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Sample records for active clinical investigation

  1. Clinical Investigations

    DTIC Science & Technology

    1977-09-30

    compounds. (2) Determine differences in these patterns compared to those produced by capsaicin (N-(4-hydroxy-3- methanybezyl) non -trans-6-eniamide) an...Elliott’s B Solution, Sterile as Methotrexate Diluent for Intrathecal Use WORK UNIT NO: 76/28 S. PRINCIPAL INVESTIrfATOR: Dr. J Swaney, MD ASSOCIATE...INVESTIGATORS: OBJECTIVES The object of this study is to determine if the use of Elliott’s B solution as diluent for intrathecal Methotrexate will reduce the

  2. Catalog of Completed Studies, US Army Health Care Studies and Clinical Investigation Activity.

    DTIC Science & Technology

    1984-12-10

    Environment Substudy: AD A139001 Effects of Chemical Protective Clothing on the Performance of Basic Medical Tasks (HCSD Report #83-001) 8 DATE TITLE...Contact urticaria to parabens , Arch. Dermatol, 1979, 115:1231-1232. *13 Smith, E. B., Padilla, R. S., McCabe, J. M., Becker, L. E., Benzoyl...Chemical Environment . --3-Report #83-001. Ft. Sam Houston, TX: Health Care Studies and Clinical Investigation Activity, December 1982. 19 Penetar, D. M

  3. [Advances on investigation of chemical constituents, pharmacological activities and clinical applications of Capparis spinosa].

    PubMed

    Yang, Tao; Liu, Yu-Qing; Wang, Chang-Hong; Wang, Zheng-Tao

    2008-11-01

    In this paper, the chemical constituents, pharmacological activities and clinical applications of Capparis spinosa had been reviewed. The constituents of C. spinosa include the saccharides and glycosides, flavonoids, alkaloids, terpenoids and volatile oils, fatty acids and steroides and so on. C. spinosa had many extensive pharmacological effects such as anti-inflammatory, odynolysis, antifungus, hepatoprotective effect, hypoglycemic activity, antioxidation, anti-hyperlipemia, anticoagulated blood, smooth muscle stimulation, anti-stress reaction, improve memory. It was used to treat arthrolithiasis, rheumarthritis and dermatosis in clinic in domestic, and it would have a broad application prospects.

  4. Preliminary investigation of Brain Network Activation (BNA) and its clinical utility in sport-related concussion

    PubMed Central

    Reches, A.; Kutcher, J.; Elbin, R. J.; Or-Ly, H.; Sadeh, B.; Greer, J.; McAllister, D. J.; Geva, A.; Kontos, A. P.

    2017-01-01

    ABSTRACT Background: The clinical diagnosis and management of patients with sport-related concussion is largely dependent on subjectively reported symptoms, clinical examinations, cognitive, balance, vestibular and oculomotor testing. Consequently, there is an unmet need for objective assessment tools that can identify the injury from a physiological perspective and add an important layer of information to the clinician’s decision-making process. Objective: The goal of the study was to evaluate the clinical utility of the EEG-based tool named Brain Network Activation (BNA) as a longitudinal assessment method of brain function in the management of young athletes with concussion. Methods: Athletes with concussion (n = 86) and age-matched controls (n = 81) were evaluated at four time points with symptom questionnaires and BNA. BNA scores were calculated by comparing functional networks to a previously defined normative reference brain network model to the same cognitive task. Results: Subjects above 16 years of age exhibited a significant decrease in BNA scores immediately following injury, as well as notable changes in functional network activity, relative to the controls. Three representative case studies of the tested population are discussed in detail, to demonstrate the clinical utility of BNA. Conclusion: The data support the utility of BNA to augment clinical examinations, symptoms and additional tests by providing an effective method for evaluating objective electrophysiological changes associated with sport-related concussions. PMID:28055228

  5. Clinical Investigation Program Report.

    DTIC Science & Technology

    1981-10-01

    Arousal Correlates of Psycho- therapy and Behavior Treatment. (0) 26 1981 Environmental Stress and Electromyographic Correlates of Chronic Posterior Trunk...Studies. Univ of North Carolina at Chapel Hill, Vol 2, Jun 1981. ACCEPTED Armstrong, R.D.: Stress in the Military Family. Accepted by Fan Prac J. DENTAL...Chief Clinical Management Conference, Ft Sam Houston, TX, Jan 1981. DEPARTMENT OF PSYCHIATRY & NEUROLOGY Armitage, D.T.: Physical Activity and Stress

  6. Clinical Investigation Program Report

    DTIC Science & Technology

    1992-10-01

    paper was based on Protocol 91-17 and was presented at the AMA National Conference in Washington, DC, in May 1992. Recipient of The Sixth Annual Dental ...Research Director, Dental Activity Chief, Department of Ministry & Pastoral Care Chief, Nursing Education & Staff Development Chief, Department of...Virus (HIV-l) Infection. (0) DENTAL ACTIVITY 1990 An in vivo Study of Dentinal Tubule Occlusion by Ferric 29 91-3 Oxalate. (C) 1990 The Effects of

  7. Clinical Investigation Program.

    DTIC Science & Technology

    1979-10-01

    Evaluation of Specific IgE in Nasal Secretions of Patients with Seasonal Rhinitis and Negative Skin Tests. American Academy of Allergy , New Orleans, LA...52 R.0 Immunotherapy 4 Pri ncipal FY Investigator Title Init. Status Page Nickles, Lactic Acid Metabolism in Laboratory 78 C,Pr,SP 53 D. J. Models...Chemotherapy with BCG 79 T 58 W. C. Immunotherapy in High Risk Melanoma Patients Waterfield, Naloxone Prior to Chemotherapy to 79 T 59 W. C. Prevent

  8. [Macrolide-lincosamide-streptogramin B (MLSB) resistance phenotypes in clinical Staphylococcus isolates and investigation of telithromycin activity].

    PubMed

    Uzun, Berrin; Güngör, Serdar; Pektaş, Bayram; Aksoy Gökmen, Ayşegül; Yula, Erkan; Koçal, Funda; Kaya, Selçuk

    2014-07-01

    Staphylococci are one of the most common pathogens isolated from nosocomial and community acquired infections. Antibiotics such as clindamycin and erythromycin have been useful options for treating skin and soft-tissue infections caused by staphylococci. However, expression of macrolide-lincosamide-streptogramin B resistance (MLSB) can limit the effectiveness of these drugs. The aims of this study were to investigate the prevalence and phenotypes of MLSB resistance in staphylococcus strains isolated from clinical samples and to determine the telithromycin activity against these isolates. A total of 218 strains [92 Staphylococcus aureus and 126 coagulase-negative staphylococci (CNS)] isolated from different clinical samples (wound, abscess, blood, sterile body fluids, catheter, upper respiratory tract samples) between February 2011 to December 2012 were included in the study. The isolates were identified by using conventional methods and automated bacterial identification system (BD Phoenix 100™ System, Becton Dickinson, USA). Methicillin resistance of the isolates was determined with the use of cefoxitin (30 µg) disk and telithromycin (15 µg) activity was detected by Kirby-Bauer disk diffusion method. MLSB resistance phenotypes were investigated by the D-test method using erythromycin (15 µg) and clindamycin (2 µg) disks. Of 92 S.aureus isolates, 23 were methicillin-resistant (MRSA) and 69 were methicillin-susceptible (MSSA), whereas 78 of 126 CNS isolates were methicillin-resistant (MRCNS) and 48 were methicillin-susceptible (MSCNS). Hundred and seventy-two (79%) isolates were found as erythromycin-resistant, and the rates of erythromycin resistance in MRSA, MSSA, MRCNS and MSCNS strains were 83%, 71%, 95% and 63%, respectively. Inducible type of MLSB resistance (iMLSB type) was observed in 26%, 6%, 51% and 33%; chromosomal resistance (cMLSB type) in 32%, 27%, 27% and 17% and efflux pump connected resistance (MSB type) in 42%, 67%, 22% and 50% of the MRSA

  9. [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

  10. 77 FR 60440 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-03

    ... HUMAN SERVICES Food and Drug Administration Clinical Investigator Training Course AGENCY: Food and Drug... are cosponsoring a 3- day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide clinical...

  11. 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

  12. New generation azole antifungals in clinical investigation.

    PubMed

    Girmenia, Corrado

    2009-09-01

    Considerable progress in treating systemic mycoses has been achieved in the past years through development of new drugs in association with more advanced diagnostic procedures. Here, we review the pharmacological, microbiological and clinical development progress with the so-called 'second generation' triazoles: voriconazole, posaconazole, ravuconazole, isavuconazole and albaconazole. All these drugs exhibit a favourable pharmacokinetic and toxicity profile and possess high activity against resistant and emerging pathogens. However, only voriconazole and posaconazole have been adequately investigated in Phase III studies and have been approved by the regulatory agencies in the treatment and prophylaxis of invasive fungal infections, respectively. On the contrary, ravuconazole, isavuconazole and albaconazole have not been investigated in adequate clinical trials and, in the absence of proper data, the real possibilities of these agents as competitors for the treatment and prevention of invasive mycoses in the clinical setting are still unknown. The drug interactions and the variability in the absorption and/or metabolism of the triazoles, in particular voriconazole and posaconazole, may determine an unpredictable exposure of the pathogens to the antifungal treatments. Literature evidences strongly support the use of therapeutic drug monitoring for these triazoles which may be crucial for the proper management of severe invasive fungal infections.

  13. 78 FR 63988 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... HUMAN SERVICES Food and Drug Administration Clinical Investigator Training Course AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration's (FDA's) Center for Drug Evaluation and... in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials;...

  14. Medical Services: Clinical Investigation Program

    DTIC Science & Technology

    2007-11-02

    epidemiological surveys that involve tests or procedures of no more than minimal risk. (See the glossary for the definition of an epidemiological survey... definite criteria.) b. Who will be notified. G–10. Adverse reactions Include— a. Definition of subject reactions. b. Immediate reporting. c. Routine...some laser and hemodialysis systems. Subinvestigator See associate investigator. Test A p r o c e s s b y w h i c h d a t a a c c u m u l a t e d t o

  15. 76 FR 45577 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ... HUMAN SERVICES Food and Drug Administration Clinical Investigator Training Course AGENCY: Food and Drug... Programs and the Clinical Trials Transformation Initiative (CTTI) are cosponsoring a 3-day training course... training course is intended to provide investigators with expertise in the design, conduct, and analysis...

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

    DTIC Science & Technology

    1984-10-01

    Medicine Annual Faculty Development Fellowship Symoosium. University of North Carolina, Chapel Hill, NC, Jun 1984. Saultz 3: Neurolinguistic program : Use in...AD-fli48 168 CLINICAL INVESTIGATION PROGRAM RCS MED-300 (RI)(U) 1/3 DWIGHT DAVID EISENHOWER ARMY MEDICAL CENTER FORT GORDON GA DEPT OF CLINICAL...CHART m NATIONAL BUREAU OF STANDMMfl-1963-A 1.0 1111 N CLINICAL leINVESTIGATION PROGRAM *REPORT 00 00 q.4ft Thsdocument has been approved for public

  17. 75 FR 57472 - Clinical Investigator Training Course

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... HUMAN SERVICES Food and Drug Administration Clinical Investigator Training Course AGENCY: Food and Drug... training course for health care professionals responsible for, or involved in, the conduct and/or design of... clinical trials. DATES: The training course will be held on November 8 and 9, 2010, from 8 a.m. to 5...

  18. A European approach to clinical investigator training

    PubMed Central

    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

  19. An Investigation into Orthodontic Clinical Record Taking.

    PubMed

    Lee, Kennth; Torkfar, Ghazal; Fraser, Cary

    2015-01-01

    Dental examination including records taken refers to a systematic process in which dentists investigate various facets of patients' oral and general health in order to identify the underlying pathologies or concerns experienced by them. Often, a unique customized treatment plan is developed based on this process in order to maximize patients' oral health while meeting their goals and expectations. This study aims to review the orthodontic clinical record taking, with a particular emphasis on steps undertaken in a private clinic in Australia.

  20. Investigational small-molecule drug selectively suppresses constitutive CYP2B6 activity at the gene transcription level: physiologically based pharmacokinetic model assessment of clinical drug interaction risk.

    PubMed

    Zamek-Gliszczynski, Maciej J; Mohutsky, Michael A; Rehmel, Jessica L F; Ke, Alice B

    2014-06-01

    The glycogen synthase kinase-3 inhibitor LY2090314 specifically impaired CYP2B6 activity during in vitro evaluation of cytochrome P450 (P450) enzyme induction in human hepatocytes. CYP2B6 catalytic activity was significantly decreased following 3-day incubation with 0.1-10 μM LY2090314, on average by 64.3% ± 5.0% at 10 μM. These levels of LY2090314 exposure were not cytotoxic to hepatocytes and did not reduce CYP1A2 and CYP3A activities. LY2090314 was not a time-dependent CYP2B6 inhibitor, did not otherwise inhibit enzyme activity at concentrations ≤10 μM, and was not metabolized by CYP2B6. Thus, mechanism-based inactivation or other direct interaction with the enzyme could not explain the observed reduction in CYP2B6 activity. Instead, LY2090314 significantly reduced CYP2B6 mRNA levels (Imax = 61.9% ± 1.4%; IC50 = 0.049 ± 0.043 μM), which were significantly correlated with catalytic activity (r(2) = 0.87, slope = 0.77; Imax = 57.0% ± 10.8%, IC50 = 0.057 ± 0.027 μM). Direct inhibition of constitutive androstane receptor by LY2090314 is conceptually consistent with the observed CYP2B6 transcriptional suppression (Imax = 100.0% ± 10.8% and 57.1% ± 2.4%; IC50 = 2.5 ± 1.2 and 2.1 ± 0.4 μM for isoforms 1 and 3, respectively) and may be sufficiently extensive to overcome the weak but potent activation of pregnane X receptor by ≤10 μM LY2090314 (19.3% ± 2.2% of maximal rifampin response, apparent EC50 = 1.2 ± 1.1 nM). The clinical relevance of these findings was evaluated through physiologically based pharmacokinetic model simulations. CYP2B6 suppression by LY2090314 is not expected clinically, with a projected <1% decrease in hepatic enzyme activity and <1% decrease in hydroxybupropion exposure following bupropion coadministration. However, simulations showed that observed CYP2B6 suppression could be clinically relevant for a drug with different pharmacokinetic properties from LY2090314.

  1. Financial conflict-of-interest policies in clinical research: issues for clinical investigators.

    PubMed

    Boyd, Elizabeth A; Cho, Mildred K; Bero, Lisa A

    2003-08-01

    As industry sponsorship of clinical research grows, investigators' personal financial relationships with those sponsors are under increasing scrutiny. The federal government, some states, and many universities have enacted conflict-of-interest policies to monitor and regulate investigators' financial relationships. Little is known, however, about investigators' awareness of or support for these policies or their attitudes toward regulatory efforts. To explore the possible implications of conflict-of-interest policies for clinical researchers, the authors interviewed active clinical investigators at two institutions where the conflict-of-interest policies differ. The most striking feature of the interviews was the range of perceptions and attitudes expressed by clinical investigators and their implications for administrators, professional societies, and policymakers concerned with conflicts of interest. Fewer than half of the interviewed investigators could accurately describe their campus' conflict-of-interest policy. Many investigators felt that professional societies, the public, and individual investigators were appropriate monitors of conflicts of interest. Many investigators recognized the general risks associated with conflicts of interest, but felt that they personally were not at risk. A fundamental challenge facing administrators and policymakers is to demonstrate to all investigators, both clinical and nonclinical, that the potential for bias, pressure and conflict is relevant to all investigators with industry relationships.

  2. 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

  3. [Clinical activity in nursing education].

    PubMed

    Brignon, Béatrice

    2009-12-01

    The purpose of this research is to enlight the actual nursing act of the student in order to search for what makes sense in his (her) self nursing becoming and to reinterpret what is said regarding what is done. Up till, researchs were focused on declarative intentions; instead here, we go beyond using an innovative approach based on the clinical activity research method applied to the nursing education field.

  4. Department of Clinical Investigation Annual Research Progress Report.

    DTIC Science & Technology

    1995-09-30

    Cell Lysate with Subsequent Recovery of DNA Other nominees were: Adolescent Risk Behavior and the Influence of Parents and Education by MAJ Brent V... Adolescent Risk Behavior and the Influence of Parents and Education Start Date: 09/02/94 Est. Completion Date: Department: Clinical Investigation...activities, and parental involvement in providing students with information and guidance, have any effect on adolescent risk taking behavior. Technical

  5. [Clinical drug investigations. Definition of terms].

    PubMed

    Johne, A; Gerloff, T; Mai, I

    2005-04-01

    Implementation of the European Directive 2001/20/EC led to the inclusion of definitions for clinical trial and non-interventional trial in German Drug Law. Other terms, such as non-commercial clinical trial, single patient use, post marketing surveillance and public health study are less well defined. This article explains the various terms by comparing their differences and similarities.

  6. Tropical Acne: Clinical and Laboratory Investigations.

    DTIC Science & Technology

    developed in the tropical acne patients were clinically and histopathologically identical to those seen in severe pustular, cystic acne patients. The...Observations were made on the clinical, biochemical, histopathological and microbiological parameters of eleven ’tropical acne patients.’ All...tropical acne patients in the study had a previous history of mild to moderate acne vulgaris prior to their tour in Vietnam. The type of lesions which

  7. Pre-Clinical and Clinical Investigation of the Impact of Obesity on Ovarian Cancer Pathogenesis

    DTIC Science & Technology

    2015-12-01

    actively investigated in Phase 1, 2 and 3 clinical trials (34-36). Metformin is an anti- diabetic medication from the biguanide class that is widely used...as the first line treatment of type 2 diabetes . Mounting epidemiological evidence suggests that metformin use lowers cancer risk and reduces cancer...deaths among diabetic patients (37-39), including OC (40-42). Metformin may have both indirect and direct effects on tumor growth(43). Its indirect

  8. Clinical Investigation Program Report FY90

    DTIC Science & Technology

    1990-10-01

    samples were obtained and clinical evaluation was performed again. Two animals were then treated with apically- positioned mucoperiosteal flaps... false positive skin tets to WBE, suggesting that fire ant venom may be more specific in the diagnosis of fire ant allergy. 78 Detail Summary Sheet Date...this report are not to be construed as an official Department of the Army position unless so designated by other authorized documents. Approved for

  9. Investigating the productivity model for clinical nurses.

    PubMed

    Dehghan Nayeri, Nahid; Hooshmand Bahabadi, Abbas; Kazemnejad, Anoshirvan

    2014-01-01

    One of the main objectives of quantitative researches is assessment of models developed by qualitative studies. Models validation through their testing implies that the designed model is representative of the existed facts. Hence, this study was conducted to assess the clinical nurses' productivity model presented for Iranian nurses' productivity. The sample of the study consisted of 360 nurses of Tehran University of Medical Sciences. The research tool was a questionnaire for measuring the components of clinical nurses' productivity. After completing all steps of instrument psychometric and getting answers from the participants, the factors introduced in the questionnaire were named and then Lisrel Path Analysis tests were performed to analyze the components of the model. The results of the model test revealed there is an internal relationship among different components of the model. Regression Analysis showed that each increasing unit in components of the model was to be added to central variable of productivity model -human resource. Model components altogether explained 20 % of clinical nurses' productivity variance. This study found that the important component of productivity is human resources that are reciprocally related to other components of the model. Therefore, it can be stated that the managers can promote the productivity by using efficient strategies to correct human resource patterns.

  10. Azoospermia: clinical, hormonal, and biochemical investigation.

    PubMed

    Papadimas, J; Papadopoulou, F; Ioannidis, S; Spanos, E; Tarlatzis, B; Bontis, J; Mantalenakis, S

    1996-01-01

    The aim of this study was to evaluate the clinical, hormonal and biochemical characteristics of infertile men with azoospermia. A total of 187 azoospermic out of 2610 infertile men (7.2%) were studied. Mean testicular volume and basal plasma levels of FSH were the most useful parameters concerning the evaluation of azoospermia. Basal plasma levels of LH and T were useful only in azoospermic men with hypogonadism, whereas plasma PRL levels, semen volume, and seminal plasma fructose levels were not found to be of common use except in selected cases.

  11. Clinical Investigation Program. Annual Progress Report

    DTIC Science & Technology

    1990-10-01

    Adult Pigs (0) 54H89 Claybaugh, J. R. 27 Responses of Water and Electrolyte Regulating Hormones During a Saturation Dive to 450M (C) 56A89 Dice, M. S...28 Mechanism of Cold Induced Diuresis (0) 39H88 Freund, B. J. 29 Hormonal and Renal Responses to Exercise: Effects of Exercise Intensity (C) (SP) 4A88...Disturbances of the Renin-Angiotensin-Aldosterone, Antidiuretic Hormone , and Atrial Natriuretic Hormone Axes (0) 43H89 Kortepeter, M. G. 49 Clinical Utility

  12. Clinical Investigation of Benign Asbestos Pleural Effusion

    PubMed Central

    Fujimoto, Nobukazu; Gemba, Kenichi; Aoe, Keisuke; Kato, Katsuya; Yokoyama, Takako; Usami, Ikuji; Onishi, Kazuo; Mizuhashi, Keiichi; Yusa, Toshikazu; Kishimoto, Takumi

    2015-01-01

    There is no detailed information about benign asbestos pleural effusion (BAPE). The aim of the study was to clarify the clinical features of BAPE. The criteria of enrolled patients were as follows: (1) history of asbestos exposure; (2) presence of pleural effusion determined by chest X-ray, CT, and thoracentesis; and (3) the absence of other causes of effusion. Clinical information was retrospectively analysed and the radiological images were reviewed. There were 110 BAPE patients between 1991 and 2012. All were males and the median age at diagnosis was 74 years. The median duration of asbestos exposure and period of latency for disease onset of BAPE were 31 and 48 years, respectively. Mean values of hyaluronic acid, adenosine deaminase, and carcinoembryonic antigen in the pleural fluid were 39,840 ng/mL, 23.9 IU/L, and 1.8 ng/mL, respectively. Pleural plaques were detected in 98 cases (89.1%). Asbestosis was present in 6 (5.5%) cases, rounded atelectasis was detected in 41 (37.3%) cases, and diffuse pleural thickening (DPT) was detected in 30 (27.3%) cases. One case developed lung cancer (LC) before and after BAPE. None of the cases developed malignant pleural mesothelioma (MPM) during the follow-up. PMID:26689234

  13. Clinical Investigation of Benign Asbestos Pleural Effusion.

    PubMed

    Fujimoto, Nobukazu; Gemba, Kenichi; Aoe, Keisuke; Kato, Katsuya; Yokoyama, Takako; Usami, Ikuji; Onishi, Kazuo; Mizuhashi, Keiichi; Yusa, Toshikazu; Kishimoto, Takumi

    2015-01-01

    There is no detailed information about benign asbestos pleural effusion (BAPE). The aim of the study was to clarify the clinical features of BAPE. The criteria of enrolled patients were as follows: (1) history of asbestos exposure; (2) presence of pleural effusion determined by chest X-ray, CT, and thoracentesis; and (3) the absence of other causes of effusion. Clinical information was retrospectively analysed and the radiological images were reviewed. There were 110 BAPE patients between 1991 and 2012. All were males and the median age at diagnosis was 74 years. The median duration of asbestos exposure and period of latency for disease onset of BAPE were 31 and 48 years, respectively. Mean values of hyaluronic acid, adenosine deaminase, and carcinoembryonic antigen in the pleural fluid were 39,840 ng/mL, 23.9 IU/L, and 1.8 ng/mL, respectively. Pleural plaques were detected in 98 cases (89.1%). Asbestosis was present in 6 (5.5%) cases, rounded atelectasis was detected in 41 (37.3%) cases, and diffuse pleural thickening (DPT) was detected in 30 (27.3%) cases. One case developed lung cancer (LC) before and after BAPE. None of the cases developed malignant pleural mesothelioma (MPM) during the follow-up.

  14. Clinical Investigation Progran, Fiscal Year 1980.

    DTIC Science & Technology

    1980-10-01

    Lois E. GS06 00301 Admin Tech Cornette, Kuuleialoha GS05 00413 Career Intern Physiologist ii I D. FUNDING Type Preceding Year Current YearCivilian...repeated once every 2 months. PROGRESS: OTSG approval pending. Principal Investigator departing TAUC . Project is therefore terminated. 40 Detail Summary

  15. Clinical Investigation Program Annual Progress Report.

    DTIC Science & Technology

    1985-09-30

    Meals. Diabetes 30:465, 1981. (5) Sanders, L.R., Hofeldt, F.D., Kirk, M., and Levin, J.: Refined Carbohydrate as a Contributing Factor in Reactive...M.C., and Levin, J.: Refined Carbohydrate as a Contributing Factor in Reactive Hypoglycemia. Southern Medical Journal 75:1072-1075, 1982...only problem encountered is cell suspension technique needs refinement . The major principal investigator (CPT Collazo) has departed FANC. However, would

  16. Clinical Investigation Program. Annual Progress Report.

    DTIC Science & Technology

    1981-09-30

    Page 73/135 Active Antigens in House Dust (0) (P) (PR) .......... ... 030 74/101 Immuno-chemical Evaluation of Myeloproliferative and...Plasmaproliferative Diseases (C) (P) (PR) .......... .. 032 74/110 Reactive Hypoglycemia: An Analysis of Glucose-Insulin- Glucagon Interrelationships and Counter...78/118 A Precision Measurement of Anatomic Deadspace Using Multiple Inert Gas Analysis , Comparison with Fowler’s Technique and Application to Steady

  17. Methods to investigate coronary microvascular function in clinical practice.

    PubMed

    Lanza, Gaetano A; Camici, Paolo G; Galiuto, Leonarda; Niccoli, Giampaolo; Pizzi, Carmine; Di Monaco, Antonio; Sestito, Alfonso; Novo, Salvatore; Piscione, Federico; Tritto, Isabella; Ambrosio, Giuseppe; Bugiardini, Raffaele; Crea, Filippo; Marzilli, Mario

    2013-01-01

    A growing amount of data is increasingly showing the relevance of coronary microvascular dysfunction (CMVD) in several clinical contexts. This article reviews techniques and clinical investigations of the main noninvasive and invasive methods proposed to study coronary microcirculation and to identify CMVD in the presence of normal coronary arteries, also trying to provide indications for their application in clinical practice.

  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.

  19. The clinical investigator-subject relationship: a contextual approach

    PubMed Central

    2009-01-01

    Background The nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol. Results and conclusion In this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. PMID:19958542

  20. 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

  1. 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... clinical investigation. (a) An investigational new drug may be used in a clinical investigation if the... requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations;...

  2. Investigator experiences with financial conflicts of interest in clinical trials

    PubMed Central

    2011-01-01

    Background Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Methods Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. Results 844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials. Conclusion Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials. PMID:21226951

  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.

  4. Active Clinical Trials for Personalized Medicine

    PubMed Central

    Minsker, Stanislav; Zhao, Ying-Qi; Cheng, Guang

    2016-01-01

    Individualized treatment rules (ITRs) tailor treatments according to individual patient characteristics. They can significantly improve patient care and are thus becoming increasingly popular. The data collected during randomized clinical trials are often used to estimate the optimal ITRs. However, these trials are generally expensive to run, and, moreover, they are not designed to efficiently estimate ITRs. In this article, we propose a cost-effective estimation method from an active learning perspective. In particular, our method recruits only the “most informative” patients (in terms of learning the optimal ITRs) from an ongoing clinical trial. Simulation studies and real-data examples show that our active clinical trial method significantly improves on competing methods. We derive risk bounds and show that they support these observed empirical advantages. Supplementary materials for this article are available online. PMID:28018014

  5. Diagnosis and investigation in the severe asthma clinic.

    PubMed

    Wark, Peter A B; Hew, Mark; Maltby, Steven; McDonald, Vanessa M; Gibson, Peter G

    2016-01-01

    Severe asthma is recognised as an important and emerging area of unmet need in asthma. The assessment of severe asthma should include three steps; (1) determining the diagnosis of asthma, including verification that the disease is severe asthma, (2) assessing comorbidities and contributing factors that will impact on clinical severity, as well as (3) assessing asthma phenotypes. These steps recognize the importance of heterogeneity in asthma as a key factor that determines the disease course and increasingly the choice of successful therapy. This assessment should be undertaken systematically and is best done by an expert multidisciplinary team. Here, we will outline the important aspects that should be included in the clinical assessment of the patient in the severe asthma clinic, including diagnosis, clinical history, the assessment of important comorbidities and the key investigations needed to support them.

  6. 76 FR 20575 - Disqualification of a Clinical Investigator

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-13

    ... Disqualification of a Clinical Investigator AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule... that supports an application for a research or marketing permit for products regulated by FDA. This... July 12, 2011. See section VII of this document for the proposed effective date of a final rule...

  7. 78 FR 55262 - Guidance for Clinical Investigators, Sponsors, and Institutional Review Boards on Investigational...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... Institutional Review Boards on Investigational New Drug Applications--Determining Whether Human Research Studies... availability of a guidance for clinical investigators, sponsors, and institutional review boards (IRBs... Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send one...

  8. [Mitochondrial diseases: molecular mechanisms, clinical presentations and diagnosis investigations].

    PubMed

    Auré, Karine; Jardel, Claude; Lombès, Anne

    2005-09-01

    Mitochondrial diseases are relatively common inherited metabolic diseases due to mitochondrial respiratory chain dysfunction. Their clinical presentation is extremely diverse, multisystemic or confined to a single tissue, sporadic or transmitted, by maternal or mendelian inheritance. The diagnosis of mitochondrial disorders is difficult. It is based upon several types of clues both clinical (family history, type of symptoms but also their association in syndromic presentation,...) and biological (alteration of the lactate metabolism, brain imaging, morphological alterations especially of muscle tissue). The diagnosis relies upon the demonstration of a defect of the respiratory chain activities and/or upon the identification of the underlying genetic alteration. Molecular diagnosis remains quite difficult and up to-date concerns essentially mitochondrial DNA mutations. On one hand, clinical and biological presentations as well as enzymatic defects lack specificity. On the other hand, candidate genes are very numerous and part of them are probably still unknown.

  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. 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

    ... Staff: Financial Disclosure by Clinical Investigators; Correction AGENCY: Food and Drug Administration...: Financial Disclosure by Clinical Investigators.''The document was published with an incorrect docket...

  11. 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.

  12. 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.

  13. Clinical application of asparaginase activity levels following treatment with pegaspargase.

    PubMed

    Bleyer, Archie; Asselin, Barbara L; Koontz, Susannah E; Hunger, Stephen P

    2015-06-01

    Asparaginase, an enzyme used to treat acute lymphoblastic leukemia and related forms of nonHodgkin lymphoma, depletes asparagine, which leads to lymphoblast cell death. Unlike most chemotherapeutic agents, asparaginase is a foreign protein that can result in clinical allergy and/or silent hypersensitivity with production of neutralizing antibodies that inactivate asparaginase. In North America, asparaginase activity levels can now be obtained via a commercially available assay, for therapeutic drug monitoring and investigation of potential allergic reactions. Herein, we provide recommendations and a corresponding algorithm for the clinical application of this assay after treatment with pegaspargase to evaluate suspected hypersensitivity reactions and/or silent inactivation.

  14. Curvature affects Doppler investigation of vessels: implications for clinical practice.

    PubMed

    Balbis, S; Roatta, S; Guiot, C

    2005-01-01

    In clinical practice, blood velocity estimations from Doppler examination of curved vascular segments are normally different from those of nearby straight segments. The observed "accelerations," sometimes considered as a sort of stochastic disturbances, can actually be related to very specific physical effects due to vessel curvature (i.e., the development of nonaxial velocity [NAV] components) and the spreading of the axial velocity direction in the Doppler sample volume with respect to the insonation axis. The relevant phenomena and their dependence on the radius of curvature of the vessels and on the insonation angle are investigated with a beam-vessel geometry as close as possible to clinical setting, with the simplifying assumptions of steady flow, mild vessel curvature, uniform ultrasonic beam and complete vessel insonation. The insonation angles that minimize the errors are provided on the basis of the study results.

  15. [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.

  16. 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.

  17. 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

  18. Editorial: Process to progress? Investigative trials, mechanism and clinical science.

    PubMed

    Green, Jonathan

    2015-01-01

    In 2002 Helena Kraemer and colleagues published an important article on the analysis of clinical trials in mental health, which advocated a planned focus on mechanisms to investigate the processes behind treatment effects. Kraemer et al. considered not only new approaches to mediation analysis, but also a theoretical approach to factors, both pre-treatment and during treatment, that might moderate this mediation. Trials should not just be about whether a treatment 'worked', but how it worked; with the results informing modification of the intervention for the next trial by discarding aspects that were not effective and reinforcing aspects that were - an iterative procedure towards greater effectiveness. Can we enjoy similar ambitions for complex interventions within mental health? It is not so long ago when the received wisdom within the clinical and much of the research community was that it was simply impossible in practice to mount randomised controlled trials relevant to the kind of psychosocial interventions we use in child and adolescent mental health (CAMHS). How different the situation is now, with burgeoning interest in a systematic evidence base for psychological treatment and the possibilities for unexpected advances (as well as unexpected harms). Nevertheless it is probably still fair to say that the systematic use of process and mechanism study within trials in our field is the exception rather than the rule. What are the possibilities and implications for our field?

  19. [Biochemical investigation for clinical diagnosis of drug dependence].

    PubMed

    Maeda, Hitoshi; Ishikawa, Takaki; Michiue, Tomomi

    2010-08-01

    Specific biochemical marker is not available for clinical diagnosis of drug dependence at present. However, drug abuse is accompanied by a decrease in serotonin and the derivative in cerebrospinal fluid, suggesting central serotonergic dysfunction, that is associated with cognitive deficits, alterations in sleep architecture and neuroendocrine function, and increased impulsivity as well as an increase in the risk for aggressive behavior toward the self involving suicide. For central stimulant abusers, elevated plasma catecholamine levels are associated with psychotic episodes and cardiovascular complications involving tachycardia and arrhythmias. Biochemical investigation is useful for predicting drug-induced mental disorders, complications and the prognosis, and also for differentiation from other mental disorders, e.g., secondary to metabolic and infectious diseases, or management of acute intoxication.

  20. Clinical research: business opportunities for pharmacy-based investigational drug services.

    PubMed

    Marnocha, R M

    1999-02-01

    The application by an academic health center of business principles to the conduct of clinical research is described. Re-engineering of the infrastructure for clinical research at the University of Wisconsin and University of Wisconsin Hospital and Clinics began in 1990 with the creation of the Center for Clinical Trials (CCT) and the restructuring of the investigational drug services (IDS). Strategies to further improve the institution's clinical research activities have been continually assessed and most recently have centered on the adaptation of a business philosophy within the institution's multidisciplinary research infrastructure. Toward that end, the CCT and IDS have introduced basic business principles into operational activities. Four basic business concepts have been implemented: viewing the research protocol as a commodity, seeking payment for services rendered, tracking investments, and assessing performance. It is proposed that incorporation of these basic business concepts is not only compatible with the infrastructure for clinical research but beneficial to that infrastructure. The adaptation of a business mindset is likely to enable an academic health center to reach its clinical research goals.

  1. Clinical Investigation Service Annual Research Progress Report Fiscal Year 1980,

    DTIC Science & Technology

    1980-10-01

    Sarcoidosis (0) 39 DENTAL ACTIVITY 1978 The Use of Fluoride and Custom Trays to Treat Dental 41 Hypersensitivity Away From the Dental Office (T) ix Year Page...Jacoway, J.R., Lauttman, R.J., Swintak, E.F., and Buhler, J.E.: Biopsy of Minor Salivary Gland in the Diagnosis of Sarcoidosis . New Eng J Med 301:922-24...Conjunctival Biopsy in the Diagnosis of Sarcoidosis PRINCIPAL INVESTIGATOR: CPT Leslie P. Fox, MC PROFESSIONAL ASSISTANTS: COL Stanley Sollie, MC LTC

  2. 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…

  3. 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....

  4. Investigating Coincidence Techniques in Biomedical Applications of Neutron Activation Analysis

    NASA Astrophysics Data System (ADS)

    Chowdhury, P.; Gramer, R.; Tandel, S. K.; Reinhardt, C. J.

    2004-05-01

    While neutron activation analysis has been widely used in biomedical applications for some time, the use of non-radioactive tracer techniques, to monitor, for example, organ blood flow, is more recent. In these studies, pre-clinical animal models are injected with micro-spheres labeled with stable isotopes of elements that have a high neutron absorption cross-section. Subsequently, samples of blood and/or tissue from different locations in the body are subjected to neutron activation analysis to measure the propagation of the labeled micro-spheres through the body. Following irradiation, the counting (with high-resolution Ge detectors) is typically delayed by a few days to dissipate short-lived activity in the samples and improve signal-to-noise for the peaks of interest in the activation spectrum. The aim of the present study was to investigate whether coincidence techniques (for isotopes which decay via two-photon cascades) could improve signal-to-noise and turn-around times. The samples were irradiated at the 1 MW research reactor at the UMass Lowell Radiation Laboratory. The analysis of the multi-parameter coincidence data recorded in event-mode will be presented and compared with the standard method of recording singles spectra.

  5. 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.

  6. 77 FR 76049 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-26

    ... guidance entitled ``Electronic Source Data in Clinical Investigations.'' The document was published with an... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice;...

  7. Santorinicele without pancreas divisum pathophysiology: initial clinical and radiographic investigations

    PubMed Central

    2013-01-01

    Background Only one case of santorinicele without pancreas divisum pathophysiology (SWOPP) was previously reported. The purpose of the study was to determine the gross prevalence of SWOPP and santorinicele with pancreas divisum (SWPD) in community and patient populations, and investigate their clinical and radiographic features. Methods This cross-sectional study was performed at a tertiary referral centre. The Patient group comprised 2035 consecutive patients enrolled in the study who underwent magnetic resonance cholangiopancreatography (MRCP) studies. The Community group comprised 2905 consecutive subjects who participated in our whole-body medical check-up program that routinely includes MRCP studies. SWOPP was diagnosed when a saccular dilatation of the terminal portion of the dorsal pancreatic duct was observed unaccompanied by pancreas divisum or dominant dorsal duct. The prevalence of SWOPP and SWPD, and the clinical and radiological features were assessed in each group. Results Five cases of SWOPP were found in the Patient group (age range, 67–85 years; mean age, 73.6 years) (5/2035 = 0.25%; 95% confidence interval, 0.07–0.57); there were no cases of SWOPP in the Community group (0/2905 = 0.00%; 95% confidence interval, 0.00–0.10) (P = 0.01). Previous history of pancreatitis (4/5) and chronic pancreatitis (3/5) was more common in patients with SWOPP than in other subjects in the Patient or Community groups (both P < 0.05). Two cases of SWOPP were accompanied by reverse-Z type meandering main pancreatic duct. Six cases of SWPD were found. These cases were asymptomatic in 4/6, had a larger santorinicele (6.9 mm) than SWOPP patients (4.5 mm; P = 0.02), and were not associated with pancreatitis (0/6). Conclusions The second to sixth reported cases of SWOPP were presented. SWOPP is a relatively rare condition found mostly in patients suffering pancreatitis, especially chronic pancreatitis, and may be an acquired condition

  8. Decreased Antitoxic Activities among Children with Clinical Episodes of Malaria

    PubMed Central

    Jakobsen, Palle Høy; McKay, Veronica; N’Jie, Ramou; Olaleye, Ben O.; D’Alessandro, Umberto; Zhang, Gui-Hang; Eggelte, Teunis A.; Koch, Claus; Greenwood, Brian M.

