Systems

    NASA Astrophysics Data System (ADS)

    Bumanis, G.; Bajare, D.; Dembovska, L.

    2015-11-01

    Alkali activation technology can be applied for a wide range of alumo-silicates to produce innovative materials with various areas of application. Most researches focuse on the application of alumo-silicate materials in building industry as cement binder replacement to produce mortar and concrete [1]. However, alkali activation technology offers high potential also in biotechnologies [2]. In the processes where certain pH level, especially alkaline environment, must be ensured, alkali activated materials can be applied. One of such fields is water treatment systems where high level pH (up to pH 10.5) ensures efficient removal of water pollutants such as manganese [3]. Previous investigations had shown that alkali activation technology can be applied to calcined clay powder and aluminium scrap recycling waste as a foam forming agent to create porous alkali activated materials. This investigation focuses on the structural investigation of calcined kaolin and illite clay alkali activation processes. Chemical and mineralogical composition of both clays were determined and structural investigation of alkali activated materials was made by using XRD, DTA, FTIR analysis; the microstructure of hardened specimens was observed by SEM. Physical properties of the obtained material were determined. Investigation indicates the essential role of chemical composition of the clay used in the alkali activation process, and potential use of the obtained material in water treatment systems.

  1. Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks

    PubMed Central

    McDonnell, Anthony; Rex, John H.; Goossens, Herman; Bonten, Marc; Fowler, Vance G.; Dane, Aaron

    2016-01-01

    The economics of antibiotics can be improved by infectious diseases–specific clinical trial networks. While developers would still need to implement an independent phase 1 program as well as studies focused on highly resistant pathogens, standardized procedures in a network focused on usual drug resistance phenotype isolates would permit sharing of controls and would predictably generate high-quality pivotal data for product registration while creating cost and time savings in the range of 30%–40%. This would reduce economic barriers to antibiotic development and contribute to public health. PMID:27481955

  2. Investigation of benefits and costs of an ophthalmic outreach clinic in general practice.

    PubMed Central

    Gillam, S J; Ball, M; Prasad, M; Dunne, H; Cohen, S; Vafidis, G

    1995-01-01

    BACKGROUND: With the advent of general practitioner fundholding, there has been growth in outreach clinics covering many specialties. The benefits and costs of this model of service provision are unclear. AIM: A pilot study aimed to evaluate an outreach model of ophthalmic care in terms of its impact on general practitioners, their use of secondary ophthalmology services, patients' views, and costs. METHOD: A prospective study, from April 1992 to March 1993, of the introduction of an ophthalmic outreach service in 17 general practices in London was undertaken. An ophthalmic outreach team, comprising an ophthalmic medical practitioner and an ophthalmic nurse, held clinics in the practices once a month. Referral rates to Edgware General Hospital ophthalmology outpatient department over one year from the study practices were compared with those from 17 control practices. General practitioners' assessments of the scheme and its impact on their knowledge and practice of ophthalmology were sought through a postal survey of all partners and interviews with one partner in each practice. Patient surveys were conducted using self-administered structured questionnaires. A costings exercise compared the outreach model with the conventional hospital ophthalmology outpatient clinic. RESULTS: Of 1309 patients seen by the outreach team in the study practices, 480 (37%) were referred to the ophthalmology outpatient department. The annual referral rate to this department from control practices was 9.5 per 10,000 registered patients compared with 3.8 per 10,000 registered patients from study practices. A total of 1187 patients were referred to the outpatient department from control practices. An increase in knowledge of ophthalmology was reported by 18 of 47 general practitioners (38%). Nineteen (40%) of 47 general practitioners took advantage of the opportunity for inservice training with the outreach team; they were more likely to change their routine practice for ophthalmic care

  3. Clinical and Histopathologic Investigation of Periapical Actinomycosis with Cutaneous Lesion: a Case Report.

    PubMed

    Jamshidi, Davood; Moazami, Fariborz; Sobhnamayan, Fereshteh; Taheri, Ali

    2015-09-01

    Management of an extra-radicular infection is a challenging procedure that requires surgical intervention. This report describes a patient with discharging cutaneous lesion that required apical surgery. A 40-year-old woman was referred to the Department of Endodontics, Shiraz Dental School with chief complaint of a cutaneous sinus tract. She had been treated by a dermatologist and an otolaryngologist. The patient had also received orthograde root canal treatment of tooth #16. Yet, the lesion was still discharging and the patient was scheduled for surgery. Histopathologic analysis of the lesion showed actinomycosis infection. A 36-month follow-up revealed clinical and radiographic healing. PMID:26535411

  4. Investigating the genetic background of bovine digital dermatitis using improved definitions of clinical status.

    PubMed

    Schöpke, K; Gomez, A; Dunbar, K A; Swalve, H H; Döpfer, D

    2015-11-01

    Bovine digital dermatitis (DD) is an increasing claw health problem in all cattle production systems worldwide. The objective of this study was to evaluate the use of an improved scoring of the clinical status for DD via M-scores accounting for the dynamics of the disease; that is, the transitions from one stage to another. The newly defined traits were then subjected to a genetic analysis to determine the genetic background for susceptibility to DD. Data consisted of 6,444 clinical observations from 729 Holstein heifers in a commercial dairy herd, collected applying the M-score system. The M-score system is a classification scheme for stages of DD that allows a macroscopic scoring based on clinical inspections of the bovine foot, thus it describes the stages of lesion development. The M-scores were used to define new DD trait definitions with different complexities. Linear mixed models and logistic models were used to identify fixed environmental effects and to estimate variance components. In total, 68% of all observations showed no DD status, whereas 11% were scored as infectious for and affected by DD, and 21% of all observations exhibited an affected but noninfectious status. For all traits, the probability of occurrence and clinical status were associated with age at observation and period of observation. Risk of becoming infected increased with age, and month of observation significantly affected all traits. Identification of the optimal month concerning DD herd status was consistent for all trait definitions; the last month of the trial was identified. In contrast, months exhibiting the highest least squares means of transformed scores differed depending on trait definition. In this respect, traits that can distinguish between healthy, infectious, and noninfectious stages of DD can account for the infectious potential of the herd and can serve as an alert tool. Estimates of heritabilities of traits studied ranged between 0.19 (±0.11) and 0.52 (±0

  5. Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.

    PubMed

    McDonnell, Anthony; Rex, John H; Goossens, Herman; Bonten, Marc; Fowler, Vance G; Dane, Aaron

    2016-08-15

    The economics of antibiotics can be improved by infectious diseases-specific clinical trial networks. While developers would still need to implement an independent phase 1 program as well as studies focused on highly resistant pathogens, standardized procedures in a network focused on usual drug resistance phenotype isolates would permit sharing of controls and would predictably generate high-quality pivotal data for product registration while creating cost and time savings in the range of 30%-40%. This would reduce economic barriers to antibiotic development and contribute to public health. PMID:27481955

  6. Efficient Delivery of Investigational Antibacterial Agents via Sustainable Clinical Trial Networks.

    PubMed

    McDonnell, Anthony; Rex, John H; Goossens, Herman; Bonten, Marc; Fowler, Vance G; Dane, Aaron

    2016-08-15

    The economics of antibiotics can be improved by infectious diseases-specific clinical trial networks. While developers would still need to implement an independent phase 1 program as well as studies focused on highly resistant pathogens, standardized procedures in a network focused on usual drug resistance phenotype isolates would permit sharing of controls and would predictably generate high-quality pivotal data for product registration while creating cost and time savings in the range of 30%-40%. This would reduce economic barriers to antibiotic development and contribute to public health.

  7. Functional investigations on embryonic stem cells labeled with clinically translatable iron oxide nanoparticles

    NASA Astrophysics Data System (ADS)

    Liu, Jing; Wang, Liqin; Cao, Jianbo; Huang, Yue; Lin, Yu; Wu, Xiaoyun; Wang, Zhiyong; Zhang, Fan; Xu, Xiuqin; Liu, Gang

    2014-07-01

    Stem cell based therapies offer significant potential in the field of regenerative medicine. The development of superparamagnetic iron oxide (SPIO) nanoparticle labeling and magnetic resonance imaging (MRI) have been increasingly used to track the transplanted cells, enabling in vivo determination of cell fate. However, the impact of SPIO-labeling on the cell phenotype and differentiation capacity of embryonic stem cells (ESCs) remains unclear. In this study, we wrapped SPIO nanoparticles with stearic acid grafted PEI600, termed as Stearic-LWPEI-SPIO, to generate efficient and non-toxic ESC labeling tools. Our results showed that efficient labeling of ESCs at an optimized low dosage of Stearic-LWPEI-SPIO nanoparticles did not alter the differentiation and self-renewal properties of ESCs. The localization of the transplanted ESCs observed by MRI correlated well with histological studies. These findings demonstrate that Stearic-LWPEI-SPIO nanoparticles have potential to be clinically translatable MRI probes and may enable non-invasive in vivo tracking of ESCs in experimental and clinical settings during cell-based therapies.Stem cell based therapies offer significant potential in the field of regenerative medicine. The development of superparamagnetic iron oxide (SPIO) nanoparticle labeling and magnetic resonance imaging (MRI) have been increasingly used to track the transplanted cells, enabling in vivo determination of cell fate. However, the impact of SPIO-labeling on the cell phenotype and differentiation capacity of embryonic stem cells (ESCs) remains unclear. In this study, we wrapped SPIO nanoparticles with stearic acid grafted PEI600, termed as Stearic-LWPEI-SPIO, to generate efficient and non-toxic ESC labeling tools. Our results showed that efficient labeling of ESCs at an optimized low dosage of Stearic-LWPEI-SPIO nanoparticles did not alter the differentiation and self-renewal properties of ESCs. The localization of the transplanted ESCs observed by MRI

  8. Clinical and Histopathologic Investigation of Periapical Actinomycosis with Cutaneous Lesion: a Case Report

    PubMed Central

    Jamshidi, Davood; Moazami, Fariborz; Sobhnamayan, Fereshteh; Taheri, Ali

    2015-01-01

    Management of an extra-radicular infection is a challenging procedure that requires surgical intervention. This report describes a patient with discharging cutaneous lesion that required apical surgery. A 40-year-old woman was referred to the Department of Endodontics, Shiraz Dental School with chief complaint of a cutaneous sinus tract. She had been treated by a dermatologist and an otolaryngologist. The patient had also received orthograde root canal treatment of tooth #16. Yet, the lesion was still discharging and the patient was scheduled for surgery. Histopathologic analysis of the lesion showed actinomycosis infection. A 36-month follow-up revealed clinical and radiographic healing. PMID:26535411

  9. Clinical Response, Outbreak Investigation, and Epidemiology of the Fungal Meningitis Epidemic in the United States: Systematic Review.

    PubMed

    Abbas, Kaja M; Dorratoltaj, Nargesalsadat; O'Dell, Margaret L; Bordwine, Paige; Kerkering, Thomas M; Redican, Kerry J

    2016-02-01

    We conducted a systematic review of the 2012-2013 multistate fungal meningitis epidemic in the United States from the perspectives of clinical response, outbreak investigation, and epidemiology. Articles focused on clinical response, outbreak investigation, and epidemiology were included, whereas articles focused on compounding pharmacies, legislation and litigation, diagnostics, microbiology, and pathogenesis were excluded. We reviewed 19 articles by use of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) framework. The source of the fungal meningitis outbreak was traced to the New England Compounding Center in Massachusetts, where injectable methylprednisolone acetate products were contaminated with the predominant pathogen, Exserohilum rostratum. As of October 23, 2013, the final case count stood at 751 patients and 64 deaths, and no additional cases are anticipated. The multisectoral public health response to the fungal meningitis epidemic from the hospitals, clinics, pharmacies, and the public health system at the local, state, and federal levels led to an efficient epidemiological investigation to trace the outbreak source and rapid implementation of multiple response plans. This systematic review reaffirms the effective execution of a multisectoral public health response and efficient delivery of the core functions of public health assessment, policy development, and service assurances to improve population health. PMID:26681583

  10. Terbinafine hydrochloride nanovesicular gel: In vitro characterization, ex vivo permeation and clinical investigation.

    PubMed

    AbdelSamie, Sara M; Kamel, Amany O; Sammour, Omaima A; Ibrahim, Shady M

    2016-06-10

    In this work, nanovesicular chitosan gels were prepared for dermal delivery of terbinafine hydrochloride (TBN HCl). Ethosomes and vesicles containing different types of penetration enhancers (PEs) viz. Terpenes (cineole and limonene), labrasol and transcutol were developed. The prepared vesicles were evaluated for physical characteristics as well as skin interaction. The selected vesicles were incorporated into chitosan gel. An in vivo animal study was done on rat induced superficial Candida infection model. Moreover, randomized double blind clinical study was done on patients to compare the effect of the selected nanovesicular gel against the market product. Results showed the formation of nearly spherical, mostly deformable vesicular systems with size range of 95.5-530nm, zeta potential range of -0.1 to 15mV and entrapment efficiency range of 20-96.7%. Penetration enhancer vesicles (PEVs) prepared with 4% limonene (ELI4) showed the highest percent of drug deposition in the skin (53%) and the highest local accumulation efficiency value (35.3). In vivo animal study showed that the lowest fungal burden produced with ELI4 chitosan gel. Clinical studies showed cure rate of 86% within 7days treatment in case of limonene nanovesicular gel compared to 20% for market product (Lamisil® cream). PMID:27072432

  11. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients.

    PubMed

    Schulman, S; Angerås, U; Bergqvist, D; Eriksson, B; Lassen, M R; Fisher, W

    2010-01-01

    The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.

  12. Improving balance in regulatory oversight of research in children and adolescents: a clinical investigator's perspective.

    PubMed

    Rosenfield, Robert L

    2008-01-01

    The current regulatory environment, designed to protect children, imposes barriers to research in children that are a deterrent to high-quality clinical research in minors. This article summarizes the special procedures necessary to obtain approval for research in healthy children that poses more than minimal risk according to the code of federal regulations (45 CFR 46.407 and 21 CFR 50.54). The operational realities of the process are illustrated by the case of the most recent research protocol to be reviewed under these rules. The current process poses obstacles to future studies of complex research questions in children and adolescents that require unaffected controls, such as the relationship of adolescent anovulatory disorders to adult illness. It is concluded that current regulatory procedures, while protecting children, increase the potential for the neglect of important research needs of children and are a disincentive to pursuit of a career in clinical research for young clinicians. Suggestions are made for improving the balance between the need for research in children and adolescents and its regulation.

  13. Jacob Mendez DaCosta: medical teacher, clinician, and clinical investigator.

    PubMed

    Wooley, C F

    1982-11-01

    J. M. DaCosta, a scholarly, well-trained and observant clinician, was recognized during his lifetime as a well-known authority on physical diagnosis and had an unexcelled reputation as a clinical teacher. Chairman of Medicine at the Jefferson Medical College for 19 years, president of the College of Physicians of Philadelphia in 1884 and again in 1895, he was one of the original members of the Association of American Physicians and its president in 1897. Earlier in his career, his extensive Civil War study of "a form of cardiac malady common among soldiers . . . the study of which is equally interesting to the civil practitioner" was described in his 1871 paper "On Irritable Heart; A Clinical Study of a Form of Functional Cardiac Disorder and Its Consequences." Soon labeled DaCosta's syndrome, the irritable heart lineage can be traced through the soldier's heart, the effort syndrome, and neurocirculatory asthenia in World War I, anxiety neurosis in World War II, and the mitral valve prolapse syndrome in the second half of the 20th century.

  14. Active video games to promote physical activity in children with cancer: a randomized clinical trial with follow-up

    PubMed Central

    2014-01-01

    Background Low levels of physical activity, musculoskeletal morbidity and weight gain are commonly reported problems in children with cancer. Intensive medical treatment and a decline in physical activity may also result in reduced motor performance. Therefore, simple and inexpensive ways to promote physical activity and exercise are becoming an increasingly important part of children’s cancer treatment. Methods The aim of this study is to evaluate the effect of active video games in promotion of physical activity in children with cancer. The research is conducted as a parallel randomized clinical trial with follow-up. Patients between 3 and 16 years old, diagnosed with cancer and treated with vincristine in two specialized medical centers are asked to participate. Based on statistical estimates, the target enrollment is 40 patients. The intervention includes playing elective active video games and, in addition, education and consultations for the family. The control group will receive a general recommendation for physical activity for 30 minutes per day. The main outcomes are the amount of physical activity and sedentary behavior. Other outcomes include motor performance, fatigue and metabolic risk factors. The outcomes are examined with questionnaires, diaries, physical examinations and blood tests at baseline and at 2, 6, 12 and 30 months after the baseline. Additionally, the children’s perceptions of the most enjoyable activation methods are explored through an interview at 2 months. Discussion This trial will help to answer the question of whether playing active video games is beneficial for children with cancer. It will also provide further reasoning for physical activity promotion and training of motor skills during treatment. Trial registration ClinicalTrials.gov identifier: NCT01748058 (October 15, 2012). PMID:24708773

  15. Investigation of membrane active properties and antiradical activity of gossypol and its derivatives

    Technology Transfer Automated Retrieval System (TEKTRAN)

    New asymmetrical derivatives of gossypol were synthesized. The antioxidant activity of gossypol and these derivatives was studied. The interaction of these compounds with modeled lipid membranes was also studied. It was found that the antioxidant effects and ability to interact with membranes was...

  16. Characterization of five newly isolated bacteriophages active against Pseudomonas aeruginosa clinical strains.

    PubMed

    Kwiatek, Magdalena; Mizak, Lidia; Parasion, Sylwia; Gryko, Romuald; Olender, Alina; Niemcewicz, Marcin

    2015-01-01

    Pseudomonas aeruginosa is an opportunistic pathogen that causes serious infections, especially in patients with immunodeficiency. It exhibits multiple mechanisms of resistance, including efflux pumps, antibiotic modifying enzymes and limited membrane permeability. The primary reason for the development of novel therapeutics for P. aeruginosa infections is the declining efficacy of conventional antibiotic therapy. These clinical problems caused a revitalization of interest in bacteriophages, which are highly specific and have very effective antibacterial activity as well as several other advantages over traditional antimicrobial agents. Above all, so far, no serious or irreversible side effects of phage therapy have been described. Five newly purified P. aeruginosa phages named vB_PaeM_WP1, vB_PaeM_WP2, vB_PaeM_WP3, vB_PaeM_WP4 and vB_PaeP_WP5 have been characterized as potential candidates for use in phage therapy. They are representatives of the Myoviridae and Podoviridae families. Their host range, genome size, structural proteins and stability in various physical and chemical conditions were tested. The results of these preliminary investigations indicate that the newly isolated bacteriophages may be considered for use in phagotherapy.

  17. The EC4 register of European clinical chemists and EC4 activities.

    PubMed

    Jansen, Rob T P

    2002-05-21

    The freedom of movement of people and goods within the European Union (EU) has a large impact for the member states. Particularly within health care it is important to recognize, or if necessary obtain, an adequate level of the quality of profession and practice, so that citizens know that health care is offered in their country at a level comparable to other countries. The importance of recognition also applies to laboratory medicine. European Communities Confederation of Clinical Chemistry (EC4) is the organization of societies for clinical chemistry and laboratory medicine in the EU. In Europe, health care develops in the direction where patients are treated in a health care chain environment. In this chain, patients move quickly from primary health institutes to secondary and tertiary institutes, and vice versa. This situation involves many health care workers including several laboratories. Diagnosis and therapy are now 'core business' of health care. Medical laboratories play an essential role in this. The broad spectrum of medical laboratory investigations make consultancy of medical laboratory specialists ever more important. The quality of both professionals and laboratories, as well as continuity of laboratory data within and between laboratories, are of utmost importance.EC4 is active in giving support to attain such quality. In most countries, this is the case at present. EC4 plays a central role in the Coordination of Automatic Recognition of Equivalence of Standards (CARE), if such a level exists or is achieved. Such CARE is focussed at three levels, the profession, quality of laboratories and calibration of laboratory data. The EC4 Register of European Clinical Chemists is open for colleagues educated in (bio)chemistry, pharmacy, biology as well as medicine, and trained according to the EC4 Syllabus. Equivalence of standards has been granted to national training schemes of 13 European Union countries. Since its opening in 1998, the number of

  18. [Resource activation in clinical psychology and psychotherapy: review of theoretical issues and current research].

    PubMed

    Groß, L J; Stemmler, M; de Zwaan, M

    2012-08-01

    This review summarises theoretical issues and current research on working with clients' resources and strengths in clinical psychology and psychotherapy. Resource activation is considered as an important common factor in psychotherapy. In general, resource activation means an explicit focus on resources, strengths and potentials of the clients. After defining the term resources, considerations with regard to therapeutic attitude, principles of resource activation, approaches to resource diagnostics and different research strategies are presented. Current research focuses especially on the relation between resource activation and process variables in out-patient treatment.

  19. Experimental and analytical investigation of active loads control for aircraft landing gear

    NASA Technical Reports Server (NTRS)

    Morris, D. L.; Mcgehee, J. R.

    1983-01-01

    A series hydraulic, active loads control main landing gear from a light, twin-engine civil aircraft was investigated. Tests included landing impact and traversal of simulated runway roughness. It is shown that the active gear is feasible and very effective in reducing the force transmitted to the airframe. Preliminary validation of a multidegree of freedom active gear flexible airframe takeoff and landing analysis computer program, which may be used as a design tool for active gear systems, is accomplished by comparing experimental and computed data for the passive and active gears.

  20. Functional investigations on human mesenchymal stem cells exposed to magnetic fields and labeled with clinically approved iron nanoparticles

    PubMed Central

    2010-01-01

    Background For clinical applications of mesenchymal stem cells (MSCs), labeling and tracking is crucial to evaluate cell distribution and homing. Magnetic resonance imaging (MRI) has been successfully established detecting MSCs labeled with superparamagnetic particles of iron oxide (SPIO). Despite initial reports that labeling of MSCs with SPIO is safe without affecting the MSC's biology, recent studies report on influences of SPIO-labeling on metabolism and function of MSCs. Exposition of cells and tissues to high magnetic fields is the functional principle of MRI. In this study we established innovative labeling protocols for human MSCs using clinically established SPIO in combination with magnetic fields and investigated on functional effects (migration assays, quantification of colony forming units, analyses of gene and protein expression and analyses on the proliferation capacity, the viability and the differentiation potential) of magnetic fields on unlabeled and labeled human MSCs. To evaluate the imaging properties, quantification of the total iron load per cell (TIL), electron microscopy, and MRI at 3.0 T were performed. Results Human MSCs labeled with SPIO permanently exposed to magnetic fields arranged and grew according to the magnetic flux lines. Exposure of MSCs to magnetic fields after labeling with SPIO significantly enhanced the TIL compared to SPIO labeled MSCs without exposure to magnetic fields resulting in optimized imaging properties (detection limit: 1,000 MSCs). Concerning the TIL and the imaging properties, immediate exposition to magnetic fields after labeling was superior to exposition after 24 h. On functional level, exposition to magnetic fields inhibited the ability of colony formation of labeled MSCs and led to an enhanced expression of lipoprotein lipase and peroxisome proliferator-activated receptor-γ in labeled MSCs under adipogenic differentiation, and to a reduced expression of alkaline phosphatase in unlabeled MSCs under

  1. Clinical NECR in 18F-FDG PET scans: optimization of injected activity and variable acquisition time. Relationship with SNR

    NASA Astrophysics Data System (ADS)

    Carlier, T.; Ferrer, L.; Necib, H.; Bodet-Milin, C.; Rousseau, C.; Kraeber-Bodéré, F.

    2014-10-01

    The injected activity and the acquisition time per bed position for 18F-FDG PET scans are usually optimized by using metrics obtained from phantom experiments. However, optimal activity and time duration can significantly vary from a phantom set-up and from patient to patient. An approach using a patient-specific noise equivalent count rate (NECR) modelling has been previously proposed for optimizing clinical scanning protocols. We propose using the clinical NECR on a large population as a function of the body mass index (BMI) for deriving the optimal injected activity and acquisition duration per bed position. The relationship between the NEC and the signal-to-noise ratio (SNR) was assessed both in a phantom and in a clinical setting. 491 consecutive patients were retrospectively evaluated and divided into 4 BMI subgroups. Two criteria were used to optimize the injected activity and the time per bed position was adjusted using the NECR value while keeping the total acquisition time constant. Finally, the relationship between NEC and SNR was investigated using an anthropomorphic phantom and a population of 507 other patients. While the first dose regimen suggested a unique injected activity (665 MBq) regardless of the BMI, the second dose regimen proposed a variable activity and a total acquisition time according to the BMI. The NEC improvement was around 35% as compared with the local current injection rule. Variable time per bed position was derived according to BMI and anatomical region. NEC and number of true events were found to be highly correlated with SNR for the phantom set-up and partially confirmed in the patient study for the BMI subgroup under 28 kg m-2 suggesting that for the scanner, the nonlinear reconstruction algorithm used in this study and BMI < 28 kg m-2, NEC, or the number of true events linearly correlated with SNR2.