    1998-01-01

    Healthy Gambian children, children with clinical Plasmodium falciparum malaria, and children with asymptomatic P. falciparum infections were studied to investigate whether antitoxic activities may contribute to protection against malarial symptoms. Markers of inflammatory reactions, soluble tumor necrosis factor receptor I, and C-reactive protein were found in high concentrations in children with symptomatic P. falciparum malaria compared with levels in children with asymptomatic P. falciparum infections or in healthy children, indicating that inflammatory reactions are induced only in children with clinical symptoms. Concentrations of soluble tumor necrosis factor receptor I and C-reactive protein were associated with levels of parasitemia. We detected antitoxic activities in sera as measured by their capacity to block toxin-induced Limulus amoebocyte lysate (LAL) activation. Symptomatic children had decreased capacity to block induction of LAL activation by P. falciparum exoantigen. The decreased blocking activity was restored in the following dry season, when the children had no clinical malaria. Symptomatic children also had the highest immunoglobulin G (IgG) reactivities to conserved P. falciparum erythrocyte membrane protein 1 and “Pfalhesin” (band #3) peptides, indicating that such IgG antibodies are stimulated by acute disease but are lost rapidly after the disease episode. Half of the children with symptomatic infections had low levels of haptoglobin, suggesting that these children had chronic P. falciparum infections which may have caused symptoms previously. Only a few of the children with asymptomatic P. falciparum infections had high parasite counts, and antitoxic immunity in the absence of antiparasite immunity appears to be rare among children in this community. PMID:9529094

  9. 21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Clinical investigations not involving greater than... HUMAN SERVICES GENERAL PROTECTION OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.51 Clinical investigations not involving greater than minimal risk. Any...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... assure the protection of the rights and welfare of subjects in clinical investigations. DATES: Submit... the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations. The guidance should also help clinical investigators...

  11. Preliminary Investigation of an Active PLZT Lens

    NASA Technical Reports Server (NTRS)

    Lightsey, W. D.; Peters, B. R.; Reardon, P. J.; Wong, J. K.

    2001-01-01

    The design, analysis and preliminary testing of a prototype Adjustable Focus Optical Correction Lens (AFOCL) is described. The AFOCL is an active optical component composed of solid state lead lanthanum-modified zirconate titanate (PLZT) ferroelectric ceramic with patterned indium tin oxide (ITO) transparent surface electrodes that modulate the refractive index of the PLZT to function as an electro-optic lens. The AFOCL was developed to perform optical re-alignment and wavefront correction to enhance the performance of Ultra-Lightweight Structures and Space Observatories (ULSSO). The AFOCL has potential application as an active optical component within a larger optical system. As such, information from a wavefront sensor would be processed to provide input to the AFOCL to drive the sensed wavefront to the desired shape and location. While offering variable and rapid focussing capability (controlled wavefront manipulation) similar to liquid crystal based spatial light modulators (SLM), the AFOCL offers some potential advantages because it is a solid-state, stationary, low-mass, rugged, and thin optical element that can produce wavefront quality comparable to the solid refractive lens it replaces. The AFOCL acts as a positive or negative lens by producing a parabolic phase-shift in the PLZT material through the application of a controlled voltage potential across the ITO electrodes. To demonstrate the technology, a 4 mm diameter lens was fabricated to produce 5-waves of optical power operating at 2.051 micrometer wavelength. Optical metrology was performed on the device to measure focal length, optical quality, and efficiency for a variety of test configurations. The data was analyzed and compared to theoretical data available from computer-based models of the AFOCL.

  12. Clinic of Gastroenterohepatology--overview of activities.

    PubMed

    Serafimoski, V

    2013-01-01

    CThe Clinic of Gastroenterohepatology is a part of the Medical Faculty Skopje and University "St. Cyril and Methodius University, Skopje". It is organized as an educational, scientific and medical care institution. CThere are four diagnostic departments: an out-patients department, endoscopic department, ultrasound department and X-ray department. During Over the last several decades, the Clinic of Gastroenterohepatlogy Clinic has been intensively developed, primarily because of introducing the most recent and modern knowledge in gastroenterology, continuous medical education of the personneal as well education of the doctors and other medical personal from the other medical centrers in Macedonia and neighbouring countries. The hospital part of the Clinic is organized in three divisions, including an intensive care unit. In the department of Ultrasound are performed The most modern diagnostic and therapeutic procedures are performed in the Ultrasound department for: different various liver diseases, benign and malignant liver diseases, bilirye ducts obstructions, pancreas diseases, spleen diseases, and various abdominal and kidney diseases.

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

    PubMed Central

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

    2016-01-01

    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. PMID:27051470

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

    PubMed

    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.

  15. 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.

  16. 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

    ... Food and Drug Administration Staff; Design Considerations for Pivotal Clinical Investigations for... Considerations for Pivotal Clinical Investigations for Medical Devices.'' This document is intended to provide... to fulfill premarket clinical data requirements. This draft guidance is not final nor is it in...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... administer an investigational new drug to human subjects until the IND goes into effect under paragraph (b... 21 Food and Drugs 5 2013-04-01 2013-04-01 false General requirements for use of an investigational new drug in a clinical investigation. 312.40 Section 312.40 Food and Drugs FOOD AND...

  18. 78 FR 52932 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... Investigators, and Sponsors: Institutional Review Board Responsibilities for Reviewing the Qualifications of... ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Responsibilities for Reviewing the... fulfilling responsibilities related to reviewing the qualifications of investigators and adequacy of...

  19. Department of Clinical Investigation Annual Progress Report: Fiscal Year 1989

    DTIC Science & Technology

    1989-01-01

    Bacterially Synthetized b Human Granulocyte Colony Stimulating Factor (hg-CSF) Against Pseudomonas aeruginosa Infection DEPARTMENT OF MEDICINE Allergy ...C-01) A Clinical Trial to Evaluate Postoperative 30 Immunotherapy and Postoperative Systemic Chemotherapy in the Management of Resectable Colon...Publications/Presentations: None to date. -6- Annual Progress Report DEPARTMENT OF MEDICINE Allergy and Immunology Service Date: 1 October 1989 Protocol

  20. Sexually Transmitted Diseases in College Men: A Preliminary Clinical Investigation.

    ERIC Educational Resources Information Center

    Sawyer, Robin G.; Moss, Donald J.

    1993-01-01

    This study examined sexual behavior, perceived risk of human immunodeficiency virus (HIV), and pathology of 66 males attending a college health center's sexually transmitted disease clinic. Data from patients' charts indicated a group of men who, despite high-risk behaviors, perceived their risk of contracting HIV as being extremely low. (SM)

  1. 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

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators... determined, despite outstanding issues, that the information provided is sufficient to justify human clinical... maintaining appropriate subject protections. Staged approval or staged approval with conditions is most...

  2. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain... facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of...

  3. 21 CFR 312.70 - Disqualification of a clinical investigator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... are essential to the continuation of the investigation or essential to the approval of any marketing... Research or the Center for Biologics Evaluation and Research will furnish the investigator written notice... but not accepted by the Center for Drug Evaluation and Research or the Center for Biologics...

  4. [Investigation on cognition of zoonosis among veterinary clinical staff].

    PubMed

    Takinami, Kenji

    2005-10-01

    We conducted a survey to determine how much veterinary clinic staff, including veterinary surgeon and veterinary technicians, know about zoonosis. Response was 52.5%. All staff members knew of zoonosis. Staff members who knew what zoonosis meant accounted for 98%. Staff members trained in zoonosis accounted for 75% among veterinary surgeons and 66% among veterinary technicians. Staff members who thought that zoonosis would increase in future accounted for 92% among veterinary surgeons and 79% among veterinary technicians. Staff members who were asked by pet owners about zoonosis accounted for 87% among veterinary surgeons and 51% among veterinary technicians. Staff members who thought veterinary surgeons must report zoonosis to public health centers accounted for 96% among veterinary surgeons and 88% among veterinary technicians. Veterinary clinic staffs thus had correct knowledge and were aware of zoonosis. The network of medical staff and veterinary staff could therefore build on this result.

  5. 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.

  6. Clinical Investigation Program RCS MED-300 (R1).

    DTIC Science & Technology

    1985-09-30

    02 (FY85,C)(PR) *Skin Test and Measurement Technique Employed in Allergy Skin Testing ..................................................... 126 Work...Penicillin Allergy : A Collaborative Study ...... 192 Work Unit No. 85/13 (FY85,C)(PR) Clinical Efficacy of Latex Agglutination Reagent for Detection...enzymatic method. J Allergy Clin Immunol 75:124, 1985 (Abstract)* Manna B, Penney LL, Smith ML: Evaluation of a simple method for determining free

  7. 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

  8. Clinical investigation of set-shifting subtypes in anorexia nervosa.

    PubMed

    Abbate-Daga, Giovanni; Buzzichelli, Sara; Marzola, Enrica; Amianto, Federico; Fassino, Secondo

    2014-11-30

    While evidence continues to accumulate on the relevance of cognitive inflexibility in anorexia nervosa (AN), its clinical correlates remain unclear. We aimed at examining the relationship between set-shifting and clinical variables (i.e., eating psychopathology, depression, and personality) in AN. Ninety-four individuals affected by AN and 59 healthy controls (HC) were recruited. All participants were assessed using: Eating Disorders Inventory-2 (EDI-2), Temperament and Character Inventory (TCI), Beck Depression Inventory (BDI), and Wisconsin Card Sorting Test (WCST). The AN group scored worse than HCs on set-shifting. According to their neuropsychological performances, AN patients were split into two groups corresponding to poor (N=30) and intact (N=64) set-shifting subtypes. Interoceptive awareness, impulse regulation, and maturity fears on the EDI-2 and depression on the BDI differed across all groups (HC, intact, and poor set-shifting subtype). Self-directedness on the TCI differed significantly among all groups. Cooperativeness and reward dependence differed instead only between HC and AN poor set-shifting subtype. After controlling for depression, only interoceptive awareness remained significant with reward dependence showing a trend towards statistical significance. These findings suggest that multiple clinical variables may be correlated with set-shifting performances in AN. The factors contributing to impaired cognitive inflexibility could be more complex than heretofore generally considered.

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

    PubMed

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

    2007-01-01

    As with many other bacterial species, the most commonly used method to assess staphylococcal biofilm formation in vitro is the microtiter plate assay. This assay is particularly useful for comparison of multiple strains including large-scale screens of mutant libraries. When such screens are applied to the coagulase-negative staphylococci in general, and Staphylococcus epidermidis in particular, they are relatively straightforward by comparison with microtiter plate assays used to assess biofilm formation in other bacterial species. However, in the case of clinical isolates of Staphylococcus aureus, including methicillin-resistant S. aureus, we have found it necessary to employ specific modifications including precoating of the wells of the microtiter plate with plasma proteins and supplementation of the medium with both salt and glucose. In this chapter, we describe the microtiter plate assay in the specific context of clinical isolates of S. aureus and the use of these modifications. A second in vitro method, which also is generally dependent on coating with plasma proteins and supplementation of the growth medium, is the use of flow cells. In this method, bacteria are allowed to attach to a surface and then monitored with respect to their ability to remain attached to the substrate and differentiate into mature biofilms under the constant pressure of fluid shear force. Although flow cells are not applicable to large-scale screens, we have found that they provide a more reproducible and accurate assessment of the capacity of S. aureus clinical isolates to form a biofilm. They also provide a means of analyzing structural differences in biofilm architecture and isolating bacteria and/or spent media for analysis of physiological and metabolic changes associated with the adaptive response to growth in a biofilm. While a primary focus of this chapter is on the use of in vitro assays to assess biofilm formation in clinical isolates of S. aureus, it is important to

  10. 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.

  11. 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.

  12. 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

  13. 21 CFR 812.119 - Disqualification of a clinical investigator.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., the Center for Biologics Evaluation and Research, or the Center for Drug Evaluation and Research will... submitted unreliable data that are essential to the continuation of the investigation or essential to the approval or clearance of any marketing application. (d) If the Commissioner determines, after...

  14. Visual acuity with reversed-contrast charts: II. Clinical investigation.

    PubMed

    Westheimer, Gerald; Chu, Patricia; Huang, Wendy; Tran, Thuy; Dister, Robert

    2003-11-01

    Snellen visual acuity was measured in 106 patients ranging in age from 20 to 88 years in routine examinations in the general refraction clinic with two kinds of charts: the standard chart using black letters on a white background and a reversed-contrast display featuring white letters on a black background. The overall ratio of the white-on-black to the black-on-white Snellen fractions was 1.043. A scattergram relating this ratio to patient age revealed that the older the patient, the more the visual acuity was improved by switching to the reversed-contrast chart, with a regression line slope of 0.5 +/- 0.10. Impairment of the eye's optics, in particular by intraocular scatter causing a widening and flattening of the eye's point-spread function, explains these findings and suggests prognostic and therapeutic value of reversing the contrast polarity of displays.

  15. 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.

  16. Clinical advantages of dual activity in urticaria.

    PubMed

    Kontou-Fili, K

    2000-01-01

    Urticaria is a common disorder that adversely affects quality of life; work-related and recreational activities are restricted, while rest, sleep, and emotions are seriously disturbed in a significant proportion of patients. The pathogenic mechanisms vary, but cutaneous mast-cell activation with release of histamine and other vasoactive or proinflammatory mediators is thought to be the final common pathway for lesion induction in most cases. A subsequent, but incompletely understood, late-phase allergic reaction seems to prolong the inflammatory process, particularly in certain chronic forms of the disorder. Although histamine is considered an important mediator of urticaria, additional substances, including the cysteinyl leukotrienes (LTs), are putative mediators of the immediate urticarial responses and the inflammatory events that follow in some types of urticaria. A second-generation antihistamine, mizolastine, which exhibits dual activity with selective H1-receptor antagonism and, as shown in animal studies, anti-5-lipoxygenase activity, represents an advance in the treatment of urticaria. It has rapid, potent and sustained action. At the recommended 10-mg dose, mizolastine suppresses the histamine-induced wheal reaction as early as 1 h after oral administration. Compared to placebo, mizolastine significantly reduces overall patient discomfort and pruritus in patients with chronic idiopathic urticaria. Double-blind, placebo-controlled studies have also shown mizolastine to be at least as effective as other second-generation antihistamines. Furthermore, with long-term use of mizolastine over 1 year, a reduction in pruritus and the number of urticarial episodes was maintained with no evidence of tachyphylaxis or tolerance. Mizolastine has also been shown to be an effective treatment for cold-induced urticaria, causing significant delay in the whealing response to the ice-cube test and also reducing the wheal diameter.

  17. 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

  18. Clinical Investigation Program Report, RCS MED-300 (R1).

    DTIC Science & Technology

    1986-10-31

    Carolina for patients. We are presently randomizing a few patients who were previously ineligible due to high GGT’s and tubal ligation , but are eligible...Periodontal bone morphology - 40 Periodontal surgery - 36 Phantom pain - 25, 29 Polycystic ovarian syndrome - 69 Post herpetic neuralgia - 88 Postpartum...Surface Active Agent Induced Delay of Gastric Emptying. (0) (PR) (P) 21 1979 The Experimental Fat Embolism Syndrome : An Electron Microscopic Study of

  19. 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

  20. 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

  1. 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.

  2. 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

  3. General issues and precautions in the design for clinical trials of investigational new drugs.

    PubMed

    Hu, Liang-ping; Bao, Xiao-lei

    2011-02-01

    The general problems existing in the clinical trials of investigational new drugs involve some key aspects such as the guiding principles, research designs, quality controls and statistical analyses. This paper explores the eight general issues in the clinical trials of investigational new drugs and presents precautionary measures with high operability. Research on the clinical trials of investigational new drugs is a complex project, which should be carried out strictly according to the policies, laws, criteria and operating rules set by related agencies. The neglect of research designs and data analyses will lead clinical trials to failure.

  4. 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.

  5. 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

    ... developed to promote the initiation of clinical investigations to evaluate the medical devices under FDA's... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff; Food and Drug Administration Decisions...

  6. 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....

  7. Pulmonary embolism: investigation of the clinically assessed intermediate risk subgroup

    PubMed Central

    Warren, D J; Matthews, S

    2012-01-01

    Objectives The simplified Wells pre-test probability scoring algorithm for pre-investigation evaluation of pulmonary emboli (PE) is a commonly utilised and validated assessment tool. We sought to identify whether use of a dichotomised scoring system altered the overall negative predictive value (NPV) in patients referred for CT pulmonary angiography (CTPA) assessment of suspected PE. Methods Prospective data collection of all patients referred for CTPA evaluation of suspected acute PE during a 3 year period was carried out. Pre-test risk stratification was performed according to simplified Wells criteria in conjunction with plasma d-Dimer (Bio-Pool and IL test) estimation. Retrospective dichotomisation was also performed. Results 2531 patients were investigated for suspected acute PE; acute thromboemboli were confirmed in 22.7%. The overall NPV for negative d-Dimer and intermediate pre-test probability (PTP) was 98.9% [95% confidence interval (CI) 96.3–99.7%]; with retrospective dichotomisation, the NPV for the PE unlikely group was 99.0% (95% CI 94.8–99.8%). Implementation of dichotomised scoring, excluding PE unlikely with negative d-Dimer cases from further imaging, would have yielded a 4% reduction in CTPA referral pathway imaging at our institution. Conclusion We demonstrate no significant difference between exclusion in the intermediate subgroup and the retrospectively dichotomised PE unlikely group and demonstrate the high negative predictive power of the Bio-Pool and IL tests in conjunction with the Wells PTP tool. Prior to implementation of new guidelines for exclusion of patients with suspected PE from further imaging, hospitals should audit their own practice and validate the d-Dimer assay utilised at their institution. PMID:21937613

  8. Preclinical and Clinical Investigation of the Impact of Obesity on Ovarian Cancer Pathogenesis

    DTIC Science & Technology

    2014-10-01

    Award Number: W81XWH-12-1-0426 TITLE: Preclinical and Clinical Investigation of the Impact of Obesity on Ovarian Cancer Pathogenesis PRINCIPAL...ANNUAL 25 Sep 2013 - 24 Sep 2014 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER Pre-clinical and Clinical Investigation of the Impact of Obesity on Ovarian...metabolic consequences of obesity may be critical in the development of ovarian cancer (OC), resulting in biologically different cancers than those that

  9. Clinical utility of biomarkers of endothelial activation and coagulation for prognosis in HIV infection

    PubMed Central

    Graham, Susan M; Mwilu, Regina; Liles, W Conrad

    2013-01-01

    Introduction: HIV infection is associated with vascular dysfunction and adverse cardiovascular outcomes. Our objective was to review the evidence regarding the clinical utility of endothelial activation and coagulation biomarkers for the prognosis of HIV-infected patients. Methods: We searched PubMed and Embase for publications using the keywords “HIV” or “HIV infection” and “endothelium” or “coagulation”. We reviewed reference lists and hand-searched for additional relevant articles. All clinical studies that enrolled non-pregnant, HIV-infected adults, measured biomarkers reflecting endothelial activation or coagulation, and prospectively evaluated their associations with vascular dysfunction or clinical outcomes were included. Results: Seventeen studies were identified that fulfilled the inclusion criteria, of which 11 investigated endothelial activation biomarkers and 12 investigated coagulation biomarkers. Biomarkers and outcomes varied widely across studies. Overall, published studies support an association between P-selectin and venous thromboembolism in HIV-infected patients, an association between tissue-type plasminogen activator and death, and associations between D-dimer and several clinical outcomes, including venous thromboembolism, cardiovascular disease, and all-cause mortality. Conclusions: Several studies have demonstrated associations between biomarkers of endothelial activation and coagulation and clinically important outcomes in HIV-1 infection. Additional large-scale prospective investigations to determine the utility of endothelial activation and coagulation biomarkers for risk stratification and prediction of adverse outcomes are clearly warranted. PMID:23732995

  10. 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.

  11. 75 FR 31794 - Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-04

    ... Investigators, and IRBs; Frequently Asked Questions--Statement of Investigator (Form FDA 1572); Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Investigator (Form FDA 1572).'' This guidance is intended to assist sponsors, clinical investigators,...

  12. 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.

  13. 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

  14. Investigations of fungal secondary metabolites with potential anticancer activity.

    PubMed

    Balde, ElHadj Saidou; Andolfi, Anna; Bruyère, Céline; Cimmino, Alessio; Lamoral-Theys, Delphine; Vurro, Maurizio; Damme, Marc Van; Altomare, Claudio; Mathieu, Véronique; Kiss, Robert; Evidente, Antonio

    2010-05-28

    Fourteen metabolites, isolated from phytopathogenic and toxigenic fungi, were evaluated for their in vitro antigrowth activity for six distinct cancer cell lines, using the MTT colorimetric assay. Bislongiquinolide (1) and dihydrotrichodimerol (5), which belong to the bisorbicillinoid structural class, displayed significant growth inhibitory activity against the six cancer cell lines studied, while the remaining compounds displayed weak or no activity. The data show that 1 and 5 have similar growth inhibitory activities with respect to those cancer cell lines that display certain levels of resistance to pro-apoptotic stimuli or those that are sensitive to apoptosis. Quantitative videomicroscopy analysis revealed that 1 and 5 exert their antiproliferative effect through cytostatic and not cytotoxic activity. The preliminary results from the current study have stimulated further structure-activity investigations with respect to the growth inhibitory activity of compounds belonging to the bisorbicillinoid group.

  15. A facilitative versus directive approach in training clinical skills? Investigating students' clinical performance and perceptions.

    PubMed

    Berghmans, Inneke; Druine, Nathalie; Dochy, Filip; Struyven, Katrien

    2012-08-01

    Over the years, many medical school curricula have started implementing diverse student-centred teaching and learning methodologies. Previous studies, however, have indicated that students prefer more traditional and directive methodologies instead, raising questions on which training approach should be advocated. This study contrasts the effects of a student-centred (i.e. facilitative) training approach on students' clinical skills learning with students' perceptions. More specifically, a quasi-experimental study was set up in which students experienced either a directive or facilitative training approach. Data were collected by means of an OSCE on the one hand, and a questionnaire on students' perceptions of the training sessions, and two open-ended questions about students' likes and dislikes on the other hand. While no general differences were found in terms of clinical knowledge and understanding, and actual clinical performance, an interaction between students' course-specific prior knowledge and the training approach was found. Especially students with low levels of knowledge benefited more from the facilitative training approach in terms of clinical knowledge, while highly knowledgeable students experienced a negative effect of this training approach. Moreover, students' perceptions revealed that facilitative-trained students reported more deep-level learning, while the directive training approach turned out to score higher in terms of quality and perceived effects.

  16. Mass spectrometry-based proteomics and analyses of serum: a primer for the clinical investigator.

    PubMed

    Fusaro, V A; Stone, J H

    2003-01-01

    The vocabulary of proteomics and the swiftly-developing, technological nature of the field constitute substantial barriers to clinical investigators. In recent years, mass spectrometry has emerged as the most promising technique in this field. The purpose of this review is to introduce the field of mass spectrometry-based proteomics to clinical investigators, to explain many of the relevant terms, to introduce the equipment employed in this field, and to outline approaches to asking clinical questions using a proteomic approach. Examples of clinical applications of proteomic techniques are provided from the fields of cancer and vasculitis research, with an emphasis on a pattern recognition approach.

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

    PubMed

    Mallath, Mohandas K; Chawla, Tanuj

    2017-01-01

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

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

    PubMed Central

    Mallath, Mohandas K.; Chawla, Tanuj

    2017-01-01

    India's success in producing food and milk for its population (Green Revolution and White Revolution) happened because of scientific research and field trials. Likewise improving the health of Indians needs clinical research and clinical trials. A Large proportion of the sick Indians are poor, illiterate with no access to good health care. They are highly vulnerable to inducement and exploitation in clinical trials. The past two decades saw the rise and fall of clinical trials in India. The rise happened when our regulators created a favorable environment, and Indian investigators were invited to participate in global clinical trials. The gap between the demand and supply resulted in inadequate protection of the trial participants. Reports of abuses of the vulnerable trial participants followed by public interest litigations led to strengthening of regulations by the regulators. The stringent new regulations made the conduct of clinical trials more laborious and increased the cost of clinical trials in India. There was a loss of interest in sponsored clinical trials resulting in the fall in global clinical trials in India. Following repeated appeals by the investigators, the Indian regulators have recently relaxed some of the stringent regulations, while continuing to ensure the adequate patient protection. Clinical trials that are relevant to our population and conducted by well-trained investigators and monitored by trained and registered Ethics Committees will increase in the future. We must remain vigilant, avoid previous mistakes, and strive hard to protect the trial participants in the future trials. PMID:28194335

  19. Clinical investigation of the Paraperm EW rigid gas-permeable contact lens.

    PubMed

    Henry, V A; Bennett, E S; Forrest, J F

    1987-05-01

    Paraperm EW is a high oxygen flux silicone/acrylate rigid lens material currently under clinical investigation for extended wear. The purpose of this paper is to report the clinical findings after 12 months of a 2-year investigation of 18 patients fitted with this material. Fifteen were successfully wearing Paraperm EW lenses at 1 year. The only significant clinical finding was keratometric flattening at the 1-month visit. It was concluded that the Paraperm EW lens was durable, comfortable, and provided excellent visual acuity during the course of this investigation without inducing any of the ocular complications sometimes associated with extended wear of hydrogel lenses.

  20. Clinical Investigation.

    DTIC Science & Technology

    1979-09-30

    Beta Sympathetic Blockade on Meta - bolic Rate and Thyroid Function in Normal Man. Clin Res 27:1, Feb 1979. Gastroenterology Service Gremillion, D.E...031 74/101 Immuno-chemical Evaluation of Myeloproliferative and Plasmaproliferative Diseases (0) (P) (PR) .......... ... 032 74/110 Reactive...Hypoglycemia: An Analysis of Glucose-insulin- Glucagon Interrelationships and Counter Hormonal Regulatory Factors (0) (P) (PR) .... ............. ... 034 75

  1. Clinical Investigations.

    DTIC Science & Technology

    ARMY RESEARCH, *MEDICAL RESEARCH, HORMONES , BIOCHEMISTRY, ENZYMES, THYROID GLAND, ROOM TEMPERATURE, FUNGI, PATHOLOGY, PAIN, RESEARCH MANAGEMENT...PSYCHIATRY, GYNECOLOGY, ORTHOPEDICS, VETERINARY MEDICINE, ANTIDIURETICS , DENTAL ENAMEL, DIALYSIS, PARATHYROID GLANDS, OBSTETRICS.

  2. CLINICAL INVESTIGATION.

    DTIC Science & Technology

    dorsal glove-splint; epididymitis ; ampicillin; inflatable dorsal glove-splint; hydrocephalus; ventriculo sagittal sinus shunt; multifocal contact lens; peripheral nerves; accidental poisoning; children; viral exanthems.

  3. 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

  4. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Clinical investigations involving greater than... OF HUMAN SUBJECTS Additional Safeguards for Children in Clinical Investigations § 50.52 Clinical... subjects. Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter...

  5. 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.

  6. 78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-07

    ... answer different scientific questions. The guidance describes principles that should be followed for the...'s current thinking on pivotal clinical investigations for medical devices. It does not create...

  7. Applying active learning to assertion classification of concepts in clinical text.

    PubMed

    Chen, Yukun; Mani, Subramani; Xu, Hua

    2012-04-01

    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.

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

    PubMed

    Solovyova, M

    2014-12-01

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

  9. 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…

  10. 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)

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

    PubMed Central

    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. PMID:26208707

  12. Clinical relevance of polymorphonuclear (PMN-) elastase determination in semen and serum during infertility investigation.

    PubMed

    Eggert-Kruse, W; Zimmermann, K; Geissler, W; Ehrmann, A; Boit, R; Strowitzki, T

    2009-08-01

    The polymorphonuclear (PMN) elastase is secreted by activated granulocytes and is widely used as a marker of male accessory gland infection. However, the clinical value of routine determination of seminal plasma (SP) PMN elastase in asymptomatic patients during infertility investigation has not clearly been established and not much is known about the significance of PMN-elastase levels in serum as a potential biochemical determinant associated with infection/inflammation of the male genital tract. This prospective study included a total of 221 asymptomatic males from unselected subfertile couples, to evaluate the relationship of (i) serum and (ii) same-day SP PMN elastase concentrations with established semen quality parameters, including sperm functional capacity, local antisperm antibodies (ASA), seminal leucocytes, and the outcome of semen cultures including typical sexually transmitted disease pathogens, and a potential association with patients' medical history and results of clinical andrological examination. Furthermore, couples were followed up for subsequent fertility (controlled for female infertility factors). The concentrations of PMN elastase in serum and in SP were not significantly related to semen quality [with regard to microscopic (e.g. count, motility, morphology) as well as biochemical parameters, and also to local ASA of the IgG- or IgA-class]. There was no strong relationship with sperm functional capacity. No significant relationship with the outcome of the microbial screening was found. PMN-elastase levels in serum and SP were not significantly correlated and there was no association with subsequent fertility. Therefore, the value of routine determination of PMN elastase in semen and/or serum samples, particularly when used as a single parameter to screen for subclinical infection/inflammation in males under infertility investigation is limited.

  13. Epileptic activity in Alzheimer's disease: causes and clinical relevance.

    PubMed

    Vossel, Keith A; Tartaglia, Maria C; Nygaard, Haakon B; Zeman, Adam Z; Miller, Bruce L

    2017-04-01

    Epileptic activity is frequently associated with Alzheimer's disease; this association has therapeutic implications, because epileptic activity can occur at early disease stages and might contribute to pathogenesis. In clinical practice, seizures in patients with Alzheimer's disease can easily go unrecognised because they usually present as non-motor seizures, and can overlap with other symptoms of the disease. In patients with Alzheimer's disease, seizures can hasten cognitive decline, highlighting the clinical relevance of early recognition and treatment. Some evidence indicates that subclinical epileptiform activity in patients with Alzheimer's disease, detected by extended neurophysiological monitoring, can also lead to accelerated cognitive decline. Treatment of clinical seizures in patients with Alzheimer's disease with select antiepileptic drugs (AEDs), in low doses, is usually well tolerated and efficacious. Moreover, studies in mouse models of Alzheimer's disease suggest that certain classes of AEDs that reduce network hyperexcitability have disease-modifying properties. These AEDs target mechanisms of epileptogenesis involving amyloid β and tau. Clinical trials targeting network hyperexcitability in patients with Alzheimer's disease will identify whether AEDs or related strategies could improve their cognitive symptoms or slow decline.

  14. [A report on clinical PET activities in Germany].

    PubMed

    Tashiro, M; Kubota, K; Itoh, M; Sasaki, H; Moser, E

    1999-09-01

    Clinical diagnostic procedure using positron emission tomography (PET) requires high costs. To promote clinical use of PET, sociomedical evaluation is necessary. In this paper, sociomedical situations concerning clinical use of PET in Germany is reported. Some comparisons are made between Japan and this country putting emphases on several points such as 1) number of cyclotron and PET facilities, 2) social restriction to transportation of radioisotopes, 3) activities of satellite PET facilities, and 4) clinical indications for PET studies. Number of cyclotron was larger in Japan (29) than in Germany (17), but number of PET facilities was larger in Germany (47) than in Japan (29). The reason seems that in Germany transportation and buying of radioisotopes is less restricted. Hence, more than half of PET facilities in Germany are "satellite facilities" which do not have their own cyclotrons. Radioisotope distribution seems to serve as a backbone of "satellite concept." Additionally in Germany, list of clinical indications for PET study is almost completed and now is widely in applied to most cases. To promote clinical use of PET in Japan, the German system might serve as an important socioeconomic model in Europe instead of the United States.

  15. 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…

  16. 78 FR 35937 - Food and Drug Administration Decisions for Investigational Device Exemption Clinical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-14

    ... revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation... 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...

  17. 76 FR 12742 - Guidance for Industry and Food and Drug Administration Staff; Clinical Investigations of Devices...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-08

    ... investigations of medical devices indicated for the treatment of urinary incontinence. DATES: Submit either... search capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices...; Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence; Availability...

  18. Clinical Investigation of the Dopaminergic System with PET and FLUORINE-18-FLUORO-L-DOPA.

    NASA Astrophysics Data System (ADS)

    Oakes, Terrence Rayford

    1995-01-01

    Positron Emission Tomography (PET) is a tool that provides quantitative physiological information. It is valuable both in a clinical environment, where information is sought for an individual, and in a research environment, to answer more fundamental questions about physiology and disease states. PET is particularly attractive compared to other nuclear medicine imaging techniques in cases where the anatomical regions of interest are small or when true metabolic rate constants are required. One example with both of these requirements is the investigation of Parkinson's Disease, which is characterized as a presynaptic motor function deficit affecting the striatum. As dopaminergic neurons die, the ability of the striatum to affect motor function decreases. The extent of functional neuronal damage in the small sub-structures may be ascertained by measuring the ability of the caudate and putamen to trap and store dopamine, a neurotransmitter. PET is able to utilize a tracer of dopamine activity, ^ {18}F- scL-DOPA, to quantitate the viability of the striatum. This thesis work deals with implementing and optimizing the many different elements that compose a PET study of the dopaminergic system, including: radioisotope production; conversion of aqueous ^{18}F ^-into [^ {18}F]-F2; synthesis of ^{18}F- scL -DOPA; details of the PET scan itself; measurements to estimate the radiation dosimetry; accurate measurement of a plasma input function; and the quantitation of dopaminergic activity in normal human subjects as well as in Parkinson's Disease patients.

  19. 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…

  20. 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.

  1. Investigating the active centre of the Scytalidium thermophilum catalase.

    PubMed

    Yuzugullu, Yonca; Trinh, Chi H; Fairhurst, Lucy; Ogel, Zumrut B; McPherson, Michael J; Pearson, Arwen R

    2013-04-01

    Almost all monofunctional haem catalases contain a highly conserved core containing the active site, which is connected to the exterior of the enzyme by three channels. These channels have been identified as potential routes for substrate flow and product release. To further investigate the role of these molecular channels, a series of mutants of Scytalidium thermophilum catalase were generated. The three-dimensional structures of four catalase variants, N155A, V123A, V123C and V123T, have been determined at resolutions of 2.25, 1.93, 1.9 and 1.7 Å, respectively. The V123C variant contains a new covalent bond between the S atom of Cys123 and the imidazole ring of the essential His82. This variant enzyme has only residual catalase activity and contains haem b instead of the normal haem d. The H82A variant demonstrates low catalase and phenol oxidase activities (0.2 and 20% of those of recombinant wild-type catalase-phenol oxidase, respectively). The N155A and N155H variants exhibit 4.5 and 3% of the wild-type catalase activity and contain haem d, showing that Asn155 is essential for catalysis but is not required for the conversion of haem b to haem d. Structural analysis suggests that the cause of the effect of these mutations on catalysis is the disruption of the ability of dioxygen substrates to efficiently access the active site. Additional mutants have been characterized biochemically to further probe the roles of the different channels. Introducing smaller or polar side chains in place of Val123 reduces the catalase activity. The F160V, F161V and F168V mutants show a marked decrease in catalase activity but have a much lower effect on the phenol oxidase activity, despite containing substoichiometric amounts of haem.

  2. Clinical trials: active control vs placebo--what is ethical?

    PubMed

    Spławiński, Jacek; Kuźniar, Jerzy

    2004-01-01

    The quest for effective medicines is very old. In modern times two important tools have been developed to evaluate efficacy of drugs, superiority and non-inferiority types of clinical trials. The former tests the null hypothesis of micro (the difference between a tested drug and comparator) < or = 0 against micro > 0; the latter tests the null hypothesis of micro < or = - delta against, micro > - delta, where delta is the clinical difference from the comparator. In a superiority trial, a new drug is tested against a placebo; in a non-inferiority trial, a new drug is tested against active treatment. In this paper, arguments are presented to show that a superiority trial against a placebo is scientifically sound but ethically unacceptable, whereas a non-inferiority trial against active treatment is ethically sound but scientifically not reliable. Switching from a superiority type of trial with placebo to a non-inferiority trial with an active-control--following the latest revision of Declaration of Helsinki--is in practice switching from the violation of the uncertainty principle to uncertainty of results. Given human and financial resources, it appears an academic question as to which is more unethical: to violate patients' rights or to produce results without scientific value. All presented considerations lead to the conclusion that the use of a superiority trial of design with an active control instead of placebo will satisfy scientific needs, expectation of patients, and the ancient quest for effective medicines. In the era of Good (Clinical, Laboratory, Manufacture) Practice, the attention of those performing clinical trials is focused on the procedure, not always on its essence. However even the excellent performance of a trial which is not worth doing is fruitless.

  3. [Chronic active hepatitis: clinical, biochemical, and histopathologic correlation].

    PubMed

    Subauste, M C

    1989-01-01

    A retrospective study over 26 female patients with chronic active hepatitis was made. The mean age was 39 years old, the mean length of illness of 8 months; 5 patients had positive markers for hepatitis B. Patients were selected with the grade of histological activity: 8 patients had a mild form from disease (2A) and 16 with a severe one (2B). The predominant group was 2B. Severe inflammatory infiltration was the hallmark and multiobulillar necrosis, bridging, eosinophils and hiperplasia of kuppfer cells were found only in this group. Clinical features range from hepatic manifestations to systemic ones. Chronic active hepatitis may present with cholestasis, but the latter is not always related with the grade of activity. Group 2B had elevated aminotransferases and a low concentration for protrobine.

  4. Hemispheric activation differences in novice and expert clinicians during clinical decision making.

    PubMed

    Hruska, Pam; Hecker, Kent G; Coderre, Sylvain; McLaughlin, Kevin; Cortese, Filomeno; Doig, Christopher; Beran, Tanya; Wright, Bruce; Krigolson, Olav

    2016-12-01

    Clinical decision making requires knowledge, experience and analytical/non-analytical types of decision processes. As clinicians progress from novice to expert, research indicates decision-making becomes less reliant on foundational biomedical knowledge and more on previous experience. In this study, we investigated how knowledge and experience were reflected in terms of differences in neural areas of activation. Novice and expert clinicians diagnosed simple or complex (easy, hard) cases while functional magnetic resonance imaging (fMRI) data were collected. Our results highlight key differences in the neural areas activated in novices and experts during the clinical decision-making process. fMRI data were collected from ten second year medical students (novices) and ten practicing gastroenterologists (experts) while they diagnosed sixteen (eight easy and eight hard) clinical cases via multiple-choice questions. Behavioral data were collected for diagnostic accuracy (correct/incorrect diagnosis) and time taken to assign a clinical diagnosis. Two analyses were performed with the fMRI data. First, data from easy and hard cases were compared within respective groups (easy > hard, hard > easy). Second, neural differences between novices and experts (novice > expert, expert > novice) were assessed. Experts correctly diagnosed more cases than novices and made their diagnoses faster than novices on both easy and hard cases (all p's < 0.05). Time taken to diagnose hard cases took significantly longer for both novices and experts. While similar neural areas were activated in both novices and experts during the decision making process, we identified significant hemispheric activation differences between novice and expert clinicians when diagnosing hard clinical cases. Specifically, novice clinicians had greater activations in the left anterior temporal cortex and left ventral lateral prefrontal cortex whereas expert clinicians had greater activations in the right

  5. 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

  6. 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

  7. Investigation of some biologic activities of Swertia longifolia Boiss

    PubMed Central

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

    2013-01-01

    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

  8. 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.

  9. Comparative anthelmintic activity investigation of selected ethno-medicinal weeds

    NASA Astrophysics Data System (ADS)

    Pueblos, Kirstin Rhys S.; Bajalla, Mark; Pacheco, Dixie; Ganot, Sheila; Paig, Daisy; Tapales, Radyn; Lagare, Jeanne; Quimque, Mark Tristan J.

    2017-01-01

    Helminth infections are one of the seriously neglected potent diseases in many parts of the world. The problems of parasitic helminthes becoming resistant to currently available anthelmintic drugs pose a challenge for the search - relying on natural products - for new and better anthelmintics. In this paper, four abundant Philippine weeds: Chrysopogon aciculatus Trin. Cyperus brevifolius Rottb., Ruellia tuberosa Linn. and Saccharum spontaneum Linn. were investigated for their anthelmintic activities to establish basis of their folkloric claim. The hexane-soluble and chloroform-soluble extracts were obtained through sequential solvent partitioning of the crude ethanolic extract of the air-dried aerial part of each plant sample. Meanwhile, the decoction was obtained from fresh aerial part of the plant samples. All extracts were then subjected to in vitro anthelmintic screening at different concentration as per method of Ghosh, et al. against African nightcrawler earthworms (Eudrillus euginiae) in which the activity of the extracts was determined by correlation with time. The anthelmintic bioassay results revealed a dose-dependent toxicity relationship. It indicated relatively low anthelmintic activities of the decoction of the four plant samples as compared to their corresponding crude ethanol extracts. Among the crude ethanol extracts, C. brevifolius (CBE) gave fastest time to bring about paralysis and death to the test organisms at all concentrations tested. For the hexane extracts, R. tuberosa (RTH) gave better activity among other plant samples. Lastly, among the chloroform-soluble extracts, both that of C. brevifolius (CBC) and R. tuberosa (RTC) comparably showed strongest anthelmintic activities at all tested concentrations, thus, exhibited best anthelmintic activity that is remarkably comparable to the positive control, Mebendazole at the highest concentration tested. In fact, CBC and RTC showed highest anthelmintic potential compared to all extracts tested in

  10. Investigation kinetics mechanisms of adsorption malachite green onto activated carbon.

    PubMed

    Onal, Y; Akmil-Başar, C; Sarici-Ozdemir, C

    2007-07-19

    Lignite was used to prepare activated carbon (T3K618) by chemical activation with KOH. Pore properties of the activated carbon such as BET surface area, pore volume, pore size distribution, and pore diameter were characterized by t-plot based on N2 adsorption isotherm. BET surface area of activated carbon is determined as 1000 m2/g. Adsorption capacity of malachite green (MG) onto T3K618 activated carbon was investigated in a batch system by considering the effects of various parameters like initial concentration (100, 150 and 200 mg/L) and temperature (25, 40 and 50 degrees C). The adsorption process was relatively fast and equilibrium was reached after about 20 min for 100, 150 mg/L at all adsorption temperature. Equilibrium time for 200 mg/L was determined as 20 min and 40 min at 298, 313 and 323 K, respectively. Simple mass and kinetic models were applied to the experimental data to examine the mechanisms of adsorption and potential rate controlling steps such as external mass transfer, intraparticle diffusion. Pseudo second-order model was found to explain the kinetics of MG adsorption most effectively. It was found that both mass transfer and pore diffusion are important in determining the adsorption rates. The intraparticle diffusion rate constant, external mass transfer coefficient, film and pore diffusion coefficient at various temperatures were evaluated. The activation energy (Ea) was determined as 48.56, 63.16, 67.93 kJ/mol for 100, 150, 200 mg/L, respectively. The Langmiur and Freundlich isotherm were used to describe the adsorption equilibrium studies at different temperatures. Langmiur isotherm shows better fit than Freundlich isotherm in the temperature range studied. The thermodynamic parameters, such as DeltaG degrees, DeltaS and DeltaH degrees were calculated. The thermodynamics of dyes-T3K618 system indicates endothermic process.

  11. 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).

  12. 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.

  13. 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

  14. 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.

  15. [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".

  16. 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…

  17. 78 FR 13070 - Guidance for Clinical Investigators, Industry, and Food and Drug Administration Staff: Financial...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-26

    ... HUMAN SERVICES Food and Drug Administration (formerly 1999D-4396) Guidance for Clinical Investigators... recommendations made by the Office of the Inspector General (OIG), Department of Health and Human Services, in... represents FDA's current thinking on this topic. It does not create or confer any rights for or on any...

  18. Investigation of Clinically Significant Change by Severity Level in College Counseling Center Clients

    ERIC Educational Resources Information Center

    Wolgast, Brad M.; Rader, Jill; Roche, Deborah; Thompson, C. Patricia; von Zuben, F. Christian; Goldberg, Allan

    2005-01-01

    The authors investigated the number of sessions necessary for college counseling center clients of different levels of severity of distress at intake to achieve clinically significant change (CS) in therapy. The Outcome Questionnaire-45 (M. J. Lambert, N. B. Hansen, et al., 1996) was used to categorize 914 clients by severity of distress. Analyses…

  19. 21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Clinical investigations not otherwise approvable... or welfare of children. 50.54 Section 50.54 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... serious problem affecting the health or welfare of children; and (b) The Commissioner of Food and...

  20. Teaching Hypothesis-Oriented Thinking to Medical Students: The University of Florida's Clinical Investigation Program.

    ERIC Educational Resources Information Center

    Stacpoole, Peter W.; Fisher, Waldo R.; Flotte, Terence R.; Geiser, Edward A.; Theriaque, Douglas W.; Hutson, Alan D.

    2001-01-01

    Describes student-led research projects conducted at the University of Florida's General Clinical Research Center. First-year medical and M.D.-Ph.D. students collaborate on a hypothesis-driven experiment involving students as volunteer subjects and investigators. Feedback indicates students find the program useful and that it encourages pursuit of…

  1. 21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

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

  2. Template protocol for clinical trials investigating vaccines--focus on safety elements.

    PubMed

    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

    2013-11-12

    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.

  3. Department of Clinical Investigation, Annual Research Progress Report, Fiscal Year 2006 (Madigan Army Medical Center)

    DTIC Science & Technology

    2006-09-30

    Findings in Bariatric Surgery Specimens DEPARTMENT OF PEDIATRICS Cason RL #203014 T L Clinical Use of Reticulocyte Hemoglobin to Detect Iron...Status: Ongoing Title: Incidental Anatomic and Histologic Findings in Bariatric Surgery Specimens Principal Investigator: MAJ Anne L. Champeaux, MC...Collection, review and analysis of bariatric surgery specimen reports generated by the MAMC Anatomic Pathology service from 1994 through 2004 to

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. Relationship between electromyographic activity and clinically assessed rigidity studied at the wrist joint in Parkinson's disease.

    PubMed

    Meara, R J; Cody, F W

    1992-08-01

    The electromyographic (EMG) patterns recorded from wrist muscles during manually applied, repetitive flexion and extension movements of the wrist joint, used for simultaneous clinical assessment of rigidity, were studied in patients with Parkinson's disease and healthy subjects. Recordings were made whilst patients/subjects attempted voluntarily to relax the muscle of the arm whose wrist joint was manipulated. Individual patients were investigated before and at varying times after their routine daily medication as their clinical rigidity underwent associated modulations. It was often possible to induce additional alterations in clinical rigidity by instructing patients to perform an activation or Jendrassik-like manoeuvre (clenching the contralateral fist). In rigid patients, the approximately sinusoidal wrist displacements (60 deg, 1-1.5 Hz) typically elicited pronounced, cyclic modulations of EMG activities in wrist flexors and extensors; increases in EMG activity were phase-locked to the respective periods of muscle stretch. Stretch-related EMG activity reduced or disappeared as rigidity was abolished by drug therapy. The EMG patterns of patients showing cogwheel rigidity featured discrete, phasic bursts superimposed upon more generalized stretch-related increases in activity. In healthy subjects, showing no clinical rigidity, the pronounced cyclic modulations of EMG activity characteristic of rigid patients were absent during similar manually applied wrist displacements. Quantitative EMG measurements for individual patients, made 'on' and 'off' medication and as their rigidity fluctuated, indicated that mild (grade 1) and moderate (grade 2) rigidity was consistently associated with increased stretch-related activity compared with non-rigid conditions. Pair-wise statistical analysis indicated such increases in EMG to be significant. Similarly, the ratios of EMG activities in the stretched versus released muscles were significantly greater for grades 1 and 2

  9. Bacterial vectors for active immunotherapy reach clinical and industrial stages

    PubMed Central

    Le Gouëllec, Audrey; Chauchet, Xavier; Polack, Benoit; Buffat, Laurent; Toussaint, Bertrand

    2012-01-01

    Active immunotherapy based on live attenuated bacterial vectors has matured in terms of industrial development and develops through a combination of three phenomena. First, active immunotherapy that stimulates an antigen-specific cytotoxic T-cell immune response has become a reality after several years of work. Second, there is still a need to identify vectors that can deliver antigens to the cytosol of antigen-presenting cells in vivo. Third, the recent progress in the understanding of bacterial lifestyle and in developing genetic engineering tools has enabled the design of bioengineered bugs that are capable of delivering antigens. Here, we review the mechanisms by which clinical bacterial vectors deliver antigens into the cytosol of antigen-presenting cells and summarize the development strategy of the three identified firms in this field. PMID:22894945

  10. Pre-Clinical Rheumatoid Arthritis: Identification, Evaluation and Future Directions for Investigation

    PubMed Central

    Deane, Kevin D.; Norris, Jill M.; Holers, V. Michael

    2010-01-01

    Synopsis Rheumatoid arthritis (RA) likely develops in several phases, beginning with genetic risk, followed by asymptomatic autoimmunity, then finally, clinically-apparent disease. Investigating the phases of disease that exist prior to the onset of symptoms - i.e. the pre-clinical period of RA – will lead to understanding of the important relationships between genetic and environmental factors that may lead to disease, as well as allow for the development of predictive models for disease, and ultimately preventive strategies for RA. PMID:20510231

  11. 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.

  12. 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

  13. An Investigation of Activity Profiles of Older Adults

    PubMed Central

    Putnam, Michelle; Lee, Yung Soo; Greenfield, Jennifer C.; Inoue, Megumi; Chen, Huajuan

    2014-01-01

    Objectives. In this study, we advance knowledge about activity engagement by considering many activities simultaneously to identify profiles of activity among older adults. Further, we use cross-sectional data to explore factors associated with activity profiles and prospective data to explore activity profiles and well-being outcomes. Method. We used the core survey data from the years 2008 and 2010, as well as the 2009 Health and Retirement Study Consumption and Activities Mail Survey (HRS CAMS). The HRS CAMS includes information on types and amounts of activities. We used factor analysis and latent class analysis to identify activity profiles and regression analyses to assess antecedents and outcomes associated with activity profiles. Results. We identified 5 activity profiles: Low Activity, Moderate Activity, High Activity, Working, and Physically Active. These profiles varied in amount and type of activities. Demographic and health factors were related to profiles. Activity profiles were subsequently associated with self-rated health and depression symptoms. Discussion. The use of a 5-level categorical activity profile variable may allow more complex analyses of activity that capture the “whole person.” There is clearly a vulnerable group of low-activity individuals as well as a High Activity group that may represent the “active ageing” vision. PMID:24526690

  14. Investigating Longitudinal Tobacco Use Information from Social History and Clinical Notes in the Electronic Health Record.

    PubMed

    Wang, Yan; Chen, Elizabeth S; Pakhomov, Serguei; Lindemann, Elizabeth; Melton, Genevieve B

    2016-01-01

    The electronic health record (EHR) provides an opportunity for improved use of clinical documentation including leveraging tobacco use information by clinicians and researchers. In this study, we investigated the content, consistency, and completeness of tobacco use data from structured and unstructured sources in the EHR. A natural language process (NLP) pipeline was utilized to extract details about tobacco use from clinical notes and free-text tobacco use comments within the social history module of an EHR system. We analyzed the consistency of tobacco use information within clinical notes, comments, and available structured fields for tobacco use. Our results indicate that structured fields for tobacco use alone may not be able to provide complete tobacco use information. While there was better consistency for some elements (e.g., status and type), inconsistencies were found particularly for temporal information. Further work is needed to improve tobacco use information integration from different parts of the EHR.

  15. Investigating Longitudinal Tobacco Use Information from Social History and Clinical Notes in the Electronic Health Record

    PubMed Central

    Wang, Yan; Chen, Elizabeth S.; Pakhomov, Serguei; Lindemann, Elizabeth; Melton, Genevieve B.

    2016-01-01

    The electronic health record (EHR) provides an opportunity for improved use of clinical documentation including leveraging tobacco use information by clinicians and researchers. In this study, we investigated the content, consistency, and completeness of tobacco use data from structured and unstructured sources in the EHR. A natural language process (NLP) pipeline was utilized to extract details about tobacco use from clinical notes and free-text tobacco use comments within the social history module of an EHR system. We analyzed the consistency of tobacco use information within clinical notes, comments, and available structured fields for tobacco use. Our results indicate that structured fields for tobacco use alone may not be able to provide complete tobacco use information. While there was better consistency for some elements (e.g., status and type), inconsistencies were found particularly for temporal information. Further work is needed to improve tobacco use information integration from different parts of the EHR. PMID:28269918

  16. [Routines of organization of clinical tests and interviews in the ELSA-Brasil investigation center].

    PubMed

    Bensenor, Isabela M; Griep, Rosane H; Pinto, Karina Araújo; Faria, Carolina Perim de; Felisbino-Mendes, Mariana; Caetano, Edna I; Albuquerque, Liliane da Silva; Schmidt, Maria Inês

    2013-06-01

    The ELSA-Brasil (Estudo Longitudinal de Saúde do Adulto - Brazilian Longitudinal Study for Adult Health) is a prospective cohort study with extensive assessments throughout time. This article describes the routine of clinical tests and interviews performed with participants and the structuring of the Research Center physical space and teams. The ELSA-Brasil assumes that participants will be present at the Research Center to have the tests and interviews performed, according to standard protocols developed by this study. Considering the multiplicity of activities involved, each with specific needs for standardization, several predetermined orders of clinical tests and interviews were created. This ensured a high standard of quality in data collection without harm to participants' comfort. Each participant was previously assigned to a specific sequence of clinical tests and interviews with a predefined arrival time, mean length of stay of five to six hours and departure time.

  17. Investigation of clinically important benefit of anterior cervical decompression and fusion

    PubMed Central

    2006-01-01

    The objectives of the prospective randomized study are to investigate the clinically relevant change after anterior cervical decompression and fusion (ACDF) using measures of pain intensity (visual analog scale, VAS) and neck disability index (NDI). And to determine the number of subjects showing persistent pain and disability at 6-year follow-up. To investigate the possibility of differences in outcome between ACDF with the cervical intervertebral fusion cage (CIFC) and the Cloward procedure (CP). Clinically relevant change and residual, postoperative pain intensity and disability after ACDF have been investigated a little. Ninety-five patients with neck and radicular arm pain lasting for at least 6 months were randomly selected to receive ACDF with the CP or the CIFC. Questionnaires concerning pain and NDI were obtained from 83 patients (87%) at a mean follow-up time of 76 months (range 56–94 months). When evaluating clinical benefits regarding pain intensity 6 years after ACDF, according to different cut-off points and relative percentages, symptoms improved in 46–78% of patients. Improvement in NDI was seen in 18–20% of patients. Approximately 70% of the patients had persistent pain and disability at 6-year follow-up. There was no clinically important difference following CP versus CIFC. Thirty millimeter and 20% in pain intensity and NDI, respectively, are reasonable criteria to suggest a clinically relevant change after ACDF. Before patients undergo ACDF, they should be informed that they have an approximate 50% probability of achieving pain relief and little probability of functional improvement. The findings demonstrate that there is poor evidence for difference between CIFC and CP. PMID:17143633

  18. 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

  19. Defining phenotypes and disease progression in sarcomeric cardiomyopathies: contemporary role of clinical investigations.

    PubMed

    Olivotto, Iacopo; d'Amati, Giulia; Basso, Cristina; Van Rossum, Albert; Patten, Monica; Emdin, Michele; Pinto, Yigal; Tomberli, Benedetta; Camici, Paolo G; Michels, Michelle

    2015-04-01

    Mutations in cardiac sarcomere protein genes are associated with a variety of clinical phenotypes, including hypertrophic (HCM), dilated (DCM), and restrictive (RCM) cardiomyopathy as well as left ventricular non-compaction, with the overlap of morpho-functional manifestations in individual patients and families. Over time, initial phenotypes may undergo profound changes which determine clinical course and disease progression. Although genetic defects causing HCM and DCM have opposite effects at the myofilament level, a number of downstream maladaptive mechanisms, ranging from microvascular dysfunction and ischaemia to myocardial fibrosis and from diastolic dysfunction to abnormal sympathetic activation and arrhythmogenesis, seem to recur in sarcomeric cardiomyopathies, independent of the presenting phenotype. The extent and rate at which each of these features occur and evolve may be radically different in each form of cardiomyopathy, determining a clinical heterogeneity that is not only cross-sectional, but also longitudinal, i.e. time-related. Timely and sensitive detection of these long-term modifications in the clinical setting is a key to preventing advanced disease and identifying novel therapeutic targets. The present review evaluates the contribution of contemporary technology to pre-clinical diagnosis, characterization of phenotypes, and assessment of disease progression in sarcomere cardiomyopathies, including echocardiography, positron emission tomography, magnetic resonance, pathology, and circulating biomarkers.

  20. Crime Scene Investigation: Clinical Application of Chemical Shift Imaging as a Problem Solving Tool

    DTIC Science & Technology

    2016-02-26

    are vital to the medical mission. We look forward to assisting you in your future publication/presentation efforts. LINDA STEEL-GOODWIN, Col, USAF...BSC Director, Clinical Investigations & Research Support Partners in a high-performance health system. dedicated to excellence in global care...POINT OF CONTACT? (Last, First, MI.) (Include email) DUTY PHONE/PAGER No. Quintero . Susan J susan.j.quintero.civ@mail.mil 292-5290 AUTHORSHIP AND CO

  1. 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…

  2. 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.

  3. Genome-wide investigation of schizophrenia associated plasma Ndel1 enzyme activity.

    PubMed

    Gadelha, Ary; Coleman, Jonathan; Breen, Gerome; Mazzoti, Diego Robles; Yonamine, Camila M; Pellegrino, Renata; Ota, Vanessa Kiyomi; Belangero, Sintia Iole; Glessner, Joseph; Sleiman, Patrick; Hakonarson, Hakon; Hayashi, Mirian A F; Bressan, Rodrigo A

    2016-04-01

    Ndel1 is a DISC1-interacting oligopeptidase that cleaves in vitro neuropeptides as neurotensin and bradykinin, and which has been associated with both neuronal migration and neurite outgrowth. We previously reported that plasma Ndel1 enzyme activity is lower in patients with schizophrenia (SCZ) compared to healthy controls (HCs). To our knowledge, no previous study has investigated the genetic factors associated with the plasma Ndel1 enzyme activity. In the current analyses, samples from 83 SCZ patients and 92 control subjects that were assayed for plasma Ndel1 enzyme activity were genotyped on Illumina Omni Express arrays. A genetic relationship matrix using genome-wide information was then used for ancestry correction, and association statistics were calculated genome-wide. Ndel1 enzyme activity was significantly lower in patients with SCZ (t=4.9; p<0.001) and was found to be associated with CAMK1D, MAGI2, CCDC25, and GABGR3, at a level of suggestive significance (p<10(-6)), independent of the clinical status. Then, we performed a model to investigate the observed differences for case/control measures. 2 SNPs at region 1p22.2 reached the p<10(-7) level. ZFPM2 and MAD1L1 were the only two genes with more than one hit at 10(-6) order of p value. Therefore, Ndel1 enzyme activity is a complex trait influenced by many different genetic variants that may contribute to SCZ physiopathology.

  4. Activity of coumermycin against clinical isolates of staphylococci.

    PubMed Central

    Guillemin, M N; Miles, H M; McDonald, M I

    1986-01-01

    Staphylococci, particularly methicillin-resistant strains of Staphylococcus aureus, are major nosocomial pathogens in large hospitals in eastern Australia. At present vancomycin is the drug of choice for the treatment of life-threatening methicillin-resistant S. aureus infections. A possible alternative drug is coumermycin, a bis-hydroxy coumarin which inhibits DNA gyrase. Coumermycin activity was determined against clinical isolates from the Royal Melbourne Hospital. MICs of 639 staphylococcal isolates were determined by agar dilution. MICs and MBCs of 100 staphylococcal isolates were also determined by microdilution methods. The results showed that coumermycin was bactericidal, with MBCs of less than or equal to 4 micrograms/ml against all isolates tested. The results indicate that coumermycin is a potential alternative to vancomycin in the treatment of severe staphylococcal infections. PMID:3707109

  5. Mechanistic investigation of beta-galactosidase-activated MR contrast agents.

    PubMed

    Urbanczyk-Pearson, Lauren M; Femia, Frank J; Smith, Jeffrey; Parigi, Giacomo; Duimstra, Joseph A; Eckermann, Amanda L; Luchinat, Claudio; Meade, Thomas J

    2008-01-07

    We report a mechanistic investigation of an isomeric series of beta-galactosidase-activated magnetic resonance contrast agents. Our strategy focuses on the synthesis of macrocyclic caged-complexes that coordinatively saturate a chelated lanthanide. Enzyme cleavage of the complex results in an open coordination site available for water that creates a detectable MR contrast agent. The complexes consist of a DO3A Gd(III) chelator modified with a galactopyranose at the N-10 position of the macrocycle. We observed significant differences in relaxometric properties and coordination geometry that can be correlated to subtle variations of the linker between the macrocycle and the galactopyranose. After synthesis and purification of the R, S, and racemic mixtures of complexes 1 and 3 and measurement of the hydration number, water residence lifetime, and longitudinal relaxation rates, we propose mechanisms for water exclusion from the lanthanide in the precleavage state. While the stereochemistry of the linker does not influence the agents' properties, the mechanism of water exclusion for each isomer is significantly influenced by the position of modification. Data for one series with a methyl group substituted on the sugar-macrocycle linker at the alpha-position suggests a steric mechanism where the galactopyranose sugar blocks water from the Gd(III) center. In contrast, our observations for a second series with methyl substitution at the beta position of the sugar-macrocycle linker are consistent with a mechanism in which a bidentate anion occupies two available coordination sites of Gd(III) in the precleavage state.

  6. Determining the phagocytic activity of clinical antibody samples.

    PubMed

    McAndrew, Elizabeth G; Dugast, Anne-Sophie; Licht, Anna F; Eusebio, Justin R; Alter, Galit; Ackerman, Margaret E

    2011-11-30

    Antibody-driven phagocytosis is induced via the engagement of Fc receptors on professional phagocytes, and can contribute to both clearance as well as pathology of disease. While the properties of the variable domains of antibodies have long been considered critical to in vivo function, the ability of antibodies to recruit innate immune cells via their Fc domains has become increasingly appreciated as a major factor in their efficacy, both in the setting of recombinant monoclonal antibody therapy, as well as in the course of natural infection or vaccination(1-3). Importantly, despite its nomenclature as a constant domain, the antibody Fc domain does not have constant function, and is strongly modulated by IgG subclass (IgG1-4) and glycosylation at Asparagine 297(4-6). Thus, this method to study functional differences of antigen-specific antibodies in clinical samples will facilitate correlation of the phagocytic potential of antibodies to disease state, susceptibility to infection, progression, or clinical outcome. Furthermore, this effector function is particularly important in light of the documented ability of antibodies to enhance infection by providing pathogens access into host cells via Fc receptor-driven phagocytosis(7). Additionally, there is some evidence that phagocytic uptake of immune complexes can impact the Th1/Th2 polarization of the immune response(8). Here, we describe an assay designed to detect differences in antibody-induced phagocytosis, which may be caused by differential IgG subclass, glycan structure at Asn297, as well as the ability to form immune complexes of antigen-specific antibodies in a high-throughput fashion. To this end, 1 μm fluorescent beads are coated with antigen, then incubated with clinical antibody samples, generating fluorescent antigen specific immune complexes. These antibody-opsonized beads are then incubated with a monocytic cell line expressing multiple FcγRs, including both inhibitory and activating. Assay output

  7. Investigation of deregulated genes of Notch signaling pathway in human T cell acute lymphoblastic leukemia cell lines and clinical samples.

    PubMed

    Paryan, Mahdi; Mohammadi-Yeganeh, Samira; Samiee, Siamak Mirab; Soleimani, Masoud; Arefian, Ehsan; Azadmanesh, Keyhan; Poopak, Behzad; Mostafavi, Ehsan; Karimipoor, Morteza; Mahdian, Reza

    2013-10-01

    In diagnostic research challenges, quantitative real-time PCR (QPCR) has been widely utilized in gene expression analysis because of its sensitivity, accuracy, reproducibility, and most importantly, quantitativeness. Real-time PCR base kits are wildly applicable in cancer signaling pathways, especially in cancer investigations. T-cell acute lymphoblastic leukemia (T-ALL) is a type of leukemia that is more common in older children and teenagers. Deregulation of the Notch signaling pathway promotes proliferation and inhibits apoptosis of the lymphoblastic T cells. The aim of this study was to investigate the effect of Notch signaling activation on the expression of target genes using real-time QPCR and further use this method in clinical examination after validation. Two T-ALL cell lines, Jurkat and Molt-4, were used as models for activation of the Notch signaling via over-expression of the Notch1 intracellular domain. Expression analysis was performed for six downstream target genes (NCSTN, APH1, PSEN1, ADAM17, NOTCH1 and C-MYC) which play critical roles in the Notch signaling pathway. The results showed significant difference in the expression of target genes in the deregulated Notch signaling pathway. These results were also verified in 12 clinical samples bearing over-expression of the Notch signaling pathway. Identification of such downstream Notch target genes, which have not been studied inclusively, provides insights into the mechanisms of the Notch function in T cell leukemia, and may help identify novel diagnoses and therapeutic targets in acute lymphoblastic leukemia.

  8. Doing Pre-operative Investigations in Emergency Department; a Clinical Audit

    PubMed Central

    Rafiq, Muhammad Salman; Rafiq, Maria; Rafiq, Muhammad Imran; Salman, Seema Gul; Hafeez, Sania

    2017-01-01

    Introduction Pre-operative investigations for emergency surgical patients differ between centers. Following established guidelines can reduce unnecessary investigation, cost of treatment and hospital stay. The present audit was carried out to evaluate the condition of doing pre-operative investigations for three common surgical emergencies compared to National Institute for Health and Care Excellence (NICE) guidelines and local criteria. Methods A retrospective clinical audit of acute-appendicitis, abscess and hernia patients admitted to the emergency department was carried out over a one-year period from July 2014 to July 2015. Data of laboratory investigations, their indication, cost and duration of hospital stay was collected and compared with NICE-guidelines. Results A total of 201 patients were admitted to the emergency department during the audit period. These included 77(38.3%) cases of acute-appendicitis, 112 (55.7%) cases of abscesses, and 12 (6%) cases of hernia. Investigations not indicated by NICE-guidelines included 42 (20.9%) full blood counts, 29 (14.4%) random blood sugars, 26 (12.9%) urea tests, 4 (2%) chest x-rays, 13 (6.5%) electrocardiographs, and 58 (28.9%) urine analyses. These cost 25,675 Rupees (245.46 Dollars) in unnecessary investigation costs and 65.7 days of additional hospital stay. Conclusions Unnecessary investigations for emergency surgical patients can be reduced by following NICE-guidelines. This will reduce workload on emergency services, treatment costs and the length of hospital stay. PMID:28286827

  9. A methodological approach to investigating a nationwide clinical specimen contamination problem in England.

    PubMed

    Pezzoli, L; Campbell, C; Lamagni, T L; Johnson, E; Saei, A; Duckworth, G

    2009-06-11

    Outbreaks of pseudo-infection due to contamination of specimens have been described, often as localised incidents. From August 2006, several English hospital laboratories began to refer an unusually high number of isolates of the fungus Paecilomyces variotii from clinical specimens to the national mycology reference laboratory for microbiological testing. We describe the methods used during the outbreak investigation in order to provide infection control specialists with an overview of how such national incidents may be investigated. We surveyed the hospitals reporting the contamination problem and conducted microbiological and environmental sampling. We applied analytical epidemiology to supply chain data, comparing the supply lines of key equipment to affected and unaffected hospitals in England. The survey was useful to describe procedures and equipment in use in the hospitals reporting the problem. The microbiological aspects of the investigation helped us understand how the fungal spores were distributed in the hospital environment. In the supply chain investigation we used data that was previously only used for logistical purposes. Overall the investigation was methodologically challenging, with no existing protocol to guide the investigators. To our knowledge, this is a novel approach to the investigation of such a widespread contamination problem, affecting geographically disparate hospitals at the same time.

  10. ROSAT investigation of flaring and activity on Prox Cen

    NASA Technical Reports Server (NTRS)

    Haisch, Bernhard

    1993-01-01

    The objective of this program was to investigate with high sensitivity the low-level flare activity which may underlie coronal heating. This was done. The ROSAT observations of Prox Cen were scheduled for 50 ks spread out from 26 Feb. - 10 Mar. 1992. Unfortunately because of spacecraft problems many of these pointings turned out to contain no useful data or extremely truncated valid data sets. Considerable time was spent trying to determine which of the data would be scientifically useful and which would not. Fortunately, several developments took place to augment the original data in such a way that the scientific goal of advancing the study of flaring and variability was able to be achieved after all. These are as follows: (1) a second round of ROSAT observations was carried out in Feb. 1993 which only came to the attention of the PI in Apr. 1993 when a new data tape arrived; (2) simultaneous IUE observations were requested and obtained; (3) data from the UK WFC are available via the collaboration with Dr. G. Bromage; and (4) the 'cleaned-up' original data set was found to include one major flare and 2 moderate flares. Because of the problems with the original data set, the unexpected acquisition of new data only two months ago, and the availability of IUE and WFC data, an article on Prox Cen for publication is not ready at this time. Such an article is being developed and can be completed as part of ongoing ROSAT research efforts on stellar coronae and flaring.

  11. [Event-related EEG and evoked potential investigations in clinical practice].

    PubMed

    Rajna, Péter; Hidasi, Zoltán; Waldemar, Szelenberger

    2005-11-20

    Considering the limits of the traditional EEG techniques the authors review the main methods and clinical importance of the event-related EEG investigations. According to methods, these can be classified into the spectral analysis of task-related, pre-task and post-task recordings as well as stimulus-controlled measurements based on evoked potential techniques. The main results of clinical studies on the event-related EEG methods are summarized according to chief disease groups (Alzheimer's disease, epilepsy, schizophrenia, Parkinson's disease, dyslexia, depression). The authors discuss the stimulus-dependent EEG discharges (P300, cognitive potential) in detail. They present the meta-analysis of 224 recent publications on human application of these methods. They analyze the involved scientific areas and the frequency by which these methods were applied in each. Following this, the results of 83 selected clinical studies are summarized. The frequency of the application of the various event-related EEG methods and the tested wave components and other parameters are listed. Finally a summary of the main clinical results is presented again by groups of diseases (schizophrenia, behavioral disorders, traumatic lesions, enuresis nocturna, depression, memory disturbance and dementia, drug effect). Finally, the potential perspectives and the limitations of the event-related EEG methods are briefly discussed.

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

    PubMed

    Jääskeläinen, Satu K

    2004-01-01

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

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

    PubMed

    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.

  14. 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.

  15. Antimicrobial Activity of Solithromycin against Clinical Isolates of Legionella pneumophila Serogroup 1

    PubMed Central

    Mallegol, Julia; Fernandes, Prabhavathi

    2014-01-01

    The activity of solithromycin was evaluated against clinical Legionella pneumophila serogroup 1 (Lp1) isolates (n = 196) collected in Ontario, Canada, from 1980 to 2011. Its in vitro activity was compared to that of azithromycin (AZM) using the broth microdilution method. Solithromycin had a MIC50 of ≤0.015 μg/ml and a MIC90 of 0.031 μg/ml, making its activity at least 8-fold to 32-fold higher than that of AZM (MIC50 and MIC90, 0.125 μg/ml and 1 μg/ml, respectively). Ninety-nine percent of the isolates had MICs for solithromycin ranging from ≤0.015 μg/ml to 0.031 μg/ml, whereas 83.6% of the isolates showed MICs for AZM ranging from 0.062 μg/ml to 0.25 μg/ml. Interestingly, 96.7% (30 out of 31 clinical isolates) identified with higher AZM MICs (0.5 μg/ml to 2 μg/ml) belonged to the clinically prevalent sequence type 1. To investigate the intracellular activity of solithromycin, in vitro invasion assays were also performed against a subset of representative Lp1 isolates internalized within human lung epithelial cells. Solithromycin and AZM both inhibited growth of all intracellular Lp1 isolates at 1× or 8× MICs, displaying bacteriostatic effects, as would be expected with protein synthesis inhibitor rather than bactericidal activity. Solithromycin demonstrated the highest in vitro and intracellular potency against all Lp1 isolates compared to AZM. Given the rapid spread of resistance mechanisms among respiratory pathogens and the reported treatment failures in legionellosis, the development of this new fluoroketolide, already in phase 3 oral clinical studies, constitutes a promising alternative option for the treatment of legionellosis. PMID:24277019

  16. Active hydrothermal and non-active massive sulfide mound investigation using a new multiparameter chemical sensor

    NASA Astrophysics Data System (ADS)

    Han, C.; Wu, G.; Qin, H.; Wang, Z.

    2012-12-01

    Investigation of active hydrothermal mound as well as non-active massive sulfide mound are studied recently. However, there is still lack of in-situ detection method for the non-active massive sulfide mound. Even though Transient ElectroMagnetic (TEM) and Electric Self-potential (SP) methods are good, they both are labour, time and money cost work. We proposed a new multiparameter chemical sensor method to study the seafloor active hydrothermal mound as well as non-active massive sulfide mound. This sensor integrates Eh, S2- ions concentration and pH electrochemical electrodes together, and could found chemical change caused by the active hydrothermal vent, even weak chemical abnormalities by non-active massive sulfide hydrothermal mound which MARP and CTD sometimes cannot detect. In 2012, the 1st Leg of the Chinese 26th cruise, the multiparameter chemical sensor was carried out with the deepsea camera system over the Carlsberg Ridge in Indian Ocean by R/V DAYANGYIHAO. It was shown small Eh and S2- ions concentration abnormal around a site at Northwest Indian ridge. This site was also evidenced by the TV grab. In the 2nd Leg of the same cruise in June, this chemical sensor was carried out with TEM and SP survey system. The chemical abnormalities are matched very well with both TEM and SP survey results. The results show that the multiparameter chemical sensor method not only can detect active hydrothermal mound, but also can find the non-active massive sulfide hydrothermal mound.

  17. 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…

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

    PubMed Central

    Han, Mei; Lai, Lily; Wang, Si-cheng

    2017-01-01

    Background. The development of an evidence-based approach to traditional Chinese medicine (TCM), which depends on the generation of good quality evidence, requires an adequate workforce. However, the research capacity of TCM investigators is not known. Study Design. This cross-sectional study was conducted to describe the research capacity of TCM clinical investigators in China. Participants. A total of 584 participants from TCM hospitals and research centers were included. They were asked about the academic and research characteristics, needs for research capacity building, and barriers to clinical research. Results. The majority (80.82%) were qualified to at least a Master's degree, whilst a smaller proportion (40.24%) held a senior professional title. We found that academic outputs were low with the majority (62.16%) authoring less than five publications in total. The most pressing needs for building research capacity identified were training in research methodology (97.43%) and identification of research questions (86.81%), whilst the highest ranking barriers to conducting research were limited motivation, funding (40.72%), and time (37.15%). Conclusion. The methodology training, along with investment in the research workforce, needs to be urgently addressed to improve investigators' research capacity and the development of an evidence-based approach of TCM. PMID:28373888

  19. 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.

  20. 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.

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

    PubMed Central

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

    2016-01-01

    Abstract 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

  2. 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.

  3. 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

  4. 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…

  5. 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

  6. Monitoring of disease biomarkers activity and immunophenotyping as important factors in SLE clinical management.

    PubMed

    Subasic, Djemo; Karamehic, Jasenko; Delic-Sarac, Marina; Kasumovic, Mersija; Mekic, Mevludin; Eminovic, Izet; Hasanagic, Nermina

    2012-01-01

    The highly specific biomarkers for monitoring of SLE disease activity are not yet defined up to date, due to existing of different clinical SLE phenotypes caused by individual genetic variation. Basically, numerous clinical complications follow SLE patients such as nephritis, atherosclerosis and cardial, CNS, gastrointestinal and ophthalmological complications, as well. Their monitoring in clinical SLE management can be evaluated by analysing of specific biochemical parameters and require permanent clinical observation. The presence of ANAs and anti-ds-DNAs are usual diagnostic SLE autoimmunity parameters, while SLE disease activity biomarkers are C3 and C4 level, anticardiolipin antibodies, anti-Sm/RNPs and, recently level of CD4 and CD8 lymphocytes. However, the number of TCR molecules on the T-cells surface at SLE patients is lower then in normal condition, and otherwise for these receptors CD molecules make specific connection. On the other hand, the T lymphocytes can be also, therapeutical targets at SLE patients, because of their clear direct involving in SLE pathogenesis. The SLE phenotypes are characterized by double CD negativity ( CD3 +/-, CD4-) caused by abnormal level of IL-2 and IL-17. T-lymphocytes have usually alpha-beta and gamma-delta TCR receptors, but for SLE patients is characteristic lower number gama-delta TCR molecules, detected in the peripheral blood specimens. Taking into account all of the facts, we investigated the level of specific usual SLE activity biomarkers (anti-ds-DNAs, C3, C4, anticardiolipin antibodies (beta-2-IgG, beta-2-IgM, ACA-G, ACA-M, CD4 and CD8 level) in serum specimens of SLE patients who underwent to the corresponding chemotherapy in combination with other biochemical and clinical parameters. Once again proved to be, that SLE biomarker monitoring, could be useful aproach for SLE activity disease and prediction organ damage, as well. In our investigation we used the following methods: immunofluorescence microscopy (IFA

  7. Investigation of oxidation process of mechanically activated ultrafine iron powders

    NASA Astrophysics Data System (ADS)

    Lysenko, E. N.; Nikolaev, E. V.; Vlasov, V. A.; Zhuravkov, S. P.