  2. Super Saver Investigators: An Elementary, Interdisciplinary, Environmental Studies Activity Guidebook about Solid Waste and Natural Resources.

    ERIC Educational Resources Information Center

    Landis, David; And Others

    This is an elementary, interdisciplinary, environmental studies activity guidebook about solid waste and natural resources. "Super Saver Investigators" what solid waste is, where it is generated, how we manage it and could manage it better, and the consequence of mismanagement. It contains many hands-on, skill enhancing activities for elementary…

  3. Storm Surges. Teacher Guide and Activity Book. OEAGLS Investigation No. 25.

    ERIC Educational Resources Information Center

    Keir, John; Mayer, Victor J.

    This investigation is designed to help students understand storm surges on Lake Erie. Activity A includes experiments and discussions intended to help students understand what causes storm surges on Lake Erie. Activity B considers how storm surges affect water levels and, in turn, coastal areas. The student booklet contains questions, experiments,…

  4. Teachers' Beliefs Related to Activity Play in the Preschool Setting: A Phenomenological Investigation

    ERIC Educational Resources Information Center

    Pisha, Lorelei Emma

    2012-01-01

    The purpose of the present study was to investigate how early childhood teachers working in Head Start programs made meaning of preschool-age children's physical activity play by exploring their personal childhood and professional experiences with physical activity play. The study was conducted to contribute research-based recommendations for…

  5. CLINICAL SURFACES - Activity-Based Computing for Distributed Multi-Display Environments in Hospitals

    NASA Astrophysics Data System (ADS)

    Bardram, Jakob E.; Bunde-Pedersen, Jonathan; Doryab, Afsaneh; Sørensen, Steffen

    A multi-display environment (MDE) is made up of co-located and networked personal and public devices that form an integrated workspace enabling co-located group work. Traditionally, MDEs have, however, mainly been designed to support a single “smart room”, and have had little sense of the tasks and activities that the MDE is being used for. This paper presents a novel approach to support activity-based computing in distributed MDEs, where displays are physically distributed across a large building. CLINICAL SURFACES was designed for clinical work in hospitals, and enables context-sensitive retrieval and browsing of patient data on public displays. We present the design and implementation of CLINICAL SURFACES, and report from an evaluation of the system at a large hospital. The evaluation shows that using distributed public displays to support activity-based computing inside a hospital is very useful for clinical work, and that the apparent contradiction between maintaining privacy of medical data in a public display environment can be mitigated by the use of CLINICAL SURFACES.

  6. Molecular Testing for Clinical Diagnosis and Epidemiological Investigations of Intestinal Parasitic Infections

    PubMed Central

    Stensvold, C. Rune

    2014-01-01

    SUMMARY Over the past few decades, nucleic acid-based methods have been developed for the diagnosis of intestinal parasitic infections. Advantages of nucleic acid-based methods are numerous; typically, these include increased sensitivity and specificity and simpler standardization of diagnostic procedures. DNA samples can also be stored and used for genetic characterization and molecular typing, providing a valuable tool for surveys and surveillance studies. A variety of technologies have been applied, and some specific and general pitfalls and limitations have been identified. This review provides an overview of the multitude of methods that have been reported for the detection of intestinal parasites and offers some guidance in applying these methods in the clinical laboratory and in epidemiological studies. PMID:24696439

  7. Molecular testing for clinical diagnosis and epidemiological investigations of intestinal parasitic infections.

    PubMed

    Verweij, Jaco J; Stensvold, C Rune

    2014-04-01

    Over the past few decades, nucleic acid-based methods have been developed for the diagnosis of intestinal parasitic infections. Advantages of nucleic acid-based methods are numerous; typically, these include increased sensitivity and specificity and simpler standardization of diagnostic procedures. DNA samples can also be stored and used for genetic characterization and molecular typing, providing a valuable tool for surveys and surveillance studies. A variety of technologies have been applied, and some specific and general pitfalls and limitations have been identified. This review provides an overview of the multitude of methods that have been reported for the detection of intestinal parasites and offers some guidance in applying these methods in the clinical laboratory and in epidemiological studies.

  8. An investigation of halogens in Izmit hazardous and clinical waste incinerator.

    PubMed

    Cetin, Senay; Veli, Sevil; Ayberk, Savaş

    2004-01-01

    In the combustion facilities, halogens (Cl, F, Br, I) should be considered with regard to the control of the compounds such as polychlorinated dibenzodioxins (PCDD), polychlorinated dibenzofurans (PCDF), halogenated polyaromatic hydrocarbons (PAH), polychlorinated biphenyls (PCB) and volatile heavy metals formed as a result of incomplete combustion and caused adverse environmental effects. In this study halogens were observed in Izmit Hazardous and Clinical Waste Incinerator (IZAYDAS). Halogen contents of the combustion menu, flue gas, fly ash, bottom ash and filter cake were measured and their distributions in these exit streams were determined. Results showed that the major part of the halogens was partitioned to solid residues, i.e., bottom ash and filter cake which represents the removal by wet scrubbers. Fly ash and flue gas fractions of halogens were much lower due to the reduced formation of volatile compounds.

  9. Changes in muscle activity determine progression of clinical symptoms in patients with chronic spine-related muscle pain. A complex clinical and neurophysiological approach.

    PubMed

    Wytrazek, Marcin; Huber, Juliusz; Lisinski, Przemyslaw

    2011-01-01

    Spine-related muscle pain can affect muscle strength and motor unit activity. This study was undertaken to investigate whether surface electromyographic (sEMG) recordings performed during relaxation and maximal contraction reveal differences in the activity of muscles with or without trigger points (TRPs). We also analyzed the possible coexistence of characteristic spontaneous activity in needle electromyographic (eEMG) recordings with the presence of TRPs. Thirty patients with non-specific cervical and back pain were evaluated using clinical, neuroimaging and electroneurographic examinations. Muscle pain was measured using a visual analog scale (VAS), and strength using Lovett's scale; trigger points were detected by palpation. EMG was used to examine motor unit activity. Trigger points were found mainly in the trapezius muscles in thirteen patients. Their presence was accompanied by increased pain intensity, decreased muscle strength, increased resting sEMG amplitude, and decreased sEMG amplitude during muscle contraction. eEMG revealed characteristic asynchronous discharges in TRPs. The results of EMG examinations point to a complexity of muscle pain that depends on progression of the myofascial syndrome.

  10. Changes in muscle activity determine progression of clinical symptoms in patients with chronic spine-related muscle pain. A complex clinical and neurophysiological approach

    PubMed Central

    Wytra̦żek, Marcin; Huber, Juliusz; Lisiński, Przemysław

    Summary Spine-related muscle pain can affect muscle strength and motor unit activity. This study was undertaken to investigate whether surface electromyographic (sEMG) recordings performed during relaxation and maximal contraction reveal differences in the activity of muscles with or without trigger points (TRPs). We also analyzed the possible coexistence of characteristic spontaneous activity in needle electromyographic (eEMG) recordings with the presence of TRPs. Thirty patients with non-specific cervical and back pain were evaluated using clinical, neuroimaging and electroneurographic examinations. Muscle pain was measured using a visual analog scale (VAS), and strength using Lovett’s scale; trigger points were detected by palpation. EMG was used to examine motor unit activity. Trigger points were found mainly in the trapezius muscles in thirteen patients. Their presence was accompanied by increased pain intensity, decreased muscle strength, increased resting sEMG amplitude, and decreased sEMG amplitude during muscle contraction. eEMG revealed characteristic asynchronous discharges in TRPs. The results of EMG examinations point to a complexity of muscle pain that depends on progression of the myofascial syndrome PMID:22152435

  11. Clinical and microbiological investigations of typhoid fever in an infectious disease hospital in Kuwait.

    PubMed

    Dimitrov, Tsonyo; Udo, Eded E; Albaksami, Ossama; Al-Shehab, Shehab; Kilani, Abdal; Shehab, Medhat; Al-Nakkas, Aref

    2007-04-01

    A retrospective analysis of 135 typhoid cases was conducted to review the clinical, epidemiological and microbiological characteristics of enteric fever cases diagnosed and treated at the Infectious Diseases Hospital, Kuwait, from 2002 to 2005. Diagnosis of patients was based on clinical features, serology and blood culture. The susceptibility testing of the isolates to ampicillin, chloramphenicol, trimethoprim-sulfamethoxazole, ceftriaxone, ciprofloxacin and nalidixic acid was performed by the disc diffusion method, and MICs of ceftriaxone and ciprofloxacin were determined by Etest. Of 135 typhoid fever patients, 108 (88 %) were treated with ceftriaxone and 27 (20 %) were treated with ciprofloxacin. The mean time for fever defervescence with ciprofloxacin therapy was 8 days and 6.3 days for those treated with ceftriaxone. Of the 135 Salmonella enterica serotypes Typhi and Paratyphi A isolated from patients, 50 (37 %) were multidrug resistant (MDR) and 94 (69.6 %) isolates of both serotypes were nalidixic acid resistant (NAR). Between 90 and 100 % of MDR and NAR strains had decreased susceptibility to ciprofloxacin (0.125-1 microg ml(-1)). Low-level resistance to ciprofloxacin (MIC 0.125-1 microg ml(-1)) was also detected in 13.8 and 33.3 % of nalidixic acid-susceptible isolates of S. Typhi and S. Paratyphi A, respectively. All isolates were susceptible to ceftriaxone. Two relapses occurred in the ciprofloxacin-treated group. MDR strains and strains resistant to ciprofloxacin and ceftriaxone are a major threat in the developing world. A situation is fast approaching where the emergence of highly resistant Salmonella isolates is quite likely. Proper steps must be taken to avoid a pandemic spread of MDR S. Typhi strains. PMID:17374897

  12. Assessing the Effectiveness of Parent-Child Interaction Therapy with Language Delayed Children: A Clinical Investigation

    ERIC Educational Resources Information Center

    Falkus, Gila; Tilley, Ciara; Thomas, Catherine; Hockey, Hannah; Kennedy, Anna; Arnold, Tina; Thorburn, Blair; Jones, Katie; Patel, Bhavika; Pimenta, Claire; Shah, Rena; Tweedie, Fiona; O'Brien, Felicity; Leahy, Ruth; Pring, Tim

    2016-01-01

    Parent-child interaction therapy (PCIT) is widely used by speech and language therapists to improve the interactions between children with delayed language development and their parents/carers. Despite favourable reports of the therapy from clinicians, little evidence of its effectiveness is available. We investigated the effects of PCIT as…

  13. 76 FR 18558 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-04

    ... (e.g., drugs, biological products, devices) in emergency settings when an exception from the informed... planning and conducting community consultation and public disclosure activities, and the establishment of..., conduct, and oversight of research involving FDA-regulated products (e.g., drugs, biological...

  14. A Clinical Drug Library Screen Identifies Tosufloxacin as Being Highly Active against Staphylococcus aureus Persisters

    PubMed Central

    Niu, Hongxia; Cui, Peng; Yee, Rebecca; Shi, Wanliang; Zhang, Shuo; Feng, Jie; Sullivan, David; Zhang, Wenhong; Zhu, Bingdong; Zhang, Ying

    2015-01-01

    To identify effective compounds that are active against Staphylococcus aureus (S. aureus) persisters, we screened a clinical drug library consisting of 1524 compounds and identified six drug candidates that had anti-persister activity: tosufloxacin, clinafloxacin, sarafloxacin, doxycycline, thiostrepton, and chlorosalicylanilide. Among them, tosufloxacin had the highest anti-persister activity, which could completely eradicate S. aureus persisters within 2 days in vitro. Clinafloxacin ranked the second with very few persisters surviving the drug exposure. Interestingly, we found that both tosufloxacin and trovafloxacin that had high activity against persisters contained at the N-1 position the 2,4-difluorophenyl group, which is absent in other less active quinolones and may be associated with the high anti-persister activity. Further studies are needed to evaluate tosufloxacin in animal models and to explain its unique activity against bacterial persisters. Our findings may have implications for improved treatment of persistent bacterial infections. PMID:27025627

  15. An investigation on the anticandidal activity of some traditional medicinal plants in Turkey.

    PubMed

    Yiğit, Demet; Yiğit, Nimet; Ozgen, Ufuk

    2009-03-01

    Methanol and chloroform extracts obtained from eight plant species belonging to six families, which were selected depending on their use in Turkish folk medicine, including Mentha longifolia L. (Labiatae), Mentha piperita L. Hudson (Labiatae), Prongos ferulaceae (Umbelliferae), Galium verum L. (Rubiaceae), Salvia limbata C. A Meyer (Labiatae), Artemisia austriaca Jacq. (Artemiceae), Plantago lanceolata L. (Plantaginaceae) and Urtica dioica L. (Urticaceae) were evaluated for their in vitro anticandidal activity. The anticandidal activity of extracts against 99 human pathogenic clinical isolates belonging to 35 Candida albicans, 33 Candida tropicalis and 31 Candida glabrata and standard strains of Candida spp. (C. albicans ATCC 10231, C. glabrata ATCC 80030 and C. tropicalis ATCC 22019) were tested by disc diffusion method and the active extracts were assayed for the minimal inhibitory concentration (MIC). Chloroform extracts of plants have no inhibitory effect against both clinical and standard strains of Candida spp., whereas methanol extracts exhibited good activity. Among the plants tested, M. piperita showed the highest anticandidal activity with 12.3 mm inhibition zone and 1.25 mg ml(-1) MIC value against C. albicans, M. longifolia, P. lanceolata and A. austriaca also displayed activity against C. albicans and C. tropicalis. PMID:18522697

  16. An investigation on the anticandidal activity of some traditional medicinal plants in Turkey.

    PubMed

    Yiğit, Demet; Yiğit, Nimet; Ozgen, Ufuk

    2009-03-01

    Methanol and chloroform extracts obtained from eight plant species belonging to six families, which were selected depending on their use in Turkish folk medicine, including Mentha longifolia L. (Labiatae), Mentha piperita L. Hudson (Labiatae), Prongos ferulaceae (Umbelliferae), Galium verum L. (Rubiaceae), Salvia limbata C. A Meyer (Labiatae), Artemisia austriaca Jacq. (Artemiceae), Plantago lanceolata L. (Plantaginaceae) and Urtica dioica L. (Urticaceae) were evaluated for their in vitro anticandidal activity. The anticandidal activity of extracts against 99 human pathogenic clinical isolates belonging to 35 Candida albicans, 33 Candida tropicalis and 31 Candida glabrata and standard strains of Candida spp. (C. albicans ATCC 10231, C. glabrata ATCC 80030 and C. tropicalis ATCC 22019) were tested by disc diffusion method and the active extracts were assayed for the minimal inhibitory concentration (MIC). Chloroform extracts of plants have no inhibitory effect against both clinical and standard strains of Candida spp., whereas methanol extracts exhibited good activity. Among the plants tested, M. piperita showed the highest anticandidal activity with 12.3 mm inhibition zone and 1.25 mg ml(-1) MIC value against C. albicans, M. longifolia, P. lanceolata and A. austriaca also displayed activity against C. albicans and C. tropicalis.

  17. ASSESSMENT OF UPPER EXTREMITY IMPAIRMENT, FUNCTION, AND ACTIVITY FOLLOWING STROKE: FOUNDATIONS FOR CLINICAL DECISION MAKING

    PubMed Central

    Lang, Catherine E.; Bland, Marghuretta D.; Bailey, Ryan R.; Schaefer, Sydney Y.; Birkenmeier, Rebecca L.

    2012-01-01

    The purpose of this review is to provide a comprehensive approach for assessing the upper extremity (UE) after stroke. First, common upper extremity impairments and how to assess them are briefly discussed. While multiple UE impairments are typically present after stroke, the severity of one impairment, paresis, is the primary determinant of UE functional loss. Second, UE function is operationally defined and a number of clinical measures are discussed. It is important to consider how impairment and loss of function affect UE activity outside of the clinical environment. Thus, this review also identifies accelerometry as an objective method for assessing UE activity in daily life. Finally, the role that each of these levels of assessment should play in clinical decision making is discussed in order to optimize the provision of stroke rehabilitation services. PMID:22975740

  18. Two preclinical tests to evaluate anticancer activity and to help validate drug candidates for clinical trials

    PubMed Central

    López-Lázaro, Miguel

    2015-01-01

    Current approaches to assessing preclinical anticancer activity do not reliably predict drug efficacy in cancer patients. Most of the compounds that show remarkable anticancer effects in preclinical models actually fail when tested in clinical trials. We blame these failures on the complexity of the disease and on the limitations of the preclinical tools we require for our research. This manuscript argues that this lack of clinical response may also be caused by poor in vitro and in vivo preclinical designs, in which cancer patients' needs are not fully considered. Then, it proposes two patient-oriented tests to assess in vitro and in vivo anticancer activity and to help validate drug candidates for clinical evaluation. PMID:25859551

  19. Recruitment and Enrollment of Caregivers for a Lifestyle Physical Activity Clinical Trial

    PubMed Central

    Etkin, Caryn D.; Farran, Carol J.; Barnes, Lisa L.; Shah, Raj C.

    2013-01-01

    This paper presents the efficacy of the recruitment framework used for a clinical trial with sedentary family caregivers of persons with Alzheimer’s disease. An integrated social marketing approach with principles of community-based participatory research provided the theoretical framework for organizing recruitment activities. This multi-pronged approach meant that caregivers were identified from a range of geographic locations and numerous sources including a federally funded Alzheimer’s disease center, health care providers, community based and senior organizations, and broad-based media. Study enrollment projections were exceeded by 11% and resulted in enrolling N = 211 caregivers into this clinical trial. We conclude that social marketing and community-based approaches provide a solid foundation for organizing recruitment activities for clinical trials with older adults. PMID:22083931

  20. Recruitment and enrollment of caregivers for a lifestyle physical activity clinical trial.

    PubMed

    Etkin, Caryn D; Farran, Carol J; Barnes, Lisa L; Shah, Raj C

    2012-02-01

    This article presents the efficacy of the recruitment framework used for a clinical trial with sedentary family caregivers of persons with Alzheimer's disease. An integrated social marketing approach with principles of community-based participatory research provided the theoretical framework for organizing recruitment activities. This multi-pronged approach meant that caregivers were identified from a range of geographic locations and numerous sources including a federally funded Alzheimer's disease center, health care providers, community based and senior organizations, and broad-based media. Study enrollment projections were exceeded by 11% and resulted in enrolling n = 211 caregivers into this clinical trial. We conclude that social marketing and community-based approaches provide a solid foundation for organizing recruitment activities for clinical trials with older adults. PMID:22083931

  1. Stock Market Returns and Clinical Trial Results of Investigational Compounds: An Event Study Analysis of Large Biopharmaceutical Companies

    PubMed Central

    Hwang, Thomas J.

    2013-01-01

    Background 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. Methods 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. Results 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. Conclusions The release of clinical trial results is an economically significant event and has meaningful effects on market value for large biopharmaceutical companies. Stock return

  2. Factors Related to Healthy Diet and Physical Activity in Hospital-Based Clinical Nurses.

    PubMed

    Albert, Nancy M; Butler, Robert; Sorrell, Jeanne

    2014-09-30

    Hospitals often promote healthy lifestyles, but little is known about nurses' actual diet and physical activity. Greater understanding about these lifestyle choices for clinical nurses may improve existing hospital-based programs and/or create desirable services. This article discusses a study that considered diet and physical activity of clinical nurses, using elements of Pender's self-care theory as a conceptual framework. Study methods included a cross-sectional, correlational design and a convenience sample of 278 nurses who worked on units with 24 hours/day and seven days-per-week responsibilities. Participants completed diet and exercise questionnaires about perceptions of attitudes and opinions, barriers, diet benefits/exercise motivators, self-efficacy, and locus of control, and personal and work characteristics. Diet and activity categories were created. Study results demonstrated that over 50% of nurses had moderately healthy diets but were insufficiently active. Healthy diet and physical activity levels were associated with higher self-efficacy, more diet benefits and physical activity motivators, fewer perceived barriers, and confidence in body image. The article discussion and conclusion sections note areas for future research and suggest that focused interventions that address benefits, motivators, and self-efficacy may increase participation in hospital-based programs and enhance healthy lifestyle for hospital-based clinical nurses.

  3. Reductions in disease activity in the AMPLE trial: clinical response by baseline disease duration

    PubMed Central

    Schiff, Michael; Weinblatt, Michael E; Valente, Robert; Citera, Gustavo; Maldonado, Michael; Massarotti, Elena; Yazici, Yusuf; Fleischmann, Roy

    2016-01-01

    Objectives To evaluate clinical response by baseline disease duration using 2-year data from the AMPLE trial. Methods Patients were randomised to subcutaneous abatacept 125 mg weekly or adalimumab 40 mg bi-weekly, with background methotrexate. As part of a post hoc analysis, the achievement of validated definitions of remission (Clinical Disease Activity Index (CDAI) ≤2.8, Simplified Disease Activity Index (SDAI) ≤3.3, Routine Assessment of Patient Index Data 3 (RAPID3) ≤3.0, Boolean score ≤1), low disease activity (CDAI <10, SDAI <11, RAPID3 ≤6.0), Health Assessment Questionnaire-Disability Index response and American College of Rheumatology responses were evaluated by baseline disease duration (≤6 vs >6 months). Disease Activity Score 28 (C-reactive protein) <2.6 or ≤3.2 and radiographic non-progression in patients achieving remission were also evaluated. Results A total of 646 patients were randomised and treated (abatacept, n=318; adalimumab, n=328). In both treatment groups, comparable responses were achieved in patients with early rheumatoid arthritis (≤6 months) and in those with later disease (>6 months) across multiple clinical measures. Conclusions Abatacept or adalimumab with background methotrexate were associated with similar onset and sustainability of response over 2 years. Patients treated early or later in the disease course achieved comparable clinical responses. Trial registration number NCT00929864, Post-results. PMID:27110385

  4. In Vitro Activities of Garenoxacin (BMS 284756) against 108 Clinical Isolates of Gardnerella vaginalis

    PubMed Central

    Goldstein, Ellie J. C.; Citron, Diane M.; Merriam, C. Vreni; Warren, Yumi A.; Tyrrell, Kerin L.; Fernandez, Helen T.

    2002-01-01

    Garenoxacin (BMS 284756) was active against 105 of 108 (97%) recent clinical Gardnerella vaginalis isolates at ≤2 μg/ml by using the reference agar dilution method for anaerobes. Twenty-eight percent of isolates (31 of 108) were resistant to metronidazole, and 44% were resistant to doxycycline. All were susceptible to clindamycin and ampicillin-sulbactam. PMID:12435709

  5. Risk Factors for Clinically Significant Intimate Partner Violence among Active-Duty Members

    ERIC Educational Resources Information Center

    Smith Slep, Amy M.; Foran, Heather M.; Heyman, Richard E.; Snarr, Jeffery D.

    2011-01-01

    Hypothesized risk factors for men's and women's clinically significant intimate partner violence (CS-IPV) from four ecological levels (i.e., individual, family, workplace, community) were tested in a representative sample of active-duty U.S. Air Force members (N = 42,744). When considered together, we expected only individual and family factors to…

  6. 75 FR 34142 - Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-16

    ... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Study of Clinical Efficacy Information in Professional Labeling and Direct-to... on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act...

  7. Clinical Study of Student Learning Using Mastery Style versus Immediate Feedback Online Activities

    ERIC Educational Resources Information Center

    Gladding, Gary; Gutmann, Brianne; Schroeder, Noah; Stelzer, Timothy

    2015-01-01

    This paper is part of a series of studies to improve the efficacy of online physics homework activities by integrating narrated animated solutions with mastery inspired exercises. In a clinical study using first- and second-year university students, the mastery group attempted question sets in four levels, with animated solutions between each…

  8. Antimicrobial activity of propolis special extract GH 2002 against multidrug-resistant clinical isolates.

    PubMed

    Astani, A; Zimmermann, S; Hassan, E; Reichling, J; Sensch, K H; Schnitzler, P

    2013-08-01

    The need to discover and develop alternative therapies to treat multidrug-resistant bacterial infections is timely. The aim of this study was to examine the antimicrobial potential of propolis, as a purified and concentrated special extract GH 2002, against clinical isolates of Streptococcus pyogenes, methicillin-resistent Stapylococcus aureus (MRSA), vancomycin-resistant Enterococcus faecium (VRE) and Candida. Minimal inhibitory concentrations (MICs) and minimal microbicidial concentrations (MMCs) of propolis against microbial pathogens were evaluated using the broth microdilution method. Propolis extract GH 2002 revealed low MICs in the range of 0.03 to 2 mg/ml against S. pyogenes, S. aureus, E. faecium and Candida. A high bactericidal activity of propolis extract in the range of 0.06 to 1.0 mg/ml was determined for S. pyogenes and S. aureus, however propolis was not bactericidal against E. faecium. Propolis concentrations between 0.6 and 2.4 mg/ml displayed fungicidal activity against different Candida species. Whereas all tested MRSA strains were highly susceptible against propolis, only minor activity was found against VRE strains. Time-kill curves demonstrated a high antimicrobial activity at low MICs already after few hours of incubation against reference strains, clinical antibiotic-susceptible strains, clinical antifungal susceptible strains as well as all tested clinical MRSA strains, but not against VRE strains. In conclusion, clinical drug-sensitive as well as some clinical multidrug-resistant microbial isolates, i.e. MRSA, were susceptible to propolis with different degrees of susceptibility. These results suggest that the special propolis extract GH2002 might be used in the development of alternative products for therapy of microbial infections.