    2016-02-01

    The oxidation of mechanically activated ultrafine iron powders was studied using X- ray powder diffraction and thermogravimetric analyzes. The powders with average particles size of 100 nm were made by the electric explosion of wire, and were subjected to mechanical activation in planetary ball mill for 15 and 40 minutes. It was shown that a certain amount of FeO phase is formed during mechanical activation of ultrafine iron powders. According to thermogravimetric analysis, the oxidation process of non-milled ultrafine iron powders is a complex process and occurs in three stages. The preliminary mechanical activation of powders considerably changes the nature of the iron powders oxidation, leads to increasing in the temperature of oxidation onset and shifts the reaction to higher temperatures. For the milled powders, the oxidation is more simple process and occurs in a single step.

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

    PubMed Central

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

    2015-01-01

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

  9. Assessment of calcium dobesilate in diabetic retinopathy. A double-blind clinical investigation.

    PubMed

    Salama Benarroch, I; Nano, H; Pérez, H; Elizalde, F; Bisceglia, H; Salama, A

    1977-01-01

    In this double-blind, randomized trial, which lasted for 2 years, the authors investigated the efficacy of calcium dobesilate on diabetic retinopathy. 68 patients (51 on the active substance, 17 on placebo) participated in the study. The statistical analysis of the results indicate that calcium dobesilate acts as a potent angioprotector, capable of preventing both intra and extraretinal hemorrhages. The drug also lowers the incidence of exudate formation and improves visual acuity.

  10. 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.

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

    PubMed Central

    Kim, Myeong Seong

    2016-01-01

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

  12. Investigation of active-buffer pulse tube refrigerator

    NASA Astrophysics Data System (ADS)

    Zhu, Shaowei; Kakimi, Yasuhiro; Matsubara, Yoichi

    An active-buffer pulse tube refrigerator, which is a GM type pulse tube refrigerator, is described in this paper. Two or more buffers are connected at the hot end of the pulse tube through on/off valves. The main purpose of this method is to increase the efficiency. A numerical method is introduced to analyse the working process. To understand the basic mechanism, an ideal cycle is also introduced. With a prototype single stage active-buffer pulse tube refrigerator, a cooling capacity of 166 W and a percent Carnot of 13% at 80 K have been obtained.

  13. 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

  14. 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.

  15. 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...

  16. 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…

  17. 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…

  18. Recess Physical Activity Packs in Elementary Schools: A Qualitative Investigation

    ERIC Educational Resources Information Center

    Elliott, Steven; Combs, Sue; Boyce, Robert

    2011-01-01

    To supplement the present weekly allotment of 30 minutes of physical education, a school district in southeastern North Carolina identified recess time as part of the state mandated (HSP-S-000) 150 minutes of physical activity (PA) per week and have purchased fitness equipment (recess packs) for the children to use. Twelve participants were…

  19. 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…

  20. 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

  1. Clinical investigation of hypoglycemic effect of seeds of Azadirachta-inidca in type-2 (NIDDM) diabetes mellitus.

    PubMed

    Waheed, Akbar; Miana, G A; Ahmad, S I

    2006-10-01

    The present study was designed to investigate clinically the hypoglycemic effect of seeds of Azadirachta indica in Type-2 diabetes mellitus. After assaying fasting plasma and urinary glucose, 10 patients of type-2 diabetes mellitus with no previous medication, 10 patients of type-2 diabetes mellitus taking oral hypoglycemic agents with history of inadequate control and six control subjects were given low (0.5 g tid) and high (2 g tid) doses of powdered part, aqueous extract and alcoholic extract of Azadirachta indica for 14 days. On 15th day blood and urine samples for glucose were taken. Based on results obtained it was found that Azadirachta indica has significant hypoglycemic activity in high dose and can be successfully combined with oral hypoglycemic agents in type-2 diabetic patients whose diabetes is not controlled by these agents.

  2. Using clinical cases to stimulate active learning in a short periodontal continuing professional development course.

    PubMed

    Koole, Sebastiaan; Thevissen, Eric; Lindén, Ulf; Klinge, Björn; de Bruyn, Hugo

    2015-01-01

    A case-based approach was used in a two-day periodontal continuing professional development course as a strategy to stimulate active learning. The present study investigates the outcome of this course format in terms of feasibility, perceived efficiency as a learning approach and reported individual learning goals. The study was performed in five identical courses entitled'risk analysis and treatment in periodontal patients'at Malmö University between 2011-2014. Before the course, clinical cases were used to activate participants' prior knowledge and to attune their focus on the course content. During the course, cases were discussed to synchronise theory with practical application. A pre- and end-course questionnaire were developed to evaluate participants' characteristics (age, clinical expertise, experience and expectations), perceptions on feasibility and instructiveness and emerged individual learning goals. The participants (39 dentists and 78 dental hygienists) reported an average preparation time of 62 minutes (range 2-190) and had positive perceptions on the accessibility, instructiveness and difficulty of cases. Expectations ranged between refreshing, acquiring new knowledge and mastering the course subject. Most reported learning goals were related to daily clinical practice including the development of a treatment plan, when to continue non-surgical treatment or to extract teeth/perform surgery, the approach to periodontitis, how to motivate non-compliant patients and when to refer. Conclusion: The use of clinical cases to stimulate active learning in a short-term continuing professional development periodontal course was positively perceived by the dentists and dental hygienists in terms of feasibility and learning potential.

  3. 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

  4. Antifungal Activity of the Ethanol Extract from Flos Rosae Chinensis with Activity against Fluconazole-Resistant Clinical Candida

    PubMed Central

    Lin, Hui; Liu, Wei; Dai, Baodi; Yan, Lan

    2017-01-01

    This study was designed to investigate the antifungal activity of a hydroalcoholic extract from Flos Rosae Chinensis (FRC) combined with fluconazole (FCZ) against clinical isolates of Candida albicans resistant to FCZ. The minimum inhibitory concentration (MIC) of FRC was determined using a checkerboard microdilution assay. The synergistic effects of the combination of FRC and FCZ against clinical isolates of C. albicans resistant to FCZ were further confirmed by constructing time-growth curves and performing an agar diffusion test. FRC alone exerted efficient antifungal activities against C. albicans within a MIC80 ranging from 20 μg/ml to 40 μg/ml. FRC failed to enhance the effects of FCZ against sensitive C. albicans strains, although it rendered FCZ-resistant C. albicans more sensitive. These results were further confirmed by the result of in vivo study. Our study is the first to discover that FRC can inhibit the growth of C. albicans to a certain degree. An FRC antifungal mechanism study showed that FRC strengthens FCZ to inhibit the action of ergosterol biosynthesis by promoting the transformation of lanosterol to eburicol, suggesting that the antifungal mechanism of FRC involves the inhibition of ergosterol biosynthesis. PMID:28303159

  5. 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.

  6. Clinical and genetic investigation of a Brazilian family with Huntington’s disease

    PubMed Central

    de Andrade Agostinho, Luciana; Spitz, Mariana; Pereira, João Santos; Paiva, Carmen Lucia Antão

    2016-01-01

    Summary The aim of this study was to investigate a Brazilian family carrying full penetrance alleles for Huntington’s disease (HD) in order to correlate each member’s genetic and clinical features. To this end, the following scales were administered in each patient: the Beck Depression Inventory, the Mini-Mental State Examination (MMSE) and the Unified Huntington’s Disease Rating Scale (UHDRS). The patterns of CAG and CCG polymorphic regions in the HTT gene were determined, the disease burden score was calculated, and genotypes were correlated with phenotypes within this family. We suggest that HD duration, the number of years of formal education, and UHDRS status variables can explain 96.6% of the MMSE variability in HD patients. A strong significant correlation was found between the disease burden score and the UHDRS (r = 0.76; p-value = 0.049) and the MMSE (r = −0.90; p-value = 0.006). The correlations between CAG allele size and the three clinical evaluations performed in the HD patients were not statistically significant. PMID:27678206

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. The contribution of clinical phonetics to the investigation of oracy problems in the classroom.

    PubMed

    Rahilly, Joan

    2003-01-01

    This paper explains how insights from clinical linguistics can be applied to the investigation of oracy problems in the classroom. While the importance of oracy skills at school and beyond is undisputed, there is often a lack of conveniently manageable frameworks for assessing these skills. It is suggested here that methods from phonetics and phonology can be easily and profitably adopted into routine language profiling in schools and that they offer one means of uncovering potential speech difficulties in children. Two main areas are addressed: speech acquisition and speech production skills. The main focus is on the assessment of oracy in the UK, although the role of assessment in US Curriculum Framework is also considered.

  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.

  13. 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.

  14. Clinical studies involving probiotics: when FDA's investigational new drug rubric applies-and when it may not.

    PubMed

    Degnan, Fred H

    2012-01-01

    Researchers from a diverse array of scientific disciplines have focused and continue to focus on opportunities and areas for responsible clinical research involving the possible beneficial health effects of "probiotics." Investigators and researchers should be aware that not all clinical research involving probiotics reasonably falls within the requirements of the "investigational new drug" (IND) rubric administered and enforced by the US Food and Drug Administration. In determining whether an IND application is required before a clinical study may lawfully commence, investigators and researchers as well as institutional review boards should consider the regulatory classification, e.g., "drug," "new drug," "food," "food additive," "dietary supplement," etc. that applies to the substance under investigation. A potential probiotic product can fall along a continuum of regulatory classifications, each having implications on the nature and degree of regulatory requirements for clinical research and, ultimately, for claim substantiation and market access.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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

  1. Anticandidal activity of medicinal plants and Pseudomonas aeruginosa strains of clinical specimens.

    PubMed

    Bora, Limpon

    2016-04-01

    This study was designed to investigate the in vitro anticandidal activity of some medicinal plants and Pseudomonas aeruginosa strains against Candida species. The antifungal activity of methanolic extracts of five medicinal plants, namely, Cinnamomum porrectum, Lippia nudiflora, Cestrum nocturnum, Trachyspermum ammi, and Sida carpinifolia were studied. The medicinal characteristics of these plants were compared with commercially used antibiotics. The antimicrobial assay was done by agar well diffusion and the broth dilution method. Among the plants used, T. ammi and C. nocturnum were found to be more potent than the others. Twenty P. aeruginosa strains were isolated from various clinical specimens. The total inhibitions obtained were found to be 47%, 38%, and 36% in blood agar, whereas in Sabouraud dextrose agar (SDA) the inhibitions were 57%, 48%, and 37%, respectively.

  2. Antitubercular and antibacterial activity of quinonoid natural products against multi-drug resistant clinical isolates.

    PubMed

    Dey, Diganta; Ray, Ratnamala; Hazra, Banasri

    2014-07-01

    Multi-drug resistant Mycobacterium tuberculosis and other bacterial pathogens represent a major threat to human health. In view of the critical need to augment the current drug regime, we have investigated therapeutic potential of five quinonoids, viz. emodin, diospyrin, plumbagin, menadione and thymoquinone, derived from natural products. The antimicrobial activity of quinonoids was evaluated against a broad panel of multi-drug and extensively drug-resistant tuberculosis (M/XDR-TB) strains, rapid growing mycobacteria and other bacterial isolates, some of which were producers of β-lactamase, Extended-spectrum β-lactamase (ESBL), AmpC β-lactamase, metallo-beta-lactamase (MBL) enzymes, as well as their drug-sensitive ATCC counterparts. All the tested quinones exhibited antimycobacterial and broad spectrum antibacterial activity, particularly against M. tuberculosis (lowest MIC 0.25 µg/mL) and Gram-positive bacteria (lowest MIC <4 µg/mL) of clinical origin. The order of antitubercular activity of the tested quinonoids was plumbagin > emodin ~ menadione ~ thymoquinone > diospyrin, whereas their antibacterial efficacy was plumbagin > menadione ~ thymoquinone > diospyrin > emodin. Furthermore, this is the first evaluation performed on these quinonoids against a broad panel of drug-resistant and drug-sensitive clinical isolates, to the best of our knowledge.

  3. Investigation of the Antimicrobial Activity of Bacillus licheniformis Strains Isolated from Retail Powdered Infant Milk Formulae.

    PubMed

    Alvarez-Ordóñez, Avelino; Begley, Máire; Clifford, Tanya; Deasy, Thérèse; Considine, Kiera; O'Connor, Paula; Ross, R Paul; Hill, Colin

    2014-03-01

    This study investigated the potential antimicrobial activity of ten Bacillus licheniformis strains isolated from retail infant milk formulae against a range of indicator (Lactococcus lactis, Lactobacillus bulgaricus and Listeria innocua) and clinically relevant (Listeria monocytogenes, Staphylococcus aureus, Streptococcus agalactiae, Salmonella Typhimurium and Escherichia coli) microorganisms. Deferred antagonism assays confirmed that all B. licheniformis isolates show antimicrobial activity against the Gram-positive target organisms. PCR and matrix-assisted laser desorption ionization time-of-flight mass spectrometry analyses indicated that four of the B. licheniformis isolates produce the bacteriocin lichenicidin. The remaining six isolates demonstrated a higher antimicrobial potency than lichenicidin-producing strains. Further analyses identified a peptide of ~1,422 Da as the most likely bioactive responsible for the antibacterial activity of these six isolates. N-terminal sequencing of the ~1,422 Da peptide from one strain identified it as ILPEITXIFHD. This peptide shows a high homology to the non-ribosomal peptides bacitracin and subpeptin, known to be produced by Bacillus spp. Subsequent PCR analyses demonstrated that the six B. licheniformis isolates may harbor the genetic machinery needed for the synthesis of a non-ribosomal peptide synthetase similar to those involved in production of subpeptin and bacitracin, which suggests that the ~1,422 Da peptide might be a variant of subpeptin and bacitracin.

  4. Investigating activity of masticatory muscles in patients with hypermobile temporomandibular joints by using EMG

    PubMed Central

    Davoudi, Amin; Rybalov, Oleg; Shadmehr, Elham; Hatami, Amin

    2015-01-01

    Background Temporomandibular joint hypermobility (TMJH) can manifest higher range of motions in mandible. The aim of this study was to investigate and compare the activity of masticatory muscle of TMJs in healthy individuals and patients with mild, moderate and severe TMJH. Material and Methods In this clinical study, 69 patients (between the ages of 22 to 42) with manifestation of TMJH were included. The patients were divided into three groups based on their maximum mouth opening (MMO): (light) with MMO of 50-55 mm; (moderate) with MMO between 55 to 65 mm; and (severe) with MMO >65 mm. Also, 20 healthy people with profiled tomography in the last 6 months were invited as control group (healthy) with normal MMO (<50 mm). All the groups subjected to electromyogram (EMG) in 2 steps: maximal voluntary clenching (MVC) of the jaws; and during chewing of bread by using one side of the jaws voluntary. The collected data were analyzed by Student T-test and Chi-Square tests using SPSS software version 15 at significant level of 0.05. Results Both TMJs of light, moderate and severe groups showed significant differences in frequency, time of activity and rest in comparison with healthy group during chewing and MVC (all p values < 0.01). Conclusions Masticatory muscles activity reduced in relation with the severity of TMJH and higher excessive mouth opening. Key words:Electromyography, joint hypermobility, mouth opening, tempormandibular joint. PMID:26155352

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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

  10. 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."

  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. Investigation of the clinical potential of scattering foil free electron beams

    NASA Astrophysics Data System (ADS)

    Eldib, Ahmed; Jin, Lihui; Li, Jinsheng; Ma, C.-M. Charlie

    2014-02-01

    Electron beam therapy has been an important radiation therapy modality for many decades. Studies have been conducted recently for more efficient and advanced delivery of electron beam radiation therapy. X-ray contamination is a common problem that exists with all of the advanced electron beam therapy techniques such as Bolus Electron conformal therapy, segmented electron conformal therapy, and modulated electron arc therapy. X-ray contamination could add some limitations to the advancement and clinical utility of those electron modalities. It was previously shown in the literature that the scattering foil is one of the major accelerator parts contributing to the generation of bremsstrahlung photons. Thus, in this work we investigate the dosimetric characteristics of scattering foil free (SFF) electron beams and the feasibility of using those beams for breast cancer boosts. The SFF electron beams were modeled and simulated using the Monte Carlo method. CT scans of six previously treated breast patients were used for the treatment plan generation utilizing our in-house Monte Carlo-based treatment planning system. Electron boost plans with conventional beams and the SFF beams were generated, respectively, for all patients. A significant reduction of the photon component was observed with the removal of the primary scattering foil for beam energies higher than 12 MeV. Flatness was greatly affected but the difference in flatness between conventional and SFF beams was much reduced for small cone sizes, which were often used clinically for breast boosts. It was found that the SFF electron beams could deliver high-quality dose distributions as conventional electron beams for boost treatments of the breast with an added advantage of a further reduced dose to the lung and the heart.

  13. Investigation of the clinical potential of scattering foil free electron beams.

    PubMed

    Eldib, Ahmed; Jin, Lihui; Li, Jinsheng; Ma, C-M Charlie

    2014-02-21

    Electron beam therapy has been an important radiation therapy modality for many decades. Studies have been conducted recently for more efficient and advanced delivery of electron beam radiation therapy. X-ray contamination is a common problem that exists with all of the advanced electron beam therapy techniques such as Bolus Electron conformal therapy, segmented electron conformal therapy, and modulated electron arc therapy. X-ray contamination could add some limitations to the advancement and clinical utility of those electron modalities. It was previously shown in the literature that the scattering foil is one of the major accelerator parts contributing to the generation of bremsstrahlung photons. Thus, in this work we investigate the dosimetric characteristics of scattering foil free (SFF) electron beams and the feasibility of using those beams for breast cancer boosts. The SFF electron beams were modeled and simulated using the Monte Carlo method. CT scans of six previously treated breast patients were used for the treatment plan generation utilizing our in-house Monte Carlo-based treatment planning system. Electron boost plans with conventional beams and the SFF beams were generated, respectively, for all patients. A significant reduction of the photon component was observed with the removal of the primary scattering foil for beam energies higher than 12 MeV. Flatness was greatly affected but the difference in flatness between conventional and SFF beams was much reduced for small cone sizes, which were often used clinically for breast boosts. It was found that the SFF electron beams could deliver high-quality dose distributions as conventional electron beams for boost treatments of the breast with an added advantage of a further reduced dose to the lung and the heart.

  14. Meta-analysis of clinical trials with early stopping: an investigation of potential bias.

    PubMed

    Schou, I Manjula; Marschner, Ian C

    2013-12-10

    Clinical trials that stop early for benefit have a treatment difference that overestimates the true effect. The consequences of this fact have been extensively debated in the literature. Some researchers argue that early stopping, or truncation, is an important source of bias in treatment effect estimates, particularly when truncated studies are incorporated into meta-analyses. Such claims are bound to lead some systematic reviewers to consider excluding truncated studies from evidence synthesis. We therefore investigated the implications of this strategy by examining the properties of sequentially monitored studies conditional on reaching the final analysis. As well as estimation bias, we studied information bias measured by the difference between standard measures of statistical information, such as sample size, and the actual information based on the conditional sampling distribution. We found that excluding truncated studies leads to underestimation of treatment effects and overestimation of information. Importantly, the information bias increases with the estimation bias, meaning that greater estimation bias is accompanied by greater overweighting in a meta-analysis. Simulations of meta-analyses confirmed that the bias from excluding truncated studies can be substantial. In contrast, when meta-analyses included truncated studies, treatment effect estimates were essentially unbiased. Previous analyses comparing treatment effects in truncated and non-truncated studies are shown not to be indicative of bias in truncated studies. We conclude that early stopping of clinical trials is not a substantive source of bias in meta-analyses and recommend that all studies, both truncated and non-truncated, be included in evidence synthesis.

  15. 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

  16. [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.

  17. Recontacting in clinical practice: an investigation of the views of healthcare professionals and clinical scientists in the United Kingdom

    PubMed Central

    Carrieri, Daniele; Dheensa, Sandi; Doheny, Shane; Clarke, Angus J; Turnpenny, Peter D; Lucassen, Anneke M; Kelly, Susan E

    2017-01-01

    This article explores the views and experiences of healthcare professionals and clinical scientists in genetics about the existence of a duty and/or responsibility to recontact former patients when the genetic information relevant to their health, or that of family members, changes in a potentially important manner. It is based on N=30 semi-structured interviews guided by vignettes of recontacting scenarios. The sample included healthcare professionals in the United Kingdom from different medical specialties (clinical genetics, other ‘mainstream' specialties now offering genetic testing), and scientists from regional genetics laboratories. While viewing recontacting as desirable under certain circumstances, most respondents expressed concerns about its feasibility within the current constraints of the National Health Service (NHS). The main barriers identified were insufficient resources (time, staff, and suitable IT infrastructures) and lack of clarity about role boundaries and responsibilities. All of these are further complicated by genetic testing being increasingly offered by mainstream specialties. Reaching a consensus about roles and responsibilities of clinical specialties with regard to recontacting former patients in the light of evolving genetic information, and about what resources and infrastructures would be needed, was generally seen as a pre-requisite to developing guidelines about recontact. PMID:28051074

  18. 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

  19. In Vitro Antifungal Activity of Epigallocatechin 3-O-Gallate against Clinical Isolates of Dermatophytes

    PubMed Central

    Park, Bong Joo; Taguchi, Hideaki; Kamei, Katsuhiko; Matsuzawa, Tetsuhiro; Hyon, Suong-Hyu

    2011-01-01

    Previously, we reported that epigallocatechin 3-O-gallate (EGCg) has growth-inhibitory effect on clinical isolates of Candida species. In this study, we investigated the antifungal activity of EGCg and antifungal agents against thirty-five of dermatophytes clinically isolated by the international guidelines (M38-A2). All isolates exhibited good susceptibility to EGCg (MIC50, 2-4 µg/mL, MIC90, 4-8 µg/mL, and geometric mean (GM) MICs, 3.36-4 µg/mL) than those of fluconazole (MIC50, 2-16 µg/mL, MIC90, 4-32 µg/mL, and GM MICs, 3.45-25.8 µg/mL) and flucytosin (MIC50, MIC90, and GM MICs, >64 µg/mL), although they were less susceptible to other antifungal agents, such as amphotericin B, itraconazole, and miconazole. These activities of EGCg were approximately 4-fold higher than those of fluconazole, and were 4 to 16-fold higher than flucytosin. This result indicates that EGCg can inhibit pathogenic dermatophyte species. Therefore, we suggest that EGCg may be effectively used solely as a possible agent or combined with other antifungal agents for antifungal therapy in dermatophytosis. PMID:21488200

  20. Use of basophil activation test in the investigation of adverse effects to vaccines.

    PubMed

    Chirumbolo, Salvatore

    2011-08-01

    Diagnosis of adverse effects caused by vaccines mainly includes investigative approaches based on skin tests, histamine, tryptase and serum IgE levels which should allow to diagnose an IgE-mediated allergy reaction, most caused by additive components. Incidence of vaccine-related allergy and anaphylaxis due to vaccination are very poorly represented among population, based on the latest epidemiological and safety reports. Notwithstanding, routinely allergy diagnostic tools show many pitfalls and contradictory results when used to highlight an allergy onset or a clinical manifestation recalling an hypersensitivity reaction. Furthermore, adjuvants in vaccines may trigger innate cells response by toll-like receptors, thus eliciting a possible non-IgE mediated allergy phenomenon or causing B-cell activation and autoimmunity. A cellular test, such as a basophil activation test, or more widely a flow cytometry analysis of immune cells, might add new insights to the comprehension of allergy due to vaccination , thus ameliorating the diagnostic endowment in the hand of physicians.

  1. [The choice of the type of design in the clinical investigation studies. Case and control studies].

    PubMed

    Posada de la Paz, M

    2004-09-01

    Case-control studies are appropriate designs in neurology sciences to search for risk factors that have already occurred in a group of patients. In them, the subjects are selected on the basis of whether they have the disease or not and then they are compared in regards to the risk factor or prognosis investigated. These sorts of designs can be performed in a shorter and cheaper way than the regular cohort studies. They are appropriate for the evaluation of rare diseases and can examine multiple etiological factors for a single disease. On the contrary, they are not so efficient when rare exposures are involved. Incidence rates in exposed and non-exposed subjects cannot be calculated and on some occasions, the timing between exposure and outcome can be very difficult to establish. The Odds Ratio and its confident intervals is the measurement used for estimating the risk strength in this design. The clinical neurologist should be familiar with these terms, given the frequency of case-control studies described in neurology science literature, and should know their principal advantages and limitations.

  2. Clinical and genetic investigation of families with type II Waardenburg syndrome

    PubMed Central

    CHEN, YONG; YANG, FUWEI; ZHENG, HEXIN; ZHOU, JIANDA; ZHU, GANGHUA; HU, PENG; WU, WEIJING

    2016-01-01

    The present study aimed to investigate the molecular pathology of Waardenburg syndrome type II in three families, in order to provide genetic diagnosis and hereditary counseling for family members. Relevant clinical examinations were conducted on the probands of the three pedigrees. Peripheral blood samples of the probands and related family members were collected and genomic DNA was extracted. The coding sequences of paired box 3 (PAX3), microphthalmia-associated transcription factor (MITF), sex-determining region Y-box 10 (SOX10) and snail family zinc finger 2 (SNAI2) were analyzed by polymerase chain reaction and DNA sequencing. The heterozygous mutation, c.649_651delAGA in exon 7 of the MITF gene was detected in the proband and all patients of pedigree 1; however, no pathological mutation of the relevant genes (MITF, SNAI2, SOX10 or PAX3) was detected in pedigrees 2 and 3. The heterozygous mutation c.649_651delAGA in exon 7 of the MITF gene is therefore considered the disease-causing mutation in pedigree 1. However, there are novel disease-causing genes in Waardenburg syndrome type II, which require further research. PMID:26781036

  3. Incidence of Radix Entomolaris in Mandibular First Molars in Palestinian Population: A Clinical Investigation

    PubMed Central

    2014-01-01

    Purpose. The aim of this investigation was to evaluate clinically the percentage of permanent mandibular first molar teeth with three roots amongst Palestinian population. Patients and Methods. Three hundred twenty-two mandibular first molars from 185 females and 137 males scheduled for root canal treatment at the Dental Center of the Arab American University were examined over a 2-year period. The incidence of a third root revealed by periapical radiographs and the comparison of the occurrence between males and females and between the right and left sides of the mandible were recorded. Statistical Analysis. It was performed using the chi-square test with a significant level set at P < 0.05%. Results. Of the 322 treated mandibular first molars, twelve teeth were found to have a third root with an overall incidence being 3.73%. More teeth with a third root were treated on the right side of the mandible compared to the left side. Conclusion. The incidence of a third root in Palestinian population was within the range of previous reports from the Middle East but considerably lower than the percentage from the Far East. PMID:27355078

  4. Polythelia: simple atavistic remnant or a suspicious clinical sign for investigation?

    PubMed

    Galli-Tsinopoulou, Assimina; Stergidou, Dorothea

    2014-03-01

    Supernumerary nipples (or polythelia) usually appear along the embryonic milk lines or in other sites including the back, thigh, vulva, neck etc. The frequency of polythelia ranges from 0.2% to 5.6%. Despite the plethora of published cases concerning its association with other congenital malformations or syndromes with different patterns of inheritance, polythelia still remains a controversial and theoretical issue. Although most reports describe a link between supernumerary nipples and kidney/urinary tract anomalies, a potential relationship with other congenital anomalies or malignancies has also been speculated. Additionally, polythelia has been associated with genodermatoses, thus being related with an increased malignant potential, as well as with an increased risk for solid tumors such as renal adenocarcinoma, testicular cancer, prostate cancer, and urinary bladder carcinoma. The fact that the Scaramanga (ska) mutant mice presented with ectopic breast tissue imply that misregulation of the neuregulin-3 signaling pathway may be critical in the occurrence of polythelia. This is an attempt to review existing literature in order to (a) draw reliable conclusions whether polythelia is a manifestation of simple atavism or may be associated with concomitant severe conditions needing further investigation and/or management, (b) elucidate its aetiology and (c) establish appropriate clinical and laboratory approach.

  5. 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.

  6. Clinical Investigation of the Posterior scleral contraction to Treat Macular Traction Maculopathy in Highly Myopic Eyes

    PubMed Central

    Pan, An-Peng; Wan, Ting; Zhu, Shuang-Qian; Dong, Liang; Xue, An-Quan

    2017-01-01

    Myopic traction maculopathy (MTM) can cause vision disabilities in highly myopic eyes. This retrospective case series investigated the clinical outcomes of posterior scleral contraction (PSC) using genipin-cross-linked sclera as the material to treat MTM in highly myopic eyes. In total, 32 eyes from 29 highly myopic patients who underwent PSC for MTM were recruited. The changes in best-corrected visual acuity (BCVA) and axial length were evaluated, macular reattachment and macular hole (MH) closure was assessed by optical coherence tomography, and complications were evaluated. At the final follow-up, the retina was completely reattached in 25 eyes (78.1%), essentially reattached in 4 eyes (12.5%), and partially reattached in 3 eyes (9.4%). The logMAR BCVA improved significantly from 1.18 ± 0.45 preoperatively to 0.87 ± 0.45 postoperatively (P < 0.001). The 32 eyes were further divided into the MH group (16 eyes) and the non-MH group (16 eyes) for comparison. The MH was closed in 9 eyes (56.3%). The retinal reattachment rate was 75.0% in the MH group and 81.25% in the non-MH group, and the logMAR BCVA improved significantly in both groups. The PSC using genipin-cross-linked sclera as the material can effectively treat MTM in highly myopic eyes, and significant visual improvement can be achieved with minimal complications. PMID:28220890

  7. Clinical use of relaxin to facilitate birth: reasons for investigating the premise.

    PubMed

    Lee, Hyung-Yul; Zhao, Shuangping; Fields, P A; Sherwood, O D

    2005-05-01

    In the United States, both medical and nonmedical factors have driven the cesarean section rate to over 26% of all deliveries. In addition to questions of increased cost associated with operative delivery, some have questioned the ethics of performing cesarean section for nonmedical reasons. Reduction of both the duration and the pain associated with vaginal delivery would likely bring about a decline in the rate of both medical and nonmedical cesarean sections. This chapter summarizes recent findings that support the premise that through its growth-promoting and softening effects on the cervix, short-term subcutaneous administration of pharmacologic amounts of relaxin to women at term holds promise as a means of reducing the duration and discomfort associated with delivery. Two recent studies conducted in pregnant rats demonstrated that the cervix is highly responsive to relaxin during the antepartum period and that short-term subcutaneous administration of the hormone to relaxin-deficient animals not only promotes growth and softening of the cervix, but also reduces the duration of labor and delivery. Moreover, recent human clinical trials examining the influence of 24 weeks of continuous subcutaneous administration of recombinant human relaxin for the treatment of scleroderma provided evidence not only that the human reproductive tract is responsive to relaxin, but also that the administration of the hormone does not cause serious adverse side effects. It is concluded that recent findings provide an impetus for an investigation into relaxin's potential for cervical remodeling and facilitating birth in women.

  8. Clinical investigation of the lesions responsible for sensory disturbance in Minamata disease.

    PubMed

    Uchino, M; Mita, S; Satoh, H; Hirano, T; Arimura, K; Nakagawa, M; Nakamura, M; Uyama, E; Ando, Y; Wakamiya, J; Futatsuka, M

    2001-11-01

    To clarify the lesions responsible for sensory disturbance in Minamata disease (MD), we clinically investigated the characteristics of sensory disturbance. In all patients with the classical type MD, two-point discrimination was severely disturbed, but the involvement of superficial sensation was relatively mild. On short-latency somatosensory evoked potential study, the component corresponding to N20 was completely absent with normal N9, N11, and N13 components. Although 14 of 38 chronic MD patients demonstrated intact superficial sensation, 10 of these 14 showed mild to moderate disturbance in two-point discrimination. The two-point discrimination in chronic MD patients was significantly high irrespective of the disturbance of superficial sensation. These findings suggest that the sensory disturbance of MD patients may mainly be caused by a lesion in the sensory cortex rather than in the peripheral nerves. However, other foci could be also responsible for the sensory impairment, since 9 of 38 chronic MD patients showed intact two-point discrimination.

  9. A Clinical Trial to Investigate the Effect of Cynatine HNS on Hair and Nail Parameters

    PubMed Central

    Veghte, Robert H.

    2014-01-01

    Objective. A new, novel product, Cynatine HNS, was evaluated for its effects as a supplement for improving various aspects of hair and nails in a randomized, double-blind, placebo-controlled clinical trial. Methods. A total of 50 females were included and randomized into two groups. The active group (n = 25) received 2 capsules containing Cynatine HNS, comprised of Cynatine brand keratin (500 mg) plus vitamins and minerals, per day, and the placebo group (n = 25) received 2 identical capsules of maltodextrin per day for 90 days. End points for hair loss, hair growth, hair strength, amino acid composition, and hair luster were measured. End points were also measured for nail strength and the appearance of nails. Results. The results show that subjects taking Cynatine HNS showed statistically significant improvements in their hair and nails when compared to placebo. Conclusion. Cynatine HNS is an effective supplement for improving hair and nails in 90 days or less. EudraCT number is 2014-002645-22. PMID:25386609

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

    PubMed Central

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

    1995-01-01

    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

  11. Comparative in vitro activities of nemonoxacin (TG-873870), a novel nonfluorinated quinolone, and other quinolones against clinical isolates.

    PubMed

    Lauderdale, Tsai-Ling; Shiau, Yih-Ru; Lai, Jui-Fen; Chen, Hua-Chien; King, Chi-Hsin R

    2010-03-01

    The in vitro antibacterial activities of nemonoxacin (TG-873870), a novel nonfluorinated quinolone, against 770 clinical isolates were investigated. Nemonoxacin (tested as its malate salt, TG-875649) showed better in vitro activity than ciprofloxacin and levofloxacin against different species of staphylococci, streptococci, and enterococci, Neisseria gonorrhoeae, and Haemophilus influenzae. The in vitro activity of TG-875649 was also comparable to or better than that of moxifloxacin against these pathogens, which included ciprofloxacin-resistant, methicillin-resistant Staphylococcus aureus and levofloxacin-resistant Streptococcus pneumoniae.

  12. Clinical, biochemical and imaging methods of assessing osteoarthritis and clinical trials with agents claiming 'chondromodulating' activity.

    PubMed

    Theiler, R; Ghosh, P; Brooks, P

    1994-03-01

    This paper reviews, in a first part, methods used for the clinical assessment of osteoarthritis (OA) with special reference, in a second part, to trials of drugs claimed to be chondromodulating agents. The agents examined include glycosaminoglycan-peptide complex (GP-C, Rumalon) and glycosaminoglycan-polysulfate (GAGPS, Arteparon), which both showed some beneficial clinical response. However, their effect on cartilage still remains controversial. The development of a functional hip and knee OA index in clinical assessment and the role of imaging methods and biochemical markers are discussed. In future clinical trials only validated OA indices such as the Lequesne or WOMAC index and the newly established ILAR guidelines for classifying and testing drugs in OA will be accepted for registration purposes. Imaging methods including magnetic resonance imaging (MRI) offer the capacity to provide more precise information concerning cartilage destruction in OA joints. In addition, the biochemical assessment of proteoglycan fragments, bone sialoprotein (BSP), cartilage oligometric matrix protein (COMP) and the balance between stromelysin and its inhibitor (TIMP) in synovial fluid would appear to offer potential applications for the determination of joint tissue damage in the early and later stages of OA. However, these biochemical markers have yet to be validated. It is clear that in the 1990s, for a drug to be designated as disease modifying in OA, it will require a more rigorous evaluation than was hitherto required.

  13. [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.

  14. 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

    ... Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the... of investigators, adequacy of research sites, and the determination of whether an investigational new... Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and...

  15. 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'.

  16. 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.

  17. Psychological activities in neurorehabilitation: from research to clinical practice.

    PubMed

    Galante, Emanuela; Gazzi, Lidia; Caffarra, Sendy

    2011-01-01

    The goal of the present review was to present a critical description of psychological research and practice in neurorehabilitation with regard to the efficacy of treatments proposed in the clinical and neuropsychological field. PubMed, Web of Science and Cochrane databases were searched by using the keywords "psychological intervention" and one of the following neurological diseases: "stroke", "TBI", "Parkinson", "ALS", "multiple sclerosis", "dementia". Randomized and pseudo-randomized trials, reviews and single case studies were included. We identified 134 papers: 54 concerning dementia, 24 stroke, 20 multiple sclerosis, 16 Parkinson, 13 TBI and 7 ALS. Most of these papers concern the evaluation of the effectiveness of psychological treatments in chronic or progressive neurological diseases. However, they are often characterized by methodological limitations, such as a small sample size, absence of a follow-up study or a control group. Further, high quality studies could help better understand treatment effects. There was some evidence for effectiveness of cognitive-behavioural and cognitive therapies, often applied both in clinical and neuropsychological interventions. Evidence coming from individualized treatment and single case studies are also described. In line with the data collected, we summarize some evidence available for psychological testing and treatment and argue that a multidisciplinary approach and a multidimensional evaluation should be adopted. According to this position, both randomized trials and single-case studies could be taken into account. Finally, it is proposed that in order to establish the efficacy of a given treatment, both standardized and individualized measures are to be used.

  18. Active components and clinical applications of olive oil.

    PubMed

    Waterman, Emily; Lockwood, Brian

    2007-12-01

    The olive tree, Olea europaea, is native to the Mediterranean basin and parts of Asia Minor. The fruit and compression-extracted oil have a wide range of therapeutic and culinary applications. Olive oil also constitutes a major component of the "Mediterranean diet." The chief active components of olive oil include oleic acid, phenolic constituents, and squalene. The main phenolics include hydroxytyrosol, tyrosol, and oleuropein, which occur in highest levels in virgin olive oil and have demonstrated antioxidant activity. Antioxidants are believed to be responsible for a number of olive oil's biological activities. Oleic acid, a monounsaturated fatty acid, has shown activity in cancer prevention, while squalene has also been identified as having anticancer effects. Olive oil consumption has benefit for colon and breast cancer prevention. The oil has been widely studied for its effects on coronary heart disease (CHD), specifically for its ability to reduce blood pressure and low-density lipoprotein (LDL) cholesterol. Antimicrobial activity of hydroxytyrosol, tyrosol, and oleuropein has been demonstrated against several strains of bacteria implicated in intestinal and respiratory infections. Although the majority of research has been conducted on the oil, consumption of whole olives might also confer health benefits.

  19. Peak endocardial acceleration-based clinical testing of the "BEST" DDDR pacemaker. European PEA Clinical Investigation Group.

    PubMed

    Langenfeld, H; Krein, A; Kirstein, M; Binner, L

    1998-11-01

    The peak endocardial acceleration (PEA, unit g) shows a near correlation with myocardial contractility during the isometric systolic contraction of the heart (dP/dtmax), with sympathetic activity and, thus, with physiological heart rate modulation. The (Biomechanical Endocardial Sorin Transducer (BEST) sensor is incorporated in the tip of a pacing lead and measures PEA directly near the myocardium. In an international study, the lead was implanted with the dual chamber pacemaker Living-1 (Sorin) in 105 patients. The behavior of the PEA signal was tested under conditions of physical and mental stress and during daily life activities by 24-hour recordings of PEA (PEA Holter) at 1 to 2 months and approximately 1 year after implantation. Implantation of the BEST lead was performed without complications in all patients. The sensor functioned properly in the short- and long-term in 98% of patients. Although PEA values differed from patient to patient, the values closely reflected the variations in sympathetic activity due to physical and mental stress in each patient. During exercise and during daily life activities a close correlation between PEA and heart rate was observed among patients with normal sinus rhythm. Peak endocardial acceleration allows a nearly physiological control of the pacing rate.

  20. 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.

  1. 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

  2. Investigating the antiplasmodial activity of primary sulfonamide compounds identified in open source malaria data.

    PubMed

    Fisher, Gillian M; Bua, Silvia; Del Prete, Sonia; Arnold, Megan S J; Capasso, Clemente; Supuran, Claudiu T; Andrews, Katherine T; Poulsen, Sally-Ann

    2017-04-01

    In the past decade there has been a significant reduction in deaths due to malaria, in part due to the success of the gold standard antimalarial treatment - artemisinin combination therapies (ACTs). However the potential threat of ACT failure and the lack of a broadly effective malaria vaccine are driving efforts to discover new chemical entities (NCEs) to target this disease. The primary sulfonamide (PS) moiety is a component of several clinical drugs, including those for treatment of kidney disease, glaucoma and epilepsy, however this chemotype has not yet been exploited for malaria. In this study 31 PS compounds sourced from the GlaxoSmithKline (GSK) Tres Cantos antimalarial set (TCAMS) were investigated for their ability to selectively inhibit the in vitro growth of Plasmodium falciparum asexual stage malaria parasites. Of these, 14 compounds were found to have submicromolar activity (IC50 0.16-0.89 μM) and a modest selectivity index (SI) for the parasite versus human cells (SI > 12 to >43). As the PS moiety is known to inhibit carbonic anhydrase (CA) enzymes from many organisms, the PS compounds were assessed for recombinant P. falciparum CA (PfCA) mediated inhibition of CO2 hydration. The PfCA inhibition activity did not correlate with antiplasmodial potency. Furthermore, no significant difference in IC50 was observed for P. falciparum versus P. knowlesi (P > 0.05), a Plasmodium species that is not known to contain an annotated PfCA gene. Together these data suggest that the asexual intraerythrocytic stage antiplasmodial activity of the PS compounds examined in this study is likely unrelated to PfCA inhibition.

  3. Clinical and Pharmacological Investigation of Myotoxicity in Sri Lankan Russell’s Viper (Daboia russelii) Envenoming

    PubMed Central

    Johnston, Christopher; Kuruppu, Sanjaya; Kneisz, Daniela; Maduwage, Kalana; Kleifeld, Oded; Smith, A. Ian; Siribaddana, Sisira; Buckley, Nicholas A.; Hodgson, Wayne C.; Isbister, Geoffrey K.

    2016-01-01

    Background Sri Lankan Russell’s viper (Daboia russelii) envenoming is reported to cause myotoxicity and neurotoxicity, which are different to the effects of envenoming by most other populations of Russell’s vipers. This study aimed to investigate evidence of myotoxicity in Russell’s viper envenoming, response to antivenom and the toxins responsible for myotoxicity. Methodology and Findings Clinical features of myotoxicity were assessed in authenticated Russell’s viper bite patients admitted to a Sri Lankan teaching hospital. Toxins were isolated using high-performance liquid chromatography. In-vitro myotoxicity of the venom and toxins was investigated in chick biventer nerve-muscle preparations. Of 245 enrolled patients, 177 (72.2%) had local myalgia and 173 (70.6%) had local muscle tenderness. Generalized myalgia and muscle tenderness were present in 35 (14.2%) and 29 (11.8%) patients, respectively. Thirty-seven patients had high (>300 U/l) serum creatine kinase (CK) concentrations in samples 24h post-bite (median: 666 U/l; maximum: 1066 U/l). Peak venom and 24h CK concentrations were not associated (Spearman’s correlation; p = 0.48). The 24h CK concentrations differed in patients without myotoxicity (median 58 U/l), compared to those with local (137 U/l) and generalised signs/symptoms of myotoxicity (107 U/l; p = 0.049). Venom caused concentration-dependent inhibition of direct twitches in the chick biventer cervicis nerve-muscle preparation, without completely abolishing direct twitches after 3 h even at 80 μg/ml. Indian polyvalent antivenom did not prevent in-vitro myotoxicity at recommended concentrations. Two phospholipase A2 toxins with molecular weights of 13kDa, U1-viperitoxin-Dr1a (19.2% of venom) and U1-viperitoxin-Dr1b (22.7% of venom), concentration dependently inhibited direct twitches in the chick biventer cervicis nerve-muscle preparation. At 3 μM, U1-viperitoxin-Dr1a abolished twitches, while U1-viperitoxin-Dr1b caused 70% inhibition of

  4. SU-E-T-185: Clinically-Relevant Investigation of Flattening Filter Free Skin Dose

    SciTech Connect

    Guy, C; Karki, K; Sharma, M; Kim, S

    2015-06-15

    Purpose: Flattening-filter-free (FFF) beams are increasingly used for small-field treatments due to inherent advantages like higher MU efficiency and reduced treatment time and scatter dose. Removal of the flattening-filter increases the electron contamination and low-energy x-rays. As such, surface-dose characteristics are different from traditional flattened (FF) beams. The goal of this work is to investigate surface dose of 6/10 MV FFF and FF beams under conditions representative of emerging complex techniques like small-field stereotactic treatments which use small fields formed with multi-leaf-collimators (MLCs) at closer SSDs. Methods: A parallel-plate PTW Markus-chamber (N23343) placed in custom air- and water-equivalent phantoms was used to measure surface-dose at 2/3/4/6/8/10/20/30 cm{sup 2} field sizes, at 80/90/100 cm source-to-surface distances, and at fields defined by jaws and MLCs. The effect of dose rate (600 and 1400/2400 MU/min) was also investigated at 100 cm SSD. Measurements were performed on TrueBeam linac (Varian Medical Systems, Palo Alto, CA) for 6X/6XFFF/10X/10XFFF beam energies. Results: No dose-rate dependence was seen for FFF skin-dose. Air-phantom measurements were, on average, 5±3% larger than for water-phantom measurements. With SSD increase from 80 to 100 cm, skin-dose decreased by an average of 3.9±2.5%. FFF beams were found to be more sensitive to SSD changes in comparison to FF beams. The difference in skin dose between MLC- and jaw-fields was less variable with field size for FFF compared to FF beams. 10 MV beams showed greater difference in FFF-to-FF ratio, 50% (jaws) and 22% (MLC), between the largest and smallest field sizes compared to 6 MV beams, 30% (jaws) and 9% (MLC). Conclusion: Under clinically-relevant conditions, surface dose for FFF beams was higher at small field size (<10 cm), lower at largest field size (30 cm), more sensitive to SSD changes, and had less variation with field size compared to dose for FF beams.

  5. 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)

  6. Complement activation by Coccidioides immitis: in vitro and clinical studies.

    PubMed Central

    Galgiani, J N; Yam, P; Petz, L D; Williams, P L; Stevens, D A

    1980-01-01

    Mycelial- or spherule-phase derivatives of Coccidioides immitis caused a decrease in vitro of total hemolytic complement in serum from a nonsensitized person. Activation involved both classic and alternative pathways as shown by deprssion of hemolytic C4 and by generation of products of activation of components C3, C4, and factor B. In addition, functional complement activity or immunoreactive levels of complement components or both were measured in 23 patients with self-limited or disseminated coccidioidomycosis. Low total hemolytic complement was found in nine, usually during the early phase of primary illness, and was transient. Hemolytic C4 was low, and the effect of inulin to decrease complement levels was blunted, suggested both classic and alternative pathways may be deficient. However, associated depression of immunoreactive levels of components assayed (C3, C4, C5, factor B, and properdin) was not consistently found. This disparity raises the possibility of enhanced in vitro inactivation analogous to activation by immune complexes. Images Fig. 2 PMID:6901703

  7. Cytotoxic Activities of Alkylphosphocholines against Clinical Isolates of Acanthamoeba spp.

    PubMed Central

    Walochnik, Julia; Duchêne, Michael; Seifert, Karin; Obwaller, Andreas; Hottkowitz, Thomas; Wiedermann, Gerhard; Eibl, Hansjörg; Aspöck, Horst

    2002-01-01

    Free-living amoebae of the genus Acanthamoeba are causing serious chronic conditions such as destructive keratitis in contact lens wearers or granulomatous amoebic encephalitis in individuals with compromised immune systems. Both are characterized by the lack of availability of sufficiently effective and uncomplicated, manageable treatments. Hexadecylphosphocholine (miltefosine) is licensed for use as a topical antineoplastic agent, but it is also active in vitro against several protozoan parasites, and it was applied very successfully for the treatment of human visceral leishmaniasis. The aim of our study was to evaluate the efficacy of hexadecylphosphocholine and other alkylphosphocholines (APCs) against Acanthamoeba spp. The in vitro activities of eight different APCs against three Acanthamoeba strains of various pathogenicities were determined. All substances showed at least amoebostatic effects, and some of them disrupted the amoebae, as shown by the release of cytoplasmic enzyme activity. Hexadecylphosphocholine exhibited the highest degree of cytotoxicity against trophozoites, resulting in complete cell death at a concentration as low as 40 μM, and also displayed significant cysticidal activity. Hexadecylphosphocholine may be a promising new candidate for the topical treatment of Acanthamoeba keratitis and, conceivably, even for the oral treatment of granulomatous amoebic encephalitis. PMID:11850250

  8. Cytotoxic activities of alkylphosphocholines against clinical isolates of Acanthamoeba spp.

    PubMed

    Walochnik, Julia; Duchêne, Michael; Seifert, Karin; Obwaller, Andreas; Hottkowitz, Thomas; Wiedermann, Gerhard; Eibl, Hansjörg; Aspöck, Horst

    2002-03-01

    Free-living amoebae of the genus Acanthamoeba are causing serious chronic conditions such as destructive keratitis in contact lens wearers or granulomatous amoebic encephalitis in individuals with compromised immune systems. Both are characterized by the lack of availability of sufficiently effective and uncomplicated, manageable treatments. Hexadecylphosphocholine (miltefosine) is licensed for use as a topical antineoplastic agent, but it is also active in vitro against several protozoan parasites, and it was applied very successfully for the treatment of human visceral leishmaniasis. The aim of our study was to evaluate the efficacy of hexadecylphosphocholine and other alkylphosphocholines (APCs) against Acanthamoeba spp. The in vitro activities of eight different APCs against three Acanthamoeba strains of various pathogenicities were determined. All substances showed at least amoebostatic effects, and some of them disrupted the amoebae, as shown by the release of cytoplasmic enzyme activity. Hexadecylphosphocholine exhibited the highest degree of cytotoxicity against trophozoites, resulting in complete cell death at a concentration as low as 40 microM, and also displayed significant cysticidal activity. Hexadecylphosphocholine may be a promising new candidate for the topical treatment of Acanthamoeba keratitis and, conceivably, even for the oral treatment of granulomatous amoebic encephalitis.

  9. Radiochemical studies, pre-clinical investigation and preliminary clinical evaluation of (170)Tm-EDTMP prepared using in-house freeze-dried EDTMP kit.

    PubMed

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

    2017-01-05

    The objective of the present work is to formulate (170)Tm-EDTMP using an in-house freeze-dried EDTMP kit and evaluate its potential as a bone pain palliation agent. Patient dose of (170)Tm-EDTMP was prepared with high radiochemical purity using the lyophilized kit at room temperature within 15min. Pre-clinical evaluation in normal Wistar rats revealed selective skeletal accumulation with extended retention. Preliminary clinical investigation in 8 patients with disseminated skeletal metastases exhibited selective uptake in the bone and retention therein for a long duration.

  10. Antifungal Activity of Hydroalcoholic Extract of Chrysobalanus icaco Against Oral Clinical Isolates of Candida Species

    PubMed Central

    Silva, João Paulo Bastos; Peres, Ana Regina Maués Noronha; Paixão, Thiago Portal; Silva, Andressa Santa Brígida; Baetas, Ana Cristina; Barbosa, Wagner Luiz Ramos; Monteiro, Marta Chagas; Andrade, Marcieni Ataíde

    2017-01-01

    Background: Chrysobalanus icaco is a medicinal plant commonly used to treat fungal infections in Brazilian Amazonian region. Objective: This work aimed to evaluate the antifungal activity of the hydroalcoholic extract of C. icaco (HECi) against oral clinical isolates of Candida spp. and to determine the pharmacognostic parameters of the herbal drug and the phytochemical characteristics of HECi. Materials and Methods: The pharmacognostic characterization was performed using pharmacopoeial techniques. Phytochemical screening, total flavonoid content, and high-performance liquid chromatography (HPLC) analysis were used to investigate the chemical composition of the HECi. A broth microdilution method was used to determine the antifungal activity of the extract against 11 oral clinical isolates of Candida spp. Results: Herbal drug presented parameters which were within the limits set forth in current Brazilian legislation. A high amount of flavonoid content (132,959.33 ± 12,598.23 μg quercetin equivalent/g of extract) was found in HECi. Flavonoids such as myricetin and rutin were detected in the extract by HPLC analyses. HECi showed antifungal activity against oral isolates of Candida albicans and Candida parapsilosis (minimum inhibitory concentrations [MIC] 3.12 and 6.25 mg/mL, respectively), and C. albicans American American Type Culture Collection (MIC <1.56 mg/mL). Conclusion: HECi was shown to possess antifungal activity against Candida species with clinical importance in the development of oral candidiasis, and these activities may be related to its chemical composition. The antifungal activity detected for C. icaco against Candida species with clinical importance in the development of oral candidiasis can be attributed to the presence of flavonoids in HECi, characterized by chromatographic and spectroscopic techniques. SUMMARY Chrysobalanus icaco presents a high amount of flavonoids in its constitutionLC analysis was able to identify the flavonoids myricetin

  11. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE INVESTIGATIONAL NEW DRUG APPLICATION Drugs Intended... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and...

  12. An Investigation into Techniques for the Determination of Moisture Content on Activated Carbon

    DTIC Science & Technology

    1991-09-01

    Activated carbon (or charcoal ) is a universal adsorbent for the removal of a variety of organic/inorganic contaminants, in both gaseous and aqueous phase...AD-A245 938 i * *~fl Nadoni Waren AN INVESTIGATION INTO TECHNIQUES FOR THE DETERMNATION OF MOISTURE CONTENT ON ACTIVATED CARBON (U) by L.E. Cameron...INVESTIGATION INTO TECHNIQUES FOR THE DETERMINATION OF MOISTURE CONTENT ON ACTIVATED CARBON (U) by L.E. Cameron and S.H.C. Liang Chemical Protecti

  13. The Impact of Institutional Review Boards (IRBs) on Clinical Innovation: A Survey of Investigators and IRB Members.

    PubMed

    Stryjewski, Tomasz P; Kalish, Brian T; Silverman, Benjamin; Lehmann, Lisa Soleymani

    2015-12-01

    We conducted a survey to assess the perspectives of principal investigators and Institutional Review Board (IRB) members on the impact of the IRB structure on the conduct of research and innovative therapy, defined as a nonstandard treatment intended to enhance the well-being of an individual patient. Although investigators and IRB members agreed that the IRB provides adequate protection to study subjects (97% vs. 100%) and an ethically insightful review (88% vs. 100%), a third of clinical investigators felt that the IRB review process limits clinical innovation, in comparison with only 4% of IRB representatives. Limitations of the current IRB review process were explored. We propose several measures to improve the IRB review process while maintaining the protection of human research subjects, including the use of centralized IRBs, the opening of IRB meetings to investigators, the development of metrics and outcome measures for the IRB, and the promotion of guidelines that distinguish research and innovative therapy.

  14. Radiosensitization of human pancreatic cancer cells by MLN4924, an investigational NEDD8-activating enzyme inhibitor.

    PubMed

    Wei, Dongping; Li, Hua; Yu, Jie; Sebolt, Jonathan T; Zhao, Lili; Lawrence, Theodore S; Smith, Peter G; Morgan, Meredith A; Sun, Yi

    2012-01-01

    Radiotherapy is used in locally advanced pancreatic cancers in which it can improve survival in combination with gemcitabine. However, prognosis is still poor in this setting in which more effective therapies remain needed. MLN4924 is an investigational small molecule currently in phase I clinical trials. MLN4924 inhibits NAE (NEDD8 Activating Enzyme), a pivotal regulator of the E3 ubiquitin ligase SCF (SKP1, Cullins, and F-box protein), that has been implicated recently in DNA damage and repair. In this study, we provide evidence that MLN4924 can be used as an effective radiosensitizer in pancreatic cancer. Specifically, MLN4924 (20-100 nmol/L) effectively inhibited cullin neddylation and sensitized pancreatic cancer cells to ionizing radiation in vitro with a sensitivity enhancement ratio of approximately 1.5. Mechanistically, MLN4924 treatment stimulated an accumulation of several SCF substrates, including CDT1, WEE1, and NOXA, in parallel with an enhancement of radiation-induced DNA damage, aneuploidy, G(2)/M phase cell-cycle arrest, and apoptosis. RNAi-mediated knockdown of CDT1 and WEE1 partially abrogated MLN4924-induced aneuploidy, G(2)/M arrest, and radiosensitization, indicating a causal effect. Furthermore, MLN4924 was an effective radiosensitizer in a mouse xenograft model of human pancreatic cancer. Our findings offer proof-of-concept for use of MLN4924 as a novel class of radiosensitizer for the treatment of pancreatic cancer.

  15. Clinical value of monitoring eosinophil activity in asthma.

    PubMed Central

    Koller, D Y; Herouy, Y; Götz, M; Hagel, E; Urbanek, R; Eichler, I

    1995-01-01

    To evaluate the use of eosinophil cationic protein (ECP) in monitoring disease activity in childhood asthma, serum ECP in 175 asthmatic children was assessed. Forty five patients with cystic fibrosis, 23 with lower respiratory tract infections (LRTI), and 87 healthy children were used as controls. Serum ECP concentrations (34.3 micrograms/l v 9.8 micrograms/l) were significantly higher in children with bronchial asthma than in healthy control subjects. In symptomatic patients with asthma serum ECP concentrations were increased compared with those from asymptomatic patients (40.2 micrograms/l v 14.4 micrograms/l), irrespective of treatment modalities (that is steroids, beta 2 agonists, or sodium cromoglycate). Moreover, atopy and infection appeared to be factors enhancing eosinophil activity in bronchial asthma as measured by serum ECP (58.4 micrograms/l v 36.8 micrograms/l and 68.8 micrograms/l v 42.2 micrograms/l, respectively). In a longitudinal trial, antiasthmatic treatment modalities (that is steroids) reduced serum ECP within four weeks (42.2 micrograms/l v 19.0 micrograms/l). In conclusion, the data indicate that (1) eosinophils also play a central part in childhood asthma; (2) serum concentrations of ECP in children with bronchial asthma are related to the disease severity and may thus be used for monitoring inflammation in childhood asthma; (3) eosinophil activity appears to be enhanced by atopy and infection; and (4) longitudinal measurements of serum ECP concentrations may be useful for optimising anti-inflammatory treatment in children with bronchial asthma. PMID:8554357

  16. Electrodermal activity in depression: clinical and biochemical correlates.

    PubMed

    Mirkin, A M; Coppen, A

    1980-07-01

    Electrodermal activity was measured in a group of depressive patients and normal controls. Those patients classified as endogenous on the Newcastle Scale had significantly lower skin conductance levels than either the non-endogenous patients or controls. The endogenous depressives also contained significantly more non-responders to the experimental stimuli. The lack of responsiveness to external stimulation in non-responders is associated with a significantly lower rate of blood platelet 5-hydroxytryptamine uptake, suggesting that endogenous depressives have biological characteristics that distinguish them from other depressive groups and that electrodermal measures may be useful in the classification of depressive illness.

  17. 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.

  18. 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

  19. 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

  20. [Development of a Guideline on Clinical investigation of Medicinal Product in the Treatment of Depression in Japan].

    PubMed

    Nakabayashi, Tetsuo

    2011-08-01

    Drug development is one of the methods for qualitative improvement of medical treatment. The Ministry of Health, Labour and Welfare in Japan (MHLW) published "A Guideline on Clinical Investigation of Medicinal Product in the Treatment of Depression" in November 2010. The guideline was developed by a Japanese expert working group in psychiatry and regulatory science. The purpose of the guideline is to describe accepted principles and practices in the conduct of both individual clinical trials and development strategy for new medicinal products intended to be used for treating depression and to facilitate efficient drug development. This document describes the major issues discussed during the guideline development. This work was supported by Grants-in-Aid from the Research Committee of "A Guideline on Clinical Investigation of Medicinal Product in the Treatment of Depression", MHLW.

  1. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... contribute to the subject's well-being, may involve children as subjects only if the IRB finds that: (a) The... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Clinical investigations involving greater than... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  2. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... contribute to the subject's well-being, may involve children as subjects only if the IRB finds that: (a) The... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Clinical investigations involving greater than... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  3. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... contribute to the subject's well-being, may involve children as subjects only if the IRB finds and documents... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Clinical investigations involving greater than... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  4. 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...

  5. 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

  6. 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

  7. 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

    2015-05-02

    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.

  8. Mixing tests: diagnostic aides in the investigation of prolonged prothrombin times and activated partial thromboplastin times.

    PubMed

    Kershaw, Geoffrey; Orellana, Daniel

    2013-04-01

    Mixing tests are a relatively simple procedure used in the hemostasis laboratory as a first-line investigation into the cause of an abnormal screening test, typically a prolonged activated partial thromboplastin time and/or a prolonged prothrombin time. The mixing test involves combining the test plasma with normal plasma, then repeating the screening test on the mixture to assess whether the clotting time becomes normal or remains prolonged. The primary purpose of a mixing test is to guide further investigations. When mixing test results "normalize," this suggests the test plasma is deficient in clotting factor(s) and thus specific factor assays can be performed to determine which are reduced. When the mixing test result does not "normalize," this suggests the presence of an inhibitor or other type of interference (e.g., the presence of an anticoagulant such as high-dose heparinoids), and so the laboratory needs to determine if this is a lupus anticoagulant or a specific coagulation factor inhibitor, or another type of inhibitor. Because these follow-up investigations are more costly and time-consuming than the basic screening tests, the appropriate performance and interpretation of mixing tests is advantageous for the laboratory. Moreover, the correct laboratory approach is also clinically relevant, as patient management is ultimately affected, and an incorrect interpretation may lead to inappropriate therapies being established. Components of a mixing test that can influence result interpretation include the sensitivity of the used screening reagents to various factor deficiencies and inhibitors, the source or composition of the normal plasma, and the setting of cutoffs for the formula used in expressing mixing test results. Numerous and differing criteria for mixing test interpretation have been suggested historically, which can lead to confusion as to which approach is the most appropriate. The use of differing criteria will also lead to differing

  9. 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…

  10. Pre-clinical investigation of Diabetes Mellitus as a risk factor for schizophrenia.

    PubMed

    Heylmann, Alexandra S Almeida; Canever, Lara; Gress, Katia; Gomes, Sarah T; Fachim, Isadora; Michels, Carolina; Stopassoli, Geórgia C; Mastella, Gustavo A; Steckert, Amanda V; Damiani, Adriani P; Andrade, Vanessa M de; Quevedo, João; Zugno, Alexandra I

    2017-03-07

    This study investigated the behavioral and biochemical parameters of DM1 as a risk factor in an animal model of schizophrenia (SZ). All groups: 1 Control (saline+saline); 2 Alloxan (alloxan+saline); 3 Ketamine (saline+ketamine); 4 (Alloxan+Ketamine) were fasted for a period of 18hours before the subsequent induction of DM via a single intraperitoneal (i.p) injection of alloxan (150mg/kg). From the 4th to the 10th days, the animals were injected i.p with ketamine (25mg/kg) or saline, once a day, to induce a model of SZ and 30minutes after the last administration were subjected to behavioral testing. After, the animals were decapitated and the brain structures were removed. Ketamine induced hyperactivity and in the social interaction, ketamine, alloxan and the association of alloxan+ketamine increased the latency and decreased the number of contacts between animals. The animals from the ketamine, alloxan and alloxan+ketamine groups showed a prepulse startle reflex (PPI) deficit at the three intensities (65, 70 and 75dB). Ketamine was shown to be capable of increasing the activity of acetylcholinesterase (AChE) in the brain structures. Combination of alloxan+ketamine seems to have an exacerbated effect within the cholinergic system. For lipid peroxidation and protein carbonyls, alloxan+ketamine appear to have intensified lipid and protein damage in the three structures. Ketamine and the combination of ketamine+alloxan induced DNA damage in both frequency and damage index. This research found a relationship between DM1 and SZ.

  11. Investigating nurses' knowledge, attitudes, and skills patterns towards clinical management system: results of a cluster analysis.

    PubMed

    Chan, M F

    2006-09-01

    To determine whether definable subtypes exist within a cohort of Hong Kong nurses as related to the clinical management system use in their clinical practices based on their knowledge, attitudes, skills, and background factors. Data were collected using a structured questionnaire. The sample of 242 registered nurses was recruited from three hospitals in Hong Kong. The study employs personal and demographic variables, knowledge, attitudes, and skills scale. A cluster analysis yielded two clusters. Each cluster represents a different profile of Hong Kong nurses on the clinical management system use in their clinical practices. The first group (Cluster 1) was labeled 'lower attitudes, less skilful and average knowledge' group, and represented 55.4% of the total respondents. The second group (Cluster 2) was labeled as 'positive attitudes, good knowledge but less skilful'. They comprised almost 44.6% of this nursing sample. Cluster 2 had more older nurses, the majority were educated to the baccalaureate or above level, with more than 10 years working experience, and they held a more senior ranking then Cluster 1. A clear profile of Hong Kong nurses may benefit healthcare professionals in making appropriate education or assistance to prompt the use of the clinical management system by nurses an officially recognized profession. The findings were useful in determining nurse-users' specific needs and their preferences for modification of the clinical management system. Such findings should be used to formulate strategies to encourage nurses to resolve actual problems following computer training and to increase the depth and breadth of nurses' knowledge, attitudes, and skills toward such system.

  12. [Clinical features in fatal Spanish influenza: Japanese Army Hospital medical records investigation].

    PubMed

    Fujikura, Yuji; Kawana, Akihiko; Kato, Yasuyuki; Mizuno, Yasutaka; Kudo, Koichiro

    2010-03-01

    Pandemic influenza preparedness requires a thorough knowledge of past pandemics. Tokyo First Army Hospital medical records from January 1918 to December 1920 found recently included 132 consecutive records of those diagnosed with influenza. We report on the clinical features in 8 fatal cases. Inpatient mortality was found to be 6.1% (8/132). Cough was noted in 6 (75%) and thoracic rales in 8 (100%) on admission, mimicking pneumonia. Bloody sputum was noted in 5 (62.5%) and diarrhea in 4 (50%), with marked hemorrhagic and digestive symptoms, resembling highly pathogenic avian influenza. Clinical features may differ from seasonal influenza, making early detection and treatment essential especially in severe cases.

  13. 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.

  14. U.S. Food and Drug Administration inspections of clinical investigators: overview of results from 1977 to 2009.

    PubMed

    Morgan-Linnell, Sonia K; Stewart, David J; Kurzrock, Razelle

    2014-07-01

    The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research is responsible for evaluating drug safety and efficacy, including oversight of clinical trials and principal investigators. The FDA Clinical Investigator Inspection List (CIIL) contains online, detailed, relevant information of all FDA inspections. We reviewed FDA inspections of clinical investigators to ascertain their outcome and included all inspections on the list (July 1977 through December 31, 2009; n = 9,481 inspections). Eighty-eight percent of inspections were "data audit" (primary purpose = verification of data), and the rest (12%) were "for cause." The number of inspections each year significantly increased over time (P < 0.0001) and averaged 350 per year in the past decade. No deficiencies were found in only 11.2% of all "data audit" and 5% of all "for cause" inspections. Only 31% of inspections resulted in "no action indicated." About two thirds of inspections resulted in some finding, requiring either voluntary investigator action (61.3% of inspections) or official FDA action (3.9%). The most frequently cited deficiencies were failure to follow investigational plan (34%), inadequate informed consent form (28%), and inadequate/inaccurate records (27%). In conclusion, over the past decade, the FDA has performed approximately 350 inspections per year, with the number increasing over time. The vast majority of FDA inspections yield deficiency findings and, as a result, only about one third of inspections have an outcome of "no action indicated."

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

    PubMed

    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.

  16. 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

  17. 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.

  18. 75 FR 1790 - Draft Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: IRB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-13

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Institutional Review Boards, Clinical... Approval'' (September 1998, Office of Health Affairs, Food and Drug Administration). To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office...

  19. 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…

  20. 76 FR 30175 - Draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-24

    ... HUMAN SERVICES Food and Drug Administration (Formerly FDA-1999-D-0792) Draft Guidance for Clinical... comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug... http://www.regulations.gov . Submit written comments to the Division of Dockets Management...

  1. 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

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

    PubMed Central

    2015-01-01

    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

  3. [A combination of clinical medicine and social welfare activities of the Ophthalmic Rehabilitation Clinic at Juntendo University].

    PubMed

    Takabayashi, Masako

    2003-12-01

    I intend to analyze in this paper tha activities of the Ophthalmic Rehabilitation Clinic at Juntendo University in order to clarify how social welfare is incorporated with medical care in rehabilitation. The patients who feel little hope of recovery often suffer a great sense of emptiness until they finally manage to rehabilitate themselves in society. The clinic was founded for them in 1964 inside the Department of Ophthalmology, Juntendo University. The Department has been providing consultation with the visually handicapped. The program consists of counseling, educational guidance, daily training, etc. It is quite remarkable that the rehabilitation program, in addition to the medical examination, has been introduced to the outpatients who have visual handicaps.

  4. The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee.

    PubMed

    Seymour, Lesley; Ivy, S Percy; Sargent, Daniel; Spriggs, David; Baker, Laurence; Rubinstein, Larry; Ratain, Mark J; Le Blanc, Michael; Stewart, David; Crowley, John; Groshen, Susan; Humphrey, Jeffrey S; West, Pamela; Berry, Donald

    2010-03-15

    The optimal design of phase II studies continues to be the subject of vigorous debate, especially studies of newer molecularly targeted agents. The observations that many new therapeutics "fail" in definitive phase III studies, coupled with the numbers of new agents to be tested as well as the increasing costs and complexity of clinical trials, further emphasize the critical importance of robust and efficient phase II design. The Clinical Trial Design Task Force (CTD-TF) of the National Cancer Institute (NCI) Investigational Drug Steering Committee (IDSC) has published a series of discussion papers on phase II trial design in Clinical Cancer Research. The IDSC has developed formal recommendations about aspects of phase II trial design that are the subject of frequent debate, such as endpoints (response versus progression-free survival), randomization (single-arm designs versus randomization), inclusion of biomarkers, biomarker-based patient enrichment strategies, and statistical design (e.g., two-stage designs versus multiple-group adaptive designs). Although these recommendations in general encourage the use of progression-free survival as the primary endpoint, randomization, inclusion of biomarkers, and incorporation of newer designs, we acknowledge that objective response as an endpoint and single-arm designs remain relevant in certain situations. The design of any clinical trial should always be carefully evaluated and justified based on characteristic specific to the situation.

  5. 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

  6. Waves on the Great Lakes. Teacher Guide and Activity Book. OEAGLS Investigation No. 27.

    ERIC Educational Resources Information Center

    Keir, John; Mayer, Victor J.

    This document contains a student guide and a teacher guide on the topic of waves. The investigation includes three activities which lead students to an understanding of how waves are formed and how they move in water. Activity A introduces students to the parts of a wave. A demonstration using a stream table leads them to discover different…

  7. 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…

  8. 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,…

  9. Investigating the Effectiveness of an Analogy Activity in Improving Students' Conceptual Change for Solution Chemistry Concepts

    ERIC Educational Resources Information Center

    Calik, Muammer; Ayas, Alipasa; Coll, Richard K.

    2009-01-01

    This paper reports on an investigation on the use of an analogy activity and seeks to provide evidence of whether the activity enables students to change alternative conceptions towards views more in accord with scientific views for aspects of solution chemistry. We were also interested in how robust any change was and whether these changes in…

  10. The Developmental Process of Clinical Supervisors in Training: An Investigation of the Supervisor Complexity Model.

    ERIC Educational Resources Information Center

    Baker, Stanley B.; Exum, Herbert A.; Tyler, Richard E.

    2002-01-01

    Investigates the supervisor complexity model (SCM) using the Psychotherapy Supervisor Development Scale (PSDS) to ascertain development over a 15-week supervision practicum for 12 doctoral students. A set of retrospective interview questions produced responses used to investigate the viability of the 4 proposed discrete developmental stages in the…

  11. [Antimicrobial activities of cefetamet against clinical isolates from urinary tract infection].

    PubMed

    Ishii, Y; Suzuki, Y; Ishihara, R; Nakazawa, A; Deguchi, K

    1996-12-01

    In order to evaluate antimicrobial activity of cefetamet (CEMT), minimum inhibitory concentrations (MICs) of CEMT and control drugs were determined against Gram-negative rods mainly from complicated urinary tract infections examined in our laboratory from April to September of 1994. The results are summarized as follows; 1. The obtained strains were Citrobacter diversus 20, Citrobacter freundii 30, Enterobacter aerogenes 20, Enterobacter cloacae 30, Serratia marcescens 30, Proteus mirabilis 30, Proteus vulgaris 20 and Morganella morganii 30 strains, a total of 210 strains. 2. Excluding some resistant strains, the MIC-distribution showed showed that CEMT had strong antimicrobial activities against those strains from the MIC-distribution of this investigation. Compared to reports on CEMT in 1989, the MIC80 of CEMT in this investigation against clinical isolates were similar. The MIC50's of CEMT against E. aerogenes, S. marcescens, P. mirabilis, P. vulgaris and M. morganii in the previous examination were equal to or similar to the current results, but the MIC50's against C. freundii and E. cloacae were lower than the value of this report. The detection frequency of highly resistant strains of C. freundii and E. cloacae to cefteram and cefixime were similar to that of CEMT-resistant strains. Multiple drug resistant strains, among these bacterial species seemed to be increasing. 3. Compared to oral antibacterial agents of oxime cephems that were used in the past, CEMT showed higher peak values of urinary excretion concentration and higher blood levels were sustained for a longer period of time. CEMT-PI will be effective against urinary tract infections.

  12. 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.

  13. Clinical and investigative applications of Raman spectroscopy in Urology and Andrology.

    PubMed

    Osterberg, E Charles; Laudano, Melissa A; Li, Philip S

    2014-03-01

    Raman spectroscopy (RS) is an optical technique that allows for real-time interrogation of biologic tissues with chemical specificity. Using a diode laser, incident photons are scattered on the tissue of interest and the spectral wavelength output is a reflection of the tissues' molecular fingerprint. Naturally, this technology has come into clinical usage to evaluate benign versus malignant tissue. Within the field of Urology, RS has seen tremendous growth as an optical biopsy tool for the real-time evaluation of diseases of the bladder, prostate, kidney, and testis. With such growing fervor for this emerging spectroscopic modality, we present a current summary of clinical studies utilizing RS within Urology and Andrology to highlight its potential applications.

  14. Clinical and investigative applications of Raman spectroscopy in Urology and Andrology

    PubMed Central

    Osterberg, E. Charles; Laudano, Melissa A.

    2014-01-01

    Raman spectroscopy (RS) is an optical technique that allows for real-time interrogation of biologic tissues with chemical specificity. Using a diode laser, incident photons are scattered on the tissue of interest and the spectral wavelength output is a reflection of the tissues’ molecular fingerprint. Naturally, this technology has come into clinical usage to evaluate benign versus malignant tissue. Within the field of Urology, RS has seen tremendous growth as an optical biopsy tool for the real-time evaluation of diseases of the bladder, prostate, kidney, and testis. With such growing fervor for this emerging spectroscopic modality, we present a current summary of clinical studies utilizing RS within Urology and Andrology to highlight its potential applications. PMID:26816755

  15. 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.

  16. Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1987

    DTIC Science & Technology

    1987-10-01

    O’Rourke T, George CB: Clinical Usefulness of an Algorithm for the Early Diagnosis of Spinal Metastatic Disease. J Clin Oncol Submitted for...Comparison of Magnetic Resonance Imaging to Com- 4 puter Tomography in the Early Diagnosis of Metastases to the Axial Skeleton. Cancer -10- a...Truncus Arteriosus: A Review of Diagnosis and Current Management. Amer J Dis Children Hartman KR, Triche TT, Kinsella TJ, Miser JA: Histopathology: A

  17. Investigating the Role of Radiation Therapy Breast Cancer Clinical and Translational Research

    DTIC Science & Technology

    2006-05-01

    Biology & Therapy, Vol. 4 (2), In press, May 2005. Michael is attending graduate school. 4. Jordan Booty: “Time course of lymphedema ...completed. An analysis of patients with minimal lymphedema has been accepted for presentation at the 2006 annual meeting of the American Society for...Clinical Oncology (ASCO). An analysis of the overall patterns of lymphedema time course has been submitted to the 2006 ASTRO meeting. Two manuscripts

  18. Blood stream infections caused by Acinetobacter baumannii group in Japan - Epidemiological and clinical investigation.

    PubMed

    Fujikura, Yuji; Yuki, Atsushi; Hamamoto, Takaaki; Kawana, Akihiko; Ohkusu, Kiyofumi; Matsumoto, Tetsuya

    2016-06-01

    Acinetobacter calcoaceticus-Acinetobacter baumannii complex, especially A. baumannii, Acinetobacter pittii and Acinetobacter nosocomialis, constitutes an important group of nosocomial pathogens; however, epidemiological or clinical characteristics and prognosis is limited in Japan. From 2009 to 2013, 47 blood stream infection cases resulting from A. baumannii group were reviewed at the National Defense Medical College, an 800-bed tertiary hospital. To determine the genospecies, further comparative nucleotide sequence analyses of the RNA polymerase b-subunit (rpoB) gene were performed. Sequence analysis of rpoB gene showed that 25 (49.0%), 17 (33.3%) and 5 (9.8%) cases were caused by A. baumannii, A. pittii and A. nosocomialis, respectively. The 30-day and in-hospital mortality rates of A. baumannii were 8.5% and 25.5%, respectively, and there were no significant differences between Acinetobacter species. Clinical characteristics were statistically insignificant. Multidrug-resistant Acinetobacter species were detected in 3 cases (5.9%) with same pulsed-field gel electrophoresis (PFGE) pattern and A. baumannii was less susceptible to amikacin and levofloxacin. In this study, the mortality and clinical characteristics were similar among A. baumannii group isolate cases despite some showing drug resistance. However, identification of Acinetobacter species helps to initiate appropriate antibiotic therapy in earlier treatment phase, because A. baumannii shows some drug resistance.

  19. Investigation of ultra low-dose scans in the context of quantum-counting clinical CT

    NASA Astrophysics Data System (ADS)

    Weidinger, T.; Buzug, T. M.; Flohr, T.; Fung, G. S. K.; Kappler, S.; Stierstorfer, K.; Tsui, B. M. W.