  9. A clinical investigation of the efficacy of a tooth-whitening gel.

    PubMed

    Sielski, Chester; Conforti, Nicholas; Stewart, Bernal; Chaknis, Pat; Petrone, Margaret E; DeVizio, William; Volpe, Anthony R; Proskin, Howard M

    2003-08-01

    The objective of this randomized, controlled, examiner-blind, parallel-group clinical study was to determine whether a tooth-whitening gel (Colgate Simply White Night Clear Whitening Gel) can significantly lighten teeth when used once daily at night, as compared with a commercially available dentifrice. Following a baseline tooth shade evaluation using the VITA Shade Guide, qualifying adult male and female subjects from the Buffalo, New York area were randomized into 2 treatment groups, which were balanced for baseline VITA Shade Guide scores, gender, and age. The treatment groups were: (1) a commercially available dentifrice only; and (2) a tooth-whitening gel in addition to a commercially available dentifrice. Subjects assigned to the 2 groups were given the dentifrice and a soft-bristled toothbrush. In addition, subjects in one of the groups were given the tooth-whitening gel. All subjects were instructed to brush their teeth for 1 minute twice daily (morning and evening) with the dentifrice. The subjects in the group also using the tooth-whitening gel were further instructed to apply the gel once daily at night, as per manufacturer instructions. Evaluations of tooth shade for each subject were repeated after 2 weeks, and again after 3 weeks of product use. In addition, evaluations of tooth shade for subjects using the tooth-whitening gel were later conducted at 6 months after product use. Seventy-five subjects complied with the protocol and completed the study. At the 2-week and 3-week examinations, subjects using the tooth-whitening gel and dentifrice exhibited statistically significant (P < .05) tooth shade lightening relative to baseline tooth shade. Furthermore, at the 2-week and 3-week examinations, subjects using the tooth-whitening gel exhibited statistically significant (P < .05) tooth shade lightening relative to subjects using only the dentifrice. In addition, the 6-month-postuse examination showed that subjects using the tooth-whitening gel exhibited

  10. Use of artificial stomach-duodenum model for investigation of dosing fluid effect on clinical trial variability.

    PubMed

    Polster, Christopher S; Atassi, Faraj; Wu, Sy-Juen; Sperry, David C

    2010-10-01

    Lilly Compound X (LCX) is an oncology drug that was tested in a phase I clinical study using starch blend capsules. The drug was given to a small patient population (4 patients) and showed large inter- and intra-patient variability. In order to evaluate the possible effect of stomach pH on exposure and ways to mitigate the variability issue, artificial stomach-duodenum (ASD) experiments were conducted to investigate the hypothesis that carefully selected dosing fluids would have an impact in minimizing exposure variability caused by the formulation, which could lead to more consistent evaluation of drug absorption in patients. The ASD data corroborates the observed variability, and was a good tool to investigate the effect of stomach pH and potential dosing solutions on duodenal concentrations. Administering capsules co-formulated with Captisol (10% drug load) along with Sprite was shown by the ASD to be an effective way to increase duodenal concentrations as well as to reduce the difference between duodenal concentrations for different gastric pH. The reduction in variability of duodenum AUC (in ASD) is expected to correlate well with a reduction of variability in patient exposure. The dosing regimen of Sprite/Captisol is therefore suggested for future clinical trials involving LCX. Furthermore, for design of early phase clinical trials, ASD technology can be used to assist in choosing the proper dosing solution to mitigate absorption and exposure variability issues. PMID:20669969

  11. Simulating an investigative study of clinical cancer samples: use of tissue slides and PCR-based promoter-hypermethylation analysis.

    PubMed

    Chew, Yuan Yuan; Chin, Cheen Fei; Yeong, Foong May

    2015-01-01

    Topics on the molecular basis underlying cancer are quite popular among students. Also, excellent textbooks abound that provide interesting materials for discussion during lectures and tutorials about major events leading to cancer formation and progression. However, much less is available for students to conduct experiments for the analysis of cancer samples in undergraduate modules where there is a limited time-frame. Given the difficulty of working with cancer samples and the scarcity of good samples even in the clinical laboratories, it is impossible to run large-class practicals using patients' samples. Here, we describe the use of tissue slides in combination with polymerase-chain reaction (PCR) as a means of simulating an investigative approach to supplement students' learning of clinical research. By using tissue slides for histo-pathological examinations and specific budding yeast genomic DNA and primers adapted to demonstrate methylation-specific PCR, we designed an inquiry-based lab session to simulate the clinical investigation of a cohort of biopsies that students could analyze in a one-session practical.

  12. Implementation of objective activity monitoring to supplement the interpretation of ambulatory esophageal PH investigations.

    PubMed

    Kwasnicki, R M; Ley Greaves, R; Ali, R; Gummett, P A; Yang, G Z; Darzi, A; Hoare, J

    2016-04-01

    Conventional catheter-based systems used for ambulatory esophageal pH monitoring have been reported to affect patient behavior. As physical activity has been associated with gastroesophageal reflux disease (GERD), there is a risk that abnormal behavior will degrade the value of this diagnostic investigation and consequent management strategies. The aim of this study was to quantify the effect of conventional pH monitoring on behavior and to investigate the temporal association between activity and reflux. A total of 20 patients listed for 24 hours pH monitoring underwent activity monitoring using a lightweight ear-worn accelerometer (e-AR sensor, Imperial College London) 2 days prior to, and during their investigation. PH was measured and recorded using a conventional nasogastric catheter and waist-worn receiver. Daily activity levels, including subject-specific activity intensity quartiles, were calculated and compared. Physical activity was added to the standard pH output to supplement interpretation. Average patient activity levels decreased by 26.5% during pH monitoring (range -4.5 to 51.0%, P = 0.036). High-intensity activity decreased by 24.4% (range -4.0 to 75.6%, P = 0.036), and restful activity increased on average by 34% although this failed to reach statistical significance (-24.0 to 289.2%, P = 0.161). Some patients exhibited consistent associations between bouts of activity and acidic episodes. The results of this study support the previously reported reduction in activity during ambulatory esophageal pH monitoring, with the added reliability of objective data. In the absence of more pervasive pH monitoring systems (e.g. wireless), quantifying activity changes in the setting of activity-induced reflux might guide the physicians' interpretation of patient DeMeester scores resulting in more appropriate management of GERD.

  13. Clinical Assessment and Management of Spondyloarthritides in the Middle East: A Multinational Investigation

    PubMed Central

    Hammoudeh, Mohammed; Al Rayes, Hanan; Gado, Kamel; Shirazy, Khalid; Deodhar, Atul

    2015-01-01

    Data on spondyloarthritis (SpA) from the Middle East are sparse and the management of these diseases in this area of the world faces a number of challenges, including the relevant resources to enable early diagnosis and referral and sufficient funds to aid the most appropriate treatment strategy. The objective was to report on the characteristics, disease burden, and treatment of SpA in the Middle East region and to highlight where management strategies could be improved, with the overall aim of achieving better patient outcomes. This multicenter, observational, cross-sectional study collected demographic, clinical, laboratory, and treatment data on 169 consecutive SpA patients at four centers (Egypt, Kuwait, Qatar, and Saudi Arabia). The data collected presents the average time from symptom onset to diagnosis along with the presence of comorbidities in the region and comparisons between treatment with NSAIDs and biologics. In the absence of regional registries of SpA patients, the data presented here provide a rare snapshot of the characteristics, disease burden, and treatment of these patients, highlighting the management challenges in the region. PMID:26793241

  14. Pressure Drop in Tortuosity/Kinking of the Internal Carotid Artery: Simulation and Clinical Investigation

    PubMed Central

    Wang, Lijun; Zhao, Feng; Wang, Daming; Hu, Shen; Liu, Jiachun; Zhou, Zhilun; Lu, Jun; Qi, Peng; Song, Shiying

    2016-01-01

    Background. Whether carotid tortuosity/kinking of the internal carotid artery leads to cerebral ischemia remains unclear. There is very little research about the hemodynamic variation induced by carotid tortuosity/kinking in the literature. The objective of this study was to research the blood pressure changes induced by carotid tortuosity/kinking. Methods. We first created a geometric model of carotid tortuosity/kinking. Based on hemodynamic boundary conditions, the hemodynamics of carotid tortuosity and kinking were studied via a finite element simulation. Then, an in vitro system was built to validate the numerical simulation results. The mean arterial pressure changes before and after carotid kinking were measured using pressure sensors in 12 patients with carotid kinking. Results. Numerical simulation revealed that the pressure drops increased with increases in the kinking angles. Clinical tests and in vitro experiments confirmed the numerical simulation results. Conclusions. Carotid kinking leads to blood pressure reduction. In certain conditions, kinking may affect the cerebral blood supply and be associated with cerebral ischemia. PMID:27195283

  15. Investigation of vibration-induced artifact in clinical diffusion-weighted imaging of pediatric subjects.

    PubMed

    Berl, Madison M; Walker, Lindsay; Modi, Pooja; Irfanoglu, M Okan; Sarlls, Joelle E; Nayak, Amritha; Pierpaoli, Carlo

    2015-12-01

    It has been reported that mechanical vibrations of the magnetic resonance imaging scanner could produce spurious signal dropouts in diffusion-weighted images resulting in artifactual anisotropy in certain regions of the brain with red appearance in the Directionally Encoded Color maps. We performed a review of the frequency of this artifact across pediatric studies, noting differences by scanner manufacturer, acquisition protocol, as well as weight and position of the subject. We also evaluated the ability of automated and quantitative methods to detect this artifact. We found that the artifact may be present in over 50% of data in certain protocols and is not limited to one scanner manufacturer. While a specific scanner had the highest incidence, low body weight and positioning were also associated with appearance of the artifact for both scanner types evaluated, making children potentially more susceptible than adults. Visual inspection remains the best method for artifact identification. Software for automated detection showed very low sensitivity (10%). The artifact may present inconsistently in longitudinal studies. We discuss a published case report that has been widely cited and used as evidence to set policy about diagnostic criteria for determining vegetative state. That report attributed longitudinal changes in anisotropy to white matter plasticity without considering the possibility that the changes were caused by this artifact. Our study underscores the need to check for the presence of this artifact in clinical studies, analyzes circumstances for when it may be more likely to occur, and suggests simple strategies to identify and potentially avoid its effects.

  16. Clinicians' emotional responses and Psychodynamic Diagnostic Manual adult personality disorders: A clinically relevant empirical investigation.

    PubMed

    Gazzillo, Francesco; Lingiardi, Vittorio; Del Corno, Franco; Genova, Federica; Bornstein, Robert F; Gordon, Robert M; McWilliams, Nancy

    2015-06-01

    The aim of this study is to explore the relationship between level of personality organization and type of personality disorder as assessed with the categories in the Psychodynamic Diagnostic Manual (PDM; PDM Task Force, 2006) and the emotional responses of treating clinicians. We asked 148 Italian clinicians to assess 1 of their adult patients in treatment for personality disorders with the Psychodiagnostic Chart (PDC; Gordon & Bornstein, 2012) and the Personality Diagnostic Prototype (PDP; Gazzillo, Lingiardi, & Del Corno, 2012) and to complete the Therapist Response Questionnaire (TRQ; Betan, Heim, Zittel-Conklin, & Westen, 2005). The patients' level of overall personality pathology was positively associated with helpless and overwhelmed responses in clinicians and negatively associated with positive emotional responses. A parental and disengaged response was associated with the depressive, anxious, and dependent personality disorders; an exclusively parental response with the phobic personality disorder; and a parental and criticized response with narcissistic disorder. Dissociative disorder evoked a helpless and parental response in the treating clinicians whereas somatizing disorder elicited a disengaged reaction. An overwhelmed and disengaged response was associated with sadistic and masochistic personality disorders, with the latter also associated with a parental and hostile/criticized reaction; an exclusively overwhelmed response with psychopathic patients; and a helpless response with paranoid patients. Finally, patients with histrionic personality disorder evoked an overwhelmed and sexualized response in their clinicians whereas there was no specific emotional reaction associated with the schizoid and the obsessive-compulsive disorders. Clinical implications of these findings were discussed.

  17. A Mixed-methods Investigation of Sensory Response Patterns in Barth Syndrome: A Clinical Phenotype?

    PubMed Central

    Reynolds, Stacey; Kreider, Consuelo; Bendixen, Roxanna

    2012-01-01

    Barth syndrome is a genetic disorder that affects approximately 1/500,000 boys each year. While treatment of medical complications associated with Barth is of primary importance, there is a concomitant need to look at behavioral and clinical features of the disorder. The purpose of this study was to examine the prevalence of atypical sensory processing in 21 boys with Barth syndrome and to explore if phenotypic patterns of sensory responsiveness may be useful in early diagnosis. Using a mixed methods approach, we found that sensory issues related to feeding and eating were ubiquitous in our sample, with some behaviors such as strong gag reflex identifiable early in development. Specifically, boys with Barth had a strong preference for salty, cheesy, and spicy foods while having an overall restricted repertoire of foods they would eat (e.g. picky eaters). In boys with Barth as they age, auditory sensitivity and auditory filtering issues also emerged as potential sensory-related behaviors affecting academic performance and participation. Overall, this study suggests that early identification of sensory patterns in Barth may assist in differential diagnosis and create opportunities for early interventions that may minimize the impact of these behaviors on function and participation. PMID:22711649

  18. Performance and specificity rates in the Test of Memory Malingering: an investigation into pediatric clinical populations.

    PubMed

    Loughan, Ashlee R; Perna, Robert

    2014-01-01

    Symptom validity tests are becoming standard as an effort measure during pediatric neuropsychological assessment. An important component of symptom validity test use is understanding limitations of these measures and how select clinical groups may have difficulty with them. Research has begun to clarify the limits of the Test of Memory Malingering (TOMM) with diverse childhood diagnoses. This study compared TOMM scores of children (N = 86) classified with common childhood disorders. Findings suggest that a substantial proportion of children performed below the recommended cutoff score of 45 on Trial 2 and attained varied specificity rates. This included children with conduct disorders (85%), affective disorders (92%), traumatic brain injury (83%), attention-deficit hyperactivity disorder (93%), learning disabilities (100%), and pervasive developmental disorder (88%). The group with the most children scoring below the cutoff was children with intellectual disabilities (76%). This finding is consistent with some of the adult research suggesting that very limited cognitive ability may compromise TOMM performance. Caution may be necessary when drawing conclusions about test-taking effort based on the recommended TOMM cutoff scores when evaluating children with disabilities. PMID:24236938

  19. Clinical experience and laboratory investigations in patients with anti-NMDAR encephalitis

    PubMed Central

    Dalmau, Josep; Lancaster, Eric; Martinez-Hernandez, Eugenia; Rosenfeld, Myrna R; Balice-Gordon, Rita

    2011-01-01

    Since its discovery in 2007, the encephalitis associated with antibodies against the N-methyl-D-aspartate receptor (NMDAR) has entered the mainstream of neurology and other disciplines. Most patients with anti-NMDAR encephalitis develop a multistage illness that progresses from psychosis, memory deficits, seizures, and language disintegration into a state of unresponsiveness with catatonic features often associated with abnormal movements, and autonomic and breathing instability. The disorder predominantly affects children and young adults, occurs with or without tumour association, and responds to treatment but can relapse. The presence of a tumour (usually an ovarian teratoma) is dependent on age, sex, and ethnicity, being more frequent in women older than 18 years, and slightly more predominant in black women than it is in white women. Patients treated with tumour resection and immunotherapy (corticosteroids, intravenous immunoglobulin, or plasma exchange) respond faster to treatment and less frequently need second-line immunotherapy (cyclophosphamide or rituximab, or both) than do patients without a tumour who receive similar initial immunotherapy. More than 75% of all patients have substantial recovery that occurs in inverse order of symptom development and is associated with a decline of antibody titres. Patients’ antibodies cause a titre-dependent, reversible decrease of synaptic NMDAR by a mechanism of crosslinking and internalisation. On the basis of models of pharmacological or genetic disruption of NMDAR, these antibody effects reveal a probable pathogenic relation between the depletion of receptors and the clinical features of anti-NMDAR encephalitis. PMID:21163445

  20. Pilot clinical study to investigate the human whole blood spectrum characteristics in the sub-THz region.

    PubMed

    Tseng, Tzu-Fang; You, Borwen; Gao, Hao-Cheng; Wang, Tzung-Dau; Sun, Chi-Kuang

    2015-04-01

    We have conducted a pilot clinical study to not only investigate the sub-THz spectra of ex-vivo fresh human whole blood of 28 patients following 8-hours fasting guideline, but also to find out the critical blood ingredients of which the concentration dominantly affects those sub-THz spectra. A great difference between the sub-THz absorption properties of human blood among different people was observed, while the difference can be up to ~15% of the averaged absorption coefficient of the 28 samples. Our pilot clinical study indicates that triglycerides and the number of red blood cells were two dominant factors to have significant negative correlation to the sub-THz absorption coefficients. PMID:25968774

  1. [On the antipyretic effect of paracetamol. Clinical investigation with two different forms of application (author's transl)].

    PubMed

    Götte, R; Liedtke, R

    1978-01-01

    144 children, aged between 15 days and 12 years, suffering from febrile condition of various etiology, were treated with differentiated single doses of paracetamol (N-acetyl-p-aminophenol) in form of syrup, suppositories and a combination of syrup with the antihistamine doxylaminsuccinate. During investigation periods of four hours, applying reduced doses, the syrup application showed the same antipyretic effects as those obtained with paracetamol suppositories. When administering the combination with doxylaminsuccinate, the antipyretic effect was reduced and the psychomotoric superactivity did not improve. A control of the actual rectal dosage scheme for repetitive applications is recommended and the combination of paracetamol with sedatives is to be discussed. PMID:304522

  2. Clinical and epidemiological investigation of a fatal anthrax case in China.

    PubMed

    Chen, Haiying; Bao, Wanguo; Wang, Yang; Zhang, Kaiyu; Wang, Feng

    2015-02-19

    Anthrax is a recessive infectious disease caused by the bacterium Bacillus anthracis, and is primarily a zoonotic disease. Until recently, Bacillus anthracis infections were relatively infrequent and confined to agrarian communities in underdeveloped countries. No anthrax cases were reported in Changchun City in the past few decades until a male patient from the Inner Mongolia Autonomous Region presented the anthrax disease manifestation. This paper describes an anthrax patient's diagnosis, isolation and treatment which involved institutions in two different Chinese provinces; the foci epidemiological investigation alongside with the outbreak management process, which is of great significance to control the spread of the recessive infection is also described.

  3. A Method for Utilizing Bivariate Efficacy Outcome Measures to Screen Regimens for Activity in 2-Stage Phase II Clinical Trials

    PubMed Central

    Rubinstein, Larry; Litwin, Samuel; Yothers, Greg

    2012-01-01

    Background Most phase II clinical trials utilize a single primary endpoint to determine the promise of a regimen for future study. However, many disorders manifest themselves in complex ways. For example, migraine headaches can cause pain, auras, photophobia, and emesis. Investigators may believe a drug is effective at reducing migraine pain and the severity of emesis during an attack. Nevertheless, they could still be interested in proceeding with development of the drug if it is effective against only one of these symptoms. Such a study would be a candidate for a clinical trial with co-primary endpoints. Purpose The purpose of the article is to provide a method for designing a 2-stage clinical trial with dichotomous co-primary endpoints of efficacy that has the ability to detect activity on either response measure with high probability when the drug is active on one or both measures, while at the same time rejecting the drug with high probability when there is little activity on both dimensions. The design enables early closure for futility and is flexible with regard to attained accrual. Methods The design is proposed in the context of cancer clinical trials where tumor response is used to assess a drug's ability to kill tumor cells and progression-free survival (PFS) status after a certain period is used to evaluate the drug's ability to stabilize tumor growth. Both endpoints are assumed to be distributed as binomial random variables, and uninteresting probabilities of success are determined from historical controls. Given the necessity of accrual flexibility, exhaustive searching algorithms to find optimum designs do not seem feasible at this time. Instead, critical values are determined for realized sample sizes using specific procedures. Then accrual windows are found to achieve a design's desired level of significance, probability of early termination (PET), and power. Results The design is illustrated with a clinical trial that examined bevacizumab in

  4. Variation in the timing of puberty: clinical spectrum and genetic investigation.

    PubMed

    Palmert, M R; Boepple, P A

    2001-06-01

    Human puberty begins with the reemergence of GnRH secretion from its relative quiescence during childhood, activating a cascade of pituitary-gonadal maturation. This transition begins across a wide range of ages, and the rate of subsequent sexual maturation can be quite varied. The factors that regulate the hypothalamic-pituitary-gonadal axis and modulate the timing of puberty remain elusive, but it is clear that some regulation is under genetic control. Here, we discuss how new advances in genetic research may provide the tools to help unravel this long-standing mystery.

  5. Results and lessons from clinical trials using dietary supplements for cancer: direct and indirect investigations.

    PubMed

    Moyad, M A

    2001-11-01

    Randomized controlled trials are generally regarded as the standard of study designs to determine potential causality. The inclusion of a placebo group in these trials, when appropriate, is generally needed to access the efficacy of a drug or dietary supplement. The recent increasing use of dietary supplements and herbal medications by patients makes it imperative to reevaluate the past findings of clinical studies. Several large-scale trials of dietary supplements have been tested in various populations to determine their effect on cancer prevention. Other trials have focused on patients already diagnosed with cancer. In the latter case, it is difficult to involve a placebo because of the serious nature of the disease. Nevertheless, much has been gleaned from these trials directly and indirectly. Overall, when analyzing primary endpoints in these trials, the results have been discouraging and even support the nonuse of certain supplements because of potential adverse effects. Other secondary endpoints in these same trials have revealed some potential encouraging and discouraging data. Individuals who currently qualify for the potential use of dietary supplements for cancer may be restricted to those who have a deficiency in a certain compound despite adequate dietary sources or lifestyle changes. Those individuals with a smoking history or other unhealthy lifestyle seem to have the most to gain or lose from taking certain dietary supplements for cancer. The time seems more than ripe to evaluate past adequate trials with supplements, such as beta-carotene, N-acetyl-cysteine, selenium, shark cartilage, vitamin C, vitamin E, and others. Again, these studies have been disappointing, but they provide insight for the clinician and patient of what to potentially expect when using these supplements for cancer. In addition, indirect trials for other conditions (cardiovascular) may provide future insight into possible results for future cancer prevention trials.

  6. OCULAR MANIFESTATIONS OF VON HIPPEL–LINDAU DISEASE: CLINICAL AND GENETIC INVESTIGATIONS

    PubMed Central

    Chew, Emily Ying

    2005-01-01

    Purpose To describe the clinical spectrum of lesions involving the visual system in von Hippel–Lindau (VHL) disease, the genetic alterations, and the molecular genetic properties of retinal hemangioblastomas. Methods In this prospective case-series, 406 patients with VHL disease had systemic and ocular evaluations. Genetic mutations within six pathological specimens were evaluated, using microdissection and polymerase chain reaction amplification. Results Half of the 406 patients (199 families) with VHL disease had ocular involvement. Visual acuity was 20/20 or better in 170 patients (84.5%) with hemangioblastomas; six (3%) were legally blind. Thirty-three (8.2%) had unilateral enucleations. Genetic mutations were detected in all VHL patients. The patients with complete deletion were less likely to have ocular VHL compared with those patients with partial deletion, missense, and nonsense mutation (9% versus 45%) (P < .0001), suggesting the importance of the gene or areas of genes on chromosome 3 for the development of retinal hemangioblastomas. The molecular genetic assessments of the pathology specimens showed that the foamy “stromal” cells were affected with the genetic mutations. There is an up-regulation of vascular endothelial growth factor, which was expressed in the ocular lesions. Conclusions In this series, the largest of its kind, patients with ocular lesions of VHL disease are referred mostly from physicians. The systemic genetic mutation evaluations suggest that a certain gene or groups of genes in chromosome 3p are crucial for both the development and maintenance of the retinal tumor. This is the first series to find a difference between the phenotype and genotype. PMID:17057815

  7. [In vitro bactericidal activities of new oral penem, faropenem against the various clinical isolates].