    2012-03-01

    In clinical computed tomography (CT), images from patient examinations taken with conventional scanners exhibit noise characteristics governed by electronics noise, when scanning strongly attenuating obese patients or with an ultra-low X-ray dose. Unlike CT systems based on energy integrating detectors, a system with a quantum counting detector does not suffer from this drawback. Instead, the noise from the electronics mainly affects the spectral resolution of these detectors. Therefore, it does not contribute to the image noise in spectrally non-resolved CT images. This promises improved image quality due to image noise reduction in scans obtained from clinical CT examinations with lowest X-ray tube currents or obese patients. To quantify the benefits of quantum counting detectors in clinical CT we have carried out an extensive simulation study of the complete scanning and reconstruction process for both kinds of detectors. The simulation chain encompasses modeling of the X-ray source, beam attenuation in the patient, and calculation of the detector response. Moreover, in each case the subsequent image preprocessing and reconstruction is modeled as well. The simulation-based, theoretical evaluation is validated by experiments with a novel prototype quantum counting system and a Siemens Definition Flash scanner with a conventional energy integrating CT detector. We demonstrate and quantify the improvement from image noise reduction achievable with quantum counting techniques in CT examinations with ultra-low X-ray dose and strong attenuation.

  20. Impact of the 2010 Consensus Recommendations of the Clinical Trial Design Task Force of the NCI Investigational Drug Steering Committee.

    PubMed

    Seymour, Lesley; Groshen, Susan; Rosner, Gary L; Sullivan, Daniel M; Spriggs, David R; Reeves, Steven; Gravell, Amy; Ivy, S Percy; Ratain, Mark J

    2015-11-15

    Oncology phase III trials have a high failure rate, leading to high development costs. The Clinical Trials Design Task Force of the Investigational Drug Steering Committee of the NCI Cancer Therapy and Evaluation Program developed Recommendations regarding the design of phase II trials. We report here on the results of a Concordance Group review charged with documenting whether concordance rates improved after the publication of the Recommendations. One hundred and fifty-five trials were reviewed. Letter of Intents (LOI) from the post-Recommendation period were more likely to be randomized (44% vs. 34%) and biomarker selected (19% vs. 10%). Single-arm studies using time-to-event endpoints (benchmarked against historical data) were similar, as was the type of tumor. There was a significant improvement in the rate of concordance, with 74% of LOIs scored as concordant compared with 58% before the Recommendations (P = 0.042). This included a marked decrease in the use of single-arm designs to evaluate the activity of drug combinations (19% vs. 5%, P = 0.009). There were areas for which clarification was warranted, including the need for protocols to include further development plans, the use of realistic benchmarks, the careful evaluation of historical controls, and the use of a standard treatment option as a control. Ongoing critical evaluation of current trial design methodology and the development of new Guidelines when appropriate will continue to improve drug development ensuring that safe and effective cancer therapeutics are made available to our patients as quickly and efficiently as possible.

  1. Echicetin coated polystyrene beads: a novel tool to investigate GPIb-specific platelet activation and aggregation.

    PubMed

    Navdaev, Alexey; Subramanian, Hariharan; 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.

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

    PubMed Central

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

    2011-01-01

    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

  3. 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.

  4. 77 FR 69632 - Draft Guidance for Industry on Electronic Source Data in Clinical Investigations; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... document provides guidance to sponsors, contract research organizations (CROs), data management centers... Investigations.'' This revised draft document provides guidance to sponsors, CROs, data management centers... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Electronic Source Data...

  5. Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1986,

    DTIC Science & Technology

    1986-10-01

    DAVIDSON, H. O SWOG 8216/38: Comparison of 8CG Immunotherapy and 286 #84/18 Adriamycin for Superficial Bladder Cancer DAVIDSON, H. 0 SWOG 8219... Allergy /Immunology Facility: MAMC Principal Investigator: LTC William P. Andrade, MC Associate Investigators: LTC Gary B. Carpenter, MC MAJ richael...presence or ibsence of positive allergy skin tests, prior dosage of steroid as determinant of response, and adverse occurrences. SProress: Three patients

  6. Additional safeguards for children in clinical investigations of food and drug administration-regulated products. Final rule.

    PubMed

    2013-02-26

    The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.

  7. Scientific Rationale Supporting the Clinical Development Strategy for the Investigational Aurora A Kinase Inhibitor Alisertib in Cancer.

    PubMed

    Niu, Huifeng; Manfredi, Mark; Ecsedy, Jeffrey A

    2015-01-01

    Alisertib (MLN8237) is a selective small molecule inhibitor of Aurora A kinase that is being developed in multiple cancer indications as a single agent and in combination with other therapies. A significant amount of research has elucidated a role for Aurora A in orchestrating numerous activities of cells transiting through mitosis and has begun to shed light on potential non-mitotic roles for Aurora A as well. These biological insights laid the foundation for multiple clinical trials evaluating the antitumor activity of alisertib in both solid cancers and heme-lymphatic malignancies. Several key facets of Aurora A biology as well as empirical data collected in experimental systems and early clinical trials have directed the development of alisertib toward certain cancer types, including neuroblastoma, small cell lung cancer, neuroendocrine prostate cancer, atypical teratoid/rhabdoid tumors, and breast cancer among others. In addition, these scientific insights provided the rationale for combining alisertib with other therapies, including microtubule perturbing agents, such as taxanes, EGFR inhibitors, hormonal therapies, platinums, and HDAC inhibitors among others. Here, we link the key aspects of the current clinical development of alisertib to the originating scientific rationale and provide an overview of the alisertib clinical experience to date.

  8. 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

  9. Investigating the prediction ability of survival models based on both clinical and omics data: two case studies.

    PubMed

    De Bin, Riccardo; Sauerbrei, Willi; Boulesteix, Anne-Laure

    2014-12-30

    In biomedical literature, numerous prediction models for clinical outcomes have been developed based either on clinical data or, more recently, on high-throughput molecular data (omics data). Prediction models based on both types of data, however, are less common, although some recent studies suggest that a suitable combination of clinical and molecular information may lead to models with better predictive abilities. This is probably due to the fact that it is not straightforward to combine data with different characteristics and dimensions (poorly characterized high-dimensional omics data, well-investigated low-dimensional clinical data). In this paper, we analyze two publicly available datasets related to breast cancer and neuroblastoma, respectively, in order to show some possible ways to combine clinical and omics data into a prediction model of time-to-event outcome. Different strategies and statistical methods are exploited. The results are compared and discussed according to different criteria, including the discriminative ability of the models, computed on a validation dataset.

  10. Targeted molecular investigation in patients within the clinical spectrum of Auriculocondylar syndrome.

    PubMed

    Romanelli Tavares, Vanessa L; Zechi-Ceide, Roseli M; Bertola, Debora R; Gordon, Christopher T; Ferreira, Simone G; Hsia, Gabriella S P; Yamamoto, Guilherme L; Ezquina, Suzana A M; Kokitsu-Nakata, Nancy M; Vendramini-Pittoli, Siulan; Freitas, Renato S; Souza, Josiane; Raposo-Amaral, Cesar A; Zatz, Mayana; Amiel, Jeanne; Guion-Almeida, Maria L; Passos-Bueno, Maria Rita

    2017-04-01

    Auriculocondylar syndrome, mainly characterized by micrognathia, small mandibular condyle, and question mark ears, is a rare disease segregating in an autosomal dominant pattern in the majority of the families reported in the literature. So far, pathogenic variants in PLCB4, GNAI3, and EDN1 have been associated with this syndrome. It is caused by a developmental abnormality of the first and second pharyngeal arches and it is associated with great inter- and intra-familial clinical variability, with some patients not presenting the typical phenotype of the syndrome. Moreover, only a few patients of each molecular subtype of Auriculocondylar syndrome have been reported and sequenced. Therefore, the spectrum of clinical and genetic variability is still not defined. In order to address these questions, we searched for alterations in PLCB4, GNAI3, and EDN1 in patients with typical Auriculocondylar syndrome (n = 3), Pierre Robin sequence-plus (n = 3), micrognathia with additional craniofacial malformations (n = 4), or non-specific auricular dysplasia (n = 1), which could represent subtypes of Auriculocondylar syndrome. We found novel pathogenic variants in PLCB4 only in two of three index patients with typical Auriculocondylar syndrome. We also performed a detailed comparative analysis of the patients presented in this study with those previously published, which showed that the pattern of auricular abnormality and full cheeks were associated with molecularly characterized individuals with Auriculocondylar syndrome. Finally, our data contribute to a better definition of a set of parameters for clinical classification that may be used as a guidance for geneticists ordering molecular testing for Auriculocondylar syndrome. © 2017 Wiley Periodicals, Inc.

  11. 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.

  12. Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1993. Volume 1

    DTIC Science & Technology

    1993-10-01

    Steroid In Reducing Post- Tonsillectomy Morbidity. 309 o0) C-89-91 Compassionate Use Protocol for Centoxin (HA-lA). (C) 310 C-90-91 Phase I Protocol...treated with Nd:YAG Laser to Patients Not Treated with Laser : Survival and Clinical data. Chest 1993; 10:44S. Atkins, J; Johnson, JE; Blanton, HM. The...Medical Center. 308 Detail Summary Sheet Date: 15 Dec 93 Protocol Number: C-76-91 Status: Ongoing Title: Efficacy of Steroid in Reducing Post- Tonsillectomy

  13. ACP Best Practice No 181: Chemical pathology clinical investigation and management of nephrolithiasis.

    PubMed

    Reynolds, T M

    2005-02-01

    Renal stones have afflicted humans for millennia but there is still no solution to this problem. This review discusses the laboratory and metabolic aspects of the clinical management of patients with renal stones, both primary and secondary in origin. First, non-pharmacological interventions such as increased fluid intake, decreased protein consumption, dietary changes in sodium, calcium, oxalate, potassium, purine, vitamins, and essential fatty acids are considered. Then specific pharmacological treatment to modify urine calcium, oxalate, urate, citrate, and acidity are considered. Finally, more unusual types of stone are examined.

  14. 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

  15. Clinical, biochemical and molecular investigations of three Taiwanese children with Laron syndrome.

    PubMed

    Yang, Chen; Chen, Julia Yi-Ru; Lai, Chien-Cherng; Lin, Hsiu-Chen; Yeh, Geng-Chang; Hsu, Hsun-Hui

    2004-02-01

    Three children of two Taiwanese families were diagnosed with Laron syndrome, two sisters and one boy. Both sets of parents were consanguineous. Clinically, all three presented with the typical craniofacies of Laron syndrome, consisting of prominent forehead and hypoplastic nasal bridge, high-pitched voice, short stature, and central obesity. Biochemically, their levels of serum IGF-I were less than 5 microg/ml before and after an IGF-I generation test, and levels of IGFBP-3 were reduced in all three patients. Sequence analysis of the growth hormone receptor gene revealed that all three carried a homozygous missense D152G mutation in exon 6.

  16. Are exposure index values consistent in clinical practice? A multi-manufacturer investigation.

    PubMed

    Butler, M L; Rainford, L; Last, J; Brennan, P C

    2010-01-01

    The advent of digital radiography poses the risk of unnoticed increases in patient dose. Manufacturers have responded to this by offering an exposure index (EI) value to the clinician. Whilst the EI value is a measure of the air kerma at the detector surface, it has been recommended by international agencies as a method of monitoring radiation dose to the patient. Recent studies by the group have shown that EI values are being used in clinical practice to monitor radiation dose and assess image quality. This study aims to compare the clinical consistency of the EI value in computed radiography (CR) and direct digital radiography (DR) systems. An anthropormorphic phantom was used to simulate four common radiographic examinations: skull, pelvis, chest and hand. These examinations were chosen as they provide contrasting exposure parameters, image detail and radiation dose measurements. Four manufacturers were used for comparison: Agfa Gaevert CR, Carestream CR, Philips Digital Diagnost DR and Siemens DR. For each examination, the phantom was placed in the optimal position and exposure parameters were chosen in accordance with European guidelines and clinical practice. Multiple exposures were taken and the EI recorded. All exposure parameters and clinical conditions remained constant throughout. For both DR systems, the EI values remained consistent throughout. No significant change was noted in any examination. In both CR systems, there were noteworthy fluctuations in the EI values for all examinations. The largest for the Agfa system was a variation of 1.88-2.21 for the skull examination. This represents to the clinician a doubling of detector dose, despite all exposure parameters remaining constant. In the Kodak system, the largest fluctuation was seen for the chest examination where the EI ranged from 2560 to 2660, representing approximately an increase of 30 % in radiation dose, despite consistent parameters. The fluctuations seen with the CR systems are most

  17. 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

  18. 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

  19. 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

  20. 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.

  1. An investigation of the mimetic enzyme activity of two-dimensional Pd-based nanostructures.

    PubMed

    Wei, Jingping; Chen, Xiaolan; Shi, Saige; Mo, Shiguang; Zheng, Nanfeng

    2015-12-07

    In this work, we investigated the mimetic enzyme activity of two-dimensional (2D) Pd-based nanostructures (e.g. Pd nanosheets, Pd@Au and Pd@Pt nanoplates) and found that they possess intrinsic peroxidase-, oxidase- and catalase-like activities. These nanostructures were able to activate hydrogen peroxide or dissolved oxygen for catalyzing the oxidation of organic substrates, and decompose hydrogen peroxide to generate oxygen. More systematic investigations revealed that the peroxidase-like activities of these Pd-based nanomaterials were highly structure- and composition-dependent. Among them, Pd@Pt nanoplates displayed the highest peroxidase-like activity. Based on these findings, Pd-based nanostructures were applied for the colorimetric detection of H2O2 and glucose, and also the electro-catalytic reduction of H2O2. This work offers a promising prospect for the application of 2D noble metal nanostructures in biocatalysis.

  2. [Somewhere in tertiary hospital clinical laboratory in pursuance of personnel sharp injury incidence status investigation and relative factor analysis].

    PubMed

    Ding, E; Li, W H; Wang, P; Jian, X D

    2016-07-20

    Objective: Investigation in tertiary hospital clinical laboratory in pursuance of the current state of the sharp injury incidence and influencing factors, analyze the causes and discuss the control strategy. Methods: Application of cross-sectional survey method, according to the unified investigation questionnaire investigation, with chi-square test and the multi-factor Logistic regression analysis methods to analyze research data. Results: The work environment exit contact with injection needles, glass and other sharps, contact with noise, contact with chemicals, contact the patient's blood and other biological specimens, high-risk groups, the patient and family to negative emotions, by patients and their families complain or abuse related influencing factors. In the organization and management factors, in order to work strength is insufficient for the most dissatisfied, protective equipment, medical staff personal cognitive factors of occupational exposure, failing to abide by the medical care standard operation and high incidence after exposure to failed to report. Somewhere in tertiary hospital clinical laboratory in pursuance of the incidence of sharps injuries associated with five factors: different jobs, working strength, protective equipment perfect or not, sharp instrument use and disposal of medical wastes. Conclusion: Tertiary hospital clinical laboratory in pursuance of the incidence of sharp injury related to many factors, Hospitals should formulate corresponding rules and regulations, improve the working environment, the standard safety operation, reduced the incidence of sharps injuries.

  3. 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.

  4. 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).

  5. PET/SPECT molecular imaging in clinical neuroscience: recent advances in the investigation of CNS diseases

    PubMed Central

    Lu, Feng-Mei

    2015-01-01

    Molecular imaging is an attractive technology widely used in clinical practice that greatly enhances our understanding of the pathophysiology and treatment in central nervous system (CNS) diseases. It is a novel multidisciplinary technique that can be defined as real-time visualization, in vivo characterization and qualification of biological processes at the molecular and cellular level. It involves the imaging modalities and the corresponding imaging agents. Nowadays, molecular imaging in neuroscience has provided tremendous insights into disturbed human brain function. Among all of the molecular imaging modalities, positron emission tomography (PET) and single photon emission computed tomography (SPECT) have occupied a particular position that visualize and measure the physiological processes using high-affinity and high-specificity molecular radioactive tracers as imaging probes in intact living brain. In this review, we will put emphasis on the PET/SPECT applications in Alzheimer’s disease (AD) and Parkinson’s disease (PD) as major CNS disorders. We will first give an overview of the main classical molecular neuroimaging modalities. Then, the major clinical applications of PET and SPECT along with molecular probes in the fields of psychiatry and neurology will be discussed. PMID:26029646

  6. Clinical investigation into the initial diagnosis and treatment of 539 patients with stage IV lung cancer

    PubMed Central

    Shao, Qian; Liu, Shanshan; Wang, Wei; Zhang, Yingjie; Li, Fengxiang; Li, Jianbin

    2017-01-01

    Objective The aim of the study was to analyze clinical data, including the types of pathologic classification, metastatic organs, treatment strategy, and prognosis of patients with stage IV lung cancer. Methods A retrospective analysis of the clinical features of 539 patients with stage IV lung cancer who were initially diagnosed and treated in 2009 was conducted. There were 146 cases of single organ metastases and 393 cases of multiple organ metastases. The Kaplan-Meier method and multivariate Cox regression analysis were performed to analyze the influence of age, pathological classification, metastatic organs, and treatment strategy on overall survival. Results The 1-, 2-, and 3-year survival rates were 64.2% (n=346), 19.7% (n=106), and 1.5% (n=8), respectively. Metastases to the liver and pleura predicted poor prognosis, although bone metastases predicted relatively good prognosis. The prognosis of single brain metastasis was relatively better than that of multiple brain metastases. Multi-factor analysis showed that the patient’s age, different metastatic organs, the numbers of metastatic organs, and different treatment were independent risk factors for survival. Conclusion The prognosis for patients with stage IV lung cancer is poor. Patient’s age, the type and number of metastatic organs, and method of treatment are the main factors affecting survival. PMID:28203086

  7. 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

  8. Assessment of a Clinical Pharmacy Activity in a Pediatric Inpatient Department in Cote D’ivoire

    PubMed Central

    Abrogoua, Danho Pascal; Békégnran, César Pacôme; Gro, Bi Marius; Doffou, Elisée; Folquet, Madeleine Amorissani

    2016-01-01

    Background: Clinical pharmacy activities in a pediatric inpatient department help to improve the management of patients clinically and economically. Objective: To assess the relevance of pharmaceutical interventions (PIs) in a pediatric inpatient department in Abidjan (Cote d’Ivoire). Materials and Methods: We carried out a cross-sectional, descriptive study from February to September 2014. The information collected was classified according to the classification of drug-related problems (DRPs) and PIs of the French Society of Clinical Pharmacy. The score assigned to each PI varied from PI0 (without direct clinical impact) to PI3 (vital clinical impact) as the importance of the potential clinical impact of the DRP was correlated to the severity of clinical consequences avoided by the PI. The relevance of PIs was assessed by their rate of acceptance by physicians and by the analysis of their clinical impact. Results: A total of 116 PIs were performed with 31% performed during medical rounds, 68.1% during patients’ records analysis, and 0.1% on patient's admission. The main DRPs were related to noncompliance with recommendations (24.1%), overdose (21.1%), and underdosing (13.8%). The most important PIs were dose adjustment (31.8%), accuracy of drugs administration modalities (29.3%), and proposals of therapeutic choice (27.6%). The acceptance rate of PIs was highly significant (94.8%). The majority of PIs (67.3%) was assessed as having a significant clinical impact (PI1) and 16.4% of PIs as very significant clinical impact (PI2). A single PI (0.9%) was found with vital clinical impact. Conclusion: PIs performed were relevant and contributed to the therapeutic optimization and the prevention of iatrogenic events in pediatric inpatients. PMID:28104969

  9. [Canine panosteitis: an idiopathic bone disease investigated in the light of a new hypothesis concerning pathogenesis. Part 1: Clinical and diagnostic aspects].

    PubMed

    Schawalder, P; Andres, H U; Jutzi, K; Stoupis, C; Bösch, C

    2002-03-01

    Panosteitis, an idiopathic bone disease of young dogs, was investigated in the light of a new, empirically based hypothesis governing its pathogenesis. Extensive clinical observations suggest a close relationship between the incidence of this disease and the commercialization of various protein-rich, high-calorie dog foods. The theory of an "osseous compartment syndrome" provides a hypothetical pathogenesis, which corroborates this findings. An excessive accumulation of protein causes intraosseous edema due to its osmotic effects. Because bone is a rigid compartment, this leads to an increase in intramedullary pressure and compression of blood vessels. Subsequent osseous ischemia leads to a deficient metabolic state (decreased oxygenation, inadequate influx of nutritive substances, local acidosis, decreased removal of metabolites, disruption of local biochemical processes, etc.), and a vicious circle is created due to the resulting local inflammation. The disease is aggravated by increased metabolism due to excessive physical activity. Within the context of a pilot study, clinical, radiographic, scintigraphic and thermographic examinations and a therapeutic trial with benzopyron were carried out. In addition, more modern investigative tools, including osteomyelography, magnetic resonance tomography and intraosseous pressure measurements were used to provide objective data concerning the pathogenesis of panosteitis. In most cases, clinical remission was seen within days of monotherapy with the proteolytic substance, benzopyron (Cumartrin). This finding appears to corroborate our hypothesis.

  10. 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

  11. An fMRI Study Investigating Adolescent Brain Activation by Rewards and Feedback

    PubMed Central

    Choi, Won-Hee; Kim, Yeoung-Rang; Oh, Jong-Hyun; Lee, Sang-Ick; Shin, Chul-Jin; Kim, Sie-Kyeong; Ju, Gawon; Lee, Seungbok; Jo, Seongwoo; Ha, Tae Hyon

    2013-01-01

    Objective This study aimed to investigate the adolescent brain activation patterns in response to performance feedback (PF), social reward (SR) and monetary reward (MR) and their association with psychological factors. Methods Functional magnetic resonance imaging (fMRI) was performed while middle school boys (n=15) performed tests pertained to PF, SR and MR. The brain activation pattern in each condition was investigated, and the extent of brain activation in each of the three conditions was compared at once. Results The caudate and the dorsal prefrontal area were activated in all three conditions. Furthermore, the cuneus showed significantly greater activation in the PF condition than the SR or MR condition. And the self - related areas, such as the right precentral gyrus and paracenral lobule, were more activated in the SR condition than the PF or MR condition. The left middle frontal gyrus was more activated in the MR condition than the PF or SR condition. Conclusion Not only various reward stimuli but also feedback stimulus might commonly activate dorsal prefrontal and subcortical area in adolescents. Moreover, several different brain activation patterns were also observed in each condition. The results of this study could be applied to planning of learning and teaching strategy for adolescents in various ways. PMID:23482680

  12. 76 FR 18558 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-04

    ... HUMAN SERVICES Food and Drug Administration (Formerly Docket No. 2006D-0331) Guidance for Institutional... investigations involve human subjects who have a life-threatening medical condition (for which available treatments are unproven or unsatisfactory), and who, because of their condition (e.g., traumatic brain...

  13. 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…

  14. 21 CFR 50.54 - Clinical investigations not otherwise approvable that present an opportunity to understand...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

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

  15. [Experimental and clinical investigations on reapplicability of resterilized intravascular catheters (author's transl)].

    PubMed

    Langmaack, H; Mendera, C; Wenz, W; Wink, K; Lehnert, H; Daschner, F

    1982-01-01

    Catheters for cardiovascular and other angiographic investigations can be resterilized by ethyl-oxide. The procedure of sterilisation has to be controled permanently. Reapplicability of catheters has become quite common because of the high price of new catheters. In spite of optimal resterilisation and permanent controll some patients still get fever attacks, because endotoxins cannot be eliminated by this method.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-12

    ... may vary. To enhance human subject protections and reduce regulatory burden, FDA and the Office for Human Research Protections (OHRP) have been actively working to harmonize the Agencies' regulatory... HUMAN SERVICES Food and Drug Administration Draft Guidance for Institutional Review Boards,...

  18. 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.

  19. 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.

  20. 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

  1. Airways microbial flora in COPD patients in stable clinical conditions and during exacerbations: a bronchoscopic investigation.

    PubMed

    Pela, R; Marchesani, F; Agostinelli, C; Staccioli, D; Cecarini, L; Bassotti, C; Sanguinetti, C M

    1998-06-01

    Patients affected with chronic obstructive pulmonary disease (COPD) undergo frequent exacerbations of their illness characterized by increased cough and expectoration. The precise aetiology of these episodes often remains unknown. In the absence of clinical or radiographic signs of pneumonia, bacterial or viral cultures of sputum usually provide little useful information. Thus, we performed fibreoptic bronchoscopy using a protected specimen brush (PSB) to obtain uncontaminated secretions for culture from 56 patients with COPD, 16 with stable clinical conditions and 40 affected with exacerbations of the disease. The aim of our study was to evaluate bronchial microbial flora by quantitative aerobic and anaerobic culture of each specimen. Twenty five subjects (45%), 4 (16%) in stable state and 21 (84%) with COPD exacerbations, had specimens which gave rise to significant bacterial growth (> 10(3) colony forming units.mL-1). The predominant bacteria were Streptococcus pneumoniae (in 10 cases) and alpha-haemolytic streptococci (in 6 cases); other bacteria found were coagulase-negative staphylococci and Branhamella catarralis in (2 cases each), and Proteus mirabilis, Haemophilus influenzae, Pseudomonas aeruginosa, Aerococcus viridans and Chromobacterium violaceum (each in a single case only). Although significant bacterial growth was more frequently found in patients with chronic obstructive pulmonary disease exacerbations and in those with a higher degree of bronchial inflammation, the differences between the two groups of patients were not statistically significant. Nevertheless, the results obtained in our study confirm the validity of and the need for reliable sampling methods (like the protected specimen brush) to demonstrate significant bacterial colonization of the airways in chronic obstructive pulmonary disease patients.

  2. 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

  3. 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.

  4. 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.

  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. Combining clinical studies and analogue experiments to investigate cognitive mechanisms in posttraumatic stress disorder

    PubMed Central

    Ehring, Thomas; Kleim, Birgit; Ehlers, Anke

    2013-01-01

    Research into cognitive mechanisms in posttraumatic stress disorder (PTSD) typically comprises two types of studies. The first group of studies is conducted with survivors of traumatic events and assesses the association between PTSD and cognitive variables with questionnaires and/or information processing paradigms. In the second group of studies, healthy non-traumatized individuals are exposed to an analogue stressor (e.g., a stressful film) and cognitive variables of interest are usually experimentally manipulated to investigate their effects on analogue PTSD symptoms. This review illustrates how studies of trauma survivors and analogue studies with non-traumatized populations can be usefully combined. Two examples for this approach are presented: (1) research into the role of perceptual priming for trauma-related stimuli and (2) research into trauma-related rumination. The advantages and limitations of both types of studies are discussed and it is argued that a combination of both approaches is needed to investigate cognitive mechanisms in PTSD. PMID:23814633

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

    DTIC Science & Technology

    1993-10-01

    of Neurogenic Motor Evoked Potentials (NMEP) and 386 Spinal Cord Protection in the Swine Model. (C) A-15-90 Hemodynamics Effects of Dobutamine in a...Potentials (NMEP) and Spinal Cord Protection in the Swine Model. Start date: 1 Jun 90 Estimated completion date: Principal Investigator: Facility: Paul D...NMEPs) as a noninvasive intraoperative monitor of spinal cord protection during thoracic aorta surgery. Technical Approach: This study will be conducted

  8. Annual Progress Report (FY-79) Clinical Investigation Service. Walter Reed Army Medical Center

    DTIC Science & Technology

    1979-09-30

    1979. Boehm TM. Correlations among Glycosylated Hemoglobins, Weight Reduc- tion, and Hyperglycemia in the Treatment of Obese Diabetes Mellitus...easurement os A-I-C in the Assessment of Etficacy of Diabetic Treatment . Investigator: Timothv ,M. Boehm, IAJ MC Objectives: a) To compare hemoqlo in A-I...Dresentinp with nephropathy and retinopathy with similar diabetics without complications raeardine age, sex, duration of disease, and insulin requirement

  9. 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

  10. Scanning electron microscopy in the investigation of the in vitro hemolytic activity of Trichomonas vaginalis.

    PubMed

    Rosset, Iveli; Tasca, Tiana; Tessele, Paola M; De Carli, Geraldo A

    2002-04-01

    The in vitro hemolytic activity of Trichomonas vaginalis has been previously demonstrated, but the mechanisms involved remain to be elucidated. In this work we used scanning electron microscopy to investigate the contact dependency of the hemolytic phenomenon caused by the parasites. The erythrocytes adhered to the parasites' surface and were phagocytosed. These observations suggest that the contact between T. vaginalis and erythrocytes may be an important mechanism in the injury caused to the erythrocytes. The hemolytic activity of T. vaginalis may be an efficient means of obtaining nutrients for the parasite and allow the investigation of the mechanism used by T. vaginalis to damage cellular membranes.

  11. 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

  12. Investigation of frequency response of microwave active ring resonator based on ferrite film

    NASA Astrophysics Data System (ADS)

    Martynov, M. I.; Nikitin, A. A.; Ustinov, A. B.; Kalinikos, B. A.

    2016-11-01

    The complex transmission coefficient of active ring resonators based on ferrite-film delay lines was investigated both theoretically and experimentally. Influence of the parameters of the delay line on the transmission coefficients was investigated. It was shown that the resonant frequencies of the ring depend on the ferrite film thickness and the distance between spin-wave antennae. These dependences give possibility to control the shape of the transmission coefficient that in combination with magnetic tuning provide flexibility for microwave applications.

  13. The clinical utility of basophil activation testing in diagnosis and monitoring of allergic disease.

    PubMed

    Hoffmann, H J; Santos, A F; Mayorga, C; Nopp, A; Eberlein, B; Ferrer, M; Rouzaire, P; Ebo, D G; Sabato, V; Sanz, M L; Pecaric-Petkovic, T; Patil, S U; Hausmann, O V; Shreffler, W G; Korosec, P; Knol, E F

    2015-11-01

    The basophil activation test (BAT) has become a pervasive test for allergic response through the development of flow cytometry, discovery of activation markers such as CD63 and unique markers identifying basophil granulocytes. Basophil activation test measures basophil response to allergen cross-linking IgE on between 150 and 2000 basophil granulocytes in <0.1 ml fresh blood. Dichotomous activation is assessed as the fraction of reacting basophils. In addition to clinical history, skin prick test, and specific IgE determination, BAT can be a part of the diagnostic evaluation of patients with food-, insect venom-, and drug allergy and chronic urticaria. It may be helpful in determining the clinically relevant allergen. Basophil sensitivity may be used to monitor patients on allergen immunotherapy, anti-IgE treatment or in the natural resolution of allergy. Basophil activation test may use fewer resources and be more reproducible than challenge testing. As it is less stressful for the patient and avoids severe allergic reactions, BAT ought to precede challenge testing. An important next step is to standardize BAT and make it available in diagnostic laboratories. The nature of basophil activation as an ex vivo challenge makes it a multifaceted and promising tool for the allergist. In this EAACI task force position paper, we provide an overview of the practical and technical details as well as the clinical utility of BAT in diagnosis and management of allergic diseases.

  14. 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.

  15. Hemispheric Activation Differences in Novice and Expert Clinicians during Clinical Decision Making

    ERIC Educational Resources Information Center

    Hruska, Pam; Hecker, Kent G.; Coderre, Sylvain; McLaughlin, Kevin; Cortese, Filomeno; Doig, Christopher; Beran, Tanya; Wright, Bruce; Krigolson, Olav

    2016-01-01

    Clinical decision making requires knowledge, experience and analytical/non-analytical types of decision processes. As clinicians progress from novice to expert, research indicates decision-making becomes less reliant on foundational biomedical knowledge and more on previous experience. In this study, we investigated how knowledge and experience…

  16. The clinical significance of K-Cl cotransport activity in red cells of patients with HbSC disease.

    PubMed

    Rees, David C; Thein, Swee Lay; Osei, Anna; Drasar, Emma; Tewari, Sanjay; Hannemann, Anke; Gibson, John S

    2015-05-01

    HbSC disease is the second commonest form of sickle cell disease, with poorly understood pathophysiology and few treatments. We studied the role of K-Cl cotransport activity in determining clinical and laboratory features, and investigated its potential role as a biomarker. Samples were collected from 110 patients with HbSC disease and 41 with sickle cell anemia (HbSS). K-Cl cotransport activity was measured in the oxygenated (K-Cl cotransport(100)) and deoxygenated (K-Cl cotransport(0)) states, using radioactive tracer studies. K-Cl cotransport activity was high in HbSC and decreased significantly on deoxygenation. K-Cl cotransport activity correlated significantly and positively with the formation of sickle cells. On multiple regression analysis, K-Cl cotransport increased significantly and independently with increasing reticulocyte count and age. K-Cl cotransport activity was increased in patients who attended hospital with acute pain in 2011 compared to those who did not (K-Cl cotransport(100): mean 3.87 versus 3.20, P=0.009, independent samples T-test; K-Cl cotransport(0): mean 0.96 versus 0.68, P=0.037). On logistic regression only K-Cl cotransport was associated with hospital attendance. Increased K-Cl cotransport activity was associated with the presence of retinopathy, but this effect was confounded by age. This study links variability in a fundamental aspect of cellular pathology with a clinical outcome, suggesting that K-Cl cotransport is central to the pathology of HbSC disease. Increased K-Cl cotransport activity is associated with increasing age, which may be of pathophysiological significance. Effective inhibition of K-Cl cotransport activity is likely to be of therapeutic benefit.

  17. Investigation of Vibration Induced Artifact in Clinical Diffusion-Weighted Imaging of Pediatric Subjects

    PubMed Central

    Berl, Madison M.; Walker, Lindsay; Modi, Pooja; Irfanoglu, M. Okan; Sarlls, Joelle; Nayak, Amritha; Pierpaoli, Carlo

    2015-01-01

    It has been reported that mechanical vibrations of the MRI 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. PMID:26350492

  18. Investigating the Performance of Second Language Medical Students on Lengthy Clinical Vignettes.

    PubMed

    Raymond, Mark R; Ling, Yu; Grabovsky, Irina

    2016-10-19

    This study evaluated the extent to which medical students with limited English-language experience are differentially impacted by the additional reading load of test items consisting of long clinical vignettes. Participants included 25,012 examinees who completed Step 2 of the U.S. Medical Licensing Examination®. Test items were categorized into five levels based on the number of words per item, and examinee scores at each level were evaluated as a function of English-language experience (English as a second language [ESL] status and scores on a test of English-speaking proficiency). The longest items were more difficult than the shortest items across all examinee groups, and examinees with more English-language experience scored higher than those with less experience across all five levels of word count. The effect of primary interest-the interaction of word count with English-language experience-was statistically significant, indicating that score declines for longer items were larger for examinees with less English-language experience; however, the magnitude of this interaction effect was barely detectable (η(2) = .0004, p < .001). Additional analyses supported the conclusion that the differential effect for examinees with less English-language experience was small but worthy of continued monitoring.

  19. A cluster analysis to investigating nurses' knowledge, attitudes, and skills regarding the clinical management system.

    PubMed

    Chan, M F

    2007-01-01

    Nurses' knowledge, attitudes, and skills regarding the Clinical Management System are explored by identifying profiles of nurses working in Hong Kong. A total of 282 nurses from four hospitals completed a self-reported questionnaire during the period from December 2004 to May 2005. Two-step cluster analysis yielded two clusters. The first cluster (n = 159, 56.4%) was labeled "negative attitudes, less skillful, and average knowledge" group. The second cluster (n = 123, 43.6%) was labeled "positive attitudes, good knowledge, but less skillful." There was a positive correlation in cluster 1 for nurses' knowledge and attitudes (rs = 0.28) and in cluster 2 for nurses' skills and attitudes (rs = 0.25) toward computerization. The study showed that senior and more highly educated nurses generally held more positive attitudes to computerization, whereas the attitudes among younger and less well educated nurses generally were more negative. Such findings should be used to formulate strategies to encourage nurses to resolve actual problems following computer training and to increase the depth and breadth of nurses' computer knowledge and skills and improve their attitudes toward computerization.

  20. 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

  1. 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.

  2. 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

  3. 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.

  4. Investigating the prevention of hospital-acquired infection through standardized teaching ward rounds in clinical nursing.

    PubMed

    Zhang, R

    2015-04-22

    This study aimed to explore the effect of standardized teaching ward rounds in clinical nursing on preventing hospital-acquired infection. The experimental group comprised 120 nursing students from our hospital selected between June 2010 and June 2012. The control group consisted of 120 nursing students selected from May 2008 to May 2010. Traditional teaching ward rounds for nursing education were carried out with the control group, while a standardized teaching ward round was carried out with the experimental group. The comprehensive application of nursing abilities and skills, the mastering of situational infection knowledge, and patient satisfaction were compared between the two groups. The applied knowledge of nursing procedures and the pass rate on comprehensive skill tests were significantly higher in the experimental group than in the control group (P < 0.05). The rate of mastery of sterilization and hygiene procedures was also higher in the experimental group than in the control group (P < 0.05). The patient satisfaction rate with infection control procedures in the experimental group time period was 98.09%, which was significantly higher than patient satisfaction in the control group time period (93.05%, P < 0.05). Standardized teaching ward rounds for nursing education expanded the knowledge of the nursing staff in controlling hospital-acquired infection and enhanced the ability of comprehensive application and awareness of infection control procedures.

  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. 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

  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. 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.

  9. Infectious Diseases in the Nursing Home Setting: Challenges and Opportunities for Clinical Investigation

    PubMed Central

    Juthani-Mehta, Manisha; Quagliarello, Vincent J.

    2011-01-01

    The global population is aging. With the high prevalence of dementia and functional decline in older Americans, many aging adults with disabilities reside in nursing homes in their final stage of life. Immunosenescence, multiple comorbid disease, and grouped quarter living all coalesce in nursing home residents to increase the risk for infectious disease. The unique issues involved with diagnosis, prognosis, and management of infectious diseases in nursing home residents make research based in the nursing home setting both necessary and exciting for the physician investigator. This review discusses the opportunities and challenges involved with research of the evolving public health problem of infections among nursing home residents. PMID:20822459

  10. Identification of Clinically Used Drugs That Activate Pregnane X ReceptorsS⃞

    PubMed Central

    Shukla, Sunita J.; Sakamuru, Srilatha; Huang, Ruili; Moeller, Timothy A.; Shinn, Paul; VanLeer, Danielle; Auld, Douglas S.; Austin, Christopher P.

    2011-01-01

    The pregnane X receptor (PXR) binds xenobiotics and regulates the expression of several drug-metabolizing enzymes and transporters. Human PXR (hPXR) activation and CYP3A4 induction can be involved in drug-drug interactions, resulting in reduced efficacy or increased toxicity. However, there are known species-specific differences with regard to PXR activation that should be taken into account when animal PXR data are extrapolated to humans. We profiled 2816 clinically used drugs from the National Institutes of Health Chemical Genomics Center Pharmaceutical Collection for their ability to activate hPXR and rat PXR (rPXR) at the cellular level, induce human CYP3A4 at the cellular level, and bind human PXR at the protein level. From 6 to 11% of drugs were identified as active across the four assays, which included assay-specific and pan-active compounds. The lowest concordance was observed between the hPXR and rPXR assays, and many compounds active in both assays nonetheless demonstrated significant potency differences between species. Analysis based on clustering potency values demonstrated the greatest activity correlation between the hPXR activation and CYP3A4 induction assays. Structure-activity relationship analysis identified chemical scaffolds that were pan-active (e.g., dihydropyridine calcium channel blockers) and others that were uniquely active in individual assays (e.g., steroids and fatty acids). These results provide important information on PXR activation by clinically used drugs, highlight the species specificity of PXR activation by xenobiotics, and provide a means of prioritizing compounds for follow-up studies and optimization efforts. PMID:20966043

  11. Sulfite oxidase deficiency. Biochemical and clinical investigations of a hereditary metabolic disorder in sulfur metabolism.