    PubMed

    Matsuzaki, K; Nishiyama, T; Hasegawa, M; Kobayashi, I; Kaneko, A; Sasaki, J

    1999-05-01

    The minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of faropenem (FRPM) more compared with those of various oral beta-lactams against 15 isolates each of 6 species of microorganism. FRPM possessed potent in vitro antibacterial activity against both aerobic and anaerobic Gram-positive bacteria tested. FRPM showed the same activity as new oral cephems such as cefdinir, cefditoren and cefcapene against all Gram-negative bacteria, but K. pneumoniae strains were less susceptible. The MBC of FRPM against S. pneumoniae and the other strains tested equal and were within 1 dilution the MIC of that, respectively. These results suggest that FRPM has excellent in vitro bactericidal activity against clinical isolates and is a clinically useful for the chemotherapy of bacterial infections. PMID:10480050

  8. [Phospholipase, proteinase and hemolytic activities of Candida albicans isolates obtained from clinical specimens].

    PubMed

    Yenişehirli, Gülgün; Bulut, Yunus; Tunçoglu, Ebru

    2010-01-01

    This study was aimed to determine the phospholipase, proteinase and hemolytic activities of Candida albicans strains isolated from clinical specimens. A total of 147 C. albicans strains isolated from blood (n = 29), respiratory specimens (n = 44), urine (n = 52), pus (n = 17) and stool (n = 5) were included in the study. Proteinase and phospholipase activities were determined in 81% and 76% of C. albicans isolates, respectively. All C. albicans isolates revealed beta-hemolytic activity on Sabouraud dextrose agar supplemented with 7% fresh sheep blood and 3% glucose. Phospholipase and proteinase positivity were highest among the respiratory isolates. Proteinase activity of respiratory (93%) and blood (83%) isolates were statistically significantly higher than that of urine (77%; p = 0.032), pus (65%; p = 0.007) and stool isolates (60%; p = 0.026). While phospholipase activity showed statistically significant difference between respiratory (84%) and pus (53%) isolates (p = 0.014), no statistically significant difference was determined for blood (79%), urine (75%) and stool (80%) isolates (p > 0.05). Two blood isolates with 4+ proteinase activity and 3 urine isolates with 3+ proteinase activity were phospholipase negative. One urine isolate with 4+ phospholipase activity and 4 with 3+ phospholipase activity were proteinase negative. Phospholipase and proteinase negative 1 isolate from stool and 1 isolate from pus were found to have 4+ hemolytic activity. In conclusion, besides proteinase and phospholipase enzyme activities, hemolytic activity may play an important role for the C.albicans infections. The pathogenetic role of these virulence factors should be evaluated by further clinical studies.

  9. Cell-associated hemolysis activity in the clinical strain of Pseudomonas fluorescens MFN1032

    PubMed Central

    2010-01-01

    Background MFN1032 is a clinical Pseudomonas fluorescens strain able to grow at 37°C. MFN1032 cells induce necrosis and apoptosis in rat glial cells at this temperature. This strain displays secretion-mediated hemolytic activity involving phospholipase C and cyclolipopeptides. Under laboratory conditions, this activity is not expressed at 37°C. This activity is tightly regulated and is subject to phase variation. Results We found that MFN1032 displays a cell-associated hemolytic activity distinct from the secreted hemolytic activity. Cell-associated hemolysis was expressed at 37°C and was only detected in vitro in mid log growth phase in the presence of erythrocytes. We studied the regulation of this activity in the wild-type strain and in a mutant defective in the Gac two-component pathway. GacS/GacA is a negative regulator of this activity. In contrast to the Pseudomonas fluorescens strains PfO-1 and Pf5, whose genomes have been sequenced, the MFN1032 strain has the type III secretion-like genes hrcRST belonging to the hrpU operon. We showed that disruption of this operon abolished cell-associated hemolytic activity. This activity was not detected in P.fluorescens strains carrying similar hrc genes, as for the P. fluorescens psychrotrophic strain MF37. Conclusions To our knowledge this the first demonstration of cell-associated hemolytic activity of a clinical strain of Pseudomonas fluorescens. Moreover, this activity seems to be related to a functional hrpU operon and is independent of biosurfactant production. Precise link between a functional hrpU operon and cell-associated hemolytic activity remains to be elucidated. PMID:20416103

  10. Tobacco Assessment in Actively Accruing National Cancer Institute Cooperative Group Program Clinical Trials

    PubMed Central

    Peters, Erica N.; Torres, Essie; Toll, Benjamin A.; Cummings, K. Michael; Gritz, Ellen R.; Hyland, Andrew; Herbst, Roy S.; Marshall, James R.; Warren, Graham W.

    2012-01-01

    Purpose Substantial evidence suggests that tobacco use has adverse effects on cancer treatment outcomes; however, routine assessment of tobacco use has not been fully incorporated into standard clinical oncology practice. The purpose of this study was to evaluate tobacco use assessment in patients enrolled onto actively accruing cancer clinical trials. Methods Protocols and forms for 155 actively accruing trials in the National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program were evaluated for tobacco use assessment at enrollment and follow-up by using a structured coding instrument. Results Of the 155 clinical trials reviewed, 45 (29%) assessed any form of tobacco use at enrollment, but only 34 (21.9%) assessed current cigarette use. Only seven trials (4.5%) assessed any form of tobacco use during follow-up. Secondhand smoke exposure was captured in 2.6% of trials at enrollment and 0.6% during follow-up. None of the trials assessed nicotine dependence or interest in quitting at any point during enrollment or treatment. Tobacco status assessment was higher in lung/head and neck trials as well as phase III trials, but there was no difference according to year of starting accrual or cooperative group. Conclusion Most actively accruing cooperative group clinical trials do not assess tobacco use, and there is no observable trend in improvement over the past 8 years. Failure to incorporate standardized tobacco assessments into NCI-funded Cooperative Group Clinical Trials will limit the ability to provide evidence-based cessation support and will limit the ability to accurately understand the precise effect of tobacco use on cancer treatment outcomes. PMID:22689794

  11. Motor programme activating therapy influences adaptive brain functions in multiple sclerosis: clinical and MRI study.

    PubMed

    Rasova, Kamila; Prochazkova, Marie; Tintera, Jaroslav; Ibrahim, Ibrahim; Zimova, Denisa; Stetkarova, Ivana

    2015-03-01

    There is still little scientific evidence for the efficacy of neurofacilitation approaches and their possible influence on brain plasticity and adaptability. In this study, the outcome of a new kind of neurofacilitation approach, motor programme activating therapy (MPAT), was evaluated on the basis of a set of clinical functions and with MRI. Eighteen patients were examined four times with standardized clinical tests and diffusion tensor imaging to monitor changes without therapy, immediately after therapy and 1 month after therapy. Moreover, the strength of effective connectivity was analysed before and after therapy. Patients underwent a 1-h session of MPAT twice a week for 2 months. The data were analysed by nonparametric tests of association and were subsequently statistically evaluated. The therapy led to significant improvement in clinical functions, significant increment of fractional anisotropy and significant decrement of mean diffusivity, and decrement of effective connectivity at supplementary motor areas was observed immediately after the therapy. Changes in clinical functions and diffusion tensor images persisted 1 month after completing the programme. No statistically significant changes in clinical functions and no differences in MRI-diffusion tensor images were observed without physiotherapy. Positive immediate and long-term effects of MPAT on clinical and brain functions, as well as brain microstructure, were confirmed.

  12. Active multimodal psychotherapy in children and adolescents with suicidality: description, evaluation and clinical profile.

    PubMed

    Högberg, Goran; Hällström, Tore

    2008-07-01

    The aim of this study was to describe and evaluate the clinical pattern of 14 youths with presenting suicidality, to describe an integrative treatment approach, and to estimate therapy effectiveness. Fourteen patients aged 10 to 18 years from a child and adolescent outpatient clinic in Stockholm were followed in a case series. The patients were treated with active multimodal psychotherapy. This consisted of mood charting by mood-maps, psycho-education, wellbeing practice and trauma resolution. Active techniques were psychodrama and body-mind focused techniques including eye movement desensitization and reprocessing. The patients were assessed before treatment, immediately after treatment and at 22 months post treatment with the Global Assessment of Functioning Scale. The clinical pattern of the group was observed. After treatment there was a significant change towards normality in the Global Assessment of Functioning scale both immediately post-treatment and at 22 months. A clinical pattern, post trauma suicidal reaction, was observed with a combination of suicidality, insomnia, bodily symptoms and disturbed mood regulation. We conclude that in the post trauma reaction suicidality might be a presenting symptom in young people. Despite the shortcomings of a case series the results of this study suggest that a mood-map-based multimodal treatment approach with active techniques might be of value in the treatment of children and youth with suicidality.

  13. Imipenem and meropenem: Comparison of in vitro activity, pharmacokinetics, clinical trials and adverse effects

    PubMed Central

    Zhanel, George G; Simor, Andrew E; Vercaigne, Lavern; Mandell, Lionell

    1998-01-01

    OBJECTIVE: To compare and contrast imipenem and meropenem in terms of in vitro activity, pharmacokinetics, clinical efficacy and adverse effects. DATA SELECTION: MEDLINE search from 1975 to 1997 and follow-up of references. DATA EXTRACTION: Clinical trials comparing imipenem with meropenem, or either imipenem or meropenem with standard therapy in the treatment of serious infections were selected. DATA SYNTHESIS: Imipenem, the first carbapenem, was first marketed in 1987; meropenem was introduced to the market in 1996. In general, imipenem is more active against Gram-positive cocci while meropenem is more active against Gram-negative bacilli. The agents display similar pharmacokinetics. Clinical studies in patients with serious infections (intra-abdominal infection, respiratory infection, septicemia, febrile neutropenia) report similar bacteriological and clinical cure rates with imipenem and meropenem. Meropenem is approved for the treatment of bacterial meningitis, whereas imipenem is not. Adverse effects are similar. CONCLUSIONS: Current literature supports the use of imipenem at a dose of 500 mg every 6 h and meropenem at 1 g every 8 h for the treatment of severe infections. For the treatment of serious infections, imipenem (500 mg every 6 h or 2 g/day [$98/day]) is more economical than meropenem (1 g every 8 h or 3 g/day [$142/day]) based on acquisition cost. PMID:22346545

  14. Olfactory Hallucinations without Clinical Motor Activity: A Comparison of Unirhinal with Birhinal Phantosmia

    PubMed Central

    Henkin, Robert I.; Potolicchio, Samuel J.; Levy, Lucien M.

    2013-01-01

    Olfactory hallucinations without subsequent myoclonic activity have not been well characterized or understood. Herein we describe, in a retrospective study, two major forms of olfactory hallucinations labeled phantosmias: one, unirhinal, the other, birhinal. To describe these disorders we performed several procedures to elucidate similarities and differences between these processes. From 1272, patients evaluated for taste and smell dysfunction at The Taste and Smell Clinic, Washington, DC with clinical history, neurological and otolaryngological examinations, evaluations of taste and smell function, EEG and neuroradiological studies 40 exhibited cyclic unirhinal phantosmia (CUP) usually without hyposmia whereas 88 exhibited non-cyclic birhinal phantosmia with associated symptomology (BPAS) with hyposmia. Patients with CUP developed phantosmia spontaneously or after laughing, coughing or shouting initially with spontaneous inhibition and subsequently with Valsalva maneuvers, sleep or nasal water inhalation; they had frequent EEG changes usually ipsilateral sharp waves. Patients with BPAS developed phantosmia secondary to several clinical events usually after hyposmia onset with few EEG changes; their phantosmia could not be initiated or inhibited by any physiological maneuver. CUP is uncommonly encountered and represents a newly defined clinical syndrome. BPAS is commonly encountered, has been observed previously but has not been clearly defined. Mechanisms responsible for phantosmia in each group were related to decreased gamma-aminobutyric acid (GABA) activity in specific brain regions. Treatment which activated brain GABA inhibited phantosmia in both groups. PMID:24961619

  15. Investigating primary marine aerosol properties: CCN activity of sea salt and mixed particles

    NASA Astrophysics Data System (ADS)

    King, S. M.; Butcher, A. C.; Rosenoern, T.; Coz, E.; Lieke, K. I.; de Leeuw, G.; Nilsson, E. D.; Bilde, M.

    2012-04-01

    Sea salt particles ejected as a result of bubbles bursting from artificial seawater in a closed stainless steel tank were sampled for size distribution, morphology, and cloud condensation nucleus (CCN) activity. The two-component artificial seawater consisted of salt, either NaCl or sea salt, and one organic compound in deionized water. Several organic molecules representative of oceanic organic matter were investigated. Bubbles were generated either by aeration through a porous diffuser or by water jet impingement on the surface of the artificial seawater. The effect of bubble lifetime, which was controlled by varying the depth of the diffuser in the water column, on particle size and CCN activity was investigated and was found to be insignificant for the organic compounds studied. The CCN activities of particles produced from diffuser-generated bubbles were generally governed by the high hygroscopicity of salt, such that activation was indistinguishable from that of salt, except in the case of very low mass ratio of salt to organic matter in the seawater solution. There was, however, a considerable decrease in CCN activity for particles produced from jet impingement on seawater that had a salinity of 10‰ and contained 0.45 mM of sodium laurate, an organic surfactant. The production of a thick foam layer from impingement may explain the difference in activation and supports hypotheses that particle production from the two methods of generating bubbles is not similar. Accurate conclusions from observed CCN activities of particles from artificial seawater containing organic matter require knowledge of the CCN activity of the inorganic component, especially as a small amount of the inorganic can heavily influence activation. Therefore, the CCN activity of both artificial sea salt and NaCl were measured and compared. Part of the discrepancy observed between the CCN activities of the two salts may be due to morphological differences, which were investigated using

  16. Antimicrobial activity of de novo designed cationic peptides against multi-resistant clinical isolates.

    PubMed

    Faccone, Diego; Veliz, Omar; Corso, Alejandra; Noguera, Martin; Martínez, Melina; Payes, Cristian; Semorile, Liliana; Maffía, Paulo Cesar

    2014-01-01

    Antibiotic resistance is one of the main problems concerning public health or clinical practice. Antimicrobial peptides appear as good candidates for the development of new therapeutic drugs. In this study we de novo designed a group of cationic antimicrobial peptides, analyzed its physicochemical properties, including its structure by circular dichroism and studied its antimicrobial properties against a panel of clinical isolates expressing different mechanisms of resistance. Three cationic alpha helical peptides exhibited antimicrobial activity comparable to, or even better than the comparator omiganan (MBI-226).

  17. A meta-meta-analysis of the effect of physical activity on depression and anxiety in non-clinical adult populations.

    PubMed

    Rebar, Amanda L; Stanton, Robert; Geard, David; Short, Camille; Duncan, Mitch J; Vandelanotte, Corneel

    2015-01-01

    Amidst strong efforts to promote the therapeutic benefits of physical activity for reducing depression and anxiety in clinical populations, little focus has been directed towards the mental health benefits of activity for non-clinical populations. The objective of this meta-meta-analysis was to systematically aggregate and quantify high-quality meta-analytic findings of the effects of physical activity on depression and anxiety for non-clinical populations. A systematic search identified eight meta-analytic outcomes of randomised trials that investigated the effects of physical activity on depression or anxiety. The subsequent meta-meta-analyses were based on a total of 92 studies with 4310 participants for the effect of physical activity on depression and 306 study effects with 10,755 participants for the effect of physical activity on anxiety. Physical activity reduced depression by a medium effect [standardised mean difference (SMD) = -0.50; 95% CI: -0.93 to -0.06] and anxiety by a small effect (SMD = -0.38; 95% CI: -0.66 to -0.11). Neither effect showed significant heterogeneity across meta-analyses. These findings represent a comprehensive body of high-quality evidence that physical activity reduces depression and anxiety in non-clinical populations.

  18. Clinical efficiency investigation of laparoscopic uterine artery occlusion combined with myomectomy for uterine fibroids.

    PubMed

    Yin, Xiang-Hua; Gao, Ling-Ling; Gu, Yang; Song, Jing-Zhe; Gao, Jing; Ji, Xiao-Ping

    2014-01-01

    To investigate the effectiveness of laparoscopic uterine artery occlusion combined with myomectomy for uterine fibroids. From August 2008 to August 2009, forty-eight women with uterine fibroids desiring to preserve their uteri underwent laparoscopic myomectomy. Among them, 18 women received laparoscopic uterine artery occlusion before uterine myomectomy while the others received laparoscopic myomectomy only. All of the 48 cases with uterine fibroids underwent laparoscopic myomectomy successfully, and no patient developed Intraoperative or postoperative complications. The average operation time was (105.6±27.6) min, and the average surgical blood loss was (87.52±18.35) ml. Blocking uterine artery before laparoscopic myomectomy is valuable and feasible for the management of women with symptomatic fibroids. Adopting this method can obtain pleasing therapeutic effect. The method can reduce blood loss thus make the surgical field clean and clear, and it can reduce the operating time and recurrence rate. It can also reduce electro-coagulation on the surgical surface and therefore cause less tissue necrosis and lower incidence of complications. PMID:24995096

  19. Investigation of the use of thermography for research and clinical applications in pregnant women

    NASA Astrophysics Data System (ADS)

    Topalidou, Anastasia; Downe, Soo

    2016-03-01

    Background: The possibility of using thermal imaging, as a non-invasive method, in medicine may provide potential ability of advanced imaging. Objective: The conduction of a preliminary study in healthy non-pregnant females in order to investigate the imaging ability of thermography and its implementation; and to determine hot and cold areas in order to create a "map" of temperature distribution of the abdomen and the torso. Methods: Participants were 18-45 years old non-pregnant women (n = 10), who were measured at 4 different distances. Two thermal imaging cameras and their corresponding software were used to measure abdomen, low back, left and right side of the torso. Results: There were no statistically significant differences in the mean values of the exported temperatures according the distance and the angle between the camera and the subject. The inferior part of the rectus abdominis muscle recorded the coldest zone and the umbilicus appeared as the most prominent hot spot. Conclusions: Thermography shows to be a potential non-invasive technique offering new options in the evaluation of pregnant and laboring women.

  20. Clinical efficiency investigation of laparoscopic uterine artery occlusion combined with myomectomy for uterine fibroids.

    PubMed

    Yin, Xiang-Hua; Gao, Ling-Ling; Gu, Yang; Song, Jing-Zhe; Gao, Jing; Ji, Xiao-Ping

    2014-01-01

    To investigate the effectiveness of laparoscopic uterine artery occlusion combined with myomectomy for uterine fibroids. From August 2008 to August 2009, forty-eight women with uterine fibroids desiring to preserve their uteri underwent laparoscopic myomectomy. Among them, 18 women received laparoscopic uterine artery occlusion before uterine myomectomy while the others received laparoscopic myomectomy only. All of the 48 cases with uterine fibroids underwent laparoscopic myomectomy successfully, and no patient developed Intraoperative or postoperative complications. The average operation time was (105.6±27.6) min, and the average surgical blood loss was (87.52±18.35) ml. Blocking uterine artery before laparoscopic myomectomy is valuable and feasible for the management of women with symptomatic fibroids. Adopting this method can obtain pleasing therapeutic effect. The method can reduce blood loss thus make the surgical field clean and clear, and it can reduce the operating time and recurrence rate. It can also reduce electro-coagulation on the surgical surface and therefore cause less tissue necrosis and lower incidence of complications.

  1. Clinical efficiency investigation of laparoscopic uterine artery occlusion combined with myomectomy for uterine fibroids

    PubMed Central

    Yin, Xiang-Hua; Gao, Ling-Ling; Gu, Yang; Song, Jing-Zhe; Gao, Jing; Ji, Xiao-Ping

    2014-01-01

    To investigate the effectiveness of laparoscopic uterine artery occlusion combined with myomectomy for uterine fibroids. From August 2008 to August 2009, forty-eight women with uterine fibroids desiring to preserve their uteri underwent laparoscopic myomectomy. Among them, 18 women received laparoscopic uterine artery occlusion before uterine myomectomy while the others received laparoscopic myomectomy only. All of the 48 cases with uterine fibroids underwent laparoscopic myomectomy successfully, and no patient developed Intraoperative or postoperative complications. The average operation time was (105.6±27.6) min, and the average surgical blood loss was (87.52±18.35) ml. Blocking uterine artery before laparoscopic myomectomy is valuable and feasible for the management of women with symptomatic fibroids. Adopting this method can obtain pleasing therapeutic effect. The method can reduce blood loss thus make the surgical field clean and clear, and it can reduce the operating time and recurrence rate. It can also reduce electro-coagulation on the surgical surface and therefore cause less tissue necrosis and lower incidence of complications. PMID:24995096

  2. Does size matter? An investigation into the Rey Complex Figure in a pediatric clinical sample.

    PubMed

    Loughan, Ashlee R; Perna, Robert B; Galbreath, Jennifer D

    2014-01-01

    The Rey Complex Figure Test (RCF) copy requires visuoconstructional skills and significant attentional, organizational, and problem-solving skills. Most scoring schemes codify a subset of the details involved in figure construction. Research is unclear regarding the meaning of figure size. The research hypothesis of our inquiry is that size of the RCF copy will have neuropsychological significance. Data from 95 children (43 girls, 52 boys; ages 6-18 years) with behavioral and academic issues revealed that larger figure drawings were associated with higher RCF total scores and significantly higher scores across many neuropsychological tests including the Wechsler Individual Achievement Test-Second Edition (WIAT-II) Word Reading (F = 5.448, p = .022), WIAT-II Math Reasoning (F = 6.365, p = .013), Children's Memory Scale Visual Delay (F = 4.015, p = .048), Trail-Making Test-Part A (F = 5.448, p = .022), and RCF Recognition (F = 4.862, p = .030). Results indicated that wider figures were associated with higher cognitive functioning, which may be part of an adaptive strategy in helping facilitate accurate and relative proportions of the complex details presented in the RCF. Overall, this study initiates the investigation of the RCF size and the relationship between size and a child's neuropsychological profile. PMID:24236943

  3. Preliminary investigation of a sealed, remotely activated silver-zinc battery

    NASA Technical Reports Server (NTRS)

    Wheat, C. G.

    1977-01-01

    Methods necessary to provide a remotely activated, silver zinc battery capable of an extended activated stand while in a sealed condition were investigated. These requirements were to be accomplished in a battery package demonstrating an energy density of at least 35 watt hours per pound. Several methods of gas suppression were considered in view of the primary nature of this unit and utilized the electroplated dendritic zinc electrode. Amalgamation of the electrode provided the greatest suppression of gas at the zinc electrode. The approach to extending the activated stand capability of the remotely activated battery was through evaluation of three basic methods of remote, multi-cell activation; 1) the electrolyte manifold, 2) the gas manifold and 3) the individual cell. All three methods of activation can be incorporated into units which will meet the minimum energy density requirement.

  4. The novel AKT inhibitor afuresertib shows favorable safety, pharmacokinetics, and clinical activity in multiple myeloma

    PubMed Central

    Spencer, Andrew; Yoon, Sung-Soo; Harrison, Simon J.; Morris, Shannon R.; Smith, Deborah A.; Brigandi, Richard A.; Gauvin, Jennifer; Kumar, Rakesh; Opalinska, Joanna B.

    2014-01-01

    The PI3K/AKT pathway is constitutively active in hematologic malignancies, providing proliferative and antiapoptotic signals and possibly contributing to drug resistance. We conducted an open-label phase 1 study to evaluate the maximum tolerated dose (MTD), safety, pharmacokinetics, and clinical activity of afuresertib—an oral AKT inhibitor—in patients with advanced hematologic malignancies. Seventy-three patients were treated at doses ranging from 25 to 150 mg per day. The MTD was established at 125 mg per day because of 2 dose-limiting toxicities in the 150-mg cohort (liver function test abnormalities). The most frequent adverse events were nausea (35.6%), diarrhea (32.9%), and dyspepsia (24.7%). Maximum plasma concentrations and area under the plasma concentration-time curves from time 0 to 24 hours were generally dose proportional at >75-mg doses; the median time to peak plasma concentrations was 1.5 to 2.5 hours post dose, with a half-life of approximately 1.7 days. Three multiple myeloma patients attained partial responses; an additional 3 attained minimal responses. Clinical activity was also observed in non-Hodgkin lymphoma, Langerhan's cell histiocytosis, and Hodgkin disease. Single-agent afuresertib showed a favorable safety profile and demonstrated clinical activity against hematologic malignancies, including multiple myeloma. This trial was registered at www.clinicaltrials.gov as #NCT00881946. PMID:25075128

  5. Signal intensity, clinical activity and cross-sectional areas on MRI scans in thyroid eye disease.

    PubMed

    Mayer, E J; Fox, D L; Herdman, G; Hsuan, J; Kabala, J; Goddard, P; Potts, M J; Lee, R W J

    2005-10-01

    The signal intensity from inflamed extra-ocular muscles on short tau inversion recovery (STIR)-sequence magnetic resonance imaging (MRI) is known to correlate with clinical scores of thyroid eye disease (TED) severity. Twenty-one patients who had undergone repeated MRI scanning for TED were studied retrospectively. Signal intensity of extra-ocular muscles (from STIR-sequence MRI) and cross-sectional area (from STIR and T1 MRI) were correlated with Mourits' clinical activity score (CAS). The area of highest signal intensity within the most inflamed extra-ocular muscle, and the average cross-sectional signal intensity of the most inflamed extra-ocular muscle reliably correlated with CAS, and this was maintained as disease activity changed over time. In contrast, isolated measures of muscle cross-sectional area did not correlate with CAS. The extra-ocular muscle cross-sectional area calculated from STIR-sequence MR images was greater than that measured on T1 images. This suggests that muscle area from STIR-sequence MRI may also detect peri-muscular inflammation. We conclude that the peak signal intensity from the most inflamed extra-ocular muscle remains the most reliable correlate of clinical disease activity obtained from these images. STIR-sequence MRI scans provide a number of useful measures of disease activity in TED.

  6. Determination of Carboxypeptidase Activity in Clinical Pathogens by Gas Chromatography–Mass Spectrometry

    PubMed Central

    Lough, Fraser; Perry, John D.; Stanforth, Stephen P.; Dean, John R.

    2016-01-01

    ABSTRACT A novel method for the determination of benzoic acid has been employed to identify carboxypeptidase activities in clinically relevant pathogens. Benzoic acid was determined after chemical derivatization by gas chromatography–mass spectrometry (GC–MS). N-Benzoyl amino acid substrates were evaluated for the detection of carboxypeptidase activities in a number of clinical pathogens. Upon enzymatic hydrolysis of these substrates, benzoic acid was produced which was detected by extraction from the liquid culture supernatant, derivatization as the trimethylsilyl ester, with subsequent analysis by GC–MS. Enzymatic hydrolysis of N-benzoyl glycine was observed for S. agalactiae, M. morganii, and A. baumannii. In addition, P. fluorescens was found to hydrolyze N-benzoyl-L-glutamic acid. Although the method provides an alternative approach for determining carboxypeptidase activity, ultimately it would not be a suitable method in a clinical setting. However, the method is well-suited for identifying carboxypeptidase activities that have not been previously described or to corroborate a carboxypeptidase assay with the ninhydrin reagent. PMID:27226648

  7. Enhancement of antibiotic activity by efflux inhibitors against multidrug resistant Mycobacterium tuberculosis clinical isolates from Brazil

    PubMed Central

    Coelho, Tatiane; Machado, Diana; Couto, Isabel; Maschmann, Raquel; Ramos, Daniela; von Groll, Andrea; Rossetti, Maria L.; Silva, Pedro A.; Viveiros, Miguel

    2015-01-01

    Drug resistant tuberculosis continues to increase and new approaches for its treatment are necessary. The identification of M. tuberculosis clinical isolates presenting efflux as part of their resistant phenotype has a major impact in tuberculosis treatment. In this work, we used a checkerboard procedure combined with the tetrazolium microplate-based assay (TEMA) to study single combinations between antituberculosis drugs and efflux inhibitors (EIs) against multidrug resistant M. tuberculosis clinical isolates using the fully susceptible strain H37Rv as reference. Efflux activity was studied on a real-time basis by a fluorometric method that uses ethidium bromide as efflux substrate. Quantification of efflux pump genes mRNA transcriptional levels were performed by RT-qPCR. The fractional inhibitory concentrations (FIC) indicated synergistic activity for the interactions between isoniazid, rifampicin, amikacin, ofloxacin, and ethidium bromide plus the EIs verapamil, thioridazine and chlorpromazine. The FICs ranged from 0.25, indicating a four-fold reduction on the MICs, to 0.015, 64-fold reduction. The detection of active efflux by real-time fluorometry showed that all strains presented intrinsic efflux activity that contributes to the overall resistance which can be inhibited in the presence of the EIs. The quantification of the mRNA levels of the most important efflux pump genes on these strains shows that they are intrinsically predisposed to expel toxic compounds as the exposure to subinhibitory concentrations of antibiotics were not necessary to increase the pump mRNA levels when compared with the non-exposed counterpart. The results obtained in this study confirm that the intrinsic efflux activity contributes to the overall resistance in multidrug resistant clinical isolates of M. tuberculosis and that the inhibition of efflux pumps by the EIs can enhance the clinical effect of antibiotics that are their substrates. PMID:25972842

  8. Epidemiology, clinical features, laboratory investigations and early diagnosis of dengue fever in adults: a descriptive study in Sri Lanka.

    PubMed

    Kularatne, S A M; Gawarammana, I B; Kumarasiri, P R V

    2005-05-01

    A descriptive observational study was conducted to identify the epidemiology, clinical features, laboratory investigations and markers for early diagnosis of acute dengue virus infection in adults. We enrolled 404 patients over a period of two years, beginning from 2001, at the Teaching Hospital Peradeniya, Sri Lanka. Based on serology, 239 patients were grouped as: IgM 43 (18%), IgG and IgM 140 (58%), and IgG 28 (12%). The clinically diagnosed group without serology numbered 165 patients. Most of the parameters between groups showed a similar pattern: mean age of 30 years, mean duration of fever 7 days (range 1-19 days). Mean total white blood cell and platelet counts started to fall from the second day of fever, with the lowest counts on the 5th to 7th days. Packed cell volume (PCV) showed minimum fluctuation. One hundred and sixty (88%) patients showed elevated liver enzymes (ALT and AST), with 122 of them having a two-fold increase. Three patients died, and complications such as myocarditis, large effusions, encephalopathy, acute renal failure, acute liver failure and diarrhea were observed. These results suggest that a combination of clinical picture, thrombocytopenia, leukopenia and elevated liver enzymes could be used as markers for early diagnosis of dengue infection. Furthermore, evidence-based guidelines should be developed for managing dengue infection in adults.

  9. The 5 alpha-reductase inhibitory components from heartwood of Artocarpus incisus: structure-activity investigations.

    PubMed

    Shimizu, K; Fukuda, M; Kondo, R; Sakai, K

    2000-02-01

    The methanol extract of heartwood of Artocarpus incisus showed potent 5 alpha-reductase inhibitory activity. We investigated the 5 alpha-reductase inhibitory effects of nine compounds isolated from A. incisus. Chlorophorin (IC50 = 37 microM) and artocarpin (IC50 = 85 microM) showed more potent inhibitory effects than did alpha-linolenic acid, which is known as a naturally occurring potent inhibitor. Structure-activity investigations suggested that the presence of an isoprene substituent (prenyl and geranyl) would enhance 5 alpha-reductase inhibitory effects.

  10. Clinical Relevance of VPAC1 Receptor Expression in Early Arthritis: Association with IL-6 and Disease Activity

    PubMed Central

    Seoane, Iria V.; Ortiz, Ana M.; Piris, Lorena; Lamana, Amalia; Juarranz, Yasmina; García-Vicuña, Rosario; González-Álvaro, Isidoro; Gomariz, Rosa P.; Martínez, Carmen

    2016-01-01

    Background The vasoactive intestinal peptide (VIP) receptors VPAC1 and VPAC2 mediate anti-inflammatory and immunoregulatory responses in rheumatoid arthritis (RA). Data on the expression of these receptors could complement clinical assessment in the management of RA. Our goal was to investigate the correlation between expression of both receptors and the 28-Joint Disease Activity Score (DAS28) in peripheral blood mononuclear cells (PBMCs) from patients with early arthritis (EA). We also measured expression of IL-6 to evaluate the association between VIP receptors and systemic inflammation. Methods We analyzed 250 blood samples collected at any of the 5 scheduled follow-up visits from 125 patients enrolled in the Princesa Early Arthritis Register Longitudinal study. Samples from 22 healthy donors were also analyzed. Sociodemographic, clinical, and therapeutic data were systematically recorded. mRNA expression levels were determined using real-time PCR. Then, longitudinal multivariate analyses were performed. Results PBMCs from EA patients showed significantly higher expression of VPAC2 receptors at baseline compared to healthy donors (p<0.001). With time, however, VPAC2 expression tended to be significantly lower while VPAC1 receptor expression increased in correlation with a reduction in DAS28 index. Our results reveal that more severe inflammation, based on high levels of IL-6, is associated with lower expression of VPAC1 (p<0.001) and conversely with increased expression of VPAC2 (p<0.001). A major finding of this study is that expression of VPAC1 is lower in patients with increased disease activity (p = 0.001), thus making it possible to differentiate between patients with various degrees of clinical disease activity. Conclusion Patients with more severe inflammation and higher disease activity show lower levels of VPAC1 expression, which is associated with patient-reported impairment. Therefore, VPAC1 is a biological marker in EA. PMID:26881970

  11. [Formation and treatment of pathologic scars--clinical and micromorphologic investigations (author's transl)].

    PubMed

    Kerl, H; Auböck, L; Bayer, U

    1981-03-01

    The results of treatment with Calmurid and Calmurid-HC in patients with hypertrophic scars and keloids of various causes are reported. Histochemical and ultrastructural investigations were performed in individual cases before and after treatment. The following results were found: 1. In the context of keloid prophylaxis and scar care, application of Calmurid and Calmurid-HC has proved very effective. The results of treating hypertrophic scars with urea preparations are also to be evaluated optimistically. 2. The local treatment with Calmurid or Calmurid-HC generally does not have a substantial influence on cosmetically disturbing keloids. However, the skin becomes smoother, more elastic and more resistant under Calmurid or Calmurid-HC therapy; a reduction in the size of the keloid mass is observed only in individual cases. 3. In short, the results are consistent with those which can be obtained with other external preparations which are specially recommended for treatment of scars and keloids. Success of treatment is especially dependent on the age of the lesion. 4. Disturbances in glycosaminoglycan (GAG) and collagen metabolism as well as enzyme defects are the most significant factors in the pathogenesis of pathological scars. The histochemical and electron microscopic studies reveal (of course with the necessary caution in the interpretation) that Calmurid and Calmurid-HC show an effect on distribution of GAG and on the enzyme pattern of the fibroblasts. The preparations may possibly affect the disturbed processes of collagen and GAG synthesis. The reduction of the mast cells in keloids and hypertrophic scars under Calmurid treatment is noteworthy. PMID:7234039

  12. Investigation of the mechanical properties of the human crural fascia and their possible clinical implications.

    PubMed

    Stecco, Carla; Pavan, Piero; Pachera, Paola; De Caro, Raffaele; Natali, Arturo

    2014-01-01

    The mechanical properties of deep fasciae strongly affect muscular actions, development of pathologies, such as acute and chronic compartment syndromes, and the choice of the various fascial flaps. Actually, a clear knowledge of the mechanical characterization of these tissues still lacks. This study focuses attention on experimental tests of different regions of human crural fascia taken from an adult frozen donor. Tensile tests along proximal-distal and medial-lateral direction at a strain rate of 120 %/s were performed at the purpose of evaluating elastic properties. Viscous phenomena were investigated by applying incremental relaxation tests at total strain of 7, 9 and 11 % and observing stress decay for a time interval of 240 s. The elastic response showed that the fascia in the anterior compartment is stiffer than in the posterior compartment, both along the proximal-distal and medial-lateral directions. This result can explain why the compartment syndromes are more frequent in this compartment with respect to posterior one. Furthermore, the fascia is stiffer along the proximal-distal than along medial-lateral direction. This means that the crural fascia can adapt to the muscular variation of volume in a transversal direction, while along the main axis it could be considered as a structure that contributes to transmitting the muscular forces at a distance and connecting the different segments of the limb. The stress relaxation tests showed that the crural fascia needs 120 s to decrease stress of 40 %, suggesting a similar time also in the living so that the static stretching could have an effect on the fascia.

  13. fMRI investigation of response inhibition, emotion, impulsivity, and clinical high-risk behavior in adolescents

    PubMed Central

    Brown, Matthew R. G.; Benoit, James R. A.; Juhás, Michal; Dametto, Ericson; Tse, Tiffanie T.; MacKay, Marnie; Sen, Bhaskar; Carroll, Alan M.; Hodlevskyy, Oleksandr; Silverstone, Peter H.; Dolcos, Florin; Dursun, Serdar M.; Greenshaw, Andrew J.

    2015-01-01

    High-risk behavior in adolescents is associated with injury, mental health problems, and poor outcomes in later life. Improved understanding of the neurobiology of high-risk behavior and impulsivity shows promise for informing clinical treatment and prevention as well as policy to better address high-risk behavior. We recruited 21 adolescents (age 14–17) with a wide range of high-risk behavior tendencies, including medically high-risk participants recruited from psychiatric clinics. Risk tendencies were assessed using the Adolescent Risk Behavior Screen (ARBS). ARBS risk scores correlated highly (0.78) with impulsivity scores from the Barratt Impulsivity scale (BIS). Participants underwent 4.7 Tesla functional magnetic resonance imaging (fMRI) while performing an emotional Go/NoGo task. This task presented an aversive or neutral distractor image simultaneously with each Go or NoGo stimulus. Risk behavior and impulsivity tendencies exhibited similar but not identical associations with fMRI activation patterns in prefrontal brain regions. We interpret these results as reflecting differences in response inhibition, emotional stimulus processing, and emotion regulation in relation to participant risk behavior tendencies and impulsivity levels. The results are consistent with high impulsivity playing an important role in determining high risk tendencies in this sample containing clinically high-risk adolescents. PMID:26483645

  14. Effect of low-level laser therapy after rapid maxillary expansion: a clinical investigation.

    PubMed

    Garcia, Valentin Javier; Arnabat, J; Comesaña, Rafael; Kasem, Khaled; Ustrell, Josep Maria; Pasetto, Stefano; Segura, Oscar Pozuelo; ManzanaresCéspedes, Maria Cristina; Carvalho-Lobato, Patricia

    2016-08-01

    To evaluate the effectiveness low-level laser therapy (LLLT) on the repair of the mid palatal suture, after rapid maxillary expansion (RME). A single-operator, randomized single-blind placebo-controlled study was performed at the Orthodontic Department at the Dental Hospital of Bellvitge. Barcelona University, Hospitalet de Llobregat, Spain. Thirty-nine children (range 6-12 years old), completed RME and were randomized to receive active LLLT (n = 20) or placebo (n = 19). The laser parameters and dose were 660 nm, 100 mW, CW, InGaAlP laser, illuminated area 0.26 cm(2), 332 mW/cm(2), 60 s to four points along midpalatal suture, and 30 s to a point each side of the suture. A total of seven applications were made on days 1, 7, 14, 28, 42, 56, and 70 of the retention phase RME. A cone beam computed tomography (CBCT) scan was carried out on the day of the first laser treatment, and at day 75, a second CBCT scan was performed. Two radiologists synchronized the slices of two scans to be assessed. P = 0.05 was considered to be statistically significant. At day 75 of the suture, the irradiated patients presented a greater percentage of approximate zones in the anterior (p = 0.008) and posterior (p = 0.001) superior suture-and less approximation in the posterior superior suture (p = 0.040)-than the placebo group. LLLT appears to stimulate the repair process during retention phase after RME. PMID:27236292

  15. Teaching clinical communication: a mainstream activity or just a minority sport?

    PubMed

    Silverman, Jonathan

    2009-09-01

    This plenary presentation from the EACH International Conference on Communication in Healthcare in Oslo 2008, takes an honest look at the present state of communication teaching and considers how to take the next steps to move communication into the very centre of medical education. Although clinical communication teaching has become increasingly accepted as a formal component of the medical curriculum, there is still a problem to be faced. Communication still often appears in medical education to be a peripheral element rather than a mainstream activity truly perceived by schools and learners as central to all clinical interactions. This presentation explores why clinical communication often appears to be a minority sport in medical education, considers how to overcome this via integration throughout the curriculum, looks at five specific examples of integration in action, presents a new UK consensus statement which helps integrate communication into the mainstream, and finally explores the progression to maturity in communication curricula.

  16. What clinical activities do advanced-practice registered dietitian nutritionists perform? Results of a Delphi study.

    PubMed

    Brody, Rebecca A; Byham-Gray, Laura; Touger-Decker, Riva; Passannante, Marian R; Rothpletz Puglia, Pamela; O'Sullivan Maillet, Julie

    2014-05-01

    Activities performed by advanced-practice registered dietitian nutritionists (RDNs) have yet to be clearly elucidated. The study aimed to gain consensus on the practice activities of advanced-practice RDNs who provide direct clinical nutrition care. A three-round Delphi study was conducted. Purposive sampling identified 117 RDN experts working as clinicians and/or managers in direct care settings that met inclusion criteria for advanced-level practice. In Round 1, 85 experts provided open-ended advanced-level practice activities linked to the Nutrition Care Process sections. Using content analysis, the responses were coded into activity statements. In Round 2, experts rated the essentiality of these activities. In Round 3, experts re-rated statements not reaching consensus while viewing their previous rating, the group median, and comments. Median ratings of 1.0 to 3.0 were defined as essential, 4.0 were neither essential nor nonessential, and 5.0 to 7.0 were nonessential. Consensus was reached when the interquartile range of responses to each question was <2.0. Seventy-six (89.4%) experts completed all rounds. From 770 comments, 129 activity statements were generated. All statements reached consensus: 97.7% as essential; 0.8% as nonessential; and 1.5% as neither. Of essential activities, 67.5% were highly essential with limited variability (median=1.0; interquartile range≤2.0). Advanced-practice RDNs' tasks are patient-centered and reflect complex care; involve a comprehensive and discriminating approach; are grounded in advanced knowledge and expertise in clinical nutrition; include use of advanced interviewing, education, and counseling strategies; and require communication with patient, families, and the health care team. The high-level of consensus from experts suggest advanced-level clinical nutrition practice exists and can be defined.

  17. Antibacterial activities of Ligaria cuneifolia and Jodina rhombifolia leaf extracts against phytopathogenic and clinical bacteria.

    PubMed

    Soberón, José R; Sgariglia, Melina A; Dip Maderuelo, María R; Andina, María L; Sampietro, Diego A; Vattuone, Marta A

    2014-11-01

    Six plant extracts prepared from Ligaria cuneifolia and Jodina rhombifolia were screened for their potential antimicrobial activities against phytopathogens and clinically standard reference bacterial strains. Bioautography and broth microdilution methods were used to study samples antibacterial activities against 7 bacterial strains. The minimum inhibitory concentrations (MICs) and minimum bactericidal concentrations (MBCs) of samples were attained. An antibacterial activity guided isolation and identification of active compounds was carried out for L. cuneifolia methanolic extract (LCME). Both methanolic and aqueous extracts from L. cuneifolia showed inhibitory activities against phytopathogenic bacteria, with MICs ranging from 2.5 to 156 μg mL(-1) for LCME and 5 mg mL(-1) for the aqueous extract. None of the three J. rhombifolia extracts showed significant antibacterial activities against phytopathogenic strains (MIC > 5 mg mL(-1)), except for the aqueous extracts against Pseudomonas syringae (MIC = 312 μg mL(-1)). Only LCME showed bactericidal activities against phytopathogenic strains (MBCs = 78 μg mL(-1)). The LCME exhibited significant inhibitory activity against reference clinical strains: Escherichia coli (MIC = 156 μg mL(-1)) and Staphylococcus aureus (MIC = 78 μg mL(-1), MBC = 312 μg mL(-1)). LCME active compounds were identified as flavonol mono and diglycosides, and gallic acid. The antibacterial activity of purified compounds was also evaluated. A synergistic effect against S. aureus was found between gallic acid and a quercetin glycoside. Hence, anti-phytopathogenic bacteria potential compounds isolated from L. cuneifolia could be used as an effective source against bacterial diseases in plants. PMID:24894684

  18. Paraoxonase-1 Enzyme Activity Assay for Clinical Samples: Validation and Correlation Studies

    PubMed Central

    Garelnabi, Mahdi; Younis, Abdelmoneim

    2015-01-01

    Background Paraoxonase-1 (PON1) enzyme is reported in various types of tissues and linked to numerous pathophysiological disorders. It is a potential biomarker in many pathological conditions such as cardiovascular diseases. Material/Methods We conducted several small-scale studies to evaluate PON1 performance as affected by sample types, storage, and interferences. We also carried out short-term studies to compare the performance of the widely used PON1 assay to the similar commercially available PON1 kit assay method; sample size for the method comparison was N=40, and the number varied for other validation experiments. Results Our studies using various types of anticoagulants show that samples collected in tubes with NaF, citrate, EDTA, clot activator, and sodium heparin have increased PON1 levels that are 49%, 24.5%, 19.8%, 11.4%, and 8%, respectively, higher compared to serum samples collected in plain tubes. However, samples collected in lithium heparin tubes demonstrated 10.4% lower PON1 levels compared to serum collected in plain tubes. Biological interference such as hemolysis has little effect on PON1 levels; however, samples spiked with lipids have shown 13% lower PON 1 levels. Our studies comparing the PON1 method commonly available for PON1 assay and a similar non-ELISA commercially available PON1 kit method showed a weak Spearman correlation coefficient of R2=0.40 for the range of 104.9–245.6 U/L. Conclusions The current study provides new validation data on enzyme PON1 performance. While no appreciable change was seen with storage, samples type affects the enzyme performance. Our results should encourage additional clinical studies to investigate other aspects of factors known to affect PON1 enzyme function and performance. PMID:25814092

  19. Qualitative investigation of patients’ experience of a glaucoma virtual clinic in a specialist ophthalmic hospital in London, UK

    PubMed Central

    Kotecha, Aachal; Bonstein, Karen; Cable, Richard; Cammack, Jocelyn; Clipston, Jane; Foster, Paul

    2015-01-01

    Objectives To explore how patients felt about delivery of care in a novel technician-delivered virtual clinic compared with delivery of care in a doctor-delivered model. Design A qualitative investigation using one-to-one interviews before and after patients’ appointments at either the standard outpatient glaucoma clinic or the new technician-delivered virtual glaucoma clinic (Glaucoma Screening and Stable Monitoring Service, GSMS). Setting A glaucoma clinic based in a tertiary ophthalmic specialist hospital in London. Participants 43 patients (38 Caucasian, 5 African/Afro-Caribbean) were interviewed prior to their glaucoma appointment; 38 patients were interviewed between 4 and 6 weeks after their appointment. Consecutive patients were identified from patient reception lists and telephoned prior to their appointment inviting them to participate. Results Trust in the patient–provider relationship emerged as a key theme in patients’ acceptance of not being seen in a traditional doctor-delivered service. Patients who were well informed regarding their glaucoma status and low risk of progression to sight loss were more accepting of the GSMS. Patients valued the reassurance received through effective communication with their healthcare practitioner at the time of their appointment. Conclusions This study suggests that patients are accepting of moving to a model of service delivery whereby the doctor is removed from the consultation as long as they are informed about the status of their condition and reassured by the interaction with staff they meet. This study highlights the importance of patient engagement when introducing new models of service delivery. PMID:26671959

  20. Clinical Research and the Training of Host Country Investigators: Essential Health Priorities for Disease-Endemic Regions

    PubMed Central

    Koita, Ousmane A.; Murphy, Robert L.; Fongoro, Saharé; Diallo, Boubakar; Doumbia, Seydou O.; Traoré, Moussa; Krogstad, Donald J.