    PubMed

    Shih, V E; Abroms, I F; Johnson, J L; Carney, M; Mandell, R; Robb, R M; Cloherty, J P; Rajagopalan, K V

    1977-11-10

    Study of a 4 1/2-year-old boy with the unusual combination of acute infantile hemiplegia, ectopia lentis and the absence of homocystinuria showed large amounts of abnormal sulfur-containing metabolites (sulfite, thiosulfate and S-sulfocysteine) in the urine. Sulfite and S-sulfocysteine were also present in the plasma. His inorganic sulfate excretion was only 50 per cent of total sulfur, as compared with 75 to 95 per cent by controls. Loading with L-cysteine hydrochloride and L-methionine further increased the excretion of sulfite and thiosulfate, but not inorganic sulfate excretion. Sulfite oxidase activity in skin fibroblasts average 1.07 nmol of cytochrome d reduced per milligram of protein per minute in control lines; it was not detectable (less than 5 per cent) in the patient. Activity was reduced in both parents (0.50 in the father and 0.32 in the mother)--compatible with autosomal recessive inheritance. Good biochemical responses to a low sulfur amino acid diet suggest that early treatment may benefit the patient.

  12. 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.

  13. Low-Dose Hyperradiosensitivity: Is There a Place for Future Investigation in Clinical Settings?

    SciTech Connect

    Valentini, Vincenzo; Massaccesi, Mariangela; Balducci, Mario; Mantini, Giovanna; Micciche, Francesco; Mattiucci, Gian Carlo; Dinapoli, Nicola; Meduri, Bruno; D'Agostino, Giuseppe Roberto; Salvi, Giovanna; Nardone, Luigia

    2010-02-01

    Background and Purpose: In vitro radiation doses of below 0.5 Gy have been shown to be more effective than higher doses per unit dose in killing clonogenic cells of many epithelial tumor cell lines. This phenomenon is known as low-dose hyperradiosensitivity. Preclinical studies have now suggested that there is synergism between chemotherapy and low-dose fractionated radiotherapy (LD-FRT). To test the clinical efficacy of this approach, we prospectively evaluated concurrent palliative chemotherapy and LD-FRT in patients with various types of epithelial tumors. Methods and Materials: Patients suffering from relapses or metastases of epithelial tumors were scheduled to receive concurrent LD-FRT (two fractions of 0.4 Gy per day) and chemotherapy. Radiologic assessments were performed after three cycles of chemotherapy plus LD-FRT. Results: Between June 2006 and October 2007, 12 patients with lung cancer, 7 patients with head-and-neck tumors, 2 patients with breast cancer, and 1 patient with esophageal carcinoma, for a total patient population of 22, underwent concomitant LD-FRT and chemotherapy. All patients but 3 (86%) had received previous treatments for their cancer. The median total dose of LD-FRT delivered was 800 cGy (range, 320-1280 cGy). The overall response rate was 45% (42% in previously treated patients). Grade 3-4 hematologic toxicities (Radiation Therapy Oncology Group ratings) were observed in 2 patients. At a median follow-up of 6.5 months, however, no local toxicity was observed. Conclusion: In our experience, concurrent LD-FRT and chemotherapy was well tolerated. Because the response rate seems promising, prospective Phase II studies of the strategy are now under way.

  14. In vitro activity of tigecycline against patient isolates collected during phase 3 clinical trials for hospital acquired pneumonia.

    PubMed

    Petersen, Peter J; Tuckman, Margareta; Jones, C Hal

    2010-02-03

    The in vitro activity of tigecycline was evaluated against 819 baseline pathogens isolated from 383 patients enrolled in the phase 3 clinical trial investigating the efficacy of tigecycline in hospital acquired pneumonia (HAP). The trials were global, enrolling patients in 27 countries. Tigecycline was active against the most prevalent pathogens in HAP, including gram-positive and gram-negative strains (90% of MICs ≤2 µg/mL for the entire collection). The spectrum of activity of tigecycline included important pathogens such as Staphylococcus aureus (including methicillin-resistant S. aureus), Enterococcus faecalis, Streptococcus pneumoniae, Acinetobacter baumannii/calcoaceticus complex, Escherichia coli, Klebsiella pneumonia, and Enterobacter cloacae. As reported previously, a few genera, such as Pseudomonas aeruginosa and the Proteeae, were generally less susceptible to tigecycline by comparison to other gram-negative pathogens. The excellent in vitro, expanded, broad-spectrum activity of tigecycline in the clinical isolates confirmed the potential utility of tigecycline for pathogens associated with with hospital acquired pneumonia infections.

  15. In vitro activity of tigecycline against patient isolates collected during phase 3 clinical trials for diabetic foot infections.

    PubMed

    Petersen, Peter J; Ruzin, Alexey; Tuckman, Margareta; Jones, C Hal

    2010-04-01

    The in vitro activity of tigecycline and comparative antimicrobial agents was evaluated against 1828 primary baseline pathogens isolated from 844 patients enrolled in the phase 3 clinical trials investigating the efficacy of tigecycline in diabetic foot infection (DFI). The trials were global, enrolling patients in 30 countries. Tigecycline was active against the most prevalent pathogens in DFI, including Gram-positive and Gram-negative isolates of both aerobic and anaerobic bacteria with 95% of MICs < or =2 microg/mL for the entire collection. The spectrum of activity of tigecycline included important pathogens for DFI, such as Staphylococcus aureus, Enterococcus faecalis, Streptococcus agalactiae, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis. As reported previously, Pseudomonas aeruginosa and several pathogens in the Proteeae group were generally less susceptible to tigecycline by comparison to other Gram-negative pathogens. The excellent in vitro expanded broad-spectrum activity of tigecycline in the clinical isolates confirmed the potential utility of tigecycline for pathogens associated with DFIs.

  16. In vitro activity of tigecycline against patient isolates collected during phase 3 clinical trials for hospital acquired pneumonia

    PubMed Central

    Petersen, Peter J.; Tuckman, Margareta; Jones, C. Hal

    2010-01-01

    The in vitro activity of tigecycline was evaluated against 819 baseline pathogens isolated from 383 patients enrolled in the phase 3 clinical trial investigating the efficacy of tigecycline in hospital acquired pneumonia (HAP). The trials were global, enrolling patients in 27 countries. Tigecycline was active against the most prevalent pathogens in HAP, including gram-positive and gram-negative strains (90% of MICs ≤2 µg/mL for the entire collection). The spectrum of activity of tigecycline included important pathogens such as Staphylococcus aureus (including methicillin-resistant S. aureus), Enterococcus faecalis, Streptococcus pneumoniae, Acinetobacter baumannii/calcoaceticus complex, Escherichia coli, Klebsiella pneumonia, and Enterobacter cloacae. As reported previously, a few genera, such as Pseudomonas aeruginosa and the Proteeae, were generally less susceptible to tigecycline by comparison to other gram-negative pathogens. The excellent in vitro, expanded, broad-spectrum activity of tigecycline in the clinical isolates confirmed the potential utility of tigecycline for pathogens associated with with hospital acquired pneumonia infections. PMID:24470884

  17. 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

  18. Perceived barriers and facilitators to increasing physical activity among people with musculoskeletal disorders: a qualitative investigation to inform intervention development

    PubMed Central

    McPhail, Steven M; Schippers, Mandy; Marshall, Alison L; Waite, Monique; Kuipers, Pim

    2014-01-01

    Purpose Musculoskeletal conditions can impair people’s ability to undertake physical activity as they age. The purpose of this qualitative study was to investigate perceived barriers and facilitators to undertaking physical activity reported by patients accessing ambulatory hospital clinics for musculoskeletal disorders. Patients and methods A questionnaire with open-ended items was administered to patients (n=217, 73.3% of 296 eligible) from three clinics providing ambulatory services for nonsurgical treatment of musculoskeletal disorders. The survey included questions to capture the clinical and demographic characteristics of the sample. It also comprised two open-ended questions requiring qualitative responses. The first asked the participant to describe factors that made physical activity more difficult, and the second asked which factors made it easier for them to be physically active. Participants’ responses to the two open-ended questions were read, coded, and thematically analyzed independently by two researchers, with a third researcher available to arbitrate any unresolved disagreement. Results The mean (standard deviation) age of participants was 53 (15) years; n=113 (52.1%) were male. A total of 112 (51.6%) participants reported having three or more health conditions; n=140 (64.5%) were classified as overweight or obese. Five overarching themes describing perceived barriers for undertaking physical activity were “health conditions”, “time restrictions”, “poor physical condition”, “emotional, social, and psychological barriers”, and “access to exercise opportunities”. Perceived physical activity facilitators were also aligned under five themes, namely “improved health state”, “social, emotional, and behavioral supports”, “access to exercise environment”, “opportunities for physical activities”, and “time availability”. Conclusion It was clear from the breadth of the data that meaningful supports and

  19. The effects of skin tone on race-related amygdala activity: an fMRI investigation

    PubMed Central

    Denson, Thomas F.; Lickel, Brian; Lu, Zhong-Lin; Nandy, Anirvan; Maddox, Keith B.

    2007-01-01

    Previous work has shown differential amygdala response to African-American faces by Caucasian individuals. Furthermore, behavioral studies have demonstrated the existence of skin tone bias, the tendency to prefer light skin to dark skin. In the present study, we used functional magnetic resonance imaging (fMRI) to investigate whether skin tone bias moderates differential race-related amygdala activity. Eleven White participants viewed photographs of unfamiliar Black and White faces with varied skin tone (light, dark). Replicating past research, greater amygdala activity was observed for Black faces than White faces. Furthermore, dark-skinned targets elicited more amygdala activity than light-skinned targets. However, these results were qualified by a significant interaction between race and skin tone, such that amygdala activity was observed at equivalent levels for light- and dark-skinned Black targets, but dark-skinned White targets elicited greater amygdala activity than light-skinned White targets. PMID:18985117

  20. Investigation of Biofilm Formation and its Association with the Molecular and Clinical Characteristics of Methicillin-resistant Staphylococcus aureus

    PubMed Central

    Cha, Jeong-Ok; Yoo, Jae Il; Yoo, Jung Sik; Chung, Hae-Sun; Park, Sun-Hee; Kim, Hwa Su; Lee, Yeong Seon; Chung, Gyung Tae

    2013-01-01

    Objectives To investigate the biofilm-forming related factors against MRSA bloodstream isolates and evaluates their clinical features and treatment outcomes by biofilm production. Methods We collected 126 consecutive methicillin-resistant Staphylococcus aureus (MRSA) causing blood stream infections (BSIs) at 10 tertiary hospitals from 2007 to 2009. We investigated biofilm-forming ability using a microtiter plate assay, and molecular characteristics including multilocus sequence typing, staphylococcal cassette chromosome mec and accessory gene regulator types. We compared the clinical characteristics and outcomes of patients infected with biofilm-forming and non-biofilm-forming MRSA isolates. Results Of the 126 samples, 86 (68.3%), including 5 strong level (OD570 ≥ 1.0) and 81 weak level (0.2 ≤ OD570 < 1.0), had biofilm-forming capacity. Detection of fibronectinbinding protein in biofilm-forming strains was significantly higher than biofilm non-forming ones (p = 0.001) and three enterotoxin genes (sec-seg-sei) islands had a high frequency regardless of biofilm production. However, biofilm-forming strains were more likely to be multidrug resistant (three or more non-β-lactam antibiotics) than biofilm non-forming ones [79.2% vs. 59.2%, p = 0.015, odds ratio (OR) 2.629, 95% confidence interval (CI) 1.92–5.81]. Clinical features of patients with BSIs caused by biofilm-forming MRSA strains were more likely to be hospital onset [77.9% vs. 60.0%, p = 0.024, OR 2.434, 95% CI 1.11–5.33) and more frequently occurred in patients with use of invasive devices [85.7% vs. 61.2%, p = 0.002, OR 3.879, 95% CI 1.61–8.97]. The other clinical features were compared with the clinical outcomes of the two groups and were not significant (p > 0.05). Conclusion Biofilm-forming MRSA strains showed higher frequency of fnbB gene than biofilm non-forming ones and more incidence rates on particular genotypes. And, their patient's features were not significantly different between two

  1. Do clinical and experimental investigations support an antiatherogenic role for dietary phytosterols/stanols?

    PubMed

    Lottenberg, Ana Maria; Bombo, Renata P A; Ilha, Angela; Nunes, Valeria Sutti; Nakandakare, Edna R; Quintão, Eder C R

    2012-04-01

    The plasma cholesterol-reducing effect of phytosterols (PS) has been recognized in several studies, but the usefulness of PS in preventing coronary heart disease remains controversial, as some investigations claim that the high PS concentrations found in plasma and specific tissues are related to an increased risk of cardiovascular events. It has also been demonstrated that PS may induce inflammation and reduce cholesterol efflux from macrophages, conditions that are directly implicated in the development of atherosclerosis. As to arterial dysfunction and atherosclerosis, some studies have concluded that plasma PS concentrations are unrelated or only weakly related or that PS intake or plasma PS concentrations are harmful. Thus, in light of the National Cholesterol Education Program-ATPIII report, it is necessary to evaluate the relevance of their findings. To this end, we have evaluated the studies conducted on cells, animal models, and humans regarding the influence of PS on the development of atherosclerosis.

  2. A clinical investigation of the surgical correction of myopia by the method of Fyodorov.

    PubMed

    Cowden, J W; Bores, L D

    1981-08-01

    The surgical correction of myopia using the method of Fyodorov known as radial keratotomy consists of 16 partial thickness, radial incisions in the cornea, which result in central flattening and peripheral bulging, reducing the degree of myopia. The purpose of this investigation was to determine: (1) the amount of myopia correctable; (2) the time required for stabilization of corneal curvature changes; (3) the degree to which the variables affect the results; (4) the surgical and postoperative complications; and (5) patient motivation and satisfaction. Preliminary results revealed a significant reduction of the myopia. The keratometry readings and refractive correction required appeared to stabilize by the third month. Fluctuating vision and increased glare were the most frequent complications encountered. The preliminary results of 20 cases followed for six months postradial keratotomy are reported.

  3. 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…

  4. 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…

  5. 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…

  6. 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…

  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. The Investigation of the Relation between Physical Activity and Academic Success

    ERIC Educational Resources Information Center

    Iri, Ruchan; Ibis, Serkan; Aktug, Zait Burak

    2017-01-01

    The purpose of the study is to investigate the interaction among Physical Activity Levels (PAL), academic successes, perceived academic competency and Motor Skills (MS) of male and female students at the age of 14-17 in terms of gender variable. The PALs, perceived academic competency and academic successes were determined through International…

  9. 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…

  10. 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…

  11. 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…

  12. 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…

  13. 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…

  14. Evaluation of some biological tests as parameters for microbial activities in soils. II. Field investigations.

    PubMed

    Abd-El-Malek, Y; Monib, M; Rizk, S G; Shehata, S M

    1976-01-01

    Investigations were designed to study the effect of certain factors on the microbial activities in soil. The parameters, used as an index of the microbial activities, were total bacterial counts, dehydrogenase activity, oxidation of organic carbon, and CO2 evolved/7 days. Bahteem Farm clay soil was examined for determining the effects of depth, type of fertilization, and crop rotation on the microbial activities. It appears that the microbial activities, as indicated by the tested parameters, were more pronounced in the surface 15 cm-layer than in the subsurface layer (15-30 cm). Results of all the parameters tested showed markedly higher increases with farmyard manure than with nitrogenous fertilizer and in the control, without significant differences between the latter two. Moreover, the time of sampling had no effect on the results obtained for all parameters. Different types of rotations did not exert significant variation in total bacterial counts, though more than one crop per year increased the organic carbon content of soil and mostly the dehydrogenase activity, whereas the evolution of CO2 tended to decrease. At Gabal el-Asfar Farm, the effect of irrigation with sewage effluent, for long periods, on the microbial activities of sandy soil was investigated. Sewage water stimulated the total bacteria, raised the dehydrogenase activity, the organic carbon, and the production of CO2. In North El Tahreer and Mariut Sectors, the effect of both the type and age of cultivation on the microbial activities in the calcareous soils were examined. Cultivation raised the figures of all the tested parameters progressively with time of cultivation. It was also noticed that crops exerted more beneficial effects on microbial activities than orchards, and the dehydrogenase test was the most reliable parameter to reveal this fact.

  15. Serum Calprotectin Discriminates Subclinical Disease Activity from Ultrasound-Defined Remission in Patients with Rheumatoid Arthritis in Clinical Remission

    PubMed Central

    Hulejova, Hana; Zavada, Jakub; Komarc, Martin; Hanova, Petra; Klein, Martin; Mann, Herman; Sleglova, Olga; Olejarova, Marta; Forejtova, Sarka; Ruzickova, Olga; Vencovsky, Jiri; Pavelka, Karel; Senolt, Ladislav

    2016-01-01

    Objective Clinical remission in some patients with rheumatoid arthritis (RA) may be associated with ongoing synovial inflammation that is not always detectable on clinical examination or reflected by laboratory tests but can be visualized by musculoskeletal ultrasound. The goal of our study was to determine the levels of serum calprotectin, a major leukocyte protein, in patients with RA in clinical remission and to investigate the ability of serum calprotectin levels to distinguish patients in ultrasound-defined remission from those with residual ultrasound subclinical inflammation. Methods Seventy RA patients in clinical remission underwent clinical and ultrasound examination. Ultrasound examination was performed according to the German US7 score. Ultrasound remission was defined as grey scale (GS) range 0–1 and power Doppler (PD) range 0. The levels of serum calprotectin and C-reactive protein (CRP) were determined. The discriminatory capacity of calprotectin and CRP in detecting residual ultrasound inflammation was assessed using ROC curves. Results The total number of patients fulfilling the DAS28-ESR, DAS28-CRP, SDAI and CDAI remission criteria was 58, 67, 32 and 31, respectively. Residual synovial inflammation was found in 58–67% of the patients who fulfilled at least one set of clinical remission criteria. Calprotectin levels were significantly higher in patients with residual synovial inflammation than in those with ultrasound-defined remission (mean 2.5±1.3 vs. 1.7±0.8 μg/mL, p<0.005). Using ultrasound-defined remission criteria, calprotectin had an AUC of 0.692, p<0.05 using DAS28-ESR remission criteria and an AUC of 0.712, p<0.005 using DAS28-CRP remission criteria. Calprotectin correctly distinguished ultrasound remission from subclinical activity in 70% of patients. CRP (AUC DAS28-ESR = 0.494, p = NS; AUC DAS28-CRP = 0.498, p = NS) had lower and insignificant discriminatory capacity. Conclusion The present study demonstrates the potential of

  16. Emergence of quantification in clinical investigation and the quest for certainty in therapeutics: the road from Hammurabi to Kefauver.

    PubMed

    Eknoyan, Garabed

    2005-01-01

    Throughout most of history, medical knowledge was descriptive in nature and derived from the work of individual investigators of independent mind pursuing careful but often chance observations. Using deductive reasoning, these findings were then generalized, authoritatively presented, and dogmatically promulgated. This, coupled with firmly grounded principles of divine determinism, precluded any serious consideration of randomness, even when variations from recorded, but erroneous, statements were actually observed. Although probability remained an integral component of diagnosis and therapy, it was only as an attribute of opinion and not one supported by numbers. The gradual erosion of this edifice began during the scientific revolution of the seventeenth century that led to the burgeoning of the sciences basic to medicine. Although clinicians applauded these contributions, they failed to apply the inductive method of investigation to the study of disease or to therapy. The "numerical method" of Pierre Louis (1787-1872) first introduced systematic quantification into medicine during the first half of the nineteenth century. Analysis of quantifiable data found its principal application in epidemiology, which flourished during the second half of the nineteenth century. The subsequent adoption of probability calculus for the analysis of quantifiable data, during the first half of the twentieth century, refined the process further and led to the gradual emergence of medical statistics, with a distinct role in clinical research. The mathematical precision provided by quantification and statistical analysis established certainty in medicine and ultimately changed the conjectural art of clinical practice into a disciplined science founded on clinical investigation, the very basis of present-day, evidence-based medicine.

  17. [Multi-organ failure as first clinical sign of macrophage activation syndrome in childhood Still's disease].

    PubMed

    López-Sánchez, M; Rubio-López, I; Obeso-González, T; Teja-Barbero, J L; Santidrián-Miguel, J P; Peiro-Callizo, E

    2010-10-01

    Macrophage activation syndrome is a form of secondary haemophagocytic lymphohistiocytosis seen in the context of rheumatic diseases. It is seen most frequently in association with systemic onset juvenile arthritis or childhood Still's disease. Hemophagocytosis is part of a sepsis-like clinical syndrome caused by hypercytokinemia due to a highly stimulated but ineffective immune response. Coagulopathy and hemorrhages, decreased white cell count, elevated levels of aspartate aminotransferase, fever, rash, hepatosplenomegaly and central nervous system dysfunction are some of diagnostic criteria of macrophage activation syndrome, but it is very difficult to diagnose due to the lack of specific clinical signs. We report a 8-year-old child who was admitted to the ICU with lethargy, fever, acute respiratory failure, coagulopathy, metabolic acidosis and multiorgan failure. Septic shock was suspected, but he was diagnosed with macrophage activation syndrome and treated with corticosteroids and intravenous immunoglobulin and later discharged from the ICU.

  18. [Active alveolar expansion for prevention of postoperative atelectasis. Functional and clinical effectiveness].

    PubMed

    Adolf, J; Dickmann, A

    1985-12-13

    In a prospective study, the functional and clinical effectiveness of active alveolar expansion was tested by means of an incentive spirometer on 30 patients each of a treatment and control group. All patients (average age 61 and 58 years, respectively) had undergone a transabdominal pelvic artery reconstruction. Pre-operatively active alveolar expansion significantly reduced intrapulmonary right to left shunting from 11.1% to 4.2% of cardiac output (P less than 0.01). Correspondingly, right to left shunting on the second to fifth postoperative day was reduced significantly (P less than 0.05) by 5-10% of cardiac output in the treatment group, cardiac output being significantly (P less than 0.05) reduced by 1 l/min average. Clinically and radiologically there was a definite reduction in pulmonary complications from 40% to 13%. Peri-operatively performed active alveolar expansion is thus an effective method for the reduction of postoperative functional atelectasis and pulmonary complications.

  19. Steroid therapy in clinically stable but serologically active systemic lupus erythematosus prevents severe disease flares.

    PubMed

    Cardiel, Mario H; Almagro, Raúl Menor

    2007-05-01

    Evaluation of: Tseng CE, Buyon JP, Kim M et al. The effect of moderate-dose corticosteroids in preventing severe flares in patients with serologically active, but clinically stable, systemic lupus erythematosus: findings of a prospective, randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 54, 3623-3632 (2006). Systemic lupus erythematosus is an autoimmune disease of unknown origin. Flares and remissions are commonly seen in clinical settings. These clinical flares can have several degrees of severity, some of which require intensive immunosuppressive treatment and/or hospitalization. Clinicians treating these patients have looked at different strategies for prevention, early detection and prompt treatment of a lupus flare. Clinical information and laboratory findings have been proposed to reach these goals and preventive steroid adjustment has even been used in some cases without convincing results. This paper presents results from a controlled, multicenter, double-blind clinical trial evaluating the effectiveness of short-term corticosteroid treatment for preventing severe flares in which elevations of C3a by 50% were accompanied by a 25% increase in the anti-double-stranded DNA titer in patients with inactive or stable/active systemic lupus erythematosus. Results suggest that this strategy can prevent severe lupus flares.

  20. 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.

  1. Design, synthesis, and biological evaluation of novel investigational nonapeptide KISS1R agonists with testosterone-suppressive activity.

    PubMed

    Asami, Taiji; Nishizawa, Naoki; Matsui, Hisanori; Nishibori, Kimiko; Ishibashi, Yoshihiro; Horikoshi, Yasuko; Nakayama, Masaharu; Matsumoto, Shin-ichi; Tarui, Naoki; Yamaguchi, Masashi; Matsumoto, Hirokazu; Ohtaki, Tetsuya; Kitada, Chieko

    2013-11-14

    Metastin/kisspeptin is a 54 amino acid peptide ligand of the KISS1R receptor and is a critical regulator of GnRH secretion. The N-terminally truncated peptide, metastin(45-54), possesses a 10-fold higher receptor-binding affinity than full-length metastin and agonistic KISS1R activity but is rapidly inactivated in rodent plasma. We have developed a decapeptide analog [D-Tyr(45),D-Trp(47),azaGly(51),Arg(Me)(53)]metastin(45-54) with improved serum stability compared with metastin(45-54) but with decreased KISS1R agonistic activity. Amino acid replacements at positions 45-47 led to an enhancement of KISS1R agonistic activity and metabolic stability. N-terminal truncation resulted in a stable nonapeptide, [D-Tyr(46),D-Pya(4)(47),azaGly(51),Arg(Me)(53)]metastin(46-54), compound 26, which displayed KISS1R binding affinities comparable to metastin(45-54) and had improved serum stability. Compound 26 reduced plasma testosterone in male rats and is the first short-length metastin analog to possess testosterone suppressive activities. Compound 26 has led to the elucidation of investigational analogs TAK-683 and TAK-448, both of which have undergone clinical evaluation for hormone-dependent diseases such as prostate cancer.

  2. Ellagic acid derivatives from Syzygium cumini stem bark: investigation of their antiplasmodial activity.

    PubMed

    Simões-Pires, Claudia A; Vargas, Sandra; Marston, Andrew; Ioset, Jean-Robert; Paulo, Marçal Q; Matheeussen, An; Maes, Louis

    2009-10-01

    Bioguided fractionation of Syzygium cumini (Myrtaceae) bark decoction for antiplasmodial activity was performed, leading to the isolation of three known ellagic acid derivatives (ellagic acid, ellagic acid 4-O-alpha-L-2"-acetylrhamnopyranoside, 3-O-methylellagic acid 3'-O-alpha-L-rhamnopyranoside), as well as the new derivative 3-O-methylellagic acid 3'-O-beta-D-glucopyranoside. Activity investigation was based on the reduction of P. falciparum (PfK1) parasitaemia in vitro and the inhibition of beta-hematin formation, a known mechanism of action of some antimalarial drugs. Among the investigated ellagic acid derivatives, only ellagic acid was able to reduce P. falciparum parasitaemia in vitro and inhibit beta-hematin formation, suggesting that free hydroxyl groups are necessary for activity within this class of compounds.

  3. 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.

  4. World's First Clinical Case of Gene-Activated Bone Substitute Application

    PubMed Central

    Deev, R. V.; Drobyshev, A. Y.; Isaev, A. A.; Eremin, I. I.

    2016-01-01

    Treatment of patients with large bone defects is a complex clinical problem. We have initiated the first clinical study of a gene-activated bone substitute composed of the collagen-hydroxyapatite scaffold and plasmid DNA encoding vascular endothelial growth factor. The first patient with two nonunions of previously reconstructed mandible was enrolled into the study. Scar tissues were excised; bone defects (5–14 mm) between the mandibular fragments and nonvascularized rib-bone autograft were filled in with the gene-activated bone substitute. No adverse events were observed during 12 months of follow-up. In 3 months, the average density of newly formed tissues within the implantation zone was 402.21 ± 84.40 and 447.68 ± 106.75 HU in the frontal and distal regions, respectively, which correlated with the density of spongy bone. Complete distal bone defect repair with vestibular and lingual cortical plates formation was observed in 6 and 12 months after surgery; thereby the posterior nonunion was successfully eliminated. However, there was partial resorption of the proximal edge of the autograft entailed to relapse of the anterior nonunion. Thus, the first clinical data on the safety and efficacy of the gene-activated bone substitute were obtained. Given a high complexity of the clinical situation the treatment, results might be considered as promising. NCT02293031. PMID:27891264

  5. 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

  6. Helicobacter pylori neutrophil-activating protein: from molecular pathogenesis to clinical applications.

    PubMed

    Fu, Hua-Wen

    2014-05-14

    Helicobacter pylori (H. pylori) neutrophil-activating protein (HP-NAP) was originally identified as a virulence factor of H. pylori for its ability to activate neutrophils to generate respiratory burst by releasing reactive oxygen species. Later on, HP-NAP was also found to be involved in the protection of H. pylori from DNA damage, supporting the survival of H. pylori under oxidative stress. This protein is highly conserved and expressed by virtually all clinical isolates of H. pylori. The majority of patients infected with H. pylori produced antibodies specific for HP-NAP, suggesting its important role in immunity. In addition to acting as a pathogenic factor by activating the innate immunity through a wide range of human leukocytes, including neutrophils, monocytes, and mast cells, HP-NAP also mediates adaptive immunity through the induction of T helper cell type I responses. The pro-inflammatory and immunomodulatory properties of HP-NAP not only make it play an important role in disease pathogenesis but also make it a potential candidate for clinical use. Even though there is no convincing evidence to link HP-NAP to a disease outcome, recent findings supporting the pathogenic role of HP-NAP will be reviewed. In addition, the potential clinical applications of HP-NAP in vaccine development, clinical diagnosis, and drug development will be discussed.

  7. A language activity monitor for supporting AAC evidence-based clinical practice.

    PubMed

    Hill, K J; Romich, B A

    2001-01-01

    Augmentative and alternative communication (AAC) evidence-based practice requires the collection and analysis of performance data. This article presents the development, evaluation, and application of automated performance monitoring tools for use in clinical practice. Language activity monitoring (LAM) is the systematic data collection of the actual language activity of an individual who relies on AAC. Work completed to date includes the development and evaluation of the language activity monitor function, which now is commercially available in three forms: (1) a standard feature built into modern high performance AAC systems, (2) an external add-on package for use with older AAC devices based on synthetic speech, and (3) software that allows the personal computer to serve as an LAM in the clinical environment. The LAM records the time and content of language events (the generation of one or more letters or words). A logging protocol suitable for clinical application has been in use since late 1998. The logged data is uploaded periodically to a computer for editing, analysis, and the generation of a summary measure report. The applications of this work in the areas of clinical service delivery are presented.

  8. 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.

  9. 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.

  10. 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.

  11. Investigating Molecular Mechanisms of Activation and Mutation of the HER2 Receptor Tyrosine Kinase through Computational Modeling and Simulation.

    PubMed

    Telesco, Shannon E; Shih, Andrew; Liu, Yingting; Radhakrishnan, Ravi

    2011-01-01

    Human epidermal growth factor receptor 2 (HER2)/ErbB2 is a receptor tyrosine kinase belonging to the EGFR/ErbB family and is overexpressed in 20-30% of human breast cancers. Since there is a growing effort to develop pharmacological inhibitors of the HER2 kinase for the treatment of breast cancer, it is clinically valuable to rationalize how specific mutations impact the molecular mechanism of receptor activation. Although several crystal structures of the ErbB kinases have been solved, the precise mechanism of HER2 activation remains unknown, and it has been suggested that HER2 is unique in its requirement for phosphorylation of Y877, a key tyrosine residue located in the activation loop (A-loop). In our studies, discussed here, we have investigated the mechanisms that are important in HER2 kinase domain regulation and compared them with the other ErbB family members, namely EGFR and ErbB4, to determine the molecular basis for HER2's unique mode of activation. We apply computational simulation techniques at the atomic level and at the electronic structure (quantum mechanical) level to elucidate details of the mechanisms governing the kinase domains of these ErbB members. Through analysis of our simulation results, we have discovered potential regulatory mechanisms common to EGFR, HER2, and ErbB4, including a tight coupling between the A-loop and catalytic loop that may contribute to alignment of residues required for catalysis in the active kinase. We further postulate an autoinhibitory mechanism whereby the inactive kinase is stabilized through sequestration of catalytic residues. In HER2, we also predict a role for phosphorylated Y877 in bridging a network of hydrogen bonds that fasten the A-loop in its active conformation, suggesting that HER2 may be unique among the ErbB members in requiring A-loop tyrosine phosphorylation for functionality. In EGFR, HER2, and ErbB4, we discuss the possible effects of activating mutations. Delineation of the activation

  12. Clinical neurological examination, neuropsychology, electroencephalography and computed tomographic head scanning in active amateur boxers.

    PubMed

    McLatchie, G; Brooks, N; Galbraith, S; Hutchison, J S; Wilson, L; Melville, I; Teasdale, E

    1987-01-01

    Twenty active amateur boxers were studied seeking evidence of neurological dysfunction and, if present, the best method for detecting it. Seven of these boxers had an abnormal clinical neurological examination, eight an abnormal EEG and nine of 15 examined had abnormal neuropsychometry. The CT scan was abnormal in only one. An abnormal clinical examination correlated significantly (p less than 0.05) with an increasing number of fights, and an abnormal EEG with decreasing age (p less than 0.05). In several of the neuropsychometric tests, the boxers were significantly worse than controls (p less than 0.05). Neuropsychometry was the best method for detecting neurological dysfunction.

  13. Clinical activity of sunitinib in patients with advanced desmoplastic round cell tumor: a case series.

    PubMed

    Italiano, Antoine; Kind, Michèle; Cioffi, Angela; Maki, Robert G; Bui, Binh

    2013-09-01

    Desmoplastic small round cell tumor (DSRCT) is a rare and aggressive malignancy with poor outcome occurring in adolescents and young adults. Therapeutic options for patients with advanced disease are limited. Preclinical studies have shown that VEGFR-2 and VEGFA are overexpressed in DSRCT and that DSRCT xenografts were highly responsive to anti-VEGF agents such as bevacizumab. We report here the clinical activity of sunitinib in eight patients with DSCRT. Our data suggest that sunitinib may be associated with clinical benefit even in heavily pretreated patients.

  14. 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).

  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. Preliminary investigation on the phytochemistry and antimicrobial activity of Senna alata L. flower.

    PubMed

    Idu, M; Omonigho, S E; Igeleke, C L

    2007-03-01

    Preliminary studies on the phytochemistry and extracts of water, methanol, chloroform and petroleum ether, of Senna alata flowers were examined for antimicrobial properties. Extracts tested at a final concentration of 500 microg mL(-1) produced in vitro antimicrobial activities in assays against clinical isolates of Staphylococus aureus, Candida albicans, Escherichia coli, Proteus vulgaris, Pseudomonans aureginosa and Bacillus subtilis. The zones of inhibitions produced by the extracts in agar diffusion assay against the test micro organisms ranged from 4 to 10 mm while the gentamycin antibiotic control, produced zones that measured 5 mm. Preliminary phytochemical analysis of the plant extracts showed the presence of phenols, tannins, anthraquinoes, saponins, flavonoids.

  17. Investigation of photodynamic activity of water-soluble porphyrins in vitro and in vivo

    NASA Astrophysics Data System (ADS)

    Gyulkhandanyan, Grigor V.; Ghambaryan, Sona S.; Amelyan, Gayane V.; Ghazaryan, Robert K.; Arsenyan, Flora H.; Gyulkhandanyan, Aram G.

    2006-02-01

    Photodynamic therapy (PDT) is the method of photosensitized tumor treatment. It is based on the photosensitizer (PS) selective accumulation in tumors, its subsequent activation under the light influence and oxygen active form formation that results in tumor destruction. Photodynamic action of some new water-soluble porphyrins was investigated in our laboratory. Dose-dependent effect of these porphyrins was shown on PC-12 murine pheochromocytoma cell line. The results revealed that the efficiency of the investigated porphyrins decreased in the following way: TOEPyP (meso-tetra-(4-N-oxyethylpyridyl)porphyrin) > Zn-TOEPyP > Ag-TOEPyP. It was shown that TOEPyP possessed nearly the same photodynamic activity (LD50) as well-known photosensitizer chlorin e6. These porphyrins have also demonstrated quite high photodynamic activity in vivo. The results were obtained in the experiments on white mice with engrafted C-180 (Croker's sarcoma). Antitumor activity of these porphyrins in the dark was 30-40%, whereas photodynamic activity was 45-60%.

  18. Application of PCR to a clinical and environmental investigation of a case of equine botulism.

    PubMed Central

    Szabo, E A; Pemberton, J M; Gibson, A M; Thomas, R J; Pascoe, R R; Desmarchelier, P M

    1994-01-01

    PCR for the detection of botulinum neurotoxin gene types A to E was used in the investigation of a case of equine botulism. Samples from a foal diagnosed with toxicoinfectious botulism in 1985 were reanalyzed by PCR and the mouse bioassay in conjunction with an environmental survey. Neurotoxin B was detected by mouse bioassay in culture enrichments of serum, spleen, feces, and intestinal contents. PCR results compared well with mouse bioassay results, detecting type B neurotoxin genes in these samples and also in a liver sample. Other neurotoxin types were not detected by either test. Clostridium botulinum type B was shown to be prevalent in soils collected from the area in which the foal was raised. Four methods were used to test for the presence of botulinum neurotoxin-producing organisms in 66 soil samples taken within a 5-km radius: PCR and agarose gel electrophoresis (types A to E), PCR and an enzyme-linked assay (type B), hybridization of crude alkaline cell lysates with a type B-specific probe, and the mouse bioassay (all types). Fewer soil samples were positive for C. botulinum type B by the mouse bioassay (15%) than by any of the DNA-based detection systems. Hybridization of a type B-specific probe to DNA dot blots (26% of the samples were positive) and PCR-enzyme-linked assay (77% of the samples were positive) were used for the rapid analysis of large numbers of samples, with sensitivity limits of 3 x 10(6) and 3,000 cells, respectively. Conventional detection of PCR products by gel electrophoresis was the most sensitive method (300-cell limit), and in the present environmental survey, neurotoxin B genes only were detected in 94% of the samples. Images PMID:7989554

  19. 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.

  20. 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

  1. Antibacterial activity of crotalid venoms against oral snake flora and other clinical bacteria.

    PubMed

    Talan, D A; Citron, D M; Overturf, G D; Singer, B; Froman, P; Goldstein, E J

    1991-07-01

    Despite heavy oral and fang contamination of crotalid species with a wide variety of potentially pathogenic bacteria, crotalid envenomation is associated with a low incidence of bacterial infection. Minimal inhibitory and bactericidal concentrations of venoms from three crotalid species were determined against six aerobic and eight anaerobic reference and oral crotalid microorganisms. All anaerobic isolates were resistant to greater than 20,480 micrograms/ml, whereas variable activity (range, 5-20,480 micrograms/ml) was observed for aerobic strains. Further studies against other aerobic clinical isolates demonstrated that venom had the greatest activity (MIC, less than or equal to 80 micrograms/ml) against staphylococci, Pseudomonas aeruginosa, and Enterobacter, Citrobacter, Proteus, and Morganella species. Inhibitory activity was lost with prolonged incubation for many gram-negative species. Crotalid venoms are broadly active against aerobic gram-negative and -positive bacteria. This activity may play a role in the low incidence of infection after envenomation injuries.