    2016-01-01

    The health-care needs and resources of disease-endemic regions such as west Africa have been a major focus during the recent Ebola outbreak. On the basis of that experience, we call attention to two priorities that have unfortunately been ignored thus far: 1) the development of clinical research facilities and 2) the training of host country investigators to ensure that the facilities and expertise necessary to evaluate candidate interventions are available on-site in endemic regions when and where they are needed. In their absence, as illustrated by the recent uncertainty about the use of antivirals and other interventions for Ebola virus disease, the only treatment available may be supportive care, case fatality rates may be unacceptably high and there may be long delays between the time potential interventions become available and it becomes clear whether those interventions are safe or effective. On the basis of our experience in Mali, we urge that the development of clinical research facilities and the training of host country investigators be prioritized in disease-endemic regions such as west Africa. PMID:26598570

  1. Pott’s disease in Moroccan children: Clinical features and investigation of the IL-12/IFN-γ pathway

    PubMed Central

    el Azbaoui, Safa; Mrani, Nidal Alaoui; Sabri, Ayoub; Jouhadi, Zineb; Ailal, Fatima; Bousfiha, Ahmed Aziz; Najib, Jilali; Hafidi, Naima El; Deswarte, Caroline; Schurr, Erwin; Bustamante, Jacinta; Boisson-Dupuis, Stéphanie; Casanova, Jean-Laurent; Abel, Laurent; Baghdadi, Jamila EL

    2016-01-01

    Setting Tuberculosis spondylodiscitis (TS) or Pott’s disease is an extra-pulmonary form of TB that is rare and difficult to diagnose in children. Some cases of severe TB in children were recently explained by inborn errors of immunity affecting the IL-12/IFN-γ axis. Objective To analyze the clinical data for Moroccan children with TS, and to perform immunological and genetic explorations of the IL-12/IFN-γ axis. Design We studied nine children with TS diagnosed between 2012 and 2014. We investigated the IL-12/IFN-γ circuit by both whole-blood assays and sequencing of the coding regions of 14 core genes of this pathway. Results TS diagnosis was based on a combination of clinical, biological, histological, and radiological data. QuantiFERON TB Gold in Tube results were positive in 75% of patients. Whole-blood assays showed normal IL-12 and IFN-γ production in all but one patient, who displayed impaired decreased response to IL-12. No candidate disease-causing mutations were detected in the exonic regions of the 14 genes. Conclusions The diagnosis of TS in children remains challenging, and is based largely on imaging. Further investigations of TS in children are required to determine the role of genetic defects in pathways that may or may not be related to the IL-12/IFN-γ axis. PMID:26614186

  2. Relationship between Histological and Clinical Course of Psoriasis: A Pilot Investigation by Reflectance Confocal Microscopy during Goeckerman Treatment.

    PubMed

    Archid, Rami; Duerr, Hans Peter; Patzelt, Alexa; Philipp, Sandra; Röwert-Huber, Hans-Joachim; Ulrich, Martina; Meinke, Martina Claudia; Knorr, Fanny; Lademann, Jürgen

    2016-01-01

    Alterations of the skin microvasculature are known to play an important role in the development and maintenance of psoriatic skin lesions. In this study, we investigated lesional skin in 11 psoriatic patients during a modified Goeckerman treatment using reflectance confocal microscopy (RCM) to study the relationship between clinical clearance and histological normalization of psoriatic skin and the significance of histological abnormalities on the course of disease. The treatment regimen resulted in a significant reduction of the Psoriasis Area and Severity Index (PASI) as well as capillary and papillary diameters (p < 0.0001). The capillary and papillary diameters were still enlarged when compared to those in normal skin (p < 0.001). Capillary and papillary diameters correlated with each other prior to and after treatment (correlation coefficient = 0.63 and 0.64, p = 0.01 and 0.002, respectively) but not with the PASI. Capillary and papillary diameters after treatment and percentage reduction of the PASI during treatment seemed to be better predictors for the clinical course of relapse than the PASI after treatment. These findings make the subclinical changes of psoriatic skin vessels and dermal papillae a legitimate target for treatment. Further investigations of a large group of patients are needed to evaluate the potential of RCM findings as successor of the PASI in the monitoring of psoriasis. PMID:26841099

  3. Echicetin Coated Polystyrene Beads: A Novel Tool to Investigate GPIb-Specific Platelet Activation and Aggregation

    PubMed Central

    Petunin, Alexey; Clemetson, Kenneth J.; Gambaryan, Stepan; Walter, Ulrich

    2014-01-01

    von Willebrand factor/ristocetin (vWF/R) induces GPIb-dependent platelet agglutination and activation of αIIbβ3 integrin, which also binds vWF. These conditions make it difficult to investigate GPIb-specific signaling pathways in washed platelets. Here, we investigated the specific mechanisms of GPIb signaling using echicetin-coated polystyrene beads, which specifically activate GPIb. We compared platelet activation induced by echicetin beads to vWF/R. Human platelets were stimulated with polystyrene beads coated with increasing amounts of echicetin and platelet activation by echicetin beads was then investigated to reveal GPIb specific signaling. Echicetin beads induced αIIbβ3-dependent aggregation of washed platelets, while under the same conditions vWF/R treatment led only to αIIbβ3-independent platelet agglutination. The average distance between the echicetin molecules on the polystyrene beads must be less than 7 nm for full platelet activation, while the total amount of echicetin used for activation is not critical. Echicetin beads induced strong phosphorylation of several proteins including p38, ERK and PKB. Synergistic signaling via P2Y12 and thromboxane receptor through secreted ADP and TxA2, respectively, were important for echicetin bead triggered platelet activation. Activation of PKG by the NO/sGC/cGMP pathway inhibited echicetin bead-induced platelet aggregation. Echicetin-coated beads are powerful and reliable tools to study signaling in human platelets activated solely via GPIb and GPIb-triggered pathways. PMID:24705415

  4. Investigating the Experiences of Childhood Cancer Patients and Parents Participating in Optional Nontherapeutic Clinical Research Studies in the UK

    PubMed Central

    Errington, Julie; Malik, Ghada; Evans, Julie; Baston, Jenny; Parry, Annie; Price, Lisa; Johnstone, Hina; Peters, Selena; Oram, Victoria; Howe, Karen; Whiteley, Emma; Tunnacliffe, Jane

    2016-01-01

    Background While the majority of childhood cancer clinical trials are treatment related, additional optional research investigations may be carried out that do not directly impact on treatment. It is essential that these studies are conducted ethically and that the experiences of families participating in these studies are as positive as possible. Methods A questionnaire study was carried out to investigate the key factors that influence why families choose to participate in optional nontherapeutic research studies, the level of understanding of the trials involved, and the experiences of participation. Results A total of 100 participants from six UK centers were studied; 77 parents, 10 patients >16 years, and 13 patients aged 8–15 years. Ninety‐seven percent of parents and 90% of patients felt that information provided prior to study consent was of the right length, with 52% of parents and 65% of patients fully understanding the information provided. Seventy‐four percent of parents participated in research studies in order to “do something important”, while 74% of patients participated “to help medical staff”. Encouragingly, <5% of participants felt that their clinical care would be negatively affected if they did not participate. Positive aspects of participation included a perception of increased attention from medical staff. Negative aspects included spending longer periods in hospital and the requirement for additional blood samples. Ninety‐six percent of parents and 87% of patients would participate in future studies. Conclusions The study provides an insight into the views of childhood cancer patients and their parents participating in nontherapeutic clinical research studies. Overwhelmingly, the findings suggest that participation is seen as a positive experience. PMID:26928983

  5. Active surveillance for prostate cancer: a narrative review of clinical guidelines.

    PubMed

    Bruinsma, Sophie M; Bangma, Chris H; Carroll, Peter R; Leapman, Michael S; Rannikko, Antti; Petrides, Neophytos; Weerakoon, Mahesha; Bokhorst, Leonard P; Roobol, Monique J

    2016-03-01

    In the past decade active surveillance (AS) of men with localized prostate cancer has become an increasingly popular management option, and a range of clinical guidelines have been published on this topic. Existing guidelines regarding AS for prostate cancer vary widely, but predominantly state that the most suitable patients for AS are those with pretreatment clinical stage T1c or T2 tumours, serum PSA levels <10 ng/ml, biopsy Gleason scores of 6 or less, a maximum of one or two tumour-positive biopsy core samples and/or a maximum of 50% of cancer per core sample. Following initiation of an AS programme, most guidelines recommend serial serum PSA measurements, digital rectal examinations and surveillance biopsies to check for and identify pathological indications of tumour progression. Definitions of disease reclassification and progression differ among guidelines and multiple criteria for initiation of definitive treatment are proposed. The variety of descriptions of criteria for clinically insignificant prostate cancer indicates a lack of consensus on optimal AS and intervention thresholds. A single set of guidelines are needed in order to reduce variations in clinical practice and to optimize clinical decision-making. To enable truly evidence-based guidelines, further research that combines existing evidence, while also gathering information from more long-term studies is needed. PMID:26813955

  6. Investigating the performance of CoxOy/activated carbon catalysts for ethyl acetate catalytic combustion

    NASA Astrophysics Data System (ADS)

    Xie, Hongmei; Zhao, Xiaoping; Zhou, Guilin; He, Xiaoling; Lan, Hai; Jiang, Zongxuan

    2015-01-01

    The catalytic properties of Co-supported activated carbon (AC) catalysts for ethyl acetate catalytic elimination in air were investigated. Results showed that air atmosphere promoted the generation of high-valence state cobalt oxides, and promote the production of reactive oxygen species (ROS) in the Co3O4/AC catalyst. ROS crucially functioned in improving the catalytic activity of Co3O4/AC catalysts. Therefore, CoACA catalyst prepared in air exhibited higher catalytic activity than CoACN catalyst prepared in nitrogen, and CoACA catalyst led to high ethyl acetate conversion (>93%) and stability at a low reaction temperature (210 °C).

  7. Activity of Natural Polyether Ionophores: Monensin and Salinomycin against Clinical Staphylococcus epidermidis Strains.

    PubMed

    Stefańska, Joann; Stępień, Karolina; Huczyński, Adam; Tyski, Stefan

    2015-01-01

    Staphylococcus epidermidis, a coagulase-negative Staphylococcus, is the most important pathogen responsible for chronic nosocomial infections. These bacteria produce extracellular slime and form biofilms on various biotic and abiotic surfaces. Bacterial biofilms are very resistant to standard antimicrobial therapy and difficult to eradicate, so it is important to search for new more effective anti-biofilm agents, for example in the group of natural substances. The aim of the study was to examine the activity of two ionophores-salinomycin and monensin against clinical S. epidermidis strains, using MIC/MBC method and biofilm formation inhibition assay. Bacterial strains were tested also for slime production using Congo Red Agar. Both tested ionophore antibiotics showed the highest activity against planktonic bacteria of clinical as well as standard S. epidermidis strains and effectively inhibited the formation of bacterial biofilm.

  8. Clinical development of reovirus for cancer therapy: An oncolytic virus with immune-mediated antitumor activity

    PubMed Central

    Gong, Jun; Sachdev, Esha; Mita, Alain C; Mita, Monica M

    2016-01-01

    Reovirus is a double-stranded RNA virus with demonstrated oncolysis or preferential replication in cancer cells. The oncolytic properties of reovirus appear to be dependent, in part, on activated Ras signaling. In addition, Ras-transformation promotes reovirus oncolysis by affecting several steps of the viral life cycle. Reovirus-mediated immune responses can present barriers to tumor targeting, serve protective functions against reovirus systemic toxicity, and contribute to therapeutic efficacy through antitumor immune-mediated effects via innate and adaptive responses. Preclinical studies have demonstrated the broad anticancer activity of wild-type, unmodified type 3 Dearing strain reovirus (Reolysin®) across a spectrum of malignancies. The development of reovirus as an anticancer agent and available clinical data reported from 22 clinical trials will be reviewed. PMID:27019795

  9. Activity of Natural Polyether Ionophores: Monensin and Salinomycin against Clinical Staphylococcus epidermidis Strains.

    PubMed

    Stefańska, Joann; Stępień, Karolina; Huczyński, Adam; Tyski, Stefan

    2015-01-01

    Staphylococcus epidermidis, a coagulase-negative Staphylococcus, is the most important pathogen responsible for chronic nosocomial infections. These bacteria produce extracellular slime and form biofilms on various biotic and abiotic surfaces. Bacterial biofilms are very resistant to standard antimicrobial therapy and difficult to eradicate, so it is important to search for new more effective anti-biofilm agents, for example in the group of natural substances. The aim of the study was to examine the activity of two ionophores-salinomycin and monensin against clinical S. epidermidis strains, using MIC/MBC method and biofilm formation inhibition assay. Bacterial strains were tested also for slime production using Congo Red Agar. Both tested ionophore antibiotics showed the highest activity against planktonic bacteria of clinical as well as standard S. epidermidis strains and effectively inhibited the formation of bacterial biofilm. PMID:26638535

  10. [Activity and Future Perspective of Local Independent Clinical Trial Group (OGSG)].

    PubMed

    Tsujinaka, Toshimasa

    2016-04-01

    Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG) was established in 2000 and has been conducting investigator initiated multi-institutional collaboration trials regarding the treatment of gastrointestinal cancer, especially using chemotherapeutic agents. Although organization of OGSG has been renovated to perform post-marketing clinical trials with high quality, OGSG is now facing severe financial crisis because of shortage of donation from pharmaceutical companies. Here, present problems and future perspectives are discussed. PMID:27220796

  11. Investigation of plant latices of Asteraceae and Campanulaceae regarding proteolytic activity.

    PubMed

    Sytwala, Sonja; Domsalla, André; Melzig, Matthias F

    2015-12-01

    Occurrence of plant latices is widespread, there are more than 40 families of plants characterized to establish lactiferous structures. The appearance of hydrolytic active proteins, incorporated in latices is already characterized, and hydrolytic active proteins are considerable, and for several plant families, the occurrence of hydrolytic active proteins is already specified e.g. Apocynaceae Juss., Caricaceae Dumort, Euphorbiaceae Juss., Moraceae Gaudich and Papaveraceae Juss. In our investigation, focused on latex bearing plants of order Asterales, Asteraceae and Campanulaceae in particular. The present outcomes represent a comprehensive study, relating to the occurrence of proteolytic active enzymes of order Asterales for the first time. 131 different species of Asteraceae and Campanulaceae were tested, and the appearance of plant latex proteases were determined in different quantities. Proteolytic activity was investigated by inhibitory studies and determination of residual activity in the following, enable us to characterize the proteases. Most of the considered species exhibit a serine protease activity and a multiplicity of species exhibited two or more subclasses of proteases.

  12. Investigation of plant latices of Asteraceae and Campanulaceae regarding proteolytic activity.

    PubMed

    Sytwala, Sonja; Domsalla, André; Melzig, Matthias F

    2015-12-01

    Occurrence of plant latices is widespread, there are more than 40 families of plants characterized to establish lactiferous structures. The appearance of hydrolytic active proteins, incorporated in latices is already characterized, and hydrolytic active proteins are considerable, and for several plant families, the occurrence of hydrolytic active proteins is already specified e.g. Apocynaceae Juss., Caricaceae Dumort, Euphorbiaceae Juss., Moraceae Gaudich and Papaveraceae Juss. In our investigation, focused on latex bearing plants of order Asterales, Asteraceae and Campanulaceae in particular. The present outcomes represent a comprehensive study, relating to the occurrence of proteolytic active enzymes of order Asterales for the first time. 131 different species of Asteraceae and Campanulaceae were tested, and the appearance of plant latex proteases were determined in different quantities. Proteolytic activity was investigated by inhibitory studies and determination of residual activity in the following, enable us to characterize the proteases. Most of the considered species exhibit a serine protease activity and a multiplicity of species exhibited two or more subclasses of proteases. PMID:26458257

  13. Silibinin Improves the Effects of Methotrexate in Patients with Active Rheumatoid Arthritis: Pilot Clinical Study

    PubMed Central

    Hussain, Saad Abdulrahman; Mortada, Ahmed Hashem; Jasim, Nazar Abdulateef; Gorial, Faiq Isho

    2016-01-01

    Objectives Our study sought to evaluate the effects of silibinin in patients with active rheumatoid arthritis (RA) treated with methotrexate (MTX). Methods We conducted a randomized multi-center, double-blind, placebo-controlled clinical trial over a 16-week treatment period at the Al-Sader and Baghdad Teaching Hospitals in Najaf and Baghdad, respectively. A total of 60 patients (30 of each sex) with active RA, already maintained on 12 mg MTX weekly for at least three consecutive months, were included in the study. Patients were randomly allocated to receive either 120 mg silibinin twice daily or a placebo, combined with their regular MTX regimen. The patients were evaluated by measuring disease activity score using the 28-joint Disease Activity Score, Simple Disease Activity Index, and Health Assessment Questionnaire–Disability Index scores at the start and end of the study. Blood samples were evaluated for the erythrocyte sedimentation rate (ESR), hemoglobin (Hb), high-sensitivity C-reactive protein (hs-CRP), creatine kinase (CK), anti-cyclic citrullinated peptide (CCP), and the serum cytokine levels of tumor necrosis factor (TNF)-α, interleukin (IL)-6, IL-8, IL-10, and IL-2. Results Silibinin significantly decreases the already elevated clinical scores compared to placebo treatment. ESR, IL-8, IL-6, TNF-α, anti-CCP, hs-CRP levels were significantly reduced. Additionally, the use of silibinin significantly increases Hb, IL-10, and IL-2 levels. Conclusion Silibinin may improve the effects of MTX on certain biochemical and clinical markers of patients with active RA. PMID:27403238

  14. How do interprofessional student teams interact in a primary care clinic? A qualitative analysis using activity theory.

    PubMed

    Kent, Fiona; Francis-Cracknell, Alison; McDonald, Rachael; Newton, Jennifer M; Keating, Jennifer L; Dodic, Miodrag

    2016-10-01

    Practice based interprofessional education opportunities are proposed as a mechanism for health professionals to learn teamwork skills and gain an understanding of the roles of others. Primary care is an area of practice that offers a promising option for interprofessional student learning. In this study, we investigated what and how students from differing professions learn together. Our findings inform the design of future interprofessional education initiatives. Using activity theory, we conducted an ethnographic investigation of interprofessional education in primary care. During a 5 months period, we observed 14 clinic sessions involving mixed discipline student teams who interviewed people with chronic disease. Teams were comprised of senior medicine, nursing, occupational therapy, pharmacy and physiotherapy entry level students. Semi-structured interviews were also conducted with seven clinical educators. Data were analysed to ascertain the objectives, tools, rules and division of labour. Two integrated activity systems were identified: (1) student teams gathering information to determine patients' health care needs and (2) patients either as health consumers or student educators. Unwritten rules regarding 'shared contribution', 'patient as key information source' and 'time constraints' were identified. Both the significance of software literacy on team leadership, and a pre-determined structure of enquiry, highlighted the importance of careful consideration of the tools used in interprofessional education, and the way they can influence practice. The systems of practice identified provide evidence of differing priorities and values, and multiple perspectives of how to manage health. The work reinforced the value of the patients' voice in clinical and education processes. PMID:26781698

  15. Investigating a Novel Activation-Repolarisation Time Metric to Predict Localised Vulnerability to Reentry Using Computational Modelling

    PubMed Central

    Hill, Yolanda R.; Child, Nick; Hanson, Ben; Wallman, Mikael; Coronel, Ruben; Plank, Gernot; Rinaldi, Christopher A.; Gill, Jaswinder; Smith, Nicolas P.; Taggart, Peter; Bishop, Martin J.

    2016-01-01

    Exit sites associated with scar-related reentrant arrhythmias represent important targets for catheter ablation therapy. However, their accurate location in a safe and robust manner remains a significant clinical challenge. We recently proposed a novel quantitative metric (termed the Reentry Vulnerability Index, RVI) to determine the difference between activation and repolarisation intervals measured from pairs of spatial locations during premature stimulation to accurately locate the critical site of reentry formation. In the clinic, the method showed potential to identify regions of low RVI corresponding to areas vulnerable to reentry, subsequently identified as ventricular tachycardia (VT) circuit exit sites. Here, we perform an in silico investigation of the RVI metric in order to aid the acquisition and interpretation of RVI maps and optimise its future usage within the clinic. Within idealised 2D sheet models we show that the RVI produces lower values under correspondingly more arrhythmogenic conditions, with even low resolution (8 mm electrode separation) recordings still able to locate vulnerable regions. When applied to models of infarct scars, the surface RVI maps successfully identified exit sites of the reentrant circuit, even in scenarios where the scar was wholly intramural. Within highly complex infarct scar anatomies with multiple reentrant pathways, the identified exit sites were dependent upon the specific pacing location used to compute the endocardial RVI maps. However, simulated ablation of these sites successfully prevented the reentry re-initiation. We conclude that endocardial surface RVI maps are able to successfully locate regions vulnerable to reentry corresponding to critical exit sites during sustained scar-related VT. The method is robust against highly complex and intramural scar anatomies and low resolution clinical data acquisition. Optimal location of all relevant sites requires RVI maps to be computed from multiple pacing

  16. Investigating a Novel Activation-Repolarisation Time Metric to Predict Localised Vulnerability to Reentry Using Computational Modelling.

    PubMed

    Hill, Yolanda R; Child, Nick; Hanson, Ben; Wallman, Mikael; Coronel, Ruben; Plank, Gernot; Rinaldi, Christopher A; Gill, Jaswinder; Smith, Nicolas P; Taggart, Peter; Bishop, Martin J

    2016-01-01

    Exit sites associated with scar-related reentrant arrhythmias represent important targets for catheter ablation therapy. However, their accurate location in a safe and robust manner remains a significant clinical challenge. We recently proposed a novel quantitative metric (termed the Reentry Vulnerability Index, RVI) to determine the difference between activation and repolarisation intervals measured from pairs of spatial locations during premature stimulation to accurately locate the critical site of reentry formation. In the clinic, the method showed potential to identify regions of low RVI corresponding to areas vulnerable to reentry, subsequently identified as ventricular tachycardia (VT) circuit exit sites. Here, we perform an in silico investigation of the RVI metric in order to aid the acquisition and interpretation of RVI maps and optimise its future usage within the clinic. Within idealised 2D sheet models we show that the RVI produces lower values under correspondingly more arrhythmogenic conditions, with even low resolution (8 mm electrode separation) recordings still able to locate vulnerable regions. When applied to models of infarct scars, the surface RVI maps successfully identified exit sites of the reentrant circuit, even in scenarios where the scar was wholly intramural. Within highly complex infarct scar anatomies with multiple reentrant pathways, the identified exit sites were dependent upon the specific pacing location used to compute the endocardial RVI maps. However, simulated ablation of these sites successfully prevented the reentry re-initiation. We conclude that endocardial surface RVI maps are able to successfully locate regions vulnerable to reentry corresponding to critical exit sites during sustained scar-related VT. The method is robust against highly complex and intramural scar anatomies and low resolution clinical data acquisition. Optimal location of all relevant sites requires RVI maps to be computed from multiple pacing

  17. Investigating Pre-Service Early Childhood Teachers' Attitudes towards the Computer Based Education in Science Activities

    ERIC Educational Resources Information Center

    Yilmaz, Nursel; Alici, Sule

    2011-01-01

    The purpose of this study was to investigate pre-service early childhood teachers' attitudes towards using Computer Based Education (CBE) while implementing science activities. More specifically, the present study examined the effect of different variables such as gender, year in program, experience in preschool, owing a computer, and the…

  18. Investigating Mediations in Student Activities in an English Immersion Context in Mainland China

    ERIC Educational Resources Information Center

    Liang, Xiaohua

    2009-01-01

    This study aims to investigate the role of mediation in the learning process from a sociocultural perspective, activity theory in particular. This study was carried out in a primary English immersion school within the CCUEI Programs in Mainland China. Data were collected mainly through observations and interviews, which were then supplemented by…

  19. Authentic Experience within Investigative Activities: The Role of Reflection in the Learning Environment.

    ERIC Educational Resources Information Center

    Petrosino, Anthony J., Jr.

    This document examines how a unit on model rockets, designed to be a "hands-on" activity within the "Mission to Mars" curriculum that was implemented in the Nashville (Tennessee) area middle schools, has been used to investigate children's understanding of experimentation. A literature review explores some of the traditional constraints placed on…

  20. Investigation of the Relations between Religious Activities and Subjective Well-Being of High School Students

    ERIC Educational Resources Information Center

    Eryilmaz, Ali

    2015-01-01

    This study aims to investigate the relation between participation in religious activities and the subjective wellbeing of high school students. The study group involves 196 participants, 99 female and 97 male; all of the participants were adolescents attending high school in Eskisehir, Turkey, their ages varying from 14 to 16. The measurement…

  1. Young Children's Literacy in the Activity Space of the Library: A Geosemiotic Investigation

    ERIC Educational Resources Information Center

    Nichols, Sue

    2011-01-01

    An ecological approach, emphasizing the importance of understanding multiple contexts for learning, underpins this study of libraries as activity spaces for young children's literacy participation. Five libraries serving a diversity of communities were the subject of ethnographic investigation incorporating participant observation, visual…

  2. Problematic Internet Use among Turkish University Students: A Multidimensional Investigation Based on Demographics and Internet Activities

    ERIC Educational Resources Information Center

    Tekinarslan, Erkan; Gurer, Melih Derya

    2011-01-01

    This study investigated the Turkish undergraduate university students' problematic Internet use (PIU) levels on different dimensions based on demographics (e.g., gender, Internet use by time of day), and Internet activities (e.g., chat, entertainment, social networking, information searching, etc.). Moreover, the study explored some predictors of…

  3. Going Underground: A Field Investigation and Lab Activity on Karst Topography and Water Systems

    ERIC Educational Resources Information Center

    O'Dell, Gary; Gonzalez-Espada, Wilson

    2011-01-01

    Students learn science best with activities that mirror the way scientists work. This article describes how geologists investigate groundwater flow systems in areas of karst topography--geologic formations shaped by dissolving bedrock--and provides a way for students to replicate this research. Students also use electric current to model water…

  4. Investigating Learner Attitudes toward E-Books as Learning Tools: Based on the Activity Theory Approach

    ERIC Educational Resources Information Center

    Liaw, Shu-Sheng; Huang, Hsiu-Mei

    2016-01-01

    This paper investigates the use of e-books as learning tools in terms of learner satisfaction, usefulness, behavioral intention, and learning effectiveness. Based on the activity theory approach, this research develops a research model to understand learner attitudes toward e-books in two physical sizes: 10? and 7?. Results suggest that screen…

  5. Locating Active Plate Boundaries by Earthquake Data. Crustal Evaluation Education Project. Teacher's Guide [and] Student Investigation.

    ERIC Educational Resources Information Center

    Stoever, Edward C., Jr.

    Crustal Evolution Education Project (CEEP) modules were designed to: (1) provide students with the methods and results of continuing investigations into the composition, history, and processes of the earth's crust and the application of this knowledge to man's activities and (2) to be used by teachers with little or no previous background in the…

  6. An Investigation into Social Learning Activities by Practitioners in Open Educational Practices

    ERIC Educational Resources Information Center

    Schreurs, Bieke; Van den Beemt, Antoine; Prinsen, Fleur; Witthaus, Gabi; Conole, Gráinne; De Laat, Maarten

    2014-01-01

    By investigating how educational practitioners participate in activities around open educational practices (OEP), this paper aims at contributing to an understanding of open practices and how these practitioners learn to use OEP. Our research is guided by the following hypothesis: Different social configurations support a variety of social…

  7. Investigating Acceptance toward Mobile Learning to Assist Individual Knowledge Management: Based on Activity Theory Approach

    ERIC Educational Resources Information Center

    Liaw, Shu-Sheng; Hatala, Marek; Huang, Hsiu-Mei

    2010-01-01

    Mobile devices could facilitate human interaction and access to knowledge resources anytime and anywhere. With respect to wide application possibilities of mobile learning, investigating learners' acceptance towards it is an essential issue. Based on activity theory approach, this research explores positive factors for the acceptance of m-learning…

  8. Mass spectrometric detection of ricin and its activity in food and clinical samples.

    PubMed

    Kalb, Suzanne R; Barr, John R

    2009-03-15

    Ricin is a potent toxin capable of inhibiting protein synthesis and causing death or respiratory failure. Because of its high availability and lethality, ricin is considered a likely agent for bioterrorism. Rapidly determining contamination of food product with ricin and human exposure to ricin is therefore an important public health goal. In this work, we report the development of a method that detects ricin and its activity in food or clinical samples. This method involves immunocapture of the toxin, an examination of the activity of the ricin protein upon a DNA substrate that mimics the toxin's natural RNA target, and analysis of tryptic fragments of the toxin itself. It is the combination of these three techniques, all performed on the same sample, which allows for a sensitive and selective analysis of ricin isolated from a food or clinical sample. This measurement includes a measure of the toxin's activity. The utility of this method was demonstrated on ricin spiked into food and clinical samples consisting of milk, apple juice, serum, and saliva. PMID:19228034

  9. Clinical engineering in Italy: the activity of the National Research Council.

    PubMed

    Merletti, R; Bravar, D

    1990-11-01

    The results of a five-year effort to rationalise the process of acquisition and management of medical instrumentation in Italy are reported and discussed. The research programme, sponsored by the National Research Council of Italy, was completed in 1988 and focused on (1) acquisition of technology by hospitals; (2) assessment of performance evaluation and preventive maintenance procedures for biomedical equipment; (3) cost analysis of high-technology health services; (4) analysis of clinical engineering activities in Italy. The present situation and guidelines for the future are outlined. In Italy there are no official positions for clinical engineers in public hospitals; however seven health-delivery institutions have established some activity in the field and a total of 15 engineers are involved in it. Despite the obvious advantage shown by the experience of these pilot institutions, the field has serious difficulties in developing due to the policy of the Ministry of Health and the consequent lack of positions. To reach the level of service provided in other European or North American countries, Italy would need at least 500 clinical engineers and 2500 biomedical equipment technicians. However, the lack of professional opportunities does not encourage training activities in the field. PMID:2287174

  10. Developing clinical competency in crisis event management: an integrated simulation problem-based learning activity.

    PubMed

    Liaw, S Y; Chen, F G; Klainin, P; Brammer, J; O'Brien, A; Samarasekera, D D

    2010-08-01

    This study aimed to evaluate the integration of a simulation based learning activity on nursing students' clinical crisis management performance in a problem-based learning (PBL) curriculum. It was hypothesized that the clinical performance of first year nursing students who participated in a simulated learning activity during the PBL session would be superior to those who completed the conventional problem-based session. The students were allocated into either simulation with problem-based discussion (SPBD) or problem-based discussion (PBD) for scenarios on respiratory and cardiac distress. Following completion of each scenario, students from both groups were invited to sit an optional individual test involving a systematic assessment and immediate management of a simulated patient facing a crisis event. A total of thirty students participated in the first post test related to a respiratory scenario and thirty-three participated in the second post test related to a cardiac scenario. Their clinical performances were scored using a checklist. Mean test scores for students completing the SPBD were significantly higher than those who completing the PBD for both the first post test (SPBD 20.08, PBD 18.19) and second post test (SPBD 27.56, PBD 23.07). Incorporation of simulation learning activities into problem-based discussion appeared to be an effective educational strategy for teaching nursing students to assess and manage crisis events.

  11. Antibiofilm Activity of the Brown Alga Halidrys siliquosa against Clinically Relevant Human Pathogens.

    PubMed

    Busetti, Alessandro; Thompson, Thomas P; Tegazzini, Diana; Megaw, Julianne; Maggs, Christine A; Gilmore, Brendan F

    2015-06-01

    The marine brown alga Halidrys siliquosa is known to produce compounds with antifouling activity against several marine bacteria. The aim of this study was to evaluate the antimicrobial and antibiofilm activity of organic extracts obtained from the marine brown alga H. siliquosa against a focused panel of clinically relevant human pathogens commonly associated with biofilm-related infections. The partially fractionated methanolic extract obtained from H. siliquosa collected along the shores of Co. Donegal; Ireland; displayed antimicrobial activity against bacteria of the genus Staphylococcus; Streptococcus; Enterococcus; Pseudomonas; Stenotrophomonas; and Chromobacterium with MIC and MBC values ranging from 0.0391 to 5 mg/mL. Biofilms of S. aureus MRSA were found to be susceptible to the algal methanolic extract with MBEC values ranging from 1.25 mg/mL to 5 mg/mL respectively. Confocal laser scanning microscopy using LIVE/DEAD staining confirmed the antimicrobial nature of the antibiofilm activity observed using the MBEC assay. A bioassay-guided fractionation method was developed yielding 10 active fractions from which to perform purification and structural elucidation of clinically-relevant antibiofilm compounds. PMID:26058011

  12. Evaluation of Potential Clinical Surrogate Markers of a Trauma Induced Alteration of Clotting Factor Activities

    PubMed Central

    Payas, Arzu; Schoeneberg, Carsten; Wegner, Alexander; Kauther, Max Daniel; Lendemans, Sven

    2016-01-01

    Objective. The aim of this study was to identify routinely available clinical surrogate markers for potential clotting factor alterations following multiple trauma. Methods. In 68 patients admitted directly from the scene of the accident, all soluble clotting factors were analyzed and clinical data was collected prospectively. Ten healthy subjects served as control group. Results. Patients showed reduced activities of clotting factors II, V, VII, and X and calcium levels (all P < 0.0001 to 0.01). Levels of hemoglobin and base deficit correlated moderately to highly with the activities of a number of clotting factors. Nonsurvivors and patients who needed preclinical intubation or hemostatic therapy showed significantly reduced factor activities at admission. In contrast, factor VIII activity was markedly elevated after injury in general (P < 0.0001), but reduced in nonsurvivors (P < 0.05). Conclusions. Multiple trauma causes an early reduction of the activities of nearly all soluble clotting factors in general. Initial hemoglobin and, with certain qualifications, base deficit levels demonstrated a potential value in detecting those underlying clotting factor deficiencies. Nevertheless, their role as triggers of a hemostatic therapy as well as the observed response of factor VIII to multiple trauma and also its potential prognostic value needs further evaluation. PMID:27433474

  13. Antibiofilm Activity of the Brown Alga Halidrys siliquosa against Clinically Relevant Human Pathogens

    PubMed Central

    Busetti, Alessandro; Thompson, Thomas P.; Tegazzini, Diana; Megaw, Julianne; Maggs, Christine A.; Gilmore, Brendan F.

    2015-01-01

    The marine brown alga Halidrys siliquosa is known to produce compounds with antifouling activity against several marine bacteria. The aim of this study was to evaluate the antimicrobial and antibiofilm activity of organic extracts obtained from the marine brown alga H. siliquosa against a focused panel of clinically relevant human pathogens commonly associated with biofilm-related infections. The partially fractionated methanolic extract obtained from H. siliquosa collected along the shores of Co. Donegal; Ireland; displayed antimicrobial activity against bacteria of the genus Staphylococcus; Streptococcus; Enterococcus; Pseudomonas; Stenotrophomonas; and Chromobacterium with MIC and MBC values ranging from 0.0391 to 5 mg/mL. Biofilms of S. aureus MRSA were found to be susceptible to the algal methanolic extract with MBEC values ranging from 1.25 mg/mL to 5 mg/mL respectively. Confocal laser scanning microscopy using LIVE/DEAD staining confirmed the antimicrobial nature of the antibiofilm activity observed using the MBEC assay. A bioassay-guided fractionation method was developed yielding 10 active fractions from which to perform purification and structural elucidation of clinically-relevant antibiofilm compounds. PMID:26058011

  14. Investigation of spherical loudspeaker arrays for local active control of sound.

    PubMed

    Peleg, Tomer; Rafaely, Boaz

    2011-10-01

    Active control of sound can be employed globally to reduce noise levels in an entire enclosure, or locally around a listener's head. Recently, spherical loudspeaker arrays have been studied as multiple-channel sources for local active control of sound, presenting the fundamental theory and several active control configurations. In this paper, important aspects of using a spherical loudspeaker array for local active control of sound are further investigated. First, the feasibility of creating sphere-shaped quiet zones away from the source is studied both theoretically and numerically, showing that these quiet zones are associated with sound amplification and poor system robustness. To mitigate the latter, the design of shell-shaped quiet zones around the source is investigated. A combination of two spherical sources is then studied with the aim of enlarging the quiet zone. The two sources are employed to generate quiet zones that surround a rigid sphere, investigating the application of active control around a listener's head. A significant improvement in performance is demonstrated in this case over a conventional headrest-type system that uses two monopole secondary sources. Finally, several simulations are presented to support the theoretical work and to demonstrate the performance and limitations of the system.

  15. [Informed consent for clinical investigation in the critically ill patient. An introduction to the regulation 536/2014/EC on clinical investigation of medicinal products for human use, repealing Directive 2001/20/EC].

    PubMed

    Savonitto, Stefano; Coppola, Teresa; Braglia, Paola; Ciccone, Alfonso

    2016-05-01

    The principle of patient information, awareness and documented consent for the participation in clinical trials is a cornerstone in the modern ethics of clinical research. However, this procedure is seldom applicable in the critically ill patient who becomes suddenly incapable of fully evaluating the risk vs benefit of the alternative therapeutic options. This issue becomes particularly problematic in those conditions where the benefit of any intervention is highly time-dependent, such as acute myocardial infarction, stroke, cardiac arrest, polytrauma and other similar conditions. The new directive 536/2014/EC defines the concept that in these cases the expert clinician and the Ethics Committees, based upon a rigorous study protocol, are in better conditions, as compared to patients' proxies and any legal representative, to take an appropriate decision. This decision should be later confirmed (deferred consent) by the patient, in case he returns competent, or by his proxies or legal tutor, in order to use experimental data. The new directive ends a long period of disparity among the Member States, some of which had taken unilateral decisions allowing the participation of incapable patients, whereas others, among which Italy, had a more conservative approach. Unfortunately, owing to technical and bureaucratic issues, the new regulation is unlikely to become active before the beginning of 2018. PMID:27310904

  16. Seeing the Moon: A Series of Inquiry Activities Using Light to Investigate the Moon

    NASA Astrophysics Data System (ADS)

    Shupla, Christine; Runyon, C.; Shipp, S.; Tremain, A. H.

    2007-12-01

    Seeing the Moon: Using Light to Investigate the Moon is a series of educational activity modules created for the Moon Mineralogy Mapper instrument aboard the Chandrayaan-1. In these modules, classroom students investigate light and the geologic history of the Moon. Through the hands-on inquiry based activities, 5th to 8th grade students experiment with light and color, collect and analyze authentic data from rock samples using an ALTA reflectance spectrometer, map the rock types of the Moon, and develop theories of the Moon's history. This poster will describe the activities and share the location of the modules. This poster will also share information on the availability of loaner kits which including rock samples and sets of the ALTA reflectance spectrometer.

  17. Investigation of the chemical composition-antibacterial activity relationship of essential oils by chemometric methods.

    PubMed

    Miladinović, Dragoljub L; Ilić, Budimir S; Mihajilov-Krstev, Tatjana M; Nikolić, Nikola D; Miladinović, Ljiljana C; Cvetković, Olga G

    2012-05-01

    The antibacterial effects of Thymus vulgaris (Lamiaceae), Lavandula angustifolia (Lamiaceae), and Calamintha nepeta (Lamiaceae) Savi subsp. nepeta var. subisodonda (Borb.) Hayek essential oils on five different bacteria were estimated. Laboratory control strain and clinical isolates from different pathogenic media were researched by broth microdilution method, with an emphasis on a chemical composition-antibacterial activity relationship. The main constituents of thyme oil were thymol (59.95%) and p-cymene (18.34%). Linalool acetate (38.23%) and β-linalool (35.01%) were main compounds in lavender oil. C. nepeta essential oil was characterized by a high percentage of piperitone oxide (59.07%) and limonene (9.05%). Essential oils have been found to have antimicrobial activity against all tested microorganisms. Classification and comparison of essential oils on the basis of their chemical composition and antibacterial activity were made by utilization of appropriate chemometric methods. The chemical principal component analysis (PCA) and hierachical cluster analysis (HCA) separated essential oils into two groups and two sub-groups. Thyme essential oil forms separate chemical HCA group and exhibits highest antibacterial activity, similar to tetracycline. Essential oils of lavender and C. nepeta in the same chemical HCA group were classified in different groups, within antibacterial PCA and HCA analyses. Lavender oil exhibits higher antibacterial ability in comparison with C. nepeta essential oil, probably based on the concept of synergistic activity of essential oil components. PMID:22389175

  18. Distinct properties of telmisartan on agonistic activities for peroxisome proliferator-activated receptor γ among clinically used angiotensin II receptor blockers: drug-target interaction analyses.

    PubMed

    Kakuta, Hirotoshi; Kurosaki, Eiji; Niimi, Tatsuya; Gato, Katsuhiko; Kawasaki, Yuko; Suwa, Akira; Honbou, Kazuya; Yamaguchi, Tomohiko; Okumura, Hiroyuki; Sanagi, Masanao; Tomura, Yuichi; Orita, Masaya; Yonemoto, Takako; Masuzaki, Hiroaki

    2014-04-01

    A proportion of angiotensin II type 1 receptor blockers (ARBs) improves glucose dyshomeostasis and insulin resistance in a clinical setting. Of these ARBs, telmisartan has the unique property of being a partial agonist for peroxisome proliferator-activated receptor γ (PPARγ). However, the detailed mechanism of how telmisartan acts on PPARγ and exerts its insulin-sensitizing effect is poorly understood. In this context, we investigated the agonistic activity of a variety of clinically available ARBs on PPARγ using isothermal titration calorimetry (ITC) and surface plasmon resonance (SPR) system. Based on physicochemical data, we then reevaluated the metabolically beneficial effects of telmisartan in cultured murine adipocytes. ITC and SPR assays demonstrated that telmisartan exhibited the highest affinity of the ARBs tested. Distribution coefficient and parallel artificial membrane permeability assays were used to assess lipophilicity and cell permeability, for which telmisartan exhibited the highest levels of both. We next examined the effect of each ARB on insulin-mediated glucose metabolism in 3T3-L1 preadipocytes. To investigate the impact on adipogenesis, 3T3-L1 preadipocytes were differentiated with each ARB in addition to standard inducers of differentiation for adipogenesis. Telmisartan dose-dependently facilitated adipogenesis and markedly augmented the mRNA expression of adipocyte fatty acid-binding protein (aP2), accompanied by an increase in the uptake of 2-deoxyglucose and protein expression of glucose transporter 4 (GLUT4). In contrast, other ARBs showed only marginal effects in these experiments. In accordance with its highest affinity of binding for PPARγ as well as the highest cell permeability, telmisartan superbly activates PPARγ among the ARBs tested, thereby providing a fresh avenue for treating hypertensive patients with metabolic derangement. PMID:24424487

  19. Bio-active nanoemulsions enriched with gold nanoparticle, marigold extracts and lipoic acid: In vitro investigations.

    PubMed

    Guler, Emine; Barlas, F Baris; Yavuz, Murat; Demir, Bilal; Gumus, Z Pinar; Baspinar, Yucel; Coskunol, Hakan; Timur, Suna

    2014-09-01

    A novel and efficient approach for the preparation of enriched herbal formulations was described and their potential applications including wound healing and antioxidant activity (cell based and cell free) were investigated via in vitro cell culture studies. Nigella sativa oil was enriched with Calendula officinalis extract and lipoic acid capped gold nanoparticles (AuNP-LA) using nanoemulsion systems. The combination of these bio-active compounds was used to design oil in water (O/W) and water in oil (W/O) emulsions. The resulted emulsions were characterized by particle size measurements. The phenolic content of each nanoemulsion was examined by using both colorimetric assay and chromatographic analyses. Two different methods containing cell free chemical assay (1-diphenyl-2-picrylhydrazyl method) and cell based antioxidant activity test were used to evaluate the antioxidant capacities. In order to investigate the bio-activities of the herbal formulations, in vitro cell culture experiments, including cytotoxicity, scratch assay, antioxidant activity and cell proliferation were carried out using Vero cell line as a model cell line. Furthermore, to monitor localization of the nanoemulsions after application of the cell culture, the cell images were monitored via fluorescence microscope after FITC labeling. All data confirmed that the enriched N. sativa formulations exhibited better antioxidant and wound healing activity than N. sativa emulsion without any enrichment. In conclusion, the incorporation of AuNP-LA and C. officinalis extract into the N. sativa emulsions significantly increased the bio-activities. The present work may support further studies about using the other bio-active agents for the enrichment of herbal preparations to strengthen their activities.

  20. Bio-active nanoemulsions enriched with gold nanoparticle, marigold extracts and lipoic acid: In vitro investigations.

    PubMed

    Guler, Emine; Barlas, F Baris; Yavuz, Murat; Demir, Bilal; Gumus, Z Pinar; Baspinar, Yucel; Coskunol, Hakan; Timur, Suna

    2014-09-01

    A novel and efficient approach for the preparation of enriched herbal formulations was described and their potential applications including wound healing and antioxidant activity (cell based and cell free) were investigated via in vitro cell culture studies. Nigella sativa oil was enriched with Calendula officinalis extract and lipoic acid capped gold nanoparticles (AuNP-LA) using nanoemulsion systems. The combination of these bio-active compounds was used to design oil in water (O/W) and water in oil (W/O) emulsions. The resulted emulsions were characterized by particle size measurements. The phenolic content of each nanoemulsion was examined by using both colorimetric assay and chromatographic analyses. Two different methods containing cell free chemical assay (1-diphenyl-2-picrylhydrazyl method) and cell based antioxidant activity test were used to evaluate the antioxidant capacities. In order to investigate the bio-activities of the herbal formulations, in vitro cell culture experiments, including cytotoxicity, scratch assay, antioxidant activity and cell proliferation were carried out using Vero cell line as a model cell line. Furthermore, to monitor localization of the nanoemulsions after application of the cell culture, the cell images were monitored via fluorescence microscope after FITC labeling. All data confirmed that the enriched N. sativa formulations exhibited better antioxidant and wound healing activity than N. sativa emulsion without any enrichment. In conclusion, the incorporation of AuNP-LA and C. officinalis extract into the N. sativa emulsions significantly increased the bio-activities. The present work may support further studies about using the other bio-active agents for the enrichment of herbal preparations to strengthen their activities. PMID:25009101

  1. Feasibility and Validity of the Pediatric Ulcerative Colitis Activity Index in Routine Clinical Practice

    PubMed Central

    Dotson, Jennifer L.; Crandall, Wallace V.; Zhang, Peixin; Forrest, Christopher B; Bailey, L. Charles; Colletti, Richard B.; Kappelman, Michael D.

    2014-01-01

    Objectives The Pediatric Ulcerative Colitis Activity Index (PUCAI) is a non-invasive disease activity index developed as a clinical trial endpoint. More recently, practice guidelines have recommended the use of PUCAI in routine clinical care. We therefore sought to evaluate the feasibility, validity and responsiveness of PUCAI in a large, diverse collection of pediatric gastroenterology practices. Methods We extracted data from the two most recent encounters for patients with ulcerative colitis in the ImproveCareNow registry. Feasibility was determined by the percent of patients for whom all PUCAI components were recorded, validity by correlation of PUCAI scores across Physician Global Assessment (PGA) categories, and responsiveness to change by the correlation between the change in PUCAI and PGA scores between visits. Results 2503 patients were included (49.5% male, age 15.2±4.1 years, disease duration 3.7±3.2 years). All items in the PUCAI were completed for 96% of visits. PUCAI demonstrated excellent discriminatory ability between remission, mild and moderate disease; discrimination between moderate and severe disease was less robust. There was good correlation with PGA [r=0.76 (p<0.001), weighted kappa k=0.73 (p<0.001)]. The PUCAI change scores correlated well with PGA change scores (p<0.001). Test-retest reliability of the PUCAI was good (intra-class correlation coefficient=0.72 [95% CI 0.70–0.75], p<0.001). Guyatt’s responsiveness statistic was 1.18 and the correlation of ΔPUCAI with ΔPGA was 0.69 (p<0.001). Conclusions The PUCAI is feasible to use in routine clinical settings. Evidence of its validity and responsiveness support its use as a clinical tool for monitoring disease activity for patients with ulcerative colitis. PMID:25221935

  2. A cross-sectional study investigating clinical predictors and physical experiences of pain in Parkinson’s disease

    PubMed Central

    Rana, Abdul Qayyum; Saeed, Usman; Masroor, Mohamed Sufian; Yousuf, Muhammad Saad; Siddiqui, Ishraq

    2013-01-01

    Summary Pain is a non-motor symptom of Parkinson’s disease (PD) that is often neglected due to its high prevalence in both the PD and the normal elderly population. The aims of this cross-sectional study were to establish the prevalence of pain, investigate its clinical predictors and analyze physical experiences of pain as described by PD patients. A total of 121 patients diagnosed with PD were included. The patients underwent a neurological examination and a structured interview and completed questionnaires focusing on clinical types and physical experiences of pain. Logistic regressions were used to analyze possible predictors. Pain was reported by 80 (66%) patients with a mean age at PD diagnosis of 67.26±11.43 years. The most common clinical types of pain experienced by the patients were dystonic pain (48%), paresthesia/neuropathic pain (36%) and musculoskeletal pain (28%). The PD patients described their physical experience of pain as aching (46%), a feeling of tension (18%), sharp pain (12%), deep pain (12%) and dull pain (11%). Patients with PD affecting the right side of the body were four times more likely to report pain on the right side of the body; however, no such relation was found for the left side of the body. A higher UPDRS-III scale score and longer PD duration reduced the likelihood of patients reporting dull pain. The presence of paresthesia/neuropathic pain was shown to decrease the likelihood of patients reporting sharp pain. No significant relationships were found between the magnitude of pain and gender, age at PD diagnosis, PD duration, UPDRS-III score, or Hoehn and Yahr stage of PD. Although 40% of the PD patients felt that medication had a (direct) effect on their pain, no relationship could be found between pain severity and PD medication. PMID:24598399

  3. Investigating the effects of a sensorimotor rhythm-based BCI training on the cortical activity elicited by mental imagery

    NASA Astrophysics Data System (ADS)

    Toppi, J.; Risetti, M.; Quitadamo, L. R.; Petti, M.; Bianchi, L.; Salinari, S.; Babiloni, F.; Cincotti, F.; Mattia, D.; Astolfi, L.