  2. 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

  3. The Contribution of Antibiotic Resistance Mechanisms in Clinical Burkholderia cepacia Complex Isolates: An Emphasis on Efflux Pump Activity

    PubMed Central

    Tseng, Sung-Pin; Tsai, Wan-Chi; Liang, Chih-Yuan; Lin, Yin-Shiou; Huang, Jun-Wei; Chang, Chung-Yu; Tyan, Yu-Chang; Lu, Po-Liang

    2014-01-01

    Due to the limited information of the contribution of various antibiotic resistance mechanisms in clinical Burkholderia cepacia complex isolates, Antibiotic resistance mechanisms, including integron analysis, identification of quinolone resistance-determining region mutations, measurement of efflux pump activity, and sequence analysis of efflux pump regulators, were investigated in 66 clinical B. cepacia complex isolates. Species were identified via recA-RFLP and MALDI-TOF. Four genomovars were identified by recA-RFLP. B. cenocepacia (genomovar III) was the most prevalent genomovar (90.1%). Most isolates (60/66, 90.9%) were correctly identified by MALDI-TOF analysis. Clonal relatedness determined by PFGE analysis revealed 30 pulsotypes, including two major pulsotypes that comprised 22.7% and 18.2% of the isolates, respectively. Seventeen (25.8%) isolates harboured class 1 integron with various combinations of resistance genes. Among six levofloxacin-resistant isolates, five had single-base substitutions in the gyrA gene and three demonstrated efflux pump activities. Among the 42 isolates exhibiting resistance to at least one antimicrobial agent, 94.4% ceftazidime-resistant isolates (17/18) and 72.7% chloramphenicol-resistant isolates (16/22) demonstrated efflux pump activity. Quantitation of efflux pump RNA level and sequence analysis revealed that over-expression of the RND-3 efflux pump was attributable to specific mutations in the RND-3 efflux pump regulator gene. In conclusion, high-level expression of efflux pumps is prevalent in B. cepacia complex isolates. Mutations in the RND-3 efflux pump regulator gene are the major cause of efflux pump activity, resulting in the resistance to antibiotics in clinical B. cepacia complex isolates. PMID:25153194

  4. The contribution of antibiotic resistance mechanisms in clinical Burkholderia cepacia complex isolates: an emphasis on efflux pump activity.

    PubMed

    Tseng, Sung-Pin; Tsai, Wan-Chi; Liang, Chih-Yuan; Lin, Yin-Shiou; Huang, Jun-Wei; Chang, Chung-Yu; Tyan, Yu-Chang; Lu, Po-Liang

    2014-01-01

    Due to the limited information of the contribution of various antibiotic resistance mechanisms in clinical Burkholderia cepacia complex isolates, Antibiotic resistance mechanisms, including integron analysis, identification of quinolone resistance-determining region mutations, measurement of efflux pump activity, and sequence analysis of efflux pump regulators, were investigated in 66 clinical B. cepacia complex isolates. Species were identified via recA-RFLP and MALDI-TOF. Four genomovars were identified by recA-RFLP. B. cenocepacia (genomovar III) was the most prevalent genomovar (90.1%). Most isolates (60/66, 90.9%) were correctly identified by MALDI-TOF analysis. Clonal relatedness determined by PFGE analysis revealed 30 pulsotypes, including two major pulsotypes that comprised 22.7% and 18.2% of the isolates, respectively. Seventeen (25.8%) isolates harboured class 1 integron with various combinations of resistance genes. Among six levofloxacin-resistant isolates, five had single-base substitutions in the gyrA gene and three demonstrated efflux pump activities. Among the 42 isolates exhibiting resistance to at least one antimicrobial agent, 94.4% ceftazidime-resistant isolates (17/18) and 72.7% chloramphenicol-resistant isolates (16/22) demonstrated efflux pump activity. Quantitation of efflux pump RNA level and sequence analysis revealed that over-expression of the RND-3 efflux pump was attributable to specific mutations in the RND-3 efflux pump regulator gene. In conclusion, high-level expression of efflux pumps is prevalent in B. cepacia complex isolates. Mutations in the RND-3 efflux pump regulator gene are the major cause of efflux pump activity, resulting in the resistance to antibiotics in clinical B. cepacia complex isolates.

  5. Primary Sjögren's syndrome--clinical and laboratory markers of disease activity.

    PubMed

    Oxholm, P

    1992-10-01

    Primary Sjögren's syndrome is a chronic autoimmune disorder of the lacrimal and salivary glands, reflecting general involvement of the exocrine tissues and leading to functional impairment. This polyglandular disease is often associated with systemic extraglandular manifestations, and laboratory tests usually indicate polyclonal B-lymphocyte hyperactivity. Clinical and laboratory markers monitoring the disease processes are needed for improved management of primary Sjögren's syndrome. However, incomplete knowledge of the long-term course of inflammation as well as of clinical manifestations makes precise and simple directions for monitoring disease activity in primary Sjögren's syndrome difficult. This review describes potential primary (eg, salivary gland histopathology, autoantibodies, soluble interleukin-2 receptors, and beta 2-microglobulin) and secondary disease activity markers (clinical and laboratory signs of glandular and extraglandular organ damage) and their known associations. The importance of genetic characteristics, patient age, and symptom duration for the disease activity markers is indicated. The systematic use of primary and secondary disease activity markers will improve our understanding of primary Sjögren's syndrome and help create better guidelines for monitoring the disease.

  6. Epipolymorphisms associated with the clinical outcome of autoimmune arthritis affect CD4+ T cell activation pathways.

    PubMed

    Spreafico, Roberto; Rossetti, Maura; Whitaker, John W; Wang, Wei; Lovell, Daniel J; Albani, Salvatore

    2016-11-29

    Multifactorial diseases, including autoimmune juvenile idiopathic arthritis (JIA), result from a complex interplay between genetics and environment. Epigenetic mechanisms are believed to integrate such gene-environment interactions, fine-tuning gene expression, and possibly contributing to immune system dysregulation. Although anti-TNF therapy has strongly increased JIA remission rates, it is not curative and up to 80% of patients flare upon treatment withdrawal. Thus, a crucial unmet medical and scientific need is to understand the immunological mechanisms associated with remission or flare to inform clinical decisions. Here, we explored the CD4(+) T-cell DNA methylome of 68 poly-articular and extended oligo-articular JIA patients, before and after anti-TNF therapy withdrawal, to identify features associated with maintenance of inactive disease. Individual CpG sites were clustered in coherent modules without a priori knowledge of their function through network analysis. The methylation level of several CpG modules, specifically those enriched in CpG sites belonging to genes that mediate T-cell activation, uniquely correlated with clinical activity. Differences in DNA methylation were already detectable at the time of therapy discontinuation, suggesting epigenetic predisposition. RNA profiling also detected differences in T-cell activation markers (including HLA-DR) but, overall, its sensitivity was lower than epigenetic profiling. Changes to the T-cell activation signature at the protein level were detectable by flow cytometry, confirming the biological relevance of the observed alterations in methylation. Our work proposes epigenetic discrimination between clinical activity states, and reveals T-cell-related biological functions tied to, and possibly predicting or causing, clinical outcome.

  7. Enhancement of antibiotic activity by efflux inhibitors against multidrug resistant Mycobacterium tuberculosis clinical isolates from Brazil.

    PubMed

    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.

  8. Epipolymorphisms associated with the clinical outcome of autoimmune arthritis affect CD4+ T cell activation pathways

    PubMed Central

    Spreafico, Roberto; Rossetti, Maura; Whitaker, John W.; Wang, Wei; Lovell, Daniel J.; Albani, Salvatore

    2016-01-01

    Multifactorial diseases, including autoimmune juvenile idiopathic arthritis (JIA), result from a complex interplay between genetics and environment. Epigenetic mechanisms are believed to integrate such gene–environment interactions, fine-tuning gene expression, and possibly contributing to immune system dysregulation. Although anti-TNF therapy has strongly increased JIA remission rates, it is not curative and up to 80% of patients flare upon treatment withdrawal. Thus, a crucial unmet medical and scientific need is to understand the immunological mechanisms associated with remission or flare to inform clinical decisions. Here, we explored the CD4+ T-cell DNA methylome of 68 poly-articular and extended oligo-articular JIA patients, before and after anti-TNF therapy withdrawal, to identify features associated with maintenance of inactive disease. Individual CpG sites were clustered in coherent modules without a priori knowledge of their function through network analysis. The methylation level of several CpG modules, specifically those enriched in CpG sites belonging to genes that mediate T-cell activation, uniquely correlated with clinical activity. Differences in DNA methylation were already detectable at the time of therapy discontinuation, suggesting epigenetic predisposition. RNA profiling also detected differences in T-cell activation markers (including HLA-DR) but, overall, its sensitivity was lower than epigenetic profiling. Changes to the T-cell activation signature at the protein level were detectable by flow cytometry, confirming the biological relevance of the observed alterations in methylation. Our work proposes epigenetic discrimination between clinical activity states, and reveals T-cell–related biological functions tied to, and possibly predicting or causing, clinical outcome. PMID:27849614

  9. 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.

  10. 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

  11. In vitro activity of U-63196E, a new cephalosporin, against clinical bacterial isolates.

    PubMed Central

    Eliopoulos, G M; Gardella, A; DeGirolami, P; Moellering, R C

    1984-01-01

    The in vitro activity of U-63196E, a new cephalosporin, was compared with those of other extended-spectrum cephalosporins and penicillins against clinical bacterial isolates. Against Pseudomonas aeruginosa, the activity of U-63196E was comparable to those of cefoperazone and piperacillin, each of which inhibited 90% of strains at concentrations of less than or equal to 16 micrograms/ml. The new drug also demonstrated activity against a variety of other bacterial species, but it was generally less active than cefotaxime, moxalactam, and cefoperazone against members of the family Enterobacteriaceae and staphylococci. The presence of any 1 of 10 plasmid-mediated beta-lactamases in a series of otherwise isogenic laboratory strains of P. aeruginosa resulted in a significant reduction in the activity of U-63196E in comparison with its activity against the parent strain, which lacks these enzymes. Combinations of U-63196E with tobramycin demonstrated bacteriostatic synergism against 11 of 20 clinical isolates of P. aeruginosa. PMID:6610385

  12. Clinical significance of plasminogen activator inhibitor activity in patients with exercise-induced ischemia

    SciTech Connect

    Sakata, K.; Kurata, C.; Taguchi, T.; Suzuki, S.; Kobayashi, A.; Yamazaki, N.; Rydzewski, A.; Takada, Y.; Takada, A. )

    1990-10-01

    To assess the fibrinolytic system in patients with exercise-induced ischemia and its relation to ischemia and severity of coronary artery disease (CAD), 47 patients with CAD confirmed by results of coronary angiography underwent symptom-limited multistage exercise thallium-201 emission computed tomography. All patients with CAD had exercise-induced ischemia as assessed from thallium-201 images. Pre- and peak exercise blood samples from each patient and preexercise blood samples from control subjects were assayed for several fibrinolytic components and were also assayed for plasma adrenaline. The extent of ischemia was defined as delta visual uptake score (total visual uptake score in delayed images minus total visual uptake score in initial images) and the severity of CAD as the number of diseased vessels. In the basal condition, plasminogen activator inhibitor (PAI) activity was significantly higher in patients with exercise-induced ischemia as compared to control subjects (p less than 0.01), although there were no significant differences in other fibrinolytic variables between the two groups. Moreover, PAI activity in the basal condition displayed a significantly positive correlation with the extent of ischemia (r = 0.47, p less than 0.01). Patients with exercise-induced ischemia were divided into two groups (24 with single-vessel disease and 23 with multivessel disease). There were no significant differences in coronary risk factors, hemodynamics, or plasma adrenaline levels during exercise between single-vessel and multivessel disease except that delta visual uptake score was significantly higher in multivessel disease (p less than 0.01).

  13. Antibacterial activity of three newly-synthesized chalcones & synergism with antibiotics against clinical isolates of methicillin-resistant Staphylococcus aureus

    PubMed Central

    Božić, Dragana D.; Milenković, Marina; Ivković, Branka; Cirković, Ivana

    2014-01-01

    Background & objectives: Multidrug-resistance of methicillin-resistant Staphylococcus aureus (MRSA) is a serious therapeutical problem. Chalcones belong to a group of naturally occurring flavonoids, usually found in various plant species, and have potent antibacterial, antiviral and antifungal activities. The goal of this study was to evaluate the antibacterial effect of three newly-synthesized chalcones against clinical isolates of MRSA, and their synergism with β-lactam and non- β-lactam antibiotics. Methods: Antimicrobial activity of the three newly-synthesized chalcones was tested against 19 clinical isolates of MRSA and a laboratory control strain of MRSA (ATCC 43300). The synergism with β-lactams: cefotaxime (CFX), ceftriaxone (CTX), and non-β-lactam antibiotics: ciprofloxacin (CIP), gentamicin (GEN) and trimethoprim/sulphamethoxazole (TMP-SMX) was investigated by checkerboard method. Results: All evaluated compounds showed significant anti-MRSA activity with MIC values from 25-200 μg/ml. Observed synergism with antibiotics demonstrated that chalcones significantly enhanced the efficacy of CIP, GEN and TMP-SMX. Interpretation & conclusions: Our study demonstrated that three newly-synthesized chalcones exhibited significant anti-MRSA effect and synergism with non-β-lactam antibiotics. The most effective compound was 1,3-Bis-(2-hydroxy-phenyl)-propenone. Our results provide useful information for future research of possible application of chalcones in combination with conventional anti-MRSA therapy as promising new antimicrobial agents. PMID:25222788

  14. 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.

  15. [Recent progress and challenges in investigator-driven clinical development of novel drugs and medical devices at the University of Tokyo Hospital].

    PubMed

    Arakawa, Yoshihiro

    2013-01-01

    At the University of Tokyo Hospital, investigator-driven clinical development of novel drugs and medical devices is mainly supported by the Translational Research Center and Clinical Research Support Center. The former supports non-clinical research and the preparation of test materials and the latter supports clinical trials. The Clinical Research Support Center was established in 2010 by the reorganization of the former Clinical Research Center, which was established in 2001. The center adopted International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) as a standard guideline for clinical trials and prepared standard operation procedures and templates for protocols and informed consent documents in 2001 and, thereafter, provided consultation services to researchers for protocol development. In 2010, the service was extended to project management, data management and monitoring to support the credibility of clinical trials. In 2011, The University of Tokyo Hospital was selected by the government as a base for the early and exploratory clinical development of drugs in the fields of psychological and neurological diseases. For this purpose, a phase 1 unit for early phase clinical pharmacology trials is now being built. The center provides training courses for clinical research coordinators and hold seminars for clinical researchers; however, the biggest challenge remains the education and training of medical students who will lead clinical trials in the future.

  16. Investigation of antiaromatase activity using hepatic microsomes of Nile tilapia (Oreochromis niloticus).

    PubMed

    Sassa-Deepaeng, Tanongsak; Chaisri, Wasana; Pikulkaew, Surachai; Okonogi, Siriporn

    2017-03-19

    Microsomal aromatase enzymes of humans and rats have been used in antiaromatase assays, but enzyme activity is species-specific. The current study extracted hepatic microsomes of Nile tilapia (Oreochromis niloticus) to investigate and compare the antiaromatase activity of chrysin, quercetin, and quercitrin. This activity was evaluated using a dibenzylfluorescein (DBF) assay. Results revealed that the age and body weight of Nile tilapia affected the yield of extracted microsomes. Extraction of hepatic microsomes of Nile tilapia was most effective when using a reaction medium with a pH of 8.0. A DBF assay using Nile tilapia microsomes revealed significant differences in levels of antiaromatase activity for chrysin, quercetin, and quercitrin. Chrysin was the most potent aromatase inhibitor, with an IC50 of 0.25 mg/mL. In addition, chrysin is an aromatase inhibitor that also inhibits the proliferation of cancer cells. Hepatic microsomes of Nile tilapia can be used to investigate and compare the antiaromatase activity of different compounds.

  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. Investigation of platelet aggregation inhibitory activity by phenyl amides and esters of piperidinecarboxylic acids.

    PubMed

    de Candia, Modesto; Summo, Luciana; Carrieri, Antonio; Altomare, Cosimo; Nardecchia, Adele; Cellamare, Saverio; Carotti, Angelo

    2003-04-03

    A series of anilides and phenyl esters of piperidine-3-carboxylic acid (nipecotic acid) were synthesized and tested for the ability to inhibit aggregation of human platelet rich-plasma triggered by adenosine 5'-diphosphate (ADP) and adrenaline. As a rule, amides were about two times more active than the corresponding esters, and derivatives bearing substituents at the para position of the phenyl ring were significantly more active than the meta-substituted ones. Among the tested compounds, 4-hexyloxyanilide of nipecotic acid (18a) was found to be the most active one, its IC(50) value being close to that of the most active bis-3-carbamoylpiperidines reported in literature (ca. 40 micro M) and aspirin (ca. 60 microM) in ADP- and adrenaline-induced aggregation, respectively. Compared with the isomeric 4-hexyloxyanilides of piperidine-2-carboxylic (pipecolinic) and piperidine-4-carboxylic (isonipecotic) acids, compound 18a showed higher activity, and a Hansch-type quantitative structure-activity relationship (QSAR) study highlighted lipophilicity and increase in electron density of the phenyl ring as the properties which mainly increase the antiplatelet activity (r(2)=0.74, q(2)=0.64). The interaction of nipecotoyl anilides with phosphatidylinositol, a major component of the inner layer of the platelet membranes, was investigated by means of flexible docking calculation methods to give an account of a key event underlying their biological action.

  19. Physical activity and lung cancer risk in the European Prospective Investigation into Cancer and Nutrition Cohort.

    PubMed

    Steindorf, Karen; Friedenreich, Christine; Linseisen, Jakob; Rohrmann, Sabine; Rundle, Andrew; Veglia, Fabrizio; Vineis, Paolo; Johnsen, Nina Fønns; Tjønneland, Anne; Overvad, Kim; Raaschou-Nielsen, Ole; Clavel-Chapelon, Françoise; Boutron-Ruault, Marie-Christine; Schulz, Mandy; Boeing, Heiner; Trichopoulou, Antonia; Kalapothaki, Victoria; Koliva, Maria; Krogh, Vittorio; Palli, Domenico; Tumino, Rosario; Panico, Salvatore; Monninkhof, Evelyn; Peeters, Petra H; Boshuizen, Hendriek C; Bueno-de-Mesquita, H Bas; Chirlaque, Maria-Dolores; Agudo, Antonio; Larrañaga, Nerea; Quirós, José R; Martínez, Carmen; Barricarte, Aurelio; Janzon, Lars; Berglund, Göran; Bingham, Sheila; Khaw, Kay-Tee; Key, Timothy J; Norat, Teresa; Jenab, Mazda; Cust, Anne; Riboli, Elio

    2006-11-15

    Research conducted predominantly in male populations on physical activity and lung cancer has yielded inconsistent results. We examined this relationship among 416,277 men and women from the European Prospective Investigation into Cancer and Nutrition (EPIC). Detailed information on recent recreational, household and occupational physical activity, smoking habits and diet was assessed at baseline between 1992 and 2000. Relative risks (RR) were estimated using Cox regression. During 6.3 years of follow-up we identified 607 men and 476 women with incident lung cancer. We did not observe an inverse association between recent occupational, recreational or household physical activity and lung cancer risk in either males or females. However, we found some reduction in lung cancer risk associated with sports in males (adjusted RR = 0.71; 95% confidence interval 0.50-0.98; highest tertile vs. inactive group), cycling (RR = 0.73; 0.54-0.99) in females and non-occupational vigorous physical activity. For occupational physical activity, lung cancer risk was increased for unemployed men (adjusted RR = 1.57; 1.20-2.05) and men with standing occupations (RR = 1.35; 1.02-1.79) compared with sitting professions. There was no evidence of heterogeneity of physical activity associations across countries, or across any of the considered cofactors. For some histologic subtypes suggestive sex-specific reductions, limited by subgroup sizes, were observed, especially with vigorous physical activity. In total, our study shows no consistent protective associations of physical activity with lung cancer risk. It can be assumed that the elevated risks found for occupational physical activity are not produced mechanistically by physical activity itself but rather reflect exposure to occupation-related lung cancer risk factors.

  20. Phytochemical investigation of sesquiterpenes from the fruits of Schisandra chinensis and their cytotoxic activity.

    PubMed

    Venkanna, A; Siva, B; Poornima, B; Vadaparthi, P R Rao; Prasad, K Rajendra; Reddy, K Ashok; Reddy, G Bhanu Prakash; Babu, K Suresh

    2014-06-01

    Phytochemical investigation of ethanolic extract from the fruits of Schisandra chinensis led to the isolation of four new sesquiterpenes (1-4); their structures were determined by a combination of NMR (1D and 2D) and MS spectroscopic techniques. In addition, all these isolates were screened for their cytotoxic activities against MCF-7, Caco-2, Hela, Lncap, Hep G2 and MDA-MB231 cancer cell lines. Results indicated that compounds 2 and 3 displayed potent cytotoxic activity against Caco2 cell lines with IC50 values of 17.10 μg/mM and 16.46 μg/mM, respectively.

  1. Numerical investigation of oscillatory multiphase flow in porous medium with chemically active skeleton

    NASA Astrophysics Data System (ADS)

    Konyukhov, A. V.; Zavialov, I. N.

    2016-11-01

    Self-oscillating mode of reaction front propagation in multiphase flow in the porous medium with chemically active skeleton is investigated numerically. The considered flow represents an immiscible displacement process, such that the displacing fluid and the skeleton of the porous medium have chemically active components which react with production of gaseous phase. The calculations have demonstrated strong influence of the reaction kinetics on stability of the reactive flow. The presence of a time delay between the change of concentration of the reactants and the change of the reaction rate is shown to stimulate transition of the reaction front propagation to the oscillatory mode.

  2. Barbiturate bearing aroylhydrazine derivatives: Synthesis, NMR investigations, single crystal X-ray studies and biological activity

    NASA Astrophysics Data System (ADS)

    Giziroglu, Emrah; Sarikurkcu, Cengiz; Aygün, Muhittin; Basbulbul, Gamze; Soyleyici, H. Can; Firinci, Erkan; Kirkan, Bulent; Alkis, Ayse; Saylica, Tayfur; Biyik, Halil

    2016-03-01

    A series of barbituric acid aroylhydrazine derivatives have been prepared from their corresponding 1,3-dimethyl-5-acetyl barbituric acid and aroylhydrazines. All compounds have been fully characterized by using FT-IR, multinuclear NMR (1H, 13C) and Mass (MS) spectrometry. We also describe the X-ray crystal structure of 3a, which crystallizes in the monoclinic P21/n space group. The crystal structure is stabilized with infinite linear chains of dimeric units. Furthermore, all compounds were investigated for their tyrosinase inhibition, antioxidative and antimicrobial activies. The results from biological activity assays have shown that all of compounds have excellent antioxidant, significant tyrosinase inhibition and moderate antimicrobial activity.

  3. An investigation of the mimetic enzyme activity of two-dimensional Pd-based nanostructures

    NASA Astrophysics Data System (ADS)

    Wei, Jingping; Chen, Xiaolan; Shi, Saige; Mo, Shiguang; Zheng, Nanfeng

    2015-11-01

    In this work, we investigated the mimetic enzyme activity of two-dimensional (2D) Pd-based nanostructures (e.g. Pd nanosheets, Pd@Au and Pd@Pt nanoplates) and found that they possess intrinsic peroxidase-, oxidase- and catalase-like activities. These nanostructures were able to activate hydrogen peroxide or dissolved oxygen for catalyzing the oxidation of organic substrates, and decompose hydrogen peroxide to generate oxygen. More systematic investigations revealed that the peroxidase-like activities of these Pd-based nanomaterials were highly structure- and composition-dependent. Among them, Pd@Pt nanoplates displayed the highest peroxidase-like activity. Based on these findings, Pd-based nanostructures were applied for the colorimetric detection of H2O2 and glucose, and also the electro-catalytic reduction of H2O2. This work offers a promising prospect for the application of 2D noble metal nanostructures in biocatalysis.In this work, we investigated the mimetic enzyme activity of two-dimensional (2D) Pd-based nanostructures (e.g. Pd nanosheets, Pd@Au and Pd@Pt nanoplates) and found that they possess intrinsic peroxidase-, oxidase- and catalase-like activities. These nanostructures were able to activate hydrogen peroxide or dissolved oxygen for catalyzing the oxidation of organic substrates, and decompose hydrogen peroxide to generate oxygen. More systematic investigations revealed that the peroxidase-like activities of these Pd-based nanomaterials were highly structure- and composition-dependent. Among them, Pd@Pt nanoplates displayed the highest peroxidase-like activity. Based on these findings, Pd-based nanostructures were applied for the colorimetric detection of H2O2 and glucose, and also the electro-catalytic reduction of H2O2. This work offers a promising prospect for the application of 2D noble metal nanostructures in biocatalysis. Electronic supplementary information (ESI) available: TEM images, EDX and dispersion stability of Pd-based nanomaterials

  4. 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.

  5. Clinical development of combination strategies in immunotherapy: are we ready for more than one investigational product in an early clinical trial?

    PubMed

    Perez-Gracia, Jose L; Berraondo, Pedro; Martinez-Forero, Ivan; Alfaro, Carlos; Suarez, Natalia; Gurpide, Alfonso; Sangro, Bruno; Hervas-Stubbs, Sandra; Ochoa, Carmen; Melero, Jose A; Melero, Ignacio

    2009-09-01

    Stimulating the innate and adaptive immunity against cancer necessitates the tricking of a system evolved to fight microbial pathogens and directing its activity towards transformed self-tissue. Efficacious interventions to start and sustain the response will probably require a number of agents to tamper simultaneously or sequentially with several immune mechanisms. Although master switches controlling various functions may exist, the goal of a curative immune response will probably demand the combined actions of several therapeutic components. Synergy occurs when drugs interact in ways that enhance or magnify one or more effects or side effects. In cancer immunotherapy, two agents that have minor or no therapeutic effects as single agents can be powerful when combined. Mouse experimentation provides multiple examples of synergistic combinations. Elements to be combined include chiefly: tumor vaccines, adoptive T-cell therapies, cytokines, costimulatory molecules, molecular deactivation of immunosuppressive or tolerogenic pathways and immunostimulatory monoclonal antibodies. These novel therapies, even as single agents, are extremely complex products to be developed owing to the associated biomolecules, cell therapies or gene therapies. At present, drug-development programs are run individually for each immunotherapeutic agent and combinations are considered only at a later stage in clinical development, even in the absence of formal compulsory regulations to prevent clinical trials with combinations. As a result, instead of the search for maximal efficacy, ease of combination with standard treatments, intellectual property management, regulations and business-based decisions often guide the way. Even though the maximal effort must be made in order to prevent adverse effects in patients, it seems reasonable that combination pilot trials should be performed at an early stage, following safe completion of Phase I trials. These trials should be performed based on

  6. Investigation of osteogenic activity of primary rabbit periosteal cells stimulated by multi-axial tensile strain.

    PubMed

    Chiu, Chih-Hao; Liu, Jun-Liang; Chang, Chih-Hsuan; Lei, Kin Fong; Chen, Alvin Chao-Yu

    2017-03-01

    Periosteum-derived cells was indicated to respond to mechanical force and have stem cell potential capable of differentiating into multiple tissue. Investigation of osteogenic activity under mechanical stimulation is important to understand the therapeutic conditions of fracture healing. In this work, a cell culture platform was developed for respectively providing isotropic and anisotropic axial strain. Primary rabbit periosteal cells were isolated and cultured in the chamber. Multi-axial tensile strain was received and osteogenic activity was investigated by mRNA expressions of CBFA1 and OPN. The highest mRNA expression was found in moderate strain (5-8%) under anisotropic axial strain. These results provided important foundation for further in vivo studies and development of tailor-made stretching rehabilitation equipment.

  7. [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.

  8. Assessment of rheumatoid activity based on clinical features and blood and synovial fluid analysis.

    PubMed Central

    Farr, M; Kendall, M J; Young, D W; Meynell, M J; Hawkins, C F

    1976-01-01

    Joint inflammation in rheumatoid arthritis has been assessed, and the most useful guides to disease activity were determined by analysis of synovial fluid and blood together with the history of joint disability. The patient's own evaluation of the amount of pain suffered was the most useful clinical assessment. Differential cell count and glucose estimations were the most helpful guides in the synovial fluid, while C-reactive protein in the serum most accurately reflected disease activity. The effects of systemic steroids on these indices were studied, and the differences between seronegative and seropositive patients noted. PMID:942273

  9. Experimental investigation of different active noise control concepts applied to a passenger car equipped with an active windshield

    NASA Astrophysics Data System (ADS)

    Misol, M.; Algermissen, S.; Monner, H. P.

    2012-05-01

    The main purpose of this work is the implementation and experimental investigation of different active structural acoustic control (ASAC) concepts for the reduction of interior noise in an automobile passenger compartment. For the control experiments, a medium-class test car was used, which had been equipped with an active windshield. The active windshield consists of the serial-production laminated glass pane augmented with piezoceramic patch-transducers applied to the blackened rim of the windshield. A multi-reference test provided measurement data for the identification of a local discrete-time state-space model (SSM). The subsequent acquisition of frequency response functions (FRF) by way of using the same actuators but measuring on a much finer grid provided the database for the formulation of a least-squares problem to derive a global system model. Based on the local and global discrete-time SSMs, different controllers were designed and experimentally realized. The comparison of the vibration levels in open- and closed-loop showed a global reduction of 5-7 dB in the acoustically relevant frequency band containing the second and third structural resonance of the windshield system. The occurrence of complex operational deflection shapes (ODS) was identified as the main limitation concerning the disturbance rejection of the active system. The acoustic performance of the ASAC system is reflected in a reduction up to 15 dB in sound pressure level (SPL).

  10. Investigation of the atmospheric particulates deposited on leaves using instrumental neutron activation analysis

    NASA Astrophysics Data System (ADS)

    Cercasov, V.

    A method for the separation of surface contamination on plant leaves by plastic film stripping was applied. The particulate matter embedded in the film was analysed by neutron activation. The investigation was directed especially towards the determination of the trace element content of the suitable plastic matrices and of the influence of solvents. The practicability of this method is demonstrated by analysing films stripped from plant leaves with different degrees of pollution.

  11. 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.

  12. Clinical criteria for the assessment of disease activity in Graves' ophthalmopathy: a novel approach.

    PubMed Central

    Mourits, M P; Koornneef, L; Wiersinga, W M; Prummel, M F; Berghout, A; van der Gaag, R

    1989-01-01

    Patients with serious inflammatory Graves' ophthalmopathy should be treated with anti-inflammatory drugs or radiotherapy to prevent complications like fibrosis, while those with non-inflammatory ophthalmopathy may be treated by surgery immediately. It is often difficult, however, to distinguish inflammatory from non-inflammatory Graves' disease. We therefore present a simple clinical classification here to differentiate between these two conditions. This classification is based on the classical signs of inflammation--pain, redness, swelling, and impaired function. After two consecutive clinical examinations an 'activity score' can be determined, ranging from 0 to 10 points. In a retrospective study testing the efficacy of this classification we found that patients with an activity score of 3 or more at the beginning of therapy responded well to anti-inflammatory drugs, while those with a lower activity score mostly did not. Comparing the pretreatment activity score with the degree of enlargement of the extraocular muscles on the CT scan, we found a significant correlation between these two parameters: the higher the activity score, the more the enlargement of the muscles. We conclude that this classification facilitates the proper selection of patients for treatment. Images PMID:2765444

  13. Clinical regressions and broad immune activation following combination therapy targeting human NKT cells in myeloma

    PubMed Central

    Richter, Joshua; Neparidze, Natalia; Zhang, Lin; Nair, Shiny; Monesmith, Tamara; Sundaram, Ranjini; Miesowicz, Fred; Dhodapkar, Kavita M.

    2013-01-01

    Natural killer T (iNKT) cells can help mediate immune surveillance against tumors in mice. Prior studies targeting human iNKT cells were limited to therapy of advanced cancer and led to only modest activation of innate immunity. Clinical myeloma is preceded by an asymptomatic precursor phase. Lenalidomide was shown to mediate antigen-specific costimulation of human iNKT cells. We treated 6 patients with asymptomatic myeloma with 3 cycles of combination of α-galactosylceramide–loaded monocyte-derived dendritic cells and low-dose lenalidomide. Therapy was well tolerated and led to reduction in tumor-associated monoclonal immunoglobulin in 3 of 4 patients with measurable disease. Combination therapy led to activation-induced decline in measurable iNKT cells and activation of NK cells with an increase in NKG2D and CD56 expression. Treatment also led to activation of monocytes with an increase in CD16 expression. Each cycle of therapy was associated with induction of eosinophilia as well as an increase in serum soluble IL2 receptor. Clinical responses correlated with pre-existing or treatment-induced antitumor T-cell immunity. These data demonstrate synergistic activation of several innate immune cells by this combination and the capacity to mediate tumor regression. Combination therapies targeting iNKT cells may be of benefit toward prevention of cancer in humans (trial registered at clinicaltrials.gov: NCT00698776). PMID:23100308

  14. Clinical regressions and broad immune activation following combination therapy targeting human NKT cells in myeloma.

    PubMed

    Richter, Joshua; Neparidze, Natalia; Zhang, Lin; Nair, Shiny; Monesmith, Tamara; Sundaram, Ranjini; Miesowicz, Fred; Dhodapkar, Kavita M; Dhodapkar, Madhav V

    2013-01-17

    Natural killer T (iNKT) cells can help mediate immune surveillance against tumors in mice. Prior studies targeting human iNKT cells were limited to therapy of advanced cancer and led to only modest activation of innate immunity. Clinical myeloma is preceded by an asymptomatic precursor phase. Lenalidomide was shown to mediate antigen-specific costimulation of human iNKT cells. We treated 6 patients with asymptomatic myeloma with 3 cycles of combination of α-galactosylceramide-loaded monocyte-derived dendritic cells and low-dose lenalidomide. Therapy was well tolerated and led to reduction in tumor-associated monoclonal immunoglobulin in 3 of 4 patients with measurable disease. Combination therapy led to activation-induced decline in measurable iNKT cells and activation of NK cells with an increase in NKG2D and CD56 expression. Treatment also led to activation of monocytes with an increase in CD16 expression. Each cycle of therapy was associated with induction of eosinophilia as well as an increase in serum soluble IL2 receptor. Clinical responses correlated with pre-existing or treatment-induced antitumor T-cell immunity. These data demonstrate synergistic activation of several innate immune cells by this combination and the capacity to mediate tumor regression. Combination therapies targeting iNKT cells may be of benefit toward prevention of cancer in humans.

  15. 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

  16. Acrosin activity in turkey spermatozoa: assay by clinical method and effect of zinc and benzamidine on the activity.

    PubMed

    Glogowski, J; Jankowski, J; Faruga, A; Ottobre, J S; Ciereszko, A

    2001-09-15

    We optimized a clinical assay developed for measuring total acrosin activity for mammalian and fish semen for use in turkey spermatozoa. The main modifications included dilution of semen to a final concentration of 25 to 1000 x 10(3) spermatozoa, an increase of Triton X-100 concentration to 0.05% and 1 hr preincubation without substrate, Acrosin activity in turkey spermatozoa was much higher than in human spermatozoa (about 100-times) but similar to that of boar sperm. To optimize this assay for turkey spermatozoa, it was necessary to use higher Triton X-100 concentrations in the reaction mixture. There was a better catalytic efficiency at higher temperatures and a special requirement for a preincubation period for proacrosin activation. We observed high inhibition of acrosin activity by zinc added during preincubation (90% at 0.01 mM of zinc chloride). Benzamidine also inhibited turkey acrosin, and the extent of inhibition was similar for the incubation or preincubation period. When zinc ions were added during incubation, this inhibition was lower (24%). The results suggest that zinc influences proacrosin activation of turkey spermatozoa. This influence may be important for successful long-term storage of spermatozoa in the hen's oviduct.

  17. Investigations of the synergistic enhancement of antimicrobial activity in mixtures of magainin 2 and PGLa.

    PubMed

    Glattard, Elise; Salnikov, Evgeniy S; Aisenbrey, Christopher; Bechinger, Burkhard

    2016-03-01

    Magainins are antimicrobial peptides isolated from the African clawed frog Xenopus laevis. They interact with bacterial membranes where they cause channel formation and membrane disruption. When added as a cocktail magainin 2 and PGLa are considerably more efficient when compared to the corresponding amounts of individual components. In order to investigate this synergistic interaction of PGLa and magainin a number of magainin variants have been prepared and investigated in biological and biophysical assays. In particular we report on the antimicrobial activities and solid-state NMR investigations of magainins that have been extended by a carboxyterminal GGC tripeptide to form covalently linked dimers. Notably, when the formation of the covalent linkage is prevented by exchanging the cystein by serine or alanine no loss in efficiency was observed indicating that the covalent interaction is not necessary for synergistic interaction. In a next step peptides labelled with (15)N and (2)H were reconstituted into oriented membranes and their topology studied by solid-state NMR spectroscopy. The tendency of some of these peptides to adopt membrane-spanning alignments does not correlate with their synergistic activities in antimicrobial assays. In contrast, the stable alignment of PGLa parallel to the surface of membranes made of Escherichia coli lipid extracts is strongly suggestive that the peptides develop synergistic activities when in an in-planar configuration. Notably, the phospholipid head groups of these samples show a high degree of disturbance suggesting that the synergistic interactions between the magainin peptides could be mediated through the lipid phase.

  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.

  19. An investigation of antioxidant and anti-inflammatory activities from blood components of Crocodile (Crocodylus siamensis).

    PubMed

    Phosri, Santi; Mahakunakorn, Pramote; Lueangsakulthai, Jiraporn; Jangpromma, Nisachon; Swatsitang, Prasan; Daduang, Sakda; Dhiravisit, Apisak; Thammasirirak, Sompong

    2014-10-01

    Antioxidant and anti-inflammatory activities were found from Crocodylus siamensis (C. siamensis) blood. The 2,2'-azino-bis(3-ethylbenzthiazoline-6-sulfonic acid) (ABTS) radical scavenging, nitric oxide scavenging, hydroxyl radical scavenging and linoleic peroxidation assays were used to investigate the antioxidant activities of the crocodile blood. Results show that crocodile blood components had antioxidant activity, especially hemoglobin (40.58 % nitric oxide radical inhibition), crude leukocyte extract (78 % linoleic peroxidation inhibition) and plasma (57.27 % hydroxyl radical inhibition). Additionally, the anti-inflammatory activity of the crocodile blood was studied using murine macrophage (RAW 264.7) as a model. The results show that hemoglobin, crude leukocyte extract and plasma were not toxic to RAW 264.7 cells. Also they showed anti-inflammatory activity by reduced nitric oxide (NO) and interleukin 6 (IL-6) productions from lipopolysaccharide (LPS)-stimulated cells. The NO inhibition percentages of hemoglobin, crude leukocyte extract and plasma were 31.9, 48.24 and 44.27 %, respectively. However, only crude leukocyte extract could inhibit IL-6 production. So, the results of this research directly indicate that hemoglobin, crude leukocyte extract and plasma of C. siamensis blood provide both antioxidant and anti-inflammatory activities, which could be used as a supplementary agent in pharmaceutical products.

  20. NCI will no longer support investigator-initiated phase III clinical trials through R01 and P01s grants | Division of Cancer Prevention

    Cancer.gov

    The NCI has traditionally provided support for all phases of clinical trials and interventions via grants and cooperative agreements (including the R03, R21, R01, P01, U01, U10, and UM1 mechanisms). Historically, the majority of early phase trials have been conducted under R03, R21, R01, P01, U01, and UM1 activity codes, whereas most Phase III clinical trials have been conducted under the U10 activity code, with a limited number of Phase III clinical trials performed under the R01, P01, and U01 activity codes... |