    2014-06-01

    Objective. It is well known that to acquire sensorimotor (SMR)-based brain-computer interface (BCI) control requires a training period before users can achieve their best possible performances. Nevertheless, the effect of this training procedure on the cortical activity related to the mental imagery ability still requires investigation to be fully elucidated. The aim of this study was to gain insights into the effects of SMR-based BCI training on the cortical spectral activity associated with the performance of different mental imagery tasks. Approach. Linear cortical estimation and statistical brain mapping techniques were applied on high-density EEG data acquired from 18 healthy participants performing three different mental imagery tasks. Subjects were divided in two groups, one of BCI trained subjects, according to their previous exposure (at least six months before this study) to motor imagery-based BCI training, and one of subjects who were naive to any BCI paradigms. Main results. Cortical activation maps obtained for trained and naive subjects indicated different spectral and spatial activity patterns in response to the mental imagery tasks. Long-term effects of the previous SMR-based BCI training were observed on the motor cortical spectral activity specific to the BCI trained motor imagery task (simple hand movements) and partially generalized to more complex motor imagery task (playing tennis). Differently, mental imagery with spatial attention and memory content could elicit recognizable cortical spectral activity even in subjects completely naive to (BCI) training. Significance. The present findings contribute to our understanding of BCI technology usage and might be of relevance in those clinical conditions when training to master a BCI application is challenging or even not possible.

  4. [Copper and cadmium toxicities to activated sludge investigated with ToxTell biosensor].

    PubMed

    Wang, Xue-Jiang; Wang, Xin; Liu, Mian; Wu, Zhen; Yang, Lian-Zhen; Xia, Si-Qing

    2012-06-01

    Effects of different concentrations of Cu2+, Cu2+ and Cd2+ combined pollution on the removal performance of COD in activated sludge system were investigated, and the ToxTell biosensor with activated sludge was constructed to determine the toxicity of Cu2+, Cu2+ and Cd2+ combined pollution. The results showed that there was no significant impact on the activated sludge process when Cu2+ concentration was lower than 10 mg x L(-1), and the addition of Cd2+ enhanced the inhibition of COD removal, and the maximum inhibition efficiency of COD reached at about 1.5 h. With the increase of aeration time, the COD removal efficiency increased slowly again. The toxicity measurement with ToxTell biosensor was close to the biological effects (inhibition efficiencies of COD), which showed that the ToxTell biosensor could be used well in the early warming determination of Cu2+ and Cd2+ in the activated sludge process.

  5. The Use of LS-DYNA in the Columbia Accident Investigation and Return to Flight Activities

    NASA Technical Reports Server (NTRS)

    Gabrys, Jonathan; Schatz, Josh; Carney, Kelly; Melis, Matthew; Fasanella, Edwin L.; Lyle, Karen H.

    2004-01-01

    During the launch of the Space Shuttle Columbia on January 16, 2003, foam originating from the external tank impacted the shuttle's left wing 81 seconds after lift-off. Then on February 1st, Space Shuttle Columbia broke-up during re-entry. In the weeks that followed, the Columbia Accident Investigation Board had formed various teams to investigate every aspect of the tragedy. One of these teams was the Impact Analysis Team, which was asked to investigate the foam impact on the wing leading edge. This paper will describe the approach and methodology used by the team to support the accident investigation, and more specifically the use of LS-DYNA for analyzing the foam impact event. Due to the success of the analytical predictions, the impact analysis team has also been asked to support Return to Flight activities. These activities will analyze a far broader range of impact events, but not with just foam and not only on the wing leading edge. The debris list has expanded and so have the possible impact locations. This paper will discuss the Return to Flight activities and the use of LS-DYNA to support them.

  6. Cytomorphometric and clinical investigation of the gingiva before and after low-level laser therapy of gingivitis in children.

    PubMed

    Igic, Marija; Mihailovic, Dragan; Kesic, Ljiljana; Milasin, Jelena; Apostolovic, Mirjana; Kostadinovic, Ljiljana; Janjic, Olivera Trickovic

    2012-07-01

    Gingival epithelial cells are the first physical barrier against periodontal pathogenic microorganisms. Bacterial products may penetrate the epithelium and directly disturb its integrity. We investigated the clinical and cytomorphological status of the gingiva in children with gingivitis before and after low-level laser therapy. The study enrolled 130 children divided into three groups: group 1 comprised 50 children with chronic catarrhal gingivitis who received basic treatment, group 2 comprised 50 children with chronic catarrhal gingivitis who received low-level laser treatment in addition to basic treatment, and group 3 comprised 30 children with healthy gingiva as controls. Oral hygiene and the status of the gingiva were assessed using the appropriate indexes before and after treatment. Inflammation of the gingiva was monitored by cytomorphometric evaluation. Cytomorphometric analysis revealed a statistically significant difference (p < 0.001) in the size of the nuclei of the stratified squamous epithelial cells of the gingiva before and after treatment in chronic catarrhal gingivitis. Evaluation using clinical parameters showed that treatment of gingivitis with basic treatment was successful. Cytomorphometric analysis showed that after basic treatment the nuclei of the stratified squamous epithelial cells of the gingiva were reduced in size, although not to the size found in healthy gingiva. However, after adjuvant low-level laser therapy, the size of the nuclei of the stratified squamous epithelial cells in the gingiva matched the size of the nuclei in the cells in healthy gingiva.

  7. Students' clinical learning in an emerging dental school: an investigation in international collaboration between Michigan and Ghana.

    PubMed

    Peters, Mathilde C; Adu-Ababio, Francis; Jarrett-Ananaba, Nejay P; Johnson, Lynn A

    2013-12-01

    The dearth of dental faculty members is a widely known problem that is exacerbated in countries that are attempting to begin dental education programs. This collaboration between Kwame Nkrumah University of Science and Technology and the University of Michigan investigated if dental students who have just started their clinical dental education can learn the knowledge and skills required for identifying and restoring cavitated caries lesions through compact course delivery. There were three instructional blocks: 1) didactic seminar; 2) seminar, simulated hands-on skills instruction, and clinical observation/assisting with treatment of schoolchildren; and 3) seminar, simulated skills training, and application to schoolchildren. Each dental student completed a questionnaire measuring knowledge and perceptions of knowledge, experience, and confidence at five points in time. The dental students' knowledge increased significantly as well as their perceived knowledge, experience, and confidence (p<0.0001). In general, the students showed proficiency in delivering simple treatments. The project showed that an integrated compact course delivery model may assist emerging dental schools to cope with the challenging shortage of resident faculty members. PMID:24319137

  8. Trick maneuvers in cervical dystonia: investigation of movement- and touch-related changes in polymyographic activity.

    PubMed

    Wissel, J; Müller, J; Ebersbach, G; Poewe, W

    1999-11-01

    Antagonistic gestures or trick maneuvers are well-known clinical features to reduce or abolish dystonic posturing in cervical dystonia (CD). The maneuvers typically consist of a finger touch to the facial skin but their physiology remains unknown. To determine the temporal profile of geste maneuver performance, 25 patients with idiopathic CD were studied by means of polymyography of six cervical muscles prior to any botulinum toxin treatment. Two piezoelectric elements fixed to a fingertip of the hand involved in the trick maneuver and to the facial target region, respectively, were used to relate the essential points of the trick maneuver time course (start of geste-arm movement, facial contact, end of contact, end of movement) to changes in polymyographic activity. Thirteen patients (52%) showed marked reductions of electromyographic (EMG) activity (> or =50% in at least one muscle) during arm movement, definitely prior to contact between fingers and facial target area; in the remaining 12 patients (48%), geste-related EMG effects were confined to facial-finger contact. These results might indicate different physiological mechanisms in clinically indistinguishable antagonistic gestures.

  9. Clinical Metabolomics: The New Metabolic Window for Inborn Errors of Metabolism Investigations in the Post-Genomic Era.

    PubMed

    Tebani, Abdellah; Abily-Donval, Lenaig; Afonso, Carlos; Marret, Stéphane; Bekri, Soumeya

    2016-01-01

    Inborn errors of metabolism (IEM) represent a group of about 500 rare genetic diseases with an overall estimated incidence of 1/2500. The diversity of metabolic pathways involved explains the difficulties in establishing their diagnosis. However, early diagnosis is usually mandatory for successful treatment. Given the considerable clinical overlap between some inborn errors, biochemical and molecular tests are crucial in making a diagnosis. Conventional biological diagnosis procedures are based on a time-consuming series of sequential and segmented biochemical tests. The rise of "omic" technologies offers holistic views of the basic molecules that build a biological system at different levels. Metabolomics is the most recent "omic" technology based on biochemical characterization of metabolites and their changes related to genetic and environmental factors. This review addresses the principles underlying metabolomics technologies that allow them to comprehensively assess an individual biochemical profile and their reported applications for IEM investigations in the precision medicine era.

  10. Clinical Metabolomics: The New Metabolic Window for Inborn Errors of Metabolism Investigations in the Post-Genomic Era

    PubMed Central

    Tebani, Abdellah; Abily-Donval, Lenaig; Afonso, Carlos; Marret, Stéphane; Bekri, Soumeya

    2016-01-01

    Inborn errors of metabolism (IEM) represent a group of about 500 rare genetic diseases with an overall estimated incidence of 1/2500. The diversity of metabolic pathways involved explains the difficulties in establishing their diagnosis. However, early diagnosis is usually mandatory for successful treatment. Given the considerable clinical overlap between some inborn errors, biochemical and molecular tests are crucial in making a diagnosis. Conventional biological diagnosis procedures are based on a time-consuming series of sequential and segmented biochemical tests. The rise of “omic” technologies offers holistic views of the basic molecules that build a biological system at different levels. Metabolomics is the most recent “omic” technology based on biochemical characterization of metabolites and their changes related to genetic and environmental factors. This review addresses the principles underlying metabolomics technologies that allow them to comprehensively assess an individual biochemical profile and their reported applications for IEM investigations in the precision medicine era. PMID:27447622

  11. Ethanolic extracts of Tinospora cordifolia and Alstonia scholaris show antimicrobial activity towards clinical isolates of methicillin-resistant and carbapenemase-producing bacteria.

    PubMed

    Bonvicini, Francesca; Mandrone, Manuela; Antognoni, Fabiana; Poli, Ferruccio; Gentilomi, Giovanna Angela

    2014-01-01

    The aim of this study was to determine the in vitro antimicrobial activity of crude extracts of three plants from Ayurveda tradition (Tinospora cordifolia, Alstonia scholaris, Crataeva nurvala) against reference microbial strains and clinical isolates of methicillin-resistant Staphylococcus aureus (MRSA) and carbapenemase-producing Klebsiella pneumoniae. IC50 values were obtained by micro-dilution methods meeting the requirements of the NCCLS standard. The cytotoxicity of the extracts was also investigated on a mammalian cell line. Extracts displayed a variable degree of antimicrobial activity and did not interfere with mammalian cell proliferation. T. cordifolia and A. scholaris exhibited a higher inhibitory activity against clinical isolates of MRSA and carbapenemase-producing K. pneumoniae compared with reference strains, while C. nurvala exhibited a different behaviour. An antifungal activity towards Candida albicans was observed for A. scholaris extract. Results indicate that constituents from T. cordifolia and A. scholaris may be a potential source of new therapeutic strategies for infectious diseases. PMID:24749692

  12. Using cultural-historical activity theory to study clinical reasoning in context.

    PubMed

    Toth-Cohen, Susan

    2008-06-01

    The aim of this paper is to describe sources of conflict and congruence in critical areas of practice with caregivers of persons with dementia, using cultural-historical activity theory as an analytic framework. Findings are drawn from an ethnographic study that described the context of occupational therapists' (OTs') clinical reasoning in a funded, home-based environmental skill-building program designed to help caregivers manage the daily care of a family member with dementia. Data were gathered through observation of intervention sessions, debriefing sessions, semi-structured interviews with therapists, and review of intervention documentation. Primary sources of conflict and congruence within the identified practice context included conflicts between therapists and caregivers concerning which environmental strategies were best for addressing problems in caregiving and expectations regarding OT and caregiver roles. Areas of congruence included the fit between intervention protocols used to guide treatment and the approaches therapists developed to help caregivers modify care receivers' living environments. The study revealed the complexity of OT practice and demonstrated that practice contexts can be systematically analyzed using cultural-historical activity theory to determine key factors influencing clinical reasoning. The approach also presents an alternative perspective on clinical reasoning that more directly integrates clients/caregivers and therapists as co-constructors of OT intervention.

  13. Disease activity in Graves' ophthalmopathy: diagnosis with orbital MR imaging and correlation with clinical score.

    PubMed

    Tortora, Fabio; Cirillo, Mario; Ferrara, Marco; Belfiore, Maria Paola; Carella, Carlo; Caranci, Ferdinando; Cirillo, Sossio

    2013-10-01

    In Graves' ophthalmopathy (GO) it is important to distinguish acute inflammation at an early stage, responsive to immunosuppressive treatment, from inactive fibrotic end stage disease, unresponsive to the same treatment. The purpose of this study was to identify the most relevant signal intensities on orbital MR imaging with contrast administration both to classify patients according to their clinical activity score (defined by a cut-off value of 3) and to make a prediction of patient's CAS. Such threshold was considered as widely used in literature. Sixteen consecutive patients with a diagnosis of GO in different phases of thyroid disease based on clinical and orbital MR imaging signs, and six normal volunteers were examined. Orbital MR imaging was performed on a 1.5 Tesla MR Unit. MR scans were assessed by an experienced neuroradiologist, blinded to the clinical examinations. We found a statistical correlation between CAS and both STIR and contrast enhanced T1-weighted sequences. There was also a statistically significant correlation between STIR and contrast-enhanced T1 images disclosing the possibility of avoiding the injection of contrast medium. Our study proved that signal intensity values on STIR sequence increase in the inflammatory oedematous phase of disease. We confirmed the correlation between signal intensities on this sequence and CAS, showing an increase in signal intensity proportional to the CAS value. So we validated MRI use to establish the activity phase of disease more sensitively than CAS alone.

  14. Disease Activity in Graves' Ophthalmopathy: Diagnosis with Orbital MR Imaging and Correlation with Clinical Score

    PubMed Central

    Tortora, Fabio; Cirillo, Mario; Ferrara, Marco; Belfiore, Maria Paola; Carella, Carlo; Caranci, Ferdinando; Cirillo, Sossio

    2013-01-01

    Summary In Graves' ophthalmopathy (GO) it is important to distinguish acute inflammation at an early stage, responsive to immunosuppressive treatment, from inactive fibrotic end stage disease, unresponsive to the same treatment. The purpose of this study was to identify the most relevant signal intensities on orbital MR imaging with contrast administration both to classify patients according to their clinical activity score (defined by a cut-off value of 3) and to make a prediction of patient's CAS. Such threshold was considered as widely used in literature. Sixteen consecutive patients with a diagnosis of GO in different phases of thyroid disease based on clinical and orbital MR imaging signs, and six normal volunteers were examined. Orbital MR imaging was performed on a 1.5 Tesla MR Unit. MR scans were assessed by an experienced neuroradiologist, blinded to the clinical examinations. We found a statistical correlation between CAS and both STIR and contrast enhanced T1-weighted sequences. There was also a statistically significant correlation between STIR and contrast-enhanced T1 images disclosing the possibility of avoiding the injection of contrast medium. Our study proved that signal intensity values on STIR sequence increase in the inflammatory oedematous phase of disease. We confirmed the correlation between signal intensities on this sequence and CAS, showing an increase in signal intensity proportional to the CAS value. So we validated MRI use to establish the activity phase of disease more sensitively than CAS alone. PMID:24199816

  15. Clinical relevance of and risk factors for HSV-related tracheobronchitis or pneumonia: results of an outbreak investigation

    PubMed Central

    Engelmann, Ilka; Gottlieb, Jens; Meier, Astrid; Sohr, Dorit; Ruhparwar, Arjang; Henke-Gendo, Cornelia; Gastmeier, Petra; Welte, Tobias; Schulz, Thomas Friedrich; Mattner, Frauke

    2007-01-01

    Introduction Herpes simplex virus (HSV) type 1 was identified in respiratory specimens from a cluster of eight patients on a surgical intensive care unit within 8 weeks. Six of these patients suffered from HSV-related tracheobronchitis and one from HSV-related pneumonia only. Our outbreak investigation aimed to determine the clinical relevance of and risk factors associated with HSV-related tracheobronchitis or pneumonia in critically ill patients, and to investigate whether the cluster was caused by nosocomial transmission. Methods A retrospective cohort study was performed to identify risk factors for the outcomes of HSV-related tracheobronchitis or pneumonia and death using univariable analysis as well as logistic regression analysis. Viruses were typed by molecular analysis of a fragment of the HSV type 1 glycoprotein G. Results The cohort of patients covering the outbreak period comprised 53 patients, including six patients with HSV-related tracheobronchitis and one patient with pneumonia only. HSV-related tracheobronchitis or pneumonia was associated with increased mortality (100% in patients with versus 17.8% in patients without HSV-related tracheobronchitis or pneumonia; P < 0.0001). The interaction of longer duration of ventilation and tracheotomy was associated with HSV-related tracheobronchitis or pneumonia in multivariable analysis. Identical HSV type 1 glycoprotein G sequences were found in three patients and in two patients. The group of three identical viral sequences belonged to a widely circulating strain. The two identical viral sequences were recovered from bronchoalveolar lavages of one patient with HSV-related tracheobronchitis and of one patient without clinical symptoms. These viral sequences showed unique polymorphisms, indicating probable nosocomial transmission. Conclusion HSV-related tracheobronchitis or pneumonia is associated with increased mortality in critically ill patients. Care should be taken to avoid nosocomial transmission and

  16. Multi-physiopathological consequences of the c.1392G>T CFTR mutation revealed by clinical and cellular investigations.

    PubMed

    Farhat, Raed; El-Seedy, Ayman; El-Moussaoui, Kamal; Pasquet, Marie-Claude; Adolphe, Catherine; Bieth, Eric; Languepin, Jeanne; Sermet-Gaudelus, Isabelle; Kitzis, Alain; Ladevèze, Véronique

    2015-02-01

    This study combines a clinical approach and multiple level cellular analyses to determine the physiopathological consequences of the c.1392G>T (p.Lys464Asn) CFTR exon 10 mutation, detected in a CF patient with a frameshift deletion in trans and a TG(11)T(5) in cis. Minigene experiment, with different TG(m)T(n) alleles, and nasal cell mRNA extracts were used to study the impact of c.1392G>T on splicing in both in cellulo and in vivo studies. The processing and localization of p.Lys464Asn protein were evaluated, in cellulo, by western blotting analyses and confocal microscopy. Clinical and channel exploration tests were performed on the patient to determine the exact CF phenotype profile and the CFTR chloride transport activity. c.1392G>T affects exon 10 splicing by inducing its complete deletion and encoding a frameshift transcript. The polymorphism TG(11)T(5) aggravates the effects of this mutation on aberrant splicing. Analysis of mRNA obtained from parental airway epithelial cells confirmed these in cellulo results. At the protein level the p.Lys464Asn protein showed neither maturated form nor membrane localization. Furthermore, the in vivo channel tests confirmed the absence of CFTR activity. Thus, the c.1392G>T mutation alone or in association with the TG repeats and the poly T tract revealed obvious impacts on splicing and CFTR protein processing and functionality. The c.[T(5); 1392G>T] complex allele contributes to the CF phenotype by affecting splicing and inducing a severe misprocessing defect. These results demonstrate that the classical CFTR mutations classification is not sufficient: in vivo and in cellulo studies of a possible complex allele in a patient are required to provide correct CFTR mutation classification, adequate medical counseling, and adapted therapeutic strategies.

  17. An Investigation into Cloud Condensation Nuclei (CCN) Activation in the Southwestern United States

    NASA Astrophysics Data System (ADS)

    Crosbie, E. C.; Youn, J.; Wonaschuetz, A.; Sorooshian, A.

    2013-12-01

    Cloud condensation nuclei (CCN) comprise a key component of the total aerosol with critical influences on weather and climate. The importance of CCN concentration is often linked to radiative feedbacks associated with cloud albedo, which has important consequences for climate sensitivity, however the importance of CCN may also extend to cloud dynamics in convective environments and atmospheric electricity. We present data from fifteen months of field measurements taken in an urban environment on a rooftop of a building at the University of Arizona campus in Tucson, Arizona. CCN were measured at high temporal resolution concurrently with measurements of particle size distributions, meteorological parameters, and the composition of the organic fraction of the aerosol. We investigate monthly, weekly, and diurnal patterns in the data along with activation ratio and apparent activation diameter, which provide important insight into the micro-scale dependencies of cloud activation. Furthermore, we examine the relationship between CCN and local and regional meteorology, with particular focus on the North American Monsoon season, to investigate feedback and response mechanisms relating to dynamics, microphysics, and chemistry. Monsoon aerosol are shown to have favorable composition to allow for higher CCN activity and thus lower apparent activation diameters. This finding coincides with enhanced aqueous-phase chemistry to produce more hygroscopic aerosol constituents such as sulfate and water-soluble organic compounds.

  18. In Vitro Activities of Garenoxacin (BMS-284756) against 170 Clinical Isolates of Nine Pasteurella Species

    PubMed Central

    Goldstein, Ellie J. C.; Citron, Diane M.; Merriam, C. Vreni; Warren, Yumi A.; Tyrrell, Kerin L.; Fernandez, Helen T.

    2002-01-01

    The in vitro susceptibilities of 170 clinical isolates plus 12 American Type Culture Collection strains of Pasteurella species comprising nine species and three Pasteurella multocida subspecies were studied by an agar dilution method. Garenoxacin (BMS-284756), a new des-fluoro(6) quinolone, was active at ≤0.06 μg/ml against all isolates, including four β-lactamase-producing strains, with >90% of the strains susceptible to ≤0.008 μg/ml. Garenoxacin was generally 1 to 2 dilutions more active than levofloxacin and moxifloxacin and was the most active agent tested. Cefoxitin required 1 μg/ml for inhibition of 51 of 182 (29%) of strains, and 3 strains (also β-lactamase producers) were resistant to doxycycline. PMID:12183274

  19. Chemical and biological investigation of N-hydroxy-valdecoxib: An active metabolite of valdecoxib.

    PubMed

    Erdélyi, Péter; Fodor, Tamás; Varga, Agnes Kis; Czugler, Mátyás; Gere, Anikó; Fischer, János

    2008-05-01

    The inhibition of cyclooxygenase enzymes plays an important role in the treatment of inflammatory diseases. N-Hydroxy-4-(5-methyl-3-phenylisoxazol-4-yl)benzenesulfonamide (3)-a primary metabolite of the highly selective COX-2 inhibitor valdecoxib-was synthesized and stabilized as its monohydrate (3a.H(2)O). The anti-inflammatory properties of 3a.H(2)O were investigated in carrageenan-induced edema and in acute and chronic pain models. Based on our biological investigation, we conclude that N-hydroxy-valdecoxib 3a is an active metabolite of valdecoxib.

  20. Investigation of MTH1 activity via mismatch-based DNA chain elongation.

    PubMed

    Gao, Tao; Gu, Shiyu; Liu, Fengzhen; Li, Liudi; Wang, Zhaoxia; Yang, Jie; Li, Genxi

    2016-01-28

    Accumulation and misincorporation of oxidative damaged 8-oxo-7,8-dihydroguanine triphosphates (8-oxo-dGTP) in genomic DNA may cause serious cellular function disorders. MutT Homolog 1 (MTH1), a protein enzyme that can help to prevent 8-oxo-dGTP misincorporation, plays critical roles in oxidative stress neutralization, oncogene-associated tumor malignancy, and anticancer therapies. So, in this work, a simple and function-oriented method is developed for the assay of MTH1 activity. Specifically, a mismatch-based ("8-oxoG: A" mismatch) DNA chain elongation strategy (MB-DCE) is firstly proposed to reveal the misincorporation efficiency of 8-oxo-dGTP. Then, further coupled with the inherent activity of MTH1 to prevent 8-oxo-dGTP misincorporation, a relationship can be established to reveal the activity of MTH1 through MB-DCE. As the method is designed directly towards the cellular function of MTH1, activity of MTH1 in different breast cancer cell lines has been detected, implying the potential application of this assay method for biomedical research and clinical diagnose in the future. PMID:26755138